CancerVax Corporation
Filed pursuant to Rule 424(b)(3)
Registration Number 333-131817
ANNUAL
MEETING OF STOCKHOLDERS
MERGER PROPOSED YOUR VOTE IS VERY
IMPORTANT
The boards of directors of CancerVax Corporation, or CancerVax,
and Micromet AG, or Micromet, have approved a merger combining
CancerVax and Micromet. Subject to CancerVax stockholder
approval of the merger, and upon the terms and subject to the
conditions set forth in the merger agreement, CancerVax has
agreed to issue, and Micromet securityholders will receive,
shares of CancerVax common stock such that Micromet
securityholders will own approximately 67.5% of the combined
company on a fully-diluted basis, and CancerVax securityholders
will own approximately 32.5% of the combined company on a
fully-diluted basis.
The merger agreement provides that Carlsbad Acquisition
Corporation, or Merger Sub, which is a wholly-owned subsidiary
of CancerVax, will merge with and into Micromet, Inc., or
Micromet Parent, with Micromet Parent becoming a wholly-owned
subsidiary of CancerVax and the surviving corporation of the
merger. The merger agreement also provides that immediately
prior to the merger, the holders of equity interests of Micromet
will exchange their interests for shares of common stock of
Micromet Parent in an exchange transaction, which will result in
Micromet becoming a wholly-owned subsidiary of Micromet Parent.
Accordingly, as a result of the merger, Micromet Parent will
survive as a wholly-owned direct subsidiary of CancerVax and, in
turn, Micromet will be a wholly-owned indirect subsidiary of
CancerVax. Following the merger, CancerVax will change its
corporate name to Micromet, Inc. as required by the merger
agreement.
Stockholders of CancerVax will be asked, at CancerVaxs
annual meeting of stockholders, among other proposals, to
approve the issuance of shares of CancerVax common stock to the
stockholders of Micromet Parent in the merger, and the resulting
change of control of CancerVax.
The date, time and place of the CancerVax annual meeting is as
follows:
May 3, 2006
9:00 a.m., local time
CancerVax Corporation
2110 Rutherford Road
Carlsbad, CA 92008
This proxy statement/prospectus provides you with information
about CancerVax, Micromet and the proposed merger. All
information required to be distributed in the 2005 annual report
to CancerVax stockholders in connection with the CancerVax
annual meeting is included in this proxy statement/prospectus.
No separate annual report will be distributed to CancerVax
stockholders prior to the CancerVax annual meeting. You may
obtain other information about CancerVax from documents filed
with the Securities and Exchange Commission. We encourage you to
carefully read the entire proxy statement/prospectus.
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David F. Hale
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Christian Itin, Ph.D.
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President and Chief Executive
Officer
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Chief Executive Officer
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CancerVax Corporation
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Micromet AG
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FOR A DISCUSSION OF SIGNIFICANT MATTERS THAT SHOULD BE
CONSIDERED BEFORE VOTING AT THE ANNUAL MEETING, SEE RISK
FACTORS BEGINNING ON PAGE 31.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES REGULATORS HAVE APPROVED OR DISAPPROVED THIS
TRANSACTION OR THE CANCERVAX COMMON STOCK TO BE ISSUED IN THE
MERGER OR DETERMINED WHETHER THIS PROXY STATEMENT/PROSPECTUS IS
ACCURATE OR ADEQUATE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
This proxy statement/prospectus is dated March 31, 2006,
and is first being mailed to stockholders of CancerVax and
Micromet on or about April 4, 2006.
THIS PROXY STATEMENT/PROSPECTUS IS NOT AN OFFER TO SELL THESE
SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT
PERMITTED.
CANCERVAX
CORPORATION
2110 Rutherford Road
Carlsbad, CA 92008
(760) 494-4200
NOTICE OF ANNUAL MEETING OF
STOCKHOLDERS
TO BE
HELD ON MAY 3, 2006
To the Stockholders of CancerVax Corporation:
On behalf of the board of directors of CancerVax Corporation, a
Delaware corporation, we are pleased to deliver this proxy
statement/prospectus for the proposed merger combining CancerVax
and Micromet AG, a corporation organized under the laws of
Germany. An annual meeting of stockholders of CancerVax will be
held on May 3, 2006 at 9:00 a.m., local time, at
CancerVax Corporation, 2110 Rutherford Road, Carlsbad,
California, for the following purposes:
1. To consider and vote upon a proposal to approve the
issuance of CancerVax common stock pursuant to the Agreement and
Plan of Merger and Reorganization, dated as of January 6,
2006 and amended as of March 17, 2006, by and among
CancerVax, Carlsbad Acquisition Corporation, a wholly-owned
subsidiary of CancerVax, Micromet, Inc., a Delaware corporation,
and Micromet AG, a corporation organized under the laws of
Germany, and the resulting change of control of CancerVax, as
described in the attached proxy statement/prospectus.
2. To approve an amendment to CancerVaxs amended and
restated certificate of incorporation to increase the number of
authorized shares of common stock from 75,000,000 shares to
150,000,000 shares, which represents an additional
75,000,000 shares, as described in the attached proxy
statement/prospectus.
3. To authorize the board of directors of CancerVax to
amend in its discretion CancerVaxs amended and restated
certificate of incorporation to effect a reverse stock split of
the CancerVax common stock, at a ratio within the range of 1:2
to 1:4, and at such ratio to be determined by the board of
directors of CancerVax, as described in the attached proxy
statement/prospectus.
4. To approve an amendment to CancerVaxs amended and
restated certificate of incorporation to change the name of
CancerVax Corporation to Micromet, Inc.
5. To elect three directors for a three-year term to expire
at the 2009 annual meeting of stockholders; provided, however,
that, if the merger is completed, CancerVaxs board of
directors will consist of the nine people identified in the
accompanying proxy statement/prospectus.
6. To ratify the selection of Ernst & Young LLP as
CancerVaxs independent registered public accounting firm
for the fiscal year ending December 31, 2006.
7. To consider and vote upon an adjournment of the annual
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
Proposal Nos. 1 through 6.
8. To transact such other business as may properly come
before the annual meeting or any adjournment or postponement
thereof.
The board of directors of CancerVax has fixed March 27,
2006 as the record date for the determination of stockholders
entitled to notice of, and to vote at, the annual meeting and
any adjournment or postponement thereof. Only holders of record
of shares of CancerVax common stock at the close of business on
the record date are entitled to notice of, and to vote at, the
annual meeting. At the close of business on the record date,
CancerVax had 27,955,139 shares of common stock outstanding
and entitled to vote.
Your vote is important. The affirmative vote of the holders
of a majority of the votes cast in person or by proxy at the
CancerVax annual meeting is required for approval of
Proposal Nos. 1, 6 and 7 above. The affirmative vote of
holders of a majority of the outstanding common stock is
required for approval of Proposal Nos. 2, 3 and 4. The
affirmative vote of holders of a plurality of the votes cast in
person or by proxy is required to elect the directors in
Proposal No. 5. Even if you plan to attend the annual
meeting in person, we request that you sign and return the
enclosed proxy and thus ensure that your shares will be
represented at
the annual meeting if you are unable to attend. If you sign,
date and mail your proxy card without indicating how you wish to
vote, your proxy will be counted as a vote in favor of
Proposal Nos. 1 through 7. If you fail to return your proxy
card, the effect will be that your shares will not be counted
for purposes of determining whether a quorum is present at the
annual meeting and will count as a vote against
Proposal Nos. 2, 3 and 4. If you do attend the
CancerVax annual meeting and wish to vote in person, you may
withdraw your proxy and vote in person.
By Order of the Board of Directors,
David F. Hale
President and Chief Executive Officer
Carlsbad, California
March 31, 2006
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO,
AND IN THE BEST INTERESTS OF, CANCERVAX AND ITS STOCKHOLDERS AND
HAS APPROVED EACH SUCH PROPOSAL. THE CANCERVAX BOARD OF
DIRECTORS RECOMMENDS THAT CANCERVAX STOCKHOLDERS VOTE
FOR EACH SUCH PROPOSAL.
TABLE OF
CONTENTS
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7
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F-1
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F-2
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MICROMET
AG AUDITED FINANCIAL STATEMENTS
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F-26
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ANNEXES:
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iii
QUESTIONS
AND ANSWERS ABOUT THE MERGER
Except where specifically noted, the following information
and all other information contained in this proxy
statement/prospectus does not give effect to the proposed
reverse stock split described in CancerVaxs
Proposal No. 3.
The following section provides answers to frequently asked
questions about the merger and the effect of the merger on
holders of CancerVax common stock and Micromet capital stock.
This section, however, only provides summary information.
CancerVax and Micromet urge you to read carefully the remainder
of this proxy statement/prospectus, including the annexes to
this proxy statement/prospectus, because the information in this
section does not provide all the information that might be
important to you regarding the merger and the other matters
being considered at the annual meeting.
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A: |
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CancerVax and Micromet have entered into an Agreement and Plan
of Merger and Reorganization, dated as of January 6, 2006
and amended as of March 17, 2006, which is referred to in
this proxy statement/prospectus as the merger agreement, that
contains the terms and conditions of the proposed merger of
CancerVax and Micromet. Subject to CancerVax stockholder
approval of the merger, and upon the terms and subject to the
conditions set forth in the merger agreement, CancerVax has
agreed to issue, and Micromet stockholders will receive, shares
of CancerVax common stock such that Micromet shareholders,
option holders, warrant holders and note holders will own
approximately 67.5% of the combined company on a fully-diluted
basis, and CancerVax stockholders, option holders and warrant
holders will own approximately 32.5% of the combined company on
a fully-diluted basis. |
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The merger agreement provides that Carlsbad Acquisition
Corporation, or Merger Sub, which is a wholly-owned subsidiary
of CancerVax, will merge with and into Micromet, Inc., or
Micromet Parent, with Micromet Parent becoming a wholly-owned
subsidiary of CancerVax and the surviving corporation of the
merger. The merger agreement also provides that immediately
prior to the merger, the holders of equity interests of Micromet
will exchange their interests for shares of common stock of
Micromet Parent in an exchange transaction, which will result in
Micromet becoming a wholly-owned subsidiary of Micromet Parent.
Accordingly, as a result of the merger, Micromet Parent will
survive as a wholly-owned direct subsidiary of CancerVax and, in
turn, Micromet will be a wholly-owned indirect subsidiary of
CancerVax. Following the merger, CancerVax will change its
corporate name to Micromet, Inc. as required by the merger
agreement. |
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For a more complete description of the merger, please see the
section entitled The Merger Agreement on
page 93 of this proxy statement/prospectus. |
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Why are the two companies proposing to merge? |
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Micromet has significant scientific expertise and a promising
pipeline of novel, antibody-derived therapeutic product
candidates for the treatment of cancer and autoimmune and
inflammatory diseases. CancerVax has a U.S. infrastructure
that includes an experienced Chief Executive Officer who will
become Chairman of the combined company, unrestricted cash, a
Nasdaq listing, and selected ongoing product development
programs. The companies believe that together they will be
better able to achieve the goal of providing new medicines to
patients and returns for stockholders. For a discussion of our
reasons for the merger, we urge you to read the information
under Reasons for the Merger on page 72 of this
proxy statement/prospectus. |
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Why am I receiving this proxy statement/prospectus? |
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You are receiving this proxy statement/prospectus because you
have been identified as a securityholder of either CancerVax or
Micromet. If you are a stockholder of CancerVax, you are
entitled to vote at CancerVaxs annual meeting. This
document serves as both a proxy statement of CancerVax, used to
solicit proxies for the annual meeting, and as a prospectus of
CancerVax, used to offer shares of CancerVax common stock to
Micromet shareholders in exchange for shares of Micromet Parent
common stock pursuant to the terms of the merger agreement. This
document contains important information about the merger, the
shares of CancerVax common stock to be issued in the merger and
the annual meeting of CancerVax stockholders, and you should
read it carefully. |
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What is required to consummate the merger? |
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To consummate the merger, CancerVax stockholders must approve
(a) the issuance of shares of CancerVax common stock in the
merger, and the resulting change of control of CancerVax, which
require the affirmative vote of holders of a majority of the
votes cast in person or by proxy at the CancerVax annual
meeting, and (b) the amendments to CancerVaxs amended
and restated certificate of incorporation approving the increase
in CancerVaxs authorized common stock, a reverse stock
split and change of CancerVaxs name to Micromet,
Inc., which require the affirmative vote of holders of a
majority of CancerVaxs outstanding common stock.
Stockholder approval of the sole stockholder of Micromet Parent
has already been obtained. In addition to CancerVax obtaining
stockholder approval and CancerVax and Micromet obtaining
appropriate regulatory approvals, each of the other closing
conditions set forth in the merger agreement must be satisfied
or waived. For a more complete description of the closing
conditions under the merger agreement, we urge you to read the
section entitled The Merger
Agreement Conditions to the Merger on
page 106 of this proxy statement/prospectus. |
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What will Micromet shareholders receive in the merger? |
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As a result of the merger, Micromet shareholders, option
holders, warrant holders and note holders in the aggregate will
receive shares of CancerVax common stock, and options and
warrants to acquire shares of CancerVax common stock, equal to
approximately 67.5% of the fully-diluted shares of the combined
company. |
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For a more complete description of what Micromet shareholders
will receive in the merger, please see the sections entitled
Market Price and Dividend Data on page 21 and
The Merger Agreement Merger
Consideration; Manner and Basis of Converting Shares on
page 94. |
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Who will be the directors of the combined company following
the merger? |
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Following the merger, the board of directors of the combined
company will be as follows: |
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Name
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Current Affiliation
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David F. Hale (who will serve as
Chairman)
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President and Chief Executive
Officer of CancerVax
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Barclay Phillips
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Director of CancerVax, Managing
Director of Vector Fund Management
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Phillip Schneider
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Director of CancerVax
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Michael Carter
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Director of CancerVax, Member of
Supervisory Board of Micromet, Venture Partner at SV Life
Sciences Advisers LLP
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Christian Itin
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Chief Executive Officer of Micromet
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Jerry Benjamin
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Member of Supervisory Board of
Micromet, General Partner of Advent Venture Partners
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Otello Stampacchia
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Member of Supervisory Board of
Micromet, Chief Investment Adviser of the Omega Fund
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John Berriman
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Member of Supervisory Board of
Micromet
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There will be one additional member that is expected to be
appointed to the board of directors prior to the closing, which
individual will be designated by Micromet. |
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Who will be the executive officers of the combined company
immediately following the merger? |
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Immediately following the merger, the executive management team
of the combined company is expected to be composed primarily of
certain members of Micromets executive management team
prior to the merger and is contemplated to include the following
individuals: |
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Position in the
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Name
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Combined Company
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Current Position
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Christian Itin, Ph.D.
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President and Chief Executive
Officer
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Micromets Chief Executive
Officer
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Patrick A.
Baeuerle, Ph.D.
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Senior Vice President and Chief
Scientific Officer
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Micromets Chief Scientific
Officer
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Gregor
Mirow, M.D., M.B.A.
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Senior Vice President of Operations
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Micromets Chief Financial
and Chief Operating Officer
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Carsten Reinhardt,
M.D., Ph.D.
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Senior Vice President of Clinical
Development
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Micromets Senior Vice
President of Clinical Development
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William R. LaRue
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Senior Vice President, Chief
Financial Officer
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CancerVaxs Senior Vice
President, Chief Financial Officer
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The voluntary resignation of William LaRue will become effective
on June 1, 2006. Mr. LaRue has agreed to provide
consulting services to the combined company until
August 15, 2006, in order to assist with post-merger
integration activities, for compensation of $50,000.
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What are the material U.S. federal income tax consequences of
the merger to me? |
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The merger has been structured to qualify as a tax-free
reorganization within the meaning of Section 368(a) of the
Internal Revenue Code of 1986, as amended, and CancerVax and
Micromet have agreed to use their commercially reasonable
efforts in order for Micromet Parent to obtain the opinion of
its counsel, Cooley Godward LLP, regarding such qualification.
As a result of the mergers qualification as a
reorganization, Micromet Parent stockholders will not recognize
gain or loss for United States federal income tax purposes upon
the exchange of shares of Micromet Parent common stock for
shares of CancerVax common stock, except with respect to cash
received in lieu of fractional shares of CancerVax common stock. |
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Tax matters are very complicated, and the tax consequences of
the merger to a particular stockholder will depend in part on
such stockholders circumstances. Accordingly, we urge you
to consult your own tax advisor for a full understanding of the
tax consequences of the merger to you, including the
applicability and effect of federal, state, local and foreign
income and other tax laws. |
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For more information, please see the section entitled
Material U.S. Federal Income Tax Consequences on
page 90 of this proxy statement/prospectus. |
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As a CancerVax stockholder, how does CancerVaxs board
of directors recommend that I vote? |
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After careful consideration, CancerVaxs board of directors
recommends that CancerVax stockholders vote: |
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FOR Proposal No. 1 to approve
the issuance of shares of CancerVax common stock in the merger,
and the resulting change of control of CancerVax;
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FOR Proposal No. 2 to approve
an amendment to CancerVaxs amended and restated
certificate of incorporation to increase the number of
authorized shares of common stock from 75,000,000 shares to
150,000,000 shares, which represents an additional
75,000,000 shares;
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FOR Proposal No. 3 to
authorize the board of directors of CancerVax to amend in its
discretion CancerVaxs amended and restated certificate of
incorporation to effect a reverse stock split of the CancerVax
common stock, at a ratio within the range of 1:2 to 1:4, and at
such ratio to be determined by the board of directors of
CancerVax;
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FOR Proposal No. 4 to approve
an amendment to CancerVaxs amended and restated
certificate of incorporation to change the name of
CancerVax Corporation to Micromet, Inc.,
to be effective at the closing of the merger;
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FOR Proposal No. 5 to elect three
directors for a three-year term to expire at the
2009 annual meeting of stockholders; provided, however,
that if the merger is completed, CancerVaxs board of
directors will consist of the nine people identified in this
proxy statement/prospectus. The present board of directors of
CancerVax has nominated and recommends for election as director
the following persons:
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(1) David F. Hale
(2) Donald L. Morton, M.D.
(3) Michael G. Carter, M.B., Ch.B., F.R.C.P;
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FOR Proposal No. 6 to ratify
the selection of Ernst & Young LLP as CancerVaxs
independent registered public accounting firm for the fiscal
year ending December 31, 2006; and
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FOR Proposal No. 7 to adjourn
the annual meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of Proposal Nos. 1 through 6. |
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Q: |
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As a CancerVax stockholder, what risks should I consider in
deciding whether to vote in favor of the share issuance? |
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A: |
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You should carefully review the section of this proxy
statement/prospectus entitled Risk Factors beginning
on page 31, which sets forth certain risks and
uncertainties related to the merger, risks and uncertainties to
which the combined companys business will be subject, and
risks and uncertainties to which each of CancerVax and Micromet,
as an independent company, is subject. |
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Q: |
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When do you expect the merger to be consummated? |
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We anticipate that the merger will occur sometime soon after the
CancerVax annual meeting, but we cannot predict the exact
timing. For more information, please see the section entitled
The Merger Agreement Conditions to the
Merger on page 106 of this proxy statement/prospectus. |
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Q: |
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How will the merger affect stock options for Micromet common
stock? |
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A: |
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At the effective time of the merger, each outstanding stock
option to purchase Micromet Parent common stock not exercised
prior to the merger will be converted into an option to purchase
CancerVax common stock. After the merger, each Micromet Parent
option assumed by CancerVax may be exercised for a number of
shares of CancerVax common stock determined by the exchange
ratio contained in the merger agreement and described fully
herein. For more information, please see the section entitled
The Merger Agreement Merger
Consideration; Manner and Basis of Converting Shares on
page 94 of this proxy statement/prospectus. |
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Additionally, because the listing standards of the Nasdaq
National Market may require CancerVax to have, among other
things, a $5.00 per share minimum bid price upon the
closing of the merger, the holders of CancerVax common stock
will be asked to approve a reverse stock split of CancerVax
common stock. The reverse stock split will combine between
two (2) and four (4) of the outstanding shares of CancerVax
common stock into one (1) share of CancerVax common stock.
The reverse stock split will not change the number of authorized
shares of common stock or preferred stock, or the par value of
CancerVaxs common stock or preferred stock. For more
information, please see the section entitled CancerVax
Proposal No. 3 Authorization of the
CancerVax Board of Directors to Effect the Reverse Stock
Split on page 117 of this proxy statement/prospectus. |
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What do I need to do now? |
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We urge you to read this proxy statement/prospectus carefully,
including its annexes, and to consider how the merger affects
you. If you are a CancerVax stockholder, you may provide your
proxy instructions in three different ways. First, you can mail
your signed proxy card in the enclosed return envelope.
Alternatively, you can provide your proxy instructions via the
toll-free call center set up for this purpose at 1-866-540-5760.
Finally, you can provide your proxy instructions via the
Internet at |
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http://www.proxyvoting.com/cnvx. Please provide your proxy
instructions only once and as soon as possible so that your
shares can be voted at the annual meeting of CancerVax
stockholders. Micromet shareholders do not need to vote to
approve the merger, and the sole stockholder of Micromet Parent
has already consented to the merger, as more fully described
under Micromet, Inc. Stockholder Approval on page 68
of this proxy statement/prospectus. |
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What happens if I do not return a proxy card or otherwise
provide proxy instructions? |
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If you are a CancerVax stockholder, the failure to return your
proxy card or otherwise provide proxy instructions could be a
factor in establishing a quorum for the annual meeting of
CancerVax stockholders and will have the same effect as voting
against Proposals Nos. 2, 3 and 4. |
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If your shares of CancerVax common stock are registered directly
in your name with CancerVaxs transfer agent you are
considered, with respect to those shares, the stockholder of
record, and the proxy materials and proxy card are being sent
directly to you by CancerVax. If you are a CancerVax stockholder
of record as of March 27, 2006, you may attend the annual
meeting of CancerVax stockholders to be held on May 3, 2006
and vote your shares in person, rather than signing and
returning your proxy card or otherwise providing proxy
instructions. |
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If your shares of CancerVax common stock are held in a brokerage
account or by another nominee, you are considered the beneficial
owner of shares held in street name, and the proxy
materials are being forwarded to you together with a voting
instruction card. As the beneficial owner, you are also invited
to attend the annual meeting of CancerVax stockholders. Since a
beneficial owner is not the stockholder of record, you may not
vote these shares in person at the annual meeting unless you
obtain a legal proxy from the broker, trustee or
nominee that holds your shares, giving you the right to vote the
shares at the meeting. |
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If my CancerVax shares are held in street name by
my broker, will my broker vote my shares for me? |
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Your broker will not be able to vote your shares of CancerVax
common stock without instructions from you. You should instruct
your broker to vote your shares, following the procedure
provided by your broker. |
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May I change my vote after I have provided proxy
instructions? |
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Yes. You may change your vote at any time before your proxy is
voted at the annual meeting. You can do this in one of three
ways. First, you can send a written notice stating that you
would like to revoke your proxy. Second, you can submit new
proxy instructions either on a new proxy card, by telephone or
via the Internet. Third, you can attend the meeting and vote in
person. Your attendance alone will not revoke your proxy. If you
have instructed a broker to vote your shares of CancerVax common
stock, you must follow directions received from your broker to
change those instructions. |
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Should I send in my stock certificates now? |
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If you are a Micromet shareholder and exchange your shares into
shares of Micromet Parent, after the merger is completed,
CancerVax will send you written instructions for exchanging your
stock certificates for CancerVax stock certificates. You will
also receive instructions regarding how to receive cash in lieu
of any fractional shares. If Proposal No. 3 is
approved and effected, CancerVax stockholders will also exchange
their stock certificates and you will receive written
instructions from CancerVaxs transfer agent for exchanging
your shares of CancerVax common stock. |
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Am I entitled to appraisal rights? |
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Under Delaware law, Micromet shareholders and holders of
CancerVax common stock are not entitled to appraisal rights in
connection with the merger. The sole stockholder of Micromet
Parent has already consented to the merger and accordingly is
not entitled to assert appraisal rights. |
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Who is paying for this proxy solicitation? |
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CancerVax is conducting this proxy solicitation and will bear
the cost of soliciting proxies, including the preparation,
assembly, printing and mailing of this proxy
statement/prospectus, the proxy card and any additional
information furnished to stockholders. CancerVax may also
reimburse brokerage houses and other custodians, nominees and
fiduciaries for their costs of forwarding proxy and solicitation
materials to beneficial owners. |
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Who can help answer my questions? |
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If you are a CancerVax stockholder and would like additional
copies, without charge, of this proxy statement/prospectus or if
you have questions about the merger, including the procedures
for voting your shares, you should contact: |
CancerVax Corporation
Attn: Investor Relations
2110 Rutherford Road
Carlsbad, California 92008
(760) 494-4200
E-mail:
investors@cancervax.com
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If you are a Micromet shareholder and would like additional
copies, without charge, of this proxy statement/prospectus or if
you have questions about the merger, you should contact: |
Micromet AG
Attn: Investor Relations
Staffelseestr. 2
81477 Munich
Germany
Phone: +49 (0) 89/895277-0
Email: ir@micromet.de
6
SUMMARY
This summary highlights selected information from this proxy
statement/prospectus. To understand the merger fully, you should
read carefully this entire document and the documents to which
we refer, including the annexes attached hereto. See Where
You Can Find More Information on page 247. The merger
agreement is attached as Annex A to this proxy
statement/prospectus. We encourage you to read the merger
agreement as it is the legal document that governs the merger.
We have included page references in parentheses to direct you to
a more detailed description of the topics presented in this
summary.
Except where specifically noted, the following information
and all other information contained in this proxy
statement/prospectus does not give effect to the proposed
reverse stock split described in CancerVaxs
Proposal No. 3.
THE
COMPANIES
CancerVax Corporation
2110 Rutherford Road
Carlsbad, California 92008
(760) 494-4200
CancerVax is a biotechnology company focused on the research,
development and commercialization of novel biological products
for the treatment of cancer. CancerVaxs leading product
candidate, D93, is a humanized, monoclonal, anti-angiogenic
antibody that is currently being evaluated in pre-clinical
studies. D93 has been shown to selectively bind to denatured or
remodeled protein in diseased or damaged tissues, but not to
native collagen in the extra-cellular matrix of healthy tissue,
and has demonstrated the ability to selectively bind to
denatured collagen targets in colon, melanoma, lung, and breast
cancer tumors grown in xenogeneic mouse models. CancerVax
submitted an Investigational New Drug Application, or IND, for
D93 to the U.S. Food and Drug Administration in February
2006, to initiate a Phase I clinical trial for D93.
Carlsbad Acquisition Corporation is a wholly-owned subsidiary of
CancerVax that was incorporated in Delaware in
January 2006. Carlsbad Acquisition Corporation does not
engage in any operations and exists solely to facilitate the
merger.
Micromet AG
Staffelseestr. 2
81477 Munich
Germany
+49
(0) 89/895277-0
Micromet AG is a privately-held European biopharmaceutical
company focused on the development of antibody-based drugs.
Micromets leading product candidate, adecatumumab (MT201),
is a recombinant human monoclonal antibody with a binding
specificity to epithelial cell adhesion molecule
(Ep-CAM).
Adecatumumab (MT201) is being evaluated in two European
Phase 2 clinical trials, one in patients with prostate
cancer, and one in patients with metastatic breast cancer.
Adecatumumab (MT201) is also being studied as a combination
therapy with
Taxotere®
(docetaxel) in a Phase 1 clinical trial for the treatment
of patients with metastatic breast cancer. Micromets other
leading product candidate, MT103, is being evaluated in a
European Phase 1 clinical trial for the treatment of
patients with non-Hodgkins lymphoma.
Micromet, Inc., which was incorporated in Delaware in
January 2006, does not engage in any operations and exists
solely to facilitate the merger.
The
Combined Company
The combined companys U.S. headquarters immediately
following the consummation of the merger will be located at
CancerVaxs current principal executive offices in
Carlsbad, California, while the combined companys German
headquarters will remain in Munich, Germany. The combined
company intends to move its U.S. headquarters to the
eastern United States later in 2006. As a result of the merger,
former Micromet shareholders will
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possess majority control of the combined company. Current
management of Micromet will be responsible for the
day-to-day
management of the combined company.
RISKS
ASSOCIATED WITH CANCERVAX, MICROMET AND THE MERGER (PAGE
31)
The merger (including the possibility that the merger may not be
completed) poses a number of risks to each company and its
respective security holders. In addition, both CancerVax and
Micromet are subject to various risks associated with their
businesses and their industries. The risks are discussed in
greater detail under the caption Risk Factors
beginning on page 31 of this proxy statement/prospectus.
CancerVax and Micromet both encourage you to read and consider
all of these risks carefully.
REASONS
FOR THE MERGER
The following discussion of the parties reasons for the
merger contains a number of forward-looking statements that
reflect the current views of CancerVax and/or Micromet with
respect to future events that may have an effect on their future
financial performance. Forward-looking statements are subject to
risks and uncertainties. Actual results and outcomes may differ
materially from the results and outcomes discussed in the
forward-looking statements. Cautionary statements that identify
important factors that could cause or contribute to differences
in results and outcomes include those discussed in
Summary Forward-Looking Information
and Risk Factors.
Mutual Reasons for the Merger
(Page 73). CancerVax and Micromet believe
that the combined company represents a biotechnology company
with the following potential advantages:
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Deep Pipeline. The product pipeline for the
combined company includes six drugs in various stages of
development, including product candidates in Phase 2 and
Phase 1 clinical trials, and in pre-clinical studies.
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Attractive Markets. The markets to be
addressed by the clinical stage or pre-clinical product
candidates of the combined company represent sizable and
underserved or unmet medical needs. The product candidates may
provide significant medical benefits for patients and returns
for investors.
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Financial Resources. The financial resources
of the combined company will allow it to continue to focus on
execution with respect to its product portfolio.
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Experienced Management Team. It is expected
that the combined company will be led by experienced senior
management from Micromet. Micromets chief executive
officer, Christian Itin, will become president and chief
executive officer and serve on the board of directors.
Patrick A. Baeuerle, currently chief scientific officer of
Micromet, will become chief scientific officer of the combined
entity. Carsten Reinhardt, currently senior vice president of
clinical development of Micromet, will become senior vice
president of clinical development of the combined entity. Gregor
Mirow, Micromets chief financial officer and chief
operating officer, will be senior vice president of operations.
David F. Hale, currently president and chief executive officer
of CancerVax, will become chairman of the board of directors of
the combined company. CancerVaxs chief financial officer,
William R. LaRue, and general counsel, Hazel M. Aker, have
agreed to provide consulting services to the combined company
until August 15, 2006, each for compensation of $50,000, in
order to assist with post-merger integration activities.
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CancerVaxs Reasons for the Merger
(Page 73). The CancerVax board of directors
approved the merger based on a number of factors, including the
following:
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Broad Pipeline. CancerVax currently has one
product candidate, D93, in pre-clinical development, and has
announced its intention to sublicense its rights to SAI-EGF,
which is in clinical development, and its rights to two other
product candidates in pre-clinical development. The addition of
the two Micromet product candidates currently being evaluated in
three clinical trials, and a number of additional Micromet
product candidates in pre-clinical development, significantly
broadens the product pipeline.
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Risk Diversification. The addition of
Micromets two clinical-stage product candidates to the
portfolio potentially affords significant risk diversification
for CancerVax stockholders. One of Micromets product
candidates, adecatumumab (MT201), is currently being evaluated
in two Phase 2 clinical trials and as a
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combination therapy with
Taxotere®
in a Phase 1 clinical trial. A second Micromet product
candidate,
MT103, is
the subject of an ongoing Phase 1 clinical trial.
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Access to Markets. By merging, CancerVax and
Micromet will create a trans-Atlantic biotechnology company with
access to both the U.S. and European markets.
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Fairness Opinion. Piper Jaffray & Co.
delivered its opinion to CancerVaxs board of directors
that, as of January 6, 2006 and based on and subject to the
factors, assumptions and limitations set forth therein, the
total merger consideration to be paid to the holders of Micromet
Parent common stock in the merger was fair to CancerVax from a
financial point of view. The full text of Piper Jaffrays
written opinion, dated January 6, 2006, is attached to this
proxy statement/prospectus as Annex C. You are encouraged
to read this opinion carefully in its entirety for a description
of the procedures followed, assumptions made, matters considered
and limitations on the review undertaken by Piper Jaffray. Piper
Jaffrays opinion is addressed to the CancerVax board of
directors and does not constitute a recommendation to any
stockholder as to any matters relating to the merger.
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In addition to considering the strategic factors outlined above,
the CancerVax board of directors considered the following
factors in reaching its conclusion to approve the merger and to
recommend that the CancerVax stockholders approve the issuance
of shares of CancerVax common stock in the merger and resulting
change of control of CancerVax, all of which it viewed as
generally supporting its decision to approve the business
combination with Micromet:
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the results of the due diligence review of Micromets
businesses and operations by CancerVaxs management, legal
advisors and financial advisors;
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the terms and conditions of the merger agreement, including the
following related factors:
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the determination that the relative percentage ownership of
CancerVax securityholders and Micromet securityholders is fixed
and captures the respective ownership interests of the CancerVax
and Micromet securityholders in the combined company based on
valuations of CancerVax and Micromet at the time of the
boards approval of the merger agreement and avoids
fluctuations caused by near-term market volatility;
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the nature of the conditions to Micromets obligation to
consummate the merger and the limited risk of non-satisfaction
of such conditions;
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the no solicitation provisions governing Micromets ability
to engage in negotiations with, provide any confidential
information or data to, and otherwise have discussions with, any
person relating to an alternative acquisition proposal;
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the limited ability of the parties to terminate the merger
agreement;
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the possible effects of the provisions of the merger agreement
regarding termination fees; and
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the likelihood that the merger will be consummated on a timely
basis.
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In the course of its deliberations, CancerVaxs board of
directors also considered a variety of risks and other
countervailing factors related to entering into the merger
agreement, including the following:
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the risks, challenges and costs inherent in combining the
operations and the substantial expenses to be incurred in
connection with the merger, including the possibility that
delays or difficulties in completing the integration could
adversely affect the combined companys operating results
and preclude the achievement of some benefits anticipated from
the merger;
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the possible volatility, at least in the short term, of the
trading price of CancerVaxs common stock resulting from
the merger announcement;
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the possible loss of key management, scientific or other
personnel of the combined company as a result of the management
and other changes that will be implemented in integrating the
businesses, and the difficulties associated with operating a
company with significant distances between its two key locations;
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the risk of diverting managements attention from other
strategic priorities to implement merger integration efforts;
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the risk that the merger might not be consummated in a timely
manner or at all and the potential adverse effect of the public
announcement of the merger on CancerVaxs reputation;
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the risk to CancerVaxs business, operations and financial
results in the event that the merger is not consummated; and
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various other applicable risks associated with the combined
company and the merger, including those described in the section
of this proxy statement/prospectus entitled Risk
Factors.
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Micromets Reasons for the Merger
(Page 75). The Micromet supervisory board
approved the merger based on a number of factors, including the
following:
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Alternative Strategic
Relationships. Micromets supervisory
boards view as to the relative benefits of a transaction
with CancerVax when compared to the benefits of a transaction
with other third parties.
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Historical and Current Information. Historical
and current information concerning Micromets business,
including its financial performance and condition, operations,
management and competitive position, current industry and
economic conditions, and Micromets prospects if it was to
remain an independent company, including: (a) the risk that
adecatumumab (MT201) clinical trial results would be negative or
inconclusive; (b) the risk of adverse outcomes in its other
clinical trials; and (c) its need to obtain additional
financing and the likely terms on which it would be able to
obtain that financing.
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U.S. Presence of CancerVax. The fact that
by merging with CancerVax, Micromet would have access to the
U.S. capital markets as part of a trans-Atlantic company.
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Capital. CancerVaxs cash balance, which
is expected to be in excess of $20 million if the merger
closes on or around May 3, 2006, and the combined
companys ability as a public company to raise additional
capital.
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Liquidity. CancerVaxs status as a public
company whose common stock is traded on the Nasdaq National
Market, which would provide Micromets shareholders with
the possibility of additional liquidity.
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In addition to considering the strategic factors outlined above,
the Micromet supervisory board considered the following factors
in reaching its conclusion to approve the merger, all of which
it viewed as generally supporting its decision to approve the
business combination with CancerVax:
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CancerVaxs attractiveness as a strategic partner,
including CancerVaxs:
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substantial capital and ability to raise further capital,
particularly in light of Micromets cash needs and limited
cash resources; and
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public company infrastructure and stock liquidity;
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the opportunity for Micromet shareholders to participate in the
long-term value of Micromets development programs through
the ownership of the combined companys common stock;
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the aggregate value to be received by Micromet Parent
stockholders in the merger;
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the terms and conditions of the merger agreement, including the
following related factors:
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the expectation that the merger will be treated as a tax-free
reorganization for U.S. federal income tax purposes, with
the result that the Micromet Parent stockholders will generally
not recognize taxable gain or loss for U.S. federal income
tax purposes;
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the determination that the fixed relative percentage ownership
ratio of CancerVax securityholders and Micromet securityholders
is consistent with market practice for a merger of this type and
captures the respective ownership interests of the CancerVax and
Micromet securityholders in the combined company
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based on Micromets perceived valuations of CancerVax and
Micromet at the time of the boards approval of the merger
agreement;
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the fact that shares of CancerVax common stock issued to
Micromet Parent stockholders will be registered on
Form S-4
and will be freely tradable for Micromet Parent stockholders who
are not affiliates of Micromet;
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the requirement that the issuance of shares of CancerVax common
stock in the merger be submitted to a vote of the stockholders
of CancerVax;
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the limited number and nature of the conditions to
CancerVaxs obligation to consummate the merger and the
limited risk of non-satisfaction of such conditions;
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Micromets rights under the merger agreement to consider
certain unsolicited acquisition proposals under certain
circumstances should Micromet receive a superior proposal; and
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the conclusion of Micromets supervisory board that the
$2,000,000 termination fee, and the circumstances when such fee
may be payable, were reasonable;
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the likelihood that the merger will be consummated on a timely
basis, including the likelihood that the merger will receive all
necessary regulatory approvals; and
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the major risks and uncertainties of alternatives to the merger,
such as Micromet remaining an independent company.
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In the course of its deliberations, Micromets supervisory
board also considered a variety of risks and other
countervailing factors related to entering into the merger
agreement, including the following:
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Risks of Combination. The challenges and costs
of combining the operations and the substantial expenses to be
incurred in connection with the merger, including the risks that
delays or difficulties in completing the integration and the
inability to retain key employees as a result of the management
and other changes that will be implemented in integrating the
businesses could adversely affect the combined companys
operating results and preclude the achievement of some benefits
anticipated from the merger;
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Stock Price. The price volatility of
CancerVaxs common stock, which may reduce the value of the
CancerVax common stock that Micromet Parent stockholders will
receive upon the consummation of the merger;
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Value. The inability of Micromets
shareholders to realize the long-term value of the successful
execution of Micromets current strategy as an independent
company;
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Reputation. The possibility that the merger
might not be completed and the potential adverse effect of the
public announcement of the merger on Micromets reputation
and ability to obtain financing in the future;
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Break-up Fee. The $2,000,000 termination fee
payable to CancerVax upon the occurrence of certain events, and
the potential effect of such termination fee in deterring other
potential acquirors from proposing an alternative transaction
that may be more advantageous to Micromet shareholders;
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Diversion of Resources. The risk of diverting
managements attention from other strategic priorities to
implement merger integration efforts;
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Completion Risk. The risk that the merger
might not be consummated in a timely manner or at all; and
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Other Risks. Various other applicable risks
associated with the combined company and the merger, including
those described in the section of this proxy
statement/prospectus entitled Risk Factors.
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11
EFFECT OF
FAILURE TO APPROVE THE MERGER BY THE STOCKHOLDERS
CancerVax
CancerVax will continue to have significant cash resources. The
growth of CancerVax will be largely based on the success of a
single product candidate, D93, for the treatment of patients
with solid tumors, as CancerVax is currently pursuing
sublicensing opportunities for
SAI-EGF, its
clinical-stage product candidate, and two pre-clinical product
candidates. CancerVax submitted an IND for D93 to the FDA in
February 2006, and plans to initiate a Phase 1 clinical
trial for D93 later in 2006, however, this product candidate
will require substantial testing in humans prior to
commercialization. CancerVax may lack the personnel and
financial resources to complete the testing of D93 in a timely
manner and, as a result, could lose its rights to develop this
product candidate.
Micromet
Micromet will continue to have a broad and deep pipeline of
product candidates. The growth of Micromet will be largely based
on the success of the product candidates in its portfolio. To
support the development, registration and commercialization of
those product candidates, Micromet will soon need to raise
significant additional capital.
COMPARATIVE
PER SHARE MARKET PRICE INFORMATION
CancerVax common stock is listed on the Nasdaq National Market
under the symbol CNVX. On January 6, 2006, the
last full trading day prior to the public announcement of the
proposed merger, CancerVax common stock closed at $1.49. On
March 27, 2006, CancerVax common stock closed at $3.00.
Micromet is a private company and no public market exists for
its ordinary shares or preference shares.
NUMBER OF
STOCKHOLDERS
As of the record date of March 27, 2006, there were
approximately 214 holders of record of CancerVax common
stock.
As of March 27, 2006, there were approximately 43 holders
of record of Micromet ordinary shares and preference shares.
THE
CANCERVAX ANNUAL MEETING
The
CancerVax Annual Meeting (Page 64)
Time, Date and Place. The annual meeting of
the stockholders of CancerVax will be held on May 3, 2006,
at CancerVax Corporation at 2110 Rutherford Road, Carlsbad,
California at 9:00 a.m., local time, to vote on Proposal
No. 1 to approve the issuance of shares of CancerVax common
stock in the merger, and the resulting change of control of
CancerVax; Proposal No. 2 to approve the amendment to
CancerVaxs amended and restated certificate of
incorporation to increase the number of authorized shares of
common stock from 75,000,000 shares to
150,000,000 shares; Proposal No. 3 to approve the
authorization of the board of directors of CancerVax to amend in
its discretion CancerVaxs amended and restated certificate
of incorporation to effect a reverse stock split of
CancerVaxs common stock, at a ratio within the range of
1:2 to 1:4; Proposal No. 4 to approve the
amendment to CancerVaxs amended and restated certificate
of incorporation to change the name of CancerVax
Corporation to Micromet, Inc.; Proposal
No. 5 to elect three directors for a three-year term to
expire at the 2009 annual meeting of stockholders; provided,
however, that, if the merger is completed, CancerVaxs
board of directors will consist of the nine people identified in
this proxy statement/prospectus under Management of the
Combined Company After the Merger below; Proposal
No. 6 to ratify the selection of Ernst & Young LLP as
CancerVaxs independent registered public accounting firm
for the fiscal year ending December 31, 2006; and
Proposal No. 7 to adjourn the annual meeting, if
necessary, if a quorum is present, to solicit additional proxies
if there are not sufficient votes in favor of
Proposal Nos. 1 through 6.
Record Date and Voting Power for
CancerVax. You are entitled to vote at the
CancerVax annual meeting if you owned shares of CancerVax common
stock at the close of business on March 27, 2006, the
record date for the CancerVax annual meeting. You will have one
vote at the annual meeting for each share of CancerVax common
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stock you owned at the close of business on the record date.
There are 27,955,139 shares of CancerVax common stock
entitled to vote at the annual meeting.
CancerVax Required Vote. The affirmative vote
of the holders of a majority of the votes cast in person or by
proxy at the CancerVax annual meeting is required for approval
of Proposal Nos. 1, 6 and 7 above. The affirmative
vote of holders of a majority of the outstanding common stock is
required for approval of Proposal Nos. 2, 3 and 4. The
affirmative vote of holders of a plurality of the votes cast in
person or by proxy is required to elect the directors in
Proposal No. 5.
Share Ownership of Management. As of
March 27, 2006, the directors and executive officers of
CancerVax, together with their affiliates, beneficially owned
approximately 37.3% of the shares entitled to vote at the
CancerVax annual meeting. Certain executive officers and
affiliates of CancerVax, holding approximately 30% of
CancerVaxs outstanding common stock, have agreed to vote
their shares in favor of the issuance of shares of CancerVax
common stock in the merger, and the resulting change of control
of CancerVax.
RECOMMENDATIONS
TO CANCERVAX STOCKHOLDERS
The CancerVax board of directors has determined and believes
that the issuance of shares of CancerVax common stock in the
merger, and the resulting change of control of CancerVax, is
advisable and fair to, and in the best interest of, CancerVax
and its stockholders. The CancerVax board of directors
recommends that the holders of CancerVax common stock vote:
For Proposal No. 1 to approve the issuance
of shares of CancerVax common stock in the merger, and the
resulting change of control of CancerVax;
For Proposal No. 2 to approve the increase
in the number of authorized shares of common stock to
150,000,000;
For Proposal No. 3 to authorize the
CancerVax board of directors to effect the reverse stock split;
For Proposal No. 4 to approve the name
change of CancerVax Corporation to Micromet,
Inc.;
For Proposal No. 5 to elect three directors for a
three-year term to expire at the 2009 annual meeting of
stockholders; provided, however, that, if the merger is
completed, CancerVaxs board of directors will consist of
the nine people identified in this proxy statement/prospectus;
For Proposal No. 6 to ratify the selection
of Ernst & Young LLP as CancerVaxs independent
registered public accounting firm for the fiscal year ending
December 31, 2006; and
For Proposal No. 7 to adjourn the
CancerVax annual meeting, if necessary, if a quorum is present,
to solicit additional proxies if there are not sufficient votes
in favor of proposal Nos. 1 through 6.
CancerVax
Proposal No. 1 Approval of the Issuance of
Shares of CancerVax Common Stock in the Merger and the Resulting
Change of Control of CancerVax
The
Merger (Page 69)
Merger Sub will be merged with and into Micromet Parent.
Micromet Parent will be the surviving corporation and will
continue as a wholly-owned subsidiary of CancerVax. Immediately
prior to the merger, the holders of equity interests of Micromet
will exchange their interests for shares of common stock in
Micromet Parent in an exchange transaction (the Micromet
Reorganization) that will result in Micromet becoming a
wholly-owned subsidiary of Micromet Parent. As a result of the
merger, Micromet will survive as a wholly-owned indirect
subsidiary of CancerVax. Following the merger, CancerVax will
change its name to Micromet, Inc. In the merger, all shares of
Micromet Parent capital stock will be cancelled and Micromet
shareholders, option holders, warrant holders and note holders
will receive the number of shares, or options and warrants to
acquire shares, of CancerVax common stock equal to approximately
67.5% of the fully-diluted shares of the combined company. The
approval of this matter by CancerVax stockholders is contingent
upon receiving stockholder approval of CancerVax Proposal Nos. 1
through 4. Micromet and Micromet Parent have already approved
the merger. No separate approval of the
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merger by the shareholders of Micromet is required and the sole
stockholder of Micromet Parent has already consented to the
merger.
Merger
Consideration; Manner and Basis of Converting Shares (Page
94)
As a result of the merger, all shares of Micromet Parent capital
stock will automatically be cancelled and Micromet Parent
stockholders, together with holders of options, warrants and
other rights to acquire shares of Micromet Parent common stock,
will receive an aggregate number of shares of CancerVax common
stock equal to 67.5% of the fully-diluted shares of the combined
company. There will be no adjustment to the total number of
shares of CancerVax common stock to be issued to Micromet Parent
stockholders or holders of options, warrants or other rights to
acquire shares of Micromet Parent common stock for changes in
the market price of CancerVax common stock. Further, the merger
agreement does not include a price-based termination right.
Accordingly, the market value of the shares of CancerVax issued
in connection with the merger will depend on the market value of
the shares of CancerVax common stock at the time of
effectiveness of the merger, and could vary significantly from
the market value on the date of this document.
The fixed number of shares of CancerVax common stock to be
issued in exchange for all shares of Micromet Parent stock at
the consummation of the merger will be allocated among:
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holders of Micromet Parent common stock;
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holders of options to purchase Micromet Parent common stock
(which shares will become issuable upon the exercise of options
to purchase CancerVax common stock, as more fully described
under Micromet Parent Stock Options below);
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holders of warrants to purchase Micromet Parent common
stock; and
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holders of rights to purchase shares of capital stock of
Micromet to the extent such shares have not been exchanged for
shares of Micromet Parent common stock or rights to purchase
shares of Micromet Parent common stock.
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The shares of CancerVax common stock to be issued in connection
with the merger will be allocated to the Micromet Parent
stockholders and holders of options, warrants and other rights
to acquire shares of Micromet Parent common stock on a pro rata
basis.
Micromet
Parent Stock Options (Page 96)
Each outstanding option granted by Micromet Parent to purchase
shares of Micromet Parent common stock will be converted into an
option to acquire CancerVax common stock having the same terms
and conditions as the Micromet Parent stock option. The number
of shares that the new CancerVax option will be exercisable for
and the exercise price of the new CancerVax option will reflect
the exchange ratio in the merger. The number of shares of
CancerVax common stock issuable upon the exercise of each stock
option will be rounded down to the nearest whole number of
shares of CancerVax common stock, and the exercise price will be
rounded up to the nearest whole cent. The number of shares of
CancerVax common stock issuable upon exercise of the new
CancerVax options is part of the 67.5% of the fully-diluted
shares of the combined company described under Merger
Consideration; Manner and Basis for Converting Shares.
Micromet
Parent Warrants (Page 96)
Each outstanding warrant granted by Micromet Parent to purchase
shares of Micromet Parent common stock will be converted into a
warrant to acquire CancerVax common stock having the same terms
and conditions as the Micromet Parent warrant. The number of
shares that the new CancerVax warrant will be exercisable for
and the exercise price of the new CancerVax warrant will reflect
the exchange ratio in the merger. The number of shares of
CancerVax common stock issuable upon the exercise of each
warrant will be rounded down to the nearest whole number of
shares of CancerVax common stock, and the exercise price will be
rounded up to the nearest whole cent. The number of shares of
CancerVax common stock issuable upon exercise of the new
CancerVax warrants is part of
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the 67.5% of the fully-diluted shares of the combined company
described under Merger Consideration; Manner and Basis for
Converting Shares.
MedImmune
Note (Page 96)
In conjunction with the execution of a collaboration agreement
between Micromet and MedImmune, Inc. in 2003, Micromet issued a
10,000,000 convertible note to MedImmune Ventures, Inc.
The terms of that note, as amended on October 11, 2005,
provide that the holder has the right, immediately prior to the
effectiveness of the merger, to convert the note in full into
Micromet preference shares series (A new) if the pre-money
valuation of Micromet in such transaction is 120,000,000
or more; if the valuation of Micromet is less, the conversion
rate is a pro rata percentage determined as the pre-money
valuation of Micromet in such transaction divided by
120,000,000, multiplied by one hundred. In addition, if
the combined company after the merger holds more than
30,000,000 in cash, then MedImmune has the right (but not
the obligation) to accelerate repayment of the loan in an amount
equal to the principal balance multiplied by a fraction
(A) the numerator of which is the amount of cash held by
the combined company in excess of 30,000,000 and
(B) the denominator of which is 30,000,000, to the
extent such principal balance has not been converted as
described in the immediately preceding sentence. As a result, if
the combined company has at least 60,000,000 in cash,
MedImmune may require the loan to be repaid in full. In each
case, any remainder of the note remains outstanding until the
due date in accordance with the terms of the note. The note
bears interest at 4.5% per annum and is due in June 2010
unless earlier converted or repaid. MedImmune has informed
Micromet that it desires to convert its note to the fullest
extent possible in connection with the merger. Based upon the
closing price of CancerVax stock on March 27, 2006, it is
expected that all of the principal under the MedImmune note will
convert in connection with the merger.
Fairness
Opinion Received by CancerVax (Page 77)
Piper Jaffray delivered its opinion to CancerVaxs board of
directors that, as of January 6, 2006 and based on and
subject to the factors, assumptions and limitations set forth
therein, the total merger consideration to be paid to the
holders of Micromet Parent common stock in the merger was fair
to CancerVax from a financial point of view. For the purposes of
Piper Jaffrays opinion, the shares of CancerVax common
stock to be exchanged for outstanding shares of Micromet Parent
common stock (determined as set forth in Section 1.6(a)(ii)
of the merger agreement) were referred to as the merger
consideration.
The full text of the written opinion of Piper Jaffray, dated
January 6, 2006, which sets forth the assumptions made,
procedures followed, matters considered and limitations on the
review undertaken in connection with the opinion, is attached to
this proxy statement/prospectus as Annex C. Piper Jaffray
provided its opinion for the information and assistance of
CancerVaxs board of directors in connection with its
consideration of the merger. The Piper Jaffray opinion is not a
recommendation as to how any holder of CancerVax common stock
should vote with respect to the issuance of shares of CancerVax
common stock in the merger. CancerVax urges you to read the
entire opinion carefully.
Interests
of CancerVaxs Executive Officers and Directors in the
Merger (Page 85)
When considering the recommendation by the CancerVax board of
directors, you should be aware that a number of CancerVaxs
executive officers and directors have interests in the merger
that are different from those of other CancerVax stockholders.
David F. Hale is the President and Chief Executive Officer, a
member of the board of directors, a stockholder and a holder of
options to purchase stock of CancerVax. Hazel M. Aker is the
Senior Vice President, General Counsel and Secretary, a
stockholder and a holder of options to purchase stock of
CancerVax. William R. LaRue is the Senior Vice President and
Chief Financial Officer, a stockholder and a holder of options
to purchase stock of CancerVax. Upon closing of the merger,
David Hale will become the Chairman of the board of directors of
the combined corporation. William LaRue and Hazel Aker have
agreed to provide consulting services to the combined company
until August 15, 2006, each for compensation of $50,000, in
order to assist with post-merger integration activities. David
Hale, Hazel Aker and William LaRue participated in the
negotiation and approval of the terms of
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the merger on behalf of CancerVax, following disclosure of all
material facts regarding their respective interests (or
potential interests) in the merger.
Following the merger, in addition to David Hale, current
CancerVax board members Phillip Schneider, Michael Carter and
Barclay Phillips will continue to serve on the board of
directors of the combined corporation.
As of March 27, 2006, all directors and executive officers
of CancerVax, together with their affiliates, beneficially owned
37.3% of the shares of CancerVax common stock. Approval of the
merger requires the affirmative vote of the holders of a
majority of CancerVaxs outstanding common stock. Certain
CancerVax officers and directors, and their affiliates, have
also entered into voting agreements in connection with the
merger. The voting agreements are discussed in greater detail
under the caption Voting Agreements beginning on
page 113.
For a more complete description of the interests of current and
former officers and directors of CancerVax, please see the
section entitled Interests of CancerVaxs Executive
Officers and Directors in the Merger on page 85 of
this proxy statement/prospectus.
Interests
of Micromets Executive Officers and Directors in the
Merger (Page 87)
You also should be aware that a number of Micromets
executive officers and directors have interests in the merger
that are different from those of other Micromet stockholders.
Christian Itin is the Chief Executive Officer of Micromet and a
shareholder and holder of options to purchase ordinary shares of
Micromet. Patrick A. Baeuerle is the Chief Scientific Officer of
Micromet and a shareholder and holder of options to purchase
ordinary shares of Micromet. Gregor K. Mirow is the Chief
Financial Officer and Chief Operating Officer of Micromet and a
shareholder and holder of options to purchase ordinary shares of
Micromet. Carsten Reinhardt is the Senior Vice President,
Clinical Development of Micromet. Upon consummation of the
Micromet Reorganization, each of Drs. Itin, Baeuerle and
Mirow will be stockholders and optionholders of Micromet Parent
and will receive shares of CancerVax common stock in the merger
and have their options to purchase Micromet Parent common stock
assumed by CancerVax.
Upon the closing of the merger, Dr. Itin will become the
President and Chief Executive Officer of the combined
corporation, Dr. Baeuerle will become Senior Vice President
and Chief Scientific Officer of the combined corporation,
Dr. Mirow will become Senior Vice President of Operations
of the combined corporation and Dr. Reinhardt will become
Senior Vice President, Clinical Development of the combined
corporation. Each of Drs. Itin and Mirow participated in
the negotiation and approval of the terms of the merger on
behalf of Micromet following disclosure of all material facts
regarding their respective interests (or potential interests) in
the merger.
Following the merger, current members of the Micromet
supervisory board Jerry Benjamin, John Berriman, Michael Carter
and Otello Stampacchia will continue to serve on the board of
directors of the combined company. Dr. Carter also is a
current director of CancerVax.
As of March 27, 2006, all directors and executive officers
of Micromet, together with their affiliates, beneficially owned
34.7% of the ordinary shares of Micromet, 48.6% of the Micromet
preference shares series (A new) and 58.6% of the Micromet
preference shares series (B new). Upon consummation of the
Micromet Reorganization, all directors and executive officers of
Micromet, together with their affiliates, will own approximately
54.5% of the outstanding common stock of Micromet Parent.
Consummation of the Micromet Reorganization requires the
agreement to exchange at least 55% of the Micromet AG
preference shares series (B new) for shares of Micromet Parent
common stock. Certain of the officers and directors of Micromet,
and their affiliates, have also entered into voting agreements
in connection with the merger. The voting agreements are
discussed in greater detail under the caption Voting
Agreements beginning on page 113.
For a more complete description of the interests of current and
former officers and directors of Micromet AG, please see the
section entitled Interests of Micromets Executive
Officers and Directors in the Merger on page 87 of
this proxy statement/prospectus.
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Restrictions
on Resales; Affiliate Agreements Relating to Micromet Affiliates
(Page 92)
The shares of CancerVax common stock to be received by Micromet
Parent stockholders in the merger will be registered under the
Securities Act of 1933 and, except as described in this section,
may be freely traded without restriction. CancerVaxs
registration statement on
Form S-4,
of which this proxy statement/prospectus is a part, does not
cover the resale of shares of CancerVax common stock to be
received in connection with the merger by persons who are deemed
to be affiliates of Micromet or Micromet Parent. The
shares of CancerVax common stock to be issued in the merger and
received by persons who are deemed to be affiliates
of Micromet or Micromet Parent may be resold by them only in
transactions registered under the Securities Act of 1933, exempt
from registration by the resale provisions of Rule 145
under the Securities Act of 1933 or as otherwise permitted under
the Securities Act of 1933. Persons who are deemed to be
affiliates of Micromet or Micromet Parent prior to
the merger include individuals or entities that control, are
controlled by, or are under common control with Micromet or
Micromet Parent and may include officers and directors, as well
as principal stockholders, of Micromet or Micromet Parent.
Affiliates of Micromet and Micromet Parent will be notified
separately of their affiliate status. Under the terms of the
merger agreement, CancerVax has agreed to file as soon as
practicable, and in any event within 45 days after the
effective time of the merger, a resale registration statement to
cover the resale by former affiliates of Micromet Parent and
Micromet of shares of CancerVax common stock received by such
stockholders in the merger. In addition, CancerVax agreed to use
commercially reasonable efforts to keep the resale registration
statement continuously effective until the earlier of the date
upon which all of the shares held by such stockholders may be
resold under Rule 145 without restriction and the date upon
which all such shares have been sold pursuant to the resale
registration statement.
The merger agreement provides that Micromet will use
commercially reasonable efforts to secure signed affiliate
agreements from all persons who are, may become or might be
deemed to be affiliates of Micromet or Micromet Parent, and who
will receive CancerVax common stock in connection with the
merger. These affiliate agreements provide that these persons
will not sell, transfer or otherwise dispose of their shares of
CancerVax common stock unless they do so in compliance with
securities laws governing sales by affiliates.
Limitation
on Soliciting, Discussing and Negotiating Other Acquisition
Proposals (Page 105)
CancerVax and Micromet have each agreed, and have further agreed
to ensure that their representatives do not, prior to the
consummation of the merger, directly or indirectly, solicit,
initiate, knowingly encourage, induce or facilitate the making,
submission or announcement of, or enter into discussions or
negotiations with any person with respect to, any alternative
acquisition proposal or any inquiry that would reasonably be
expected to lead to an alternative acquisition proposal for
their respective company. CancerVax and Micromet have also
agreed to notify each other upon receipt of any alternative
acquisition proposal or any inquiry that would reasonably be
expected to lead to an alternative acquisition proposal,
including the terms of the alternative acquisition proposal or
inquiry and the identity of the person making the alternative
acquisition proposal or inquiry. However, if CancerVax or
Micromet receives an unsolicited bona fide written acquisition
proposal that is a superior acquisition proposal, or could
reasonably be expected to lead to a superior acquisition
proposal, prior to the CancerVax annual meeting, then CancerVax
or Micromet, as the case may be, may provide nonpublic
information to, and engage in discussions and negotiations with,
the third party making the acquisition proposal so long as
certain conditions set forth in the merger agreement are
satisfied.
Obligations
of the CancerVax Board of Directors and Micromet Supervisory
Board with Respect to Their Recommendations and Holding the
CancerVax Meeting of Stockholders (Page 104)
Subject to certain conditions, the board of directors of
CancerVax or Micromet may withdraw or modify their respective
recommendation in support of the issuance of shares of CancerVax
common stock in the merger or the adoption of the merger
agreement, as the case may be. In the event that the board of
directors of either company withdraws or modifies its
recommendation in a manner adverse to the other company, that
company may be required under certain circumstances to pay a
termination fee of $2,000,000 to the other company.
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Conditions
to the Merger (Page 106)
The respective obligations of CancerVax and Micromet to
consummate the merger are subject to the satisfaction of certain
conditions described herein.
Termination
of the Merger Agreement (Page 109)
Either CancerVax or Micromet can terminate the merger agreement
under certain circumstances described herein, which would
prevent the merger from being consummated.
Expenses
and Termination Fees (Page 111)
Subject to limited exceptions, all fees and expenses incurred in
connection with the merger agreement will be paid by the company
incurring such expenses. A termination fee of $2,000,000 may be
payable by either CancerVax or Micromet to the other party upon
the termination of the merger agreement under certain
circumstances.
Material
U.S. Federal Income Tax Consequences
(Page 90)
As provided in the merger agreement, Cooley Godward LLP, counsel
to Micromet and Micromet Parent, will issue a tax opinion to the
effect that the merger will constitute a reorganization under
Section 368 of the Internal Revenue Code of 1986, as
amended. In such a reorganization, a Micromet Parent stockholder
generally will not recognize any gain or loss for
U.S. federal income tax purposes upon the exchange of its
shares of Micromet Parent common stock for shares of CancerVax
common stock. However, any cash received for any fractional
share will result in the recognition of gain or loss as if such
stockholder sold its fractional share. A Micromet Parent
stockholders tax basis in the shares of CancerVax common
stock that it receives in the merger will equal its current tax
basis in its Micromet Parent common stock exchanged in the
merger, as the case may be (reduced by the basis allocable to
any fractional share interest for which it receives cash).
Tax matters can be complicated, and the tax consequences of
the merger to you will depend on the facts of your own
situation. You should consult your own tax advisors to fully
understand the tax consequences of the merger to you, including
the applicability and effect of federal, state, local and
foreign income and other tax laws.
Regulatory
Approvals (Page 92)
As of the date of this proxy statement/prospectus, neither
CancerVax, Micromet nor Micromet Parent is required to make
filings or to obtain approvals or clearances from any antitrust
regulatory authorities in the United States or other countries
to consummate the merger. In the United States, CancerVax must
comply with applicable federal and state securities laws and the
rules and regulations of the Nasdaq National Market in
connection with the issuance of shares of CancerVax common stock
in the merger and the filing of this proxy statement/prospectus
with the Securities and Exchange Commission.
Anticipated
Accounting Treatment (Page 92)
The merger will be treated by CancerVax as a reverse merger
under the purchase method of accounting in accordance with
U.S. generally accepted accounting principles. For
accounting purposes, Micromet is considered to be acquiring
CancerVax in this transaction. Therefore, the aggregate
consideration paid in connection with the merger, together with
the direct costs of acquisition, will be allocated to
CancerVaxs tangible and intangible assets and liabilities
based on their fair market values. The assets and liabilities
and results of operations of CancerVax will be consolidated into
the results of operations of Micromet as of the effective date
of the merger. These allocations will be based on a valuation
that has not yet been finalized.
Appraisal
Rights (Page 92)
Under Delaware law, Micromet shareholders and holders of
CancerVax common stock are not entitled to appraisal rights in
connection with the merger. The sole stockholder of Micromet
Parent has already consented to the merger and accordingly is
not entitled to assert appraisal rights.
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CancerVax
Proposal No. 2 Approval of Amendment
to the Amended and Restated Certificate of Incorporation of
CancerVax to Increase Authorized Common Stock
(Page 116)
CancerVax currently does not have authorized sufficient shares
to effectuate the merger. At the CancerVax meeting, holders of
CancerVax stock will be asked to approve an amendment of
CancerVaxs amended and restated certificate of
incorporation to increase the number of authorized shares of
CancerVax common stock to 150,000,000, while the number of
authorized shares of preferred stock will remain unchanged.
CancerVaxs amended and restated certificate of
incorporation currently authorizes 75,000,000 shares of
common stock and 10,000,000 shares of preferred stock. On
March 27, 2006, 27,955,139 shares of CancerVax common
stock were outstanding.
CancerVax
Proposal No. 3 Authorization of the
CancerVax Board of Directors to Effect the Reverse Stock Split
(Page 117)
At the CancerVax meeting, holders of CancerVax common stock will
be asked to approve the proposal to authorize CancerVaxs
board of directors to, at their discretion, amend the CancerVax
amended and restated certificate of incorporation to effect a
reverse stock split of the issued and outstanding shares of
CancerVax common stock at a ratio within the range of
1:2 and 1:4. If approved by the CancerVax
stockholders, the reverse stock split would become effective
upon the closing of the merger. The CancerVax board may effect
only one reverse stock split in connection with this
Proposal No. 3. The CancerVax boards decision
will be based on a number of factors, including market
conditions, existing and expected trading prices for
CancerVaxs common stock and the listing requirements of
the Nasdaq National Market. Even if the stockholders approve the
reverse stock split, CancerVax reserves the right not to effect
the reverse stock split if the CancerVax board does not deem it
to be in the best interests of CancerVax and its stockholders to
effect the reverse stock split. The CancerVax board may
determine to effect the reverse stock split, if it is approved
by the stockholders, even if the other proposals to be acted
upon at the meeting are not approved, including the issuance of
shares in the merger.
The form of the proposed amendment to the CancerVax amended and
restated certificate of incorporation to effect the reverse
stock split, as more fully described below, will effect the
reverse stock split but will not change the number of authorized
shares of common stock or preferred stock, or the par value of
CancerVaxs common stock or preferred stock.
CancerVax
Proposal No. 4 Approval of Name
Change (Page 122)
In connection with the merger, CancerVax is proposing to amend
CancerVaxs amended and restated certificate of
incorporation to change the name of the corporation from
CancerVax Corporation to Micromet, Inc.
The primary reason for the corporate name change is that
management believes this will allow for brand recognition of
CancerVaxs and Micromets products and services
through the creation of a single brand name. CancerVaxs
management believes that the current name will no longer
accurately reflect the business of the combined company and the
mission of the combined company subsequent to the consummation
of the merger. Insofar as the proposed new corporate name will
reflect a combination of Micromets business with CancerVax
following the merger, the proposed name change and the amendment
of CancerVaxs amended and restated certificate of
incorporation, even if approved by the stockholders at the
annual meeting, will only be filed with the office of the
Secretary of State of the State of Delaware and, therefore,
become effective if the merger is consummated. The approval of
the name change to Micromet, Inc. is a condition to the
consummation of the merger.
CancerVax
Proposal No. 5 Election of CancerVax
Directors (Page 123)
At the CancerVax meeting, three nominees for director are to be
elected as Class III directors. The nominees are
David F. Hale, Donald L. Morton, M.D. and
Michael G. Carter, M.B., Ch.B., F.R.C.P., who are each
members of CancerVaxs present board of directors. The
Class I and Class II directors have one year and two
years, respectively, remaining on their terms of office.
However, if the merger is completed, the board of directors of
the combined company will consist of Messrs. Hale,
Phillips, Schneider and Carter, who are currently directors of
CancerVax, and
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Messrs. Benjamin, Stampacchia, and Berriman, who are
currently directors of Micromet, and Messrs. Itin and one
additional member to be designated by Micromet.
CancerVax
Proposal No. 6 Ratification of Selection
of CancerVaxs Independent Registered Public Accounting
Firm (Page 131)
CancerVaxs board of directors and audit committee have
selected Ernst & Young LLP as our independent
registered public accounting firm for the fiscal year ending
December 31, 2006 and have directed that management submit
the selection of the independent registered public accounting
firm to the stockholders for ratification at the annual meeting.
Ernst & Young LLP has audited our financial statements
since June 1998, our date of inception, and through the year
ending December 31, 2005. Representatives of Ernst &
Young LLP will be present at the annual meeting, will have
an opportunity to make a statement if they so desire and will be
available to respond to appropriate questions. Stockholders are
not required to ratify the selection of Ernst &
Young LLP as our independent registered public accounting
firm. However, CancerVax is submitting the selection of Ernst
& Young LLP to the stockholders for ratification as a
matter of good corporate practice. If you fail to ratify the
selection, our board of directors and the audit committee will
reconsider whether or not to retain Ernst & Young LLP.
Even if the selection is ratified, our board of directors and
the audit committee in their discretion may direct the
appointment of a different independent registered public
accounting firm at any time during the year if they determine
that such a change would be in the best interests of CancerVax
and its stockholders.
CancerVax
Proposal No. 7 Approval of Possible
Adjournment of the Annual Meeting (Page 133)
If CancerVax fails to receive a sufficient number of votes to
approve Proposal Nos. 1 through 6, CancerVax may
propose to adjourn the annual meeting, if a quorum is present,
for a period of not more than 30 days for the purpose of
soliciting additional proxies to approve
Proposal Nos. 1 through 6. CancerVax currently
does not intend to propose adjournment at the annual meeting if
there are sufficient votes to approve Proposal Nos. 1
through 6.
20
MARKET
PRICE AND DIVIDEND DATA
CancerVax common stock is listed on the Nasdaq National Market
under the symbol CNVX. The following table presents,
for the periods indicated, the range of high and low per share
sales prices for CancerVax common stock as reported on the
Nasdaq National Market since CancerVaxs initial public
offering on October 30, 2003. Micromet is a private company
and its ordinary shares and preference shares are not publicly
traded.
CancerVax
Common Stock
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
Year Ended December 31,
2003
|
|
|
|
|
|
|
|
|
Fourth Quarter (beginning
October 30, 2003)
|
|
$
|
13.24
|
|
|
$
|
8.82
|
|
Year Ended December 31,
2004
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
13.35
|
|
|
$
|
9.25
|
|
Second Quarter
|
|
$
|
12.27
|
|
|
$
|
6.99
|
|
Third Quarter
|
|
$
|
8.93
|
|
|
$
|
5.55
|
|
Fourth Quarter
|
|
$
|
11.45
|
|
|
$
|
7.38
|
|
Year Ended December 31,
2005
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
11.00
|
|
|
$
|
6.02
|
|
Second Quarter
|
|
$
|
6.71
|
|
|
$
|
2.70
|
|
Third Quarter
|
|
$
|
4.24
|
|
|
$
|
2.76
|
|
Fourth Quarter
|
|
$
|
3.46
|
|
|
$
|
1.31
|
|
Year Ended December 31,
2006
|
|
|
|
|
|
|
|
|
First Quarter (through
March 27, 2006)
|
|
$
|
3.55
|
|
|
$
|
1.32
|
|
On January 6, 2006, the last trading day prior to
announcement of the merger, the closing price of
CancerVaxs common stock was $1.49, for an aggregate value
of CancerVax of $41.7 million, so if the merger was
consummated on that day, the value attributable to the Micromet
capital stock in the aggregate, or to approximately 67.5% of the
fully-diluted shares of the combined company, would equal
$86.5 million. On March 27, 2006, the closing price of
CancerVaxs common stock was $3.00, for an aggregate value
of CancerVax of $83.9 million, so if the merger was
consummated on that day, the value attributable to the Micromet
Parent capital stock in the aggregate, or to approximately 67.5%
of the fully-diluted shares of the combined company, would equal
$174.2 million. Accordingly, the value per share allocable
to the holders of capital stock of Micromet Parent, assuming
consummation of the Micromet Reorganization, as of
January 6, 2006 and March 27, 2006, would be $25.07
and $50.47, respectively.
Because the market price of CancerVax common stock is subject to
fluctuation, the market value of the shares of CancerVax common
stock that holders of Micromet Parent capital stock will receive
in the merger may increase or decrease.
Following the consummation of the merger and successful
reapplication to the NASD for initial inclusion, CancerVax
common stock will continue to be listed on the Nasdaq National
Market and there will be no public market for the Micromet
ordinary shares and preference shares.
Dividends
CancerVax has never declared or paid any cash dividends on its
capital stock. CancerVax currently intends to retain any future
earnings to finance the growth and development of its business
and, therefore, does not anticipate paying any cash dividends in
the foreseeable future. Any future determination to pay cash
dividends will be at the discretion of CancerVaxs board of
directors and will depend upon its financial condition,
operating results, capital requirements, covenants in
CancerVaxs debt instruments, and such other factors as the
board of directors deems relevant.
Micromet has never declared or paid any cash dividends on its
capital stock nor does it intend to do so.
21
CANCERVAX
SELECTED HISTORICAL CONSOLIDATED FINANCIAL DATA
The following table sets forth selected historical financial
data of CancerVax. The statement of operations data for the
years ended December 31, 2003, 2004 and 2005 and the
balance sheet data as of December 31, 2004 and 2005 have
been derived from CancerVaxs audited consolidated
financial statements contained in this proxy
statement/prospectus. The statement of operations data for the
years ended December 31, 2001 and 2002 and the balance
sheet data as of December 31, 2001, 2002 and 2003 have been
derived from CancerVaxs audited consolidated financial
statements which are not included in this proxy
statement/prospectus. This information is only a summary and you
should read the following tables in conjunction with
CancerVaxs financial statements and related notes and
CancerVaxs Managements Discussion and Analysis
of Financial Condition and Results of Operations,
contained in this proxy statement/prospectus. Historical results
are not necessarily indicative of the results to be expected in
the future.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2001
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
|
(In thousands, except per share
amounts)
|
|
|
Consolidated Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License fee
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
316
|
|
|
$
|
24,683
|
|
Collaborative research and
development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,210
|
|
|
|
15,925
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,526
|
|
|
|
40,608
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
13,910
|
|
|
|
24,517
|
|
|
|
27,725
|
|
|
|
43,102
|
|
|
|
38,751
|
|
General and administrative
|
|
|
5,441
|
|
|
|
6,514
|
|
|
|
6,826
|
|
|
|
12,310
|
|
|
|
11,993
|
|
Amortization of employee
stock-based
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compensation(1)
|
|
|
|
|
|
|
1,412
|
|
|
|
2,643
|
|
|
|
1,864
|
|
|
|
555
|
|
Restructuring charges
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,918
|
|
Impairment of long-lived assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,366
|
|
Purchased in-process research and
development
|
|
|
|
|
|
|
2,840
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
19,351
|
|
|
|
35,283
|
|
|
|
37,194
|
|
|
|
57,276
|
|
|
|
81,583
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
909
|
|
|
|
691
|
|
|
|
553
|
|
|
|
920
|
|
|
|
1,843
|
|
Interest expense
|
|
|
(140
|
)
|
|
|
(621
|
)
|
|
|
(932
|
)
|
|
|
(756
|
)
|
|
|
(487
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
769
|
|
|
|
70
|
|
|
|
(379
|
)
|
|
|
164
|
|
|
|
1,356
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(18,582
|
)
|
|
|
(35,213
|
)
|
|
|
(37,573
|
)
|
|
|
(55,586
|
)
|
|
|
(39,619
|
)
|
Accretion to redemption value of
redeemable convertible preferred stock
|
|
|
(4,105
|
)
|
|
|
(7,635
|
)
|
|
|
(7,867
|
)
|
|
|
|
|
|
|
|
|
Deemed dividend resulting from
beneficial conversion feature on Series C preferred stock
|
|
|
|
|
|
|
|
|
|
|
(14,775
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common
stockholders
|
|
$
|
(22,687
|
)
|
|
$
|
(42,848
|
)
|
|
$
|
(60,215
|
)
|
|
$
|
(55,586
|
)
|
|
$
|
(39,619
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
$
|
(266.02
|
)
|
|
$
|
(153.85
|
)
|
|
$
|
(13.30
|
)
|
|
$
|
(2.08
|
)
|
|
$
|
(1.42
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to
compute basic and diluted net loss per share
|
|
|
85
|
|
|
|
279
|
|
|
|
4,527
|
|
|
|
26,733
|
|
|
|
27,848
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
|
|
|
(1) |
|
Amortization of employee stock-based compensation is allocated
among operating expense categories as follows (in thousands): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
Research and development
|
|
$
|
379
|
|
|
$
|
838
|
|
|
$
|
531
|
|
|
$
|
81
|
|
General and administrative
|
|
|
1,033
|
|
|
|
1,805
|
|
|
|
1,333
|
|
|
|
474
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,412
|
|
|
$
|
2,643
|
|
|
$
|
1,864
|
|
|
$
|
555
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
December 31,
|
|
|
|
2001
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Consolidated Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
securities
available-for-sale
|
|
$
|
10,103
|
|
|
$
|
36,201
|
|
|
$
|
107,092
|
|
|
$
|
65,073
|
|
|
$
|
51,195
|
|
Working capital
|
|
|
5,853
|
|
|
|
29,466
|
|
|
|
97,268
|
|
|
|
73,382
|
|
|
|
24,319
|
|
Total assets
|
|
|
20,795
|
|
|
|
55,187
|
|
|
|
127,007
|
|
|
|
116,160
|
|
|
|
63,297
|
|
Long-term debt, net of current
portion
|
|
|
3,353
|
|
|
|
7,379
|
|
|
|
1,811
|
|
|
|
6,355
|
|
|
|
|
|
Redeemable convertible preferred
stock
|
|
|
32,455
|
|
|
|
96,582
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
(26,129
|
)
|
|
|
(68,977
|
)
|
|
|
(129,192
|
)
|
|
|
(184,778
|
)
|
|
|
(224,397
|
)
|
Total stockholders equity
(deficit)
|
|
|
(20,663
|
)
|
|
|
(55,878
|
)
|
|
|
112,773
|
|
|
|
71,458
|
|
|
|
32,711
|
|
23
MICROMET
SELECTED HISTORICAL CONSOLIDATED FINANCIAL DATA
The following table sets forth selected historical financial
data of Micromet. The statement of operations data for the years
ended December 31, 2003, 2004 and 2005 and the balance
sheet data as of December 31, 2004 and 2005 have been
derived from Micromets audited financial statements which
are included elsewhere in this proxy statement/prospectus. The
statement of operations data for the year ended
December 31, 2002 and the balance sheet data as of
December 31, 2003 have been derived from Micromets
audited financial statements, which are not included in this
proxy statement/prospectus. The statement of operations data for
the year ended December 31, 2001 and the balance sheet data
as of December 31, 2001 and 2002 have been derived from
Micromets unaudited financial statements which are not
included in this proxy statement/prospectus. This information is
only a summary and you should read the following tables in
conjunction with Micromets financial statements and
related notes and Micromets Managements
Discussion and Analysis of Financial Condition and Results of
Operations, contained in this proxy statement/prospectus.
Historical results are not necessarily indicative of the results
to be expected in the future.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2001
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Statement of Operations
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
3,741
|
|
|
|
13,189
|
|
|
|
13,459
|
|
|
|
20,779
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
11,387
|
|
|
|
22,428
|
|
|
|
26,173
|
|
|
|
26,598
|
|
|
|
23,923
|
|
General and administrative
|
|
|
1,383
|
|
|
|
2,566
|
|
|
|
3,916
|
|
|
|
4,493
|
|
|
|
4,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
12,770
|
|
|
|
24,994
|
|
|
|
30,089
|
|
|
|
31,091
|
|
|
|
28,510
|
|
Loss from operations
|
|
|
(12,770
|
)
|
|
|
(21,253
|
)
|
|
|
(16,900
|
)
|
|
|
(17,632
|
)
|
|
|
(7,731
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
423
|
|
|
|
(308
|
)
|
|
|
(2,054
|
)
|
|
|
(2,522
|
)
|
|
|
(3,662
|
)
|
Net loss
|
|
|
(12,347
|
)
|
|
|
(21,561
|
)
|
|
|
(18,954
|
)
|
|
|
(20,154
|
)
|
|
|
(11,393
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
December 31,
|
|
|
|
2001
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
13,545
|
|
|
|
7,040
|
|
|
|
3,062
|
|
|
|
9,088
|
|
|
|
6,572
|
|
Total assets
|
|
|
46,788
|
|
|
|
44,633
|
|
|
|
36,441
|
|
|
|
36,648
|
|
|
|
24,381
|
|
Long-term debt, net of current
portion
|
|
|
5,887
|
|
|
|
7,419
|
|
|
|
7,867
|
|
|
|
7,240
|
|
|
|
4,670
|
|
Convertible notes payable, net of
current portion
|
|
|
3,696
|
|
|
|
13,413
|
|
|
|
23,840
|
|
|
|
29,490
|
|
|
|
10,000
|
|
Accumulated deficit
|
|
|
(25,944
|
)
|
|
|
(47,401
|
)
|
|
|
(66,458
|
)
|
|
|
(86,612
|
)
|
|
|
(102,023
|
)
|
Total stockholders equity
(deficit)
|
|
|
34,953
|
|
|
|
14,509
|
|
|
|
(4,181
|
)
|
|
|
(24,356
|
)
|
|
|
(12,271
|
)
|
24
SELECTED
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL DATA
The following selected unaudited pro forma condensed combined
financial information was prepared using the purchase method of
accounting. For accounting purposes, Micromet is considered to
be acquiring CancerVax in the merger. The CancerVax and Micromet
unaudited pro forma condensed combined balance sheet data assume
that the merger of CancerVax and Micromet was consummated on
December 31, 2005, and combines CancerVaxs and
Micromets historical balance sheets as of
December 31, 2005. The CancerVax and Micromet unaudited pro
forma condensed combined statement of operations data assume
that the merger of CancerVax and Micromet was consummated on
January 1, 2005. The unaudited pro forma condensed combined
statement of operations data for the year ended
December 31, 2005 combines CancerVaxs and
Micromets historical statements of operations for the year
ended December 31, 2005.
The selected unaudited pro forma condensed combined financial
data are presented for illustrative purposes only and are not
necessarily indicative of the combined financial position or
results of operations of future periods or the results that
actually would have been realized had the entities been a single
entity during this period. The selected unaudited pro forma
condensed combined financial data as of and for the year ended
December 31, 2005 are derived from the unaudited pro forma
condensed combined financial statements at page 142 of this
proxy statement/prospectus and should be read in conjunction
with those statements and the related notes. See Unaudited
Pro Forma Condensed Combined Financial Statements.
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
|
(In thousands, except
|
|
|
|
per share amounts)
|
|
|
Unaudited Pro Forma Condensed
Combined Statement of Operations Data:
|
|
|
|
|
Revenues
|
|
$
|
66,486
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
|
66,876
|
|
General and administrative
|
|
|
17,048
|
|
Amortization of employee
stock-based compensation
|
|
|
5,091
|
|
Restructuring charges
|
|
|
4,918
|
|
Impairment of long-lived assets
|
|
|
25,366
|
|
|
|
|
|
|
Total operating expenses
|
|
|
119,299
|
|
|
|
|
|
|
Other expense, net
|
|
|
(3,021
|
)
|
|
|
|
|
|
Net loss
|
|
|
(55,834
|
)
|
|
|
|
|
|
Beneficial conversion charge on
issuance of preferred shares
|
|
|
(5,004
|
)
|
Net loss attributable to common
stockholders
|
|
$
|
(60,838
|
)
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
$
|
(0.71
|
)
|
|
|
|
|
|
Weighted average shares used to
compute basic and diluted net loss per share
|
|
|
85,861
|
|
|
|
|
|
|
25
|
|
|
|
|
|
|
As of
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Unaudited Pro Forma Condensed
Combined Balance Sheet Data:
|
|
|
|
|
Cash, cash equivalents and
securities
available-for-sale
|
|
$
|
41,816
|
|
Working capital
|
|
|
12,132
|
|
Total assets
|
|
|
65,405
|
|
Long-term debt, net of current
portion
|
|
|
4,498
|
|
Convertible note payable, net of
current portion
|
|
|
11,845
|
|
Accumulated deficit
|
|
|
(139,505
|
)
|
Total stockholders equity
|
|
|
8,722
|
|
26
DESCRIPTION
OF CANCERVAXS COMMON STOCK
Common
Stock
As of March 27, 2006, the authorized common stock of
CancerVax consisted of 75,000,000 shares of common stock,
of which 27,955,139 shares were issued and outstanding.
Dividend
Rights
Subject to preferences that may apply to shares of preferred
stock outstanding at the time, the holders of outstanding shares
of CancerVax common stock are entitled to receive dividends out
of assets legally available at the times and in the amounts as
our board of directors may from time to time determine.
Voting
Rights
Each CancerVax common stockholder is entitled to one vote for
each share of common stock held on all matters submitted to a
vote of stockholders. Cumulative voting for the election of
directors is not provided for in our amended and restated
certificate of incorporation, which means that the holders of a
majority of the shares voted can elect all of the directors then
standing for election.
No
Preemptive or Similar Rights
Our common stock is not entitled to preemptive rights and is not
subject to conversion or redemption.
Right
to Receive Liquidation Distributions
Upon our liquidation, dissolution or winding-up, the assets
legally available for distribution to our stockholders are
distributable ratably among the holders of our common stock and
any participating preferred stock outstanding at that time after
payment of liquidation preferences, if any, on any outstanding
preferred stock and payment of other claims of creditors.
Anti-Takeover
Provisions
The provisions of the Delaware General Corporation Law, or DGCL,
CancerVaxs amended and restated certificate of
incorporation and bylaws may have the effect of delaying,
deferring, or discouraging another person from acquiring control
of CancerVax.
CancerVax is subject to Section 203 of the DGCL, which,
subject to certain exceptions, prohibits a Delaware corporation
from engaging in any business combination with an
interested stockholder for a period of three years
following the time that such stockholder became an interested
stockholder, unless:
|
|
|
|
|
the board of directors of the corporation approves either the
business combination or the transaction that resulted in the
stockholder becoming an interested stockholder, prior to the
time the interested stockholder attained that status;
|
|
|
|
upon the closing of the transaction that resulted in the
stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the number of shares
outstanding those shares owned (a) by persons who are
directors and also officers and (b) by employee stock plans
in which employee participants do not have the right to
determine confidentially whether shares held subject to the plan
will be tendered in a tender or exchange offer; or
|
|
|
|
at or subsequent to such time, the business combination is
approved by the board of directors and authorized at an annual
or special meeting of stockholders, and not by written consent,
by the affirmative vote of at least two-thirds of the
outstanding voting stock that is not owned by the interested
stockholder.
|
With certain exceptions, an interested stockholder
is a person or group who or which owns 15% or more of the
corporations outstanding voting stock (including any
rights to acquire stock pursuant to an option, warrant,
27
agreement, arrangement or understanding, or upon the exercise of
conversion or exchange rights, and stock with respect to which
the person has voting rights only), or is an affiliate or
associate of the corporation and was the owner of 15% or more of
such voting stock at any time within the previous three years.
In general, Section 203 defines a business combination to
include:
|
|
|
|
|
any merger or consolidation involving the corporation and the
interested stockholder;
|
|
|
|
any sale, transfer, pledge or other disposition of 10% or more
of the assets of the corporation involving the interested
stockholder;
|
|
|
|
subject to certain exceptions, any transaction that results in
the issuance or transfer by the corporation of any stock of the
corporation to the interested stockholder;
|
|
|
|
any transaction involving the corporation that has the effect of
increasing the proportionate share of the stock or any class or
series of the corporation beneficially owned by the interested
stockholder; or
|
|
|
|
the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation.
|
A Delaware corporation may opt out of this provision
with an express provision in its original amended and restated
certificate of incorporation or an express provision in its
amended and restated certificate of incorporation or bylaws
resulting from a stockholders amendment approved by at
least a majority of the outstanding voting shares. However,
CancerVax has not opted out of this provision.
Section 203 could prohibit or delay mergers or other
takeover or
change-in-control
attempts and, accordingly, may discourage attempts to acquire
CancerVax.
Transfer
Agent
The transfer agent for CancerVax common stock is Mellon Investor
Services LLC.
Listing
CancerVax common stock is quoted on the Nasdaq National Market
under the symbol CNVX.
28
COMPARATIVE
HISTORICAL AND PRO FORMA PER SHARE DATA
The following information does not give effect to the
proposed reverse stock split of CancerVax common stock described
in CancerVaxs Proposal No. 3.
The information below reflects:
|
|
|
|
|
the historical net loss and book value per share of CancerVax
common stock and the historical net loss and book value per
Micromet ordinary share in comparison with the unaudited pro
forma net loss and book value per share after giving effect to
the proposed merger of CancerVax with Micromet on a purchase
basis;
|
|
|
|
|
|
the equivalent historical net loss and book value per share
attributable to an estimated 58,012,946 shares of CancerVax
common stock which would have been issued to the holders of
Micromet capital stock, assuming the merger was consummated on
January 1, 2005; and
|
|
|
|
|
|
the contemplated exchange of all Micromet equity interests for
shares of common stock of Micromet Parent in the Micromet
Reorganization.
|
You should read the tables below in conjunction with the
respective audited financial statements and related notes of
CancerVax and Micromet included elsewhere in this proxy
statement/prospectus and the unaudited pro forma condensed
financial information and notes related to such financial
statements included elsewhere in this proxy statement/prospectus.
CANCERVAX
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31, 2005
|
|
|
Historical Per Common Share
Data:
|
|
|
|
|
Net loss per common
share basic and diluted
|
|
$
|
(1.42
|
)
|
Book value per share
|
|
$
|
1.17
|
|
MICROMET
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31, 2005
|
|
|
Historical Per Ordinary Share
Data(1):
|
|
|
|
|
Net loss per ordinary
share basic and diluted
|
|
|
(3.35
|
)
|
Book value per share
|
|
|
(3.61
|
)
|
|
|
(1) |
All per share data have been restated to give retroactive effect
to an equity restructuring and reverse stock split of Micromet
shares effected in October 2005.
|
CANCERVAX
AND MICROMET
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31, 2005
|
|
|
Combined Pro Forma Per Common
Share Data:
|
|
|
|
|
Net loss per combined
share basic and diluted
|
|
$
|
(0.71
|
)
|
Book value per combined share
|
|
$
|
0.10
|
|
29
FORWARD-LOOKING
INFORMATION
This proxy statement/prospectus includes forward-looking
statements within the meaning of the safe harbor
provisions of the United States Private Securities Litigation
Reform Act of 1995. Words such as anticipate,
believes, budget, continue,
could, estimate, expect,
forecast, intend, may,
plan, potential, predicts,
project, should, will and
similar expressions are intended to identify such
forward-looking statements. Forward-looking statements in this
proxy statement/prospectus include, without limitation,
statements regarding benefits of the proposed merger and future
expectations concerning available cash and cash equivalents, the
expected timing of the conclusion of clinical trials, the timing
of regulatory filings, and other matters that involve known and
unknown risks, uncertainties and other factors that may cause
actual results, levels of activity, performance or achievements
to differ materially from results expressed in or implied by
this proxy statement/prospectus. Such risk factors include,
among others:
|
|
|
|
|
difficulties encountered in integrating merged businesses;
|
|
|
|
uncertainties as to the timing of the merger, approval of the
transaction by the stockholders of CancerVax and the
satisfaction of closing conditions to the transaction, including
the receipt of regulatory approvals, if any;
|
|
|
|
the competitive environment in the life sciences industry;
|
|
|
|
whether the companies can successfully develop new products and
the degree to which these gain market acceptance;
|
|
|
|
the success and timing of our preclinical studies and clinical
trials;
|
|
|
|
the companies ability to obtain and maintain regulatory
approval for their product candidates and the timing of such
approvals;
|
|
|
|
the companies plans to research, develop and commercialize
their product candidates;
|
|
|
|
regulatory developments in the United States and foreign
countries; and
|
|
|
|
the companies ability to obtain and maintain intellectual
property protection for their product candidates.
|
Actual results may differ materially from those contained in the
forward-looking statements in this proxy statement/prospectus.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of
this proxy statement/prospectus. All forward-looking statements
are qualified in their entirety by this cautionary statement.
30
RISK
FACTORS
You should consider the following factors in evaluating
whether to approve the issuance of shares of CancerVax common
stock in the merger and the resulting change in control of
CancerVax. These factors should be considered in conjunction
with the other information included by CancerVax and Micromet in
this proxy statement/prospectus.
References to we, us and
our in these risk factors refer to the operations of
the combined company as it would exist following the merger.
Risks
Relating to the Proposed Merger
After
the merger, we will need to modify our finance and accounting
systems, procedures and controls to incorporate the operations
of Micromet, which modifications may be time consuming and
expensive to implement, and there is no guarantee that we will
be able to do so.
As a public reporting company, we are required to comply with
the Sarbanes-Oxley Act of 2002 and the related rules and
regulations of the Securities and Exchange Commission, including
Section 404 of the Sarbanes-Oxley Act of 2002. Although we
believe that we currently have adequate finance and accounting
systems, procedures and controls for our business on a
standalone basis, after the merger we will need to upgrade the
existing, and implement additional, procedures and controls to
incorporate the operations of Micromet. These updates may
require significant time and expense, and there can be no
guarantee that we will be successful in implementing them.
Furthermore, CancerVaxs managerial, financial and
accounting personnel are expected to terminate their employment
with us soon after the merger. The loss of these personnel could
limit our ability to successfully complete these updates. If we
are unable to complete the required modifications to our
internal control reporting or if our independent registered
public accounting firm is unable to provide us with an
unqualified report as to the effectiveness of our internal
control over financial reporting, investors could lose
confidence in the reliability of our internal control over
financial reporting, which could have a material adverse effect
on our stock price.
If we
are not successful in integrating our organizations, we may not
be able to operate efficiently after the merger.
Achieving the benefits of the merger will depend in part on the
successful integration of CancerVaxs and Micromets
technical and business operations and personnel in a timely and
efficient manner. The integration process requires coordination
of the personnel of both companies, and involves the integration
of systems, applications, policies, procedures, business
processes and operations. This process may be difficult and
unpredictable because of possible conflicts and differing
opinions on business, scientific and regulatory matters.
Moreover, the integration of the two companies will present
challenges resulting from the transatlantic nature of the
combined company. If we cannot successfully integrate our
technical and business operations and personnel, we may not
realize the expected benefits of the merger.
Integrating
our companies may divert managements attention away from
our operations.
The successful integration of CancerVaxs and
Micromets technical and business operations and personnel
may place a significant burden on our management and internal
resources. The diversion of managements attention and any
difficulties encountered in the transition and integration
process could result in delays in our clinical trial and product
development programs and could otherwise harm our business,
financial condition and operating results.
We
expect to incur significant costs integrating the companies into
a single business.
We expect to incur significant costs integrating
CancerVaxs and Micromets technical and business
operations and personnel, which include costs for:
|
|
|
|
|
employee redeployment, relocation or severance;
|
|
|
|
|
|
conversion of information systems;
|
|
|
|
|
|
combining administrative teams and processes;
|
31
|
|
|
|
|
reorganization of facilities and disposition of excess
facilities; and
|
|
|
|
|
|
relocation or disposition of excess equipment.
|
If we
fail to retain key employees, the benefits of the merger could
be diminished.
The successful combination of CancerVax and Micromet will
depend, in part, on the retention of key personnel. There can be
no assurance that the combined company will be able to retain
its key management and scientific personnel. If we fail to
retain such key employees, we may not realize the anticipated
benefits of the merger. Additionally, the voluntary resignation
of William R. LaRue, CancerVaxs Chief Financial
Officer, will become effective June 1, 2006 and the
voluntary resignation of Hazel M. Aker, CancerVaxs
General Counsel, will become effective upon the closing of the
merger.
If one
or more of the product candidates in the merged company cannot
be shown to be safe and effective in clinical trials, is not
approvable or not commercially successful, then the benefits of
the merger may not be realized.
The combined company will have two product candidates in
clinical trials, and we plan to commence clinical trials for one
additional product candidate in 2006 and at least one product
candidate in 2007. All of these product candidates must be
rigorously tested in clinical trials, and be shown to be safe
and effective before the U.S. Food and Drug Administration
or other regulatory authorities outside the U.S. will consider
them for approval. Failure to demonstrate that one or more of
our product candidates is safe and effective, or significant
delays in demonstrating such safety and efficacy, could diminish
the benefits of the merger. Failure to obtain marketing approval
of one or more of our product candidates from appropriate
regulatory authorities, or significant delays in obtaining such
approval, could diminish the benefits of the merger. If approved
for sale, our product candidates must be successfully
commercialized. Failure to successfully commercialize one or
more of our product candidates could diminish the benefits of
the merger.
Because
Micromet Parent stockholders will receive a fixed number of
shares of CancerVax common stock in the merger, rather than a
fixed value, if the market price of CancerVax common stock
declines, Micromet Parent stockholders will receive
consideration in the merger of lesser value.
The aggregate number of shares of common stock of CancerVax to
be issued to Micromet Parent stockholders is fixed. Accordingly,
the aggregate number of shares that Micromet Parent stockholders
will receive in the merger will not change, even if the market
price of CancerVax common stock changes. In recent years, the
stock market in general, and the securities of biotechnology
companies in particular, have experienced extreme price and
volume fluctuations. These market fluctuations may adversely
affect the market price of CancerVax common stock. The market
price of CancerVax common stock upon and after the consummation
of the merger could be lower than the market price on the date
of the merger agreement or the current market price.
Failure
to complete the merger could adversely affect CancerVaxs
stock price and CancerVaxs and Micromets future
business and operations.
The merger is subject to the satisfaction of closing conditions,
including approval by CancerVax stockholders, and neither
CancerVax nor Micromet can assure you that the merger will be
successfully completed. In the event that the merger is not
consummated, CancerVax and Micromet may be subject to many
risks, including the costs related to the merger, such as legal,
accounting and advisory fees, which must be paid even if the
merger is not completed, and the payment by either Micromet or
CancerVax of a termination fee under certain circumstances. If
the merger is not consummated, the market price of CancerVax
common stock could decline.
Completion
of the merger may result in dilution of future earnings per
share to the stockholders of CancerVax.
The completion of the merger may result in greater net losses or
a weaker financial condition compared to that which would have
been achieved by either CancerVax or Micromet on a stand-alone
basis. The merger could fail to produce the benefits that the
companies anticipate, or could have other adverse effects that
the companies currently
32
do not foresee. In addition, some of the assumptions that
either company has made, such as the achievement of operating
synergies, may not be realized. In this event, the merger could
result in greater losses as compared to the losses that would
have been incurred by CancerVax if the merger had not occurred.
The
costs associated with the merger are difficult to estimate, may
be higher than expected and may harm the financial results of
the combined company.
CancerVax and Micromet estimate that they will incur aggregate
direct transaction costs of approximately $4.1 million
associated with the merger, and additional costs associated with
the consolidation and integration of operations, which cannot be
estimated accurately at this time. If the total costs of the
merger exceed our estimates or the benefits of the merger do not
exceed the total costs of the merger, the financial results of
the combined company could be adversely affected.
Micromet
executive officers and directors may have interests that are
different from, or in addition to, those of Micromet
shareholders generally.
The executive officers and directors of Micromet may have
interests in the merger that are different from, or are in
addition to, those of Micromet shareholders generally. These
interests include ownership through affiliated entities of
CancerVax common stock, certain Micromet directors being
nominated for election to the CancerVax board of directors at
the effective time of the merger, the issuance of options to
Micromet management immediately prior to the transaction, which
will be assumed by CancerVax, the adoption of new employment
agreements for certain Micromet executives in connection with
the merger and/or the provision and continuation of
indemnification and insurance arrangements for current directors
of Micromet following consummation of the merger. In addition,
you should be aware that Michael Carter has a significant
relationship with both companies due to his position as a
current director of both CancerVax and Micromet. See the section
entitled The Merger Interests of
Micromets Executive Officers and Directors in the
Merger starting on page 87.
Risks
Relating to CancerVax
Risks
Relating to CancerVaxs Business
Our
business to date has been largely dependent on the success of
Canvaxin, which was the subject of Phase 3 clinical trials
that we terminated in 2005. Although we ceased the development
of Canvaxin and have reduced our workforce, we may be unable to
successfully manage our remaining resources, including available
cash, while we seek to implement the merger with
Micromet.
Both of our Phase 3 clinical trials for Canvaxin in patients
with advanced-stage melanoma were discontinued during 2005 based
upon the recommendations of the independent Data and Safety
Monitoring Board, or DSMB, with oversight responsibility for
these clinical trials, that the data were unlikely to provide
significant evidence of a survival benefit for Canvaxin-treated
patients versus patients who received placebo. We had previously
devoted substantially all of our research, development and
clinical efforts and financial resources toward the development
of Canvaxin. In connection with the termination of our clinical
trials for Canvaxin, we announced restructuring activities,
including significant workforce reductions, and in 2005 incurred
non-recurring charges associated with our restructuring
activities aggregating $5.1 million, which includes
employee severance costs of $3.5 million, leased facility
exit costs of $1.4 million and contract termination costs
of $0.2 million. In addition, we anticipate continued
workforce reductions and associated employee severance and other
costs in 2006. As a result of the discontinuation of our
clinical trials, development program and manufacturing
operations for Canvaxin, we are planning to sublease our
manufacturing facility, which includes the additional production
suite, our warehouse facility and our corporate headquarters and
research and development facility. We cannot predict whether any
such subleasing arrangements would be consummated on favorable
terms or at all, and anticipate that such transactions may
require us to incur significant additional costs and obtain
third-party consents beyond our control. We may be unable to
adequately reduce expenses associated with our existing
manufacturing, administrative and warehouse facilities, clinical
trial agreements and other commitments related to Canvaxin.
33
The
remaining product candidates in our pipeline are in early stages
of development and our efforts to develop and commercialize
these product candidates are subject to a high risk of failure.
If we fail to successfully develop our product candidates, our
ability to generate revenues will be substantially
impaired.
The process of successfully developing product candidates for
the treatment of human diseases is very time-consuming,
expensive and unpredictable and there is a high rate of
attrition for product candidates in preclinical and clinical
trials. Until recently, our business strategy depended upon the
successful clinical development of Canvaxin and the subsequent
development of additional pipeline product candidates to
complement our initial focus on Canvaxin. Our remaining product
candidates are in earlier stages of development than Canvaxin,
so we will require substantial additional financial resources,
as well as research, development and clinical capabilities, to
pursue the development of these product candidates, and we may
never develop an approvable product.
Our remaining principal product candidates are D93, a humanized,
anti-angiogenic monoclonal antibody, and SAI-EGF, a product
candidate that targets the epidermal growth factor receptor, or
EGFR, signaling pathway. In February 2006, we submitted an
Investigational New Drug Application, or IND, to initiate a
Phase 1 clinical trial for D93 in patients with solid
tumors in 2006, but we have not yet received approval from the
FDA to commence clinical trials with D93. In order to approve
our IND for D93 to initiate a Phase 1 clinical trial, the
FDA may request substantial additional testing or information,
which could result in delays, increased costs and uncertainty.
We have announced our intention to sub-license our rights to
SAI-EGF and the other product candidates that we licensed from
CIMAB, S.A., a Cuban company, and on January 13, 2006, we
received a letter from CIMAB notifying us of their belief that
we are in breach of our agreement with CIMAB as a result of our
failure to make a milestone payment. If we are unable to resolve
the dispute, then CIMAB may seek to terminate the agreement for
breach.
Subject to our diligence obligations to our licensors for these
product candidates, we are considering strategic alternatives
with respect to certain other of our product candidates given
the substantial reduction in our research and development and
clinical resources in connection with the termination of our
Canvaxin development activities. We may be unable to
successfully develop these product candidates ourselves, and we
also may be unable to enter into strategic collaborations with
third parties to pursue the development of these product
candidates. Even if we are able to identify potential strategic
collaborators or licensees for these product candidates, we may
be unable to obtain required consents from our licensors and the
financial terms available to us may not be acceptable. In any
event, we do not anticipate that any of our product candidates
will reach the market for at least several years.
We do not know whether our planned preclinical development or
clinical trials for our product candidates will begin on time or
be completed on schedule, if at all. In addition, we do not know
whether these clinical trials will result in marketable
products. We cannot assure you that any of our product
candidates will:
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be successfully developed;
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prove to be safe and effective in clinical trials;
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be approved for marketing by United States or foreign regulatory
authorities;
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be adequately protected by our intellectual property rights or
the rights of our licensors;
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be capable of being produced in commercial quantities at
acceptable costs;
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achieve market acceptance and be commercially viable; or
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be eligible for third party reimbursement from governmental or
private insurers.
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We are
subject to extensive government regulation that increases the
cost and uncertainty associated with our efforts to gain
regulatory approval of our product candidates.
Preclinical development, clinical trials, manufacturing and
commercialization of our product candidates are all subject to
extensive regulation by United States and foreign governmental
authorities. It takes many years and significant expenditures to
obtain the required regulatory approvals for biological
products. Satisfaction of regulatory requirements depends upon
the type, complexity and novelty of the product candidate and
requires substantial resources. As demonstrated by the
discontinuation of our Phase 3 clinical trials of Canvaxin
in patients with advanced-stage melanoma, we cannot be certain
that any of our product candidates will be shown to be safe
34
and effective, or that we will ultimately receive approval from
the FDA or foreign regulatory authorities to market these
products. In addition, even if granted, product approvals and
designations such as fast-track and orphan drug may be withdrawn
or limited at a later time.
We
have no manufacturing capabilities or manufacturing personnel
and expect to depend on third parties to manufacture the product
candidates that we are currently developing. We will be
dependent on sole-source suppliers to provide our product
candidates for early-stage clinical trials.
We do not operate any facilities for manufacturing D93 or any of
the other product candidates that we may develop in the future.
As a result, we will rely on third parties to manufacture these
product candidates for our early-stage clinical trials. Our
dependence upon third parties for the manufacture of these
product candidates may result in unforeseen delays or other
problems beyond our control.
In January 2005, we entered into an agreement with AppTec
Laboratory Services, Inc., to manufacture D93 for early-stage
clinical trials. There can be no assurance that we, AppTec or
any other third party manufacturing organization will be able to
develop adequate manufacturing capabilities to supply the
quantities of D93 needed for our clinical trials or
commercialization of this product candidate.
There are a limited number of manufacturers that are capable of
manufacturing biological product candidates. We may not be able
to obtain services from such manufacturers in a timely manner,
if at all, to meet our requirements for clinical trials and,
subject to the receipt of regulatory approvals, commercial sale.
We also depend on third party contract laboratories to perform
quality control testing of our product candidates.
Under our licensing agreement, CIMAB has the right and
obligation, subject to specified terms and conditions, to supply
SAI-EGF for Phase 1 and Phase 2 clinical trials, and
for Phase 3 clinical trials and commercialization in
countries in our territory other than the United States, Canada
and Mexico. Production of these product candidates may require
raw materials for which the sources and amounts are limited. Any
inability to obtain adequate supplies of such raw materials
could significantly delay the development, regulatory approval
and marketing of these product candidates. In addition, prior to
the initiation of Phase 3 clinical trials in the U.S., we
will need to transfer the manufacturing and quality assurance
processes for these product candidates to a facility outside of
Cuba. Our ability to transfer information to CIMAB that might be
beneficial in
scaling-up
such manufacturing processes is significantly limited due to
U.S. government restrictions. Difficulties or delays in the
transfer of the manufacturing and quality processes related to
these product candidates could cause significant delays in the
initiation of the Phase 3 clinical trials and in the
establishment of our own commercial-scale manufacturing
capabilities for these products. There can be no assurance that
we or CIMAB will be able to develop adequate manufacturing
capabilities to supply the quantities of SAI-EGF needed for
clinical trials or commercial-scale quantities.
Product
liability claims may damage our reputation and, if insurance
proves inadequate, the product liability claims may harm our
business.
We may be exposed to the risk of product liability claims that
is inherent in the manufacturing, testing and marketing of
therapies for treating people with cancer or other diseases.
Patients who participated in our clinical trials for Canvaxin or
patients who participate in our future clinical trials of our
other product candidates may bring product liability claims. A
product liability claim may damage our reputation by raising
questions about a products safety and efficacy and could
limit our ability to continue to conduct clinical trials and
develop or product candidates. If our claims experience results
in higher rates, or if product liability insurance otherwise
becomes costlier because of general economic, market or industry
conditions, then we may not be able to maintain product
liability coverage on acceptable terms.
Although we have product liability and clinical trial liability
insurance with coverage limits of $5 million, this coverage
may be inadequate, or may be unavailable in the future on
acceptable terms, if at all. Defending a suit, regardless of its
merit, could be costly and could divert management attention.
35
Changes
in the laws or regulations of the United States or Cuba related
to the conduct of our business with CIMAB may adversely affect
our ability to develop and commercialize or sublicense our
rights to SAI-EGF and the two other product candidates that we
have licensed from that company.
The United States government has maintained an embargo against
Cuba for more than 40 years. The embargo is administered by
the Office of Foreign Assets Control, or OFAC, of the
U.S. Department of Treasury. Without a license from OFAC,
U.S. individuals and companies may not engage in any
transaction in which Cuba or Cubans have an interest. In order
to enter into and carry out our licensing agreements with CIMAB,
we have obtained from OFAC a license authorizing us to carry out
all transactions set forth in the license agreements that we
have entered into with CIMAB for the development, testing,
licensing and commercialization of SAI-EGF, and with CIMAB and
YM Biosciences for the two other product candidates that target
the EGF receptor signaling pathway. In the absence of such a
license from OFAC, the execution of and our performance under
these agreements could have exposed us to legal and criminal
liability. At any time, there may occur for reasons beyond our
control a change in United States or Cuban law, or in the
regulatory environment in the U.S. or Cuba, or a shift in
the political attitudes of either the U.S. or Cuban
governments, that could result in the suspension or revocation
of our OFAC license or in our inability to carry out part or all
of the licensing agreements with CIMAB. There can be no
assurance that the U.S. or Cuban governments will not
modify existing law or establish new laws or regulations that
may adversely affect our ability to develop, test, license and
commercialize these product candidates. Our OFAC license may be
revoked or amended at anytime in the future, or the U.S. or
Cuban governments may restrict our ability to carry out all or
part of our respective duties under the licensing agreements
between us, CIMAB and YM BioSciences. Similarly, any such
actions may restrict CIMABs ability to carry out all or
part of its licensing agreements with us. In addition, we cannot
be sure that the FDA or other regulatory authorities will accept
data from the clinical trials of these products that were
conducted in Cuba as the basis for our applications to conduct
additional clinical trials, or as part of our application to
seek marketing authorizations for such products.
In 1996, a significant change to the United States embargo
against Cuba resulted from congressional passage of the Cuban
Liberty and Democratic Solidarity Act, also known as the
Helms-Burton Bill. That law authorizes private lawsuits for
damages against anyone who traffics in property confiscated,
without compensation, by the government of Cuba from persons who
at the time were, or have since become, nationals of the United
States. We do not own any property in Cuba and do not believe
that any of CIMABs properties or any of the scientific
centers that are or have been involved in the development of the
technology that we have licensed from CIMAB were confiscated by
the government of Cuba from persons who at the time were, or who
have since become, nationals of the U.S. However, there can
be no assurance that our understanding in this regard is
correct. We do not intend to traffic in confiscated property,
and have included provisions in our licensing agreements to
preclude the use of such property in association with the
performance of CIMABs obligations under those agreements.
As part of our interactions with CIMAB, we will be subject to
the U.S. Commerce Departments export administration
regulations that govern the transfer of technology to foreign
nationals. Specifically, we or our sublicensees, if any, will
require a license from the Commerce Departments Bureau of
Industry and Security, or BIS, in order to export or otherwise
transfer to CIMAB any information that constitutes technology
under the definitions of the Export Administration Regulations,
or EAR, administered by BIS. The export licensing process may
take months to be completed, and the technology transfer in
question may not take place unless and until a license is
granted by the Commerce Department. Due to the unique status of
the Republic of Cuba, technology that might otherwise be
transferable to a foreign national without a Commerce Department
license requires a license for export or transfer to a Cuban
national. If we or our sublicensees fail to comply with the
export administration regulations, we may be subject to both
civil and criminal penalties. There can be no guarantee that any
license application will be approved by BIS or that a license,
once issued, will not be revoked, modified, suspended or
otherwise restricted for reasons beyond our control due to a
change in U.S.-Cuba policy or for other reasons.
36
As a
result of the reduction in our workforce that we announced in
October 2005, and continuing restructuring activities initiated
in January 2006, we may not be successful in retaining key
employees and in attracting qualified new employees as required
in the future. If we are unable to retain our management,
scientific staff and scientific advisors or to attract
additional qualified personnel, our product development efforts
will be seriously jeopardized.
In October 2005, we announced the discontinuation of any further
development and manufacturing activities with respect to
Canvaxin, and a corporate restructuring plan that included a
reduction in our workforce from 183 to 52 employees. In
January 2006, we initiated additional restructuring measures,
which will result in the further reduction of our workforce to
approximately 10 employees by the completion of the
proposed merger with Micromet. This planned reduction includes
the termination of David F. Hale, CancerVaxs President and
Chief Executive Officer, who will become chairman of the
combined company. Additionally, the voluntary resignation of
William R. LaRue, CancerVaxs Chief Financial Officer,
will become effective June 1, 2006 and the voluntary
resignation of Hazel M. Aker, CancerVaxs General
Counsel, will become effective upon the closing of the merger.
Competition among biotechnology companies for qualified
employees is intense, and the ability to retain and attract
qualified individuals is critical to our success. We may
experience further reductions in force due to voluntary employee
resignations and a diminished ability to recruit new employees
to further the development of our product candidates. We may be
unable to attract or retain key personnel on acceptable terms,
if at all.
We have relationships with scientific advisors at academic and
other institutions, some of whom conduct research at our request
or assist us in formulating our research, development or
clinical strategy. These scientific advisors are not our
employees and may have commitments to, or consulting or advisory
contracts with, other entities that may limit their availability
to us. We have limited control over the activities of these
scientific advisors and can generally expect these individuals
to devote only limited time to our activities. Failure of any of
these persons to devote sufficient time and resources to our
programs could harm our business. In addition, these advisors
may have arrangements with other companies to assist those
companies in developing technologies that may compete with our
products.
We do not maintain key person life insurance on any
of our officers, employees or consultants.
We may
become involved in securities class action litigation that could
divert managements attention and harm our
business.
The stock market has from time to time experienced significant
price and volume fluctuations that have affected the market
prices for the common stock of pharmaceutical and biotechnology
companies. These broad market fluctuations may cause the market
price of our common stock to decline. In the past, following
periods of volatility in the market price of a particular
companys securities, securities class action litigation
has often been brought against that company. We may become
involved in this type of litigation in the future. Litigation
often is expensive and diverts managements attention and
resources, which could adversely affect our business.
If our
competitors develop and market products that are more effective
than our existing product candidates or any products that we may
develop, or obtain marketing approval before we do, our
commercial opportunity will be reduced or
eliminated.
The biotechnology and pharmaceutical industries are subject to
rapid and significant technological change. We have many
potential competitors, including major drug and chemical
companies, large, diversified biotechnology companies, smaller,
specialized biotechnology firms, universities and other research
institutions. These companies and other institutions may develop
technologies and products that are more effective than our
product candidates or that would make our technology and product
candidates obsolete or non-competitive. Many of these companies
and other institutions have greater financial and technical
resources and development, production and marketing capabilities
than we do. In addition, many of these companies and other
institutions have more experience than we do in preclinical
testing, human clinical trials and manufacturing of new or
improved biological therapeutics, as well as in obtaining FDA
and foreign regulatory approvals.
37
Various companies are developing or commercializing products
that are used for the treatment of forms of cancer and other
diseases that we have targeted for product development. Some of
these products use therapeutic approaches that may compete
directly with our product candidates. These companies may
succeed in obtaining approvals from the FDA and foreign
regulatory authorities for their products sooner than we do for
ours.
Specifically, we face competition from a number of companies
working in the fields of specific active immunotherapy for the
treatment of solid tumors, anti-angiogenesis, and signal
transduction through the EGFR pathway. We expect that
competition among products approved for sale will be based on
various factors, including product efficacy, safety,
reliability, availability, price and patent position. Some of
these products use therapeutic approaches that may compete
directly with our product candidates, and the companies
developing these competing technologies may have significantly
greater resources that we do, and may succeed in obtaining
approvals from the FDA and foreign regulatory authorities for
their products sooner than we do for ours.
We are aware of a number of competitive products currently
available in the marketplace or under development for the
prevention and treatment of the diseases we have targeted for
product development. For example, a number of companies are
currently developing products in the field of anti-angiogenesis
for the treatment of patients with tumors. These products use a
number of substances designed to inhibit angiogenesis, such as
vascular endothelial growth factor, or VEGF, VEGF receptor,
platelet-derived growth factor, or PDGF, receptor, integrins,
collagen, and matrix metalloprotienases. Genentechs
Avastin®
(bevacizumab) is an anti-angiogenic monoclonal antibody
targeting the VEGF growth factor. It has been approved by FDA
for the treatment of patients with metastatic colorectal cancer.
Pfizers
Sutent®
(sunitinib malate) was recently approved by the FDA for the
treatment of patients with a specific type of stomach cancer and
kidney cancer, and Bayer and Onyx Pharmaceuticals
Nexavar®
(sorafenib tosylate) was approved by the FDA for the treatment
of patients with gastric cancer. A proposed mechanism of action
for both Nexavar and Sutent is inhibition of the VEGF receptor.
A number of other VEGF growth factor and VEGF receptor
antagonists are also under development, as well as a number of
agents targeting other potential anti-angiogenic mechanisms. We
are unaware of any products in development that specifically
target the same denatured collagen as our D93 product candidate.
We expect that competition among anti-angiogenic products
approved for sale will be based on various factors, including
product efficacy, safety, reliability, availability, price and
patent position. As a result, any product candidates that we may
develop may be rendered obsolete and noncompetitive.
Additionally, several products that target the EGFR signaling
pathway in the treatment of cancer have recently been approved
by the FDA or are in the late phases of clinical development.
The approved products are AstraZeneca Pharmaceutical LPs
Iressatm
(gefitinib), an EGFR-targeted tyrosine kinase inhibitor for
refractory Stage IV Non-small lung cancer, or NSCLC,
ImClone Systems, Inc.s
Erbituxtm
(cetuximab), an EGFR monoclonal antibody for Stage IV
refractory colorectal cancer, and Genentech, Inc. and OSI
Pharmaceuticals, Inc.s EGFR-targeted tyrosine kinase
inhibitor,
Tarcevatm
(erlotinib HCl), for the treatment of patients with locally
advanced or metastatic NSCLC after failure of at least one prior
chemotherapy regimen, as well as in combination with Eli
Lilly & Companys
Gemzar®
(gemcitabine) for the treatment of patients with locally
advanced pancreatic cancer. Two other products that are
currently being evaluated in Phase 3 clinical trials are
GlaxoSmithKlines lapatinib (GW572016), a tyrosine kinase
dual inhibitor of EGFR and HER-2, which is being studied in
patients with advanced metastatic breast cancer whose disease
progressed on
Herceptin®
(trastuzumab) therapy, and Abgenix, Inc. and Amgen, Inc.s
panitumumab (ABX-EGF), a fully human monoclonal antibody
targeting the EGFR, which is being studied in patients with
advanced colorectal and renal cell cancer. Several other
monoclonal antibodies and tyrosine kinase inhibitors targeting
the EGFR signaling pathway are in the early stages of
development. If we receive approval to market and sell any of
our product candidates that target the EGFR signaling pathway,
we may compete with certain of these companies and their
products as well as other product candidates in varying stages
of development. In addition, researchers are continually
learning more about the treatment of NSCLC and other forms of
cancer, and new discoveries may lead to new technologies for
treatment.
We also face competition from pharmaceutical and biotechnology
companies, academic institutions, governmental agencies and
private research organizations in recruiting and retaining
highly qualified scientific personnel and consultants and in the
development and acquisition of technologies. Moreover,
technology controlled by third parties that may be advantageous
to our business may be acquired or licensed by our competitors,
thereby preventing us from obtaining technology on commercially
reasonable terms, if at all. Because part of our strategy is
38
to target markets outside of the United States through
collaborations with third parties, we will compete for the
services of third parties that may have already developed or
acquired internal biotechnology capabilities or made commercial
arrangements with other biopharmaceutical companies to target
the diseases on which we have focused.
Risks
Related to CancerVaxs Financial Results and Need for
Financing
We
have a history of losses and expect to incur substantial losses
and negative operating cash flows for the foreseeable future,
and we may never achieve sustained profitability.
We have incurred $190.0 million in net losses from our
inception through December 31, 2005. We expect to increase
our operating expenses over the next several years as we conduct
clinical trials with D93, expand our research and development
activities, acquire or license new technologies and product
candidates and contract for manufacturing and quality services
for our product candidates that are in clinical trials. The
extent of our future operating losses and the timing of
profitability are highly uncertain, and we may never generate
revenue. In October 2005, we announced restructuring activities,
including workforce reductions, and we incurred non-recurring
charges associated with our restructuring activities aggregating
$5.1 million, which includes employee severance costs of
$3.5 million, leased facility exit costs of
$1.4 million and contract termination costs of
$0.2 million. We anticipate that we will incur additional
costs as a result of the restructuring plan in 2006, including
additional employee severance costs, costs associated with the
closure of our manufacturing facilities and contract
terminations. Because of the numerous risks and uncertainties
associated with our restructuring activities and our product
development efforts, we are unable to predict the extent of any
future losses or when we will become profitable, if at all.
We do not expect to generate any revenue for several years
because our remaining pipeline product candidates are in the
early stages of development. Our ability to generate revenue
depends on a number of factors, including our ability to
successfully develop and obtain regulatory approvals to
commercialize D93 and our other product candidates, and our
ability to sublicense SAI-EGF and the other product candidates
licensed from CIMAB. We have not yet completed the development,
including obtaining regulatory approvals, of any products and,
consequently, have not generated revenues from the sale of
products. Even if these early-stage product candidates receive
regulatory approval, we will need to establish and maintain
sales, marketing and distribution capabilities, and even if we
are able to commercialize our product candidates, we may not
achieve profitability for at least several years after
generating material revenue, if ever. If we are unable to become
profitable, we may be unable to continue our operations.
If we
fail to obtain the capital necessary to fund our operations, we
will be unable to develop or commercialize our product
candidates and our ability to operate as a going concern may be
adversely affected.
Absent the proposed merger with Micromet, we believe that our
existing cash, cash equivalents, and securities
available-for-sale
as of December 31, 2005 and any remaining
pre-commercialization cost-sharing payments from our
collaboration for Canvaxin with Serono Technologies, S.A., will
be sufficient to meet our projected operating requirements until
September 30, 2007. In addition to our workforce reductions
and the termination of our Canvaxin development activities, we
have announced our intention to consummate the merger with
Micromet. We may not successfully implement any of these
alternatives, and even if we determine to pursue one or more of
these alternatives, we may be unable to do so on acceptable
financial terms. Our restructuring measures implemented to date
and the proposed merger with Micromet may disappoint investors
and further depress the price of our common stock and the value
of an investment in our common stock thereby limiting our
ability to raise additional funds.
We will require substantial funds to conduct development
activities, including preclinical testing and clinical trials of
our product candidates, including D93. Our ability to conduct
the required development activities related to these product
candidates will be significantly limited if we are unable to
obtain the necessary capital. We may seek to raise additional
funds to meet our working capital and capital expenditure needs.
We have filed a shelf registration statement, declared effective
by the Securities and Exchange Commission on December 9,
2004, under which we may raise up to $80 million through
the sale of our common stock. We may also raise additional funds
through additional debt financing or through additional
strategic collaboration agreements. However, we do not
39
know whether additional financing will be available when needed,
or whether it will be available on favorable terms or at all.
Having insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or
to relinquish greater or all rights to product candidates at an
earlier stage of development or on less favorable terms than we
would otherwise choose. Failure to obtain adequate financing
also may adversely affect our ability to operate as a going
concern.
Our future capital requirements will depend on, and could
increase significantly as a result of, many factors, including:
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our ability to complete the termination of our clinical trials
of Canvaxin in patients with advanced-stage melanoma, as well as
the associated development and manufacturing activities, and to
sublease on satisfactory terms the manufacturing, administrative
and warehouse facilities associated with the production of
Canvaxin;
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the costs involved in the research, preclinical and clinical
development, and manufacturing of D93 and our other product
candidates;
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our ability to successfully sublicense SAI-EGF and the other
product candidates licensed from CIMAB on favorable terms and
conditions;
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the costs involved in obtaining and maintaining regulatory
approvals for our product candidates;
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the scope, prioritization and number of programs we pursue;
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the costs involved in preparing, filing, prosecuting,
maintaining, enforcing and defending patent and other
intellectual property claims;
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potential product liability claims associated with Canvaxin, D93
or our other product candidates;
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the costs associated with manufacturing our product candidates;
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our ability to enter into corporate collaborations and the terms
and success of these collaborations;
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our acquisition and development of new technologies and product
candidates; and
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competing technological and market developments.
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If we
do not establish and maintain strategic collaborations to fund
our product development activities, we may have to reduce or
delay our rate of product development and increase our
expenditures.
We intend to rely on strategic collaborations for research,
development, marketing and commercialization of our product
candidates. We have not yet obtained regulatory approval for,
marketed or sold any of our product candidates in the United
States or elsewhere and we will need to build our internal
marketing and sales capabilities or enter into successful
collaborations for these services in order to ultimately
commercialize our product candidates. Establishing strategic
collaborations is difficult and time-consuming. Our discussions
with potential collaborators may not lead to the establishment
of new collaborations on favorable terms, if at all. For
example, potential collaborators may reject collaborations based
upon their assessment of our financial, regulatory or
intellectual property position. Any collaborations we may
develop in the future may never result in the successful
development or commercialization of our product candidates or
the generation of sales revenue. To the extent that we enter
into co-promotion or other collaborative arrangements, our
product revenues are likely to be lower than if we directly
marketed and sold any products that we may develop.
Management of our relationships with our collaborators will
require:
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significant time and effort from our management team;
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coordination of our research and development programs with the
research and development priorities of our
collaborators; and
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effective allocation of our resources to multiple projects.
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If we enter into research and development collaborations at an
early phase of product development, our success will in part
depend on the performance of our corporate collaborators. We
will not directly control the amount or timing of resources
devoted by our corporate collaborators to activities related to
our product candidates. Our corporate collaborators may not
commit sufficient resources to our research and development
programs or the commercialization, marketing or distribution of
our product candidates. If any corporate collaborator fails to
commit sufficient resources, our preclinical or clinical
development programs related to the collaboration could be
delayed or terminated. Also, our collaborators may pursue
existing or other development-stage products or alternative
technologies in preference to those being developed in
collaboration with us. Finally, our collaborators may terminate
our relationships, and we may be unable to establish additional
corporate collaborations in the future on acceptable terms, if
at all. If clinical trials of our product candidates are not
successful, or if we fail to make required milestone or royalty
payments to our collaborators or to observe other obligations in
our agreements with them, our collaborators may have the right
to terminate those agreements. For example, Serono may terminate
our collaboration agreement for Canvaxin for convenience upon
180 days prior notice.
Our
operating and financial flexibility, including our ability to
borrow money, is limited by certain debt
arrangements.
In December 2004, we entered into a loan and security agreement
with a financing institution, and have borrowed the full
$18.0 million available under this credit facility. In
order to secure our obligations under this loan and security
agreement, we granted the bank a first priority security
interest in substantially all of our assets, excluding our
intellectual property. We used the proceeds from the loan
agreement primarily to construct and equip an additional
production suite in our existing manufacturing facility and to
create additional warehouse and laboratory space to support the
manufacture of Canvaxin. The terms of our loan and security
agreement require that it be repaid in full upon the occurrence
of a change of control event, such as the consummation of our
merger with Micromet.
The loan agreement contains various customary affirmative and
negative covenants, including, without limitation:
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financial reporting;
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limitation on liens;
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limitations on the occurrence of future indebtedness;
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maintenance of a minimum amount of cash in deposit accounts of
our lenders or in the accounts of affiliates of our lenders;
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limitations on mergers and other consolidations;
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limitations on dividends;
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limitations on investments; and
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limitations on transactions with affiliates.
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In addition, under this loan agreement, we are generally
obligated to maintain, as of the last day of each quarter, cash,
cash equivalents and securities
available-for-sale
in an amount at least equal to the greater of (i) our
quarterly cash burn multiplied by 2 or (ii) the then
outstanding principal amount of the obligations under such
agreement multiplied by 1.5. In the event that we breach this
financial covenant, we are obligated to pledge and deliver to
the bank a certificate of deposit in an amount equal to the
aggregate outstanding principal amount of the obligations under
such agreement.
Our loan agreements contain certain customary events of default,
which generally include, among others, non-payment of principal
and interest, violation of covenants, cross defaults, the
occurrence of a material adverse change in our ability to
satisfy our obligations under our loan agreements or with
respect to one of our lenders security interest in our
assets and in the event we are involved in certain insolvency
proceedings. Upon the occurrence of an event of default, our
lenders may be entitled to, among other things, accelerate all
of our
41
obligations and sell our assets to satisfy our obligations under
our loan agreements. In addition, in an event of default, our
outstanding obligations may be subject to increased rates of
interest.
In addition, we may incur additional indebtedness from time to
time to finance acquisitions, investments or strategic alliances
or capital expenditures or for other purposes. Our level of
indebtedness could have negative consequences for us, including
the following:
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our ability to obtain additional financing, if necessary, for
working capital, capital expenditures, acquisitions or other
purposes may be impaired or such financing may not be available
on favorable terms;
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payments on our indebtedness will reduce the funds that would
otherwise be available for our operations and future business
opportunities;
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we may be more highly leveraged than our competitors, which may
place us at a competitive disadvantage;
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our debt level reduces our flexibility in responding to changing
business and economic conditions; and
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there would be an adverse effect on our business and financial
condition if we are unable to service our indebtedness or obtain
additional financing, as needed.
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Our
quarterly operating results and stock price may fluctuate
significantly.
We expect our results of operations to be subject to quarterly
fluctuations. The level of our revenues, if any, and results of
operations at any given time, will be based primarily on the
following factors:
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the progress of our restructuring activities, including with
respect to the discontinuation of our Phase 3 clinical
trials for Canvaxin and the related termination of employees and
closure of our manufacturing facilities;
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the status of development of our other product candidates;
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the time at which we enter into research and license agreements
with strategic collaborators that provide for payments to us,
and the timing and accounting treatment of payments to us, if
any, under those agreements;
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whether or not we achieve specified research or
commercialization milestones under any agreement that we enter
into with collaborators and the timely payment by commercial
collaborators of any amounts payable to us;
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the addition or termination of research programs or funding
support;
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the timing of milestone and other payments that we may be
required to make to others; and
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variations in the level of expenses related to our product
candidates or potential product candidates during any given
period.
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These factors may cause the price of our stock to fluctuate
substantially. We believe that quarterly comparisons of our
financial results are not necessarily meaningful and should not
be relied upon as an indication of our future performance.
Risks
Related to CancerVaxs Intellectual Property and
Litigation
Our
success depends on whether we are able to maintain and enforce
our licensing arrangements with various third party
licensors.
We hold rights to commercialize our anti-angiogenesis product
candidates under agreements that require, among other things,
royalty payments on future sales, if any, and our achievement of
certain development milestones. On October 15, 2004, we
amended and restated our collaboration agreement with Applied
Molecular Evolution, Inc., or AME, which is now a wholly-owned
subsidiary of Eli Lilly and Company, under which AME utilized
its technology to humanize a murine monoclonal antibody, which
is now referred to as D93, and another of our anti-angiogenic
monoclonal antibodies. Under the amended and restated
collaboration agreement, AME may terminate the agreement if we
fail to make milestone or royalty payments to AME. In February
2006, we submitted
42
an IND for D93, as required under our agreement with AME;
however, AME may also terminate the agreement if we fail to meet
certain other specified clinical development obligations. In the
event of such termination, we will be required to grant to AME
an exclusive license for all of our patent rights relating to
the humanized monoclonal antibodies that are the subject of this
agreement and the products that incorporate or are derived from
one or more of the humanized monoclonal antibodies that are the
subject of the agreement. AME also received a right of first
negotiation to obtain from us an exclusive license under our
intellectual property rights related to the making, using and
selling of any products that incorporate or are derived from one
or more of the humanized monoclonal antibodies that are the
subject of the agreement should we decide to negotiate with or
seek a collaborator for the commercialization of such product.
The amended and restated collaboration agreement also obligates
us to pay for the preparation, filing, prosecution, maintenance
and enforcement of all patent applications directed at the
humanized monoclonal antibodies that are the subject of the
amended agreement. We made a $0.2 million payment to AME in
the fourth quarter of 2004 in connection with the execution of
the amended and restated collaboration agreement.
We hold exclusive rights through two agreements with CIMAB to
develop and commercialize within a specific territory, which
includes the U.S., Canada, Japan, Australia, New Zealand,
Mexico, the countries comprising the European Union and certain
other countries in Europe, SAI-EGF, a product candidate being
evaluated in Phase 2 clinical trials that target the EGFR
signaling pathway for the treatment of cancer. In addition, we
obtained from CIMAB and YM BioSciences the exclusive rights to
develop and commercialize, within the same territory,
SAI-TGF-a,
which targets transforming growth factor-alpha, and
SAI-EGFR-ECD, which targets the extracellular domain of the EGF
receptor, both of which are in preclinical development. In
exchange for these rights, we will pay to CIMAB and YM
BioSciences technology access fees and transfer fees totaling
$5.7 million, to be paid over the first three years of the
agreement. We will also make future milestone payments to CIMAB
and YM BioSciences up to a maximum of $34.7 million upon
meeting certain regulatory, clinical and commercialization
objectives, as well as royalties on future sales of commercial
products, if any. Each agreement terminates upon the later of
the expiration of the last of any patent rights to licensed
products that are developed under each respective agreement or
15 years after the date of the first commercial sale of the
last product licensed or developed under the agreements. CIMAB
may terminate one or both of the agreements if we have not used
reasonable commercial efforts to submit an IND to the FDA for
the leading product candidate by July 12, 2006, or if the
first regulatory approval for marketing this product candidate
within our territory is not obtained by July 12, 2016,
provided that CIMAB has timely complied with all of its
obligations under the agreements, or if CIMAB does not receive
timely payment of the initial access fees and technology
transfer fees under the agreements. In addition, if CIMAB does
not receive payments under the agreements due to changes in
U.S. law, actions by the U.S. government or by order
of any U.S. court for a period of more than one year, CIMAB
may terminate our rights to the licensed product candidates in
countries within our territory other than the U.S. and Canada.
We may terminate the agreements for any reason following
180 days written notice to CIMAB. On January 13, 2006,
we received a letter from CIMAB notifying us of their belief
that we are in breach of our agreement as a result of our
failure to make a milestone payment. If we are unable to resolve
the dispute, then CIMAB may seek to terminate the agreement for
breach.
Although the license agreements with CIMAB are governed by the
laws of England and Wales, their enforcement may necessitate
pursuing legal proceedings and obtaining orders in other
jurisdictions, including the U.S. and the Republic of Cuba.
There can be no assurance that a court judgment or order
obtained in one jurisdiction will be enforceable in another. In
addition, as is the case in many developing countries, the
commercial legal environment in Cuba may be subject to political
risk. It is possible that we may not be able to enforce our
legal rights in Cuba or against Cuban entities to the same
extent as we would in a country with a commercial and legal
system more consistent with United States or western European
practice. Termination of these license arrangements or
difficulties in the enforcement of such arrangements may have a
material adverse effect on our business, operations and
financial condition.
We have announced our intention to actively seek to sublicense
our rights to the three product candidates licensed from CIMAB,
but there can be no guarantee that we will be successful in our
efforts to consummate a sublicense on terms and conditions that
will be acceptable.
We also hold rights to a human monoclonal antibody under a
license from M-Tech Therapeutics, which can be terminated if we
determine not to file and obtain approval of an IND application
for a licensed product by a specified
43
date and conduct clinical trials for such product, or if we
determine not to file and obtain approval of an IND application
for a licensed product by a specified date because of negative
pre-clinical results.
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If we
were to materially breach any of our license or collaboration
agreements, we could lose our ability to commercialize the
related technologies, and our business could be materially and
adversely affected.
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We are party to intellectual property licenses and agreements
that are important to our business and expect to enter into
similar licenses and agreements in the future. These licenses
and agreements impose various research, development,
commercialization, sublicensing, royalty, indemnification,
insurance and other obligations on us. If we or our
collaborators fail to perform under these agreements or
otherwise breach obligations thereunder, we could lose
intellectual property rights that are important to our business.
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We
cannot be certain we will be able to obtain additional patent
protection to protect our product candidates and
technology.
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We cannot be certain that additional patents will be issued on
our product candidates that target the EGFR signaling pathways,
or that any patents will be issued on our anti-angiogenesis
product candidates, as a result of pending applications filed to
date. If a third party has also filed a patent application
relating to an invention claimed by us or our licensors, we may
be required to participate in an interference proceeding
declared by the U.S. Patent and Trademark Office to
determine priority of invention, which could result in
substantial uncertainties and cost for us, even if the eventual
outcome is favorable to us. The degree of future protection for
our proprietary rights is uncertain. For example:
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we or our licensors might not have been the first to make the
inventions covered by each of our patents and our pending patent
applications;
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we or our licensors might not have been the first to file patent
applications for these inventions;
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others may independently develop similar or alternative
technologies or duplicate any of our technologies;
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it is possible that none of our pending patent applications will
result in issued patents;
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any patents under which we hold rights may not provide us with a
basis for commercially-viable products, may not provide us with
any competitive advantages or may be challenged by third parties
as not infringed, invalid, or unenforceable under United States
or foreign laws;
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any of the issued patents under which we hold rights may not be
valid or enforceable; or
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we may develop additional proprietary technologies that are not
patentable and which may not be adequately protected through
trade secrets, for example, if a competitor independently
develops duplicative, similar, or alternative technologies.
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Additionally, there may be risks related to the licensing of the
proprietary rights for the product candidates that target the
EGFR signaling pathway that were developed in Cuba. Under
current Cuban patent law, ownership of the inventions of the
Cuban inventors for which patent applications have been filed
rests with the state.
If we
are not able to protect and control our unpatented trade
secrets, know-how and other technological innovation, we may
suffer competitive harm.
We also rely on proprietary trade secrets and unpatented
know-how to protect our research, development and manufacturing
activities, particularly when we do not believe that patent
protection is appropriate or available. However, trade secrets
are difficult to protect. We attempt to protect our trade
secrets and unpatented know-how by requiring our employees,
consultants and advisors to execute a confidentiality and
non-use agreement. We cannot guarantee that these agreements
will provide meaningful protection, that these agreements will
not be breached, that we will have an adequate remedy for any
such breach, or that our trade secrets will not otherwise become
known or independently developed by a third party. Our trade
secrets, and those of our present or future collaborators that
we utilize by agreement, may become known or may be
independently discovered by others, which could adversely affect
the competitive position of our product candidates.
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If our
products violate third party patents or were derived from a
patients cell lines without the patients consent, we
could be forced to pay royalties or cease selling our
products.
Our commercial success will depend in part on not infringing the
patents or violating the proprietary rights of third parties. We
are aware of competing intellectual property relating to our
areas of practice. Competitors or third parties may obtain
patents that may cover subject matter we use in developing the
technology required to bring our products to market, that we use
in producing our products, or that we use in treating patients
with our products.
In addition, from time to time we receive correspondence
inviting us to license patents from third parties. There has
been, and we believe that there will continue to be, significant
litigation in the pharmaceutical industry regarding patent and
other intellectual property rights. While we believe that our
pre-commercialization activities fall within the scope of an
available exemption against patent infringement provided by
35 U.S.C. § 271(e), and that our subsequent
manufacture of our commercial products will also not require the
license of any of these patents, claims may be brought against
us in the future based on these or other patents held by others.
Third parties could bring legal actions against us claiming we
infringe their patents or proprietary rights, and seek monetary
damages and seeking to enjoin clinical testing, manufacturing
and marketing of the affected product or products. If we become
involved in any litigation, it could consume a substantial
portion of our resources, regardless of the outcome of the
litigation. If any of these actions are successful, in addition
to any potential liability for damages, we could be required to
obtain a license to continue to manufacture or market the
affected product, in which case we may be required to pay
substantial royalties or grant cross-licenses to our patents.
However, there can be no assurance that any such license will be
available on acceptable terms or at all. Ultimately, we could be
prevented from commercializing a product, or forced to cease
some aspect of our business operations, as a result of claims of
patent infringement or violation of other intellectual property
rights, which could harm our business.
We know that others have filed patent applications in various
countries that relate to several areas in which we are
developing products. Some of these patent applications have
already resulted in patents and some are still pending. The
pending patent applications may also result in patents being
issued. In addition, patent applications are secret until
patents are published in the United States or foreign countries,
and in certain circumstances applications are not published
until a patent issues, so it may not be possible to be fully
informed of all relevant third party patents. Publication of
discoveries in the scientific or patent literature often lags
behind actual discoveries. All issued patents are entitled to a
presumption of validity under the laws of the United States and
certain other countries. Issued patents held by others may
therefore limit our ability to develop commercial products. If
we need licenses to such patents to permit us to develop or
market our product candidates, we may be required to pay
significant fees or royalties and we cannot be certain that we
would be able to obtain such licenses at all.
We may
be involved in lawsuits or proceedings to protect or enforce our
patent rights, trade secrets or know-how, which could be
expensive and time consuming.
There has been significant litigation in the biotechnology
industry over patents and other proprietary rights. Our patents
and patents that we have licensed the rights to may be the
subject of other challenges by our competitors in Europe, the
United States and elsewhere. Furthermore, our patents and the
patents that we have licensed the rights to may be circumvented,
challenged, narrowed in scope, declared invalid, or
unenforceable. Legal standards relating to the scope of claims
and the validity of patents in the biotechnology field are still
evolving, and no assurance can be given as to the degree of
protection any patents issued to or licensed to us would
provide. The defense and prosecution of intellectual property
suits and related legal and administrative proceedings can be
both costly and time consuming. Litigation and interference
proceedings could result in substantial expense to us and
significant diversion of effort by our technical and management
personnel. Further, the outcome of patent litigation is subject
to uncertainties that cannot be adequately quantified in
advance, including the demeanor and credibility of witnesses and
the identity of the adverse party. This is especially true in
biotechnology related patent cases that may turn on the
testimony of experts as to technical facts upon which experts
may reasonably disagree. An adverse determination in an
interference proceeding or litigation to which we may become a
party could subject us to significant liabilities to third
parties or require us to seek licenses from third parties. If
required, the necessary licenses may not be available on
acceptable terms or at all. Adverse determinations in a judicial
or administrative
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proceeding or failure to obtain necessary licenses could prevent
us from commercializing our product candidates, which could have
a material and adverse effect on our business, financial
condition and results of operations.
Risk
Relating to CancerVax Common Stock
We
face possible delisting from the Nasdaq National Market, which
would result in a limited public market for our common
stock.
Our common stock trades on the Nasdaq National Market, which
specifies certain requirements for the continued listing of
common stock. There are several requirements for the continued
listing of our common stock on the Nasdaq National Market
including, but not limited to, a minimum stockholders
equity value of $10.0 million and a minimum stock bid price
of $1.00 per share. While we currently are in compliance
with these requirements, there can be no guarantee that we will
continue to remain in compliance. As of December 31, 2005,
we had a stockholders deficit of $224.4 million, and
our closing stock price as of March 27, 2006 was $3.00 per
share. While we expect that our stock would continue to trade on
the Over The Counter Bulletin Board following any delisting
from the Nasdaq National Market, any such delisting of our
common stock could have a material adverse effect on the market
price of, and the efficiency of the trading market for, our
common stock. Also, if in the future we were to determine that
we need to seek additional equity capital, a delisting could
have an adverse effect on our ability to raise such equity
capital.
Future
sales of our common stock may cause our stock price to
decline.
Our current stockholders hold a substantial number of shares of
our common stock that they will be able to sell in the public
market. A significant portion of these shares are held by a
small number of stockholders. Sales by our current stockholders
of a substantial number of our shares could significantly reduce
the market price of our common stock. Moreover, the holders of a
substantial number of shares of our common stock have rights,
subject to some conditions, to require us to file registration
statements covering their shares or to include their shares in
registration statements that we may file for ourselves or other
stockholders. We have also registered shares of our common stock
that we may issue under our stock incentive plans and employee
stock purchase plan. These shares generally can be freely sold
in the public market upon issuance. If any of these holders
cause a large number of securities to be sold in the public
market, the sales could reduce the trading price of our common
stock. These sales also could impede our ability to raise future
capital.
Our
stock price may be volatile, and you may lose all or a
substantial part of your investment.
The market price for our common stock is volatile and may
fluctuate significantly in response to a number of factors, most
of which we cannot control, including:
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our ability to successfully complete our merger with Micromet;
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developments in our restructuring activities, including with
respect to the discontinuation of our Phase 3 clinical
trials for Canvaxin, and the related termination of employees
and closure of our manufacturing facilities;
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changes in the regulatory status of our product candidates,
including results of our clinical trials for D93, our leading
humanized, anti-angiogenic monoclonal antibody;
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changes in significant contracts, new technologies,
acquisitions, commercial relationships, joint ventures or
capital commitments;
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announcements of the results of clinical trials by companies
with product candidates in the same therapeutic category as our
product candidates;
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events affecting Serono or our collaboration agreement with
Serono;
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fluctuations in stock market prices and trading volumes of
similar companies;
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announcements of new products or technologies, clinical trial
results, commercial relationships or other events by us or our
competitors;
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our ability to successfully complete sublicensing arrangements
with respect to our product candidates that target the EGFR
signaling pathway;
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variations in our quarterly operating results;
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changes in securities analysts estimates of our financial
performance;
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changes in accounting principles;
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sales of large blocks of our common stock, including sales by
our executive officers, directors and significant stockholders;
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additions or departures of key personnel; and
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discussion of CancerVax or our stock price by the financial and
scientific press and online investor communities such as chat
rooms.
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If our
officers and directors choose to act together, they can
significantly influence our management and operations in a
manner that may be in their best interests and not in the best
interests of other stockholders.
As of March 27, 2006, our officers and directors, together
with their affiliates, beneficially owned approximately 37.3% of
our common stock. As a result, these stockholders, acting
together, can significantly influence all matters requiring
approval by our stockholders, including the election of
directors and the approval of mergers or other business
combination transactions. The interests of this group of
stockholders may not always coincide with our interests or the
interests of other stockholders, and they may act in a manner
that advances their best interests and not necessarily those of
other stockholders.
Our
stockholder rights plan, anti-takeover provisions in our
organizational documents and Delaware law may discourage or
prevent a change in control, even if an acquisition would be
beneficial to our stockholders, which could affect our stock
price adversely and prevent attempts by our stockholders to
replace or remove our current management.
Our stockholder rights plan and provisions contained in our
amended and restated certificate of incorporation and amended
and restated bylaws contain provisions that may delay or prevent
a change in control, discourage bids at a premium over the
market price of our common stock and adversely affect the market
price of our common stock and the voting and other rights of the
holders of our common stock. The provisions in our amended and
restated certificate of incorporation and bylaws include:
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dividing our board of directors into three classes serving
staggered three-year terms;
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prohibiting our stockholders from calling a special meeting of
stockholders;
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permitting the issuance of additional shares of our common stock
or preferred stock without stockholder approval;
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prohibiting our stockholders from making certain changes to our
amended and restated certificate of incorporation or bylaws
except with
662/3%
stockholder approval; and
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requiring advance notice for raising matters of business or
making nominations at stockholders meetings.
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We are also subject to provisions of the Delaware corporation
law that, in general, prohibit any business combination with a
beneficial owner of 15% or more of our common stock for five
years unless the holders acquisition of our stock was
approved in advance by our board of directors.
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Risks
Relating to Micromet
Risks
Relating to Micromets Financial Results and Need for
Financing
We
have incurred substantial losses, we expect to continue to incur
substantial losses and we may never achieve
profitability.
We have incurred substantial losses to date and we expect to
incur substantial losses for the foreseeable future. We have no
current sources of material ongoing revenue. As of
December 31, 2005, we had an accumulated deficit of
approximately 102.0 million. We have not
commercialized any products to date, either alone or with a
third party collaborator. If we are not able to commercialize
any products, whether alone or with a collaborator, we will not
achieve profitability. Even if our collaboration agreements
provide funding for a portion of our research and development
expenses for some of our programs, we expect to spend
significant capital to fund our internal research and
development programs for the foreseeable future. As a result, we
will need to generate significant revenues in order to achieve
profitability. We cannot be certain whether or when this will
occur because of the significant uncertainties that affect our
business. Our failure to become and remain profitable may
depress the market price of our common stock and could impair
our ability to raise capital, expand our business, diversify our
product offerings or continue our operations.
We
will require additional financing, which may be difficult to
obtain and may dilute your ownership interest in
us.
We will require substantial funds to continue our research and
development programs. We believe that our existing cash and
working capital should be sufficient to fund our operations
through the third quarter of 2006, and if Micromets
shareholders invest an additional 4,000,000, as is
currently contemplated under an investment agreement with such
shareholders, then into the fourth quarter of 2006. However, our
future capital requirements may vary from what we expect. There
are factors that may affect our future capital requirements and
accelerate our need for additional financing. Many of these
factors are outside our control, including the following:
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continued progress in our research and development programs, as
well as the magnitude of these programs;
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our ability to establish and maintain collaborative arrangements;
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the timing, receipt and amount of research funding and
milestone, license, royalty and other payments, if any, from
collaborators;
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the timing, receipt and amount of sales revenues and associated
royalties to us, if any, from our product candidates in the
market; and
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the costs of preparing, filing, prosecuting, maintaining and
enforcing patent claims and other patent-related costs,
including litigation costs and technology license fees.
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We expect to seek additional funding through public or private
financings and may seek additional funding for programs that are
not currently licensed to collaborators, from new strategic
collaborators. However, the biotechnology market in general, and
the market for our common stock, in particular, is likely to be
highly volatile. Due to market conditions and the status of our
development pipeline, additional funding may not be available to
us on acceptable terms, or at all. If we fail to obtain such
additional financing on a timely basis, our ability to continue
our research and development activities will be adversely
affected.
If we raise additional funds through the issuance of equity
securities, our stockholders may experience substantial
dilution, or the equity securities may have rights, preferences
or privileges senior to existing stockholders. If we raise
additional funds through debt financings, these financings may
involve significant cash payment obligations and covenants that
restrict our ability to operate our business and make
distributions to our stockholders. We also could elect to seek
funds through arrangements with collaborators or others that may
require us to relinquish rights to certain technologies, product
candidates or products.
We currently have an outstanding promissory note issued to Curis
in the amount of 2,000,000. While we do not believe that
the merger triggers the obligation to repay any substantial
amounts under the terms of this note, Curis has informed us that
it does not agree with our interpretation and has initiated a
legal action regarding
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this matter. In the event that we were required to repay any
substantial portion of the amounts outstanding under this note,
it would have a material adverse effect on Micromets
financial resources in the near term.
We may
not receive some or all of a capital contribution that certain
of our investors have committed to make to us.
Under the terms of an investment agreement entered into in
connection with a recently completed financing, the investors
agreed to provide an additional cash contribution to Micromet in
the aggregate amount of approximately 4,000,000 on or
before March 31, 2006. As of the date of this proxy
statement/prospectus, these investors have not provided this
additional capital and there can be no guarantee that these
investors will actually contribute this capital. Moreover, under
the terms of the investment agreement, Micromet does not have
standing to bring any action to enforce the investors
obligations to provide this funding. If the investors fail to
provide this additional capital as required under the terms of
the investment agreement, it would have a material adverse
impact on Micromets capital resources in the near term,
which would likely require Micromet to seek capital from other
sources sooner that it otherwise would be required to do so.
If the
estimates we make and the assumptions on which we rely in
preparing our financial statements prove inaccurate, our actual
results may vary significantly.
Our financial statements have been prepared in accordance with
accounting principles generally accepted in the United States.
The preparation of these financial statements requires us to
make estimates and judgments that affect the reported amounts of
our assets, liabilities, revenues and expenses, the amounts of
charges taken by us and related disclosure. We base our
estimates on historical experience and on various other
assumptions that we believe to be reasonable under the
circumstances. We cannot assure you that our estimates, or the
assumptions underlying them, will be correct. Accordingly, our
actual financial results may vary significantly from the
estimates contained in our financial statements.
Risks
Relating to Micromets Collaborations
We are
dependent on collaborators for the development and
commercialization of many of our product candidates. If we lose
any of these collaborators, of if they fail or delay in
developing or commercializing our product candidates, our
anticipated product pipeline and operating results would
suffer.
The success of our strategy for development and
commercialization of product candidates depends upon our ability
to form and maintain productive strategic collaborations. We
currently have strategic collaborations with Serono and
MedImmune. We expect to enter into additional collaborations in
the future. Our existing and any future collaborations may not
be scientifically or commercially successful.
The risks that we face in connection with these collaborations
include the following:
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Each of our collaborators has significant discretion in
determining the efforts and resources that it will apply to the
collaboration. The timing and amount of any future royalty and
milestone revenue that we may receive under such collaborative
arrangements will depend on, among other things, such
collaborators efforts and allocation of resources.
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All of our strategic collaboration agreements are for fixed
terms and are subject to termination under various
circumstances, including in some cases, on short notice without
cause. If any collaborator were to terminate an agreement, we
may be required to undertake product development, manufacturing
and commercialization and we may not have the funds or
capability to do this, which could result in a discontinuation
or delay of such program.
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Our collaborators may develop and commercialize, either alone or
with others, products and services that are similar to or
competitive with the products and services that are the subject
of the collaboration with us.
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Our collaborators may change the focus of their development and
commercialization efforts. Pharmaceutical and biotechnology
companies historically have re-evaluated their priorities
following mergers and consolidations, which have been common in
recent years in these industries. The ability of certain of our
product
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candidates to reach their potential could be limited if our
collaborators decrease or fail to increase spending related to
such product candidates.
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If
Serono merges with another company or is acquired, it may
adversely impact our development of adecatumumab
(MT201).
Serono has recently been rumored to be the target of potential
merger discussions. If Serono were to merge with, or be acquired
by, another company, it is likely that that company would
evaluate whether to continue the development of adecatumumab
(MT201). If Seronos acquiror or merger partner elected not
to continue the collaboration with Micromet, the rights to
develop adecatumumab (MT201) would revert back to Micromet.
Serono has the right to terminate our collaboration upon
180 days written notice. There can be no guarantee that
Micromet would be able to find a replacement collaborator to
continue the development of adecatumumab (MT201) on terms as
favorable as the Serono collaboration, or at all. Additionally,
if a replacement collaborator could be located, the process of
identifying and negotiating the terms of the relationship with
such a collaborator, would likely be time consuming and
expensive. As a result, we could experience a material delay or
complete cessation in developing adecatumumab (MT201), which
would likely have a material adverse impact on our future
business prospects, results of operations, liquidity and capital
resources.
Risks
Related to Micromets Business, Industry, Strategy and
Operations
We
face substantial competition, which may result in our
competitors discovering, developing or commercializing products
before or more successfully than we do.
Our product candidates face competition with existing and new
products being developed by biotechnology, medical device and
pharmaceutical companies, as well as universities and other
research institutions. For example, research in the fields of
antibody-based therapeutics for the treatment of cancer and
inflammatory disease is highly competitive. A number of entities
are seeking to identify and patent antibodies, potentially
active proteins and other potentially active compounds without
specific knowledge of their therapeutic function. Our
competitors may discover, characterize and develop important
inducing molecules or genes in advance of us.
Many of our competitors have substantially greater capital
resources, research and development staffs and facilities than
we have. Efforts by other biotechnology, medical device and
pharmaceutical companies could render our programs or products
uneconomical or result in therapies superior to those that we
develop alone or with a collaborator. For those programs that we
have selected for further internal development, we face
competition from companies that are more experienced in product
development and commercialization, obtaining regulatory
approvals and product manufacturing. As a result, they may
develop competing products more rapidly and at a lower cost. For
those programs that are subject to a collaboration agreement,
competitors may discover, develop and commercialize products,
which render our products non-competitive or obsolete. We expect
competition to intensify in antibody research as technical
advances in the field are made and become more widely known.
Since
our product candidates may have different efficacy profiles in
certain clinical indications, sub-indications or patient
profiles and we have limited resources, our election to focus on
a particular indication, sub-indication and patient profile may
result in our failure to capitalize on other potentially
profitable applications of our product candidates.
We have limited financial and managerial resources. These
limitations require us to focus on a select group of product
candidates in specific therapeutic areas and to forego the
exploration of other product opportunities. While our
technologies may permit us to work in multiple areas, resource
commitments may require trade-offs resulting in delays in the
development of certain programs or research areas, which may
place us at a competitive disadvantage. Our decisions as to
resource allocation may not lead to the development of viable
commercial products and may divert resources away from other
market opportunities, which ultimately prove to be more
profitable.
Our
growth could be limited if we are unable to attract and retain
key personnel and consultants.
Our success depends on the ability to attract, train and retain
qualified scientific and technical personnel to further our
research and development efforts. The loss of services of one or
more of our key employees or
50
consultants could have a negative impact on our business and
operating results. Locating candidates with the appropriate
qualifications can be difficult. Although we expect to be able
to attract and retain sufficient numbers of highly skilled
employees for the foreseeable future, we may not be able to do
so.
Any growth and expansion into areas and activities that may
require additional human resources or expertise, such as
regulatory affairs and compliance, would require us to either
hire new key personnel or obtain such services via an
outsourcing arrangement. The pool of personnel with the skills
that we require is limited, and we may not be able to hire or
contract such additional personnel.
Risks
Relating to Micromets Intellectual Property
If we
breach any of the agreements under which we license or have
acquired intellectual property from others, we could lose
intellectual property rights that are important to our
business.
We are a party to intellectual property licenses and agreements
that are important to our business and expect to enter into
similar licenses and agreements in the future. These licenses
and agreements impose various research, development,
commercialization, sublicensing, royalty, indemnification,
insurance and other obligations on us. If we or our
collaborators fail to perform under these agreements or
otherwise breach obligations thereunder, we could lose
intellectual property rights that are important to our business.
We may
become involved in expensive patent litigation or other
intellectual property proceedings which could result in
liability for damages or require us to stop our development and
commercialization efforts.
One of our patents became the subject of an opposition
proceeding before the European Patent Office in March 2004. The
opponent alleged that the patent did not fulfill all of the
applicable requirements for issuance of a patent. In January
2006, the Opposition Division of the European Patent Office
revoked the opposition in oral proceedings and maintained the
patent as granted. The opponent can appeal the decision and
request a hearing in front of the Board of Appeal of the
European Patent Office and, it is possible that the Board of
Appeal could overrule the decision of the Opposition Division
and rule that the patent is invalid. If this were to occur, it
could have a material adverse impact on our ability to protect
our intellectual property.
Risks
Relating to Micromets Clinical and Regulatory
Matters
The
preliminary results of our Phase 2 clinical trial of
adecatumumab (MT201) in patients with prostate cancer suggest
that the primary endpoint of the trial was not reached and, if
final assessment of the trial results confirm this conclusion,
we may be forced to discontinue development of this product
candidate in prostate cancer.
Preliminary results from our Phase 2 clinical trial of
adecatumumab (MT201) in patients with prostate cancer indicate
that the primary endpoint (mean change in prostate specific
antigen, compared to placebo control) was not reached in the
trial. A recently performed expert review meeting has confirmed
the inconclusiveness of the current data set and has suggested
that additional post-hoc subanalyses be performed before coming
to a final assessment of this trial. If, upon final assessment,
we conclude that the trial did not meet its endpoint, we will be
forced to consider whether to discontinue pursuing the
development of adecatumumab (MT201) for the treatment of
prostate cancer. If we elect to abandon our development of
adecatumumab (MT201) for the treatment of prostate cancer, this
would have a material adverse impact on our future results of
operations.
Although
the preliminary results of our Phase 2 clinical trial of
adecatumumab (MT201) in patients with breast cancer are
encouraging, upon review of the final results we may
nevertheless conclude that the trial was
unsuccessful.
Based on a review of the preliminary results from our
Phase 2 clinical trial of adecatumumab (MT201) in patients
with breast cancer, it appears that the trial more likely than
not satisfied its primary clinical endpoint (a statistically
significant increase in clinical benefit rate in patients
receiving a high dose of the drug, as compared to patients
receiving a low dose). However, the database used to perform
this preliminary analysis has not been locked or been subject to
a formal data cleaning process, and the radiographs from the
patients in this clinical trial are still
51
subject to the assessment of an independent review board as some
centralized radiology assessments differ from the radiology
assessments performed at the local clinical trial sites. A final
assessment of the study data will not be possible until the
study is completed, all data discrepancies are resolved and the
database is locked, which is currently anticipated to occur in
the second half of 2006. Once the database has been locked and a
final assessment of the trial data is performed, we may discover
that the trial did not meet its primary endpoint. If, upon final
assessment, we conclude that the trial did not meet its
endpoints, we will be forced to consider whether to discontinue
pursuing the development of adecatumumab (MT201) for the
treatment of breast cancer. If we elect to abandon our
development of adecatumumab (MT201) for the treatment of breast
cancer, this would have a material adverse impact on our future
results of operations.
We
previously terminated three Phase 1 trials involving
short-term infusion regimens of MT103 due to the adverse event
profile and a lack of perceived tumor response, and there can be
no assurance that our current continuous infusion Phase 1
trial of MT103 will produce a different outcome.
In April 2004, we initiated a Phase 1 dose finding study
designed to evaluate the safety and tolerability of a continuous
intravenous infusion of MT103 over 4-8 weeks at different
dose levels in patients with relapsed Non-Hodgkins
Lymphoma. We previously terminated three other Phase 1
trials for MT103, which involved a short-term (as opposed to a
continuous) infusion of MT103, due to adverse events and the
lack of observed tumor responses. Although we have redesigned
the dosing regime for our ongoing Phase 1 trial, and based
upon on the preliminary data we currently are seeing
considerably fewer adverse events in response to the new dosing
regime, there can be no assurance that our ongoing continuous
infusion trial will not produce the same adverse events
witnessed in our previous short-term infusion trials for MT103.
Risks
Relating to Micromets Product Manufacturing and
Sales
We
will depend on our collaborators and third-party manufacturers
to produce most, if not all, of our products under development,
and if these third parties do not successfully manufacture these
products our business will be harmed.
We have no manufacturing experience or manufacturing
capabilities for clinical or commercial material. In order to
continue to develop product candidates, apply for regulatory
approvals, and commercialize our products, we or our
collaborators must be able to manufacture products in clinical
and commercial quantities, in compliance with regulatory
requirements, at acceptable costs and in a timely manner. The
manufacture of our product candidates may be complex, difficult
to accomplish and difficult to
scale-up
when large-scale production is required. Manufacture may be
subject to delays, inefficiencies and poor or low yields of
quality products. The cost of manufacturing some of our products
may make them prohibitively expensive. If supplies of any of our
product candidates or related materials become unavailable on a
timely basis or at all or are contaminated or otherwise lost,
clinical trials by us and our collaborators could be seriously
delayed. This is due to the fact that such materials are
time-consuming to manufacture and cannot be readily obtained
from third-party sources.
To the extent that we, or our collaborators, seek to enter into
manufacturing arrangements with third parties, we and such
collaborators will depend upon these third parties to perform
their obligations in a timely and effective manner and in
accordance with government regulations. Contract manufacturers
may breach their manufacturing agreements because of factors
beyond our control or may terminate or fail to renew a
manufacturing agreement based on their own business priorities
at a time that is costly or inconvenient for us. Contract
manufacturers are subject to ongoing periodic, unannounced
inspection by the FDA and corresponding state and foreign
agencies or their designees to ensure strict compliance with
current good manufacturing practices and other governmental
regulations and corresponding foreign standards. Failure of
contract manufacturers or our collaborators or us to comply with
applicable regulations could result in sanctions being imposed,
including fines, injunctions, civil penalties, failure of
regulatory authorities to grant marketing approval of our
product candidates, delays, suspension or withdrawal of
approvals, seizures or recalls of product candidates, operating
restrictions and criminal prosecutions, any of which could
significantly and adversely affect our business. If we need to
change manufacturers, the FDA and corresponding foreign
regulatory agencies must approve these manufacturers in advance.
This would involve testing and pre-approval inspections to
ensure compliance with FDA and foreign regulations and
standards.
52
If third-party manufacturers fail to perform their obligations,
our competitive position and ability to generate revenue may be
adversely affected in a number of ways, including;
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we and our collaborators may not be able to initiate or continue
clinical trials of products that are under development;
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we and our collaborators may be delayed in submitting
applications for regulatory approvals for our product
candidates; and
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we and our collaborators may not be able to meet commercial
demands for any approved products.
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We
have no sales or marketing experience and, as such, will depend
significantly on third parties who may not successfully sell our
products.
We have no sales, marketing or product distribution experience.
If we receive required regulatory approvals, we plan to rely
primarily on sales, marketing and distribution arrangements with
third parties, including our collaborative partners. For
example, as part of Micromets agreements with Serono and
MedImmune, Micromet has granted its collaborators rights to
distribute certain products resulting from such collaborations,
if any are ever successfully developed. We may have to enter
into additional marketing arrangements in the future and we may
not be able to enter into these additional arrangements on terms
which are favorable to us, if at all. In addition, we may have
limited or no control over the sales, marketing and distribution
activities of these third parties and sales through these third
parties could be less profitable to us than direct sales. These
third parties could sell competing products and may devote
insufficient sales efforts to our products. Our future revenues
will be materially dependent upon the success of the efforts of
these third parties.
We may seek to independently market products that are not
already subject to marketing agreements with other parties. If
we determine to perform sales, marketing and distribution
functions ourselves, we could face a number of additional risks,
including:
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we may not be able to attract and build a significant and
skilled marketing staff or sales force;
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the cost of establishing a marketing staff or sales force may
not be justifiable in light of the revenues generated by any
particular product; and
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our direct sales and marketing efforts may not be successful.
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Risks
Faced by Both CancerVax and Micromet Relating to the Life
Sciences Industry
If our
third-party manufacturers facilities do not follow current
good manufacturing practices, our product development and
commercialization efforts may be harmed.
There are a limited number of manufacturers that operate under
the FDAs and European Unions good manufacturing
practices regulations and are capable of manufacturing products.
Third-party manufacturers may encounter difficulties in
achieving quality control and quality assurance and may
experience shortages of qualified personnel. A failure of
third-party manufacturers to follow current good manufacturing
practices or other regulatory requirements and to document their
adherence to such practices may lead to significant delays in
the availability of products for commercial use or clinical
study, the termination of, or hold on a clinical study, or may
delay or prevent filing or approval of marketing applications
for our products. In addition we could be subject to sanctions
being imposed on us, including fines, injunctions and civil
penalties. Changing manufacturers may require additional
clinical trials and the revalidation of the manufacturing
process and procedures in accordance with FDA mandated current
good manufacturing practices and will require FDA approval. This
revalidation may be costly and time consuming. If we are unable
to arrange for third-party manufacturing of our products, or to
do so on commercially reasonable terms, we may not be able to
complete development or marketing of our products.
53
If we
fail to obtain an adequate level of reimbursement for our
products by third-party payors, there may be no commercially
viable markets for our products or the markets may be much
smaller than expected.
The availability and levels of reimbursement by governmental and
other third-party payors affect the market for our products. The
efficacy, safety and cost-effectiveness of our products as well
as the efficacy, safety and cost-effectiveness of any competing
products will determine the availability and level of
reimbursement. These third-party payors continually attempt to
contain or reduce the costs of healthcare by challenging the
prices charged for healthcare products and services. In certain
countries, particularly the countries of the European Union, the
pricing of prescription pharmaceuticals is subject to
governmental control. In these countries, pricing negotiations
with governmental authorities can take six to twelve months or
longer after the receipt of regulatory marketing approval for a
product. To obtain reimbursement or pricing approval in some
countries, we may be required to conduct clinical trials that
compare the cost-effectiveness of our products to other
available therapies. If reimbursement for our products is
unavailable or limited in scope or amount or if pricing is set
at unsatisfactory levels, our revenues would be reduced.
Another development that may affect the pricing of drugs is
regulatory action regarding drug reimportation into the United
States. The Medicare Prescription Drug, Improvement and
Modernization Act of 2003, which became law in December 2003,
requires the Secretary of the U.S. Department of Health and
Human Services to promulgate regulations allowing drug
reimportation from Canada into the United States under certain
circumstances. These provisions will become effective only if
the Secretary certifies that such imports will pose no
additional risk to the publics health and safety and
result in significant cost savings to consumers. To date, the
Secretary has made no such finding, but he could do so in the
future. Proponents of drug reimportation may also attempt to
pass legislation that would remove the requirement for the
Secretarys certification or allow reimportation under
circumstances beyond those anticipated under current law. If
legislation is enacted, or regulations issued, allowing the
reimportation of drugs, it could decrease the reimbursement we
would receive for any products that we may commercialize,
negatively affecting our anticipated revenues and prospects for
profitability.
We may
not be successful in establishing additional strategic
collaborations, which could adversely affect our ability to
develop and commercialize products.
As an integral part of our ongoing research and development
efforts, we periodically review opportunities to establish new
collaborations, joint ventures and strategic collaborations for
the development and commercialization of products in our
development pipeline. We face significant competition in seeking
appropriate collaborators and the negotiation process is
time-consuming and complex. We may not be successful in our
efforts to establish additional strategic collaborations or
other alternative arrangements. Even if we are successful in our
efforts to establish a collaboration or agreement, the terms
that we establish may not be favorable to us. Finally, such
strategic alliances or other arrangements may not result in
successful products and associated revenue.
We
expect to rely heavily on third parties for the conduct of
clinical trials of our product candidates. If these clinical
trials are not successful, or if we or our collaborators are not
able to obtain the necessary regulatory approvals, we will not
be able to commercialize our product candidates.
In order to obtain regulatory approval for the commercial sale
of our product candidates, we and our collaborators will be
required to complete extensive preclinical studies as well as
clinical trials in humans to demonstrate to the FDA and foreign
regulatory authorities that our product candidates are safe and
effective. We have limited experience in conducting clinical
trials and expect to rely primarily on collaborative partners
and contract research organizations for their performance and
management of clinical trials of our product candidates.
Clinical development, including preclinical testing, is a long,
expensive and uncertain process. Accordingly, preclinical
testing and clinical trials, if any, of our product candidates
under development may not be successful. We and our
collaborators could experience delays in preclinical or clinical
trials of any of our product candidates, obtain unfavorable
results in a development program, or fail to obtain regulatory
approval for the commercialization of a product. Preclinical
studies or clinical trials may produce negative, inconsistent or
inconclusive results, and we or our collaborators may decide, or
regulators may require us, to conduct additional preclinical
studies or clinical
54
trials. The results from early clinical trials may not be
statistically significant or predictive of results that will be
obtained from expanded, advanced clinical trials.
Furthermore, the timing and completion of clinical trials, if
any, of our product candidates depend on, among other factors,
the number of patients we will be required to enroll in the
clinical trials and the rate at which those patients are
enrolled. Any increase in the required number of patients,
decrease in recruitment rates or difficulties retaining study
participants may result in increased costs, program delays or
both.
Also, our products under development may not be effective in
treating any of our targeted disorders or may prove to have
undesirable or unintended side effects, toxicities or other
characteristics that may prevent or limit their commercial use.
Institutional review boards or regulators, including the FDA,
may hold, suspend or terminate our clinical research or the
clinical trials of our product candidates for various reasons,
including non-compliance with regulatory requirements or if, in
their opinion, the participating subjects are being exposed to
unacceptable health risks. Additionally, the failure of third
parties conducting or overseeing the operation of the clinical
trials to perform their contractual or regulatory obligations in
a timely fashion could delay the clinical trials. Failure of
clinical trials can occur at any stage of testing. Any of these
events would adversely affect our ability to market a product
candidate.
Even
if our products are approved by regulatory authorities, if we
fail to comply with ongoing regulatory requirements, or if we
experience unanticipated problems with our products, these
products could be subject to restrictions or withdrawal from the
market.
Any product for which we obtain marketing approval, along with
the manufacturing processes, post-approval clinical data and
promotional activities for such product, will be subject to
continual review and periodic inspections by the FDA and other
regulatory bodies. Even if regulatory approval of a product is
granted, the approval may be subject to limitations on the
indicated uses for which the product may be marketed or contain
requirements for costly post-marketing testing and surveillance
to monitor the safety or efficacy of the product. Later
discovery of previously unknown problems with our products,
including unanticipated adverse events or adverse events of
unanticipated severity or frequency, manufacturer or
manufacturing processes, or failure to comply with regulatory
requirements, may result in restrictions on such products or
manufacturing processes, withdrawal of the products from the
market, voluntary or mandatory recall, fines, suspension of
regulatory approvals, product seizures, injunctions or the
imposition of civil or criminal penalties.
The
development process necessary to obtain regulatory approval is
lengthy, complex and expensive. If we and our collaborative
partners do not obtain necessary regulatory approvals, then our
business will be unsuccessful and the market price of our common
stock will substantially decline.
To the extent that we, or our collaborative partners, are able
to successfully advance a product candidate through the clinic,
we, or such partner, will be required to obtain regulatory
approval prior to marketing and selling such product.
The process of obtaining FDA and other required regulatory
approvals is expensive. The time required for FDA and other
approvals is uncertain and typically takes a number of years,
depending on the complexity and novelty of the product. The
process of obtaining FDA and other required regulatory approvals
for many of our products under development is further
complicated because some of these products use non-traditional
or novel materials in non-traditional or novel ways, and the
regulatory officials have little precedent to follow. Moreover,
an unrelated biotech company recently observed multiple severe
adverse reactions in a Phase 1 trial of an antibody that
stimulates T cells. This development could cause the FDA or
comparable international regulatory authorities to become less
supportive of
T-cell
related drugs such as the product candidates in Micromets
portfolio. With respect to internal programs to date, we have
limited experience in filing and prosecuting applications to
obtain marketing approval.
Any regulatory approval to market a product may be subject to
limitations on the indicated uses for which we, or our
collaborative partners, may market the product. These
limitations may restrict the size of the market for the product
and affect reimbursement by third-party payers. In addition,
regulatory agencies may not grant approvals on a timely basis or
may revoke or significantly modify previously granted approvals.
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We, or our collaborative partners, also are subject to numerous
foreign regulatory requirements governing the manufacturing and
marketing of our potential future products outside of the United
States. The approval procedure varies among countries,
additional testing may be required in some jurisdictions, and
the time required to obtain foreign approvals often differs from
that required to obtain FDA approvals. Moreover, approval by the
FDA does not ensure approval by regulatory authorities in other
countries, and vice versa.
As a result of these factors, we or our collaborators may not
successfully begin or complete clinical trials in the time
periods estimated, if at all. Moreover, if we or our
collaborators incur costs and delays in development programs or
fail to successfully develop and commercialize products based
upon our technologies, we may not become profitable and our
stock price could decline.
We,
and our collaborators, are subject to governmental regulations
other than those imposed by the FDA. We, and any of our
collaborators, may not be able to comply with these regulations,
which could subject us, or such collaborators, to penalties and
otherwise result in the limitation of our or such
collaborators operations.
In addition to regulations imposed by the FDA, we and our
collaborators are subject to regulation under the Occupational
Safety and Health Act, the Environmental Protection Act, the
Toxic Substances Control Act, the Research Conservation and
Recovery Act, as well as regulations administered by the Nuclear
Regulatory Commission, national restrictions on technology
transfer, import, export and customs regulations and certain
other local, state or federal regulations. From time to time,
other federal agencies and congressional committees have
indicated an interest in implementing further regulation of
biotechnology applications. We are not able to predict whether
any such regulations will be adopted or whether, if adopted,
such regulations will apply to our business, or whether we or
our collaborators would be able to comply with any applicable
regulations.
Failure
to obtain regulatory approval in foreign jurisdictions will
prevent us from marketing our products abroad.
We intend to market our products in international markets. In
order to market our products in the European Union and many
other foreign jurisdictions, we must obtain separate regulatory
approvals. The approval procedure varies among countries and can
involve additional testing, and the time required to obtain
approval may differ from that required to obtain FDA approval.
The foreign regulatory approval process may include all of the
risks associated with obtaining FDA approval. We may not obtain
foreign regulatory approvals on a timely basis, if at all.
Approval by the FDA does not ensure approval by regulatory
authorities in other countries, and approval by one foreign
regulatory authority does not ensure approval by regulatory
authorities in other foreign countries or by the FDA. We may not
be able to file for regulatory approvals and may not receive
necessary approvals to commercialize our products in any market.
We are
subject to uncertainty relating to health care reform measures
and reimbursement policies which, if not favorable to our
product candidates, could hinder or prevent our product
candidates commercial success.
The continuing efforts of the government, insurance companies,
managed care organizations and other payors of health care costs
to contain or reduce costs of health care may adversely affect:
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our ability to generate revenues and achieve profitability;
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the future revenues and profitability of our potential
customers, suppliers and collaborators; and
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the availability of capital.
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In certain foreign markets, the pricing of prescription
pharmaceuticals is subject to government control. In the United
States, given recent federal and state government initiatives
directed at lowering the total cost of health care, the
U.S. Congress and state legislatures will likely continue
to focus on health care reform, the cost of prescription
pharmaceuticals and on the reform of the Medicare and Medicaid
systems. For example, legislation was enacted on
December 8, 2003, which provides a new Medicare
prescription drug benefit that began in 2006 and mandates other
reforms. While we cannot predict the full effects of the
implementation of this new legislation or whether any
56
legislative or regulatory proposals affecting our business will
be adopted, the implementation of this legislation or
announcement or adoption of these proposals could have a
material and adverse effect on our business, financial condition
and results of operations.
Our ability to commercialize our product candidates successfully
will depend in part on the extent to which governmental
authorities, private health insurers and other organizations
establish appropriate reimbursement levels for the cost of our
products and related treatments. Third-party payors are
increasingly challenging the prices charged for medical products
and services. Also, the trend toward managed health care in the
United States, which could significantly influence the purchase
of health care services and products, as well as legislative
proposals to reform health care or reduce government insurance
programs, may result in lower prices for our product candidates
or exclusion of our product candidates from reimbursement
programs. The cost containment measures that health care payors
and providers are instituting and the effect of any health care
reform could materially and adversely affect our results of
operations.
If
physicians and patients do not accept the products that we may
develop, our ability to generate product revenue in the future
will be adversely affected.
The product candidates that we may develop may not gain market
acceptance among physicians, healthcare payors, patients and the
medical community. Market acceptance of and demand for any
product that we may develop will depend on many factors,
including:
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our ability to provide acceptable evidence of safety and
efficacy;
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convenience and ease of administration;
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prevalence and severity of adverse side effects;
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availability of alternative treatments;
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cost effectiveness;
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effectiveness of our marketing strategy and the pricing of any
product that we may develop;
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publicity concerning our products or competitive products; and
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our ability to obtain third-party coverage or reimbursement.
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In addition, our decision to discontinue our Phase 3
clinical trials for Canvaxin in patients with advanced-stage
melanoma based upon the recommendations of the independent DSMB
could create negative publicity that, although not directly
related to our remaining product candidates, could nevertheless
affect their market acceptance. Even if we receive regulatory
approval and satisfy the above criteria for our product
candidates, physicians may be reluctant to recommend, or
patients may be reluctant to use, our products.
We
face the risk of product liability claims and may not be able to
obtain insurance.
Our business exposes us to the risk of product liability claims
that is inherent in the testing, manufacturing, and marketing of
drugs and related devices. Although we have product liability
and clinical trial liability insurance that we believe is
appropriate, this insurance is subject to deductibles and
coverage limitations. We may not be able to obtain or maintain
adequate protection against potential liabilities. In addition,
if any of our product candidates are approved for marketing, we
may seek additional insurance coverage. If we are unable to
obtain insurance at acceptable cost or on acceptable terms with
adequate coverage or otherwise protect against potential product
liability claims, we will be exposed to significant liabilities,
which may harm our business. These liabilities could prevent or
interfere with our product commercialization efforts. Defending
a suit, regardless of merit, could be costly, could divert
management attention and might result in adverse publicity or
reduced acceptance of our products in the market.
57
Our
operations involve hazardous materials and we must comply with
environmental laws and regulations, which can be
expensive.
Our research and development activities involve the controlled
use of hazardous materials, including chemicals and radioactive
and biological materials. Our operations also produce hazardous
waste products. We are subject to a variety of federal, state
and local regulations relating to the use, handling, storage and
disposal of these materials. We generally contract with third
parties for the disposal of such substances and store certain
low-level radioactive waste at our facility until the materials
are no longer considered radioactive. We cannot eliminate the
risk of accidental contamination or injury from these materials.
We may be required to incur substantial costs to comply with
current or future environmental and safety regulations. If an
accident or contamination occurred, we would likely incur
significant costs associated with civil penalties or criminal
fines and in complying with environmental laws and regulations.
We do not have any insurance for liabilities arising from
hazardous materials. Compliance with environmental laws and
regulations is expensive, and current or future environmental
regulation may impair our research, development or production
efforts.
The
life sciences industry is highly competitive and subject to
rapid technological change.
The life sciences industry is highly competitive and subject to
rapid and profound technological change. Our present and
potential competitors include major pharmaceutical companies, as
well as specialized biotechnology and life sciences firms in the
United States and in other countries. Most of these companies
have considerably greater financial, technical and marketing
resources than we do. Additional mergers and acquisitions in the
pharmaceutical and biotechnology industries may result in even
more resources being concentrated in our competitors. Our
existing or prospective competitors may develop processes or
products that are more effective than ours or be more effective
at implementing their technologies to develop commercial
products faster. Our competitors may succeed in obtaining patent
protection
and/or
receiving regulatory approval for commercializing products
before us. Developments by our competitors may render our
product candidates obsolete or non-competitive.
We also experience competition from universities and other
research institutions, and we frequently compete with others in
acquiring technology from those sources. These industries have
undergone, and are expected to continue to undergo, rapid and
significant technological change, and we expect competition to
intensify as technical advances in each field are made and
become more widely known. There can be no assurance that others
will not develop technologies with significant advantages over
those that we are seeking to develop. Any such development could
harm our business.
Legislative
or regulatory reform of the healthcare system may affect our
ability to sell our products profitably.
In both the United States and certain foreign jurisdictions,
there have been a number of legislative and regulatory changes
to the healthcare system in ways that could impact upon our
ability to sell our products profitably. In the United States in
recent years, new legislation has been enacted at the federal
and state levels that would effect major changes in the
healthcare system, either nationally or at the state level.
These new laws include a prescription drug benefit for Medicare
beneficiaries and certain changes in Medicare reimbursement.
Given the recent enactment of these laws, it is still too early
to determine its impact on the pharmaceutical industry and our
business. Further federal and state proposals are likely. More
recently, administrative proposals are pending and others have
become effective that would change the method for calculating
the reimbursement of certain drugs. The adoption of these
proposals and potential adoption of pending proposals may affect
our ability to raise capital, obtain additional collaborators or
market our products. Such proposals may reduce our revenues,
increase our expenses or limit the markets for our products. In
particular, we expect to experience pricing pressures in
connection with the sale of our products due to the trend toward
managed health care, the increasing influence of health
maintenance organizations and additional legislative proposals.
58
We may
incur substantial costs enforcing our patents, defending against
third-party patents, invalidating third-party patents or
licensing third-party intellectual property, as a result of
litigation or other proceedings relating to patent and other
intellectual property rights.
We may not have rights under some patents or patent applications
that may cover technologies that we use in our research, drug
targets that we select, or product candidates that we seek to
develop and commercialize. Third parties may own or control
these patents and patent applications in the United States and
abroad. These third parties could bring claims against us or our
collaborators that would cause us to incur substantial expenses
and, if successful against us, could cause us to pay substantial
damages. Further, if a patent infringement suit were brought
against us or our collaborators, we or they could be forced to
stop or delay research, development, manufacturing or sales of
the product or product candidate that is the subject of the
suit. We or our collaborators therefore may choose to seek, or
be required to seek, a license from the third-party and would
most likely be required to pay license fees or royalties or
both. These licenses may not be available on acceptable terms,
or at all. Even if we or our collaborators were able to obtain a
license, the rights may be nonexclusive, which would give our
competitors access to the same intellectual property.
Ultimately, we could be prevented from commercializing a
product, or forced to cease some aspect of our business
operations, as a result of patent infringement claims, which
could harm our business.
There has been substantial litigation and other proceedings
regarding patent and other intellectual property rights in the
pharmaceutical and biotechnology industries. Although we are not
currently a party to any patent litigation or any other
adversarial proceeding, including any interference proceeding
declared before the United States Patent and Trademark Office,
regarding intellectual property rights with respect to our
products and technology, we may become so in the future. We are
not currently aware of any actual or potential third party
infringement claim involving our products. The cost to us of any
patent litigation or other proceeding, even if resolved in our
favor, could be substantial. The outcome of patent litigation is
subject to uncertainties that cannot be adequately quantified in
advance, including the demeanor and credibility of witnesses and
the identity of the adverse party, especially in biotechnology
related patent cases that may turn on the testimony of experts
as to technical facts upon which experts may reasonably
disagree. Some of our competitors may be able to sustain the
costs of such litigation or proceedings more effectively than we
can because of their substantially greater financial resources.
If a patent or other proceeding is resolved against us, we may
be enjoined from researching, developing, manufacturing or
commercializing our products without a license from the other
party and we may be held liable for significant damages. We may
not be able to obtain any required license on commercially
acceptable terms or at all.
Uncertainties resulting from the initiation and continuation of
patent litigation or other proceedings could harm our ability to
compete in the marketplace. Patent litigation and other
proceedings may also absorb significant management time.
We may
not be successful in our efforts to expand our portfolio of
products and develop additional delivery
technologies.
A key element of our strategy is to discover, develop and
commercialize a portfolio of new drugs and technologies to
deliver those drugs safely and efficiently. We are seeking to do
so through our internal research programs and in-licensing. A
significant portion of the research that we are conducting
involves new and unproven technologies. Research programs to
identify new disease targets, product candidates and delivery
technologies require substantial technical, financial and human
resources whether or not any candidates or technologies are
ultimately identified. Our research programs may initially show
promise in identifying potential product candidates or delivery
technologies, yet fail to yield product candidates or delivery
technologies for clinical development for any of the following
reasons:
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research methodology used may not be successful in identifying
potential product candidates;
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potential delivery technologies may not safely or efficiently
deliver our drugs; and
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product candidates may on further study be shown to have harmful
side effects or other characteristics that indicate they are
unlikely to be effective drugs.
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59
If we are unable to discover suitable potential product
candidates, develop additional delivery technologies through
internal research programs or in-license suitable products or
delivery technologies on acceptable business terms, our business
prospects will suffer.
If we
are unable to protect our intellectual property rights, our
competitors may develop and market products with similar
features that may reduce demand for our potential
products.
The following factors are important to our success:
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receiving patent protection for our product candidates;
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preventing others from infringing our intellectual property
rights; and
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maintaining our patent rights and trade secrets.
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We will be able to protect our intellectual property rights in
patents and trade secrets from unauthorized use by third parties
only to the extent that such intellectual property rights are
covered by valid and enforceable patents or are effectively
maintained as trade secrets.
To date, we have sought to protect our proprietary position by
filing U.S. and foreign patent applications related to our
important proprietary technology, inventions and improvements.
Because the patent position of pharmaceutical companies involves
complex legal and factual questions, the issuance, scope and
enforceability of patents cannot be predicted with certainty.
Patents, if issued, may be challenged, invalidated or
circumvented. U.S. patents and patent applications may also
be subject to interference proceedings, and U.S. patents
may be subject to reexamination proceedings in the
U.S. Patent and Trademark Office and foreign patents may be
subject to opposition or comparable proceedings in corresponding
foreign patent offices, which proceedings could result in either
loss of the patent or denial of the patent application or loss
or reduction in the scope of one or more of the claims of the
patent or patent application. In addition, such interference,
reexamination and opposition proceedings may be costly. Thus,
any patents that we own or license from others may not provide
any protection against competitors. Furthermore, an adverse
decision in an interference proceeding can result in a
third-party receiving the patent rights sought by us, which in
turn could affect our ability to market a potential product to
which that patent filing was directed. Our pending patent
applications, those that we may file in the future, or those
that we may license from third parties may not result in patents
being issued. If issued, they may not provide us with
proprietary protection or competitive advantages against
competitors with similar technology. Furthermore, others may
independently develop similar technologies or duplicate any
technology that we have developed. We rely on third-party
payment services for the payment of foreign patent annuities and
other fees. Non-payment or delay in payment of such fees,
whether intentional or unintentional, may result in loss of
patents or patent rights important to our business. Many
countries, including certain countries in Europe, have
compulsory licensing laws under which a patent owner may be
compelled to grant licenses to third parties. For example,
compulsory licenses may be required in cases where the patent
owner has failed to work the invention in that
country, or the third-party has patented improvements. In
addition, many countries limit the enforceability of patents
against government agencies or government contractors. In these
countries, the patent owner may have limited remedies, which
could materially diminish the value of the patent. Moreover, the
legal systems of certain countries, particularly certain
developing countries, do not favor the aggressive enforcement of
patent and other intellectual property protection which makes it
difficult to stop infringement.
In addition, our ability to enforce our patent rights depends on
our ability to detect infringement. We are not currently aware
of any actual or potential infringement claim involving our
intellectual property rights. It is difficult to detect
infringers who do not advertise the compounds that are used in
their products. Any litigation to enforce or defend our patent
rights, even if we prevail, could be costly and time-consuming
and would divert the attention of management and key personnel
from business operations.
We have also relied on trade secrets, know-how and technology,
which are not protected by patents, to maintain our competitive
position. We have sought to protect this information by entering
into confidentiality agreements with parties that have access to
it, such as strategic partners, collaborators, employees and
consultants. Any of these parties may breach these agreements
and disclose our confidential information or our competitors
might learn of the information in some other way. If any trade
secret, know-how or other technology not protected by a patent
were disclosed to, or independently developed by a competitor,
our business, financial condition and results of operations
could be materially adversely affected.
60
If
licensees or assignees of our intellectual property rights
breach any of the agreements under which we have licensed or
assigned our intellectual property to them, we could be deprived
of important intellectual property rights and future
revenue.
We are a party to intellectual property out-licenses,
collaborations and agreements that are important to our business
and expect to enter into similar agreements with third parties
in the future. Under these agreements, we license or transfer
intellectual property to third parties and impose various
research, development, commercialization, sublicensing, royalty,
indemnification, insurance, and other obligations on them. If a
third party fails to comply with these requirements, we
generally retain the right to terminate the agreement, and to
bring a legal action in court or in arbitration. In the event of
breach, we may need to enforce our rights under these agreements
by resorting to arbitration or litigation. During the period of
arbitration or litigation, we may be unable to effectively use,
assign or license the relevant intellectual property rights and
may be deprived of current or future revenues that are
associated with such intellectual property.
We may
be subject to damages resulting from claims that we or our
employees have wrongfully used or disclosed alleged trade
secrets of their former employers.
Many of our employees were previously employed at other
biotechnology or pharmaceutical companies, including our
competitors or potential competitors. Although no claims against
us are currently pending, we may be subject to claims that these
employees or we have inadvertently or otherwise used or
disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend
against these claims. Even if we are successful in defending
against these claims, litigation could result in substantial
costs and be a distraction to management. If we fail in
defending such claims, in addition to paying money claims, we
may lose valuable intellectual property rights or personnel. A
loss of key personnel or their work product could hamper or
prevent our ability to commercialize certain product candidates,
which would adversely affect commercial development efforts.
Changes
in, or interpretations of, accounting rules and regulations,
such as expensing of stock options, could result in unfavorable
accounting charges or require us to change our compensation
policies.
Accounting methods and policies for biopharmaceutical companies,
including policies governing revenue recognition, expenses,
accounting for stock options and in-process research and
development costs are subject to further review, interpretation
and guidance from relevant accounting authorities, including the
Securities and Exchange Commission. Changes to, or
interpretations of, accounting methods or policies in the future
may require us to reclassify, restate or otherwise change or
revise our financial statements, including those contained in
this proxy statement/prospectus. Historically, CancerVax has
recorded employee stock-based compensation charges only if the
stock option exercise price is less than the fair value of
CancerVaxs common stock on the date of grant.
Historically, Micromet has used the minimal value method to
recognize any employee stock-based compensation charges in
accordance with Statement of Financial Accounting Standards No.
123. The Financial Accounting Standards Board issued in
December 2004 Statement of Financial Accounting Standards
No. 123(revised), or SFAS No. 123R, which will require
us to recognize in our results of operations in the first annual
period beginning after June 15, 2005 the fair value of
stock awards granted and purchases under employee stock purchase
plans. Upon our adoption of SFAS No. 123R, our operating
expenses will increase. We rely heavily on stock options to
motivate existing employees and attract new employees. Once we
are required to expense stock awards, we may choose to reduce
our reliance on stock awards as a motivational tool. If we
reduce our use of stock awards, it may be more difficult for us
to attract and retain qualified employees. If we do not reduce
our reliance on stock awards, our reported losses will increase.
61
THE
COMPANIES
CancerVax
We are a biotechnology company focused on the research,
development and commercialization of novel biological products
for the treatment and control of cancer.
On October 3, 2005, we and Serono Technologies, S.A., our
collaboration partner for Canvaxin, announced the
discontinuation of our Phase 3 clinical trial of our
leading product candidate, Canvaxin, in patients with
Stage III melanoma, based on the recommendation of the
independent Data and Safety Monitoring Board, or DSMB, which
completed its planned, third, interim analysis of data from this
study on September 30, 2005. In April 2005, we
announced the discontinuation of our Phase 3 clinical trial
of Canvaxin in patients with Stage IV melanoma based upon a
similar recommendation of the independent DSMB. The DSMB
concluded, based on its planned, interim analysis of the data
from these studies, that the data were unlikely to provide
significant evidence of a survival benefit for Canvaxin-treated
patients versus those receiving placebo. There were no
significant safety issues identified with either of the
Phase 3 clinical trials of Canvaxin, and the
recommendations to close the studies were not made because of
any potential safety concerns.
In October 2005, we announced that our board of directors had
approved a restructuring plan designed to realign resources in
light of the decision to discontinue our Phase 3 clinical
trial of Canvaxin in patients with Stage III melanoma, as
well as all further development of Canvaxin and manufacturing
activities at our Canvaxin manufacturing facilities. Under the
restructuring plan, in 2005 we reduced our workforce from 183 to
52 employees at December 31, 2005 and closed our
biologics manufacturing facility and our warehouse facility. We
are actively seeking to sublease all three of our principal
facilities. In 2005, we recorded a non-recurring charge
associated with our restructuring activities of
$4.9 million. This non-recurring restructuring charge
includes $3.5 million of employee severance costs, the
substantial majority of which were cash expenditures that were
paid in the fourth quarter of 2005, and $1.4 million of
leased facility exit costs, representing the estimated future
costs to be incurred under the operating leases for our
biologics manufacturing facility and our warehouse facility, net
of estimated sublease rentals. In 2005, we also recorded a
non-recurring charge for contract termination costs of
$0.2 million, which is included in research and development
expenses. In connection with our restructuring activities, we
also recorded a non-recurring, non-cash charge for the
impairment of long-lived assets of $25.4 million in 2005 to
write-down the carrying value of certain of our long-lived
assets to their estimated fair value.
In January 2006, we implemented additional restructuring
measures which, when fully implemented, will result in the
further reduction of our workforce to approximately
10 employees by the completion of our proposed merger with
Micromet. In connection with the workforce reduction, in 2006 we
anticipate incurring approximately $3.0 million of
additional employee severance costs. We also anticipate
incurring additional leased facility exit costs in 2006,
primarily related to our corporate headquarters and research and
development facility. At this time, we are unable to reasonably
estimate the expected amount of such additional leased facility
exit costs, although our remaining obligations under the
operating lease for our corporate headquarters and research and
development facility aggregated $11.2 million as of
December 31, 2005. We may also incur additional contract
termination and other restructuring costs. We anticipate that
our restructuring efforts will be substantially completed by the
end of the second quarter of 2006.
We have other product candidates in research and preclinical
development, including four humanized, anti-angiogenic
monoclonal antibodies and several peptides that potentially
treat various solid tumors, as well as three product candidates
targeting the epidermal growth factor receptor, or EGFR,
signaling pathway for the treatment of cancer. Our efforts to
identify, develop, commercialize and, in the case of the three
product candidates that target the EGFR signaling pathway, to
sublicense these product candidates are in an early stage and,
therefore, these efforts are subject to a high risk of failure.
In February 2006, we submitted an Investigational New Drug
Application, or IND, to initiate a Phase 1 clinical trial
for D93, our leading humanized, anti-angiogenic monoclonal
antibody, in patients with solid tumors. We plan to actively
seek to sublicense
SAI-EGF and
our two other product candidates that target the EGFR signaling
pathway.
62
CancerVax was incorporated in Delaware in June 1998. The
address of its principal executive office is
2110 Rutherford Road, Carlsbad, CA 92008 and its telephone
number is
(760) 494-4200.
The CancerVax website address is www.cancervax.com. CancerVax
does not incorporate the information on its website into this
proxy statement/prospectus, and you should not consider it part
of this proxy statement/prospectus.
Merger
Sub
Carlsbad Acquisition Corp., or Merger Sub, is a wholly-owned
subsidiary of CancerVax that was incorporated in Delaware in
January 2006. Merger Sub does not engage in any operations
and exists solely to facilitate the merger.
Micromet
AG
Micromet is a private biotechnology company with a focus on the
development of novel, proprietary antibody-based products for
cancer and inflammatory and autoimmune diseases. Two product
candidates are currently in clinical trials. Adecatumumab
(MT201), a recombinant human monoclonal antibody is being
evaluated in two Phase 2 clinical trials for the treatment
of certain solid tumors. In addition, MT103 is being studied in
a Phase 1 clinical trial. Micromet has established a
powerful drug development platform based on its
BiTEtm
technology, a unique drug format that leverages the cytotoxic
potential of T cells, the most powerful killer
cells of the human immune system.
Micromet was incorporated in Germany in December 1993.
Micromets principal executive offices are located at
Staffelseestrasse 2, 81477 Munich, Germany, and its
telephone number is 49 89 895 277 0.
Micromets website is located at www.micromet.de. Micromet
does not incorporate the information on its website into this
proxy statement/prospectus, and you should not consider it part
of this proxy statement/prospectus.
Micromet,
Inc.
Micromet, Inc., or Micromet Parent, was incorporated in Delaware
in January 2006. Micromet Parent does not engage in any
operations and exists solely to facilitate the merger. Prior to
the closing of the merger, stockholders of Micromet will
exchange their ordinary and preference shares of Micromet for
shares of common stock of Micromet Parent on a
1-for-1 basis.
63
THE
ANNUAL MEETING OF CANCERVAX STOCKHOLDERS
Date,
Time and Place
The annual meeting of CancerVax stockholders will be held on
May 3, 2006, at CancerVax Corporation, 2110 Rutherford
Road, Carlsbad, California commencing at 9:00 a.m. local
time. We are sending this proxy statement/prospectus to you in
connection with the solicitation of proxies by the CancerVax
board of directors for use at the CancerVax annual meeting and
any adjournments or postponements of the annual meeting.
Purposes
of the CancerVax Annual Meeting
The purposes of the CancerVax annual meeting are:
1. To consider and vote upon a proposal to approve the
issuance of CancerVax common stock pursuant to the Agreement and
Plan of Merger and Reorganization, dated as of January 6,
2006 and amended as of March 17, 2006, by and among
CancerVax, Carlsbad Acquisition Corporation, a wholly-owned
subsidiary of CancerVax, Micromet, Inc., a Delaware corporation,
and Micromet AG, a corporation organized under the laws of
Germany, and the resulting change of control of CancerVax.
2. To approve an amendment to CancerVaxs amended and
restated certificate of incorporation to increase the number of
authorized shares of common stock from 75,000,000 shares to
150,000,000 shares, which represents an additional
75,000,000 shares.
3. To authorize the board of directors of CancerVax to
amend in its discretion CancerVaxs amended and restated
certificate of incorporation to effect a reverse stock split of
the CancerVax common stock, at a ratio within the range of
1:2 to 1:4, and at such ratio to be determined by the
board of directors of CancerVax, as described in this proxy
statement/prospectus.
4. To approve an amendment to CancerVaxs amended and
restated certificate of incorporation to change the name of
CancerVax Corporation to Micromet, Inc.
5. To elect three directors for a three-year term to expire
at the 2009 annual meeting of stockholders; provided, however,
that, if the merger is completed, CancerVaxs board of
directors will consist of the nine people identified in this
proxy statement/prospectus.
6. To ratify the selection of Ernst & Young LLP as
CancerVaxs independent registered public accounting firm
for the fiscal year ending December 31, 2006.
7. To consider and vote upon an adjournment of the annual
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
Proposal Nos. 1 through 6.
8. To transact such other business as may properly come
before the annual meeting or any adjournment or postponement
thereof.
Recommendation
of CancerVaxs Board of Directors
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT THE ISSUANCE OF SHARES OF CANCERVAX COMMON STOCK IN
THE MERGER, AND THE RESULTING CHANGE OF CONTROL OF CANCERVAX, IS
ADVISABLE TO, AND IN THE BEST INTERESTS OF, CANCERVAX AND ITS
STOCKHOLDERS AND HAS APPROVED SUCH ITEMS. THE CANCERVAX BOARD OF
DIRECTORS RECOMMENDS THAT CANCERVAX STOCKHOLDERS VOTE
FOR PROPOSAL NO. 1 TO APPROVE THE ISSUANCE
OF SHARES OF CANCERVAX COMMON STOCK IN THE MERGER, AND THE
RESULTING CHANGE OF CONTROL OF CANCERVAX.
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT THE AMENDMENT OF CANCERVAXS AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION TO INCREASE THE NUMBER OF
AUTHORIZED SHARES OF COMMON STOCK IS ADVISABLE TO, AND IN
THE BEST INTERESTS OF, CANCERVAX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH INCREASE. THE CANCERVAX BOARD OF DIRECTORS
RECOMMENDS THAT
64
CANCERVAX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 2 TO APPROVE THE INCREASE IN THE NUMBER
OF AUTHORIZED SHARES OF COMMON STOCK.
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT IT IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, CANCERVAX
AND ITS STOCKHOLDERS TO AUTHORIZE CANCERVAXS BOARD OF
DIRECTORS IN ITS DISCRETION TO AMEND CANCERVAXS AMENDED
AND RESTATED CERTIFICATE OF INCORPORATION TO EFFECT A REVERSE
STOCK SPLIT OF THE ISSUED AND OUTSTANDING SHARES OF
CANCERVAXS COMMON STOCK (SUCH SPLIT TO COMBINE A NUMBER OF
OUTSTANDING SHARES OF CANCERVAXS COMMON STOCK BETWEEN
TWO (2) AND FOUR (4), SUCH NUMBER CONSISTING OF ONLY
WHOLE SHARES, INTO ONE (1) SHARE OF CANCERVAXS COMMON
STOCK). THE CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT
CANCERVAX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 3 TO AUTHORIZE THE CANCERVAX BOARD OF
DIRECTORS TO EFFECT THE REVERSE STOCK SPLIT.
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT THE AMENDMENT OF CANCERVAXS AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION TO CHANGE THE NAME OF CANCERVAX
CORPORATION TO MICROMET, INC. IS ADVISABLE TO, AND
IN THE BEST INTERESTS OF, CANCERVAX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH NAME CHANGE. THE CANCERVAX BOARD OF DIRECTORS
RECOMMENDS THAT CANCERVAX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 4 TO APPROVE THE NAME CHANGE.
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT, IN THE EVENT THE MERGER IS NOT CONSUMMATED, THE ELECTION
OF MR. HALE, DR. MORTON AND DR. CARTER TO THE
CANCERVAX BOARD OF DIRECTORS IS ADVISABLE TO, AND IN THE BEST
INTERESTS OF, CANCERVAX AND ITS STOCKHOLDERS AND HAS APPROVED
SUCH ELECTION; PROVIDED, HOWEVER, THAT IF THE MERGER IS
COMPLETED, CANCERVAXS BOARD OF DIRECTORS WILL CONSIST OF
THE NINE PEOPLE IDENTIFIED IN THIS PROXY STATEMENT/PROSPECTUS.
THE CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT CANCERVAX
STOCKHOLDERS VOTE FOR PROPOSAL NO. 5 TO APPROVE
THE ELECTION.
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT THE SELECTION OF ERNST & YOUNG LLP AS
CANCERVAXS INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
FOR THE YEAR ENDING DECEMBER 31, 2006 IS ADVISABLE TO, AND
IN THE BEST INTERESTS OF, CANCERVAX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH SELECTION. THE CANCERVAX BOARD OF DIRECTORS
RECOMMENDS THAT CANCERVAX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 6 TO RATIFY THE SELECTION OF ERNST &
YOUNG LLP AS CANCERVAXS INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM.
THE CANCERVAX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT ADJOURNING THE CANCERVAX ANNUAL MEETING, IF NECESSARY, IF A
QUORUM IS PRESENT, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE
NOT SUFFICIENT VOTES IN FAVOR OF PROPOSAL NOS. 1 THROUGH 6
IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, CANCERVAX AND ITS
STOCKHOLDERS AND HAS APPROVED AND ADOPTED THE PROPOSAL.
ACCORDINGLY, THE CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT
CANCERVAX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 7 TO ADJOURN THE CANCERVAX ANNUAL
MEETING, IF NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT
ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF
PROPOSAL NOS. 1 THROUGH 6.
Record
Date and Voting Power
Only holders of record of CancerVax common stock at the close of
business on the record date, March 27, 2006, are entitled
to notice of, and to vote at, the CancerVax annual meeting.
There were approximately 214 holders of record of CancerVax
common stock at the close of business on the record date.
Because many of such shares are held by brokers and other
institutions on behalf of stockholders, CancerVax is unable to
estimate the total number of
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stockholders represented by these record holders. At the close
of business on the record date, 27,955,139 shares of
CancerVax common stock were issued and outstanding. Each share
of CancerVax common stock entitles the holder thereof to one
vote on each matter submitted for stockholder approval. See
CancerVax Security Ownership by Certain Beneficial
Owners for information regarding persons known to the
management of CancerVax to be the beneficial owners of more than
5% of the outstanding shares of CancerVax common stock.
Voting
and Revocation of Proxies
The proxy accompanying this proxy statement/prospectus is
solicited on behalf of the board of directors of CancerVax for
use at the CancerVax annual meeting.
If you are a stockholder of record, you may vote in person at
the annual meeting or vote by proxy using the enclosed proxy
card. Whether or not you plan to attend the meeting, we urge you
to vote by proxy to ensure your vote is counted. You may still
attend the meeting and vote in person if you have already voted
by proxy.
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To vote in person, come to the annual meeting and we will give
you a ballot when you arrive.
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To vote using the proxy card, simply mark, sign and date your
proxy card and return it promptly in the postage-paid envelope
provided. If you return your signed proxy card to us before the
annual meeting, we will vote your shares as you direct.
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To vote over the telephone, dial toll-free
1-866-540-5760
using a touch-tone phone and follow the recorded instructions.
You will be asked to provide the company number and control
number from the enclosed proxy card. Your vote must be received
by 11:59 p.m., Eastern Standard Time on May 2, 2006 to
be counted.
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To vote on the Internet, go to http://www.proxyvoting.com/cnvx
to complete an electronic proxy card. You will be asked to
provide the company number and control number from the enclosed
proxy card. Your vote must be received by 11:59 p.m.,
Eastern Standard Time on May 2, 2006 to be counted.
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All properly executed proxies that are not revoked will be voted
at the CancerVax annual meeting and at any adjournments or
postponements of the annual meeting in accordance with the
instructions contained in the proxy. If a holder of CancerVax
common stock executes and returns a proxy and does not specify
otherwise, the shares represented by that proxy will be voted
FOR Proposal No. 1 to approve the issuance
of shares of CancerVax common stock in the merger, and the
resulting change of control of CancerVax; FOR
Proposal No. 2 to approve the increase in the number
of shares of authorized common stock; FOR
Proposal No. 3 to authorize the CancerVax board of
directors to effect the reverse stock split; FOR
Proposal No. 4 to change the name of CancerVax
Corporation to Micromet, Inc.; FOR
Proposal No. 5 to elect three directors for a three-year
term to expire at the 2009 annual meeting of stockholders;
provided, however, that, if the merger is completed,
CancerVaxs board of directors will consist of the nine
people identified in this proxy statement/prospectus;
FOR Proposal No. 6 to ratify the selection of
Ernst & Young LLP as CancerVaxs independent
registered public accounting firm for the fiscal year ending
December 31, 2006; and FOR
Proposal No. 7 to adjourn the annual meeting, if
necessary, if a quorum is present, to solicit additional proxies
if there are not sufficient votes in favor of
Proposal Nos. 1 through 6 in accordance with the
recommendation of the CancerVax board of directors.
A CancerVax stockholder who has submitted a proxy may revoke it
at any time before it is voted at the CancerVax annual meeting
by executing and returning a proxy bearing a later date,
providing proxy instructions via the telephone or the Internet
(your latest telephone or Internet proxy is counted), filing
written notice of revocation with the Secretary of CancerVax
stating that the proxy is revoked or attending the annual
meeting and voting in person.
Required
Vote
The presence, in person or by proxy, at the annual meeting of
the holders of a majority of the shares of CancerVax common
stock outstanding and entitled to vote at the annual meeting is
necessary to constitute a quorum at the meeting. Abstentions and
broker non-votes will be counted towards a quorum. Approval of
Proposal Nos. 1, 6 and 7 requires the affirmative
vote of the holders of a majority of the votes cast in person or
by proxy at the annual meeting. Approval of each of
Proposal Nos. 2, 3 and 4 requires the affirmative vote
of the holders of a majority of
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the outstanding shares of CancerVax common stock. The
affirmative vote of holders of a plurality of the votes cast in
person or by proxy at the annual meeting is required to elect
the directors in Proposal No. 5.
Votes will be counted by the inspector of election appointed for
the meeting, who will separately count For and
Against votes, abstentions and broker non-votes.
Abstentions will be counted towards the vote total for each
proposal and will have the same effect as Against
votes. Broker non-votes will have the same effect as
Against votes for any proposal except Proposal
Nos. 1, 6 and 7. For Proposal Nos. 1, 6 and
7, broker non-votes will have no effect and will not be counted
towards the vote total.
At the record date for the annual meeting, the directors and
executive officers of CancerVax owned approximately 37.3% of the
outstanding shares of CancerVax common stock entitled to vote at
the meeting. Stockholders owning approximately
8,354,687 shares of CancerVax common stock, representing
approximately 30% of the outstanding shares of CancerVax common
stock as of the record date, are subject to voting agreements
and irrevocable proxies. Each such stockholder has agreed in the
voting agreements to vote all shares of CancerVax common stock
owned by him, her or it as of the record date in favor of the
issuance of shares of CancerVax common stock in the merger. Each
also granted Micromet an irrevocable proxy to vote their shares
of CancerVax common stock in favor of the issuance of shares of
CancerVax common stock in the merger and the resulting change in
control of CancerVax. See Voting Agreements on page
113 of this proxy statement/prospectus.
Solicitation
of Proxies
In addition to solicitation by mail, the directors, officers,
employees and agents of CancerVax may solicit proxies from
CancerVaxs stockholders by personal interview, telephone,
telegram or otherwise. CancerVax will bear the costs of the
solicitation of proxies from its stockholders. Arrangements will
also be made with brokerage firms and other custodians, nominees
and fiduciaries who are record holders of CancerVax common stock
for the forwarding of solicitation materials to the beneficial
owners of CancerVax common stock. CancerVax will reimburse these
brokers, custodians, nominees and fiduciaries for the reasonable
out-of-pocket expenses they incur in connection with the
forwarding of solicitation materials.
Other
Matters
As of the date of this proxy statement/prospectus, the CancerVax
board of directors does not know of any business to be presented
at the CancerVax annual meeting other than as set forth in the
notice accompanying this proxy statement/prospectus. If any
other matters should properly come before the annual meeting, it
is intended that the shares represented by proxies will be voted
with respect to such matters in accordance with the judgment of
the persons voting the proxies.
67
MICROMET,
INC. STOCKHOLDER APPROVAL
The sole stockholder of Micromet Parent has already consented to
the merger. No separate stockholder approval of the stockholders
of Micromet is required under Delaware law. As a result, there
will not be a separate meeting of the stockholders of Micromet
or Micromet Parent to approve the merger, and Micromet Parent is
not soliciting proxies for the approval of the merger. The
exchange of Micromet shares for shares of Micromet Parent as
part of the Micromet Reorganization is the only action required
by stockholders of Micromet in order to complete the merger.
68
CANCERVAX
PROPOSAL NO. 1 APPROVAL OF ISSUANCE
OF SHARES OF CANCERVAX COMMON STOCK IN THE MERGER AND RESULTING
CHANGE OF CONTROL OF CANCERVAX
General
Description of the Merger
At the effective time, Merger Sub will be merged with and into
Micromet Parent. Micromet Parent will be the surviving
corporation and will continue as a wholly-owned subsidiary of
CancerVax. Immediately prior to the merger, the holders of
equity interests of Micromet will exchange their Micromet
interests for shares of common stock in Micromet Parent in an
exchange transaction, the Micromet Reorganization, that will
result in Micromet becoming a wholly-owned subsidiary of
Micromet Parent. Accordingly, as a result of the merger,
Micromet will survive as a wholly-owned direct subsidiary of
Micromet Parent and an indirect subsidiary of CancerVax.
Following the merger, CancerVax will change its name to
Micromet, Inc. In the merger, all shares of Micromet Parent
capital stock will be cancelled and, by virtue of the Micromet
Reorganization and the merger, Micromet stockholders, option
holders, warrant holders and note holders will receive the
number of shares of CancerVax common stock, or options or
warrants to acquire shares of CancerVax common stock, equal to
approximately 67.5% of the fully-diluted shares of the combined
company. Each Micromet Parent stockholder who would otherwise be
entitled to receive a fraction of a share of CancerVax common
stock (after aggregating all fractional shares to be received by
such stockholder) will instead be paid in cash for such
fractional share. The sole stockholder of Micromet Parent has
already approved the merger and no separate approval of the
merger by the shareholders of Micromet is required.
Background
of the Merger
Starting in January 2005, Micromets supervisory board and
management initiated a process to evaluate strategic options,
including an initial public offering or a merger transaction.
Micromet conducted a review of potential merger partners that
included both domestic and foreign public and private companies.
In parallel, the company performed an exploratory assessment of
the financial markets to evaluate the possibilities of, and
risks associated with, an initial public offering in Europe.
Micromet subsequently decided that, given the then-current
market conditions, the company would not pursue an initial
public offering until at least the first quarter of 2006.
During the first half of 2005, Micromet held initial discussions
with several parties under confidentiality agreements about
possible mergers or acquisitions. None of these discussions
advanced to in-depth discussions and were terminated.
In August 2005, Micromet began discussions with another party
that led to in depth discussions about a possible merger.
Between August 2005 and December 9, 2005, Micromet and the
other potential merger party, with the assistance of their
respective counsel and accountants, conducted due diligence
investigations and negotiated the terms of a possible
transaction between the parties.
On October 3, 2005, CancerVax and Serono Technologies,
S.A., its collaboration partner for Canvaxin, announced the
discontinuation of CancerVaxs Phase 3 clinical trial
of its leading product candidate, Canvaxin, in patients with
Stage III melanoma, based on the recommendation of the
independent Data and Safety Monitoring Board, which completed
its planned, third, interim analysis of data from this study on
September 30, 2005. As a result, CancerVax decided to
explore various strategic alternatives, including the potential
sale of the company. A special committee of the board of
directors, comprised of Messrs. Hale, Kiss, Phillips and
Schneider, was formed to explore such alternatives.
On October 5, 2005, CancerVaxs chief executive
officer, David F. Hale, at the request of the special committee,
contacted the Chairman of Micromets supervisory board,
Jerry Benjamin, to explore the possibility of a transaction
between the two companies.
On October 18, 2005, Micromet and CancerVax entered into a
confidentiality agreement to evaluate the possibility of a
merger. On the same day Micromets chief executive officer,
Christian Itin, and chief scientific officer, Patrick A.
Baeuerle, provided CancerVax management with a presentation on
Micromets product pipeline
69
and technologies. In addition, Dr. Itin and Mr. Hale
met to discuss the possibility of a transaction between
CancerVax and Micromet.
On November 3, 2005, at a telephonic meeting of
CancerVaxs board of directors, CancerVaxs special
committee updated the board regarding its evaluation of
strategic alternatives, including a potential merger with
Micromet, and the engagement of an investment banker to assist
in the process. Dr. Michael Carter, a director of both
CancerVax and Micromet, did not participate in any substantive
discussions regarding Micromet or a potential merger in this
board meeting or any other board meeting.
On November 9, 2005, CancerVaxs special committee
approved Piper Jaffray as the companys financial advisor
in connection with its consideration of a potential merger with
Micromet and other possible strategic options for the company
and for the rendering of a fairness opinion regarding the
consideration paid or received in any resulting transaction.
The special committee discussed with Mr. Hale the possible
terms of a transaction and requested that Mr. Hale continue
discussions with Micromet.
On November 13 and 14, 2005, Dr. Itin and
Mr. Hale met in Munich to continue discussions about a
possible transaction between CancerVax and Micromet.
On November 15, 2005, Mr. Benjamin and Mr. Hale
met in London to continue the discussions about a potential
transaction between the parties.
On November 16 and 17, 2005, the CancerVax management team
conducted an
on-site due
diligence meeting at Micromets offices in Munich, Germany.
On November 25, 2005, Micromet instructed its outside
counsel, Cooley Godward LLP, to begin work on a possible
transaction with CancerVax.
On November 29, 2005, at a telephonic meeting of
CancerVaxs board of directors, CancerVaxs special
committee updated the board regarding the evaluation of
strategic alternatives, including discussions regarding a
potential merger with Micromet. During this meeting the special
committee provided Mr. Hale with further guidance on
possible terms of a merger and requested that Mr. Hale
continue discussions with Micromet.
On December 5, 2005, Mr. Benjamin and Mr. Hale
met in London to negotiate merger terms for a transaction
between the parties.
On December 6 and December 7, 2005, at a meeting of
CancerVaxs board of directors, Piper Jaffray made a
presentation regarding Micromet and a potential schedule for a
possible transaction with Micromet. The board of directors also
discussed several other potential companies with which it might
pursue a possible strategic transaction. At this meeting, the
board decided that the special committee should consist only of
non-management directors, and Messrs. Kiss, Phillips and
Schneider continued as the special committee.
On December 7 and 8, 2005, Micromets management team,
representatives from Cooley Godward and auditors from
Ernst & Young held
on-site due
diligence meetings at CancerVaxs headquarters in Carlsbad,
California.
On December 9, 2005, Micromet terminated its discussions
with the other potential merger partner.
On December 13, 2005, Micromets supervisory board
discussed the rationale for a merger with CancerVax and the
possible terms for such a transaction. After discussing the
benefits of this opportunity when compared to other
alternatives, the supervisory board instructed management to
continue its discussions with CancerVax.
On December 14, 2005, Cooley Godward provided to counsel to
CancerVax, Latham & Watkins LLP, an initial draft of
the merger agreement. Thereafter, Cooley Godward and
Latham & Watkins had a number of conversations
concerning the terms of the merger agreement.
In a telephone conference call on December 14, 2005,
Micromets management informed CancerVaxs board of
directors of the clinical results of its Phase 2 clinical
trial in prostate cancer, its ongoing Phase 2 trial in
metastatic breast cancer, its ongoing Phase 1 trial
combining adecatumumab (MT201) with docetaxel and the ongoing
Phase 1
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trial with MT103. In addition, Micromet management presented a
brief update on its preclinical programs for MT110 and MT203.
On December 15, 2005, at a telephonic meeting of
CancerVaxs board of directors, the board discussed a
potential merger transaction with Micromet and agreed to proceed
with the negotiation of such transaction.
On December 16, 2005, Latham & Watkins provided a
revised draft of the merger agreement to Cooley Godward.
From December 16, 2005 through January 6, 2006, the
parties, together with their respective outside counsel, engaged
in negotiations regarding the merger agreement and related
documentation, affiliate agreements and voting agreements,
including termination rights and fees, indemnification and
escrow provisions, representations and warranties and covenants.
During this period, final agreement on these and other issues
was reached over the course of numerous discussions involving
CancerVax and Micromets respective management and counsel.
In addition, during this period, the parties continued their due
diligence reviews.
On December 16, 2005, Micromets supervisory board
authorized Micromet management to enter into an exclusivity
agreement with CancerVax and to negotiate a definitive merger
agreement. In addition, on December 16, 2005, the
supervisory board discussed the potential terms of such a
transaction, including the proposed exchange ratio.
On December 19, 2005, CancerVaxs board of directors
convened by telephone to discuss the status of the Micromet
transaction, including provisions of the merger agreement, legal
due diligence, and management issues. At this meeting, Latham
& Watkins and Piper Jaffray made presentations to
CancerVaxs board of directors.
On December 20, 2005, CancerVaxs special committee of
the board of directors convened by teleconference to discuss the
Micromet transaction.
On December 22, 2005, representatives of Micromets
supervisory board convened by telephone to discuss the merger
agreement. Dr. Itin provided an overview of the process and
status of the negotiations. Representatives from Cooley Godward
discussed the merger agreement and the ongoing negotiations. The
supervisory board provided guidance concerning further
negotiations.
On December 22, 2005, Micromet and CancerVax entered into
an exclusivity agreement to negotiate a definitive merger
agreement by January 6, 2006.
On January 3, 2006, representatives of Micromets
supervisory board convened by teleconference to discuss the
transaction. Dr. Itin provided an update of the current
state of negotiations with CancerVax.
On January 3, 2006, CancerVaxs board of directors
convened by teleconference to discuss the merger transaction.
Mr. Hale updated the board on the status of the
negotiations with Micromet. Ms. Aker and Messrs. Ebel
and LaRue then reviewed various aspects of the transaction,
including transaction structure, due diligence, Micromets
capital structure and financials, and outstanding issues.
On January 4, 2006, representatives of Micromets
supervisory board convened by teleconference to discuss the
transaction. Dr. Itin, representatives of Cooley Godward
and representatives of Ernst & Young provided an
overview of the diligence process and the findings from such
review. The supervisory board provided guidance with respect to
areas for further review. Also on this day, Micromet Parent was
incorporated in the State of Delaware.
On January 5, 2006, representatives of Micromets
supervisory board convened by teleconference to discuss the
transaction. Dr. Itin, representatives of Cooley Godward
and representatives of Ernst & Young provided an update
to their diligence review.
Between January 3 and January 6, 2006, Micromet and
CancerVax executives and their respective counsels continued due
diligence and completed negotiation of the merger agreement.
On January 6, 2006, the Micromet supervisory board met to
discuss the merger agreement. Micromet management discussed the
strategic benefits of a merger. Representatives from Cooley
Godward provided an overview of the merger agreement and the
results of its ongoing diligence review. Micromets
supervisory board, after considering the findings of the due
diligence investigation, the terms of the merger agreement and
the related
71
documents, and the various presentations, approved the merger
and the merger agreement and the related documentation.
Dr. Carter did not participate in the discussion and
abstained from voting on the merger and related matters.
On January 6, 2006, CancerVaxs board of directors
convened by teleconference to discuss the merger transaction. A
representative from Latham & Watkins provided an
overview of the merger agreement and related documents and a
full discussion ensued. Representatives of Piper Jaffray then
made a presentation regarding its financial analyses related to
the merger consideration to be paid to holders of Micromet
Parent common stock and delivered to the special committee and
the board of directors of CancerVax its oral opinion,
subsequently confirmed in writing, that as of January 6,
2006 and based on and subject to the factors, assumptions and
limitations set forth therein, the total merger consolidation to
be paid to the holders of Micromet Parent common stock in the
merger was fair to CancerVax from a financial point of view. The
special committee then unanimously recommended to the board to
proceed with the transaction. CancerVaxs board of
directors, after considering the terms of the merger agreement
and the related documents, and the various presentations,
approved the merger and the merger agreement and related
documents. Dr. Carter did not participate in the discussion and
abstained from voting on the merger and related matters.
On the evening of Friday, January 6, 2006, Micromet and
CancerVax executed the merger agreement. On Monday,
January 9, 2006, the parties issued a joint press release
announcing the execution of the merger agreement.
On March 17, 2006, the parties entered into an amendment to
the merger agreement to make certain modifications to reflect
Micromet Parents approval process for the merger.
The
Combined Company
The combined companys U.S. headquarters immediately
following the completion of the merger will be located at
CancerVaxs current principal executive offices in
Carlsbad, California, while its German headquarters will remain
in Munich, Germany. The combined company intends to move its
U.S. headquarters to the eastern United States later in
2006. As a result of the merger, former Micromet Parent
stockholders will possess majority control of the combined
company. Following the merger, the executive management team of
the combined company is expected to be composed primarily of
certain members of Micromets executive management team
prior to the merger and will likely include the following
individuals:
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Name
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Position in the Combined
Company
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Current Position
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Christian Itin, Ph.D.
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President and Chief Executive
Officer
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Micromets Chief Executive
Officer
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Patrick A. Baeuerle, Ph.D.
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Senior Vice President and
Chief Scientific Officer
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Micromets Chief Scientific
Officer
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Gregor Mirow, M.D.,
M.B.A.
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Senior Vice President of Operations
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Micromets Chief Financial
and
Chief Operating Officer
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Carsten Reinhardt,
M.D., Ph.D.
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Senior Vice President of Clinical
Development
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Micromets Senior Vice
President of Clinical Development
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William R. LaRue
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Senior Vice President, Chief
Financial Officer
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CancerVaxs Senior Vice
President, Chief Financial Officer
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The voluntary resignation of William LaRue will become effective
on June 1, 2006. Mr. LaRue has agreed to provide
consulting services to the combined company for compensation of
$50,000 until August 15, 2006 in order to assist with
post-merger integration activities.
The combined company intends to continue developing certain of
CancerVaxs current product candidates as well as
Micromets product candidates.
Reasons
for the Merger
The following discussion of the parties reasons for the
merger contains a number of forward-looking statements that
reflect the current views of CancerVax
and/or
Micromet with respect to future events that may have an effect
on their future financial performance. Forward-looking
statements are subject to risks and uncertainties.
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Actual results and outcomes may differ materially from the
results and outcomes discussed in the forward-looking
statements. Cautionary statements that identify important
factors that could cause or contribute to differences in results
and outcomes include those discussed in
Summary Forward-Looking Information
and Risk Factors.
Mutual
Reasons for the Merger
CancerVax and Micromet believe that the combined company
represents a biotechnology company with the following potential
advantages:
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Deep Pipeline. The product pipeline for the
combined company is composed of six drugs in various stages of
development, including product candidates in Phase 2
clinical trials and in pre-clinical studies.
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Attractive Markets. The markets to be
addressed by the clinical stage or pre-clinical product
candidates of the combined company represent sizable and
underserved or unmet medical needs. The product candidates may
provide significant medical benefits for patients and returns
for investors.
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Financial Resources. The financial resources
of the combined company will allow it to immediately focus on
execution with respect to its product portfolio.
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Experienced Management Team. It is expected
that the combined company will be led by experienced senior
management from Micromet. Christian Itin, currently chief
executive officer of Micromet, will become president and chief
executive officer and serve on the board of directors. Patrick
A. Baeuerle, currently chief scientific officer of Micromet,
will become chief scientific officer of the combined entity.
Gregor Mirow, Micromets chief financial officer and chief
operating officer, will be senior vice president of operations,
Carsten Reinhardt, Micromets senior vice president of
clinical development will continue to serve as senior vice
president of clinical development of the combined company. David
F. Hale, currently president and chief executive officer of
CancerVax, will become chairman of the board of directors of the
combined company. CancerVaxs chief financial officer,
William R. LaRue, and general counsel, Hazel M. Aker,
have agreed to remain at CancerVax through June 1, 2006 and
the completion of the merger, respectively, and to provide
consulting services to the combined company until
August 15, 2006, each for compensation of $50,000, in order
to assist with post-merger integration activities.
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CancerVaxs
Reasons for the Merger
The CancerVax board of directors approved the merger based on a
number of factors, including the following:
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Broad Pipeline. CancerVax currently has one
product candidate, D93, in pre-clinical development, and has
announced its intention to sublicense its rights to SAI-EGF,
which is in clinical development, and its rights to two other
product candidates in pre-clinical development. The addition of
the two Micromet product candidates currently being evaluated in
three clinical trials, and a number of additional Micromet
product candidates in pre-clinical development, significantly
broadens the product pipeline.
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Risk Diversification. The addition of
Micromets two clinical-stage product candidates to the
portfolio potentially affords significant risk diversification
for CancerVax stockholders. One of Micromets product
candidates, adecatumumab (MT201), is currently being evaluated
in two Phase 2 clinical trials and as a combination therapy
with
Taxotere®
in a Phase 1 clinical trial. A second Micromet product
candidate,
MT103, is
the subject of an ongoing Phase 1 clinical trial.
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Access to Markets. By merging, CancerVax and
Micromet will create a trans-Atlantic biotechnology company with
access to both the U.S. and European markets.
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Fairness Opinion. Piper Jaffray & Co.
delivered its opinion to CancerVaxs board of directors
that, as of January 6, 2006 and based on and subject to the
factors, assumptions and limitations set forth therein, the
total merger consideration to be paid to the holders of Micromet
Parent common stock in the merger was fair to CancerVax from a
financial point of view. The full text of Piper Jaffrays
written opinion, dated January 6, 2006, is attached to this
proxy statement/prospectus as Annex C. You are encouraged
to read this opinion carefully in its entirety for a description
of the procedures followed, assumptions made, matters considered
and limitations on the review undertaken by Piper Jaffray. Piper
Jaffrays opinion is addressed to the
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CancerVax board of directors and does not constitute a
recommendation to any stockholder as to any matters relating to
the merger.
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In addition to considering the strategic factors outlined above,
the CancerVax board of directors considered the following
factors in reaching its conclusion to approve the merger and to
recommend that the CancerVax stockholders approve the issuance
of shares of CancerVax common stock in the merger and the
resulting change of control of CancerVax, all of which it viewed
as generally supporting its decision to approve the business
combination with Micromet:
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the results of the due diligence review of Micromets
businesses and operations by CancerVaxs management, legal
advisors and financial advisors;
|
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|
the terms and conditions of the merger agreement, including the
following related factors:
|
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|
|
|
|
the determination that the relative percentage ownership of
CancerVax securityholders and Micromet securityholders is fixed
and captures the respective ownership interests of the CancerVax
and Micromet securityholders in the combined company based on
valuations of CancerVax and Micromet at the time of the
boards approval of the merger agreement and avoids
fluctuations caused by near-term market volatility;
|
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|
the nature of the conditions to Micromets obligation to
consummate the merger and the limited risk of non-satisfaction
of such conditions;
|
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|
the no solicitation provisions governing Micromets ability
to engage in negotiations with, provide any confidential
information or data to, and otherwise have discussions with, any
person relating to an alternative acquisition proposal;
|
|
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|
the limited ability of the parties to terminate the merger
agreement;
|
|
|
|
the possible effects of the provisions of the merger agreement
regarding termination fees;
|
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|
|
|
|
the likelihood that the merger will be consummated on a timely
basis, including the likelihood that the merger will receive all
necessary regulatory approvals; and
|
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|
the likelihood of retaining key Micromet employees to help
manage the combined company.
|
In the course of its deliberations, CancerVaxs board of
directors also considered a variety of risks and other
countervailing factors related to entering into the merger
agreement, including:
|
|
|
|
|
the risks, challenges and costs inherent in combining the
operations and the substantial expenses to be incurred in
connection with the merger, including the possibility that
delays or difficulties in completing the integration could
adversely affect the combined companys operating results
and preclude the achievement of some benefits anticipated from
the merger;
|
|
|
|
the possible volatility, at least in the short term, of the
trading price of CancerVaxs common stock resulting from
the merger announcement;
|
|
|
|
|
|
the possible loss of key management, scientific or other
personnel of the combined company as a result of the management
and other changes that will be implemented in integrating the
businesses, and the difficulties associated with operating a
company with significant distances between its two key locations;
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|
|
the risk of diverting managements attention from other
strategic priorities to implement merger integration efforts;
|
|
|
|
the risk that the merger might not be consummated in a timely
manner or at all and the potential adverse effect of the public
announcement of the merger on CancerVaxs reputation;
|
|
|
|
the risk to CancerVaxs business, operations and financial
results in the event that the merger is not consummated;
|
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|
|
the potential incompatibility of business cultures; and
|
74
|
|
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|
|
various other applicable risks associated with the combined
company and the merger, including those described in the section
of this proxy statement/prospectus entitled Risk
Factors.
|
The foregoing information and factors considered by
CancerVaxs board of directors are not intended to be
exhaustive but are believed to include all of the material
factors considered by CancerVaxs board of directors. In
view of the wide variety of factors considered in connection
with its evaluation of the merger and the complexity of these
matters, CancerVaxs board of directors did not find it
useful, and did not attempt, to quantify, rank or otherwise
assign relative weights to these factors. In considering the
factors described above, individual members of CancerVaxs
board of directors may have given different weight to different
factors. CancerVaxs board of directors conducted an
overall analysis of the factors described above, including
thorough discussions with, and questioning of, CancerVaxs
management and CancerVaxs legal and financial advisors,
and considered the factors overall to be favorable to, and to
support, its determination.
Micromets
Reasons for the Merger
The Micromet supervisory board approved the merger based on a
number of factors, including the following:
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|
Alternative Strategic
Relationships. Micromets supervisory
boards view as to the limited potential for other third
parties to enter into strategic relationships with Micromet or
to acquire Micromet, particularly based on the thorough and
formal process Micromet conducted and the results of such
process.
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|
Historical and Current Information. Historical
and current information concerning Micromets business,
including its financial performance and condition, operations,
management and competitive position, current industry and
economic conditions, and Micromets prospects if it was to
remain an independent company, including: (a) the risk that
adecatumumab (MT201) clinical trial results would be negative or
inconclusive; (b) the risk of adverse outcomes in its other
clinical trials; and (c) its need to obtain additional
financing and the likely terms on which it would be able to
obtain that financing.
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|
U.S. Presence of CancerVax. The fact that
by merging with CancerVax, Micromet would have access to the
U.S. capital markets as part of a trans-Atlantic company.
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|
Capital. CancerVaxs cash balance, which
is expected to be in excess of $20 million if the merger
closes on or around May 3, 2006, and CancerVaxs
ability as a public company to raise additional capital.
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|
Liquidity. CancerVaxs status as a public
company whose common stock is traded on the Nasdaq National
Market, which would provide Micromets stockholders with
the possibility of additional liquidity.
|
In addition to considering the strategic factors outlined above,
the Micromet supervisory board considered the following factors
in reaching its conclusion to approve the merger, all of which
it viewed as generally supporting its decision to approve the
business combination with CancerVax:
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|
CancerVaxs attractiveness as a strategic partner,
including CancerVaxs:
|
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|
|
|
substantial capital and ability to raise further capital,
particularly in light of Micromets cash needs and limited
cash resources; and
|
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public company infrastructure and stock liquidity;
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|
the opportunity for Micromet shareholders to participate in the
long-term value of Micromets development programs through
the ownership of CancerVax common stock;
|
|
|
|
the aggregate value to be received by Micromet Parent
stockholders in the merger;
|
|
|
|
the terms and conditions of the merger agreement, including the
following related factors:
|
|
|
|
|
|
the expectation that the merger will be treated as a tax-free
reorganization for U.S. federal income tax purposes, with
the result that in the merger the Micromet Parent stockholders
will generally not recognize taxable gain or loss for
U.S. federal income tax purposes;
|
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|
the determination that the relative percentage ownership of
CancerVax securityholders and Micromet securityholders is fixed
and consistent with market practice for a merger of this type
and captures the
|
75
|
|
|
|
|
respective ownership interests of the CancerVax and Micromet
securityholders in the combined company based on Micromets
perceived valuations of CancerVax and Micromet at the time of
the boards approval of the merger agreement;
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|
the fact that shares of CancerVax common stock issued to
Micromet Parent stockholders will be registered on
Form S-4
and will be freely tradable for Micromet Parent stockholders who
are not affiliates of Micromet;
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|
the requirement that the issuance of shares of CancerVax common
stock in the merger be submitted to a vote of the stockholders
of CancerVax;
|
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|
the limited number and nature of the conditions to
CancerVaxs obligation to consummate the merger and the
limited risk of non-satisfaction of such conditions;
|
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|
Micromets rights under the merger agreement to consider
certain unsolicited acquisition proposals under certain
circumstances should Micromet receive a superior proposal;
|
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|
the conclusion of Micromets supervisory board that the
$2,000,000 termination fee, and the circumstances when such fee
may be payable, were reasonable;
|
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|
|
|
the likelihood that the merger will be consummated on a timely
basis, including the likelihood that the merger will receive all
necessary regulatory approvals; and
|
|
|
|
the major risks and uncertainties of alternatives to the merger,
such as Micromet remaining an independent company.
|
In the course of its deliberations, Micromets supervisory
board also considered a variety of risks and other
countervailing factors related to entering into the merger
agreement, including the following:
|
|
|
|
|
the challenges and costs of combining the operations and the
substantial expenses to be incurred in connection with the
merger, including the risks that delays or difficulties in
completing the integration and the inability to retain key
employees as a result of the management and other changes that
will be implemented in integrating the business could adversely
affect the combined companys operating results and
preclude the achievement of some benefits anticipated from the
merger;
|
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|
|
|
the price volatility of CancerVaxs common stock, which may
reduce the value of the CancerVax common stock that Micromet
Parent stockholders will receive upon the consummation of the
merger and, in particular, possibly result in the holders of
Micromet Parent common stock receiving no consideration in the
merger;
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|
the inability of Micromets shareholders to realize the
long-term value of the successful execution of Micromets
current strategy as an independent company;
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|
the possibility that the merger might not be completed and the
potential adverse effect of the public announcement of the
merger on Micromets reputation and ability to obtain
financing in the future;
|
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|
the $2,000,000 termination fee payable to CancerVax upon the
occurrence of certain events, and the potential effect of such
termination fee in deterring other potential acquirors from
proposing an alternative transaction that may be more
advantageous to Micromet shareholders;
|
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|
|
|
the risk of diverting managements attention from other
strategic priorities to implement merger integration efforts;
|
|
|
|
|
|
the risk that the merger might not be consummated in a timely
manner or at all; and
|
|
|
|
|
|
various other applicable risks associated with the combined
company and the merger, including those described in the section
of this proxy statement/prospectus entitled Risk
Factors.
|
The foregoing information and factors considered by
Micromets supervisory board are not intended to be
exhaustive but are believed to include all of the material
factors considered by Micromets supervisory board. In view
of the wide variety of factors considered in connection with its
evaluation of the merger and the complexity of
76
these matters, the Micromet supervisory board did not find it
useful, and did not attempt, to quantify, rank or otherwise
assign relative weights to these factors. In considering the
factors described above, individual members of the Micromet
supervisory board may have given different weight to different
factors. The Micromet supervisory board conducted an overall
analysis of the factors described above, including thorough
discussions with, and questioning of, Micromets management
and Micromets legal advisors, and considered the factors
overall to be favorable to, and to support, its determination.
Opinion
of CancerVaxs Financial Advisor
The CancerVax board of directors retained Piper Jaffray to act
as its financial advisor, and if requested, to render to
CancerVaxs board of directors an opinion as to the
fairness, from a financial point of view, to CancerVax of the
Merger Consideration (as defined below) to be paid by CancerVax
to the holders of common stock of Micromet Parent in the merger.
On January 6, 2006, Piper Jaffray delivered its oral
opinion to the CancerVax board of directors, which opinion was
subsequently confirmed in writing, to the effect that, as of
January 6, 2006, and based upon and subject to the factors,
assumptions and limitations set forth in the written opinion and
described below, the Merger Consideration to be paid to the
holders of Micromet Parent common stock in the merger was fair,
from a financial point of view, to CancerVax. For purposes of
Piper Jaffrays opinion, the shares of CancerVax common
stock to be exchanged for outstanding shares of Micromet Parent
common stock (determined as set forth in Section 1.6(a)(ii)
of the merger agreement) were referred to as the Merger
Consideration.
The full text of the Piper Jaffray written opinion dated as
of January 6, 2006, which sets forth, among other things,
the assumptions made, procedures followed, matters considered
and limitations on the scope of the review undertaken by Piper
Jaffray in rendering its opinion, is attached as Annex C to
this proxy statement/prospectus and is incorporated in its
entirety herein by reference. You are urged to, and should,
carefully read the Piper Jaffray opinion in its entirety. The
Piper Jaffray opinion addresses only the fairness, from a
financial point of view and as of the date of the opinion, to
CancerVax of the Merger Consideration to be paid by CancerVax to
the holders of common stock of Micromet Parent in the merger.
The Piper Jaffray opinion was directed to the CancerVax board of
directors and was not intended to be, and does not constitute, a
recommendation to any CancerVax stockholder as to how any
CancerVax stockholder should vote or act on any matter relating
to the proposed merger.
In arriving at its opinion, Piper Jaffray, among other things,
reviewed:
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|
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|
|
the financial terms of a draft of the merger agreement, dated
January 5, 2006;
|
|
|
|
certain publicly available financial, business and operating
information related to CancerVax and Micromet;
|
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|
certain internal financial, operating and other data with
respect to Micromet prepared and furnished to Piper Jaffray by
the management of Micromet;
|
|
|
|
certain internal financial projections for Micromet for the
period ending December 31, 2020, which were prepared for
financial planning purposes (financial projections for 2005
through 2010 were prepared by the management of Micromet with
certain adjustments based on guidance from the management of
CancerVax and financial projections for 2011 through 2020 were
prepared by the management of CancerVax based on guidance from
the management of Micromet);
|
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|
certain internal financial, operating and other data with
respect to CancerVax prepared and furnished to Piper Jaffray by
the management of CancerVax;
|
|
|
|
certain internal financial projections for CancerVax for the
period ending December 31, 2006, which were prepared for
financial planning purposes and furnished to Piper Jaffray by
the management of CancerVax;
|
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|
the reported prices and trading activity of CancerVax common
stock and similar information for certain other companies deemed
by Piper Jaffray to be comparable to CancerVax;
|
|
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|
the financial performance of certain other publicly traded
companies deemed comparable to CancerVax and Micromet by Piper
Jaffray;
|
77
|
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|
the financial terms, to the extent publicly available, of
certain comparable merger transactions; and
|
|
|
|
a discounted cash flow analysis for Micromet on a stand-alone
basis.
|
Piper Jaffray also conducted discussions with members of the
senior management of CancerVax and Micromet with respect to the
business and prospects of CancerVax and Micromet on a
stand-alone basis and on a combined basis following the merger.
The following is a summary of the material financial analyses
that Piper Jaffray prepared and relied on in delivering its
opinion to CancerVaxs board of directors at its meeting
held on January 6, 2006. The preparation of analyses and a
fairness opinion is a complex analytic process involving various
determinations as to the most appropriate and relevant methods
of financial analysis and the application of those methods to
the particular circumstances and, therefore, this summary does
not purport to be a complete description of the analyses
performed by Piper Jaffray or of its presentation to the
CancerVax board of directors on January 6, 2006.
This summary includes information presented in tabular format.
In order to understand fully the financial analyses used by
Piper Jaffray, these tables must be read together with the text
of each summary and considered as a whole. The tables alone do
not constitute a complete description of the financial analyses.
The order in which these analyses are presented below, and the
results of those analyses, should not be taken as any indication
of the relative importance or weight given to these analyses by
Piper Jaffray or the CancerVax board of directors. Except as
otherwise noted, the following quantitative information, to the
extent that it is based on market data, is based on market data
as it existed on or before December 30, 2005, and is not
necessarily indicative of current market conditions.
Implied
Consideration
Based on the terms of Section 1.6(a)(ii) of the merger
agreement and information and assumptions furnished by
management of CancerVax and Micromet, Piper Jaffray calculated
an estimate of the conversion factor at which shares of Micromet
Parent common stock would be converted into shares of CancerVax
common stock, the aggregate share and share equivalents issuable
in the merger to Micromet securityholders and the implied value
of that consideration. All share information was based on data
furnished by management of CancerVax and Micromet as of
January 5, 2006, did not give effect to the proposed
reverse stock split of CancerVax common stock, and, at the
direction of management of CancerVax, assumed that shares of
Micromet capital stock would be convertible into an equal number
of shares of Micromet Parent common stock in the Micromet
Reorganization and that a portion of the outstanding convertible
debt of Micromet held by MedImmune would convert prior to the
merger into 316,449 shares of Micromet Parent common stock.
Based on (i) 27.9 million outstanding shares of
CancerVax common stock, (ii) 3.3 million shares of
CancerVax common stock issuable upon exercise of outstanding
options and warrants of CancerVax using the adjusted
fully-diluted stock method prescribed by the merger agreement,
(iii) outstanding shares, and options, warrants and
convertible debt exercisable or convertible into shares,
aggregating 4.1 million shares of Micromet Parent common
stock, and (iv) the exchange ratio factor set forth in the
merger agreement, Piper Jaffray calculated a conversion factor
in the merger of 15.7690 shares of CancerVax common stock
for each outstanding share of Micromet Parent common stock and a
resulting pro forma ownership of the combined company (on the
adjusted fully-diluted basis referred to above) by former
Micromet securityholders of approximately 64.9 million
shares of CancerVax common stock, or 67.5% of the combined
company, and by CancerVax securityholders of approximately
31.2 million shares of CancerVax common stock, or 32.5% of
the combined company. Based on CancerVaxs stock price of
$1.38 per share as of December 30, 2005, its aggregate
market capitalization of $38.7 million and the estimated
67.5% pro forma ownership of the combined company by Micromet
securityholders, Piper Jaffray calculated the implied equity
value for Micromet as a stand-alone entity using the treasury
stock method as of December 30, 2005 to be approximately
$87.5 million and the implied enterprise value (equity
value plus estimated debt, net of estimated cash, converted to
US dollars at the rate of $1.18 per Euro) of Micromet as a
stand-alone entity as of December 30, 2005 to be
approximately $96.1 million.
78
Micromet
Analyses
Comparable
Companies Analysis (Oncology Companies)
Piper Jaffray reviewed selected data for Micromet and compared
this data to certain publicly available financial, operating and
stock market data for selected publicly traded companies that
are in the biopharmaceutical industry and have lead therapeutic
programs in oncology that Piper Jaffray believes are at a
similar stage of development as Micromet. Piper Jaffray selected
these companies based on information obtained by searching
Securities and Exchange Commission filings, public company
disclosures, press releases, industry and popular press reports,
databases and other sources. Piper Jaffray identified and
analyzed eight comparable companies:
|
|
|
Biocryst
Pharmaceuticals, Inc.
|
|
Genvec, Inc.
|
Cytokinetics,
Incorporated
|
|
Kosan Biosciences
Incorporated
|
CuraGen Corporation
|
|
Seattle Genetics, Inc.
|
Entremed, Inc.
|
|
Sunesis
Pharmaceuticals, Inc.
|
The financial data analyzed as part of this analysis included,
among other things:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
Comparable Company Values
(Oncology Companies)
|
|
|
|
Implied Value
|
|
|
(at December 30,
2005)
|
|
|
|
of Micromet(1)
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
|
|
|
(In millions)
|
|
|
|
|
|
Equity Value
|
|
$
|
87.5
|
|
|
$
|
93.1
|
|
|
$
|
151.6
|
|
|
$
|
182.9
|
|
|
$
|
453.1
|
|
Net Cash(2)
|
|
$
|
(8.7
|
)
|
|
$
|
33.4
|
|
|
$
|
54.4
|
|
|
$
|
51.7
|
|
|
$
|
71.0
|
|
Enterprise Value
|
|
$
|
96.1
|
|
|
$
|
52.9
|
|
|
$
|
92.4
|
|
|
$
|
131.2
|
|
|
$
|
397.3
|
|
|
|
|
(1) |
|
As of December 30, 2005. |
|
(2) |
|
Estimated as of December 31, 2005. Micromets
estimated net cash based on Micromet management projection. |
Comparable
Companies Analysis (Biotechnology Initial Public Offering
Companies)
Piper Jaffray reviewed selected data for Micromet and compared
this data to certain publicly available financial, operating and
stock market data for selected publicly traded companies that
are in the biopharmaceutical industry and that completed the
initial public offering of their common stock during the period
from January 1, 2004 through December 30, 2005. Piper
Jaffray selected these companies based on information obtained
by searching Securities and Exchange Commission filings, public
company disclosures, press releases, industry and popular press
reports, databases and other sources. Piper Jaffray identified
and analyzed 22 comparable companies:
|
|
|
ACADIA
Pharmaceuticals, Inc.
|
|
Dynavax Technologies
Corporation
|
Advanced Life Sciences
Holdings
|
|
Favrille, Inc.
|
Avalon
Pharmaceuticals, Inc.
|
|
GTx, Inc.
|
Alnylam
Pharmaceuticals, Inc.
|
|
Icagen, Inc.
|
Anadys
Pharmaceuticals, Inc.
|
|
Inhibitex, Inc.
|
Barrier Therapeutics,
Inc.
|
|
Momenta
Pharmaceuticals, Inc.
|
CombinatoRx,
Incorporated
|
|
Metabasis
Therapeutics, Inc.
|
Corcept Therapeutics
Incorporated
|
|
Memory Pharmaceuticals
Corp.
|
CoTherix, Inc.
|
|
Renovis, Inc.
|
Critical Therapeutics,
Inc.
|
|
Sunesis
Pharmaceuticals, Inc.
|
Cytokinetics,
Incorporated
|
|
Threshold
Pharmaceuticals, Inc.
|
79
The financial data analyzed as part of this analysis included,
among other things:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable Company Values
(Initial Public Offerings)
|
|
|
|
Implied Value
|
|
|
(at December 30,
2005)
|
|
|
|
of Micromet(1)
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
(In millions)
|
|
|
Equity Value
|
|
$
|
87.5
|
|
|
$
|
38.6
|
|
|
$
|
213.2
|
|
|
$
|
239.7
|
|
|
$
|
700.1
|
|
Net Cash(2)
|
|
$
|
(8.7
|
)
|
|
$
|
(10.2
|
)
|
|
$
|
79.0
|
|
|
$
|
73.1
|
|
|
$
|
160.5
|
|
Enterprise Value
|
|
$
|
96.1
|
|
|
$
|
42.7
|
|
|
$
|
137.5
|
|
|
$
|
166.6
|
|
|
$
|
539.7
|
|
|
|
|
(1) |
|
As of December 30, 2005. |
|
(2) |
|
Estimated as of December 31, 2005. Micromets
estimated net cash based on Micromet management projection. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable Company Values
(Initial Public Offerings)
|
|
|
|
Implied Value
|
|
|
(Immediately Prior to
IPO)
|
|
|
|
of Micromet(1)
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
(In millions)
|
|
|
Equity Value
|
|
$
|
87.5
|
|
|
$
|
56.9
|
|
|
$
|
123.2
|
|
|
$
|
145.3
|
|
|
$
|
288.3
|
|
Enterprise Value
|
|
$
|
96.1
|
|
|
$
|
17.0
|
|
|
$
|
96.4
|
|
|
$
|
118.6
|
|
|
$
|
265.4
|
|
|
|
|
(1) |
|
As of December 30, 2005. |
Comparable
M&A Transactions Analysis
Piper Jaffray reviewed selected data for Micromet and compared
this data to corresponding data from a group of seven selected
merger and acquisition transactions, which Piper Jaffray
believed to be comparable to the merger. Each of the seven
comparable merger and acquisition transactions involved a
transaction announced and completed since January 1, 2002
and a target company that had a therapeutic program that was in
a similar stage of development as Micromet. Piper Jaffray
identified and analyzed seven such transactions:
|
|
|
|
|
AstraZeneca PLCs acquisition of KuDOS Pharmaceuticals
|
|
|
|
Cephalon, Inc.s acquisition of Salmedix, Inc.
|
|
|
|
Aphton Corporations acquisition of Igenon AG
|
|
|
|
MGI Pharma, Inc.s acquisition of Aesgen, Inc.
|
|
|
|
Allergan, Inc.s acquisition of Oculex Pharmaceuticals, Inc.
|
|
|
|
Cell Therapeutics, Inc.s acquisition of Novuspharma SpA
|
|
|
|
Schering AGs acquisition of Collateral Therapeutics, Inc.
|
The financial data analyzed as part of this analysis included,
among other things:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Implied Value
|
|
|
Comparable Transaction
Values
|
|
|
|
of Micromet(1)
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
|
|
|
(In millions)
|
|
|
|
|
|
Equity Value
|
|
$
|
87.5
|
|
|
$
|
32
|
|
|
$
|
160
|
|
|
$
|
158
|
|
|
$
|
236
|
|
Enterprise Value
|
|
$
|
96.1
|
|
|
$
|
32
|
|
|
$
|
135
|
|
|
$
|
137
|
|
|
$
|
230
|
|
|
|
|
(1) |
|
As of December 30, 2005. |
Comparable
Reverse Merger Transactions Analysis
Piper Jaffray reviewed selected data for Micromet and compared
this data to corresponding data from a group of three selected
merger and acquisition transactions, which Piper Jaffray
believed to be comparable to the merger. Each of the three
comparable merger and acquisition transactions involved a
transaction announced and completed
80
since January 1, 2005 and a merger of a public company and
a private company (stock for stock) in which the securityholders
of the private company became the holders of a majority of the
equity ownership of the combined company. Piper Jaffray
identified and analyzed three such transactions:
|
|
|
|
|
Xcyte Therapies, Inc.s acquisition of Cyclacel Group plc
|
|
|
|
Corgentech Inc.s acquisition of AlgoRx Pharmaceuticals,
Inc.
|
|
|
|
Maxim Pharmaceuticals, Inc.s acquisition of EpiCept
Corporation
|
The financial data analyzed as part of this analysis included,
among other things:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Implied Value
|
|
|
Comparable Transaction
Values
|
|
|
|
of Micromet(1)
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
|
|
|
(In millions)
|
|
|
|
|
|
Equity Value
|
|
$
|
87.5
|
|
|
$
|
36
|
|
|
$
|
98
|
|
|
$
|
88
|
|
|
$
|
130
|
|
Enterprise Value
|
|
$
|
96.1
|
|
|
$
|
26
|
|
|
$
|
101
|
|
|
$
|
76
|
|
|
$
|
102
|
|
|
|
|
(1) |
|
As of December 30, 2005. |
Discounted
Cash Flow Analysis
Using a discounted cash flow analysis, Piper Jaffray calculated
a range of theoretical values for Micromet based on (i) the
net present value of implied annual cash flows of
Micromets business and (ii) the net present value of
a terminal value, which is an estimate of the future value of
Micromets business at the end of the calendar year 2020
based upon a multiple of revenue. Piper Jaffray used certain
internal financial projections for Micromet which were prepared
for financial planning purposes (financial projections for 2005
through 2010 were prepared by the management of Micromet with
certain adjustments based on guidance from the management of
CancerVax and financial projections for 2011 through 2020 were
prepared by the management of CancerVax with guidance from the
management of Micromet). Piper Jaffray calculated the range of
net present values for Micromet based on a range of discount
rates of 30% to 40% and a range of revenue multiples for a
terminal value of 7.0x to 9.0x applied to the projected fiscal
year 2020 revenue. This analysis yielded a range of estimated
enterprise values for Micromet of between $72.6 million and
$286.1 million and a range of estimated equity values
between $61.3 million and $274.8 million.
CancerVax
Analyses
Selected
Market Information Concerning CancerVax
Piper Jaffray reviewed selected market information concerning
CancerVaxs common stock. Among other things, Piper Jaffray
noted the following with respect to the trading of
CancerVaxs common stock:
|
|
|
|
|
Market Price as of
December 30, 2005
|
|
$
|
1.38
|
|
30-day
trading average
|
|
$
|
1.41
|
|
60-day
trading average
|
|
$
|
1.46
|
|
90-day
trading average
|
|
$
|
1.99
|
|
52-week
high
|
|
$
|
11.09
|
|
52-week
low
|
|
$
|
1.31
|
|
Piper Jaffray also noted that CancerVax discontinued its
Phase 3 clinical trial development of Canvaxin in patients
with Stage III melanoma in October 2005 after the
independent Data and Safety Monitoring Board found that this
Phase 3 clinical trial was unlikely to provide significant
evidence of overall survival benefit.
Piper Jaffray presented daily stock price and volume data for
CancerVax common stock for the twelve-month period from
December 30, 2004 to December 30, 2005. Piper
Jaffrays analysis concerning CancerVax common stock was
based on information concerning CancerVax and its common stock
available as of December 30, 2005.
81
Comparable
Companies Analysis
Piper Jaffray reviewed selected financial data for CancerVax and
compared this to available financial, operating and stock market
data for selected publicly traded companies in the
biopharmaceutical industry that Piper Jaffray believes have
encountered clinical delays, negative clinical results or other
circumstances similar to those encountered by CancerVax. Piper
Jaffray selected these companies based on information obtained
by searching Securities and Exchange Commission filings, public
company disclosures, press releases, industry and popular press
reports, databases and other sources. Piper Jaffray identified
and analyzed eight such comparable companies, as well as an
additional three such comparable companies that were involved in
a reverse merger transaction (with values compared immediately
prior to the announcement of such reverse merger transactions):
Comparable
Pharmaceutical Companies:
|
|
|
Advancis
Pharmaceutical Corporation
|
|
Inex Pharmaceuticals
Corporation
|
Aphton Corporation
|
|
IntraBiotics
Pharmaceuticals, Inc.
|
Axonyx Inc.
|
|
NeoRx Corporation
|
Cellegy
Pharmaceuticals, Inc.
|
|
Praecis
Pharmaceuticals Incorporated
|
Comparable
Pharmaceutical Companies Involved in a Reverse Merger
Transaction:
|
|
|
Corgentech Inc.
|
|
Xcyte Therapies, Inc.
|
Maxim Pharmaceuticals,
Inc.
|
|
|
The financial data analyzed as part of this analysis included,
among other things:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable Biopharmaceutical
Companies
|
|
|
|
CancerVax(1)
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
(In millions)
|
|
|
Equity Value
|
|
$
|
38.7
|
|
|
$
|
4.5
|
|
|
$
|
29.5
|
|
|
$
|
29.1
|
|
|
$
|
45.5
|
|
Net Cash(2)
|
|
$
|
32.9
|
|
|
$
|
(2.8
|
)
|
|
$
|
22.5
|
|
|
$
|
29.6
|
|
|
$
|
66.9
|
|
Enterprise Value
|
|
$
|
5.8
|
|
|
$
|
(21.4
|
)
|
|
$
|
1.0
|
|
|
$
|
(0.2
|
)
|
|
$
|
21.5
|
|
|
|
|
(1) |
|
As of December 30, 2005. |
|
(2) |
|
Estimated as of December 31, 2005. CancerVaxs
estimated net cash based on CancerVax management projection. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable Biopharmaceutical
Companies
|
|
|
|
|
|
|
(Immediately Prior to Reverse
Merger Transaction)
|
|
|
|
CancerVax(1)
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
(In millions)
|
|
|
Equity Value
|
|
$
|
38.7
|
|
|
$
|
9.0
|
|
|
$
|
38.3
|
|
|
$
|
41.1
|
|
|
$
|
75.9
|
|
Net Cash(2)
|
|
$
|
32.9
|
|
|
$
|
22.1
|
|
|
$
|
23.0
|
|
|
$
|
44.7
|
|
|
$
|
89.1
|
|
Enterprise Value
|
|
$
|
5.8
|
|
|
$
|
(13.2
|
)
|
|
$
|
(13.1
|
)
|
|
$
|
(3.6
|
)
|
|
$
|
15.4
|
|
|
|
|
(1) |
|
As of December 30, 2005. |
|
(2) |
|
Estimated as of December 31, 2005. CancerVaxs
estimated net cash based on CancerVax management projection. |
Comparable
M&A Transactions Analysis
Piper Jaffray reviewed selected financial data for CancerVax and
compared this data to corresponding data from a group of five
selected merger and acquisition transactions, which Piper
Jaffray believed to be comparable to this transaction. Each of
the five comparable merger and acquisition transactions involved
a public-to-public merger
82
announced and completed since January 1, 2002 and a target
company whose cash and equivalents comprised a significant
percentage of the targets assets. Piper Jaffray identified
and analyzed five such transactions:
|
|
|
|
|
GenVec, Inc.s acquisition of Diacrin, Inc.
|
|
|
|
Inflazyme Pharmaceuticals Ltd.s acquisition of
GLYCODesign, Inc.
|
|
|
|
Dendreon Corporations acquisition of Corvas International,
Inc.
|
|
|
|
Hyseq, Inc.s acquisition of Variagenics, Inc.
|
|
|
|
Exelixis, Inc.s acquisition of Genomica Corporation
|
The financial data analyzed as part of this analysis included,
among other things:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable Transaction
Values
|
|
|
|
CancerVax
|
|
|
Low
|
|
|
Median
|
|
|
Mean
|
|
|
High
|
|
|
|
|
|
|
(Dollars in millions)
|
|
|
Equity Value
|
|
$
|
38.7
|
|
|
$
|
8.2
|
|
|
$
|
53.6
|
|
|
$
|
57.7
|
|
|
$
|
110.0
|
|
Enterprise Value
|
|
$
|
5.8
|
|
|
$
|
(4.5
|
)
|
|
$
|
(0.8
|
)
|
|
$
|
(1.7
|
)
|
|
$
|
0.4
|
|
Estimated Cash at Close(1)
|
|
$
|
19.1
|
|
|
$
|
7.0
|
|
|
$
|
47.2
|
|
|
$
|
52.7
|
|
|
$
|
109.0
|
|
Implied Premium of Equity Value to
Estimated Cash at Close
|
|
|
101.9
|
%
|
|
|
0.9
|
%
|
|
|
15.8
|
%
|
|
|
13.1
|
%
|
|
|
18.3
|
%
|
|
|
|
(1) |
|
Based on financial statements and public information.
CancerVaxs estimated cash at close (not including
restricted cash) based on CancerVax management estimates
(estimated close of the merger transaction on March 31,
2006). |
Although the summary set forth above does not purport to be a
complete description of the analyses performed by Piper Jaffray,
the material analyses performed by Piper Jaffray in rendering
its opinion have been summarized above. The preparation of a
fairness opinion is a complex process and is not necessarily
susceptible to partial analysis or summary description. Piper
Jaffray believes that its analyses and the summary set forth
above must be considered as a whole and that selecting portions
of its analyses or of the summary, without considering the
analyses as a whole or all of the factors included in its
analyses, would create an incomplete view of the processes
underlying the analyses set forth in the Piper Jaffray opinion.
In arriving at its opinion, Piper Jaffray considered the results
of all of its analyses and did not attribute any particular
weight to any factor or analysis considered by it. Instead,
Piper Jaffray made its determination as to the fairness on the
basis of its experience and financial judgment after considering
the results of all of its analyses. The fact that any specific
analysis has been referred to in the summary above is not meant
to indicate that this analysis was given greater weight than any
other analysis. No company or transaction used in the above
analyses as a comparison is directly comparable to CancerVax,
Micromet or the proposed merger.
The analyses were prepared solely for purposes of Piper Jaffray
providing its opinion to the CancerVax board of directors that,
as of the date of the opinion, the Merger Consideration to be
paid by CancerVax to the holders of common stock of Micromet
Parent in the merger was fair, from a financial point of view,
to CancerVax. These analyses do not purport to be appraisals or
valuations. In performing its analyses, Piper Jaffray made
numerous assumptions with respect to industry performance,
general business and economic conditions and other matters. The
analyses performed by Piper Jaffray are based upon forecasts by
CancerVax and Micromet management of future results, which are
not necessarily indicative of actual values or actual future
results and may be significantly more or less favorable than
suggested by these analyses. These analyses are inherently
subject to uncertainty, being based upon numerous factors or
events beyond the control of the parties or their respective
advisors. Piper Jaffray does not assume responsibility if future
results are materially different from those forecasted.
Piper Jaffray relied upon and assumed the accuracy, completeness
and fairness of the information provided to it by CancerVax and
Micromet or otherwise made available to it, and did not assume
the responsibility to independently verify this information.
Each of CancerVax and Micromet has advised Piper Jaffray that
they do not publicly disclose internal financial information of
the type provided to Piper Jaffray and that such information was
prepared for financial planning purposes and not with the
expectation of public disclosure. Piper Jaffray also
83
assumed, in reliance upon the assurances of the management of
CancerVax and Micromet, that the information provided to Piper
Jaffray by CancerVax and Micromet was prepared on a reasonable
basis in accordance with industry practice and the management of
CancerVax and Micromet was not aware of any information or facts
that would make the information provided to Piper Jaffray
incomplete or misleading. With respect to financial forecasts,
projections and other estimates and business outlook information
reviewed by Piper Jaffray, Piper Jaffray assumed that such
information reflected the best currently available estimates and
judgments of the management of CancerVax and Micromet and was
based on reasonable assumptions. Piper Jaffray expressed no
opinion as to such financial forecasts and other estimates and
business outlook information or the assumptions on which they
are based. In arriving at its opinion, Piper Jaffray relied,
with CancerVaxs board of directors consent, on
advice of the outside counsel and the independent accountants
provided to CancerVax and Micromet, and on the assumptions of
the management of CancerVax and Micromet, as to all accounting,
legal, tax and financial reporting matters with respect to
CancerVax, Micromet and the merger agreement, including, without
limitation, the amount of the Merger Consideration.
Piper Jaffray assumed, with CancerVaxs board of
directors consent, (a) that the merger will qualify
as a tax-free reorganization under the United States Internal
Revenue Code, (b) that the merger will be completed on the
terms set forth in the merger agreement reviewed by Piper
Jaffray, without amendments and with full satisfaction of all
covenants, conditions and obligations without any waiver, and
(c) that all necessary regulatory approvals and consents
required for the merger will be obtained in a manner that will
not adversely affect CancerVax, Micromet or the contemplated
benefits of the merger.
Piper Jaffray did not assume responsibility for performing, and
did not perform, any appraisals or valuations of specific assets
or liabilities (fixed, contingent or other) of CancerVax or
Micromet and was not furnished with any appraisals or
valuations. Piper Jaffray made no physical inspection of the
facilities of either entity in connection with rendering the
opinion. The analyses performed by Piper Jaffray were going
concern analyses. Piper Jaffray expressed no opinion regarding
the liquidation value of any entity. Without limiting the
generality of the foregoing, Piper Jaffray did not undertake any
independent analysis of any outstanding, pending or threatened
litigation, regulatory action, possible unasserted claims or
other contingent liabilities to which CancerVax, Micromet or any
of CancerVaxs or Micromets respective affiliates was
a party or may be subject, and at the direction of the CancerVax
board of directors, and with its consent, Piper Jaffrays
opinion made no assumption concerning, and therefore did not
consider, the potential effects of litigation, claims,
investigations, or possible assertions of claims, or the
outcomes or damages arising out of any such matters. Further,
notwithstanding the analyses Piper Jaffray performed were going
concern analyses, Piper Jaffray expressed no opinion as to the
viability of CancerVax following the merger, including the
potential for or timing of commercialization of any product or
service, the nature and extent of CancerVaxs financing
needs or the ability of CancerVax to satisfy any such financing
needs.
Piper Jaffrays opinion was necessarily based on the
information available to it, the facts and circumstances as they
existed and were subject to evaluation as of the date of the
opinion; events occurring after the date of the opinion could
materially affect the assumptions used by Piper Jaffray in
preparing its opinion. Piper Jaffray expressed no opinion as to
the prices at which shares of CancerVax or Micromet have traded
or may trade following announcement of the merger or at any
future time after the date of the opinion. Piper Jaffray has not
undertaken and is not obligated to affirm or revise its opinion
or otherwise comment on any events occurring after the date it
was given.
While Piper Jaffray rendered its opinion and provided certain
analyses to the board of directors of CancerVax, Piper Jaffray
was not requested to, and did not make, any recommendation to
the board of directors as to the specific form or amount of the
consideration to be paid by CancerVax in the merger, which was
determined through negotiations between CancerVax and Micromet.
Piper Jaffrays written opinion, which was addressed to
CancerVaxs board of directors, addresses only the
fairness, from a financial point of view, to CancerVax of the
Merger Consideration to be paid by CancerVax to the holders of
common stock of Micromet Parent in the merger as of the date of
the opinion, does not address any other terms or agreement
relating to the merger, and does not address CancerVaxs
underlying business decision to proceed with, or effect, the
merger or structure thereof, or the relative merits of the
merger compared to any alternative business strategy or
transaction in which CancerVax might engage. Although CancerVax
engaged directly in an extensive effort to solicit a business
combination, except for a limited number of parties with which
Piper Jaffray made contact about a possible business
combination, Piper Jaffray was
84
not requested to solicit, and did not solicit, any business
combination involving CancerVax or any other alternative
transaction.
Piper Jaffray is a nationally recognized investment banking firm
and is regularly engaged as a financial advisor in connection
with mergers and acquisitions, underwritings and secondary
distributions of securities and private placements. The
CancerVax board of directors selected Piper Jaffray to render
its fairness opinion in connection with the proposed merger on
the basis of its experience and reputation in acting as a
financial advisor in connection with mergers and acquisitions.
In the ordinary course of its business, Piper Jaffray and its
affiliates may actively trade securities of CancerVax for its
own account or the account of its customers and, accordingly, it
may at any time hold a long or short position in such
securities. Piper Jaffray has provided investment banking
services to CancerVax from time to time for compensation and
Piper Jaffray may seek to provide investment banking services to
CancerVax and Micromet in the future, for which Piper Jaffray
may receive compensation. In particular, Piper Jaffray was a
co-managing underwriter of CancerVaxs initial public
offering in October 2003 for which it received customary fees.
Piper Jaffray also makes a market in CancerVax common stock.
Piper Jaffray acted as financial advisor to CancerVax in
connection with the merger and, under the terms of
CancerVaxs engagement letter with Piper Jaffray, Piper
Jaffray will receive from CancerVax upon consummation of the
merger a fee equal to $1,250,000 (less a $100,000 retainer
previously paid). The opinion fee was not contingent upon the
consummation of the merger. Whether or not the proposed merger
is consummated, CancerVax has also agreed to reimburse Piper
Jaffray for its reasonable
out-of-pocket
expenses and to indemnify it against certain liabilities
relating to or arising out of services performed by Piper
Jaffray in rendering its opinion to the CancerVax board of
directors.
Interests
of CancerVaxs Executive Officers and Directors in the
Merger
In considering the recommendation of the CancerVax board of
directors with respect to issuing shares of CancerVax common
stock as contemplated by the merger agreement, CancerVax
stockholders should be aware that certain members of the board
of directors and executive officers of CancerVax have interests
in the merger that are different from, or in addition to, their
interests as CancerVax stockholders. These interests present a
conflict of interest. The CancerVax board of directors was aware
of these conflicts of interest during its deliberations on the
merits of the merger and in making its decision in approving the
merger, the merger agreement and the related transactions.
Board
of Directors and Management
David F. Hale is the President and Chief Executive Officer, a
member of the board of directors, a stockholder and a holder of
options to purchase stock of CancerVax. Hazel M. Aker is the
General Counsel and Secretary, a stockholder and a holder of
options to purchase stock of CancerVax. William R. LaRue is the
Chief Financial Officer, a stockholder and a holder of options
to purchase stock of CancerVax. Upon closing of the merger,
David Hale will become the Chairman of the board of directors of
the combined corporation. William LaRue and Hazel Aker have
agreed to remain at CancerVax through June 1, 2006 and the
completion of the merger, respectively, and to provide
consulting services to the combined company until
August 15, 2006, each for compensation of $50,000, in order
to assist with post-merger integration activities. David Hale,
Hazel Aker and William LaRue participated in the negotiation and
approval of the terms of the merger on behalf of CancerVax,
following disclosure of all material facts regarding their
respective interests (or potential interests) in the merger.
As of March 27, 2006, entities affiliated with Forward
Ventures IV, L.P. beneficially owned approximately 5.3% of
CancerVax common stock (on an as-converted basis). Following the
merger, these entities will own approximately 1.7% of CancerVax
common stock. Ivor Royston, M.D., the managing member of
Forward IV Associates, L.L.C., which is the general partner
of Forward Ventures IV, L.P., is the current chairman of
the board of CancerVax. As of March 27, 2006, Dr. Royston
owned exercisable options to purchase 19,166 shares of
common stock and Colette Royston, Dr. Roystons wife,
owned 12,130 shares of CancerVax common stock.
Following the merger, in addition to David Hale, current
CancerVax board members Phillip Schneider, Michael Carter and
Barclay Phillips will continue to serve on the board of
directors of the combined corporation.
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Ownership Interest
As of March 27, 2006, all directors and executive officers
of CancerVax, together with their affiliates, beneficially owned
37.3% of the shares of CancerVax common stock. Approval of the
merger requires the affirmative vote of the holders of a
majority of CanverVaxs outstanding common stock. Certain
CancerVax officers and directors, and their affiliates, have
also entered into voting agreements in connection with the
merger. The voting agreements are discussed in greater detail
under the caption Voting Agreements beginning on
page 113.
For a more complete description of the interests of current and
former officers and directors of CancerVax, please see the
section entitled CancerVax Security Ownership by Certain
Beneficial Owners on page 134 of this proxy
statement/prospectus.
Equity
Compensation Plans
Amended
and Restated 2003 Equity Incentive Award Plan and the Third
Amended and Restated 2000 Stock Incentive Plan
Under the 2003 Equity Incentive Award Plan, or 2003 Plan, and
the 2000 Stock Incentive Plan, if an option or award
holders employment or service relationship is terminated
in connection with a change of control, including the proposed
merger, of CancerVax or as a result of an involuntary
termination other than for cause or by the option or award
holder for good reason (other than in connection with a general
reduction in workforce) within two years following the merger,
that option or award holders outstanding options or awards
will become 100% vested and exercisable immediately.
In March 2006, stock option grants were made to David F. Hale,
William R. LaRue, Dennis E. Van Epps, Guy Gammon and Hazel
M. Aker under the 2003 Plan. In connection with the stock option
awards, the employment agreements of each executive officer were
amended to provide that the stock option awards will not vest on
an accelerated basis in connection with CancerVaxs
proposed merger with Micromet or otherwise pursuant to the
employment agreements. Instead, the stock options granted to
Mr. Hale will vest in monthly increments over a three year
period commencing on the first monthly anniversary of the date
of grant, subject to Mr. Hales continued employment
or service with CancerVax on such dates. The stock options
granted to Messrs. LaRue and Van Epps, Dr. Gammon and Ms. Aker
will vest in full upon the termination of the recipients
employment or service with CancerVax and will remain exercisable
for a period of one year following such termination.
The stock option grants described above were awarded in the
following amounts: Mr. Hale (100,000 shares), Mr. LaRue (60,000
shares), Ms. Aker (60,000 shares), Dr. Gammon (50,000 shares)
and Mr. Van Epps (50,000 shares).
Employment
Agreements
David F.
Hale
David F. Hales employment with CancerVax will be
terminated upon the closing of the merger. Mr. Hales
amended and restated employment agreement provides that, upon
his termination of employment following the closing of the
merger, he will be entitled to receive 18 months of salary
continuation payments, an amount equal to the average of his
bonuses for the three fiscal years prior to the date of
termination, payable over an 18 month period commencing on
the date of termination, healthcare and life insurance benefits
continuation at CancerVaxs expense for 18 months,
plus $15,000 towards outplacement services.
Mr. Hales amended and restated employment agreement
also provides that, upon his termination of employment upon the
closing of the merger, all of Mr. Hales unvested
stock awards will become immediately vested.
Other
Employment Agreements
On November 15, 2005, CancerVax entered into amended and
restated employment agreements with the following executives:
Hazel M. Aker, Debra J. Arnold, Guy Gammon, Robert L. Jones,
William R. LaRue, John Petricciani, and Dennis E. Van Epps. On
June 14, 2005, CancerVax entered into an employment
agreement with
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Carol Gallagher. On June 23, 2005, CancerVax entered into
an employment agreement with Jeffrey S. Silverman. Of these
executives, the employment of the following has recently been
terminated without cause by CancerVax: Carol Gallagher
(effective March 15, 2006); Jeff Silverman (effective March 15,
2006); and Dennis Van Epps (effective April 15, 2006). The
employment of each of Debra Arnold, Robert Jones and John
Petricciani was terminated effective December 16, 2005. The
resignation of William LaRue will become effective June 1,
2006 and the resignation of Hazel Aker will become effective
upon the closing of the merger, however both Mr. LaRue and
Ms. Aker have agreed to provide consulting services to the
combined company until August 15, 2006, each for
compensation of $50,000, in order to assist with post-merger
integration activities.
The employment agreements with the above executives provide the
executives with certain severance benefits in the event his or
her employment is terminated. The employment agreements provide
that, in the event the executives employment is terminated
by CancerVax other than for cause or if the executive resigns
for good reason, he or she will receive 12 months of salary
continuation payments, an amount equal to the average of his or
her annual bonuses for the three fiscal years prior to the
termination, prorated for the period during the fiscal year that
the executive was employed, healthcare and life insurance
benefits continuation at CancerVaxs expense for
12 months, plus $15,000 towards outplacement services. If
such termination or resignation occurs more than six months
prior to or more than 12 months following a change of
control of CancerVax, including the proposed merger, that
portion of the executives stock awards which would have
vested if he or she had remained employed for an additional
12 months will immediately vest on the date of termination.
Since Mr. LaRue and Ms. Aker have resigned without good reason,
they will not be entitled to any of the foregoing severance
benefits under their employment agreements.
The employment agreements also provide that, in the event of a
change of control, including the proposed merger, 50% of each
executives unvested stock awards, excluding the March 2006
stock awards to Mr. Hale, Mr. LaRue, Mr. Van Epps, Dr.
Gammon and Ms. Aker as described above, will immediately become
vested. In addition, with respect to stock awards granted prior
to the date of the employment agreements, if the
executives employment is terminated by CancerVax other
than for cause or if he or she resigns with good reason within
12 months following the merger of CancerVax, any remaining
unvested portion of such stock awards will immediately vest on
the date of termination. With respect to stock awards granted on
or after the date of the employment agreements, if such
termination occurs within six months prior to or within
12 months following the merger of CancerVax, any remaining
unvested portion of such stock awards will immediately vest on
the later of the date of termination or the date of the change
of control. The resignations of Mr. LaRue and Ms. Aker
are voluntary and as such will not trigger accelerated vesting
of their remaining unvested stock awards.
Interests
of Micromets Executive Officers and Directors in the
Merger
In considering the approval of the supervisory board of Micromet
with respect to the merger, the Micromet Reorganization and the
transactions contemplated by the merger agreement, Micromet
shareholders should be aware that certain members of the
supervisory board of Micromet and executive officers of Micromet
have interests in the merger that are different from, or in
addition to, their interests as Micromet shareholders. These
interests present a conflict of interest. The Micromet
supervisory board was aware of these conflicts of interest
during its deliberations on the merits of the merger and in
making its decision in approving the Micromet Reorganization,
the merger, the merger agreement and the related transactions.
Supervisory
Board and Management
Christian Itin is the Chief Executive Officer of Micromet and a
shareholder and holder of options to purchase ordinary shares of
Micromet. Patrick A. Baeuerle is the Chief Scientific Officer of
Micromet and a shareholder and holder of options to purchase
ordinary shares of Micromet. Gregor K. Mirow is the Chief
Financial Officer and Chief Operating Officer of Micromet and a
shareholder and holder of options to purchase ordinary shares of
Micromet. Carsten Reinhardt is the Senior Vice President,
Clinical Development of Micromet. Upon consummation of the
Micromet Reorganization, each of Drs. Itin, Baeuerle and
Mirow will be stockholders and optionholders of Micromet Parent
and will receive shares of CancerVax common stock in the merger
and have their options to purchase Micromet Parent common stock
assumed by CancerVax.
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Upon the closing of the merger, Dr. Itin will become the
President and Chief Executive Officer of the combined
corporation, Dr. Baeuerle will become Senior Vice President
and Chief Scientific Officer of the combined corporation,
Dr. Mirow will become Senior Vice President of Operations
of the combined corporation and Dr. Reinhardt will become
Senior Vice President, Clinical Development of the combined
corporation. Each of Drs. Itin and Mirow participated in
the negotiation and approval of the terms of the merger on
behalf of Micromet following disclosure of all material facts
regarding their respective interests (or potential interests) in
the merger.
Following the merger, current members of the Micromet
supervisory board Jerry Benjamin, John Berriman, Michael Carter
and Otello Stampacchia will continue to serve on the board of
directors of the combined company. Dr. Carter also is a
current director of CancerVax.
Supervisory
Board and Executive Officers Stock Ownership
As of March 27, 2006, all directors and executive officers of
Micromet, together with their affiliates, beneficially owned
34.7% of the ordinary shares of Micromet, 48.6% of the Micromet
preference shares series (A new) and 58.6% of the Micromet
preference shares series (B new). Upon consummation of the
Micromet Reorganization, all directors and executive officers of
Micromet, together with their affiliates, will own approximately
54.5% of the outstanding common stock of Micromet Parent.
Consummation of the Micromet Reorganization requires approval of
at least 55% of the Micromet preference shares series (B
new). Certain of the officers and directors of Micromet, and
their affiliates, have also entered into voting agreements in
connection with the merger. The voting agreements are discussed
in greater detail under the caption Voting
Agreements beginning on page 113.
As of March 27, 2006, Omega Fund beneficially owned no
ordinary shares of Micromet, 10.8% of the Micromet preference
shares series (A new) and 22.8% of the Micromet preference
shares series (B new). Upon consummation of the Micromet
Reorganization, Omega Fund I, L.P. will own approximately 18.0%
of the outstanding common stock of Micromet Parent. Following
the merger, based on shares outstanding as of March 27,
2006, Omega Fund I, L.P. will own approximately 12.1% of the
common stock of the combined company. Otello Stampacchia, Chief
Investment Adviser to Omega Fund I, L.P., is a current director
of Micromet and has been nominated for election to the CancerVax
board of directors at the effective time of the merger.
As of March 27, 2006, entities affiliated with 3i Group plc
beneficially owned no ordinary shares of Micromet, 13.4% of the
Micromet preference shares series (A new) and 18.5% of the
Micromet preference shares series (B new). Upon consummation of
the Micromet Reorganization, 3i Group plc will own approximately
16.2% of the outstanding common stock of Micromet Parent.
Following the merger, based on shares outstanding as of
March 27, 2006, 3i Group plc will own approximately 11.0%
of the common stock of the combined company. Clemens Doppler, a
director of 3i, is a current director of Micromet but will not
remain on the board of directors of the combined company.
As of March 27, 2006, entities affiliated with Schroder
Venture Managers Limited (the Schroders Entities)
beneficially owned no ordinary shares of Micromet, 6.7% of the
Micromet preference shares series (A new) and 2.8% of the
Micromet preference shares series (B new). Upon consummation of
the Micromet Reorganization, the Schroders entities will own
approximately 4.1% of the outstanding common stock of Micromet
Parent. Following the merger, based on shares outstanding as of
March 27, 2006, the Schroder Entities will own
approximately 2.8% of the common stock of the combined company.
As of March 27, 2006, International Biotechnology Trust plc
beneficially owned 0.5% of the ordinary shares of Micromet, 8.1%
of the Micromet preferred shares series (A new) and 11.1% of the
Micromet preferred series (B new). Upon consummation of the
Micromet reorganization, International Biotechnology Trust will
own approximately 9.8% of the outstanding common stock of
Micromet Parent. International Biotechnology Trust also owns
386,502 shares of CancerVax common stock. Following the
merger, based on shares outstanding as of March 27, 2006,
International Biotechnology Trust will own approximately 7.1% of
the common stock of the combined company. Dr. Michael Carter,
venture partner at SV Life Science Advisers LLP, advisor to the
manager of Schroder Ventures International Life Sciences Fund
and to the manager of International Biotechnology Trust plc, is
a current director of both Micromet and CancerVax, and will
remain on the board of directors of the combined company.
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As of March 27, 2006, entities affiliated with Advent
Venture Partners beneficially owned approximately 0.5% of the
ordinary shares of Micromet, 24.4% of the Micromet preference
shares series (A new) and 17.3% of the Micromet preference
shares series (B new). Upon consummation of the Micromet
Reorganization, the Advent entities will own approximately 19.5%
of the outstanding common stock of Micromet Parent. Following
the merger, based on shares outstanding as of March 27,
2006, the entities affiliated with Advent Venture Partners will
own approximately 13.2% of the common stock of the combined
company. Jerry Benjamin, a partner of Advent Venture Partners,
is a current director of Micromet and has been nominated for
election to the CancerVax board of directors at the effective
time of the merger.
Combined
Company Board of Directors
Following the merger, the board of directors of CancerVax will
be David Hale (who will serve as Chairman), Phillip Schneider,
Michael Carter, Barclay Phillips, Christian Itin, Jerry
Benjamin, Otello Stampacchia, John Berriman and an additional
member to be identified by Micromet prior to the closing of the
merger.
Indemnification;
Directors and Officers Insurance
For six years after the closing of the merger, CancerVax has
agreed to maintain in effect, for the benefit of each individual
who is an officer or director of Micromet Parent, Micromet or
CancerVax at date of the merger agreement, the existing
directors and officers insurance policies or an
insurance and indemnification policy that is not less favorable
than the existing directors and officers insurance
policies. CancerVax shall not, however, be required to pay an
annual premium for such directors and officers
insurance policy that is in excess of 200% of the last annual
premium paid by CancerVax for the existing directors and
officers insurance policies prior to the merger agreement.
Employment
Agreements
In October 2002, Micromet entered into an employment agreement
with Dr. Christian Itin, its chief executive officer, which
was amended in October 2005. Dr. Itin currently receives an
annual base salary of 260,000 and he is eligible to
receive an annual performance bonus of up to 60,000. His
employment can be terminated with twelve months prior
notice, or for good cause at any time. In the event of
disability, Dr. Itin would be paid his salary for six
months. Dr. Itin is subject to a non-compete obligation for
a period of twelve months following the termination of his
employment. During the period of the non-compete obligation,
Dr. Itin will be paid the statutorily required amounts
under German law, but in no event less than 50% of his salary
immediately preceding his termination. In addition, Micromet
maintains disability and life insurance for Dr. Itin.
In October 2002, Micromet entered into an employment agreement
with Prof. Patrick A. Baeuerle, its chief scientific
officer, which was amended in October 2005. Prof. Baeuerle
currently receives an annual base salary of 230,000 and is
eligible to receive an annual performance bonus of up to
50,000. The other terms of his employment are
substantially the same as described above for Dr. Itin.
In October 2002, Micromet entered into an employment agreement
with Dr. Gregor Mirow, its chief financial officer and
chief operating officer, which was amended in October 2005.
Dr. Mirow currently receives an annual base salary of
187,000 and is eligible to receive an annual performance
bonus of up to 40,000. The other terms of his employment
are substantially the same as described above for Dr. Itin.
In June 2005, Micromet entered into an employment agreement with
Dr. Carsten Reinhardt, M.D., Ph.D., its senior
vice president of clinical development, which was amended in
October 2005. Dr. Reinhardt currently receives an annual
base salary of 180,000 and is eligible to receive an
annual performance bonus of up to 20,000. The other terms
of his employment are substantially the same as described above
for Dr. Itin.
In connection with, and effective upon the closing of, the
merger, it is anticipated that the existing employment
agreements between Micromet and Drs. Itin, Baeuerle, Mirow
and Reinhardt will be cancelled and replaced with agreements
between such individuals and the combined entity. The terms of
such agreements have not been finalized and remain subject to
negotiation.
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Micromet,
Inc. 2006 Equity Incentive Award Plan
It is anticipated that immediately prior to the merger, Micromet
Parent shall issue to certain officers, directors, founders and
employees of Micromet options to acquire up to
335,775 shares of Micromet Parent common stock. Such
options are being issued to provide incentives to such
individuals and shall be issued, in part, to replace current
Micromet options that will not be exchanged in the Micromet
Reorganization or assumed by CancerVax in the merger. The
options will be issued by Micromet Parent under a to-be-adopted
Micromet, Inc. 2006 Equity Incentive Award Plan, which shall be
substantially similar to the CancerVax Amended and Restated 2003
Equity Incentive Award Plan. For a given participant under the
2006 Equity Incentive Award Plan, 50% of the options granted to
such individual shall vest upon grant, with the remaining 50%
vesting ratably on a monthly basis over the 24 months
following the date of grant. The exercise price for such options
shall be set at approximately 25% of the closing price of a
share of CancerVax common stock on the date immediately
preceding the date of grant of the option (as adjusted for the
exchange ratio). In the merger, such options shall become
options to acquire shares of CancerVax common stock in
accordance with the terms of the merger agreement and as
described in this proxy statement/prospectus under The
Merger Agreement Micromet Parent Stock
Options.
Material
Federal Income Tax Consequences
The following discussion summarizes the material
U.S. federal income tax considerations of the merger that
are expected to apply generally to Micromet Parent stockholders
upon an exchange of their Micromet Parent common stock for
CancerVax common stock in the merger. This summary is based upon
current provisions of the Internal Revenue Code of 1986, as
amended, or the Code, existing regulations under the Code and
current administrative rulings and court decisions, all of which
are subject to change. Any change, which may or may not be
retroactive, could alter the tax consequences to CancerVax,
Micromet Parent or the stockholders of Micromet Parent as
described in this summary. In addition, this summary assumes the
truth and satisfaction of the statements and conditions
described below as the basis for the tax opinion of Cooley
Godward LLP. No attempt has been made to comment on all
U.S. federal income tax consequences of the merger that may
be relevant to particular holders, including holders who:
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are subject to special tax rules such as dealers in securities,
foreign persons, mutual funds, regulated investment companies,
real estate investment trusts, insurance companies or tax-exempt
entities;
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are subject to the alternative minimum tax provisions of the
Code;
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acquired their shares in connection with stock option or stock
purchase plans or in other compensatory transactions;
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hold their shares as a hedge or as part of a hedging, straddle
or other risk reduction strategy; or
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do not hold their shares as capital assets; or
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acquired their Micromet Parent common stock upon exercise of a
warrant.
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In addition, the following discussion does not address the tax
consequences of the merger under state, local and foreign tax
laws. Furthermore, the following discussion does not address any
of the following:
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the tax consequences of transactions effectuated before, after
or at the same time as the merger, whether or not they are in
connection with the merger, including, without limitation, the
reorganization in which Micromet shareholders will exchange
their interests for shares of common stock of Micromet Parent
and Micromet will become a wholly owned subsidiary of Micromet
Parent, or transactions in which Micromet shares are acquired or
CancerVax shares are disposed of;
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the tax consequences to holders of options issued by Micromet
Parent which are assumed by CancerVax in connection with the
merger; or
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the tax implications of a failure of the merger to qualify as a
reorganization.
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Accordingly, holders of Micromet shares who will become
holders of Micromet Parent common stock as part of the Micromet
Reorganization are advised and expected to consult their own tax
advisors regarding
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the federal income tax consequences of the merger in light of
their personal circumstances and the consequences of the merger
under state, local and foreign tax laws.
As set forth in the merger agreement, Cooley Godward LLP will
render a tax opinion that the merger will constitute a
reorganization within the meaning of Section 368 of the
Code, or a Reorganization. The tax opinion discussed in this
section is conditioned upon certain assumptions stated in the
tax opinion and is based on the truth and accuracy, as of the
completion of the merger, of certain representations and other
statements made by CancerVax and Micromet in certificates
delivered to counsel. If any such representations and other
statements made in such certificates are inaccurate, or by the
consummation of the merger becomes inaccurate, then the tax
opinion may no longer be valid.
No ruling from the Internal Revenue Service has been or will be
requested in connection with the merger. In addition,
stockholders of Micromet Parent should be aware that the tax
opinion discussed in this section is not binding on the IRS, and
the IRS could adopt a contrary position and a contrary position
could be sustained by a court.
Subject to the assumptions and limitations discussed above, it
is the opinion of Cooley Godward LLP, tax counsel to Micromet
and Micromet Parent, that the merger will be treated for
U.S. federal income tax purposes as a reorganization.
Accordingly, the following material U.S. federal income tax
consequences will result:
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CancerVax, Merger Sub, Micromet Parent and Micromet will each be
a party to the reorganization;
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CancerVax, Merger Sub, Micromet Parent and Micromet will not
recognize any gain or loss solely as a result of the merger;
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stockholders of Micromet Parent will not recognize any gain or
loss upon the receipt of solely CancerVax common stock for their
Micromet Parent common stock, other than with respect to cash
received in lieu of fractional shares of CancerVax common stock;
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the aggregate tax basis of the shares of CancerVax common stock
received by a Micromet Parent stockholder in the merger
(including any fractional share deemed received) will be the
same as the aggregate basis of the shares of Micromet Parent
common stock surrendered in exchange therefor;
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the holding period of the shares of CancerVax common stock
received by a Micromet Parent stockholder in the merger will
include the holding period of the shares of Micromet Parent
common stock surrendered in exchange therefor; and
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cash payments received by Micromet Parent stockholders in lieu
of fractional shares will be treated as if such fractional
shares of CancerVax common stock were issued in the merger and
then sold. A stockholder of Micromet Parent who receives such
cash will recognize gain or loss equal to the difference, if
any, between such stockholders basis in the fractional
share and the amount of cash received. Such gain or loss will be
a capital gain or loss and any such capital gain will be
long-term capital gain if the Micromet Parent common stock was
held by such stockholder as a capital asset at the effective
time of the merger and such stockholders holding period
for his, her or its Micromet Parent common stock is more than
one year.
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Micromet Parent stockholders are required to attach a statement
to their tax returns for the year in which the merger is
consummated that contains the information listed in Treasury
Regulation Section 1.368-3(b).
Such statement must include the stockholders tax basis in
the stockholders Micromet Parent common stock and a
description of the CancerVax common stock received.
The preceding discussion is intended only as a summary of
certain U.S. federal income tax consequences of the merger
and does not purport to be a complete analysis or discussion of
all of the mergers potential tax effects. Micromet
shareholders who will become stockholders of Micromet Parent are
urged to consult their own tax advisors as to the specific tax
consequences to them of the merger, including tax return
reporting requirements, and the applicability and effect of
federal, state, local and other applicable tax laws.
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Anticipated
Accounting Treatment
The merger will be treated by CancerVax as a reverse merger
under the purchase method of accounting in accordance with
U.S. generally accepted accounting principles. For
accounting purposes, Micromet is considered to be acquiring
CancerVax in this transaction. Therefore, the aggregate
consideration paid in connection with the merger, together with
the direct costs of acquisition, will be allocated to
CancerVaxs tangible and intangible assets and liabilities
based on their fair market values. The assets and liabilities
and results of operations of CancerVax will be consolidated into
the results of operations of Micromet as of the effective date
of the merger. These allocations will be based upon a valuation
that has not yet been finalized.
Appraisal
Rights
Under Delaware law, Micromet shareholders and holders of
CancerVax common stock are not entitled to appraisal rights in
connection with the merger. The sole stockholder of Micromet
Parent has already consented to the merger and accordingly is
not entitled to assert appraisal rights.
Regulatory
Approvals
As of the date of this proxy statement/prospectus, neither
CancerVax nor Micromet or Micromet Parent is required to make
filings or to obtain approvals or clearances from any antitrust
regulatory authorities in the United States or other countries
to consummate the merger. In the United States, CancerVax must
comply with applicable federal and state securities laws and the
rules and regulations of the Nasdaq National Market in
connection with the issuance of shares of CancerVax common stock
in the merger and the filing of this proxy statement/prospectus
with the SEC.
Restrictions
on Resales
The shares of CancerVax common stock to be received by Micromet
Parent stockholders in the merger will be registered under the
Securities Act of 1933 and, except as described in this section,
may be freely traded without restriction. CancerVaxs
registration statement on
Form S-4,
of which this proxy statement/prospectus is a part, does not
cover the resale of shares of CancerVax common stock to be
received in connection with the merger by persons who are deemed
to be affiliates of Micromet or Micromet Parent. The
shares of CancerVax common stock to be issued in the merger and
received by persons who are deemed to be affiliates
of Micromet or Micromet Parent may be resold by them only in
transactions registered under the Securities Act of 1933, exempt
from registration by the resale provisions of Rule 145
under the Securities Act of 1933 or as otherwise permitted under
the Securities Act of 1933. Persons who are deemed to be
affiliates of Micromet or Micromet Parent prior to
the merger include individuals or entities that control, are
controlled by, or are under common control with Micromet or
Micromet Parent and may include officers and directors, as well
as principal stockholders, of Micromet or Micromet Parent.
Affiliates of Micromet and Micromet Parent will be notified
separately of their affiliate status.
The merger agreement provides that Micromet will use
commercially reasonable efforts to secure signed affiliate
agreements from all persons who are, become or might be deemed
to be affiliates of Micromet or Micromet Parent, and who will
receive CancerVax common stock in connection with the merger.
These affiliate agreements provide that these persons will not
sell, transfer or otherwise dispose of their shares of CancerVax
common stock unless they do so in compliance with securities
laws governing sales by affiliates.
Under the terms of the merger agreement, CancerVax has agreed to
file as soon as practicable, and in any event within
45 days after the effective time of the merger, a resale
registration statement to cover the resale by former affiliates
of Micromet Parent and Micromet of shares of CancerVax common
stock received by such stockholders in the merger. In addition,
CancerVax agreed to use commercially reasonable efforts to keep
the resale registration statement continuously effective until
the earlier of the date upon which all of the shares held by
such stockholders may be resold under Rule 145 without
restriction and the date upon which all such shares have been
sold pursuant to the resale registration statement.
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THE
MERGER AGREEMENT
The following description describes the material terms of the
merger agreement. This description of the merger agreement is
qualified in its entirety by reference to the full text of the
merger agreement which is attached as Annex A to this proxy
statement/prospectus and is incorporated herein by reference.
The merger agreement has been included to provide you with
information regarding its terms. We encourage you to read the
entire merger agreement. The merger agreement is not intended to
provide any other factual information about CancerVax, Micromet
or Micromet Parent. Such information can be found elsewhere
in this proxy statement/prospectus and in the case of CancerVax,
in the other public filings CancerVax makes with the Securities
and Exchange Commission, which are available without charge at
www.sec.gov.
Micromet
Reorganization
In order to facilitate the merger, Micromet Parent has been
formed as a new corporation, which has not had any operations to
date and which will not have any operations other than to
effectuate the Micromet Reorganization and to merge with Merger
Sub. As part of the Micromet Reorganization, all Micromet
ordinary shares, preference shares series (A new) and preference
shares series (B new) will be exchanged for shares of Micromet
Parent common stock on a
1-for-1
basis. It is a condition to the completion of the merger that
the Micromet Reorganization shall have occurred.
In order to effectuate the Micromet Reorganization, the
stockholders of Micromet must exchange their shares of Micromet
capital stock for shares of Micromet Parent common stock. The
current Micromet Shareholders Agreement contains a drag-along
provision that provides that stockholders holding 55% of the
outstanding shares of preference shares series (B new)
electing to exchange their shares for shares of Micromet Parent
common stock may force the remaining parties to the agreement,
which includes all stockholders of Micromet other than Enzon
Pharmaceuticals, Inc., to exchange their shares of Micromet
capital stock for shares of Micromet Parent common stock.
Therefore, in order to effectuate the Micromet Reorganization,
and in order to complete the merger, holders of at least 55% of
the outstanding shares of preference shares series (B new)
must elect to exchange all of their shares of Micromet capital
stock for shares of Micromet Parent common stock. As of
March 27, 2006 holders of 68.5% of preference
shares series (B new) have entered into agreements whereby
they commit to exchange their shares in the Micromet
Reorganization.
In addition, prior to the closing of the merger, Micromet Parent
will establish the Micromet, Inc. 2006 Equity Incentive Award
Plan, the Micromet Parent Plan. Pursuant to the Micromet Parent
Plan, options to acquire up to 335,775 shares of Micromet
Parent common stock will be issued by Micromet Parent prior to
the closing of the merger. In the merger, these options will be
exchanged for options to acquire shares of CancerVax common
stock in accordance with the terms of the merger agreement. None
of the existing options to acquire ordinary shares of Micromet
will be exchanged in connection with the Micromet Reorganization
and all such options will be terminated after the closing of the
merger in accordance with their terms.
In the Micromet Reorganization, the warrants to acquire Micromet
preference shares series (A new) currently held by GATX/ETV will
be exchanged for warrants to acquire shares of Micromet Parent
common stock (the Micromet Parent Warrants). In the
merger, these Micromet Parent Warrants will then be exchanged
for warrants to acquire shares of CancerVax common stock in
accordance with the terms of the merger agreement. Other than
the warrants held by GATX/ETV, none of the existing warrants to
acquire shares of Micromet capital stock will be exchanged in
the Micromet Reorganization and all such warrants will expire to
the extent unexercised as of the closing of the merger.
In the Micromet Reorganization, all outstanding debt instruments
of Micromet will remain as debt obligations of Micromet, subject
to the rights of MedImmune to convert some or all of its
promissory note into capital stock of Micromet, as described
below in Convertible Promissory Note issued to MedImmune
Ventures, Inc. To the extent that MedImmune elects to
convert some or all of its promissory note into capital stock of
Micromet, these shares will be exchanged for shares of Micromet
Parent common stock in the Micromet Reorganization and then
converted into the right to receive shares of CancerVax common
stock in the merger.
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Immediately upon consummation of the Micromet Reorganization,
all outstanding shares of Micromet capital stock will be held by
Micromet Parent (with the potential exception of up to
16,836 Micromet ordinary shares currently held by Enzon
Pharmaceuticals, Inc.), with Micromet Parent surviving the
merger as a wholly-owned subsidiary of CancerVax.
Except where specifically noted, the following information
and all other information contained in this proxy
statement/prospectus does not give effect to the proposed
reverse stock split of CancerVax common stock described in
CancerVaxs Proposal No. 3.
Structure
of the Merger
The merger agreement provides that at the effective time,
Carlsbad Acquisition Corp., or Merger Sub, a wholly-owned
subsidiary of CancerVax, will be merged with and into Micromet
Parent. Upon the consummation of the merger, Micromet Parent
will continue as the surviving corporation and will be a
wholly-owned direct subsidiary of CancerVax.
Effective
Time of the Merger
The merger agreement requires the parties to consummate the
merger after all of the conditions to the consummation of the
merger contained in the merger agreement are satisfied or
waived, including the completion of the Micromet Reorganization
and the approval of the issuance of shares of CancerVax common
stock in the merger by the stockholders of CancerVax. The merger
will become effective upon the filing of a certificate of merger
with the Secretary of State of the State of Delaware or at such
later time as is agreed by CancerVax and Micromet Parent and
specified in the certificate of merger. However, because the
consummation of the merger may be subject to governmental and
regulatory approvals and other conditions, we cannot predict the
exact timing of the consummation of the merger.
Merger
Consideration; Manner and Basis of Converting Shares
At the effective time, all shares of Micromet Parent capital
stock will automatically be cancelled and Micromet Parent
stockholders, together with holders of options, warrants and
other rights to acquire shares of Micromet Parent common stock,
will receive an aggregate number of shares of CancerVax common
stock equal to 67.5% of the fully-diluted shares of the combined
company. There will be no adjustment to the total number of
shares of CancerVax common stock to be issued to Micromet Parent
stockholders or holders of options, warrants or other rights to
acquire shares of Micromet Parent common stock for changes in
the market price of CancerVax common stock. Further, the merger
agreement does not include a price-based termination right.
Accordingly, the market value of the shares of CancerVax issued
in connection with the merger will depend on the market value of
the shares of CancerVax common stock at the time of
effectiveness of the merger, and could vary significantly from
the market value on the date of this document.
The fixed number of shares of CancerVax common stock to be
issued in exchange for all shares of Micromet Parent stock at
the consummation of the merger will be allocated among:
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holders of Micromet Parent common stock;
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holders of options to purchase Micromet Parent common stock
(which shares of CancerVax will become issuable upon the
exercise of options to purchase CancerVax common stock which are
being issued in replacement of the outstanding options to
purchase Micromet Parent common stock, as more fully described
under Micromet Parent Stock Options below);
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holder of warrants to purchase Micromet Parent common
stock; and
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holders of shares of capital stock of Micromet to the extent
such shares have not been exchanged for shares of Micromet
Parent common stock in the Micromet Reorganization.
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The shares of CancerVax common stock to be issued in connection
with the merger will be allocated to the Micromet Parent
stockholders and holders of options, warrants and other rights
to acquire shares of Micromet Parent common stock on a pro rata
basis.
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Fractional
Shares
No fractional shares of CancerVax common stock will be issued in
the merger. Instead, each Micromet Parent stockholder otherwise
entitled to a fractional share of CancerVax common stock (after
aggregating all fractional shares of CancerVax common stock
issuable to such stockholder) will be entitled to receive in
cash the dollar amount (rounded to the nearest whole cent),
without interest, determined by multiplying such fraction by the
closing sale price for one share of CancerVax common stock as
quoted on the Nasdaq National Market on the date the merger
becomes effective.
Surrender
of Micromet Parent Stock Certificates
The merger agreement provides that, promptly after the effective
time of the merger, CancerVax will deposit with a reputable bank
or trust company, as the exchange agent, stock certificates
representing the shares of CancerVax common stock issuable to
the Micromet Parent stockholders and a sufficient amount of cash
to make payments in lieu of fractional shares.
The merger agreement provides that, as promptly as practicable
following the effective time of the merger, the exchange agent
for the merger will mail to each record holder of Micromet
Parent common stock immediately prior to the effective time of
the merger and after giving effect to the Micromet
Reorganization a letter of transmittal and instructions for
surrendering and exchanging the record holders Micromet
Parent stock certificates. Upon surrender of a Micromet Parent
common stock certificate for exchange to the exchange agent,
together with a duly signed letter of transmittal, and such
other documents as the exchange agent may reasonably require,
the holder of the Micromet Parent stock certificate will be
entitled to receive the following:
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a certificate representing CancerVax common stock; and
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cash in lieu of any fractional share of CancerVax common stock.
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The stock certificate so surrendered will be cancelled.
After the effective time, all holders of certificates
representing shares of Micromet Parent common stock that were
outstanding immediately prior to the effective time of the
merger will cease to have any rights as stockholders of Micromet
Parent. In addition, no transfer of Micromet Parent common stock
after the effective time of the merger will be registered on the
stock transfer books of Micromet Parent.
If any Micromet Parent stock certificate has been lost, stolen
or destroyed, the owner of such certificate may deliver to the
exchange agent an affidavit claiming such certificate has been
lost, stolen or destroyed in order to receive the shares of
CancerVax common stock issuable to the holder of such
certificate.
From and after the effective time of the merger, until it is
surrendered and exchanged, each certificate that previously
evidenced Micromet Parent common stock will be deemed to
represent only the right to receive shares of CancerVax common
stock and cash in lieu of any fractional share of CancerVax
common stock. CancerVax will not pay dividends or other
distributions on any shares of CancerVax common stock to be
issued in exchange for any unsurrendered Micromet Parent stock
certificate until the Micromet Parent stock certificate is
surrendered as provided in the merger agreement.
The
Exchange Ratio
On the date that the merger closes, the parties will determine
the aggregate number of shares of CancerVax common stock
outstanding (assuming the exercise of all outstanding warrants
to purchase shares of CancerVax common stock and the exercise of
all outstanding options to purchase shares of CancerVax common
stock that have exercise prices per share that are less than the
greater of $3.31 and the average closing price for a share of
CancerVax common stock for the five trading days immediately
preceding the closing date, as well as all options issued after
January 6, 2006 to the extent that such option grant has
not been specifically approved by Micromet). This total number
of shares of CancerVax common stock (subject to certain
adjustments) will then be multiplied by the exchange ratio of
2.076923 to reflect the agreed-upon ownership allocation between
Micromet Parent and CancerVax. The number of shares of CancerVax
common stock to be delivered to Micromet Parent stockholders
will be reduced to cover the shares of CancerVax common stock
issuable upon exercise of Micromet Parent stock
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options, warrants and other rights to acquire Micromet Parent
common stock that are being assumed by CancerVax in the merger,
as well as any remaining shares of Micromet that were not
exchanged for shares of Micromet Parent common stock in the
Micromet Reorganization.
If the number of shares of common stock of CancerVax changes
before the merger is completed because of a reorganization,
recapitalization, reclassification, stock dividend, stock split,
reverse stock split, or other similar event, then, by operation
of the exchange ratio, an appropriate and proportionate
adjustment will be made to the number of shares of CancerVax
common stock to be issued to the Micromet Parent stockholders
and holders of options, warrants and other rights to acquire
shares of Micromet Parent common stock.
Micromet
Parent Stock Options
At the effective time of the merger, each outstanding option
granted by Micromet Parent to purchase shares of Micromet Parent
common stock will be converted into an option to acquire
CancerVax common stock having the same terms and conditions as
the Micromet Parent stock option had before the effective time.
The number of shares that the new CancerVax option will be
exercisable for and the exercise price of the new CancerVax
option will reflect the exchange ratio in the merger. The number
of shares of CancerVax common stock issuable upon the exercise
of each stock option will be rounded down to the nearest whole
number of shares of CancerVax common stock, and the exercise
price will be rounded up to the nearest whole cent. The number
of shares of CancerVax common stock issuable upon exercise of
the new CancerVax options is part of the 67.5% of the
fully-diluted shares of the combined company described under
Merger Consideration; Manner and Basis for Converting
Shares. Current options to purchase Micromet shares will
terminate after the closing of the merger in accordance with
their terms.
CancerVax has agreed to file with the SEC, within 60 days
after the effective date of the merger, a registration statement
relating to the shares of CancerVax common stock issuable upon
exercise of the new CancerVax options.
Micromet
Parent Warrants
At the effective time of the merger, each outstanding warrant
granted by Micromet Parent to purchase shares of Micromet Parent
common stock will be converted into a warrant to acquire
CancerVax common stock having the same terms and conditions as
the Micromet Parent warrant had before the effective time. The
number of shares that the new CancerVax warrant will be
exercisable for and the exercise price of the new CancerVax
warrant will reflect the exchange ratio in the merger. The
number of shares of CancerVax common stock issuable upon the
exercise of each warrant will be rounded down to the nearest
whole number of shares of CancerVax common stock, and the
exercise price will be rounded up to the nearest whole cent. The
number of shares of CancerVax common stock issuable upon
exercise of the new CancerVax warrants is part of the 67.5% of
the fully-diluted shares of the combined company described under
Merger Consideration; Manner and Basis for Converting
Shares.
Convertible
Promissory Note Issued to MedImmune Ventures,
Inc.
In conjunction with the execution of a collaboration agreement
between Micromet and MedImmune, Inc. in 2003, Micromet issued a
10,000,000 convertible note to MedImmune Ventures, Inc.
The terms of that note, as amended on October 11, 2005,
provide that the holder has the right, immediately prior to the
effectiveness of the merger, to convert the note in full into
Micromet preference shares series (A new) if the pre-money
valuation of Micromet is 120,000,000 or more; if the
valuation is less, the conversion rate is a pro rata percentage
determined as the pre-money valuation divided by
120,000,000, multiplied by one hundred. In the event that
MedImmune elected to convert the applicable portion of the note
into preference shares series (A new), such shares would be
converted into shares of Micromet Parent common stock in the
Micromet Reorganization, and into the right to receive the
merger consideration in the merger. In addition, if the combined
company after the merger holds more than 30,000,000 in
cash, then MedImmune has the right (but not the obligation) to
accelerate repayment of the loan in an amount equal to the
principal balance multiplied by a fraction (A) the
numerator of which is the amount of cash held by the combined
company in excess of 30,000,000 and (B) the
denominator of which is 30,000,000, to the extent such
principal balance has not been converted as described in the
immediately preceding sentence. As a result, if the combined
company has at least 60,000,000 in cash, MedImmune may
require the loan to be repaid in
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full. In each case, the remainder of the note remains
outstanding until the due date in accordance with the terms of
the note. The note bears interest at 4.5% per annum and is
due in June 2010 unless earlier converted or repaid. MedImmune
has informed Micromet that it desires to convert its note to the
fullest extent possible in connection with the merger. Based
upon the closing price of CancerVax stock on March 27,
2006, it is expected that all of the principal under the
MedImmune note will convert in connection with the merger.
Representations
and Warranties
The merger agreement contains customary representations and
warranties of CancerVax (including Merger Sub) and Micromet
Parent (including Micromet AG) made to, and solely for the
benefit of, each other. The representations and warranties
expire at the effective time of the merger. The assertions
embodied in those representations and warranties are qualified
by information in confidential disclosure schedules that
CancerVax and Micromet Parent have exchanged in connection with
signing the merger agreement. While CancerVax and Micromet
Parent do not believe that they contain information securities
laws require the parties to publicly disclose other than
information that has already been so disclosed, the disclosure
schedules do contain information that modifies, qualifies and
creates exceptions to the representations and warranties set
forth in the attached merger agreement. Accordingly, you should
not rely on the representations and warranties as
characterizations of the actual state of facts, since they were
only made as of the date of the merger agreement and are
modified in important part by the underlying disclosure
schedules. These disclosure schedules contain information that
has been included in CancerVaxs general prior public
disclosures, as well as additional non-public information
concerning both CancerVax and Micromet Parent. Moreover,
information concerning the subject matter of the representations
and warranties may have changed since the date of the merger
agreement, which subsequent information may or may not be fully
reflected in CancerVaxs public disclosures.
Covenants;
Conduct of Business Prior to the Merger
Affirmative Covenants of Micromet Parent and Micromet.
Subject to certain exceptions, Micromet Parent and Micromet have
agreed that before the effective time, they will:
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provide CancerVax and its representatives with reasonable access
during normal business hours to Micromet Parents and
Micromets representatives, personnel and assets and to all
existing books, records, tax returns, work papers and other
documents and information relating to Micromet Parent and
Micromet;
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provide CancerVax and its representatives with such copies of
the existing books, records, tax returns, work papers, product
data, and other documents and information relating to Micromet
Parent and Micromet, and with such additional financial,
operating and other data and information regarding Micromet
Parent and Micromet as CancerVax may reasonably request;
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permit CancerVaxs officers and other employees to meet,
upon reasonable notice and during normal business hours, with
the chief financial officer and other officers and managers of
Micromet Parent and Micromet responsible for Micromet
Parents and Micromets financial statements and the
internal controls of Micromet Parent and Micromet to discuss
such matters as CancerVax may deem necessary or appropriate in
order to enable CancerVax to satisfy its obligations under the
Sarbanes-Oxley Act;
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subject to applicable law, provide CancerVax with:
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unaudited monthly consolidated balance sheets, statements of
operations, statements of stockholders equity and
statements of cash flows of Micromet Parent and Micromet;
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(2)
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all material operating and financing reports prepared by
Micromet Parent or Micromet for its senior management;
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(3)
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written materials or communications sent by Micromet Parent or
Micromet to its stockholders;
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(4)
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subject to limited exceptions, any material notice, document or
other communication sent by or on behalf of Micromet Parent or
Micromet to any other party to a material contract to which
Micromet Parent or Micromet is a party;
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(5)
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any notice, report or other document filed with or otherwise
furnished, submitted or sent to any governmental entity on
behalf of Micromet Parent or Micromet in connection with the
merger;
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(6)
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any non-privileged notice, document or other communication sent
by or on behalf of, or sent to, Micromet Parent or Micromet
relating to any pending or threatened legal proceeding involving
or affecting Micromet Parent or Micromet; and
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(7)
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any material notice, report or other document received by
Micromet Parent or Micromet from any governmental entity;
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conduct their businesses and operations in the ordinary course
of business, in compliance with all applicable laws and the
requirements of all material contracts to which they are a party;
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preserve intact their current business organization, keep
available the services of their current officers and other
employees and maintain their relations and goodwill with all
material suppliers, customers, landlords, creditors, licensors,
licensees, employees and other persons having material business
relationships with Micromet Parent or Micromet;
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promptly notify CancerVax of any notice or other communication
alleging that the consent of such person is or may be required
in connection with the merger or any legal proceeding against,
relating to, involving or otherwise affecting Micromet Parent or
Micromet that is commenced, or, to the knowledge of Micromet
Parent or Micromet, threatened against, Micromet Parent or
Micromet;
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promptly notify CancerVax in writing of the discovery by
Micromet Parent of (a) any event, condition, fact or
circumstance that occurred or existed on or prior to the date of
the merger agreement and that caused or constitutes a material
inaccuracy in any representation or warranty made by Micromet
Parent or Micromet, (b) any event, condition, fact or
circumstance that occurs, arises or exists after the date of the
merger agreement and that would cause or constitute a material
inaccuracy in any representation or warranty made by Micromet
Parent or Micromet if such representation or warranty had been
made as of the time of the occurrence, existence or discovery of
such event, condition, fact or circumstance or such event,
condition, fact or circumstance had occurred, arisen or existed
on or prior to the date of the merger agreement, (c) any
material breach of any covenant or obligation of Micromet Parent
or Micromet and (d) any event, condition, fact or
circumstance that could reasonably be expected to make the
timely satisfaction of any of the conditions precedent to the
closing of the merger impossible or materially less likely;
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use their commercially reasonable efforts to cause each person
who may reasonably be deemed to be an affiliate of Micromet or
Micromet Parent for purposes of Rule 145 of the Securities
Act to execute and deliver to CancerVax an executed affiliate
and market stand-off agreement;
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use their commercially reasonable efforts to cause the delivery
to CancerVax of Micromets audited consolidated balance
sheet at December 31, 2004 and the related consolidated
statements of income, cash flow and shareholders equity
for the year ended December 31, 2004; and
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use their commercially reasonable efforts to cause Cooley
Godward LLP to deliver to it a tax opinion satisfying the
requirements of Item 601 of
Regulation S-K
promulgated under the Securities Act.
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Negative Covenants of Micromet Parent and
Micromet. Subject to certain exceptions, Micromet
Parent and Micromet have agreed that before the effective time,
except as otherwise approved by CancerVax, they will not:
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declare, accrue, set aside or pay any dividend or make any other
distribution in respect of any shares of capital stock, or
repurchase, redeem or otherwise reacquire any shares of their
capital stock or other securities;
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subject to limited exceptions, sell, issue, grant or authorize
the sale, issuance or grant of any capital stock or other
security, any option, call, warrant or right to acquire any
capital stock or other security or any instrument convertible
into or exchangeable for any capital stock or other security;
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amend or waive any of their rights under, or permit the
acceleration of the vesting under, any provision of Micromet
Parents stock option plan, any stock option to purchase
Micromet Parent common stock, any
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agreement evidencing or relating to any outstanding stock option
or warrant to purchase Micromet Parent common stock, any
restricted stock purchase agreement, or any other contract
evidencing or relating to any equity award (whether payable in
cash or stock);
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amend or permit the adoption of any amendment to their
certificate of incorporation or bylaws or other charter or
organizational documents, or effect or become a party to any
merger, consolidation, share exchange, business combination,
amalgamation, recapitalization, reclassification of shares,
stock split, reverse stock split, division or subdivision of
shares, consolidation of shares or similar transaction (other
than the Micromet Reorganization);
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form any subsidiary or acquire any equity interest or other
interest in any other entity;
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make any capital expenditure in excess of $250,000;
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other than in the ordinary course of business consistent with
past practices, enter into or become bound by, or permit any of
the assets owned or used by them to become bound by, any
material contract, or agree to amend or terminate any material
contract;
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subject to limited exceptions, acquire, lease or license any
right or other asset from any other person or sell encumber,
convey, assign, or otherwise dispose of or transfer of, or lease
or license or sublicense, any right or other asset or interest
therein to any other person, or waive or relinquish any material
right;
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other than in the ordinary course of business consistent with
past practices, write off as uncollectible, or establish any
extraordinary reserve with respect to, any receivable or other
indebtedness;
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subject to limited exceptions, make any pledge of any of their
assets or permit any of their assets to become subject to any
encumbrances;
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lend money to any person, or incur or guarantee any indebtedness
or issue or sell any debt securities or options, warrants, calls
or other similar rights to acquire any debt securities of
Micromet Parent or Micromet;
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establish, adopt, enter into or amend any employee benefit plan
or any employee stock purchase or employee stock option plan,
pay any bonus or make any profit-sharing or similar payment to,
or increase the amount of the wages, salary, commissions, fringe
benefits or other compensation (including equity-based
compensation, whether payable in stock, cash or other property)
or remuneration payable to any of their directors or any of
their officers or other employees except as required by law;
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hire or terminate any key employee;
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pay, discharge or satisfy any claim, liability or obligation,
other than the payment, discharge or satisfaction of
non-material amounts in the ordinary course of business;
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change any of their personnel policies or other business
policies, or any of their methods of accounting or accounting
practices in any material respect;
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make any tax election, adopt or change any accounting methods,
principles or practice, file any material amendment to any tax
return, enter into any tax allocation agreement, tax sharing
agreement, tax indemnity agreement or closing agreement relating
to any material tax, surrender any right to claim a material tax
refund, or consent to any extension or waiver of the statute of
limitations period applicable to any material tax claim or
assessment;
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commence or settle any legal proceeding in a manner that would
be reasonably expected to result in a material adverse effect on
Micromet Parent;
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enter into any material transaction outside the ordinary course
of business; or
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issue any press release or make any disclosure regarding the
merger unless Micromet Parent shall have approved such press
release or disclosure in writing or CancerVax shall have
determined in good faith, upon the advice of outside legal
counsel, that such disclosure is required by applicable law and,
to the extent practicable, before such press release or
disclosure is issued or made, CancerVax advises Micromet Parent
of, and consults with Micromet Parent regarding, the text of
such press release or disclosure.
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Affirmative Covenants of CancerVax. Subject to
certain exceptions, CancerVax has agreed that before the
effective time, it will:
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provide Micromet Parent and its representatives with reasonable
access during normal business hours to Micromet Parents
representatives, personnel and assets and to all existing books,
records, tax returns, work papers and other documents and
information relating to CancerVax;
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provide Micromet Parent and its representatives with such copies
of the existing books, records, tax returns, work papers,
product data, and other documents and information relating to
CancerVax, and with such additional financial, operating and
other data and information regarding CancerVax as Micromet
Parent may reasonably request;
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subject to applicable law, provide Micromet Parent with:
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(1)
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unaudited monthly consolidated balance sheets, statements of
operations, statements of stockholders equity and
statements of cash flows of CancerVax;
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(2)
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all material operating and financing reports prepared by
CancerVax for its senior management;
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(3)
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written materials or communications sent by CancerVax to its
stockholders;
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(4)
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subject to limited exceptions, any material notice, document or
other communication sent by or on behalf of CancerVax to any
other party to a material contract to which CancerVax is a party;
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(5)
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any notice, report or other document filed with or otherwise
furnished, submitted or sent to any governmental entity on
behalf of CancerVax in connection with the merger;
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(6)
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any non-privileged notice, document or other communication sent
by or on behalf of, or sent to, CancerVax relating to any
pending or threatened legal proceeding involving or affecting
CancerVax; and
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(7)
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any material notice, report or other document received by
CancerVax from any governmental entity;
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conduct its business and operations in the ordinary course of
business, in compliance with all applicable laws and the
requirements of all material contracts to which it is a party,
and consistent with the actions customarily taken by a similarly
situated corporation engaged in the prompt and orderly
termination of its lead pharmaceutical candidate program;
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preserve intact its current business organization, keep
available the services of its current key employees and maintain
its relations and goodwill with all material suppliers,
customers, landlords, creditors, licensors, licensees, employees
and other persons having material business relationships with
CancerVax and its subsidiaries;
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promptly notify Micromet Parent of any notice or other
communication alleging that the consent of such person is or may
be required in connection with the merger or any legal
proceeding against, relating to, involving or otherwise
affecting CancerVax or its subsidiaries that is commenced, or,
to the knowledge of CancerVax, threatened against, CancerVax or
its subsidiaries;
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promptly notify Micromet Parent in writing of the discovery by
CancerVax of (a) any event, condition, fact or circumstance
that occurred or existed on or prior to the date of the merger
agreement and that caused or constitutes a material inaccuracy
in any representation or warranty made by CancerVax or Merger
Sub, (b) any event, condition, fact or circumstance that
occurs, arises or exists after the date of the merger agreement
and that would cause or constitute a material inaccuracy in any
representation or warranty made by CancerVax or Merger Sub if
such representation or warranty had been made as of the time of
the occurrence, existence or discovery of such event, condition,
fact or circumstance or such event, condition, fact or
circumstance had occurred, arisen or existed on or prior to the
date of the merger agreement, (c) any material breach of
any covenant or obligation of CancerVax or Merger Sub and
(d) any event, condition, fact or circumstance that could
reasonably be expected to make the timely satisfaction of any of
the conditions precedent to the closing of the merger impossible
or materially less likely;
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100
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subject to limited exceptions, use commercially reasonable
efforts to obtain all regulatory approvals needed to ensure that
the CancerVax common stock to be issued in the merger will be
registered or qualified or exempt from registration or
qualification under the securities law of every jurisdiction of
the United States in which any registered holder of Micromet
Parent common stock has an address of record;
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use reasonable best efforts to maintain its existing listing on
the Nasdaq National Market and to cause the shares of CancerVax
common stock to be issued as consideration in the merger to be
approved for listing on the Nasdaq National Market;
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file as soon as practicable, and in any event within
45 days after the effective time of the merger, a resale
registration statement to cover the resale by former affiliates
of Micromet Parent and Micromet of shares of CancerVax common
stock received by such stockholders in the merger, and use
commercially reasonable efforts to keep the resale registration
statement continuously effective until the earlier of the date
upon which all of the shares held by such stockholders may be
resold under Rule 145 without restriction and the date upon
which all such shares have been sold pursuant to the resale
registration statement; and
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cause the individuals listed in Section 5.12 of the merger
agreement and the schedules thereto to be elected or appointed
to the board of directors of CancerVax as of the effective time
of the merger.
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Negative Covenants of CancerVax. Subject to
certain exceptions, CancerVax has agreed that before the
effective time, except as otherwise approved by Micromet Parent,
it will not, will not agree to, and will not permit any of its
subsidiaries to:
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declare, accrue, set aside or pay any dividend or make any other
distribution in respect of any shares of its capital stock, or
repurchase, redeem or otherwise reacquire any shares of capital
stock or other securities;
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subject to limited exceptions, sell, issue, grant or authorize
the sale, issuance or grant of any capital stock or other
security, any option, call, warrant or right to acquire any
capital stock or other security or any instrument convertible
into or exchangeable for any capital stock or other security;
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amend or waive any of its rights under, or permit the
acceleration of the vesting under, any provision of any of
CancerVaxs equity incentive plans, any stock option or
warrant to purchase CancerVax common stock, any restricted stock
purchase agreement, or any other contract evidencing or relating
to any equity award (whether payable in cash or stock);
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amend or permit the adoption of any amendment to its certificate
of incorporation or bylaws or other charter or organizational
documents, or effect or become a party to any merger,
consolidation, share exchange, business combination,
amalgamation, recapitalization, reclassification of shares,
stock split, reverse stock split, division or subdivision of
shares, consolidation of shares or similar transaction or
otherwise acquire or agree to acquire any assets that are
material, individually or in the aggregate, to the business of
CancerVax;
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form any subsidiary or acquire any equity interest or other
interest in any other entity or enter into any material
partnership arrangements, joint development agreements or
strategic alliances;
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make any capital expenditure in excess of $100,000;
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other than in the ordinary course of business consistent with
past practices, enter into or become bound by, or permit any of
the assets owned or used by it to become bound by, any material
contract, or agree to amend or terminate any material contract;
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subject to limited exceptions, acquire, lease or license any
right or other asset from any other person or sell encumber,
convey, assign, or otherwise dispose of or transfer of, or lease
or license or sublicense, any right or other asset or interest
therein to any other person, or waive or relinquish any material
right;
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other than in the ordinary course of business consistent with
past practices, write off as uncollectible, or establish any
extraordinary reserve with respect to, any receivable or other
indebtedness;
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subject to limited exceptions, make any pledge of any of its
assets or permit any of its assets to become subject to any
encumbrances;
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101
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lend money to any person, or incur or guarantee any indebtedness
or issue or sell any debt securities or options, warrants, calls
or other similar rights to acquire any debt securities of
CancerVax;
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subject to limited exceptions, establish, adopt, enter into or
amend any employee benefit plan or any employee stock purchase
or employee stock option plan, or pay any bonus or make any
profit-sharing or similar payment to, or increase the amount of
the wages, salary, commissions, fringe benefits or other
compensation (including equity-based compensation, whether
payable in stock, cash or other property) or remuneration
payable to any of its directors or any of its officers or other
employees except as required by law;
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hire any employee or terminate any key employee;
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make any grant of exclusive rights to any third party;
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transfer or license to any person or entity or otherwise extend,
amend or modify in any material respect any rights to its
intellectual property, or enter into any agreements or make
other commitments or arrangements to grant, transfer or license
to any person any future patent rights, other than non-exclusive
licenses granted to customers, resellers and end users in the
ordinary course of business consistent with past practices;
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subject to limited exceptions, enter into, or materially modify,
any material contract, agreement or obligation relating to the
distribution, sale, license or marketing by third persons of
CancerVaxs or its subsidiaries products or products
licensed by CancerVax or its subsidiaries;
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pay, discharge or satisfy any claim, liability or obligation
(absolute, accrued, asserted or unasserted, contingent or
otherwise), other than the payment, discharge or satisfaction of
non-material amounts in the ordinary course of business;
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change any of its personnel policies or other business policies,
or any of its methods of accounting or accounting practices in
any material respect;
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make any tax election, adopt or change any accounting methods,
principles or practices, file any material amendment to any tax
return, enter into any tax allocation agreement, tax sharing
agreement, tax indemnity agreement or closing agreement relating
to any material tax, surrender any right to claim a material tax
refund, or consent to any extension or waiver of the statute of
limitations period applicable to any material tax claim or
assessment;
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commence or settle any legal proceeding in a manner that would
be reasonably expected to result in a material adverse effect on
CancerVax;
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enter into any material transaction outside the ordinary course
of business; or
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issue any press release or make any disclosure regarding the
merger unless CancerVax shall have approved such press release
or disclosure in writing or Micromet Parent shall have
determined in good faith, upon the advice of outside legal
counsel, that such disclosure is required by applicable law and,
to the extent practicable, before such press release or
disclosure is issued or made, Micromet Parent advises CancerVax
of, and consults with CancerVax regarding, the text of such
press release or disclosure.
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Affirmative Covenants of CancerVax and Micromet
Parent. CancerVax, Micromet Parent and Micromet
have agreed that:
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as promptly as practicable following the date of the merger
agreement, both CancerVax and Micromet Parent will prepare and
file with the SEC mutually acceptable proxy materials which
shall constitute the proxy statement/prospectus and CancerVax
shall prepare and file with the SEC a registration statement on
Form S-4
with respect to the shares of CancerVax common stock to be
issued in the merger. CancerVax and Micromet Parent shall use
commercially reasonable efforts to have the registration
statement declared effective by the SEC;
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each party will use commercially reasonable efforts to file or
otherwise submit, as soon as practicable, all applications,
notices, reports and other documents reasonably required to be
filed by such party to any governmental entity with respect to
the merger and to submit promptly any additional information
requested
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102
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by any such governmental entity, including (a) the
notification and report any forms required to be filed under the
HSR Act and (b) any notification or other document required
to be filed in connection with the merger under any applicable
foreign legal requirement relating to antitrust or competition
matters;
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subject to limited exceptions described in the merger agreement,
each party shall use commercially reasonable efforts to cause to
be taken all actions necessary to consummate the merger,
including (a) making all filings and giving all notices
required to be made and given by such party in connection with
the merger, (b) using commercially reasonable efforts to
obtain each consent reasonably required to be obtained by such
party in connection with the merger, (c) using commercially
reasonable efforts to lift any injunction prohibiting, or any
other legal bar to, the merger and (d) using commercially
reasonable efforts to satisfy the conditions precedent to the
consummation of the merger, and each party has agreed to provide
to the other party a copy of each proposed filing with any
governmental entity relating to the merger and to give the other
party a reasonable time prior to making such filing in which to
review and comment on such proposed filing or other
submission; and
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each party will use commercially reasonable efforts to cause the
merger to qualify, and will not take any actions which to their
knowledge could reasonably be expected to prevent the merger
from qualifying, as a reorganization within the
meaning of section 368(a) of the Code, and each party will
use commercially reasonable efforts in order for Micromet Parent
to obtain the opinion of its tax counsel, Cooley Godward LLP, to
the effect that the merger will constitute a
reorganization within the meaning of
section 368(a) of the Code, including the execution and
delivery to Cooley Godward LLP of tax representation letters in
customary form.
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Employee
Benefits Matters
The merger agreement provides that CancerVax, for the one-year
period after the date that the merger becomes effective, will
maintain for employees, independent contractors, officers and
directors of CancerVax as of the date the merger becomes
effective medical and dental insurance and similar benefits that
are substantially the same as such benefits provided to such
persons as of the time that the merger becomes effective. This
extension of benefits does not include any benefits related to
equity incentives or other compensation.
Nothing provided for in the merger agreement creates a right in
any employee to employment with the surviving corporation or any
subsidiary of the surviving corporation. In addition, no officer
or director who continues in such capacity with the surviving
corporation will be deemed to be a third party beneficiary of
the merger agreement, except for officers and directors of
Micromet Parent, Micromet and CancerVax to the extent of their
respective rights with respect to the maintenance of
indemnification rights and directors and officers
insurance coverage. Please see The Merger
Agreement Indemnification and Insurance
below.
Indemnification
and Insurance
The merger agreement provides that, for a period of six years
after the merger, CancerVax will observe, to the fullest extent
permitted by Delaware law, all rights of the directors and
officers of Micromet Parent, Micromet and CancerVax as of the
time the merger becomes effective to indemnification for acts
and omissions as directors and officers occurring before the
merger pursuant to the Micromet Parent or CancerVax certificate
of incorporation and bylaws and pursuant to any indemnification
agreements with Micromet Parent, Micromet or CancerVax. In
addition, the merger agreement provides that for a period of six
years after the merger, the surviving corporation will maintain
in effect a directors and officers liability
insurance policy covering the directors and officers of Micromet
Parent, Micromet and CancerVax, with coverage in amount and
scope at least as favorable as the coverage under
CancerVaxs existing policies as of the time the merger
becomes effective, except that CancerVax is not required to pay
an annual premium for such directors and officers
liability insurance policy in excess of 200% of the last annual
premium paid by CancerVax for its existing policies.
103
Obligations
of the CancerVax Board of Directors and Micromet Parent Board of
Directors with Respect to Their Recommendations and Holding a
Meeting of CancerVaxs Stockholders
CancerVax has agreed to take all action necessary to call, give
notice of and, as promptly as practicable after the registration
statement on
Form S-4
of which this proxy statement/prospectus is a part is declared
effective under the Securities Act of 1933, hold a meeting of
its stockholders for the approval of the issuance of shares of
CancerVax common stock in the merger. As noted above, the sole
stockholder of Micromet Parent has already consented to the
merger.
No vote of the shareholders of Micromet is required or being
sought. CancerVax has agreed to include a statement in this
proxy statement/prospectus to the effect that the board of
directors of CancerVax recommends that CancerVaxs
stockholders approve the issuance of shares of CancerVax common
stock in the merger at the CancerVax annual meeting. Micromet
Parent has agreed to include a statement in this proxy
statement/prospectus to the effect that the board of directors
of Micromet Parent recommends that Micromet Parents sole
stockholder vote to adopt and approve the merger agreement. The
merger agreement provides that neither the board of directors of
Micromet Parent nor the board of directors of CancerVax may
withdraw its recommendation or modify its recommendation in a
manner adverse to the other company except in certain
circumstances.
The merger agreement provides that Micromet Parents board
of directors is entitled to withhold, withdraw, modify or amend
its recommendation if certain requirements, including the
following, are met:
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Micromet Parent receives an unsolicited, bona fide written
acquisition proposal that is not withdrawn;
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Such unsolicited written acquisition proposal was not obtained
or made as a result of a breach of the merger agreement;
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Micromet Parents board of directors determines in good
faith, after having taken into account the advice of its outside
legal counsel, that such acquisition proposal is a superior
proposal;
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Micromet Parents board of directors reasonably determines
in good faith, after having taken into account the advice of its
outside legal counsel, that failure to take such actions would
constitute a breach of its fiduciary duties to its stockholders
under applicable law; and
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Micromet Parents board of directors shall have given
CancerVax at least three business days notice of its intention
to withhold, withdraw, modify or amend its recommendation.
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The merger agreement provides that CancerVaxs board of
directors is entitled to withhold, withdraw, modify or amend its
recommendation that CancerVaxs stockholders vote to
approve the issuance of shares of CancerVax common stock in the
merger if certain requirements, including the following, are met:
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CancerVax receives an unsolicited, bona fide written acquisition
proposal that is not withdrawn;
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Such unsolicited written acquisition proposal was not obtained
or made as a result of a breach of the merger agreement;
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CancerVaxs board of directors determines in good faith,
after having taken into account the advice of its outside legal
counsel, that such acquisition proposal is a superior proposal;
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CancerVaxs board of directors reasonably determines in
good faith, after having taken into account the advice of its
outside legal counsel, that failure to take such actions would
constitute a breach of its fiduciary duties to its stockholders
under applicable law; and
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CancerVaxs board of directors shall have given Micromet
Parent at least three business days notice of its intention.
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The merger agreement provides that, if either company withdraws
or modifies the recommendation of its board of directors, that
company may be required under certain circumstances to pay a
termination fee of $2,000,000 to the other company. See
Expenses and Termination Fees.
104
Limitation
on Soliciting, Discussing or Negotiating Other Acquisition
Proposals
The merger agreement contains detailed provisions prohibiting
CancerVax and Micromet Parent from seeking or entering into an
alternative transaction to the merger. Under these no
solicitation and related provisions, subject to specific
exceptions described below, CancerVax and Micromet Parent have
agreed that they will not, directly or indirectly (and that they
will ensure that their subsidiaries do not and they and their
subsidiaries representatives do not directly or
indirectly):
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initiate, solicit, induce, knowingly encourage or take any other
action designed to, or which could reasonably be expected to,
facilitate an acquisition proposal or acquisition inquiry or the
making, submission or announcement of, any acquisition proposal
or acquisition inquiry;
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furnish to any person any nonpublic information in connection
with or in response to any acquisition proposal or acquisition
inquiry;
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participate or engage in discussions or negotiations with any
person with respect to any acquisition proposal or acquisition
inquiry, except to notify such person as to the existence of
these provisions;
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approve, endorse or recommend any acquisition proposal or
acquisition inquiry; or
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enter into any letter of intent or similar document or any
contract contemplating or otherwise relating to any acquisition
proposal or acquisition inquiry.
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Exception
to Limitation on Discussing and Negotiating Other Acquisition
Proposals
The merger agreement provides that, if, prior to the annual
meeting of CancerVax stockholders, CancerVax or Micromet Parent
receives from any person an acquisition proposal that
constitutes, or could reasonably be expected to result in the
submission by such person of, a superior proposal (as described
below), then CancerVax or Micromet Parent, as applicable, may
furnish nonpublic information to, and engage in discussions and
negotiations with, the person making the acquisition proposal,
as long as:
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there has been no breach of any of the obligations described
under the heading Limitation on Soliciting, Discussing or
Negotiating Other Acquisition Proposals above;
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CancerVaxs or Micromet Parents board of directors,
as applicable, reasonably determines in good faith, after having
taken into account the advice of its outside legal counsel, that
failure to take such actions would constitute a breach of its
fiduciary duties to its stockholders under applicable law;
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CancerVaxs or Micromet Parents board of directors,
as applicable, reasonably determines in good faith, after having
taken into account the advice of its outside legal counsel, that
such acquisition proposal is a superior proposal;
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at least two business days prior to furnishing any such
nonpublic information to, or entering into discussions or
negotiations with, such person, CancerVax or Micromet Parent
gives the other party written notice of the identity of such
person and of the partys intention to furnish nonpublic
information to, or enter into discussions or negotiations with,
such person;
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the party receives from such person an executed confidentiality
agreement containing terms and conditions at least as favorable
as the provisions in the confidentiality agreement between
CancerVax and Micromet Parent;
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at least two business days prior to furnishing any nonpublic
information to such person, CancerVax or Micromet Parent
furnishes such nonpublic information to the other party to the
extent not previously furnished;
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the party shall as promptly as practicable (and in any event
within 24 hours) advise the other party orally and in
writing of any acquisition inquiry or acquisition proposal,
including the identity of the person making such acquisition
proposal or acquisition inquiry and the terms and conditions
thereof; and
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105
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the party shall keep the other party fully informed of the
status and material details (including amendments or proposed
amendments) of any such acquisition proposal or acquisition
inquiry.
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For purposes of the merger agreement, the term superior
proposal shall mean, with respect to CancerVax and
Micromet Parent, a bona fide written offer which is not
solicited after the date of the merger agreement in violation of
the merger agreement made by a third party to enter into:
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a merger, consolidation, amalgamation, share exchange, business
combination, issuance of securities, acquisition of securities,
reorganization, recapitalization, tender offer, exchange offer
or other similar transaction as a result of which either
(i) the partys stockholders prior to such transaction
in the aggregate cease to own at least 50% of the voting
securities of the entity surviving or resulting from such
transaction or (ii) in which a person or group acquires
beneficial or record ownership of securities representing 50% or
more of the partys capital stock; or
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a sale, lease, exchange transfer, license, acquisition or
disposition of any business or other disposition of at least 50%
of the assets of the party or its subsidiaries, taken as a
whole, in a single transaction or a series of related
transactions.
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For any such acquisition proposal to be deemed to be a
superior proposal, it much be for a transaction that:
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is not subject to a financing contingency;
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is reasonably capable of being consummated; and
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is on terms which such partys board of directors in good
faith concludes (after obtaining and taking into account the
advice of its financial advisors and legal counsel) are
reasonably likely to be more favorable from a financial point of
view to the partys stockholders (in their capacities as
stockholders) than the transactions contemplated by the merger
agreement (including any revisions thereto).
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Material
Adverse Effect
Several of the representations, warranties, covenants and
closing conditions of CancerVax, Merger Sub, Micromet Parent and
Micromet in the merger agreement are qualified by reference to
whether the item in question has had or could reasonably be
expected to have a material adverse effect on the
applicable company. The merger agreement provides that
material adverse effect means, when used in
connection with CancerVax, any change, effect, event,
development or circumstance that has or could reasonably be
expected to have a material adverse effect on the business,
financial or other condition, capitalization, assets,
operations, financial performance or prospects of CancerVax and
its subsidiaries taken as a whole, or on the ability of
CancerVax to consummate the transactions contemplated by the
merger agreement, other than such changes, effects, events,
developments or circumstances reasonably attributable to the
announcement or pendency of the merger or any change in the
stock price or trading volume of CancerVax. The merger agreement
provides that material adverse effect means, when
used in connection with Micromet Parent and Micromet, any
change, effect, event, development or circumstance that has or
could reasonably be expected to have a material adverse effect
on the business, financial or other condition, capitalization,
assets, operations, financial performance or prospects of
Micromet Parent and its subsidiaries taken as a whole, or on the
ability of Micromet Parent and Micromet to consummate the
transactions contemplated by the merger agreement, other than
such changes, effects, events, developments or circumstances
reasonably attributable to the Micromet Reorganization or to the
announcement or pendency of the merger.
Conditions
to the Merger
Conditions to the Obligations of Each
Party. The merger agreement contemplates that the
respective obligations of each party to effect the merger and
the other transactions contemplated in the merger agreement
shall be subject to the satisfaction at or prior to the
effective time of the following conditions, any or all of which
may be waived, in whole or in part, to the extent permitted by
applicable law:
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the registration statement shall have been declared effective by
the SEC under the Securities Act, and no stop order suspending
the effectiveness of the registration statement shall have been
issued by the SEC and no
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106
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proceedings for that purpose shall have been initiated or, to
the knowledge of Micromet Parent or CancerVax, threatened by the
SEC;
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CancerVax stockholder approval and any required Micromet Parent
stockholder approval shall have been obtained;
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no temporary restraining order, preliminary or permanent
injunction or other order preventing the consummation of the
merger shall have been issued by any court of competent
jurisdiction or other governmental body which order or
injunction remains in effect, and there shall not be any legal
requirement which makes the consummation of the merger illegal;
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any applicable waiting periods or approvals under the HSR Act
and the antitrust or competition laws of any other applicable
jurisdiction, including any material foreign antitrust
requirements, shall have expired or been terminated or received;
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the existing shares of CancerVax common stock shall have been
continually listed on the Nasdaq National Market between the
date of the merger agreement and the closing date, and the
shares of CancerVax common stock issuable to Micromet
Parents stockholders in the merger shall have been
approved for listing on the Nasdaq National Market, subject to
official notice of issuance; and
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no legal proceeding shall be pending or overtly threatened by
any governmental body:
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(1)
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intended to restrain or prohibit the consummation of the merger;
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(2)
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relating to the merger and seeking to obtain from any party any
damages or other relief that may be material to such party;
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(3)
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seeking to prohibit or limit in any material and adverse respect
a partys ability to exercise ownership rights with respect
to the stock of CancerVax;
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(4)
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that could materially and adversely affect the ability of a
party to own its assets or operate its business; or
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(5)
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seeking to compel a party to dispose of or hold separate any
material assets as a result of the merger.
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Additional Conditions to the Obligations of
CancerVax. The merger agreement contemplates that
the obligations of CancerVax and Merger Sub to effect the merger
and the other transactions contemplated by the merger agreement
are also subject to the following conditions:
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the representations and warranties of Micromet Parent and
Micromet contained in the merger agreement shall be true and
correct (without giving effect to any limitation as to
materiality or material adverse effect set forth therein) at and
as of the effective time of the merger as if made at and as of
such time (except to the extent expressly made as of an earlier
date, in which case as of such earlier date), except where the
failure of such representations and warranties to be true and
correct (without giving effect to any limitation as to
materiality or material adverse effect set forth therein) would
not, individually or in the aggregate, result in a material
adverse effect, and CancerVax shall have received a certificate
of the chief executive officer and chief financial officer of
Micromet Parent and Micromet to that effect;
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Micromet Parent and Micromet shall have performed or complied in
all material respects with all agreements and covenants required
by the merger agreement to be performed or complied with by each
of them on or prior to the effective time of the merger, and
CancerVax shall have received a certificate of the chief
executive officer and chief financial officer of Micromet Parent
and Micromet to that effect;
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certain consents of third parties required to be obtained by
Micromet Parent shall have been obtained, and CancerVax shall
have received a certificate of the chief executive officer and
chief financial officer of Micromet Parent and Micromet to that
effect;
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any governmental authorization or other consent required to be
obtained by Micromet Parent or Micromet under any applicable
antitrust or competition law or regulation or other applicable
law shall have been obtained, and CancerVax shall have received
a certificate of the chief executive officer and chief financial
officer of Micromet Parent and Micromet to that effect;
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each person who may reasonably be deemed to be an affiliate of
Micromet Parent or Micromet for purposes of Rule 145 of the
Securities Act shall have delivered to CancerVax an executed
affiliate and market stand-off agreement;
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CancerVax shall have received certificates of good standing or
equivalent documentation of Micromet Parent and Micromet in
their respective jurisdictions or organization and the various
jurisdictions in which they are qualified, and shall have
received certified charter documents and certificates as to the
incumbency of their officers and the adoption of resolutions by
their supervisory board or board of directors;
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no legal proceeding shall be pending in which, in the reasonable
judgment of CancerVax, there is a reasonable possibility of an
outcome adverse to a party (and CancerVax shall have received a
certificate of the chief executive officer and chief financial
officer of Micromet Parent and Micromet to that effect):
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(1)
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intended to restrain or prohibit the consummation of the merger;
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(2)
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relating to the merger and seeking to obtain from any party any
damages or other relief that may be material to such party;
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(3)
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seeking to prohibit or limit in any material and adverse respect
a partys ability to exercise ownership rights with respect
to the stock of the surviving corporation;
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(4)
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that could materially and adversely affect the ability of a
party to own its assets or operate its business; or
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(5)
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seeking to compel a party to dispose of or hold separate any
material assets as a result of the merger;
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Micromet Parent and Micromet shall have consummated the Micromet
Reorganization;
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none of the clinical programs of Micromet shall be subject to
any clinical hold order by the Food and Drug Administration or
the European Medicines Agency; and
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CancerVax shall have received from Micromet Parent a form of
notice to the Internal Revenue Service in accordance with the
requirements of applicable treasury regulations.
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Additional Conditions to the Obligations of Micromet
Parent. The merger agreement contemplates that
the obligations of Micromet Parent to effect the merger and the
other transactions contemplated by the merger agreement are also
subject to the following conditions:
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the representations and warranties of CancerVax and Merger Sub
contained in the merger agreement shall be true and correct
(without giving effect to any limitation as to materiality or
material adverse effect set forth therein) at and as of the
effective time of the merger as if made at and as of such time
(except to the extent expressly made as of an earlier date, in
which case as of such earlier date), except where the failure of
such representations and warranties to be true and correct
(without giving effect to any limitation as to materiality or
material adverse effect set forth therein) would not,
individually or in the aggregate, result in a material adverse
effect, and Micromet Parent shall have received a certificate of
the chief executive officer and chief financial officer of
CancerVax to that effect;
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CancerVax and Merger Sub shall have performed or complied in all
material respects with all agreements and covenants required by
the merger agreement to be performed or complied with by each of
them on or prior to the effective time of the merger, and
Micromet Parent shall have received a certificate of the chief
executive officer or chief financial officer of CancerVax to
that effect;
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certain consents of third parties required to be obtained by
CancerVax shall have been obtained, and Micromet Parent shall
have received a certificate of the chief executive officer and
chief financial officer of CancerVax to that effect;
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Micromet Parent shall received an opinion from its tax counsel,
Cooley Godward LLP, to the effect that the merger will
constitute a reorganization within the meaning of
Section 368(a) of the Code;
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Micromet Parent shall have received certificates of good
standing of CancerVax and Merger Sub in their respective
jurisdictions or organization and the various jurisdictions in
which they are qualified, and shall
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have received certified charter documents and certificates as to
the incumbency of their officers and the adoption or resolutions
by their boards of directors and stockholders;
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Micromet Parent shall have received written resignations, dated
as of the closing date and effective as of the effective time of
the merger, of the officers and directors of CancerVax who are
not to continue as officers or directors of CancerVax;
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no legal proceeding shall be pending in which, in the reasonable
judgment of Micromet Parent, there is a reasonable possibility
of an outcome adverse to a party (and Micromet Parent shall have
received a certificate of the chief executive officer and chief
financial officer of CancerVax to that effect):
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(1)
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intended to restrain or prohibit the consummation of the merger;
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(2)
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relating to the merger and seeking to obtain from any party any
damages or other relief that may be material to such party;
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(3)
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seeking to prohibit or limit in any material and adverse respect
a partys ability to exercise ownership rights with respect
to the stock of the surviving corporation;
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(4)
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that could materially and adversely affect the ability of a
party to own its assets or operate its business; or
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(5)
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seeking to compel a party to dispose of or hold separate any
material assets as a result of the merger;
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the principal executive officer and principal financial officer
of CancerVax shall have provided all necessary certifications
required by the Exchange Act to be provided in connection with
all required filings by CancerVax with the SEC between the date
of the merger agreement and the closing date;
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the amount of CancerVaxs cash, cash equivalents,
restricted cash and securities available for sale, less certain
current obligations of CancerVax, shall be no less than
$20.5 million, measured as of the earlier of the closing
date or April 30, 2006;
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CancerVax shall have caused the board of directors of CancerVax
to be constituted as provided in Section 5.12 of the merger
agreement and caused the officers of CancerVax to be appointed
as provided in the schedules to the merger agreement;
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CancerVax shall have amended its stockholder rights plan to
exclude the transactions contemplated by the merger agreement
from having any effect on such plan; and
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CancerVax shall have repaid its loan from Silicon Valley Bank in
full and all security interests held by the bank shall have been
released, or alternatively CancerVax shall have renegotiated the
terms of its loan from Silicon Valley Bank on terms acceptable
to Micromet Parent.
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Termination
of the Merger Agreement
The merger agreement provides that, at any time prior to the
effective time of the merger, either before or after the
requisite approval of the stockholders of CancerVax or Micromet
Parent has been obtained, CancerVax and Micromet Parent can
terminate the merger agreement by mutual written consent, if
such action is duly authorized by their respective boards of
directors.
The merger agreement also provides that, at any time prior to
the effective time of the merger, either before or after the
requisite approval of the stockholders of CancerVax or Micromet
Parent has been obtained, either company can terminate the
merger agreement by action taken or authorized by the board of
directors of the terminating party or parties:
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if the merger shall not have been consummated prior to
June 30, 2006; provided, however, that the right to
terminate the merger agreement under this provision shall not be
available to any party whose breach of the merger agreement has
been the cause of, or resulted in, the failure of the effective
time to occur on or before June 30, 2006;
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if any governmental entity shall have issued an order, decree or
ruling or taken any other action permanently restraining,
enjoining or otherwise prohibiting the transactions contemplated
by the merger agreement, and
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such order, decree, ruling or other action shall have become
final and nonappealable (which order, decree, ruling or other
action the parties shall have used their commercially reasonable
best efforts to resist, resolve or lift, as applicable); or
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if CancerVax stockholder approval shall not have been obtained
at CancerVaxs annual meeting duly convened therefor (or at
any adjournment or postponement thereof).
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The merger agreement also provides that, at any time prior to
the effective time of the merger, either before or after the
requisite approval of the stockholders of CancerVax or Micromet
Parent has been obtained, CancerVax can terminate the merger
agreement by action taken or authorized by its board of
directors if it is not in material breach of its obligations
under the merger agreement and if:
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at any time that any of the representations and warranties of
Micromet Parent or Micromet in the merger agreement become
untrue or inaccurate such that Section 7.1 of the merger
agreement would not be satisfied as of the time of such breach
or as of the time such representation or warranty shall have
become inaccurate, and such inaccuracy or breach (if curable)
has not been cured within 30 days after notice to Micromet
Parent;
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there has been a breach on the part of Micromet Parent or
Micromet of any of their respective covenants or agreements
contained in the merger agreement such that Section 7.2 of
the merger agreement would not be satisfied as of the time of
such breach, and such breach (if curable) has not been cured
within 30 days after notice to Micromet Parent;
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the board of directors of Micromet Parent shall have:
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(1)
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failed to make a recommendation, in accordance with the merger
agreement, or withdrawn, or adversely modified or changed,
resolved to withdraw or adversely modify or change, its
recommendation; or
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(2)
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approved or recommended, or resolved to approve or recommend, to
its stockholders an acquisition proposal other than that
contemplated by the merger agreement or entered into, or
resolved to enter into, any agreement with respect to an
acquisition proposal;
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Micromet Parent shall have failed to obtain stockholder approval
of the merger, or to consummate the Micromet Reorganization
within seven days of the approval of the merger at the CancerVax
annual meeting;
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Micromet Parent shall have entered into a letter of intent or
similar document relating to an acquisition proposal; or
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Micromet Parent or any of its directors, officers or agents
shall have willfully and intentionally breached the restrictions
described under The Merger
Agreement Limitation on Soliciting, Discussing
or Negotiating Other Acquisition Proposals above.
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The merger agreement also provides that Micromet Parent, at any
time prior to the effective time of the merger, either before or
after the requisite approval of the stockholders of CancerVax or
Micromet Parent has been obtained, can terminate the merger
agreement by action taken or authorized by its board of
directors if it is not in material breach of its obligations
under the merger agreement and if:
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at any time that any of the representations and warranties of
CancerVax or Merger Sub in the merger agreement become untrue or
inaccurate such that Section 8.1 of the merger agreement
would not be satisfied as of the time of such breach or as of
the time such representation or warranty shall have become
inaccurate, and such inaccuracy or breach (if curable) has not
been cured within 30 days after notice to CancerVax;
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there has been a breach on the part of CancerVax or Merger Sub
of any of their respective covenants or agreements contained in
the merger agreement such that Section 8.2 of the merger
agreement would not be satisfied as of the time of such breach,
and such breach (if curable) has not been cured within
30 days after notice to CancerVax;
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the board of directors of CancerVax shall have:
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(1)
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failed to make a recommendation, in accordance with the merger
agreement, or withdrawn, or adversely modified or changed,
resolved to withdraw or adversely modify or change, its
recommendation; or
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(2)
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approved or recommended, or resolved to approve or recommend, to
its stockholders an acquisition proposal other than that
contemplated by the merger agreement or entered into, or
resolved to enter into, any agreement with respect to an
acquisition proposal;
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CancerVax shall have failed to hold a meeting of its
stockholders for purposes of approval of the issuance of shares
of CancerVax common stock in the merger within 45 days
after the registration statement on
Form S-4
of which this proxy statement/prospectus is a part is declared
effective under the Securities Act of 1933;
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CancerVax shall have entered into a letter of intent or similar
document relating to an acquisition proposal; or
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CancerVax or any of its directors, officers or agents shall have
willfully and intentionally breached the restrictions described
under The Merger Agreement Limitation on
Soliciting, Discussing or Negotiating Other Acquisition
Proposals above.
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Expenses
and Termination Fees
The merger agreement provides that all expenses incurred by the
parties to the merger agreement shall be paid by the party
incurring such expenses, except that CancerVax and Micromet
Parent will share equally all fees and expenses, other than
expenses for attorneys and accountants, incurred in relation to
the printing and filing with the SEC of the registration
statement on
Form S-4
of which this proxy statement/prospectus is a part.
The merger agreement provides that Micromet Parent shall pay
CancerVax a termination fee of $2,000,000 as liquidated damages
in the event that the merger agreement is terminated as follows:
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if CancerVax shall terminate the merger agreement because:
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(1)
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the board of directors of Micromet Parent shall have:
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failed to make a recommendation, in accordance with the merger
agreement, or withdrawn, or adversely modified or changed,
resolved to withdraw or adversely modify or change, its
recommendation; or
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approved or recommended, or resolved to approve or recommend, to
its stockholders an acquisition proposal other than that
contemplated by the merger agreement or entered into, or
resolved to enter into, any agreement with respect to an
acquisition proposal;
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(2)
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Micromet Parent shall have failed to obtain stockholder approval
of the merger, or to consummate the Micromet Reorganization
within seven days of the approval of the merger at the CancerVax
annual meeting;
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(3)
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Micromet Parent shall have entered into a letter of intent or
similar document relating to an acquisition proposal; or
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(4)
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Micromet Parent or any of its directors, officers or agents
shall have willfully and intentionally breached the restrictions
described under The Merger
Agreement Limitation on Soliciting, Discussing
or Negotiating Other Acquisition Proposals above.
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The merger agreement provides that CancerVax will pay Micromet
Parent a termination fee of $2,000,000 as liquidated damages in
the event that the merger agreement is terminated as follows:
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if either party shall have terminated the merger agreement
because CancerVax stockholder approval was not obtained at
CancerVaxs stockholder meeting duly convened therefor (or
at any adjournment or postponement thereof), and prior to the
CancerVax stockholder meeting an acquisition proposal with
respect to CancerVax is publicly announced, disclosed or
otherwise communicated to CancerVaxs board of
directors; or
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if Micromet Parent shall terminate the merger agreement because:
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(1)
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the board of directors of CancerVax shall have:
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failed to make a recommendation, in accordance with the merger
agreement, or withdrawn, or adversely modified or changed,
resolved to withdraw or adversely modify or change, its
recommendation; or
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approved or recommended, or resolved to approve or recommend, to
its stockholders an acquisition proposal other than that
contemplated by the merger agreement or entered into, or
resolved to enter into, any agreement with respect to an
acquisition proposal;
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(2)
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CancerVax shall have failed to hold a meeting of its
stockholders for purposes of approval of the issuance of shares
of CancerVax common stock in the merger within 45 days
after the registration statement on
Form S-4
of which this proxy statement/prospectus is a part is declared
effective under the Securities Act of 1933;
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(3)
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CancerVax shall have entered into a letter of intent or similar
document relating to an acquisition proposal; or
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(4)
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CancerVax or any of its directors, officers or agents shall have
willfully and intentionally breached the restrictions described
under The Merger Agreement Limitation on
Soliciting, Discussing or Negotiating Other Acquisition
Proposals above.
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Amendment
and Waiver of the Merger Agreement
The merger agreement may be amended by the parties, by action
taken or authorized by their respective boards of directors, at
any time before or after approval of the matters presented in
connection with the merger by stockholders of CancerVax,
provided that after any such approval, no amendment shall be
made that by law requires further approval by CancerVaxs
or Micromet Parents stockholders, as the case may be,
without such further approval. The merger agreement may not be
amended except by an instrument in writing signed on behalf of
CancerVax, Micromet Parent and Micromet.
On March 17, 2006 the parties amended the merger agreement.
Under the amendment to the merger agreement, the parties have
agreed to permit Micromet Parent stockholders to adopt and
approve the merger agreement by written consent, rather than
through a meeting of the stockholders as contemplated by the
original merger agreement.
At any time prior to the effective time of the merger, CancerVax
or Micromet Parent may, by written consent, waive compliance by
the other party with any of the agreements or conditions
contained in the merger agreement.
112
VOTING
AGREEMENTS
The following description of the voting agreements describes
the material terms of the voting agreements. This description of
the voting agreements is qualified in its entirety by reference
to the forms of voting agreements which are attached as
Annex B to this proxy statement/prospectus and are
incorporated herein by reference. We encourage you to read the
entire forms of voting agreements.
Voting
Agreements Relating to CancerVax Shares
The Hale Family Trust, the William R. and Joyce E. LaRue Family
Trust, Hazel M. Aker, the Donald L. Morton, M.D. Family
Trust, Forward Ventures, Vector Later-Stage Equity Fund II,
L.P., Vector Later-Stage Equity Fund II (QP), 522 Fifth
Avenue Fund LLC, JP Morgan Direct Venture Capital Private
Investors II LLC and JP Morgan Direct Venture Capital
Institutional Investors II LLC have each entered into voting
agreements with Micromet dated January 6, 2006. In the
voting agreements, each stockholder granted Micromet an
irrevocable proxy to vote his, her or its shares of CancerVax
common stock:
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in favor of the merger, the adoption and approval of the merger
agreement and the transactions contemplated by the merger
agreement;
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against any action that would result in a breach of any
representation, warranty, covenant or obligation of CancerVax in
the merger agreement;
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against any merger or business combination involving CancerVax
(other than the one contemplated by the merger
agreement); and
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against any other action which would reasonably be expected to
impede or delay the merger or any of the transactions
contemplated by the merger agreement or the voting agreement.
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Each stockholder has also agreed that, before the earlier of the
date upon which the merger agreement is validly terminated or
the date upon which the merger is consummated, they will not
sell, transfer or dispose of any shares of CancerVax common
stock or any options to purchase CancerVax common stock owned by
them, except upon their death or to certain related parties, and
only if each person to whom any shares or options are
transferred agrees to be bound by the terms of the voting
agreement. Approximately 8,354,687 shares in the aggregate
(or approximately 30% of the CancerVax common stock outstanding
on the record date) are subject to voting agreements and
irrevocable proxies. In addition, options to purchase
2,234,211 shares of CancerVax common stock are subject to
voting agreements and irrevocable proxies; however, the shares
underlying such options do not carry any voting rights unless
and until such options are exercised.
Voting
Agreements Relating to Micromet Parent and Micromet
Shares
Certain shareholders affiliated with 3i Group plc.,
Schroder Ventures International Life Sciences Fund, Abingworth
Bioventures II, Advent Private Equity Fund, DG Lux Lacuna
Apo. Biotech, Medical Biohe@lth Trends, International
Biotechnology Trust plc., and The Wellcome Trust Limited
have each entered into voting agreements with CancerVax dated
January 6, 2006. In the voting agreements, each shareholder
granted CancerVax an irrevocable proxy to vote his, her or its
shares of Micromet Parent or Micromet capital stock:
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in favor of the merger and the Micromet Reorganization, the
adoption and approval of the merger agreement and the
transactions contemplated by the merger agreement;
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in favor of any action of the shareholders of Micromet to
exercise, in connection with the merger and Micromet
Reorganization, the rights granted to the holders of the
preference shares series B new to demand from other
shareholders of Micromet the sale of such holders shares;
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against any action that would result in a breach of any
representation, warranty, covenant or obligation of Micromet
Parent or Micromet in the merger agreement;
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against any merger or business combination involving Micromet
Parent or Micromet (other than the one contemplated by the
merger agreement); and
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113
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against any other action which would reasonably be expected to
impede or delay the merger or any of the transactions
contemplated by the merger agreement or the voting agreements.
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Each Micromet shareholder who is a signatory of a voting
agreement with CancerVax has also agreed that, before the
earlier of the date upon which the merger agreement is validly
terminated or the date upon which the merger is consummated,
they will not sell, transfer or dispose of any shares of
Micromet Parent or Micromet capital stock or any options to
purchase Micromet Parent or Micromet capital stock owned by
them, except upon their death or to certain related parties, and
only if each person to whom any shares or options are
transferred agrees to be bound by the terms of the voting
agreement. Approximately 1,465,199 shares in the aggregate
(or approximately 68.5% of the preference shares series
(B new) outstanding as of March 27, 2006) are
currently subject to voting agreements and irrevocable proxies.
The Micromet Reorganization and the adoption of the merger
agreement by Micromet shareholders require the affirmative
election of the holders of 55% of the preference shares series
(B new), voting together as a single class, to exchange
such shares for shares of Micromet Parent common stock.
The merger agreement provides that Micromet will use
commercially reasonable efforts to secure signed affiliate
agreements from all persons who are, become or might be deemed
to be affiliates of Micromet or Micromet Parent, and who will
receive CancerVax common stock in connection with the merger.
These affiliate agreements provide that these persons will not
sell, transfer or otherwise dispose of their shares of CancerVax
common stock unless they do so in compliance with securities
laws governing sales by affiliates.
114
COMBINED
COMPANY MANAGEMENT AFTER THE MERGER
Upon consummation of the merger, the board of directors of the
combined company will be comprised of nine members. The
following table lists the names, ages and positions of
individuals currently designated by CancerVax and Micromet to
serve as directors and executive officers of the combined
company upon consummation of the merger. The ninth member of the
board of directors is expected to be selected by Micromet prior
to the completion of the merger. The ages of the individuals are
provided as of March 27, 2006.
Executive
Officers and Directors
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Name
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Age
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Position
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Executive Officers:
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Christian Itin, Ph.D.
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41
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President, Chief Executive Officer
and Director
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Gregor K. Mirow, M.D.,
M.B.A.
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46
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Senior Vice President of Operations
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Patrick A.
Baeuerle, Ph.D.
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48
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Senior Vice President, Chief
Scientific Officer
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Carsten
Reinhardt, M.D., Ph.D.
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39
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Senior Vice President, Clinical
Development
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William R. LaRue(1)
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54
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Senior Vice President, Chief
Financial Officer
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Other Directors:
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David F. Hale
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57
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Chairman
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Phillip M. Schneider
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50
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Director
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Michael G. Carter, M.B., Ch.B.,
F.R.C.P
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68
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Director
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Barclay A. Phillips
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43
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Director
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Jerry C. Benjamin
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65
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Director
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Otello Stampacchia, Ph.D.
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36
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Director
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John E. Berriman
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57
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Director
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(1) |
The voluntary resignation of Mr. LaRue will become
effective on June 1, 2006. Mr. LaRue has agreed to
provide consulting services to the combined company until
August 15, 2006 for compensation of $50,000.
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For more information regarding the management of the combined
company, please see Management of the Combined Company
after the Merger on page 165.
THE
CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT CANCERVAXS
STOCKHOLDERS VOTE FOR PROPOSAL NO. 1 TO
APPROVE THE ISSUANCE
OF SHARES OF CANCERVAX COMMON STOCK IN THE MERGER AND
THE
RESULTING CHANGE OF CONTROL OF CANCERVAX.
115
CANCERVAX
PROPOSAL NO. 2 APPROVAL OF AMENDMENT
TO AMENDED AND RESTATED CERTIFICATE OF INCORPORATION TO INCREASE
AUTHORIZED COMMON STOCK
At the CancerVax meeting, holders of CancerVax stock will be
asked to approve the amendment of CancerVaxs amended and
restated certificate of incorporation to increase the number of
authorized shares of CancerVax common stock to 150,000,000.
CancerVaxs amended and restated certificate of
incorporation currently authorizes 75,000,000 shares of
common stock. On March 27, 2006, 27,955,139 shares of
CancerVax common stock were outstanding.
To complete the merger, approximately 58,013,000 shares of
CancerVax common stock will be issued at the effective time.
Based on the shares of CancerVax common stock outstanding and
reserved and the shares of Micromet stock outstanding and
reserved as of March 27, 2006, assuming the approval of the
increase in the authorized shares of CancerVax common stock, and
following the closing of the merger, assuming a 1-for-2 reverse
stock split, CancerVax would have approximately
42,984,000 shares of common stock issued,
6,765,000 shares of common stock reserved for issuance
under stock incentive plans, employee stock purchase plan and
warrants, and approximately 100,251,000 shares of common
stock authorized but unissued and unreserved. Similarly,
assuming a 1-for-4 reverse stock split, CancerVax would have
approximately 21,492,000 shares of common stock issued,
3,382,000 shares of common stock reserved for issuance, and
approximately 125,126,000 shares of common stock authorized
but unissued and unreserved. The reverse stock split will not
affect the number of authorized shares of CancerVax common
stock. In the event Proposal No. 2 is approved, the number
of authorized shares of CancerVax common stock will be
150,000,000.
CancerVax currently does not have sufficient authorized shares
to complete the merger and it is a condition of the transaction
that the number of authorized shares of CancerVax common stock
be increased accordingly. At present, CancerVax has no plans to
issue shares for any other purpose. However, the CancerVax board
of directors believes it is also desirable to have additional
shares available for other corporate purposes that might arise
in the future, other than in the merger. For example, although
CancerVax currently meets its obligations to deliver shares
under employee stock options and similar arrangements with
treasury shares (meaning previously issued shares that have been
reacquired by CancerVax), it may become desirable in the future
to use newly issued shares for this purpose. Shares could also
be issued from time to time for acquisitions or to raise
capital. Under some circumstances, it is also possible for a
company to use unissued shares for antitakeover purposes, but
CancerVax has no present intention to take any such action.
Whether or not any future issuance of shares unrelated to the
merger would be submitted for stockholder vote depends upon the
nature of the issuance, legal and stock exchange requirements,
and the judgment of CancerVaxs board at the time.
Votes Required to Approve the Amendment of the Amended and
Restated Certificate of Incorporation
The affirmative vote of the holders of a majority of the issued
and outstanding shares of CancerVax common stock will be
required to approve the amendment of CancerVaxs amended
and restated certificate of incorporation.
THE
CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT CANCERVAX
STOCKHOLDERS VOTE FOR PROPOSAL NO. 2 TO
APPROVE THE INCREASE IN THE NUMBER OF AUTHORIZED SHARES OF
COMMON STOCK.
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CANCERVAX
PROPOSAL NO. 3 AUTHORIZATION OF THE
CANCERVAX
BOARD OF DIRECTORS TO EFFECT THE REVERSE STOCK SPLIT
General
At the CancerVax meeting, holders of CancerVax common stock will
be asked to approve the proposal that CancerVaxs amended
and restated certificate of incorporation be amended to effect a
reverse stock split of the issued and outstanding shares of
CancerVax common stock (such split to combine a number of
outstanding shares of CancerVax common stock between two
(2) and four (4), such number consisting of only whole
shares, into one (1) share of CancerVax common stock). If
approved by the CancerVax stockholders, the reverse stock split
would become effective upon the closing of the merger. The
CancerVax board may effect only one reverse stock split in
connection with this Proposal No. 3. The CancerVax
boards decision will be based on a number of factors,
including market conditions, existing and expected trading
prices for CancerVaxs common stock and the listing
requirements of the Nasdaq National Market. Even if the
stockholders approve the reverse stock split, CancerVax reserves
the right not to effect the reverse stock split if the CancerVax
board does not deem it to be in the best interests of CancerVax
and its stockholders to effect the reverse stock split. The
CancerVax board may determine to effect the reverse stock split,
if it is approved by the stockholders, even if the other
proposals to be acted upon at the meeting are not approved,
including the issuance of shares of CancerVax common stock in
the merger.
The form of the proposed amendment to the CancerVax amended and
restated certificate of incorporation to effect the reverse
stock split, as more fully described below, will effect the
reverse stock split but will not change the number of authorized
shares of common stock or preferred stock, or the par value of
CancerVaxs common stock or preferred stock.
Purpose
The CancerVax board approved the proposal authorizing the
reverse stock split for the following reasons:
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since the listing standards of the Nasdaq National Market will
require CancerVax to have, among other things, a $5.00 per
share minimum bid price upon the closing of the merger, the
reverse stock split may be necessary in order to consummate the
merger;
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the board of directors believes effecting the reverse stock
split may be an effective means of avoiding a delisting of
CancerVaxs common stock from the Nasdaq National Market in
the future; and
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the board of directors believes a higher stock price may help
generate investor interest in CancerVax and help CancerVax
attract and retain employees.
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If the reverse stock split successfully increases the per share
price of CancerVaxs common stock, CancerVaxs board
of directors believes this increase may increase trading volume
in CancerVaxs common stock and facilitate future
financings by CancerVax.
Nasdaq
Requirements for Listing on the Nasdaq National Market
CancerVaxs common stock is quoted on the Nasdaq National
Market under the symbol CNVX.
According to Nasdaq rules, an issuer must, in a case such as
this, apply for initial inclusion following a transaction
whereby the issuer combines with a non-Nasdaq entity, resulting
in a change of control of the issuer and potentially allowing
the non-Nasdaq entity to obtain a Nasdaq listing. Accordingly,
the listing standards of the Nasdaq National Market will require
CancerVax to have, among other things, a $5.00 per share
minimum bid price upon the closing of the merger. Therefore, the
reverse stock split may be necessary in order to consummate the
merger.
Additionally, CancerVaxs board of directors believes that
maintaining its listing on the Nasdaq National Market may
provide a broader market for CancerVaxs common stock and
facilitate the use of CancerVaxs common stock in financing
and other transactions. CancerVaxs board of directors
unanimously approved the reverse stock split partly as a means
of maintaining the share price of CancerVaxs common stock
following the merger above $5.00 per share.
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One of the effects of the reverse stock split will be to
effectively increase the proportion of authorized but unissued
shares to issued shares. This could result in the combined
companys management being able to issue more shares
without further stockholder approval. For example, if CancerVax
effects the reverse stock split using the 1:2 ratio, its
authorized but unissued shares would be 32,016,000 compared to
shares issued of 42,984,000. If CancerVax effects the reverse
stock split using the 1:4 ratio, its authorized but unissued
shares would be 53,508,000 compared to shares issued of
21,492,000. CancerVax currently has no plans to issue shares,
other than in the merger and to satisfy obligations under
CancerVaxs employee stock options from time to time as
these options are exercised. The reverse stock split will not
affect the number of authorized shares of CancerVax common
stock. In the event Proposal No. 2 is approved, the number
of authorized shares of CancerVax common stock will be
150,000,000.
Potential
Increased Investor Interest
On March 27, 2006, CancerVaxs common stock closed at
$3.00 per share. In approving the proposal authorizing the
reverse stock split, CancerVaxs board of directors
considered that CancerVaxs common stock may not appeal to
brokerage firms that are reluctant to recommend lower priced
securities to their clients. Investors may also be dissuaded
from purchasing lower priced stocks because the brokerage
commissions, as a percentage of the total transaction, tend to
be higher for such stocks. Moreover, the analysts at many
brokerage firms do not monitor the trading activity or otherwise
provide coverage of lower priced stocks. Also, the CancerVax
board believes that most investment funds are reluctant to
invest in lower priced stocks.
There are risks associated with the reverse stock split,
including that the reverse stock split may not result in an
increase in the per share price of CancerVaxs common stock.
CancerVax cannot predict whether the reverse stock split will
increase the market price for CancerVaxs common stock. The
history of similar stock split combinations for companies in
like circumstances is varied. There is no assurance that:
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the market price per share of CancerVaxs common stock
after the reverse stock split will rise in proportion to the
reduction in the number of shares of CancerVaxs common
stock outstanding before the reverse stock split;
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the reverse stock split will result in a per share price that
will attract brokers and investors who do not trade in lower
priced stocks;
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the reverse stock split will result in a per share price that
will increase CancerVaxs ability to attract and retain
employees and other service providers; or
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the market price per share will either exceed or remain in
excess of the $1.00 minimum bid price as required by Nasdaq for
continued listing, or that CancerVax will otherwise meet the
requirements of Nasdaq for inclusion for trading on the Nasdaq
National Market.
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The market price of CancerVaxs common stock will also be
based on CancerVaxs performance and other factors, some of
which are unrelated to the number of shares outstanding. If the
reverse stock split is effected and the market price of
CancerVaxs common stock declines, the percentage decline
as an absolute number and as a percentage of CancerVaxs
overall market capitalization may be greater than would occur in
the absence of a reverse stock split. Furthermore, the liquidity
of CancerVaxs common stock could be adversely affected by
the reduced number of shares that would be outstanding after the
reverse stock split.
Principal
Effects of the Reverse Stock Split
If the stockholders approve the proposal to authorize
CancerVaxs board of directors to implement the reverse
stock split and CancerVaxs board of directors implements
the reverse stock split, CancerVax will amend the
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existing provision of CancerVaxs amended and restated
certificate of incorporation relating to CancerVaxs
authorized capital to add the following paragraph at the end
thereof:
Upon the effectiveness of the certificate of amendment to
the amended and restated certificate of incorporation containing
this sentence, each
[ ] shares
of the Common Stock issued and outstanding as of the date and
time immediately preceding the effective date of a reverse stock
split, shall be automatically changed and reclassified, as of
the effective date of the split and without further action, into
one (1) fully paid and nonassessable share of Common Stock.
There shall be no fractional shares issued. A holder of record
of Common Stock on the effective date of the split who would
otherwise be entitled to a fraction of a share shall, in lieu
thereof, be entitled to receive a cash payment in an amount
equal to the fraction to which the stockholder would otherwise
be entitled multiplied by the closing price of the Common Stock,
as reported in the Wall Street Journal, on the last trading day
prior to the effective date of the split (or if such price is
not available, the average of the last bid and asked prices of
the Common Stock on such day or other price determined by the
Corporations board of directors).
The reverse stock split will be effected simultaneously for all
outstanding shares of CancerVaxs common stock and the
exchange ratio will be the same for all shares of
CancerVaxs common stock. The reverse stock split will
affect all of CancerVaxs stockholders uniformly and will
not affect any stockholders percentage ownership interests
in CancerVax, except to the extent that the reverse stock split
results in any of CancerVaxs stockholders owning a
fractional share. Common stock issued pursuant to the reverse
stock split will remain fully paid and nonassessable. The
reverse stock split will not affect CancerVaxs continuing
to be subject to the periodic reporting requirements of the
Securities Exchange Act of 1934, as amended.
Procedure
for Effecting Reverse Stock Split and Exchange of Stock
Certificates
If the certificate of amendment is approved by the CancerVax
stockholders, and if CancerVaxs board of directors still
believes that a reverse stock split is in the best interests of
CancerVax and its stockholders, the CancerVax board will
determine the ratio of the reverse stock split to be
implemented. CancerVax will file the certificate of amendment
with the Secretary of State of the State of Delaware at such
time as CancerVaxs board of directors has determined to be
the appropriate effective time for the reverse stock split.
CancerVaxs board of directors may delay effecting the
reverse stock split without resoliciting stockholder approval.
The reverse stock split will become effective on the effective
date of the split. Beginning on the effective date of the split,
each certificate representing pre-split shares will be deemed
for all corporate purposes to evidence ownership of post-split
shares.
As soon as practicable after the effective date of the split,
stockholders will be notified that the reverse stock split has
been effected. CancerVax expects that CancerVaxs transfer
agent will act as exchange agent for purposes of implementing
the exchange of stock certificates. Holders of pre-split shares
will be asked to surrender to the exchange agent certificates
representing pre-split shares in exchange for certificates
representing post-split shares in accordance with the procedures
to be set forth in a letter of transmittal to be sent by
CancerVax. No new certificates will be issued to a stockholder
until such stockholder has surrendered such stockholders
outstanding certificate(s) together with the properly completed
and executed letter of transmittal to the exchange agent. Any
pre-split shares submitted for transfer, whether pursuant to a
sale or other disposition, or otherwise, will automatically be
exchanged for post-split shares. STOCKHOLDERS SHOULD NOT DESTROY
ANY STOCK CERTIFICATE(S) AND SHOULD NOT SUBMIT ANY
CERTIFICATE(S) UNTIL REQUESTED TO DO SO.
Fractional
Shares
No fractional shares will be issued in connection with the
reverse stock split. Stockholders of record who otherwise would
be entitled to receive fractional shares because they hold a
number of pre-split shares not evenly divisible by the number of
pre-split shares for which each post-split share is to be
exchanged, will be entitled, upon surrender to the exchange
agent of certificates representing such shares, to a cash
payment in lieu thereof at a price equal to the fraction to
which the stockholder would otherwise be entitled multiplied by
the closing price of the common stock, as reported in the Wall
Street Journal, on the last trading day prior to the effective
date of the split (or if such price is not available, the
average of the last bid and asked prices of the common stock on
such day or other
119
price determined by CancerVaxs board of directors). The
ownership of a fractional interest will not give the holder
thereof any voting, dividend, or other rights except to receive
payment therefor as described herein.
Stockholders should be aware that, under the escheat laws of the
various jurisdictions where stockholders reside, where CancerVax
is domiciled, and where the funds will be deposited, sums due
for fractional interests that are not timely claimed after the
effective date of the split may be required to be paid to the
designated agent for each such jurisdiction, unless
correspondence has been received by CancerVax or the exchange
agent concerning ownership of such funds within the time
permitted in such jurisdiction. Thereafter, stockholders
otherwise entitled to receive such funds will have to seek to
obtain them directly from the state to which they were paid.
Accounting
Matters
The reverse stock split will not affect the common stock capital
account on CancerVaxs balance sheet. However, because the
par value of CancerVaxs common stock will remain unchanged
on the effective date of the split, the components that make up
the common stock capital account will change by offsetting
amounts. Depending on the size of the reverse stock split the
board of directors decides to implement, the stated capital
component will be reduced to an amount between one-half
(1/2)
and one-fourth
(1/4)
of its present amount, and the additional paid-in capital
component will be increased with the amount by which the stated
capital is reduced. The per share net income or loss and net
book value of CancerVaxs common stock will be increased
because there will be fewer shares of CancerVaxs common
stock outstanding. Prior periods per share amounts will be
restated to reflect the reverse stock split.
Potential
Anti-Takeover Effect
Although the increased proportion of unissued authorized shares
to issued shares could, under certain circumstances, have an
anti-takeover effect (for example, by permitting issuances that
would dilute the stock ownership of a person seeking to effect a
change in the composition of CancerVaxs board of directors
or contemplating a tender offer or other transaction for the
combination of CancerVax with another company), the reverse
stock split proposal is not being proposed in response to any
effort of which we are aware to accumulate shares of
CancerVaxs common stock or obtain control of CancerVax,
nor is it part of a plan by management to recommend a series of
similar amendments to CancerVaxs board of directors and
stockholders. Other than the reverse stock split proposal,
CancerVaxs board of directors does not currently
contemplate recommending the adoption of any other actions that
could be construed to affect the ability of third parties to
take over or change control of CancerVax.
No
Appraisal Rights
Under the Delaware General Corporation Law, CancerVaxs
stockholders are not entitled to appraisal rights with respect
to the reverse stock split, and CancerVax will not independently
provide stockholders with any such right.
Federal
Income Tax Consequences of the Reverse Stock Split
The following is a summary of certain material federal income
tax consequences of the reverse stock split and does not purport
to be a complete discussion of all of the possible federal
income tax consequences of the reverse stock split and is
included for general information only. Further, it does not
address any state, local or foreign income or other tax
consequences. For example, the state and local tax consequences
of the reverse stock split may vary significantly as to each
stockholder, depending upon the state in which such stockholder
resides. Also, it does not address the tax consequences to
holders that are subject to special tax rules, such as banks,
insurance companies, regulated investment companies, personal
holding companies, foreign entities, nonresident alien
individuals, broker-dealers and tax-exempt entities. The
discussion is based on the provisions of the United States
federal income tax law as of the date hereof, which is subject
to change retroactively as well as prospectively. This summary
also assumes that the pre-split shares were, and the post-split
shares will be, held as a capital asset, as defined
in the Internal Revenue Code of 1986, as amended (generally,
property held for investment). The tax treatment of a
stockholder may vary depending upon the particular facts and
circumstances of such stockholder. Each stockholder
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is urged to consult with such stockholders own tax advisor
with respect to the tax consequences of the reverse stock split.
Other than the cash payments for fractional shares discussed
below, no gain or loss should be recognized by a stockholder
upon such stockholders exchange of pre-split shares for
post-split shares pursuant to the reverse stock split. The
aggregate tax basis of the post-split shares received in the
reverse stock split, including any fraction of a post-split
share deemed to have been received, will be the same as the
stockholders aggregate tax basis in the pre-split shares
that are exchanged. In general, stockholders who receive cash
upon redemption of their fractional share interests in the
post-split shares as a result of the reverse stock split will
recognize gain or loss based on their adjusted basis in the
fractional share interests redeemed. The federal income tax
liability, if any, generated by the receipt of cash in lieu of a
fractional interest should be minimal in view of the low value
of the fractional interest. The stockholders holding
period for the post-split shares will include the period during
which the stockholder held the pre-split shares surrendered in
the reverse stock split.
CancerVaxs view regarding the tax consequence of the
reverse stock split is not binding on the Internal Revenue
Service or the courts. Accordingly, each stockholder should
consult with such stockholders own tax advisor with
respect to all of the potential tax consequences to such
stockholder of the reverse stock split.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority of all
outstanding shares of CancerVaxs common stock entitled to
vote on this proposal will be required for approval of the
certificate of amendment.
THE
CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT
CANCERVAX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 3 TO AUTHORIZE
THE CANCERVAX BOARD OF DIRECTORS TO EFFECT THE REVERSE STOCK
SPLIT.
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CANCERVAX
PROPOSAL NO. 4 APPROVAL OF NAME
CHANGE
At the CancerVax meeting, holders of CancerVax stock will be
asked to approve the amendment of CancerVaxs amended and
restated certificate of incorporation to change the name of the
corporation from CancerVax Corporation to
Micromet, Inc. upon consummation of the merger. The
primary reason for the corporate name change is that management
believes this will allow for brand recognition of
CancerVaxs and Micromets products and services
through the creation of a single brand name. CancerVaxs
management believes that the current name will no longer
accurately reflect the business of the combined company and the
mission of the combined company subsequent to the consummation
of the merger. The approval of the name change by CancerVax
stockholders is a condition to the closing of the merger.
CancerVaxs management believes that a rebranding will
permit CancerVax to unify the names of the two companies,
CancerVax and Micromet, and decrease brand confusion in favor of
one recognized name. Insofar as the proposed new corporate name
will only reflect Micromets business following the merger,
the proposed name change and the amendment of CancerVaxs
amended and restated certificate of incorporation, even if
approved by the stockholders at the annual meeting, will only be
filed with the office of the Secretary of State of the State of
Delaware and, therefore, become effective if the merger is
consummated.
The affirmative vote of the holders of a majority of the
outstanding shares of CancerVax common stock entitled to vote is
necessary for the approval of the proposal to change the name of
CancerVax from CancerVax Corporation to
Micromet, Inc.
THE
CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT CANCERVAX
STOCKHOLDERS VOTE FOR PROPOSAL NO. 4 TO
APPROVE THE NAME CHANGE.
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CANCERVAX
PROPOSAL NO. 5 ELECTION OF CANCERVAX
DIRECTORS
CancerVaxs board of directors currently consists of nine
members. Our amended and restated certificate of incorporation
provides for the classification of our board of directors into
three classes, as nearly equal in number as possible, with
staggered terms of office and provides that upon the expiration
of the term of office for a class of directors, nominees for
such class shall be elected for a term of three years or until
their successors are duly elected and qualified. At the annual
meeting, three nominees for director are to be elected as
Class III directors. The nominees are David F. Hale, Donald
L. Morton, M.D. and Michael G. Carter, M.B., Ch.B.,
F.R.C.P. who are each members of our present board of directors.
The Class I and Class II directors have one year and
two years, respectively, remaining on their terms of office.
Please note that if the merger is completed, the board of
directors of the combined company will consist of
Messrs. Hale, Phillips, Schneider and Carter, each of whom
is currently a director of CancerVax; Messrs. Benjamin,
Stampacchia and Berriman, each of whom is currently a director
of Micromet; Mr. Itin, who is currently the chief executive
officer of Micromet; and one additional member to be appointed
by Micromet. A vote FOR the issuance of shares of CancerVax
common stock in the merger, and the resulting change of control
of CancerVax, is a vote to elect the directors for the terms
described above. For more information about these individuals
and the classification of our directors upon the consummation of
the merger, see Management of the Combined Company after
the Merger.
A plurality of the votes of the shares present in person or
represented by proxy at the annual meeting and entitled to vote
on the election of directors is required to elect directors. If
no contrary indication is made, proxies in the accompanying form
are to be voted for our board of directors nominees or, in
the event any of such nominees is not a candidate or is unable
to serve as a director at the time of the election (which
is not currently expected), for any nominee who shall be
designated by our board of directors to fill such vacancy.
Information
Regarding Directors
The information set forth below as to the nominees for director
has been furnished to us by the nominees:
Nominees
for Election to the Board of Directors
For a Three-Year Term Expiring at the
2009 Annual Meeting of Stockholders
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Name
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Age
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Present Position with
CancerVax
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David F. Hale
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57
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President, Chief Executive
Officer
and Director
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Donald L. Morton, M.D.
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71
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Director
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Michael G. Carter, M.B., Ch.B.,
F.R.C.P.
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68
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Director
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David F. Hale has served as President and Chief Executive
Officer of CancerVax since October 2000 and as a member of our
board of directors since December 2000. Upon consummation of the
merger, Mr. Hale will become Chairman of the board of
directors of the combined company. Beginning in June 2000,
Mr. Hale consulted with Dr. Morton on the transfer of
the rights to Canvaxin to us, our initial financing and the
commencement of our operations. From January 1998 to May 2000,
Mr. Hale served as President and Chief Executive Officer of
Women First HealthCare, Inc., a publicly-traded specialty
pharmaceuticals company. Prior to joining Women First
HealthCare, Mr. Hale served from May 1987 to November 1997
as Chairman, President and Chief Executive Officer of Gensia,
Inc., a publicly-held biopharmaceutical company, which merged
with Sicor, Inc., to form GensiaSicor, Inc., and which was
acquired by Teva Pharmaceutical Industries Limited. He also
served from February 1987 to September 1995 as Chairman of
Viagene, Inc., a publicly held biotechnology company that was
acquired by Chiron, Inc. Mr. Hale served from April 1982 to
May 1987 in several positions with Hybritech, Inc., a
publicly-traded biotechnology company that was acquired by Eli
Lilly and Co., including Senior Vice President of Marketing and
Business Development, President and Chief Operating Officer and
ultimately President and Chief Executive Officer. Prior to
joining Hybritech, Mr. Hale served from January 1980 to
April 1982 as Vice President, Sales and Marketing and then as
Vice President and General Manager with BBL Microbiology
Systems, a division of Becton,
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Dickinson & Co. From March 1971 to December 1980,
Mr. Hale held various marketing and sales management
positions with Ortho Pharmaceutical Corporation, a division of
Johnson & Johnson, Inc. Mr. Hale currently serves
as Chairman of the board of directors of Santarus, Inc. and
Somaxon Pharmaceuticals, Inc., publicly-traded specialty
pharmaceutical companies, as a director of Metabasis
Therapeutics, Inc., a publicly-traded biotechnology company, and
as a director of several privately-held biotechnology companies,
including SkinMedica, Inc. and Verus Pharmaceuticals, Inc.
Mr. Hale is also a director of the Biotechnology Industry
Organization, BIOCOM, the California Healthcare Institute and is
a co-founder and director of CONNECT. Mr. Hale received a
B.A. in biology and chemistry from Jacksonville State University.
Donald L. Morton, M.D. is our founder and has served
as a member of our board of directors since our inception in
1998. From 1991 to the present, Dr. Morton has served as
President, Medical Director,
Surgeon-in-Chief
and a member of the board of directors of the John Wayne Cancer
Institute. From 1971 to 1991, Dr. Morton served as a
professor and Chief of the Division of Surgical Oncology at the
University of California, Los Angeles School of Medicine,
and currently holds the post of Professor of Surgery Emeritus.
From 1969 to 1971, Dr. Morton served as Senior Surgeon and
head of the Tumor Immunology Section at the National Cancer
Institute. From 1960 to 1972, Dr. Morton held various
clinical and research positions at the National Cancer Institute
of the National Institutes of Health. Dr. Morton is a past
president of the World Federation of Surgical Oncology Societies
and the Society of Surgical Oncology, the largest society of
surgeons dedicated to oncology, and was the recipient of M.D.
Andersons Jeffrey A. Gottleib Memorial Award in 1995 for
cancer therapeutic research. He received the Society of Surgical
Oncologys Heritage Award in 2003. He is currently
President of the International Sentinel Node Society.
Dr. Morton has authored more than 600 papers in
peer-reviewed professional journals and has received NIH
peer-reviewed research funding for over 30 years. According
to the journal Science, June 15, 2001, he received
the most NIH peer-reviewed grant awards among clinical
investigations in 2000. Dr. Morton received a B.A. in
medical sciences (with highest honors) from the University of
California, Berkeley and M.D. (with highest honors) from the
University of California, San Francisco, where he was a
fellow in the Cancer Research Institute and completed residency
training in general and thoracic surgery.
Michael G. Carter, M.B., Ch.B., F.R.C.P. (Edinburgh) has
served as a member of CancerVaxs board of directors since
February 2001. Dr. Carter is a venture partner at S.V. Life
Sciences Advisers LLP. Dr. Carter retired from Zeneca, PLC,
a publicly-traded global pharmaceutical company, in 1998.
Dr. Carter served Zeneca as International Medical Director
from 1986 to 1989 and as International Marketing Director from
1990 to 1995. From 1985 to 1995, Dr. Carter served as a
member of the U.K. Governments Medicines Commission. From
1976 to 1984, Dr. Carter held several positions with Roche
Products, Ltd, including head of Medical Development and Medical
Affairs and Director of the Pharmaceutical Division.
Dr. Carter currently serves as a Director of several
European biopharmaceutical companies, including Micromet AG and
Fulcrum Pharmaceuticals PLC, as Chairman of the board of
directors of Metris Therapeutics, Ltd., and as a member of the
board of directors of Santarus, Inc. Dr. Carter is an
Elected Fellow of the Royal Pharmaceutical Society, Faculty of
Pharmaceutical Medicine, and of the Royal College of Physicians
of Edinburgh. Dr. Carter received a bachelors degree
in Pharmacy from London University (U.K.) and a medical degree
from Sheffield University Medical School (U.K.).
Term
Expiring at the
2007 Annual Meeting of Stockholders
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Name
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Age
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Present Position with
CancerVax
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James Clayburn
La Force, Jr., Ph.D.
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77
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Director
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Barclay A. Phillips
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43
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Director
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Gail S.
Schoettler, Ph.D.
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62
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Director
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James Clayburn La Force, Jr., Ph.D. has
served as a member of our board of directors since February
2001. From 1993 to the present, Dr. La Force has
served as Dean Emeritus of the University of California, Los
Angeles Anderson School of Management. From 1978 to 1993,
Dr. La Force was dean of the UCLA Anderson School of
Management. From 1991 to 1993, Dr. La Force served as
acting dean of the Hong Kong University of Science and
Technology. From 1962 to 1978, Dr. La Force served as
a professor at UCLA and served as Chairman of the Department of
Economics from 1969 to 1978. Dr. La Force is currently
a Director of Payden and Rygel Investment Trust, Metzler Payden
Funds, Advisors Series Trust and Arena Pharmaceuticals. He
is also a board member of the
124
Foundation for Research in Economics and Education, the Pacific
Academy for Advanced Studies and the Foundation Francisco
Marroquin. He was Chairman of President Reagans Task Force
on Food Assistance from 1983 to 1984, a member of the National
Council on the Humanities from 1981 to 1988 and member and
chairman of the State of California Workers Compensation
Advisory Committee from 1974 to 1975. Dr. La Force
received an A.B. in economics from San Diego State
University and an M.A. and Ph.D. in economics from the
University of California, Los Angeles.
Barclay A. Phillips has served as a member of
CancerVaxs board of directors since December 2000. From
1999 to the present, Mr. Phillips has been a Managing
Director of Vector Fund Management. Mr. Phillips has
investment management responsibility for Vector Later-Stage
Equity Fund, L.P. and Vector Later-Stage Equity Fund II,
L.P. From 1991 to 1999, Mr. Phillips served in various
roles including Director of Private Placements and Biotechnology
Analyst for INVESCO Funds Group, Inc. From 1985 to 1990,
Mr. Phillips held positions in sales and trading with Paine
Webber, Inc. and Shearson Lehman Hutton, Inc. Over the last ten
years, Mr. Phillips has held board positions for a number
of private companies and currently serves as a director of
Acorda Therapeutics, Inc. Mr. Phillips received a B.A. in
economics from the University of Colorado in Boulder.
Gail S. Schoettler, Ph.D. has served as a member of
our board of directors since April 2002. From 1999 to 2001,
Dr. Schoettler served as the United States Ambassador to
the World Radiocommunication Conference, where she was
responsible for negotiating a key telecommunications treaty, and
as head of the United States Department of Defenses
presidential transition for global communications, security and
intelligence. From 1995 to 1999, Dr. Schoettler was Lt.
Governor of Colorado and from 1987 to 1995 was State Treasurer
of Colorado. She has started several banks and helps manage her
familys cattle ranch, vineyard and real estate interests.
She is Chair of the Board of Fischer Imaging Corp. and a
director of Aspen Bio, Inc., Masergy Communications and A4S
Technologies, Inc., and served as a director of Air Gate PCS
until its sale in 2005. Dr. Schoettler received a B.A. in
economics from Stanford University and M.A. and Ph.D. degrees in
history from the University of California, Santa Barbara.
Term
Expiring at the
2008 Annual Meeting of Stockholders
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Name
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Age
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Present Position with
CancerVax
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Ivor Royston, M.D.
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61
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Chairman of the Board
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Robert E. Kiss, CFA
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48
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Director
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Phillip M. Schneider
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50
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Director
|
Ivor Royston, M.D. has served as our Chairman of the
Board since December 2000. Since 1990, Dr. Royston has
served as a partner at Forward Ventures, a firm he co-founded,
and is currently Managing Member of that firm. From 1990 to
2000, Dr. Royston served as President and CEO of the
non-profit Sidney Kimmel Cancer Center where he remains a member
of the Board of Trustees. From 1978 to 1990, he was on the
faculty of the medical school and cancer center at the
University of California, San Diego. In 1978,
Dr. Royston helped to found Hybritech, Inc., and in 1986 he
helped found IDEC Corporation. Dr. Royston has been
involved as a founding director of Genesys Therapeutics, which
was acquired by Cell Genesys, Inc.; GenQuest, which was acquired
by Corixa Corporation; CombiChem, which was acquired by DuPont
Pharmaceuticals Company; Sequana Therapeutics, which was
acquired by Celera Genomics Group; Genstar Therapeutics, which
is now known as Corautus Genetics; Triangle Pharmaceuticals,
which was acquired by Gilead; Applied Molecular Evolution, which
was acquired by Eli Lilly; and Variagenics, which is now known
as Nuvelo. Dr. Royston is the founding Chairman of
Targegen, and was elected Chairman of Morphotek.
Dr. Royston also serves on the board of directors of Avalon
Pharmaceuticals, Corautus Genetics and Favrille, Inc., where he
was the founding Chairman. Dr. Royston has authored over
100 scientific publications and is a nationally-recognized
physician-scientist in the area of cancer immunology.
Dr. Royston received a B.A. in human biology and an M.D.
from Johns Hopkins University and completed postdoctoral
training in internal medicine and medical oncology at Stanford
University.
Robert E. Kiss, CFA has served as a member of our board
of directors since March 2002. From 2000 to the present,
Mr. Kiss has served as a Managing Director and Portfolio
Manager of the Private Equity Group of J.P. Morgan
Investment Management Inc. From 1996 to 2000, Mr. Kiss
served as an Investment Officer with
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J.P. Morgan Capital Corporation where he was responsible
for private equity investments in a number of industries,
including health care. From 1985 to 1996, Mr. Kiss held a
variety of positions in corporate finance and mergers &
acquisitions with J.P. Morgan. Mr. Kiss received a
B.S. in civil engineering from Lehigh University.
Phillip M. Schneider has served as a member of
CancerVaxs board of directors since September 2003.
Mr. Schneider is the former Chief Financial Officer of IDEC
Pharmaceuticals Corporation. During his
15-year
tenure at IDEC, which ended in October 2002, he served as Senior
Vice President and Chief Financial Officer and played an
integral role in the companys growth. Prior to his
association with IDEC, Mr. Schneider held various
management positions at Syntex Pharmaceuticals Corporation and
was previously with KPMG, LLP. Mr. Schneider has served as
a director and chair of the audit committee of Gen-Probe
Incorporated since November 2002 and serves as a member of the
board of directors and chair of the audit committee for
Targegen, Inc., a privately held biotechnology company.
Mr. Schneider holds an M.B.A. from the University of
Southern California and a B.S. in biochemistry from the
University of California at Davis.
Board
Meetings
Our board of directors held four regularly scheduled meetings,
12 special meetings and two special telephonic meetings during
2005. No director who served as a director during the past year
attended fewer than 75% of the aggregate of the total number of
meetings of our board of directors and the total number of
meetings of committees of our board of directors on which he or
she served.
Committees
of the Board
Compensation Committee. The compensation
committee consists of Drs. Royston, Carter and
La Force. The compensation committee held seven meetings,
including telephonic meetings, during 2005. All members of the
compensation committee are independent directors, as defined in
the Nasdaq Stock Market qualification standards. The
compensation committee is governed by a written charter approved
by our board of directors. The functions of this committee
include:
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reviewing and, as it deems appropriate, recommending to our
board of directors, policies, practices and procedures relating
to the compensation of our directors, officers and other
managerial employees and the establishment and administration of
our employee benefit plans;
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exercising authority under our employee benefit plans;
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reviewing and approving executive officer and director
indemnification and insurance matters; and
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advising and consulting with our officers regarding compensation
matters related to managerial personnel.
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Audit Committee. The audit committee consists
of Messrs. Schneider and Phillips and
Dr. La Force. The audit committee held
five meetings, including telephonic meetings, during 2005.
All members of the audit committee are independent directors, as
defined in the Nasdaq Stock Market qualification standards.
Mr. Schneider qualifies as an audit committee
financial expert as that term is defined in the rules and
regulations established by the Securities and Exchange
Commission. The audit committee is governed by a written charter
approved by our board of directors. The functions of this
committee include:
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meeting with our management periodically to consider the
adequacy of our internal controls and the objectivity of our
financial reporting;
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meeting with our independent registered public accounting firm
and with internal financial personnel regarding these matters;
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pre-approving audit and non-audit services to be rendered by our
independent registered public accounting firm;
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recommending to our board of directors the engagement of our
independent registered public accounting firm and oversight of
the work of our independent auditors;
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reviewing our financial statements and periodic reports and
discussing the statements and reports with our management,
including any significant adjustments, management judgments and
estimates, new accounting policies and disagreements with
management;
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establishing procedures for the receipt, retention and treatment
of complaints received by us regarding accounting, internal
accounting controls and auditing matters;
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reviewing our financing plans and reporting recommendations to
our full board of directors for approval and to authorize
action; and
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administering and discussing with management and our independent
registered public accounting firm our code of ethics.
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Both our independent registered public accounting firm and
internal financial personnel regularly meet privately with the
audit committee and have unrestricted access to this committee.
Nominating/Corporate Governance Committee. The
nominating/corporate governance committee is comprised of
Messrs. Phillips and Kiss and Dr. Schoettler. The
nominating/corporate governance committee held four meetings,
including telephonic meetings, during 2005. All members of the
nominating/corporate governance committee are independent
directors, as defined in the Nasdaq Stock Market qualification
standards. The nominating/corporate governance committee is
governed by a written charter approved by our board of
directors. The functions of this committee include:
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identifying qualified candidates to become members of our board
of directors;
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selecting nominees for election of directors at the next annual
meeting of stockholders (or special meeting of stockholders at
which directors are to be elected);
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selecting candidates to fill vacancies of our board of directors;
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developing and recommending to our board of directors our
corporate governance guidelines; and
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overseeing the evaluation of our board of directors.
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Director
Nomination Process
Director
Qualifications
In evaluating director nominees, the nominating/corporate
governance committee considers, among others, the following
factors:
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the appropriate size of our board of directors;
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personal and professional integrity, ethics and values;
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experience in corporate management, such as serving as an
officer or former officer of a publicly held company;
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experience in our industry;
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experience as a board member of another publicly held
company; and
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experience with relevant social concerns.
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The nominating/corporate governance committees goal is to
assemble a board of directors that brings to our company a
variety of perspectives and skills derived from high quality
business and professional experience. In doing so the
nominating/corporate governance committee also considers
candidates with appropriate non-business backgrounds.
Other than the foregoing, there are no stated minimum criteria
for director nominees, although the nominating/corporate
governance committee may also consider such other facts as it
may deem are in the best interests of our company and our
stockholders. The nominating/corporate governance committee
does, however, believe it appropriate for at least one, and,
preferably, several, members of our board of directors to meet
the criteria for
127
an audit committee financial expert as defined by
Securities and Exchange Commission rules, and that a majority of
the members of our board of directors meet the definition of
independent director under the Nasdaq Stock Market
qualification standards. The nominating/corporate governance
committee also believes it appropriate for certain key members
of our management to participate as members of our board of
directors.
Identification
and Evaluation of Nominees for Directors
The nominating/corporate governance committee identifies
nominees for director by first evaluating the current members of
our board of directors willing to continue in service. Current
members with qualifications and skills that are consistent with
the nominating/corporate governance committees criteria
for board of directors service and who are willing to continue
in service are considered for re-nomination, balancing the value
of continuity of service by existing members of our board of
directors with that of obtaining a new perspective. If any
member of our board of directors does not wish to continue in
service or if our board of directors decides not to re-nominate
a member for re-election, the nominating/corporate governance
committee identifies the desired skills and experience of a new
nominee in light of the criteria above. The nominating/corporate
governance committee generally polls our board of directors and
members of management for their recommendations. The
nominating/corporate governance committee may also review the
composition and qualification of the boards of directors of our
competitors, and may seek input from industry experts or
analysts. The nominating/corporate governance committee reviews
the qualifications, experience and background of the candidates.
Final candidates are interviewed by our independent directors
and executive management. In making its determinations, the
nominating/corporate governance committee evaluates each
individual in the context of our board of directors as a whole,
with the objective of assembling a group that can best
perpetuate the success of our company and represent stockholder
interests through the exercise of sound judgment. After review
and deliberation of all feedback and data, the
nominating/corporate governance committee makes its
recommendation to our board of directors. Historically, the
nominating/corporate governance committee has not relied on
third-party search firms to identify board of directors
candidates. The nominating/corporate governance committee may in
the future choose to do so in those situations where particular
qualifications are required or where existing contacts are not
sufficient to identify an appropriate candidate.
We have not received director candidate recommendations from our
stockholders and do not have a formal policy regarding
consideration of such recommendations. However, any
recommendations received from stockholders will be evaluated in
the same manner that potential nominees suggested by board
members, management or other parties are evaluated. Stockholders
wishing to suggest a candidate for director should write to our
companys corporate secretary. In order to be considered,
the recommendation for a candidate must include the following
written information: (i) the stockholders name and
contact information; (ii) a statement that the writer is a
stockholder and is proposing a candidate for consideration by
the nominating/corporate governance committee; (iii) the
name of and contact information for the candidate and a
statement that the candidate is willing to be considered and
serve as a director, if nominated and elected; (iv) a
statement of the candidates business and educational
experience; (v) information regarding each of the factors
listed above, other than that regarding board of directors size
and composition, sufficient to enable the nominating/corporate
governance committee to evaluate the candidate; (vi) a
statement of the value that the candidate would add to our board
of directors; (vii) a statement detailing any relationship
between the candidate and any customer, supplier or competitor
of our company; (viii) detailed information about any
relationship or understanding between the proposing stockholder
and candidate; and (ix) a list of three character
references, including complete contact information for such
references.
Communications
with our Board of Directors
Our stockholders may send correspondence to our board of
directors
c/o Corporate
Secretary at CancerVax Corporation, 2110 Rutherford Road,
Carlsbad, California 92008. Our corporate secretary will review
all correspondence addressed to our board of directors, or any
individual director, for any inappropriate correspondence and
correspondence more suitably directed to management. Our
corporate secretary will forward appropriate stockholder
communications to our board of directors prior to the next
regularly scheduled meeting of our board of directors following
the receipt of the communication. Our corporate secretary will
summarize all correspondence
128
not forwarded to our board of directors and make the
correspondence available to our board of directors for its
review at our board of directors request.
Code of
Ethics
Our company has established a code of ethics that applies to our
officers, directors and employees. The code of ethics contains
general guidelines for conducting the business of our company
consistent with the highest standards of business ethics, and is
intended to qualify as a code of ethics within the
meaning of Section 406 of the Sarbanes-Oxley Act of 2002
and Item 406 of
Regulation S-K.
Corporate
Governance Documents
Our companys corporate governance documents, including the
audit committee charter, compensation committee charter,
nominating/corporate governance committee charter, code of
ethics and corporate governance guidelines, are available, free
of charge, on our website at www.cancervax.com. Please
note, however, that the information contained on the website is
not incorporated by reference in, or considered part of, this
proxy statement/prospectus. We will also provide copies of these
documents, free of charge, to any stockholder upon written
request to Investor Relations, CancerVax Corporation, 2110
Rutherford Road, Carlsbad, California 92008.
Report of
the Audit Committee
The following is the report of the audit committee with respect
to CancerVaxs audited financial statements for the year
ended December 31, 2005.
The purpose of the audit committee is to assist the board of
directors in its general oversight of CancerVaxs financial
reporting, internal controls and audit functions. In fulfilling
its oversight responsibilities, the audit committee reviewed the
audited financial statements in CancerVaxs Annual Report
on
Form 10-K
with management, including a discussion of the quality, not just
the acceptability, of the accounting principles, the
reasonableness of significant judgments, and the clarity of
disclosures in the financial statements. The audit committee is
comprised solely of independent directors as defined in the
Nasdaq Stock Market qualification standards.
The audit committee has reviewed and discussed the consolidated
financial statements with management and Ernst & Young
LLP, CancerVaxs independent registered public accounting
firm. Management is responsible for the preparation,
presentation and integrity of the financial statements;
accounting and financial reporting principles; establishing and
maintaining disclosure controls and procedures (as defined in
Exchange Act
Rule 13a-15(e));
establishing and maintaining internal control over financial
reporting (as defined in Exchange Act
Rule 13a-15(f));
evaluating the effectiveness of disclosure controls and
procedures; evaluating the effectiveness of internal control
over financial reporting; and evaluating any change in internal
control over financial reporting that has materially affected,
or is reasonably likely to materially affect, internal control
over financial reporting. Ernst & Young LLP is
responsible for performing an independent audit of the
consolidated financial statements and expressing an opinion on
the conformity of those financial statements with accounting
principles generally accepted in the United States of America,
as well as expressing an opinion on (i) managements
assessment of the effectiveness of internal control over
financial reporting and (ii) the effectiveness of internal
control over financial reporting.
During 2005, the committee periodically reviewed the results of
managements ongoing assessment of the effectiveness of
CancerVaxs internal control over financial reporting, in
response to the requirements set forth in Section 404 of
the Sarbanes-Oxley Act of 2002 and related regulations. The
audit committee was kept apprised of the progress of the
evaluation and provided oversight and advice to management
during the process. In connection with this oversight, the
committee received periodic updates provided by management and
Ernst & Young LLP at committee meetings. The committee
also reviewed managements report on the effectiveness of
internal control over financial reporting contained in
CancerVaxs Annual Report on
Form 10-K
for the year ended December 31, 2005, filed with the
Securities and Exchange Commission, as well as Ernst &
Young LLPs Report included in CancerVaxs Annual
Report on
Form 10-K
related to its audit of the consolidated financial statements,
managements assessment of the effectiveness of internal
control over financial reporting and the effectiveness of
internal control over financial reporting.
129
The audit committee has discussed with Ernst & Young
LLP the matters required to be discussed by Statement on
Auditing Standards No. 61, as amended, Communication
with Audit Committees and Public Company Accounting
Oversight Board Auditing Standard No. 2, An Audit of
Internal Control Over Financial Reporting Performed in
Conjunction with an Audit of Financial Statements,
including discussions with Ernst & Young LLP, with and
without management present, regarding the overall scope of their
audit, the results of their examination and their evaluation of
CancerVaxs internal controls, their judgments as to the
quality, not just the acceptability, of CancerVaxs
accounting policies and the overall quality of CancerVaxs
financial reporting. In addition, Ernst & Young LLP has
provided the audit committee with the written disclosures and
letter required by Independence Standards Board Standard
No. 1, as amended, Independence Discussions with
Audit Committees, and the audit committee has discussed
with Ernst & Young LLP their independence from
management.
In reliance on the reviews and discussions referred to above,
the audit committee recommended to our board of directors that
the audited financial statements be included in CancerVaxs
Annual Report on
Form 10-K
for the year ended December 31, 2005 for filing with the
Securities and Exchange Commission. The audit committee and our
board of directors also have recommended, subject to stockholder
approval, the ratification of the selection of Ernst &
Young LLP as CancerVaxs independent registered public
accounting firm for the fiscal year ending December 31,
2006.
This report of the audit committee shall not be deemed
incorporated by reference by any general statement incorporating
by reference this proxy statement/prospectus into any filing
under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, except to the extent that we
specifically incorporate this information by reference, and
shall not otherwise be deemed filed under such acts.
The foregoing report has been furnished by the audit committee.
Phillip M. Schneider
James Clayburn La Force, Jr., Ph.D.
Barclay A. Phillips
Compensation
of Directors
Our directors receive an annual fee of $16,000 for service as a
director. In addition, our directors receive $1,500 for each
regularly scheduled board meeting and $750 for each regularly
scheduled committee meeting. We reimburse our directors for
their reasonable expenses incurred in attending meetings of our
board of directors. Our directors may participate in our stock
incentive plans and employee-directors may participate in our
employee stock purchase plan. Any independent director who is
elected to our board of directors is granted an option to
purchase 25,000 shares of our common stock on the date of
his or her initial election to our board of directors. In
addition, each independent director is granted an option to
purchase 10,000 shares of common stock on the date of each
annual meeting of stockholders at an exercise price per share
equal to the fair market value of our common stock on such date.
The chairman of our audit committee receives an additional
annual option to purchase 5,000 shares of common stock and
the chairman of each of our compensation committee and our
nominating/corporate governance committee receives an additional
annual option to purchase 2,500 shares of our common stock.
Director
Attendance at Annual Meetings
Although our company does not have a formal policy regarding
attendance by members of our board of directors at our annual
meeting, we encourage all of our directors to attend. At the
time of our 2005 annual meeting of stockholders our board
consisted of ten directors, all of whom attended the 2005 annual
meeting.
THE
CANCERVAX BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS A VOTE
FOR
PROPOSAL NO. 5 TO ELECT EACH NOMINEE LISTED
ABOVE.
130
CANCERVAX
PROPOSAL NO. 6 RATIFICATION OF
SELECTION OF CANCERVAXS
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
CancerVaxs board of directors and audit committee have
selected Ernst & Young LLP as our independent
registered public accounting firm for the fiscal year ending
December 31, 2006 and have directed that management submit
the selection of the independent registered public accounting
firm to the stockholders for ratification at the annual meeting.
Ernst & Young LLP has audited our financial statements
since June 1998, our date of inception, and through the year
ending December 31, 2005. Representatives of
Ernst & Young LLP will be present at the annual
meeting, will have an opportunity to make a statement if they so
desire and will be available to respond to appropriate questions.
Stockholders are not required to ratify the selection of
Ernst & Young LLP as our independent registered public
accounting firm. However, CancerVax is submitting the selection
of Ernst & Young LLP to the stockholders for
ratification as a matter of good corporate practice. If you fail
to ratify the selection, our board of directors and the audit
committee will reconsider whether or not to retain
Ernst & Young LLP. Even if the selection is ratified,
our board of directors and the audit committee in their
discretion may direct the appointment of a different independent
registered public accounting firm at any time during the year if
they determine that such a change would be in the best interests
of CancerVax and its stockholders.
Independent
Registered Public Accounting Firm Fee Information
The following table sets forth the aggregate fees billed to us
by our independent registered public accounting firm,
Ernst & Young LLP, for 2005 and 2004:
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Years Ended
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December 31,
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2005
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2004
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(In thousands)
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Audit Fees(1)
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$
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244
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$
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290
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Audit-Related Fees(2)
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50
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Tax Fees(3)
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110
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77
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All Other Fees
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Total Fees
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$
|
404
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$
|
367
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(1) |
Includes fees for the audits of CancerVaxs annual
financial statements for 2005 and 2004 included in its annual
reports on
Form 10-K,
the audits of managements assessment of the effectiveness
of internal control over financial reporting, the reviews of
CancerVaxs interim period financial statements for 2005
and 2004 included in its quarterly reports on
Form 10-Q
and related services that are normally provided in connection
with regulatory filings or engagements.
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(2) |
Represents fees for due diligence related to the proposed merger
with Micromet.
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(3) |
Consists of fees for tax compliance services of approximately
$49,000 and $16,000 in 2005 and 2004, respectively, and fees for
tax advice and tax planning services of approximately $61,000
and $61,000 in 2005 and 2004, respectively.
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131
Audit
Committee Policy Regarding Pre-Approval of Audit and Permissible
Non-Audit Services of Our Independent Registered Public
Accounting Firm
Our audit committee has established a policy that generally
requires that all audit and permissible non-audit services
provided by our independent registered public accounting firm
will be pre-approved by the audit committee. The audit committee
has delegated pre-approval authority to its chairman when
expedition of services is necessary. These services may include
audit services, audit-related services, tax services and other
services. The audit committee considers whether the provision of
each non-audit service is compatible with maintaining the
independence of our registered public accounting firm.
Pre-approval is detailed as to the particular service or
category of services and is generally subject to a specific
budget. Our independent registered public accounting firm and
management are required to periodically report to the audit
committee regarding the extent of services provided by the
independent registered public accounting firm in accordance with
this pre-approval, and the fees for the services performed to
date.
THE
CANCERVAX BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT
CANCERVAXS STOCKHOLDERS VOTE FOR
PROPOSAL NO. 6 TO RATIFY THE
SELECTION OF ERNST & YOUNG LLP AS OUR INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM FOR THE FISCAL YEAR ENDING
DECEMBER 31, 2006.
132
CANCERVAX
PROPOSAL NO. 7 APPROVAL OF POSSIBLE
ADJOURNMENT
OF THE ANNUAL MEETING
If CancerVax fails to receive a sufficient number of votes to
approve Proposal Nos. 1 through 6, CancerVax may
propose to adjourn the annual meeting, if a quorum is present,
for a period of not more than 30 days for the purpose of
soliciting additional proxies to approve Proposal Nos. 1
through 6. CancerVax currently does not intend to propose
adjournment at the annual meeting if there are sufficient votes
to approve Proposal Nos. 1 through 6. If approval of the
proposal to adjourn the CancerVax annual meeting for the purpose
of soliciting additional proxies is submitted to stockholders
for approval, such approval requires the affirmative vote of the
holders of a majority of the votes cast in person or by proxy at
the CancerVax annual meeting.
THE
CANCERVAX BOARD OF DIRECTORS RECOMMENDS THAT
CANCERVAXS STOCKHOLDERS VOTE FOR
PROPOSAL NO. 7 TO ADJOURN
THE ANNUAL MEETING, IF NECESSARY, IF A QUORUM IS PRESENT, TO
SOLICIT
ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR
OF
PROPOSAL NOS. 1 THROUGH 6.
133
CANCERVAX
SECURITY OWNERSHIP BY CERTAIN BENEFICIAL OWNERS
Except where specifically noted, the following information
and all other information contained in this proxy
statement/prospectus does not give effect to the proposed
reverse stock split described in CancerVaxs
Proposal No. 3.
The following table sets forth information as of March 27,
2006 regarding the beneficial ownership of CancerVax common
stock by (a) each person known to CancerVaxs board of
directors to own beneficially 5% or more of CancerVax common
stock, (b) each director of CancerVax, (c) the
CancerVax Named Executive Officers (as defined below), and
(d) all of CancerVaxs current directors and executive
officers as a group. Information with respect to beneficial
ownership has been furnished by each director, officer or 5% or
more stockholder, as the case may be. The address for all
executive officers and directors is
c/o CancerVax
Corporation, 2110 Rutherford Road, Carlsbad, California 92008.
Percentage of beneficial ownership is calculated assuming
27,955,139 shares of common stock were outstanding as of
March 27, 2006. Beneficial ownership is determined in
accordance with the rules of the Securities and Exchange
Commission which generally attribute beneficial ownership of
securities to persons who possess sole or shared voting power or
investment power with respect to those securities and includes
shares of CancerVax common stock issuable pursuant to the
exercise of stock options, warrants or other securities that are
immediately exercisable or convertible or exercisable or
convertible within 60 days of March 27, 2006. Unless
134
otherwise indicated, the persons or entities identified in this
table have sole voting and investment power with respect to all
shares shown as beneficially owned by them.
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
Percent of
|
|
|
Shares
|
|
Shares
|
|
|
Beneficially
|
|
Beneficially
|
Name and Address of Beneficial
Owner
|
|
Owned
|
|
Owned
|
|
5% Stockholders:
|
|
|
|
|
|
|
|
|
Donald L. Morton, M.D.(1)
|
|
|
5,181,482
|
|
|
|
18.5
|
%
|
1374 Bella Oceana Vista
|
|
|
|
|
|
|
|
|
Pacific Palisades, CA 90630
|
|
|
|
|
|
|
|
|
Entities affiliated with
|
|
|
|
|
|
|
|
|
Legg Mason Inc.(2)
|
|
|
1,978,075
|
|
|
|
7.1
|
|
399 Park Avenue
|
|
|
|
|
|
|
|
|
New York, NY 10043
|
|
|
|
|
|
|
|
|
Entities affiliated with
AstraZeneca PLC(3)
|
|
|
1,951,098
|
|
|
|
7.0
|
|
15 Stanhope Gate
|
|
|
|
|
|
|
|
|
London W1K 1LN
|
|
|
|
|
|
|
|
|
United Kingdom
|
|
|
|
|
|
|
|
|
Entities affiliated with
Forward IV Associates, LLC(4)
|
|
|
1,486,538
|
|
|
|
5.3
|
|
9393 Towne Center Drive,
Suite 200
|
|
|
|
|
|
|
|
|
San Diego, CA 92121
|
|
|
|
|
|
|
|
|
Named Executive Officers and
Directors:
|
|
|
|
|
|
|
|
|
David F. Hale(5)
|
|
|
1,365,325
|
|
|
|
4.7
|
|
Hazel M. Aker, J.D.(6)
|
|
|
211,862
|
|
|
|
*
|
|
William R. LaRue(7)
|
|
|
215,587
|
|
|
|
*
|
|
Guy Gammon, M.B., B.Sc.,
M.R.C.P.(U.K.)(8)
|
|
|
144,054
|
|
|
|
*
|
|
Dennis Van Epps, Ph.D.(9)
|
|
|
143,907
|
|
|
|
*
|
|
John Petricciani, M.D.(10)
|
|
|
113,526
|
|
|
|
*
|
|
Ivor Royston, M.D.(11)
|
|
|
1,517,834
|
|
|
|
5.4
|
|
Michael G. Carter, M.B., Ch.B.,
F.R.C.P. (Edinburgh)(12)
|
|
|
47,799
|
|
|
|
*
|
|
Robert E. Kiss(13)
|
|
|
1,110,558
|
|
|
|
4.0
|
|
James Clayburn
La Force, Jr., Ph.D.(14)
|
|
|
64,307
|
|
|
|
*
|
|
Donald L. Morton, M.D.(1)
|
|
|
5,181,482
|
|
|
|
18.5
|
|
Barclay A. Phillips(15)
|
|
|
1,025,941
|
|
|
|
3.7
|
|
Phillip M. Schneider(16)
|
|
|
49,204
|
|
|
|
*
|
|
Gail S. Schoettler, Ph.D.(17)
|
|
|
43,029
|
|
|
|
*
|
|
All current executive officers and
directors as a group (13 persons)(18)
|
|
|
11,120,889
|
|
|
|
37.3
|
|
|
|
|
|
*
|
Represents beneficial ownership of less than 1% of CancerVax
common stock.
|
|
|
|
|
(1)
|
Represents 4,538,197 shares of common stock held of record
by the Donald L. Morton Family Trust, dated June 2, 1989,
of which Dr. Morton is the trustee, 144,471 shares of
common stock held of record by the Donald L. Morton, M.D.,
Grantor Retained Annuity Trust, dated September 6, 2002, of
which Dr. Morton is the grantor, and 400,000 shares of
common stock held of record by the Donald L. Morton, M.D.,
Grantor Retained Annuity Trust #2, dated September 27,
2005, of which Dr. Morton is the grantor. The
144,471 shares held by the Donald L. Morton, M.D.,
Grantor Retained Annuity Trust dated September 6, 2002 are
currently distributable to The Morton Childrens Trust, a
trust of which Dr. Morton is the grantor. Dr. Morton
disclaims beneficial ownership of the 144,471 shares held
by the Donald L. Morton, M.D., Grantor Retained Annuity
Trust dated September 6, 2002 and the 400,000 shares
held by the Donald L. Morton, M.D., Grantor Retained
Annuity Trust #2 dated September 27, 2005. Also
includes 98,814 shares held of record by OncoVac, Inc., of
which the Donald L. Morton Family Trust dated June 2, 1989
is the sole stockholder. The foregoing
|
135
|
|
|
|
|
information is based upon information contained in a Schedule
13G/A filed with the SEC by the foregoing person and entities on
February 14, 2006.
|
|
|
|
|
(2)
|
Represents 102,900 shares of common stock beneficially
owned by CAM North America LLC, a Delaware limited liability
corporation, 2,600 shares of common stock beneficially
owned by Salomon Brothers Asset Management, Inc., a Delaware
corporation, and 1,872,575 shares beneficially owned by
Smith Barney Fund Management LLC, a Delaware limited liability
corporation. The foregoing information is based solely upon
information contained in a Schedule 13G filed with the
Securities and Exchange Commission by the foregoing entities on
February 14, 2006.
|
|
|
(3)
|
Represents 1,951,098 shares of common stock beneficially
owned by AstraZeneca PLC, AstraZeneca Holding AB, AstraZeneca UK
Limited, AstraZeneca Treasury Limited and AstraZeneca AB. The
shares are owned directly by AstraZeneca AB. AstraZeneca AB is a
Swedish corporation and a wholly-owned subsidiary of AstraZeneca
Treasury Limited, which is an English corporation and a
wholly-owned subsidiary of AstraZeneca UK Limited, which is an
English corporation and a subsidiary of AstraZeneca Holding AB
and AstraZeneca PLC. AstraZeneca Holding AB is a Swedish
corporation and a wholly-owned subsidiary of AstraZeneca PLC, an
English corporation. The foregoing information is based solely
upon information contained in a Schedule 13G filed with the
SEC by the foregoing entities on November 14, 2003.
|
|
|
(4)
|
Represents 1,370,230 shares of common stock held of record
by Forward Ventures IV, L.P. and 116,308 shares of common
stock held of record by Forward Ventures IV B, L.P. Ivor
Royston, M.D. is the managing member of Forward IV
Associates, LLC, which is the general partner of Forward
Ventures IV, L.P. and Forward Ventures IV B, L.P.
Dr. Royston disclaims beneficial ownership of these shares
except to the extent of his pecuniary interest in the named
fund. The foregoing information is based upon information
contained in a Schedule 13D filed with the SEC by the
foregoing entities on February 10, 2004.
|
|
|
|
|
(5)
|
Represents 231,553 shares of common stock held of record by
the Hale Family Trust, dated February 10, 1986, of which
Mr. Hale is a co-trustee, and 4,544 shares held by the
Michael T. Hale Trust, dated December 26, 1991, for the
benefit of Shane Hale, Tara Hale, Erin Hale and David Garrett
Hale. Mr. Hale disclaims beneficial ownership of the
4,544 shares held by the Michael T. Hale Trust, dated
December 26, 1991. Also includes exercisable options to
purchase 1,086,526 shares of common stock, of which
65,411 shares are unvested as of May 26, 2006. Also
includes 42,702 shares of restricted stock.
|
|
|
|
|
(6)
|
Represents 40,072 shares of common stock held of record by
Ms. Aker. Also includes exercisable options to purchase
158,211 shares of common stock, of which 10,393 shares
are unvested as of May 26, 2006. Also includes
13,579 shares of restricted stock.
|
|
|
|
|
(7)
|
Represents 68,181 shares of common stock held of record by
the William R. and Joyce E. LaRue Family Trust, dated
November 4, 1991, of which Mr. LaRue is a co-trustee.
Also includes exercisable options to purchase
134,320 shares of common stock, of which 6,156 shares
are unvested as of May 26, 2006. Also includes
13,086 shares of restricted stock.
|
|
|
|
|
(8)
|
Represents 23,027 shares of common stock held of record by
Dr. Gammon. Also includes exercisable options to purchase
109,608 shares of common stock, of which 7,694 shares
are unvested as of May 26, 2006. Also includes
11,419 shares of restricted stock.
|
|
|
|
|
(9)
|
Represents 34,340 shares of common stock held of record by
Dr. Van Epps. Also includes exercisable options to purchase
98,244 shares of common stock, of which 7,694 shares
are unvested as of May 26, 2006. Also includes
11,323 shares of restricted stock.
|
|
|
(10) |
Represents 74,985 shares of common stock held of record by
Dr. Petricciani. Also includes exercisable options to
purchase 38,541 shares of common stock, none of which are
unvested as of May 26, 2006.
|
|
|
(11) |
Represents 1,370,230 shares of common stock held of record
by Forward Ventures IV, L.P. and 116,308 shares of common
stock held of record by Forward Ventures IV B, L.P. Ivor
Royston, M.D. is the managing member of Forward IV
Associates, L.L.C., which is the general partner of Forward
Ventures, IV, L.P., and Forward Ventures IV B, L.P.
Dr. Royston disclaims beneficial ownership of these shares
except to the extent of his pecuniary interest in the named
fund. Also includes 12,130 shares of common stock held by
Colette Royston, Dr. Roystons wife. Also includes
exercisable options to purchase 19,166 shares of common
stock.
|
136
|
|
|
(12) |
|
Represents 2,272 shares of common stock held of record by
Dr. Carter. Also includes exercisable options to purchase
45,527 shares of common stock, of which 237 shares are
unvested as of May 26, 2006. |
|
|
|
(13) |
|
Represents 823,389 shares of common stock held of record by
J.P. Morgan Direct Venture Capital Institutional
Investors II LLC, 235,428 shares of common stock held
of record by J.P. Morgan Direct Venture Capital Private
Investors II LLC and 32,575 shares of common stock
held of record by 522 Fifth Avenue Fund, LLC which are
affiliated with J.P. Morgan Investment Management, Inc.
Mr. Kiss is the Managing Director and Portfolio Manager of
the Private Equity Group of J.P. Morgan Investment
Management, Inc., which is affiliated with J.P. Morgan
Direct Venture Capital Institutional Investors II LLC,
J.P. Morgan Direct Venture Capital Private
Investors II LLC and 522 Fifth Avenue Fund, LLC.
Mr. Kiss disclaims beneficial ownership of these shares
except to the extent of his pecuniary interest in the named
fund. Also includes exercisable options to purchase
19,166 shares of common stock. |
|
|
|
(14) |
|
Represents 40,349 shares of common stock held of record by
Dr. La Force. Of these shares, 474 are subject to
repurchase as of May 26, 2006. Also includes exercisable
options to purchase 23,958 shares of common stock. |
|
|
|
(15) |
|
Represents 751,742 shares held of record by Vector
Later-Stage Equity Fund II (QP), L.P. and
250,580 shares held of record by Vector Later-Stage Equity
Fund II, L.P. Mr. Phillips is the managing member of
Vector Fund Management II, L.L.C. which is the general
partner of Vector Later-Stage Equity Fund II (QP), L.P. and
Vector Later-Stage Equity Fund II, L.P. Mr. Phillips
disclaims beneficial ownership of these shares, except to the
extent of his pecuniary interest in the named fund. Also
includes 3,953 shares held of record by the Barclay A.
Phillips, IRA Rollover. Also includes 500 shares held of
record by Mr. Phillips. Also includes exercisable options
to purchase 19,166 shares of common stock. |
|
|
|
(16) |
|
Represents exercisable options to purchase 49,204 shares of
common stock, of which 6,818 shares are unvested as of
May 26, 2006. |
|
|
|
(17) |
|
Represents 7,155 shares of common stock held of record by
Dr. Schoettler. Also includes exercisable options to
purchase 35,874 shares of common stock, of which
544 shares are unvested as of May 26, 2006. |
|
|
|
(18) |
|
Includes 474 shares of common stock subject to repurchase
and exercisable options to purchase 1,798,970 shares of
common stock, of which 104,947 shares are unvested as of
May 26, 2006. Also includes 92,109 shares of
restricted stock. |
137
CANCERVAX
SECTION 16(A) BENEFICIAL OWNERSHIP REPORTING
COMPLIANCE
Under Section 16(a) of the Securities Exchange Act of 1934,
as amended, directors, officers and beneficial owners of ten
percent or more of CancerVaxs common stock
(Reporting Persons) are required to report to the
Securities and Exchange Commission on a timely basis the
initiation of their status as a Reporting Person and any changes
regarding their beneficial ownership of our common stock. Based
solely on CancerVaxs review of such forms received and the
written representations of its Reporting Persons, CancerVax has
determined that no Reporting Person known to it was delinquent
with respect to their reporting obligations as set forth in
Section 16(a) of the Exchange Act.
138
MICROMET
SECURITY OWNERSHIP BY CERTAIN BENEFICIAL OWNERS
The following table and footnotes sets forth information
regarding the beneficial ownership of Micromets ordinary
shares, preference shares series (A new) and preference shares
series (B new) as of March 27, 2006, and shares of common
stock of Micromet Parent upon the consummation of the Micromet
Reorganization, and the percentage which such ownership bears to
the total number of outstanding shares of each class and all
classes as of that date by (1) persons known to Micromet to
be beneficial owners of more than 5% of any such stock,
(2) the chief executive officer and the four other most
highly compensated executive officers of Micromet who earned
over $100,000 in the last completed fiscal year and who will
become executive officers of the combined company and
(3) all current executive officers and directors.
Beneficial ownership and percentage ownership are determined in
accordance with the rules of the SEC. In computing the number of
shares beneficially owned by a person and the percentage
ownership of that person, shares of common stock underlying
options and warrants that are exercisable within 60 days of
March 27, 2006 are considered to be outstanding by the
person holding such options or warrants, but are not considered
to be outstanding for purposes of computing the percentage
ownership of any other person. To the knowledge of Micromet,
except as indicated in the footnotes to the following table and
subject to community property laws where applicable, the persons
named in this table have sole voting and investment power with
respect to all shares of capital stock of Micromet shown as
beneficially owned by them.
This table is based on the following number of shares of each
class and series of Micromet stock outstanding as of
March 27, 2006: 77,642 ordinary shares; 1,232,876
preference shares series (A new); and 2,140,539 preference
shares series (B new), and assuming the consummation of the
Micromet Reorganization, there will be 3,451,057 shares of
Micromet Parent common stock outstanding. The address for those
individuals for which an address is not otherwise indicated is:
c/o Micromet AG, Staffelseestr. 2, 81477 Munich,
Germany.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of
|
|
|
|
|
|
|
|
|
|
Percentage of
|
|
|
Percentage of
|
|
|
Outstanding
|
|
|
|
|
|
|
Percentage of
|
|
|
Outstanding
|
|
|
Outstanding
|
|
|
Micromet Parent
|
|
|
|
Number of
|
|
|
Outstanding
|
|
|
Series A (New)
|
|
|
Series B (New)
|
|
|
Common Stock
|
|
|
|
Shares
|
|
|
Ordinary
|
|
|
Preference
|
|
|
Preference
|
|
|
(after Micromet
|
|
Name and Address of Beneficial
Owner
|
|
Owned
|
|
|
Shares
|
|
|
Shares
|
|
|
Shares
|
|
|
Reorganization)(12)
|
|
|
Directors and named executive
officers:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jerry Benjamin(1)
|
|
|
672,519
|
|
|
|
*
|
|
|
|
24.4
|
%
|
|
|
17.3
|
%
|
|
|
19.5
|
%
|
Gerhard Riethmüller
|
|
|
20,190
|
|
|
|
26.0
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Clemens Doppler(3)
|
|
|
560,376
|
|
|
|
*
|
|
|
|
13.4
|
%
|
|
|
18.5
|
%
|
|
|
16.2
|
%
|
John Berriman
|
|
|
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Michael Carter
|
|
|
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Otello Stampacchia(2)
|
|
|
620,884
|
|
|
|
*
|
|
|
|
10.8
|
%
|
|
|
22.8
|
%
|
|
|
18.0
|
%
|
Christian Itin
|
|
|
550
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Patrick A. Baeuerle
|
|
|
4,300
|
|
|
|
5.5
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Gregor Mirow
|
|
|
1,500
|
|
|
|
1.9
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Carsten Reinhardt
|
|
|
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
All executive officers and
directors as a group (10 persons)(11)
|
|
|
1,880,319
|
|
|
|
34.7
|
%
|
|
|
48.6
|
%
|
|
|
58.6
|
%
|
|
|
54.5
|
%
|
139
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of
|
|
|
|
|
|
|
|
|
|
Percentage of
|
|
|
Percentage of
|
|
|
Outstanding
|
|
|
|
|
|
|
Percentage of
|
|
|
Outstanding
|
|
|
Outstanding
|
|
|
Micromet Parent
|
|
|
|
Number of
|
|
|
Outstanding
|
|
|
Series A (New)
|
|
|
Series B (New)
|
|
|
Common Stock
|
|
|
|
Shares
|
|
|
Ordinary
|
|
|
Preference
|
|
|
Preference
|
|
|
(after Micromet
|
|
Name and Address of Beneficial
Owner
|
|
Owned
|
|
|
Shares
|
|
|
Shares
|
|
|
Shares
|
|
|
Reorganization)(12)
|
|
|
Five percent
stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Entities affiliated with Advent
Venture Partners(1)
|
|
|
672,519
|
|
|
|
*
|
|
|
|
24.4
|
%
|
|
|
17.3
|
%
|
|
|
19.5
|
%
|
25 Buckingham Gate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
London SW1E 6LD
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Kingdom
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Omega Fund I, L.P.(2)
|
|
|
620,884
|
|
|
|
|
|
|
|
10.8
|
%
|
|
|
22.8
|
%
|
|
|
18.0
|
%
|
c/o Walkers SPV Limited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Walker House
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mary Street
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P.O. Box 908GT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
George Town, Grand Cayman
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cayman Islands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3i Group plc.(3)
|
|
|
560,376
|
|
|
|
|
|
|
|
13.4
|
%
|
|
|
18.5
|
%
|
|
|
16.2
|
%
|
91 Waterloo Road
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
London SE1 8XP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Kingdom
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Entities affiliated with
Schroder
Venture Managers Ltd.(4)
|
|
|
142,959
|
|
|
|
|
|
|
|
6.7
|
%
|
|
|
2.8
|
%
|
|
|
4.1
|
%
|
22 Church Street
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hamilton HM 11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bermuda
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abingworth Bioventures II
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SICAV(5)
|
|
|
213,313
|
|
|
|
|
|
|
|
6.9
|
%
|
|
|
6.0
|
%
|
|
|
6.2
|
%
|
231 Val des Bons Malades
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
L-2121 Luxembourg-Kirchberg
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DG Lux Lacuna Apo Biotech, DG Bank
Luxembourg S.A.(6)
|
|
|
179,295
|
|
|
|
|
|
|
|
6.5
|
%
|
|
|
4.6
|
%
|
|
|
5.2
|
%
|
4 rue Thomas Edison
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
L-1445 Luxembourg-Strassen
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International Biotechnology Trust
plc(7)
|
|
|
338,950
|
|
|
|
*
|
|
|
|
8.1
|
%
|
|
|
11.1
|
%
|
|
|
9.8
|
%
|
31 Gresham Street
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
London EC2V 7QA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Kingdom
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Wellcome Trust Limited(8)
|
|
|
224,172
|
|
|
|
|
|
|
|
8.1
|
%
|
|
|
5.8
|
%
|
|
|
6.5
|
%
|
210 Euston Road
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
London NW1 2BE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Kingdom
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HBM Bioventures (Cayman) Ltd.(9)
|
|
|
217,750
|
|
|
|
|
|
|
|
8.1
|
%
|
|
|
5.5
|
%
|
|
|
6.3
|
%
|
P.O. Box 30852
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SMB, Eucalyptus Building
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Crewe Road
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grand Cayman, Cayman Islands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
British West Indies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Curis, Inc.(10)
|
|
|
6,006
|
|
|
|
7.7
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
61 Moulton Street
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cambridge, MA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enzon Pharmaceuticals, Inc.
|
|
|
16,836
|
|
|
|
21.7
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
685 Route 202/206
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bridgewater, NJ 08807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gerhard Riethmüller
|
|
|
20,190
|
|
|
|
26.0
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Erich Felber
|
|
|
12,300
|
|
|
|
15.8
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
140
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of
|
|
|
|
|
|
|
|
|
|
Percentage of
|
|
|
Percentage of
|
|
|
Outstanding
|
|
|
|
|
|
|
Percentage of
|
|
|
Outstanding
|
|
|
Outstanding
|
|
|
Micromet Parent
|
|
|
|
Number of
|
|
|
Outstanding
|
|
|
Series A (New)
|
|
|
Series B (New)
|
|
|
Common Stock
|
|
|
|
Shares
|
|
|
Ordinary
|
|
|
Preference
|
|
|
Preference
|
|
|
(after Micromet
|
|
Name and Address of Beneficial
Owner
|
|
Owned
|
|
|
Shares
|
|
|
Shares
|
|
|
Shares
|
|
|
Reorganization)(12)
|
|
|
Gunther Schlimok
|
|
|
5,850
|
|
|
|
7.5
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Patrick A. Baeuerle
|
|
|
4,300
|
|
|
|
5.5
|
%
|
|
|
|
|
|
|
|
|
|
|
*
|
|
|
|
|
|
*
|
Represents beneficial ownership of less than 1%.
|
|
|
|
|
(1)
|
Consists of: 210 ordinary shares, 152,179 preference shares
series (A new) and 186,297 preference shares series (B new) held
of record by Advent Private Equity Fund III A
Limited Partnership; 103 ordinary shares, 74,562 preference
shares series (A new) and 91,239 preference shares series (B
new) held of record by Advent Private Equity Fund III
B Limited Partnership; 29 ordinary shares,
20,807 preference shares series (A new) and 25,462 preference
shares series (B new) held of record by Advent Private Equity
Fund III C Limited Partnership; 56 ordinary
shares, 40,918 preference shares series (A new) and 50,075
preference shares series (B new) held of record by Advent
Private Equity Fund III D Limited Partnership;
8 ordinary shares, 5,885 preference shares series (A
new) and 7,214 preference shares series (B new) held of record
by Advent Private Equity Fund III GmbH & Co. KG; 7
ordinary shares, 4,899 preference shares series (A new) and
5,941 preference shares series (B new) held of record by Advent
Private Equity Fund III Affiliates Limited Partnership; and
2 ordinary shares, 1,471 preference shares series (A new)
and 1,289 preference shares series (B new) held of record by
Advent Management III Limited Partnership.
Mr. Benjamin is a general partner of each of the foregoing
entities. As a result, Mr. Benjamin shares voting and
dispositive power with respect to the shares held by these
entities and disclaims beneficial ownership of the shares in
which he has no pecuniary interest.
|
|
|
(2)
|
Consists of: 133,483 preference shares series (A new) and
487,401 preference shares series (B new) held of record by Omega
Fund I, L.P. Mr. Stampacchia is Chief Investment
Advisor of Omega Fund I, L.P. As a result,
Mr. Stampacchia shares voting and dispositive power
with respect to the shares held by these entities and disclaims
beneficial ownership of the shares in which he has no pecuniary
interest.
|
|
|
(3)
|
Consists of: 164,589 preference shares series (A new) and
395,787 preference shares series (B new) held of record by 3i
Group plc. Dr. Doppler is a director of 3i, which is an advisor
to 3i Group plc. As a result, Dr. Doppler shares voting and
dispositive power with respect to the shares held by these
entities and disclaims beneficial ownership of the shares in
which he has no pecuniary interest.
|
|
|
(4)
|
Consists of: 52,324 preference shares series (A new) and 37,753
preference shares series (B new) held of record by Schroder
Ventures International Life Sciences Fund L.P. 1; 8,956
preference shares series (A new) and 8,038 preference shares
series (B new) held of record by Schroder Ventures International
Life Sciences Fund L.P. 2; 19,584 preference shares series
(A new) and 14,239 preference shares series (B new) held of
record by Schroder Ventures International Life Sciences Fund
Trust.
|
|
|
(5)
|
Consists of: 84,881 preference shares series (A new) and 128,432
preference shares series (B new) held of record by Abingworth
Bioventures II SICA V.
|
|
|
(6)
|
Consists of: 80,188 preference shares series (A new) and 99,107
preference shares series (B new) held of record by DG Lux Lacuna
Apo Biotech, DG Bank Luxembourg S.A.
|
|
|
(7)
|
Consists of: 354 ordinary shares, 100,235 preference shares
series (A new) and 238,361 preference shares series (B new) held
of record by International Biotechnology Trust plc.
|
|
|
(8)
|
Consists of: 100,235 preference shares series (A new) and
123,937 preference shares series (B new) held of record by The
Wellcome Trust Limited.
|
|
|
(9)
|
Consists of: 100,234 preference shares series (A new) and
117,516 preference shares series (B new) held of record by HBM
Bioventures (Cayman) Ltd.
|
|
|
(10)
|
All reported shares are ordinary shares.
|
|
(11)
|
Consists of: 26,955 ordinary shares, 681,722 preference shares
series (A new) and 1,314,601 preference shares series
(B new)
|
|
|
(12) |
It is anticipated that after the Micromet Reorganization, but
prior to the consummation of the merger, certain officers,
employees and members of the supervisory board of Micromet will
be granted options to purchase Micromet Parent common stock. As
the amount of and terms of such option grants have not yet been
determined, no options to purchase Micromet Parent have been
included in the table.
|
141
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
Except where specifically noted, the following information
and all other information contained in this proxy
statement/prospectus does not give effect to the proposed
reverse stock split described in CancerVaxs
Proposal No. 3.
The following unaudited pro forma condensed combined financial
statements give effect to the proposed transaction between
CancerVax and Micromet. For accounting purposes Micromet is
considered to be acquiring CancerVax in this transaction.
Accordingly, the purchase price is allocated among the fair
values of the assets and liabilities of CancerVax, while the
historical results of Micromet are reflected in the results of
the combined company. The transaction will be accounted for
under the purchase method of accounting in accordance with
Statement of Financial Accounting Standards, or SFAS,
No. 141, Business Combinations. Under the purchase
method of accounting, the total estimated purchase price,
calculated as described in Note 2 to these unaudited pro
forma condensed combined financial statements, is allocated to
the tangible and intangible assets acquired and liabilities
assumed in connection with the transaction, based on their
estimated fair values as of the completion of the transaction.
For purposes of these unaudited pro forma condensed combined
financial statements, management has made a preliminary
allocation of the estimated purchase price to the tangible and
intangible assets acquired and liabilities assumed based on
various preliminary estimates of their fair value, as described
in Note 2 to these unaudited pro forma condensed combined
financial statements. A final determination of these estimated
fair values, which cannot be made prior to the completion of the
transaction, will be based on the actual net tangible and
intangible assets of CancerVax that exist as of the date of
completion of the transaction. The actual amounts recorded as of
the completion of the transaction may differ materially from the
information presented in these unaudited pro forma condensed
combined financial statements. In addition to the receipt of the
final valuation, the impact of future integration activities,
the timing of completion of the transaction and other changes in
CancerVaxs net tangible and intangible assets that occur
prior to completion of the transaction could cause material
differences in the information presented. For example, upon
closing of the merger, as a result of CancerVaxs continued
consumption of its working capital, the final purchase price may
exceed the fair value of the assets acquired and liabilities
assumed resulting in positive goodwill.
The unaudited pro forma condensed combined financial statements
presented below are based upon the historical financial
statements of CancerVax and Micromet, adjusted to give effect to
the acquisition of CancerVax by Micromet for accounting
purposes. The pro forma adjustments are described in the
accompanying notes presented on the following pages.
The unaudited pro forma condensed combined balance sheet as of
December 31, 2005 gives effect to the proposed transaction
as if it occurred on December 31, 2005 and combines the
historical balance sheets of CancerVax and Micromet as of
December 31, 2005. The Micromet balance sheet information
was derived from its audited balance sheet as of
December 31, 2005 included herein. The CancerVax balance
sheet information was derived from its audited consolidated
balance sheet included in its Annual Report on
Form 10-K
for the year ended December 31, 2005 and also included
herein.
The unaudited pro forma condensed combined statement of
operations for the year ended December 31, 2005 is
presented as if the transaction was consummated on
January 1, 2005 and combines the historical results of
CancerVax and Micromet for the year ended December 31,
2005. The historical results of Micromet were derived from its
audited statement of operations for the year ended
December 31, 2005 included herein. The historical results
of CancerVax were derived from its audited consolidated
statement of operations included in its Annual Report on
Form 10-K
for the year ended December 31, 2005 and included herein.
The unaudited pro forma condensed combined financial statements
have been prepared by CancerVax and Micromet management for
illustrative purposes only and are not necessarily indicative of
the consolidated financial position or results of operations in
future periods or the results that actually would have been
realized had CancerVax and Micromet been a combined company
during the specified periods. The pro forma adjustments are
based on the preliminary information available at the time of
the preparation of this document. The unaudited pro forma
condensed combined financial statements, including the notes
thereto, are qualified in their entirety by reference to, and
should be read in conjunction with, the historical financial
statements of Micromet for the year ended December 31, 2005
included herein and the historical consolidated financial
statements of CancerVax included in its Annual Report on
Form 10-K
for the year ended December 31, 2005 and also included
herein.
142
Unaudited
Pro Forma Condensed Combined Balance Sheets
As of December 31, 2005
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Micromet
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
Historical ($)
|
|
|
CancerVax
|
|
|
Adjustments
|
|
|
|
|
|
Pro Forma
|
|
|
|
(A)
|
|
|
Historical ($)
|
|
|
($) (A)
|
|
|
|
|
|
Combined ($)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
7,784
|
|
|
$
|
38,932
|
|
|
$
|
(18,000
|
)
|
|
|
M
|
|
|
$
|
25,923
|
|
|
|
|
|
|
|
|
|
|
|
|
(424
|
)
|
|
|
N
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,369
|
)
|
|
|
O
|
|
|
|
|
|
Securities
available-for-sale
|
|
|
3,630
|
|
|
|
12,263
|
|
|
|
|
|
|
|
|
|
|
|
15,893
|
|
Accounts receivable
|
|
|
2,170
|
|
|
|
1,695
|
|
|
|
|
|
|
|
|
|
|
|
3,865
|
|
Property and equipment held for sale
|
|
|
|
|
|
|
|
|
|
|
904
|
|
|
|
G
|
|
|
|
904
|
|
Other current assets
|
|
|
1,044
|
|
|
|
969
|
|
|
|
|
|
|
|
|
|
|
|
2,013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
14,628
|
|
|
|
53,859
|
|
|
|
(19,889
|
)
|
|
|
|
|
|
|
48,598
|
|
Property and equipment, net
|
|
|
3,513
|
|
|
|
1,805
|
|
|
|
(1,383
|
)
|
|
|
G
|
|
|
|
3,935
|
|
Goodwill
|
|
|
|
|
|
|
5,381
|
|
|
|
(5,381
|
)
|
|
|
F
|
|
|
|
|
|
Patents, net
|
|
|
9,705
|
|
|
|
842
|
|
|
|
|
|
|
|
|
|
|
|
10,547
|
|
Restricted cash
|
|
|
636
|
|
|
|
1,280
|
|
|
|
|
|
|
|
|
|
|
|
1,916
|
|
Other assets
|
|
|
396
|
|
|
|
130
|
|
|
|
(117
|
)
|
|
|
F
|
|
|
|
409
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
28,878
|
|
|
$
|
63,297
|
|
|
$
|
(26,770
|
)
|
|
|
|
|
|
$
|
65,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY (DEFICIT)
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities
|
|
$
|
9,882
|
|
|
$
|
11,415
|
|
|
$
|
(1,903
|
)
|
|
|
F
|
|
|
$
|
22,795
|
|
|
|
|
|
|
|
|
|
|
|
|
1,085
|
|
|
|
H
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,083
|
|
|
|
I
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,657
|
|
|
|
L
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(424
|
)
|
|
|
N
|
|
|
|
|
|
Short-term note payable
|
|
|
2,852
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,852
|
|
Current portion of long-term debt
|
|
|
3,506
|
|
|
|
18,125
|
|
|
|
(18,000
|
)
|
|
|
M
|
|
|
|
2,023
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,608
|
)
|
|
|
O
|
|
|
|
|
|
Current portion of convertible
notes payable
|
|
|
2,761
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,761
|
|
Current portion of deferred revenue
|
|
|
6,035
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,035
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
25,036
|
|
|
|
29,540
|
|
|
|
(18,110
|
)
|
|
|
|
|
|
|
36,466
|
|
Long-term debt, net of current
portion
|
|
|
5,531
|
|
|
|
|
|
|
|
(1,033
|
)
|
|
|
O
|
|
|
|
4,498
|
|
Convertible notes payable, net of
current position
|
|
|
11,845
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,845
|
|
Deferred revenue, net of current
portion
|
|
|
52
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52
|
|
Other liabilities
|
|
|
948
|
|
|
|
1,046
|
|
|
|
(696
|
)
|
|
|
F
|
|
|
|
3,822
|
|
|
|
|
|
|
|
|
|
|
|
|
2,524
|
|
|
|
H
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock
|
|
|
3,974
|
|
|
|
|
|
|
|
(3,974
|
)
|
|
|
D
|
|
|
|
|
|
Common stock
|
|
|
72
|
|
|
|
1
|
|
|
|
(1
|
)
|
|
|
B
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
3,974
|
|
|
|
D
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,043
|
)
|
|
|
E
|
|
|
|
|
|
Additional paid-in capital
|
|
|
79,586
|
|
|
|
257,347
|
|
|
|
(257,347
|
)
|
|
|
B
|
|
|
|
125,613
|
|
|
|
|
|
|
|
|
|
|
|
|
42,004
|
|
|
|
C
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20
|
)
|
|
|
D
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,043
|
|
|
|
E
|
|
|
|
|
|
Stock subscription from conversion
|
|
|
23,085
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,085
|
|
Stock subscription receivable
|
|
|
(352
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(352
|
)
|
Accumulated other comprehensive loss
|
|
|
(38
|
)
|
|
|
(10
|
)
|
|
|
10
|
|
|
|
B
|
|
|
|
(38
|
)
|
Deferred compensation
|
|
|
|
|
|
|
(230
|
)
|
|
|
230
|
|
|
|
B
|
|
|
|
(84
|
)
|
|
|
|
|
|
|
|
|
|
|
|
(84
|
)
|
|
|
K
|
|
|
|
|
|
Accumulated deficit
|
|
|
(120,841
|
)
|
|
|
(224,397
|
)
|
|
|
224,397
|
|
|
|
B
|
|
|
|
(139,505
|
)
|
|
|
|
|
|
|
|
|
|
|
|
(18,936
|
)
|
|
|
J
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
272
|
|
|
|
O
|
|
|
|
|
|
Treasury stock
|
|
|
(20
|
)
|
|
|
|
|
|
|
20
|
|
|
|
D
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
(deficit)
|
|
|
(14,534
|
)
|
|
|
32,711
|
|
|
|
(9,455
|
)
|
|
|
|
|
|
|
8,722
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity (deficit)
|
|
$
|
28,878
|
|
|
$
|
63,297
|
|
|
$
|
(26,770
|
)
|
|
|
|
|
|
$
|
65,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143
Unaudited
Pro Forma Condensed Combined Statement of Operations
For the Year Ended December 31, 2005
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Micromet
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
Pro Forma
|
|
|
|
Historical
|
|
|
CancerVax
|
|
|
Adjustments
|
|
|
|
|
|
Combined
|
|
|
|
($) (A)
|
|
|
Historical($)
|
|
|
($) (A)
|
|
|
|
|
|
($)
|
|
|
Revenues
|
|
$
|
25,878
|
|
|
$
|
40,608
|
|
|
|
|
|
|
|
|
|
|
$
|
66,486
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
29,793
|
|
|
|
38,751
|
|
|
|
(1,668
|
)
|
|
|
R
|
|
|
|
66,876
|
|
General and administrative
|
|
|
5,713
|
|
|
|
11,993
|
|
|
|
(658
|
)
|
|
|
R
|
|
|
|
17,048
|
|
Amortization of employee
stock-based compensation
|
|
|
|
|
|
|
555
|
|
|
|
4,536
|
|
|
|
S
|
|
|
|
5,091
|
|
Restructuring charges
|
|
|
|
|
|
|
4,918
|
|
|
|
|
|
|
|
|
|
|
|
4,918
|
|
Impairment of long-lived assets
|
|
|
|
|
|
|
25,366
|
|
|
|
|
|
|
|
|
|
|
|
25,366
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
35,506
|
|
|
|
81,583
|
|
|
|
2,210
|
|
|
|
|
|
|
|
119,299
|
|
Other income (expense), net
|
|
|
(4,561
|
)
|
|
|
1,356
|
|
|
|
477
|
|
|
|
P
|
|
|
|
(3,021
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
264
|
|
|
|
Q
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(473
|
)
|
|
|
T
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(84
|
)
|
|
|
U
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(14,189
|
)
|
|
|
(39,619
|
)
|
|
|
(2,026
|
)
|
|
|
|
|
|
|
(55,834
|
)
|
Beneficial conversion charge on
issuance of preferred shares
|
|
|
(5,004
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,004
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common
stockholders
|
|
$
|
(19,193
|
)
|
|
$
|
(39,619
|
)
|
|
$
|
(2,026
|
)
|
|
|
|
|
|
$
|
(60,838
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
$
|
|
|
|
$
|
(1.42
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(0.71
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted averaged shares used to
compute basic and diluted net loss per share
|
|
|
|
|
|
|
27,848
|
|
|
|
58,013
|
|
|
|
V
|
|
|
|
85,861
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
144
Notes to
Unaudited Pro Forma Condensed Combined Financial
Statements
On January 6, 2006, CancerVax and Micromet entered into an
Agreement and Plan of Merger and Reorganization under which a
wholly-owned subsidiary of CancerVax, Carlsbad Acquisition
Corporation, will merge with and into Micromet, Inc., or
Micromet Parent, a newly created corporation. Micromet Parent
will become a wholly-owned subsidiary of CancerVax and the
surviving corporation of the merger. Upon completion of the
merger, the combined company will change its name to Micromet,
Inc., as contemplated under Proposal No. 4. Pursuant
to the terms of the merger agreement, CancerVax will issue to
Micromet stockholders shares of CancerVax common stock and will
assume all of the stock options, stock warrants and restricted
stock of Micromet outstanding as of the merger closing date,
such that Micromet stockholders, option holders, warrant holders
and note holders will own approximately 67.5% of the combined
company on a fully-diluted basis and CancerVax stockholders,
option holders and warrant holders will own approximately 32.5%
of the combined company on a fully-diluted basis. The merger is
intended to qualify as a tax-free reorganization under the
provisions of Section 368(a) of the Internal Revenue Code.
The merger is subject to customary closing conditions, including
approval by CancerVax stockholders.
Because Micromet stockholders will own approximately 67.5% of
the voting stock of the combined company after the transaction,
Micromet is deemed to be the acquiring company for accounting
purposes and the transaction will be accounted for as a reverse
acquisition under the purchase method of accounting for business
combinations in accordance with accounting principles generally
accepted in the United States. Accordingly, the assets and
liabilities of CancerVax will be recorded as of the merger
closing date at their estimated fair values.
The preliminary estimated total purchase price of the proposed
transaction is as follows (in thousands):
|
|
|
|
|
Fair value of CancerVax common
stock
|
|
$
|
40,725
|
|
Estimated fair value of CancerVax
stock options and stock warrants assumed
|
|
|
1,279
|
|
Estimated transaction costs
incurred by Micromet
|
|
|
1,657
|
|
|
|
|
|
|
Total preliminary estimated
purchase price
|
|
$
|
43,661
|
|
|
|
|
|
|
As of January 6, 2006, CancerVax had 27,932,160 shares
of common stock outstanding. The fair value of the CancerVax
common stock used in the determining the purchase price was
$1.46 per share based on the average of the closing prices
for a range of trading days (January 5, 2006 through
January 11, 2006, inclusive) around and including the
announcement date of the proposed transaction. The fair value of
the CancerVax stock options and stock warrants assumed by
Micromet was determined using the Black-Scholes option pricing
model with the following assumptions: stock price of $1.46,
which is the value ascribed to the CancerVax common stock in
determining the purchase price; volatility of 75%; dividend rate
of 0%; risk-free interest rate of 4.0%; and a weighted average
expected option life of 0.88 years. The estimated purchase
price is preliminary because the proposed merger has not yet
been completed. The actual purchase price may change based on
the actual number of shares of CancerVax common stock and the
number of CancerVax stock options and stock warrants outstanding
on the merger closing date and Micromets final costs to
complete the merger.
Under the purchase method of accounting, the total purchase
price is allocated to the acquired tangible and intangible
assets and assumed liabilities of CancerVax based on their
estimated fair values as of the merger closing date. The excess
of the purchase price over the fair value of assets acquired and
liabilities assumed, if any, is allocated to goodwill. The
excess of the fair value of acquired assets and liabilities
assumed over the purchase price (negative goodwill), if any, is
considered negative goodwill and, in accordance with Statement
of Financial Accounting Standard No. 141, Business
Combinations, is allocated as a pro rata reduction of the
amounts that otherwise would have been assigned to certain
acquired assets.
145
A preliminary allocation of the total preliminary estimated
purchase price, as shown above, to the acquired tangible and
intangible assets and assumed liabilities of CancerVax based on
their estimated fair values as of December 31, 2005 and a
preliminary allocation of the resulting negative goodwill are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value of
|
|
|
|
|
|
Preliminary
|
|
|
|
Assets Acquired and
|
|
|
Pro Rata Allocation
|
|
|
Allocation of
|
|
|
|
Liabilities Assumed
|
|
|
of Negative Goodwill
|
|
|
Purchase Price
|
|
|
Cash, cash equivalents and
securities
available-for-sale
|
|
$
|
51,195
|
|
|
|
|
|
|
$
|
51,195
|
|
Property and equipment held for
sale
|
|
|
904
|
|
|
|
|
|
|
|
904
|
|
Property and equipment held and
used
|
|
|
517
|
|
|
$
|
(95
|
)
|
|
|
422
|
|
In-process research and development
|
|
|
23,158
|
|
|
|
(4,222
|
)
|
|
|
18,936
|
|
Capitalized patents
|
|
|
842
|
|
|
|
|
|
|
|
842
|
|
Other assets
|
|
|
3,957
|
|
|
|
|
|
|
|
3,957
|
|
Existing assumed liabilities
|
|
|
(27,986
|
)
|
|
|
|
|
|
|
(27,986
|
)
|
Unfavorable lease liability
|
|
|
(3,610
|
)
|
|
|
|
|
|
|
(3,610
|
)
|
Assumed severance obligation
|
|
|
(1,083
|
)
|
|
|
|
|
|
|
(1,083
|
)
|
Deferred stock-based compensation
|
|
|
84
|
|
|
|
|
|
|
|
84
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
47,978
|
|
|
$
|
(4,317
|
)
|
|
$
|
43,661
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The allocation of the estimated purchase price is preliminary
because the proposed transaction has not yet been completed. The
purchase price allocation will remain preliminary until Micromet
completes its valuation of significant identifiable intangible
assets acquired (including in-process research and development)
and determines the fair values of other assets acquired and
liabilities assumed. The final determination of the purchase
price allocation is anticipated to be completed as soon as
practicable after completion of the merger and will be based on
the fair values of the assets acquired and liabilities assumed
as of the merger closing date. The final amounts allocated to
assets acquired and liabilities assumed could differ
significantly from the amounts presented in the unaudited pro
forma condensed combined financial statements. For example, upon
closing of the merger, as a result of CancerVaxs continued
consumption of its working capital, the final purchase price may
exceed the fair value of the assets acquired and liabilities
assumed resulting in positive goodwill.
After the pro rata reduction of the amounts assigned to acquired
assets for the negative goodwill, the amount of the preliminary
purchase price allocated to in-process research and development,
or IPR&D, is estimated to be $18.9 million. The
acquired IPR&D projects consists of the following: D93 and
other denatured collagen related anti-angiogenesis programs that
potentially target various solid tumors; SAI-EGF and related
programs that target the epidermal growth factor receptor, or,
EGFR, signaling pathway that potentially target non-small cell
lung cancer and various solid tumors; GD2, a humanized,
monoclonal antibody that appears to target tumor-associated
antigens that are expressed in a variety of solid tumor cancers;
and certain other non-denatured collagen related humanized,
monoclonal antibodies and peptides that potentially target
various solid tumors.
The fair value of the IPR&D projects was determined
utilizing the income approach, assuming that the rights to the
IPR&D projects will be sub-licensed to third parties in
exchange for certain up-front, milestone and royalty payments,
and the combined company will have no further involvement in the
ongoing development and commercialization of the projects. Under
the income approach, the expected future net cash flows from
sub-licensing for each IPR&D project are estimated,
risk-adjusted to reflect the risks inherent in the development
process and discounted to their net present value. Significant
factors considered in the calculation of the discount rate are
the weighted-average cost of capital and return on assets.
Management believes that the discount rate utilized is
consistent with the projects stage of development and the
uncertainties in the estimates described above. Because the
acquired IPR&D projects are in the early stages of the
development cycle, the amount allocated to IPR&D will be
recorded as an expense immediately upon completion of the merger.
146
The unaudited pro forma condensed combined financial statements
include certain pro forma adjustments to give effect to certain
significant capital transactions of Micromet occurring prior to
and as a direct result of the proposed merger, and the
acquisition of CancerVax by Micromet for accounting purposes.
The unaudited pro forma condensed combined financial statements
also include an adjustment for contractual severance liabilities
owed to the chief executive officer and certain other CancerVax
employees, in accordance with Emerging Issues Task Force, or
EITF,
No. 95-3,
Recognition of Liabilities in Connection with a Purchase
Business Combination. Additional employee severance,
employee relocation or restructuring costs associated with the
merger, if any, will result in additional assumed liabilities
and an adjustment to goodwill.
The unaudited pro forma condensed combined financial statements
do not include any adjustments for income taxes as the combined
company is anticipated to incur taxable losses for the
foreseeable future.
The pro forma adjustments are as follows (in thousands, except
share and per share amounts):
(A) The historical financial statements of Micromet have
been translated into US dollars, using an exchange rate of 1
Euro to 1.18445 US dollars for the balance sheet as of
December 31, 2005, and 1 Euro to 1.24539 US dollars for the
statement of operations for the year ended December 31,
2005. The balance sheet rate is the exchange rate as of
December 31, 2005. The statement of operations rate is an
average exchange rate for the year ended December 31, 2005.
(B) To eliminate CancerVaxs historical
stockholders equity accounts.
(C) To record the value of the CancerVax common stock,
stock options and stock warrants assumed in the merger.
(D) To reflect the conversion of all outstanding shares of
Micromet preferred stock into Micromet common stock and the
elimination of Micromets treasury stock. Upon completion
of the merger, all of the issued and outstanding shares of
Micromet common stock will be exchanged for
58,012,946 shares of CancerVax common stock pursuant to the
merger agreement.
(E) To adjust the common stock and additional paid-in
capital accounts to reflect the 85,945,106 shares of
CancerVax common stock, par value $0.00004, to be outstanding
upon the completion of the merger. The pro forma shares of
CancerVax common stock to be outstanding upon completion of the
merger has not been adjusted for the CancerVax reverse stock
split that is contemplated by Proposal No. 3.
(F) To eliminate CancerVaxs historical goodwill and
certain other assets, and leased facility exit and deferred rent
liabilities.
(G) To record the step-down in the basis of
CancerVaxs property and equipment from book value to
estimated fair value and reclassify property and equipment held
for sale to a current asset.
(H) To record the unfavorable lease liability for CancerVax
facility operating leases with above-market lease rates.
(I) To record the severance obligations due to David F.
Hale, CancerVaxs President and Chief Executive Officer,
and certain other CancerVax employees upon completion of the
merger. Mr. Hales employment will be terminated
effective upon completion of the merger, although Mr. Hale
will continue as the chairman of the board of directors of the
combined company. Because the expense associated with the
severance obligation is directly attributable to the merger and
will not have a continuing impact, it is not reflected in the
pro forma statement of operations. However, this item will be
recorded as an expense immediately following the completion of
the merger.
(J) To record the estimated fair value of in-process
research and development acquired in the merger. Because the
in-process research and development charge is directly
attributable to the merger and will not have a continuing
impact, it is not reflected in the pro forma statement of
operations. However, this item will be recorded as an expense
immediately following the completion of the merger.
147
(K) To record the deferred stock-based compensation
associated with unvested CancerVax stock options assumed in the
merger. The amortization of employee stock-based compensation
associated with the value of unvested CancerVax stock options
assumed in the merger has not been reflected in the pro forma
statement of operations because the amortization will not have a
material impact on continuing operations.
(L) To record Micromets estimated cash transaction
costs. CancerVaxs estimated transaction costs of
$2.4 million will be expensed as incurred and are not
reflected in the pro forma statement of operations.
(M) To reflect the cash repayment, upon completion of the
merger, of the $18.0 million of outstanding borrowings as
of December 31, 2005 under CancerVaxs
$18.0 million bank credit facility. The terms of the loan
agreement require that it be repaid in full upon the occurrence
of a change of control event, such as the completion of the
proposed merger.
(N) To reflect the cash repayment, upon completion of the
merger, of Micromets debtor warrant obligation with
Grundstücksverwaltungsgesellschaft mbH & Co.
Objekt Eins KG, or GEK, of 0.4 million
($0.4 million at the December 31, 2005 exchange rate).
(O) To reflect the settlement of certain of Micromets
long-term debt obligations with
Technologie-Beteiligungs-Gesellschaft mbH, or tbg, with a face
value of 2.2 million ($2.6 million at the
December 31, 2005 exchange rate) for a cash payment of
2.0 million ($2.4 million at the
December 31, 2005 exchange rate), due upon completion of
the merger. The difference between the cash settlement payment
and the face value of the debt obligations represents a gain on
debt restructuring. Because this item is directly attributable
to the merger and will not have a continuing impact, it is not
reflected in the pro forma statement of operations.
(P) To eliminate the interest expense recognized during the
year ended December 31, 2005 associated with
CancerVaxs $18.0 million bank credit facility as a
result of the repayment of the outstanding borrowings under this
credit facility upon completion of the merger.
(Q) To eliminate the interest expense recognized during the
year ended December 31, 2005 associated with certain of
Micromets long-term debt obligations with tbg as a result
of the settlement of the debt upon completion of the merger.
(R) To eliminate the historical depreciation expense on
property and equipment recognized by CancerVax for the year
ended December 31, 2005. The depreciation expense
associated with the value of CancerVax property and equipment
acquired in the merger has not been reflected in the pro forma
statements of operations because the depreciation expense will
not have a material impact on continuing operations.
(S) To adjust CancerVaxs historical amortization of
employee stock-based compensation to conform to Micromets
policy for accounting for stock-based compensation.
(T) To eliminate the estimated interest income earned
during the year ended December 31, 2005 by CancerVax as a
result of borrowing $18.0 million under its bank credit
facility in lieu of using existing cash, cash equivalents and
securities
available-for-sale.
(U) To eliminate the estimated interest income earned
during the year ended December 31, 2005 by Micromet as a
result of borrowing 2.2 million ($2.6 million at
the December 31, 2005 exchange rate) from tbg in lieu of
using existing cash, cash equivalents and securities
available-for-sale.
(V) To eliminate Micromets weighted average shares
outstanding and reflect the issuance of 58,012,946 shares
of CancerVax common stock pursuant to the merger agreement. The
pro forma weighted average shares outstanding upon completion of
the merger has not been adjusted for the CancerVax reverse stock
split that is contemplated by Proposal No. 3.
|
|
4.
|
Impact of
the Proposed Merger on Certain Micromet Debt
Obligations
|
Micromet has a convertible note payable to MedImmune Ventures,
Inc. with a face value of 10.0 million
($11.8 million at the December 31, 2005 exchange
rate). MedImmune Ventures has the right to convert the note in
full into shares of Micromet preference shares series (A new)
upon an initial public offering or reverse merger involving
Micromet if the pre-money valuation of Micromet in such
transaction is at least 120.0 million
148
($142.1 million at the December 31, 2005 exchange
rate). The conversion rate decreases ratably as Micromets
pre-money valuation in such transaction decreases. Additionally,
MedImmune Ventures has the right to call the note in full if,
immediately following an IPO or reverse merger involving
Micromet, the resulting entity has cash and cash equivalents in
excess of 60.0 million ($71.1 million at the
December 31, 2005 exchange rate). The callable amount of
the note decreases ratably as the amount of the cash and cash
equivalents of the resulting entity immediately following such
transaction decreases. No amount of the note is callable if the
cash and cash equivalents of the resulting entity immediately
following such transaction is less than 30.0 million
($35.5 million at the December 31, 2005 exchange
rate). If, at the time of closing of the merger, cash and cash
equivalents are lower than 30,000,000, no portion of the
note can be called. If cash and cash equivalents are between
30,000,000 and 60,000,000 following the completion
of the merger, the callable share of the note is adjusted pro
rata on a linear basis. MedImmune has informed Micromet that it
desires to convert its note to the fullest extent possible in
connection with the merger. Based upon the closing price of
CancerVax stock on March 27, 2006, it is expected that all
of the principal under the MedImmune note will convert in
connection with the merger. The MedImmune Ventures note is
classified as noncurrent in Micromets historical balance
sheet as of December 31, 2005.
Micromet has a non-interest bearing loan agreement with Curis,
Inc. with remaining unpaid borrowings at December 31, 2005
of 2.4 million ($2.9 million at the
December 31, 2005 exchange rate). On March 6, 2006,
Curis, Inc. filed a lawsuit against Micromet claiming that
Micromet is obligated to pay Curis the outstanding amount of
Curis convertible note of 2.0 million within
30 days after the completion of the exchange by Micromet
shareholders of a majority of the outstanding shares of Micromet
AG for shares of a third party. This would include the proposed
exchange of shares of Micromet AG for shares of Micromet, Inc.
that is contemplated by the terms of the Merger Agreement.
Micromet disputes Curis position. The total possible
exposure of Micromet is the amount claimed
(2.0 million), plus the costs of the proceedings. In
addition, if Curis prevails in the proceeding, it would be
entitled to interest on the claimed amount of
2.0 million at the base rate of the European Central
Bank plus 8%, accruing from the time of default. The remaining
unpaid balance of the Curis loan is classified as current in
Micromets historical balance sheet as of December 31,
2005.
149
CANCERVAX
EXECUTIVE COMPENSATION AND OTHER INFORMATION
CancerVax
Executive Officers and Key Employees
The following table sets forth information as to persons who
serve as our executive officers and key employees as of
March 27, 2006.
|
|
|
|
|
|
|
Name
|
|
Position
|
|
Age
|
|
|
David F. Hale
|
|
President, Chief Executive Officer
and Director
|
|
|
57
|
|
Hazel M. Aker, J.D.(1)
|
|
Senior Vice President, General
Counsel and Secretary
|
|
|
50
|
|
William R. LaRue(1)
|
|
Senior Vice President and Chief
Financial Officer
|
|
|
54
|
|
Guy Gammon, M.B., B.Sc.,
M.R.C.P.(U.K.)
|
|
Vice President, Clinical
Development
|
|
|
51
|
|
Dennis E. Van Epps, Ph.D(2)
|
|
Vice President, Research
|
|
|
59
|
|
|
|
|
(1) |
|
The voluntary resignation of Mr. LaRue will become
effective June 1, 2006 and the voluntary resignation of
Ms. Aker will become effective upon the closing of the
merger. Both Mr. LaRue and Ms. Aker have agreed to
provide consulting services to the combined company until
August 15, 2006, each for compensation of $50,000, in order
to assist in the post-merger integration activities. |
|
|
|
(2) |
|
The employment of Dr. Van Epps has been terminated without
cause by CancerVax, effective April 15, 2006. |
For information on Mr. Hale, see Proposal
No. 5 Election of CancerVax
Directors.
Hazel M. Aker, J.D. has served as our Senior Vice
President, General Counsel and Secretary since February 2003,
and as Vice President, General Counsel and Secretary from
February 2001 to February 2003. From April 2000 to March 2001,
Ms. Aker served as Vice President, General Counsel and
Secretary for Alaris Medical, Inc., and its subsidiary, Alaris
Medical Systems, Inc., a manufacturer of intravenous infusion
therapy products and patient monitoring systems. From October
1999 to April 2000, Ms. Aker served as Vice President and
General Counsel and, from December 1999 to April 2000, as Vice
President of Regulatory and Quality Affairs, for Women First
HealthCare, Inc. From May 1995 until October 1999, Ms. Aker
served as Corporate Vice President, Legal Affairs, and Assistant
General Counsel for Alaris Medical Systems, Inc., which was
formerly IVAC Medical Systems, Inc. Ms. Aker is a member of
the State Bar of California. Ms. Aker received a B.A. from
the University of California, San Diego and a J.D. from the
University of San Diego School of Law.
William R. LaRue has served as our Senior Vice President
and Chief Financial Officer since April 2001. From March 2000 to
February 2001, Mr. LaRue served as Executive Vice President
and Chief Financial Officer of eHelp Corporation, a provider of
user assistance software. From January 1997 to February 2000,
Mr. LaRue served as Vice President and Treasurer of
Safeskin Corporation, a publicly traded medical device company,
and from January 1993 to 1997 he served as Treasurer of GDE
Systems, Inc., a high technology electronic systems company.
Mr. LaRue received a B.S. in business administration and
M.B.A. from the University of Southern California.
Guy Gammon, M.B., B.Sc., M.R.C.P. (U.K.) has served as
our Vice President, Clinical Development since January 2001.
From 1994 to January 2001, Dr. Gammon held several senior
positions with JWCI, including Director, Vaccine Development and
Senior Director, Clinical Operations. At JWCI he was involved in
advancing the cancer vaccines for melanoma into Phase 3
clinical development. From August 1990 to June 1994,
Dr. Gammon served as Program Head for Immunology Discovery
at Xenova PLC, a U.K. biopharmaceutical company. Dr. Gammon
has over 30 publications in immunology, immunomodulation and
clinical immunotherapy. Dr. Gammon received a
bachelors degree in immunology and a medical degree at
University College London, London, U.K.
Dennis E. Van Epps, Ph.D. has served as our Vice
President, Research since November 2001, however Mr. Van
Epps has been terminated without cause by CancerVax, effective
April 15, 2006. From 2000 to 2001, Dr. Van Epps served
as Vice President of Research and Development, and from 1997 to
2001 as Vice President, Research, and an officer at Nexell
Therapeutics Inc., a publicly traded biotechnology company. From
1993 to 1997, Dr. Van Epps served as Vice President of
Research for Baxter Healthcare Corporations Immunotherapy
Division and as a Director at the Applied Cell Biology Center
from 1988 to 1993. From 1985 to 1988, Dr. Van Epps was a
Professor of
150
Medicine and Pathology at the University of New Mexico School
of Medicine. Prior to 1985 he held positions as Associate
Professor of Medicine and Pathology and Assistant Professor of
Medicine and Microbiology at the same medical school.
Dr. Van Epps obtained his postdoctoral training in
immunology in the Department of Medicine at the University of
New Mexico and has published over 135 manuscripts in the fields
of immunology, cell therapy, inflammation and stem cell biology.
He is also an inventor on nine patents in the fields of human
cell selection technology, stem cell culture and cell therapy.
Dr. Van Epps received a B.S. degree in zoology from Western
Illinois University and a Ph.D. in microbiology and immunology
from the University of Illinois Medical School in Chicago,
Illinois.
Executive
Compensation of CancerVax
Summary
Compensation Table
The following table sets forth certain information concerning
compensation for the fiscal years ended December 31, 2005,
2004 and 2003 received by our companys chief executive
officer and the four most highly compensated executive officers
of our company other than the chief executive officer who were
serving as executive officers as of the end of the last
completed fiscal year and, in the case of John Petricciani, who
served as an executive officer of CancerVax but was not serving
as such at the end of the last completed fiscal year (the
CancerVax Named Executive Officers).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long Term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
|
|
|
Securities
|
|
|
|
|
|
|
|
|
|
Annual Compensation
|
|
|
Other Annual
|
|
|
Stock
|
|
|
Underlying
|
|
|
All Other
|
|
Name and Principal
Position
|
|
Year
|
|
|
Salary
|
|
|
Bonus
|
|
|
Compensation(7)
|
|
|
Awards(9)
|
|
|
Options
|
|
|
Compensation
|
|
|
David F. Hale(1)
|
|
|
2005
|
|
|
$
|
534,375
|
|
|
$
|
190,750
|
(4)
|
|
$
|
|
|
|
$
|
178,425
|
|
|
|
442,200
|
(10)
|
|
$
|
17,337
|
(11)
|
President, Chief Executive
|
|
|
2004
|
|
|
|
509,583
|
|
|
|
221,450
|
(5)
|
|
|
|
|
|
|
|
|
|
|
200,000
|
|
|
|
23,451
|
(12)
|
Officer and Director
|
|
|
2003
|
|
|
|
450,000
|
|
|
|
202,500
|
(5)
|
|
|
|
|
|
|
|
|
|
|
250,000
|
|
|
|
11,223
|
(13)
|
Hazel M. Aker, J.D.(2)
|
|
|
2005
|
|
|
|
252,279
|
|
|
|
63,700
|
(4)
|
|
|
|
|
|
|
89,213
|
|
|
|
212,550
|
(10)
|
|
|
|
|
Senior Vice President,
|
|
|
2004
|
|
|
|
229,167
|
|
|
|
68,727
|
(5)
|
|
|
|
|
|
|
|
|
|
|
50,000
|
|
|
|
|
|
General Counsel and Secretary
|
|
|
2003
|
|
|
|
218,450
|
|
|
|
71,706
|
(5)
|
|
|
|
|
|
|
|
|
|
|
39,772
|
|
|
|
|
|
William R. LaRue(2)
|
|
|
2005
|
|
|
|
251,084
|
|
|
|
61,740
|
(4)
|
|
|
|
|
|
|
89,213
|
|
|
|
197,550
|
(10)
|
|
|
|
|
Senior Vice President and
|
|
|
2004
|
|
|
|
240,151
|
|
|
|
73,806
|
(5)
|
|
|
|
|
|
|
|
|
|
|
50,000
|
|
|
|
|
|
Chief Financial Officer
|
|
|
2003
|
|
|
|
230,155
|
|
|
|
73,007
|
(5)
|
|
|
|
|
|
|
|
|
|
|
22,727
|
|
|
|
|
|
Guy Gammon, M.B., B.Sc.,
M.R.C.P.(U.K.)
|
|
|
2005
|
|
|
|
223,500
|
|
|
|
55,125
|
(4)
|
|
|
|
|
|
|
89,213
|
|
|
|
142,050
|
(10)
|
|
|
|
|
Vice President,
|
|
|
2004
|
|
|
|
206,417
|
|
|
|
62,126
|
(5)
|
|
|
|
|
|
|
|
|
|
|
30,000
|
|
|
|
|
|
Clinical Development
|
|
|
2003
|
|
|
|
198,750
|
|
|
|
61,425
|
(5)
|
|
|
|
|
|
|
|
|
|
|
28,409
|
|
|
|
|
|
Dennis E. Van Epps, Ph.D.
|
|
|
2005
|
|
|
|
221,750
|
|
|
|
54,635
|
(4)
|
|
|
|
|
|
|
89,213
|
|
|
|
142,050
|
(10)
|
|
|
|
|
Vice President, Research
|
|
|
2004
|
|
|
|
207,333
|
|
|
|
61,425
|
(5)
|
|
|
|
|
|
|
|
|
|
|
30,000
|
|
|
|
|
|
|
|
|
2003
|
|
|
|
199,167
|
|
|
|
63,394
|
(5)
|
|
|
|
|
|
|
|
|
|
|
28,409
|
|
|
|
|
|
John Petricciani, M.D.(3)
|
|
|
2005
|
|
|
|
237,050
|
|
|
|
50,492
|
(6)
|
|
|
30,824
|
(8)
|
|
|
89,213
|
|
|
|
142,550
|
(10)
|
|
|
231,000
|
(14)
|
Former Senior Vice President,
|
|
|
2004
|
|
|
|
217,276
|
|
|
|
65,464
|
(5)
|
|
|
33,466
|
(8)
|
|
|
|
|
|
|
35,000
|
|
|
|
|
|
Medical and Regulatory Affairs
|
|
|
2003
|
|
|
|
215,775
|
|
|
|
68,182
|
(5)
|
|
|
29,665
|
(8)
|
|
|
|
|
|
|
34,090
|
|
|
|
|
|
|
|
|
|
(1)
|
Mr. Hale will be the chairman of the board of directors of
the combined company but will not be an executive officer of the
combined company.
|
|
|
|
|
(2)
|
The voluntary resignation of Mr. LaRue will become
effective June 1, 2006 and the voluntary resignation of
Ms. Aker will become effective upon the closing of the
merger. Both Mr. LaRue and Ms. Aker have agreed to
provide consulting services to the combined company until
August 15, 2006, each for compensation of $50,000, in order
to assist in the post-merger integration activities.
|
|
|
|
|
(3)
|
Dr. Petriccianis employment with CancerVax was
terminated effective December 16, 2005.
|
|
|
|
|
(4)
|
Represents the annual performance bonuses earned for fiscal year
2005, to be paid in fiscal year 2006.
|
|
|
|
|
(5)
|
Represents the annual performance bonuses earned for fiscal
years 2004 and 2003, but paid in the following year.
|
151
|
|
|
|
(6)
|
Represents the pro rata portion of Dr. Petriccianis
annual performance bonus earned for fiscal year 2005, calculated
as the average of the annual performance bonuses earned by
Dr. Petricciani for the previous three fiscal years, paid
to Dr. Petricciani upon termination of his employment with
CancerVax.
|
|
|
|
|
(7)
|
In accordance with the rules of the Securities and Exchange
Commission, the other annual compensation described in this
table does not include various perquisites and other personal
benefits received by the named executive officers that do not
exceed the lesser of $50,000 or 10% of any such officers
salary and bonus disclosed in this table.
|
|
|
|
|
(8)
|
Represents amounts paid to Dr. Petricciani as a housing and
commuting allowance, including
gross-up
payments for the estimated income taxes attributable to the
housing and commuting benefit of $11,460, $11,732 and $9,941 in
2005, 2004 and 2003, respectively.
|
|
|
|
|
(9)
|
The value of restricted stock awards granted to the CancerVax
Named Executive Officers is based on the closing sale price of
CancerVax common stock on the date of grant. In February 2006,
as a result of the discontinuation of the clinical trials and
further development of Canvaxin, the compensation committee of
CancerVaxs board of directors confirmed the forfeiture of
all of the shares of restricted stock granted to the CancerVax
Named Executive Officers during the fiscal year ended
December 31, 2005.
|
|
|
(10) |
Of the stock options granted to the CancerVax Named Executive
Officers during the fiscal year ended December 31, 2005,
options to purchase 67,500 shares of CancerVax common stock
granted to Mr. Hale and options to purchase 33,750 shares of
CancerVax common stock granted to each of Ms. Aker, Mr. LaRue,
Dr. Gammon, Dr. Van Epps and Dr. Petricciani, were confirmed by
the compensation committee of CancerVaxs board of
directors to be forfeited as a result of the discontinuation of
the clinical trials and further development of Canvaxin.
|
|
|
(11) |
Represents $11,223 for disability insurance premiums for 2005
and $6,114 for whole life insurance premiums for 2005 paid on
behalf of Mr. Hale.
|
|
|
(12) |
Represents $11,223 for disability insurance premiums for 2004
and $12,228 for whole life insurance premiums for 2004 and 2003
paid on behalf of Mr. Hale.
|
|
|
(13) |
Represents disability insurance premiums paid on behalf of
Mr. Hale.
|
|
|
(14) |
Represents $231,000 of severance paid to Dr. Petricciani
upon termination of his employment with CancerVax.
|
Option
Grants in Last Fiscal Year
The following table sets forth information regarding stock
options granted by CancerVax during the year ended
December 31, 2005 to each of the CancerVax Named Executive
Officers. During the year ended December 31, 2005,
CancerVax granted stock options to purchase an aggregate of
4,130,756 shares of CancerVax common stock, of which
4,036,780 shares were granted to employees. All options
were granted at the fair market value of CancerVax common stock
on the date of grant.
152
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Individual Grants
|
|
|
Potential Realizable
|
|
|
|
Number of
|
|
|
Percent of
|
|
|
|
|
|
|
|
|
Value of Assumed
|
|
|
|
Securities
|
|
|
Options Granted
|
|
|
|
|
|
|
|
|
Annual Rates of Stock
|
|
|
|
Underlying
|
|
|
to CancerVax
|
|
|
Exercise
|
|
|
|
|
|
Price Appreciation For
|
|
|
|
Options
|
|
|
Employees in
|
|
|
Price per
|
|
|
Expiration
|
|
|
Option Term(5)
|
|
Name
|
|
Granted
|
|
|
Fiscal Year
|
|
|
Share
|
|
|
Date
|
|
|
5%
|
|
|
10%
|
|
|
David F. Hale
|
|
|
74,700
|
(1)
|
|
|
1.9
|
%
|
|
$
|
7.93
|
|
|
|
2/9/2015
|
|
|
$
|
372,539
|
|
|
$
|
944,087
|
|
|
|
|
67,500
|
(2)
|
|
|
1.7
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
336,632
|
|
|
|
853,090
|
|
|
|
|
150,000
|
(3)
|
|
|
3.7
|
|
|
|
2.82
|
|
|
|
6/14/2015
|
|
|
|
266,022
|
|
|
|
674,153
|
|
|
|
|
150,000
|
(4)
|
|
|
3.7
|
|
|
|
1.48
|
|
|
|
11/3/2015
|
|
|
|
139,615
|
|
|
|
353,811
|
|
Hazel M. Aker, J.D.
|
|
|
58,800
|
(1)
|
|
|
1.5
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
293,244
|
|
|
|
743,137
|
|
|
|
|
33,750
|
(2)
|
|
|
0.8
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
168,316
|
|
|
|
426,545
|
|
|
|
|
35,000
|
(3)
|
|
|
0.9
|
|
|
|
2.82
|
|
|
|
6/14/2015
|
|
|
|
62,072
|
|
|
|
157,302
|
|
|
|
|
15,000
|
(1)
|
|
|
0.4
|
|
|
|
2.82
|
|
|
|
6/14/2015
|
|
|
|
26,602
|
|
|
|
67,415
|
|
|
|
|
70,000
|
(4)
|
|
|
1.7
|
|
|
|
1.48
|
|
|
|
11/3/2015
|
|
|
|
65,153
|
|
|
|
165,112
|
|
William R. LaRue
|
|
|
58,800
|
(1)
|
|
|
1.5
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
293,244
|
|
|
|
743,137
|
|
|
|
|
33,750
|
(2)
|
|
|
0.8
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
168,316
|
|
|
|
426,545
|
|
|
|
|
35,000
|
(3)
|
|
|
0.9
|
|
|
|
2.82
|
|
|
|
6/14/2015
|
|
|
|
62,072
|
|
|
|
157,302
|
|
|
|
|
70,000
|
(4)
|
|
|
1.7
|
|
|
|
1.48
|
|
|
|
11/3/2015
|
|
|
|
65,153
|
|
|
|
165,112
|
|
Guy Gammon, M.B., B.Sc.,
M.R.C.P.(U.K.)
|
|
|
33,300
|
(1)
|
|
|
0.8
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
166,072
|
|
|
|
420,858
|
|
|
|
|
33,750
|
(2)
|
|
|
0.8
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
168,316
|
|
|
|
426,545
|
|
|
|
|
25,000
|
(3)
|
|
|
0.6
|
|
|
|
2.82
|
|
|
|
6/14/2015
|
|
|
|
44,337
|
|
|
|
112,359
|
|
|
|
|
50,000
|
(4)
|
|
|
1.2
|
|
|
|
1.48
|
|
|
|
11/3/2015
|
|
|
|
46,538
|
|
|
|
117,937
|
|
Dennis E. Van
Epps, Ph.D.
|
|
|
33,300
|
(1)
|
|
|
0.8
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
166,072
|
|
|
|
420,858
|
|
|
|
|
33,750
|
(2)
|
|
|
0.8
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
168,316
|
|
|
|
426,545
|
|
|
|
|
25,000
|
(3)
|
|
|
0.6
|
|
|
|
2.82
|
|
|
|
6/14/2015
|
|
|
|
44,337
|
|
|
|
112,359
|
|
|
|
|
50,000
|
(4)
|
|
|
1.2
|
|
|
|
1.48
|
|
|
|
11/3/2015
|
|
|
|
46,538
|
|
|
|
117,937
|
|
John Petricciani, M.D.
|
|
|
58,800
|
(1)
|
|
|
1.5
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
293,244
|
|
|
|
743,137
|
|
|
|
|
33,750
|
(2)
|
|
|
0.8
|
|
|
|
7.93
|
|
|
|
2/9/2015
|
|
|
|
168,316
|
|
|
|
426,545
|
|
|
|
|
25,000
|
(3)
|
|
|
0.6
|
|
|
|
2.82
|
|
|
|
6/14/2015
|
|
|
|
44,337
|
|
|
|
112,359
|
|
|
|
|
25,000
|
(4)
|
|
|
0.6
|
|
|
|
1.48
|
|
|
|
11/3/2015
|
|
|
|
23,269
|
|
|
|
58,968
|
|
|
|
|
(1) |
|
Options vest monthly over 48 months. Vesting of the options
will be accelerated in the event of certain change in control
events (each as defined and subject to the terms of the
underlying stock option agreement and the executive
officers employment agreement). |
|
|
|
(2) |
|
Options would vest only upon CancerVaxs satisfaction of
certain performance targets, as follows: one third of the shares
subject to such stock option will vest upon the successful
completion of all conformance lots required for submission of a
Biologics License Application (BLA) for
Canvaxintm,
and the remaining two thirds of the shares subject to such stock
option would vest upon the approval of a BLA or equivalent
marketing authorization for
Canvaxintm in the
U.S. or E.U. In February 2006, due to the previous
discontinuation of all clinical trials and further development
of Canvaxin, the compensation committee of CancerVaxs
board of directors confirmed the termination of these options. |
|
|
|
(3) |
|
Options vested upon the disclosure of the final results of the
Canvaxintm
MMAIT-III Phase 3 clinical trial in patients with
Stage III melanoma, which occurred on October 3, 2005. |
|
|
|
(4) |
|
Options vest monthly over 24 months. Vesting of the options
will be accelerated in the event of certain change in control
events (each as defined and subject to the terms of the
underlying stock option agreement and the executive
officers employment agreement). |
|
|
|
(5) |
|
The potential realizable value listed in the table represents
hypothetical gains that could be achieved for the options if
exercised at the end of the option term based on assumed rates
of stock price appreciation of 5% and 10% compounded annually
from the date the options were granted to their expiration date.
The 5% and 10% |
153
|
|
|
|
|
rates of appreciation are provided in accordance with the rules
of the Securities and Exchange Commission and do not represent
our estimate or projection of our future stock value. Actual
gains, if any, on option exercises will depend on the future
performance of our common stock and overall market conditions.
The potential realizable value computation does not take into
account federal or state income tax consequences of option
exercises or sales of appreciated stock. |
Aggregated
Option Exercises in Last Fiscal Year and Fiscal Year End Option
Values
The following table sets forth information regarding option
exercises in the year ended December 31, 2005 and
unexercised stock options held by the CancerVax Named Executive
Officers as of December 31, 2005. Certain of the options
shown as exercisable in the table below are immediately
exercisable, but CancerVax has the right to purchase the shares
of unvested common stock underlying some of these options upon
termination of the holders employment with CancerVax.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities
|
|
|
Value of Unexercised
|
|
|
|
|
|
|
|
|
|
Underlying Unexercised
|
|
|
In the Money
|
|
|
|
Shares
|
|
|
|
|
|
Options at
|
|
|
Options at
|
|
|
|
Acquired
|
|
|
Value
|
|
|
December 31,
2005(1)
|
|
|
December 31,
2005(2)
|
|
Name
|
|
on Exercise
|
|
|
Realized
|
|
|
Exercisable
|
|
|
Unexercisable(9)
|
|
|
Exercisable
|
|
|
Unexercisable
|
|
|
David F. Hale(3)
|
|
|
|
|
|
|
|
|
|
|
1,022,495
|
|
|
|
382,889
|
|
|
$
|
93,209
|
|
|
$
|
|
|
Hazel M. Aker, J.D.(4)
|
|
|
|
|
|
|
|
|
|
|
131,774
|
|
|
|
187,593
|
|
|
|
|
|
|
|
|
|
William R. LaRue(5)
|
|
|
|
|
|
|
|
|
|
|
109,445
|
|
|
|
174,468
|
|
|
|
|
|
|
|
|
|
Guy Gammon, M.B., B.Sc.,
M.R.C.P.(U.K.)(6)
|
|
|
|
|
|
|
|
|
|
|
93,224
|
|
|
|
124,280
|
|
|
|
|
|
|
|
|
|
Dennis E. Van Epps, Ph.D.(7)
|
|
|
|
|
|
|
|
|
|
|
81,860
|
|
|
|
124,280
|
|
|
|
|
|
|
|
|
|
John Petricciani, M.D.(8)
|
|
|
|
|
|
|
|
|
|
|
142,107
|
|
|
|
77,059
|
(10)
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Vesting of certain options will be accelerated in the event of
certain change in control events (each as defined and subject to
the terms of the underlying stock option agreement and the
executive officers employment agreement). |
|
|
|
(2) |
|
Based on the closing sale price of CancerVax common stock on
December 30, 2005 ($1.38), as reported by the Nasdaq
National Market, less the option exercise price. |
|
|
|
(3) |
|
Of the options exercisable by Mr. Hale at December 31,
2005, 101,339 of the shares of CancerVax common stock that would
be acquired upon exercise of these options would be subject to
repurchase by CancerVax at the original $3.30 per share
exercise price if, before the option shares have vested,
Mr. Hales employment terminates, subject to
exceptions. Through December 31, 2005, Mr. Hale has
exercised options to acquire 192,593 shares of CancerVax
common stock, none of which are subject to repurchase. Mr.
Hales amended and restated employment agreement provides
that, upon his termination of employment following the closing
of the merger, all of Mr. Hales unvested stock awards will
become immediately vested. |
|
|
|
(4) |
|
Of the options exercisable by Ms. Aker at December 31,
2005, 15,602 of the shares of CancerVax common stock that would
be acquired upon exercise of these options would be subject to
repurchase by CancerVax at the original $3.30 per share
exercise price if, before the option shares have vested,
Ms. Akers employment terminates, subject to
exceptions. Through December 31, 2005, Ms. Aker has
exercised options to acquire 39,771 shares of CancerVax
common stock, none of which are subject to repurchase. |
|
|
|
(5) |
|
Of the options exercisable by Mr. LaRue at
December 31, 2005, 9,376 of the shares of CancerVax common
stock that would be acquired upon exercise of these options
would be subject to repurchase by CancerVax at the original
$3.30 per share exercise price if, before the option shares
have vested, Mr. LaRues employment terminates,
subject to exceptions. Through December 31, 2005,
Mr. LaRue has exercised options to acquire
68,181 shares of CancerVax common stock, none of which are
subject to repurchase. |
|
|
|
(6) |
|
Of the options exercisable by Dr. Gammon at
December 31, 2005, 11,719 of the shares of CancerVax common
stock that would be acquired upon exercise of these options
would be subject to repurchase by CancerVax at the original
$3.30 per share exercise price if, before the option shares
have vested, |
154
|
|
|
|
|
Dr. Gammons employment terminates, subject to
exceptions. Through December 31, 2005, Dr. Gammon has
exercised options to acquire 22,727 shares of CancerVax
common stock, none of which are subject to repurchase. |
|
|
|
(7) |
|
Of the options exercisable by Dr. Van Epps at
December 31, 2005, 11,008 of the shares of CancerVax common
stock that would be acquired upon exercise of these options
would be subject to repurchase by CancerVax at the original
$3.30 per share exercise price if, before the option shares
have vested, Dr. Van Eppss employment terminates,
subject to exceptions. Through December 31, 2005,
Dr. Van Epps exercised options to acquire
34,090 shares of CancerVax common stock, none of which are
subject to repurchase. |
|
|
|
(8) |
|
Of the options exercisable by Dr. Petricciani at
December 31, 2005, none of the shares of CancerVax common
stock that would be acquired upon exercise of these options
would be subject to repurchase. Through December 31, 2005,
Dr. Petricciani exercised options to acquire
34,090 shares of CancerVax common stock, none of which are
subject to repurchase. |
|
|
|
(9) |
|
Of the unexercisable stock options held by the Named Executive
Officers at December 31, 2005, options to purchase
67,500 shares of CancerVax common stock held by
Mr. Hale and options to purchase 33,750 shares of
CancerVax common stock held by each of Ms. Aker,
Mr. LaRue, Dr. Gammon and Dr. Van Epps were
terminated by the compensation committee of CancerVaxs
board of directors in February 2006. |
|
|
|
(10) |
|
In accordance with the terms of the amended and restated
employment agreement with Dr. Petricciani, for stock awards
granted to Dr. Petricciani on or after the date of the
amended and restated employment agreement, if
Dr. Petriccianis employment with CancerVax is
terminated within six months prior to or within 12 months
following a change of control of CancerVax, any remaining
unvested portion of such stock awards will immediately vest on
the later of the date of termination or the date of the change
of control. Since Dr. Petriccianis employment with
CancerVax was terminated prior to a change of control of
CancerVax, Dr. Petriccianis remaining unvested stock
awards upon his termination remain outstanding until the later
of six months following the date of termination or the date of a
change of control. |
Restricted
Stock Award Grants in Last Fiscal Year
During the year ended December 31, 2005, CancerVax granted
restricted stock awards to the CancerVax Named Executive
Officers as follows: Mr. Hale, 22,500 shares;
Ms. Aker, 11,250 shares; Mr. LaRue,
11,250 shares; Dr. Gammon, 11,250 shares;
Dr. Van Epps, 11,250 shares; and Dr. Petricciani,
11,250 shares. The restricted stock awards granted to the
CancerVax Named Executive Officers gave each officer the right
to purchase an equivalent number of shares of CancerVaxs
common stock at a purchase price per share of $0.00004, which is
the par value of CancerVaxs common stock. The restricted
stock was subject to repurchase until such time that it vests.
The restricted stock awards would vest only upon
CancerVaxs submission of a BLA for
Canvaxintm.
In February 2006, due to the previous discontinuation of all
clinical trials and further development of Canvaxin, the
compensation committee of CancerVaxs board of directors
confirmed the forfeiture of these shares of restricted stock.
Compensation
of Directors
In fiscal year 2005, our directors received an annual fee of
$16,000 for service as a director. In addition, our directors
received $1,500 for each regularly scheduled board meeting and
$750 for each regularly scheduled committee meeting. We
reimbursed our directors for their reasonable expenses incurred
in attending meetings of our board of directors. Our directors
may participate in our stock incentive plans and
employee-directors may participate in our employee stock
purchase plan. Any independent director who was elected to our
board of directors was granted an option to purchase
25,000 shares of our common stock on the date of his or her
initial election to our board of directors. In addition, each
independent director was granted an option to purchase
10,000 shares of common stock on the date of each annual
meeting of stockholders at an exercise price per share equal to
the fair market value of our common stock on such date. The
chairman of our audit committee received an additional annual
option to purchase 5,000 shares of common stock and the
chairman of each of our compensation committee and our
nominating/corporate governance committee received an additional
annual option to purchase 2,500 shares of our common stock.
155
Employment
Arrangements and Change in Control Arrangements
Employment Agreement with David F. Hale. On
October 23, 2000, we entered into an employment agreement
with David F. Hale, our President and Chief Executive Officer,
which was subsequently amended and restated on November 15,
2004, and extended on October 14, 2005. Pursuant to the
agreement, Mr. Hale is required to devote substantially all
of his time and attention to our business and affairs. The
employment agreement has a five-year term.
The amended and restated employment agreement sets forth
Mr. Hales initial base salary of $515,000, which is
subject to increase upon review annually by and at the sole
discretion of our compensation committee and as approved by our
board of directors. Mr. Hales 2005 base salary was
$545,000. Pursuant to the amended and restated employment
agreement, Mr. Hale is entitled to participate in any
management incentive compensation plan adopted by us and will be
paid an annual bonus in accordance with the terms of such plan
as determined by the compensation committee of our board of
directors and as approved by our board of directors. We have
also agreed to pay the annual premiums on a disability insurance
policy and a $1 million life insurance policy on
Mr. Hale.
Mr. Hales amended and restated employment agreement
provides him with certain severance benefits in the event his
employment is terminated. In the event Mr. Hales
employment is terminated as a result of his death or permanent
disability, his estate will receive 12 months of salary
continuation payments, an amount equal to the average of
Mr. Hales annual bonuses for the three fiscal years
prior to the termination, plus healthcare and life insurance
benefits continuation at our expense for 12 months. In
addition, that portion of Mr. Hales stock awards
which would have vested if Mr. Hale had remained employed
for an additional 12 months will immediately vest on the
date of termination. The amended and restated employment
agreement also provides that, in the event Mr. Hales
employment is terminated by us other than for cause or if
Mr. Hale resigns for good reason, he will receive
12 months of salary continuation payments, an amount equal
to the average of his annual bonuses for the three fiscal years
prior to the termination, healthcare and life insurance benefits
continuation at our expense for 12 months, plus $15,000
towards outplacement services. If such termination or
resignation occurs more than six months prior to or more than
12 months following a change of control of our company,
that portion of Mr. Hales stock awards which would
have vested if Mr. Hale had remained employed for an
additional 12 months will immediately vest on the date of
termination. If Mr. Hales employment is terminated by
us other than for cause or if he resigns with good reason within
six months prior to or within 12 months following a change
of control, Mr. Hale will be entitled to receive
18 months of salary continuation payments, an amount equal
to the average of his bonuses for the three fiscal years prior
to the date of termination payable over an 18 month period
commencing on the date of termination, healthcare and life
insurance benefits continuation at our expense for
18 months, plus $15,000 towards outplacement services.
Mr. Hales amended and restated agreement also
provides that, in the event of a change of control of our
company, 50% of Mr. Hales unvested stock awards will
become immediately vested and all of his remaining unvested
stock awards will become immediately vested if Mr. Hale is
still employed by or providing services to us on the six-month
anniversary of the change of control. In addition, with respect
to stock awards granted prior to the date of the amended and
restated employment agreement, if Mr. Hales
employment is terminated by us other than for cause, or if
Mr. Hale resigns with good reason, dies or becomes
permanently disabled, in each case within six months following a
change of control of our company, any remaining unvested portion
of such stock awards will immediately vest on the date of
termination. With respect to stock awards granted on or after
the date of the amended and restated employment agreement, if
Mr. Hale is terminated by us other than for cause, resigns
with good reason, dies or becomes permanently disabled, in each
case within six months prior to or within six months following a
change of control of our company, any remaining unvested portion
of such stock awards will immediately vest on the later of the
date of termination or the date of the change of control.
For purposes of Mr. Hales amended and restated
employment agreement, cause generally means
Mr. Hales commission of an act of fraud, embezzlement
or dishonesty upon us that has a material adverse impact on us,
his conviction of, or plea of guilty or no contest to a felony,
his ongoing and repeated failure or refusal to perform or
neglect of his duties (where such failure, refusal or neglect
continues for 15 days following his receipt of notice from
us), his gross negligence, insubordination, material violation
of any duty of loyalty to us or any other material misconduct on
his part, his unauthorized use or disclosure of our confidential
information or trade secrets that has a material adverse impact
on us or a material breach of his employment agreement. Prior to
any determination by us
156
that cause has occurred, we will provide
Mr. Hale with written notice of the reasons for such
determination, afford him a reasonable opportunity to remedy any
such breach, and provide him an opportunity to be heard prior to
the final decision to terminate his employment.
For purposes of Mr. Hales amended and restated
employment agreement, good reason generally means a
change by us in Mr. Hales status, position or
responsibilities that represents a substantial and material
reduction thereto, the assignment to him of any duties or
responsibilities materially inconsistent with his status,
position or responsibilities, the removal of Mr. Hale or
failure to reappoint or reelect Mr. Hale to any position
(except in connection with a termination for cause, his death or
disability, or resignation without good reason), a reduction by
us in his base salary (other than pursuant to a company-wide
reduction of base salaries for employees of the company
generally), a reduction by us in his compensation and benefits
as provided on the date of the agreement, his relocation by us
to a facility or location more than 50 miles from his place
of employment, our material breach of the employment agreement,
or any purported termination by us for cause that does not
conform to the definition of cause in the employment agreement.
In addition, good reason will also exist if
Mr. Hale has not received a contemporaneous increase in his
total compensation (including benefits) which is commensurate
with increases in total compensation (including benefits)
received by a majority of our officers or if he has earned, but
not been paid, a bonus for any period under any management
incentive compensation plan adopted by us, but a majority of our
officers have been paid bonuses for such period under such plan.
Other Employment Agreements. We have also
entered into employment agreements with Hazel M. Aker, Guy
Gammon, William R. LaRue and Dennis E. Van Epps, which were
amended and restated on November 15, 2004, and with Carol
G. Gallagher and Jeffrey Silverman, which were amended on
March 15, 2006.
Pursuant to the employment agreements, each executive is
required to devote substantially all of his or her time and
attention to our business and affairs. The employment agreements
set forth the executives base salaries and annual cash
bonus eligibility. The initial base salaries of the executives
called for by these employment agreements and their 2005 base
salaries are as follows: Hazel M. Aker ($230,000, $260,000),
Carol G. Gallagher ($215,000, $215,000), Guy Gammon ($207,000,
$225,000), William R. LaRue ($241,000, $252,000), Jeffrey
Silverman ($215,000, $215,000) and Dennis E. Van Epps ($208,000,
$233,000). The employment of Ms. Gallagher,
Mr. Silverman and Mr. Van Epps has been terminated
without cause by CancerVax, effective March 15, 2006,
March 15, 2006 and April 15, 2006, respectively. The
voluntary resignation of William R. LaRue will become effective
June 1, 2006, and the voluntary resignation of Hazel M.
Aker will become effective upon the closing of the merger;
however both Mr. LaRue and Ms. Aker have agreed to
provide consulting services to the combined company until
August 15, 2006, each for compensation of $50,000, in order
to assist with post-merger integration activities. The
employment agreements do not provide for automatic annual
increases in salary, but each agreement provides for annual
salary reviews by the compensation committee of the board of
directors. Each of the executives is entitled to participate in
any management incentive compensation plan adopted by us and
will be paid an annual bonus in accordance with the terms of
such plan as determined by the Compensation Committee of our
board of directors and as approved by our board of directors. We
may terminate any of the agreements for any reason.
The employment agreements provide the executives with certain
severance benefits in the event his or her employment is
terminated. In the event the executives employment is
terminated as a result of his or her death or permanent
disability, the executives or his or her estate, as
applicable, will receive 12 months of salary continuation
payments, an amount equal to the average of the executives
annual bonuses for the three fiscal years prior to the
termination, prorated for the period during the fiscal year that
the executive was employed, plus healthcare and life insurance
benefits continuation at our expense for 12 months. In
addition, that portion of the executives stock awards
which would have vested if he or she had remained employed for
an additional 12 months will immediately vest on the date
of termination. The employment agreements also provides that, in
the event the executives employment is terminated by us
other than for cause or if the executive resigns for good
reason, he or she will receive 12 months of salary
continuation payments, an amount equal to the average of his or
her annual bonuses for the three fiscal years prior to the
termination, prorated for the period during the fiscal year that
the executive was employed, healthcare and life insurance
benefits continuation at our expense for 12 months, plus
$15,000 towards outplacement services. If such termination or
resignation occurs more than six months prior to or more than
12 months following a change of control of our company,
that portion of the executives stock awards which would
have vested if he or she had remained employed for an additional
12 months will immediately vest on the date of termination.
Since Mr. LaRue and Ms.
157
Aker have resigned without good reason, they will not be
entitled to any of the foregoing severance benefits under their
employment agreements.
The employment agreements also provide that, in the event of a
change of control of our company, 50% of each executives
unvested stock awards, excluding the March 2006 stock awards to
Mr. Hale, Mr. LaRue, Mr. Van Epps, Dr. Gammon and Ms. Aker, will
immediately become vested. In addition, with respect to stock
awards granted prior to the date of the employment agreements,
if the executives employment is terminated by us other
than for cause or if he or she resigns with good reason within
12 months following a change of control of our company, any
remaining unvested portion of such stock awards will immediately
vest on the date of termination. With respect to stock awards
granted on or after the date of the amended and restated
employment agreements, if such termination occurs within six
months prior to or within 12 months following a change of
control of our company, any remaining unvested portion of such
stock awards will immediately vest on the later of the date of
termination or the date of the change of control.
For purposes of the employment agreements, cause
generally means the executives commission of an act of
fraud, embezzlement or dishonesty upon us that has a material
adverse impact on us, the executives conviction of, or
plea of guilty or no contest to a felony, the executives
ongoing and repeated failure or refusal to perform or neglect of
his or her duties (where such failure, refusal or neglect
continues for 15 days following the executives
receipt of notice from us), the executives gross
negligence, insubordination, material violation of any duty of
loyalty to us or any other material misconduct on the part of
the executive, the executives unauthorized use or
disclosure of our confidential information or trade secrets that
has a material adverse impact on us or a material breach by the
executive of his or her employment agreement. Prior to any
determination by us that cause has occurred, we will
provide the executive with written notice of the reasons for
such determination, afford the executive a reasonable
opportunity to remedy any such breach, and provide the executive
an opportunity to be heard prior to the final decision to
terminate the executives employment.
For purposes of the employment agreements, good
reason generally means a change by us in the
executives status, position or responsibilities that
represents a substantial and material reduction thereto, the
assignment to the executive of any duties or responsibilities
materially inconsistent with his or her status, position or
responsibilities, the removal of the executive or failure to
reappoint or reelect the executive to any position (except in
connection with a termination for cause, his or her death or
disability, or resignation without good reason), a reduction by
us in the executives base salary (other than pursuant to a
company-wide reduction of base salaries for employees of the
company generally), a reduction by us in the executives
compensation and benefits as provided on the date of the
agreement, the executives relocation by us to a facility
or location more than 50 miles from the executives
place of employment, our material breach of the employment
agreement, or any purported termination by us for cause that
does not conform to the definition of cause in the employment
agreement.
Compensation
Committee Interlocks and Insider Participation
Drs. Royston, Carter and La Force serve on the compensation
committee of our board of directors. No member of the
compensation committee was at any time during the 2005 fiscal
year or at any other time an officer or employee of the Company.
None of our executive officers serve, or in the past year has
served, as a member of the board of directors or compensation
committee of any entity that has one or more executive officers
serving on our compensation committee. None of our executive
officers serve, or in the past year has served, as a member of
the compensation committee of any entity that has one or more
executive officers serving on our board of directors.
158
CancerVax
Performance Graph
The following graph illustrates a comparison of the total
cumulative stockholder return on our common stock (traded under
the symbol CNVX) since October 30, 2003, the date our stock
commenced public trading, through December 31, 2005 to two
indices: the Nasdaq Composite Index, U.S. Companies, and
the Nasdaq Pharmaceuticals Index. The graph assumes an initial
investment of $100 on October 30, 2003. The comparisons in
the graph are required by the Securities and Exchange Commission
and are not intended to forecast or be indicative of possible
future performance of our common stock.
Comparison
of Cumulative Total Return on Investment
Since October 30, 2003
159
CancerVax
Compensation Committee Report on Executive
Compensation
The compensation committee is composed of three directors of our
board of directors, each of whom is a non-employee
director within the meaning of
Rule 16b-3
under the Exchange Act and an outside director
within the meaning of Section 162(m) of the Code. The
compensation committee receives and approves each of the
elements of the executive compensation program of our company
and continually assesses the effectiveness and competitiveness
of the program. In addition, the compensation committee
administers the stock option program and other key provisions of
the executive compensation program and reviews with our board of
directors all aspects of the compensation structure for our
companys executives. Set forth below in full is the report
of the compensation committee regarding compensation paid by us
to our executive officers during 2005.
Compensation
Philosophy
Our executive compensation program is based upon a
pay-for-performance
philosophy. The executive compensation program is designed to
provide value to the executive based on the extent of individual
performance, our performance versus budgeted financial targets
and other financial measures, our longer-term financial
performance and total return to stockholders, including to the
extent share price appreciation meets, exceeds or falls short of
expectations. Under this program design, only when expectations
are exceeded can incentive payments exceed targeted levels. When
making compensation decisions for executive officers, the
compensation committee evaluates each compensation element in
the context of the executives overall total compensation.
Elements
of the Executive Compensation Program
Base Salary. As a general matter, the base
salary for each executive is initially established through
negotiation at the time the officer is hired, taking into
account such officers qualifications, experience, prior
salary and competitive salary information.
Year-to-year
adjustments to each executive officers base salary is
determined by an assessment of her or his sustained performance
against her or his individual job responsibilities including,
where appropriate, the impact of such performance on our
companys business results, current salary in relation to
the salary range designated for the job, experience and
potential for advancement.
Annual Incentive Bonuses. Payments under our
annual performance incentive bonus plan are based on achieving
individual and corporate goals. For 2005, these corporate goals
included the achievement of performance targets with respect to
our clinical trials, financial objectives, completion of our
manufacturing facility expansion, operations, quality and
analytical sciences development objectives, and the achievement
of certain development milestones with respect to new product
candidates. Despite the discontinuation of our Phase 3
clinical trials and all other development activities related to
our
Canvaxintm
product candidate in 2005, it was determined that most of the
specific corporate objectives, as well as each officers
individual objectives, had been achieved. In determining bonuses
for the executive officers, the effectiveness of our efforts to
rapidly implement restructuring measures following the
discontinuation of the
Canvaxintm
development program, as well as the execution of the merger
agreement with Micromet, AG, were also considered. Use of
corporate goals establishes a direct link between the
executives pay and our financial success. For 2005, the
individual performance of each of the executive officers during
2005 was also evaluated by the compensation committee based on
the achievement of individual performance goals set in early
2005 by the compensation committee (other than the bonus for the
President and Chief Executive Officer, whose bonus is determined
solely by reference to the achievement of corporate goals, as
further described below). The annual incentive bonus opportunity
for executives, other than the President and Chief Executive
Officer, is generally targeted at 35% of his or her salary. The
annual incentive bonus opportunity for the President and Chief
Executive Officer is generally targeted at 50% of his salary.
Long-Term Incentives. Our long-term incentives
will be primarily in the form of stock option awards. The
objective of these awards is to advance our longer-term
interests and those of our stockholders and to complement
incentives tied to annual performance. These awards will provide
rewards to executives based upon the creation of incremental
stockholder value.
Stock options will only produce value to executives if the price
of our stock appreciates, thereby directly linking the interests
of executives with those of stockholders. The number of stock
options granted will be based on the grade level of an
executives position, the executives performance in
the prior year and the executives potential
160
for continued sustained contributions to our success. The
executives right to the stock options will generally vest
over a four-year period and each option will be exercisable over
a ten-year period following its grant unless the
executives employment terminates prior to such date. In
order to preserve the linkage between the interests of
executives and those of stockholders, the executives will be
encouraged to utilize the shares obtained on the exercise of
their stock options, after satisfying the cost of exercise and
taxes, to establish a significant level of direct ownership. We
will establish share ownership expectations for our executives
to meet through the exercise of stock option awards.
CEO
Compensation
David F. Hales base salary was established pursuant to his
employment agreement. The compensation committee believes that
the total compensation of our President and Chief Executive
Officer is largely based upon the same policies and criteria
used for other executive officers as described above. Each year
the compensation committee reviews the Chief Executive
Officers total compensation, his individual performance
for the calendar year under review, as well as our
companys performance. In determining Mr. Hales
bonus for 2005, the compensation committee considered the
companys achievement of the corporate performance goals
for 2005 established by the compensation committee and described
above. Mr. Hales annual incentive bonus opportunity
for 2005 was targeted at 50% of his salary. Based on our
companys performance for the fiscal year ended
December 31, 2005, Mr. Hale received a bonus of
$190,750, which was paid in shares of our common stock. In 2005,
Mr. Hale was granted options under the Amended and Restated
2003 Equity Incentive Award Plan to purchase
(i) 142,200 shares of our common stock at
$7.93 per share, 150,000 shares of our common stock at
$2.82 per share and 150,000 shares of common stock at
$1.48 per share. Mr. Hale was also granted a
restricted stock award of 22,500 shares of our common
stock, valued at $7.93. In February 2006, as a result of the
discontinuation of the clinical trials and further development
of Canvaxin, the compensation committee confirmed the forfeiture
of the 22,500 share restricted stock award, and of 67,500
of the performance-based vesting options to purchase shares of
CancerVax common stock at $7.93 per share, both of which
had been granted in February 2005. The compensation committee
also reviewed perquisites and other compensation paid to
Mr. Hale for 2005, and found these amounts to be
reasonable. Based upon its review of data from three separate
executive compensation surveys regarding the compensation of
chief executive officers in comparable companies, the
compensation committee believes Mr. Hales total
compensation, including salary and bonus, is at a level
competitive with Chief Executive Officer total compensation
within the biotechnology industry.
Mr. Hales employment will be terminated effective
upon completion of the merger, although Mr. Hale will
continue as the chairman of the board of directors of the
combined company.
Section 162(m)
Compliance
Section 162(m) of the Code generally limits the tax
deductions a public corporation may take for compensation paid
to its Named Executive Officers to $1.0 million per
executive per year. Performance based compensation tied to the
attainment of specific goals is excluded from the limitation.
Our stockholders have previously approved the Third Amended and
Restated 2000 Stock Incentive Plan and the Amended and Restated
2003 Equity Incentive Award Plan, qualifying options and stock
appreciation rights under these plans as performance-based
compensation exempt from the Section 162(m) limits. Other
awards under these plans also may qualify as performance-based
compensation at the discretion of the compensation committee. In
addition, the compensation committee intends to evaluate our
executive compensation policies and benefit plans during the
coming year to determine whether additional actions to maintain
the tax deductibility of executive compensation are in the best
interest of our stockholders.
161
Conclusion
Through the programs described above, a significant portion of
our compensation program and realization of its benefits is
contingent on both our company and individual performance.
This report of the compensation committee shall not be deemed
incorporated by reference by any general statement incorporating
by reference this proxy statement/prospectus into any filing
under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, except to the extent that we
specifically incorporate this information by reference, and
shall not otherwise be deemed filed under such acts.
The foregoing report has been furnished by the compensation
committee.
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Ivor Royston, M.D.
Michael G. Carter, M.B., Ch.B., F.R.C.P. (Edinburgh)
James Clayburn La Force, Jr., Ph.D.
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162
MICROMET
EXECUTIVE COMPENSATION AND OTHER INFORMATION
Executive
Compensation of Micromet
The following table sets forth all compensation awarded to or
earned for the year ended December 31, 2005 by
Micromets chief executive officer and its other most
highly compensated executive officers that are expected to serve
as executive officers of the combined company following the
merger (the Micromet Named Executive Officers). The
information in the table includes the value of base salaries,
bonus awards, certain reimbursements, and certain other
compensation, whether paid or deferred.
Summary
Compensation Table
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Annual Compensation
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Name and Principal
Position
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Salary
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Bonus(2)
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Christian Itin, Chief Executive
Officer
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260,000
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45,000
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Patrick A. Baeuerle, Chief
Scientific Officer
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230,000
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32,500
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Gregor Mirow, Chief Financial
Officer and Chief Operating Officer
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187,000
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20,000
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Carsten Reinhardt, Sr. Vice
President of Clinical Development(1)
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105,000
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20,000
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(1) |
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Dr. Reinhardt joined Micromet in June 2005. Amounts
disclosed in the table above represent the total compensation
earned by Dr. Reinhardt for 2005. |
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(2) |
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Bonus payments for 2005 were made in March 2006. |
Option
Grants During 2005
No stock options were granted to the Micromet Named Executive
Officers during the fiscal year ended December 31, 2005.
Accordingly, the option grant table is not presented.
Aggregated
Option Exercises During the Fiscal Year Ended December 31,
2005 and Option Values on December 31, 2005
The following table sets forth certain information regarding
unexercised options held by the Micromet Named Executive
Officers at December 31, 2005. None of the Micromet Named
Executive Officers exercised any options during the fiscal year
ended December 31, 2005 and, accordingly, option exercise
information is not presented.
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Number of Securities
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Underlying Unexercised
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Value of Unexercised
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Options at
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In-the-Money
Options at
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December 31, 2005
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December 31,
2005(1)
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Name
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Exercisable
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Unexercisable
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Exercisable
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Unexercisable
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Christian Itin
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165,700
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Patrick A. Baeuerle
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130,200
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Gregor Mirow
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109,550
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Carsten Reinhardt
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(1) |
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Each outstanding option as of December 31, 2005 had an
exercise price in excess of the fair market value of one
ordinary share, and therefore there were not any
in-the-money
options at December 31, 2005. |
Micromet
Employment and Change in Control Agreements
We expect to enter into amended employment agreements with each
of our executive officers prior to the completion of the merger.
163
Micromet
Employment Agreements
In October 2002, Micromet entered into an employment agreement
with Dr. Christian Itin, Ph.D., its chief executive
officer, which was amended in October 2005. Dr. Itin
currently receives an annual base salary of 260,000 and he
is eligible to receive an annual performance bonus of up to
60,000. His employment can be terminated with twelve
months prior notice, or for good cause at any time. In the
event of disability, Dr. Itin would be paid his salary for
six months. Dr. Itin is subject to a non-compete obligation
for a period of twelve months following the termination of his
employment. During the period of the non-compete obligation,
Dr. Itin will be paid the statutorily required amounts, but
in no event less than 50% of his salary immediately preceding
his termination. In addition, we maintain disability and life
insurance for Dr. Itin.
In October 2002, Micromet entered into an employment agreement
with Prof. Patrick A. Baeuerle, its chief scientific officer,
which was amended in October 2005. Prof. Baeuerle currently
receives an annual base salary of 230,000 and is eligible
to receive an annual performance bonus of up to 50,000.
The other terms of his employment are substantially the same as
described above for Dr. Itin.
In October 2002, Micromet entered into an employment agreement
with Mr. Gregor Mirow, M.D., M.B.A., its chief
financial officer and chief operating officer, which was amended
in October 2005. Mr. Mirow currently receives an annual
base salary of 187,000 and is eligible to receive an
annual performance bonus of up to 40,000. The other terms
of his employment are substantially the same as described above
for Dr. Itin.
In June 2005, Micromet entered into an employment agreement with
Mr. Carsten Reinhardt, M.D., Ph.D., its senior
vice president of clinical development, which was amended in
October 2005. Mr. Reinhardt currently receives an annual
base salary of 180,000 and is eligible to receive an
annual performance bonus of up to 20,000. The other terms
of his employment are substantially the same as described above
for Dr. Itin.
In connection with, and effective upon the closing of, the
merger, it is anticipated that the existing employment
agreements between Micromet and Drs. Itin, Baeuerle, Mirow
and Reinhardt will be cancelled and replaced with agreements
between such individuals and the combined entity. The terms of
such agreements have not been finalized and remain subject to
negotiation.
Micromet,
Inc. 2006 Equity Incentive Award Plan
It is anticipated that immediately prior to the merger, Micromet
Parent shall issue to certain officers, directors, founders and
employees of Micromet options to acquire up to
335,775 shares of Micromet Parent common stock. Such
options are being issued to incentive such individuals and shall
be issued, in part, to replace current Micromet options that
will not be exchanged in the Micromet Reorganization or assumed
by CancerVax in the merger. The options shall be issued by
Micromet Parent under a to-be-adopted Micromet, Inc. 2006 Equity
Incentive Award Plan, which shall be substantially similar to
the CancerVax Amended and Restated 2003 Equity Incentive Award
Plan. For a given participant under the 2006 Equity Incentive
Award Plan, 50% of the options granted to such individual shall
vest upon grant, with the remaining 50% vesting ratably on a
monthly basis over the 24 months following the date of
grant. The exercise price for such options shall be set at
approximately 25% of the closing price of a share of CancerVax
common stock on the date immediately preceding the date of grant
of the option (as adjusted for the exchange ratio). In the
merger, such options shall be exchanged for options to acquire
shares of CancerVax common stock in accordance with the terms of
the merger agreement.
164
MANAGEMENT
OF THE COMBINED COMPANY
AFTER THE MERGER
Upon consummation of the merger, the board of directors of the
combined company will be comprised of nine members. The
following table lists the names, ages and positions of
individuals currently designated by CancerVax and Micromet to
serve as directors and executive officers of the combined
company upon consummation of the merger. The ninth member of the
board of directors is expected to be selected by Micromet prior
to the completion of the merger. The ages of the individuals are
provided as of March 27, 2006.
Executive
Officers and Directors
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Name
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Age
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Position
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Executive Officers:
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Christian Itin, Ph.D.
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41
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President, Chief Executive Officer
and Director
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Gregor K. Mirow, M.D.,
M.B.A.
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46
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Senior Vice President, Operations
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Patrick A.
Baeuerle, Ph.D.
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48
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Senior Vice President, Chief
Scientific Officer
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Carsten
Reinhardt, M.D., Ph.D.
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39
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Senior Vice President, Clinical
Development
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William R. LaRue(1)
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54
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Senior Vice President, Chief
Financial Officer
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Directors:
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David F. Hale
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57
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Chairman
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Phillip M. Schneider(3)
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50
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Director
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Michael G. Carter, M.B., Ch.B.,
F.R.C.P(2)(4)
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68
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Director
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Barclay A. Phillips(3)(4)
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43
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Director
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Jerry C. Benjamin(2)(4)
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65
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Director
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Otello Stampacchia, Ph.D.(2)
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36
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Director
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John E. Berriman(2)(3)
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57
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Director
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(1) |
The voluntary resignation of Mr. LaRue will become effective on
June 1, 2006. Mr. LaRue has agreed to provide consulting
services to the combined company until August 15, 2006 for
compensation of $50,000.
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(2) |
Member of compensation committee.
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(3) |
Member of audit committee.
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(4) |
Member of nominating/corporate governance committee.
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Executive
Officers
Christian Itin, Ph.D. has served as Chief Executive
Officer of Micromet since March 2004, as Chief Business Officer
from April 2002 to March 2004, as Vice President Business and
Corporate Development from September 2001 to April 2002, Vice
President of Corporate Development from September 2000 to
September 2001 and as Head of IP and Licensing from September
1999 to September 2000. Before joining Micromet, Mr. Itin
was a co-founder of Zyomyx, Inc. (Hayward, CA, USA), a protein
chip company. Mr. Itin received a Diploma in biology and a
Ph.D. in cell biology from the University of Basel, Switzerland;
he also performed post-doctoral research at the Biocenter of
Basel University and at Stanford University School of Medicine,
CA.
Gregor K. Mirow, M.D., M.B.A. has served as the
Chief Operating Officer and Chief Financial Officer of Micromet
since June 1999. From January 1997 to April 1999, Mr. Mirow
served as Managing Director of the Rentschler Medical Drug
Group, a drug development company. From January 1990 to December
1996, Mr. Mirow worked as a management consultant in a
variety of life science fields. Mr. Mirow received his
medical degree at the Technical University of Munich in 1986 and
an M.B.A. from the Wharton School of the University of
Pennsylvania in 1989.
Patrick A. Baeuerle, Ph.D. has served as
Micromets Chief Scientific Officer since October 1998.
From February 1996 to September 1998, Mr. Baeuerle headed
the drug discovery activities of Tularik Inc. in South
San Francisco, CA, as Director, Drug Discovery. From
October 1994 to February 1996, Mr. Baeuerle served as a
full Professor and Chairman of Biochemistry at the Medical
Faculty of Freiburg University, Germany. In 1989, he was awarded
a group leader position at the Gene Center in Martinsried,
Germany, where he did seminal research on
165
transcription factor NF-kappaB. According to a survey by the
Institute for Scientific Information (ISI, Philadelphia, PA,
USA), Mr. Baeuerle was Germanys most frequently cited
biomedical scientist of the past decade, and
38th worldwide. He has published more than 190 scientific
papers, and four educational children books on biology. In
addition, Mr. Baeuerle is the first recipient of the Prix
Européen de lAvenir and an elected member of the
European Molecular Biology Organization (EMBO). He was appointed
Honorary Professor of Immunology at the University of Munich in
2000. Mr. Baeuerle performed his Ph.D. work at the Max
Planck Institute for Psychiatry in Martinsried and at the
European Molecular Biology Laboratory (EMBL) in Heidelberg,
obtained a Ph.D. degree in biology from the University of
Munich, and performed his post-doctoral research with David
Baltimore at the Whitehead Institute of the Massachusetts
Institute of Technology (MIT), Cambridge, MA.
Carsten Reinhardt, M.D., Ph.D., has served as
Senior Vice President Clinical Development of Micromet since
June 2005. Before joining Micromet, Mr. Reinhardt was
International Medical Leader for Herceptin^ at
Hoffmann-La Roche (Basel, Switzerland) between 2003 and
2005, and Head of Clinical Development at Fresenius Biotech
(Munich, Germany) until 2003. From 1995 to 2000,
Mr. Reinhardt worked at various academic institutions
(University of Tübingen, Max-Planck-Institute of
Psychiatry, Munich) to complete his curriculum in Neurology.
Between 1991 and 1995 Mr. Reinhardt performed his Ph.D.
thesis in Cellular Immunology at the Institute of Immunology in
Munich, Germany. Mr. Reinhardt received a Medical Degree in
1994 from University of Munich, Germany. Mr. Reinhardt is a
Visiting Professor for Pharmaceutical Medicine at the University
of Basel.
William R. LaRue has served as CancerVaxs Senior
Vice President and Chief Financial Officer since April 2001.
From March 2000 to February 2001, Mr. LaRue served as Executive
Vice President and Chief Financial Officer of eHelp Corporation,
a provider of user assistance software. From January 1997 to
February 2000, Mr. LaRue served as Vice President and Treasurer
of Safeskin Corporation, a publicly traded medical device
company, and from January 1993 to 1997 he served as Treasurer of
GDE Systems, Inc., a high technology electronic systems company.
Mr. LaRue serves on the board of directors of Cadence
Pharmaceuticals, Inc., a privately-held specialty pharmaceutical
company. Mr. LaRue received a B.S. in business administration
and M.B.A. from the University of Southern California.
Each officer will be elected by the companys board of
directors and will serve at the boards discretion.
Directors
David F. Hale has served as President and Chief Executive
Officer of CancerVax since October 2000 and as a member of our
board of directors since December 2000. Upon consummation of the
merger, Mr. Hale will become Chairman of the Board of
Directors of the combined company. Beginning in June 2000,
Mr. Hale consulted with Dr. Morton on the transfer of
the rights to Canvaxin to us, our initial financing and the
commencement of our operations. From January 1998 to May 2000,
Mr. Hale served as President and Chief Executive Officer of
Women First HealthCare, Inc., a publicly-traded specialty
pharmaceuticals company. Prior to joining Women First
HealthCare, Mr. Hale served from May 1987 to November 1997
as Chairman, President and Chief Executive Officer of Gensia,
Inc., a publicly-held biopharmaceutical company, which merged
with Sicor, Inc., to form GensiaSicor, Inc., and which was
recently acquired by Teva Pharmaceutical Industries Limited. He
also served from February 1987 to September 1995 as Chairman of
Viagene, Inc., a publicly held biotechnology company that was
acquired by Chiron, Inc. Mr. Hale served from April 1982 to
May 1987 in several positions with Hybritech, Inc., a
publicly-traded biotechnology company that was acquired by Eli
Lilly and Co., including Senior Vice President of Marketing and
Business Development, President and Chief Operating Officer and
ultimately President and Chief Executive Officer. Prior to
joining Hybritech, Mr. Hale served from January 1980 to
April 1982 as Vice President, Sales and Marketing and then as
Vice President and General Manager with BBL Microbiology
Systems, a division of Becton, Dickinson & Co. From
March 1971 to December 1980, Mr. Hale held various
marketing and sales management positions with Ortho
Pharmaceutical Corporation, a division of Johnson &
Johnson, Inc. Mr. Hale currently serves as Chairman of the
Board of Directors of Santarus, Inc. and Somaxon
Pharmaceuticals, Inc., publicly-traded specialty pharmaceutical
companies, as a director of Metabasis Therapeutics, Inc.,
publicly-traded biotechnology company, and as a director of
several privately-held biotechnology companies, including
SkinMedica, Inc. and Verus Pharmaceuticals, Inc. Mr. Hale
is also a director of the Biotechnology Industry Organization,
BIOCOM, the California Healthcare Institute and is a co-founder
and director of CONNECT. Mr. Hale received a B.A. in
biology and chemistry from Jacksonville State University.
166
Phillip M. Schneider has served as a member of
CancerVaxs board of directors since September 2003.
Mr. Schneider is the former Chief Financial Officer of IDEC
Pharmaceuticals Corporation. During his
15-year
tenure at IDEC, which ended in October 2002, he served as Senior
Vice President and Chief Financial Officer and played an
integral role in the companys growth. Prior to his
association with IDEC, Mr. Schneider held various
management positions at Syntex Pharmaceuticals Corporation and
was previously with KPMG, LLP. Mr. Schneider has served as
a director and chair of the audit committee of Gen-Probe
Incorporated since November 2002 and serves as a member of the
board of directors and chair of the audit committee for
Targegen, Inc., a privately held biotechnology company.
Mr. Schneider holds an M.B.A. from the University of
Southern California and a B.S. in biochemistry from the
University of California at Davis.
Michael G. Carter, M.B., Ch.B., F.R.C.P. (Edinburgh) has
served as a member of CancerVaxs board of directors since
February 2001. Dr. Carter is a venture partner at S.V. Life
Sciences Advisers LLP. Dr. Carter retired from Zeneca, PLC,
a publicly-traded global pharmaceutical company, in 1998.
Dr. Carter served Zeneca as International Medical Director
from 1986 to 1989 and as International Marketing Director from
1990 to 1995. From 1985 to 1995, Dr. Carter served as a
member of the U.K. Governments Medicines Commission. From
1976 to 1984, Dr. Carter held several positions with Roche
Products, Ltd, including head of Medical Development and Medical
Affairs and Director of the Pharmaceutical Division.
Dr. Carter currently serves as a Director of several
European biopharmaceutical companies, including Micromet AG and
Fulcrum Pharmaceuticals PLC, as Chairman of the Board of
Directors of Metris Therapeutics, Ltd., and as a member of the
board of directors of Santarus, Inc. Dr. Carter is an
Elected Fellow of the Royal Pharmaceutical Society, Faculty of
Pharmaceutical Medicine, and of the Royal College of Physicians
of Edinburgh. Dr. Carter received a bachelors degree
in Pharmacy from London University (U.K.) and a medical degree
from Sheffield University Medical School (U.K.).
Barclay A. Phillips has served as a member of
CancerVaxs board of directors since December 2000. From
1999 to the present, Mr. Phillips has been a Managing
Director of Vector Fund Management. Mr. Phillips has
investment management responsibility for Vector Later-Stage
Equity Fund, L.P. and Vector Later-Stage Equity Fund II,
L.P. From 1991 to 1999, Mr. Phillips served in various
roles including Director of Private Placements and Biotechnology
Analyst for INVESCO Funds Group, Inc. From 1985 to 1990,
Mr. Phillips held positions in sales and trading with Paine
Webber, Inc. and Shearson Lehman Hutton, Inc. Over the last ten
years, Mr. Phillips has held board positions for a number
of private companies and currently serves as a Director of
Acorda Therapeutics, Inc. Mr. Phillips received a B.A. in
economics from the University of Colorado in Boulder.
Christian Itin will become a director of the combined
company in connection with the consummation of the merger.
Please see the preceding Executive Officers section
for information regarding Mr. Itin.
Jerry C. Benjamin will become a director of the combined
company in connection with the consummation of the merger.
Mr. Benjamin has been a General Partner of Advent Venture
Partners, a venture capital management firm in London, since
1985. Mr. Benjamin also serves on the board of directors of
Orthofix International N.V., an international orthopedics
company listed on NASDAQ. In the past, Mr. Benjamin has
been a director of a number of public and private health care
companies.
Otello Stampacchia, Ph.D. will become a director of
the combined company in connection with the consummation of the
merger. An Italian citizen, Mr. Stampacchia has served as
Chief Investment Adviser of the Omega Fund since 2005. The Omega
Fund is an investment vehicle specializing in providing
liquidity to existing investors in health care companies through
the acquisition and subsequent management of direct investment
positions. Omega acquires ownership interests in public and
private biopharmaceutical and device companies, focusing on
Western Europe and the USA. Otello has been involved in various
venture capital activities in biotechnology since 2001, formerly
as Head of Life Sciences Investments at NIB Capital Private
Equity (now Alpinvest Partners), a private equity asset manager
with currently over EUR32bn under management. Previously,
Mr. Stampacchia was a member of the health care Corporate
Finance and M&A team at Goldman Sachs International in
London, and he helped to initiate the health care investment
activities of Index Securities (now Index Ventures).
Mr. Stampacchia has a Ph.D. in Molecular Biology from the
University of Geneva (Switzerland) and a European Doctorate in
Biotechnology (EDBT) from the European Association for Higher
Education in Biotechnology.
John E. Berriman will become a director of the combined
company in connection with the consummation of the merger. Since
May 2004, Mr. Berriman has been a consultant and a
non-executive director of a number of private
167
and public biotech companies. He served as a member of the
board of directors of Alnylam Pharmaceuticals, Inc. from July
2003 until December 2005. From August 2001 until May 2004,
Mr. Berriman served as a director of Abingworth Management,
a venture capital firm specializing in life science biomedical
companies. Mr. Berriman was a consultant to Abingworth
Management from March 1997 to August 2001. From 1989 until 1996
Mr. Berriman was an executive director of Celltech pic.
Board
Composition
Upon consummation of the merger, the board of directors of the
combined company will be comprised of nine members. All
directors hold office until their successors have been elected
and qualified or until their earlier death, resignation,
disqualification or removal. Our Amended and Restated
Certificate of Incorporation provides that the terms of office
of the directors are divided into three classes:
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Class I, whose term will expire at the annual meeting of
stockholders to be held in 2007;
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Class II, whose term will expire at the annual meeting of
stockholders to be held in 2008; and
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Class III, whose term will expire at the annual meeting of
stockholders to be held in 2009.
|
Upon the consummation of the merger, Class I will consist
of Messrs. Benjamin, Phillips and Stampacchia,
Class II will consist of Messrs. Schneider, Itin and
an individual to be designated by Micromet prior to the closing
of the merger, and Class III will consist of
Messrs. Hale, Carter and Berriman. At each annual meeting
of stockholders, the successors to directors whose terms will
then expire serve from the time of election and qualification
until the third annual meeting following election and until
their successors are duly elected and qualified. A resolution of
the board of directors or affirmative vote of the holders of at
least
662/3%
of our outstanding voting stock may change the authorized number
of directors. Any additional directorships resulting from an
increase in the number of directors will be distributed among
the three classes so that, as nearly as possible, each class
will consist of one third of the directors. This classification
of the board of directors may have the effect of delaying or
preventing changes in control or management of our company.
Board
Committees
Our board of directors has an audit committee, a compensation
committee and a corporate governance and nominating committee.
Compensation Committee. Upon consummation of
the merger, our compensation committee will consist of
Messrs. Benjamin (chairman), Berriman, Carter and
Stampacchia, each of whom will be a non-management member of our
board of directors. The functions of this committee include:
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reviewing and, as it deems appropriate, recommending to our
board of directors, policies, practices and procedures relating
to the compensation of our directors, officers and other
managerial employees and the establishment and administration of
our employee benefit plans;
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exercising authority under our stock incentive plan; and
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advising and consulting with our officers regarding managerial
personnel and development.
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Audit Committee. Upon consummation of the
merger, our audit committee will consist of
Messrs. Schneider (chairman), Berriman and Phillips, each
of whom will be a non-management member of our board of
directors. The functions of this committee include:
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meeting with our management periodically to consider the
adequacy of our internal controls and the objectivity of our
financial reporting;
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meeting with our independent auditors and with internal
financial personnel regarding these matters;
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recommending to our board of directors the engagement of our
independent auditors;
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reviewing our audited financial statements and reports and
discussing the statements and reports with our management,
including any significant adjustments, management judgments and
estimates, new accounting policies and disagreements with
management; and
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168
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reviewing our financial plans and reporting recommendations to
our full board for approval and to authorize action. Both our
independent auditors and internal financial personnel regularly
meet privately with our audit committee and have unrestricted
access to this committee.
|
Nominating/Corporate Governance
Committee. Upon consummation of the merger, our
nominating/ corporate governance committee will consist of
Messrs. Phillips (chairman), Benjamin and Carter, each of
whom will be a non-management member of our board of directors.
The functions of this committee include:
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reviewing and recommending nominees for election as directors;
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assessing the performance of the board of directors;
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developing guidelines for board composition; and
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reviewing and administering our corporate governance guidelines
and considering other issues relating to corporate governance
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Compensation Committee Interlocks and Insider
Participation. The combined companys
compensation committee of the board of directors will consist of
Messrs. Benjamin, Berriman, Carter and Stampacchia.
Mr. Benjamin will be the chairman of the compensation
committee. No member of the compensation committee will have
been at any time an officer or employee of the Company. None of
the combined companys executive officers serves, or in the
past year has served, as a member of the board of directors or
compensation committee of any entity that has one or more
executive officers serving on the compensation committee. None
of the combined companys executive officers serves, or in
the past year has served, as a member of the compensation
committee of any entity that has one or more executive officers
serving on our board of directors.
Compensation
of Directors
Upon consummation of the merger, our directors will receive an
annual fee of $16,000 for service as a director. In addition,
our directors will receive $1,500 for each regularly scheduled
board meeting and $1,000 for each regularly scheduled committee
meeting. We will reimburse our directors for their reasonable
expenses incurred in attending meetings of our board of
directors. Our directors may participate in our stock incentive
plans and employee-directors may participate in our employee
stock purchase plan. Upon consummation of the merger, each of
our directors other than our chairman will be granted an option
to purchase 35,000 shares of our common stock at an
exercise price per share equal to the fair market value of our
common stock on such date. Such options will vest over a
three-year period. Any independent director who is subsequently
elected to our board of directors will be granted an option to
purchase 35,000 shares of our common stock on the date of
his or her initial election to our board of directors. Such
options will vest over a three-year period. In addition, each
independent director other than our chairman will be granted an
option to purchase 15,000 shares of common stock on the
date of each annual meeting (beginning with the 2007 annual
meeting) at an exercise price per share equal to the fair market
value of our common stock on such date. Such options will vest
over a one-year period. The chairman of our audit committee will
receive an additional annual option to purchase
7,500 shares of common stock, the chairman of our
compensation committee will receive an additional annual option
to purchase 5,000 shares of common stock, and the chairman
of our nominating/corporate governance committee will receive an
additional annual option to purchase 2,500 shares of our
common stock. Such options will vest over a one-year period.
Upon consummation of the merger, our chairman will receive an
annual fee of $85,000 for service as chairman of our board of
directors. In addition to the regular directors fees, in fiscal
year 2006, in lieu of cash, our chairmans compensation
will be paid at the time of consummation of the merger in
restricted stock under our equity incentive plan. Upon
consummation of the merger, our chairman will be granted an
option to purchase 70,000 shares of our common stock at an
exercise price per share equal to the fair market value of our
common stock on such date. Such option will vest over a
three-year period. In addition, our chairman will be granted an
option to purchase 30,000 shares of common stock on the
date of each annual meeting (beginning with the 2007 annual
meeting) at an exercise price per share equal to the fair market
value of our common stock on such date. Such option will vest
over a one-year period.
169
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
CancerVax
Certain Relationships and Transactions
Employment
Agreements
CancerVax has entered into employment agreements, offer letters
and bonus agreements with its executive officers. For more
information regarding these agreements, see CancerVax
Executive Compensation Employment
Agreements.
Canvaxin
Technology Transactions
In 1998, OncoVac, Inc., which is wholly owned by Dr. Morton
and was previously named CancerVax, Inc., cross-licensed the
rights to patents, patent applications, cell banks and
manufacturing know-how from John Wayne Cancer Institute, or
JWCI. Dr. Morton currently serves as Medical Director,
Surgeon-in-Chief
and a member of the board of directors of JWCI. In July 2000,
OncoVac assigned all of its rights and obligations under that
agreement to us. Under the cross-license, as assigned to us, we
retain exclusive rights to commercialize Canvaxin for the
treatment of cancer and JWCI retains a license to use Canvaxin
and related technology for research and educational purposes.
Pursuant to the cross-license agreement and the assignment, we
issued 284,090 shares of our common stock to JWCI and
agreed to pay an aggregate of $1,250,000 to JWCI, of which
$500,000 was paid upfront and the remainder is due in annual
installments of $125,000 through June 2006. Of the total amount,
$125,000 remains unpaid as of December 31, 2005. We also
are obligated to pay JWCI 50% of the initial net royalties we
receive from any sublicensees from sales of Canvaxin, if any, up
to a maximum of $3.5 million. Subsequently, we are
obligated to pay JWCI a 1% royalty on net sales of Canvaxin to
third parties, if any, by us, our sublicensees and affiliates.
In July 2001, we entered into a clinical trial services
agreement with JWCI. Under the terms of the clinical trial
services agreement, as amended, we will make annual payments of
$25,000 to JWCI while payments to the clinical trial sites are
covered by National Cancer Institute grants and thereafter an
annual amount equal to the greater of actual amounts incurred by
JWCI in connection with the Canvaxin Phase 3 clinical
trials or $50,000. We also will reimburse JWCI for certain
expenses incurred. During the year ended December 31, 2005,
we paid to JWCI approximately $0.1 million for services
provided to us under the clinical trials services agreements,
participation in the clinical trials and certain other services.
Other
Related Party Transactions
In December 2004, in connection with the signing of our
collaboration agreement with Serono Technologies, S.A., we
entered into an amended and restated investors rights
agreement with Serono and certain other holders of our common
stock, including entities affiliated with Dr. Morton,
Forward IV Associates, LLC, Vector Fund Management II,
L.L.C., J.P. Morgan Investment Management, Inc. and
Mr. Hale, whereby we granted these entities registration
rights with respect to their shares of common stock.
We have entered into indemnification agreements with each of our
executive officers and directors. These indemnification
agreements require us to indemnify these individuals to the
fullest extent permitted by Delaware law.
We had a consulting and noncompete agreement with
Dr. Morton that expired in September 2005. Under the
terms of the agreement, as amended, we paid Dr. Morton
$12,500 per month through September 2005 to provide
consulting services related to the development and
commercialization of Canvaxin and our other product candidates
as well as consult on medical and technical matters as requested.
We have entered into agreements and transactions with our
management described under the heading CancerVax Executive
Compensation and Other Information.
We believe that all of the transactions described above were on
terms at least as favorable to us as they would have been had we
entered into those transactions with unaffiliated third parties.
170
CancerVax
Director and Officer Indemnification
CancerVax has entered into an indemnification agreement with
each of its directors and officers for the indemnification of,
and advancement of expenses to, these persons to the full extent
permitted by Delaware law. CancerVax also intends to enter into
an indemnification agreement with each of its future directors
and officers.
At present CancerVax is not aware of any pending litigation or
proceeding involving any of its directors, officers, employees
or agents in such persons capacity with CancerVax where
indemnification will be required or permitted. CancerVax is also
not aware of any threatened litigation or proceeding that might
result in a claim for indemnification.
CancerVax believes that all of the transactions set forth above
were made on terms no less favorable to CancerVax than could
have been obtained from unaffiliated third parties. All future
transactions between CancerVax and its officers, directors,
principal stockholders and their affiliates will be approved by
a majority of CancerVaxs board of directors, including a
majority of the independent and disinterested directors, and
will continue to be on terms no less favorable to CancerVax than
could be obtained from unaffiliated third parties.
Micromet
Certain Relationships and Transactions
Employment
Agreements
Micromet has entered into employment agreements and bonus
arrangements with certain of its executive officers, and intends
to replace such agreements with to-be-negotiated agreements with
the combined company in connection with the merger. For more
information regarding these agreements, see Micromet
Employment Agreements. In addition, in connection with the
merger, certain Micromet officers, directors and employees will
be issued options to acquire Micromet Parent common stock, which
options will be assumed by CancerVax in the merger. For more
information, see Micromet, Inc. 2006 Equity Incentive
Award Plan.
October 11,
2005 Recapitalization
On October 11, 2005, in connection with an equity financing
led by its existing investors, Micromet undertook a
recapitalization, pursuant to which all outstanding shares of
its preferred stock were converted into a new series of
preferred stock, the preference shares series (A new). The
investors invested an aggregate of 4,000,000 in a new
series of preferred stock, the preference shares series (new
B) representing approximately 62% of the companys
combined capital stock. Under the terms of the investment, the
holders of the preference shares series (B new) are entitled to
a liquidation preference of three times their original purchase
price on a liquidation event at which such shares remain
outstanding. As a consequence of the Micromet reorganization,
such shares will be exchanged for shares of common stock of
Micromet Parent and therefore will not receive any liquidation
preference in connection with the merger. Under the terms of the
investment agreement entered into in connection with the
transaction, the investors in the financing agreed to invest an
additional approximately 4,000,000, either through a
purchase of shares, through a private placement, of a public
company that merges with Micromet (which would include the
proposed merger with CancerVax) on or before March 31,
2006, or as an additional capital contribution to Micromet if
such a merger has not been completed by March 31, 2006.
Micromet
Shareholders Agreement
On October 11, 2005, substantially all of the Micromet
shareholders, including all of its executive officers, entered
into a shareholders agreement (the Micromet Shareholders
Agreement). The Micromet Shareholders Agreement was
entered into in connection with the October 11, 2005
financing. The Micromet Shareholders Agreement provides for
weighted average antidilution rights in favor of the holders of
preference shares series (B new) in the event that Micromet
issues, or agrees to issue additional shares for a lower
purchase price per share than the per share purchase price of
the preference shares series (B new), subject to limited
exceptions. The Micromet Shareholders Agreement also provides
for a right of first refusal in favor of all shareholders in the
event that a shareholder wishes to sell his, her or its shares.
The Micromet Shareholders Agreement also contains a drag-along
171
provision pursuant to which the holders of 55% or more of the
outstanding preference shares series (B new) (the Required
Majority) may require the remaining parties to the
Micromet Shareholders Agreement to join them in selling or
exchanging their shares of Micromet stock to a third party on
the same terms and conditions as the Required Majority. The
Micromet Shareholders Agreement also provides for the payment of
a liquidation preference in favor of the preference shares
series (B new) and provides the holders of Micromet preference
shares a veto right with respect to significant corporate events
and transactions, including a merger, liquidation, and charter
amendment.
Outstanding
Indebtedness for Stock Subscriptions
In connection with the issuance of shares of treasury stock by
Micromet in 1998, Micromet currently is owed 154,000 from
Peter Kufer, 127,000 from Gregor Mirow and 16,000
from Christian Itin, all current employees of Micromet. Under
the terms of those obligations, those amounts will be due and
payable as a result of the merger with CancerVax.
172
COMBINED
COMPANY SECURITY OWNERSHIP BY CERTAIN BENEFICIAL
OWNERS
Except where specifically noted, the following information
and all other information contained in this joint proxy
statement/prospectus does not give effect to the proposed
reverse stock split described in CancerVaxs
Proposal No. 3.
The following table sets forth information as of March 27,
2006 regarding the beneficial ownership of the combined company
upon consummation of the merger by (a) each person known to
CancerVaxs and Micromets boards of directors to own
beneficially 5% or more of the combined company upon
consummation of the merger, (b) each director of CancerVax
and Micromet who will be a director of the combined company,
(c) the Named Executive Officers of CancerVax and Micromet
(as defined below who will continue as an executive officer of
the combined company), and (d) all of the combined
companys directors and executive officers as a group.
Information with respect to beneficial ownership has been
furnished by each director, officer or 5% or more stockholder,
as the case may be.
The number of shares beneficially owned upon consummation of the
merger assumes an exchange ratio of 16.824 shares of
CancerVax common stock issued for each share of Micromet Parent
common stock outstanding. This exchange ratio is subject to
change based on the relative number of shares, options and
warrants of each of CancerVax and Micromet Parent outstanding at
the effective time of the merger. Percentage of beneficial
ownership in the combined company is calculated assuming
86,015,810 shares of common stock will be outstanding upon
the consummation of the merger. Beneficial ownership is
determined in accordance with the rules of the Securities and
Exchange Commission which generally attribute beneficial
ownership of securities to persons who possess sole or shared
voting power or investment power with respect to those
securities and includes shares of CancerVax and Micromet common
stock issuable pursuant to the exercise of stock options,
warrants or other securities that are immediately exercisable or
convertible or exercisable or convertible within 60 days of
March 27, 2006. Unless otherwise indicated, the persons or
entities identified in this table have sole voting and
investment power with respect to all shares shown as
beneficially owned by them.
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
Percent of
|
|
|
|
Shares
|
|
|
Shares
|
|
|
|
Beneficially
|
|
|
Beneficially
|
|
Name and Address of Beneficial
Owner
|
|
Owned(1)
|
|
|
Owned
|
|
|
5% Stockholders:
|
|
|
|
|
|
|
|
|
Entities affiliated with Advent
Venture Partners
|
|
|
11,314,460
|
|
|
|
13.2
|
%
|
Omega Fund I, LP
|
|
|
10,445,752
|
|
|
|
12.1
|
|
3i Group plc
|
|
|
9,427,766
|
|
|
|
11.0
|
|
International Biotechnology Trust
plc
|
|
|
6,088,997
|
|
|
|
7.1
|
|
Donald L. Morton, M.D.
|
|
|
5,181,482
|
|
|
|
6.0
|
|
Named Executive Officers and
Directors:
|
|
|
|
|
|
|
|
|
David F. Hale
|
|
|
1,365,325
|
|
|
|
1.6
|
|
William R. LaRue
|
|
|
215,587
|
|
|
|
*
|
|
Michael G. Carter, M.B., Ch.B.,
F.R.C.P. (Edinburgh)
|
|
|
47,799
|
|
|
|
*
|
|
Barclay A. Phillips
|
|
|
1,025,941
|
|
|
|
1.2
|
|
Phillip M. Schneider
|
|
|
49,204
|
|
|
|
*
|
|
Christian Itin
|
|
|
9,253
|
|
|
|
*
|
|
Patrick A. Baeuerle
|
|
|
72,343
|
|
|
|
*
|
|
Gregor Mirow
|
|
|
25,236
|
|
|
|
*
|
|
Carsten Reinhardt
|
|
|
|
|
|
|
*
|
|
Jerry Benjamin
|
|
|
11,314,460
|
|
|
|
13.2
|
|
John Berriman
|
|
|
|
|
|
|
*
|
|
173
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
Percent of
|
|
|
|
Shares
|
|
|
Shares
|
|
|
|
Beneficially
|
|
|
Beneficially
|
|
Name and Address of Beneficial
Owner
|
|
Owned(1)
|
|
|
Owned
|
|
|
Otello Stampacchia
|
|
|
10,445,752
|
|
|
|
12.1
|
|
All executive officers and
directors as a group (12 persons)
|
|
|
24,570,900
|
|
|
|
28.6
|
|
|
|
* |
Represents beneficial ownership of less than 1% of the
outstanding common shares of the combined company.
|
|
|
|
|
(1)
|
It is anticipated that after the Micromet Reorganization, but
prior to the consummation of the merger, certain employees and
members of the supervisory board of Micromet will be granted
options to purchase Micromet Parent common stock. As the amount
of and terms of such option grants have not yet been determined,
no options to purchase Micromet Parent have been included in the
table.
|
174
COMPARATIVE
RIGHTS OF CANCERVAX STOCKHOLDERS
AND MICROMET SHAREHOLDERS
CancerVax is incorporated under the laws of the State of
Delaware and, accordingly, the rights of the stockholders of
CancerVax are currently, and will continue to be, governed by
the Delaware General Corporation Law, or the DGCL. Micromet is
incorporated under the laws of Germany, and prior to the
consummation of the merger, the rights of Micromet shareholders
are governed by the German Stock Corporation Act,
Micromets Articles of Association and the Micromet
Shareholders Agreement. Before the consummation of the
merger, the rights of holders of CancerVax common stock are also
governed by the amended and restated certificate of
incorporation of CancerVax and the bylaws of CancerVax. After
the consummation of the merger, the rights of CancerVax
stockholders will continue to be governed by the DGCL, the
amended and restated certificate of incorporation of CancerVax,
and the bylaws of CancerVax.
The following is a summary of the material differences between
the rights of CancerVax stockholders and the rights of Micromet
shareholders under each companys respective charter
documents, corporate laws and contractual arrangements. While we
believe that this summary covers the material differences
between the two, this summary may not contain all of the
information that is important to you. This summary is not
intended to be a complete discussion of the respective rights of
CancerVax and Micromet stockholders and is qualified in its
entirety by reference to the DGCL, the German Stock Corporation
Act and the various documents of CancerVax and Micromet that we
refer to in this summary. You should carefully read this entire
proxy statement/prospectus and the other documents we refer to
in this proxy statement/prospectus for a more complete
understanding of the differences between being a shareholder of
CancerVax and being a shareholder of Micromet. CancerVax has
filed its documents referred to herein with the SEC and will
send copies of these documents to you upon your request. See the
section entitled Where You Can Find More Information.
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|
|
|
|
|
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Micromet
|
|
CancerVax
|
|
Authorized Capital Stock
|
|
The authorized capital stock of
Micromet is EUR 3,451,057, divided into 3,451,057 non-par value
registered shares with a stated value of 1 per share, of
which 77,642 shares are ordinary shares and 3,373,415
shares are preference shares, 1,232,876 of which are
designated as Series (A new) and 2,140,539 of which
are designated as Series (B new).
In addition, Micromet has contingent capital in order to serve
stock options, convertible bonds and option bonds as follows:
(i) up to 600,305 ordinary shares for the employee
stock option plan 2000; (ii) up to 600 ordinary
shares for the option bonds of the members of the Supervisory
Board 2001; (iii) up to 600 ordinary shares for the
option bonds of the members of the Supervisory Board 2002; (iv)
up to 8,786 preference shares of Series (A new) for
the option bonds of GATX/ETV 2002; (v) up to 11,933
ordinary shares for the employee stock option plan 2002;
(vi) up to 600 ordinary shares for the option bonds
of the members of the Supervisory Board 2003; (vii) up to
1,756 preference shares of Series (A new) for the
option bonds of GATX/ETV 2003; (viii) up to 880,500
preference shares series (A new) for the convertible bond
of MedImmune and (ix) up to 5,194 shares of
preference shares series (B new) for the bridge
conversion.
|
|
CancerVaxs certificate of
incorporation currently authorizes the issuance of 85,000,000
shares, consisting of two classes: 75,000,000 shares
of common stock, $0.00004 par value per share, and
10,000,000 shares of preferred stock, $0.00004 par
value per share. After giving effect to Proposal No. 3. to
amend CancerVaxs certificate of incorporation to effect
the reverse stock split, the number of shares of authorized
common stock will be increased to 150,000,000.
|
Number of Directors
|
|
Micromets Articles of
Association provide that the number of the members of its
|
|
CancerVaxs certificate of
incorporation provides that the number of directors shall
|
175
|
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|
|
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|
Micromet
|
|
CancerVax
|
|
|
|
supervisory board is six which are
to be elected by the Shareholders Meeting. Under the
Shareholders Agreement dated October 11, 2005, the
shareholders of Micromet shall exercise their voting rights for
the six members in the Shareholders Meeting in accordance
with the nomination rights for one member each of Omega Fund
I, L.P., 3i Group plc, SV Life Sciences, Advent Limited,
all shareholders by a majority of 75% of the votes cast, and the
holders of shares of common stock (provided that for the latter
a 55% majority of all shares of preference shares series
(B new) has the right to nominate a new independent
chairman of the supervisory board replacing the member nominated
by the holders of shares of common stock).
|
|
be fixed exclusively by resolution
adopted by the affirmative vote of a majority of the directors.
|
|
|
The members of the supervisory
board are elected by the Shareholders Meeting for a term
of four fiscal years, provided that the fiscal year in which the
term of office begins is not taken into account, so that the
members of the supervisory board of Micromet will usually have a
term of approximately five years. However, the
Shareholders Meeting may determine a shorter term for all
or individual members. The members of the supervisory board may
be re-elected, and there is no limit on the number of additional
terms.
|
|
|
|
|
Micromets Articles of
Association provide that the number of the members of the
Management Board may be one or more and shall be fixed by the
supervisory board with a simple majority of the votes cast.
Members of the Management Board are appointed by the supervisory
board with a simple majority of the votes cast for a fixed term
not exceeding five years. A re-election, in each case not
exceeding five years, is possible, provided that it may happen
only in the last year of the preceding term. There is no limit
on the number of additional terms.
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|
|
Cumulative Voting
|
|
The German Stock Corporation Act
does not allow cumulative voting.
|
|
CancerVaxs certificate of
incorporation does not provide for cumulative voting, and as a
result, holders of CancerVax common stock have no cumulative
voting rights in connection with the election of directors.
|
Classification of board of
directors
|
|
In accordance with the German Stock
Corporation Act (Aktiengesetz), Micromet has a two-tier
board system consisting of the Micromet Management Board
(Vorstand) and the Micromet supervisory board
(Aufsichtsrat). The German Stock Corporation Act
prohibits simultaneous membership on the Management Board and
the supervisory board.
|
|
CancerVax has a classified board of
directors. CancerVaxs certificate of incorporation
provides that the board of directors is divided into three
classes, with board of directors members serving three year
terms.
|
|
|
Under the German Stock Corporation
Act, all members of the supervisory board are equal. The
supervisory board elects from among its members a chairman and
a
|
|
|
176
|
|
|
|
|
|
|
Micromet
|
|
CancerVax
|
|
|
|
deputy chairman. Under
Micromets Articles of Association, in the event of a tied
vote, the chairman (or in his absence the deputy chairman) has
the casting vote.
|
|
|
|
|
Under the German Stock Corporation
Act, in general all members of the Management Board are equal.
Deputy members of the Management Board are permissible, however
they have all rights and obligations as the other members of the
Management Board, but internally have less duties. If the
Management Board consists of more than one member, the
supervisory board may appoint a chairman of the Management Board
(CEO).
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|
|
Removal of Directors
|
|
The members of the Micromet
supervisory board elected by the Shareholders Meeting may
be removed upon the affirmative vote of a simple majority of the
votes cast at a Shareholders Meeting with or without good
cause. A member of the supervisory board appointed by
shareholders in accordance with the Shareholders Agreement
may at any time be removed and replaced by such shareholders.
Any member of the Micromet supervisory board can be removed for
good cause, including gross breach of duty, by a court decision
upon request of the Micromet supervisory board. In such case,
Micromet supervisory boards ability to take such action
requires a simple majority vote with the member affected having
no voting power.
|
|
CancerVaxs bylaws provide
that any director or the entire board may be removed, for cause,
from the board at any meeting of stockholders by
662/3%
of the outstanding stock of the corporation.
|
|
|
The members of the Micromet
Management Board may be removed prior to the expiration of their
term of office by the Micromet supervisory board only for
reasons amounting to good cause, such as gross breach of duty,
inability to duly fulfill their responsibilities or revocation
of confidence by the Shareholders Meeting requiring the
affirmative vote of a simple majority of the votes cast.
|
|
|
Vacancies on the board of directors
|
|
In the case of any vacancy on the
Micromet supervisory board, whether the result of death,
resignation or removal, the Shareholders Meeting may
determine a substitute member at the election of a member of the
supervisory board. Further, if any vacancy occurs, the
Shareholders Meeting may fill the vacancy by electing a
new member. In urgent cases, vacancies on the Micromet
supervisory board may be filled for an interim period until the
next election by the Shareholders Meeting, by the
competent court upon a motion by the Micromet Management Board,
a member of the Micromet supervisory board or a shareholder.
In the case of vacancies on the Micromet Management Board, the
Micromet supervisory board may fill the vacancy by appointing a
new member.
|
|
CancerVaxs bylaws provide
that vacancies on the board may be filled by a vote of the
majority of the directors then in office, even though less than
a quorum of the board of directors, or by a sole remaining
director. Any director elected in accordance with the preceding
sentence shall hold office until the next annual election of
directors and until their successors are duly elected and shall
qualify, unless sooner displaced.
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177
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Micromet
|
|
CancerVax
|
|
Stockholder Action by Written
Consent
|
|
Under the German Stock Corporation
Act, shareholders may not take any action by written consent in
lieu of the Shareholders Meeting.
|
|
CancerVaxs certificate of
incorporation and bylaws specify that any action that may be
taken or is required to be taken at an annual or special meeting
of stockholders may not be taken without a meeting.
|
Amendment of Charter
|
|
Amendments of the Micromet Articles
of Association may be proposed either by the Micromet
supervisory board, the Micromet Management Board or by a
shareholder or group of shareholders holding at least 5% of the
issued shares or at least the notional par value amount of EUR
500,000.
According to the Micromet Articles of Association, a resolution
amending the Micromet Articles of Association generally must be
passed by the following votes: (i) a simple majority of
the votes cast; (ii) a simple majority of the issued
shares represented at the Shareholders Meeting; and (iii)
a majority of at least 75% of the issued shares of
preferred stock represented at the Shareholders Meeting.
|
|
CancerVaxs certificate of
incorporation may be amended in any manner otherwise permitted
by law, with the exception that Article V (relating to the
composition of the board of directors), Article VII
(relating to alterations and amendments to CancerVaxs
bylaws, election of directors, actions by written consent and
stockholder special meetings), Article VIII (relating to
indemnification of directors and officers), Article IX
(relating to director liability to CancerVax), and Article
XI (relating to amendment of the certificate of
incorporation) require the affirmative vote of the holders of
662/3%
of the voting power of the outstanding shares of voting stock,
voting together as a single class.
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|
|
In addition, if the relationship
between classes of shares is amended to the disadvantage of any
class of shares, the German Stock Corporation Act additionally
requires a special resolution of the holders of such class of
shares with a simple majority of the issued shares of such class
represented at the Shareholders Meeting and a simple
majority of the votes cast.
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|
|
|
|
The German Stock Corporation Act
also requires that certain resolutions amending the Articles of
Association be passed by a majority of at least three- quarters
of the issued shares represented at the Shareholders
Meeting and a simple majority of the votes cast at the meeting,
including resolutions relating to: (i) capital increase
with an exclusion of preemptive rights; (ii) capital
decrease; (iii) the creation of authorized capital
(genehmigtes Kapital) or conditional capital
(bedingtes Kapital); or (iv) amendments of the
corporate purpose of Micromet; provided that (except in case of
an amendment of the corporate purpose) a special resolution of
each class of shares with a majority of 75% of the issued shares
of each class represented at the Shareholders Meeting and
a simple majority of the votes cast is required.
|
|
|
Amendment of Bylaws
|
|
Not applicable.
|
|
CancerVaxs bylaws may be
amended by the affirmative vote of the holders of
662/3%
of the outstanding shares of voting stock, voting together as a
single class. CancerVaxs bylaws also permit the board of
directors to adopt, amend or repeal the bylaws.
|
Special meetings of Stockholders
|
|
A special Shareholders
Meeting of Micromet may be called at any time by the Micromet
Management Board or, in cases required by law, the Micromet
supervisory
|
|
CancerVaxs bylaws provide
that special meetings of the stockholders may be called, for any
purpose, by the chairman of the board of directors or the
president and shall
|
178
|
|
|
|
|
|
|
Micromet
|
|
CancerVax
|
|
|
|
board. A special
Shareholders Meeting must be called by the Micromet
Management Board upon request of stockholders holding in the
aggregate shares representing at least 5% of the issued shares.
The request must be made in writing to the Micromet Management
Board stating the purpose of and reasons for the special
Shareholders Meeting.
|
|
be called by the president or the
secretary at the request of the board.
|
Notice of Stockholder Meetings
|
|
The Shareholders Meeting is
called by the Management Board or, in the cases provided by law,
the supervisory board giving at least one months notice,
whereby the day of the Shareholders Meeting and the day of
sending the notice shall not be counted. The notice has to
include the agenda and has to be made in the electronic federal
gazette (elektronischer Bundesanzeiger). The
Shareholders Meeting may also be called by registered mail
if all stockholders are known by name.
|
|
CancerVaxs bylaws require
that notice of a meeting shall be given to stockholders not less
than 10 days or more than 60 days before the date of
the meeting.
|
|
|
The Micromet Articles of
Association provide that the Shareholders Meeting shall
take place at Micromets registered seat or in any city
where a German stock exchange has its seat.
|
|
|
|
|
The German Stock Corporation Act
provides that the annual general Shareholders Meeting
called to resolve in particular the discharge of the Management
Board and the supervisory board, the appointment of the members
of the supervisory board, the election of the auditors, the
application of the balance sheet profits and the approval of the
financial statements in cases required by law, must take place
within the first eight months of each fiscal year.
|
|
|
Delivery and Notice Requirements of
Stockholder Nominations and Proposals
|
|
See preceding section.
|
|
CancerVaxs bylaws provide
that in order for a stockholder to make a nomination or propose
business at an annual meeting of the stockholders, the
stockholder must give timely written notice to CancerVaxs
secretary not later than the close of business on the 90th
day nor earlier than the close of business on the 120th
day prior to the first anniversary of the preceding
years annual meeting; provided, however, that if the date
of annual meeting has changed by more than 30 days before
or 60 days after the date of the preceding years
annual meeting, notice by the stockholder to be timely must be
received not earlier than the close of business on the 120th
day prior to such annual meeting and not later than the
close of business on the later of the 90th day prior to
such annual meeting or the 10th day following the earlier
of (i) the day on which notice of the meeting was mailed
or (ii) the date public announcement of the date of such
meeting is first made by the corporation.
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179
|
|
|
|
|
|
|
Micromet
|
|
CancerVax
|
|
|
|
|
|
The CancerVax stockholders
written notice must set forth: (A) as to each person whom
the stockholder proposed to nominate for election or reelection
as a director all information relating to such person that is
required to be disclosed in solicitations of proxies for
election of directors in an election contest, or is otherwise
required, in each case pursuant to Regulation 14A under
the Securities Exchange Act of 1934 (including such
persons written consent to being named in the proxy
statement as a nominee and to serving as a director if elected);
(B) as to any other business that the stockholder proposes
to bring before the meeting, a brief description of the business
desired to be brought before the meeting, the reasons for
conducting such business at the meeting and any material
interest in such business of such stockholder and the beneficial
owner, if any, on whose behalf the proposal is made; and (C)
as to the stockholder giving the notice and the beneficial
owner, if any, on whose behalf the nomination or proposal is
made: (I) the name and address of such stockholder and of
such beneficial owner, as they appear on CancerVaxs books;
(II) the class and number of shares of CancerVax which are
owned beneficially and of record by such stockholder and such
beneficial owner; (III) a representation that the
stockholder is a holder of record of stock of the corporation
entitled to vote at such meeting and intends to appear in person
or by proxy at the meeting to propose such business or
nomination; and (IV) a representation whether the
stockholder or the beneficial owner, if any, intends or is part
of a group which intends (y) to deliver a proxy statement
and/or form
of proxy to holders of at least the percentage of the
corporations outstanding capital stock required to approve
or adopt the proposal or elect the nominee
and/or (z)
otherwise to solicit proxies from stockholders in support of
such proposal or nomination.
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Stockholder Approval Rights
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Resolutions are passed at the
Micromet Shareholders Meeting by a simple majority of the
votes cast, unless a higher vote
and/or a
majority of the capital represented at the Shareholders
Meeting
and/or
special resolutions of particular classes of shares are required
by law or the Micromet Articles of Association.
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Each share of CancerVax common
stock and preferred stock is entitled to one vote on matters
submitted to the CancerVax stockholders under the DGCL or as
required by the Certification of Incorporation.
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Under the German Stock Corporation
Act and Micromet Articles of Association, the following actions
require the approval of a majority of at least 75% of the issued
shares represented at the Shareholders Meeting passing the
resolution and a simple majority of the votes cast at that
meeting: (i) capital increases with an exclusion of
preemptive rights; (ii) creation of
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Micromet
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CancerVax
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authorized capital or conditional
capital; (iii) capital decreases; (iv) a dissolution
of Micromet; (v) amendments of the corporate purpose of
Micromet; (vi) a merger of Micromet or any other form of
transformation (Umwandlung) of Micromet, including,
without limitation, spin-offs (Spaltungen), a transfer of
all or virtually all of Micromet AGs assets, a change of
Micromets corporate form, the execution of intercompany
agreements (Unternehmensverträge), integrations
(Eingliederungen); provided that (except in case of a
transfer of all or virtually all of Micromets assets, the
execution of intercompany agreements, integrations, amendments
of the corporate purpose and the dissolution of Micromet) a
special resolution of each class of shares with a majority of
75% of the issued shares of each class represented at the
Shareholders Meeting and a simple majority of the votes
cast is required by law.
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Under the Articles of Association
of Micromet and the Shareholders Agreement of Micromet,
the following resolutions in addition require the consent of the
holders of shares of preferred stock to be passed with a
majority of 75% of the issued shares of preferred stock
represented at the Shareholders Meeting: (i)
transformations (Umwandlungen); (ii) a
disposal of more than 50% of the assets of Micromet (according
to fair market values); (iii) merger of Micromet with
another entity; (iv) amendments to the Certificate of
Incorporation; (v) capital increases, capital decreases,
creation of authorized capital or conditional capital, creation
of new classes of shares; (vi) dissolution of Micromet;
(vii) approval of intercompany agreements
(Unternehmensverträge); (viii) integrations
(Eingliederungen); (ix) election of the auditors;
(x) distributions to the stockholders; (xi) creation
of new classes of shares; and (xii) redemption of
shares.
If for any reason each class of shares is required also to pass
a special resolution in respect of any of the matters mentioned
in the foregoing sentence, each stockholder must exercise his
voting rights in such special resolutions of the holders of
shares of common stock or the holders of shares of preferred
stock in the same way as the majority of the stockholders of
Micromet vote in the respective resolution of the Micromet
Shareholders Meeting.
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Proxy
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According to the German Stock
Corporation Act and Micromets Articles of Association, any
shareholder may, in writing, appoint a proxy to exercise his or
her rights at Shareholders Meetings including in
particular without limitation
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CancerVaxs bylaws provide
that every person entitled to vote shall have the right to do so
in person or may authorize another person to act for him by a
proxy dated not more than three years prior to the meeting,
unless the proxy provides for a longer
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Micromet
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CancerVax
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voting rights. There is no time
limitation for such proxy provided that the proxy itself may
limit its term. Each proxy is revocable for the future at the
pleasure of the person executing it.
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period. An agent who is appointed
need not be a stockholder.
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Preemptive Rights
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Under the German Stock Corporation
Act, in general, an existing stockholder in a stock corporation
has a preemptive right (Bezugsrecht) to subscribe for any
issue by the corporation of new shares, including securities
convertible into shares, securities with warrants to purchase
shares, profit-sharing certificates and securities with a profit
participation, in proportion to the shares held by the
stockholder in the existing capital of such corporation. The
German Stock Corporation Act provides that this preemptive right
can be excluded only by a resolution of the Shareholders
Meeting, provided there is a justification for such exclusion.
The approval of a majority of at least 75% of the issued shares
represented at the Shareholders Meeting and a simple
majority of the votes cast at such Shareholders Meeting is
required to exclude preemptive rights.
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CancerVaxs certificate of
incorporation does not grant any preemptive rights.
CancerVaxs bylaws are silent as to preemptive rights.
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To the extent preemptive rights are
not exercised by the existing stockholders, the other
stockholders shall have a further preemptive right with respect
to such shares on a pro rata basis before third parties are
granted any right to subscribe for shares.
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Dividends
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Under the German Stock Corporation
Act, dividends may be declared and paid by resolution of the
Shareholders Meeting out of any distributable balance
sheet profits shown in the corporations audited and
approved financial statements for the preceding fiscal year.
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CancerVaxs bylaws provide
that dividends may be declared and paid on the common stock from
funds lawfully available as and when determined by the board of
directors and subject to any preferential dividend rights of any
then outstanding preferred stock.
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The holders of the shares of
preferred stock are not entitled to any preferential dividends.
Dividends are paid to the stockholders pro rata to their
respective participation in the share capital.
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Limitation of Personal Liability of
Directors
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See following section.
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CancerVaxs certificate of
incorporation provides a director shall not be personally liable
for monetary damages for breach of fiduciary duty as a director,
except that liability is not eliminated (i) for any breach of
his or her duty of loyalty to the CancerVax or its stockholders,
(ii) for acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of the
law, (iii) under Section 174 of the DGCL, or (iv)
for any transaction from which the director derives an
improper personal benefit.
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Furthermore, if the DGCL is amended
to authorize corporate action further eliminating or limiting
the personal liability of directors, then the liability of a
director shall be eliminated to the fullest extent permitted by
the DGCL, as so amended.
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Micromet
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CancerVax
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Indemnification of Officers and
Directors
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Under German law, a corporation may
indemnify its officers (leitende Angestellte), and, under
certain circumstances, German labor law requires a stock
corporation to do so. However, a corporation may not, as a
general matter, indemnify members of the Management Board or the
supervisory board. A German stock corporation may, however,
purchase directors and officers insurance on the
basis of a corresponding resolution of the Shareholders
Meeting. The insurance may be subject to any mandatory
restrictions imposed by German law. In addition, German law may
permit a corporation to indemnify a member of the Management
Board or the supervisory board for attorneys fees incurred
if such member is the successful party in a suit in a country,
like the United States, where winning parties are required to
bear their own costs, if German law would have required the
losing party to pay the members attorneys fees had
the suit been brought in Germany.
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CancerVaxs certificate of
incorporation provides that CancerVax shall indemnify and hold
harmless any person who was or is a party or is threatened to be
made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by CancerVax) by reason of
the fact that he or she is or was a director or officer of
CancerVax, or is or was serving at the request of the
Corporation as a director or officer of another corporation,
partnership, joint venture, trust, employee benefit plan or
other enterprise, against expenses (including attorneys
fees), judgments, fines and amounts paid in settlement actually
and reasonably incurred by him or her in connection with such
action, suit or proceeding if he or she acted in good faith and
in a manner he or she reasonably believed to be in or not
opposed to the best interests of the Corporation, and, with
respect to any criminal action or proceeding, had no reasonable
cause to believe his or her conduct was unlawful.
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CancerVax shall indemnify and hold
harmless any person who was or is a party or is threatened to be
made a party to any threatened, pending or completed action or
suit by or in the right of CancerVax to procure a judgment in
its favor by reason of the fact that he or she is or was a
director or officer of CancerVax, or is or was serving at the
request of CancerVax as a director or officer of another
corporation, partnership, joint venture, trust, employee benefit
plan or other enterprise against expenses (including
attorneys fees) actually and reasonably incurred by him or
her in connection with the defense or settlement of such action
or suit if he or she acted in good faith and in a manner he or
she reasonably believed to be in or not opposed to the best
interests of CancerVax; except that no indemnification shall be
made in respect of any claim, issue or matter as to which such
person shall have been adjudged to be liable to the CancerVax
unless and only to the extent that the Court of Chancery of the
State of Delaware or the court in which such action or suit was
brought shall determine upon application that, despite the
adjudication of liability but in view of all the circumstances
of the case, such person is fairly and reasonably entitled to
indemnity for such expenses which the Court of Chancery of the
State of Delaware or such other court shall deem proper.
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CancerVaxs bylaws provide
that the corporation may indemnify every person who was or is a
party or is or was threatened to be made a party to any action,
suit, or proceeding, whether civil, criminal,
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Micromet
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CancerVax
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administrative or investigative,
by reason of the fact that he or she is or was an employee or
agent of the corporation or, while an employee or agent of the
corporation, is or was serving at the request of the corporation
as an employee or agent or trustee of another corporation,
partnership, joint venture, trust, employee benefit plan or
other enterprise, against expenses (including counsel fees),
judgments, fines and amounts paid in settlement actually and
reasonably incurred by him or her in connection with such
action, suit or proceeding, to the extent permitted by
applicable law.
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Dissenters Rights
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A valuation proceeding
(Spruchverfahren) is available to Micromets
shareholders under the German Stock Corporation Act and the
German Transformation Act (Umwandlungsgesetz) to
determine the adequacy of the consideration to be paid in
certain corporate transactions. These transactions include,
among other things: (i) a merger; (ii) a control and
profit transfer agreement between a controlling shareholder and
its dependent company; (iii) the forced withdrawal of
minority shareholders from the corporation upon the
corporations integration with a parent corporation holding
shares representing at least 95% of the nominal capital of the
corporation to be integrated; and (iv) the compulsory
acquisition of minority shareholders by a majority shareholder
holding at least 95% of the issued shares.
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Appraisal rights are not available
to CancerVax stockholders with respect to the merger.
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These rights are available to
shareholders, provided that in each case the shareholder
complies with the procedural requirements specified in the
respective statutory provisions.
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Certain Business Combination
Restrictions
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The German Securities Acquisitions
and Takeovers Act provides that the Management Board of the
target company may not take any measures that could prevent a
bid from being successful. This shall not apply to actions that
a prudent and diligent manager of the company not affected by a
takeover bid would have taken, nor to the search for a competing
bid, nor to actions having the approval of target companys
supervisory board, nor to actions taken by the Management Board
with the approval of the supervisory board on the basis of an
authorization by the Shareholders Meeting prior to the bid
to take actions falling within the scope of the
Shareholders Meeting for the purpose of preventing the
success of takeover bids.
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Under Delaware law a corporation
can elect not to be governed by §203 of the DGCL, which
generally protects publicly traded Delaware corporations from
hostile takeovers and from certain actions following such
takeovers. CancerVax has not made this election and is therefore
governed by §203 of the DGCL.
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Vote on Business Combinations
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German law does not specifically
regulate business combinations with interested
stockholders. However, certain general principles of German law
may restrict business combinations under various circumstances.
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Neither the CancerVax certificate
of incorporation nor its bylaws contain any provisions relating
to business combinations.
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Micromet
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CancerVax
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Rights on Liquidation
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In the event of any liquidation of
Micromet, a sale of at least 50% of all shares in Micromet in a
single transaction or a series of related transactions or a sale
of more than 50% of the assets of Micromet (calculated at fair
market values), and in case of an exchange of shares,
contribution or merger within the meaning of the German Act on
the Transformation of Companies, provided that after such
transactions having become effective, the shareholders of
Micromet hold 50% or less of the voting rights in the new legal
entity or the rights of the shareholders of Micromet are not to
remain valid and unaffected in the new legal entity, the holders
of the shares of preference shares have the following
preference: (i) the proceeds are first to be paid to the
holders of shares of preference shares series (B
new) up to an amount of EUR 19.647 (or after payment
of the second tranche of the investment of October 11,
2005 EUR 25.2273) per share of preference shares series
(B new) plus the declared but not distributed dividends
attributable to the preference shares series (B new); (ii)
with the same rank as the holders of shares of preference
shares series (B new), the management and key employees of
Micromet, the founders and certain members of the supervisory
board of Micromet shall receive a certain percentage of the
total proceeds to be defined in the trade sale pool model that
would be determined by the compensation committee of the
Micromet supervisory board; (iii) the remaining proceeds
are then to be paid to the holders of shares of preference
shares series (A new) up to an amount of EUR 49.818
per preference shares series (A new) plus the
declared but not distributed dividends attributable to the
preference shares series (A new); and (iv) from any
remaining proceeds, 5% shall be allocated to the holders of
ordinary shares pro rata based on the number of shares and the
remaining 95% shall be allocated to the holders of preference
shares pro rata based on the number of preference shares.
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Each share of CancerVax
common stock and preferred stock share ratably in any
proceeds of a liquidation of CancerVax.
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185
INFORMATION
REGARDING CANCERVAXS BUSINESS
Overview
We are a biotechnology company focused on the research,
development and commercialization of novel biological products
for the treatment and control of cancer. We were incorporated in
Delaware in June 1998 and commenced substantial operations in
the third quarter of 2000.
On October 3, 2005, we and Serono Technologies, S.A.,
announced the discontinuation of the Phase 3 clinical trial
of our leading product candidate, Canvaxin, in patients with
Stage III melanoma, based on the recommendation of the
independent Data and Safety Monitoring Board, or DSMB. The DSMB
concluded, based on its planned, third interim analysis of the
data from this study, that the data were unlikely to provide
significant evidence of a survival benefit for Canvaxin-treated
patients versus those who received placebo. In April 2005, we
announced the discontinuation of our Phase 3 clinical trial
of Canvaxin in patients with Stage IV melanoma based upon a
similar recommendation of the independent DSMB. There were no
significant safety issues identified with either of the
Phase 3 clinical trials of Canvaxin, and the
recommendations to close the studies were not made because of
any potential safety concerns.
In October 2005, we announced that our board of directors had
approved a restructuring plan designed to realign resources in
light of the decision to discontinue our Phase 3 clinical
trial of Canvaxin in patients with Stage III melanoma, as
well as all further development of Canvaxin and manufacturing
activities at our Canvaxin manufacturing facilities. Under the
restructuring plan, in 2005 we reduced our workforce from 183 to
52 employees at December 31, 2005 and closed our biologics
manufacturing facility and our warehouse facility. We are
actively seeking to sublease all three of our principal
facilities. In 2005, we recorded a non-recurring charge
associated with our restructuring activities of
$4.9 million. This non-recurring restructuring charge
includes $3.5 million of employee severance costs, the
substantial majority of which were cash expenditures that were
paid in the fourth quarter of 2005, and $1.4 million of
leased facility exit costs, representing the estimated future
costs to be incurred under the operating leases for our
biologics manufacturing facility and our warehouse facility, net
of estimated sublease rentals. In 2005, we also recorded a
non-recurring charge for contract termination costs of
$0.2 million, which is included in research and development
expenses. In connection with our restructuring activities, we
also recorded a non-recurring, non-cash charge for the
impairment of long-lived assets of $25.4 million in 2005 to
write-down the carrying value of certain of our long-lived
assets to their estimated fair value.
In January 2006, we implemented additional restructuring
measures which, when fully implemented, will result in the
further reduction of our workforce to approximately
10 employees by the completion of our proposed merger with
Micromet. In connection with this workforce reduction, in 2006
we anticipate incurring approximately $3.0 million of
additional employee severance costs. We also anticipate
incurring additional leased facility exit costs in 2006,
primarily related to our corporate headquarters and research and
development facility. At this time, we are unable to reasonably
estimate the expected amount of such additional leased facility
exit costs, although our remaining obligations under the
operating lease for our corporate headquarters and research and
development facility aggregated $11.2 million as of
December 31, 2005. We may also incur additional contract
termination and other restructuring costs. We anticipate that
our restructuring efforts will be substantially completed by the
end of the second quarter of 2006.
We have other product candidates in research and preclinical
development, including four anti-angiogenic monoclonal
antibodies and several peptides that may be useful for the
treatment of patients with various solid tumors. In February
2006, we submitted an Investigational New Drug Application, or
IND, to initiate a Phase 1 clinical trial for D93, our
leading humanized, anti-angiogenic monoclonal antibody, in
patients with solid tumors.
We also have rights to three product candidates targeting the
epidermal growth factor receptor, or EGFR, signaling pathway for
the treatment of cancer, and we plan to actively seek
sublicensing opportunities for these product candidates.
Our efforts to identify, develop and commercialize and, in the
case of the three product candidates that target the EGFR
signaling pathway, to sublicense, these product candidates are
in an early stage and, therefore, these efforts are subject to a
high risk of failure.
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Industry
Background
Cancer
The World Health Organization estimated that more than
10 million people were diagnosed with cancer worldwide in
the year 2000 and that this number will increase to
15 million by 2020. In addition, the World Health
Organization estimated that 6 million people died from the
disease in 2000. The American Cancer Society estimated that over
1.3 million people in the United States were diagnosed with
cancer in 2004 and over 500,000 people died from the disease.
One in every four deaths in the United States is due to cancer.
Cancer is the second leading cause of death in the United
States, and has become the leading cause of death in people over
age 85.
The increasing number of people diagnosed with cancer and the
approval of new cancer treatments are factors that are expected
to continue to fuel the growth of the world wide cancer market.
The U.S. National Health Information Business Intelligence
Reports reports that, on a world-wide basis, the revenues for
cancer drugs are expected to grow from $35.5 billion in
2003 to $53.1 billion in 2009.
Anti-Angiogenesis
for the Treatment of Cancer
In a process known as angiogenesis, cancer cells stimulate the
formation of new blood vessels in order to bring oxygen and
nutrients to rapidly-growing tumor tissue. Angiogenesis involves
proliferation of cells that form new blood vessels and are
involved in the remodeling of the extracellular matrix, a dense
protein network that provides support and growth signals to
blood vessels and tumors, and regulates cellular processes such
as adhesion, migration, gene expression and differentiation.
During angiogenesis, cancer cells secrete growth factors that
activate endothelial cells on the blood vessels supplying the
tumor. Activation of these endothelial cells results in growth
and proliferation of new blood vessels. In addition, the
extracellular matrix is degraded by proteolytic enzymes.
Degradation of the extracellular matrix contributes to the
release of additional growth factors, facilitates the movement
of activated endothelial cells, and supports the growth of new
blood vessels. These processes encourage tumor growth through
nourishment of the existing tumor, as well as by creating
pathways for metastasis of the tumor. By inhibiting the
angiogenesis process, it may be possible to restrict blood
supply to a tumor and limit its ability to grow and metastasize.
Immunotherapy
for the Treatment of Cancer
The bodys immune system is a natural defense mechanism
tasked with recognizing and combating cancer cells, viruses,
bacteria and other disease-causing organisms. This defense is
carried out mainly by white blood cells in the immune system.
Specific types of white blood cells, known as T cells and
B cells, are responsible for carrying out two types of
immune responses in the body, the cell-mediated immune response,
and the humoral, or antibody-based, immune response,
respectively.
Cancer cells produce molecules known as tumor-associated
antigens, which are present in normal cells but are
over-produced in cancer cells. The T cells and B cells
have receptors on their surfaces that enable them to recognize
the tumor-associated antigens. For instance, once a B cell
recognizes a tumor-associated antigen, it triggers the
production of antibodies that kill the tumor cells. T cells
play more diverse roles, including the identification and
destruction of tumor cells by direct cell-to-cell contact.
While cancer cells naturally trigger a T cell-based immune
response during the initial appearance of the disease, the
immune system response may not be sufficiently robust to
eradicate the cancer. The human body has developed numerous
immune suppression mechanisms to prevent the immune system from
destroying the bodys normal tissues. Cancer cells have
been shown to utilize these mechanisms to suppress the
bodys immune response against cancer cells. Even with an
activated immune system, the number and size of tumors can
overwhelm the immune system.
Research focused on the activation of the immune system in the
treatment of cancer has increased significantly in recent years.
Unlike traditional chemotherapeutic or radiotherapeutic
approaches to cancer treatment that are designed to kill cancer
cells directly, immunotherapy approaches to cancer are intended
to activate and stimulate the bodys immune system to fight
the cancer. When administered to patients, monoclonal antibodies
target specific
187
receptors on the surface of a cancer cell or a secreted protein
and either interfere directly with the functioning of cancer
cells, or bind to cancer cells and activate various cytotoxic
mechanisms that may help destroy the cancer.
The immune system may also be harnessed to inactivate
tumor-promoting signaling pathways, such as the EGF receptor
signaling pathway, which may interfere with cancer cell growth,
and to target specific molecules in the bloodstream or receptors
on the surface of cells. EGF is one of several molecules that
bind to the EGF receptor, and may be responsible for activating
a series of intracellular processes that stimulate cell growth,
enhance metastasis, and protect the tumor cells from cell death
from treatments such as chemotherapy. While many cells in the
human body express the EGF receptor, most solid tumor cell types
express the EGF receptor in excessive quantities. By targeting
EGF or the EGF receptor with specific active immunotherapies,
cancer cell growth and proliferation may be suppressed or
eliminated.
Our
Pipeline
The table below lists our principal product candidates:
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Commercialization
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Product Candidates
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Targeted Disease
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Status
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Rights
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Anti-Angiogenesis
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IND submitted in
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D93
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Solid tumors
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February 2006
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CancerVax
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Various other monoclonal
antibodies and peptides
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Solid tumors,
ophthalmic diseases
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Research
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CancerVax
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EGFR Signaling
Pathway
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SAI-EGF
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Non-small-cell
lung cancer
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Phase 1/2
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CancerVax(a)
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SAI-TGF-α
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Solid tumors
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Preclinical
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CancerVax(a)
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SAI-EGFR-ECD
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Solid tumors
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Preclinical
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CancerVax(a)
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(a) |
CancerVax has the right to commercialize SAI-EGF, SAI-TGF-α
and SAI-EGFR-ECD in the United States, Canada, Japan, Australia,
New Zealand, Mexico and specified countries in Europe, including
but not limited to, Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,
the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the
United Kingdom.
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Anti-Angiogenesis
Programs
Through our January 2002 acquisition of Cell-Matrix, Inc., we
acquired unique therapeutic and diagnostic anti-angiogenesis
technology. To complement this technology, in June 2003, we
licensed from New York University the rights to several peptides
that may also inhibit angiogenesis. These product candidates
have a mechanism of action that is distinct from
Avastin®
(bevacizumab; Genenetch), a product approved for metastatic
colorectal cancer that targets the vascular endothelial growth
factor, and from other anti-angiogenesis product candidates
currently in development by other companies. We believe that
these antibodies and peptides may provide us with an opportunity
to develop products that may be beneficial for the treatment of
patients with various solid tumors.
Our
Anti-Angiogenesis Platform
The extracellular matrix is a molecular network that provides
mechanical support to cells and tissues and contains biochemical
information important to cellular processes such as cell
proliferation, adhesion and migration. Our monoclonal antibodies
and peptides bind specifically to hidden, or cryptic, binding
sites on extracellular matrix proteins that become exposed as a
result of the denaturation of collagen that occurs during tumor
formation. Binding of our monoclonal antibodies or peptides to
these degraded or denatured extracellular matrix proteins may
inhibit angiogenesis and the growth, proliferation and
metastasis of tumor cells.
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This approach to inhibiting angiogenesis may have several
therapeutic advantages. Because our monoclonal antibodies and
proteins bind preferentially to extracellular matrix proteins
that have been denatured during angiogenesis rather than to the
native, undenatured forms of collagen or laminin, we believe
that these product candidates may have greater tumor site
specificity than other therapies, especially those characterized
by broad biologic activity. Additionally, the denatured proteins
in the extracellular matrix may provide a better long-term
therapeutic target than binding sites found directly on tumor
cells since the proteins in the extracellular matrix represent a
stable structure and are less likely to undergo mutations
typical of cancer cells. Due to the unique mechanism through
which our monoclonal antibodies and proteins inhibit
angiogenesis, they may have the potential to be used in
combination with other anti-angiogenic agents or with treatments
such as chemotherapy and radiation.
D93
Based on pre-clinical data presented at scientific meetings over
the past two years, we submitted an IND to initiate a
Phase 1 clinical trial with D93, our leading humanized,
anti-angiogenic monoclonal antibody, in patients with solid
tumors in February 2006.
In a presentation at the 2005 American Association of Cancer
Research, or AACR, annual meeting, we demonstrated that D93
inhibited tumor cell growth in a dose-dependent manner, as
compared to controls, in several in vivo tumor models. In
addition, in an orthotopic human breast cancer model in mice,
the combination of D93 with
Taxol®
(paclitaxel) resulted in a greater inhibition of tumor growth
than either agent alone. These results suggest that D93 may have
potential for use in the treatment of a variety of solid tumors
and have the potential to be combined with other therapies.
The ability to distinguish tumor cells from normal cells is a
key advantage of monoclonal antibody therapies. In a second
presentation at the 2005 AACR annual meeting, our scientists
showed data indicating that D93 specifically binds around blood
vessels in human patient tumor sections, but does not bind to
corresponding normal sections from the same tissues and
patients. D93 was also shown to specifically bind to denatured
collagen, but not to native collagen or other proteins found in
the extracellular matrix.
At the 2004 AACR annual meeting, we presented data indicating
that D93 inhibited tumor growth in a mouse model using human
melanoma cells by 56%. D93 also inhibited human breast tumor
growth by 84% in an animal model designed to more closely mimic
breast cancer by generating human breast carcinomas in the
mammary pads of mice.
We believe that our anti-angiogenic product candidates may be
useful in other pathological conditions associated with
angiogenesis, such as choroidal neovascularization, or CNV, an
ophthalmologic condition caused by excess growth of blood
vessels within the eye that is the major cause of severe visual
loss in patients with age-related macular degeneration. Data
presented during the 2004 Annual Meeting of the Association for
Research in Vision and Ophthalmology demonstrated that in a
murine model of CNV, another of our anti-angiogenic monoclonal
antibodies, H8, preferentially recognized areas of new vascular
growth but not existing normal vasculature and inhibited
angiogenesis in a dose-dependent manner.
Product
Candidates Targeting the EGF Receptor Signaling
Pathway
In July 2004 our wholly-owned subsidiaries Tarcanta, Inc. and
Tarcanta, Limited, signed an agreement with CIMAB, S.A., a Cuban
company, whereby Tarcanta obtained the exclusive rights to
develop and commercialize SAI-EGF, a product candidate that
targets the EGF receptor signaling pathway, in a specific
territory, which includes the United States, Canada, Japan,
Australia, New Zealand, Mexico and certain countries in Europe.
In addition, these two subsidiaries signed an agreement with
CIMAB and YM BioSciences, Inc., a Canadian company, to obtain
the exclusive rights to develop and commercialize
SAI-TGF-α, which targets transforming growth factor-alpha,
and SAI-EGFR-ECD, which targets the extracellular domain of the
EGF receptor, within the same territory. Both of these product
candidates are in preclinical development. In late 2005, we
announced plans to actively seek sublicensing opportunities for
all three of these product candidates.
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EGF
Receptor Signaling Pathway Role in Regulating
Tumor Growth
Dysregulation of the EGF receptor signaling pathway is
associated with tumor growth and metastasis, decreased
effectiveness of chemotherapy and radiotherapy, and decreased
overall survival. EGF and TGF-α are molecules that bind to
and activate the EGF receptor. Increased stimulation of the EGF
receptor signaling pathway, as a direct result of
over-expression of the EGF receptor, EGF or TGF-α, may
contribute to dysregulation of the EGF receptor pathway. In
addition, cancerous cells may secrete EGF and TGF-α, which
in turn fuels their growth and proliferation by increased
activation of the EGF receptor pathway.
Interference with signaling through the EGF receptor signaling
pathway represents a therapeutic approach with potentially broad
clinical applications. Over-stimulation of this pathway has been
documented in breast, colorectal, brain, head and neck,
non-small-cell lung, ovarian, pancreatic and prostate cancers.
Our
Product Candidates Targeting the EGF Receptor Signaling
Pathway
The three product candidates that we have licensed that target
the EGF receptor signaling pathway are designed to stimulate the
immune system to produce antibodies to EGF, TGF-α and the
extracellular domain of the EGF receptor, respectively, and
ultimately reduce signaling through the EGF receptor. Since each
of these product candidates targets a different aspect of the
EGF receptor signaling pathway, it is possible that they may be
used as single agents, in combination with each other, or in
combination with other EGF receptor-targeted therapies. In
addition, they may also be used with cytotoxics or other novel
therapies for the treatment of cancer.
Phase 2
Clinical Trial Results with SAI-EGF
SAI-EGF is an investigational product candidate composed of
recombinant human EGF that has been coupled to a proprietary
immunogenic carrier protein, known as p64K. SAI-EGF, which is
administered with a general immune system stimulant known as an
immunologic adjuvant, stimulates the immune system to produce
antibodies that target EGF. The anti-EGF antibodies bind to EGF
circulating in the patients bloodstream and interrupt EGF
receptor signaling. This approach differs from existing EGF
receptor inhibitors, such as monoclonal antibodies and tyrosine
kinase inhibitors, in two important ways. First, it utilizes the
bodys own defense mechanisms to target the EGF receptor
pathway, and second, it targets circulating EGF, which activates
the EGF receptor, as opposed to targeting the receptor itself.
The SAI-EGF product candidate has been studied in Phase 1
and Phase 2 clinical trials conducted by CIMAB or YM
Biosciences in Canada, the United Kingdom and Cuba.
At the 2005 American Society of Clinical Oncology, or ASCO,
annual meeting, data was presented by CIMAB updating the results
of ongoing Phase 2 clinical trials sponsored by CIMAB in
patients with unresectable Stage IIIb and Stage IV
non-small-cell lung cancer. SAI-EGF was reported to induce an
anti-EGF immune response in treated patients, with significantly
more SAI-EGF-treated patients (67%) demonstrating antibody titer
levels at least two times baseline compared to control patients
(37%). In addition, 53% of the SAI-EGF-treated patients had a
good antibody response (defined as at least four times baseline
levels and at least 1:4000 sera dilution), compared to only 3.3%
of the control patients. SAI-EGF treatment was also reported to
reduce serum EGF concentrations. Fifty-nine percent (p<0.05)
of the SAI-EGF-treated patients achieved EGF serum
concentrations of less than or equal to 168pg/mL during the
study, as compared to 19% of control patients. In the
SAI-EGF-treated patients, the increase of anti-EGF antibody
titers was reported to correlate with decreasing EGF serum
concentrations (p=0.001), while this effect was not observed in
control patients. The preliminary results reported in this study
suggest that increased survival may be related to good anti-EGF
antibody responses (p=0.0002) or low EGF serum concentrations
(p=0.0069). Overall, a statistically significant difference in
survival between SAI-EGF-treated and control patients was not
demonstrated in this preliminary analysis of results (p=0.07).
No serious adverse events were reported.
SAI-TGF-α
(preclinical)
SAI-TGF-α is an investigational product candidate that may
stimulate the immune system to develop anti-TGF-α
antibodies, another common molecule that activates the EGF
receptor. Blocking TGF-α may provide a therapeutic benefit
in certain cancers and may also enhance the therapeutic effect
when used in combination with other EGF receptor inhibitors.
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SAI-EGFR-ECD
(preclinical)
SAI-EGFR-ECD is an investigational product candidate that may
stimulate the immune system to develop antibodies that target a
portion of the EGF receptor that resides outside of the cell
membrane, i.e. the extracellular domain. Stimulating the immune
system with a therapeutic directed against the receptor itself
may offer a unique approach to targeting the EGF receptor
pathway.
Other
Technology
Scripps
Research Institute
Our wholly-owned subsidiary Cell-Matrix, Inc., or Cell-Matrix,
entered into a license agreement with The Scripps Research
Institute, or Scripps, in 2001 under which we were granted an
exclusive worldwide license to technology related to
angiogenesis, including anti-angiogenic diagnostic applications.
In consideration for the license, Scripps received an up-front
license fee of $50,000, and will receive royalties on future net
sales of products relating to the licensed technology, including
a minimum annual royalty payment of $10,000 commencing on the
third anniversary of the agreement. In addition, Scripps will
receive milestone payments, up to a maximum of $1.2 million
per therapeutic product and $0.4 million per diagnostic
product, based on meeting certain regulatory and clinical
milestones. From January 2002, the date we acquired Cell-Matrix
and assumed this agreement, through December 31, 2005, we
have paid an additional approximately $24,000 to Scripps under
the license agreement for the reimbursement of certain patent
expenses. The license agreement terminates upon the later of the
expiration of the last of any patent rights to licensed products
that are developed under the agreement or 15 years after
the date of the first commercial sale of the last product
licensed or developed under the agreement.
New
York University
In June 2003, Cell-Matrix licensed from New York University, or
NYU, the exclusive worldwide commercial rights to several
peptides that appear to inhibit angiogenesis in preclinical
models. Pursuant to our licensing arrangement, NYU received an
initial license fee of $0.2 million, paid in three equal
annual installments, and subsequent annual license maintenance
fees of $15,000. Cell-Matrix is also obligated to pay milestone
payments, up to a maximum of $0.8 million per product
relating to the licenses, based on regulatory and clinical
milestones and royalties on both future net sales of products
relating to the licenses and payments received as consideration
for the grant of a sublicense, if any. Through December 31,
2005, Cell-Matrix has paid approximately $0.3 million to
NYU under the agreement representing two installments of the
initial license fee and reimbursement of certain patent
expenses. The agreement terminates upon the later of the
expiration of the last of any patent rights to licensed products
that are developed under this agreement, or 15 years after
the date of the first commercial sale of the last product
licensed or developed under the agreement. Cell-Matrix may
terminate the agreement for any reason following
180 days written notice to NYU. This agreement may be
terminated by NYU if Cell-Matrix fails to meet specified
commercial development obligations under the agreement and we do
not materially cure this failure in one year.
Our
Strategy
Our objective is to establish our position as a leader in the
development and marketing of biological products for the
treatment and control of cancer. Key aspects of our corporate
strategy include the following:
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Initiate a Phase 1 Clinical Trial with
D93. We plan to initiate a clinical trial with
D93, our leading anti-angiogenic monoclonal antibody product
candidate, in early 2006.
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Advance the Development of Our Preclinical Product Candidates
and Identify Additional Product Candidates Based on Our
Anti-Angiogenesis Technology Platform. We plan to
continue the development of our other preclinical
anti-angiogenesis antibodies and peptides, and to leverage our
research and preclinical experience in anti-angiogenesis to
identify additional product candidates that will interact with
sites exposed during the denaturation and remodeling of the
extracellular matrix. In addition, we intend to explore using
our anti-angiogenesis product candidates in combination with
other therapies, such as chemotherapy and radiation.
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Seek Sublicensing Opportunities for Our Product Candidates
Targeting the EGF Receptor Signaling Pathway. We
plan to actively seek sublicensing opportunities for SAI-EGF and
our other two product candidates that target the EGF receptor
signaling pathway.
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Expand Our Product Pipeline and Technologies Through
Acquisitions and Licensing. In addition to our
internal development efforts, we plan to selectively license and
acquire product opportunities, technologies and businesses that
complement our target markets.
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Patents
and Proprietary Technology
Our success will depend in large part on our ability to:
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maintain and obtain patent and other proprietary protection for
cell lines, antigens, antibodies, peptides and delivery systems;
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defend patents;
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preserve trade secrets; and
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operate without infringing the patents and proprietary rights of
third parties.
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We intend to seek appropriate patent protection for our
proprietary technologies by filing patent applications when
possible in the United States and selected other countries. Our
policy is to seek patent protection for the inventions that we
consider important to the development of our business. As of
December, 2005 we owned or have rights to over 150 issued or
pending U.S. and foreign patents. We intend to continue using
our scientific expertise to pursue and file patent applications
on new developments with respect to uses, methods and
compositions to enhance our intellectual property position in
the field of cancer treatment.
Although we believe our rights under patents and patent
applications provide a competitive advantage, the patent
positions of pharmaceutical and biotechnology companies are
highly uncertain and involve complex legal and factual
questions. We may not be able to develop further patentable
products or processes, and may not be able to obtain patents
from pending applications. Even if patent claims are allowed,
the claims may not issue, or in the event of issuance, may not
be sufficient to protect the technology owned by or licensed to
us.
Any patents or patent rights that we obtain may be circumvented,
challenged or invalidated by our competitors. We rely on
third-party payment services for the payment of foreign patent
annuities and other fees. Non-payment or delay in payment of
such fees, whether intentional or unintentional, may result in
loss of patents or patent rights important to our business. Many
countries, including certain countries in Europe, have
compulsory licenses laws under which a patent owner may be
compelled to grant licenses to third parties. For example,
compulsory licenses may be required in cases where the patent
owner has filed to work the invention in that
country, or the third-party has patented improvements. In
addition, many countries limit the enforceability of patents
against government agencies or government contractors. In these
countries, the patent owner may have limited remedies, which
would materially diminish the value of the patent. Moreover, the
legal systems of certain countries, particularly in certain
developing countries, do not favor the aggressive enforcement of
patent and other intellectual property protection which makes it
difficult to stop infringement. Our patents may be the subject
of other challenges by our competitors in Europe, the United
States and elsewhere.
Additionally, because it is not possible to predict with
certainty what patent claims may issue from pending applications
and because patent prosecution can proceed in secret prior to
issuance of a patent, third parties may obtain patents with
claims of unknown scope relating to our product candidates which
they could attempt to assert against us. Further, as we develop
our products, we may infringe the current patents of third
parties or patents that may issue in the future.
Although we believe that our product candidates, production
methods and other activities do not currently infringe the valid
and enforceable intellectual property rights of any third
parties, we cannot be certain that a third party will not
challenge our position in the future. From time to time we
receive correspondence inviting us to license patents from third
parties. There has been, and we believe that there will continue
to be, significant litigation in the biopharmaceutical and
pharmaceutical industries regarding patent and other
intellectual property rights. As
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noted above, we believe that our pre-commercialization
activities fall within the scope of 35 U.S.C.
§ 271(e). We also believe that our subsequent
manufacture of Canvaxin will also not require the license of any
patents known to us.
Nevertheless, third parties could bring legal actions against us
claiming we infringe their patents or proprietary rights, and
seek monetary damages and seeking to enjoin clinical testing,
manufacturing and marketing of the affected product or products.
If we become involved in any litigation, it could consume a
substantial portion of our resources, regardless of the outcome
of the litigation. If any of these actions are successful, in
addition to any potential liability for damages, we could be
required to obtain a license to continue to manufacture or
market the affected product, in which case we may be required to
pay substantial royalties or grant cross-licenses to our
patents. However, there can be no assurance that any such
license will be available on acceptable terms or at all.
Ultimately, we could be prevented from commercializing a
product, or forced to cease some aspect of our business
operations, as a result of claims of patent infringement or
violation of other intellectual property rights, which could
harm our business.
Additionally, to enforce patents issued to us or to determine
the scope and validity of other parties proprietary
rights, we may also become involved in litigation or in
interference proceedings declared by the United States Patent
and Trademark Office, which could result in substantial costs to
us or an adverse decision as to the priority of our inventions.
We may be involved in interference
and/or
opposition proceedings in the future.
We are party to several license agreements that give us rights
to use technologies in our research and development, including
intellectual property for technology related to Canvaxin from
Cancer Diagnostics Laboratories, Inc. and JWCI, to our product
candidates that target the EGF receptor signaling pathway from
CIMAB, to our angiogenesis and anti-angiogenesis technology from
USC, Scripps, NYU and AME, and to certain human antibody
technology from M-Tech Therapeutics. These parties have been
responsible for filing various patent applications, including
patents and patent applications containing composition claims
that encompass the three cancer cell lines used for Canvaxin,
patent applications directed towards the product candidates that
target the EGF receptor signaling pathway and patent
applications directed to our angiogenesis technology. We may be
unable to maintain our licenses and may be unable to secure
additional licenses in the future. Therefore, we may be forced
to abandon certain product areas or develop alternative methods
for operating in those areas.
We also rely on trade secrets and proprietary know-how,
especially when we do not believe that patent protection is
appropriate or can be obtained. However, trade secrets are
difficult to protect. Our policy is to require each of our
employees, consultants and advisors to execute a confidentiality
and inventions agreement before beginning their employment,
consulting or advisory relationship with us obligating them not
to disclose our confidential information. We cannot guarantee
that these agreements will provide meaningful protection, that
these agreements will not be breached, that we will have an
adequate remedy for any such breach, or that our trade secrets
will not otherwise become known or independently developed by a
third party. Our trade secrets, and those of our present or
future collaborators that we utilize by agreement, may become
known or may be independently discovered by others, which could
adversely affect the competitive position of our product
candidates.
Competition
We face competition from a number of companies that are
evaluating various technologies and approaches to the treatment
of cancer.
For example, a number of companies are currently developing
products in the field of anti-angiogenesis for the treatment of
tumors. These products use a number of substances designed to
inhibit angiogenesis, such as vascular endothelial growth
factor, or VEGF, VEGF receptor, platelet-derived growth factor,
or PDGF, receptor, integrins, collagen, and matrix
metalloprotienases. Genentechs
Avastin®
(bevacizumab) is an anti-angiogenic monoclonal antibody
targeting the VEGF growth factor. It has been approved by FDA
for the treatment of patients with metastatic colorectal cancer.
Pfizers
Sutent®
(sunitinib malate) was recently approved by the FDA for the
treatment of patients with a specific type of stomach cancer and
kidney cancer, and Bayer and Onyx Pharmaceuticals
Nexavar®
(sorafenib tosylate) was approved by the FDA for the treatment
of patients with gastric cancer. A proposed mechanism of action
for both Nexavar and Sutent is inhibition of the VEGF receptor.
A number of other VEGF growth factor and VEGF receptor
antagonists are also under development, as well as a number of
agents
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targeting other potential anti-angiogenic mechanisms. We are
unaware of any products in development that specifically target
the same denatured collagen as our D93 product candidate. We
expect that competition among anti-angiogenic products approved
for sale will be based on various factors, including product
efficacy, safety, reliability, availability, price and patent
position. As a result, any product candidates that we may
develop may be rendered obsolete and noncompetitive.
Additionally, several products that target the EGFR signaling
pathway in the treatment of cancer have recently been approved
by the FDA or are in the late phases of clinical development.
The approved products are AstraZeneca Pharmaceutical LPs
Iressatm
(gefitinib), an EGFR-targeted tyrosine kinase inhibitor for
refractory Stage IV NSCLC, ImClone Systems, Inc.s
Erbituxtm
(cetuximab), an EGFR monoclonal antibody for Stage IV
refractory colorectal cancer, and Genentech, Inc. and OSI
Pharmaceuticals, Inc.s EGFR-targeted tyrosine kinase
inhibitor,
Tarcevatm
(erlotinib HCl), for the treatment of patients with locally
advanced or metastatic NSCLC after failure of at least one prior
chemotherapy regimen, as well as in combination with Eli
Lilly & Companys
Gemzar®
(gemcitabine) for the treatment of patients with locally
advanced pancreatic cancer. Two other products that are
currently being evaluated in Phase 3 clinical trials are
GlaxoSmithKlines lapatinib (GW572016), a tyrosine kinase
dual inhibitor of EGFR and HER-2, which is being studied in
patients with advanced metastatic breast cancer whose disease
progressed on
Herceptin®
(trastuzumab) therapy, and Abgenix, Inc.s and Amgen,
Inc.s panitumumab (ABX-EGF), a fully human monoclonal
antibody targeting the EGFR, which is being studied in patients
with advanced colorectal and renal cell cancer. Several other
monoclonal antibodies and tyrosine kinase inhibitors targeting
the EGFR signaling pathway are in the early stages of
development. If we receive approval to market and sell any of
our product candidates that target the EGFR signaling pathway,
we may compete with certain of these companies and their
products as well as other product candidates that are currently
in varying stages of development. In addition, researchers are
continually learning more about the treatment of NSCLC and other
forms of cancer, and new discoveries may lead to new
technologies for treatment.
Additionally, we may encounter competition from pharmaceutical
and biotechnology companies, academic institutions, governmental
agencies and private research organizations in recruiting and
retaining highly qualified scientific personnel and consultants
and in the development and acquisition of technologies.
Moreover, technology controlled by third parties that may be
advantageous to our business may be acquired or licensed by our
competitors, thereby preventing us from obtaining technology on
commercially reasonable terms, if at all. Because part of our
strategy is to target markets outside of the United States
through collaborations with third parties, we will compete for
the services of third parties that may have already developed or
acquired internal biotechnology capabilities or made commercial
arrangements with other biopharmaceutical companies to target
the diseases on which we have focused.
Government
Regulation and Product Approval
General
Governmental authorities in the United States and other
countries extensively regulate the preclinical and clinical
testing, manufacturing, labeling, storage, record-keeping,
advertising, promotion, export, marketing and distribution,
among other things, of biologic products. In the United States,
the FDA under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act and other federal statutes and
regulations subjects pharmaceutical and biologic products to
rigorous review. If we do not comply with applicable
requirements, we may be fined, the government may refuse to
approve our marketing applications or allow us to manufacture or
market our product candidates and products, and we may be
criminally prosecuted. The FDA also has the authority to revoke
previously granted marketing authorizations if we fail to comply
with regulatory standards or if we encounter problems following
initial marketing.
FDA
Approval Process
To obtain approval of a new product from the FDA, we must, among
other requirements, submit data supporting safety and efficacy
as well as detailed information on the manufacture and
composition of the product candidate. In most cases, this
entails extensive laboratory tests and preclinical and clinical
trials. This testing and the preparation of necessary
applications and processing of those applications by the FDA are
expensive and typically
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take many years to complete. The FDA may not act quickly or
favorably in reviewing these applications, and we may encounter
significant difficulties or costs in our efforts to obtain FDA
approvals that could delay or preclude us from marketing any
products we may develop. The FDA also may require post-marketing
testing and surveillance to monitor the safety and efficacy of
approved products or place conditions on any approvals that
could restrict the commercial applications of these products.
Regulatory authorities may withdraw product approvals if we fail
to comply with regulatory standards or if we encounter problems
at any time following initial marketing. With respect to
patented products or technologies, delays imposed by the
governmental approval process may materially reduce the period
during which we will have the exclusive right to exploit the
products or technologies.
The process required by the FDA before a new drug or biologic
may be marketed in the United States generally involves the
following: completion of preclinical laboratory and animal
testing; submission of an IND, which must become effective
before human clinical trials may begin; performance of adequate
and well-controlled human clinical trials to establish the
safety and efficacy of the proposed drug or biologic for its
intended use; and submission and approval of a New Drug
Application, or NDA, for a drug, or a Biologics License
Application, or BLA, for a biologic. The sponsor typically
conducts human clinical trials in three sequential phases, but
the phases may overlap. In Phase 1 clinical trials, the
product is tested in a small number of patients or healthy
volunteers, primarily for safety at one or more doses. In
Phase 2, in addition to safety, the sponsor evaluates the
efficacy of the product in targeted indications, and identifies
possible adverse effects and safety risks, in a patient
population that is usually larger than Phase 1 clinical
trials. Phase 3 clinical trials typically involve
additional testing for safety and clinical efficacy in an
expanded patient population at geographically-dispersed clinical
trial sites. Clinical trials must be conducted in accordance
with the FDAs Good Clinical Practices requirements. Prior
to commencement of each clinical trial, the sponsor must submit
to the FDA a clinical plan, or protocol, accompanied by the
approval of the committee responsible for overseeing clinical
trials at one of the clinical trial sites. The FDA may order the
temporary or permanent discontinuation of a clinical trial at
any time if it believes that the clinical trial is not being
conducted in accordance with FDA requirements or presents an
unacceptable risk to the clinical trial patients. The ethics
committee at each clinical site may also require the clinical
trial at that site to be halted, either temporarily or
permanently, for the same reasons.
The sponsor must submit to the FDA the results of the
preclinical and clinical trials, together with, among other
things, detailed information on the manufacture and composition
of the product, in the form of a new drug application, or NDA,
or, in the case of a biologic, a BLA. Our monoclonal antibody
product candidates will be regulated as drugs. In a process that
may take from several months to several years, the FDA reviews
these applications and, when and if it decides that adequate
data are available to show that the new compound is both safe
and effective and that other applicable requirements have been
met, approves the drug or biologic for marketing. The amount of
time taken for this approval process is a function of a number
of variables, including whether the product has received a fast
track designation, the quality of the submission and studies
presented, the potential contribution that the compound will
make in improving the treatment of the disease in question, and
the workload at the FDA. It is possible that our product
candidates will not successfully proceed through this approval
process or that the FDA will not approve them in any specific
period of time, or at all.
The FDA may, during its review of a NDA or BLA, ask for
additional test data. If the FDA does ultimately approve the
product, it may require post-marketing testing, including
potentially expensive Phase 4 studies, to monitor the
safety and effectiveness of the product. In addition, the FDA
may in some circumstances impose restrictions on the use of the
product, which may be difficult and expensive to administer and
may require prior approval of promotional materials.
We will also be subject to a variety of regulations governing
clinical trials and sales of our products outside the United
States. Whether or not FDA approval has been obtained, approval
of a product by the comparable regulatory authorities of foreign
countries and regions must be obtained prior to the commencement
of marketing the product in those countries. The approval
process varies from one regulatory authority to another and the
time may be longer or shorter than that required for FDA
approval. In the European Union, Canada, and Australia,
regulatory requirements and approval processes are similar, in
principle, to those in the United States.
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Ongoing
Regulatory Requirements
Before approving an NDA or BLA, the FDA will inspect the
facilities at which the product is manufactured and will not
approve the product unless the manufacturing facilities are in
compliance with FDAs good manufacturing practices, or GMP,
regulations which govern the manufacture, holding and
distribution of a product. Manufacturers of biologics also must
comply with FDAs general biological product standards.
Following approval, the FDA periodically inspects drug and
biologic manufacturing facilities to ensure continued compliance
with the good manufacturing practices regulations. Manufacturers
must continue to expend time, money and effort in the areas of
production and quality control and record keeping and reporting
to ensure full compliance with those requirements. Failure to
comply with these requirements subjects the manufacturer to
possible legal or regulatory action, such as suspension of
manufacturing or recall or seizure of product. Adverse
experiences with the product must be reported to the FDA and
could result in the imposition of marketing restrictions through
labeling changes or market removal. Product approvals may be
withdrawn if compliance with regulatory requirements is not
maintained or if problems concerning safety or efficacy of the
product occur following approval.
The labeling, advertising, promotion, marketing and distribution
of a drug or biologic product also must be in compliance with
FDA and Federal Trade Commission, or FTC, requirements which
include, among others, standards and regulations for off-label
promotion, industry sponsored scientific and educational
activities, promotional activities involving the internet, and
direct-to-consumer
advertising. The FDA and FTC have very broad enforcement
authority, and failure to abide by these regulations can result
in penalties, including the issuance of a Warning Letter
directing the company to correct deviations from regulatory
standards and enforcement actions that can include seizures,
injunctions and criminal prosecution.
Manufacturers are also subject to various laws and regulations
governing laboratory practices, the experimental use of animals,
and the use and disposal of hazardous or potentially hazardous
substances in connection with their research. In each of these
areas, as above, the FDA has broad regulatory and enforcement
powers, including the ability to levy fines and civil penalties,
suspend or delay issuance of product approvals, seize or recall
products, and deny or withdraw approvals.
Employees
As of December 31, 2005, we employed 52 full-time
employees, of whom approximately 28 were engaged in research,
clinical development and regulatory affairs, 2 in manufacturing
and quality assurance, and 22 in administration, finance,
management information systems, corporate development, marketing
and human resources. Nine of our employees hold a
Ph.D., M.D. or Pharm.D. degree and are engaged in
activities relating to research and development, manufacturing,
quality assurance and business development. In January 2006, we
implemented additional restructuring measures which, when fully
implemented, will result in the further reduction of our
workforce to approximately 10 employees by the completion
of our proposed merger with Micromet.
Facilities
Our corporate headquarters and research and development facility
of approximately 60,000 square feet located in Carlsbad,
California is leased under a ten-year operating lease that
commenced in July 2002. Our biologics manufacturing facility
consists of approximately 51,000 square feet of space
located in the Los Angeles, California, area. JWCI entered into
an original operating lease for 25,600 square feet of space
in July 1999, with a commencement date in August 1999, which was
subsequently assigned to us. We entered into an amendment to our
lease to add 25,150 square feet of space at the same
address on October 1, 2001. Our lease is scheduled to
expire on August 14, 2011. In August 2004, we signed a
seven-year operating lease for a 42,681 square foot
warehouse, laboratory and office facility located in the Los
Angeles, California area, near our biologics manufacturing
facility.
Subsequent to the decision to discontinue the Phase 3
clinical trials of
Canvaxintm,
we have closed our biologics manufacturing facility and
our warehouse facility in Los Angeles, and have engaged real
estate brokers in an effort to assign or sublease our principal
offices and other facilities.
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MANAGEMENTS
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS OF CANCERVAX
The following discussion contains forward-looking statements,
which involve risks and uncertainties. Our actual results could
differ materially from those anticipated in these
forward-looking statements as a result of various factors,
including those set forth under the caption Risk
Factors. This Managements Discussion and Analysis of
Financial Condition and Results of Operations should be read in
conjunction with our consolidated financial statements and
related notes included elsewhere in this proxy
statement/prospectus.
Overview
We are a biotechnology company focused on the research,
development and commercialization of novel biological products
for the treatment and control of cancer.
Proposed
Merger with Micromet AG
On January 6, 2006, we entered into an Agreement and Plan
of Merger and Reorganization with Micromet AG, or Micromet, a
privately-held German company, that contains the terms and
conditions of our proposed merger with that company. The merger
agreement provides that our wholly-owned subsidiary, Carlsbad
Acquisition Corporation, will merge with and into Micromet,
Inc., or Micromet Parent, a newly created parent corporation of
Micromet. Micromet Parent will become a wholly-owned subsidiary
of ours and will be the surviving corporation of the merger.
Pursuant to the terms of the merger agreement, we will issue to
Micromet stockholders shares of our common stock and will assume
all of the stock options, stock warrants and restricted stock of
Micromet outstanding as of the merger closing date, such that
the Micromet stockholders, option holders, warrant holders and
note holders will own approximately 67.5% of the combined
company on a fully-diluted basis and our stockholders, option
holders and warrant holders will own approximately 32.5% of the
combined company on a fully-diluted basis. The merger is subject
to customary closing conditions, including approval by our
stockholders. We anticipate that the merger will be completed
soon after CancerVaxs annual meeting.
Discontinuation
of Canvaxin Clinical Trials and Development and Manufacturing
Activities
On October 3, 2005, we and Serono Technologies, S.A., our
Canvaxin collaboration partner, announced the discontinuation of
our Phase 3 clinical trial of our leading product
candidate, Canvaxin, in patients with Stage III melanoma,
based on the recommendation of the independent Data and Safety
Monitoring Board, or DSMB, which completed its planned, third,
interim analysis of data from this study on September 30,
2005. In April 2005, we announced the discontinuation of our
Phase 3 clinical trial of Canvaxin in patients with
Stage IV melanoma based upon a similar recommendation of
the independent DSMB. The DSMB concluded, based on its planned,
interim analysis of the data from these studies, that the data
were unlikely to provide significant evidence of a survival
benefit for Canvaxin-treated patients versus those receiving
placebo. There were no significant safety issues identified with
either of the Phase 3 clinical trials of Canvaxin, and the
recommendations to close the studies were not made because of
any potential safety concerns. As a result of the
discontinuation of the Canvaxin Phase 3 clinical trials, in
October 2005 we and Serono announced the discontinuation of all
further development and manufacturing activities with respect to
Canvaxin.
In October 2005, we announced that our board of directors had
approved a restructuring plan designed to realign resources in
light of the decision to discontinue our Phase 3 clinical
trial of Canvaxin in patients with Stage III melanoma, as
well as all further development of Canvaxin and manufacturing
activities at our Canvaxin manufacturing facilities. Under the
restructuring plan, in 2005 we reduced our workforce from 183 to
52 employees at December 31, 2005 and closed our biologics
manufacturing facility and our warehouse facility. We are
actively seeking to sublease all three of our principal
facilities. In 2005, we recorded a non-recurring charge
associated with our restructuring activities of
$4.9 million. This non-recurring restructuring charge
includes $3.5 million of employee severance costs, the
substantial majority of which were cash expenditures that were
paid in the fourth quarter of 2005, and $1.4 million of
leased facility exit costs, representing the estimated future
costs to be incurred under the operating leases for our
biologics manufacturing facility and our warehouse facility, net
of estimated sublease rentals. In 2005, we also recorded a
non-recurring charge for contract termination costs of
$0.2 million,
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which is included in research and development expenses. In
connection with our restructuring activities, we also recorded a
non-recurring, non-cash charge for the impairment of long-lived
assets of $25.4 million in 2005 to write-down the carrying
value of certain of our long-lived assets to their estimated
fair value.
In January 2006, we implemented additional restructuring
measures which, when fully implemented, will result in the
further reduction of our workforce to approximately 10 employees
by the completion of our proposed merger with Micromet. In
connection with this workforce reduction, in 2006 we anticipate
incurring approximately $3.0 million of additional employee
severance costs. We also anticipate incurring additional leased
facility exit costs in 2006, primarily related to our corporate
headquarters and research and development facility. At this
time, we are unable to reasonably estimate the expected amount
of such additional leased facility exit costs, although our
remaining obligations under the operating lease for our
corporate headquarters and research and development facility
aggregated $11.2 million as of December 31, 2005. We
may also incur additional contract termination and other
restructuring costs. We anticipate that our restructuring
efforts will be substantially completed by the end of the second
quarter of 2006.
Ongoing
Business Activities
We have other product candidates in research and preclinical
development, including four humanized, anti-angiogenic
monoclonal antibodies and several peptides that may be useful
for the treatment of patients with various solid tumors. In
February 2006, we submitted an Investigational New Drug
Application, or IND, with the U.S. Food and Drug
Administration to initiate a Phase 1 clinical trial for
D93, our leading humanized, anti-angiogenic monoclonal antibody,
in patients with solid tumors.
We also have rights to three product candidates targeting the
epidermal growth factor receptor, or EGFR, signaling pathway for
the treatment of cancer, and we plan to actively seek
sublicensing opportunities for these product candidates.
Our efforts to identify, develop and commercialize and, in the
case of the three product candidates that target the EGFR
signaling pathway, to sublicense, these product candidates are
in an early stage and, therefore, these efforts are subject to a
high risk of failure.
We were incorporated in Delaware in June 1998 and have incurred
net losses since inception. As of December 31, 2005, our
accumulated deficit was approximately $224.4 million. We
expect to incur substantial and increasing losses for the next
several years as we:
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advance our preclinical anti-angiogenesis product candidates
into clinical development;
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expand our research and development programs; and
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in-license technology and acquire or invest in businesses,
products or technologies that are complementary to our own.
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We have a limited history of operations. To date, we have funded
our operations primarily through sales of equity securities as
well as bank financing to fund certain equipment and leasehold
improvement expenditures.
Our business is subject to significant risks, including the
risks inherent in developing our early stage product candidates,
the regulatory approval process, the results of our research and
development efforts, our ability to manufacture our product
candidates, competition from other products, uncertainties
associated with obtaining and enforcing patent rights, with
maintaining our licenses related to our product candidates,
obtaining the capital necessary to fund our ongoing operations
and establishing and maintaining strategic collaborations to
fund our product development efforts.
Research
and Development
Through December 31, 2005, our research and development
expenses consisted primarily of costs associated with the
clinical development of Canvaxin, including costs associated
with the Phase 3 clinical trials of Canvaxin, production of
Canvaxin for use in these clinical trials and manufacturing
process, quality systems and analytical development for
Canvaxin, including compensation and other personnel expenses,
supplies and materials, costs for
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consultants and related contract research, facility costs,
license fees and depreciation. We charge all research and
development expenses to operations as they are incurred. From
our inception through December, 2005, we incurred costs of
approximately $135.0 million associated with the research
and development of Canvaxin, representing over 89% of our total
research and development expenses.
Under our collaboration agreement with Serono, we were entitled
to receive milestone payments upon the achievement of certain
development, regulatory and sales based objectives related to
Canvaxin. As a result of the discontinuation of all further
development and manufacturing activities with respect to
Canvaxin, we do not anticipate receiving any of these milestone
payments, but we will continue to share equally with Serono
certain costs associated with the discontinuation of the
Canvaxin development program and manufacturing operations, as
contemplated under the collaboration agreement. Serono may
terminate the collaboration agreement for convenience upon
180 days prior notice. Either party may terminate the
agreement for the material breach or bankruptcy of the other
party. In the event of a termination of the agreement, rights to
Canvaxin will revert to us.
Following the discontinuation of all further Canvaxin
development and manufacturing activities, our research and
development activities will primarily be focused on the
development of product candidates based on our proprietary
anti-angiogenesis technology.
We are unable to estimate with any certainty the costs we will
incur in the continued development of our other product
candidates. However, we expect our research and development
costs associated with these product candidates to increase as we
continue to develop new indications and move these product
candidates through preclinical and clinical trials.
Clinical development timelines, likelihood of success and total
costs vary widely. We anticipate that we will make
determinations as to which research and development projects to
pursue and how much funding to direct to each project on an
on-going basis in response to the scientific and clinical
success of each product candidate.
The costs and timing for developing and obtaining regulatory
approvals of our product candidates vary significantly for each
product candidate and are difficult to estimate. The expenditure
of substantial resources will be required for the lengthy
process of clinical development and obtaining regulatory
approvals as well as to comply with applicable regulations. Any
failure by us to obtain, or any delay in obtaining, regulatory
approvals could cause our research and development expenditures
to increase and, in turn, have a material adverse effect on our
results of operations.
Critical
Accounting Policies and Estimates
Our discussion and analysis of our financial condition and
results of operations are based on our consolidated financial
statements, which have been prepared in accordance with
accounting principles generally accepted in the United States.
The preparation of the consolidated financial statements
requires us to make estimates and judgments that affect the
reported amounts of assets, liabilities, revenues and expenses
and the related disclosure of contingent assets and liabilities.
We review our estimates on an on-going basis, including those
related to revenue recognition, the valuation of goodwill,
intangibles and other long-lived assets and restructuring
activities. We base our estimates on historical experience and
on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the bases for
making judgments about the carrying values of assets and
liabilities. Actual results may differ from these estimates
under different assumptions or conditions. Our accounting
policies are described in more detail in Note 1 to our
consolidated financial statements included elsewhere in this
proxy statement/prospectus. We have identified the following as
the most critical accounting policies and estimates used in the
preparation of our consolidated financial statements.
Revenue
Recognition
We recognize revenue in accordance with the provisions of
Securities and Exchange Commission Staff Accounting Bulletin, or
SAB, No. 104, Revenue Recognition in Financial
Statements, and Emerging Issues Task Force, or EITF, Issue
No. 00-21,
Accounting for Revenue Arrangements with Multiple
Deliverables. Accordingly, revenue is recognized once all of
the following criteria are met: (i) persuasive evidence of
an arrangement exists; (ii) delivery of the products
and/or
services has occurred; (iii) the selling price is fixed or
determinable; and
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(iv) collectibility is reasonably assured. Any amounts
received prior to satisfying these revenue recognition criteria
are recorded as deferred revenue in our consolidated balance
sheets.
Collaborative research and development revenues, representing
the portion of our pre-commercialization expenses incurred under
collaboration agreements that are shared with our partners, are
recognized as revenue in the period in which the related
expenses are incurred, assuming that collectibility is
reasonably assured and the amount is reasonably estimable.
Nonrefundable up-front license fees where we have continuing
involvement in research and development
and/or other
performance obligations are initially deferred and recognized as
license fee revenue over the estimated period until completion
of our performance obligations.
Our estimates of the period over which we recognize revenue are
based on the contractual terms of the underlying arrangement,
the level of effort required for us to fulfill our obligations
and the anticipated timing of the fulfillment of our
obligations. As our product candidates move through the clinical
development and regulatory approval process, our estimates of
the period over which we recognize revenue from nonrefundable
up-front license fees and milestone payments, if any, may
change. The effect of changes in our estimates of the revenue
recognition period will be recognized prospectively over the
remaining estimated period. We regularly review our estimates of
the period over which we have ongoing performance obligations.
Goodwill
In accordance with Statement of Financial Accounting Standards,
or SFAS No. 142, Goodwill and Other Intangible
Assets, we do not amortize goodwill. Instead, we review
goodwill for impairment at least annually and whenever events or
changes in circumstances indicate a reduction in the fair value
of the reporting unit to which the goodwill has been assigned.
Conditions that would necessitate a goodwill impairment
assessment include a significant adverse change in legal factors
or in the business climate, an adverse action or assessment by a
regulator, unanticipated competition, a loss of key personnel,
or the presence of other indicators that would indicate a
reduction in the fair value of the reporting unit to which the
goodwill has been assigned. SFAS No. 142 prescribes a
two-step process for impairment testing of goodwill. The first
step of the impairment test is used to identify potential
impairment by comparing the fair value of the reporting unit to
which the goodwill has been assigned to its carrying amount,
including the goodwill. Such a valuation requires significant
estimates and assumptions including but not limited to:
determining the timing and expected costs to complete in-process
projects, projecting regulatory approvals, estimating future
cash inflows from product sales and other sources, and
developing appropriate discount rates and probability rates by
project. If the carrying value of the reporting unit exceeds the
fair value, the second step of the impairment test is performed
in order to measure the impairment loss.
Our goodwill had a carrying value of $5.4 million at each
of December 31, 2005 and 2004 and resulted from our
acquisition of Cell-Matrix, Inc. in January 2002. We have
assigned the goodwill to our Cell-Matrix reporting unit. In the
fourth quarter of 2005, we performed our annual goodwill
impairment test for fiscal year 2005 in accordance with
SFAS No. 142 and determined that the carrying amount
of goodwill was recoverable. In determining the fair value of
the Cell-Matrix reporting unit, we considered internal
risk-adjusted cash flow projections which utilize several key
assumptions, including estimated timing and costs to complete
development of the anti-angiogenesis technology and estimated
future cash inflows from anticipated future collaborations and
projected product sales. Our analysis of the fair value of the
Cell-Matrix reporting unit assumes the timely and successful
completion of development of the anti-angiogenesis technology.
The major risks and uncertainties associated with the timely and
successful completion of development of the anti-angiogenesis
technology include the risk that we will not be able to confirm
the safety and efficacy of the technology with data from
clinical trials and the risk that we will not be able to obtain
necessary regulatory approvals. No assurance can be given that
the underlying assumptions used to forecast the cash flows or
the timely and successful completion of development will
materialize as estimated.
Subsequent to the completion of our annual goodwill impairment
assessment for 2005, as a result of our proposed merger with
Micromet, we performed an additional impairment assessment of
our goodwill. In determining the fair value of our Cell-Matrix
reporting unit for this goodwill impairment assessment, we
assumed that the rights to the technology acquired from
Cell-Matrix would be sublicensed to third parties in exchange
for certain
200
up-front, milestone and product sale royalty payments, and we
would have no further involvement in the ongoing development and
commercialization of the technology. The estimated future net
cash flows resulting from the sublicensing of the technology
were risk-adjusted to reflect the risks inherent in the
development process and discounted to their net present value.
Based on the goodwill impairment assessment performed, we
determined that the carrying amount of goodwill was recoverable.
We cannot assure you that our future reviews of goodwill
impairment will not result in a material charge.
Impairment
of Long-Lived Assets and Restructuring Activities
In accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, long-lived
assets to be held and used, including property and equipment and
intangible assets subject to amortization, are reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount of the assets might not be recoverable.
Conditions that would necessitate an impairment assessment
include a significant decline in the market price of an asset or
asset group, a significant adverse change in the extent or
manner in which an asset or asset group is being used, a
significant adverse change in legal factors or in the business
climate that could affect the value of a long-lived asset or
asset group, or the presence of other indicators that would
indicate that the carrying amount of an asset or asset group is
not recoverable. Determination of recoverability is based on the
undiscounted future cash flows resulting from the use of the
asset or asset group and its eventual disposition. The
determination of the undiscounted cash flows requires
significant estimates and assumptions including but not limited
to: determining the timing and expected costs to complete
in-process projects, projecting regulatory approvals and
estimating future cash inflows from product sales and other
sources. In the event that such cash flows are not expected to
be sufficient to recover the carrying amount of the asset or
asset group, the carrying amount of the asset is written down to
its estimated fair value.
As a result of our decision to discontinue all further
development and manufacturing activities with respect to
Canvaxin and our proposed merger with Micromet, in 2005 we
performed a recoverability test of our long-lived assets,
including property and equipment and patents, in accordance with
SFAS No. 144. Our ability to recover the carrying
value of our property and equipment is based on the estimated
undiscounted future net cash flows expected to result from the
disposition of our property and equipment, including the
estimated future cash inflows from anticipated sales of property
and equipment, net of estimated asset disposition costs. Our
estimate of the undiscounted future net cash flows expected to
result from the disposition of our property and equipment
considered the physical condition of the assets, quoted market
prices for similar assets and the period of time in which we
intend to dispose of the assets.
Our ability to recover the carrying value of our patents is
based on the estimated undiscounted future net cash flows
expected to result from our sublicensing of the rights to the
patents and underlying technology, including the estimated
future cash inflows from up-front, milestone and product sale
royalty payments, net of estimated ongoing development costs.
Our estimate of the undiscounted future net cash flows expected
to result from the disposition of our patents considered the
technologys stage of development and market potential.
Based on the recoverability analysis performed, management does
not believe that the estimated undiscounted future cash flows
expected to result from the disposition of certain of our
long-lived assets are sufficient to recover the carrying value
of these assets. Accordingly, in 2005 we recorded a
non-recurring, non-cash charge for the impairment of long-lived
assets of $25.4 million to write-down the carrying value of
these assets to their estimated fair value.
Under the restructuring plan approved by our board of directors
in October 2005, we reduced our workforce from 183 to 52
employees at December 31, 2005 and closed our biologics
manufacturing facility and our warehouse facility. We are
actively seeking to sublease all three of our principal
facilities. In 2005, we recorded a non-recurring charge
associated with our restructuring activities of
$4.9 million. The non-recurring restructuring charge
includes $3.5 million of employee severance costs, the
substantial majority of which were cash expenditures that were
paid in the fourth quarter of 2005, and $1.4 million of
leased facility exit costs, representing the estimated future
costs to be incurred under the operating leases for our
biologics manufacturing facility and our warehouse facility, net
of estimated sublease rentals. In 2005, we also recorded a
non-recurring charge for contract termination costs of
$0.2 million, which is included in research and development
expenses.
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In January 2006, we implemented additional restructuring
measures which, when fully implemented, will result in the
further reduction of our workforce to approximately 10 employees
by the completion of our proposed merger with Micromet. In
connection with this workforce reduction, in 2006 we anticipate
incurring approximately $3.0 million of additional employee
severance costs. We also anticipate incurring additional leased
facility exit costs in 2006, primarily related to our corporate
headquarters and research and development facility. At this
time, we are unable to reasonably estimate the expected amount
of such additional leased facility exit costs, although our
remaining obligations under the operating lease for our
corporate headquarters and research and development facility
aggregated $11.2 million as of December 31, 2005. We
may also incur additional contract termination and other
restructuring costs. The timing and amounts of these
restructuring costs will be based on, among other things, our
ability to sublease our facilities, the timing of such subleases
and the sublease rental rates obtained and the estimated
termination dates of our employees and contracts. No assurance
can be given that the underlying assumptions used to estimate
the amounts of these restructuring costs will materialize as
estimated. Differences between our estimates and the actual
timing of subleases and the sublease rates obtained and the
actual timing and amounts paid for employee and contract
terminations may result in additional restructuring costs. We
anticipate that our restructuring efforts will be substantially
completed by the end of the second quarter of 2006.
Results
of Operations
Comparison
of the Years Ended December 31, 2005 and 2004
Revenues. Total revenues were
$40.6 million for the year ended December 31, 2005,
compared to $1.5 million for the year ended
December 31, 2004. Revenues for the years ended
December 31, 2005 and 2004 consisted of license fee
revenues of $24.7 million and $0.3 million,
respectively, and collaborative research and development
revenues of $15.9 million and $1.2 million,
respectively, from our collaboration agreement with Serono.
License fee revenues represent the portion of the
$25.0 million up-front license fee received from Serono in
January 2005 recognized as revenue. As a result of the
discontinuation of Canvaxin development and manufacturing
activities, we have no further substantive performance
obligations to Serono under the collaboration agreement related
to the ongoing development and commercialization of Canvaxin.
Accordingly, we recognized the remaining deferred up-front
license fee as revenue in 2005. Collaborative research and
development revenues represent Seronos 50% share of our
Canvaxin pre-commercialization expenses under the agreement,
which were incurred by us after the effective date of the
collaboration agreement.
Research and Development Expenses. Research
and development expenses were $38.8 million for the year
ended December 31, 2005, compared to $43.1 million for
the year ended December 31, 2004. The $4.3 million
decrease in research and development expenses was due to
decreased personnel expenses resulting from the reduction in our
workforce in connection with our restructuring activities,
decreased clinical trial expenses due to the discontinuation of
the Phase 3 clinical trials of Canvaxin in 2005 and
$1.0 million of technology access and transfer fees under
our agreements with CIMAB, S.A. and YM BioSciences, Inc., which
were recognized as research and development expenses in 2005, as
compared to $4.3 million of technology access and transfer
fees recognized in 2004. The decrease in research and
development expenses was offset by increased facilities expenses
associated with our warehouse facility leased in August 2004,
contract manufacturing and laboratory services expenses
associated with D93 and our 50% share of Canvaxin
pre-commercialization expenses incurred by Serono under the
collaboration agreement.
Non-cash employee stock-based compensation of $0.1 million
and $0.5 million for the years ended December 31, 2005
and 2004, respectively, was excluded from research and
development expenses and reported under a separate caption.
General and Administrative Expenses. General
and administrative expenses were $12.0 million for the year
ended December 31, 2005, compared to $12.3 million for
the year ended December 31, 2004. The $0.3 million
decrease in general and administrative expenses was primarily
due to decreased personnel expenses resulting from the reduction
in our workforce in connection with our restructuring activities
and decreased outside legal fees, offset by our 50% share of
Canvaxin pre-commercialization expenses incurred by Serono under
the collaboration agreement.
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Non-cash employee stock-based compensation of $0.5 million
and $1.3 million for the years ended December 31, 2005
and 2004, respectively, was excluded from general and
administrative expenses and reported under a separate caption.
Amortization of Employee Stock-based
Compensation. Employee stock-based compensation
results from stock options granted to our employees and
directors prior to our initial public offering with exercise
prices that were deemed to be below the estimated fair value of
the underlying common stock on the option grant date as well as
stock awards with performance-based vesting provisions granted
to employees in 2005. We recorded the spread between the
exercise price of the stock option or purchase price of the
restricted stock and the fair value of the underlying common
stock as deferred employee stock-based compensation. We amortize
the deferred employee stock-based compensation as a non-cash
charge to operations on an accelerated basis over the vesting
period of the award. Amortization of deferred employee
stock-based compensation was $0.6 million and
$1.9 million for the years ended December 31, 2005 and
2004, respectively.
Restructuring Charges. Under the restructuring
plan approved by our board of directors in October 2005, we
reduced our workforce from 183 to 52 employees at
December 31, 2005 and closed our biologics manufacturing
facility and our warehouse facility. In 2005, we recorded a
non-recurring charge associated with our restructuring
activities of $4.9 million, consisting of $3.5 million
of employee severance costs and $1.4 million of leased
facility exit costs.
Impairment of Long-lived Assets. As a result
of the discontinuation of all further Canvaxin development and
manufacturing activities, we recorded a non-recurring, non-cash
charge for the impairment of long-lived assets of
$25.4 million in 2005 to write-down the carrying value of
certain of our long-lived assets to their estimated fair value
in accordance with SFAS No. 144.
Interest Income. Interest income for the year
ended December 31, 2005 was $1.8 million, compared to
$0.9 million for the year ended December 31, 2004. The
$0.9 million increase in interest income was primarily due
to higher rates of interest on invested balances in 2005.
Interest Expense. Interest expense for the
year ended December 31, 2005 was $0.5 million,
compared to $0.8 million for the year ended
December 31, 2004. The $0.3 million decrease was
primarily due to the capitalization of interest expense on our
$18.0 million bank credit facility in 2005 related to the
expansion of our biologics manufacturing facility.
Comparison
of the Years Ended December 31, 2004 and 2003
Revenues. Total revenues were
$1.5 million for the year ended December 31, 2004,
compared to no revenues for the year ended December 31,
2003. Revenues for the year ended December 31, 2004
consisted of license fee revenues of $0.3 million and
collaborative research and development revenues of
$1.2 million from our collaboration agreement with Serono.
The $25.0 million up-front license fee received from Serono
was being recognized as license fee revenue on a straight-line
basis over approximately 3.3 years, which primarily
represented the estimated period until regulatory approval and
commercialization of Canvaxin in patients with Stage IV
melanoma in the United States. Collaborative research and
development revenues represent Seronos 50% share of our
pre-commercialization expenses under the agreement, which were
incurred by us after the effective date of the collaboration
agreement.
Research and Development Expenses. Research
and development expenses were $43.1 million for the year
ended December 31, 2004, compared to $27.7 million for
the year ended December 31, 2003. The $15.4 million
increase in research and development expenses primarily reflects
additional investment in personnel in the manufacturing, quality
and research and development departments, increased clinical
trial expenses associated with increased patient enrollment in
our Phase 3 clinical trials of our lead product candidate,
Canvaxin, including costs associated with the production of
Canvaxin for use in these clinical trials, $4.3 million of
technology access and transfer fees under our agreements with
CIMAB and YM BioSciences, which were recognized as research and
development expenses in 2004, and payments totaling
$1.3 million made under our sublicense agreement with
SemaCo, Inc., which were recognized as research and development
expenses.
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Non-cash employee stock-based compensation of $0.5 million
and $0.8 million for the years ended December 31, 2004
and 2003, respectively, was excluded from research and
development expenses and reported under a separate caption.
General and Administrative Expenses. General
and administrative expenses were $12.3 million for the year
ended December 31, 2004, compared to $6.8 million for
the year ended December 31, 2003. The $5.5 million
increase in general and administrative expenses primarily
reflects additional investment in personnel in the finance and
marketing and business development departments, increased
directors and officers insurance premiums and other expenses
associated with our becoming a publicly-traded company,
increased legal fees and other expenses related to business
development activities and increased expenses associated with
marketing activities.
Non-cash employee stock-based compensation of $1.3 million
and $1.8 million for the years ended December 31, 2004
and 2003, respectively, was excluded from general and
administrative expenses and reported under a separate caption.
Amortization of Employee Stock-based
Compensation. During the initial public offering
process, we re-evaluated the historical estimated fair value of
our common stock considering the anticipated initial public
offering price. As a result, the exercise price of certain stock
options that were previously granted to our employees and
directors was deemed to be below the revised estimated fair
value of the underlying common stock on the option grant date.
We recorded this spread between the exercise price and the
revised estimated fair value as deferred employee stock-based
compensation. We amortize the deferred employee stock-based
compensation as a non-cash charge to operations on an
accelerated basis over the vesting period of the options.
Amortization of deferred employee stock-based compensation was
$1.9 million and $2.6 million for the years ended
December 31, 2004 and 2003, respectively.
Interest Income. Interest income for the year
ended December 31, 2004 was $0.9 million, compared to
$0.6 million for the year ended December 31, 2003. The
$0.3 million increase in interest income was primarily due
to higher average invested balances in 2004 resulting from the
proceeds from the sale of our Series C preferred stock and
our initial public offering of common stock in the second half
of 2003.
Interest Expense. Interest expense for the
year ended December 31, 2004 was $0.8 million,
compared to $0.9 million for the year ended
December 31, 2003. The $0.1 million decrease was
primarily due to lower long-term debt balances in 2004 due to
the full repayment in January 2004 of the notes payable that
were assumed in the January 2002 acquisition of Cell-Matrix,
offset by the interest expense associated with the prepayment in
full of certain equipment and tenant improvement loans in
December 2004.
Liquidity
and Capital Resources
As of December 31, 2005, we had $51.2 million in cash,
cash equivalents and securities
available-for-sale
as compared to $65.1 million as of December 31, 2004,
a decrease of $13.9 million. This decrease was primarily
due to the use of cash to fund ongoing operations,
$3.1 million of payments for employee severance benefits
and $13.8 million of net purchases of property and
equipment, offset by payments aggregating $39.7 million
received from Serono under the collaboration agreement and
$11.8 million of proceeds from long-term debt.
Net cash used in operating activities was $11.1 million for
the year ended December 31, 2005, compared to
$46.1 million for the year ended December 31, 2004.
The increase in cash flows from operating activities was
primarily due to payments aggregating $39.7 million
received from Serono under the collaboration agreement,
including the $25.0 million up-front license fee received
from Serono in January 2005.
Net cash used in investing activities was $2.1 million for
the year ended December 31, 2005, compared to
$26.4 million for the year ended December 31, 2004.
Significant components of cash flows from investing activities
for the year ended December 31, 2005 included a
$12.1 million net decrease in our securities
available-for-sale
portfolio and $13.8 million of net purchases of property
and equipment. Significant components of cash flows from
investing activities for the year ended December 31, 2004
included a $19.6 million net increase in our securities
available-for-sale
portfolio, $7.2 million of purchases of property and
equipment and a $0.7 million decrease in restricted cash.
204
Net cash provided by financing activities was $11.5 million
for the year ended December 31, 2005, compared to
$11.4 million for the year ended December 31, 2004.
Cash flows from financing activities for the year ended
December 31, 2005 primarily consisted of proceeds from
borrowings on our $18.0 million bank credit facility.
Significant components of cash flows from financing activities
for the year ended December 31, 2004 included the
$12.0 million proceeds from the issuance of
1.0 million shares of our common stock to Serono in
December 2004 and net payments on long-term debt of
$1.0 million.
Our future capital uses and requirements depend on numerous
forward-looking factors. These factors include but are not
limited to the following:
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our ability to rapidly and cost-effectively complete the closure
activities associated with our clinical trials and development
and manufacturing activities for Canvaxin, and to sublease our
manufacturing and warehouse facilities associated with Canvaxin
on satisfactory terms;
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our ability to sublease our corporate headquarters and research
and development facility;
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the costs involved in the research and preclinical and clinical
development of D93 and our other anti-angiogenesis product
candidates;
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the costs involved in obtaining and maintaining regulatory
approvals for our product candidates;
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the scope, prioritization and number of programs we pursue;
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the costs involved in preparing, filing, prosecuting,
maintaining, enforcing and defending patent and other
intellectual property claims;
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the manufacturing costs associated with our product candidates;
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our ability to enter into corporate collaborations and the terms
and success of these collaborations;
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our acquisition and development of new technologies and product
candidates;
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the risk of product liability claims inherent in the
manufacturing, testing and marketing of therapies for treating
people with cancer or other diseases; and
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competing technological and market developments.
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Under our merger agreement with Micromet, either party may be
obligated to pay a termination fee of $2.0 million if the
merger agreement is terminated under certain circumstances.
Additionally, we anticipate incurring an aggregate of
approximately $2.4 million of expenses associated with the
merger, of which we have incurred approximately
$1.0 million through December 31, 2005.
Under the restructuring plan approved by our board of directors
in October 2005, we reduced our workforce from 183 to 52
employees at December 31, 2005 and closed our biologics
manufacturing facility and our warehouse facility. We are
actively seeking to sublease all three of our principal
facilities. In January 2006, we implemented additional
restructuring measures which, when fully implemented, will
result in the further reduction of our workforce to
approximately 10 employees by the completion of our proposed
merger with Micromet. In connection with this workforce
reduction, in 2006 we anticipate incurring approximately
$3.0 million of additional employee severance costs. We
also anticipate incurring additional leased facility exit costs
in 2006, primarily related to our corporate headquarters and
research and development facility. At this time, we are unable
to reasonably estimate the expected amount of such additional
leased facility exit costs, although our remaining obligations
under the operating lease for our corporate headquarters and
research and development facility aggregated $11.2 million
as of December 31, 2005. We may also incur additional
contract termination and other restructuring costs. We
anticipate that our restructuring efforts will be substantially
completed by the end of the second quarter of 2006.
In December 2004, we entered into an $18.0 million loan and
security agreement with a financing institution. As of
March 27, 2006, we have borrowed the full
$18.0 million available under the credit facility, of which
$1.3 million was used to repay our outstanding borrowings
under a credit facility secured in 2002 and the remaining
borrowings were used to finance certain capital expenditures. At
our election, borrowings under the credit facility bear interest
at a variable interest rate equal to the greater of the
banks prime rate or 4.75%. The interest rate on the
205
outstanding borrowings under this credit facility was 7.25% as
of December 31, 2005. Through December 31, 2005, we
made interest-only payments on the outstanding borrowings under
the credit facility. Commencing January 2006, we are also
required to make principal payments due in 48 monthly
installments. All borrowings under the credit facility must be
paid in full by December 31, 2009.
We have granted the financing institution a first priority
security interest in substantially all of our assets, excluding
our intellectual property. In addition to various customary
affirmative and negative covenants, the loan and security
agreement requires us to maintain, as of the last day of each
calendar quarter, aggregate cash, cash equivalents and
securities
available-for-sale
in an amount at least equal to the greater of (i) our
quarterly cash burn multiplied by 2 or (ii) the then
outstanding principal amount of the obligations under such
agreement multiplied by 1.5. In the event that we breach this
financial covenant, we are obligated to pledge and deliver to
the bank a certificate of deposit in an amount equal to the
then-outstanding borrowings under the credit facility. We were
in compliance with our debt covenants as of December 31,
2005.
The loan and security agreement contains certain customary
events of default, including, among other things, non-payment of
principal and interest, violation of covenants, the occurrence
of a material adverse change in our ability to satisfy our
obligations under the loan agreement or with respect to the
lenders security interest in our assets and in the event
we are involved in certain insolvency proceedings. Upon the
occurrence of an event of default, the lender may be entitled
to, among other things, accelerate all of our obligations and
sell our assets to satisfy our obligations under the loan
agreement. In addition, in an event of default, our outstanding
obligations may be subject to increased rates of interest. The
terms of the loan and security agreement also require that it be
repaid in full upon the occurrence of a change in control event,
such as the consummation of our proposed merger with Micromet AG
(see Note 10). Accordingly, as management believes it is
probable that the proposed merger with Micromet will be
consummated in 2006, we have classified the outstanding
borrowings under the credit facility as current as of
December 31, 2005.
To date, we have funded our operations primarily through the
sale of equity securities as well as through equipment and
leasehold improvement financing. Through December 31, 2005,
we have received aggregate net proceeds of approximately
$208.6 million from the sale of equity securities. In
addition, through December 31, 2005, we have borrowed an
aggregate of approximately $27.3 million under certain
credit facilities primarily to finance the purchase of equipment
and leasehold improvements. Our remaining obligation under these
credit facilities as of December 31, 2005 consists solely
of borrowings under our $18.0 million bank credit facility.
We expect that operating losses and negative cash flows from
operations will continue for at least the next several years.
Absent our proposed merger with Micromet, we believe that our
existing cash, cash equivalents and securities
available-for-sale
as of December 31, 2005 and the remaining cost-sharing
payments from Serono associated with the costs of the
discontinuation of the Canvaxin development program and
manufacturing operations will be sufficient to meet our
projected operating requirements until September 30, 2007.
We will need to raise additional funds to meet future working
capital and capital expenditure needs. We have filed a shelf
registration statement, declared effective by the Securities and
Exchange Commission on December 9, 2004, under which we may
raise up to $80 million through the sale of our common
stock. We may also raise additional funds through additional
debt financing or through additional strategic collaboration
agreements. We do not know whether additional financing will be
available when needed, or whether it will be available on
favorable terms, or at all. If we were to raise additional funds
through the issuance of common stock under our shelf
registration statement or otherwise, substantial dilution to our
existing stockholders would likely result. If we were to raise
additional funds through additional debt financing, the terms of
the debt may involve significant cash payment obligations as
well as covenants and specific financial ratios that may
restrict our ability to operate our business. Having
insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or
to relinquish greater or all rights to product candidates at an
earlier stage of development or on less favorable terms than we
would otherwise choose. Failure to obtain adequate financing may
adversely affect our ability to operate as a going concern.
206
Contractual
Obligations
The following summarizes our long-term contractual obligations
as of December 31, 2005 (in thousands):
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Payments Due by Period
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Less than
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1 to
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4 to
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After
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Contractual
Obligations
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Total
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1 Year
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3 Years
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5 Years
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5 Years
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Operating leases
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$
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18,463
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$
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2,762
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$
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5,794
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$
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6,210
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$
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3,697
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Contractual payments under
licensing and research and development agreements
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2,805
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1,955
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410
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110
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330
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Equipment and tenant improvement
loans
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18,000
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18,000
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Installment obligation due to JWCI
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125
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125
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$
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39,393
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$
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22,842
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$
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6,204
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$
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6,320
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$
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4,027
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We have entered into three irrevocable standby letters of credit
in connection with the operating leases for our three primary
facilities. The amount of the letter of credit related to the
operating lease for our corporate headquarters and research and
development facility is $0.4 million, varying up to a
maximum of $1.9 million based on our cash position. The
amount of the letter of credit related to the operating lease
for our manufacturing facility is $0.6 million, decreasing
through the end of the lease term. The amount of the letter of
credit related to the operating lease for our warehouse facility
is $0.3 million. At each of December 31, 2005 and
2004, the amounts of the letters of credit totaled
$1.3 million. To secure the letters of credit, we pledged
twelve-month certificates of deposit for similar amounts as of
December 31, 2005 and 2004 which have been classified as
restricted cash in our consolidated balance sheets.
We have entered into licensing and research and development
agreements with various universities, research organizations and
other third parties under which we have received licenses to
certain intellectual property, scientific know-how and
technology. In consideration for the licenses received, we are
required to pay license and research support fees, milestone
payments upon the achievement of certain success-based
objectives
and/or
royalties on future sales of commercialized products, if any. We
may also be required to pay minimum annual royalties and the
costs associated with the prosecution and maintenance of the
patents covering the licensed technology. If all potential
product candidates under these agreements were successfully
developed and commercialized, the aggregate amount of milestone
payments we would be required to pay is at least
$42 million over the terms of the related agreements in
addition to royalties on net sales of each commercialized
product.
Related
Party Transactions
For a description of our related party transactions, see
Note 5 to our consolidated financial statements included
elsewhere in this proxy statement/prospectus.
Off-Balance
Sheet Arrangements
Through December 31, 2005, we did not have any
relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured
finance or special purpose entities, which would have been
established for the purpose of facilitating off-balance sheet
arrangements or other contractually narrow or limited purposes.
In addition, we do not engage in trading activities involving
non-exchange traded contracts. As such, we are not materially
exposed to any financing, liquidity, market or credit risk that
could arise if we had engaged in these relationships. We do not
have relationships or transactions with persons or entities that
derive benefits from their non-independent relationship with us
or our related parties other than what is disclosed in
Note 5 to our consolidated financial statements included
elsewhere in this proxy statement/prospectus.
Recent
Accounting Pronouncements
In November 2005, the Financial Accounting Standards Board, or
FASB, issued FASB Staff Position Nos.
FAS 115-1
and
FAS 124-1,
or FSP Nos. 115-1 and 124-1, The Meaning of
Other-Than-Temporary
Impairment and Its Application to Certain Investments, which
provides guidance on determining when investments in certain
debt and equity securities are considered impaired, whether that
impairment is
other-than-temporary,
and on measuring
207
such impairment loss. FSP Nos. 115-1 and 124-1 also includes
accounting considerations subsequent to the recognition of
other-than-temporary
impairments and requires certain disclosures about unrealized
losses that have not been recognized as
other-than-temporary
impairments. We will adopt FSP Nos. 115-1 and 124-1 in the first
quarter of 2006. While we are currently evaluating the impact on
our consolidated financial statements of the adoption of FSP
Nos. 115-1 and 124-1, we do not anticipate that it will have a
significant impact on our results of operations and financial
position.
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment, or
SFAS No. 123R. SFAS No. 123R requires that
employee stock-based compensation is measured based on its fair
value on the grant date and is treated as an expense that is
reflected in the financial statements over the related service
period. SFAS No. 123R applies to all employee equity
awards granted after adoption and to the unvested portion of
equity awards outstanding as of adoption. In April 2005, the
Securities and Exchange Commission adopted an amendment to
Rule 4-01(a)
of
Regulation S-X
that delays the implementation of SFAS No. 123R until
the first interim or annual period of the registrants
first fiscal year beginning on or after June 15, 2005. As a
result, we currently anticipate adopting SFAS No. 123R
using the modified-prospective method effective January 1,
2006. While we are currently evaluating the impact on our
consolidated financial statements of the adoption of
SFAS No. 123R, we anticipate that it will have a
significant impact on our results of operations for 2006 and
future periods although our overall financial position will not
be affected.
208
CANCERVAX
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
As of December 31, 2005 and 2004, our financial instruments
consisted principally of cash, cash equivalents and securities
available-for-sale.
These financial instruments, principally comprised of corporate
obligations and U.S. government obligations, are subject to
interest rate risk and will decline in value if interest rates
increase. Because of the relatively short maturities of our
investments, we do not expect interest rate fluctuations to
materially affect the aggregate value of our financial
instruments. We have not used derivative financial instruments
in our investment portfolio. Additionally, we do not invest in
foreign currencies or other foreign investments.
Borrowings under our $18.0 million bank credit facility
secured in December 2004 bear interest at a variable interest
rate equal to the greater of the banks prime rate or 4.75%
(7.25% as of December 31, 2005) and therefore expose
us to interest rate risk. Based on the outstanding borrowings
under our $18.0 million bank credit facility at
December 31, 2005 of $18.0 million, a 1% hypothetical
increase in the prime rate would result in an approximately
$0.2 million increase in our annual interest expense.
209
INFORMATION
REGARDING MICROMETS BUSINESS
Overview
We are a biotechnology company focused on the research, and
development of novel biological products for the treatment and
control of cancer, and inflammatory and autoimmune diseases. We
were founded in 1993 as spin-off from the Institute for
Immunology at Munich University. As of March 2006, our product
pipeline consists of two clinical product candidates,
adecatumumab (MT201) and MT103, and five preclinical product
candidates, MT110, MT203, MT204,
BITEtm-I
and
BITEtm-II.
We also have a strong proprietary technology platform for the
development of additional antibody-based product candidates.
Adecatumumab (MT201) is a recombinant human monoclonal antibody
that we currently are evaluating in one Phase 2 clinical
trial in patients with metastatic breast cancer and in one
Phase 2 clinical trial in patients with prostate cancer. In
addition, we are testing a combination of adecatumumab (MT201)
with taxotere in a Phase 1 clinical trial for the treatment
of patients with metastatic breast cancer. Adecatumumab (MT201)
targets the epithelial cell adhesion molecule, or Ep-CAM, which
is over-expressed on most types of solid tumors, including
prostate, breast, colon, gastric, ovarian, pancreatic and lung
cancer.
MT103, a product candidate in Phase 1 clinical development,
is the first member of a new class of therapeutic bispecific
single-chain antibodies, called
BiTEtm
molecules, aimed at using the most efficient immune effector
cells cytotoxic T cells to
repeatedly eliminate tumor cells. MT103 binds to CD19, a cell
surface antigen found on normal and malignant B cells, and to
the CD3 complex found on all T cells. Similar to monoclonal
antibodies, MT103 must be maintained in the body at a certain
concentration for several weeks to be effective. Due to its
relatively short half-life in the body, we are currently
administering MT103 in our clinical trials over a period of
4-8 weeks using portable intravenous infusion pumps.
MT110 is a
BiTEtm
molecule that combines binding specificities for Ep-CAM and for
the CD3 complex and that may be useful for the treatment of
various solid tumors. We are currently conducting preclinical
development activities for MT110 and expect to initiate a
Phase 1 clinical trial in 2007.
MT203 is a human antibody that neutralizes
granulocyte/macrophage colony stimulating factor, or GM-CSF, a
cytokine controlling innate immunity aberrantly expressed in
numerous human pro-inflammatory diseases. MT203 has the
potential to treat a wide variety of acute and chronic
inflammatory diseases including rheumatoid arthritis, asthma,
psoriasis and multiple sclerosis.
MT204 is a humanized antibody that neutralizes interleukin-2, or
IL-2, a cytokine that controls activation of T cells and
natural killer cells. MT204 is at an early stage of pre-clinical
development.
BITEtm-I
and
BITEtm-II
are
BITEtm
molecules that are being developed with MedImmune, Inc.
Our goal is to commercialize products for the treatment of
cancer and inflammatory and autoimmune diseases that have
significant unmet medical needs. We believe that our novel
technologies, product candidates and product development
expertise in these fields will continue to enable us to identify
and develop promising new product opportunities for these
critical markets.
Industry
Background
The World Health Organization estimated that more than
10 million people were diagnosed with cancer worldwide in
the year 2000 and that this number will increase to
15 million by 2020. In addition, the World Health
Organization estimated that 6 million people died from the
disease in 2000. The American Cancer Society estimated that over
1.3 million people in the United States were diagnosed with
cancer in 2005 and over 500,000 people died from the disease.
One in every four deaths in the United States is due to cancer.
Cancer is the second leading cause of death in the United
States, and has become the leading cause of death in people over
age 85.
The increasing number of people diagnosed with cancer and the
approval of new cancer treatments are factors that are expected
to continue to fuel the growth of the world-wide cancer market.
The U.S. National Health Information Business Intelligence
Reports states that, on a world-wide basis, the revenues for
cancer drugs are expected to grow from $35.5 billion in
2003 to $53.1 billion in 2009.
210
Immunotherapy
for the Treatment of Cancer
The bodys immune system is a natural defense mechanism
tasked with recognizing and combating cancer cells, viruses,
bacteria and other disease-causing factors. This defense is
carried out by the white blood cells of the immune system and
through a set of cytolytic enzymes that assemble on specific
antibodies bound to the cell surface of target cells. Specific
types of white blood cells, known as T and B cells, are
responsible for carrying out two types of immune responses in
the body, the cell-mediated immune response, and the humoral or
antibody-based immune response, respectively.
Cancer cells produce molecules known as tumor-associated
antigens, which are present in normal cells but are
over-produced or modified in cancer cells. The T and B cells
have receptors on their surfaces that enable them to recognize
the tumor-associated antigens. For instance, once a B cell
recognizes a tumor-associated antigen, it triggers the
production of diffusible antibodies that reach and kill the
tumor cells. T cells play more diverse roles, including the
identification and destruction of tumor cells by direct
cell-to-cell
contact.
While cancer cells naturally trigger a T-cell-based immune
response during the initial appearance of the disease, the
immune system response may not be sufficiently robust to
eradicate the cancer. The human body has developed numerous
immune suppression mechanisms to prevent the immune system from
destroying the bodys normal tissues. Cancer cells have
been shown to utilize these mechanisms to suppress the
bodys natural immune response against cancer cells. Even
with an activated immune system, the number and size of tumors
can overwhelm the immune system.
Our product candidates are designed to enhance the
patients immune response to tumor cells through the use of
either specific recombinant antibodies for the eradication of
cancer cells, such as adecatumumab (MT201), or
BiTEtm
molecules, which mark cancer cells for elimination by the
patients T cells.
Breast
Cancer
Overview
Breast cancer is the second most common cancer in women and the
second most common cause of malignancy-related death worldwide.
Although the incidence of breast cancer is rising in many
developed countries, primarily because of the growing number of
elderly women, more women are surviving the disease and those
who are not cured are living longer. These achievements result
from improved screening methods allowing earlier diagnosis,
targeted surgery, post-surgical use of adjuvant treatments, and
the use of successive hormonal and cytotoxic treatments for
patients with metastatic disease.
Current
Therapies for Breast Cancer
Although there is a consensus with regards to the approach to
the diagnosis and treatment of patients with breast cancer,
medical practice varies most in the treatment of low risk,
early-stage patients. As a consequence of wide-spread
mammography screening, more than 80% of all invasive breast
tumors are diagnosed in stage I or II. In these stages, the
primary treatment is surgery, often combined with radiation. The
additional treatment regime is dependent on several factors,
including whether the cancer has infiltrated the patients
lymph nodes. More aggressive therapy, often including first line
chemotherapy, is used to treat patients with a high risk of
relapse or who have lymph node metastases.
Research has determined that the over-expression of the HER-2
gene contributes to the uncontrolled growth of tumor cells. It
is estimated that approximately one in five patients with
metastatic breast cancer is HER-2 positive, and that these
patients are likely to have a more aggressive form of cancer. As
a result, patients with breast cancer are routinely tested for
over-expression of HER-2, and those who test positive are
typically offered treatment with Genentech, Inc.s
monoclonal antibody,
Herceptin®,
or trastuzumab.
Patients diagnosed with stage III breast cancer often
receive pre-operative chemotherapy to reduce tumor size,
followed by surgery and radiotherapy. After surgery, patients
undergo adjuvant chemotherapy to decrease the risk of a
recurrence.
211
Treatment for patients with metastatic, or stage IV, breast
cancer is generally intended to prolong life and improve quality
of life. Within this group, prognosis and therapy depend on the
presence of hormone receptors for estrogen and progesterone
(ER+/PR+).
Patients with a positive hormone receptor status normally
receive hormone therapy or aromatase inhibitors. They have a
lower risk of progression than patients lacking hormone
receptors on their tumor. Depending on the velocity of
progression, they either undergo second and third line hormone
therapy or they switch to chemotherapy. Patients with a higher
risk of progression or hormone receptor negative status
(ER-/PR-)
will typically receive chemotherapy. Radiation therapy may be
warranted in specific cases with symptomatic metastases.
Herceptin®
has been licensed since 1998 in the U.S. and since 2000 in the
EU for the treatment of patients with HER-2 positive metastatic
breast cancer either in combination with paclitaxel after
anthracyclin pre-treatment, or as monotherapy in patients with
second or third-line metastatic breast cancer.
Unmet
Medical Needs
Despite recent advances, current breast cancer treatments do not
adequately address patients needs. In particular, the
following therapies are still needed:
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More effective therapies for patients with stage IV
disease, whose cancer has metastasized to another area of the
body;
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Less toxic, more convenient secondary therapies to reduce the
risk of a relapse; and
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Therapies that increase the overall survival of patients with
stage II/III disease.
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Our
Approach
We believe that, if approved, our product candidate adecatumumab
(MT201), which is a recombinant human monoclonal antibody that
targets Ep-CAM, may offer a unique approach in treating patients
with metastatic breast cancer. Over-expression of Ep-CAM has
been shown to reduce the time and rate of survival of patients
with node-positive breast cancer with a high level of
statistical significance (p<0.0001), and has also been shown
to promote the proliferation, migration and invasiveness of
breast cancer cells. A high level of Ep-CAM expression has been
found in approximately 42% of patients with primary breast
cancer. These patients may respond to treatment with
adecatumumab (MT201). By elimination of tumor cells
overexpressing Ep-CAM, treatment with adecatumumab (MT201) as
monotherapy may result in an increased time to disease
progression, and if added to standard chemotherapy, such as
taxanes, in increased response rates
and/or time
to progression.
Prostate
Cancer
Prostate cancer is the second most frequent cancer among men,
with approximately 350,000 new cases diagnosed in 2003
worldwide. Established therapies include surgery, hormonal
treatment and chemotherapy. Still, approximately 70,000 men
worldwide die every year due to prostate cancer, indicating that
there remains a large unmet medical need for effective treatment.
In general, prostate cancer first appears as a small,
well-differentiated lesion, which doubles in size every two to
four years. If the tumor has a size of 4-5 cm upon diagnosis, it
most likely has spread to other areas in the body. As with most
other solid tumors, prostate cancer is classified by stages and
is divided into four main categories, as follows:
Table
1: Stages of Prostate Cancer
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Stage
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|
Description
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I
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Very small tumor, no infiltration
of lymph nodes, no metastases
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II
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Small tumor, no infiltration of
lymph nodes, no metastases
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III
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Locally advanced tumor
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IV
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|
Locally advanced tumor;
infiltration of lymph nodes
and/or
distant metastases
|
Early patient classification is based on tumor localization and
disease progression. Stage I and II comprise patients with
tumors confined to the prostate gland. Patients with
Stage III disease have locally advanced cancer,
212
with a primary tumor less restricted to the prostate and often
residual tumor cells that have spread to other areas of the body.
Current
Therapies for Prostate Cancer
After initial diagnosis of prostate cancer within stages I-III,
patients typically undergo either radiation therapy or surgical
removal of the prostate and tumor tissue. Local therapy of
patients with stage I and II disease can be curative; median
survival is likely to exceed five years. The relapse rate of
treated patients with stage I/II disease is approximately 40%.
Patients with stage III and IV prostate cancer are
usually not curable; the median survival time for such patients
ranges from five to seven years. Late-stage patients have three
treatment options; (i) watch and wait, which applies mostly
for elderly men above 70 years of age, followed by hormone
treatment after symptoms appear; (ii) hormone therapy; and
(iii) radiation therapy followed by hormone treatment.
While initially effective against late-stage prostate cancer,
standard hormone therapy loses its effectiveness over time as
the tumor becomes resistant to the treatment. After failure of
first line hormone therapy, patients may receive second and
third line hormone treatment or chemotherapy. Prostate cancer
that no longer responds to hormone therapy is known as hormone
refractory prostate cancer (HRPC). Once the patient becomes
refractory to hormone treatment, chemotherapy is the last option
for treatment. The median survival time for patients with HRPC
is approximately one year.
The first major breakthrough for patients with HRPC has been
achieved with the approval of Sanofi Aventis
Taxotere®
(or docetaxel), for this indication. This drug increased the
overall survival time of patients with HRPC from 16.5 to
18.9 months. Docetaxel is the standard of care for the
treatment of patients with HRPC, however, additional therapies
are needed.
Unmet
Medical Needs
The most significant unmet medical needs with respect to the
treatment of patients with HRPC include:
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Treatments that improve upon the standard of care for patients
with HRPC; and
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Treatments that delay the progression of or prevent HRPC.
|
Our
Approach
Approximately 87% of prostate cancer patients overexpress
Ep-CAM, the target for our adecatumumab (MT201) product
candidate, to a high level on their primary tumors and on
metastases. A number of studies have shown a positive
correlation between the level of Ep-CAM expression and the
grade, stage and rate of progression of prostate cancer. Based
on the high intensity and homogeneity of Ep-CAM expression on
cells of tumors, adecatumumab (MT201) may have potential for the
treatment of patients with prostate cancer.
Non-Hodgkins
Lymphoma
Non-Hodgkins lymphoma, or NHL, is a condition whose
incidence is among the fastest growing of all cancers. A number
of studies have shown Ep-CAM expression in patients with
prostate cancer is independent of disease stage, grade and
Gleasonscore.
Indolent NHL tumors grow slowly and are divided into several
subtypes, of which follicular lymphomas are the most common.
Approximately 10% of patients with indolent lymphoma are
diagnosed at stage I or localized stage II, and are
potentially curable with radiotherapy. Patients diagnosed with
stage II, III, or IV disease are often
asymptomatic and remain under periodic observation. Treatment is
generally initiated when they become symptomatic or when
biological evidence of increasingly active disease such as
rapidly enlarging lymph nodes occurs, although studies are being
conducted to evaluate the treatment of asymptomatic patients.
First line treatment for patients with indolent NHL is usually
chemotherapy, although recent data indicate that
Genentechs, Biogen-Idec and Roches
Rituxan®,
or rituximab, plus chemotherapy may also provide benefit.
Rituxan®
is a monoclonal antibody that targets CD20, an antigen widely
expressed on B-cells. Patients often cycle between remission and
relapse, and may survive for as long as eight to ten years
following initial diagnosis. Upon relapse, patients may
213
receive chemotherapy plus
Rituxan®,
Rituxan®
alone, or chemotherapy. Refractory patients may receive
radio-labeled monoclonal antibodies targeting CD20
(radioimmunotherapy). A transformation from indolent to
aggressive lymphoma is also observed in some patients.
Aggressive NHL tumors are rapidly growing tumors and are divided
into many subtypes, with diffuse, large,
B-cell
lymphomas comprising the largest subtype. First-line treatment
for aggressive NHL is a chemotherapy regimen plus
Rituxan®,
and results in a cure for approximately 50% of patients treated.
The overall survival of patients who do not respond to
first-line therapy is limited to a few years. Young patients and
those with good clinical status may benefit from bone marrow
transplantation, but most are treated with combinations of
chemotherapy and
Rituxan®
or radioimmunotherapy.
Our
Approach
MT103 is a recombinant, lymphoma-directed bispecific
single-chain antibody construct that targets CD19, which is
highly expressed on B-cells. Preliminary preclinical and
clinical data have demonstrated that MT103 may induce responses
to both indolent and aggressive NHL. Micromet has selected the
CD19 target for MT103 for a number of reasons. First, the CD19
marker is used in the clinic to distinguish lymphoma derived
from B cells from those derived from T cells. CD19 serves as a
co-receptor of the B cell receptor and is highly specific for
the B cell lineage. Second, by not binding CD20, which is the
target for a number of antibody-based therapies
(Rituxan®,
Bexxar®,
Zevalin®),
it is conceivable to combine MT103 with anti-CD20 therapies, as
there will be no competition between the therapeutic agents to
bind to the same target antigen. Third, certain human B cell
malignancies express CD19 but not CD20, such as those derived
from early stages of B cell development. In addition to the
treatment of CD20-positive lymphomas, MT103 will provide an
opportunity to treat B cell malignancies that lack CD20,
that have a low level of CD20 expression, or that have lost CD20
expression during treatment with anti-CD20 antibody therapies,
we believe that our MT103 product candidate, if approved, may
offer patients additional benefit in the treatment of NHL.
Our
Product Pipeline
Our current product pipeline consists of two clinical product
candidates, adecatumumab (MT201) and MT103, and five preclinical
product candidates, MT110, MT203, MT204,
BITEtm-I
and
BITEtm-II.
The following table summarizes the current status of our product
candidates in clinical and preclinical development.
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Product Candidate
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Primary Indication
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Collaborator
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Status
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Adecatumumab (MT201)
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Metastatic Breast Cancer
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|
Serono
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Clinical Phase 2
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Prostate Cancer
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MT103
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Indolent Non-Hodgkins
Lymphoma
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MedImmune
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Clinical Phase 1
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MT110
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Advanced adenocarcinoma
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Pre-clinical
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MT203
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Inflammatory diseases
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Pre-clinical
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MT204
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|
Inflammatory diseases
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|
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|
Pre-clinical
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BITEtm-I
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MedImmune
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Pre-clinical
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BITEtm-II
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|
MedImmune
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Pre-clinical
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Adecatumumab
(MT201)
Our product candidate adecatumumab (MT201) is a recombinant
human monoclonal antibody of the IgG1 subclass with a binding
specificity to Ep-CAM. Ep-CAM is a cell surface protein that is
over-expressed on most solid tumor types, including prostate,
breast, colon, gastric, ovarian, pancreatic and lung cancer.
Overexpression of Ep-CAM has been shown to promote the
proliferation, migration and invasiveness of breast cancer
cells. Moreover, highly tumorigenic human breast cancer stem
cells are characterized by expression of Ep-CAM. In addition,
expression of Ep-CAM has been shown to be associated with
decreased survival in a number of cancer indications, including
breast, gall bladder, bile duct, ovarian and ampullary
pancreatic cancer.
214
Adecatumumab (MT201) is administered intravenously. The
anticipated treatment regimen consists of intravenous
application over a 60-120 minute period every 2-3 weeks,
either as a monotherapy or in combination with standard
chemotherapy. Adecatumumab (MT201) is expected to bind to Ep-CAM
on tumor tissue and recruit complement, natural killer cells and
other immune cells to the tumor. Complement-dependent and
antibody-dependent cellular cytotoxicity are believed to be the
key modes of action of adecatumumab (MT201) that trigger tumor
cell destruction.
As discussed further under Collaborations below,
adecatumumab (MT201) is the subject of an exclusive worldwide
collaboration with Ares Trading S.A., a wholly-owned subsidiary
of Serono International, S.A., a Swiss corporation. We entered
into the collaboration with Serono in December 2004.
Clinical
Trials
The following table describes the status of the clinical trials
for adecatumumab (MT201):
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Number of
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Phase of Clinical
Trial
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|
Indication
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|
Status
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|
Subjects
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Phase 2 (adecatumumab (MT201)
as a single agent)
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Metastatic breast cancer
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Ongoing, recruitment completed
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112
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Phase 2 (adecatumumab (MT201)
as a single agent)
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Prostate cancer
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Ongoing, treatment completed
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84
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Phase 1 (adecatumumab (MT201)
+ Docetaxel)
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Metastatic breast cancer
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Ongoing
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Up to 12
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Phase 1 (adecatumumab (MT201)
as a single agent)
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Hormone Refractory Prostate Cancer
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Completed
|
|
20
|
Phase 2
Clinical Trial Patients with Metastatic Breast
Cancer (adecatumumab (MT201) as a Single Agent)
Adecatumumab (MT201) is currently being evaluated in an ongoing
Phase 2 clinical trial in patients with metastatic breast
cancer. We initiated enrollment in this clinical trial in
February 2004, and completed enrollment in October 2005, with a
total of 112 patients from 26 sites in five European
countries. This clinical trial is a randomized, open-label,
multi-center, parallel group study designed to provide
preliminary information regarding the efficacy and safety of
adecatumumab (MT201) when administered up to 24 weeks to
patients who test positive for expression of the adecatumumab
(MT201) target antigen Ep-CAM.
The patients in this clinical trial were stratified into two
groups (high and low) according to their level of Ep-CAM
expression. Of the 112 patients, 71 were grouped in the
high Ep-CAM expression group, while 38 were in the low Ep-CAM
expression group. Three patients were Ep-CAM negative. Patients
in each expression group were then randomly divided into two
equal dosage groups, either the low dose treatment group
(2 mg/kg body weight) or the high dose treatment group
(6 mg/kg body weight).
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Treatment Groups
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Ep-CAM Expression
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MT201 Dosing
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Group I
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Moderate Ep-CAM Expression on
Primary Tumor
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2 mg/kg adecatumumab (MT201)
i.v., every two weeks
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Group II
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Moderate Ep-CAM Expression on
Primary Tumor
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6 mg/kg adecatumumab (MT201)
i.v., every two weeks
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Group III
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High Ep-CAM Expression on Primary
Tumor
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2 mg/kg adecatumumab (MT201)
i.v., every two weeks
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Group IV
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High Ep-CAM Expression on Primary
Tumor
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6 mg/kg adecatumumab (MT201)
i.v., every two weeks
|
The protocol calls for each patient to receive a total of up to
14 infusions of adecatumumab (MT201) over 24 weeks of
therapy unless disease progression or treatment-limiting
toxicity occurs. Patients with at least stable disease after
24 weeks (to be confirmed by an Independent Review Board)
may continue treatment with adecatumumab (MT201) in a
follow-up
study.
215
The primary endpoint of the study evaluates the clinical benefit
rate, which comprises the percentage of patients whose disease
has been stabilized over 24 weeks of therapy or whose
tumors have demonstrated a partial response or a complete
response, each as defined using standard Response Evaluation
Criteria in Solid Tumors, or RECIST. Efficacy evaluations occur
every six weeks after the first administration of adecatumumab
(MT201) until week 24, and then every eight weeks
thereafter. These evaluations include a thoracic CT scan or
chest X-rays, an abdominal CT scan or MRI, and bone scintigraphy
for patients with bone metastasis. Responses are assessed using
RECIST, and responses must be confirmed at a
follow-up
evaluation at least four weeks later.
In December 2005, our staff performed a preliminary analysis of
data from the first 70 patients who were Ep-CAM positive.
Of this group, 67 patients received at least one infusion,
and had at least one tumor assessment after start of therapy.
Tumor assessment revealed 16 cases of stable disease at week 12.
Of these, at least 7 patients showed stable disease for at
least 24 weeks.
While no centrally confirmed decrease in tumor size was detected
at this early analysis, the overall group of 67 patients
showed a statistically significant (p=0.0348) increase in median
time to disease progression in those patients who received a
high dose of adecatumumab (MT201) as compared to patients who
received a low dose. The greatest increase in median time to
disease progression was observed in patients with high Ep-CAM
expression who received a high dose of adecatumumab (MT201) when
compared to all other patients (p=0.0238).
The database used to perform this preliminary analysis has not
been locked or subjected to a formal data cleaning process.
Additionally, the radiographs from the patients in this clinical
trial will be subjected to the assessment of an independent
review board, as some centralized radiology assessments differ
from the radiology assessments performed at the local clinical
trial sites. A final assessment of the study data will not be
possible until the study is completed, all data discrepancies
are resolved and the database is locked, which is currently
anticipated to occur in the second half of 2006.
Phase 2
Clinical Trial Patients with Prostate Cancer
(adecatumumab (MT201) as a Single Agent)
In May 2005, we completed enrolment for this study of
84 patients at 20 sites in four European countries. The
last patient received his last treatment in October 2005. This
trial is a double-blind, randomized, placebo-controlled,
multi-center study to investigate the efficacy and safety of two
different dose regimens of adecatumumab (MT201) in patients with
increasing serum PSA after radical prostatectomy for prostate
cancer. The study is designed to evaluate the anti-tumor
activity of adecatumumab (MT201) by delaying further PSA
increase in patients with increasing serum PSA after radical
prostatectomy for treatment of prostate cancer.
Each patient had a scheduled total of 12 visits, including one
screening visit, seven visits during the treatment period, and
four
follow-up
visits. PSA was measured at the screening visit, during
treatment at day 1, 29 and 57 and during
follow-up at
week 13, 15, 20 and 24. Bone scintigraphy, chest X-ray and
pelvic CT scanning were performed at the screening and at any
time during the study in case of confirmed biological
progression, if PSA was ³ 20
ng/ml, or in case of clinical disease progression.
Preliminary results from this study indicate that the primary
endpoint, which is defined as the mean change in total serum PSA
from baseline compared to placebo control, was not reached. It
is difficult to assess the significance of this finding, as the
high level of variability of individual PSA values at the
baseline PSA reading may have unduly complicated the analysis. A
recently performed expert review meeting has confirmed the
inconclusiveness of the current data set and has suggested that
additional post-hoc subanalyses be performed before coming to a
final assessment of this trial.
Phase 1
Clinical Trial Patients with Metastatic Breast
Cancer (adecatumumab (MT201) in Combination with
Docetaxel)
The ongoing Phase 1 clinical trial in patients with
metastatic breast cancer is an open-label, multi-center study to
investigate the safety and tolerability of intravenous infusions
of a combination of increasing doses of adecatumumab (MT201) and
a standard dose of Docetaxel in patients with Ep-CAM-positive
relapsed or primary refractory advanced-stage breast cancer. The
first patient was enrolled in this study in April 2005. We are
216
conducting this clinical trial in four locations, two each in
Germany and Austria. Results from this study are expected in
2007.
Phase 1
Clinical Trial Patients with Hormone Refractory
Prostate Cancer (adecatumumab (MT201) as a Single
Agent)
In 2003, we completed a Phase 1/2 open label dose
escalation clinical trial of adecatumumab (MT201) in patients
with HRPC. Patients were treated with two intravenous infusions
of adecatumumab (MT201) at doses up to
262 mg/m2
body surface (corresponding to approximately 6 mg/kg). No
dose-limiting toxicity was reported at any of the doses
investigated, and the maximum tolerated dose was not reached.
Most of the adverse events were mild or moderate. Severe adverse
events were reported in four patients, three of whose adverse
events were considered not related to study drug. The adverse
event observed in the fourth patient was a fever <39ºC
(<102.2ºF) and was classified as a severe adverse event
due to prolonged hospitalization of the patient resulting from
the fever.
Upon repetitive administration, adecatumumab (MT201) had a serum
half-life in humans of 15 days and showed linear
pharmacokinetics. The highest doses of adecatumumab (MT201)
induced transient and robust increases of TNF-alpha, and all
antibody doses led to a transient redistribution of peripheral
natural killer cells. Both of these results indicate immune cell
activation by the antibody.
Twenty patients had baseline assessments and 19 had
follow-up
assessments of tumor lesions by CT scans. Of these, nine
patients had measurable target lesions at baseline and, of these
nine patients, one patient had a non-confirmed partial response,
five patients had stable disease, two patients had progressive
disease, and one patient was lost to follow-up.
Regulatory
Pathway
In August 2001, we filed a clinical trials notification with the
Paul-Ehrlich-Institute, the relevant regulatory agency in
Germany, and commenced the first clinical trial of adecatumumab
(MT201) in patients with HRPC in September 2001. We initiated
Phase 2 clinical trials in February 2004 in patients with
prostate cancer and in March 2004 in patients with metastatic
breast cancer, with all the necessary regulatory approvals in
the relevant European countries where the studies were
conducted. In November 2004, we received approval for an IND
application from the United States FDA to conduct a Phase 2
clinical trial in patients with metastatic breast cancer. If the
ongoing Phase 2 clinical trials of adecatumumab (MT201) as
a single-agent are successfully completed, we will evaluate the
clinical program and consider conducting further exploratory
and, potentially, pivotal clinical trials in the relevant
indications. The pivotal clinical trials of adecatumumab (MT201)
will be designed to meet the requirements for a Biologics
License Application to the FDA and the corresponding application
for marketing authorization to the European Medicines Agency, or
EMEA.
MT103
MT103 is a recombinant, lymphoma-directed, bispecific
single-chain antibody that was generated using Micromets
BiTEtm
technology. MT103 consists of four immunoglobulin variable
domains assembled into a single polypeptide chain. Two of the
variable domains form the binding site for CD19, a cell surface
antigen expressed on most B cells and B tumor cells.
The other two variable domains form the binding site for the CD3
complex on T cells. The resulting recombinant molecule is
produced by fermentation with eukaryotic cells.
Mechanism
of Action
BiTEtm
molecules are designed to direct the bodys cytotoxic, or
cell-destroying, T cells against tumor cells, and represent
a new therapeutic approach to cancer therapy. MT103 has shown
cytotoxic efficacy against CD19-positive lymphoma cells in
preclinical tests using cell culture and mouse models at very
low concentrations and at low ratios of T, or effector, cells to
tumor target cells. Lymphoma-directed cytotoxicity has also been
achieved in preclinical tests with unstimulated human
T cells and in the absence of additional T cell
stimuli.
BiTEtm
molecules have been shown to induce an immunological synapse
between a T cell and a tumor cell in the same manner as
observed in physiological T cell attacks. These cytolytic
synapses mediate the delivery of
217
cytotoxic proteins called perforin and granzymes from
T cells into tumor cells, ultimately inducing a
self-destruction process in the tumor cell referred to as
apoptosis, or programmed cell death. In the presence of
BiTEtm
molecules, T cells have been demonstrated to serially eliminate
tumor cells, which explains the activity of
BiTEtm
molecules at very low concentrations and even at very low ratios
of T cells to target cells. Through the killing process,
T cells start to proliferate, which leads to an increased
number of T cells at the site of attack. It is believed
that this effect may have the potential to improve the function
of a patients immune system.
As discussed further under Collaborations below, in
June 2003, we announced an agreement to jointly develop MT103
with MedImmune, Inc. of Gaithersburg, MD.
Clinical
Trials
Clinical Trial MT103 I/01-2001 (Relapsed B Cell
Malignancies); Clinical Trial MT103 I/01-2002 (Relapsed
Non-Hodgkins Lymphoma); Clinical Trial MT103 I/01-2003
(Chronic Lymphocytic Leukemia)
From 2002 to 2004, we have conducted three Phase 1 clinical
trials, in which MT103 was given as repeated short-term
infusions.
We initiated clinical trial MT103 I/01-2001 in January 2002 as
an open-label, multi-center, inter-patient dose escalation study
in which each patient was scheduled to receive six infusions of
MT103 over two or four hours on study days 0, 2,
4, 14, 16 and 18. A total of 15 patients were treated
in doses up to
3.0 g/m2.
We terminated this trial in May 2003 due to evidence that the
dose level and dosing regimen had to be refined.
In November 2002 and November 2003, we initiated intra-patient
dose escalation Phase 1 trials MT103 I/01-2002 and MT103
I/01-2003 to investigate the safety profile of an intra-patient
dose escalation scheme of short-term infusions. Four patients
completed the MT103 treatment phase. Three patients in the
twice-weekly treatment group were permanently discontinued from
study treatment; two patients after the second
(2 g/m2)
and one patient after the third
(4 g/m2)
infusion of MT103, respectively. We terminated both trials in
January 2004.
Although some decrease in peripheral B cell counts were
occasionally seen, we could not observe objective clinical tumor
responses in any of the 22 patients treated with short-term
infusions of MT103. Based on initial findings on an estimated
half-life of MT103 of about two hours, we concluded that this
treatment regimen may not lead to sufficiently high plasma
levels over time (i.e., AUC and through levels) as is required
for sustained T cell activation, and that a different
dosing regimen may, therefore, be needed.
Clinical
Trial MT103 104 (Relapsed NHL)
Based on the findings made in the three Phase 1 clinical
trials mentioned above, we initiated a new Phase 1 dose
finding study in April 2004 designed to evaluate the safety and
tolerability of a continuous intravenous infusion of MT103 over
4-8 weeks at different dose levels in patients with
relapsed NHL. The study, which is set up as an open-label,
multi-center, dose escalation study, is being conducted in
Germany. Patients are being enrolled sequentially into five dose
cohorts. A maximally tolerated dose has not yet been reached. In
the first three cohorts no dose limiting toxicities were
observed, and evaluation of cohort four is ongoing. Of
17 patients who have received at least 2 weeks of
treatment and who have passed the first control CT scan, at
week 4, two patients have shown a partial tumor response
and one patient has shown a complete tumor response, based on
reference radiology assessment according to standardized
Cheson-criteria for tumor response assessment of NHL. All three
of these patients with responses were in cohort 4, the
highest dose level reached thus far.
Side
Effect Profile of MT103 as Observed in Clinical Trials
The most frequent clinical adverse events observed so far were
related to the release of cytokines by the patients immune
cells. Cytokines are small proteins that allow communication
between cells of the immune system and between immune cells and
other types of cells in the organism. Cytokines are typically
produced by activated immune cells, e.g. T cells, and thus
were expected in connection with the treatment of patients with
MT103. Cytokine release was transient and reduced after multiple
administrations of MT103. Clinically, the adverse events
consisted of fever, rigor, fatigue, vomiting, rapid heartbeat,
hypertension, headache and back pain. Most of these events were
of mild or moderate severity. The most frequent laboratory
abnormalities were seen in various
218
hematological parameters, coagulation parameters, and blood
chemistry, and were mostly mild to moderate in nature and
clinical significance. About 80% of all clinical adverse events
and laboratory abnormalities occurred on the day of the first
infusion, with a decreasing incidence during the subsequent
infusions. This is known as a first-dose cytokine release
syndrome.
In the first three Phase 1 clinical trials of MT103,
serious adverse events included infections, dyspnoea,
hypersensitivity and various symptoms of the central nervous
system, or CNS, including tremor, speech disorder, somnolence,
disorientation, confusion, fatigue, urinary incontinence and
vertigo. CNS effects led to termination of the treatment in a
total of six patients in the short-term infusion trials. With
one exception, all these events were fully reversible within
hours to days. One patient suffered seizures and a myocardial
ischemia. The patient died 49 days after last dosing due to
a refractory pneumonia. The autopsy found that this patient
suffered from terminal-stage, chronic lymphatic leukemia, with
massive tumor cell infiltration of the lung. Based on adverse
events and the lack of tumor responses in patients treated with
the short-term infusion regimen, we terminated those studies,
and developed a new dosing regimen continuous
infusion designed to reduce side effects and to
obtain tumor responses in NHL patients.
Based on patients in cohorts one to three, the frequency of
adverse events in the ongoing continuous infusion trial was
lower compared to the previous short-term infusion regimens,
despite the fact that MT103 was present for 4-8 weeks in
patients in the continuous infusion study while it was only
present for a few hours in the patients in the short-term
infusion studies. We did not observe the CNS-related side
effects in cohorts one to three that were seen in the short term
infusion trials, and no dose limiting toxicity was observed. One
out of seven patients of cohort four has shown fully reversible
CNS side effects. The safety evaluation of cohort number four is
ongoing.
Regulatory
Pathway
MT103 is under clinical development in Europe. In addition, we
and MedImmune currently anticipate submitting an IND to commence
clinical testing of MT103 in the United States in 2006. If the
ongoing Phase 1 clinical trial of MT103 is successfully
completed, we will evaluate the clinical program and consider
further exploratory and, potentially, Phase 2 clinical
trials in the relevant indications.
We have received orphan drug designation from the EMEA, for the
use of MT103 as a treatment for mantle cell lymphoma, or MCL,
and chronic lymphatic lymphoma, or CLL. Orphan drug designation
is designed to encourage manufacturers to develop drugs intended
for rare diseases or conditions affecting fewer than 5 in 10,000
individuals in the European Union. Orphan drug designation also
qualifies the applicant for tax credits and marketing
exclusivity for seven years following the date of the
drugs marketing approval by the EMEA. MedImmune has
received orphan drug designation for the use of MT103 in the
treatment of indolent
B-cell
lymphoma, excluding CLL and NHL with CNS involvement.
MT110
MT110 is a
BiTEtm
molecule that combines binding specificities for Ep-CAM and for
the CD3 complex on T cells. Ep-CAM is a cell surface
antigen that is over-expressed by many types of solid tumors.
Mechanism
of Action and Preclinical Activities
BiTEtm
molecules are designed to direct the bodys cytotoxic
T cells against tumor cells, and represent a new
therapeutic approach to cancer therapy. MT110 has shown
cytotoxic efficacy against Ep-CAM-positive tumor cells, at very
low concentrations and at low ratios of T cells to tumor
target cells in preclinical tests using cell culture and mouse
models. Of note, MT110 and other Ep-CAM-specific
BiTEtm
molecules were capable of inducing durable elimination of
established tumors in mouse models. Likewise, human metastatic
tissue from ovarian cancer patients implanted under the skin of
mice was eliminated by low doses of intravenously administered
MT110. This suggested that MT110 penetrated the human tumor and
re-directed human tumor-infiltrating T cells for lysis of
tumor cells.
MT110 has been shown to induce an immunological synapse between
a T cell and a tumor cell, in the same manner as observed
in physiological T cell attacks. These cytolytic synapses
mediate the delivery of cytotoxic
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proteins called perforin and granzymes from T cells into
tumor cells, ultimately inducing apoptosis, or programmed cell
death. In the presence of
BiTEtm
molecules, T cells have been demonstrated to serially
eliminate tumor cells, which explains the activity of
BiTEtm
molecules even at very low ratios of T cells to target
cells. Through the killing process, T cells start to
proliferate which leads to an increased number of T cells
at the site of attack. It is believed that this effect may have
the potential to improve the function of a patients immune
system.
Regulatory
Pathway
We plan to submit an IND with the FDA, or an investigational
medicinal product dossier, or IMPD, with the EMEA, for MT110 in
2007.
MT203
MT203 is a human antibody that we believe has the potential to
treat a variety of acute and chronic inflammatory diseases,
including rheumatoid arthritis, asthma, psoriasis and multiple
sclerosis. It neutralizes granulocyte/macrophage colony
stimulating factor, or GM-CSF, a pro-inflammatory cytokine
controlling the innate arm of the immune system. GM-CSF
primarily acts in chronic phases of numerous human diseases,
including rheumatoid arthritis, asthma, psoriasis and multiple
sclerosis. Using an antibody to neutralize GM-CSF has been shown
to prevent or even cure symptoms in numerous animal models
mimicking the respective human diseases. We generated MT203
using phage display guided selection.
Mechanism
of Action
Like marketed antibody drugs
Humira®,
Avastin®
and
Remicade®,
MT203 acts by neutralizing a soluble protein ligand, thereby
preventing it from binding to its high-affinity cell surface
receptor. This therapeutic principle is well validated. MT203 is
the first human antibody designed to neutralize the biological
activity of human and non-human primate GM-CSF.
Preclinical
Activities
The binding characteristics of MT203 to GM-CSF have been
characterized in detail, and this product candidate has shown
biological activity in numerous cell-based assays. We have used
a surrogate antibody neutralizing mouse GM-CSF to demonstrate
that inhibition of GM-CSF is highly potent in preventing
rheumatoid arthritis in a mouse model in which TNF
neutralization is largely ineffective. This surrogate antibody
has comparable binding characteristics to MT203.
Regulatory
Pathway
We plan to submit an IND with the FDA, or an IMPD with the EMEA,
for MT203 in 2007.
MT204
MT204 is a humanized antibody that we believe has the potential
to treat a variety of acute and chronic inflammatory diseases,
including rheumatoid arthritis, psoriasis and multiple
sclerosis. We designed MT204 to neutralize interleukin-2, or
IL-2, an inflammation-causing cytokine controlling activation of
T cells and natural killer cells. Intereference with
IL-2
signaling is a well validated anti-inflammatory therapeutic
approach as exemplified by small molecule drugs, such as
cyclosporine or tacrolimus, and by antibodies blocking the
high-affinity IL-2 receptor
(Simulect®
and
Zenapax®).
MT204 is the first humanized antibody targeting soluble human
and non-human primate IL-2 and has been shown to have properties
superior to those of receptor-blocking antibodies.
Mechanism
of Action
Like marketed antibody drugs
Humira®,
Avastin®
and
Remicade®,
MT204 acts by neutralizing a soluble protein ligand, which is a
well established therapeutic approach. MT204 does not only
prevent binding of IL-2 to its intermediate-affinity receptor on
natural killer cells, but could inactivate the high-affinity
receptor with bound IL-2. This is a novel mode of antibody
action, which could cause MT204 to have potent anti-inflammatory
activity.
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Preclinical
Activities
The binding characteristics of MT204 to IL-2 and IL-2 receptors
have been characterized in detail using various assay systems.
While the mechanism of action of MT204 is understood, the
antibody is still in an early stage of development.
Our
Strategy
Our objective is to establish a position as a leader in the
research, development and commercialization of highly active,
antibody-based drugs for the treatment of patients with cancer
and inflammatory and autoimmune diseases. Key aspects of our
corporate strategy include the following:
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Co-develop Compounds with Established Pharmaceutical and
Biopharmaceutical Companies. We are working with
Serono and MedImmune to complete ongoing clinical studies and
enter into the next stage of clinical development for two of our
current product candidates. If the data from our Phase 2
clinical trials for these product candidates are positive, we
will prepare for Phase 3 or additional Phase 2
clinical trials for the treatment of patients with breast cancer
and prostate cancer. If the data from our Phase 1 trial in
patients with NHL are positive, we expect to move into
Phase 2 clinical trials.
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Maintain Commercialization Opportunities in
Collaborations. We have retained the right to
co-promote adecatumumab (MT201) in Europe and the USA, and
have full commercialization rights for MT103 outside of North
America. We will continue to pursue this partnering and
investment strategy in future collaborations.
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Advance the Development of Our Clinical-Stage Product
Candidates Adecatumumab (MT201) and MT103. We
plan to actively participate in additional studies for
adecatumumab (MT201) and we plan to initiate a Phase 1/2
clinical trial with MT103 upon the availability of data from the
current dose-finding clinical trial.
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Advance the Development of Our Preclinical Product
Candidates. We plan to initiate the production of
clinical trial-grade material for MT110 in 2006, and to commence
clinical trials upon the availability of such material in 2007.
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Pursue Additional Collaborations for Our Product
Candidates. We will continue to seek development
partners for some or all of the product candidates in our
product portfolio.
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Leverage Our Internal Pipeline Generating
Capabilities. Our current pipeline of human IgG1
antibodies, as well as our
BiTEtm
molecules, have all been generated internally. We will continue
to leverage that capability for early-stage development
collaborations, as well as for generating additional product
candidates for our own pipeline.
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Intellectual
Property
Our success will depend in large part on our ability to:
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maintain and obtain patent and other proprietary protection for
cell lines, antigens, antibodies and delivery systems;
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2. defend patents;
3. preserve trade secrets; and
4. operate without infringing the patents and proprietary
rights of third parties.
We actively seek appropriate patent protection for our
proprietary technologies by filing patent applications in the
United States and selected other countries. Our policy is to
seek patent protection for the inventions that we consider
important to the development of our business.
As of December 31, 2005, we owned or licensed approximately
69 U.S. patents, 42 U.S. patent applications, 93
foreign patents, and 106 foreign and international patent
applications related to our technologies, compounds, and their
use for the treatment of human disease. The number of licensed
patents does not include various divisionals,
221
continuations and
continuations-in-part
of the licensed patents and patent applications which are also
licensed to us. Our issued patents in the United States expire
during 2008 and 2018, and our issued patents in Europe and
Australia expire in 2019. We intend to continue using our
scientific expertise to pursue and file patent applications on
new developments with respect to products, uses, methods and
compositions to enhance our intellectual property position in
the field of treatment of human diseases.
Although we believe that our portfolio of patents and patent
applications provides a competitive advantage, the patent
positions of pharmaceutical and biotechnology companies are
highly uncertain and involve complex legal and factual
questions. We face the risk that we may not be able to develop
further patentable products or processes, and may not be able to
obtain patents from pending applications. Even if patent claims
are allowed, the claims may not issue, or in the event of
issuance, the scope of the claims may not be sufficient to
protect the technology owned by or licensed to us. In addition,
any patents or patent rights we obtained may be circumvented,
challenged or invalidated by competitors. Any efforts defend the
patents and to oppose such actions by our competitors may be
costly and time-consuming and would, in any event, divert the
attention of our management and key personnel from business
operations.
Additionally, because it is not possible to predict with
certainty what patent claims may issue from pending
applications, and because patent prosecution can proceed in
secret prior to issuance of a patent, third parties may obtain
patents with claims of unknown scope relating to our product
candidates and assert those patents against us. As we continue
developing its product candidates, we may infringe the current
patents of third parties or patents that may issue in the future.
Although we believe that our product candidates, production
methods and other activities do not currently infringe the valid
and enforceable intellectual property rights of any third
parties, we cannot be certain that a third party will not
challenge our position in the future. From time to time, we
receive correspondence inviting us to license patents from third
parties. There has been, and we believe that there will continue
to be, significant litigation in the biopharmaceutical and
pharmaceutical industries regarding patent and other
intellectual property rights. Third parties could bring legal
actions against us claiming infringement of their patents or
proprietary rights, seeking monetary damages or injunctions
against clinical testing, manufacturing and marketing of the
affected product or products. If we become involved in any such
litigation, it could consume a substantial portion of our
resources, regardless of the outcome of the litigation. If any
of these actions are successful, in addition to any potential
liability for damages, we could be required to obtain a license
to continue to manufacture or market the affected product, in
which case we may be required to pay substantial royalties or
grant cross-licenses to our patents. However, there can be no
assurance that any such license will be available on acceptable
terms or at all. Ultimately, we could be prevented from
commercializing a product, or forced to cease some aspect of our
business operations, as a result of claims of patent
infringement or violation of other intellectual property rights,
which could harm our business.
We may become involved in litigation or in interference
proceedings declared by the United States Patent and Trademark
Office relating to the scope and validity of patents or patent
applications belonging to us or to other parties. Such
proceedings can involve complex factual and legal questions, and
their outcome is uncertain. Such proceedings could result in
substantial costs to us, as well as in significant limitations
on the scope of exclusivity afforded by our patents and patent
applications.
We also rely on trade secrets and proprietary know-how,
especially when we do not believe that patent protection is
appropriate or can be obtained. However, trade secrets are
difficult to protect. Our policy requires each employee,
consultant and advisor to execute a confidentiality agreement
before beginning his or her relationship with us. Under this
agreement, the individual is obligated not to disclose Micromet
confidential information. We cannot guarantee that these
agreements will provide meaningful protection, that these
agreements will not be breached, that we will have an adequate
remedy for any such breach, or that our trade secrets will not
otherwise become known or independently developed by a third
party. Our trade secrets, and those of our present or future
collaborators that we utilize by agreement, may become known or
may be independently discovered by others, which could adversely
affect the competitive position of our product candidates.
Many of our employees were previously employed by other
pharmaceutical or biotechnology companies, including our
competitors or potential competitors. We may be subject to
claims that these employees have used or
222
disclosed proprietary information or trade secrets of their
former employers, whether inadvertently or otherwise. Litigation
may be necessary to resolve such claims. Even if we are
successful in defending such claims, the defense may result in
substantial costs and may disrupt our normal business
operations. If we fail in defending such claims, in addition to
paying money damages, we may lose access to valuable proprietary
technology or personnel.
License
Agreements and Collaborations
We have entered into several contractual agreements with third
parties for the licensing of certain technologies or products.
These agreements provide for the payment by us of license fees,
milestones and royalties upon future net sales. We entered into
the following significant license agreements:
Isogenis
Inc. (formerly Biohybrid, Inc).
In October 1999, we and entered into an agreement with
Biohybrid, Inc. (now called Isogenis, Inc.) granting us a
worldwide, exclusive license under U.S. Patent
No. 5,078,998, entitled Hybrid ligand directed to
activation of cytotoxic effector lymphocytes and associated
target antigens, as well as certain related technologies.
Under this agreement, we have certain diligence obligations with
respect to the development of licensed products; these
obligations may be satisfied by using reasonable efforts to
develop at least one licensed product. If we fail to satisfy our
diligence obligations, Isogenis has the option of making the
license non-exclusive. We are obligated to pay a low
single-digit royalty on net sales of licensed products in the
United States. If we sublicense our rights under this agreement,
Isogenis is entitled to a portion of the fees received by us
from the sublicensee. The agreement also provides for a minimum
annual royalty. Finally, we are obligated to pay a success
milestone upon receipt of the first marketing approval of each
licensed product in the United States. Our
BiTEtm
product candidates may be subject to the payment obligations in
this agreement.
The term of this agreement continues until expiration of the
last valid claim in the licensed patents. Either party may
terminate the agreement for the other partys uncured
material breach. In addition, Isogenis may terminate the
agreement in the case of our bankruptcy, insolvency, or
cessation of business. We may terminate the agreement if our
license becomes non-exclusive as described above, or if any
claims of the licensed patent are declared invalid. The
agreement does not provide for termination at will by us.
Dyax
Corporation
In October 2000, we entered into a non-exclusive license
agreement with Dyax Corporation for the use of certain patented
technology (including certain phage display techniques) for
screening and research of antibody products binding to Ep-CAM,
including adecatumumab (MT201). We have paid an initial license
fee and a success-based milestone payment under this agreement.
Additional such payments will become due upon achievement of
various clinical and regulatory milestones. No royalties are due
under this agreement.
The term of this agreement continues until expiration of the
last valid claim in the licensed patents. Either party may
terminate the agreement for the other partys uncured
material breach. In addition, we may terminate the agreement at
will.
Curis,
Inc.
In June 2001, we entered into an agreement with Curis, Inc. to
purchase certain single-chain antigen binding molecule patents
and license rights from Curis. In exchange for these patent and
license rights, we paid to Curis an initial license fee, issued
to Curis shares of our common stock, and provided a convertible
note in the amount of 4,068,348. In addition, we are
obligated to pay royalties on net sales of products based on the
acquired technology. We are also required to pay to Curis 20% of
all supplemental revenues in excess of $8,000,000 in
the aggregate. Supplemental Revenues includes both
(i) proceeds received by us as damages or settlements for
infringement of the purchased technology, and (ii) amounts
received by us from licensing or sublicensing the purchased
technology. In October 2004, we exchanged the convertible note
issued to Curis for an interest-free loan in the amount of
4,500,000.
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Cambridge
Antibody Technology Limited
We have entered into the following agreements with Cambridge
Antibody Technology Ltd. (CAT):
Non-exclusive Product License Agreement Regarding Ep-CAM
Target. On September 3, 2003, we signed a
product license agreement with CAT granting us a non-exclusive,
worldwide license to develop and commercialize antibodies
binding to the Ep-CAM target using certain patented technology
and know-how controlled by CAT in the field of phage display
technology. Phage display is a useful research technology that
allows proteins to be displayed on the surface of a virus. We
paid an initial license fee upon signing of this agreement and
will pay development milestones and royalties upon sale of
licensed products.
Non-exclusive Product License Agreement Regarding GM-CSF
Target. On September 3, 2003, we signed a
non-exclusive worldwide product license agreement with CAT with
reference to the GM-CSF target. The agreement grants to us the
right, in the course of our joint research activities with Enzon
(as described below), to use CATs patented technology to
develop products that are directed at the GM-CSF target. We paid
to CAT an initial license fee on the effective date and will pay
milestones and royalties upon sale of licensed products.
Cross-License with CAT and Enzon Pharmaceuticals, Inc.
(Enzon). On September 3, 2003,
Micromet, Enzon and CAT entered into a cross-license agreement
to enable each party to access to the other parties
proprietary technology. This agreement superseded an existing
cross-license arrangement among the parties. Pursuant to the
current agreement, each contractual partner licenses the others
under patents and know-how relating to the field of single-chain
antibodies (in the case of licenses granted by Enzon and
Micromet) or phage display technology (in the case of licenses
granted by CAT). This technology may be used by the parties for
the research and development of antibody products in certain
defined fields. CAT paid an initial license fee under this
agreement. Additionally, CAT is obligated to pay to us and
Enzon: (i) annual license maintenance fees and fees for
sublicenses granted by CAT, and (ii) annual sublicense
maintenance fees until the termination of such sublicense or the
expiration of all licensed patents included in such sublicense,
whichever occurs first. We and Enzon are obligated to pay
corresponding maintenance and sublicense fees based on the use
of the licensed phage display technology by our respective
sublicensees.
Enzon
Pharmaceuticals, Inc.
In April 2002, we entered into a cross-license agreement with
Enzon, Inc. (now Enzon Pharmaceuticals, Inc.) relating to each
partys portfolio of patents relating to single-chain
antibodies and their use in the treatment of disease. This
agreement was amended and restated by mutual agreement of the
parties in June 2004. Under the cross-license agreement, we
receive a non-exclusive, royalty-bearing license under
Enzons single-chain antibody patent portfolio to exploit
licensed products other than
BiTEtm
products, as well as an exclusive, royalty-free license under
such portfolio to exploit
BiTEtm
products. We also granted to Enzon a non-exclusive,
royalty-bearing license under our single-chain antibody patent
portfolio to exploit licensed products; however, Enzons
right to use
BiTEtm
molecules is limited to non-commercial research applications.
Each partys license is subject to certain narrow
exclusions that correspond to exclusive rights previously
granted to third parties.
The cross-license agreement provides for payment by each party
to the other party of fixed success fees upon the achievement of
certain clinical and regulatory milestones. In addition, each
party is obligated to pay a low single-digit royalty on net
sales of products that are covered by any patents within the
consolidated patent portfolio, irrespective of which party owns
the relevant patent(s). The royalty is tiered based on
aggregate, worldwide net sales levels of the applicable licensed
product. As noted above, we do not owe a royalty under this
agreement on net sales of
BiTEtm
products.
The term of the cross-license agreement continues until
expiration of the last valid claim in the consolidated patent
portfolio. Either party may terminate the agreement upon
determination by a court of competent jurisdiction that the
other party has committed a material breach of the agreement.
Neither party has the right to unilaterally terminate the
agreement without cause.
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Collaborations
We engage in collaborations with private industry and academic
institutions in the course of conducting our research and
clinical studies, including the following.
Serono
International, S.A.
In December 2004, we entered into a collaboration agreement with
Ares Trading S.A., a wholly-owned subsidiary of Serono
International S.A., a leading Swiss biotechnology firm. Pursuant
to the agreement, we granted Serono a worldwide license under
our relevant patents and know-how to develop, manufacture,
commercialize and use adecatumumab (MT201) for the prevention
and treatment of any human disease. Serono paid an initial
license fee of $10,000,000. Under the terms of the agreement,
Serono bears all costs of product development and manufacturing
subject to our participation right as described below.
Upon receipt of either of the final study reports for the
ongoing Phase 2 trials in breast cancer and prostate
cancer, which are expected in the second half of 2006, Serono
will decide whether to continue development of adecatumumab
(MT201). Should Serono elect to continue developing adecatumumab
(MT201) after receipt of the second final study report, it must
make an agreed upon milestone payment. Overall, the agreement
provides for Serono to pay up to $138 million in milestone
fees if adecatumumab (MT201) successfully developed and
registered worldwide in at least three indications.
Upon completion of the currently ongoing phase 2 clinical
trials, we may elect to participate in the costs and expenses of
developing and selling adecatumumab (MT201) in the United States
and/or Europe. If we participate, then we will share up to 50%
of the development costs, as well as certain other expenses,
depending on the territory for which we have exercised our
co-development option. The parties will co-promote and share the
profits from sales of adecatumumab (MT201) in the territories
for which the parties shared the development costs. In the other
territories, Serono will pay a royalty on net sales of
adecatumumab (MT201).
In addition to its right to terminate the agreement following
receipt by Serono of the final study report for either of the
ongoing Phase 2 trials, Serono may terminate the agreement
for convenience upon 180 days prior notice. Either
party may terminate for the material breach or bankruptcy of the
other. In the event of a termination of the agreement, all
product rights will revert to us.
MedImmune,
Inc.
MT103 Collaboration and License Agreement. On
June 6, 2003, we signed an agreement with MedImmune to
jointly develop MT103. Under the terms of the collaboration and
license agreement, MedImmune receives Micromets product
rights to MT103 in North America and will assume responsibility
for clinical development, registration and commercialization of
the product in that region. As part of the agreement, MedImmune
will develop the commercial manufacturing process and supply
clinical trial material as well as commercial products for all
markets. We retain rights to MT103 outside of North America. We
will receive milestone payments based on the successful
development, filing, registration and sale of MT103, as well as
royalties on MedImmunes North American sales of the
product. In addition, MedImmune will cover certain development
costs incurred by us necessary to support an Investigational New
Drug Application, or IND, submission for MT103. After submitting
the IND, the parties will share development costs of jointly
conducted clinical trials.
BiTETM
Research Agreement. Concurrently with the MT103
collaboration agreement, the parties also executed an agreement
for the creation and development of up to six new products based
on the
BiTETM
platform. We are entitled to receive milestones and royalties on
sales of all resulting
BiTETM
products. Furthermore, we have the option to obtain
(i) exclusive rights to develop and sell
BiTETM
compounds in Europe, provided that such compounds are not based
on MedImmunes proprietary targets, and (ii) the right
to co-promote in Europe
BiTETM
compounds that are based on MedImmunes proprietary
targets. For each new
BiTETM
molecule, MedImmune is obligated to reimburse our full
development costs, up to and including Phase 1 clinical
trials.
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Enzon
Pharmaceuticals, Inc.
Research Collaboration. In April 2002, we
entered into a multi-year strategic collaboration with Enzon to
identify and develop the next generation of antibody-based
therapeutics. After executing this agreement, the partners
established a research and development unit at our facility and
generated several new single-chain antibody compounds and
monoclonal antibodies against targets in the field of
inflammatory and autoimmune diseases. In June 2004, we amended
and restated this collaboration with Enzon to advance novel SCA
therapeutics toward clinical development.
In November 2005, the parties agreed to end the companies
collaboration on mutually agreeable terms. The termination of
the research and development collaboration does not affect the
companies other agreements, including the Cross-License
Agreement and the Exclusive IP Marketing Agreement.
Exclusive IP Marketing Agreement. In April
2002, we entered with Enzon into an Exclusive IP Marketing
Agreement, which was amended and restated by the parties in June
2004. Under this agreement, we serve as the exclusive marketing
partner for both parties consolidated portfolio of patents
relating to single-chain antibody technology. Licensing revenues
are shared equally with Enzon, as are associated marketing and
legal costs.
The term of the IP marketing agreement continues until
expiration of the last valid claim in the consolidated patent
portfolio. Either party may terminate the agreement upon
determination by a court of competent jurisdiction that the
other party has committed a material breach of the agreement. In
addition, the marketing agreement terminates automatically upon
termination of the cross-license agreement between us and Enzon.
Neither party has the right to unilaterally terminate the
agreement without cause prior to September 30, 2007; after
such date, either party may terminate it at will.
Novuspharma
SpA, now Cell Therapeutics, Inc.
In August 2002, we entered into a collaboration agreement with
Novuspharma SpA. Under this agreement Novuspharma would have
collaborated with us on the development of adecatumumab (MT201)
on a world-wide basis, co-promoted the product upon certain
conditions and shared profits generated by the sale or licensing
of the product worldwide. On February 10, 2004, following
the acquisition of Novuspharma by Cell Therapeutics, or CTI,
this agreement was terminated on the basis of CTIs failure
to meet its contractual payment obligations. The related legal
proceedings are described under Legal Proceedings
below. As a result of such termination, CTI has no remaining
rights to adecatumumab (MT201).
Manufacturing
and Supply
Adecatumumab
(MT201)
In December 2003, we entered into a process development
agreement with Boehringer Ingelheim Pharma GmbH & Co.
KG. Under the agreement, Boehringer Ingelheim will develop a
commercial scale process for adecatumumab (MT201) by using its
proprietary high expression cell line and
state-of-the-art
manufacturing technology. Boehringer Ingelheim will supply us
with material for clinical trials.
If we do not enter into a commercial supply agreement with
Boehringer Ingelheim, or if we intend to establish a second
source of supply, we will have the right to manufacture
adecatumumab (MT201) under a license to Boehringer
Ingelheims high expression technology and the process
developed for the adecatumumab (MT201) antibody. Such license
would carry an obligation for us to pay milestones and royalties
on future net sales of adecatumumab (MT201).
MT103
The production process for MT103 has been established at
MedImmune, which has taken the responsibility to expand the
production process to market scale and produce material for U.S.
and non-U.S. markets.
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Preclinical
Programs
Non-GMP production agreements have been established with various
manufacturers for our pre-clinical compounds.
Government
Regulation and Product Approval
General
Governmental authorities in the United States and other
countries extensively regulate the preclinical and clinical
testing, manufacturing, labeling, storage, record-keeping,
advertising, promotion, export, marketing and distribution of
biologic products. In the United States, the FDA under the
Federal Food, Drug, and Cosmetic Act, the Public Health Service
Act and other federal statutes and regulations subjects
pharmaceutical and biologic products to rigorous review. Parties
that fail to comply with applicable requirements may be fined,
may have their marketing applications rejected, and may be
criminally prosecuted. The FDA also has the authority to revoke
previously granted marketing authorizations upon failure to
comply with regulatory standards or in the event of serious
adverse events following initial marketing.
FDA
Approval Process
The process required by the FDA before a new drug or biologic
may be marketed in the United States generally involves the
following: completion of preclinical laboratory and animal
testing; submission of an IND, which must become effective
before human clinical trials may begin; performance of adequate
and well-controlled human clinical trials to establish the
safety and efficacy of the proposed drug or biologic for its
intended use; and submission and approval of a New Drug
Application, or NDA, for a drug, or a Biologics License
Application, or BLA, for a biologic. The sponsor typically
conducts human clinical trials in three sequential phases, but
the phases may overlap. In Phase 1 clinical trials, the
product is tested in a small number of patients or healthy
volunteers, primarily for safety at one or more doses. In
Phase 2, in addition to safety, the sponsor evaluates the
efficacy of the product in targeted indications, and identifies
possible adverse effects and safety risks, in a patient
population that is usually larger than Phase 1 clinical
trials. Phase 3 clinical trials typically involve
additional testing for safety and clinical efficacy in an
expanded patient population at geographically-dispersed clinical
trial sites. Clinical trials must be conducted in accordance
with the FDAs Good Clinical Practices requirements. Prior
to commencement of each clinical trial, the sponsor must submit
to the FDA a clinical plan, or protocol, accompanied by the
approval of the ethics committee responsible for overseeing
clinical trione of the clinical trial sites. The FDA may order
the temporary or permanent discontinuation of a clinical trial
at any time if it believes that the clinical trial is not being
conducted in accordance with FDA requirements or presents an
unacceptable risk to the clinical trial patients. The ethics
committee at each clinical site may also require the clinical
trial at that site to be halted, either temporarily or
permanently, for the same reasons.
The sponsor must submit to the FDA the results of the
preclinical and clinical trials, together with, among other
things, detailed information on the manufacture and composition
of the product, in the form of an NDA, or, in the case of a
biologic, a BLA. In a process that may take from several months
to several years, the FDA reviews these applications and, when
and if it decides that adequate data are available to show that
the new compound is both safe and effective and that other
applicable requirements have been met, approves the drug or
biologic for sale. The amount of time taken for this approval
process is a function of a number of variables, including
whether the product has received a fast track designation, the
quality of the submission and studies presented, the potential
contribution that the compound will make in improving the
treatment of the disease in question, and the workload at the
FDA. It is possible that our product candidates will not
successfully proceed through this approval process or that the
FDA will not approve them in any specific period of time, or at
all.
The FDA may, during its review of a NDA or BLA, ask for
additional test data. If the FDA does ultimately approve the
product, it may require additional testing, including
potentially expensive Phase 4 studies, to monitor the
safety and effectiveness of the product. In addition, the FDA
may in some circumstances impose restrictions on the use of the
product, which may be difficult and expensive to administer and
may require prior approval of promotional materials.
227
We will also be subject to a variety of regulations governing
clinical trials and sales of our products outside the United
States. Whether or not FDA approval has been obtained, approval
of a product by the comparable regulatory authorities of foreign
countries and regions must be obtained prior to the commencement
of selling the product in those countries. The approval process
varies from one regulatory authority to another and the time may
be longer or shorter than that required for FDA approval. In the
European Union, Canada, and Australia, regulatory requirements
and approval processes are similar, in principle, to those in
the United States.
Ongoing
Regulatory Requirements
Before approving an NDA or BLA, the FDA will inspect the
facilities at which the product is manufactured and will not
approve the product unless the manufacturing facilities are in
compliance with FDAs Good Manufacturing Practices, or GMP,
regulations which govern the manufacture, storage and
distribution of a product. Manufacturers of biologics also must
comply with FDAs general biological product standards.
Following approval, the FDA periodically inspects drug and
biologic manufacturing facilities to ensure continued compliance
with the GMP regulations. Manufacturers must continue to expend
time, money and effort in the areas of production, quality
control, record keeping and reporting to ensure full compliance
with those requirements. Failure to comply with GMP regulations
subjects the manufacturer to possible legal or regulatory
action, such as suspension of manufacturing or recall or seizure
of product. Adverse experiences with the product must be
reported to the FDA and could result in the imposition of
marketing restrictions through labeling changes or market
removal. Product approvals may be withdrawn if compliance with
regulatory requirements is not maintained or if problems
concerning safety or efficacy of the product occur following
approval.
The labeling, advertising, promotion, marketing and distribution
of a drug or biologic product also must be in compliance with
FDA and Federal Trade Commission, or FTC, requirements which
include, among others, standards and regulations for off-label
promotion, industry sponsored scientific and educational
activities, promotional activities involving the internet, and
direct-to-consumer
advertising. The FDA and FTC have very broad enforcement
authority, and failure to abide by these regulations can result
in penalties, including the issuance of a warning letter
directing the company to correct deviations from regulatory
standards and enforcement actions that can include seizures,
injunctions and criminal prosecution.
Manufacturers are also subject to various laws and regulations
governing laboratory practices, the experimental use of animals,
and the use and disposal of hazardous or potentially hazardous
substances in connection with their research. In each of these
areas, as above, the FDA has broad regulatory and enforcement
powers, including the ability to levy fines and civil penalties,
suspend or delay issuance of product approvals, seize or recall
products, and deny or withdraw approvals.
Competition
We face competition from a number of companies that are
marketing products or evaluating various product candidates,
technologies and approaches for the treatment of cancer and
inflammatory diseases. Specifically, we face competition from a
number of companies working in the fields of antibody-derived
therapies for the treatment of solid tumors and B cell
lymphomas. We expect that competition among products approved
for sale will be based on various factors, including product
efficacy, safety, reliability, convenience, availability,
pricing and patent position. Some of these products use
therapeutic approaches that may compete directly with our
product candidates, and the companies developing these competing
technologies may have significantly more resources than we do,
and may succeed in obtaining approvals from the FDA and foreign
regulatory authorities for their products sooner than we do for
ours.
Hormone
Refractory Prostate Cancer
Established
Therapies
The main treatment modalities for prostate cancer include:
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watchful waiting;
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local therapy (prostatectomy or radiotherapy, either external
beam radiation therapy or brachytherapy);
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hormonal therapy; and
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chemotherapy.
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Watchful waiting is generally reserved for elderly men, who,
because of short life expectancy or slowly progressing disease,
are more likely to die from reasons other than prostate cancer.
Clinicians believe local therapies alone can cure patients
diagnosed with early-stage (I or II) prostate-confined
disease. Hormonal therapy is used primarily to delay disease
progression when local therapies have failed. Chemotherapy is
generally reserved for hormone-refractory disease to mitigate
symptoms.
A growing trend in prostate cancer treatment is the use of
intermittent therapy. Hormonal therapies are often administered
for three years or more as adjuvant therapy. Although their
side-effect profile is mild compared with that of many
chemotherapy agents, they do have several undesirable effects
(e.g., hot flashes, sexual dysfunction, gynecomastia (excessive
development of mammary glands)). To reduce these side effects
and improve their quality of life, patients are increasingly
requesting suspensions of treatment.
In May 2004, the FDA approved the regimen of docetaxel
(Sanofi-Aventiss
Taxotere®)/prednisone
(Mercks
Decortin®)
for the treatment of hormone-refractory prostate cancer. This
regimens apparent efficacy is prompting further research
into the use of docetaxel in combination with other chemotherapy
agents in the hope of improving overall survival for this
indication. In November 2004, docetaxel was approved in Europe
for the treatment of metastatic, hormone-refractory prostate
cancer. Mitoxantrone (Serono/Wyeth Lederles
Novantrone®,
Baxters
Onkotrone®)
is marketed for the treatment of hormone-refractory metastatic
prostate cancer in combination with prednisone.
Emerging
Therapies
There are numerous cytotoxic agents in development, whose
fundamental aim is to exert selective toxicity toward cancer
cells. Examples in clinical development include:
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Ixabepilone (Bristol-Myers Squibbs BMS-247550) is an
epothilone tubulin inhibitor in Phase 1 trials;
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Patupilone (Novartiss EPO-906) is an intravenously
administered formulation of epothilone B in Phase 2 trials;
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Satraplatin (GPC Biotechs JM-216) is a third-generation
oral platinum agent in Phase 3 clinical trials; and
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Irofulven (MGI Pharmas MGI-114) is an acylfulvene in
Phase 2 clinical trials;
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amonafide dihydrochloride (ChemGenex Therapeutics
Quinamed®)
in Phase 2 clinical trials;
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amonafide malate (Xanthuss
Xanafide®)
in Phase 2 clinical trials;
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Cell Therapeutics BBR-3576, an aza-anthrapyrazole in
Phase 2 clinical trials; and
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Kyowa Hakko Kogyos KW-2170, a pyrazoloacridone alkylating
agent and topoisomerase II inhibitor in Phase 2
clinical trials.
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Endothelin-receptor antagonists represent a new generation of
oral, targeted, cytostatic agents. Examples in clinical
development include:
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Atrasentan (Abbott Laboratories
Xinlay®),
an oral, small-molecule, selective
ET-A-receptor
antagonist in Phase 2 trials; and
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AstraZenecas ZD-4054, a second
ET-A-receptor
antagonist in Phase 2 trials.
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Angiogenesis inhibitors in development for prostate cancer span
a wide range of classes, including monoclonal antibodies,
selective metalloproteinase inhibitors, and thalidomide and its
derivatives. Examples include:
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Bevacizumab (Genentech/Roches
Avastin®),
a recombinant humanized Monoclonal antibody to VEGF, which has
been approved for colorectal cancer, is being studied in
Phase 3 clinical trials;
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Thalidomide (Celgenes Thalidomid), approved for the acute
treatment of erythema nodosum leprosum, is being studied in
multiple Phase 2 and Phase 3 clinical trials; and
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CC-4047 (Celgenes
Actimid®),
the lead compound in a series of thalidomide derivatives,
recently completed Phase 2 clinical trials.
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The development of vaccines is one of the most active areas of
prostate cancer research. Examples in clinical development
include:
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Dendreons
Provenge®,
a dendritic cell-based vaccine in Phase 3 trials; and
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Cell Genesyss GVAX, consisting of tumor cells that have
been irradiated and genetically modified administered by
intradermal injection, in Phase 3 trials.
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Immunoconjugation is a means of delivering cytotoxic molecules
to tumor cells. The effector molecules are attached to
monoclonal antibodies, which target the agent to specific
antigens expressed on the tumor cell. As an example, Millennium
Pharmaceuticals MLN-591 RL, a radiolabeled version of
MLN-591, a PSMA-specific Monoclonal antibody, is in
Phase 1/2 clinical trials.
Breast
Cancer
Established
Therapies
The treatment of breast cancer employs a multimodal approach,
using hormone therapy, chemotherapy, biological agents,
radiotherapy, and surgery. Treatment selection is tied primarily
to disease stage, estrogen and progesterone receptor status,
performance status, and, increasingly, HER2 expression. Hormone
therapy and/or chemotherapy are given in the following
circumstances:
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Neoadjuvant therapy (prior to surgery) to reduce tumor size and
facilitate surgery;
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Adjuvant therapy (postsurgery) to prevent recurrence (both local
and distant); and
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Palliative treatment of metastatic disease, where it might also
be used to prolong survival. At this time, metastatic breast
cancer is not considered to be curable, although treatment and
survival can be long-term in a minority of patients.
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Treatment choice reflects the specific patient and tumor
characteristics and the likelihood of relapse. Relevant factors
include the patients age, menopausal status, performance
status, estrogen-receptor/progesterone receptor status, tumor
histology, level of HER2 expression, lymph node involvement, and
presence of metastatic disease. A large number of
drugs given alone, in combination, or in
sequence have demonstrated clinical benefit in
breast cancer patients and have been adopted into clinical
practice. Generally, neoadjuvant and adjuvant chemotherapy uses
combinations of drugs each with a different
mechanism of action and complementary toxicity
profile to maximize efficacy while minimizing
toxicity.
More recently, taxanes have been introduced into neoadjuvant and
adjuvant chemotherapy treatment regimens, primarily for
high-risk (typically node-positive) patients. To date, mature
data are available from three large trials in which patients
were randomized to receive either a taxane-containing regimen or
a non-taxane-containing regimen.
Studies show that both combination and sequential therapy
(sequential lines of various single-agent chemotherapies) have
their place in the treatment of metastatic breast cancer. Given
the heterogeneity of breast cancer, physicians must be flexible
in their approach to treating the disease. Thus, treatment of
patients with metastatic disease tends to be very
individualized; optimal treatment regimens have yet to be
determined. Sequential therapy may be particularly appropriate
for older patients or those with reduced performance status
because it enables the optimal delivery and management of
single-drug therapy and potentially reduces the risk of toxicity
without reducing the quality of life.
Newer drug combinations show survival advantages over
single-agent therapy in metastatic breast cancer and have
manageable side-effect profiles. Such combination treatments may
be preferable to sequential therapy in patients who require
immediate reduction in their tumor burden, and many clinicians
now favor combination
230
regimens for first-line treatment of metastatic disease,
particularly for patients with rapidly progressing disease in
need of rapid control. Examples include:
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trastuzumab/paclitaxel (Roche/Genentech/Chugais
Herceptin®;
Bristol-Myers Squibbs
Taxol®;
generics); and
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Docetaxel/Prostate Capecitabine (Sanofi-Aventiss
Taxotere®;
Roche/Chugais
Xeloda®).
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Emerging
Therapies
Epothilones may in the future challenge the place of taxanes in
neoadjuvant and adjuvant therapy and in the treatment of
metastatic disease. Bristol-Myers Squibbs ixabepilone is
the leading agent in this class for breast cancer treatment and
is being studied in multiple Phase 2 trials. Another
epothilone, epothilone D (KOS-862), is undergoing clinical
investigation for breast cancer by Roche and Kosan in
Phase 3 trials.
In addition, Eli Lilly is developing a multitargeted
antifolate/antimetabolite compound called pemetrexed (Alimta).
Pemetrexed was approved initially for malignant pleural
mesothelioma in the United States in February 2004 and has since
been approved in the United States and Europe as a second-line
therapy for non-small-cell lung cancer (NSCLC). Pemetrexed is in
Phase 2 trials for breast cancer in the United States and
Europe.
Moreover, Wyeth is developing temsirolimus, which is an ester
analogue of rapamycin with improved aqueous solubility and
pharmacokinetic properties. Temsirolimus selectively inhibits
the mammalian target of rapamycin (known as mTOR), an enzyme
required to control a cells life cycle, preventing cell
division into new cells.
Angiogenesis, the formation of new blood vessels, plays a major
role in many normal physiological processes and in several
pathological conditions, including solid tumor growth and
metastasis. Numerous companies are developing compounds that
inhibit angiogenesis. Agents within this class in early-phase
development for breast cancer include:
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AstraZenecas ZD-6474;
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EntreMeds 2-methoxyestradiol (2-ME2); and
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Bayer/Onyxs sorafenib (BAY-43-9006).
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Bevacizumab (Genentechs/Roche/Chugais
Avastin®),
a humanized monoclonal antibody designed to inhibit
angiogenesis, is approved for marketing in the United States and
the European Union for colorectal cancer, and is under
development for numerous other cancers. Phase 3 trials are
ongoing in non-small-cell lung, renal cell, ovarian, pancreatic,
prostate, and breast cancer.
GlaxoSmithKlines lapatinib is an orally administered EGFR
tyrosine kinase inhibitor that has the added benefit of blocking
ErbB-2/HER2 tyrosine kinase. Genentech/Roche/Chugais
next-generation HER2 directed monoclonal antibody, pertuzumab
(Omnitarg), inhibits HER2 dimerization and is currently in
clinical trials for a range of solid cancers, including breast
cancer. Erlotinib (OSI-774/CP-358774/Tarceva), another EGFR
tyrosine kinase inhibitor, is under development by OSI
Pharmaceuticals in alliance with Genentech and Roche.
Alternative approaches include gene therapy and antisense
approaches to treat cancer, an example of which is
Introgens Advexin, an adenoviral p53 gene therapy
for the treatment of multiple tumors.
Indolent
Non-Hodgkin Lymphoma
There are numerous agents in development to treat indolent
non-Hodgkin Lymphoma. Chlorambucil (GlaxoSmithKlines
Leukeran®)
and cyclophosphamide (Bristol-Myers Squibbs
Cytoxan®;
others) both show single-agent activity against symptomatic
advanced-stage indolent NHL. Fludarabine (Berlexs
Fludara®)
is approved in all major markets for the treatment of chronic
lymphocytic leukemia (CLL). Pentostatin (SuperGens
Nipent®)
is marketed in Japan for the treatment of T-cell lymphoma.
Rituximab (Genentech/Idec/Zenyaku Kogyos
Rituxan®;
Roches
MabThera®)
is a chimeric human-mouse monoclonal antibody active against the
CD20 antigen. The FDA has approved its use for follicular NHL.
In
231
aggressive NHL, rituximab is usually given with each cycle of
chemotherapy (i.e., R-CHOP).
Rituxan®
has become the standard of care for 2nd line follicular NHL
patients in the United States and the European Union.
In addition, radiolabeled antibodies to CD20 have been
developed, including:
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Idec Pharmaceuticals Ibritumomab tiuxetan
(Zevalin®),
a murine labelled with yttrium-90 (murine CD20 antibody);
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GlaxoSmithklines tositumomab
(Bexxar®),
labeled with
iodine-131(murine
CD20 antibody);
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Zevalin®
is marketed for the radioimmunotherapy of low-grade (indolent)
CD20-positive NHL;
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rituximab is marked for refractory low-grade NHL, and
CD20-positive transformed NHL; and
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Bexxar®
is marketed for the treatment of low-grade (indolent) NHL.
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Moreover, the anti-CD22 monoclonal antibody epratuzumab
(Immunomedics LymphoCide) is under clinical investigation
in its naked (unlabeled) and radiolabeled
(90Y)
forms.
Legal
Proceedings
Litigation
with Cell Therapeutics, Inc. (CTI)
In the summer of 2003, it was announced that our collaborator
Novuspharma SpA was to be acquired by CTI. After approval at the
shareholders meetings of both companies, the merger was
effected on January 2, 2004. Although our management
attempted to enter into dialogue with the new collaborator at an
early stage, the first meeting did not take place until the
acquisition had been concluded. At this meeting on
January 7, 2004, the management of CTI announced that it
was no longer prepared to make any payments related to
outstanding invoices and future obligations as contractually
agreed.
As a reaction to the refusal to pay, we initiated a full review
of the financial impact on our future operational activities.
The results of this review included that a significant reduction
of project-related and personnel expenses was required in order
to offset the loss of income resulting from CTIs refusal
to honor its contractual payment obligations. After approval was
obtained from the supervisory board, our company was
restructured at the end of January 2004, including the reduction
of our workforce from 135 full-time employees to 90.
On February 10, 2004, the agreement with CTI was terminated
on the basis of CTIs failure to meet its contractual
payment obligations. As a result of such termination, CTI has no
remaining rights to adecatumumab (MT201). On the same date, we
initiated legal proceedings against CTI for breach of contract.
On February 23, 2004, CTI filed a counterclaim against us.
Based on assessment of the contract, management believes that it
is more likely than not that CTI will not prevail in its
countersuit, and therefore no reserves have been set aside for
this counterclaim. In December 2005, the parties submitted the
dispute to nonbinding mediation. Although discussions with the
mediator are ongoing as the litigation continues, there can be
no assurance that the parties will be able to reach agreement on
this matter.
Expenses related to the litigation activities were recorded at
approximately 826,000 in 2004.
Patent
Opposition in Europe
Micromets patent EP1071752B1 was opposed under
Articles 99 and 100 of the European Patent Convention, or
EPC, by Affimed Therapeutics AG in March 2004. The opponent
alleged that the patent does not fulfill the requirements of the
EPC. On January 19, 2006, the Opposition Division of the
European Patent Office (EPO) revoked the opposition in oral
proceedings according to Article 116 of the EPC and
maintained the patent as granted. The opponent can appeal the
decision and request a hearing in front of the Board of Appeal
of the EPO.
Curis,
Inc.
On March 6, 2006, Curis, Inc. filed a lawsuit against
Micromet in the Local Court of Munich I. Curis claims that
Micromet is obligated to pay Curis the outstanding amount of
Curis promissory note of 2,000,000 within
30 days after the completion of the exchange by Micromet
shareholders of a majority of the outstanding shares of
232
Micromet AG for shares of a third party. This would include the
proposed exchange of shares of Micromet AG for shares of
Micromet, Inc. that is contemplated by the terms of the Merger
Agreement. Micromet disputes Curis position, but agrees
that an amount of 533,333 of the loan will become payable
in October 2006. The total possible exposure of Micromet is the
amount claimed (2,000,000), plus the costs of the
proceedings. In addition, if Curis prevails in the proceeding,
it would be entitled to interest on the claimed amount of
2,000,000 at the base rate of the European Central Bank
plus 8%, accruing from the time of default.
The Local Court of Munich I has set a deadline of April 4,
2006 for Micromet to notify the court whether it intends to
challenge the lawsuit, and a deadline of April 18, 2006 for
Micromet to file a writ stating its defenses against the
lawsuit. A date for the hearing has not been determined yet, but
a hearing would likely be set by the court following its receipt
of Micromets defenses.
Facilities
Our corporate headquarters and research and development facility
of approximately 81,161 square feet located in Munich,
Germany is leased under a ten-year operating lease that
commenced in July 2002. We have options to renew this lease for
additional periods of five years. We believe that this facility
will suffice for our anticipated future corporate headquarters
and research and development requirements through 2007. We have
no other facilities.
Employees
As of December 31, 2005, we employed 87 full-time
employees, of whom approximately 57 were engaged in research,
clinical development and regulatory affairs, 16 in manufacturing
and quality assurance, and 14 in administration, finance,
management information systems, corporate development, marketing
and human resources. Thirty-seven of our employees hold a Ph.D.
or M.D. degree and are engaged in activities relating to
research and development, manufacturing, quality assurance and
business development.
233
MANAGEMENTS
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS OF MICROMET
The following discussion and analysis of financial condition
and results of operations should be read together with
Selected Financial Data, and Micromets
financial statements and accompanying notes appearing elsewhere
in this proxy statement/prospectus. This discussion contains
forward-looking statements, based on current expectations and
related to future events and Micromets future financial
performance, that involve risks and uncertainties.
Micromets actual results may differ materially from those
anticipated in these forward-looking statements as a result of
many important factors, including those set forth above under
Risk Factors Risks Relating to
Micromet and elsewhere in this proxy statement/prospectus.
Unless otherwise stated, all financial data are presented in
euros ().
Overview
Micromet is a biotechnology company focused on the research,
development and commercialization of novel biological products
for the treatment and control of cancer and inflammatory and
autoimmune diseases in potentially large drug markets with
significant unmet medical needs. Micromets product
pipeline consists of two clinical product candidates,
adecatumumab (MT201) and MT103, and five preclinical product
candidates, MT110, MT203, MT204,
BiTEtm-I
and
BiTEtm-II.
Micromet started its clinical program for its lead product
candidate (adecatumumab) with a Phase 1 clinical trial in
patients with hormone-refractory prostate cancer in September
2001 in Germany. Phase 2 clinical trials were started in
February 2004 in patients with prostate cancer and in March 2004
in patients with metastatic breast cancer. Adecatumumab (MT201)
is being evaluated as a monotherapy in these two clinical
trials. In addition, adecatumumab (MT201) is being evaluated in
a Phase 1 clinical trial in combination with docetaxel in
patients with metastatic breast cancer. An Investigational New
Drug Application, or IND was approved by the Food and Drug
Administration, or FDA, in November 2004 for a Phase 2
study in patients with metastatic breast cancer.
A second clinical program, MT103, a
BiTEtm
compound, is in a Phase 1 dose escalation clinical trial in
patients with indolent non-Hodgkins Lymphoma.
In addition, Micromet has product candidates in pre-clinical
development including therapeutic human antibodies and
BiTEtm
molecules that may be used to treat patients with inflammatory
diseases and cancer.
Micromet believes that its novel technologies, product
candidates and clinical development experience in these fields
will continue to enable it to identify and develop promising new
product opportunities in these critical markets.
Each of Micromets programs will require many years and
significant costs to advance through development. Typically it
takes many years from the initial identification of a lead
compound to the completion of pre-clinical and clinical trials,
before applying for possible marketing approval from the FDA or
equivalent international regulatory agencies. The risk that a
program has to be terminated in part or in full for safety
reasons, or lack of adequate efficacy is very high. In
particular, Micromet can neither predict
which if any potential product
candidates can be successfully developed and for which marketing
approval may be obtained, nor predict the time and cost to
complete development.
As Micromet obtains results from pre-clinical studies or
clinical trials, it may elect to discontinue clinical trials for
certain product candidates for safety and /or efficacy reasons.
It may also elect to discontinue development of one or more
product candidates in order to focus its resources on more
promising product candidates. Micromets business strategy
includes entering into collaborative agreements with third
parties for the development and commercialization of its product
candidates. Depending on the structure of such collaborative
agreements, a third party may take over the clinical trial
process for one of Micromets product candidates. In such a
situation, the third party, rather than Micromet, may in fact
control development and commercialization decisions for the
respective product candidate. Consistent with its business
model, Micromet may enter into additional collaboration
agreements in the future. Micromet cannot predict the terms of
such agreements or their potential impact on Micromets
capital requirements. Micromets inability to complete its
research and development projects in a timely manner, or
234
its failure to enter into new collaborative agreements, when
appropriate, could significantly increase capital requirements
and affect Micromets liquidity.
Since Micromets inception, it has financed its operations
through private placements of preferred stock, government grants
for research, research-contribution revenues from its
collaborations with pharmaceutical companies, and debt
financing. To date, Micromet has incurred significant expenses
and has not achieved any product revenues from sales of its
products.
From inception through December 31, 2005, Micromet incurred
research and development expenses of 120,790,000. Micromet
expects to incur substantial additional research and development
expenses that may increase from historical levels as it moves
its compounds into more advanced stages of clinical development
and increases its pre-clinical efforts for its human antibodies
and BiTE molecules in anti-inflammatory and autoimmune diseases
and cancer. Micromet believes that it has adequate resources to
fund its operations into the third quarter of 2006 and, if
Micromets existing shareholders invest an additional
4,000,000, as is currently expected under an investment
agreement with such shareholders, then into the fourth quarter
of 2006.
Currently, Micromet has strategic collaborations with Serono and
MedImmune to develop therapeutic antibodies in cancer. Micromet
also has an exclusive marketing agreement with Enzon to market
and license to third parties the companies respective
single-chain antibody patent estates.
Micromets strategic collaborations and license agreements
generally provide for Micromets research, development and
commercialization programs to be partly or wholly funded by its
collaborators and provide Micromet with the opportunity to
receive additional payments if specified development or
commercialization milestones are achieved, as well as royalty
payments upon the successful commercialization of any products
based upon the collaborations.
Under the adecatumumab (MT201) collaboration agreement with Ares
Trading, S.A., a wholly-owned subsidiary of Serono
International, S.A. (Serono), Micromet received a
$10,000,000 up-front payment from Serono and the agreement
provides for potential future clinical development milestone
payments of up to an additional $138,000,000. The collaboration
agreement for MT103 with MedImmune provides for potential future
milestone payments and royalty payments based on net sales from
MT103. A second agreement with MedImmune for the development of
new
BiTEtm
molecules provides for potential future milestone payments and
royalty payments based on future sales of the
BiTEtm
product candidates currently under development. The potential
milestone payments are subject to successful completion of
development and obtaining marketing approval for one or more
indications and one or more national markets.
Micromet intends to pursue additional collaborations to provide
resources for further development of its product candidates and
expects to continue to grant technology access licenses.
However, Micromet cannot forecast with any degree of certainty
whether it will be able to enter into collaborative agreements,
and if it does, on what terms it might do so. Micromet may also
seek funding through public or private financings. If Micromet
is successful in raising additional funds through the issuance
of equity securities, stockholders may experience substantial
dilution, or the equity securities may have rights, preferences
or privileges senior to existing stockholders. If Micromet is
successful in raising additional funds through debt financings,
these financings may involve significant cash payment
obligations and covenants that restrict Micromets ability
to operate its business. There can be no assurance that Micromet
will be successful in raising additional capital on acceptable
terms, or at all.
Critical
Accounting Policies and the Use of Estimates
Micromets financial statements are prepared in conformity
with accounting principles generally accepted in the United
States. Such statements require management to make estimates and
assumptions that affect the amounts reported in Micromets
financial statements and accompanying notes. Actual results
could differ materially from
235
those estimates. The significant policies in Micromets
financial statements requiring significant estimates and
judgments are as follows:
Revenue
Recognition
Micromet currently recognizes revenue resulting from the
licensing and use of its technology and from services it
performs in connection with the licensed technology. These
revenues are typically derived from Micromets proprietary
patent portfolio.
Micromet enters into patent licenses and research and
development agreements that may contain multiple elements, such
as upfront license fees, reimbursement of research and
development expenses, milestones related to the achievement of
particular stages in product development and royalties. As a
result, significant judgment is required to determine the
appropriate accounting, including whether the deliverables
specified in a multiple element arrangement should be treated as
separate units of accounting for revenue recognition purposes,
and if so, how the aggregate contract value should be allocated
among the deliverable elements and when to recognize revenue for
each element. Micromet recognizes revenue for delivered elements
only when the fair values of undelivered elements are known,
when the associated earnings process is complete, and when
payment is reasonably assured. Changes in the allocation of the
contract value between deliverable elements might impact the
timing of revenue recognition, but would not change the total
revenue recognized on the contract.
Long-Lived
and Intangible Assets
The evaluation for impairment of long-lived and intangible
assets requires significant management estimates and judgment.
Subsequent to the initial recording of long-lived and intangible
assets, Micromet must test such assets for impairment. When
Micromet conducts its impairment tests, factors that are
important in determining whether impairment might exist include
assumptions regarding its underlying business and product
candidates and other factors specific to each asset being
evaluated. Any changes in key assumptions about the business and
its prospects, or changes in market conditions or other external
factors, could result in impairment. Such impairment charge, if
any, could have a material adverse effect on Micromets
results of operations.
Fair
Value of Equity and Debt Instruments
As part of entering into the merger agreement with CancerVax,
Micromet has reassessed its estimate of the fair value for
financial reporting purposes of its ordinary and preference
shares for the years ended December 31, 2005, 2004, and
2003. Micromet did not obtain contemporaneous valuations from an
independent valuation specialist. Micromet obtained
retrospective valuations as of December 31, 2004 and
June 30, 2003 and a contemporaneous valuation as of
December 31, 2005 from an independent valuation specialist.
The valuations as of other points in time were performed
retrospectively by management. Valuations performed by the
independent valuation specialists were based on an income
approach (discounted cash flows) and corroborated by a market
approach (analysis of comparable companies and transactions).
Valuations performed by management was based on a market
approach (analysis of fluctuations in stock price of comparable
companies) taking into consideration the price Micromet received
in November 2001 for its preference shares of 11.97
(425 after giving effect to the 1-for-35.5 reverse stock
split described below under Liquidity and Capital
Resources), since this was an arms-length transaction.
Starting at the beginning of 2002, the biotechnology industry
experienced a significant decline in market capitalization.
Accordingly, Micromet decreased the estimated fair value of its
preference and ordinary shares to approximately 2 to
4 per preference and ordinary share in the first half
of 2003 (71 to 142 after giving effect to the
1-for-35.5 reverse stock split). This was corroborated by an
estimated fair value range of 1 to 2 per
ordinary share as of June 30, 2003 (35.5 to 71
after giving effect to the 1-for-35.5 reverse stock
split) per the independent valuation specialist. Micromet
calculated an estimated fair value of its ordinary shares of
3 per ordinary share as of June 2004 (106.5
after giving effect to the 1-for-35.5 reverse stock split ).
This was corroborated by an estimated fair value range of
3 to 4 per ordinary share as of
December 31, 2004 per the independent valuation
specialist (106.5 to 142 after giving effect to the
1-for-35.5 reverse stock split). As of December 31, 2005
the independent valuation specialist provided an estimated fair
value range of 25 to 30 per ordinary share of
Micromet.
236
In the determination of the fair value of the debt and equity
instruments granted, Micromet used an interest rate of 2.5% to
5% based on the risk-free interest rate of German government
bond issuances and a volatility of approximately 75% to 95%. For
Micromets stock-based compensation issued to its employees
and supervisory board members, Micromet calculated the minimum
value using a near-zero volatility.
Micromets reassessment of estimated fair value for the
years ended December 31, 2005, 2004, and 2003 did not
result in a change in fair value of stock options granted to
employees and supervisory board members or in warrants granted
to third parties. In addition, Micromets reassessment of
fair value of ordinary and preference shares did not result in
any beneficial conversion features in its convertible debt
agreements.
Financial
Operations Overview
General. Micromets future operating
results will depend largely on the magnitude of payments from
current and potential future corporate collaborators and the
progress of other product candidates currently in its research
and development pipeline. The results of its operations will
vary significantly from year to year and quarter to quarter and
depend on, among other factors, the timing of its entry into new
collaborations, the timing of the receipt of payments from
collaborators and the cost and outcome of clinical trials.
Micromet believes that its existing capital resources at
December 31, 2005 should enable it to maintain current and
planned operations into the third quarter of 2006, including
expected spending related to its co-development of MT103, its
product candidate for the treatment of patients with
non-Hodgkins Lymphoma, which is under development with
MedImmune, and increased spending for pre-clinical compound
MT110. Micromets ability to continue funding planned
operations beyond the third quarter of 2006 is dependent upon
the success of its collaborations, ability to maintain or reduce
its expenses and cash requirements and ability to raise
additional funds through equity, debt or other sources of
financing. A discussion of certain risks and uncertainties that
could affect Micromets liquidity, capital requirements and
ability to raise additional funds is set forth above under the
heading Risk Factors Risks Relating To
Micromet.
Micromet does not expect to generate any revenue from the sale
of products for several years, if ever. Substantially all of
Micromets revenue to date has been derived from license
fees, research and development payments, and other amounts such
as milestone payments or down-payments received from strategic
collaborators and licensees, including Serono, MedImmune and
Enzon. In the future, Micromet will seek to generate revenue
from a combination of license fees, research and development
funding and milestone payments in connection with strategic
licenses and collaborations, and royalties resulting from the
sale of products which incorporate its intellectual property and
from sales of any products it successfully develops and
commercializes, either alone or in collaboration with third
parties. Micromet expects that any revenue generated will
fluctuate from quarter to quarter as a result of the timing and
amount of payments received under strategic collaborations, and
the amount and timing of payments it receives upon the sale of
products, to the extent that any are successfully commercialized.
The following table summarizes our primary research and
development programs, including the current development status
of each program. The term preclinical means Micromet is seeking
to obtain demonstrations of therapeutic efficacy in preclinical
models of human disease and relevant toxicology and safety data
required for an IND submission with the FDA or equivalent
international institutions, which will be required prior to
commencing a Phase 1 clinical trial to assess safety in
humans.
|
|
|
|
|
|
|
Product Candidate
|
|
Primary Indication
|
|
Collaborator
|
|
Status
|
|
Adecatumumab (MT201)(1)
|
|
Metastatic Breast Cancer
|
|
Serono
|
|
Clinical Phase 2
|
|
|
Prostate Cancer
|
|
|
|
|
MT103(2)
|
|
Indolent non-Hodgkins
|
|
MedImmune
|
|
Clinical Phase 1
|
|
|
Lymphoma
|
|
|
|
|
MT110
|
|
Solid tumors
|
|
|
|
Pre-clinical
|
MT203(3)
|
|
Inflammatory diseases
|
|
|
|
Pre-clinical
|
MT204
|
|
Inflammatory diseases
|
|
|
|
Pre-clinical
|
BiTEtmI
|
|
|
|
MedImmune
|
|
Pre-clinical
|
BiTEtmII
|
|
|
|
MedImmune
|
|
Pre-clinical
|
237
|
|
(1) |
This product candidate has been licensed to Serono. Under the
license arrangement, Serono has acquired global rights to the
product candidate. Serono has an obligation to fully fund all
ongoing clinical studies. Serono has a right to terminate the
contract upon availability of Phase 2 data, and such data
is expected in the second half of 2006. Upon availability of
such data, Serono will be required to make a decision as to
whether to continue the program. Serono will make certain
milestone payments up to approximately $138,000,000 if the
product is successfully developed and registered worldwide in
three or more indications. In addition, Micromet will receive
royalties based on future net sales of the product (as defined
in the agreement). Under certain terms and conditions, Micromet
may elect to share in the development and commercialization of
the product in the US and the European Union in exchange for a
share of profits and in lieu of royalties.
|
|
|
(2) |
Micromet has established a collaboration agreement with respect
to this product candidate with MedImmune. Under the terms of the
agreement, MedImmune has licensed the MT103 product rights for
North America. Micromet has retained all rights for the rest of
the world. Under the agreement, each party bears the costs of
development in its respective region. In case of programs that
are conducted jointly, Micromet bears 40% and MedImmune bears
60% of development costs.
|
|
|
(3) |
This program was formerly licensed to Enzon.
|
Revenue-Generating
Research and Development Collaborations
Serono
International, S.A.
In December 2004, Micromet entered into a collaboration
agreement with a wholly-owned subsidiary of Serono International
S.A., a leading Swiss biotechnology firm (Serono).
Pursuant to the agreement, Micromet granted Serono a worldwide
license under its relevant patents and know-how to develop,
manufacture, commercialize and use adecatumumab (MT201) for the
prevention and treatment of any human disease. Serono paid an
initial license fee of $10,000,000. Under the terms of the
agreement, Serono bears all costs of product development and
manufacturing subject to Micromets participation right as
described below.
Upon receipt of either of the final study reports for the
ongoing Phase 2 trials in breast cancer and prostate
cancer, which are expected in the second half of 2006, Serono
may either elect to terminate the agreement (in which case all
rights to adecatumumab (MT201) return to Micromet) or to
continue the development of adecatumumab (MT201) at its own
expense. Should Serono elect to continue developing adecatumumab
(MT201) after receipt of the second final study report, it must
make an agreed upon milestone payment. Overall, the agreement
provides for Serono to pay up to $138,000,000 in milestone fees
if adecatumumab (MT201) is successfully developed and registered
worldwide in at least three indications.
Upon completion of the currently ongoing phase 2 clinical
trials, Micromet may elect to participate in the costs and
expenses of developing and selling adecatumumab (MT201) in the
United States
and/or
Europe. If Micromet participates, then Micromet will share up to
50% of the development costs, as well as certain other expenses,
depending on the territory for which Micromet has exercised our
co-development option. The parties will co-promote and share the
profits from sales of adecatumumab (MT201) in the territories
for which the parties shared the development costs. In the other
territories, Serono will pay a royalty on net sales of
adecatumumab (MT201).
Enzon,
Inc. (now Enzon Pharmaceuticals, Inc.)
In April 2002, Micromet entered into a multi-year strategic
collaboration with Enzon to identify and develop further
innovation of antibody-based therapeutics. In June 2004, the
parties amended and restated the collaboration agreement to
advance Single-Chain Antibody (SCA) therapeutics
toward clinical development.
In November 2005, the parties entered into an agreement to end
the collaboration to identify and develop antibody-based
therapeutics for the treatment of inflammatory and autoimmune
diseases. The termination was jointly agreed by the parties as a
consequence of Enzons efforts to redirect its investments
to projects strategically aligned with its near- and long-term
business objectives, including an increased focus on cancer.
Under the termination agreement, Enzon made a final payment of
1,180,000 in November 2005 to Micromet in satisfaction of
its obligations under the collaboration. In addition, Micromet
receives rights to the lead compound (MT203)
238
generated within the scope of the collaboration, and Enzon will
receive royalties on any future sales of MT203 products.
The termination of the research and development collaboration
does not affect the companies other agreements, including
a cross-license agreement between the parties and a marketing
agreement under which Micromet is the exclusive marketing party
for the two companies combined intellectual property
estate in the field of SCA technology. Under the marketing
agreement, the two companies share equally in any revenues
resulting from Micromets marketing and related licensing
activities.
MedImmune,
Inc.
MT103 Collaboration and License Agreement. On
June 6, 2003, Micromet entered into an agreement with
MedImmune to jointly develop its B cell tumor drug, MT103, the
most-advanced product candidate of its
BiTEtm
platform. Under the terms of the collaboration and license
agreement, MedImmune receives Micromets product rights to
MT103 in North America and will assume responsibility for
clinical development, registration and commercialization of the
product in that region. As part of the agreement, MedImmune will
develop the commercial manufacturing process and supply clinical
trial material as well as commercial products for all markets.
Micromet retains rights to MT103 outside of North America.
Micromet will receive milestone payments based on the successful
development, filing, registration and marketing of MT103, as
well as royalties on MedImmunes North American sales of
the product, if any. In addition, MedImmune will cover certain
development costs incurred by Micromet that are necessary to
support the submission of an IND with the FDA for MT103. After
submission of the IND, the parties will share development costs
of jointly conducted clinical trials in accordance with the
specifications of the agreement.
BiTEtm
Research Agreement. In addition to the MT103
co-development agreement, the parties have agreed to collaborate
to create and develop up to six new products based on the
BiTEtm
platform. Micromet is entitled to receive milestones and
royalties on future product sales of all resulting
BiTEtm
products. Furthermore, Micromet has the option to obtain
exclusive European rights for
BiTEtm
compounds based on targets non-proprietary to MedImmune and the
option to receive co-promotion rights in Europe for
BiTEtm
compounds based on MedImmunes proprietary targets. For
each new
BiTEtm
molecule, MedImmune will cover full development costs up to
Phase 1. Micromet will be responsible for the generation of
the new
BiTEtm
molecules.
Novuspharma
S.p.A., now Cell Therapeutics, Inc.
In August 2002, Micromet entered into a collaboration agreement
with Novuspharma SpA (now Cell Therapeutics, Inc. (CTI)). Under
this agreement Novuspharma agreed to collaborate with Micromet
on the development of adecatumumab (MT201) on a world-wide basis
and co-promote the product upon certain conditions, and
Novuspharma acquired the right to share profits generated by the
sale or licensing of the product worldwide. Novuspharma was
required to make certain milestone payments and pay 40% to 50%
of the development expenses. In consideration of the payments,
Micromet was required to pay Novuspharma 40% of any profits
generated in the future by the product.
During 2003, Novuspharma announced that it was to be acquired by
CTI. The acquisition was completed on January 2, 2004.
Subsequently, CTI management announced that it would not make
any payments to Micromet for outstanding invoices and
contractually agreed obligations. On February 10, 2004 the
collaboration agreement with CTI was terminated on the basis of
the failure of CTI to meet its contractual payment obligations.
On the same date, Micromet commenced legal proceedings against
CTI for breach of contract. On February 23, 2004, CTI filed
a counterclaim against Micromet. Based on its assessment of the
contract, management believes that it is likely that Micromet
will prevail against CTI in its countersuit and therefore no
provisions have been made in the financial statements.
Restructuring
Plan
A budget deficit arose due to the termination of the
Novuspharma/CTI collaboration of approximately 14,000,000
in 2004. In order to ensure adequate liquidity and to continue
the clinical programs, extensive restructuring measures were
initiated.
239
The restructuring measures included reduction of Micromets
workforce from 135 full-time employees to 90. This was
initiated in January 2004 and completed at the end of March
2004. As part of this restructuring, Micromet paid termination
benefits of approximately 297,000 (of which 264,000
and 33,000 were included in research and development and
general and administrative expense during the year ended
December 31, 2004, respectively).
In December 2004, Micromet vacated portions of its leased
building. The fair value of the liability at the cease-use date
was determined based on the remaining lease rentals, reduced by
estimated sublease rentals that could be reasonably obtained and
discounted using an interest rate of 17%. Accordingly, Micromet
recorded a provision amounting to 840,000 in the year
ended December 31, 2004.
Comparison
of Results of Operations for the Years Ended December 31,
2005, 2004, and 2003
Revenues
Revenues for the years ended December 31, 2005, 2004 and
2003 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands)
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements
|
|
|
18,638
|
|
|
|
11,681
|
|
|
|
13,112
|
|
License fees
|
|
|
2,050
|
|
|
|
1,691
|
|
|
|
50
|
|
Other
|
|
|
91
|
|
|
|
87
|
|
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
20,779
|
|
|
|
13,459
|
|
|
|
13,189
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues relate primarily to collaboration agreements for the
further development of Micromets product candidate
pipeline. In 2005, revenues increased by approximately 60%
compared to 2004 mainly due to the Serono collaboration, which
was entered in December 2004. In 2005, revenues from the
collaborations with MedImmune were approximately
4,513,000, from Serono approximately 10,780,000 and
from Enzon approximately 3,346,000. In 2004, revenues were
11% lower than 2003, primarily as a result of the decrease in
revenues from Novuspharma, partially offset by the increase in
revenues from MedImmune. In 2004, revenues from MedImmune were
approximately 5,518,000, from Enzon approximately
2,668,000, from Novuspharma approximately 2,583,000
and from Serono approximately 911,000. In 2003, revenues
included research and development contributions from Novuspharma
of approximately 8,028,000, from Enzon of approximately
2,832,000, and from MedImmune of approximately
2,249,000.
Operating
Expenses
Operating expenses for the years ended December 31, 2005,
2004 and 2003 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands)
|
|
|
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
23,923
|
|
|
|
26,598
|
|
|
|
26,173
|
|
General and administrative
|
|
|
4,587
|
|
|
|
4,493
|
|
|
|
3,916
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
28,510
|
|
|
|
31,091
|
|
|
|
30,089
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and Development Expenses
Research and development expense consists of costs incurred to
discover, research and develop product candidates. These
expenses consist primarily of salaries and related expenses for
personnel, outside service costs including production of
clinical material, fees for services in the context of clinical
trials, medicinal chemistry, consulting and sponsored research
collaborations, and occupancy and depreciation charges. Micromet
expenses research and development costs as incurred.
240
Any failure to complete the development of its product
candidates in a timely manner could have a material adverse
effect on Micromets operations, financial position and
liquidity. A discussion of risks and uncertainties associated
with completing projects on schedule, or at all, and some
consequences of failing to do so, are set forth above in
Risk Factors Risks Relating to
Micromet.
The decrease in research and development expenses in the year
ended December 31, 2005 is primarily due to decreases in
the amounts related to the use of third parties and decreases in
restructuring costs. Research and development expenses paid to
third parties for the years ended December 31, 2005, 2004
and 2003 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands)
|
|
|
Third party R&D
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Process Development
|
|
|
2,559
|
|
|
|
6,416
|
|
|
|
7,623
|
|
Preclinical Development
|
|
|
597
|
|
|
|
483
|
|
|
|
715
|
|
Clinical Development
|
|
|
3,335
|
|
|
|
2,071
|
|
|
|
1,102
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total third party R&D expenses
|
|
|
6,491
|
|
|
|
8,970
|
|
|
|
9,440
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Process development expenses were mainly incurred for production
of good manufacturing practice, or GMP grade clinical trial
material, as well as fermentation, purification and formulation
development. In 2005, spending on process development decreased
substantially from 6,416,000 in 2004 to 2,559,000.
In 2005, investments in process development were 1,545,000
on MT201 and 1,014,000 on other programs in the
preclinical stage. In 2004, 6,416,000 was spent on process
development, of which 6,097,000 was spent on clinical
trial material for adecatumumab (MT201). In 2003 7,623,000
was spent on process development, of which 6,275,000 was
spent for development and production of adecatumumab (MT201) and
1,274,000 was spent on development and production of MT103.
Preclinical development expenses cover pharmacological
in vitro and in vivo experiments as well as development of
analytical testing procedures. Preclinical development expenses
in 2005 was 597,000, compared to 483,000 in 2004 and
715,000 in 2003.
Spending on clinical trials increased to 3,335,000 in
2005, compared to 2,071,000 in 2004 and 1,102,000 in
2003. The increase is mainly due to increased clinical spending
for adecatumumab (MT201) Phase 2 clinical trials, which was
2,873,000 in 2005, compared to 1,334,000 in 2004 and
600,000 in 2003.
As a consequence of the restructuring of operations during 2004,
Micromet reorganized its operations in order to vacate space
that could be offered for subleases. Micromet also recorded
840,000 for losses on sublease for the remaining lease
period in the year ended December 31, 2004. Micromet
recorded an impairment charge of 315,000 related to
leasehold improvements that will no longer be utilized. The
losses on the sublease and the impairment charge are included in
research and development expense in 2004. There were no
corresponding charges incurred in 2003 or 2005.
General
and Administrative Expenses
General and administrative expense consists primarily of
salaries and other related costs for personnel in executive,
finance, accounting, legal, information technology, corporate
communications and human resource functions. Other costs include
facility costs not otherwise included in research and
development expense, insurance, and professional fees for legal
and accounting services.
General and administrative expenses were 4,587,000,
4,493,000 and 3,916,000 for the years ended
December 31, 2005, 2004 and 2003, respectively. In 2005
general and administrative expenses increased by approximately
2%, primarily due to increased fees for advisory fees for
consultation on general financing strategies and valuation and
other issues. In 2004, general and administrative expenses
increased by approximately 14.7% over 2003. This increase is
primarily due to expenses incurred in connection with
Micromets restructuring in 2004.
241
Other
income/expense
Interest expense, interest income and other income (expense) for
the years ended December 31, 2005, 2004 and 2003 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands)
|
|
|
Interest expense
|
|
|
(4,148
|
)
|
|
|
(2,367
|
)
|
|
|
(2,072
|
)
|
Interest income
|
|
|
270
|
|
|
|
212
|
|
|
|
583
|
|
Other income/(expense)
|
|
|
216
|
|
|
|
(367
|
)
|
|
|
(565
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
(3,662
|
)
|
|
|
(2,522
|
)
|
|
|
(2,054
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense increased to 4,148,000 in 2005, compared
to 2,367,000 in 2004 and 2,072,000 in 2003 mainly
due to 2,331,000 of accrued interest in 2005 related to a
24% interest bearing note which was issued in November 2004,
compared to 188,000 incurred in 2004 related to this note.
The note was converted in January 2006 into preferred shares of
Micromet. Other interest expense in 2005, 2004 and 2003 related
to borrowings from eight silent partnerships bearing interest at
annual rates between 6% and 9% and accrued interest for the same
partnerships for final payments payable upon the due date, a 7%
interest bearing convertible note from Curis, which was modified
to a non-interest bearing note in December 2004, a 3% interest
bearing convertible note from Enzon, which was converted into
common shares in January 2006 and a 4.5% interest bearing
convertible note issued in 2003 to MedImmune.
Interest income is primarily derived by interest bearing
investment activities. In 2005, interest income increased by 27%
to 270,000 compared to 212,000 in 2004, as a result
of larger average cash balances and increased interest rates.
Interest income decreased in 2004 from 583,000 in 2003 due
to a reduction in cash, cash equivalents and short-term
investments. Interest income varies with the amounts of cash
Micromet has available for investing at any given time.
Other income (expense) for the years ended December 31,
2005 and 2004 primarily reflects fluctuations in the exchange
rate between the Euro and US Dollar. As of
December 31, 2004, a $10,000,000 payment was outstanding
that resulted in unrealized loss on exchange. Upon payment of
this amount in January 2005, gain on exchange was recognized. In
2003, other expenses were 565,000, primarily due to
accruals for contingent liabilities in connection with
withholding tax duty on royalty payments affecting foreign
recipients.
Liquidity
and Capital Resources
The accompanying financial statements have been prepared
assuming that Micromet will continue as a going concern. This
basis of accounting contemplates the recovery of Micromets
assets and the satisfaction of its liabilities in the normal
course of business. As of December 31, 2005 Micromet had an
accumulated deficit of approximately 102,023,000 and
expects to continue to incur substantial, and possibly
increasing, operating losses for the next several years.
Micromet has financed its operations through private placements
of shares, grant and research contribution revenues,
collaborator revenues, and debt financing.
As of December 31, 2005 and 2004, Micromet had cash, cash
equivalents and short-term investments of 9,637,000 and
9,344,000, respectively.
Short-term investments are highly liquid investments with a
maturity of three months or less at date of purchase and consist
of time deposits and investments in money market funds with
commercial banks and financial institutions, short-term
commercial paper, and government obligations.
In October, 2005, Micromet simplified its capital structure
through conversion of the pre-existing preferred shares series
(A through F) into a new class of voting preferred shares
(Series A) in a ratio of one old share for one new
share. Furthermore, Micromet effected a
1-for-35.5
reverse stock split for all outstanding common and preferred
shares and related options and convertible instruments. In
addition, Micromets shareholders resolved to further
invest up to 8,000,000 in shares of new preferred stock
(Series A) and preferred stock (Series B). In the
242
fourth quarter of 2005, the shareholders invested
4,018,000 of this amount in preferred stock
(Series A) and preferred stock (Series B).
Micromet determined that there was a beneficial conversion
feature in this issuance of convertible preferred stock. At the
date of issuance, the excess of the aggregate fair value of the
common shares that the holder would receive at conversion over
the proceeds received is approximately 72,275,000. A
beneficial conversion charge, which is limited to the amount of
proceeds received, of 4,018,000 was recorded as a discount
on the value of preferred stock and an increase in additional
paid-in capital. Because the preferred stock is immediately
convertible, Micromet fully amortized such beneficial conversion
feature on the date of issuance.
In December 2005, upon request by the Company, Enzon exercised
the conversion option on a convertible note with a nominal value
of 9,302,000 that was issued to Enzon in March 2002. In
January 2006, the note was converted into 16,836 common shares
of Micromet at a conversion price of 552.50 per
common share. In addition, in January 2006, a 10,000,000
convertible note, plus accrued interest, issued in October 2004
to current investors, was converted into preferred shares of
Micromet.
Micromet believes that it has adequate resources to fund
operations into the third quarter of 2006, and if
Micromets existing shareholders invest an additional
3,982,000, as currently contemplated by an investment
agreement with such shareholders, then into the fourth quarter
of 2006.
The cash flows used in operations primarily consist of salaries
and wages for employees, fees paid in connection with conducting
clinical trials, expenses for clinical material production,
facility and facility-related costs for its office and
laboratories, fees paid in connection with preclinical studies,
laboratory supplies, consulting fees, and legal fees. To date,
the source of revenue from operations has been payments received
from collaborators and to a lesser extent royalties on licensing
of patents. Micromets primary source of cash flows from
operations for the foreseeable future will be up-front license
payments, payments for the achievement of milestones, and funded
research and development that it may receive under collaboration
agreements. The timing of any new collaboration agreements and
any payments under collaboration agreements cannot be easily
predicted and may vary significantly from quarter to quarter.
Net cash used in operating activities was 1,288,000,
12,780,000 and 15,697,000 for the years ended
December 31, 2005, 2004 and 2003, respectively. The
reduction in cash used in 2005 is substantially due to the
receipt of a $10,000,000 up-front license fee payment from
Serono, which was received in January 2005. Cash used in
operating activities was primarily to fund Micromets
net losses of 11,393,000, 20,154,000 and
18,954,000 for the years ended December 31, 2005,
2004 and 2003, respectively, partially offset by non-cash
charges, including depreciation and amortization, accrued
interest expense on notes payable and amortization of intangible
assets. Cash used in operations could increase if Micromet
progresses its pre-clinical product candidate to clinical trials
and as it advances products through advanced stages of clinical
development. Micromet expects that the increase in cash used
will be partially offset by anticipated payments received under
collaboration agreements with MedImmune and Serono, assuming
these collaborations continue in accordance with their terms.
Depreciation and amortization relate to the patent portfolio
that was purchased from Curis in 2001 and to investments into
Micromets premises in Munich. Deferred revenues for the
years ended December 31, 2005 and 2004 are mainly derived
by the revenue recognition within the license and collaboration
agreement with Serono. Revenue related to the upfront license
fee payment and revenue related to the research and development
services are considered to be a combined unit of accounting and
such revenues are recognized ratably over the period of the
research and development program. Furthermore, Micromet received
an up-front payment of 4,000,000 from CTI (formerly
Novuspharma) in 2002 and was recognizing the payment ratably
over the expected collaboration period. Due to the termination
of the collaboration, the remaining portion was recognized in
2004. As of December 31, 2004 accounts payable include
invoices for material production that were paid in January 2005.
Net cash provided by (used in) investing activities was
(2,888,000), 11,321,000 and 1,300,000 for the
years ended December 31, 2005, 2004, and 2003,
respectively. Net cash provided by (used in) investing
activities is primarily derived from sales and purchases of
short-term investments.
Net cash provided by financing activities in 2005 was
1,660,000, which primarily resulted from a capital
increase of 4,018,000 in October 2005 and repayment of
long-term debt obligations of 2,310,000, including a
243
payment of 1,250,000 to Curis. Net cash provided by
financing activities in 2004 was 7,485,000, as compared to
10,419,000 in 2003. Significant components of cash flows
from financing activities in 2004 included the proceeds of
10,000,000 received upon the issuance of convertible notes
to Micromets existing investors and net payments of long
term debt of 2,494,000. Significant components of cash
flows from financing activities in 2003 included proceeds of
10,000,000 received upon the issuance of a convertible
note to MedImmune, proceeds from long term financings of
1,386,000 and net payments of long term debt of
927,000.
Micromet plans to continue to evaluate the potential of pursuing
strategic collaborations to provide resources for further
development of its product candidates. Micromet cannot forecast
with any degree of certainty whether it will be able to enter
into a collaborative agreement on favorable terms or at all.
Micromet may also seek funding through public or private
financings. If Micromet is successful in raising additional
funds through the issuance of equity securities, stockholders
will experience substantial dilution, or the equity securities
may have rights, preferences or privileges senior to existing
shareholders. If Micromet is successful in raising additional
funds through debt financings, these financings may involve
significant cash payment obligations and covenants that restrict
Micromets ability to operate its business and make
distributions to its shareholders. There can be no assurance
that Micromet will be successful in seeking additional capital
on acceptable terms, or at all.
Contractual obligations. Micromet has
contractual obligations related to its facility lease, research
agreements and financing agreements. The following table sets
forth Micromets significant contractual obligations as of
December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual obligations (in
thousands)
|
|
Total
|
|
|
<1 year
|
|
|
1-3 years
|
|
|
4-5 years
|
|
|
>5 years
|
|
|
ETV loans(1)
|
|
|
92
|
|
|
|
92
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases(2)
|
|
|
14,422
|
|
|
|
2,272
|
|
|
|
4,517
|
|
|
|
4,236
|
|
|
|
3,397
|
|
Convertible note obligations(3)
|
|
|
12,331
|
|
|
|
2,331
|
|
|
|
|
|
|
|
10,000
|
|
|
|
|
|
Silent partnership obligations(4)
|
|
|
7,502
|
|
|
|
2,832
|
|
|
|
4,670
|
|
|
|
|
|
|
|
|
|
Curis loan(5)
|
|
|
2,408
|
|
|
|
2,408
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations
|
|
|
36,755
|
|
|
|
9,935
|
|
|
|
9,187
|
|
|
|
14,236
|
|
|
|
3,397
|
|
|
|
(1) |
Equipment purchases were financed under loan agreements with ETV
bearing interest at annual rates between 11% and 13%.
|
|
|
(2) |
Operating leases were entered into for our premises at
Staffelseestrasse 2, 81477 Munich in June 2002. The leases
expire in June 2012.
|
|
|
(3) |
Convertible notes issued to
|
|
|
|
|
(i)
|
MedImmune for 10,000,000 due in June 2010, bearing
interest at an annual rate of 4.5% initially. In October 2005,
the conversion elements of this note were adjusted to reflect a
capital restructuring of Micromet that included a
1-for-35.5
reverse stock split, a consolidation of all existing series of
preferred shares into preference shares Series (A new) and the
creation of new preference shares Series (B new). As result, the
MedImmune note is now convertible into preference shares series
(A new). In addition, the conversion features of the note were
also changed such that the note may be converted in full upon a
an initial public offering or merger in which the valuation of
Micromet is equal or higher than 120,000,000, with the
convertibility of the note reduced on a linear basis at lower
valuations. A call feature has been added to the note, allowing
MedImmune to call the note in full if, after the merger is
completed, the combined entity has cash or cash equivalents in
excess of 60,000,000. If, at the time of closing of the
merger, cash and cash equivalents are lower than
30,000,000, no portion of the note can be called. If cash
and cash equivalents are between 30,000,000 and
60,000,000 following the completion of the merger, the
callable share of the note is adjusted pro rata on a linear
basis. MedImmune has informed Micromet that it desires to
convert its note to the fullest extent possible in connection
with the merger. Based upon the closing price of CancerVax stock
on March 27, 2006, it is expected that all of the principal
under the MedImmune note will convert in connection with the
merger; and
|
|
|
|
|
(ii)
|
In November 2004, Micromet issued convertible notes in the
aggregate nominal value of 10,000,000 to certain of its
shareholders which bear interest at 24% per annum and were
due on December 31, 2006. In
|
244
|
|
|
|
|
December 2005 and January 2006, Micromet received notification
from holders of the 2004 convertible notes of their intent to
convert. In January 2006, the convertible notes including
accrued interest were converted into 18,704 preferred shares
Series (B new). As of December 31, 2005, 2,331,000
including accrued interest, was recorded in current liabilities
related to the 2004 convertible notes.
|
|
|
(4) |
Micromet has entered into eight different loan agreements
between 1996 and 2000 with silent partnerships. Each of these
agreements carries an annual interest rate between 6% and 7%
payable quarterly. In addition, beginning with the sixth year of
each contract, each note has an additional annual interest rate
of 6-7% and a one-time payment of 30-35%, payable when the
principal amount is due. In January 2006, the parties agreed to
modify the payment schedule for certain of the loan contracts.
Upon consummation of the merger with CancerVax, Micromets
obligations under agreements 1, 2, 4 and 6 will be repaid
in full for an aggregate payment of 2,000,000, including
accrued interest and success fees. Obligations from agreements 3
and 5 will remain payable as set forth in the table below. The
due dates for contracts 7 and 8 will remain as set forth in the
table below following the merge with CancerVax. If Micromet
engages in any equity financing prior to the due date under
these agreements, up to a maximum of 20% of the proceeds from
such financing will be used to repay any unpaid obligations
under agreements 7 and 8. Application of proceeds from such
financings will be applied first to agreement 7, followed
by agreement 8.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Date
|
|
Principal
|
|
|
Interest
|
|
|
Payment
|
|
|
One Time Due Date
|
|
|
1) October 25, 1996
|
|
|
716,064
|
|
|
|
257,783
|
|
|
|
214,819
|
|
|
|
December 31, 2006
|
|
2) October 25, 1996
|
|
|
177,009
|
|
|
|
63,723
|
|
|
|
53,103
|
|
|
|
December 31, 2006
|
|
3) February 3, 1999
|
|
|
760,151
|
|
|
|
266,053
|
|
|
|
266,053
|
|
|
|
December 31, 2008
|
|
4) February 3, 1999
|
|
|
476,349
|
|
|
|
142,905
|
|
|
|
142,905
|
|
|
|
December 31, 2008
|
|
5) February 3, 1999
|
|
|
262,433
|
|
|
|
91,851
|
|
|
|
91,851
|
|
|
|
December 31, 2008
|
|
6) February 3, 1999
|
|
|
164,453
|
|
|
|
49,336
|
|
|
|
49,336
|
|
|
|
December 31, 2008
|
|
7) January 1, 1997
|
|
|
893,073
|
|
|
|
401,883
|
|
|
|
312,575
|
|
|
|
December 31, 2006
|
|
8) January 1, 2000
|
|
|
1,661,699
|
|
|
|
598,212
|
|
|
|
581,595
|
|
|
|
December 31, 2008
|
|
|
|
(5) |
In October 2004, Micromet exchanged a convertible note issued to
Curis, Inc. for a non-interest bearing loan in the amount of
4,500,000. Two payments of 1,250,000 each were made
in November 2004 and October 2005. Of the remaining
2,000,000 balance, 533,333 is due and payable in
October 2006. However, upon an exit event (defined as
(i) the listing of Micromet shares on an exchange;
(ii) a sale of 50% or more of Micromet shares; (iii) a
sale of all Micromet assets; or (iv) a merger in which
Micromet shareholders hold less than 50% of the combined stock
of the surviving entity), the remaining balance becomes payable
within 30 days. As such, the entire 2,408,000,
including the deferred gain of 408,000 from debt
restructuring, is included as a current contractual obligation
as of December 31, 2005. On March 6, 2006, Curis, Inc.
filed a lawsuit against Micromet claiming that Micromet is
obligated to pay Curis the outstanding amount of Curis
convertible note of 2,000,000 within 30 days after the
completion of the exchange by Micromet shareholders of a
majority of the outstanding shares of Micromet AG for shares of
a third party. This would include the proposed exchange of
shares of Micromet AG for shares of Micromet, Inc. that is
contemplated by the terms of the Merger Agreement. Micromet
disputes Curis position but agrees that an amount of
533,333 of the loan will become payable in October 2006.
The total possible exposure of Micromet is the amount claimed
(2,000,000), plus the costs of the proceedings. In
addition, if Curis prevails in the proceeding, it would be
entitled to interest on the claimed amount of 2,000,000 at
the base rate of the European Central Bank plus 8%, accruing
from the time of default.
|
245
MICROMET
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Micromets primary exposure to market risk is interest
income sensitivity, which is affected by changes in the general
level of interest rates, particularly because the majority of
its investments are in short-term marketable securities.
Micromet is also subject to exchange rate sensitivity,
particularly the euro/U.S. dollar exchange rate as a result of
the fact that its functional currency is the euro and certain of
its revenues and expenses are denominated in U.S. dollars.
Micromet believes that it is not subject to significant interest
expense risk due to the fixed interest rates on the majority of
its outstanding debt. It was subject to exchange rate
sensitivity for its convertible note to Enzon, which included an
option for repayment in U.S. dollars. However, this note
was converted in December 2005, eliminating any market risk
related to the note. Due to the nature of its short-term
investments and the limited denomination of its revenues and
expenses in currencies other than the euro, Micromet believes
that it is not subject to any material market risk exposure.
LEGAL
MATTERS
The validity of the CancerVax common stock to be issued in the
merger has been passed upon for CancerVax by Latham &
Watkins LLP. Certain tax consequences of the merger have been
passed upon for Micromet by Cooley Godward LLP. Certain
attorneys of Latham & Watkins LLP beneficially own
4,104 shares of CancerVax common stock.
EXPERTS
The financial statements of CancerVax Corporation at
December 31, 2005 and 2004, and for each of the three years
in the period ended December 31, 2005, included in this
proxy statement/prospectus and registration statement, have been
audited by Ernst & Young LLP, independent registered
public accounting firm, as set forth in their report, appearing
elsewhere herein, and are included in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
The financial statements of Micromet at December 31, 2005
and 2004, and for each of the three years in the period ended
December 31, 2005, included in this proxy
statement/prospectus and registration statement, have been
audited by Ernst & Young AG, independent auditors, as
set forth in their report (which contains an explanatory
paragraph describing conditions that raise substantial doubt
about Micromets ability to continue as a going concern, as
described in Note 2 to the financial statements), appearing
elsewhere herein, and are included in reliance upon such report
given on the authority of said firm as experts in accounting and
auditing.
HOUSEHOLDING
OF PROXY MATERIALS
The SEC has adopted rules that permit companies and
intermediaries (e.g., brokers) to satisfy the delivery
requirements for proxy statements and annual reports with
respect to two or more stockholders sharing the same address by
delivering a single proxy statement addressed to those
stockholders. This process, which is commonly referred to as
householding, potentially means extra convenience
for stockholders and cost savings for companies.
This year, a number of brokers with account holders who are
CancerVax stockholders will be householding our
proxy materials. A single proxy statement will be delivered to
multiple stockholders sharing an address unless contrary
instructions have been received from the affected stockholders.
Once you have received notice from your broker that they will be
householding communications to your address,
householding will continue until you are notified
otherwise or until you revoke your consent. If, at any time, you
no longer wish to participate in householding and
would prefer to receive a separate proxy statement and annual
report, please notify your broker or direct your written request
to our Secretary, care of CancerVax Corporation, 2110 Rutherford
Road, Carlsbad, California 92008 or contact our Secretary at
(760) 494-4200. Stockholders who currently receive multiple
copies of the proxy statement at their address and would like to
request householding of their communications should
contact their broker.
246
WHERE YOU
CAN FIND MORE INFORMATION
CancerVax has filed annual, quarterly and current reports, proxy
statements and other information with the SEC. You may read and
copy any reports, statements or other information that CancerVax
files at the SECs public reference room in
Washington, D.C. Please call the SEC at
1-800-SEC-0330
for further information on the public reference room.
CancerVaxs public filings are also available to the public
from commercial document retrieval services and at the Internet
web site maintained by the SEC at http://www.sec.gov. Reports,
proxy statements and other information concerning CancerVax also
may be inspected at the offices of the National Association of
Securities Dealers, Inc., Listing Section, 1735 K Street,
Washington, D.C. 20006.
CancerVax has filed a
Form S-4
registration statement to register with the SEC the offer and
sale of the shares of CancerVax common stock to be issued to
Micromet Parent stockholders in connection with the merger. This
proxy statement/prospectus is a part of that registration
statement and constitutes a prospectus and proxy statement of
CancerVax.
CancerVax has supplied all information contained in this proxy
statement/prospectus relating to CancerVax and Merger Sub, and
Micromet has supplied all information relating to Micromet and
Micromet Parent.
You should rely only on the information contained in this proxy
statement/prospectus to vote your shares at the annual meeting.
We have not authorized anyone to provide you with information
that differs from that contained in this proxy
statement/prospectus. This proxy statement/prospectus is dated
March 31, 2006. You should not assume that the information
contained in this proxy statement/prospectus is accurate as of
any date other than that date, and neither the mailing of this
proxy statement/prospectus to stockholders nor the issuance of
shares of CancerVax common stock in the merger shall create any
implication to the contrary.
CancerVax, the CancerVax logos and all other CancerVax product
and service names are registered trademarks or trademarks of
CancerVax Corporation in the United States and in other select
countries. Micromet, the Micromet logos and all other Micromet
product and service names are registered trademarks or
trademarks of Micromet AG in the United States and in other
select countries.
®
and
tm
indicate U.S. registration and U.S. trademark,
respectively. Other third-party logos and product/trade names
are registered trademarks or trade names of their respective
companies.
247
INDEX TO
CONSOLIDATED FINANCIAL STATEMENTS
CANCERVAX
CORPORATION
|
|
|
|
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|
Page
|
|
|
Audited Financial Statements
for the years ended December 31, 2005, 2004 and
2003
|
|
|
|
|
|
|
|
F-2
|
|
|
|
|
F-3
|
|
|
|
|
F-4
|
|
|
|
|
F-5
|
|
|
|
|
F-7
|
|
|
|
|
F-8
|
|
MICROMET
AG
|
|
|
|
|
Audited Financial Statements
for the years ended December 31, 2005, 2004 and
2003
|
|
|
|
|
|
|
|
F-26
|
|
|
|
|
F-27
|
|
|
|
|
F-28
|
|
|
|
|
F-29
|
|
|
|
|
F-30
|
|
|
|
|
F-31
|
|
F-1
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of
Directors and Stockholders
CancerVax Corporation:
We have audited the accompanying consolidated balance sheets of
CancerVax Corporation (the Company) as of
December 31, 2005 and 2004, and the related consolidated
statements of operations, stockholders equity, and cash
flows for each of the three years in the period ended
December 31, 2005. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the consolidated
financial position of CancerVax Corporation at December 31,
2005 and 2004, and the consolidated results of its operations
and its cash flows for each of the three years in the period
ended December 31, 2005, in conformity with
U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of CancerVax Corporations internal control
over financial reporting as of December 31, 2005, based on
criteria established in Internal
Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission
and our report dated March 9, 2006 expressed an unqualified
opinion thereon.
/s/ Ernst & Young LLP
San Diego, California
March 9, 2006
F-2
CANCERVAX
CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value amounts)
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
38,932
|
|
|
$
|
40,588
|
|
Securities
available-for-sale
|
|
|
12,263
|
|
|
|
24,485
|
|
Receivables under collaborative
agreement
|
|
|
1,695
|
|
|
|
26,210
|
|
Other current assets
|
|
|
969
|
|
|
|
1,573
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
53,859
|
|
|
|
92,856
|
|
Property and equipment, net
|
|
|
1,805
|
|
|
|
15,650
|
|
Goodwill
|
|
|
5,381
|
|
|
|
5,381
|
|
Patents, net
|
|
|
842
|
|
|
|
625
|
|
Restricted cash
|
|
|
1,280
|
|
|
|
1,280
|
|
Other assets
|
|
|
130
|
|
|
|
368
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
63,297
|
|
|
$
|
116,160
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities
|
|
$
|
11,415
|
|
|
$
|
11,354
|
|
Current portion of deferred revenue
|
|
|
|
|
|
|
7,595
|
|
Current portion of long-term debt
|
|
|
18,125
|
|
|
|
525
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
29,540
|
|
|
|
19,474
|
|
Deferred revenue, net of current
portion
|
|
|
|
|
|
|
17,139
|
|
Long-term debt, net of current
portion
|
|
|
|
|
|
|
6,355
|
|
Other liabilities
|
|
|
1,046
|
|
|
|
1,734
|
|
Commitments
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $.00004 par
value; 10,000 shares authorized; no shares issued and
outstanding
|
|
|
|
|
|
|
|
|
Common stock, $.00004 par
value; 75,000 shares authorized; 27,924 and
27,808 shares issued and outstanding at December 31,
2005 and 2004, respectively
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in capital
|
|
|
257,347
|
|
|
|
257,582
|
|
Accumulated other comprehensive
loss
|
|
|
(10
|
)
|
|
|
(71
|
)
|
Deferred compensation
|
|
|
(230
|
)
|
|
|
(1,276
|
)
|
Accumulated deficit
|
|
|
(224,397
|
)
|
|
|
(184,778
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
32,711
|
|
|
|
71,458
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
63,297
|
|
|
$
|
116,160
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-3
CANCERVAX
CORPORATION
CONSOLIDATED
STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
License fee
|
|
$
|
24,683
|
|
|
$
|
316
|
|
|
$
|
|
|
Collaborative research and
development
|
|
|
15,925
|
|
|
|
1,210
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
40,608
|
|
|
|
1,526
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
38,751
|
|
|
|
43,102
|
|
|
|
27,725
|
|
General and administrative
|
|
|
11,993
|
|
|
|
12,310
|
|
|
|
6,826
|
|
Amortization of employee
stock-based compensation
|
|
|
555
|
|
|
|
1,864
|
|
|
|
2,643
|
|
Restructuring charges
|
|
|
4,918
|
|
|
|
|
|
|
|
|
|
Impairment of long-lived assets
|
|
|
25,366
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
81,583
|
|
|
|
57,276
|
|
|
|
37,194
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
1,843
|
|
|
|
920
|
|
|
|
553
|
|
Interest expense
|
|
|
(487
|
)
|
|
|
(756
|
)
|
|
|
(932
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
1,356
|
|
|
|
164
|
|
|
|
(379
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(39,619
|
)
|
|
|
(55,586
|
)
|
|
|
(37,573
|
)
|
Accretion to redemption value of
redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
(7,867
|
)
|
Deemed dividend resulting from
beneficial conversion feature on Series C preferred stock
|
|
|
|
|
|
|
|
|
|
|
(14,775
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common
stockholders
|
|
$
|
(39,619
|
)
|
|
$
|
(55,586
|
)
|
|
$
|
(60,215
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
$
|
(1.42
|
)
|
|
$
|
(2.08
|
)
|
|
$
|
(13.30
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted averaged shares used to
compute basic and diluted net loss per share
|
|
|
27,848
|
|
|
|
26,733
|
|
|
|
4,527
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The allocation of employee
stock-based compensation is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
81
|
|
|
$
|
531
|
|
|
$
|
838
|
|
General and administrative
|
|
|
474
|
|
|
|
1,333
|
|
|
|
1,805
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
555
|
|
|
$
|
1,864
|
|
|
$
|
2,643
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
CANCERVAX
CORPORATION
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Convertible
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Comprehensive
|
|
|
|
|
|
|
|
|
Stockholders
|
|
|
|
Preferred Stock
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Income
|
|
|
Deferred
|
|
|
Accumulated
|
|
|
Equity
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
(Loss)
|
|
|
Compensation
|
|
|
Deficit
|
|
|
(Deficit)
|
|
|
Balance at December 31, 2002
|
|
|
27,189
|
|
|
$
|
1
|
|
|
|
496
|
|
|
$
|
|
|
|
$
|
14,409
|
|
|
$
|
(43
|
)
|
|
$
|
(1,268
|
)
|
|
$
|
(68,977
|
)
|
|
$
|
(55,878
|
)
|
Issuance of common stock under
equity compensation plans and upon exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
133
|
|
|
|
|
|
|
|
263
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
263
|
|
Deferred employee stock-based
compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,999
|
|
|
|
|
|
|
|
(4,999
|
)
|
|
|
|
|
|
|
|
|
Amortization of deferred employee
stock-based compensation, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(271
|
)
|
|
|
|
|
|
|
2,914
|
|
|
|
|
|
|
|
2,643
|
|
Issuance of stock options to
consultants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
131
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
131
|
|
Issuance of warrants in conjunction
with a research consulting agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
245
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
245
|
|
Issuance of common stock in initial
public offering
|
|
|
|
|
|
|
|
|
|
|
6,000
|
|
|
|
|
|
|
|
65,139
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,139
|
|
Conversion of redeemable
convertible preferred stock into common stock
|
|
|
|
|
|
|
|
|
|
|
13,892
|
|
|
|
1
|
|
|
|
145,623
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
145,624
|
|
Conversion of convertible preferred
stock into common stock
|
|
|
(27,189
|
)
|
|
|
(1
|
)
|
|
|
6,215
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend resulting from
beneficial conversion feature on Series C redeemable
convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,775
|
|
|
|
|
|
|
|
|
|
|
|
(14,775
|
)
|
|
|
|
|
Accretion to redemption value of
redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,867
|
)
|
|
|
(7,867
|
)
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(37,573
|
)
|
|
|
(37,573
|
)
|
Unrealized gain on securities
available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46
|
|
|
|
|
|
|
|
|
|
|
|
46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(37,527
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
26,736
|
|
|
|
1
|
|
|
|
245,314
|
|
|
|
3
|
|
|
|
(3,353
|
)
|
|
|
(129,192
|
)
|
|
|
112,773
|
|
Issuance of common stock under
equity compensation plans, net
|
|
|
|
|
|
|
|
|
|
|
72
|
|
|
|
|
|
|
|
376
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
376
|
|
Amortization of deferred employee
stock-based compensation, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(213
|
)
|
|
|
|
|
|
|
2,077
|
|
|
|
|
|
|
|
1,864
|
|
Issuance of stock options to
consultants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
105
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
105
|
|
Issuance of common stock in
connection with collaboration agreement
|
|
|
|
|
|
|
|
|
|
|
1,000
|
|
|
|
|
|
|
|
12,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,000
|
|
F-5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Convertible
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Comprehensive
|
|
|
|
|
|
|
|
|
Stockholders
|
|
|
|
Preferred Stock
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Income
|
|
|
Deferred
|
|
|
Accumulated
|
|
|
Equity
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
(Loss)
|
|
|
Compensation
|
|
|
Deficit
|
|
|
(Deficit)
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(55,586
|
)
|
|
|
(55,586
|
)
|
Unrealized loss on securities
available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(74
|
)
|
|
|
|
|
|
|
|
|
|
|
(74
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(55,660
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
27,808
|
|
|
|
1
|
|
|
|
257,582
|
|
|
|
(71
|
)
|
|
|
(1,276
|
)
|
|
|
(184,778
|
)
|
|
|
71,458
|
|
Issuance of common stock under
equity compensation plans, net
|
|
|
|
|
|
|
|
|
|
|
116
|
|
|
|
|
|
|
|
242
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
242
|
|
Deferred employee stock-based
compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
324
|
|
|
|
|
|
|
|
(324
|
)
|
|
|
|
|
|
|
|
|
Amortization of deferred employee
stock-based compensation, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(815
|
)
|
|
|
|
|
|
|
1,370
|
|
|
|
|
|
|
|
555
|
|
Issuance of stock options to
consultants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(39,619
|
)
|
|
|
(39,619
|
)
|
Unrealized gain on securities
available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61
|
|
|
|
|
|
|
|
|
|
|
|
61
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(39,558
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
|
|
|
$
|
|
|
|
|
27,924
|
|
|
$
|
1
|
|
|
$
|
257,347
|
|
|
$
|
(10
|
)
|
|
$
|
(230
|
)
|
|
$
|
(224,397
|
)
|
|
$
|
32,711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-6
CANCERVAX
CORPORATION
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(39,619
|
)
|
|
$
|
(55,586
|
)
|
|
$
|
(37,573
|
)
|
Adjustments to reconcile net loss
to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation
|
|
|
631
|
|
|
|
2,113
|
|
|
|
2,913
|
|
Investment income from securities
available-for-sale
|
|
|
148
|
|
|
|
413
|
|
|
|
216
|
|
Depreciation
|
|
|
2,359
|
|
|
|
2,071
|
|
|
|
1,891
|
|
Amortization of patents and other
intangible assets
|
|
|
64
|
|
|
|
225
|
|
|
|
252
|
|
Deferred rent
|
|
|
(309
|
)
|
|
|
324
|
|
|
|
446
|
|
Impairment of long-lived assets
|
|
|
25,366
|
|
|
|
|
|
|
|
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Receivables under collaborative
agreement
|
|
|
24,515
|
|
|
|
(1,210
|
)
|
|
|
|
|
Other assets
|
|
|
780
|
|
|
|
(599
|
)
|
|
|
(759
|
)
|
Accounts payable and accrued
liabilities
|
|
|
(289
|
)
|
|
|
6,433
|
|
|
|
1,742
|
|
Deferred revenue
|
|
|
(24,734
|
)
|
|
|
(266
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities
|
|
|
(11,088
|
)
|
|
|
(46,082
|
)
|
|
|
(30,872
|
)
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and
equipment, net
|
|
|
(13,751
|
)
|
|
|
(7,192
|
)
|
|
|
(1,575
|
)
|
Purchases of securities
available-for-sale
|
|
|
(23,687
|
)
|
|
|
(56,722
|
)
|
|
|
(2,942
|
)
|
Maturities of securities
available-for-sale
|
|
|
35,822
|
|
|
|
37,161
|
|
|
|
1,998
|
|
Sale of securities
available-for-sale
|
|
|
|
|
|
|
|
|
|
|
5,481
|
|
Increase in patents
|
|
|
(439
|
)
|
|
|
(331
|
)
|
|
|
(183
|
)
|
(Increase) decrease in restricted
cash
|
|
|
|
|
|
|
720
|
|
|
|
(450
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
investing activities
|
|
|
(2,055
|
)
|
|
|
(26,364
|
)
|
|
|
2,329
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from long-term debt
|
|
|
11,770
|
|
|
|
6,230
|
|
|
|
462
|
|
Payments on long-term debt
|
|
|
(525
|
)
|
|
|
(7,253
|
)
|
|
|
(2,900
|
)
|
Proceeds from equity compensation
plans, net
|
|
|
242
|
|
|
|
376
|
|
|
|
263
|
|
Proceeds from issuance of common
stock, net
|
|
|
|
|
|
|
12,000
|
|
|
|
65,139
|
|
Proceeds from issuance of preferred
stock, net
|
|
|
|
|
|
|
|
|
|
|
41,177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing
activities
|
|
|
11,487
|
|
|
|
11,353
|
|
|
|
104,141
|
|
(Decrease) increase in cash and
cash equivalents
|
|
|
(1,656
|
)
|
|
|
(61,093
|
)
|
|
|
75,598
|
|
Cash and cash equivalents at
beginning of year
|
|
|
40,588
|
|
|
|
101,681
|
|
|
|
26,083
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of
year
|
|
$
|
38,932
|
|
|
$
|
40,588
|
|
|
$
|
101,681
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow
information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for
interest
|
|
$
|
783
|
|
|
$
|
751
|
|
|
$
|
750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of
non-cash activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on
securities
available-for-sale
|
|
$
|
61
|
|
|
$
|
(74
|
)
|
|
$
|
46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants in connection
with research consulting agreement
|
|
$
|
|
|
|
$
|
|
|
|
$
|
245
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of preferred stock into
common stock
|
|
$
|
|
|
|
$
|
|
|
|
$
|
145,624
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred up-front license fee
receivable under collaborative agreement
|
|
$
|
|
|
|
$
|
24,684
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-7
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
|
|
1.
|
Organization
and Summary of Significant Accounting Policies
|
Organization
and Business
We were incorporated in Delaware in June 1998 and commenced
substantial operations in the third quarter of 2000. We are
focused on the research, development and commercialization of
novel biological products for the treatment and control of
cancer.
On October 3, 2005, we announced that our board of
directors had approved a restructuring plan designed to realign
resources in light of the decision to discontinue the
Phase 3 clinical trial of our lead product candidate,
Canvaxin, in patients with Stage III melanoma, as well as
all further development and manufacturing activities with
respect to Canvaxin (see Note 2).
On January 6, 2006, we entered into an Agreement and Plan
of Merger and Reorganization with Micromet AG, or Micromet, a
privately-held German company, as discussed more fully in
Note 10.
Principles
of Consolidation
The accompanying consolidated financial statements include our
accounts and those of our wholly-owned subsidiaries. All
intercompany accounts and transactions have been eliminated in
consolidation.
Use of
Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires our management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Our management has made a number of
estimates and assumptions relating to the reported amounts of
assets, liabilities, revenues and expenses and the related
disclosure of contingent assets and liabilities in conformity
with accounting principles generally accepted in the United
States. On an on-going basis, we evaluate our estimates,
including those related to revenue recognition, the valuation of
goodwill, intangibles and other long-lived assets and
restructuring activities. We base our estimates on historical
experience and on various other assumptions that we believe to
be reasonable under the circumstances. Actual results could
differ from those estimates.
Cash
and Cash Equivalents
Cash and cash equivalents are comprised of highly liquid
investments with an original maturity of less than three months
when purchased. Our cash equivalents as of December 31,
2005 and 2004 totaled $36.9 million and $38.7 million,
respectively, and consisted primarily of money market accounts.
Securities
Available-for-Sale
We consider investments with a maturity date of more than three
months from the date of purchase to be short-term investments
and we have classified these securities as
available-for-sale.
Such investments are carried at fair value. Changes in fair
value are recorded as unrealized gains and losses which are
included as accumulated other comprehensive income (loss) in
stockholders equity. The cost of
available-for-sale
securities sold is determined based on the specific
identification method.
We review the fair value of our securities
available-for-sale
at least quarterly to determine if declines in the fair value of
individual securities are
other-than-temporary
in nature. If we believe the decline in the fair value of an
individual security is
other-than-temporary,
we write-down the carrying value of the security to its
estimated fair value, generally determined using quoted market
prices. To determine if a decline in the fair value of an
investment is
other-than-temporary,
we consider several factors including, among others, the period
of time and extent to which the estimated fair value has been
less than cost, overall market conditions, the historical and
projected future
F-8
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
financial condition of the issuer of the security and our
ability and intent to hold the security for a period of time
sufficient to allow for a recovery of the market value.
Fair
Value of Financial Instruments
We carry our cash and cash equivalents and securities
available-for-sale
at market value. The carrying amount of receivables under
collaborative agreement, accounts payable and accrued
liabilities are considered to be representative of their
respective fair values due to their short-term nature. Our
long-term debt bears interest at a variable rate based on the
prime rate and therefore we believe the fair value of our
long-term debt approximates its carrying value.
Concentrations
of Risk
Financial instruments that potentially subject us to a
significant concentration of credit risk consist primarily of
cash and cash equivalents and securities
available-for-sale.
We maintain deposits in federally insured financial institutions
in excess of federally insured limits. We do not believe we are
exposed to significant credit risk due to the financial position
of the depository institutions in which those deposits are held.
Additionally, we have established guidelines regarding
diversification of our investment portfolio and maturities of
investments, which are designed to maintain safety and liquidity.
Impairment
of Long-Lived Assets
In accordance with Statement of Financial Accounting Standards,
or SFAS, No. 144, Accounting for the Impairment or
Disposal of Long-Lived Assets, long-lived assets to be held
and used, including property and equipment, patents and
intangible assets subject to amortization, are reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount of the assets or related asset group
may not be recoverable. Determination of recoverability is based
on an estimate of undiscounted future cash flows resulting from
the use of the asset and its eventual disposition. In the event
that such cash flows are not expected to be sufficient to
recover the carrying amount of the asset or asset group, the
carrying amount of the asset is written down to its estimated
fair value. Long-lived assets to be disposed of are carried at
fair value less costs to sell.
In 2005, we performed a recoverability test of our long-lived
assets, including property and equipment and patents, in
accordance with SFAS No. 144 as a result of our
decision to discontinue all further development and
manufacturing activities with respect to Canvaxin and our
proposed merger with Micromet (see Note 10). Our ability to
recover the carrying value of our property and equipment is
based on the estimated undiscounted future net cash flows
expected to result from the disposition of our property and
equipment, including the estimated future cash inflows from
anticipated sales of property and equipment, net of estimated
asset disposition costs. Our estimate of the undiscounted future
net cash flows expected to result from the disposition of our
property and equipment considered the physical condition of the
assets, quoted market prices for similar assets and the period
of time in which we intend to dispose of the assets.
Our ability to recover the carrying value of our patents is
based on the estimated undiscounted future net cash flows
expected to result from our sublicensing of the rights to the
patents and underlying technology, including the estimated
future cash inflows from up-front, milestone and product sale
royalty payments, net of estimated ongoing development costs.
Our estimate of the undiscounted future net cash flows expected
to result from the disposition of our patents considered the
technologys stage of development and market potential.
Based on the recoverability analysis performed, management does
not believe that the estimated undiscounted future cash flows
expected to result from the disposition of certain of our
long-lived assets are sufficient to recover the carrying value
of these assets. Accordingly, in 2005 we recorded a
non-recurring, non-cash charge for the impairment of long-lived
assets of $25.4 million to write-down the carrying value of
these assets to their estimated fair value, of which
$25.2 million related to property and equipment and
$0.2 million related to patents.
F-9
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Property
and Equipment
Property and equipment, at cost, consists of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Leasehold improvements
|
|
$
|
22,966
|
|
|
$
|
10,335
|
|
Manufacturing and laboratory
equipment
|
|
|
8,967
|
|
|
|
6,364
|
|
Office equipment and furniture
|
|
|
1,919
|
|
|
|
1,735
|
|
Computer equipment
|
|
|
1,480
|
|
|
|
1,362
|
|
Construction in progress
|
|
|
|
|
|
|
1,908
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,332
|
|
|
|
21,704
|
|
Less accumulated depreciation and
amortization
|
|
|
(33,527
|
)
|
|
|
(6,054
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,805
|
|
|
$
|
15,650
|
|
|
|
|
|
|
|
|
|
|
During 2005, we capitalized to construction in progress a total
of $0.4 million of interest costs related to the expansion
of our biologics manufacturing facility in Los Angeles,
California.
As a result of our decision to discontinue all further
development and manufacturing activities with respect to
Canvaxin, in 2005 we recorded a non-recurring, non-cash charge
for the impairment of property and equipment of
$25.2 million, which is included in accumulated
depreciation and amortization as of December 31, 2005. The
impairment reserve is reduced as impaired assets are disposed.
Property and equipment is depreciated over the estimated useful
lives of the underlying assets (ranging from three to seven
years) using the straight-line method. Leasehold improvements
are amortized over the estimated useful life of the asset or the
lease term, whichever is shorter.
Patents
We capitalize the costs associated with the preparation, filing
and maintenance of certain of our patents and patent
applications and amortize these costs on a straight-line basis
over 14 years, which represents the expected life of the
patents and patent applications. Gross patent costs were
$1.2 million and $0.7 million, and accumulated
amortization of patent costs was $0.4 million and
$0.1 million as of December 31, 2005 and 2004,
respectively. The estimated future annual amortization of
patents is not anticipated to be significant.
As a result of our decision to discontinue all further
development and manufacturing activities with respect to
Canvaxin, in 2005 we recorded a non-recurring, non-cash charge
for the impairment of patents of $0.2 million, which is
included in accumulated amortization of patent costs as of
December 31, 2005.
Goodwill
We have goodwill with a carrying value of $5.4 million at
December 31, 2005 and 2004, which resulted from our
acquisition of Cell-Matrix, Inc. in January 2002. We have
assigned the goodwill to our Cell-Matrix reporting unit. In
accordance with SFAS No. 142, Goodwill and Other
Intangible Assets, we do not amortize goodwill. Instead, we
review goodwill for impairment at least annually and more
frequently if events or changes in circumstances indicate a
reduction in the fair value of the reporting unit to which the
goodwill has been assigned. Goodwill is determined to be
impaired if the fair value of the reporting unit to which the
goodwill has been assigned is less than its carrying amount,
including the goodwill. In the fourth quarter of 2005, we
performed our annual goodwill impairment assessment in
accordance with SFAS No. 142 and determined that the
carrying amount of goodwill was recoverable.
F-10
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Subsequent to the completion of our annual goodwill impairment
assessment for 2005, as a result of our proposed merger with
Micromet (see Note 10), we performed an additional
impairment assessment of our goodwill. In determining the fair
value of our Cell-Matrix reporting unit for this goodwill
impairment assessment, we assumed that the rights to the
technology acquired from Cell-Matrix would be sublicensed to
third parties in exchange for certain up-front, milestone and
product sale royalty payments, and we would have no further
involvement in the ongoing development and commercialization of
the technology. The estimated future net cash flows resulting
from the sublicensing of the technology were risk-adjusted to
reflect the risks inherent in the development process and
discounted to their net present value. Based on the goodwill
impairment assessment performed, we determined that the carrying
amount of goodwill was recoverable.
Revenue
Recognition
We recognize revenue in accordance with the provisions of
Securities and Exchange Commission Staff Accounting Bulletin, or
SAB, No. 104, Revenue Recognition in Financial
Statements, and Emerging Issues Task Force, or EITF, Issue
No. 00-21,
Accounting for Revenue Arrangements with Multiple
Deliverables. Accordingly, revenue is recognized once all of
the following criteria are met: (i) persuasive evidence of
an arrangement exists; (ii) delivery of the products and/or
services has occurred; (iii) the selling price is fixed or
determinable; and (iv) collectibility is reasonably
assured. Any amounts received prior to satisfying these revenue
recognition criteria are recorded as deferred revenue in the
accompanying consolidated balance sheets.
Collaborative research and development revenues, representing
the portion of our pre-commercialization expenses incurred under
collaboration agreements that are shared with our partners, are
recognized as revenue in the period in which the related
expenses are incurred, assuming that collectibility is
reasonably assured and the amount is reasonably estimable.
Nonrefundable up-front license fees where we have continuing
involvement in research and development and/or other performance
obligations are initially deferred and recognized as revenue
over the estimated period until completion of our performance
obligations. We regularly review our estimates of the period
over which we have an ongoing performance obligation.
All revenues recognized to date relate to our collaboration with
Serono Technologies, S.A. for the worldwide development and
commercialization of Canvaxin.
Research
and Development
Research and development expenses consist primarily of costs
associated with the clinical trials of our product candidates,
compensation and other expenses for research and development
personnel, supplies and development materials, contract
manufacturing, laboratory testing and research costs, facility
costs and depreciation. Expenditures relating to research and
development are expensed as incurred.
Net
Loss Per Share
We calculate net loss per share in accordance with
SFAS No. 128, Earnings Per Share. Accordingly,
basic and diluted loss per share is calculated by dividing net
loss applicable to common stockholders by the weighted average
F-11
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
number of common shares outstanding for the period, reduced by
the weighted average unvested common shares subject to
repurchase, without consideration for common stock equivalents.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands, except per share
amounts)
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, as reported
|
|
$
|
(39,619
|
)
|
|
$
|
(55,586
|
)
|
|
$
|
(37,573
|
)
|
Accretion to redemption value of
redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
(7,867
|
)
|
Deemed dividend resulting from
beneficial conversion feature on Series C preferred stock
|
|
|
|
|
|
|
|
|
|
|
(14,775
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common
stockholders, as reported
|
|
$
|
(39,619
|
)
|
|
$
|
(55,586
|
)
|
|
$
|
(60,215
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding
|
|
|
27,856
|
|
|
|
26,784
|
|
|
|
4,643
|
|
Weighted average unvested common
shares subject to repurchase
|
|
|
(8
|
)
|
|
|
(51
|
)
|
|
|
(116
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
used to calculate basic and diluted loss per share
|
|
|
27,848
|
|
|
|
26,733
|
|
|
|
4,527
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
$
|
(1.42
|
)
|
|
$
|
(2.08
|
)
|
|
$
|
(13.30
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following common stock equivalents were excluded from the
calculation of diluted loss per share as their effect would be
antidilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Common stock subject to repurchase
|
|
|
2
|
|
|
|
25
|
|
|
|
91
|
|
Stock options
|
|
|
5,599
|
|
|
|
3,182
|
|
|
|
2,032
|
|
Restricted stock awards
|
|
|
172
|
|
|
|
|
|
|
|
|
|
Stock warrants
|
|
|
86
|
|
|
|
86
|
|
|
|
86
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,859
|
|
|
|
3,293
|
|
|
|
2,209
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-Based
Compensation
We account for our employee stock-based compensation under the
provisions of Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees, and related
interpretations. Accordingly, stock-based compensation expense
related to employee stock awards is recorded if, on the date of
grant, the fair value of the underlying stock exceeds the
exercise price of the award. Deferred stock-based compensation
is recognized for the difference between the exercise price of
stock options granted and the estimated fair value of our common
stock on the date of grant. Deferred stock-based compensation is
amortized on an accelerated basis in accordance with Financial
Accounting Standards Board, or FASB, Interpretation, or FIN,
No. 28, Accounting for Stock Appreciation Rights and
Other Variable Stock Option or Award Plans, over the vesting
period of the related awards, which is generally four years. In
2005, 2004 and 2003, we recognized stock-based compensation
expense related to employee stock awards of $0.6 million,
$1.9 million and $2.6 million, respectively.
F-12
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table illustrates the effect on net loss and loss
per share for 2005, 2004 and 2003 if we had applied the fair
value recognition provisions of SFAS No. 123,
Accounting for Stock-based Compensation, as amended, to
employee stock-based compensation. For purposes of the pro forma
disclosures, the estimated fair value of employee stock awards
is amortized to expense over the vesting period of the related
awards using the accelerated method.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands, except per share
amounts)
|
|
|
Net loss applicable to common
stockholders, as reported
|
|
$
|
(39,619
|
)
|
|
$
|
(55,586
|
)
|
|
$
|
(60,215
|
)
|
Add: Stock-based employee
compensation expense included in net loss applicable to common
stockholders, as reported
|
|
|
555
|
|
|
|
1,864
|
|
|
|
2,643
|
|
Deduct: Stock-based employee
compensation expense determined under the fair value based
method for all awards
|
|
|
(5,091
|
)
|
|
|
(6,256
|
)
|
|
|
(3,763
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss applicable to
common stockholders
|
|
$
|
(44,155
|
)
|
|
$
|
(59,978
|
)
|
|
$
|
(61,335
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share, as reported
|
|
$
|
(1.42
|
)
|
|
$
|
(2.08
|
)
|
|
$
|
(13.30
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net
loss per share
|
|
$
|
(1.59
|
)
|
|
$
|
(2.24
|
)
|
|
$
|
(13.55
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair value of our employee stock options was estimated at
the date of grant using the Black-Scholes option pricing model
with the following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Expected volatility
|
|
|
71
|
%
|
|
|
70
|
%
|
|
|
70
|
%
|
Risk-free interest rate
|
|
|
4.00
|
%
|
|
|
3.25
|
%
|
|
|
2.63
|
%
|
Expected life in years
|
|
|
4.64
|
|
|
|
4.89
|
|
|
|
4.85
|
|
Weighted average per share grant
date fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options granted with
exercise prices below fair value
|
|
$
|
|
|
|
$
|
|
|
|
$
|
7.14
|
|
Stock options granted with
exercise prices equal to fair value
|
|
$
|
2.71
|
|
|
$
|
6.47
|
|
|
$
|
6.29
|
|
The fair value of our employee stock purchase plan, or ESPP,
purchase rights was estimated at the date of grant using the
Black-Scholes option pricing model with the following weighted
average assumptions for 2005 and 2004: dividend yield of 0%,
volatility of 70%, risk-free interest rates of 3.28% and 1.99%,
respectively, and expected life of 0.50 and 0.53 years,
respectively. The weighted average grant date fair value of ESPP
purchase rights was $1.09 and $3.95 per share for 2005 and
2004, respectively.
As required under SFAS No. 123, the pro forma effects
of employee stock-based compensation on net loss are estimated
at the date of grant using the Black-Scholes option pricing
model. The Black-Scholes option pricing model was developed for
use in estimating the fair value of traded options that have no
vesting restrictions and are fully transferable. Because our
employee stock-based compensation has characteristics
significantly different from those of traded options, and
because changes in the subjective input assumptions can
materially affect the fair value estimate, we believe that the
existing models do not necessarily provide a reliable single
measure of the fair value of our employee stock-based
compensation.
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment, or
SFAS No. 123R. SFAS No. 123R requires that
employee stock-based compensation is measured based on its fair
value on the grant date and is treated as an expense that is
reflected in the financial statements over the related service
period.
F-13
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
SFAS No. 123R applies to all employee equity awards
granted after adoption and to the unvested portion of equity
awards outstanding as of adoption. We will adopt
SFAS No. 123R using the modified-prospective method
effective January 1, 2006. While we are currently
evaluating the impact on our consolidated financial statements
of the adoption of SFAS No. 123R, we anticipate that
it will have a significant impact on our results of operations
for 2006 and future periods although our overall financial
position will not be effected.
We also periodically grant stock options to non-employees in
exchange for services, which we account for in accordance with
SFAS No. 123 and EITF Issue
No. 96-18,
Accounting for Equity Instruments That are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling
Goods and Services. Accordingly, the value of stock options
granted to non-employees, determined using the Black-Scholes
option pricing model, is periodically revalued as the options
vest and is recognized to expense over the related service
period. In 2005, 2004 and 2003, we recognized expense related to
non-employee stock options of approximately $14,000,
$0.1 million and $0.1 million, respectively.
Income
Taxes
Deferred income taxes reflect the net tax effects of temporary
differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts
used for income tax purposes, using enacted tax rates in effect
for the year in which the differences are expected to reverse.
Valuation allowances are established, when necessary, to reduce
deferred tax assets to the amount expected to be realized.
Segment
Information
We operate in one segment, which is the research, development
and commercialization of novel biological products for the
treatment and control of cancer. The chief operating
decision-makers review our operating results on an aggregate
basis and manage our operations as a single operating segment.
Guarantees
We account for guarantees in accordance with
FIN No. 45, Guarantors Accounting and
Disclosure Requirements for Guarantees, Including Indirect
Guarantees of Indebtedness of Others. FIN No. 45
requires that a guarantor recognize, at the inception of a
guarantee, a liability for the fair value of certain guarantees
and requires certain disclosures to be made by a guarantor about
its obligations under certain guarantees that it has issued.
In the ordinary course of our business, we enter into agreements
with third parties, including corporate partners, contractors
and clinical sites, which contain standard indemnification
provisions. Under these provisions, we generally indemnify and
hold harmless the indemnified party for losses suffered or
incurred by the indemnified party as a result of our activities.
Although the maximum potential amount of future payments we
could be required to make under these indemnification provisions
is unlimited, to date we have not incurred material costs to
defend lawsuits or settle claims related to these
indemnification provisions. Additionally, we have insurance
policies that, in most cases, would limit our exposure and
enable us to recover a portion of any amounts paid. Therefore,
we believe the estimated fair value of these agreements is
minimal and accordingly, we have not accrued any liabilities for
these agreements as of December 31, 2005.
Effect
of New Accounting Standards
In November 2005, the FASB issued FASB Staff Position Nos.
FAS 115-1
and
FAS 124-1,
or FSP Nos. 115-1 and 124-1, The Meaning of
Other-Than-Temporary
Impairment and Its Application to Certain Investments, which
provides guidance on determining when investments in certain
debt and equity securities are considered impaired, whether that
impairment is
other-than-temporary,
and on measuring such impairment loss. FSP Nos. 115-1 and 124-1
also includes accounting considerations subsequent to the
recognition of
other-than-temporary
impairments and requires certain disclosures about unrealized
losses that have not been recognized as
other-than-temporary
F-14
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
impairments. We will adopt FSP Nos. 115-1 and 124-1 in the first
quarter of 2006. While we are currently evaluating the impact on
our consolidated financial statements of the adoption of FSP
Nos. 115-1 and 124-1, we do not anticipate that it will have a
significant impact on our results of operations and financial
position.
|
|
2.
|
Restructuring
Activities
|
Under the restructuring plan approved by our board of directors
in October 2005, we reduced our workforce from 183 to 52
employees as of December 31, 2005 and closed our biologics
manufacturing facility and our warehouse facility. We are
actively pursuing sublease tenants for these two facilities as
well as our corporate headquarters and research and development
facility.
In accordance with SFAS No. 146, Accounting for the
Costs of Exit or Disposal Activities, during 2005, we
recorded a non-recurring charge associated with our
restructuring activities of $4.9 million, consisting of
$3.5 million of employee severance costs and
$1.4 million of leased facility exit costs. In 2005, we
also recorded a non-recurring charge for contract termination
costs of $0.2 million, which is included in research and
development expenses. Included in accrued liabilities as of
December 31, 2005 is a liability for restructuring
activities of $2.5 million, consisting of $0.4 million
of employee severance costs, $1.9 million of leased
facility exit costs and $0.2 million of contract
termination costs. The liability for employee severance costs of
$0.4 million primarily represents the estimated future
severance payments to be made to employees terminated in 2005.
The liability for leased facility exit costs of
$1.9 million represents the estimated future costs to be
incurred under the operating leases for our biologics
manufacturing facility and our warehouse facility, net of
estimated sublease rentals. The liability for contract
termination costs of $0.2 million represents the estimated
future costs to be incurred under contracts terminated in 2005
in accordance with the contract terms.
In January 2006, we implemented additional restructuring
measures which, when fully implemented, will result in the
further reduction of our workforce to approximately 10 employees
by the completion of our proposed merger with Micromet (see
Note 10). In connection with this workforce reduction, in
2006 we anticipate incurring approximately $3.0 million of
additional employee severance costs. We also anticipate
incurring additional leased facility exit costs in 2006,
primarily related to our corporate headquarters and research and
development facility. At this time, we are unable to reasonably
estimate the expected amount of such additional leased facility
exit costs, although our remaining obligations under the
operating lease for our corporate headquarters and research and
development facility aggregated $11.2 million as of
December 31, 2005. We may also incur additional contract
termination and other restructuring costs. We anticipate that
our restructuring efforts will be substantially completed by the
end of the second quarter of 2006.
|
|
3.
|
Securities
Available-For-Sale
|
Securities
available-for-sale
consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Amortized
|
|
|
Accrued
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
|
|
|
|
Cost
|
|
|
Interest
|
|
|
Gains
|
|
|
Losses
|
|
|
Fair Value
|
|
|
December 31,
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government securities
|
|
$
|
5,237
|
|
|
$
|
45
|
|
|
$
|
|
|
|
$
|
(5
|
)
|
|
$
|
5,277
|
|
Corporate debt securities
|
|
|
6,938
|
|
|
|
53
|
|
|
|
|
|
|
|
(5
|
)
|
|
|
6,986
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
12,175
|
|
|
$
|
98
|
|
|
$
|
|
|
|
$
|
(10
|
)
|
|
$
|
12,263
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government securities
|
|
$
|
9,897
|
|
|
$
|
90
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
9,987
|
|
Corporate debt securities
|
|
|
14,468
|
|
|
|
101
|
|
|
|
|
|
|
|
(71
|
)
|
|
|
14,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
24,365
|
|
|
$
|
191
|
|
|
$
|
|
|
|
$
|
(71
|
)
|
|
$
|
24,485
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-15
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
All securities
available-for-sale
as of December 31, 2005 have contractual maturities of less
than 12 months.
None of our securities
available-for-sale
as of December 31, 2005 and 2004 were in a continuous
unrealized loss position for more than 12 months. The
unrealized losses on these securities were primarily caused by
recent increases in market interest rates and we have the
ability and intent to hold these securities until a recovery of
fair value, which may be at maturity. As a result, and
considering the relative insignificance of the unrealized loss
positions, management does not believe these securities to be
other-
than-temporarily
impaired as of December 31, 2005.
|
|
4.
|
Accounts
Payable and Accrued Liabilities
|
Accounts payable and accrued liabilities consists of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Accounts payable
|
|
$
|
3,748
|
|
|
$
|
4,963
|
|
Accrued employee benefits
|
|
|
1,032
|
|
|
|
2,967
|
|
Accrued clinical trial patient
costs
|
|
|
914
|
|
|
|
1,047
|
|
Accrued payments under
collaborative research and development agreements
|
|
|
1,900
|
|
|
|
800
|
|
Liability for restructuring
activities
|
|
|
2,469
|
|
|
|
|
|
Other accrued liabilities and
expenses
|
|
|
1,352
|
|
|
|
1,577
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
11,415
|
|
|
$
|
11,354
|
|
|
|
|
|
|
|
|
|
|
|
|
5.
|
Related
Party Transactions
|
We were founded in 1998 by Donald L. Morton, M.D., who is
currently Medical Director and Surgeon-in-Chief and a member of
the board of directors of the John Wayne Cancer Institute, or
JWCI, a cancer research institute located in Santa Monica,
California. Dr. Morton is a member of our board of
directors and a significant stockholder. Since our inception in
1998, we have entered into various transactions with
Dr. Morton and entities affiliated with Dr. Morton,
including JWCI.
JWCI provided us with certain services related to our Canvaxin
Phase 3 clinical trials under a clinical trial services
agreement and is a participating site in the clinical trials. As
a result of our decision to discontinue the Phase 3
clinical trial of Canvaxin in patients with Stage III
melanoma, as well as all further development and manufacturing
activities with respect to Canvaxin, our agreements with JWCI
were terminated in December 2005. In 2005, 2004 and 2003, we
paid to JWCI $0.1 million, $0.3 million and
$0.4 million, respectively, for services provided under the
clinical trial services agreement, participation in the clinical
trials and certain other services.
We had a consulting and non-compete agreement with
Dr. Morton that expired in September 2005. Under the terms
of the agreement, as amended, we paid Dr. Morton
$12,500 per month to provide consulting services related to
the development and commercialization of Canvaxin and our other
product candidates as well as consult on medical and technical
matters as requested.
Under an agreement we entered into in 2000 with OncoVac, Inc.,
an entity owned by Dr. Morton, we agreed to pay an
aggregate of $1,250,000 to JWCI, of which $500,000 was paid
upfront and the remainder is due in annual installments of
$125,000 through June 2006. Of the total amount, $125,000
remains unpaid as of December 31, 2005 (see Note 6).
F-16
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6.
|
Debt
Obligations and Lease Commitments
|
Debt
Obligations
Debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Equipment and tenant improvement
loans
|
|
$
|
18,000
|
|
|
$
|
6,630
|
|
Installment obligations due to
JWCI (Note 5)
|
|
|
125
|
|
|
|
250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,125
|
|
|
|
6,880
|
|
Current portion of debt
|
|
|
(18,125
|
)
|
|
|
(525
|
)
|
|
|
|
|
|
|
|
|
|
Long-term debt, less current
portion
|
|
$
|
|
|
|
$
|
6,355
|
|
|
|
|
|
|
|
|
|
|
In December 2004, we entered into an $18.0 million loan and
security agreement with a financing institution. As of
December 31, 2005, we have borrowed the full
$18.0 million available under the credit facility, of which
$1.3 million was used to repay our outstanding borrowings
under a credit facility secured in 2002 and the remaining
borrowings were used to finance certain capital expenditures. At
our election, borrowings under the credit facility bear interest
at a variable interest rate equal to the greater of the
banks prime rate or 4.75%. The interest rate on the
outstanding borrowings under this credit facility was 7.25% as
of December 31, 2005. Through December 31, 2005, we
made interest-only payments on the outstanding borrowings under
the credit facility. Commencing January 2006, we are also
required to make principal payments due in 48 monthly
installments. All borrowings under the credit facility must be
paid in full by December 31, 2009.
We have granted the financing institution a first priority
security interest in substantially all of our assets, excluding
our intellectual property. In addition to various customary
affirmative and negative covenants, the loan and security
agreement requires us to maintain, as of the last day of each
calendar quarter, aggregate cash, cash equivalents and
securities
available-for-sale
in an amount at least equal to the greater of (i) our
quarterly cash burn multiplied by 2 or (ii) the then
outstanding principal amount of the obligations under such
agreement multiplied by 1.5. In the event that we breach this
financial covenant, we are obligated to pledge and deliver to
the bank a certificate of deposit in an amount equal to the
then-outstanding borrowings under the credit facility. We were
in compliance with our debt covenants as of December 31,
2005.
The loan and security agreement contains certain customary
events of default, including, among other things, non-payment of
principal and interest, violation of covenants, the occurrence
of a material adverse change in our ability to satisfy our
obligations under the loan agreement or with respect to the
lenders security interest in our assets and in the event
we are involved in certain insolvency proceedings. Upon the
occurrence of an event of default, the lender may be entitled
to, among other things, accelerate all of our obligations and
sell our assets to satisfy our obligations under the loan
agreement. In addition, in an event of default, our outstanding
obligations may be subject to increased rates of interest. The
terms of the loan and security agreement also require that it be
repaid in full upon the occurrence of a change in control event,
such as the consummation of our proposed merger with Micromet AG
(see Note 10). Accordingly, as management believes it is
probable that the proposed merger with Micromet will be
consummated in 2006, we have classified the outstanding
borrowings under the credit facility as current as of
December 31, 2005.
During 2001, we entered into a $4.0 million loan and
security agreement with a financing institution pursuant to
which we drew down the entire line of $4.0 million to
finance certain capital expenditures. The outstanding borrowings
under this credit facility were repaid in full in July 2005. We
issued warrants in connection with this loan as discussed in
Note 8.
F-17
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Lease
Commitments
We lease our biologics manufacturing facility under an operating
lease which expires in August 2011 with options to renew under
varying terms. We also have a ten-year lease for our corporate
headquarters and research and development facility that
commenced in July 2002 and has two renewal options for five
years each. We issued warrants in connection with this lease
agreement as discussed in Note 8. In August 2004, we signed
a seven-year lease for a warehouse facility near our
manufacturing facility with an option to renew for an additional
five years. We also lease certain office equipment under
operating leases which expire through 2010.
For accounting purposes, we recognize rent expense on a
straight-line basis over the term of the related operating
leases. Rent expense recognized in excess of rent paid is
reflected as a deferred rent liability, which is included in
other liabilities in the accompanying consolidated balance
sheets. In 2005, 2004 and 2003, rent expense totaled
$3.7 million, $3.2 million and $3.0 million,
respectively.
As discussed in Note 2, under the restructuring plan
approved by our board of directors in October 2005, we closed
our biologics manufacturing facility and our warehouse facility
and we are actively pursuing sublease tenants for these two
facilities as well as our corporate headquarters and research
and development facility. There can be no assurance that we will
ultimately be able to sublease these facilities on favorable
terms to us, if at all, and we may incur certain costs
associated with subleasing these facilities, including real
estate agent commissions.
We have entered into three irrevocable standby letters of credit
in connection with the operating leases for our three primary
facilities. The amount of the letter of credit related to the
operating lease for our corporate headquarters and research and
development facility is $0.4 million, varying up to a
maximum of $1.9 million based on our cash position. The
amount of the letter of credit related to the operating lease
for our manufacturing facility is $0.6 million, decreasing
through the end of the lease term. The amount of the letter of
credit related to the operating lease for our warehouse facility
is $0.3 million. At each of December 31, 2005 and
2004, the amounts of the letters of credit totaled
$1.3 million. To secure the letters of credit, we pledged
twelve-month certificates of deposit for similar amounts as of
December 31, 2005 and 2004 which have been classified as
restricted cash in the accompanying consolidated balance sheets.
Annual principal payments due under our debt obligations and
annual future minimum payments under our lease commitments are
as follows at December 31, 2005 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equipment
|
|
|
Installment
|
|
|
|
|
|
|
and Tenant
|
|
|
Obligation
|
|
|
Operating
|
|
|
|
Improvement Loans
|
|
|
Due to JWCI
|
|
|
Leases
|
|
|
2006
|
|
$
|
18,000
|
|
|
$
|
125
|
|
|
$
|
2,762
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
2,848
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
2,946
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
3,051
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
3,159
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
3,697
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
18,000
|
|
|
$
|
125
|
|
|
$
|
18,463
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7.
|
Collaborative
Research and Development and Licensing Agreements
|
Serono
In December 2004, we entered into a collaboration and license
agreement with Serono for the worldwide development and
commercialization of Canvaxin. Under the agreement, we received
from Serono a $12.0 million payment in December 2004 for
the purchase of 1.0 million shares of our common stock and
a non-refundable up-front license fee of $25.0 million in
January 2005. We initially deferred the up-front license fee
from Serono and
F-18
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
were recognizing it as license fee revenue on a straight-line
basis over our estimated performance obligation period. Under
the agreement, we were also entitled to receive milestone
payments from Serono upon the achievement of certain
development, regulatory and sales based objectives and we share
equally with Serono certain costs to develop and commercialize
Canvaxin in the United States. Collaborative research and
development revenues recognized to date represent Seronos
50% share of our Canvaxin pre-commercialization expenses under
the collaboration agreement.
As a result of the discontinuation of all further development
and manufacturing activities with respect to Canvaxin, we have
no further substantive performance obligations to Serono under
the collaboration agreement related to the ongoing development
and commercialization of Canvaxin. Accordingly, in 2005 we
recognized the remaining deferred up-front license fee from
Serono as revenue. Additionally, we do not anticipate receiving
any of the milestone payments under the collaboration agreement,
but we will continue to share equally with Serono certain costs
associated with the discontinuation of the Canvaxin development
program and manufacturing operations, as contemplated under the
agreement.
Serono may terminate the agreement for convenience upon
180 days prior notice. Either party may terminate the
agreement for the material breach or bankruptcy of the other
party. In the event of a termination of the agreement, rights to
Canvaxin will revert to us.
CIMAB,
S.A. and YM BioSciences, Inc.
In July 2004, we signed agreements with CIMAB, S.A., a Cuban
corporation, and YM BioSciences, Inc., a Canadian corporation,
whereby we obtained the exclusive rights to develop and
commercialize in a specific territory, which includes the U.S.,
Canada, Japan, Australia, New Zealand, Mexico and certain
countries in Europe, three specific active immunotherapeutic
product candidates that target the epidermal growth factor
receptor, or EGFR, signaling pathway for the treatment of
cancer. In exchange, we will pay to CIMAB and YM BioSciences
technology access and transfer fees totaling $5.7 million,
to be paid over the first three years of the agreement. We will
also make future milestone payments to CIMAB and YM BioSciences
up to a maximum of $34.7 million upon meeting certain
regulatory, clinical and commercialization objectives, and
royalties on future sales of commercial products, if any. In
late 2005, we announced plans to actively seek sublicensing
opportunities for all three of these product candidates.
Due to the stage of development of the licensed technology and
the risk associated with technology developed in Cuba, the
amounts payable to CIMAB and YM BioSciences prior to product
commercialization are being charged to research and development
expense. Through December 31, 2005, we have recognized an
aggregate of $5.3 million of research and development
expenses under the agreements, of which $3.1 million has
been paid to CIMAB and YM BioSciences as of December 31,
2005.
The agreements terminate upon the later of the expiration of the
last of any patent rights to licensed products that are
developed under the agreements or 15 years after the date
of the first commercial sale of the last product licensed or
developed under the agreements. CIMAB may terminate the
agreements if we have not used reasonable commercial efforts to
submit an investigational new drug application, or IND, to the
United States Food and Drug Administration, or FDA, for the
leading product candidate by July 12, 2006, or if the first
regulatory approval for marketing this product candidate within
our territory is not obtained by July 12, 2016, provided
that CIMAB has timely complied with all of its obligations under
the agreements, or if CIMAB does not receive timely payment of
the initial technology access and transfer fees. In addition, if
CIMAB does not receive payments under the agreements due to
changes in United States law, actions by the United States
government or by order of any United States court for a period
of more than one year, CIMAB may terminate our rights to the
licensed product candidates in countries within our territory
other than the United States and Canada. We may terminate the
agreement for any reason following 180 days written notice
to CIMAB.
F-19
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Other
Licensing and Research and Development Agreements
We have entered into licensing and research and development
agreements with various universities, research organizations and
other third parties under which we have received licenses to
certain intellectual property, scientific know-how and
technology. In consideration for the licenses received, we are
required to pay license and research support fees, milestone
payments upon the achievement of certain success-based
objectives
and/or
royalties on future sales of commercialized products, if any. We
may also be required to pay minimum annual royalties and the
costs associated with the prosecution and maintenance of the
patents covering the licensed technology. If all potential
product candidates under these agreements were successfully
developed and commercialized, the aggregate amount of milestone
payments we would be required to pay is at least approximately
$42 million over the terms of the related agreements as
well as royalties on net sales of each commercialized product.
Annual future minimum payments under our licensing and research
and development agreements, including our agreements with CIMAB
and YM BioSciences, are as follows at December 31, 2005 (in
thousands):
|
|
|
|
|
2006
|
|
$
|
1,955
|
|
2007
|
|
|
355
|
|
2008
|
|
|
55
|
|
2009
|
|
|
55
|
|
2010
|
|
|
55
|
|
Thereafter
|
|
|
330
|
|
|
|
|
|
|
|
|
$
|
2,805
|
|
|
|
|
|
|
Preferred
Stock
Prior to our initial public offering, or IPO, in November 2003,
we issued shares of various series of redeemable convertible and
convertible preferred stock and recorded non-cash charges
related to the accrual of the dividends due on our redeemable
convertible preferred stock and the accretion of the difference
between the carrying value and redemption value of the
redeemable convertible preferred stock. Additionally, in August
2003, we recorded a non-cash deemed dividend on our
Series C redeemable convertible preferred stock of
$14.8 million, as the Series C redeemable convertible
preferred stock was considered to have been issued with a
beneficial conversion feature. The charges associated with the
accrued dividends, accretion and deemed dividend resulted in an
increase to the net loss applicable to common stockholders in
the calculation of basic and diluted net loss per common share
and a decrease to total stockholders equity. Upon
completion of our IPO, all outstanding shares of our preferred
stock automatically converted into an aggregate of
20.1 million shares of common stock.
Stock
Warrants
We have outstanding, fully exercisable stock warrants that upon
cash exercise will result in the issuance of approximately
86,000 shares of our common stock. The exercise prices of
the warrants are $10.78 per share and $11.75 per share
and the warrants will expire between November 2006 and June
2013. The warrants provide the holder with the option to
exercise the warrants with a (i) cash payment;
(ii) cancellation of our indebtedness to the holder; or
(iii) net issuance exercise based on the fair market value
of our common stock on the date of exercise.
Equity
Compensation Plans
On June 10, 2004, our stockholders approved the Amended and
Restated 2003 Equity Incentive Award Plan, or 2003 Plan, which
effectively terminates the Third Amended and Restated 2000 Stock
Incentive Plan, or the 2000
F-20
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Plan. The 2003 Plan authorizes the grant of equity awards to
purchase the number of shares of our common stock equal to the
sum of (i) 2,500,000 shares, (ii) the number of
shares of common stock remaining available for grant under the
2000 Plan as of June 10, 2004, and (iii) the number of
shares of common stock underlying any options granted under the
2000 Plan on or before June 10, 2004 that expire or are
canceled without having been exercised in full or that are
repurchased by us. Additionally, on June 10 of each year during
the term of the 2003 Plan commencing June 10, 2004, the
number of shares authorized for the grant of equity awards under
the 2003 Plan will increase by an amount equal to the lesser of
(i) 5% of our outstanding common shares on such date,
(ii) 2,500,000 shares, or (iii) a lesser amount
determined by our board of directors. Potential types of equity
awards that may be granted under the 2003 Plan include stock
options, restricted stock, stock appreciation rights,
performance-based awards, dividend equivalents, stock payments
and deferred stock. The terms and conditions of specific awards
are set at the discretion of our board of directors although
generally awards vest over four years, expire no later than ten
years from the date of grant and do not have exercise prices
less than the fair market value of the underlying common stock.
Additionally, under certain circumstances, all or a portion of
outstanding awards under the 2003 Plan may become immediately
vested and exercisable in full upon a change of control, as
defined in the 2003 Plan. Our proposed merger with Micromet, as
described in Note 10, does not trigger the change of
control provision under the 2003 Plan. To date, we have granted
stock options and restricted stock under the 2003 Plan. At
December 31, 2005, equity awards to purchase approximately
1,254,000 shares of our common stock remain available for
grant under the 2003 Plan.
Prior to its termination, the 2000 Plan, which was approved by
our stockholders, allowed for the grant of incentive and
nonstatutory stock options to purchase shares of our common
stock to employees, directors, and third parties. Options
granted under the 2000 Plan generally expire no later than ten
years from the date of grant and vest over a period of four
years. The 2000 Plan allowed for certain options to be exercised
prior to the time such options are vested and all unvested
shares of common stock are subject to repurchase at the exercise
price paid for such shares. At December 31, 2005, 2004 and
2003, approximately 2,000, 25,000 and 91,000 shares,
respectively, of common stock were subject to repurchase.
A summary of stock option activity under the 2000 Plan and the
2003 Plan is as follows (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
Number of
|
|
|
Average
|
|
|
|
Options
|
|
|
Exercise Price
|
|
|
Outstanding at December 31,
2002
|
|
|
1,058
|
|
|
$
|
2.12
|
|
Granted:
|
|
|
|
|
|
|
|
|
Exercise prices below fair value
|
|
|
895
|
|
|
|
3.45
|
|
Exercise prices equal to fair value
|
|
|
301
|
|
|
|
10.76
|
|
Exercised
|
|
|
(131
|
)
|
|
|
2.00
|
|
Cancelled
|
|
|
(91
|
)
|
|
|
2.44
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31,
2003
|
|
|
2,032
|
|
|
|
3.98
|
|
Granted (all equal to fair value)
|
|
|
1,371
|
|
|
|
10.96
|
|
Exercised
|
|
|
(42
|
)
|
|
|
2.66
|
|
Cancelled
|
|
|
(179
|
)
|
|
|
8.39
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31,
2004
|
|
|
3,182
|
|
|
|
6.76
|
|
Granted (all equal to fair value)
|
|
|
4,131
|
|
|
|
4.64
|
|
Exercised
|
|
|
(11
|
)
|
|
|
2.66
|
|
Cancelled
|
|
|
(1,703
|
)
|
|
|
7.35
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31,
2005
|
|
|
5,599
|
|
|
$
|
5.02
|
|
|
|
|
|
|
|
|
|
|
F-21
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes information about stock options
outstanding under our equity compensation plans at
December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
|
Options Exercisable
|
|
|
|
|
|
|
Weighted Average
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
Range of
|
|
Number
|
|
|
Remaining
|
|
|
Average
|
|
|
Number
|
|
|
Average
|
|
Exercise
|
|
Outstanding
|
|
|
Contractual Life
|
|
|
Exercise
|
|
|
Exercisable
|
|
|
Exercise
|
|
Prices
|
|
(thousands)
|
|
|
(years)
|
|
|
Price
|
|
|
(thousands)
|
|
|
Price
|
|
|
$1.08-1.08
|
|
|
386
|
|
|
|
4.99
|
|
|
$
|
1.08
|
|
|
|
386
|
|
|
$
|
1.08
|
|
1.48-1.60
|
|
|
1,041
|
|
|
|
9.84
|
|
|
|
1.48
|
|
|
|
82
|
|
|
|
1.48
|
|
2.16-2.82
|
|
|
990
|
|
|
|
9.09
|
|
|
|
2.77
|
|
|
|
854
|
|
|
|
2.77
|
|
2.97-3.30
|
|
|
966
|
|
|
|
7.02
|
|
|
|
3.30
|
|
|
|
951
|
|
|
|
3.30
|
|
3.44-7.84
|
|
|
524
|
|
|
|
9.07
|
|
|
|
6.94
|
|
|
|
57
|
|
|
|
6.67
|
|
7.93-8.62
|
|
|
776
|
|
|
|
9.10
|
|
|
|
7.94
|
|
|
|
133
|
|
|
|
8.01
|
|
9.15-11.55
|
|
|
420
|
|
|
|
8.27
|
|
|
|
10.37
|
|
|
|
291
|
|
|
|
10.24
|
|
11.98-12.87
|
|
|
496
|
|
|
|
8.12
|
|
|
|
12.22
|
|
|
|
298
|
|
|
|
12.30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1.08-12.87
|
|
|
5,599
|
|
|
|
8.44
|
|
|
$
|
5.02
|
|
|
|
3,052
|
|
|
$
|
4.57
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2005, 2004 and 2003, options to purchase
approximately 3,052,000, 1,800,000 and 1,540,000 shares,
respectively, were exercisable at weighted average exercise
prices of $4.57, $3.77 and $3.06 per share, respectively.
Included in the stock options granted in 2005 under the 2003
Plan were stock options to purchase approximately
860,000 shares of our common stock that would vest only
upon our satisfaction of certain performance targets, of which
stock options to purchase approximately 311,000 shares
remain outstanding as of December 31, 2005. The vesting of
these stock options is as follows: one-third of the shares
subject to such options would vest upon the successful
completion of all conformance lots required for submission of a
Biologics License Application, or BLA, for Canvaxin, and the
remaining two-thirds of the shares subject to such options would
vest upon the approval of a BLA or equivalent marketing
authorization for Canvaxin in the U.S or European Union. In
February 2006, due to the previous discontinuation of all
clinical trial and further development of Canvaxin, the
compensation committee of our board of directors confirmed the
termination of these stock options.
In 2005, we also granted to certain employees restricted stock
awards for the purchase of an aggregate of approximately
246,000 shares of our common stock under the 2003 Plan, of
which awards to purchase approximately 172,000 shares
remain outstanding as of December 31, 2005. The restricted
stock awards give each employee the right to purchase an
equivalent number of shares of our common stock at a purchase
price per share equal to the par value of our common stock. The
restricted stock is subject to repurchase until such time that
it vests. The restricted stock awards would vest only upon our
submission of a BLA for Canvaxin. In February 2006, due to the
previous discontinuation of all clinical trial and further
development of Canvaxin, the compensation committee of our board
of directors confirmed the forfeiture of the remaining
outstanding restricted stock awards.
We also have an Employee Stock Purchase Plan, or ESPP, which was
approved by our stockholders in 2003. The ESPP initially allowed
for the issuance of up to 300,000 shares of our common
stock, increasing annually on December 31 by the lesser of
(i) 30,000 shares, (ii) 1% of the outstanding
shares of our common stock on such date, or (iii) a lesser
amount determined by our board of directors. Under the terms of
the ESPP, employees can elect to have up to 20% of their annual
compensation withheld to purchase shares of our common stock.
The purchase price of the common stock is equal to 85% of the
lower of the fair market value per share of our common stock on
the commencement date of the applicable offering period or the
purchase date. In 2005 and 2004, approximately 105,000 and
32,000 shares, respectively, were purchased under the ESPP
and approximately 253,000 shares remain available for
issuance under the ESPP as of December 31, 2005.
F-22
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Stockholder
Rights Plan
On November 3, 2004, we adopted a Stockholder Rights Plan,
or the Rights Plan. Pursuant to the Rights Plan, our board of
directors declared a dividend distribution of one preferred
share purchase right, or Right, on each outstanding share of our
common stock. Subject to limited exceptions, the Rights will be
exercisable if a person or group acquires 15% or more of our
common stock or announces a tender offer for 15% or more of our
common stock. If we are acquired in a merger or other business
combination transaction that has not been approved by our board
of directors, each Right will entitle its holder to purchase, at
the Rights then-current exercise price, a number of the
acquiring companys common shares having a market value at
the time of twice the Rights exercise price. Under certain
circumstances, each Right will entitle the common stockholders
to buy one one-thousandth of a share of our newly created
Series A Junior Participating Preferred Stock at an
exercise price of $95.00 per share. Our board of directors
will be entitled to redeem the Rights at $0.01 per right at
any time before a person or group has acquired 15% or more of
our outstanding common stock. The Rights Plan will expire in
2014. Our proposed merger with Micromet, as described in
Note 10, does not trigger the exercise provisions under the
Rights Plan.
Common
Shares Reserved For Future Issuance
At December 31, 2005, we have approximately 7,278,000
common shares reserved for issuance under our equity
compensation plans and approximately 86,000 common shares
reserved for issuance upon the exercise of outstanding stock
warrants.
There was no income tax benefit attributable to net losses for
2005, 2004 and 2003. The difference between taxes computed by
applying the U.S. federal corporate tax rate of 35% and the
actual income tax provision in 2005, 2004 and 2003 is primarily
the result of establishing a valuation allowance on our deferred
tax assets.
The tax effects of temporary differences and tax loss and credit
carryforwards that give rise to significant portions of deferred
tax assets and liabilities are comprised of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$
|
46,198
|
|
|
$
|
32,713
|
|
Orphan drug and research and
development credit carryforwards
|
|
|
43,390
|
|
|
|
37,791
|
|
Property and equipment and
intangibles
|
|
|
12,983
|
|
|
|
2,787
|
|
Deferred revenues
|
|
|
20
|
|
|
|
10,078
|
|
Accrued liabilities and deferred
rent
|
|
|
1,618
|
|
|
|
1,485
|
|
Other, net
|
|
|
1,437
|
|
|
|
1,304
|
|
|
|
|
|
|
|
|
|
|
Total net deferred tax assets
|
|
|
105,646
|
|
|
|
86,158
|
|
Valuation allowance for deferred
tax assets
|
|
|
(105,646
|
)
|
|
|
(86,158
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred taxes
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
The increase in the valuation allowance for deferred tax assets
in 2005 and 2004 of $19.5 million and $31.0 million,
respectively, was due primarily to the inability to utilize net
operating loss, orphan drug and research and development credits.
At December 31, 2005, we had net operating loss
carryforwards for federal and state income tax purposes of
approximately $107.9 million and $147.0 million,
respectively, which expire beginning in 2018 and 2010,
respectively, unless previously utilized. We also had orphan
drug credit carryforwards and research and
F-23
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
development credit carryforwards for federal income tax purposes
of approximately $39.7 million and $0.6 million,
respectively, which expire beginning in 2019 unless previously
utilized. In addition, we had research and development credit
carryforwards for state income tax purposes of approximately
$4.7 million, which are not expected to expire.
In connection with our acquisition of Cell-Matrix, Inc. in 2002,
we recognized approximately $1.8 million of net deferred
tax assets consisting principally of federal and state net
operating loss carryforwards, federal and state research and
development credit carryforwards and tax basis in depreciable
and amortizable assets. Due to the uncertainty over the
realization of these assets, a valuation allowance has been
recorded against the net deferred tax assets acquired.
Subsequent tax benefits resulting from realization of these
deferred tax assets will be applied to reduce the valuation
allowance and goodwill related to the Cell-Matrix acquisition.
As a result of the change in control for Cell-Matrix, the
utilization of the acquired net operating loss and tax credit
carryforwards will be subject to annual limitations in
accordance with Internal Revenue Code, or IRC, Sections 382
and 383.
Pursuant to IRC Sections 382 and 383, upon completion our
proposed merger with Micromet (see Note 10), use of our net
operating loss and tax credit carryforwards will be limited.
|
|
10.
|
Subsequent
Event Merger
|
On January 6, 2006, we entered into an Agreement and Plan
of Merger and Reorganization with Micromet that contains the
terms and conditions of our proposed merger with that company.
The merger agreement provides that our wholly-owned subsidiary,
Carlsbad Acquisition Corporation, will merge with and into
Micromet, Inc., or Micromet Parent, a newly created parent
corporation of Micromet. Micromet Parent will become a
wholly-owned subsidiary of ours and will be the surviving
corporation of the merger. Pursuant to the terms of the merger
agreement, we will issue to Micromet stockholders shares of our
common stock and will assume all of the stock options, stock
warrants and restricted stock of Micromet outstanding as of the
merger closing date, such that the Micromet stockholders, option
holders, warrant holders and note holders will own approximately
67.5% of the combined company on a fully-diluted basis and our
stockholders, option holders and warrant holders will own
approximately 32.5% of the combined company on a fully-diluted
basis.
Because Micromet securityholders will own approximately 67.5% of
the voting stock of the combined company after the merger,
Micromet is deemed to be the acquiring company for accounting
purposes and the transaction will be accounted for as a reverse
acquisition under the purchase method of accounting for business
combinations in accordance with accounting principles generally
accepted in the United States. Accordingly, our assets and
liabilities will be recorded as of the merger closing date at
their estimated fair values.
The merger is intended to qualify as a tax-free reorganization
under the provisions of Section 368(a) of the Internal
Revenue Code. The merger is subject to customary closing
conditions, including approval by our stockholders. We
anticipate that the merger will be completed soon after
CancerVaxs annual meeting. Either party may be obligated
to pay a termination fee of $2.0 million if the merger
agreement is terminated under certain circumstances.
Additionally, we anticipate incurring an aggregate of
approximately $2.4 million of expenses associated with the
merger, of which we have incurred approximately
$1.0 million through December 31, 2005. We filed with
the U.S. Securities and Exchange Commission on
February 13, 2006 a registration statement on
Form S-4
that will be amended and includes a preliminary proxy
statement/prospectus and other relevant documents in connection
with the proposed merger.
F-24
CANCERVAX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
11.
|
Quarterly
Financial Data (unaudited)
|
The following quarterly financial data, in the opinion of
management, reflects all adjustments, consisting of normal
recurring adjustments, necessary for a fair presentation of
results for the periods presented (in thousands, except per
share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
2005
|
|
|
|
First
|
|
|
Second
|
|
|
Third
|
|
|
Fourth
|
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Total revenues(1)
|
|
$
|
6,626
|
|
|
$
|
6,246
|
|
|
$
|
26,015
|
|
|
$
|
1,721
|
|
Total operating
expenses(2) (3)
|
|
|
13,602
|
|
|
|
13,841
|
|
|
|
36,415
|
|
|
|
17,725
|
|
Net loss
|
|
|
(6,613
|
)
|
|
|
(7,194
|
)
|
|
|
(9,990
|
)
|
|
|
(15,822
|
)
|
Basic and diluted net loss per
common share
|
|
|
(0.24
|
)
|
|
|
(0.26
|
)
|
|
|
(0.36
|
)
|
|
|
(0.57
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
2004
|
|
|
|
First
|
|
|
Second
|
|
|
Third
|
|
|
Fourth
|
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Total revenues
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
1,526
|
|
Total operating expenses
|
|
|
12,890
|
|
|
|
12,851
|
|
|
|
15,768
|
|
|
|
15,767
|
|
Net loss
|
|
|
(12,831
|
)
|
|
|
(12,754
|
)
|
|
|
(15,656
|
)
|
|
|
(14,345
|
)
|
Basic and diluted net loss per
common share
|
|
|
(0.48
|
)
|
|
|
(0.48
|
)
|
|
|
(0.59
|
)
|
|
|
(0.53
|
)
|
|
|
|
(1) |
|
Included in total revenues in the third quarter of 2005 is the
remaining deferred up-front license fee received from Serono of
$19.7 million (see Note 7). |
|
|
|
(2) |
|
Included in total operating expenses in the third and fourth
quarters of 2005 are non-recurring, non-cash charges for the
impairment of long-lived assets of $22.8 million and
$2.6 million, respectively (see Note 1). |
|
|
|
(3) |
|
Included in total operating expenses in the fourth quarter of
2005 is a non-recurring charge associated with our restructuring
activities totaling $5.1 million (see Note 2). |
F-25
The Supervisory Board and Shareholders of Micromet AG:
We have audited the accompanying balance sheets of Micromet AG
as of December 31, 2005 and 2004, and the related
statements of operations, changes in stockholders equity
(deficit), and cash flows for each of the three years in the
period ended December 31, 2005. These financial statements
are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with auditing standards
generally accepted in the United States. Those standards require
that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of
material misstatement. We were not engaged to perform an audit
of the Companys internal control over financial reporting.
Our audits included consideration of internal control over
financial reporting as a basis for designing audit procedures
that are appropriate in the circumstances, but not for the
purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting.
Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by
management, and evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Micromet AG at December 31, 2005 and 2004, and the
results of its operations and its cash flows for each of the
three years in the period ended December 31, 2005 in
conformity with accounting principles generally accepted in the
United States.
The accompanying financial statements have been prepared
assuming that Micromet AG will continue as a going concern. As
more fully described in Note 2, the Company has incurred
recurring operating losses and has a working capital deficiency.
These conditions raise substantial doubt about the
Companys ability to continue as a going concern.
Managements plans in regard to these matters are also
described in Note 2. The financial statements do not
include any adjustments to reflect the possible future effects
on the recoverability and classification of assets or the
amounts and classification of liabilities that may result from
the outcome of this uncertainty.
Munich, March 29, 2006
Ernst & Young AG
Wirtschaftsprüfungsgesellschaft
|
|
|
/s/ Gert von BorriesG.
von BorriesGerman Public Auditor
|
|
/s/ Elia NapolitanoDr.
E. NapolitanoGerman Public Auditor
|
F-26
MICROMET
AG
BALANCE SHEETS
(In thousand of Euros, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
6,572
|
|
|
|
9,088
|
|
Short-term investments
|
|
|
3,065
|
|
|
|
256
|
|
Accounts receivable
|
|
|
1,832
|
|
|
|
11,613
|
|
Prepaid expenses and other current
assets
|
|
|
881
|
|
|
|
1,362
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
12,350
|
|
|
|
22,319
|
|
Property and equipment, net
|
|
|
2,966
|
|
|
|
3,865
|
|
Loans to related parties
|
|
|
180
|
|
|
|
180
|
|
Loans to employees
|
|
|
59
|
|
|
|
59
|
|
Patents, net
|
|
|
8,194
|
|
|
|
9,683
|
|
Deposit
|
|
|
95
|
|
|
|
95
|
|
Restricted cash and short-term
investments held as collateral
|
|
|
537
|
|
|
|
447
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
24,381
|
|
|
|
36,648
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY (DEFICIT)
|
Accounts payable
|
|
|
1,087
|
|
|
|
2,769
|
|
Accrued expenses
|
|
|
5,517
|
|
|
|
5,473
|
|
Other liabilities
|
|
|
1,739
|
|
|
|
956
|
|
Short-term note
|
|
|
2,408
|
|
|
|
3,658
|
|
Current portion of long-term debt
obligations
|
|
|
2,960
|
|
|
|
971
|
|
Current portion of convertible
notes payable
|
|
|
2,331
|
|
|
|
|
|
Current portion of deferred revenue
|
|
|
5,095
|
|
|
|
9,562
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
21,137
|
|
|
|
23,389
|
|
Convertible notes payable, net of
current portion
|
|
|
10,000
|
|
|
|
29,490
|
|
Deferred revenue, net of current
portion
|
|
|
44
|
|
|
|
54
|
|
Other non-current liabilities
|
|
|
801
|
|
|
|
831
|
|
Long-term debt obligations, net of
current portion
|
|
|
4,670
|
|
|
|
7,240
|
|
Stockholders equity
(deficit):
|
|
|
|
|
|
|
|
|
Convertible preferred stock,
issuable in series, stated value of 1 per share:
|
|
|
|
|
|
|
|
|
Authorized shares: 4,269,651 in
2005 and 1,118,658 in 2004
|
|
|
|
|
|
|
|
|
Issued and outstanding shares:
3,354,711 in 2005 and 227,616 in 2004 (aggregate liquidation
preference of 65,437 in 2005 and 61,419 in 2004)
|
|
|
3,355
|
|
|
|
228
|
|
Common stock, stated value of
1 per share:
|
|
|
|
|
|
|
|
|
Authorized shares: 691,680 in 2005
and 2004
|
|
|
|
|
|
|
|
|
Issued and outstanding shares:
60,806 in 2005 and 2004
|
|
|
61
|
|
|
|
61
|
|
Additional paid-in capital
|
|
|
67,192
|
|
|
|
62,283
|
|
Stock subscription from conversion
|
|
|
19,490
|
|
|
|
|
|
Stock subscription receivables
|
|
|
(297
|
)
|
|
|
(299
|
)
|
Accumulated deficit
|
|
|
(102,023
|
)
|
|
|
(86,612
|
)
|
Accumulated other comprehensive
income (loss)
|
|
|
(32
|
)
|
|
|
|
|
Treasury stock, at cost
(1,400 shares in 2005 and 2004)
|
|
|
(17
|
)
|
|
|
(17
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
(deficit)
|
|
|
(12,271
|
)
|
|
|
(24,356
|
)
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity (deficit)
|
|
|
24,381
|
|
|
|
36,648
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are integral part of these financial
statements.
F-27
MICROMET
AG
STATEMENTS OF OPERATIONS
(In thousand of Euros)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements
|
|
|
18,638
|
|
|
|
11,681
|
|
|
|
13,112
|
|
License fees
|
|
|
2,050
|
|
|
|
1,691
|
|
|
|
50
|
|
Other
|
|
|
91
|
|
|
|
87
|
|
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
20,779
|
|
|
|
13,459
|
|
|
|
13,189
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
23,923
|
|
|
|
26,598
|
|
|
|
26,173
|
|
General and administrative
|
|
|
4,587
|
|
|
|
4,493
|
|
|
|
3,916
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
28,510
|
|
|
|
31,091
|
|
|
|
30,089
|
|
Loss from operations
|
|
|
(7,731
|
)
|
|
|
(17,632
|
)
|
|
|
(16,900
|
)
|
Other income
(expenses)
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(4,148
|
)
|
|
|
(2,367
|
)
|
|
|
(2,072
|
)
|
Interest income
|
|
|
270
|
|
|
|
212
|
|
|
|
583
|
|
Other income/(expense)
|
|
|
216
|
|
|
|
(367
|
)
|
|
|
(565
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(11,393
|
)
|
|
|
(20,154
|
)
|
|
|
(18,954
|
)
|
Beneficial conversion charge on
issuance of preferred shares
|
|
|
(4,018
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common
stockholders
|
|
|
(15,411
|
)
|
|
|
(20,154
|
)
|
|
|
(18,954
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are integral part of these financial
statements.
F-28
MICROMET
AG
STATEMENTS OF STOCKHOLDERS EQUITY
(In thousand of Euros, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Stock
|
|
|
Stock
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Preferred Stock
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Subscription
|
|
|
Subscription
|
|
|
Accumulated
|
|
|
Comprehensive
|
|
|
Treasury Stock
|
|
|
Stockholders
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
from Conversion
|
|
|
Receivables
|
|
|
Deficit
|
|
|
Income (Loss)
|
|
|
Shares
|
|
|
Amount
|
|
|
Equity (Deficit)
|
|
|
Balance at January 1,
2003
|
|
|
227,616
|
|
|
|
228
|
|
|
|
60,806
|
|
|
|
61
|
|
|
|
62,247
|
|
|
|
|
|
|
|
(327
|
)
|
|
|
(47,504
|
)
|
|
|
(281
|
)
|
|
|
1,400
|
|
|
|
(17
|
)
|
|
|
14,407
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments received for stock
subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
Stock based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
|
|
Issuance of warrants in connection
with debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,954
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,954
|
)
|
Unrealized gain (loss) on
short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
214
|
|
|
|
|
|
|
|
|
|
|
|
214
|
|
Realized gain (loss) on short-term
investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102
|
|
|
|
|
|
|
|
|
|
|
|
102
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,638
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2003
|
|
|
227,616
|
|
|
|
228
|
|
|
|
60,806
|
|
|
|
61
|
|
|
|
62,281
|
|
|
|
|
|
|
|
(311
|
)
|
|
|
(66,458
|
)
|
|
|
35
|
|
|
|
1,400
|
|
|
|
(17
|
)
|
|
|
(4,181
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments received for stock
subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
|
|
Stock based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,154
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,154
|
)
|
Realized gain (loss) on short-term
investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35
|
)
|
|
|
|
|
|
|
|
|
|
|
(35
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,189
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2004
|
|
|
227,616
|
|
|
|
228
|
|
|
|
60,806
|
|
|
|
61
|
|
|
|
62,283
|
|
|
|
|
|
|
|
(299
|
)
|
|
|
(86,612
|
)
|
|
|
|
|
|
|
1,400
|
|
|
|
(17
|
)
|
|
|
(24,356
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
=
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments received for stock
subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
Issuance of preferred stock in
October 2005 at 1.285 per share for cash, including
beneficial conversion recorded at 4,018
|
|
|
3,127,095
|
|
|
|
3,127
|
|
|
|
|
|
|
|
|
|
|
|
4,909
|
|
|
|
|
|
|
|
|
|
|
|
(4,018
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,018
|
|
Subscription of 16,836 common
shares in December 2005 at 552 per share from
conversion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,302
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,302
|
|
Subscription of 15,245 preferred
shares in December 2005 at 669 per share from
conversion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,188
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,188
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,393
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,393
|
)
|
Unrealized gain (loss) on
short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(32
|
)
|
|
|
|
|
|
|
|
|
|
|
(32
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,425
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2005
|
|
|
3,354,711
|
|
|
|
3,355
|
|
|
|
60,806
|
|
|
|
61
|
|
|
|
67,192
|
|
|
|
19,490
|
|
|
|
(297
|
)
|
|
|
(102,023
|
)
|
|
|
(32
|
)
|
|
|
1,400
|
|
|
|
(17
|
)
|
|
|
(12,271
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-29
MICROMET
AG
STATEMENTS OF CASH FLOWS
(In thousand of Euros)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(11,393
|
)
|
|
|
(20,154
|
)
|
|
|
(18,954
|
)
|
Adjustments to reconcile net loss
to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (gains) /loss on sale of
short-term investments
|
|
|
(95
|
)
|
|
|
(128
|
)
|
|
|
117
|
|
Depreciation and amortization
|
|
|
2,552
|
|
|
|
2,797
|
|
|
|
2,775
|
|
Provision for losses on lease
commitments and impairment of related leasehold improvements
|
|
|
|
|
|
|
1,158
|
|
|
|
|
|
Net gain on disposal of property
and equipment
|
|
|
(3
|
)
|
|
|
(3
|
)
|
|
|
(3
|
)
|
Non-cash interest on convertible
notes payable
|
|
|
2,331
|
|
|
|
558
|
|
|
|
547
|
|
Non-cash interest on long-term
debt obligations
|
|
|
479
|
|
|
|
412
|
|
|
|
390
|
|
Amortization of debt discounts
|
|
|
|
|
|
|
204
|
|
|
|
222
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
2
|
|
|
|
18
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
9,781
|
|
|
|
(8,678
|
)
|
|
|
161
|
|
Prepaid expenses and other current
assets
|
|
|
484
|
|
|
|
303
|
|
|
|
182
|
|
Accounts payable, accrued expenses
and other liabilities
|
|
|
(947
|
)
|
|
|
3,790
|
|
|
|
(142
|
)
|
Deferred revenue
|
|
|
(4,477
|
)
|
|
|
6,959
|
|
|
|
(1,010
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities
|
|
|
(1,288
|
)
|
|
|
(12,780
|
)
|
|
|
(15,697
|
)
|
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sales of short-term
investments
|
|
|
8,698
|
|
|
|
12,096
|
|
|
|
14,972
|
|
Proceeds from disposals of
property and equipment
|
|
|
3
|
|
|
|
3
|
|
|
|
4
|
|
Purchases of short-term investments
|
|
|
(11,000
|
)
|
|
|
(700
|
)
|
|
|
(13,229
|
)
|
Purchases of property and equipment
|
|
|
(52
|
)
|
|
|
(78
|
)
|
|
|
(447
|
)
|
Restricted cash held as collateral
|
|
|
(537
|
)
|
|
|
|
|
|
|
|
|
Net cash provided by/(used in)
investing activities
|
|
|
(2,888
|
)
|
|
|
11,321
|
|
|
|
1,300
|
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of
convertible notes
|
|
|
|
|
|
|
10,000
|
|
|
|
10,000
|
|
Proceeds from issuance of
preferred shares
|
|
|
4,018
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of
long-term debt obligations
|
|
|
|
|
|
|
|
|
|
|
1,386
|
|
Proceeds from stock subscription
receivable
|
|
|
2
|
|
|
|
12
|
|
|
|
16
|
|
Principal payments on long-term
debt obligations
|
|
|
(2,310
|
)
|
|
|
(2,494
|
)
|
|
|
(927
|
)
|
Principal payments on capital
lease obligations
|
|
|
(50
|
)
|
|
|
(33
|
)
|
|
|
(56
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing
activities
|
|
|
1,660
|
|
|
|
7,485
|
|
|
|
10,419
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash
and cash equivalents
|
|
|
(2,516
|
)
|
|
|
6,026
|
|
|
|
(3,978
|
)
|
Cash and cash equivalents at
beginning of period
|
|
|
9,088
|
|
|
|
3,062
|
|
|
|
7,040
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end
of period
|
|
|
6,572
|
|
|
|
9,088
|
|
|
|
3,062
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of
cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
|
1,185
|
|
|
|
1,151
|
|
|
|
895
|
|
Supplemental disclosure of
noncash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment acquired
under capital lease
|
|
|
112
|
|
|
|
|
|
|
|
|
|
Issuance of warrants in connection
with bonds payable
|
|
|
|
|
|
|
|
|
|
|
16
|
|
Subscription of 16,836 common
shares at 552 per share
|
|
|
9,302
|
|
|
|
|
|
|
|
|
|
Subscription of 15,245 preferred
shares at 669 per share
|
|
|
10,188
|
|
|
|
|
|
|
|
|
|
The accompanying notes are integral part of these financial
statements.
F-30
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS
Micromet GmbH was incorporated on December 16, 1993 (date
of inception) and was entered into the Munich Commercial
Register. On September 26, 2000 the legal form was changed
from a private limited company to a private corporation bearing
the name Micromet AG (the Company or
Micromet). The Company was registered into the
Munich Commercial Register under the number HRB 13340.
Micromet is a biotechnology company focused on the research,
development and commercialization of novel biological products
for the treatment and control of cancer and inflammatory and
autoimmune diseases. The Company has determined that it operates
in only one business segment, which primarily focuses on the
discovery and development of antibody-based drug candidates
using proprietary technologies.
|
|
2.
|
Summary
of Significant Accounting Policies
|
Basis
of Preparation
The financial statements are presented in euros and all values
are rounded to the nearest thousand (000) except for share
or per share amounts and when otherwise indicated.
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from these
estimates.
The accompanying financial statements have been prepared
assuming the Company will continue as a going concern. This
basis of accounting contemplates the recovery of the
Companys assets and the satisfaction of its liabilities in
the normal course of business. As of December 31, 2005 the
Company had an accumulated deficit of 102,023,000, had a
working capital deficiency and expects to continue to incur
substantial, and possibly increasing, operating losses for the
next several years. These conditions create substantial doubt
about the Companys ability to continue as a going concern.
The Company is continuing its efforts in research and
development and for the preclinical studies and clinical trials
of its products. These efforts, and obtaining requisite
regulatory approval, prior to commercialization, will require
substantial expenditures. Once requisite regulatory approval has
been obtained, substantial additional financing will be required
to manufacture, market and distribute its products in order to
achieve a level of revenues adequate to support the
Companys cost structure. Management of the Company
believes it has sufficient resources to fund the required
expenditures into the third quarter of 2006, and if the
Companys existing shareholders invest an additional
approximately 4,000,000, as contemplated by an investment
agreement between the Company and such shareholders, then into
the fourth quarter of 2006. The Companys business is
subject to significant risks consistent with other biotechnology
companies that are developing products for human therapeutic
use. These risks include, but are not limited to, uncertainties
regarding research and development, failure to demonstrate the
safety and efficacy of its product candidates, access to
capital, obtaining and enforcing patents, receiving regulatory
approvals, and competition with other biotechnology and
pharmaceutical companies. The Company plans to continue to
finance its operations with a combination of equity
and/or debt
financing, research and development collaborations, and in the
longer term, revenues from product sales. However, there can be
no assurance that it will successfully develop any product or,
if it does, that the product will generate revenue.
Historically, the Company has relied on a limited number of
scientists and other specialists to perform its research and
development activities. The loss of its senior employees could
materially and adversely affect the Companys operating
outcome.
Equity
Restructuring and Reverse Stock Split
On October 11, 2005, the Company and all shareholders
agreed to exchange all shares of outstanding preferred shares
for a new class of preferred shares series (A New) on a
one-for-one
basis and amend all instruments with
F-31
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
conversion options, except for the convertible note issued in
2004 to shareholders, for this equity restructuring. The 2004
convertible note, which was originally convertible into
Series H preferred shares, was amended to be convertible
into a new class of preferred shares series (B New).
Furthermore, the Company agreed on a
2-for-71
reverse stock split for all outstanding common and preferred
shares, options and other convertible securities. All share data
have been restated to give retroactive effect to this exchange
of preferred shares and reverse stock split. All preferred
instruments are convertible into the same number of common
shares pre and post restructuring (as adjusted for the reverse
stock split).
Foreign
Currency Transactions
The functional and reporting currency of the Company is the euro
(). Transactions in foreign currencies are initially
recorded at the functional currency exchange rate as of the date
of the transaction. Monetary assets and liabilities denominated
in foreign currencies are translated at the exchange rate as of
the balance sheet date, and resulting gains and losses are
recorded in the statement of operations.
Cash
Equivalents
Cash and cash equivalents on the balance sheets are comprised of
cash at banks and short-term deposits with an original maturity
of three months or less.
Deposit
As of December 31, 2005 and 2004, the Company had
95,000 as security deposits under an operating lease
agreement.
Short-Term
Investments
The Company accounts for its securities in accordance with
Statement of Financial Accounting Standard (SFAS)
No. 115, Accounting for Certain Investments in Debt and
Equity Securities (SFAS 115). Management
determines the proper classification of securities at the time
of the purchase and re-evaluates such designations as of each
balance sheet date. As of December 31, 2005 and 2004, the
investments held by the Company have been classified as
available-for-sale.
After initial recognition, available-for-sale investments are
recorded at fair value based on quoted market prices. Gains or
losses on
available-for-sale
investments are recognized as a separate component of equity
until the investment is sold, collected or otherwise disposed
of, at which time the cumulative gain or loss previously
reported in equity is included in the statements of operations.
The Company reviews its securities for impairment on a regular
basis. If a decline in the fair value of available-for-sale
securities is judged to be other than temporary, the cost basis
for the security is reduced to fair value and a new cost basis
is established. The reduction of the cost basis is included in
the statements of operations as an impairment charge. The
Company considers a decline in the market value of a marketable
security longer than six months in duration to be other than
temporary unless specific facts and circumstances indicate
otherwise.
Restricted
Cash and Short-term Investments Held as Collateral
The Company has an agreement with HVB whereby HVB will issue
guarantees to third parties, and the Company is required to
obtain permission from HVB if its short-term investment balance
declines to a level below the outstanding guarantees. The only
guarantee outstanding as of December 31, 2004 amounts to
447,000 and relates to the Companys building lease
agreement. Accordingly, short-term investments equal to the
amount of the outstanding guarantees as of December 31,
2004 are disclosed as a non-current asset.
F-32
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
The only guarantee outstanding as of December 31, 2005
amounts to 537,000 and relates to the Companys
building lease agreement. As the Company did not have any
short-term investments held at HVB as of December 31, 2005,
cash equal to the amount of the outstanding guarantee as of
December 31, 2005 is disclosed as a non-current asset.
Accounts
Receivable
Receivables are stated at their cost less an allowance for any
uncollectible amounts. The allowance for doubtful accounts is
based on managements assessment of the collectibility of
specific customer accounts. If there is a deterioration of a
customers credit worthiness or actual defaults are higher
than historical experience, managements estimates of the
recoverability of amounts due to the Company could be adversely
affected. The Company does not have a policy of requiring
collateral. Based on managements assessment, no allowance
was necessary as of December 31, 2005 and 2004.
Derivative
Financial Instruments
The Company adopts the guidance of SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities
(SFAS 133), for the recognition and measurement
of embedded derivatives that must be bifurcated from the host
debt instrument and accounted for separately. SFAS 133
requires all derivatives to be recorded on the balance sheet at
fair value. Refer to Note 8 for the terms and conditions of such
derivatives.
Property
and Equipment
Property and equipment are stated at cost, less accumulated
depreciation and amortization. Major replacements and
improvements that extend the useful life of assets are
capitalized while general repairs and maintenance are charged to
expense as incurred. Property and equipment are depreciated
using the straight-line method over the estimated useful lives
of the assets, ranging from three to ten years. Leasehold
improvements are amortized over the estimated useful lives of
the assets or the related lease term, whichever is shorter.
Patents
The Company holds patents for single-chain antigen binding
molecule technology, which it acquired from Curis, Inc. in 2001.
Patents are amortized over their estimated useful life of ten
years using the straight-line method. The patents are utilized
in revenue producing activities as well as in research and
development activities.
Impairment
of Long-Lived and Identifiable Intangible Assets
In accordance with the provisions of SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets
(SFAS 144), the Company evaluates the carrying
value of long-lived assets and identifiable intangible assets
for potential impairment whenever events or changes in
circumstances indicate that the carrying amount of such assets
may not be recoverable. Recoverability is determined by
comparing projected undiscounted cash flows associated with such
assets to the related carrying value. An impairment loss would
be recognized when the estimated undiscounted future cash flow
is less than the carrying amount of the asset. An impairment
loss would be measured as the amount by which the carrying value
of the asset exceeds the fair value of the asset. An impairment
charge on leasehold improvements of 315,000 has been
recorded for the year ended December 31, 2004. No
impairment charges have been recognized for the years ended
December 31, 2005 and 2003.
Revenue
Recognition
The Companys revenues generally consist of licensing fees,
milestone payments, royalties and fees for research services
earned from license agreements or from research and development
collaboration agreements.
F-33
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
The Company recognizes revenue upon satisfying the following
four criteria: persuasive evidence of an arrangement exists,
delivery has occurred, the price is fixed or determinable, and
collectibility is reasonably assured.
The Company recognizes revenue on development and collaboration
agreements, including upfront payments, over the expected life
of the development and collaboration agreement on a
straight-line basis.
Fees for research services performed under the agreements are
generally stated at a yearly fixed fee per research scientist.
The Company recognizes revenue as the services are performed.
Amounts received in advance of services performed are recorded
as deferred income until earned.
The Company receives initial license fees and annual renewal
fees upfront each year under license agreements. Revenue is
recognized when the above noted criteria are satisfied unless
the Company has further obligations associated with the license
granted.
Milestone payments are derived from the achievement of
predetermined goals under the collaboration agreements. For
milestones that are subject to contingencies, the related
contingent revenue is not recognized until the milestone has
been reached and customer acceptance has been obtained as
necessary. The Company received milestone payments from
collaboration agreements totalling 207,000, 0 and
1,000,000 in the years ended December 31, 2005, 2004
and 2003, respectively.
The Company is entitled to receive royalty payments on sale of
products under license and collaboration agreements. Royalties
are based upon the volume of products sold and are recognized as
revenue upon notification of sales from the customer. To date,
the Company has not received or recognized any royalty payments.
For arrangements that include multiple deliverables, the Company
identifies separate units of accounting based on the consensus
reached on Emerging Issues Task Force Issue
No. 00-21
Revenue Arrangements with Multiple Deliverables
(EITF 00-21).
EITF 00-21
provides that revenue arrangements with multiple deliverables
should be divided into separate units of accounting if certain
criteria are met. The consideration for the arrangement is
allocated to the separated units of accounting based on their
relative fair values. Applicable revenue recognition criteria is
considered separately for each unit of accounting. The Company
adopted
EITF 00-21
for all revenue arrangements after July 1, 2003.
Research
and Development
Research and development expenditures, including direct and
allocated expenses, are charged to operations as incurred.
Clinical trial materials purchased for specific research and
development projects, with no alternative future use, are
recorded as research and development expenses as received.
Total
Comprehensive Income (Loss)
Comprehensive loss amounted to 11,425,000,
20,189,000 and 18,638,000 for the years ended
December 31, 2005, 2004 and 2003, respectively. The
differences between net loss and total comprehensive loss
relates to unrealized and realized gains and losses on
available-for-sale short-term investments.
Income
Taxes
The Company accounts for income taxes under
SFAS No. 109, Accounting for Income Taxes
(SFAS 109) using the liability method. Deferred
income taxes are recognized at the enacted tax rates for
temporary differences between the financial statement and income
tax bases of assets and liabilities. Deferred tax assets are
reduced by a valuation allowance if, based upon the weight of
available evidence, it is more likely than not that some portion
or all of the related tax asset will not be recovered.
F-34
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
Stock-Based
Compensation
The Company has adopted the provisions of
SFAS No. 123, Accounting for Stock-Based Compensation
(SFAS 123). Under the guidance of
SFAS 123, the Company estimates the value of stock options
issued to employees using the Black-Scholes options pricing
model with a near-zero volatility assumption (a minimum
value model). The value is determined based on the stock
price of the Companys stock on the date of grant and
recognized as an expense over the vesting period using the
straight-line method.
Reclassifications
Certain amounts in the previous years financial statements
have been reclassified to conform to the current years
presentation.
Recent
Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board
(FASB) has issued FASB Statement No. 123
(revised 2004), Share-Based Payment
(SFAS 123(R)). SFAS 123(R) replaces FASB
Statement No. 123, Accounting for Stock-Based Compensation
(SFAS 123), supersedes APB Opinion No. 25,
Accounting for Stock Issued to Employees and amends FASB
Statement No. 95, Statement of Cash Flows. Generally, the
approach in SFAS 123(R) is similar to the approach
described in SFAS 123. However, SFAS 123(R) requires
all share-based payments to employees, including grants of
employee stock options, to be recognized in the financial
statements based on their fair values. Non-public companies are
required to adopt the new standard at the beginning of the first
annual period beginning after December 15, 2005. The
Company is in the process of assessing the impact on its
financial position, results of operations and cash flows.
In December 2004, the FASB issued SFAS No. 153,
Exchanges of Nonmonetary Assets an amendment of
APB Opinion No. 29 (SFAS 153). The guidance in
APB Opinion No. 29, Accounting for Nonmonetary
Transactions, is based on the principle that exchanges of
nonmonetary assets should be measured based on the fair value of
assets exchanged. The guidance in that Opinion, however,
included certain exceptions to that principle. This Statement
amends Opinion No. 29 to eliminate the exception for
nonmonetary exchanges of similar productive assets that do not
have commercial substance. A nonmonetary exchange has commercial
substance if the future cash flows to the entity are expected to
change significantly as a result of the exchange. SFAS 153
is effective for nonmonetary exchanges occurring in fiscal
periods beginning after June 15, 2005. The adoption of
SFAS 153 is not expected to have a material impact on the
Companys financial position and results of operations.
In May 2005, the FASB issued SFAS No. 154, Accounting
Changes and Error Corrections (SFAS 154).
SFAS 154 replaces APB Opinion No. 20, Accounting
Changes, and FASB Statement No. 3, Reporting Accounting
Changes in Interim Financial Statements, and changes the
requirements for the accounting for and reporting of a change in
accounting principle. This Statement applies to all voluntary
changes in accounting principle. It also applies to changes
required by an accounting pronouncement in the unusual instance
that the pronouncement does not include specific transition
provisions. When a pronouncement includes specific transition
provisions, those provisions should be followed. SFAS 154
requires that retrospective application of a change in
accounting principle be limited to the direct effects of the
change. Indirect effects of a change in accounting principle,
such as a change in non-discretionary profit-sharing payments
resulting from an accounting change, should be recognized in the
period of the accounting change. SFAS 154 also requires
that a change in depreciation, amortization, or depletion method
for long-lived, non-financial assets be accounted for as a
change in accounting estimate effected by a change in accounting
principle. SFAS No. 154 is effective for all
accounting changes and corrections of errors made in fiscal
years after December 15, 2005. The adoption of
SFAS No. 154 is not expected to have a material impact
on the Companys financial position and results of
operations.
F-35
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
|
|
3.
|
Short-Term
Investments
|
As of December 31, 2005, short-term investments consist of
the following (in thousand euros):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Realized
|
|
|
Market
|
|
|
|
Cost Basis
|
|
|
Gains
|
|
|
Losses
|
|
|
Gains
|
|
|
Value
|
|
|
Deutsche Bank Euro Rendite Plus
money-market funds
|
|
|
1,003
|
|
|
|
|
|
|
|
(26
|
)
|
|
|
49
|
|
|
|
1,026
|
|
Deutsche Bank ABS Fund
money-market funds
|
|
|
1,999
|
|
|
|
|
|
|
|
(6
|
)
|
|
|
46
|
|
|
|
2,039
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,002
|
|
|
|
|
|
|
|
(32
|
)
|
|
|
95
|
|
|
|
3,065
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2004, short-term investments consist of
the following (in thousand euros):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Realized
|
|
|
Market
|
|
|
|
Cost Basis
|
|
|
Gains
|
|
|
Losses
|
|
|
Gains
|
|
|
Value
|
|
|
HVB Activest money-market funds
|
|
|
700
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
|
|
703
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
700
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
|
|
703
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net gains (losses) on the sale of available-for-sale short-term
investments, determined using the specific identification method
and included in other income/(expense), amounted to
95,000, 128,000 and (117,000) for the years
ended on December 31, 2005, 2004 and 2003, respectively. An
impairment charge of 72,000 of a HVB Euro Floater
investment was recorded as other expense in 2003 because the
decline in the market value was longer than six months in
duration and deemed to be other-than-temporary.
|
|
4.
|
Property
and Equipment
|
Property and equipment consist of the following (in thousands of
euros):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated
|
|
|
December 31,
|
|
|
|
Useful Lives
|
|
|
2005
|
|
|
2004
|
|
|
Laboratory equipment
|
|
|
5 years
|
|
|
|
4,487
|
|
|
|
4,457
|
|
Computer equipment and software
|
|
|
3 years
|
|
|
|
1,157
|
|
|
|
1,021
|
|
Furniture
|
|
|
10 years
|
|
|
|
803
|
|
|
|
802
|
|
Leasehold improvements
|
|
|
10 years
|
|
|
|
2,411
|
|
|
|
2,409
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,857
|
|
|
|
8,689
|
|
Less accumulated depreciation and
amortization
|
|
|
|
|
|
|
(5,891
|
)
|
|
|
(4,824
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
|
|
|
|
2,966
|
|
|
|
3,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laboratory and computer equipment acquired under capital lease
arrangements totalled 306,000 and 194,000 on
December 31, 2005 and 2004, respectively. The accumulated
depreciation related to assets under capital lease arrangements
was approximately 187,000 and 138,000 as of
December 31, 2005 and 2004, respectively. The capital lease
equipment is amortized over the useful life of the equipment or
the lease term, whichever is less, and such amortization
expenses are included within depreciation expense.
The Company entered into a Purchase and Security Agreement with
European Technology Ventures (ETV). Under the terms
of the agreement, the Company financed approximately
3,000,000 of technical equipment purchases through a
series of bond issuances. The assets purchased were pledged as
collateral on the loans. Refer to Note 10 for the terms and
conditions of such agreements.
As discussed further in Note 9, leasehold improvements
include an asset retirement obligation in the amount of
146,000 as part of the carrying amount of the related
long-lived asset.
F-36
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
Patents consist of the following (in thousands of euros):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Patents
|
|
|
14,896
|
|
|
|
14,896
|
|
Accumulated amortization
|
|
|
(6,702
|
)
|
|
|
(5,213
|
)
|
|
|
|
|
|
|
|
|
|
Patents, net
|
|
|
8,194
|
|
|
|
9,683
|
|
|
|
|
|
|
|
|
|
|
Amortization expense on patents totalled 1,489,000 during
each of the years ended December 31, 2005, 2004 and 2003.
Future amortization for the patents is estimated to be as
follows as of December 31, 2005 (in thousands of euros):
|
|
|
|
|
2006
|
|
|
1,489
|
|
2007
|
|
|
1,489
|
|
2008
|
|
|
1,489
|
|
2009
|
|
|
1,489
|
|
2010
|
|
|
1,489
|
|
Thereafter
|
|
|
749
|
|
|
|
|
|
|
|
|
|
8,194
|
|
|
|
|
|
|
As a result of the net losses incurred by the Company since
inception, no provision for income taxes has been recorded. As
of December 31, 2005, the Company had accumulated tax net
operating loss carryforwards in Germany of approximately
96,000,000. Under German tax laws, these loss
carryforwards have an indefinite life and may be used to offset
the Companys future taxable income. Effective January
2004, the German tax authorities changed the rules concerning
deduction of loss carryforwards. This loss carryforward
deduction is now limited to 1,000,000 per year and
the deduction of the exceeding amount is limited to 60% of the
net taxable income. Net operating loss carryforwards are subject
to review and possible adjustment by the German taxing
authorities. Furthermore, under current German tax laws, certain
substantial changes in the Companys ownership may limit
the amount of net operating loss carryforwards, which could be
utilized annually to offset future taxable income.
F-37
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
Significant components of the Companys deferred tax
position consists of the following (in thousands of euros):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Deferred tax
position
|
|
|
|
|
|
|
|
|
Net operating loss carry forwards
|
|
|
37,908
|
|
|
|
30,932
|
|
Receivables
|
|
|
2,176
|
|
|
|
4,274
|
|
Curis patent depreciation
|
|
|
1,031
|
|
|
|
1,109
|
|
Accrued interest for silent
partnerships
|
|
|
79
|
|
|
|
126
|
|
Other
|
|
|
(57
|
)
|
|
|
(229
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
41,137
|
|
|
|
36,212
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
|
(41,137
|
)
|
|
|
(36,212
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to the degree of uncertainty related to the ultimate
utilization and recoverability of the loss carryforwards and
other deferred tax assets, the Company has reserved for the
deferred tax asset to the extent it exceeds any tax liabilities.
The increase in the valuation allowance for 2005 is due to the
increase in net operating loss carryforwards from operations
during the year and other temporary differences.
In the fiscal years 2005, 2004 and 2003, the income tax rate was
calculated at 40.86% of the taxable income. That rate consists
of 25.00% corporate tax, 5.50% solidarity surcharge on corporate
tax and 14.48% trade tax. Due to the net losses incurred by the
Company since inception and the degree of uncertainty related to
the ultimate utilization and recoverability of the loss
carryforwards accumulated, no income tax benefit has been
recorded in the statements of operations in the years ended
December 31, 2005, 2004 and 2003, respectively, as any
losses available for carryforward are eliminated through
increases in the valuation allowance recorded. No income taxes
were paid in the years ended December 31, 2005, 2004 and
2003.
As of December 31, 2005, deferred revenues were mainly
derived from a license and collaboration agreement with a
wholly-owned subsidiary of Serono International, S.A. as further
discussed in Note 16. Revenue related to the upfront
license fee payment and revenue related to the research and
development services are considered to be a combined unit of
accounting and such revenues are recognized rateably over the
period of the research and development program.
F-38
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
|
|
8.
|
Convertible
Notes Payable
|
Convertible notes payable consist of the following (in thousands
of euros):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Enzon, Inc convertible promissory
note
|
|
|
|
|
|
|
9,302
|
|
MedImmune, Inc convertible
promissory note
|
|
|
10,000
|
|
|
|
10,000
|
|
2004 convertible promissory notes
including accrued interest of 483,000 in 2005 and
188,000 in 2004
|
|
|
2,331
|
|
|
|
10,188
|
|
|
|
|
|
|
|
|
|
|
Total convertible notes payable
|
|
|
12,331
|
|
|
|
29,490
|
|
Less current portion
|
|
|
(2,331
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes payable, net of
current portion
|
|
|
10,000
|
|
|
|
29,490
|
|
|
|
|
|
|
|
|
|
|
Scheduled repayment of principal for outstanding convertible
notes as of December 31, 2005 were as follows (in thousands
of euros):
|
|
|
|
|
2006
|
|
|
2,331
|
|
2007
|
|
|
|
|
2008
|
|
|
|
|
2009
|
|
|
|
|
2010
|
|
|
10,000
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
Total convertible notes payable
|
|
|
12,331
|
|
|
|
|
|
|
Curis,
Inc., Cambridge, USA
In June 2001, the Company issued a convertible promissory note
in the principal amount of 4,068,000 to Curis, Inc.
(Curis) in connection with the acquisition of
patents. In November 2004, the original convertible note was
restructured into a non-interest bearing loan agreement in the
amount of 4,500,000. The carrying amount prior to
restructuring was 4,908,000, which included accrued
interest. The new loan agreement is not convertible.
Under the terms and conditions of the loan note, 1,250,000
was repaid in each of November 2004 and October 2005. The
remaining outstanding amount of 2,000,000 is due and
payable upon the closing of an exit event, as defined in the
loan agreement, or upon a qualified financing between
October 15, 2004 and October 15, 2005 that results in
gross proceeds of at least 15,000,000 as specified in the
agreement.
This debt restructuring was accounted for under
SFAS No. 15, Accounting by Debtors and Creditors for
Troubled Debt Restructuring (SFAS 15). The debt
restructuring resulted in a potential gain of 408,000,
which was not recognized at the date of restructuring because
under the terms of the agreement, penalty interest is
contingently payable in the event of a default, as specified in
the agreement. The obligations related to the loan note,
including the potential gain of 408,000, in the amounts of
2,408,000 and 3,658,000, are included in short-term
note on the balance sheets as of December 31, 2005 and
2004, respectively.
On February 1, 2006, the Company received a letter from
Curis in which Curis claims that the reverse merger with
CancerVax, as described further in Note 19, triggers an
exit event per the terms of the loan agreement of October 2004
between Micromet and Curis. Such an exit event is defined as
(i) the listing of Micromet shares on an exchange;
(ii) a sale of 50% or more of Micromet shares; (iii) a
sale of all Micromet assets; or (iv) a merger in which
Micromet shareholders hold less than 50% of the combined stock
of the surviving entity. If the reverse merger is interpreted as
an exit event, then 2,000,000 would be due and payable
within 30 days after consummation of the
F-39
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
reverse merger. That amount is in short-term note as of
December 31, 2005 and 2004. Management believes that the
reverse merger with CancerVax does not qualify as an exit event
and plans to dispute Curiss interpretation of the loan
agreement.
On March 6, 2006, Curis filed a lawsuit against the Company
in the Local Court of Munich I. Curis claims that the Company is
obligated to pay Curis the outstanding amount of Curis
loan note of 2,000,000 within 30 days after the
completion of the exchange by the Companys shareholders of
a majority of the outstanding shares of the Company for shares
of a third party. This would include the proposed exchange of
shares of the Company for shares of Micromet, Inc. that is
contemplated by the reverse merger. The Company disputes
Curis position, but agrees that an amount of 533,333
of the loan will become payable in October 2006. The total
possible exposure of the Company is the principal amount claimed
(2,000,000), plus the costs of the proceedings. In
addition, if Curis prevails in the proceeding, it would be
entitled to interest on the claimed amount of 2,000,000 at
the base rate of the European Central Bank plus 8%, accruing
from the time of default.
Interest expense in the years ended December 31, 2004 and
2003 related to the Curis convertible promissory note amounted
to 370,000 and 427,000, respectively. In 2005, no
interest expense was recorded.
Enzon,
Inc., Bridgewater, USA
In April 2002, the Company entered into multiple agreements with
Enzon Pharmaceuticals, Inc. (Enzon). In addition to
the research and development collaboration agreements, the
Company issued a convertible note to Enzon in the nominal amount
of 9,302,000. At the time of the issuance of the note the
nominal amount was the equivalent of US$8,000,000. The
convertible note has a stated nominal interest rate of 3.0%.
In June 2004, the Company and Enzon amended and restated their
collaboration agreements and the convertible note. In the event
that the Company terminates the convertible note prior to
maturity, the Company is obliged to repay an amount equal to the
greater of (i) US$8,000,000 or (ii) the fair market
value of the number of common shares in the Company as the
holder would receive upon exercise of its conversion right
(Call Option). The Company was given the right to
force Enzon to convert the debt to equity in certain
circumstances including upon cancellation of the collaboration
agreement. Furthermore, the due date of the convertible note was
extended from March 31, 2006 to March 31, 2007. The
modification of the Enzon note to allow for the early payoff
represents a significant concession by the lender. This
modification has been accounted for as a troubled debt
restructuring under SFAS 15.
Under the provisions of SFAS 133, the Call Option is an
embedded derivative that must be bifurcated and accounted for at
fair value. The estimated fair value of the Call Option at the
date of modification was 2,700,000, and this amount was
recorded as an asset at the date of modification. Since this
asset can only be realized if the Company exercises the Call
Option and settles the note payable, the gain associated with
this derivative is considered to be a contingent gain under
SFAS 15 and has been deferred. Similarly, future changes in
the fair value of the Call Option represent changes in the
contingent gain on settlement of the debt, and will be deferred
under SFAS 15. The carrying amount of the derivative and
the related deferred gain are combined with the note payable in
the financial statements. As of December 31, 2004, the
estimated fair value of the Call Option was approximately
3,400,000.
On December 19, 2005, Enzon exercised the conversion option
of the note upon request by the Company as a consequence of the
termination of the collaboration as further discussed in
Note 15. In January 2006, the Company issued 16,836 common
shares of the Company to Enzon at a conversion price of
552.50 per common share. The Call Option terminated
upon exercise of the conversion option. As of December 31,
2005 the carrying amount of the convertible note was included in
stock subscription from conversion in stockholders equity
due to the irrevocable notice received from Enzon and the
Companys irrevocable obligation to issue shares to Enzon
in accordance with the terms of the amended convertible note
agreement. Interest expense related to the Enzon note amounted
to 279,000 in the years ended December 31, 2005, 2004
and 2003.
F-40
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
MedImmune,
Inc., Gaithersburg, USA
In June 2003, the Company entered into multiple agreements with
MedImmune, Inc., or MedImmune. In addition to the research and
development collaboration agreements, the Company issued a
convertible note in the nominal amount of 10,000,000 to
MedImmune Ventures, Inc., or MedImmune Ventures. The conversion
option was subsequently amended as a consequence of the capital
restructuring on October 11, 2005. The amended convertible
note is subject to voluntary conversion into non-par value
registered preferred shares (Series A) of the Company
at a conversion price of up to 488.84 per preferred
share (Series A) in the event of an IPO, Merger or in
a Change of Control (each, as defined in the amended convertible
note). The convertible note bears nominal interest of
4.5% per year and is due in June 2010.
Upon an IPO or merger, the holder has the right to convert the
note in full into preferred shares (Series A) if the
pre-money valuation of the Company is 120,000,000 or more.
If the valuation is less than 120,000,000, the conversion
rate is a pro rata percentage which decreases ratably as the
pre-money valuation decreases from 120,000,000. The
remainder of the note remains outstanding until the due date. In
addition, upon an IPO or merger, MedImmune Ventures has the
right to call the note in full if the resulting entity has
60,000,000 or more in cash upon the first day of trading
or the closing date of the merger. If available cash is less
than 60,000,000 but more than 30,000,000, MedImmune
Ventures has the right to call the note on a pro rata basis for
amounts over 30,000,000 and increasing to
60,000,000. The remainder of the note remains outstanding
until the due date.
In the case of a Change of Control MedImmune Ventures has the
right to convert the note in full into preferred shares
(Series A) if the valuation of the Company after debt
is equal to or exceeds 144,000,000. If the valuation of
the Company is lower than 144,000,000, the note becomes
due upon the effective date of the transaction.
Interest expense in the years ended December 31, 2005, 2004
and 2003 related to the MedImmune Ventures convertible
promissory note amounted to 450,000, 450,000 and
263,000, respectively.
2004
Convertible Notes
In November 2004, the Company issued convertible notes in the
aggregate nominal value of 10,000,000 to certain
shareholders of the Company, which bore interest at 24% per
annum and were due on December 31, 2006. In December 2005
and January 2006, the Company received notification from holders
of the 2004 convertible notes of their intent to convert. In
January 2006, the convertible notes, including accrued interest,
were converted into an aggregate of 18,704 preferred shares
(Series B). As of December 31, 2005, 10,188,000,
including accrued interest, was included in stock subscription
from conversion in stockholders equity due to the
irrevocable notice received from certain noteholders in December
2005 and the Companys irrevocable obligation to issue
shares to these noteholders in accordance with the terms of the
note agreements. As of December 31, 2005, 2,331,000,
including accrued interest, remained in current liabilities
related to the 2004 convertible notes as the notice from certain
noteholders was not received until subsequent to
December 31, 2005. Interest expense amounted to
2,331,000 and 188,000 in the years ended
December 31, 2005 and 2004, respectively, related to the
2004 convertible notes.
F-41
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
|
|
9.
|
Other
Non-Current Liabilities
|
Other non-current liabilities consist of the following (in
thousands of euros):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Restructuring provision, net of
current portion
|
|
|
357
|
|
|
|
427
|
|
GEK subsidy, net of current portion
|
|
|
210
|
|
|
|
248
|
|
Asset retirement obligation
|
|
|
173
|
|
|
|
146
|
|
Capital lease obligations, net of
current portion
|
|
|
58
|
|
|
|
7
|
|
Option bonds due to related parties
|
|
|
3
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
801
|
|
|
|
831
|
|
|
|
|
|
|
|
|
|
|
The restructuring provisions are described in Note 18 in
these financial statements.
GEK
Subsidy
In December 2002, the Company entered into a subsidy agreement
with GEK Grundstücksverwaltungsgesellschaft mbH &
Co. Objekt Eins KG (GEK), whereby GEK provided
365,000 in lease incentives to the Company in conjunction
with the operating lease agreement for facilities. The subsidy
is restricted to purchases of property and equipment for
research and development activities. The subsidy has been
recorded as deferred rent and allocated between current and
other non-current liabilities and amortized on a straight-line
basis over the term of the building lease of ten years.
Asset
Retirement Obligation
In February 2001, the Company and GEK entered into a building
lease agreement. Under the terms of the agreement, GEK agreed to
lease laboratory and office space to the Company for a period of
ten years beginning on July 1, 2002.
Upon termination of the agreement, the Company under certain
conditions will be obliged to remove those leasehold
improvements that will not be taken over by GEK. In 2004, the
Company re-evaluated the fair value of the obligation to remove
leasehold improvements. Based on changes in market conditions
and the estimated future use of the lease space, the fair value
of the asset retirement obligation was estimated to be
approximately 146,000 as of December 31, 2004. The
amount will increase due to accretion through the term of the
lease agreement.
|
|
|
|
|
|
|
|
|
|
|
Liability as of
|
|
|
|
|
|
Liability as of
|
|
December 31,
|
|
|
Accretion
|
|
|
December 31,
|
|
2004
|
|
|
Expense
|
|
|
2005
|
|
|
146,000
|
|
|
|
27,000
|
|
|
|
173,000
|
|
Option
Bonds Due from Related Parties
In June 2001, the Company issued 300 option bonds with a nominal
value of 1 each, bearing an interest rate of
3.00% per annum, to selected members of the supervisory
board. The option bonds, including interest, are due on
June 8, 2009. The acquirers paid an aggregate of 300
to the Company in return for the option bonds. The option bonds
carry a total of 600 option rights to purchase common shares of
the Company. The option rights vest over 36 months and
expire on June 8, 2009.
In March 2002, the Company issued an additional 300 option bonds
with the same terms and conditions (including option rights) as
the previously issued options bonds. These option bonds and
attached option rights expire on March 28, 2010.
F-42
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
In May 2003, the Company issued an additional 2,130 option bonds
with a nominal value of 1 each, bearing nominal an
interest rate of 3.00% per annum, to selected members of
the supervisory board. The option bonds, including interest, are
due on April 26, 2011. The acquirers paid an aggregate of
2,130 to the Company in return for the option bonds. The
option bonds carry a total of 600 option rights to purchase
common shares of the Company. The option rights vest over
36 months and expire on April 26, 2011.
The shareholders meeting on May 25, 2004 amended the
exercise price, the exercise conditions of the option rights,
and the possibility to terminate the options rights in the event
of change of control of the convertible bonds issued to the
members of the supervisory board by the resolutions of the
shareholders meeting on May 20, 2004, March 27,
2002, and June 7, 2001. The exercise prices are calculated
using the same method as for the amended issue price of the
option program described in Note 12 and therefore vary
between 35.50 and 284.00 depending on an investment
multiple as defined in the agreement.
The Company has determined the fair value of these 1,800 option
rights using the minimum value method, which resulted in no
compensation expense to be recorded over the vesting period as
the fair value of the rights were determined to be zero.
Technologie-Beteiligungs-Gesellschaft
mbH
In October 1996, the Company entered into two agreements with
tbg Technologie-Beteiligungs-Gesellschaft mbH (tbg)
of the Deutsche Ausgleichsbank (the lender) to
borrow 177,000 at 6.00% interest, payable semi-annually
(Agreement No. 1) and 716,000 at 6.00%
interest, payable semi-annually (Agreement
No. 2). In March 1999, the Company entered into four
additional agreements with tbg to borrow 760,000 at 7.00%
interest, payable semi-annually (Agreement
No. 3), 476,000 at 6% interest, payable
semi-annually (Agreement No. 4), 262,000
at 7.00% interest, payable semi-annually (Agreement
No. 5), and 164,000 at 6.00% interest, payable
semi-annually (Agreement No. 6). Under these
agreements, tbg, which is indirectly owned by the German
government and was formed to support the development of
technology-oriented companies in the
start-up
phase, became a stiller Gesellschafter (silent
partner) in the Company. Silent partnerships are a common form
of investment under German business practice. Under the terms of
the silent partnership agreements, tbg is not a legal owner of
the Company and is not liable for the obligations of the
Company. tbg is not involved in the management of the Company,
but significant business decisions such as changes in the
articles of incorporation, mergers and acquisitions or
significant contractual matters are subject to its approval.
Agreements No. 1 and No. 2 expire on December 31,
2006. Agreements No. 3, No. 4, No. 5 and
No. 6 expire on December 31, 2008.
In addition to interest at the contractual rate described above,
tbg is entitled to the following:
1. If the Company earns a profit in any fiscal year during
the agreement period, the lender is entitled to a total of 9.00%
of the Companys profit before income taxes and other items
specified in the contract (profit sharing),
determined in accordance with accounting principles generally
accepted in Germany (German GAAP). The lender does
not participate in the Companys losses.
2. 11,000, 43,000, 29,000 and
10,000 per year (representing 6.00% of the nominal
amount of the loan under Agreements No. 1, No. 2,
No. 4 and No. 6, respectively) and 53,000 and
18,000 per year (representing 7% of the nominal
amount of the loan under Agreements No. 3 and
No. 5) for the 6th through the 10th year of
the agreements, due at the end of the Agreements.
3. 53,000, 215,000, 143,000 and
49,000 (representing 30.00% of the amount of the loan
under Agreements No. 1, No. 2, No. 4 and
No. 6, respectively) and 266,000 and 92,000
(representing 35.00% of the amount of the loan under Agreements
No. 3 and No. 5) due, notwithstanding when the
principal is extinguished, at the end of the Agreements.
F-43
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
The agreements state that amounts due in items 2 and 3 above may
be waived at the discretion of the lender based on its
evaluation of the overall economic condition of the
Company. The evaluation of the overall economic
condition of the Company is based upon its profitability
during the last three years before termination of the agreement
and any unrealized appreciation of assets during the term of the
agreement. The actual amounts due at the end of Agreements
No. 1 and No. 2, under items 2 and 3 above, shall be
reduced by amounts previously paid under profit sharing
(item 1 above). The Company has included amounts under
items 2 and 3 described above as elements of interest expense
and is recording such interest over the life of the silent
partnership agreements using the effective interest method. The
balance of Agreements No. 1 and 2, including accrued
and unpaid interest, amounted to 1,345,000 and
1,269,000 at December 31, 2005 and 2004,
respectively. The balance of Agreements No. 3, 4, 5
and 6, including accrued and unpaid interest, amounted to
2,280,000 and 2,150,000 at December 31, 2005
and 2004, respectively.
Bayern
Kapital GmbH
In January 1997, the Company entered into a seventh silent
partnership agreement (Agreement No. 7) with
Bayern Kapital GmbH (Bayern Kapital) under which
Bayern Kapital agreed to provide financing in the amount of
893,000 at 6.75% interest, payable quarterly. Agreement
No. 7 expires on December 31, 2006.
In addition to interest at the contractual rate described above,
Bayern Kapital is entitled to the following:
1. If the Company earns a profit in any fiscal year during
the agreement period, the lender is entitled to a total of 8.00%
of the Companys profit before income taxes and other items
specified in the contract (profit sharing),
determined in accordance with German GAAP. The lender does not
participate in the Companys losses.
2. 80,000 per year (representing 9.00% of the
nominal amount of the loan under Agreement No. 7) for
the 6th through the 10th year of the agreement, due at
the end of Agreement No. 7.
3. 313,000 (representing 35.00% of the amount of the
loan under Agreement No. 7), due notwithstanding when the
principal is extinguished, at the end of Agreement No. 7.
Except as set forth above, the contractual terms of the
aforementioned payments are the same as those described for the
tbg Agreements.
The Company has included amounts under items 2 and 3 described
above as elements of interest expense and is recording such
interest over the life of the silent partnership agreements
using the effective interest method. The balance of Agreement
No. 7, including accrued and unpaid interest, amounted to
1,487,000 and 1,381,000 at December 31, 2005
and 2004, respectively.
Technologie
Beteilungsfonds Bayern GmbH & Co. KG
In January 2000, the Company entered into an eighth silent
partnership agreement (Agreement No. 8) with
Technologie Beteilungsfonds Bayern GmbH & Co. KG
(Technologie-Fonds Bayern) under which
Technologie-Fonds Bayern agreed to provide financing in the
amount of 1,662,000 at 6.00% interest, payable quarterly.
Agreement No. 8 expires on December 31, 2008.
In addition to interest at the contractual rate described above,
Technologie-Fonds Bayern is entitled to the following:
1. If the Company earns a profit in any fiscal year during
the agreement period, the lender is entitled to a total of 9.00%
of the Companys profit before income taxes and other items
specified in the contract (profit sharing),
determined in accordance with German GAAP. The lender does not
participate in the Companys losses.
F-44
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
2. 150,000 per year (representing 9.00% of the
nominal amount of the loan under Agreement No. 8) for
the 6th through the 10th year of the agreement, due at
the end of the Agreement.
3. 582,000 (representing 35.00% of the amount of the
loan under Agreement No. 8) due, notwithstanding when
the principal is extinguished, at the end of the Agreement.
Except as set forth above, the contractual terms of the
aforementioned payments are the same as those described for the
tbg Agreements.
The Company has included amounts under items 2 and 3 described
above as elements of interest expense and is recording such
interest over the life of the silent partnership agreements
using the effective interest method. The balance of Agreement
No. 8, including accrued and unpaid interest, amounted to
2,390,000 and 2,230,000, at December 31, 2005
and 2004, respectively.
European
Technology Ventures
In June 2002, the Company entered into an agreement with
European Technology Ventures (ETV) to finance
equipment purchases up to 2,500,000. The Company can draw
down the line of credit once a month for an amount of at least
50,000. Interest on each draw is based on the three-year
swap rate on the euro, determined at the date of the draw, plus
a fixed rate of 8.50%. The Company made two draws in 2002,
totalling approximately 1,600,000, based on the three-year
swap rates of 4.31% and 3.56% at the time the draws were made.
Each draw is payable monthly over 36 months. All equipment
purchased under this agreement has been pledged as collateral.
In connection with the agreement, the Company granted to ETV
warrants to purchase 8,786 shares of the
Companys convertible preferred shares (Series A). The
strike price is 49.82 per warrant share and is
exercisable for the longer of ten years from the date of
issuance or five years after an initial public offering of the
Companys securities. The warrants issued were valued using
the Black-Scholes valuation model. The value of these warrants
was determined to be 201,000, which was recorded as a
reduction of the related ETV debt and is being amortized over
the term of the underlying debt.
In March 2003, the Company entered into a
fixed-rate-bond-with-warrants agreement (supplementary agreement
to the above agreement) to fund up to 500,000 to finance
additional equipment purchases by way of a purchase of one or
more fixed rate bonds, each with a nominal amount of not less
than 50,000, which brought the total amount available for
borrowing up to 3,000,000. Interest on each draw is based
on the three-year swap rate on the euro, determined at the date
of the draw, plus a fixed rate of 8.50%. The Company made two
draws in 2003, totalling approximately 1,400,000, based on
the three-year swap rates of 3.06% and 3.05% at the time the
draws were made. The first draw was payable over 12 months
and the second draw is payable monthly over 36 months. All
equipment purchased under this supplementary agreement has been
pledged as collateral.
In connection with the supplementary agreement, the Company
granted to ETV warrants to purchase 1,756 shares of
the Companys preferred shares (Series A). The strike
price is 49.82 per warrant share and will be
exercisable for the longer of ten years from the date of
issuance or five years after an initial public offering of the
Companys securities. The warrants issued were valued using
the Black-Scholes valuation model. The value of these warrants
was determined to be 16,000, which was recorded as a
reduction of the related ETV debt and is being amortized over
the term of the underlying debt.
Interest expense in the years ended December 31, 2005, 2004
and 2003 related to the ETV agreements, including the
amortization of the fair value of the warrants, amounted to
98,000, 264,000 and 356,000, respectively.
Grundstücksentwicklungs-
und Verwaltungsgesellschaft mbH & Co KG
In December 2002, the Company entered into an agreement with
GEDO Grundstücksentwicklungs- und Verwaltungsgesellschaft
mbH & Co KG (GEDO) in the amount of
435,000 to finance equipment purchases at an
F-45
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
interest rate of 7.50%, with principal and interest payments due
monthly over 48 months. Interest expense in the years ended
December 31, 2005, 2004 and 2003 related to the GEDO
agreement amounted to 13,000, 22,000 and
29,000, respectively.
Long-term debt obligations consist of the following (in
thousands of euros):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
tbg borrowings due
December 31, 2006; interest payable semi-annually at 6%
|
|
|
1,345
|
|
|
|
1,269
|
|
Bayern Kapital borrowings due
December 31, 2006; interest payable quarterly at 6,75%
|
|
|
1,487
|
|
|
|
1,381
|
|
tbg borrowings due
December 31, 2008; interest payable semi-annually at rates
ranging from 6% to 7%
|
|
|
2,280
|
|
|
|
2,150
|
|
Technologie-Fonds Bayern
borrowings due December 31, 2008; interest payable
quarterly at 6%
|
|
|
2,390
|
|
|
|
2,230
|
|
GEDO, borrowings due
December 31, 2006; interest payable monthly at 7,5%
|
|
|
36
|
|
|
|
140
|
|
ETV, borrowings due 36 months
after drawdown; interest payable monthly at rates ranging from
11.55% to 12.81%
|
|
|
92
|
|
|
|
1,041
|
|
|
|
|
|
|
|
|
|
|
Total long-term debt obligations
|
|
|
7,630
|
|
|
|
8,211
|
|
Less current portion
|
|
|
(2,960
|
)
|
|
|
(971
|
)
|
|
|
|
|
|
|
|
|
|
Long-term debt obligations, net of
current portion
|
|
|
4,670
|
|
|
|
7,240
|
|
|
|
|
|
|
|
|
|
|
Scheduled repayment of principal for the debt agreements is as
follows as of December 31, 2005 (in thousands of euros):
|
|
|
|
|
2006
|
|
|
2,960
|
|
2007
|
|
|
|
|
2008
|
|
|
4,670
|
|
|
|
|
|
|
Total
|
|
|
7,630
|
|
|
|
|
|
|
|
|
11.
|
Commitments
and Contingencies
|
Leases
In February 2001, the Company and GEK entered into a building
lease agreement. Under the terms of the agreement, GEK agreed to
lease laboratory and office space to the Company for a period of
ten years beginning on July 1, 2002.
In connection with the building lease agreement, the Company
entered into an agreement to receive a subsidy from GEK in the
amount of 365,000. In the event that the Company
terminates the building lease agreement prior to December 2010,
the Company is obliged to repay certain portions of the subsidy
to GEK as specified in the agreement.
In June 2005, the Company entered into an agreement with GEK to
defer a portion of its rental payments totalling 350,000
for the period between June and December 2005 and an additional
350,000 for the period between January and December 2006.
The amounts are subject to 4.00% nominal interest per annum
until December 31, 2006. Beginning January 1, 2007,
nominal interest increases to 8.00% per annum. Repayment
including accrued interest will become due in the event of an
initial public offering, asset sale or financing that results in
gross proceeds of at least 20,000,000 or upon first market
approval of a product developed by the Company. The Company
recorded 8,000 interest expense for the period between
June and December 2005 related
F-46
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
to this agreement. Deferred rent (including accrued interest) of
358,000 is included in other current liabilities as of
December 31, 2005.
Additionally, the Company leases certain equipment under various
non-cancellable operating leases with various expiration dates.
Operating lease expenses amounted to approximately
2,181,000, 2,277,000 and 2,170,000 in the
years ended December 31, 2005, 2004 and 2003, respectively.
Capital
Lease Obligations
In January 2002, the Company entered into equipment financing
agreements totalling 194,000 repayable in monthly
installments, the last of which is due August 1, 2006.
These agreements provide for interest ranging from 9.2% to
17.6% per annum.
In 2005, the Company entered into equipment financing agreements
in the total amount 112,000 for the purpose of buying
information technology equipment. The amounts are repayable in
monthly installments, the last of which is due March 1,
2008. The agreements provide for interest ranging from 0.9% to
2.9% per annum.
Future minimum lease payments under non-cancellable operating
and capital leases as of December 31, 2005 are as follows
(in thousands of euros):
|
|
|
|
|
|
|
|
|
|
|
Capital
|
|
|
Operating
|
|
|
|
Leases
|
|
|
Leases
|
|
2006
|
|
|
47
|
|
|
|
2,272
|
|
2007
|
|
|
38
|
|
|
|
2,265
|
|
2008
|
|
|
21
|
|
|
|
2,252
|
|
2009
|
|
|
|
|
|
|
2,118
|
|
2010
|
|
|
|
|
|
|
2,118
|
|
Thereafter
|
|
|
|
|
|
|
3,397
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments
|
|
|
106
|
|
|
|
14,422
|
|
|
|
|
|
|
|
|
|
|
Less: amount representing imputed
interest
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease
payments
|
|
|
101
|
|
|
|
|
|
Less: current portion
|
|
|
43
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligation, less
current portion
|
|
|
58
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
and Research and Development Agreements
The Company licenses certain of its technology from third
parties. In exchange for the right to use licensed technology in
its research and development efforts, the Company has entered
into various license agreements. These agreements generally
stipulate that the Company pay license fees and royalties on
future product sales. In addition, many of the agreements
obligate the Company to make contractually defined payments upon
the achievement of certain milestones.
License expenses and milestone payments amounted to
approximately 1,212,000, 953,000 and 309,000
for the years ended December 31, 2005, 2004 and 2003,
respectively. Of these amounts 1,025,000, 846,000
and 25,000 for the years ended December 31, 2005,
2004 and 2003, respectively, were related to the intellectual
property marketing agreement with Enzon, Inc. as discussed in
Note 15. These amounts have been included in research and
development expenses.
Furthermore, the Company is party to several research and
development agreements as discussed in Note 16.
F-47
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
The Companys fixed commitments under license and research
and development agreements are as follows (in thousand euros):
|
|
|
|
|
2006
|
|
|
83
|
|
2007
|
|
|
83
|
|
2008
|
|
|
83
|
|
|
|
|
|
|
Total minimum payments
|
|
|
249
|
|
|
|
|
|
|
Other
taxes
The Company has reserved accruals for contingent liabilities
related to non-income tax matters in the amounts of
1,136,000 and 931,000 as of December 31, 2005
and 2004, respectively. Of these amounts 266,000 and
245,000 at December 31, 2005 and 2004, respectively,
relate to the deduction and reimbursement of input Value Added
Tax (VAT) incurred on expenses related to the
increase of the stated capital. The revenue authorities have
denied the deduction and the Company has filed an appeal against
the respective assessment. The appeal is pending and depends on
the outcome of a model case pending with the supreme fiscal
court in a similar matter. The remaining accruals of
870,000 and 686,000 at December 31, 2005 and
2004, respectively, relate to withholding tax duty on royalty
payments affecting foreign recipients.
|
|
12.
|
Stockholders
Equity (Deficit)
|
Equity
transactions
On May 25, 2004, the Company approved a change in exercise
price and of the performance goal for most options issued to
employees and supervisory board members under the 2000 and 2002
stock option plans. The new exercise price is calculated using a
formula based on the ratio of the yield to invested capital,
which results in an exercise price range of between 35.50
and 284.00. The consequences of these changes on the
accounting for these options are described further in the
section of this note entitled Stock-Based
Compensation.
On October 11, 2005, the Company simplified its capital
structure through conversion of the pre-existing preferred
shares (Series A through F) into a new class of voting
preferred shares (Series A) in a ratio of one old
share for one new share. Furthermore, the Company agreed on a
2-for-71
reverse stock split for all outstanding common and preferred
shares and related options and conversion features.
At the shareholders meeting in October 2005 the
shareholders resolved to further invest up to 8,000,000 in
shares of new preferred shares (Series A) and
preferred shares (Series B). On October 11, 2005,
Micromet received proceeds of 4,018,000 upon issuance of
1,005,260 shares of Series A preferred stock and
2,121,835 shares of Series B preferred stock (combined
3,127,095 shares) to existing shareholders at approximately
1.285 per share. Every holder of shares of preferred
stock is entitled to demand at any time that the shares be
converted, whether individually or in total, into shares of
common stock at a ratio of one-to-one.
The Company determined that there was a beneficial conversion
feature in this issuance of convertible preferred stock. At the
date of issuance, the excess of the aggregate fair value of the
common shares that the holder would receive at conversion over
the proceeds received is approximately 72,275,000. A
beneficial conversion charge, which is limited to the amount of
proceeds received, of 4,018,000 was recorded as a discount
on the value of preferred stock and an increase in additional
paid-in capital. Because the preferred stock is immediately
convertible, the Company fully amortized such beneficial
conversion feature on the date of issuance.
As discussed in Note 8, in December 2005 and January 2006
the Company received notification from holders of the 2004
convertible notes of their intent to convert. On
December 19, 2005, Enzon exercised the conversion option of
its convertible note upon request by the Company as a
consequence of the termination of the collaboration as discussed
in Notes 8 and 16. In January 2006, 18,704 shares of
preferred shares (Series B) were issued in full
F-48
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
satisfaction of the principal and accrued interest of the 2004
convertible preferred notes and 16,836 shares of common
stock were issued in full satisfaction of the Enzon convertible
note. The Enzon convertible note and certain of the 2004
convertible notes (where the conversion notices were received
before December 31, 2005) are included in
stockholders equity as stock subscription from conversion
due to the irrevocable notice received from these noteholders
and the Companys irrevocable obligation to issue shares to
these noteholders in accordance with the terms of the original
note agreements.
Convertible
Preferred Stock
Subsequent to the capital restructuring resolved on
October 11, 2005, the Company is authorized to issue two
classes of convertible preferred stock: Series A and
Series B. The Companys convertible preferred stock
has the following significant characteristics, as amended:
Voting
Rights
Convertible preferred stockholders are entitled to one vote per
share.
Dividend
Rights
Convertible preferred stockholders and common stockholders are
entitled to dividends, if and when declared. Convertible
preferred stockholders are not entitled to any preferred
dividend payments as compared to common stockholders. No
dividends were declared through December 31, 2005.
Anti-Dilution
Protection
If new shares in the Company are issued, certain anti-dilution
provisions shall apply. No rights have been exercised through
December 31, 2005.
Rights of
First Refusal
A stockholder intending to sell his or her current or future
stockholding in the Company out of consideration shall offer
such shares for sale to all other stockholders. All other
shareholders (the First Right Holders) are entitled
to accept the offer in ratio to their respective stockholding in
the Company. If any stockholder waives first rights, the
remaining preferred shareholders are entitled to the right of
first refusal on the waived rights pro rata to their respective
shareholding in the Company. The rights of first refusal may
only be exercised or waived by a stockholder in whole, not in
part.
Veto
Rights
The following resolutions require a 75% majority approval of the
holders of convertible preferred stock: 1) transformation
of the Company within the meaning of § 1 of the German Act
on Transformation of Companies; 2) sale of more than 75% of
the Companys assets; 3) merger of the Company with
another entity; 4) liquidation of the Company;
5) amendments to the Companys Articles of
Association; 6) actions concerning the increase or
reduction of share capital; 7) granting of consent in
respect of the conclusion of corporate agreements within the
meaning of § 291 of the German Stock Corporation Act;
8) integration within the meaning of § 139 of the
German Stock Corporation Act; 9) creation of new classes of
shares which grant equal or preferred rights as compared to
preference shares; 10) appointment of auditors;
11) election and dismissal of members of the Companys
supervisory board; 12) redemption of shares; and
13) distribution to stockholders.
Liquidation/Sale
Proceeds
In the event of dissolution of the Company, the holders of
preferred shares shall have the following preference rights. Up
to the amount of 19.647 per each preferred share
(Series B), plus the amount of the resolved but
F-49
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
undistributed dividends attributable to the preferred shares
(Series B), of the liquidation proceeds shall be first paid
out to the holders of preferred shares (Series B). In the
event that the liquidation proceeds are not sufficient for the
payment of such amounts, the liquidation proceeds shall be
distributed to the holders of preferred shares (Series B),
among them in proportion to the number of preferred shares
(Series B) held by them, respectively.
Thereafter, up to the amount of 49.818 per each
preferred share (Series A), plus the amount of the resolved
but undistributed dividends attributable to the preferred shares
(Series A), of the remaining liquidation proceeds shall be
paid out to the holders of preferred shares (Series A). In
the event that the remaining liquidation proceeds are not
sufficient for the payment of such amounts, the liquidation
proceeds shall be distributed to the holders of preferred shares
(Series A), among them in proportion to the number of
preferred shares (Series A) held by them, respectively.
After the aforementioned payments to the holders of the
preferred shares (Series B) and
(Series A) have been made, 5% of any remaining
liquidation proceeds shall be distributed to the holders of
common shares pro rata, and the remaining 95% of any remaining
liquidation proceeds shall be distributed to the holders of
preferred shares pro rata.
Terms of
Conversion
Every holder of preferred shares is entitled to demand at any
time that the shares be converted, whether individually or in
total, into common shares at a ratio of one-to-one.
A summary of convertible preferred shares is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate
|
|
|
|
|
|
|
Shares
|
|
|
|
|
|
Liquidation
|
|
|
|
Shares
|
|
|
Issued and
|
|
|
Share
|
|
|
Preference
|
|
|
|
Authorized
|
|
|
Outstanding
|
|
|
Price
|
|
|
(outstanding shares)
|
|
December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series (A new)
|
|
|
2,123,918
|
|
|
|
1,232,876
|
|
|
|
50.63
|
|
|
|
62,423,865
|
|
Series (B new)
|
|
|
2,145,733
|
|
|
|
2,121,835
|
|
|
|
1.42
|
|
|
|
3,013,131
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269,651
|
|
|
|
3,354,711
|
|
|
|
|
|
|
|
65,436,996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series (A new)
|
|
|
1,118,658
|
|
|
|
227,616
|
|
|
|
269.83
|
|
|
|
61,418,605
|
|
Series (B new)
|
|
|
23,898
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,142,556
|
|
|
|
227,616
|
|
|
|
|
|
|
|
61,418,605
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
Subscription Receivable
During 1998, treasury stock was issued to employees in exchange
for non-interest bearing stock subscription receivables. The
balance of such receivables as of December 31, 2005 and
2004 was 297,000 and 299,000, respectively. Such
receivables are recorded as a reduction of stockholders
equity.
Stock
Option Plan
In December 2000, the Company adopted the 2000 Stock Option Plan
(2000 Plan), which provides for the granting of
incentive stock options to selected employees, executives and
its affiliates. The 2000 Plan authorized the grant of options to
purchase up to 600,305 shares of the Companys common
stock. Options granted may be exercisable after three years and
in general vest rateably over a three-year period commencing
with the grant date and expire no later than eight years from
the date of grant. As of December 31, 2005, 6,592 options
remain available for grant under this plan.
F-50
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
In November 2002, the Company adopted the 2002 Stock Option Plan
(2002 Plan), which provides for the granting of
incentive stock options to selected employees, executives and
its affiliates. The 2002 Plan authorized the grant of options to
purchase up to 11,933 shares of the Companys common
stock. Options granted may be exercisable after three years and
in general vest rateably over a three-year period commencing
with the grant date and expire no later than eight years from
the date of grant. As of December 31, 2005, 2,279 options
remain available for grant under this plan.
The shareholders meeting on May 25, 2004 approved the
change in issue price and of the performance goal of the options
granted under the 2000 Stock Option Plan, the 2002 Stock Option
Plan and options granted to supervisory board members. The issue
price to purchase a no par share is calculated using a formula
that depends on an investment multiple in the scenarios of an
initial public offering or a change in control. The investment
multiple is determined on the basis of the ratio of the yield to
the invested capital as described in the plan. In predefined
steps, the issue price increases as the investment multiple
increases. Depending on the investment multiple, the issue price
is between 35.50 and 284.00 as described in the plan.
The Companys stock option activity (including grants to
supervisory board members) for the years ended on
December 31, 2005, 2004 and 2003 is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
Options
|
|
|
Average
|
|
|
|
Outstanding
|
|
|
Exercise Price
|
|
|
|
|
|
|
(euro)
|
|
Balance at January 1,
2003
|
|
|
595,399
|
|
|
|
8.58
|
|
Granted to employees
|
|
|
9,451
|
|
|
|
6.34
|
|
Granted to supervisory board
members
|
|
|
600
|
|
|
|
11.97
|
|
Forfeited
|
|
|
(10,974
|
)
|
|
|
8.62
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2003
|
|
|
594,476
|
|
|
|
7.89
|
*
|
Forfeited
|
|
|
(21,184
|
)
|
|
|
6.34
|
|
Granted to employees
|
|
|
4,761
|
|
|
|
35.5 - 284.0
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2004
|
|
|
578,053
|
|
|
|
35.5 - 284.0
|
|
Forfeited
|
|
|
(825
|
)
|
|
|
35.5 - 284.0
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2005
|
|
|
577,228
|
|
|
|
35.5 - 284.0
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
As noted above, outstanding options (including options to
supervisory board members) were modified in May 2004. Amounts
presented in the table above at dates prior to May 2004 do not
reflect such modifications.
|
As of December 31, 2005 and 2004, 577,228 and 578,053
options, respectively, were outstanding, of which 574,349 and
570,654, respectively, were vested. The weighted average fair
value of options granted during 2005, 2004 and 2003 was 0.
As of December 31, 2005, the weighted average remaining
contractual life of outstanding options was 3.55 years. As
of December 31, 2005 and 2004, no options were exercisable
as the performance goals were not met.
F-51
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
Stock-Based
Compensation
There were no options granted in the year ended
December 31, 2005. The fair value of each option grant in
2004 and 2003 was estimated on the date of grant using the
Black-Scholes option-pricing model with the following weighted
average assumptions and results for options granted during the
periods presented:
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
2003
|
|
Weighted average risk free
interest rate
|
|
|
3.42
|
%
|
|
|
3.89
|
%
|
Expected dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Expected life (in years)
|
|
|
4.00
|
|
|
|
4.00
|
|
Weighted average calculated fair
value at grant date
|
|
|
0.00
|
|
|
|
0.00
|
|
The modification in May 2004 of the options granted under the
2000 Plan and 2002 Plan was accounted for in accordance with
SFAS 123. Under the guidance of SFAS 123, a
modification of an option award is treated as an exchange of the
previously issued option award for a new option award. Any
incremental fair value in measuring the new award would be
amortized along with any remaining unamortized compensation from
the original award over the new vesting period. The modification
did not result in any incremental compensation expense for the
modified options.
The Company recognized stock compensation expense of 2,000
and 18,000 for 2004 and 2003, respectively, primarily
related to stock options granted prior to fiscal 2002. In 2005,
no stock compensation expense was recorded.
Loans
to Related Parties
Beginning in 1998, the Company granted unsecured loans to
related parties and employees with interest rates ranging from
5.5% to 6.0%. The outstanding loans to related parties totalled
239,000 as of each of December 31, 2005 and 2004.
|
|
14.
|
Financial
Risk Management Objectives and Policies
|
The Companys principal financial instruments comprise of
long-term debt, convertible notes, capital leases, cash and
short-term investments. The Company has various other financial
instruments such as accounts receivable and accounts payable.
Foreign
Currency Risk
The Company has transactional currency exposure. Such exposure
arises from revenues generated in currencies other than the
Companys measurement currency. Approximately 23%, 33% and
22% of the Companys revenue was denominated in US dollars
in 2005, 2004 and 2003, respectively. Although the Company has
significant customers with the US dollar as their functional
currency, the majority of the Companys transactions are
contracted in euros. Rendered services contracted in US dollars
are exposed to movements in the US$/euro exchange rates within
contractually agreed fluctuation ranges. Certain license fees
and milestone payments are denominated in US dollars. The
Company has not hedged this exposure.
Credit
and Liquidity Risk
Financial instruments that potentially subject the Company to
credit and liquidity risk consist primarily of cash, cash
equivalents, short-term investments and accounts receivable.
It is the Companys policy to place all of its cash
equivalents, short-term investments and deposits with
high-credit quality issuers. In the event of a default by the
institution holding the cash, cash equivalents, short-term
F-52
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
investments and restricted cash, the Company is exposed to
credit risk to the extent of the amounts recorded on the balance
sheets. The Company continually monitors the credit quality of
the financial institutions which are counterparts to its
financial instruments.
The Companys accounts receivable is subject to credit risk
as a result of customer concentrations.
Customers comprising greater than 10% of the accounts receivable
balances presented as a percentage of total receivables are as
follows:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
Abbot Laboratories
|
|
|
57
|
%
|
|
|
|
|
MedImmune, Inc.
|
|
|
37
|
%
|
|
|
12
|
%
|
Serono International S.A.
|
|
|
|
|
|
|
87
|
%
|
Customers comprising greater than 10% of total revenues
presented as a percentage of total revenues are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
Serono International S.A.
|
|
|
52
|
%
|
|
|
|
|
|
|
|
|
MedImmune, Inc.
|
|
|
22
|
%
|
|
|
41
|
%
|
|
|
17
|
%
|
Enzon, Inc.
|
|
|
16
|
%
|
|
|
20
|
%
|
|
|
22
|
%
|
CTI, Inc.
|
|
|
|
|
|
|
19
|
%
|
|
|
61
|
%
|
The Company had unbilled accounts receivable of approximately
698,000 and 2,887,000 as of December 31, 2005
and 2004, respectively. The amounts are included in accounts
receivable.
Fair
Value of Financial Instruments
The carrying value of cash and cash equivalents, accounts
receivable and accounts payable approximate their fair value
based upon the expected short-term settlement of these
instruments. The fair value of marketable securities is based
upon quoted market prices.
The valuation analysis of financial instruments essentially
assumes that investors holding the underlying debt instruments
of the Company face two risks that need to be reflected in the
fair value ranges which are: (a) the risk of technical
success of the research and development projects/technology and
(b) the potential lack of funds to support the research and
development projects/technology given limited funds available as
per the valuation dates (Default Risk). The Default
Risk of the Company is essentially represented by the
Companys future success in raising sufficient funds to
support its research activities until cash flow break-even.
In determining fair values, the Company used a discounted cash
flow model with current incremental borrowing rates for
long-term debt and similar convertible debt instruments.
In determining fair values, the conversion of certain 2004
convertible notes in the aggregate value of 10,188,000,
including accrued interest, into preferred shares and the
conversion of the Enzon Convertible Note in the carrying amount
of 9,302,000 into common shares have been included in the
fair value model due to the irrevocable notice received from
these noteholders and the Companys irrevocable obligation
to issue shares to these noteholders in accordance with the
terms of the note agreements. The conversions have become
effective by issuance of the preferred and common shares to the
holders on January 3, 2006 as further discussed in
Note 8 and 19.
F-53
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
The estimates of fair value of the following financial
instruments are summarized as follows (in thousands of euros):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005
|
|
|
December 31, 2004
|
|
|
|
Carrying
|
|
|
Fair
|
|
|
Carrying
|
|
|
Fair
|
|
|
|
Amount
|
|
|
Value
|
|
|
Amount
|
|
|
Value
|
|
Curis, Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loan note
|
|
|
2,408
|
|
|
|
772
|
|
|
|
3,250
|
|
|
|
1,407
|
|
MedImmune Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible note due June 6,
2010
|
|
|
10,000
|
|
|
|
7,459
|
|
|
|
10,000
|
|
|
|
8,292
|
|
Enzon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible note due
March 31, 2007
|
|
|
|
|
|
|
|
|
|
|
9,302
|
|
|
|
5,892
|
|
Shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes due
December 31, 2006
|
|
|
2,331
|
|
|
|
87
|
|
|
|
10,000
|
|
|
|
15,726
|
|
tbg (Silent Partner)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings due December 31,
2006
|
|
|
1,345
|
|
|
|
1,271
|
|
|
|
1,269
|
|
|
|
1,136
|
|
Bayern Kapital (Silent Partner)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings due December 31,
2006
|
|
|
1,487
|
|
|
|
1,429
|
|
|
|
1,381
|
|
|
|
1,276
|
|
tbg (Silent Partner)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings due December 31,
2008
|
|
|
2,280
|
|
|
|
1,972
|
|
|
|
2,15
|
|
|
|
1,776
|
|
Technologie-Fonds Bayern (Silent
Partner)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings due December 31,
2008
|
|
|
2,390
|
|
|
|
2,050
|
|
|
|
2,230
|
|
|
|
2,018
|
|
European Technology Ventures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings due 36 months
after drawdown
|
|
|
92
|
|
|
|
88
|
|
|
|
1,041
|
|
|
|
966
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
22,333
|
|
|
|
15,128
|
|
|
|
40,623
|
|
|
|
38,489
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company has entered into several contractual agreements with
third parties for the licensing of certain technologies or
products. In exchange for, or in receipt of, the rights to the
technology or products, the agreements provide for the payment
of license fees, milestones and royalties upon future net sales.
The Company entered into the following significant license
agreements:
Isogenis,
Inc., Colorado, USA
In October 1999, the Company entered into a license agreement
with Isogenis, Inc. (formerly Biohybrid, Inc.) related to the
usage and patent rights of hybrid ligand directed to activation
of cytotoxic effector lymphocytes and target associated
antigens. Upon the sale of products developed using the licensed
patents and technology, the Company will pay royalty fees on net
sales in the US as defined in the agreement. Furthermore, the
Company is obligated to pay guaranteed annual license fees and
certain milestones for each licensed product developed under the
agreement and commercialized in the US.
Expenses associated with this agreement were US$100,000 for each
of the years ended December 31, 2005, 2004 and 2003.
Dyax
Corporation, Massachusetts, USA
In October 2000, the Company entered into a license agreement
with Dyax Corporation for the usage of certain phase display
techniques.
F-54
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
Under the terms of the agreement, the Company is obliged to pay
an initial license fee and certain milestone payments as defined
in the agreement.
No expenses were incurred or recorded under this agreement in
the years ended December 31, 2005, 2004 and 2003.
Curis,
Inc., Cambridge, USA
In June 2001, the Company and Curis entered into an agreement
for the Company to purchase certain single-chain antigen binding
molecule patents and license rights from Curis. In exchange for
these patents and license rights, the Company paid Curis
approximately 9,464,000 in cash, 213,213 shares of
its common stock valued at approximately 1,900,000 and
provided a convertible note valued at approximately
3,500,000 (face value of 4,068,000). As described in
Note 8, the convertible note was amended in November 2004.
As further consideration, the Company is required to pay
royalties on net sales for products based on the acquired
technology as specified in the agreement. In addition, the
Company is required to pay to Curis 20.00% of all supplemental
revenues in excess of US$8,000,000. Supplemental revenues are
defined in the agreement as net enforcement revenues and net
technology revenues. Net enforcement revenues are proceeds
received as damages and/or settlements for infringement of the
purchased technology resulting from suits filed by the Company.
Net technology revenues are amounts received by the Company for
licensing or sublicensing the purchased technology.
No expenses were incurred or recorded under this agreement in
the years ended December 31, 2005, 2004 and 2003.
Cambridge
Antibody Technology Limited, Cambridgeshire, Great
Britain
The Company has the following agreements with Cambridge Antibody
Technology Ltd. (CAT):
1. Non-exclusive
Product License Agreement regarding EpCAM target
The Company and CAT signed a product license agreement on
September 3, 2003 granting the Company a non-exclusive,
worldwide license to develop and commercialize antibodies
binding to the EpCAM target based on the patents in-licensed by
CAT in the field of phage display technology and the
corresponding CAT background knowledge. The Company paid an
initial license fee on the effective date of the agreement and
will pay milestones and royalties as defined in the agreement.
In addition, the Company has granted to CAT a non-exclusive
worldwide license free of charge for improvements to its phage
display technology.
2. Non-exclusive
Product License Agreement regarding GM-CSF target
On November 3, 2003, the Company and CAT entered into a
non-exclusive worldwide product license agreement with reference
to the GM-CSF target. The agreement grants to the Company the
right, in the course of its joint research activities with
Enzon, to develop products in the field of the GM-CSF target
using the technology patented by CAT. The Company paid to CAT an
initial license fee on the effective date of the agreement and
will pay certain milestones and royalties as defined in the
agreement. The costs will be shared between the Company and
Enzon as part of their joint research activities.
No expenses were incurred or recorded under these agreements in
the years ended December 31, 2005 and 2004. In the year
ended December 31, 2003, expenses associated with the
agreements with CAT were 160,000.
Intellectual
Property Marketing Agreement, Enzon, Inc., Bridgewater,
USA
In April 2002, the Company and Enzon entered into an
intellectual property marketing agreement to jointly market
their complementary patent estates in the field of single-chain
antibody (SCA) technology. The intellectual property
marketing agreement associated with the cross-license agreement
between the Company
F-55
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
and Enzon designates the Company as the exclusive marketing
partner for the consolidated intellectual property portfolio. In
consideration for the licenses granted, the Company receives
initial license fees, annual license maintenance fees as well as
milestone and royalty payments from the development and
commercialization of any resulting products. Revenues from
resulting products received from third parties are subject to
royalty payments to Enzon. Costs related to the marketing
activities will be shared between the Company and Enzon.
On September 3, 2003, the Company and CAT signed a
cross-license agreement to enable CAT, the Company and Enzon to
access each partys technology. Pursuant to the agreement,
each contractual partner provides the other with certain patents
in the field of single-chain antibodies or phage display
technology, together with its related know-how on the research
and development of antibody products in the defined research
fields. The cross-license agreement is subject to initial
license fees, annual maintenance fees and to fees for
sublicenses granted to other third parties, as well as annual
sublicense maintenance fees until the termination of such
sublicense or the last to expire valid claim under such
sublicense agreement, whichever occurs first.
In 2003, the Company granted a research license to ESBATech AG
(ESBATech) under the intellectual property marketing
agreement. ESBATech also has the option to extend the scope of
the license to use single-chain antibodies in the development of
therapeutics.
In 2004, the Company entered into research license agreements
with BioInvent AB, Merck & Co., Inc., and EvoGenix Pty
Ltd. in the field of SCAs. Arizeke Pharmaceuticals Inc. received
a product license for development and commercialisation of SCAs
targeting its proprietary pIgR antigen.
In 2005, the Company granted access to single-chain antibody
technology to Abbott Laboratories (Abbott),
Alligator Bioscience AB (Alligator), Haptogen Ltd.
(Haptogen) and an undisclosed biopharmaceutical
company. Abbott, Alligator and Haptogen received research
licenses and an undisclosed biopharmaceutical company received a
product license for the development and commercialisation of an
SCA product for the treatment of cancer.
The Company recorded revenue associated with the license
agreements of approximately 2,050,000, 1,691,000 and
50,000 in the years ended December 31, 2005, 2004 and
2003, respectively. Royalties paid to Enzon were approximately
1,025,000, 846,000 and 25,000 in the years
ended December 31, 2005, 2004 and 2003, respectively, and
were included in research and development expenses.
|
|
16.
|
Research
and Development Agreements
|
The Company is party to the following significant research and
development agreements related to its research and development
strategy:
Enzon,
Inc., Bridgewater, USA
In April 2002, the Company entered into a multi-year strategic
collaboration with Enzon to identify and develop the next
generation of antibody-based therapeutics. In June 2004, the
Company and Enzon amended and restated their collaboration to
advance certain novel Single-Chain Antibody (SCA)
therapeutics toward clinical development. During the first phase
of the collaboration, between April 2002 and June 2004, the
parties established a research and development unit at the
Companys facility and generated several new SCA compounds
and monoclonal antibodies against targets in the field of
inflammatory and autoimmune diseases.
On November 28, 2005, the Company and Enzon announced an
agreement to end the companies collaboration. Under the
termination agreement, Enzon made a final payment to the Company
in satisfaction of its obligations under the collaboration. In
addition, the Company received rights to the lead compound
(MT203) generated within the scope of the collaboration and
Enzon will receive royalties on any future product sales. The
termination of the research and development collaboration does
not impact the other existing agreements between the Company and
Enzon.
F-56
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
The Company and Enzon will continue to market their combined
complementary patent estates in the field of SCAs, with the
Company being the exclusive worldwide marketing partner as
discussed in Note 15.
The Company recorded revenue of approximately 3,346,000,
2,668,000 and 2,832,000 associated with the
collaboration agreement in the years ended December 31,
2005, 2004 and 2003, respectively.
The Company recorded fees billed by Enzon of approximately
50,000, 50,000 and 309,000 associated with the
collaboration agreement in the years ended December 31,
2005, 2004 and 2003, respectively, which are included in
research and development expenses in the statements of
operations.
Cell
Therapeutics Inc., Seattle, USA (formerly Novuspharma S.p.A.,
Bresso, Italy)
In August 2002, the Company entered into a collaboration
agreement with Novuspharma S.p.A. (which subsequently was
acquired by Cell Therapeutics, Inc.) to collaborate on the
development of adecatumumab (MT201) a fully human monoclonal
antibody. The agreement was terminated in February 2004, as
disclosed in Note 17.
MedImmune,
Inc., Gaithersburg, USA
On June 6, 2003, the Company entered into the following
agreements with MedImmune:
1. MT103
Collaboration and License Agreement
On June 6, 2003, the Company and MedImmune signed an
agreement to jointly develop the Companys B cell tumor
drug, MT103, the most advanced representative of the
Companys BiTE platform. Under the terms of the
collaboration and license agreement, MedImmune received the
Companys product rights to MT103 in North America and
assumed responsibility for clinical development, registration
and commercialization of the product in that region. As part of
the agreement, MedImmune will develop the commercial
manufacturing process and supply clinical trial material as well
as commercial products for all markets. The Company retained
rights to MT103 outside of North America. The Company will
receive milestone payments based on the successful development,
filing, registration and marketing of MT103, as well as
royalties on MedImmunes North American sales of the
product. In addition, MedImmune will cover certain development
costs incurred by the Company necessary to support the
Investigational New Drug (IND) application filing
for MT103. After submission of the IND, the parties will share
development costs of jointly conducted clinical trials in
accordance with the specifications of the agreement.
The Company recorded revenue of approximately 1,790,000,
2,968,000 and 1,997,000 associated with the
agreement in the years ended December 31, 2005, 2004 and
2003, respectively.
2. BiTE
Research Agreement
In addition to the MT103 co-development agreement, the parties
will collaborate to create and develop up to six new products
based on the BiTE platform. The Company is entitled to receive
milestones and royalties on future product sales of all
resulting BiTE products. Furthermore, the Company has the option
to obtain exclusive European rights for BiTE compounds based on
targets non-proprietary to MedImmune and the option to receive
co-promotion rights in Europe for BiTE compounds based on
MedImmunes proprietary targets. For each new BiTE
molecule, MedImmune will cover full development costs up to
Phase 1. The Company will be responsible for the generation
of the new BiTE molecules.
The Company recorded revenue of approximately 2,723,000,
2,550,000 and 252,000 associated with the agreement
in the years ended December 31, 2005, 2004 and 2003,
respectively.
F-57
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
Rentschler
Biotechnologie GmbH
In September 2002, the Company entered into a process
development agreement with Rentschler Biotechnology GmbH
(Rentschler) to establish fermentation and
down-stream processing procedures under GMP (Good
Manufacturing Practices) requirements in the 250L
fermenter scale for the adecatumumab (MT201) program. This
agreement was amended on August 19, 2004 by a new
production agreement for clinical trial material. Under the
terms of the new agreement, the drug substance is billed at a
fixed price per gram in accordance with the contractual
specifications.
The Company recorded expenses of approximately 393,000,
3,424,000 and 4,900,000 in the years ended
December 31, 2005, 2004 and 2003, respectively, related to
this agreement, which are included in research and development
expenses in the statements of operations.
Boehringer
Ingelheim Pharma GmbH & Co. KG
In December 2003, the Company entered into a process development
agreement with Boehringer Ingelheim Pharma GmbH & Co.
KG (Boehringer Ingelheim). Under the agreement,
Boehringer Ingelheim will develop a commercial scale process for
adecatumumab (MT201) by using its proprietary, high expression
cell line and
state-of-the-art
manufacturing technology. Boehringer Ingelheim will supply the
Company with material for clinical trials and future
commercialization, as required in a
time-to-market
approach.
In addition, the Company has the option of obtaining a license
to Boehringer Ingelheims high expression technology for
the manufacturing of the adecatumumab (MT201) antibody. The
license granted by Boehringer Ingelheim carries an obligation
for the Company to pay milestones and royalties on future net
sales. Boehringer Ingelheim received an option for commercial
manufacturing of adecatumumab (MT201). The option has not been
exercised at this time.
Expenses associated with this agreement were approximately
1,277,000, and 2,609,000 in the years ended
December 31, 2005 and 2004, respectively, which are
included in research and development expenses in the statements
of operations.
Serono
International S.A., Geneva, Switzerland
In December 2004, the Company and a wholly-owned subsidiary of
Serono International S.A. (Serono) entered into a
collaboration agreement for further development and
commercialization of adecatumumab (MT201). The Company and
Serono desire to obtain marketing approval of adecatumumab
(MT201) for various indications, and thereafter to have one or
both parties commercialize adecatumumab (MT201). Serono has the
right to terminate the collaboration agreement upon
180 days written notice.
The Company granted to Serono an exclusive, worldwide license,
with the right to sublicense, under the licensed technology, to
make, use or sell the product and to all data, information,
know-how, materials and regulatory or institutional
authorizations pertaining to the product.
Subject to the terms and conditions of the agreement, the
Company will complete the ongoing Phase 2 clinical trials
in patients with prostate cancer or metastatic breast cancer,
including the collection of data and the preparation of final
reports pertaining thereto (the Micromet Program).
In addition, the Company is responsible for the management of
the Companys Process Development Agreement with Boehringer
Ingelheim and certain preclinical work.
Serono will be responsible for all development expenses incurred
by the parties. Serono will reimburse the Companys
internal expenses at a certain rate under the Micromet Program.
Serono paid a non-refundable initial license fee in the amount
of US$10,000,000.
F-58
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
Serono will make certain milestone payments, up to approximately
US$138,000,000 if the product is successfully developed and
registered worldwide in three or more indications. In addition,
the Company will receive royalties based on future net sales of
the product as defined in the agreement. Under certain terms and
conditions, Micromet may elect to share in the development and
commercialisation of the product in the US and EU in exchange
for a share of profits and in lieu of royalties.
The deliverables within the license and collaboration agreement
with Serono have been considered for separation. The license
granted and the payments for research and development services
performed under the Micromet Program of the collaboration
agreement have been identified as a combined unit of accounting.
Revenue related to the combined unit of accounting will be
recognized using a proportionate performance model over the
period of the Micromet Program.
Revenues related to product sales will be recognized when such
sales occur.
The Company recognized revenues of approximately
10,780,000 and 911,000 associated with this license
and collaboration agreement in the years ended December 31,
2005 and 2004, respectively.
|
|
17.
|
Litigation
Concerning Cell Therapeutics Inc., Seattle, USA
|
On January 2, 2004, the Companys collaborator,
Novuspharma S.p.A., was acquired by Cell Therapeutics Inc.
(CTI). Subsequently, CTI management announced that
it would not make any payments to the Company for outstanding
invoices and contractual obligations.
On February 10, 2004, the collaboration agreement with CTI
was terminated on the basis of the failure of CTI to meet its
contractual payment obligations. On the same date, the Company
commenced legal proceedings against CTI for breach of contract.
On February 23, 2004, CTI filed a counterclaim against the
Company. Based on assessment of the contract, management
believes that it is likely the Company will prevail against the
countersuit and therefore no financial provisions have been
made. In December 2005, the parties submitted the dispute to
non-binding mediation. Although discussions with the mediator
are ongoing as the litigation continues, there can be no
assurance that the parties will be able to reach agreement on
this matter.
Prior to termination of the agreement, 4,930,000 of
invoices submitted for payment to Novuspharma were not paid, of
which 2,180,000 was invoiced in 2003 and 2,750,000
was invoiced in 2004. As collectability was not reasonably
assured, the Company did not record revenues and receivables
related to these unpaid invoices.
The Company received an up-front payment of 4,000,000 from
Novuspharma S.p.A. in 2002 and was recognizing the payment
ratably over the expected collaboration period. Due to the
termination of the collaboration, the remaining portion was
recognized in the year ended December 31, 2004.
Extensive restructuring measures were initiated in 2004 after
the termination of the Cell Therapeutics, Inc. collaboration.
The restructuring measures included reduction of the
Companys workforce from 135 full-time employees to
90, which was initiated in January 2004 and completed at the end
of March 2004. As part of this restructuring, the Company paid
termination benefits of approximately 297,000
(264,000 and 33,000 included in research and
development and general and administrative expense,
respectively).
As a consequence of the restructuring of operations during 2004,
the Company ceased use of certain space under the building lease
agreement in December 2004. Pursuant to SFAS 146,
Accounting for Costs Associated with Exit or Disposal
Activities, the fair value of the liability at the cease-use
date should be determined based on the remaining lease rentals,
reduced by estimated sublease rentals that could be reasonably
obtained. Accordingly, the Company recorded provisions in the
amount of 840,000, determined using a credit-adjusted risk
free discount
F-59
MICROMET
AG
NOTES TO
FINANCIAL STATEMENTS (Continued)
rate of 17%, for losses on sublease for the remaining lease
period as of December 31, 2004. Activity of the
restructuring provision in 2005 is as follows:
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|
|
|
|
|
|
|
|
|
|
Accrued
|
|
|
|
|
|
|
|
|
Accrued
|
|
Balance as of
|
|
|
Amounts
|
|
|
|
|
|
Balance as of
|
|
December 31,
|
|
|
Paid in
|
|
|
Accretion
|
|
|
December 31,
|
|
2004
|
|
|
Period
|
|
|
Expense
|
|
|
2005
|
|
|
|
840,000
|
|
|
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(452,000
|
)
|
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|
118,000
|
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506,000
|
|
Conversion
of Convertible Notes
As discussed in Notes 8 and 12, on January 3,
2006, the convertible notes in the aggregate nominal amount of
10,000,000 issued in 2004 to certain shareholders of the
Company were converted into an aggregate of 18,704 shares
of preferred shares (Series B).
As discussed in Notes 8, 12 and 16, on
December 19, 2005, Enzon exercised the conversion option of
its convertible note upon request by the Company as a
consequence of the termination of its collaboration. In January
2006, the Company issued 16,836 common shares of the Company to
Enzon at a conversion price of 552.50 per common
share.
Signing
of Merger Agreement with CancerVax, Inc., California,
USA
On January 6, 2006, the Company entered into an Agreement
and Plan of Merger and Reorganization which was amended on
March 17, 2006 (as so amended, the Merger
Agreement) with CancerVax Corporation
(CancerVax), Micromet, Inc. (Micromet
Parent) and Carlsbad Acquisition Corporation (Merger
Sub). Upon the terms and subject to the conditions set
forth in the Merger Agreement, CancerVax has agreed to issue,
and the Companys stockholders will receive, shares of
CancerVax common stock such that the Companys
securityholders will own approximately 67.5% of the fully
diluted shares of the combined company, and CancerVax
securityholders will own approximately 32.5% of the fully
diluted shares of the combined company, in each case on a pro
forma basis and based on the exchange ratio set forth in the
Merger Agreement.
The Merger Agreement provides that Merger Sub, which is a
wholly-owned subsidiary of CancerVax, will merge with and into
Micromet Parent, with Micromet Parent becoming a wholly-owned
subsidiary of CancerVax and the surviving corporation of the
merger. The Merger Agreement also provides that immediately
prior to the merger, the holders of equity interests of the
Company will exchange their interests for shares of common stock
of Micromet Parent. Accordingly, as a result of the merger,
Micromet Parent will survive as a wholly-owned direct subsidiary
of CancerVax and, in turn, the Company will be a wholly-owned
indirect subsidiary of CancerVax.
Amendment
to the Silent Partnership Agreements
In January 2006, certain of the silent partnership agreements
were amended to accelerate repayment of amounts due (principal,
accrued interest, and one-time payments) upon the occurrence of
certain events. The amended silent partnership agreements with
Bayern Kapital GmbH and Technologie Beteiligungsfonds Bayern
GmbH & Co. KG state that repayment of certain amounts
due is required upon further rounds of financing of the Company
and after the consummation of the merger with CancerVax. The
amount subject to accelerated repayment is dependent on the
amount of the further financing, up to a total of
3,449,000 plus accrued and unpaid interest.
Four of the six silent partnership agreements with tbg
Technologie-Beteiligungs-Gesellschaft mbH were amended to
require repayment of all amounts due, which is a total of
1,994,000 plus accrued interest and unpaid interest,
within 14 days after the consummation of the merger with
CancerVax.
F-60
ANNEX A
AGREEMENT AND PLAN OF MERGER AND REORGANIZATION
among:
CancerVax
Corporation,
a Delaware corporation;
Carlsbad Acquisition
Corporation,
a Delaware corporation;
Micromet,
Inc.,
a Delaware corporation; and
Micromet AG,
a German corporation
Dated as of January 6, 2006
A-1
AGREEMENT
AND PLAN OF MERGER AND REORGANIZATION
This Agreement and
Plan of Merger and Reorganization (this
Agreement) is made and entered into as
of January 6, 2006, by and among
CancerVax
Corporation, a Delaware corporation
(CancerVax);
Carlsbad Acquisition
Corporation, a Delaware corporation
(Merger Sub);
Micromet,
Inc., a Delaware corporation
(Parent); and
Micromet
AG, a corporation organized under the laws of Germany
(Micromet). Certain capitalized terms
used in this Agreement are defined in Exhibit A.
Recitals
A. After the date of this Agreement, holders
of equity interests in Micromet will effect an exchange of their
interests for shares of common stock of Parent, as a result of
which Micromet will become a wholly-owned subsidiary of Parent
(the Micromet Recapitalization).
B. CancerVax, Parent and Micromet intend to
effect a merger of Merger Sub into Parent (the
Merger) in accordance with this
Agreement and the DGCL. Upon consummation of the Merger, Merger
Sub will cease to exist, and Parent will become a wholly-owned
subsidiary of CancerVax.
C. CancerVax, Merger Sub, Parent and Micromet
intend that the Merger qualify as a tax-free reorganization
within the meaning of Section 368(a) of the Code.
D. The Board of Directors of CancerVax
(i) has determined that the Merger is fair to, and in the
best interests of, CancerVax and its stockholders, (ii) has
approved this Agreement, the Merger, the issuance of shares of
CancerVax Common Stock to the stockholders of Parent pursuant to
the terms of this Agreement, the change of control of CancerVax,
and the other actions contemplated by this Agreement and
(iii) has determined to recommend that the stockholders of
CancerVax vote to approve the issuance of shares of CancerVax
Common Stock to the stockholders of Parent pursuant to the terms
of this Agreement, the change of control of CancerVax and such
other actions as contemplated by this Agreement.
E. The Board of Directors of Merger Sub
(i) has determined that the Merger is fair to, and in the
best interests of, Merger Sub and its sole stockholder,
(ii) has approved this Agreement, the Merger, and the other
actions contemplated by this Agreement and (iii) has
determined to recommend that the stockholder of Merger Sub vote
to approve the Merger and such other actions as contemplated by
this Agreement.
F. The Board of Directors of Parent
(i) has determined that the Merger is advisable and fair
to, and in the best interests of, Parent and its stockholders,
(ii) has approved this Agreement, the Merger and the other
transactions contemplated by this Agreement and has deemed this
Agreement advisable and (iii) has approved and determined
to recommend the approval and adoption of this Agreement and the
approval of the Merger to the stockholders of Parent.
G. In order to induce CancerVax to enter into
this Agreement and to cause the Merger to be consummated,
certain stockholders of Micromet (who, pursuant to the Micromet
Recapitalization will become stockholders of Parent) are
executing voting agreements in favor of CancerVax concurrently
with the execution and delivery of this Agreement in the form
substantially attached hereto as Exhibit B (the
Parent Stockholder Voting Agreements).
H. In order to induce Micromet and Parent to
enter into this Agreement and to cause the Merger to be
consummated, certain stockholders of CancerVax are executing
voting agreements in favor of Parent concurrently with the
execution and delivery of this Agreement in the form
substantially attached hereto as Exhibit C (the
CancerVax Stockholder Voting
Agreements).
A-5
Agreement
The parties to this Agreement, intending to be legally bound,
agree as follows:
Section 1. Description
of Transaction
1.1 Micromet
Recapitalization. Immediately prior to the
Closing Date, the stockholders of Micromet as of the date of
this Agreement shall consummate the Micromet Recapitalization
described on Part 1.1 of the Parent Disclosure Schedule
pursuant to which Micromet shall become a direct wholly-owned
subsidiary of Parent.
1.2 Merger of Merger Sub into
Parent. Upon the terms and subject to the
conditions set forth in this Agreement, at the Effective Time
(as defined in Section 1.4), Merger Sub shall be merged
with and into Parent, and the separate existence of Merger Sub
shall cease. Parent will continue as the surviving corporation
in the Merger (the Surviving
Corporation).
1.3 Effects of the Merger. The
Merger shall have the effects set forth in this Agreement and in
the applicable provisions of the DGCL. As a result of the
Merger, Parent will become a wholly-owned subsidiary of
CancerVax.
1.4 Closing; Effective
Time. Unless this Agreement is earlier
terminated pursuant to the provisions of Section 9.1 of
this Agreement, and subject to the satisfaction or waiver of the
conditions set forth in Sections 6, 7 and 8 of this
Agreement, the consummation of the Merger (the
Closing) shall take place at the
offices of Cooley Godward LLP, One Freedom Square, 11951 Freedom
Drive, Reston, Virginia, as promptly as practicable (but in no
event later than the fifth Business Day following the
satisfaction or waiver of the last to be satisfied or waived of
the conditions set forth in Sections 6, 7 and 8 (other than
those conditions that by their nature are to be satisfied at the
Closing, but subject to the satisfaction or waiver of each of
such conditions) or at such other time, date and place as Parent
and CancerVax may mutually agree in writing. The date on which
the Closing actually takes place is referred to as the
Closing Date. At the Closing, the
Parties hereto shall cause the Merger to be consummated by
executing and filing with the Secretary of State of the State of
Delaware a Certificate of Merger with respect to the Merger,
satisfying the applicable requirements of the DGCL and in a form
reasonably acceptable to CancerVax and Parent. The Merger shall
become effective at the time of the filing of such Certificate
of Merger with the Secretary of State of the State of Delaware
or at such later time as may be specified in such Certificate of
Merger with the consent of Micromet (the time as of which the
Merger becomes effective being referred to as the
Effective Time).
1.5 Certificate of Incorporation and Bylaws;
Directors and Officers. At the Effective
Time, unless otherwise determined by CancerVax prior to the
Effective Time:
(a) the Certificate of Incorporation of the Surviving
Corporation shall be the Certificate of Incorporation of Parent
immediately prior to the Effective Time, until thereafter
amended as provided by the DGCL and such Certificate of
Incorporation;
(b) the Certificate of Incorporation of CancerVax shall be
the Certificate of Incorporation of CancerVax immediately prior
to the Effective Time, until thereafter amended as provided by
the DGCL and such Certificate of Incorporation; provided,
however, that at the Effective Time, CancerVax shall file an
amendment to its certificate of incorporation to change the name
of CancerVax to Micromet, Inc. and to increase the
authorized shares of CancerVax Common Stock to
150,000,000 shares;
(c) the Bylaws of the Surviving Corporation shall be the
Bylaws of Parent immediately prior to the Effective Time, until
thereafter amended as provided by the DGCL and such
Bylaws; and
(d) (i) the directors of Parent immediately prior to
the Effective Time shall be the initial directors of the
Surviving Corporation, each to hold office in accordance with
the Certificate of Incorporation and Bylaws of the Surviving
Corporation, and (ii) the officers of Parent immediately
prior to the Effective Time shall be the initial officers of the
Surviving Corporation, in each case until their respective
successors are duly elected or appointed and qualified.
A-6
1.6 Conversion of
Shares. (a) At the Effective Time, by
virtue of the Merger and without any further action on the part
of CancerVax, Merger Sub, Parent, Micromet or any stockholder of
Parent:
(i) any shares of Parent Common Stock held as treasury
stock or held or owned by Parent, Merger Sub or any Subsidiary
of Parent immediately prior to the Effective Time shall be
canceled and retired and shall cease to exist, and no
consideration shall be delivered in exchange therefor; and
(ii) subject to Section 1.6(c), each share of Parent
Common Stock outstanding immediately prior to the Effective Time
(excluding shares to be canceled pursuant to
Section 1.6(a)(i) and excluding Dissenting Shares) shall be
converted solely into the right to receive a number of shares of
CancerVax Common Stock (such number, the Conversion
Factor) equal to (x) the product of
(I) the sum of (A) the number of shares of CancerVax
Common Stock outstanding immediately prior to the Effective
Time, (B) the number of shares of CancerVax Common Stock
issuable upon the exercise of Included CancerVax Options
outstanding immediately prior to the Effective Time and
(C) the number of shares of CancerVax Common Stock issuable
upon the exercise of CancerVax Warrants outstanding immediately
prior to the Effective Time and (II) a number equal to the
Exchange Ratio, divided by (y) the sum of (I) the
number of shares of Parent Common Stock outstanding immediately
prior to the Effective Time, (II) the number of shares of
Parent Common Stock issuable upon the exercise of Parent Options
and Parent Warrants outstanding immediately prior to the
Effective Time, (III) the number of shares of Parent Common
Stock issuable upon the conversion of the convertible security
described in Part 2.3(d)(ii) of the Parent Disclosure
Schedule, and (IV) the number of shares of Parent Common
Stock that would be issuable with respect to the shares of
Micromet Common Stock set forth in Part 2.5(o) of the
Parent Disclosure Schedule to the extent that such shares of
Parent Common Stock are not included under
subsection 1.6(a)(ii)(y)(I) above, in each case outstanding
immediately prior to the Effective Time.
(b) No fractional shares of CancerVax Common Stock shall be
issued in connection with the Merger, and no certificates or
scrip for any such fractional shares shall be issued. Any holder
of Parent Common Stock who would otherwise be entitled to
receive a fraction of a share of CancerVax Common Stock (after
aggregating all fractional shares of CancerVax Common Stock
issuable to such holder) shall, in lieu of such fraction of a
share and upon surrender of such holders Parent Stock
Certificate(s) (as defined in Section 1.7), be paid in cash
the dollar amount (rounded to the nearest whole cent), without
interest, determined by multiplying such fraction by the closing
price of a share of CancerVax Common Stock on the NASDAQ
National Market on the date the Merger becomes effective.
(c) All Parent Options outstanding immediately prior to the
Effective Time under Parents 2006 Equity Incentive Award
Plan (the Parent Stock Option Plan)
shall be exchanged for options to purchase CancerVax Common
Stock in accordance with Section 5.5.
(d) All Parent Warrants outstanding immediately prior to
the Effective Time shall be exchanged for warrants to purchase
CancerVax Common Stock, except that: (i) stock covered by
such Parent Warrants shall be shares of CancerVax Common Stock;
(ii) each reference in such Parent Warrant to a number of
shares of Parent Common Stock shall be deemed amended to refer
instead to a number of shares of CancerVax Common Stock
determined by multiplying the number of shares of Parent Common
Stock issuable in the Micromet Recapitalization for the
referenced shares of Parent Common Stock by the Conversion
Factor, and rounding the resulting number down to the nearest
whole number of shares of CancerVax Common Stock; (iii) the
per share exercise price for the CancerVax Common Stock issuable
upon exercise of such Parent Warrant assumed by CancerVax shall
be determined by dividing the effective per share exercise price
of Parent Common Stock subject to such Parent Warrant, as in
effect immediately prior to the Effective Time, by the
Conversion Factor, and rounding the resulting exercise price up
to the nearest whole cent; and (iv) any restriction on the
exercise of any Parent Warrant assumed by CancerVax shall
continue in full force and effect and the term, exercisability,
vesting schedule and other provisions of such Parent Warrant
shall otherwise remain unchanged; provided, however,
that: each Parent Warrant assumed by CancerVax in accordance
with this Section 1.6(d) shall, in accordance with its
terms, be subject to further adjustment as appropriate to
reflect any stock split, division or subdivision of shares,
stock dividend, reverse stock split, consolidation of shares,
reclassification, recapitalization or other similar transaction
with respect to CancerVax Common Stock subsequent to the
Effective Time.
A-7
1.7 Closing of Parents Transfer
Books. At the Effective Time: (a) all
shares of Parent Common Stock outstanding immediately prior to
the Effective Time shall automatically be canceled and retired
and shall cease to exist, and all holders of certificates
representing shares of Parent Common Stock that were outstanding
immediately prior to the Effective Time shall cease to have any
rights as stockholders of Parent; and (b) the stock
transfer books of Parent shall be closed with respect to all
shares of Parent Common Stock outstanding immediately prior to
the Effective Time. No further transfer of any such shares of
Parent Common Stock shall be made on such stock transfer books
after the Effective Time. If, after the Effective Time, a valid
certificate previously representing any shares of Parent Common
Stock outstanding immediately prior to the Effective Time (a
Parent Stock Certificate) is presented
to the Exchange Agent (as defined in Section 1.8) or to the
Surviving Corporation, such Parent Stock Certificate shall be
canceled and shall be exchanged as provided in Section 1.8.
1.8 Surrender of Certificates.
(a) On or prior to the Closing Date, CancerVax shall select
a reputable bank or trust company to act as exchange agent in
the Merger (the Exchange Agent). At
the Effective Time, CancerVax shall deposit with the Exchange
Agent: (i) certificates representing the shares of
CancerVax Common Stock issuable pursuant to Section 1.6;
and (ii) cash sufficient to make payments in lieu of
fractional shares in accordance with Section 1.6(b). The
shares of CancerVax Common Stock and cash amounts so deposited
with the Exchange Agent, together with any dividends or
distributions received by the Exchange Agent with respect to
such shares, are referred to collectively as the
Exchange Fund.
(b) Promptly after the Effective Time, the Parties shall
cause the Exchange Agent to mail to the Persons who were record
holders of Parent Stock Certificates immediately prior to the
Effective Time: (i) a letter of transmittal in customary
form and containing such provisions as CancerVax may reasonably
specify (including a provision confirming that delivery of
Parent Stock Certificates shall be effected, and risk of loss
and title to Parent Stock Certificates shall pass, only upon
delivery of such Parent Stock Certificates to the Exchange
Agent); and (ii) instructions for use in effecting the
surrender of Parent Stock Certificates in exchange for
certificates representing CancerVax Common Stock. Upon surrender
of a Parent Stock Certificate to the Exchange Agent for
exchange, together with a duly executed letter of transmittal
and such other documents as may be reasonably required by the
Exchange Agent or CancerVax: (A) the holder of such Parent
Stock Certificate shall be entitled to receive in exchange
therefor a certificate representing the number of whole shares
of CancerVax Common Stock that such holder has the right to
receive pursuant to the provisions of Section 1.6 (and cash
in lieu of any fractional share of CancerVax Common Stock); and
(B) the Parent Stock Certificate so surrendered shall be
canceled. Until surrendered as contemplated by this
Section 1.8(b), each Parent Stock Certificate shall be
deemed, from and after the Effective Time, to represent only the
right to receive shares of CancerVax Common Stock (and cash in
lieu of any fractional share of CancerVax Common Stock) as
contemplated by Section 1.6. If any Parent Stock
Certificate shall have been lost, stolen or destroyed, upon the
making of an affidavit of that fact by the owner thereof,
CancerVax shall cause the Exchange Agent to deliver the shares
of CancerVax Common Stock with respect to the shares of Parent
Common Stock previously represented by such Parent Stock
Certificate.
(c) Notwithstanding anything to the contrary contained in
this Agreement, no shares of CancerVax Common Stock (or
certificates therefor) shall be delivered in exchange for any
Parent Stock Certificate to any Person who may be an
affiliate (as that term is used in Rule 145
under the Securities Act) of Parent until such Person shall have
delivered to CancerVax a duly executed Affiliate Agreement as
contemplated by Section 5.10.
(d) No dividends or other distributions declared or made
with respect to CancerVax Common Stock with a record date after
the Effective Time shall be paid to the holder of any
unsurrendered Parent Stock Certificate with respect to the
shares of CancerVax Common Stock that such holder has the right
to receive in the Merger until such holder surrenders such
Parent Stock Certificate in accordance with this
Section 1.8 (at which time such holder shall be entitled,
subject to the effect of applicable abandoned property, escheat
or similar laws, to receive all such dividends and
distributions, without interest).
(e) Any portion of the Exchange Fund that remains
undistributed to holders of Parent Stock Certificates as of the
date 180 days after the Closing Date shall be delivered to
CancerVax upon demand, and any holders of Parent Stock
Certificates who have not theretofore surrendered their Parent
Stock Certificates in accordance with this Section 1.8
shall thereafter look only to CancerVax for satisfaction of
their claims for CancerVax Common Stock,
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cash in lieu of fractional shares of CancerVax Common Stock and
any dividends or distributions with respect to shares of
CancerVax Common Stock.
(f) Each of the Exchange Agent and the Surviving
Corporation shall be entitled to deduct and withhold from any
consideration deliverable pursuant to this Agreement to any
holder of any Parent Stock Certificate such amounts as CancerVax
determines in good faith are required to be deducted or withheld
from such consideration under the Code or any provision of
state, local or foreign tax law or under any other applicable
Legal Requirement. To the extent such amounts are so deducted or
withheld, such amounts shall be treated for all purposes under
this Agreement as having been paid to the Person to whom such
amounts would otherwise have been paid.
(g) No party to this Agreement shall be liable to any
holder of any Parent Stock Certificate or to any other Person
with respect to any shares of CancerVax Common Stock (or
dividends or distributions with respect thereto), or for any
cash amounts, delivered to any public official pursuant to any
applicable abandoned property law, escheat law or similar Legal
Requirement.
1.9 Appraisal Rights.
(a) Notwithstanding any provision of this Agreement to the
contrary, shares of Parent Common Stock that are outstanding
immediately prior to the Effective Time and which are held by
stockholders who have exercised and perfected appraisal rights
for such shares of Parent Common Stock in accordance with the
DGCL (collectively, the Dissenting
Shares) shall not be converted into or represent
the right to receive the per share amount of the merger
consideration described in Section 1.6 attributable to such
Dissenting Shares. Such stockholders shall be entitled to
receive payment of the appraised value of such shares of Parent
Common Stock held by them in accordance with the DGCL, unless
and until such stockholders fail to perfect or effectively
withdraw or otherwise lose their appraisal rights under the
DGCL. All Dissenting Shares held by stockholders who shall have
failed to perfect or who effectively shall have withdrawn or
lost their right to appraisal of such shares of Parent Common
Stock under the DGCL shall thereupon be deemed to be converted
into and to have become exchangeable for, as of the Effective
Time, the right to receive the per share amount of the merger
consideration attributable to such Dissenting Shares upon their
surrender in the manner provided in Section 1.6.
(b) Parent shall give CancerVax prompt written notice of
any demands by dissenting stockholders received by the Parent,
withdrawals of such demands and any other instruments served on
Parent and any material correspondence received by Parent in
connection with such demands.
1.10 Further Action. If, at any
time after the Effective Time, any further action is determined
by the Surviving Corporation to be necessary or desirable to
carry out the purposes of this Agreement or to vest the
Surviving Corporation with full right, title and possession of
and to all rights and property of Parent and Micromet, then the
officers and directors of the Surviving Corporation shall be
fully authorized, and shall use their commercially reasonable
efforts (in the name of Parent, in the name of Merger Sub, in
the name of Micromet and otherwise) to take such action.
1.11 Tax Consequences. For
federal income tax purposes, the Merger is intended to
constitute a reorganization within the meaning of
Section 368(a) of the Code. The parties to this Agreement
adopt this Agreement as a plan of reorganization
within the meaning of Sections 1.368-2(g) and 1.368-3(a) of
the United States Treasury Regulations.
Section 2. Representations
and Warranties of Parent and Micromet
Each of Parent and Micromet represents and warrants to CancerVax
and Merger Sub as follows, except as set forth in the written
disclosure schedule delivered by Parent to CancerVax (the
Parent Disclosure Schedule). The
Parent Disclosure Schedule shall be arranged in sections and
subsections corresponding to the numbered and lettered sections
and subsections contained in this Section 2. The
disclosures in any section or subsection of the Parent
Disclosure Schedule shall qualify other sections and subsections
in this Section 2 to the extent it is reasonably clear from
a reading of the disclosure that such disclosure is applicable
to such other sections and subsections. The inclusion of any
information in the Parent Disclosure Schedule (or any update
thereto) shall not be deemed to be an admission or
acknowledgment, in and of itself, that such information is
required by the terms
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hereof to be disclosed, is material, has resulted in or would
result in a Parent Material Adverse Effect, or is outside the
Ordinary Course of Business.
2.1 Subsidiaries; Due Organization; Etc.
(a) Each of the Micromet Parties is set forth on
Part 2.1(a) of the Parent Disclosure Schedule. Parent does
not have and has never had any Subsidiaries other than Micromet
(after giving effect to the Micromet Recapitalization) and
Micromet does not have and has never had any Subsidiaries. None
of the Micromet Parties own any capital stock of, or any equity
interest of any nature in, any Entity (other than the other
Micromet Parties, as applicable), other than the Entities
identified in Part 2.1(a) of the Parent Disclosure
Schedule. None of the Micromet Parties has agreed or is
obligated to make, or is bound by any Contract under which it
may become obligated to make, any future investment in or
capital contribution to any other Entity. None of the Micromet
Parties has, at any time, been a general partner of, or has
otherwise been liable for any of the debts or other obligations
of, any general partnership, limited partnership or other Entity.
(b) Each of the Micromet Parties is a corporation duly
organized, validly existing and in good standing under the laws
of the jurisdiction of its incorporation and has all necessary
power and authority: (i) to conduct its business in the
manner in which its business is currently being conducted;
(ii) to own and use its assets in the manner in which its
assets are currently owned and used; and (iii) to perform
its obligations under all Contracts by which it is bound.
(c) Each of the Micromet Parties is qualified to do
business as a foreign corporation, and is in good standing,
under the laws of all jurisdictions where the nature of its
business requires such qualification other than in jurisdictions
where the failure to be so qualified individually or in the
aggregate would not be reasonably expected to have a Parent
Material Adverse Effect.
2.2 Certificate of Incorporation;
Bylaws. Micromet has delivered to CancerVax
accurate and complete copies of the certificate of
incorporation, bylaws and other charter and organizational
documents of the respective Micromet Parties, including all
amendments thereto.
2.3 Capitalization, Etc.
(a) The authorized capital stock of Parent consists of
10,000,000 shares of Parent Common Stock, par value
$.001 per share, of which no shares have been issued and
are outstanding as of the date of this Agreement. Upon
consummation of the Micromet Recapitalization, there will be
3,767,516 shares of Parent Common Stock issued and
outstanding, all equity interests of Micromet will be held by
Parent (except as set forth on Part 2.5(o) of the Parent
Disclosure Schedule) and no other shares of capital stock of
Parent will be outstanding. Parent does not hold any shares of
its capital stock in its treasury. All of the outstanding shares
of Parent Common Stock have been duly authorized and validly
issued, and are fully paid and nonassessable. None of the
outstanding shares of Parent Common Stock is entitled or subject
to any preemptive right, right of participation, right of
maintenance or any similar right or any right under the
Shareholders Agreement. None of the outstanding shares of Parent
Common Stock is subject to any right of first refusal in favor
of Parent or Micromet. Except as contemplated herein, there is
no Parent Contract relating to the voting or registration of, or
restricting any Person from purchasing, selling, pledging or
otherwise disposing of (or granting any option or similar right
with respect to), any shares of Parent Common Stock. None of the
Micromet Parties is under any obligation, or is bound by any
Contract pursuant to which it may become obligated, to
repurchase, redeem or otherwise acquire any outstanding shares
of Parent Common Stock or other securities. Part 2.3(a) of
the Parent Disclosure Schedule accurately and completely
describes all repurchase rights held by Parent or Micromet with
respect to shares of Parent Common Stock (including shares
issued pursuant to the exercise of stock options), and specifies
which of those repurchase rights are currently exercisable.
(b) As of the date of this Agreement, the outstanding
capital stock of Micromet consists of
(i) 77,652 shares of Micromet Common Stock,
(ii) 1,232,876 shares of Preference Shares Series (A
new), and (iii) 2,140,539 shares of Preference Shares
Series (B new), of which shares are issued and outstanding.
Micromet does not hold any shares of its capital stock in its
treasury. All of the outstanding shares of Micromet Common Stock
and Micromet Preferred Stock have been duly authorized and
validly issued, and are fully paid and nonassessable. None of
the outstanding shares of Micromet Common Stock or Micromet
Preferred Stock is entitled or subject to any preemptive right,
right of participation, right of maintenance or any similar
right. None of the outstanding shares of Micromet Common
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Stock or Micromet Preferred Stock is subject to any right of
first refusal in favor of Parent or Micromet. Except as
contemplated herein, there is no Parent Contract relating to the
voting or registration of, or restricting any Person from
purchasing, selling, pledging or otherwise disposing of (or
granting any option or similar right with respect to), any
shares of Micromet Common Stock or Micromet Preferred Stock.
None of the Micromet Parties is under any obligation, or is
bound by any Contract pursuant to which it may become obligated,
to repurchase, redeem or otherwise acquire any outstanding
shares of Micromet Common Stock, Micromet Preferred Stock or
other securities. Part 2.3(b) of the Parent Disclosure
Schedule accurately and completely describes all repurchase
rights held by Parent or Micromet with respect to shares of
Micromet Common Stock (including shares issued pursuant to the
exercise of stock options) and Micromet Preferred Stock, and
specifies which of those repurchase rights are currently
exercisable.
(c) Except for the Parent Stock Option Plan, Parent does
not have any stock option plan or any other plan, program,
agreement or arrangement providing for any equity or
equity-based compensation for any Person. Parent has reserved
366,472 shares of Parent Common Stock for issuance under
the Parent Stock Option Plan, of which no shares have been
exercised and no shares are subject to issuance pursuant to
stock options granted and outstanding under the Parent Stock
Option Plan and 366,472 shares of Parent Common Stock are
reserved for future issuance pursuant to stock options not yet
granted under the Parent Stock Option Plan. Options to purchase
shares of Parent Common Stock are referred to in this Agreement
as Parent Options. Part 2.3(b) of
the Parent Disclosure Schedule sets forth the following
information with respect to each Parent Option outstanding as of
the date of this Agreement: (A) the name of the optionee;
(B) the number of shares of Parent Common Stock subject to
such Parent Option; (C) the exercise price of such Parent
Option; (D) the date on which such Parent Option was
granted; (E) the applicable vesting schedule, and the
extent to which such Parent Option is vested and exercisable as
of the date of this Agreement; (F) the date on which such
Parent Option expires; and (G) whether such Parent Option
is an incentive stock option (as defined in the
Code) or a non-qualified stock option. Parent has delivered to
CancerVax accurate and complete copies of all stock option plans
pursuant to which Parent has ever granted stock options, and the
forms of all stock option agreements evidencing such options,
copies of resolutions of the board of directors approving option
grants and copies of stockholder resolutions approving all stock
option plans pursuant to which Parent has ever granted stock
options.
(d) Except for the outstanding Parent Options or as set
forth on Part 2.3(d) of the Parent Disclosure Schedule,
there is no: (i) outstanding subscription, option, call,
warrant or right (whether or not currently exercisable) to
acquire any shares of the capital stock or other securities of
any of the Micromet Parties; (ii) outstanding security,
instrument or obligation that is or may become convertible into
or exchangeable for any shares of the capital stock or other
securities of any of the Micromet Parties;
(iii) stockholder rights plan (or similar plan commonly
referred to as a poison pill) or Contract under
which any of the Micromet Parties is or may become obligated to
sell or otherwise issue any shares of its capital stock or any
other securities; or (iv) condition or circumstance that
may give rise to or provide a basis for the assertion of a claim
by any Person to the effect that such Person is entitled to
acquire or receive any shares of capital stock or other
securities of any of the Micromet Parties. There are no
outstanding or authorized stock appreciation, phantom stock,
profit participation or other similar rights with respect to
Parent.
(e) All outstanding shares of Parent Common Stock, options,
warrants and other securities of Parent have been issued and
granted in compliance with all applicable securities laws.
(f) Upon consummation of the Micromet Recapitalization, all
of the outstanding shares of capital stock of Micromet will be
owned beneficially and of record by Parent (except as set forth
on Part 2.5(o) of the Parent Disclosure Schedule), free and
clear of any Encumbrances. Prior to consummation of the Micromet
Recapitalization, all corporate and shareholder consents
required to approve the Micromet Recapitalization, including but
not limited to all approvals under the Shareholders Agreement,
will have been obtained. As of the consummation of the Micromet
Recapitalization, the signatories to the Parent Stockholder
Voting Agreements will hold at least 55% of the Preference
Shares Series (B new) of Micromet and, upon consummation of the
Micromet Recapitalization, will hold at least a majority of the
outstanding shares of common stock of Parent (assuming
conversion of the convertible security as set forth on
Part 2.3(d)(ii) of the Parent Disclosure Schedule).
2.4 Financial
Statements. Part 2.4 of the Parent
Disclosure Schedule includes true and complete copies of
Micromets audited consolidated balance sheet at
December 31, 2003, Micromets unaudited consolidated
balance
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sheet at December 31, 2004, Micromets audited
consolidated statements of income, cash flow and
shareholders equity for the years ended December 31,
2003, and 2002, and Micromets unaudited consolidated
statements of income, cash flow and shareholders equity
for the year ended December 31, 2004 (collectively, the
Micromet Financials). The Micromet
Financials (i) were prepared in accordance with United
States general accepted accounting principles
(GAAP)(except as may be indicated in
the footnotes to such Micromet Financials and that unaudited
financial statements may not have notes thereto and other
presentation items that may be required by GAAP and are subject
to normal and recurring year-end adjustments that are not
reasonably expected to be material in amount) applied on a
consistent basis unless otherwise noted therein throughout the
periods indicated and (ii) fairly present the financial
condition and operating results of the Micromet Parties as of
the dates and for the periods indicated therein.
2.5 Absence of Changes. Since
the date of the Micromet Unaudited Interim Balance Sheet:
(a) there has not been any Parent Material Adverse Effect
or an event or development that would, individually or in the
aggregate, reasonably be expected to have a Parent Material
Adverse Effect, between the date of the Micromet Unaudited
Interim Balance Sheet and the date of this Agreement;
(b) there has not been any material loss, damage or
destruction to, or any material interruption in the use of, any
of the assets or business of any of the Micromet Parties
(whether or not covered by insurance);
(c) none of the Micromet Parties has: (i) declared,
accrued, set aside or paid any dividend or made any other
distribution in respect of any shares of capital stock; or
(ii) repurchased, redeemed or otherwise reacquired any
shares of capital stock or other securities;
(d) none of the Micromet Parties has sold, issued or
granted, or authorized the issuance of: (i) any capital
stock or other security (except for Parent Common Stock issued
upon the valid exercise of outstanding Parent Options and Parent
Common Stock issued or to be issued in connection with the
Micromet Recapitalization); (ii) any option, warrant or
right to acquire any capital stock or any other security (except
for Parent Options identified in Part 2.3(b) of the Parent
Disclosure Schedule); or (iii) any instrument convertible
into or exchangeable for any capital stock or other security;
(e) neither Parent nor Micromet has amended or waived any
of its rights under, or permitted the acceleration of vesting
under any provision of: (i) the Parent Stock Option Plan;
(ii) any Parent Option or any Contract evidencing or
relating to any Parent Option; (iii) any restricted stock
purchase agreement; or (iv) any other Contract evidencing
or relating to any equity award (whether payable in cash or
stock);
(f) there has been no amendment to the certificate of
incorporation, bylaws or other charter or organizational
documents of any of the Micromet Parties, and none of the
Micromet Parties has effected or been a party to any merger,
consolidation, share exchange, business combination,
recapitalization, reclassification of shares, stock split,
reverse stock split or similar transaction;
(g) none of the Micromet Parties has formed any Subsidiary
or acquired any equity interest or other interest in any other
Entity, other than in connection with the Micromet
Recapitalization;
(h) none of the Micromet Parties has: (i) lent money
to any Person; (ii) incurred or guaranteed any
indebtedness; (iii) issued or sold any debt securities or
options, warrants, calls or other rights to acquire any debt
securities; (iv) guaranteed any debt securities of others;
or (v) made any capital expenditure or commitment in excess
of $250,000;
(i) none of the Micromet Parties has, other than in the
Ordinary Course of Business: (i) adopted, established or
entered into any Parent Employee Plan; (ii) caused or
permitted any Parent Employee Plan to be amended, other than as
required by law; or (iii) paid any bonus or made any
profit-sharing or similar payment to, or increased the amount of
the wages, salary, commissions, fringe benefits or other
compensation or remuneration payable to, any of its directors or
employees;
(j) none of the Micromet Parties has changed any of its
methods of accounting or accounting practices;
(k) none of the Micromet Parties has made any material Tax
election, filed any material amendment to any Tax Return,
entered into any tax allocation agreement, tax sharing
agreement, tax indemnity agreement or
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closing agreement relating to any material Tax, surrendered any
right to claim a material Tax refund, or consented to any
extension or waiver of the statute of limitations period
applicable to any material Tax claim or assessment;
(l) none of the Micromet Parties has commenced or settled
any Legal Proceeding;
(m) none of the Micromet Parties has entered into any
material transaction outside the Ordinary Course of Business;
(n) none of the Micromet Parties have sold, leased or
otherwise irrevocably disposed of any of its material assets or
properties, nor has any security interest been created in such
assets or properties, except in the Ordinary Course of Business
consistent with past practices;
(o) there has been no amendment or termination of any
Parent Material Contract between the date of the Micromet
Unaudited Interim Balance Sheet and the date of this Agreement;
(p) there has been no (i) material change in pricing
or royalties set or charged by any of the Micromet Parties to
its customers or licensees, (ii) agreements by any of the
Micromet Parties to change pricing or royalties set or charged
by persons who have licensed Intellectual Property to any of the
Micromet Parties, or (iii) as of the date of this
Agreement, material change in pricing or royalties set or
charged by persons who have licensed Intellectual Property to
any of the Micromet Parties; and
(q) none of the Micromet Parties has negotiated, agreed or
committed to take any of the actions referred to in
clauses (c) through (p) above
(other than negotiations between the Parties to enter into this
Agreement).
2.6 Title to Assets. The
Micromet Parties own, and have good and valid title to, or, in
the case of leased properties and assets, valid leasehold
interests in, all tangible properties or assets and equipment
used or held for use in their business or operations or
purported to be owned by them and following the Micromet
Recapitalization will continue to own, and have good and valid
title to, or, in the case of leased properties and assets, valid
leasehold interests in, all tangible properties or assets and
equipment used or held for use in their business or operations,
including: (a) all assets reflected on the Micromet
Unaudited Interim Balance Sheet (except for inventory sold or
otherwise disposed of in the Ordinary Course of Business since
the date of the Micromet Unaudited Interim Balance Sheet); and
(b) all other assets reflected in the books and records of
the Micromet Parties as being owned by the Micromet Parties. All
of said assets are owned by the Micromet Parties free and clear
of any Encumbrances, except for: (i) any lien for current
taxes not yet due and payable; (ii) minor liens that have
arisen in the Ordinary Course of Business and that do not (in
any case or in the aggregate) materially detract from the value
of the assets subject thereto or materially impair the
operations of any of the Micromet Parties; and (iii) liens
described in Part 2.6 of the Parent Disclosure Schedule.
2.7 Real Property;
Leasehold. None of the Micromet Parties own
any real property or any interest in real property, except for
the leaseholds created under the real property leases identified
in Part 2.7 of the Parent Disclosure Schedule which are in
full force and effect and with no existing default thereunder.
2.8 Intellectual Property.
(a) Micromet owns, or has the right to use, sell or
license, and has the right to bring actions for the infringement
of, all Micromet IP Rights, except for any failure to own
or have the right to use, sell or license that would not
reasonably be expected to have a Parent Material Adverse Effect.
(b) To the Knowledge of the Micromet Parties, set forth in
Schedule 2.8(b) is an accurate, true and complete listing
of all Micromet Registered IP owned by, licensed by, used
by, or under the control of, the Micromet Parties.
(c) To the Knowledge of the Micromet Parties, Micromet
holds in each case the sole, exclusive, valid, and lawful title
to any and all of the Micromet IP Rights set forth in
Schedule 2.8(b), and has not granted any liens, mortgages,
material encumbrances, security interests, licenses,
sublicenses, or other agreements to any of such Micromet IP
Rights, other than those set out in Schedule 2.8(c).
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(d) The execution, delivery and performance of this
Agreement and the consummation of the Contemplated Transactions
will not constitute a breach of any Micromet IP Rights
Agreement, will not cause the forfeiture or termination or give
rise to a right of forfeiture or termination of any Micromet IP
Rights or impair the right of Micromet or the Surviving
Corporation to use, sell or license any Micromet IP Rights
or portion thereof, except for the occurrence of any such
breach, forfeiture, termination or impairment that would not
individually or in the aggregate, reasonably be expected to
result in a Parent Material Adverse Effect. Each of the Micromet
IP Rights Agreements is valid and binding on Micromet and in
full force and effect; (ii) Micromet has not received any
notice of termination or cancellation under such agreement, or
received any notice of breach or default under such agreement,
which breach has not been cured or waived; and
(iii) Micromet, and to the Knowledge of Parent and
Micromet, any other party to such agreement, is not in breach or
default thereof in any material respect.
(e) Except as set forth on Part 2.8(e) of the Parent
Disclosure Schedule, to the Knowledge of Parent and Micromet,
neither the manufacture, marketing, license, sale or intended
use of any product or technology currently licensed or sold or
under development by the Micromet Parties violates any license
or agreement between a Micromet Party and any third party or, to
the Knowledge of Parent and Micromet, infringes any valid
intellectual property right of any other party (against which
the Micromet Parties do not reasonably believe they have a valid
defense), which infringement would reasonably be expected to
have a Parent Material Adverse Effect. To the Knowledge of
Parent and Micromet, no third party is infringing upon, or
violating any license or agreement with a Micromet Party
relating to any Micromet IP Rights. There is no current, pending
(excluding any proceedings for which service of process has not
been effected) or, to the Knowledge of Parent and Micromet,
threatened challenge, claim, litigation or proceeding including,
but not limited to, opposition, interference or other proceeding
in any patent or other government office, contesting the
validity, ownership or right to use, sell, license or dispose of
any Micromet IP Rights, nor has Parent or Micromet received any
written notice asserting that any Micromet IP Rights or the
proposed use, sale, license or disposition thereof conflicts or
infringes or will conflict or infringe with the rights of any
other party.
(f) To the Knowledge of the Micromet Parties, all necessary
steps which are necessary or desirable to maintain the Micromet
IP Rights have been taken, including payment of any public,
annuity and maintenance fees.
(g) The Micromet Parties have used reasonable efforts to
maintain their material trade secrets in confidence, including
entering into licenses and contracts that generally require
licensees, contractors and other third persons with access to
such trade secrets to keep such trade secrets confidential.
2.9 Agreements, Contracts and
Commitments. Except as set forth on
Part 2.9 of the Parent Disclosure Schedule, none of the
Micromet Parties is a party to or bound by:
(a) any bonus, deferred compensation, incentive
compensation, pension, profit-sharing or retirement plans, or
any other employee benefit plans or arrangements;
(b) any employment or consulting agreement, contract or
commitment with any officer or director or Key Employee, not
terminable by Micromet on ninety (90) days notice without
liability, except to the extent general principles of wrongful
termination law may limit Micromets ability to terminate
employees at will;
(c) any agreement or plan, including, without limitation,
any stock option plan, stock appreciation right plan or stock
purchase plan, any of the benefits of which will be increased,
or the vesting of benefits of which will be accelerated, by the
occurrence of any of the Contemplated Transactions or the value
of any of the benefits of which will be calculated on the basis
of any of the Contemplated Transactions;
(d) any agreement of indemnification or guaranty not
entered into in the Ordinary Course of Business other than
indemnification agreements between Parent or Micromet and any of
their respective officers or directors;
(e) any agreement, contract or commitment containing any
covenant limiting the freedom of Micromet to engage in any line
of business or compete with any Person;
(f) any agreement, contract or commitment relating to
capital expenditures and involving obligations after the date of
this Agreement in excess of $250,000 and not cancelable without
penalty;
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(g) any agreement, contract or commitment currently in
force relating to the disposition or acquisition of assets not
in the Ordinary Course of Business or any ownership interest in
any corporation, partnership, joint venture or other business
enterprise;
(h) any mortgages, indentures, loans, notes or credit
agreements, security agreements or other agreements or
instruments relating to the borrowing of money or extension of
credit in excess of $250,000 or any loans or debt obligations
with officers or directors of Parent or Micromet;
(i) (i) any distribution agreement (identifying any
that contain exclusivity provisions); (ii) any dealer,
distributor, joint marketing, alliance, joint venture,
cooperation, development or other agreement currently in force
under which a Micromet Party has continuing material obligations
to jointly market any product, technology or service, or any
material agreement pursuant to which a Micromet Party has
continuing material obligations to jointly develop any
Intellectual Property that will not be owned, in whole or in
part, by a Micromet Party; or (iii) any material agreement,
contract or commitment currently in force to license any third
party to manufacture or reproduce any Micromet Party product,
service or technology or any material agreement, contract or
commitment currently in force to sell or distribute any Micromet
Party products or service except agreements with distributors or
sales representatives in the Ordinary Course of Business; or
(j) any other agreement, contract or commitment
(i) which involve payment or receipt by any Micromet Party
under any such agreement, contract or commitment of $250,000 or
more in the aggregate or (ii) that are material to the
business or operations of the Micromet Parties.
Except as set forth on Part 2.9 of the Parent Disclosure
Schedule, the Micromet Parties have not, nor to Micromets
or Parents Knowledge, as of the date of this Agreement has
any other party to a Parent Material Contract (as defined
below), breached, violated or defaulted under, or received
notice that it has breached, violated or defaulted under, any of
the terms or conditions of any of the agreements, contracts or
commitments to which the Micromet Parties are a party or by
which any of them is bound of the type described in
clauses (a) through (j) above (any such agreement, contract
or commitment, a Parent Material
Contract) in such manner as would permit any other
party to cancel or terminate any such Parent Material Contract,
or would permit any other party to seek damages which would
reasonably be expected to have a Parent Material Adverse Effect.
As to Micromet, as of the date of this Agreement each Parent
Material Contract is valid, binding, enforceable and in full
force and effect, subject to: (i) laws of general
application relating to bankruptcy, insolvency and the relief of
debtors; and (ii) rules of law governing specific
performance, injunctive relief and other equitable remedies.
2.10 Liabilities.
(a) As of the date hereof, none of the Micromet Parties has
any liability, indebtedness, obligation, expense, claim,
deficiency, guaranty or endorsement of any kind, whether
accrued, absolute, contingent, matured, unmatured or other
(whether or not required to be reflected in the financial
statements in accordance with GAAP) (each a
Liability), individually or in the
aggregate, except for: (a) Liabilities identified as such
in the liabilities column of the Micromet Unaudited
Interim Balance Sheet; (b) normal and recurring current
Liabilities that have been incurred by the Micromet Parties
since the date of the Micromet Unaudited Interim Balance Sheet
in the Ordinary Course of Business and which are not in excess
of $250,000 in the aggregate; (c) Liabilities for
performance of obligations of the Micromet Parties under Parent
Contracts; and (d) Liabilities described in Part 2.10
of the Parent Disclosure Schedule.
(b) Part 2.10(b) of the Parent Disclosure Schedule
sets forth a complete and correct list of the Silent
Partnerships involving the Micromet Parties, including the
agreements related thereto. Micromet has delivered to CancerVax
current, accurate and complete copies of all agreements related
to the Silent Partnerships to which any of the Micromet Parties
is a party, including all amendments thereto, and none of the
agreements related to the Silent Partnerships has been modified
since the date of this Agreement. Upon a termination of a Silent
Partnership, the amounts due for such termination shall be those
set forth in the applicable Silent Partnership agreement.
2.11 Compliance; Permits; Restrictions.
(a) None of the Micromet Parties is in conflict with, or in
default or violation of or has received any written notice of
violations with respect to (i) any Legal Requirement
applicable to such Micromet Parties or by which their
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business or properties is bound or affected, or (ii) any
material note, bond, mortgage, indenture, contract, agreement,
lease, license, permit, franchise or other instrument or
obligation to which such Micromet Party is a party or by which
such Micromet Party or its business or property is bound or
affected. No investigation or review by any Governmental Body or
authority is pending or, to the Knowledge of Micromet or Parent,
threatened against any Micromet Party, nor has any Governmental
Body or authority indicated to any of the Micromet Parties an
intention to conduct the same. There is no agreement, judgment,
injunction, order or decree binding upon the Micromet Parties
which has or could reasonably be expected to have the effect of
prohibiting or materially impairing any business practice of the
Micromet Parties, any acquisition of material property by any of
the Micromet Parties or the conduct of business by the Micromet
Parties as currently conducted.
(b) The Micromet Parties hold all Governmental
Authorizations which are material to the operation of the
business of Parent and Micromet (collectively, the
Micromet Permits). Each of the
Micromet Parties is in compliance with the terms of the Micromet
Permits. No action, proceeding, revocation proceeding, amendment
procedure, writ, injunction or claim is pending or, to the
Knowledge of Micromet, threatened, which seeks to revoke or
limit any Micromet Permit. The rights and benefits of each
material Micromet Permit will be available to the Surviving
Corporation immediately after the Effective Time on terms
substantially identical to those enjoyed by the Micromet Parties
as of the date of this Agreement and immediately prior to the
Effective Time.
(c) There are no proceedings pending with respect to a
violation by the Micromet Parties of the Federal Food, Drug, and
Cosmetic Act (FDCA), Food and Drug
Administration (FDA) regulations
adopted thereunder, the Controlled Substance Act or any other
similar legislation or regulation promulgated by any other
United States Governmental Body or the EMEA.
2.12 Tax Matters.
(a) Each of the Micromet Parties has filed all Tax Returns
that it was required to file under applicable Legal
Requirements. All such Tax Returns were correct and complete in
all material respects and have been prepared in material
compliance with all applicable Legal Requirements. All material
Taxes due and owing by each of the Micromet Parties (whether or
not shown on any Tax Return) have been paid. Except for standard
general extension of the monthly filing deadline for VAT
preliminary tax returns (Umsatzsteuer-Voranmeldungen) by one
month at the level of Micromet, none of the Micromet Parties is
currently the beneficiary of any extension of time within which
to file any Tax Return. No claim has ever been made by an
authority in a jurisdiction where the Micromet Parties do not
file Tax Returns that any of them is or may be subject to
taxation by that jurisdiction. There are no material
Encumbrances for Taxes (other than Taxes not yet due and
payable) upon any of the assets of any of the Micromet Parties.
(b) Each of the Micromet Parties has withheld and paid all
Taxes required to have been withheld and paid in connection with
any amounts paid or owing to any employee, independent
contractor, creditor, stockholder, or other third party.
(c) None of the Micromet Parties has received from any
Governmental Body any (i) notice indicating an intent to
open an audit or other review, (ii) request for information
related to Tax matters, or (iii) notice of deficiency or
proposed adjustment of or any amount of Tax proposed, asserted,
or assessed by any Governmental Body against any of the Micromet
Parties. No proceedings are pending or being conducted with
respect to any Tax matter and no power of attorney with respect
to any Tax matter is currently in force. There are no matters
under discussion with any Governmental Body, or known to any
Micromet Party with respect to Taxes that are likely to result
in an additional material Liability for Taxes with respect to
any Micromet Party. The Micromet Parties have delivered or made
available to CancerVax complete and accurate copies of foreign,
federal, state and local income Tax Returns of each Micromet
Party (and predecessors of each) for the years ended
December 31, 2002, 2003 and 2004, and complete and accurate
copies of all examination reports and statements of deficiencies
assessed against or agreed to by any Micromet Party (and their
respective predecessors) since December 31, 2001.
(d) None of the Micromet Parties has waived any statute of
limitations in respect of Taxes or agreed to any extension of
time with respect to a Tax assessment or deficiency nor has any
request been made in writing for any such extension or waiver.
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(e) None of the Micromet Parties has filed a consent under
former section 341(f) of the Code concerning collapsible
corporations. None of the Micromet Parties is a party to any
Contract that has resulted or would reasonable be expected to
result, separately or in the aggregate, in the payment of
(i) any excess parachute payment within the
meaning of section 280G of the Code (or any corresponding
provisions of state, local or foreign Tax law) and (ii) any
amount that will not be fully deductible as a result of
section 162(m) of the Code (or any corresponding provisions
of state, local or foreign Tax law). None of the Micromet
Parties has been a United States real property holding
corporation within the meaning of section 897(c)(2) of the
Code during the applicable period specified in
section 897(c)(1)(A)(ii) of the Code. None of the Micromet
Parties is a party to any Tax allocation, Tax sharing or similar
agreement (including indemnity agreements other than employee
tax equalization agreements). No Micromet Party has been a
member of an Affiliated Group filing a consolidated federal
income Tax Return (other than a group the common parent of which
was Parent or Micromet). No Micromet Party has any Liability for
the Taxes of any Person (other than such Micromet Party and any
Subsidiary of such Micromet Party) under regulation 1.1502-6 of
the Code (or any similar provision of state, local, or foreign
law), pursuant to Section 75 of the German General Tax Act
(§ 75 Abgabenordnung), as a transferee or
successor, by contract, or otherwise.
(f) The unpaid Taxes of the Micromet Parties (A) did
not, as of the date of the Micromet Unaudited Interim Balance
Sheet, exceed the reserve for Tax Liability (rather than any
reserve for deferred Taxes established to reflect timing
differences between book and Tax income) set forth on the face
of the Micromet Unaudited Interim Balance Sheet (rather than any
notes thereto), and (B) will not exceed that reserve as
adjusted for the passage of time through the Closing Date in
accordance with the past custom and practice of the Micromet
Parties in filing their Tax Returns. Since the date of the
Micromet Unaudited Interim Balance Sheet, no Micromet Party
incurred any Liability for Taxes outside the Ordinary Course of
Business or otherwise inconsistent with past custom and practice.
(g) No transactions or arrangements involving the Micromet
Parties have taken place or are in existence, which are such
that any provision relating to transfer pricing might be invoked
by a German Tax authority. The Micromet Parties maintain all
documentation, and comply in all material respects with the
obligations set forth in Section 90 of the German General
Tax Act (§ 90 Abgabenordnung) and the regulations
thereunder. Micromet does not have any equity that, from a
German corporate income tax perspective, has to be characterized
as tainted within the meaning of Section 38
subsection 1 of the German Corporate Income Tax Act
(§ 38 Abs. 1 Körperschaftsteuergesetz).
None of the Micromet Parties owns German situs real estate
within the meaning of Section 2 German Real Estate Transfer
Tax Act (Grunderwerbsteuergesetz).
2.13 Employee and Labor Matters; Benefit Plans.
(a) Micromet has provided to CancerVax, with respect to
each employee of each of the Micromet Parties (including any
employee of any of the Micromet Parties who is on a leave of
absence or on layoff status):
(i) the name of such employee, the Micromet Party by which
such employee is employed;
(ii) such employees title; and
(iii) such employees annualized compensation as of
the date of this Agreement.
(b) The employment of each of the Micromet Parties
employees is terminable by the applicable Micromet Party at will
(or otherwise in accordance with general principles of wrongful
termination law). Micromet has made available to CancerVax
accurate and complete copies of all employee manuals and
handbooks, disclosure materials, policy statements and other
materials relating to the employment of Parent Associates to the
extent currently effective and material.
(c) To the Knowledge of Micromet and Parent, no Key
Employee of any of the Micromet Parties intends to terminate his
employment with such Micromet Party, nor has any such employee
threatened or expressed any intention to do so.
(d) None of the Micromet Parties is a party to, bound by,
or has a duty to bargain under, any collective bargaining
agreement or other Contract with a labor organization
representing any of its employees, and there are no labor
organizations representing, purporting to represent or, to the
Knowledge of Micromet and Parent, seeking to represent any
employees of any of the Micromet Parties.
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(e) There has never been, nor has there been any threat of,
any strike, slowdown, work stoppage, lockout, job action, union,
organizing activity, question concerning representation or any
similar activity or dispute, affecting any of the Micromet
Parties or any of their employees. No event has occurred, and no
condition or circumstance exists, that might directly or
indirectly be likely to give rise to or provide a basis for the
commencement of any such strike, slowdown, work stoppage,
lockout, job action, union organizing activity, question
concerning representation or any similar activity or dispute.
(f) There is no Legal Proceeding, claim, labor dispute or
grievance pending or, to the Knowledge of Micromet and Parent,
threatened or reasonably anticipated relating to any employment
contract, privacy right, labor dispute, wages and hours, leave
of absence, plant closing notification, workers
compensation policy, long-term disability policy, harassment,
retaliation, immigration, employment statute or regulation,
safety or discrimination matter involving any Parent Associate,
including charges of unfair labor practices or discrimination
complaints, except for routine claims and disputes in the
Ordinary Course of Business.
(g) Part 2.13(g) of the Parent Disclosure Schedule
lists all written and describes all non-written employee benefit
plans (as defined in Section 3(3) of ERISA) and all bonus,
equity-based, incentive, deferred compensation, retirement or
supplemental retirement, profit sharing, severance, golden
parachute, vacation, cafeteria, dependent care, medical care,
employee assistance program, education or tuition assistance
programs and other similar fringe or employee benefit plans,
programs or arrangements, including any employment or executive
compensation or severance agreements, written or otherwise,
which are currently in effect relating to any present or former
employee or director of a Micromet Party (or any trade or
business (whether or not incorporated) which is a member of a
controlled group or which is under common control with a
Micromet Party within the meaning of Section 414 of the
Code (an ERISA Affiliate)), or which
is maintained by, administered or contributed to, or required to
be contributed to, any Micromet Party or under which any
Micromet Party has incurred or may incur any liability
(collectively, the Parent Employee
Plans).
(h) With respect to each Parent Employee Plan, Micromet has
made available to CancerVax a true and complete copy of such
Parent Employee Plan.
(i) No Parent Employee Plan is maintained or administered
in, or otherwise subject to the laws of, the United States of
America.
2.14 Environmental Matters.
(a) Each of the Micromet Parties: (i) is and has been
in compliance in all material respects with, and has not been
and is not in material violation of or subject to any material
liability under, any applicable Environmental Requirements (as
defined in Section 2.14(d)); and (ii) possesses all
permits and other Environmental Authorizations (as defined in
Section 2.14(d)), and is in compliance with the terms and
conditions thereof.
(b) To the Knowledge of Micromet and Parent: (i) all
property that is or was leased to, controlled by or used by any
of the Micromet Parties, and all surface water, groundwater and
soil associated with or adjacent to such property, is free of
any Materials of Environmental Concern (as defined in
Section 2.14(d)) or material environmental contamination of
any nature; (ii) none of the property that is or was leased
to, controlled by or used by any of the Micromet Parties
contains any underground storage tanks, asbestos, equipment
using PCBs or underground injection wells; and (iii) none
of the property that is or was leased to, controlled by or used
by any of the Micromet Parties contains any septic tanks in
which process wastewater or any Materials of Environmental
Concern have been Released (as defined in Section 2.14(d)).
(c) No Micromet Party has ever Released any Materials of
Environmental Concern except in compliance in all material
respects with all applicable Environmental Requirements.
(d) For purposes of this Agreement:
(i) Environmental Requirement
means any federal, state, local or foreign Legal Requirement,
order, writ, injunction, directive, authorization, judgment,
decree, grant, franchise, Contract or other governmental
restriction and requirement, whether judicial or administrative,
relating to pollution or protection of human health and safety,
natural resources or the environment (including ambient air,
surface water, ground water, land surface or subsurface strata),
including any Legal Requirement relating to emissions,
discharges, releases or threatened releases of Materials of
Environmental Concern, or otherwise relating to the manufacture,
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processing, distribution, use, treatment, storage, disposal,
transport or handling of Materials of Environmental Concern;
(ii) Environmental Authorization
means any Governmental Authorization required under applicable
Environmental Requirements; (iii) Materials of
Environmental Concern include chemicals,
pollutants, contaminants, wastes, toxic substances, petroleum
and petroleum products and any other substance that is now or
hereafter regulated by any Environmental Requirement or that is
otherwise a danger to health, reproduction or the environment;
and (iv) Release means any
spilling, leaking, emitting, discharging, depositing, escaping,
leaching, dumping or other releasing into the environment,
whether intentional or unintentional.
2.15 Insurance. Micromet has
delivered to CancerVax accurate and complete copies of all
material insurance policies and all material self insurance
programs and arrangements relating to the business, assets,
liabilities and operations of the Micromet Parties. Each of such
insurance policies is in full force and effect and the Micromet
Parties are in compliance with the terms thereof. Since
January 1, 2004, none of the Micromet Parties has received
any notice or other communication regarding any actual or
possible: (i) cancellation or invalidation of any insurance
policy; (ii) refusal or denial of any coverage, reservation
of rights or rejection of any material claim under any insurance
policy; or (iii) material adjustment in the amount of the
premiums payable with respect to any insurance policy. There is
no pending workers compensation or other claim under or
based upon any insurance policy of any of the Micromet Parties.
All information provided to insurance carriers (in applications
and otherwise) on behalf of the Micromet Parties is accurate and
complete. Micromet has provided timely written notice to the
appropriate insurance carrier(s) of each Legal Proceeding
pending or threatened against any of the Micromet Parties, and
no such carrier has issued a denial of coverage or a reservation
of rights with respect to any such Legal Proceeding, or informed
any of the Micromet Parties of its intent to do so.
2.16 Affiliates. Part 2.16
of the Parent Disclosure Schedule identifies each Person who is
(or who may be deemed to be) an affiliate (as that
term is used in Rule 145 under the Securities Act) of
Parent as of the date of this Agreement. Since January 1,
2005, there have been no transactions between Parent and any
Person who is an affiliate of Parent, other than in connection
with the Micromet Recapitalization.
2.17 Legal Proceedings; Orders.
(a) Except as set forth on Part 2.17 of the Parent
Disclosure Schedule, there is no pending Legal Proceeding, and
(to the Knowledge of Micromet and Parent) no Person has
threatened to commence any Legal Proceeding: (i) that
involves any of the Micromet Parties, any Micromet Associates
(in his or her capacity as such) or any of the material assets
owned or used by any of the Micromet Parties; or (ii) that
challenges, or that may have the effect of preventing, delaying,
making illegal or otherwise interfering with, the Merger or any
of the other Contemplated Transactions.
(b) There is no order, writ, injunction, judgment or decree
to which any of the Micromet Parties, or any of the assets owned
or used by any of the Micromet Parties, is subject. To the
Knowledge of Micromet and Parent, no officer or other Key
Employee of any of the Micromet Parties is subject to any order,
writ, injunction, judgment or decree that prohibits such officer
or other employee from engaging in or continuing any conduct,
activity or practice relating to the business of any of the
Micromet Parties.
2.18 Authority; Binding Nature of
Agreement. Each of Parent and Micromet has
all necessary corporate power and authority to enter into and to
perform its obligations under this Agreement. The board of
directors of Parent has: (a) determined that the Merger is
advisable and fair to and in the best interests of Parent and
its stockholders; (b) authorized and approved by all
necessary corporate action, the execution, delivery and
performance of this Agreement and the transactions contemplated
hereby, including the Merger; (c) recommended the adoption
and approval of this Agreement by the holders of Parent Common
Stock and directed that this Agreement and the Merger be
submitted for consideration by Parents stockholders at the
Parent Stockholders Meeting (as defined in
Section 5.2); and (d) to the extent necessary, adopted
a resolution having the effect of causing Parent not to be
subject to any state takeover law or similar Legal Requirement
that might otherwise apply to the Merger or any of the other
Contemplated Transactions. This Agreement has been duly executed
and delivered by each of Parent and Micromet and assuming the
due authorization, execution and delivery by CancerVax,
constitutes the legal, valid and binding obligation of Parent
and Micromet, enforceable against each of Parent and Micromet in
accordance with its terms, subject to: (i) laws of general
application relating to bankruptcy, insolvency and the relief of
debtors; and (ii) rules of law governing specific
performance, injunctive relief and other equitable remedies.
Prior to the
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execution of the Parent Stockholder Voting Agreements, the Board
of Directors of Parent approved the Parent Stockholder Voting
Agreements and the transactions contemplated thereby.
2.19 Inapplicability of Anti-takeover
Statutes. The board of directors of Parent
has taken and will take all actions necessary to ensure that the
restrictions applicable to business combinations contained in
Section 203 of the DGCL are, and will be, inapplicable to
the execution, delivery and performance of this Agreement and
the Voting Agreements and to the consummation of the Merger and
the other Contemplated Transactions. No other state takeover
statute or similar Legal Requirement applies or purports to
apply to the Merger, this Agreement, the Parent Stockholder
Voting Agreements or any of the other Contemplated Transactions.
2.20 Vote Required. The
affirmative vote of the holders of a majority of the shares of
Parent Common Stock outstanding on the record date for the
Parent Stockholders Meeting and entitled to vote (the
Required Parent Stockholder Vote) is
the only vote of the holders of any class or series of any of
the Micromet Parties capital stock necessary to adopt or
approve this Agreement and approve the Merger.
2.21 Non-Contravention;
Consents. Neither (x) the execution,
delivery or performance of this Agreement by Parent and
Micromet, nor (y) the consummation of the Merger or any of
the other Contemplated Transactions, will directly or indirectly
(with or without notice or lapse of time):
(a) contravene, conflict with or result in a violation of
(i) any of the provisions of the certificate of
incorporation, bylaws or other charter or organizational
documents of any of the Micromet Parties, or (ii) any
resolution adopted by the stockholders, the board of directors
or any committee of the board of directors of any of the
Micromet Parties;
(b) subject to compliance with the HSR Act and any foreign
antitrust Legal Requirement, contravene, conflict with or result
in a violation of, or give any Governmental Body or other Person
the right to challenge the Merger or any of the other
Contemplated Transactions or to exercise any remedy or obtain
any relief under, any Legal Requirement or any order, writ,
injunction, judgment or decree to which any of the Micromet
Parties, or any of the assets owned or used by any of the
Micromet Parties, is subject;
(c) contravene, conflict with or result in a violation of
any of the terms or requirements of, or give any Governmental
Body the right to revoke, withdraw, suspend, cancel, terminate
or modify, any Governmental Authorization that is held by any of
the Micromet Parties or that otherwise relates to the business
of any of the Micromet Parties or to any of the assets owned or
used by any of the Micromet Parties;
(d) contravene, conflict with or result in a violation or
breach of, or result in a default under, any provision of any
Parent Contract, or give any Person the right to:
(i) declare a default or exercise any remedy under any
Parent Contract; (ii) a rebate, chargeback, penalty or
change in delivery schedule under any such Parent Contract;
(iii) accelerate the maturity or performance of any Parent
Contract; or (iv) cancel, terminate or modify any term of
any Parent Contract, except, in the case of any Parent Material
Contract, any non-material breach, default, penalty or
modification and, in the case of all other Parent Contracts, any
breach, default, penalty or modification that would not result
in a Parent Material Adverse Effect;
(e) result in the imposition or creation of any Encumbrance
upon or with respect to any asset owned or used by any of the
Micromet Parties (except for minor liens that will not, in any
case or in the aggregate, materially detract from the value of
the assets subject thereto or materially impair the operations
of any of the Micromet Parties); or
(f) result in, or increase the likelihood of, the transfer
of any material asset of any of the Micromet Parties to any
Person.
Except (i) for any Consent set forth on Part 2.21 of
the Parent Disclosure Schedule under any Parent Contract,
(ii) the approval of this Agreement and the Contemplated
Transactions by Parents stockholders, (iii) an
election by Micromet Stockholders under Section 9 of the
Shareholders Agreement; (iv) the filing of the Certificate
of Merger with the Secretary of State of the State of Delaware
pursuant to the DGCL, (v) such filings under the HSR Act or
any foreign antitrust Legal Requirement and (vi) such
consents, waivers, approvals, orders, authorizations,
registrations, declarations and filings as may be required under
applicable federal and state securities laws, none of the
Micromet Parties was, is or will be required to make any filing
with or give any notice to, or to obtain any Consent from, any
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Person in connection with (x) the execution, delivery or
performance of this Agreement, or (y) the consummation of
the Merger or any of the other Contemplated Transactions.
2.22 No Financial Advisor. No
broker, finder or investment banker is entitled to any brokerage
fee, finders fee, opinion fee, success fee, transaction
fee or other fee or commission in connection with the Merger or
any of the other Contemplated Transactions based upon
arrangements made by or on behalf of any of the Micromet Parties.
Section 3. Representations
and Warranties of CancerVax And Merger Sub
CancerVax and Merger Sub represent and warrant to Parent as
follows, except as set forth in the written disclosure schedule
delivered by CancerVax to Parent (the CancerVax
Disclosure Schedule). The CancerVax Disclosure
Schedule shall be arranged in sections and subsections
corresponding to the numbered and lettered sections and
subsections contained in this Section 3. The disclosures in
any section or subsection of the CancerVax Disclosure Schedule
shall qualify other sections and subsections in this
Section 3 to the extent it is reasonably clear from a
reading of the disclosure that such disclosure is applicable to
such other sections and subsections. The inclusion of any
information in the CancerVax Disclosure Schedule (or any update
thereto) shall not be deemed to be an admission or
acknowledgment, in and of itself, that such information is
required by the terms hereof to be disclosed, is material, has
resulted in or would result in a CancerVax Material Adverse
Effect, or is outside the Ordinary Course of Business.
3.1 Subsidiaries; Due Organization; Etc.
(a) CancerVax has no Subsidiaries, except for Merger Sub
and the Entities identified in Part 3.1(a) of the CancerVax
Disclosure Schedule; and neither CancerVax nor any of the other
Entities identified in Part 3.1(a) of the CancerVax
Disclosure Schedule owns any capital stock of, or any equity
interest of any nature in, any other Entity, other than Merger
Sub and the Entities identified in Part 3.1(a) of the
CancerVax Disclosure Schedule. CancerVax has neither agreed nor
is obligated to make, or is bound by any Contract under which it
may become obligated to make, any future investment in or
capital contribution to any other Entity. CancerVax has not, at
any time, been a general partner of, or has otherwise been
liable for any of the debts or other obligations of, any general
partnership, limited partnership or other Entity.
(b) Each of CancerVax and its Subsidiaries is a corporation
duly organized, validly existing and in good standing under the
laws of the jurisdiction of its incorporation and has all
necessary power and authority: (i) to conduct its business
in the manner in which its business is currently being
conducted; (ii) to own and use its assets in the manner in
which its assets are currently owned and used; and (iii) to
perform its obligations under all Contracts by which it is bound.
(c) Each of CancerVax and its Subsidiaries is qualified to
do business as a foreign corporation, and is in good standing,
under the laws of all jurisdictions where the nature of its
business requires such qualification other than in jurisdictions
where the failure to be so qualified individually or in the
aggregate would not be reasonably expected to have a CancerVax
Material Adverse Effect.
3.2 Certificate of Incorporation; Bylaws; Charters
and Codes of Conduct. CancerVax has delivered
to Micromet accurate and complete copies of the certificate of
incorporation and bylaws or other charter documents, including
all amendments thereto, for CancerVax and its Subsidiaries.
Part 3.2 of the CancerVax Disclosure Schedule lists, and
CancerVax has delivered to Parent, accurate and complete copies
of: (a) the charters of all committees of CancerVaxs
board of directors; and (b) any code of conduct or similar
policy adopted by CancerVax or by the board of directors, or any
committee of the board of directors, of CancerVax.
3.3 Capitalization, Etc.
(a) The authorized capital stock of CancerVax consists of:
(i) 75,000,000 shares of CancerVax Common Stock, par
value $0.00004 per share, of which 27,932,160 shares
have been issued and are outstanding as of the date of this
Agreement; and (ii) 10,000,000 shares of CancerVax
Preferred Stock, par value $0.00004 per share, of which
75,000 shares have been designated as Series A Junior
Participating Preferred Stock, no shares of which have been
issued or are outstanding as of the date of this Agreement.
CancerVax does not hold any shares of its capital stock in its
treasury. All of the outstanding shares of CancerVax Common
Stock have been duly authorized and validly issued, and are
fully paid and nonassessable. None of the outstanding shares of
CancerVax Common Stock is
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entitled or subject to any preemptive right, right of
participation, right of maintenance or any similar right. None
of the outstanding shares of CancerVax Common Stock is subject
to any right of first refusal in favor of CancerVax. Except as
contemplated herein and except as identified on
Part 3.3(a)(i) of the CancerVax Disclosure Schedule there
is no CancerVax Contract relating to the voting or registration
of, or restricting any Person from purchasing, selling, pledging
or otherwise disposing of (or granting any option or similar
right with respect to), any shares of CancerVax Common Stock.
CancerVax is not under any obligation, nor is bound by any
Contract pursuant to which it may become obligated, to
repurchase, redeem or otherwise acquire any outstanding shares
of CancerVax Common Stock or other securities.
Part 3.3(a)(ii) of the CancerVax Disclosure Schedule
accurately and completely describes all repurchase rights held
by CancerVax with respect to shares of CancerVax Common Stock
(including shares issued pursuant to the exercise of stock
options) and specifies which of those repurchase rights are
currently exercisable.
(b) Except for the CancerVax Third Amended and Restated
2000 Stock Incentive Plan, the CancerVax Amended and Restated
2003 Equity Incentive Award Plan and the CancerVax Employee
Stock Purchase Plan (collectively, the CancerVax
Stock Plans), or except as set forth on
Section 3.3(b) of the CancerVax Disclosure Schedule,
CancerVax does not have any stock option plan or any other plan,
program, agreement or arrangement providing for any equity or
equity-based compensation for any Person. As of the date of this
Agreement: (i) 75,000 shares of CancerVax
Series A Junior Participating Preferred Stock are reserved
for future issuance upon exercise of the Rights issued pursuant
to the Rights Agreement, dated as of November 3, 2004, by
and between CancerVax and Mellon Investor Services LLC as Rights
Agent (the Rights Agreement);
(ii) 1,443,606 shares of CancerVax Common Stock are
subject to issuance pursuant to stock options granted and
outstanding under the Third Amended and Restated 2000 Stock
Incentive Plan; (iii) 3,981,460 shares of CancerVax
Common Stock are subject to issuance pursuant to stock options
granted and outstanding under the Amended and Restated 2003
Equity Incentive Award; (iv) 253,376 shares of
CancerVax Common Stock are reserved for issuance pursuant to the
ESPP CancerVax Stock Plans; (v) 1,591,290 shares of
CancerVax Common Stock are reserved for future issuance pursuant
to stock options not yet granted under the CancerVax Stock Plans
other than the ESPP; and (vi) 85,610 shares of
CancerVax Common Stock are reserved for future issuance pursuant
to warrants to purchase CancerVax Common Stock
(CancerVax Warrants). Options to
purchase shares of CancerVax Common Stock are referred to in
this Agreement as CancerVax Options.
Part 3.3(b) of the CancerVax Disclosure Schedule sets forth
the following information with respect to each CancerVax Option
outstanding as of the date of this Agreement: (A) the name
of the optionee; (B) the number of shares of CancerVax
Common Stock subject to such CancerVax Option; (C) the
exercise price of such CancerVax Option; (D) the date on
which such CancerVax Option was granted; (E) the applicable
vesting schedule, and the extent to which such CancerVax Option
is vested and exercisable as of the date of this Agreement;
(F) the date on which such CancerVax Option expires; and
(G) whether such CancerVax Option is an incentive
stock option (as defined in the Code) or a non-qualified
stock option. CancerVax has delivered to Micromet accurate and
complete copies of all stock option plans pursuant to which
CancerVax has ever granted stock options, the forms of all stock
option agreements evidencing such options and evidence of board
and stockholder approval of any of the CancerVax Stock Plans and
amendments thereto. CancerVax has delivered to Micromet accurate
and complete copies of all CancerVax Warrants.
(c) Except for the Rights Agreement and the outstanding
CancerVax Warrants and CancerVax Options, there is no:
(i) outstanding subscription, option, call, warrant or
right (whether or not currently exercisable) to acquire any
shares of the capital stock or other securities of CancerVax;
(ii) outstanding security, instrument or obligation that is
or may become convertible into or exchangeable for any shares of
the capital stock or other securities of CancerVax;
(iii) stockholder rights plan (or similar plan commonly
referred to as a poison pill) or Contract under
which CancerVax is or may become obligated to sell or otherwise
issue any shares of its capital stock or any other securities;
or (iv) condition or circumstance that may give rise to or
provide a basis for the assertion of a claim by any Person to
the effect that such Person is entitled to acquire or receive
any shares of capital stock or other securities of CancerVax.
There are not outstanding or authorized stock appreciation,
phantom stock, profit participating or other similar rights with
respect to CancerVax.
(d) All outstanding shares of CancerVax Common Stock and
options, warrants and other securities of CancerVax have been
issued and granted in compliance with (i) all applicable
securities laws and other applicable Legal Requirements, and
(ii) all requirements set forth in applicable Contracts.
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(e) All of the outstanding shares of capital stock of each
of CancerVaxs Subsidiaries have been duly authorized and
validly issued, are fully paid and nonassessable and free of
preemptive rights, with no personal liability attaching to the
ownership thereof, and are owned beneficially and of record by
CancerVax, free and clear of any Encumbrances.
3.4 SEC Filings; Financial Statements.
(a) CancerVax has delivered to Parent accurate and complete
copies of all registration statements, proxy statements,
Certifications (as defined below) and other statements, reports,
schedules, forms and other documents filed by CancerVax with the
SEC since August 14, 2003 (the CancerVax SEC
Documents), other than such documents that can be
obtained on the SECs website at www.sec.gov. Except
as set forth on Part 3.4 of the CancerVax Disclosure
Schedule, all statements, reports, schedules, forms and other
documents required to have been filed by CancerVax or its
officers with the SEC have been so filed on a timely basis. None
of CancerVaxs Subsidiaries is required to file any
documents with the SEC. As of the time it was filed with the SEC
(or, if amended or superseded by a filing prior to the date of
this Agreement, then on the date of such filing): (i) each
of the CancerVax SEC Documents complied in all material respects
with the applicable requirements of the Securities Act or the
Exchange Act (as the case may be); and (ii) none of the
CancerVax SEC Documents contained any untrue statement of a
material fact or omitted to state a material fact required to be
stated therein or necessary in order to make the statements
therein, in the light of the circumstances under which they were
made, not misleading. The certifications and statements required
by
(A) Rule 13a-14
under the Exchange Act and (B) 18 U.S.C. §1350
(Section 906 of the Sarbanes-Oxley Act) relating to the
CancerVax SEC Documents (collectively, the
Certifications) are accurate and
complete and comply as to form and content with all applicable
Legal Requirements. As used in this Section 3, the term
file and variations thereof shall be broadly
construed to include any manner in which a document or
information is furnished, supplied or otherwise made available
to the SEC.
(b) CancerVax maintains disclosure controls and procedures
that satisfy the requirements of
Rule 13a-15
under the Exchange Act. Such disclosure controls and procedures
are designed to ensure that all material information concerning
CancerVax is made known on a timely basis to the individuals
responsible for the preparation of CancerVaxs filings with
the SEC and other public disclosure documents. CancerVax is in
compliance with the applicable listing and other rules and
regulations of the NASDAQ National Market and has not since
August 14, 2003 received any notice from the NASDAQ
National Market asserting any non-compliance with such rules and
regulations.
(c) The financial statements (including any related notes)
contained or incorporated by reference in the CancerVax SEC
Documents: (i) complied as to form in all material respects
with the published rules and regulations of the SEC applicable
thereto; (ii) were prepared in accordance with GAAP (except
as may be indicated in the notes to such financial statements
or, in the case of unaudited financial statements, as permitted
by
Form 10-Q
of the SEC, and except that the unaudited financial statements
may not contain footnotes and are subject to normal and
recurring year-end adjustments that are not reasonably expected
to be material in amount) applied on a consistent basis unless
otherwise noted therein throughout the periods indicated; and
(iii) fairly present the consolidated financial position of
CancerVax and its consolidated Subsidiaries as of the respective
dates thereof and the consolidated results of operations and
cash flows of CancerVax and its consolidated Subsidiaries for
the periods covered thereby.
(d) CancerVaxs auditor has at all times since the
date of enactment of the Sarbanes-Oxley Act been: (i) a
registered public accounting firm (as defined in
Section 2(a)(12) of the Sarbanes-Oxley Act);
(ii) independent with respect to CancerVax and
its Subsidiaries within the meaning of
Regulation S-X
under the Exchange Act; and (iii) to the knowledge of
CancerVax, in compliance with subsections (g) through
(l) of Section 10A of the Exchange Act and the rules
and regulations promulgated by the SEC and the Public Company
Accounting Oversight Board thereunder. Part 3.4(d) of the
CancerVax Disclosure Schedule contains an accurate and complete
description of all non-audit services performed by
CancerVaxs auditors for CancerVax and its Subsidiaries
since December 31, 2003 and the fees paid for such
services. All such non-audit services were approved as required
by Section 202 of the Sarbanes-Oxley Act.
(e) Each of CancerVax and its Subsidiaries maintains a
system of internal accounting controls designed to provide
reasonable assurance that: (i) transactions are executed in
accordance with managements general or specific
authorizations; (ii) transactions are recorded as necessary
to permit preparation of financial statements in
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conformity with generally accepted accounting principles and to
maintain asset accountability; (iii) access to assets is
permitted only in accordance with managements general or
specific authorization; and (iv) the recorded
accountability for assets is compared with the existing assets
at reasonable intervals and appropriate action is taken with
respect to any differences. CancerVax maintains internal control
over financial reporting that provides reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with generally accepted accounting purposes.
(f) Part 3.4(f) of the CancerVax Disclosure Schedule
lists, and CancerVax has delivered to Micromet accurate and
complete copies of the documentation creating or governing, all
securitization transactions and off-balance sheet
arrangements (as defined in Item 303(c) of
Regulation S-K
under the Exchange Act) effected by CancerVax since
January 1, 2004.
3.5 Absence of Changes. Except
as set forth on Part 3.5 of the CancerVax Disclosure
Schedule, since the date of the CancerVax Unaudited Interim
Balance Sheet:
(a) there has not been any CancerVax Material Adverse
Effect or an event or development that would, individually or in
the aggregate, reasonably be expected to have a CancerVax
Material Adverse Effect, between the date of the CancerVax
Unaudited Interim Balance Sheet and the date of this Agreement;
(b) there has not been any material loss, damage or
destruction to, or any material interruption in the use of, any
of the assets or business of CancerVax or its Subsidiaries
(whether or not covered by insurance);
(c) CancerVax has not: (i) declared, accrued, set
aside or paid any dividend or made any other distribution in
respect of any shares of capital stock; or
(ii) repurchased, redeemed or otherwise reacquired any
shares of capital stock or other securities;
(d) CancerVax has not sold, issued or granted, or
authorized the issuance of: (i) any capital stock or other
security (except for CancerVax Common Stock issued upon the
valid exercise of outstanding CancerVax Options); (ii) any
option, warrant or right to acquire any capital stock or any
other security (except for CancerVax Options identified in
Part 3.3(b) of the CancerVax Disclosure Schedule); or
(iii) any instrument convertible into or exchangeable for
any capital stock or other security;
(e) CancerVax has not amended or waived any of its rights
under, or permitted the acceleration of vesting under any
provision of: (i) any of CancerVaxs stock option
plans; (ii) any CancerVax Option or any Contract evidencing
or relating to any CancerVax Option; (iii) any restricted
stock purchase agreement; or (iv) any other Contract
evidencing or relating to any equity award (whether payable in
cash or stock);
(f) there has been no amendment to the certificate of
incorporation, bylaws or other charter or organizational
documents of CancerVax or its Subsidiaries, and neither
CancerVax nor its Subsidiaries has effected or been a party to
any merger, consolidation, share exchange, business combination,
recapitalization, reclassification of shares, stock split,
reverse stock split or similar transaction;
(g) CancerVax has not formed any Subsidiary or acquired any
equity interest or other interest in any other Entity;
(h) Neither CancerVax nor any of its Subsidiaries has:
(i) lent money to any Person; or (ii) incurred or
guaranteed any indebtedness for borrowed money; or
(iii) issued or sold any debt securities or options,
warrants, calls or other rights to acquire any debt securities;
(iii) guaranteed any debt securities of others; or
(iv) made any capital expenditure or commitment in excess
of $100,000;
(i) Neither CancerVax nor its Subsidiaries has, other than
in the Ordinary Course of Business: (i) adopted,
established or entered into any CancerVax Employee Plan;
(ii) caused or permitted any CancerVax Employee Plan to be
amended other than as required by law; or (iii) paid any
bonus or made any profit-sharing or similar payment to, or
increased the amount of the wages, salary, commissions, fringe
benefits or other compensation or remuneration payable to, any
of its directors or employees;
(j) Neither CancerVax nor any its Subsidiaries has changed
any of its methods of accounting or accounting practices;
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(k) Neither CancerVax nor any its Subsidiaries has made any
material Tax election, filed any material amendment to any Tax
Return, entered into any tax allocation agreement, tax sharing
agreement, tax indemnity agreement or closing agreement relating
to any material Tax, surrendered any right to claim a material
Tax refund, or consented to any extension or waiver of the
statute of limitations period applicable to any material Tax
claim or assessment;
(l) Neither CancerVax nor any its Subsidiaries CancerVax
has commenced or settled any Legal Proceeding;
(m) Neither CancerVax nor any its Subsidiaries has entered
into any material transaction outside the Ordinary Course of
Business;
(n) Neither CancerVax nor any its Subsidiaries has sold,
leased or otherwise irrevocably disposed of any of its assets or
properties, nor has any security interest been created in such
assets or properties, except in the Ordinary Course of Business
consistent with past practices;
(o) there has been no amendment or termination of any
CancerVax Material Contract between the date of the CancerVax
Unaudited Interim Balance Sheet and the date of this Agreement;
(p) there has been no (i) material change in pricing
or royalties set or charged by CancerVax or any of its
Subsidiaries to its customers or licensees, (ii) agreements
by any of CancerVax or its Subsidiaries to change pricing or
royalties set or charged by persons who have licensed
Intellectual Property to any of CancerVax or its Subsidiaries,
or (iii) as of the date of this Agreement, material change
in pricing or royalties set or charged by persons who have
licensed Intellectual Property to any of CancerVax or its
Subsidiaries; and
(q) Neither CancerVax nor any its Subsidiaries has
negotiated, agreed or committed to take any of the actions
referred to in clauses (c) through (p)
above (other than negotiations between the Parties to enter into
this Agreement).
3.6 Title to Assets. Each of
CancerVax and its Subsidiaries owns and has good and valid title
to, or, in the case of leased properties and assets, valid
leasehold interests in, all tangible properties or assets and
equipment used or held for use in its business or operations or
purported to be owned by it, including: (a) all assets
reflected on the CancerVax Unaudited Interim Balance Sheet
(except for inventory sold or otherwise disposed of in the
Ordinary Course of Business since the date of the CancerVax
Unaudited Interim Balance Sheet); and (b) all other assets
reflected in the books and records of CancerVax as being owned
by CancerVax or its Subsidiaries. All of said assets are owned
by CancerVax or the applicable Subsidiary free and clear of any
Encumbrances, except for: (i) any lien for current taxes
not yet due and payable; (ii) minor liens that have arisen
in the Ordinary Course of Business and that do not (in any case
or in the aggregate) materially detract from the value of the
assets subject thereto or materially impair the operations of
CancerVax; and (iii) liens described in Part 3.6 of
the CancerVax Disclosure Schedule.
3.7 Real Property;
Leasehold. Each of CancerVax and its
Subsidiaries does not own any real property or any interest in
real property, except for the leaseholds created under the real
property leases identified in Part 3.7 of the CancerVax
Disclosure Schedule which are in full force and effect and with
no existing default thereunder.
3.8 Intellectual Property.
(a) CancerVax owns, or has the right to use, sell or
license, and has the right to bring actions for the infringement
of, all CancerVax IP Rights, except for any failure to own or
have the right to use, sell or license that would not reasonably
be expected to have a CancerVax Material Adverse Effect.
(b) To the Knowledge of CancerVax, set forth in
Schedule 3.8(b) is an accurate, true and complete listing
of all CancerVax Registered IP owned by, licensed by, used by,
or under the control of, CancerVax.
(c) To the Knowledge of CancerVax, it holds in each case
the sole, exclusive, valid, and lawful title to any and all of
the CancerVax IP Rights set forth in Schedule 3.8(b), and
have not granted any liens, mortgages, material encumbrances,
security interests, licenses, sublicenses, or other agreements
to any of such CancerVax IP Rights, other than those set out in
Schedule 3.8(c).
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(d) The execution, delivery and performance of this
Agreement and the consummation of the Contemplated Transactions
will not constitute a breach of any CancerVax IP Rights
Agreement, will not cause the forfeiture or termination or give
rise to a right of forfeiture or termination of any CancerVax IP
Rights or impair the right of the Surviving Corporation and its
Subsidiaries to use, sell or license any CancerVax IP Rights or
portion thereof, except for the occurrence of any such breach,
forfeiture, termination or impairment that would not
individually or in the aggregate, reasonably be expected to
result in a CancerVax Material Adverse Effect. Each of the
CancerVax IP Rights Agreements is valid and binding on CancerVax
or its Subsidiaries, as applicable, and in full force and
effect; (ii) CancerVax has not received any notice of
termination or cancellation under such agreement, or received
any notice of breach or default under such agreement, which
breach has not been cured or waived; and (iii) CancerVax
and its Subsidiaries, and to the Knowledge of CancerVax, any
other party to such agreement, is not in breach or default
thereof in any material respect.
(e) Except as set forth on Part 3.8(e) of the
CancerVax Disclosure Schedule, to the Knowledge of CancerVax,
neither the manufacture, marketing, license, sale or intended
use of any product or technology currently licensed or sold or
under development by CancerVax violates any license or agreement
between CancerVax or its Subsidiaries and any third party or, to
the Knowledge of CancerVax, infringes any valid intellectual
property right of any other party (against which CancerVax does
not reasonably believe it has a valid defense), which
infringement would reasonably be expected to have a CancerVax
Material Adverse Effect. To the Knowledge of CancerVax, no third
party is infringing upon, or violating any license or agreement
with CancerVax or its Subsidiaries relating to any CancerVax IP
Rights. There is no current, pending (excluding any proceedings
for which service of process has not been effected) or, to the
Knowledge of CancerVax, threatened challenge, claim, litigation
or proceeding including, but not limited to, opposition,
interference or other proceeding in any patent or other
government office, contesting the validity, ownership or right
to use, sell, license or dispose of any CancerVax IP Rights, nor
has CancerVax received any written notice asserting that any
CancerVax IP Rights or the proposed use, sale, license or
disposition thereof conflicts or infringes or will conflict or
infringe with the rights of any other party.
(f) To the Knowledge of CancerVax, all necessary steps
which are necessary or desirable to maintain the CancerVax IP
Rights have been taken, including payment of any public, annuity
and maintenance fees.
(g) CancerVax and its Subsidiaries have used reasonable
efforts to maintain their material trade secrets in confidence,
including entering into licenses and contracts that generally
require licensees, contractors and other third persons with
access to such trade secrets to keep such trade secrets
confidential.
3.9 Agreements, Contracts and
Commitments. Except as filed with the SEC and
except as listed on Part 3.9 of the CancerVax Disclosure
Schedule, neither CancerVax nor any of its Subsidiaries is a
party to or bound by:
(a) any material bonus, deferred compensation, severance,
incentive compensation, pension, profit-sharing or retirement
plans, or any other employee benefit plans or arrangements;
(b) any employment or consulting agreement, contract or
commitment with any officer or director or Key Employee, not
terminable by CancerVax or its Subsidiaries on ninety
(90) days notice without liability, except to the extent
general principles of wrongful termination law may limit
CancerVaxs or the Subsidiaries ability to terminate
employees at will;
(c) any agreement or plan, including, without limitation,
any stock option plan, stock appreciation right plan or stock
purchase plan, any of the benefits of which will be increased,
or the vesting of benefits of which will be accelerated, by the
occurrence of any of the Contemplated Transactions or the value
of any of the benefits of which will be calculated on the basis
of any of the Contemplated Transactions;
(d) any agreement of indemnification or guaranty not
entered into in the Ordinary Course of Business other than
indemnification agreements between CancerVax and any of its
officers or directors;
(e) any agreement, contract or commitment containing any
covenant limiting the freedom of CancerVax or its Subsidiaries
to engage in any line of business or compete with any Person;
(f) any agreement, contract or commitment relating to
capital expenditures and involving obligations after the date of
this Agreement in excess of $100,000 and not cancelable without
penalty;
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(g) any agreement, contract or commitment currently in
force relating to the disposition or acquisition of assets not
in the Ordinary Course of Business or any ownership interest in
any corporation, partnership, joint venture or other business
enterprise;
(h) any mortgages, indentures, loans, notes or credit
agreements, security agreements or other agreements or
instruments relating to the borrowing of money or extension of
credit in excess of $100,000;
(i) (i) any distribution agreement (identifying any
that contain exclusivity provisions); (ii) any dealer,
distributor, joint marketing, alliance, joint venture,
cooperation, development or other agreement currently in force
under which CancerVax or its Subsidiaries has continuing
material obligations to jointly market any product, technology
or service, or any material agreement pursuant to which
CancerVax or its Subsidiaries has continuing material
obligations to jointly develop any Intellectual Property that
will not be owned, in whole or in part, by CancerVax or such
Subsidiaries; or (iii) any material agreement, contract or
commitment currently in force to license any third party to
manufacture or reproduce any CancerVax product, service or
technology or any material agreement, contract or commitment
currently in force to sell or distribute any CancerVax products
or service except agreements with distributors or sales
representatives in the Ordinary Course of Business; or
(j) any other agreement, contract or commitment
(i) which involve payment or receipt by CancerVax or its
Subsidiaries under any such agreement, contract or commitment of
$250,000 or more in the aggregate or obligations after the date
of this Agreement in excess of $100,000 in the aggregate, or
(ii) that are material to the business or operations of
CancerVax and its Subsidiaries.
Except as set forth on Part 3.9 of the CancerVax Disclosure
Schedule, neither CancerVax nor any of its Subsidiaries has, nor
to CancerVaxs Knowledge, as of the date of this Agreement
has any other party to a CancerVax Material Contract (as defined
below), breached, violated or defaulted under, or received
notice that it has breached, violated or defaulted under, any of
the terms or conditions of any of the agreements, contracts or
commitments to which CancerVax or its Subsidiaries is a party or
by which it is bound of the type described in clauses (a)
through (j) above (any such agreement, contract or
commitment, a CancerVax Material
Contract) in such manner as would permit any other
party to cancel or terminate any such CancerVax Material
Contract, or would permit any other party to seek damages which
would reasonably be expected to have a CancerVax Material
Adverse Effect. As to CancerVax and its Subsidiaries, as of the
date of this Agreement each CancerVax Material Contract is
valid, binding, enforceable and in full force and effect,
subject to: (i) laws of general application relating to
bankruptcy, insolvency and the relief of debtors; and
(ii) rules of law governing specific performance,
injunctive relief and other equitable remedies.
3.10 Obligations; Liabilities.
(a) As of the date hereof, neither CancerVax nor any of its
Subsidiaries has any Liability, individually or in the
aggregate, except for: (i) Liabilities identified as such
in the liabilities column of the CancerVax Unaudited
Interim Balance Sheet; (ii) normal and recurring current
Liabilities that have been incurred by CancerVax or its
Subsidiaries since the date of the CancerVax Unaudited Interim
Balance Sheet in the Ordinary Course of Business, which are not
in excess of $100,000 in the aggregate; and
(iii) Liabilities described in Part 3.10 of the
CancerVax Disclosure Schedule.
(b) Part 3.10 of the CancerVax Disclosure Schedule
sets forth a complete and correct detail of all restoration or
remediation liabilities under existing real property leases to
which CancerVax or its Subsidiaries is a party.
(c) Part 3.10 of the CancerVax Disclosure Schedule
sets forth a complete and correct detail of all ongoing
obligations of CancerVax under (i) confidentiality
agreements that include non-solicitation or
no-shop provisions, (ii) material transfer
agreements and (iii) consulting agreements, in each case to
which CancerVax or any of its Subsidiaries is a party.
(d) There are no ongoing obligations of CancerVax or its
Subsidiaries with respect to any clinical trial conducted by or
on behalf of CancerVax or its Subsidiaries.
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3.11 Compliance; Permits; Restrictions.
(a) Neither CancerVax nor any of its Subsidiaries is in
conflict with, or in default or violation of or has received any
written notice of violations with respect to (i) any Legal
Requirement applicable to CancerVax or any of its Subsidiaries
or by which its business or properties is bound or affected, or
(ii) any material note, bond, mortgage, indenture,
contract, agreement, lease, license, permit, franchise or other
instrument or obligation to which CancerVax or any of its
Subsidiaries is a party or by which CancerVax or any of its
Subsidiaries or their business or property is bound or affected.
No investigation or review by any Governmental Body or authority
is pending or, to the Knowledge of CancerVax, threatened against
CancerVax or any of its Subsidiaries, nor has any Governmental
Body or authority indicated to CancerVax an intention to conduct
the same. There is no agreement, judgment, injunction, order or
decree binding upon CancerVax or any of its Subsidiaries which
has or could reasonably be expected to have the effect of
prohibiting or materially impairing any business practice of
CancerVax or its Subsidiaries, any acquisition of material
property by CancerVax or its Subsidiaries or the conduct of
business by CancerVax and its Subsidiaries as currently
conducted.
(b) CancerVax and its Subsidiaries hold all Governmental
Authorizations which are material to the operation of their
businesses (collectively, the CancerVax
Permits). Each of CancerVax and its Subsidiaries
is in compliance with the terms of the CancerVax Permits. No
action, proceeding, revocation proceeding, amendment procedure,
writ, injunction or claim is pending or, to the Knowledge of
CancerVax, threatened, which seeks to revoke or limit any
CancerVax Permit. The rights and benefits of each material
CancerVax Permit will be available to the Surviving Corporation
immediately after the Effective Time on terms substantially
identical to those enjoyed by CancerVax and its Subsidiaries as
of the date of this Agreement and immediately prior to the
Effective Time.
(c) There are no proceedings pending with respect to a
violation by CancerVax or any of its Subsidiaries of the FDCA,
FDA regulations adopted thereunder, the Controlled Substance Act
or any other legislation or regulation promulgated by any other
United States Governmental Body or the EMEA.
3.12 Tax Matters.
(a) CancerVax has filed all Tax Returns that it was
required to file under applicable Legal Requirements. All such
Tax Returns were correct and complete in all material respects
and have been prepared in material compliance with all
applicable Legal Requirements. All material Taxes due and owing
by CancerVax and its Subsidiaries (whether or not shown on any
Tax Return) have been paid. CancerVax is not currently the
beneficiary of any extension of time within which to file any
Tax Return. No claim has ever been made by an authority in a
jurisdiction where CancerVax does not file Tax Returns that it
is or may be subject to taxation by that jurisdiction. There are
no material Encumbrances for Taxes (other than Taxes not yet due
and payable) upon any of the assets of CancerVax or its
Subsidiaries.
(b) CancerVax has withheld and paid all Taxes required to
have been withheld and paid in connection with any amounts paid
or owing to any employee, independent contractor, creditor,
stockholder, or other third party.
(c) CancerVax has not received from any Governmental Body
any (i) notice indicating an intent to open an audit or
other review, (ii) request for information related to Tax
matters, or (iii) notice of deficiency or proposed
adjustment of or any amount of Tax proposed, asserted, or
assessed by any Governmental Body against CancerVax. No
proceedings are pending or being conducted with respect to any
Tax and no power of attorney with respect to any Tax Matter is
currently in force. There are no matters under discussion with
any Governmental Body, or known to CancerVax with respect to
Taxes that are likely to result in an additional material
Liability for Taxes with respect to CancerVax. CancerVax and its
Subsidiaries have delivered or made available to Micromet
complete and accurate copies of foreign, federal, state and
local income Tax Returns of CancerVax and each of its
Subsidiaries (and predecessors of each) for the years ended
December 31, 2002, 2003 and 2004, and complete and accurate
copies of all examination reports and statements of deficiencies
assessed against or agreed to by CancerVax and any of its
Subsidiaries (and their respective predecessors) since
December 31, 2001.
(d) CancerVax has not waived any statute of limitations in
respect of Taxes or agreed to any extension of time with respect
to a Tax assessment or deficiency nor has any request been made
in writing for any such extension or waiver.
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(e) CancerVax has not filed a consent under former
section 341(f) of the Code concerning collapsible
corporations. Neither CancerVax nor any of its Subsidiaries is a
party to any Contract that has resulted or would reasonably be
expected to result, separately or in the aggregate, in the
payment of (i) any excess parachute payment
within the meaning of section 280G of the Code (or any
corresponding provisions of state, local or foreign Tax law) and
(ii) any amount that will not be fully deductible as a
result of section 162(m) of the Code (or any corresponding
provisions of state, local or foreign Tax law). CancerVax has
not been a United States real property holding corporation
within the meaning of section 897(c)(2) of the Code during
the applicable period specified in section 897(c)(1)(A)(ii)
of the Code. CancerVax is not a party to any Tax allocation, Tax
sharing or similar agreement (including indemnity agreements
other than employee tax equalization agreements). Neither
CancerVax nor any of its Subsidiaries has been a member of an
Affiliated Group filing a consolidated federal income Tax Return
(other than a group the common parent of which was CancerVax).
Neither CancerVax or any of its Subsidiaries has any Liability
for the Taxes of any Person (other than CancerVax and any
Subsidiary of CancerVax) under regulation 1.1502-6 of the Code
(or any similar provision of state, local, or foreign law), as a
transferee or successor, by contract, or otherwise.
(f) The unpaid Taxes of CancerVax (A) did not, as of
the date of the CancerVax Unaudited Interim Balance Sheet,
exceed the reserve for Tax Liability (rather than any reserve
for deferred Taxes established to reflect timing differences
between book and Tax income) set forth on the face of CancerVax
Unaudited Interim Balance Sheet (rather than any notes thereto),
and (B) will not exceed that reserve as adjusted for the
passage of time through the Closing Date in accordance with the
past custom and practice of CancerVax in filing its Tax Returns.
Since the date of the CancerVax Unaudited Interim Balance Sheet,
neither CancerVax nor any of its Subsidiaries incurred any
Liability for Taxes outside the Ordinary Course of Business or
otherwise inconsistent with past custom and practice.
3.13 Employee and Labor Matters; Benefit Plans.
(a) CancerVax has provided to Micromet, with respect to
each employee of CancerVax and its Subsidiaries (including any
employee of CancerVax or its Subsidiaries who is on a leave of
absence or on layoff status):
(i) the name of such employee;
(ii) such employees title; and
(iii) such employees annualized compensation as of
the date of this Agreement.
(b) The employment of CancerVaxs and the
Subsidiaries employees is terminable by CancerVax or such
Subsidiary at will (subject to the terms of applicable
employment agreements). CancerVax has made available to Micromet
accurate and complete copies of all employee manuals and
handbooks, disclosure materials, policy statements and other
materials relating to the employment of CancerVax Associates to
the extent currently effective and material.
(c) To the Knowledge of CancerVax, no Key Employee of
CancerVax or any of its Subsidiaries intends to terminate his
employment with CancerVax or such Subsidiary, nor has any such
Key Employee threatened or expressed any intention to do so.
(d) Neither CancerVax nor any of its Subsidiaries is a
party to, bound by, or has a duty to bargain under, any
collective bargaining agreement or other Contract with a labor
organization representing any of its employees, and there are no
labor organizations representing, purporting to represent or, to
the Knowledge of CancerVax, seeking to represent any employees
of CancerVax or its Subsidiaries.
(e) There has never been, nor has there been any threat of,
any strike, slowdown, work stoppage, lockout, job action, union
organizing activity, question concerning representation or any
similar activity or dispute, affecting CancerVax or any of its
Subsidiaries or any of their employees. No event has occurred,
and no condition or circumstance exists, that might directly or
indirectly be likely to give rise to or provide a basis for the
commencement of any such strike, slowdown, work stoppage,
lockout, job action, union organizing activity, question
concerning representation or any similar activity or dispute.
(f) Neither CancerVax nor any of its Subsidiaries is or has
never been engaged in any unfair labor practice within the
meaning of the National Labor Relations Act. There is no Legal
Proceeding, claim, labor dispute or
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grievance pending or, to the Knowledge of CancerVax, threatened
or reasonably anticipated relating to any employment contract,
privacy right, labor dispute, wages and hours, leave of absence,
plant closing notification, workers compensation policy,
long-term disability policy, harassment, retaliation,
immigration, employment statute or regulation, safety or
discrimination matter involving any CancerVax Associate,
including charges of unfair labor practices or discrimination
complaints, except for routine claims and disputes in the
Ordinary Course of Business.
(g) Part 3.13(g) of the CancerVax Disclosure Schedule
lists all written and describes all non-written employee benefit
plans (as defined in Section 3(3) of ERISA) and all bonus,
equity-based, incentive, deferred compensation, retirement or
supplemental retirement, profit sharing, severance, golden
parachute, vacation, cafeteria, dependent care, medical care,
employee assistance program, education or tuition assistance
programs and other similar fringe or employee benefit plans,
programs or arrangements, including any employment or executive
compensation or severance agreements, written or otherwise,
which are currently in effect relating to any present or former
employee or director of CancerVax or its Subsidiaries (or any
trade or business (whether or not incorporated) which is an
ERISA Affiliate or which is maintained by, administered or
contributed to, or required to be contributed to, CancerVax or
any ERISA Affiliate or under which CancerVax or any ERISA
Affiliate has incurred or may incur any liability (collectively,
the CancerVax Employee Plans).
(h) With respect to each CancerVax Employee Plan, CancerVax
has made available to Micromet a true and complete copy of, to
the extent applicable, (i) such CancerVax Employee Plan,
(ii) the three (3) most recent annual reports
(Form 5500) as filed with the IRS, (iii) each
currently effective trust agreement related to such CancerVax
Employee Plan, (iv) the most recent summary plan
description for each CancerVax Employee Plan for which such
description is required, along with all summaries of material
modifications, amendments, resolutions and all other material
plan documentation related thereto in the possession of
CancerVax, (v) the most recent actuarial report relating to
any CancerVax Employee Plan subject to Title IV of ERISA
and (vi) the most recent IRS determination or opinion
letter issued with respect to any CancerVax Employee Plan.
(i) No CancerVax Employee Plan is an employee pension
benefit plan (within the meaning of Section 3(2) of
ERISA) subject to Title IV of ERISA, and neither CancerVax
nor any ERISA Affiliate has ever maintained, contributed to or
partially or fully withdrawn from any such plan. No CancerVax
Employee Plan is a Multiemployer Plan or single-employer
plan under multiple controlled groups as described in
Section 4063 of ERISA, and neither CancerVax nor any ERISA
Affiliate has ever contributed to or had an obligation to
contribute, or incurred any liability in respect of a
contribution, to any Multiemployer Plan. No CancerVax Employee
Plan is a multiple employer plan within the meaning
of Section 413(c) of the Code or Section 3(40) of
ERISA.
3.14 Environmental Matters.
(a) Each of CancerVax and its Subsidiaries: (i) is and
has been in compliance in all material respects with, and has
not been and is not in material violation of or subject to any
material liability under, any applicable Environmental
Requirements; and (ii) possesses all permits and other
Environmental Authorizations, and is in compliance with the
terms and conditions thereof.
(b) To the Knowledge of CancerVax: (i) all property
that is or was leased to, controlled by or used by CancerVax or
its Subsidiaries, and all surface water, groundwater and soil
associated with or adjacent to such property, is free of any
Materials of Environmental Concern or material environmental
contamination of any nature; (ii) none of the property that
is or was leased to, controlled by or used by CancerVax or its
Subsidiaries contains any underground storage tanks, asbestos,
equipment using PCBs or underground injection wells; and
(iii) none of the property that is or was leased to,
controlled by or used by CancerVax or its Subsidiaries contains
any septic tanks in which process wastewater or any Materials of
Environmental Concern have been Released.
(c) Neither CancerVax nor any of its Subsidiaries has ever
Released any Materials of Environmental Concern except in
compliance in all material respects with all applicable
Environmental Requirements.
3.15 Insurance.
(a) CancerVax has delivered to Micromet accurate and
complete copies of all material insurance policies and all
material self insurance programs and arrangements relating to
the business, assets, liabilities and operations of
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CancerVax and its Subsidiaries. Each of such insurance policies
is in full force and effect and CancerVax and its Subsidiaries
are in compliance with the terms thereof. Other than customary
end of policy notifications from insurance carriers, since
January 1, 2004, neither CancerVax nor any of its
Subsidiaries has received any notice or other communication
regarding any actual or possible: (i) cancellation or
invalidation of any insurance policy; (ii) refusal or
denial of any coverage, reservation of rights or rejection of
any material claim under any insurance policy; or
(iii) material adjustment in the amount of the premiums
payable with respect to any insurance policy. There is no
pending workers compensation or other claim under or based
upon any insurance policy of CancerVax or its Subsidiaries. All
information provided to insurance carriers (in applications and
otherwise) on behalf of CancerVax and its Subsidiaries is
accurate and complete. CancerVax and its Subsidiaries have
provided timely written notice to the appropriate insurance
carrier(s) of each Legal Proceeding pending or threatened
against CancerVax or its Subsidiaries, and no such carrier has
issued a denial of coverage or a reservation of rights with
respect to any such Legal Proceeding, or informed CancerVax or
its Subsidiaries of its intent to do so.
(b) CancerVax has made available to Micromet accurate and
complete copies of the existing policies (primary and excess) of
directors and officers liability insurance
maintained by CancerVax and its Subsidiaries as of the date of
this Agreement (the Existing D&O
Policies). Part 3.15(b) of the CancerVax
Disclosure Schedule accurately sets forth the most recent annual
premiums paid by CancerVax and its Subsidiaries with respect to
the Existing D&O Policies.
3.16 Transactions with
Affiliates. Except as set forth in the
CancerVax SEC Documents filed prior to the date of this
Agreement, since the date of CancerVaxs last proxy
statement filed with the SEC, no event has occurred that would
be required to be reported by CancerVax pursuant to
Item 404 of
Regulation S-K
promulgated by the SEC. Part 3.16 of the CancerVax
Disclosure Schedule identifies each Person who is (or who may be
deemed to be) an affiliate (as that term is used in
Rule 145 under the Securities Act) of CancerVax or its
Subsidiaries as of the date of this Agreement.
3.17 Legal Proceedings; Orders.
(a) There is no pending Legal Proceeding, and (to the
Knowledge of CancerVax) no Person has threatened to commence any
Legal Proceeding: (i) that involves CancerVax or any of its
Subsidiaries, any CancerVax Associate (in his or her capacity as
such) or any of the material assets owned or used by CancerVax
or its Subsidiaries; or (ii) that challenges, or that may
have the effect of preventing, delaying, making illegal or
otherwise interfering with, the Merger or any of the other
Contemplated Transactions.
(b) There is no order, writ, injunction, judgment or decree
to which CancerVax or any of its Subsidiaries, or any of the
assets owned or used by CancerVax or its Subsidiaries, is
subject. To the Knowledge of CancerVax, no officer or other Key
Employee of CancerVax or its Subsidiaries is subject to any
order, writ, injunction, judgment or decree that prohibits such
officer or other employee from engaging in or continuing any
conduct, activity or practice relating to the business of
CancerVax or its Subsidiaries.
3.18 Authority; Binding Nature of
Agreement. Each of CancerVax and its
Subsidiaries has all necessary corporate power and authority to
enter into and to perform its obligations under this Agreement.
Each of the boards of directors of CancerVax and Merger Sub (at
meetings duly called and held) has: (a) determined that the
Merger is advisable and fair to and in the best interests of
such Party and its stockholders; (b) duly authorized and
approved by all necessary corporate action, the execution,
delivery and performance of this Agreement and the transactions
contemplated hereby, including the Merger; (c) recommended
the adoption and approval of this Agreement by the holders of
CancerVax Common Stock and directed that this Agreement and the
issuance of shares of CancerVax Common Stock in the Merger be
submitted for consideration by CancerVaxs stockholders at
the CancerVax Stockholders Meeting (as defined in
Section 5.3); and (d) to the extent necessary, adopted
a resolution having the effect of causing CancerVax or Merger
Sub not to be subject to any state takeover law or similar Legal
Requirement that might otherwise apply to the Merger or any of
the other Contemplated Transactions. This Agreement has been
duly executed and delivered by CancerVax and Merger Sub, and
assuming the due authorization, execution and delivery by Parent
and Micromet, constitutes the legal, valid and binding
obligation of CancerVax or Merger Sub (as applicable),
enforceable against each of CancerVax and Merger Sub in
accordance with its terms, subject to: (i) laws of general
application relating to bankruptcy, insolvency and the relief of
debtors; and (ii) rules of law governing specific
performance, injunctive relief and other equitable remedies.
Prior to the execution of the CancerVax
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Stockholder Voting Agreements, the Board of Directors of
CancerVax approved the CancerVax Stockholder Voting Agreements
and the transactions contemplated thereby.
3.19 Inapplicability of Anti-takeover
Statutes. The boards of directors of
CancerVax and Merger Sub have taken and will take all actions
necessary to ensure that the restrictions applicable to business
combinations contained in Section 203 of the DGCL are, and
will be, inapplicable to the execution, delivery and performance
of this Agreement and to the consummation of the Merger and the
other Contemplated Transactions. No other state takeover statute
or similar Legal Requirement applies or purports to apply to the
Merger, this Agreement, the CancerVax Stockholder Voting
Agreements or any of the other Contemplated Transactions.
3.20 Vote Required. The
affirmative vote of: (i) the holders of a majority of the
shares of CancerVax Common Stock voting at the CancerVax
Stockholders Meeting is the only vote of the holders of any
class or series of CancerVaxs capital stock necessary to
approve the issuance of CancerVax Common Stock in the Merger and
the Change of Control; and (ii) the holders of a majority
of the shares of CancerVax Common Stock entitled to vote at the
CancerVax Stockholders Meeting is the only vote of the holders
of any class or series of CancerVaxs capital stock
necessary to approve the Charter Amendment and the Reverse Split
(collectively, the Required CancerVax Stockholder
Vote).
3.21 Non-Contravention;
Consents. Neither (x) the execution,
delivery or performance of this Agreement by CancerVax or Merger
Sub, nor (y) the consummation of the Merger or any of the
other Contemplated Transactions, will directly or indirectly
(with or without notice or lapse of time):
(a) contravene, conflict with or result in a violation of
(i) any of the provisions of the certificate of
incorporation, bylaws or other charter or organizational
documents of CancerVax or Merger Sub, or (ii) any
resolution adopted by the stockholders, the board of directors
or any committee of the board of directors of CancerVax or
Merger Sub;
(b) subject to compliance with the HSR Act and any foreign
antitrust Legal Requirement, contravene, conflict with or result
in a violation of, or give any Governmental Body or other Person
the right to challenge the Merger or any of the other
Contemplated Transactions or to exercise any remedy or obtain
any relief under, any Legal Requirement or any order, writ,
injunction, judgment or decree to which CancerVax or its
Subsidiaries, or any of the assets owned or used by CancerVax or
its Subsidiaries, is subject;
(c) contravene, conflict with or result in a violation of
any of the terms or requirements of, or give any Governmental
Body the right to revoke, withdraw, suspend, cancel, terminate
or modify, any Governmental Authorization that is held by
CancerVax or its Subsidiaries or that otherwise relates to the
business of CancerVax or its Subsidiaries or to any of the
assets owned or used by CancerVax or its Subsidiaries;
(d) contravene, conflict with or result in a violation or
breach of, or result in a default under, any provision of any
CancerVax Contract, or give any Person the right to:
(i) declare a default or exercise any remedy under any
CancerVax Contract; (ii) a rebate, chargeback, penalty or
change in delivery schedule under any such CancerVax Contract;
(iii) accelerate the maturity or performance of any
CancerVax Contract; or (iv) cancel, terminate or modify any
term of any CancerVax Contract; except, in the case of any
CancerVax Material Contract, any non-material breach, default,
penalty or modification and, in the case of all other CancerVax
Contracts, any breach, default, penalty or modification that
would not result in a CancerVax Material Adverse Effect;
(e) result in the imposition or creation of any Encumbrance
upon or with respect to any asset owned or used by CancerVax or
its Subsidiaries (except for minor liens that will not, in any
case or in the aggregate, materially detract from the value of
the assets subject thereto or materially impair the operations
of CancerVax); or
(f) result in, or increase the likelihood of, the transfer
of any material asset of CancerVax or its Subsidiaries to any
Person.
Except (i) for any Consent set forth on Part 3.21 of
the CancerVax Disclosure Schedule under any CancerVax Contract,
(ii) the approval of the Merger, the issuance of shares of
CancerVax Common Stock in the Merger, the Charter Amendment, the
Change of Control and the Reverse Split, (iii) the filing
of the Certificate of Merger with
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the Secretary of State of the State of Delaware pursuant to the
DGCL, (iv) such filings under the HSR Act, any foreign
antitrust Legal Requirement and (v) such consents, waivers,
approvals, orders, authorizations, registrations, declarations
and filings as may be required under applicable federal and
state securities laws, neither CancerVax nor any of its
Subsidiaries was, is nor will be required to make any filing
with or give any notice to, or to obtain any Consent from, any
Person in connection with (x) the execution, delivery or
performance of this Agreement, or (y) the consummation of
the Merger or any of the other Contemplated Transactions.
3.22 No Financial
Advisor. Except for Piper Jaffray, no broker,
finder or investment banker is entitled to any brokerage fee,
finders fee, opinion fee, success fee, transaction fee or
other fee or commission in connection with the Merger or any of
the other Contemplated Transactions based upon arrangements made
by or on behalf of CancerVax or any of its Subsidiaries.
3.23 Valid Issuance. The
CancerVax Common Stock to be issued in the Merger will, when
issued in accordance with the provisions of this Agreement, be
validly issued, fully paid and nonassessable.
Section 4. Certain
Covenants of the Parties
4.1 Access and
Investigation. Subject to the terms of the
Confidentiality Agreement which the parties agree will continue
in full force following the date of this Agreement, during the
period commencing on the date of this Agreement and ending at
the Effective Time (the Pre-Closing
Period), upon reasonable notice each Party shall,
and shall cause such Partys Representatives to:
(a) provide the other Party and such other Partys
Representatives with reasonable access during normal business
hours to such Partys Representatives, personnel and assets
and to all existing books, records, Tax Returns, work papers and
other documents and information relating to such Party and its
Subsidiaries; (b) provide the other Party and such other
Partys Representatives with such copies of the existing
books, records, Tax Returns, work papers, product data, and
other documents and information relating to such Party and its
Subsidiaries, and with such additional financial, operating and
other data and information regarding such Party and its
Subsidiaries as the other Party may reasonably request; and
(c) permit the other Partys officers and other
employees to meet, upon reasonable notice and during normal
business hours, with the chief financial officer and other
officers and managers of such Party responsible for such
Partys financial statements and the internal controls of
such Party to discuss such matters as the other Party may deem
necessary or appropriate in order to enable the other Party to
satisfy its obligations under the Sarbanes-Oxley Act and the
rules and regulations relating thereto. Without limiting the
generality of any of the foregoing, during the Pre-Closing
Period, each Party shall promptly provide the other Party with
copies of:
(i) the unaudited monthly consolidated balance sheets of
such Party as of the end of each calendar month and the related
unaudited monthly consolidated statements of operations,
statements of stockholders equity and statements of cash
flows for such calendar month, which shall be delivered within
twenty days after the end of such calendar month;
(ii) all material operating and financial reports prepared
by such Party for its senior management, including sales
forecasts, marketing plans, development plans, discount reports,
write-off reports, hiring reports and capital expenditure
reports prepared for its senior management;
(iii) any written materials or communications sent by or on
behalf of a Party to its stockholders;
(iv) any material notice, document or other communication
sent by or on behalf of a Party to any party to any CancerVax
Material Contract or Parent Material Contract, as applicable, or
sent to a Party by any party to any CancerVax Material Contract
or Parent Material Contract, as applicable (other than any
communication that relates solely to routine commercial
transactions between such Party and the other party to any such
CancerVax Material Contract or Parent Material Contract, as
applicable, and that is of the type sent in the Ordinary Course
of Business and consistent with past practices);
(v) any notice, report or other document filed with or
otherwise furnished, submitted or sent to any Governmental Body
on behalf of a Party in connection with the Merger or any of the
Contemplated Transactions;
(vi) any non-privileged notice, document or other
communication sent by or on behalf of, or sent to, a Party
relating to any pending or threatened Legal Proceeding involving
or affecting such Party; and
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(vii) any material notice, report or other document
received by a Party from any Governmental Body.
Notwithstanding the foregoing, any Party may restrict the
foregoing access to the extent that any Legal Requirement
applicable to such party requires such Party or its Subsidiaries
to restrict or prohibit access to any such properties or
information.
4.2 Operation of CancerVaxs Business.
(a) Except as set forth on Part 4.2 of the CancerVax
Disclosure Schedule, during the Pre-Closing Period:
(i) Each of CancerVax and its Subsidiaries shall conduct
its business and operations: (A) in the Ordinary Course of
Business; (B) in compliance with all applicable Legal
Requirements and the requirements of all Contracts that
constitute material Contracts; and (C) consistent with the
actions customarily taken by a similarly situated corporation
engaged in the prompt and orderly termination of its lead
pharmaceutical candidate program; (ii) Subject to the
preceding clause (i), each of CancerVax and its
Subsidiaries shall preserve intact its current business
organization, keep available the services of its current Key
Employees and maintains its relations and goodwill with all
material suppliers, customers, landlords, creditors, licensors,
licensees, employees and other Persons having material business
relationships with CancerVax and its Subsidiaries; and
(iii) CancerVax shall promptly notify Parent of:
(A) any notice or other communication from any Person
alleging that the Consent of such Person is or may be required
in connection with any of the Contemplated Transactions; and
(B) any Legal Proceeding against, relating to, involving or
otherwise affecting CancerVax or its Subsidiaries that is
commenced, or, to the Knowledge of CancerVax, threatened
against, CancerVax or its Subsidiaries.
(b) Except as set forth in Part 4.2 of the CancerVax
Disclosure Schedule, and subject to any legal requirement
applicable to CancerVax or any of its Subsidiaries, during the
Pre-Closing Period, neither CancerVax nor any of its
Subsidiaries shall, without the prior written consent of
Micromet:
(i) declare, accrue, set aside or pay any dividend or make
any other distribution in respect of any shares of capital
stock, or repurchase, redeem or otherwise reacquire any shares
of capital stock or other securities;
(ii) sell, issue, grant or authorize the sale, issuance or
grant of: (A) any capital stock or other security;
(B) any option, call, warrant or right to acquire any
capital stock or other security; or (C) any instrument
convertible into or exchangeable for any capital stock or other
security, or (D) reserve for issuance any additional
grants, and or shares under any CancerVax Stock Plan, except
that, notwithstanding anything to the contrary in this
Section 4.2, CancerVax may issue shares of CancerVax Common
Stock (x) upon the valid exercise of CancerVax Options and
CancerVax Warrants, in each case outstanding as of the date of
this Agreement, and (y) in satisfaction of severance
obligations outstanding as of the date of this Agreement (and
CancerVax may amend the terms of outstanding severance
arrangements to provide for payment in CancerVax Common Stock in
lieu of cash) and for the payment of bonuses to employees;
(iii) amend or waive any of its rights under, or permit the
acceleration of the vesting under, any provision of:
(A) any of the CancerVax Stock Plans; (B) any
CancerVax Option or CancerVax Warrants or any agreement
evidencing or relating to any outstanding stock option or
warrant; (C) any restricted stock purchase agreement; or
(D) any other Contract evidencing or relating to any equity
award (whether payable in cash or stock);
(iv) amend or permit the adoption of any amendment to its
certificate of incorporation or bylaws or other charter or
organizational documents, or effect or become a party to any
merger, consolidation, share exchange, business combination,
amalgamation, recapitalization, reclassification of shares,
stock split, reverse stock split, division or subdivision of
shares, consolidation of shares or similar transaction or
otherwise acquire or agree to acquire any assets that are
material, individually or in the aggregate, to the business of
CancerVax;
(v) form any Subsidiary or acquire any equity interest or
other interest in any other Entity or enter into any material
partnership arrangements, joint development agreements or
strategic alliances;
(vi) make any capital expenditure in excess of $100,000;
(vii) other than in the Ordinary Course of Business
consistent with past practices, enter into or become bound by,
or permit any of the assets owned or used by it to become bound
by, any material Contract, or agree to amend or terminate any
material Contract;
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(viii) acquire, lease or license any right or other asset
from any other Person or sell encumber, convey, assign, or
otherwise dispose of or transfer of, or lease or license or
sublicense, any right or other asset or interest therein to any
other Person (except in each case for assets (that are not
material individually or in the aggregate) acquired, leased,
licensed or disposed of by CancerVax or its Subsidiaries in the
Ordinary Course of Business and consistent with past practices),
or waive or relinquish any material right;
(ix) other than in the Ordinary Course of Business
consistent with past practices, write off as uncollectible, or
establish any extraordinary reserve with respect to, any
receivable or other indebtedness;
(x) make any pledge of any of its assets or permit any of
its assets to become subject to any Encumbrances, except for
pledges of or Encumbrances with respect to immaterial assets
made in the Ordinary Course of Business consistent with past
practices;
(xi) lend money to any Person, or incur or guarantee any
indebtedness or issue or sell any debt securities or options,
warrants, calls or other similar rights to acquire any debt
securities of CancerVax;
(xii) establish, adopt, enter into or amend any CancerVax
Employee Plan or any employee stock purchase or employee stock
option plan, or, except as contemplated by this Agreement or by
any CancerVax Employee Plan in effect as of the date of this
Agreement and disclosed on the CancerVax Disclosure Schedule,
pay any bonus or make any profit-sharing or similar payment to,
or increase the amount of the wages, salary, commissions, fringe
benefits or other compensation (including equity-based
compensation, whether payable in stock, cash or other property)
or remuneration payable to any of its directors or any of its
officers or other employees except as required by law;
(xiii) hire any employee or terminate any Key Employee;
(xiv) make any grant of exclusive rights to any third party;
(xv) transfer or license to any person or entity or
otherwise extend, amend or modify in any material respect any
rights to the Intellectual Property, or enter into any
agreements or make other commitments or arrangements to grant,
transfer or license to any person any future patent rights,
other than non-exclusive licenses granted to customers,
resellers and end users in the Ordinary Course of Business
consistent with past practices;
(xvi) enter into, or materially modify, any material
contract, agreement or obligation relating to the distribution,
sale, license or marketing by third Persons of CancerVaxs
or its Subsidiaries products or products licensed by
CancerVax or its Subsidiaries, other than nonexclusive
contracts, agreements or obligations entered into in the
Ordinary Course of Business that can be terminated or cancelled
by CancerVax or its Subsidiaries without material penalty or
further material payment and without more than ninety
(90) days notice;
(xvii) pay, discharge or satisfy any claim, liability or
obligation (absolute, accrued, asserted or unasserted,
contingent or otherwise), other than the payment, discharge or
satisfaction of non-material amounts in the Ordinary Course of
Business;
(xviii) change any of its personnel policies or other
business policies, or any of its methods of accounting or
accounting practices in any material respect;
(xix) make any Tax election, adopt or change any accounting
methods, principles or practices, file any material amendment to
any Tax Return, enter into any tax allocation agreement, tax
sharing agreement, tax indemnity agreement or closing agreement
relating to any material Tax, surrender any right to claim a
material Tax refund, or consent to any extension or waiver of
the statute of limitations period applicable to any material Tax
claim or assessment;
(xx) commence or settle any Legal Proceeding in a manner
that would be reasonably expected to result in a CancerVax
Material Adverse Effect;
(xxi) enter into any material transaction outside the
Ordinary Course of Business; or
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(xxii) agree or commit to take any of the actions described
in clauses (i) through (xxi) of
this Section 4.2(b).
(c) During the Pre-Closing Period, CancerVax shall promptly
notify Parent in writing, by delivering an updated CancerVax
Disclosure Schedule, of: (i) the discovery by CancerVax of
any event, condition, fact or circumstance that occurred or
existed on or prior to the date of this Agreement and that
caused or constitutes a material inaccuracy in any
representation or warranty made by CancerVax in this Agreement;
(ii) any event, condition, fact or circumstance that
occurs, arises or exists after the date of this Agreement and
that would cause or constitute a material inaccuracy in any
representation or warranty made by CancerVax in this Agreement
if: (A) such representation or warranty had been made as of
the time of the occurrence, existence or discovery of such
event, condition, fact or circumstance; or (B) such event,
condition, fact or circumstance had occurred, arisen or existed
on or prior to the date of this Agreement; (iii) any
material breach of any covenant or obligation of CancerVax; and
(iv) any event, condition, fact or circumstance that could
reasonably be expected to make the timely satisfaction of any of
the conditions set forth in Sections 6, 7 or 8 impossible
or materially less likely. Without limiting the generality of
the foregoing, CancerVax shall promptly advise Parent in writing
of any Legal Proceeding or material claim threatened, commenced
or asserted against or with respect to, or otherwise affecting,
CancerVax or its Subsidiaries or (to the Knowledge of CancerVax)
any director, officer or Key Employee of CancerVax or its
Subsidiaries. No notification given to Parent pursuant to this
Section 4.2(c) shall change, limit or otherwise affect any
of the representations, warranties, covenants or obligations of
CancerVax contained in this Agreement or the CancerVax
Disclosure Schedule for purposes of Section 8.1.
4.3 Operation of Parents and Micromets
Business.
(a) Except as set forth on Part 4.3 of the Parent
Disclosure Schedule, during the Pre-Closing Period:
(i) Parent and Micromet shall conduct their respective
business and operations: (A) in the Ordinary Course of
Business and in accordance with past practices; and (B) in
compliance with all applicable Legal Requirements and the
requirements of all Contracts that constitute material
Contracts; and (ii) Parent and Micromet shall preserve
intact its current business organization, keep available the
services of its current officers and other employees and
maintains its relations and goodwill with all suppliers,
customers, landlords, creditors, licensors, licensees, employees
and other Persons having business relationships with Parent or
Micromet; and (iii) Parent shall promptly notify CancerVax
of: (A) any notice or other communication from any Person
alleging that the Consent of such Person is or may be required
in connection with any of the Contemplated Transactions; and
(B) any Legal Proceeding against, relating to, involving or
otherwise affecting the Micromet Parties that is commenced, or,
to the Knowledge of Micromet or Parent, threatened against, the
Micromet Parties.
(b) Except as set forth in Part 4.3 of the Parent
Disclosure Schedule, and subject to any Legal Requirement
applicable to the Micromet Parties, during the Pre-Closing
Period, Parent and Micromet agree that none of the Micromet
Parties shall, without the prior written consent of CancerVax:
(i) declare, accrue, set aside or pay any dividend or make
any other distribution in respect of any shares of capital
stock, or repurchase, redeem or otherwise reacquire any shares
of capital stock or other securities (other than the Micromet
Recapitalization);
(ii) sell, issue, grant or authorize the sale, issuance or
grant of: (A) any capital stock or other security;
(B) any option, call, warrant or right to acquire any
capital stock or other security; or (C) any instrument
convertible into or exchangeable for any capital stock or other
security, or (D) reserve for issuance any additional
grants, and or shares under the Parent Stock Option Plan, except
that (x) Parent and Micromet may grant to their employees
in the Ordinary Course of Business stock options to acquire up
to 366,472 shares of Parent Common Stock; provided, that in
connection with the grant of such options Parent or Micromet
shall have received all necessary consents to the transactions
contemplated by this Agreement from the recipient of such
options, and (y) Parent and Micromet may issue shares of
Parent Common Stock or Micromet Common Stock, as applicable,
upon the valid exercise of stock options outstanding as of the
date of this Agreement and stock options granted after the date
of this Agreement pursuant to foregoing clause (x);
(iii) amend or waive any of its rights under, or permit the
acceleration of the vesting under, any provision of:
(A) the Parent Stock Option Plan; (B) any Parent
Option or any agreement evidencing or relating to any
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outstanding stock option or warrant; (C) any restricted
stock purchase agreement; or (D) any other Contract
evidencing or relating to any equity award (whether payable in
cash or stock);
(iv) amend or permit the adoption of any amendment to its
certificate of incorporation or bylaws or other charter or
organizational documents, or effect or become a party to any
merger, consolidation, share exchange, business combination,
amalgamation, recapitalization, reclassification of shares,
stock split, reverse stock split, division or subdivision of
shares, consolidation of shares or similar transaction (other
than the Micromet Recapitalization);
(v) form any Subsidiary or acquire any equity interest or
other interest in any other Entity;
(vi) make any capital expenditure in excess of $250,000;
(vii) other than in the Ordinary Course of Business
consistent with past practices, enter into or become bound by,
or permit any of the assets owned or used by it to become bound
by, any material Contract, or agree to amend or terminate any
material Contract;
(viii) acquire, lease or license any right or other asset
from any other Person or sell encumber, convey, assign, or
otherwise dispose of or transfer of, or lease or license or
sublicense, any right or other asset or interest therein to any
other Person (except in each case for assets (that are not
material individually or in the aggregate) acquired, leased,
licensed or disposed of by any of the Micromet Parties in the
Ordinary Course of Business and consistent with past practices),
or waive or relinquish any material right;
(ix) other than in the Ordinary Course of Business
consistent with past practices, write off as uncollectible, or
establish any extraordinary reserve with respect to, any
receivable or other indebtedness;
(x) make any pledge of any of its assets or permit any of
its assets to become subject to any Encumbrances, except for
pledges of or Encumbrances with respect to immaterial assets
made in the Ordinary Course of Business consistent with past
practices;
(xi) lend money to any Person, or incur or guarantee any
indebtedness or issue or sell any debt securities or options,
warrants, calls or other similar rights to acquire any debt
securities of Parent or Micromet;
(xii) establish, adopt, enter into or amend any Parent
Employee Plan or any employee stock purchase or employee stock
option plan, pay any bonus or make any profit-sharing or similar
payment to, or increase the amount of the wages, salary,
commissions, fringe benefits or other compensation (including
equity-based compensation, whether payable in stock, cash or
other property) or remuneration payable to any of its directors
or any of its officers or other employees except as required by
law;
(xiii) hire or terminate any Key Employee;
(xiv) pay, discharge or satisfy any claim, liability or
obligation (absolute, accrued, asserted or unasserted,
contingent or otherwise), other than the payment, discharge or
satisfaction of non-material amounts in the Ordinary Course of
Business;
(xv) change any of its personnel policies or other business
policies, or any of its methods of accounting or accounting
practices in any material respect;
(xvi) make any Tax election, adopt or change any accounting
methods, principles or practice, file any material amendment to
any Tax Return, enter into any tax allocation agreement, tax
sharing agreement, tax indemnity agreement or closing agreement
relating to any material Tax, surrender any right to claim a
material Tax refund, or consent to any extension or waiver of
the statute of limitations period applicable to any material Tax
claim or assessment;
(xvii) commence or settle any Legal Proceeding in a manner
that would be reasonably expected to result in a Parent Material
Adverse Effect;
(xviii) enter into any material transaction outside the
Ordinary Course of Business; or
(xix) agree or commit to take any of the actions described
in clauses (i) through (xviii) of
this Section 4.3(b).
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(c) During the Pre-Closing Period, Parent shall promptly
notify CancerVax in writing, by delivery of an updated Parent
Disclosure Schedule, of: (i) the discovery by the Micromet
Parties of any event, condition, fact or circumstance that
occurred or existed on or prior to the date of this Agreement
and that caused or constitutes a material inaccuracy in any
representation or warranty made by the Micromet Parties in this
Agreement; (ii) any event, condition, fact or circumstance
that occurs, arises or exists after the date of this Agreement
and that would cause or constitute a material inaccuracy in any
representation or warranty made by the Micromet Parties in this
Agreement if: (A) such representation or warranty had been
made as of the time of the occurrence, existence or discovery of
such event, condition, fact or circumstance; or (B) such
event, condition, fact or circumstance had occurred, arisen or
existed on or prior to the date of this Agreement;
(iii) any material breach of any covenant or obligation of
the Micromet Parties; and (iv) any event, condition, fact
or circumstance that could reasonably be expected to make the
timely satisfaction of any of the conditions set forth in
Sections 6, 7 or 8 impossible or materially less likely.
Without limiting the generality of the foregoing, Parent shall
promptly advise CancerVax in writing of any Legal Proceeding or
material claim threatened, commenced or asserted against or with
respect to, or otherwise affecting, the Micromet Parties or (to
the Knowledge of Micromet or Parent) any director, officer or
Key Employee of the Micromet Parties. No notification given to
CancerVax pursuant to this Section 4.3(c) shall change,
limit or otherwise affect any of the representations,
warranties, covenants or obligations of the Micromet Parties
contained in this Agreement or the Parent Disclosure Schedule
for purposes of Section 7.1.
4.4 No Solicitation.
(a) Each Party agrees that neither it nor any of its
Subsidiaries shall, nor shall it nor any of its Subsidiaries
authorize or permit any of the officers, directors, investment
bankers, attorneys or accountants retained by it or any of its
Subsidiaries to, and that it shall use commercially reasonable
efforts to cause its and its Subsidiaries non-officer
employees and other agents not to (and shall not authorize any
of them to) directly or indirectly: (i) solicit, initiate,
encourage, induce or knowingly facilitate the communication,
making, submission or announcement of any Acquisition Proposal
or Acquisition Inquiry or take any action that could reasonably
be expected to lead to an Acquisition Proposal or Acquisition
Inquiry; (ii) furnish any information regarding such Party
to any Person in connection with or in response to an
Acquisition Proposal or Acquisition Inquiry; (iii) engage
in discussions or negotiations with any Person with respect to
any Acquisition Proposal or Acquisition Inquiry;
(iv) approve, endorse or recommend any Acquisition
Proposal; or (v) execute or enter into any letter of intent
or similar document or any Contract contemplating or otherwise
relating to any Acquisition Transaction; provided,
however, that, notwithstanding anything contained in this
Section 4.4(a), prior to the adoption and approval of this
Agreement by the Required Parent Stockholder Vote or the
Required CancerVax Stockholder Vote, as applicable, each Party
may furnish nonpublic information regarding such Party to, and
enter into discussions or negotiations with, any Person in
response to a Superior Offer that is submitted to such Party by
such Person (and not withdrawn) if: (A) neither such Party
nor any Representative of such Party shall have breached this
Section 4.4; (B) the board of directors of such Party
concludes in good faith based on the advice of outside legal
counsel, that the failure to take such action is reasonably
likely to result in a breach of the fiduciary duties of the
board of directors of such Party under applicable Legal
Requirements; (C) at least two Business Days prior to
furnishing any such nonpublic information to, or entering into
discussions with, such Person, such Party gives the other Party
written notice of the identity of such Person and of such
Partys intention to furnish nonpublic information to, or
enter into discussions with, such Person; (D) such Party
receives from such Person an executed confidentiality agreement
containing provisions (including nondisclosure provisions, use
restrictions, non-solicitation provisions, no hire provisions
and standstill provisions) at least as favorable to
such Party as those contained in the Confidentiality Agreement;
and (E) at least two Business Days prior to furnishing any
such nonpublic information to such Person, such Party furnishes
such nonpublic information to the other Party (to the extent
such nonpublic information has not been previously furnished by
such Party to the other Party). Without limiting the generality
of the foregoing, each Party acknowledges and agrees that, in
the event any Representative of such Party (whether or not such
Representative is purporting to act on behalf of such Party)
takes any action that, if taken by such Party, would constitute
a breach of this Section 4.4 by such Party, the taking of
such action by such Representative shall be deemed to constitute
a breach of this Section 4.4 by such Party for purposes of
this Agreement.
(b) If any Party or any Representative of such Party
receives an Acquisition Proposal or Acquisition Inquiry at any
time during the Pre-Closing Period, then such Party shall
promptly (and in no event later than 24 hours after
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such Party becomes aware of such Acquisition Proposal or
Acquisition Inquiry) advise the other Party orally and in
writing of such Acquisition Proposal or Acquisition Inquiry
(including the identity of the Person making or submitting such
Acquisition Proposal or Acquisition Inquiry, and the terms
thereof). Such Party shall keep the other Party fully informed
with respect to the status and terms of any such Acquisition
Proposal or Acquisition Inquiry and any modification or proposed
modification thereto.
(c) Each Party shall immediately cease and cause to be
terminated any existing discussions with any Person that relate
to any Acquisition Proposal or Acquisition Inquiry as of the
date of this Agreement.
(d) Each Party shall not release or permit the release of
any Person from, or waive or permit the waiver of any provision
of or right under, any confidentiality, non-solicitation, no
hire, standstill or similar agreement (whether
entered into prior to or after the date of this Agreement) to
which such Party is a party or under which such Party has any
rights, and shall enforce or cause to be enforced each such
agreement to the extent requested by the other Party. Each Party
shall promptly request each Person that has executed a
confidentiality or similar agreement in connection with its
consideration of a possible Acquisition Transaction or equity
investment to return to such Party all confidential information
heretofore furnished to such Person by or on behalf of such
Party.
Section 5. Additional
Agreements of the Parties
5.1 Registration Statement; Joint Proxy
Statement/Prospectus.
(a) As promptly as practicable after the date of this
Agreement, the Parties shall prepare and cause to be filed with
the SEC the Joint Proxy Statement/Prospectus and CancerVax shall
prepare and cause to be filed with the SEC the
Form S-4
Registration Statement, in which the Joint Proxy
Statement/Prospectus will be included as a prospectus. Each of
the Parties shall use commercially reasonable efforts to cause
the
Form S-4
Registration Statement and the Joint Proxy Statement/Prospectus
to comply with the applicable rules and regulations promulgated
by the SEC, to respond promptly to any comments of the SEC or
its staff and to have the
Form S-4
Registration Statement declared effective under the Securities
Act as promptly as practicable after it is filed with the SEC.
Each of the Parties shall use commercially reasonable efforts to
cause the Joint Proxy Statement/Prospectus to be mailed to
Parents and CancerVaxs stockholders as promptly as
practicable after the
Form S-4
Registration Statement is declared effective under the
Securities Act. Each Party shall promptly furnish to the other
Party all information concerning such Party and such
Partys subsidiaries and such Partys stockholders
that may be required or reasonably requested in connection with
any action contemplated by this Section 5.1. If any event
relating to any of the Micromet Parties occurs, or if Micromet
becomes aware of any information, that should be disclosed in an
amendment or supplement to the
Form S-4
Registration Statement or the Joint Proxy Statement/Prospectus,
then Micromet shall promptly inform CancerVax thereof and shall
cooperate with CancerVax in filing such amendment or supplement
with the SEC and, if appropriate, in mailing such amendment or
supplement to the stockholders of Parent.
(b) Prior to the Effective Time, CancerVax shall use
commercially reasonable efforts to obtain all regulatory
approvals needed to ensure that the CancerVax Common Stock to be
issued in the Merger will (to the extent required) be registered
or qualified or exempt from registration or qualification under
the securities law of every jurisdiction of the United States in
which any registered holder of Parent Common Stock has an
address of record on the record date for determining the
stockholders entitled to notice of and to vote at the Parent
Stockholders Meeting; provided, however, that
CancerVax shall not be required: (i) to qualify to do
business as a foreign corporation in any jurisdiction in which
it is not now qualified; or (ii) to file a general consent
to service of process in any jurisdiction.
5.2 Parent Stockholders Meeting; Micromet
Recapitalization.
(a) Parent shall take all action necessary under all
applicable Legal Requirements to call, give notice of and hold a
meeting of the holders of Parent Common Stock to vote on the
adoption and approval of this Agreement (the Parent
Stockholders Meeting). The Parent
Stockholders Meeting shall be held as promptly as
practicable after the
Form S-4
Registration Statement is declared effective under the
Securities Act. Parent shall ensure that all proxies solicited
in connection with the Parent Stockholders Meeting are
solicited in compliance with all applicable Legal Requirements.
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(b) Parent and Micromet agree that, subject to
Section 5.2(c): (i) Parents board of directors
shall recommend that Parents stockholders vote to adopt
and approve this Agreement and the Merger and shall use
commercially reasonable efforts to solicit such approval,
(ii) the Joint Proxy Statement/Prospectus shall include a
statement to the effect that the board of directors of Parent
recommends that Parents stockholders vote to adopt and
approve this Agreement at the Parent Stockholders Meeting
(the recommendation of Parents board of directors that
Parents stockholders vote to adopt and approve this
Agreement being referred to as the Parent Board
Recommendation); and (iii) the Parent Board
Recommendation shall not be withdrawn or modified in a manner
adverse to CancerVax, and no resolution by the board of
directors of Parent or any committee thereof to withdraw or
modify the Parent Board Recommendation in a manner adverse to
CancerVax shall be adopted or proposed.
(c) Notwithstanding anything to the contrary contained in
Section 5.2(b), at any time prior to the approval of this
Agreement by the Required Parent Stockholder Vote, Parents
board of directors may withhold, amend, withdraw or modify the
Parent Board Recommendation in a manner adverse to CancerVax if,
but only if: (i) an unsolicited, bona fide written offer
has been made that it believes in good faith, based on such
matters as it deems relevant following consultation with its
outside legal counsel, is a Superior Offer and such offer is not
withdrawn; (ii) such unsolicited, bona fide written offer
was not obtained or made as a direct or indirect result of a
breach of this Agreement; (iii) Parents board of
directors determined in good faith, based on such matters as it
deems relevant following consultation with its outside legal
counsel, that the failure to withdraw, withhold, amend, or
modify such recommendation is reasonably likely to result in a
breach of its fiduciary duties under applicable Legal
Requirements; and (iv) the Parent Board Recommendation is
not withdrawn, withheld, amend or modified in a manner adverse
to CancerVax at any time within three Business Days after
CancerVax receives written notice from Parent confirming that
Parents board of directors has determined to change its
recommendation.
(d) Parents obligation to call, give notice of and
hold the Parent Stockholders Meeting in accordance with
Section 5.2(a) shall not be limited or otherwise affected
by the commencement, disclosure, announcement or submission of
any Superior Offer or other Acquisition Proposal, or by any
withdrawal or modification of the Parent Board Recommendation.
(e) Micromet and Parent shall take all necessary action to
effectuate the Micromet Recapitalization prior to the Closing
Date.
5.3 CancerVax Stockholders Meeting.
(a) CancerVax shall take all action necessary under
applicable legal requirements to call, give notice of and hold a
meeting of the holders of CancerVax Common Stock to vote on the
issuance of CancerVax Common Stock in the Merger, the Charter
Amendment, the Change of Control, the Reverse Split (such
meeting, the CancerVax Stockholders
Meeting). The CancerVax Stockholders Meeting
shall be held as promptly as practicable after the
Form S-4
Registration Statement is declared effective under the
Securities Act. CancerVax shall ensure that all proxies
solicited in connection with the CancerVax Stockholders
Meeting are solicited in compliance with all applicable Legal
Requirements.
(b) Subject to Section 5.3(c):
(i) CancerVaxs board of directors shall recommend
that the holders of CancerVax Common Stock vote to approve the
issuance of CancerVax Common Stock in the Merger, the Charter
Amendment, the Change of Control, the Reverse Split, and such
other matters contemplated by this Agreement, and shall use
commercially reasonable efforts to solicit such approval,
(ii) the Joint Proxy Statement/Prospectus shall include a
statement to the effect that the board of directors of CancerVax
recommends that CancerVaxs stockholders vote to approve
the issuance of CancerVax Common Stock in the Merger, the
Charter Amendment, the Change of Control, the Reverse Split, and
such other matters contemplated by this Agreement (the
recommendation of CancerVaxs board of directors that
CancerVaxs stockholders vote to approve the issuance of
CancerVax Common Stock in the Merger, the Charter Amendment, the
Change of Control, the Reverse Split, and such other matters
contemplated by this Agreement being referred to as the
CancerVax Board Recommendation); and
(iii) the CancerVax Board Recommendation shall not be
withdrawn or modified in a manner adverse to Parent or Micromet,
and no resolution by the board of directors of CancerVax or any
committee thereof to withdraw or modify the CancerVax Board
Recommendation in a manner adverse to Parent or Micromet shall
be adopted or proposed.
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(c) Notwithstanding anything to the contrary contained in
Section 5.3(b), at any time prior to the approval of the
issuance of CancerVax Common Stock in the Merger by the
stockholders of CancerVax by the Required CancerVax Stockholder
Vote, CancerVaxs board of directors may withhold, amend,
withdraw or modify the CancerVax Board Recommendation in a
manner adverse to Parent if, but only if: (i) an
unsolicited, bona fide written offer has been made that it
believes in good faith, based on such matters as it deems
relevant following consultation with its outside legal counsel,
is a Superior Offer and such offer is not withdrawn;
(ii) such unsolicited, bona fide, written offer was not
obtained or made as a direct or indirect result of a breach of
this Agreement; (iii) CancerVaxs board of directors
determines in good faith, based on such matters as it deems
relevant following consultation with its outside legal counsel,
that the failure to withhold, amend, withdraw or modify such
recommendation is reasonably likely to result in a breach of its
fiduciary duties under applicable Legal Requirements; and
(iv) the CancerVax Board Recommendation is not withdrawn or
modified in a manner adverse to Parent at any time within three
Business Days after Parent receives written notice from
CancerVax confirming that CancerVaxs board of directors
has determined to change its recommendation.
(d) CancerVaxs obligation to call, give notice of and
hold the CancerVax Stockholders Meeting in accordance with
Section 5.3(a) shall not be limited or otherwise affected
by any withdrawal or modification of the CancerVax Board
Recommendation.
5.4 Regulatory Approvals. Each
Party shall use commercially reasonable efforts to file or
otherwise submit, as soon as practicable after the date of this
Agreement, all applications, notices, reports and other
documents reasonably required to be filed by such Party with or
otherwise submitted by such Party to any Governmental Body with
respect to the Merger and the other Contemplated Transactions,
and to submit promptly any additional information requested by
any such Governmental Body. Without limiting the generality of
the foregoing, the Parties shall, promptly after the date of
this Agreement, prepare and file, if any, (a) the
notification and report any forms required to be filed under the
HSR Act and (b) any notification or other document required
to be filed in connection with the Merger under any applicable
foreign Legal Requirement relating to antitrust or competition
matters. Parent, Micromet and CancerVax shall as promptly as
practicable to respond in compliance with: (i) any
inquiries or requests received from the Federal Trade Commission
or the Department of Justice for additional information or
documentation; and (ii) any inquiries or requests received
from any state attorney general, foreign antitrust or
competition authority or other Governmental Body in connection
with antitrust or competition matters.
5.5 Stock Options.
(a) Subject to Section 5.5(c), at the Effective Time,
each Parent Option that is outstanding and unexercised
immediately prior to the Effective Time, whether or not vested,
shall be converted into and become an option to purchase
CancerVax Common Stock, and CancerVax shall assume each such
Parent Option in accordance with the terms (as in effect as of
the date of this Agreement) of the stock option plan, if any,
under which such Parent Option was issued and the terms of the
stock option agreement by which such Parent Option is evidenced.
All rights with respect to Parent Common Stock under Parent
Options assumed by CancerVax shall thereupon be converted into
rights with respect to CancerVax Common Stock. Accordingly, from
and after the Effective Time: (i) each Parent Option
assumed by CancerVax may be exercised solely for shares of
CancerVax Common Stock; (ii) the number of shares of
CancerVax Common Stock subject to each Parent Option assumed by
CancerVax shall be determined by multiplying (A) the number
of shares of Parent Common Stock that were subject to such
Parent Option immediately prior to the Effective Time by
(B) the Conversion Factor, and rounding the resulting
number down to the nearest whole number of shares of CancerVax
Common Stock; (iii) the per share exercise price for the
CancerVax Common Stock issuable upon exercise of each Parent
Option assumed by CancerVax shall be determined by dividing the
effective per share exercise price of Parent Common Stock
subject to such Parent Option, as in effect immediately prior to
the Effective Time, by the Conversion Factor, and rounding the
resulting exercise price up to the nearest whole cent; and
(iv) any restriction on the exercise of any Parent Option
assumed by CancerVax shall continue in full force and effect and
the term, exercisability, vesting schedule and other provisions
of such Parent Option shall otherwise remain unchanged;
provided, however, that: (A) each Parent Option
assumed by CancerVax in accordance with this Section 5.5(a)
shall, in accordance with its terms, be subject to further
adjustment as appropriate to reflect any stock split, division
or subdivision of shares, stock dividend, reverse stock split,
consolidation of shares, reclassification, recapitalization or
other similar transaction with respect to CancerVax Common Stock
subsequent to the Effective Time; and (B) CancerVaxs
board of directors or a committee thereof shall succeed to the
authority
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and responsibility of Micromets and Parents board of
directors or any committee thereof with respect to each Parent
Option assumed by CancerVax.
(b) CancerVax shall file with the SEC, no later than
60 days after the Effective Time, a registration statement
on
Form S-8,
if available for use by CancerVax, relating to the shares of
CancerVax Common Stock issuable with respect to Parent Options
assumed by CancerVax in accordance with Section 5.5(a).
(c) At the Effective Time, CancerVax shall assume Parent
Options within the Amended and Restated 2003 Equity Incentive
Award Plan, provided that in the event that there are not
sufficient shares reserved under such plan at the Effective
Time, then CancerVax shall assume the Parent Stock Option Plan.
In such event, under such Parent Stock Option Plan, CancerVax
shall be entitled to grant stock awards, to the extent
permissible under applicable Legal Requirements, using the share
reserves of such Parent Stock Option Plan as of the Effective
Time (including any shares returned to such share reserves as a
result of the termination of Parent Options that are assumed by
CancerVax pursuant to Section 5.5(a)), except that:
(i) stock covered by such awards shall be shares of
CancerVax Common Stock; (ii) each reference in such Parent
Stock Option Plan to a number of shares of Parent Common Stock
shall be deemed amended to refer instead to a number of shares
of CancerVax Common Stock determined by multiplying the number
of shares of Parent Common Stock issuable in the Micromet
Recapitalization for the referenced shares of Parent Common
Stock by the Conversion Factor, and rounding the resulting
number down to the nearest whole number of shares of CancerVax
Common Stock; and (iii) CancerVaxs board of directors
or a committee thereof shall succeed to the authority and
responsibility of Micromets and Parents board of
directors or any committee thereof with respect to the
administration of such Parent Stock Option Plan.
(d) Prior to the Effective Time, Parent and Micromet shall
take all actions that may be necessary (under the Parent Stock
Option Plan and otherwise) to effectuate the provisions of this
Section 5.5 and to ensure that, from and after the
Effective Time, holders of Parent Options have no rights with
respect thereto other than those specifically provided in this
Section 5.5.
5.6 Employee
Benefits. CancerVax and Micromet shall cause
CancerVax to comply with terms of any employment, severance,
retention, change of control, or similar agreement set forth on
Part 3.9 of the CancerVax Disclosure Schedule, as of the
date of this Agreement, subject to the provisions of such
agreements. CancerVax and Micromet shall cause CancerVax and
each of its subsidiaries, for the period commencing at the
Effective Time and ending twelve months thereafter, to maintain
for CancerVax Associates in the aggregate, medical, dental
insurance and similar benefits (other than equity-based benefits
and compensation) that are substantially the same as such
benefits (other than equity-based benefits and compensation)
maintained for and provided to such CancerVax Associates
immediately before the Effective Time. Nothing set forth herein
shall be construed to create a right in any employee to
employment with CancerVax or any other Subsidiary of CancerVax.
5.7 Indemnification of Officers and Directors.
(a) All rights to indemnification by Parent and Micromet
existing in favor of each individual who is an officer or
director of Parent, Micromet or CancerVax of the date of this
Agreement (each such individual, an Indemnified
Person) for his acts and omissions as a director
or officer of Parent or Micromet occurring prior to the
Effective Time, as provided in Parents, Micromets or
CancerVaxs bylaws (as in effect as of the date of this
Agreement) and as provided in any Indemnification Contract
between Parent, Micromet or CancerVax and such Indemnified
Person (as in effect as of the date of this Agreement) in the
form disclosed by Micromet or CancerVax to the other Party prior
to the date of this Agreement, shall survive the Merger and
shall continue in full force and effect (to the fullest extent
such rights to indemnification are available under and are
consistent with applicable law) for a period of six years from
the date on which the Merger becomes effective.
(b) From the Effective Time until the sixth anniversary of
the date on which the Merger becomes effective, CancerVax shall
maintain in effect, for the benefit of the Indemnified Persons
with respect to their acts and omissions as directors and
officers of Parent, Micromet or CancerVax occurring prior to the
Effective Time, the Existing D&O Policies or an insurance
and indemnification policy that is no less favorable than the
Existing D&O Policies; provided, however, that
CancerVax shall not be required to pay an annual premium for
such D&O insurance with respect to the Indemnified Persons
in excess of 200% of the last annual premium paid by CancerVax
for the Existing D&O Policies prior to the date of this
Agreement.
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5.8 Additional Agreements.
(a) Subject to Section 5.8(b), the Parties shall use
commercially reasonable efforts to cause to be taken all actions
necessary to consummate the Merger and make effective the other
Contemplated Transactions. Without limiting the generality of
the foregoing, but subject to Section 5.8(b), each Party to
this Agreement: (i) shall make all filings and other
submissions (if any) and give all notices (if any) required to
be made and given by such Party in connection with the Merger
and the other Contemplated Transactions; (ii) shall use
commercially reasonable efforts to obtain each Consent (if any)
reasonably required to be obtained (pursuant to any applicable
Legal Requirement or Contract, or otherwise) by such Party in
connection with the Merger or any of the other Contemplated
Transactions or for such Contract to remain in full force and
effect, (iii) shall use commercially reasonable efforts to
lift any injunction prohibiting, or any other legal bar to, the
Merger or any of the other Contemplated Transactions,
(iv) shall use commercially reasonable efforts to satisfy
the conditions precedent to the consummation of this Agreement.
Each Party shall provide to the other Party a copy of each
proposed filing with or other submission to any Governmental
Body relating to any of the Contemplated Transactions, and shall
give the other Party a reasonable time prior to making such
filing or other submission in which to review and comment on
such proposed filing or other submission. Each Party shall
promptly deliver to the other Party a copy of each such filing
or other submission made, each notice given and each Consent
obtained by such Party during the Pre-Closing Period.
(b) Notwithstanding anything to the contrary contained in
this Agreement, no Party shall have any obligation under this
Agreement: (i) to dispose of or transfer or cause any of
its Subsidiaries to dispose of or transfer any assets;
(ii) to discontinue or cause any of its Subsidiaries to
discontinue offering any product or service; (iii) to
license or otherwise make available, or cause any of its
Subsidiaries to license or otherwise make available to any
Person any intellectual property; (iv) to hold separate or
cause any of its Subsidiaries to hold separate any assets or
operations (either before or after the Closing Date);
(v) to make or cause any of its Subsidiaries to make any
commitment (to any Governmental Body or otherwise) regarding its
future operations; or (vi) to contest any Legal Proceeding
or any order, writ, injunction or decree relating to the Merger
or any of the other Contemplated Transactions if such Party
determines in good faith that contesting such Legal Proceeding
or order, writ, injunction or decree might not be advisable.
5.9 Disclosure. Without
limiting any of either Partys obligations under the
Confidentiality Agreement, each Party shall not, and shall not
permit any of its Subsidiaries or any Representative of such
Party to, issue any press release or make any disclosure (to any
customers or employees of such Party, to the public or
otherwise) regarding the Merger or any of the other Contemplated
Transactions unless: (a) the other Party shall have
approved such press release or disclosure in writing; or
(b) such Party shall have determined in good faith, upon
the advice of outside legal counsel, that such disclosure is
required by applicable Legal Requirements and, to the extent
practicable, before such press release or disclosure is issued
or made, such Party advises the other Party of, and consults
with the other Party regarding, the text of such press release
or disclosure.
5.10 Affiliate
Agreements. Micromet shall use commercially
reasonable efforts to cause each Person identified in
Part 2.16 of the Parent Disclosure Schedule and each other
Person who is or becomes (or may be deemed to be) an
affiliate (as that term is used in Rule 145
under the Securities Act) of Micromet or Parent to execute and
deliver to CancerVax, prior to the date of the mailing of the
Joint Proxy Statement/Prospectus to Parents stockholders,
an Affiliate Agreement in the form of Exhibit D.
Parent shall not register, or allow its transfer agent to
register, on its books any transfer of any shares of Parent
Common Stock of any affiliate of Micromet or Parent
who has not provided a signed Affiliate Agreement in accordance
with this Section 5.10.
5.11 Listing. CancerVax shall
use its reasonable best efforts to maintain its existing listing
on the NASDAQ National Market and to cause the shares of
CancerVax Common Stock being issued in the Merger to be approved
for listing (subject to notice of issuance) on the NASDAQ
National Market at or prior to the Effective Time.
5.12 Directors and
Officers. Each Party shall use commercially
reasonable efforts to obtain and deliver to the other Party at
or prior to the Effective Time the resignation of each officer
and director of such Party who is not continuing as an officer
or director of CancerVax. The directors who remain on the Board
of Directors of CancerVax at the Effective Time, who the Parties
intend shall be David Hale (who shall serve as Chairman),
Phillip Schneider, Michael Carter and Barclay Phillips, shall
elect, to be effective as of the Effective Time, Christian Itin,
Jerry Benjamin, Otello Stampacchia, John Berriman and an
additional member to be identified by Micromet prior to the
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Closing (the Additional Director),
each to serve as members of the Board of Directors of CancerVax
in classes to be agreed upon by the Parties prior to the Closing
Date, and the Board of Directors of CancerVax shall cause such
directors to be nominated at the next annual meeting of
stockholders of CancerVax. The Board of Directors of CancerVax
shall appoint each of the individuals set forth on
Schedule 5.12 as officers of CancerVax, effective as of the
Effective Time.
5.13 Resale Registration
Statement. As soon as practicable and in any
event within 45 days after the Effective Time, CancerVax
shall file with the SEC, and thereafter use its commercially
reasonable efforts to have declared effective as soon as
practicable, a shelf registration statement on
Form S-3
(or if CancerVax is not eligible to use
Form S-3,
any other form that CancerVax is eligible to use) (a
Shelf Registration Statement) pursuant
to Rule 415 promulgated under the Securities Act covering
the resale by former affiliates of Parent or Micromet (including
any former affiliates of Parent or Micromet who may following
the Effective Time be current affiliates of CancerVax) of shares
of CancerVax Common Stock issued pursuant to this Agreement as
merger consideration (the Registrable Merger
Shares). In its discretion, CancerVax will be
permitted to register any other shares for resale by other
eligible selling stockholders using the Shelf Registration
Statement. CancerVax shall use commercially reasonable efforts
to keep the Shelf Registration Statement continuously effective
and usable for the resale of the Registrable Merger Shares
covered thereby for a period commencing on the date on which the
SEC declares such Shelf Registration Statement effective and
ending on the earlier of (x) the date upon which all of the
Registrable Merger Shares first become eligible for resale
pursuant to Rule 145 under the Securities Act without
restriction or (y) the first date upon which all of the
Registrable Merger Shares covered by such Shelf Registration
Statement have been sold pursuant to such Shelf Registration
Statement.
5.14 Tax Matters.
(a) CancerVax, Merger Sub, Micromet and Parent each agree
to use their respective commercially reasonable efforts to cause
the Merger to qualify, and will not take any actions which to
their knowledge could reasonably be expected to prevent the
Merger from qualifying, as a reorganization under
Section 368(a) of the Code.
(b) This Agreement is intended to constitute, and the
parties hereto hereby adopt this Agreement as, a plan or
reorganization within the meaning Treasury
Regulation Sections 1.368-2(g)
and
1.368-3(a).
CancerVax, Merger Sub, Micromet and Parent shall report the
Merger as a reorganization within the meaning of
Section 368(a) of the Code, unless otherwise required
pursuant to a determination within the meaning of
Section 1313(a) of the Code.
(c) The parties hereto shall cooperate and use their
commercially reasonable efforts in order for Parent to obtain
the opinion of Cooley Godward LLP to the effect that the Merger
will constitute a reorganization within the meaning of
Section 368(a) of the Code (the Cooley
Opinion). In connection therewith, CancerVax,
Merger Sub, Micromet and Parent shall, as of the Effective Time,
execute and deliver to Cooley Godward LLP tax representation
letters that are in substance satisfactory to each such party,
in customary form and reasonably requested by Cooley Godward
LLP, it being understood that in rendering the Cooley Opinion
Cooley Godward LLP may rely on such tax representation letters.
(d) Parent shall use commercially reasonable efforts to
cause Cooley Godward LLP to deliver to it a tax opinion
satisfying the requirements of Item 601 of
Regulation S-K
promulgated under the Securities Act.
5.15 Financial
Statements. Parent shall use commercially
reasonable efforts to cause the completion and delivery to
CancerVax of Micromets audited consolidated balance sheet
at December 31, 2004 and the related consolidated
statements of income, cash flow and shareholders equity
for the year ended December 31, 2004.
Section 6. Conditions
Precedent to Obligations of Each Party
The obligations of each Party to effect the Merger and otherwise
consummate the transactions to be consummated at the Closing are
subject to the satisfaction or, to the extent permitted by
applicable law, the written waiver by each of the Parties, at or
prior to the Closing, of each of the following conditions:
6.1 Effectiveness of Registration
Statement. The
Form S-4
Registration Statement shall have become effective in accordance
with the provisions of the Securities Act, and shall not be
subject to any stop order or proceeding (or threatened
proceeding by the SEC) seeking a stop order with respect to the
Form S-4
Registration Statement.
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6.2 No Restraints. No temporary
restraining order, preliminary or permanent injunction or other
order preventing the consummation of the Merger shall have been
issued by any court of competent jurisdiction or other
Governmental Body and remain in effect, and there shall not be
any Legal Requirement which has the effect of making the
consummation of the Merger illegal.
6.3 Stockholder Approval. This
Agreement shall have been duly adopted and approved by the
Required Parent Stockholder Vote, and the issuance of the
CancerVax Common Stock in the Merger, the Charter Amendment, the
Change of Control and the Reverse Split shall have been duly
approved by the Required CancerVax Stockholder Vote.
6.4 Listing. The existing
shares of CancerVax Common Stock shall have been continually
listed on the NASDAQ National Market as of and from the date of
this Agreement through the Closing Date, and the shares of
CancerVax Common Stock to be issued in the Merger shall be
approved for listing (subject to official notice of issuance) on
the NASDAQ National Market as of the Effective Time.
6.5 Regulatory Matters. Any
waiting period applicable to the consummation of the Merger
under the HSR Act or any material applicable foreign antitrust
requirements reasonably determined to apply prior to the Closing
to the Merger shall have expired or been terminated, and there
shall not be in effect any voluntary agreement between
CancerVax, Merger Sub, Parent or Micromet and the Federal Trade
Commission, the Department of Justice or any foreign
Governmental Body pursuant to which such Party has agreed not to
consummate the Merger for any period of time; provided, that
neither Parent or Micromet, on the one hand, nor CancerVax on
the other hand, shall enter into any such voluntary agreement
without the written consent of the other Party.
6.6 No Governmental Proceedings Relating to
Contemplated Transactions or Right to Operate
Business. There shall not be any Legal
Proceeding pending, or overtly threatened in writing by an
official of a Governmental Body in which such Governmental Body
indicates that it intends to conduct any Legal Proceeding or
taking any other action: (a) challenging or seeking to
restrain or prohibit the consummation of the Merger;
(b) relating to the Merger and seeking to obtain from
CancerVax, Merger Sub or any of the Micromet Parties, any
damages or other relief that may be material to CancerVax or the
Micromet Parties; (c) seeking to prohibit or limit in any
material and adverse respect a Partys ability to vote,
transfer, receive dividends with respect to or otherwise
exercise ownership rights with respect to the stock of
CancerVax; (d) that could materially and adversely affect
the right or ability of CancerVax or any of the Micromet Parties
to own the assets or operate the business of CancerVax or any of
the Micromet Parties; or (e) seeking to compel any of the
Micromet Parties, CancerVax or any Subsidiary of CancerVax to
dispose of or hold separate any material assets as a result of
the Merger.
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Section 7.
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Additional Conditions Precedent to Obligations of CancerVax
and Merger Sub
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The obligations of CancerVax and Merger Sub to effect the Merger
and otherwise consummate the transactions to be consummated at
the Closing are subject to the satisfaction or the written
waiver by CancerVax, at or prior to the Closing, of each of the
following conditions:
7.1 Accuracy of
Representations. The representations and
warranties of Parent and Micromet contained in this Agreement
shall have been true and correct as of the date of this
Agreement and shall be true and correct on and as of the Closing
Date with the same force and effect as if made on the Closing
Date except (A) in each case, or in the aggregate, where
the failure to be true and correct would not reasonably be
expected to have a Parent Material Adverse Effect, or
(B) for those representations and warranties which address
matters only as of a particular date (which representations
shall have been true and correct, subject to the qualifications
as set forth in the preceding clause (A), as of such
particular date) (it being understood that, for purposes of
determining the accuracy of such representations and warranties,
(i) all Parent Material Adverse Effect
qualifications and other qualifications based on the word
material contained in such representations and
warranties shall be disregarded and (ii) any update of or
modification to the Parent Disclosure Schedule made or purported
to have been made after the date of this Agreement shall be
disregarded).
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7.2 Performance of
Covenants. Each of the covenants and
obligations in this Agreement that Parent or Micromet is
required to comply with or to perform at or prior to the Closing
shall have been complied with and performed by Parent or
Micromet in all material respects.
7.3 Consents.
(a) All of the Consents set forth on Part 7.3(a) of
the Parent Disclosure Schedule shall have been obtained and
shall be in full force and effect.
(b) Any Governmental Authorization or other Consent
required to be obtained by the Micromet Parties under any
applicable antitrust or competition law or regulation or other
Legal Requirement shall have been obtained and shall remain in
full force and effect.
7.4 Agreements and Other
Documents. CancerVax shall have received the
following agreements and other documents, each of which shall be
in full force and effect:
(a) Affiliate Agreements in the form of
Exhibit D, executed by each Person who could
reasonably be deemed to be an affiliate (as that
term is used in Rule 145 under the Securities Act) of
Parent or Micromet;
(b) a certificate executed by the Chief Executive Officer
and Chief Financial Officer of Parent and Micromet confirming
that the conditions set forth in Sections 7.1, 7.2, 7.3,
and 7.5 have been duly satisfied; and
(c) certificates of good standing (or equivalent
documentation) of Parent and Micromet in their respective
jurisdictions of organization and the various foreign
jurisdictions in which they are qualified, certified charter
documents, certificates as to the incumbency of officers and the
adoption of resolutions of their boards of directors of Parent
and the Supervisory Board of Micromet authorizing the execution
of this Agreement and the consummation of the Contemplated
Transactions to be performed by Parent and Micromet hereunder.
7.5 No Other Proceedings. There
shall not be pending any Legal Proceeding in which, in the
reasonable judgment of CancerVax, there is a reasonable
possibility of an outcome that is adverse to CancerVax or any of
the Micromet Parties: (a) challenging or seeking to
restrain or prohibit the consummation of the Merger or any of
the other Contemplated Transactions; (b) relating to the
Merger or any of the other Contemplated Transactions and seeking
to obtain from CancerVax or any of the Micromet Parties, any
damages or other relief that may be material to CancerVax or the
Micromet Parties; (c) seeking to prohibit or limit in any
material respect CancerVaxs stockholders ability to
vote, transfer, receive dividends with respect to or otherwise
exercise ownership rights with respect to the stock of
CancerVax; (d) that could materially and adversely affect
the right or ability of CancerVax or any of the Micromet Parties
to own the assets or operate the business of any of the Micromet
Parties; or (e) seeking to compel any of the Micromet
Parties, CancerVax or any Subsidiary of CancerVax to dispose of
or hold separate any material assets as a result of the Merger
or any of the Contemplated Transactions.
7.6 Micromet
Recapitalization. Parent and Micromet shall
have consummated the Micromet Recapitalization.
7.7 Clinical Hold. Neither of
the Micromet Clinical Programs shall be subject to a Clinical
Hold Order by the FDA or EMEA, which Clinical Hold Order
continues in effect as of the Closing Date.
7.8 FIRPTA
Certificate. CancerVax shall have received
from Parent a form of notice to the Internal Revenue Service in
accordance with the requirements of Treasury
Regulation Section 1.897-2(h)
and in form and substance reasonably acceptable to CancerVax
along with written authorization for CancerVax to deliver such
notice form to the Internal Revenue Service on behalf of Parent
upon the closing of the Merger.
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Section 8. Additional
Conditions Precedent to Obligation of Parent
The obligations of Parent to effect the Merger and otherwise
consummate the transactions to be consummated at the Closing are
subject to the satisfaction or the written wavier by Parent, at
or prior to the Closing, of each of the following conditions:
8.1 Accuracy of
Representations. The representations and
warranties of CancerVax and Merger Sub contained in this
Agreement shall have been true and correct as of the date of
this Agreement and shall be true and correct on and as of the
Closing Date with the same force and effect as if made on the
Closing Date except (A) in each case, or in the aggregate,
where the failure to be true and correct would not reasonably be
expected to have a CancerVax Material Adverse Effect, or
(B) for those representations and warranties which address
matters only as of a particular date (which representations
shall have been true and correct, subject to the qualifications
as set forth in the preceding clause (A), as of such
particular date) (it being understood that, for purposes of
determining the accuracy of such representations and warranties,
(i) all CancerVax Material Adverse Effect
qualifications and other qualifications based on the word
material contained in such representations and
warranties shall be disregarded and (ii) any update of or
modification to the CancerVax Disclosure Schedule made or
purported to have been made after the date of this Agreement
shall be disregarded).
8.2 Performance of
Covenants. All of the covenants and
obligations in this Agreement that CancerVax or Merger Sub is
required to comply with or to perform at or prior to the Closing
shall have been complied with and performed in all material
respects.
8.3 Consents. All the Consents
set forth on Part 8.3 of the CancerVax Disclosure Schedule
shall have been obtained and shall be in full force and effect.
8.4 Documents. Parent shall
have received the following documents:
(a) the Cooley Opinion dated as of the Closing Date and
addressed to Parent;
(b) a certificate executed by the Chief Executive Officer
and Chief Financial Officer of CancerVax confirming that the
conditions set forth in Sections 8.1, 8.2, 8.3, 8.5, 8.7
and 8.8 have been duly satisfied; and
(c) certificates of good standing of each of CancerVax and
Merger Sub in its jurisdiction of organization and the various
foreign jurisdictions in which it is qualified, certified
charter documents, certificates as to the incumbency of officers
and the adoption of resolutions of its board of directors
authorizing the execution of this Agreement and the consummation
of the Contemplated Transactions to be performed by CancerVax
and Merger Sub hereunder.
(d) written resignations in forms satisfactory to Parent,
dated as of the Closing Date and effective as of the Closing,
executed by the officers and directors of CancerVax who are not
to continue as officers or directors of the Surviving
Corporation pursuant to Section 5.12 hereof.
8.5 No Other Proceedings. There
shall not be pending any Legal Proceeding in which, in the
reasonable judgment of Parent, there is a reasonable possibility
of an outcome that is adverse to CancerVax or any of the
Micromet Parties: (a) challenging or seeking to restrain or
prohibit the consummation of the Merger or any of the other
Contemplated Transactions; (b) relating to the Merger or
any of the Contemplated Transactions and seeking to obtain from
CancerVax or any of the Micromet Parties, any damages or other
relief that may be material to CancerVax or the Micromet
Parties; (c) seeking to prohibit or limit in any material
respect Parents stockholders ability to vote,
transfer, receive dividends with respect to or otherwise
exercise ownership rights with respect to the stock of
CancerVax; (d) that could materially and adversely affect
the right or ability of CancerVax or any of the Micromet Parties
to own the assets or operate the business of CancerVax or any of
the Micromet Parties; or (e) seeking to compel any of the
Micromet Parties, CancerVax or any Subsidiary of CancerVax to
dispose of or hold separate any material assets as a result of
the Merger or any of the Contemplated Transactions.
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8.6 Sarbanes-Oxley
Certifications. Neither the principal
executive officer nor the principal financial officer of
CancerVax shall have failed to provide, with respect to any
CancerVax SEC Document filed (or required to be filed) with the
SEC on or after the date of this Agreement, any necessary
certification in the form required under
Rule 13a-14
under the Exchange Act and 18 U.S.C. §1350.
8.7 CancerVax Closing
Capital. The CancerVax Closing Capital shall
be no less than the Minimum Cash Value.
8.8 Board of
Directors. CancerVax shall have caused the
Board of Directors of CancerVax to be constituted as set forth
in Section 5.12 of this Agreement.
8.9 Officers. Each of the
current officers of CancerVax who is not listed on
Schedule 5.12 shall have delivered to CancerVax their
written resignations as officers of CancerVax and each of the
individuals on Schedule 5.12 shall have been appointed
officers of CancerVax and shall serve in such capacity effective
as of the Effective Time.
8.10 Rights
Agreement. CancerVax shall have caused the
Rights Agreement to be amended in order to exclude Parent,
Micromet and their stockholders from the definition of an
Acquiring Person thereunder.
8.11 Repayment of Silicon Valley Bank
Indebtedness; Release of Liens. All
outstanding amounts owed to Silicon Valley Bank pursuant to that
certain Loan and Security Agreement dated as of
December 23, 2004 (the SVB Line)
shall have been paid in full and Silicon Valley Bank shall have
released all of its security interests in the assets of
CancerVax, or the SVB Line shall have been renegotiated on terms
acceptable to Parent in its reasonable discretion.
Section 9. Termination
9.1 Termination. This Agreement
may be terminated prior to the Effective Time (whether before or
after adoption of this Agreement by Parents stockholders
and whether before or after approval of the issuance of
CancerVax Common Stock in the Merger by CancerVaxs
stockholders):
(a) by mutual written consent duly authorized by the Boards
of Directors of CancerVax and Parent;
(b) by either CancerVax or Parent if the Merger shall not
have been consummated by June 30, 2006; provided,
however; that the right to terminate this Agreement under
this Section 9.1(b) shall not be available to any Party
whose action or failure to act has been a principal cause of the
failure of the Merger to occur on or before such date and such
action or failure to act constitutes a breach of this Agreement;
(c) by either CancerVax or Parent if a court of competent
jurisdiction or other Governmental Body shall have issued a
final and nonappealable order, decree or ruling, or shall have
taken any other action, having the effect of permanently
restraining, enjoining or otherwise prohibiting the Merger;
(d) by either CancerVax or Parent if (i) the Parent
Stockholders Meeting (including any adjournments and
postponements thereof) shall have been held and completed and
Parents stockholders shall have taken a final vote on a
proposal to adopt this Agreement, and (ii) this Agreement
shall not have been adopted at the Parent Stockholders
Meeting (and shall not have been adopted at any adjournment or
postponement thereof) by the Required Parent Stockholder Vote;
provided, however, that (A) the right to terminate this
Agreement under this Section 9.1(d) shall not be available
to Parent where the failure to obtain the Required Parent
Stockholder Vote shall have been caused by the action or failure
to act of Parent and such action or failure to act constitutes a
material breach by Parent of this Agreement; and (B) Parent
shall not be permitted to terminate this Agreement pursuant to
this Section 9.1(d) unless Parent or Micromet shall have
paid to CancerVax any fee that is required to be paid to
CancerVax under the circumstances set forth in
Section 9.3(b).
(e) by either CancerVax or Parent if (i) the CancerVax
Stockholders Meeting (including any adjournments and
postponements thereof) shall have been held and completed and
CancerVaxs stockholders shall have taken a final vote on
the issuance of shares of CancerVax Common Stock in the Merger,
and (ii) any of the Merger, the issuance of CancerVax
Common Stock in the Merger, the Charter Amendment, the Change of
Control or the Reverse Split shall not have been approved at the
CancerVax
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Stockholders Meeting (and shall not have been approved at
any adjournment or postponement thereof) by the Required
CancerVax Stockholder Vote; provided, however, that
(A) the right to terminate this Agreement under this
Section 9.1(e) shall not be available to CancerVax where
the failure to obtain the Required CancerVax Stockholder Vote
shall have been caused by the action or failure to act of
CancerVax and such action or failure to act constitutes a
material breach by CancerVax of this Agreement; and
(B) CancerVax shall not be permitted to terminate this
Agreement pursuant to this Section 9.1(e) unless CancerVax
shall have paid to Parent any fee that is required to be paid to
CancerVax under the circumstances set forth in
Section 9.3(b).
(f) by Parent (at any time prior to the approval of the
issuance of CancerVax Common Stock in the Merger by the Required
CancerVax Stockholder Vote) if a CancerVax Triggering Event
shall have occurred;
(g) by CancerVax (at any time prior to the approval of the
Merger by the Required Parent Stockholder Vote) if a Parent
Triggering Event shall have occurred;
(h) by Parent, upon a breach of any representation,
warranty, covenant or agreement on the part of CancerVax or
Merger Sub set forth in this Agreement, or if any representation
or warranty of CancerVax or Merger Sub shall have become
inaccurate, in either case such that the conditions set forth in
Section 8.1 or Section 8.2 would not be satisfied as
of the time of such breach or as of the time such representation
or warranty shall have become inaccurate, provided that if such
inaccuracy in CancerVaxs or Merger Subs
representations and warranties or breach by CancerVax or Merger
Sub is curable by CancerVax or Merger Sub, then this Agreement
shall not terminate pursuant to this Section 9.1(h) as a
result of such particular breach or inaccuracy until the earlier
of (i) the expiration of a thirty (30) day period
commencing upon delivery of written notice from CancerVax or
Merger Sub to Parent of such breach or inaccuracy and
(ii) CancerVax or Merger Sub (as applicable) ceasing to
exercise commercially reasonable efforts to cure such breach (it
being understood that this Agreement shall not terminate
pursuant to this paragraph 9.1(h) as a result of such
particular breach or inaccuracy if such breach by CancerVax or
Merger Sub is cured prior to such termination becoming
effective); and
(i) by CancerVax, upon a breach of any representation,
warranty, covenant or agreement on the part of Parent or
Micromet set forth in this Agreement, or if any representation
or warranty of Parent or Micromet shall have become inaccurate,
in either case such that the conditions set forth in
Section 7.1 or Section 7.2 would not be satisfied as
of the time of such breach or as of the time such representation
or warranty shall have become inaccurate, provided that if such
inaccuracy in Parents or Micromets representations
and warranties or breach by Parent or Micromet is curable by
Parent or Micromet, then this Agreement shall not terminate
pursuant to this Section 9.1(i) as a result of such
particular breach or inaccuracy until the earlier of
(i) the expiration of a thirty (30) day period
commencing upon delivery of written notice from Parent or
Micromet to CancerVax of such breach or inaccuracy and
(ii) Parent or Micromet ceasing to exercise commercially
reasonable efforts to cure such breach (it being understood that
this Agreement shall not terminate pursuant to this
paragraph 9.1(i) as a result of such particular breach or
inaccuracy if such breach by Parent or Micromet is cured prior
to such termination becoming effective); and
(j) by CancerVax, in the event that Micromet has not
delivered to CancerVax on or before January 27, 2006
executed Parent Stockholder Voting Agreements representing at
least 55% of the Preference Shares Series (B new),
including any executed Parent Stockholder Voting Agreements
delivered on or prior to the date hereof.
9.2 Effect of Termination. In
the event of the termination of this Agreement as provided in
Section 9.1, this Agreement shall be of no further force or
effect; provided, however, that (i) this
Section 9.2, Section 9.3, and Section 10 shall
survive the termination of this Agreement and shall remain in
full force and effect, and (ii) the termination of this
Agreement shall not relieve any Party from any liability for any
material breach of any representation, warranty, covenant,
obligation or other provision contained in this Agreement.
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9.3 Expenses; Termination Fees.
(a) Except as set forth in this Section 9.3, all fees
and expenses incurred in connection with this Agreement and the
Contemplated Transactions shall be paid by the Party incurring
such expenses, whether or not the Merger is consummated;
provided, however, that CancerVax and Parent shall share
equally all fees and expenses, other than attorneys and
accountants fees and expenses, incurred in relation to the
printing and filing with the SEC of the
Form S-4
Registration Statement (including any financial statements and
exhibits) and the Joint Proxy Statement/Prospectus (including
any preliminary materials related thereto) and any amendments or
supplements thereto.
(b) (i) If this Agreement is terminated (A) by
CancerVax or Parent pursuant to Section 9.1(e) and at any
time before the CancerVax Stockholders Meeting an
Acquisition Proposal with respect to CancerVax shall have been
publicly announced, disclosed or otherwise communicated to
CancerVaxs board of directors or (B) by Parent
pursuant to Section 9.1(f), in either case, without
duplication, CancerVax shall pay to Parent, within five Business
Days after termination, a nonrefundable fee in an amount equal
to $2,000,000.
(ii) If this Agreement is terminated (A) by CancerVax
or Parent (i) pursuant to Section 9.1(d) and at any
time before the Parent Stockholders Meeting an Acquisition
Proposal with respect to Parent or Micromet shall have been
publicly announced, disclosed or otherwise communicated to
Parents board of directors or (B) by CancerVax
pursuant to Section 9.1(g), in either case, without
duplication, Parent shall pay to CancerVax, within five Business
Days after termination, a nonrefundable fee in an amount equal
to $2,000,000.
(c) If either Party fails to pay when due any amount
payable by such Party under Section 9.3(b), then
(i) such Party shall reimburse the other Party for
reasonable costs and expenses (including reasonable fees and
disbursements of counsel) incurred in connection with the
collection of such overdue amount and the enforcement by the
other Party of its rights under this Section 9.3, and
(ii) such Party shall pay to the other Party interest on
such overdue amount (for the period commencing as of the date
such overdue amount was originally required to be paid and
ending on the date such overdue amount is actually paid to the
other Party in full) at a rate per annum equal to the
prime rate (as announced by Bank of America or any
successor thereto) in effect on the date such overdue amount was
originally required to be paid.
Section 10. Miscellaneous
Provisions
10.1 Non-Survival of Representations and
Warranties. The representations and
warranties of Parent, Merger Sub, Micromet and CancerVax
contained in this Agreement or any certificate or instrument
delivered pursuant to this Agreement shall terminate at the
Effective Time, and only the covenants that by their terms
survive the Effective Time and this Section 10 shall
survive the Effective Time.
10.2 Amendment. This Agreement
may be amended with the approval of the respective boards of
directors of Parent and CancerVax at any time (whether before or
after the adoption and approval of this Agreement by
Parents stockholders); provided, however, that
after any such adoption and approval of this Agreement by
Parents stockholders, no amendment shall be made which by
law requires further approval of the stockholders of Parent
without the further approval of such stockholders. This
Agreement may not be amended except by an instrument in writing
signed on behalf of each of Parent, Micromet and
CancerVax.
10.3 Waiver.
(a) No failure on the part of any Party to exercise any
power, right, privilege or remedy under this Agreement, and no
delay on the part of any Party in exercising any power, right,
privilege or remedy under this Agreement, shall operate as a
waiver of such power, right, privilege or remedy; and no single
or partial exercise of any such power, right, privilege or
remedy shall preclude any other or further exercise thereof or
of any other power, right, privilege or remedy.
(b) No Party shall be deemed to have waived any claim
arising out of this Agreement, or any power, right, privilege or
remedy under this Agreement, unless the waiver of such claim,
power, right, privilege or remedy is expressly set forth in a
written instrument duly executed and delivered on behalf of such
Party; and any such waiver shall not be applicable or have any
effect except in the specific instance in which it is given.
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10.4 Entire Agreement; Counterparts; Exchanges by
Facsimile. This Agreement and the other
agreements referred to in this Agreement constitute the entire
agreement and supersede all prior agreements and understandings,
both written and oral, among or between any of the Parties with
respect to the subject matter hereof and thereof; provided,
however, that the Confidentiality Agreement shall not be
superseded and shall remain in full force and effect in
accordance with its terms. This Agreement may be executed in
several counterparts, each of which shall be deemed an original
and all of which shall constitute one and the same instrument.
The exchange of a fully executed Agreement (in counterparts or
otherwise) by all Parties by facsimile shall be sufficient to
bind the Parties to the terms and conditions of this Agreement.
10.5 Applicable Law;
Jurisdiction. This Agreement shall be
governed by, and construed in accordance with, the laws of the
State of Delaware, regardless of the laws that might otherwise
govern under applicable principles of conflicts of laws. In any
action or suit between any of the parties arising out of or
relating to this Agreement or any of the Contemplated
Transactions: (a) each of the parties irrevocably and
unconditionally consents and submits to the exclusive
jurisdiction and venue of the state and federal courts located
in the State of Delaware; (b) if any such action or suit is
commenced in a state court, then, subject to applicable Legal
Requirements, no Party shall object to the removal of such
action or suit to any federal court located in the District of
Delaware; and (c) each of the parties irrevocably waives
the right to trial by jury.
10.6 Attorneys Fees. In
any action at law or suit in equity to enforce this Agreement or
the rights of any of the parties under this Agreement, the
prevailing Party in such action or suit shall be entitled to
receive a reasonable sum for its attorneys fees and all
other reasonable costs and expenses incurred in such action or
suit.
10.7 Assignability. This
Agreement shall be binding upon, and shall be enforceable by and
inure solely to the benefit of, the parties hereto and their
respective successors and assigns; provided, however,
that neither this Agreement nor any of a Partys rights or
obligations hereunder may be assigned or delegated by such Party
without the prior written consent of the other Party, and any
attempted assignment or delegation of this Agreement or any of
such rights or obligations by such Party without the other
Partys prior written consent shall be void and of no
effect. Nothing in this Agreement, express or implied, is
intended to or shall confer upon any Person (other than:
(a) the parties hereto; and (b) the Indemnified
Persons to the extent of their respective rights pursuant to
Section 5.7) any right, benefit or remedy of any nature
whatsoever under or by reason of this Agreement.
10.8 Notices. Any notice or
other communication required or permitted to be delivered to any
Party under this Agreement shall be in writing and shall be
deemed properly delivered, given and received when delivered by
hand, by registered mail, by courier or express delivery service
or by facsimile to the address or facsimile telephone number set
forth beneath the name of such Party below (or to such other
address or facsimile telephone number as such Party shall have
specified in a written notice given to the other parties hereto):
if to CancerVax or Merger Sub:
CancerVax Corporation
2110 Rutherford Road
Carlsbad, CA 92008
Telephone: (760) 494-4200
Fax: (760) 494-4282
Attention: Its General Counsel
with a copy to:
Latham & Watkins LLP
12636 High Bluff Drive
Suite 300
San Diego, CA 92130-2071
Telephone: (858) 523-5405
Fax: (858) 523-5450
Attention: Scott N. Wolfe, Esq.
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if to Parent or Micromet:
Micromet AG
Staffelseestrasse 2
81477 Munich
Germany
Telephone: 49 89 895 277-0
Fax: 49 89 895 277-105
Attention: Its President
with a copy to:
Cooley Godward LLP
One Freedom Square
11951 Freedom Drive
Reston, VA 20190-5656
Telephone: (703) 456-8006
Fax: (703) 456-8100
Attention: Christian E. Plaza, Esq.
10.9 Cooperation. Each Party
agrees to cooperate fully with the other Party and to execute
and deliver such further documents, certificates, agreements and
instruments and to take such other actions as may be reasonably
requested by the other Party to evidence or reflect the
Contemplated Transactions and to carry out the intent and
purposes of this Agreement.
10.10 Severability. Any term or
provision of this Agreement that is invalid or unenforceable in
any situation in any jurisdiction shall not affect the validity
or enforceability of the remaining terms and provisions of this
Agreement or the validity or enforceability of the offending
term or provision in any other situation or in any other
jurisdiction. If a final judgment of a court of competent
jurisdiction declares that any term or provision of this
Agreement is invalid or unenforceable, the Parties hereto agree
that the court making such determination shall have the power to
limit such term or provision, to delete specific words or
phrases or to replace such term or provision with a term or
provision that is valid and enforceable and that comes closest
to expressing the intention of the invalid or unenforceable term
or provision, and this Agreement shall be valid and enforceable
as so modified. In the event such court does not exercise the
power granted to it in the prior sentence, the Parties hereto
agree to replace such invalid or unenforceable term or provision
with a valid and enforceable term or provision that will
achieve, to the extent possible, the economic, business and
other purposes of such invalid or unenforceable term or
provision.
10.11 Other Remedies; Specific
Performance. Except as otherwise provided
herein, any and all remedies herein expressly conferred upon a
Party will be deemed cumulative with and not exclusive of any
other remedy conferred hereby, or by law or equity upon such
Party, and the exercise by a Party of any one remedy will not
preclude the exercise of any other remedy. The Parties hereto
agree that irreparable damage would occur in the event that any
of the provisions of this Agreement were not performed in
accordance with their specific terms or were otherwise breached.
It is accordingly agreed that the Parties shall be entitled to
seek an injunction or injunctions to prevent breaches of this
Agreement and to enforce specifically the terms and provisions
hereof in any court of the United States or any state having
jurisdiction, this being the addition to any other remedy to
which they are entitled at law or in equity.
10.12 Construction.
(a) For purposes of this Agreement, whenever the context
requires: the singular number shall include the plural, and vice
versa; the masculine gender shall include the feminine and
neuter genders; the feminine gender shall include the masculine
and neuter genders; and the neuter gender shall include
masculine and feminine genders.
(b) The Parties hereto agree that any rule of construction
to the effect that ambiguities are to be resolved against the
drafting Party shall not be applied in the construction or
interpretation of this Agreement.
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(c) As used in this Agreement, the words
include and including, and variations
thereof, shall not be deemed to be terms of limitation, but
rather shall be deemed to be followed by the words without
limitation.
(d) Except as otherwise indicated, all references in this
Agreement to Sections, Exhibits and
Schedules are intended to refer to Sections of this
Agreement and Exhibits and Schedules to this Agreement.
(e) The bold-faced headings contained in this Agreement are
for convenience of reference only, shall not be deemed to be a
part of this Agreement and shall not be referred to in
connection with the construction or interpretation of this
Agreement.
[Remainder of page intentionally left blank]
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In Witness
Whereof, the parties have caused this Agreement to be
executed as of the date first above written.
CancerVax
Corporation
Name: David F. Hale
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Title:
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President and Chief Executive Officer
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Carlsbad Acquisition
Corporation
Name: David F. Hale
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Title:
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President and Chief Executive Officer
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Micromet,
Inc.
Name: Christian Itin
|
|
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Title:
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President, Secretary and Treasurer
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Micromet AG
Name: Christian Itin
|
|
|
|
Title:
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Chief Executive Officer
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A-54
Exhibit A
Certain
Definitions
For purposes of the Agreement (including this Exhibit A):
Acquisition Inquiry. Acquisition
Inquiry shall mean, with respect to a Party, an
inquiry, indication of interest or request for information
(other than an inquiry, indication of interest or request for
information made or submitted by Micromet or Parent, on the one
hand or CancerVax, on the other hand, to the other Party) that
could reasonably be expected to lead to an Acquisition Proposal
with such Party.
Acquisition Proposal. Acquisition
Proposal shall mean, with respect to a Party, any
offer or proposal (other than an offer or proposal made or
submitted by Micromet or Parent, on the one hand or CancerVax,
on the other hand to the other Party) contemplating or otherwise
relating to any Acquisition Transaction with such Party.
Acquisition Transaction. Acquisition
Transaction shall mean any transaction or series
of transactions involving:
(a) any merger, consolidation, amalgamation, share
exchange, business combination, issuance of securities,
acquisition of securities, reorganization, recapitalization,
tender offer, exchange offer or other similar transaction:
(i) in which a Party is a constituent corporation;
(ii) in which a Person or group (as defined in
the Exchange Act and the rules promulgated thereunder) of
Persons directly or indirectly acquires beneficial or record
ownership of securities representing more than 15% of the
outstanding securities of any class of voting securities of a
Party or any of its Subsidiaries; or (iii) in which a Party
or any of its Subsidiaries issues securities representing more
than 15% of the outstanding securities of any class of voting
securities of such Party or any of its Subsidiaries; provided,
however, that the Micromet Recapitalization shall not be deemed
to be an Acquisition Transaction;
(b) any sale, lease, exchange, transfer, license,
acquisition or disposition of any business or businesses or
assets that constitute or account for: (i) 15% or more of
the consolidated net revenues of a Party and its Subsidiaries,
taken as a whole, consolidated net income of a Party and its
Subsidiaries, taken as a whole, or consolidated book value of
the assets of a Party and its Subsidiaries, taken as a whole; or
(ii) 15% or more of the fair market value of the assets of
a Party and its Subsidiaries, taken as a whole; or
(c) any liquidation or dissolution of a Party.
Agreement. Agreement shall
mean the Agreement and Plan of Merger to which this
Exhibit A is attached, as it may be amended from time to
time.
Business Day. Business Day
shall mean any day other than a day on which banks in both the
State of New York and in Germany are authorized or obligated to
be closed.
Clinical Hold Order. Clinical Hold
Order shall mean a order issued by the FDA or EMEA
to delay or suspend a clinical trial.
CancerVax Affiliate. CancerVax
Affiliate shall mean any Person under common
control with CancerVax within the meaning of
Sections 414(b), (c), (m) and (o) of the Code, and the
regulations issued thereunder.
CancerVax Associate. CancerVax
Associate shall mean any current or former
employee, independent contractor, officer or director of
CancerVax or any CancerVax Affiliate.
CancerVax Closing Capital. CancerVax
Closing Capital shall mean (a) the sum of
CancerVaxs cash, cash equivalents, restricted cash and
securities available-for-sale, less (b) the aggregate
amount of the CancerVax Current Obligations, measured as of the
earlier of the Closing Date and April 30, 2006.
CancerVax Common Stock. CancerVax Common
Stock shall mean the Common Stock,
$0.00004 par value per share, of CancerVax.
CancerVax Contract. CancerVax
Contract shall mean any Contract: (a) to
which CancerVax or any of its Subsidiaries is a party;
(b) by which CancerVax or any CancerVax IP Rights or any
other asset of CancerVax is or may become bound or under which
CancerVax has, or may become subject to, any obligation; or
(c) under which CancerVax or any of its Subsidiaries has or
may acquire any right or interest.
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CancerVax Current Obligations. CancerVax
Current Obligations shall mean any and all
liabilities and obligations associated with:
(i) indebtedness owed to Silicon Valley Bank,
(ii) severance or similar obligations of CancerVax as of
the Closing Date; (iii) fees payable to any financial
advisor to CancerVax; (iv) fees owed and payable to
CancerVaxs independent public accountants; (v) bonus
payments to employees upon consummation of the Merger; and
(vi) legal fees of CancerVax in connection with the
negotiation and execution of this Agreement and consummation of
the Merger and the Contemplated Transactions.
CancerVax IP Rights. CancerVax
IP Rights shall mean all Intellectual
Property owned, licensed, or controlled by CancerVax and its
Subsidiaries that is necessary or used in CancerVaxs
business as presently conducted.
CancerVax IP Rights
Agreement. CancerVax IP Rights
Agreement shall mean any instrument or agreement
governing any CancerVax IP Rights.
CancerVax Material Adverse
Effect. CancerVax Material Adverse
Effect shall mean any Effect, that, considered
together with all other Effects that had occurred prior to the
date of determination of the occurrence of the CancerVax
Material Adverse Effect, is or could reasonably be expected to
be or to become materially adverse to, or has or could
reasonably be expected to have or result in a material adverse
effect on: (a) the business, condition (financial or
otherwise), capitalization, assets (including Intellectual
Property), operations, financial performance or prospects of
CancerVax and its Subsidiaries taken as a whole; or (b) the
ability of CancerVax to consummate the Merger or any of the
other Contemplated Transactions or to perform any of its
covenants or obligations under the Agreement; provided, however,
that none of the following shall be deemed to constitute a
CancerVax Material Adverse Effect: (x) any Effect resulting
from the announcement or pendency of the Merger, and
(y) any change in the stock price or trading volume of
CancerVax independent of any other event that would be deemed to
have a CancerVax Material Adverse Effect.
CancerVax Pharmaceutical
Products. CancerVax Pharmaceutical
Products shall mean all biological and drug
products being manufactured, distributed or developed by or on
behalf of CancerVax and its Subsidiaries.
CancerVax Registered IP. CancerVax
Registered IP shall mean all CancerVax IP
Rights that are registered, filed or issued under the authority
of, with or by any Governmental Body, including all patents,
registered copyrights and registered trademarks and all
applications for any of the foregoing.
CancerVax Triggering Event. An
CancerVax Triggering Event shall be
deemed to have occurred if: (i) the board of directors of
CancerVax shall have failed to recommend that CancerVaxs
stockholders vote to approve the Merger and the issuance of
CancerVax Common Stock in the Merger, or shall for any reason
have withdrawn or shall have modified in a manner adverse to
Parent the CancerVax Board Recommendation; (ii) CancerVax
shall have failed to include in the Joint Proxy
Statement/Prospectus the CancerVax Board Recommendation;
(iii) CancerVax shall have failed to hold the CancerVax
Stockholders Meeting within 45 days after the
Form S-4
Registration Statement is declared effective under the
Securities Act; (iv) the board of directors of CancerVax
shall have approved, endorsed or recommended any Acquisition
Proposal; (v) CancerVax shall have entered into any letter
of intent or similar document or any Contract relating to any
Acquisition Proposal; (vi) CancerVax or any director,
officer or agent of CancerVax shall have willfully and
intentionally breached the provisions set forth in
Section 4.4 of the Agreement.
CancerVax Unaudited Interim Balance
Sheet. CancerVax Unaudited Interim Balance
Sheet shall mean the unaudited consolidated
balance sheet of CancerVax and its consolidated subsidiaries as
of September 30, 2005, included in CancerVaxs Report
on
Form 10-Q
for the fiscal quarter ended September 30, 2005, as filed
with the SEC prior to the date of the Agreement.
CancerVax Warrants. CancerVax
Warrants shall mean those certain warrants to
purchase an aggregate of 85,610 shares of CancerVax Common
Stock held by
M-Tech
Therapeutics, Inc., Venture Lending and Leasing III, LLC
and Mallory Management Company.
Change of Control. Change of
Control shall mean a change in control of
CancerVax for purposes of NASD Rule 4350(i)(B).
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Charter Amendment. Charter
Amendment shall mean the charter amendment set
forth in Section 1.5(b) above.
Code. Code shall mean the
Internal Revenue Code of 1986, as amended.
Confidentiality
Agreement. Confidentiality
Agreement shall mean the Confidentiality Agreement
dated October 18, 2005, between Micromet and CancerVax.
Consent. Consent shall mean
any approval, consent, ratification, permission, waiver or
authorization (including any Governmental Authorization).
Contemplated Transactions. Contemplated
Transactions shall mean the Merger and the other
transactions and actions contemplated by the Agreement.
Contract. Contract shall,
with respect to any Person, mean any written, oral or other
agreement, contract, subcontract, lease (whether real or
personal property), mortgage, understanding, arrangement,
instrument, note, option, warranty, purchase order, license,
sublicense, insurance policy, benefit plan or legally binding
commitment or undertaking of any nature to which such Person is
a party or by which such Person or any of its assets are bound
or affected under applicable law.
DGCL. DGCL shall mean the
Delaware General Corporation Law.
EMEA. EMEA shall mean the
European Medicines Agency.
Encumbrance. Encumbrance
shall mean any lien, pledge, hypothecation, charge, mortgage,
security interest, encumbrance, claim, infringement,
interference, option, right of first refusal, preemptive right,
community property interest or restriction of any nature
(including any restriction on the voting of any security, any
restriction on the transfer of any security or other asset, any
restriction on the receipt of any income derived from any asset,
any restriction on the use of any asset and any restriction on
the possession, exercise or transfer of any other attribute of
ownership of any asset).
Entity. Entity shall mean
any corporation (including any non-profit corporation),
partnership (including any general partnership, limited
partnership or limited liability partnership), joint venture,
estate, trust, company (including any company limited by shares,
limited liability company or joint stock company), firm, society
or other enterprise, association, organization or entity.
ERISA. ERISA shall mean the
Employee Retirement Income Security Act of 1974, as amended.
Exchange Act. Exchange Act
shall mean the Securities Exchange Act of 1934, as amended.
Exchange Ratio. Exchange
Ratio shall mean 2.076923.
Form S-4
Registration
Statement. Form S-4
Registration Statement shall mean the registration
statement on
Form S-4
to be filed with the SEC by CancerVax in connection with
issuance of CancerVax Common Stock in the Merger, as said
registration statement may be amended prior to the time it is
declared effective by the SEC.
Governmental Authorization. Governmental
Authorization shall mean any: (a) permit,
license, certificate, franchise, permission, variance,
exceptions, orders, clearance, registration, qualification or
authorization issued, granted, given or otherwise made available
by or under the authority of any Governmental Body or pursuant
to any Legal Requirement; or (b) right under any Contract
with any Governmental Body.
Governmental Body. Governmental
Body shall mean any: (a) nation, state,
commonwealth, province, territory, county, municipality,
district or other jurisdiction of any nature; (b) federal,
state, local, municipal, foreign or other government;
(c) governmental or quasi-governmental authority of any
nature (including any governmental division, department, agency,
commission, instrumentality, official, ministry, fund,
foundation, center, organization, unit, body or Entity and any
court or other tribunal, and for the avoidance of doubt, any
Taxing authority); or (d) self-regulatory organization
(including the NASDAQ National Market).
HSR Act. HSR Act shall mean
the Hart-Scott-Rodino Antitrust Improvements Act of 1976,
as amended.
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Included CancerVax Options. Included
CancerVax Options shall mean: (i) all
CancerVax Options outstanding as of the date hereof that have an
exercise price per share that is less than the greater of
(x) $3.31 and (y) the average closing price for a
share of CancerVax Common Stock for the five trading days
immediately preceding the Closing Date; and (ii) all
CancerVax Options issued after the date hereof (but only to the
extent such option grant has not been specifically approved in
writing by Parent prior to the issuance of such option).
Intellectual Property. Intellectual
Property shall mean (a) United States,
foreign and international patents, patent applications,
including provisional applications, statutory invention
registrations, invention disclosures and inventions,
(b) trademarks, service marks, trade names, domain names,
URLs, trade dress, logos and other source identifiers, including
registrations and applications for registration thereof,
(c) copyrights, including registrations and applications
for registration thereof, and (d) software, formulae,
customer lists, trade secrets, know-how, confidential
information and other proprietary rights and intellectual
property, whether patentable or not.
IRS. IRS shall mean the
United States Internal Revenue Service.
Joint Proxy Statement/Prospectus. Joint
Proxy Statement/Prospectus shall mean the joint
proxy statement/prospectus to be sent to Parents
stockholders in connection with the Parent Stockholders
Meeting and to CancerVaxs stockholders in connection with
the CancerVax Stockholders Meeting.
Key Employee. Key Employee
shall mean, with respect to the Micromet Parties, an executive
officer or any employee that reports directly to the Board of
Directors or Chief Executive Officer or Chief Operating Officer,
and, with respect to CancerVax, David Hale, William LaRue and
Hazel Aker.
Knowledge. Knowledge shall
mean, with respect to a Party hereto, with respect to any matter
in question, the actual knowledge of the directors and executive
officers of such party.
Legal Proceeding. Legal
Proceeding shall mean any action, suit,
litigation, arbitration, proceeding (including any civil,
criminal, administrative, investigative or appellate
proceeding), hearing, inquiry, audit, examination or
investigation commenced, brought, conducted or heard by or
before, or otherwise involving, any court or other Governmental
Body or any arbitrator or arbitration panel.
Legal Requirement. Legal
Requirement shall mean any federal, state,
foreign, material local or municipal or other law, statute,
constitution, principle of common law, resolution, ordinance,
code, edict, decree, rule, regulation, ruling or requirement
issued, enacted, adopted, promulgated, implemented or otherwise
put into effect by or under the authority of any Governmental
Body (or under the authority of the NASDAQ National Market or
the National Association of Securities Dealers).
Micromet Capital Stock. Micromet Capital
Stock shall mean the Micromet Common Stock and the
Micromet Preferred Stock.
Micromet Common Stock. Micromet Common
Stock shall mean the ordinary shares of Micromet.
Micromet IP Rights. Micromet
IP Rights shall mean all Intellectual
Property owned, licensed, or controlled by the Micromet Parties
that is necessary or used in the Micromet Parties business
as presently conducted.
Micromet IP Rights
Agreement. Micromet IP Rights
Agreement shall mean any instrument or agreement
governing, related or pertaining to any Micromet IP Rights.
Micromet Parties. Micromet
Parties shall mean Parent, Micromet and all of
their Subsidiaries.
Micromet Pharmaceutical
Products. Micromet Pharmaceutical
Products shall mean all biological and drug
products being manufactured, distributed or developed by or on
behalf of the Micromet Parties.
Micromet Preferred Stock. Micromet
Preferred Stock shall mean collectively the
Preference Shares Series A and Preference Shares
Series B of Micromet.
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Micromet Registered IP. Micromet
Registered IP shall mean all Micromet
IP Rights that are registered, filed or issued under the
authority of, with or by any Governmental Body, including all
patents, registered copyrights and registered trademarks and all
applications for any of the foregoing.
Micromet Unaudited Interim Balance
Sheet. Micromet Unaudited Interim Balance
Sheet shall mean the unaudited consolidated
balance sheet of Micromet and its consolidated subsidiaries as
of October 31, 2005, provided to CancerVax prior to the
date of the Agreement.
Micromet Clinical Program. Micromet
Clinical Programs collectively, shall mean a
clinical trial sponsored by Micromet related to adecatumumab
(MT201) or MT103.
Minimum Cash Value. Minimum Cash
Value shall mean $20,500,000.
Ordinary Course of Business. Ordinary
Course of Business shall mean, in the case of each
of Micromet and CancerVax, such actions taken in the ordinary
course of its normal operations and consistent with its past
practices.
Parent Affiliate. Parent
Affiliate shall mean any Person under common
control with Parent within the meaning of Sections 414(b),
(c), (m) and (o) of the Code, and the regulations
issued thereunder.
Parent Associate. Parent
Associate shall mean any current or former
employee, independent contractor, officer or director of any of
the Micromet Parties or any Parent Affiliate.
Parent Common Stock. Parent Common
Stock shall mean the Common Stock, $0.001 par
value per share, of Parent.
Parent Contract. Parent
Contract shall mean any Contract: (a) to
which any of the Micromet Parties is a Party; (b) by which
any of the Micromet Parties or any Parent IP Rights or any
other asset of any of the Micromet Parties is or may become
bound or under which any of the Micromet Parties has, or may
become subject to, any obligation; or (c) under which any
of the Micromet Parties has or may acquire any right or interest.
Parent Material Adverse Effect. Parent
Material Adverse Effect shall mean any effect,
change, event, circumstance or development (any such item, an
Effect) that, considered together with
all Effects that had occurred prior to the date of determination
of the occurrence of the Parent Material Adverse Effect, is or
could reasonably be expected to be or to become materially
adverse to, or has or could reasonably be expected to have or
result in a material adverse effect on: (a) the business,
condition (financial or otherwise), capitalization, assets
(including Intellectual Property), operations, financial
performance or prospects of the Micromet Parties taken as a
whole; or (b) the ability of the Micromet Parties to
consummate the Merger or any of the other Contemplated
Transactions or to perform any of its covenants or obligations
under the Agreement; provided, however, that no Effect resulting
from the consummation of the Micromet Recapitalization or the
announcement or pendency of the Merger shall be deemed to
constitute a Parent Material Adverse Effect.
Parent Options. Parent
Options shall mean options to purchase shares of
Parent Common Stock issued by Parent.
Parent Warrant. Parent
Warrants shall mean warrants to purchase shares of
Parent Common Stock issued by Parent as set forth on
Part 2.3(d)(i) of the Parent Disclosure Schedule.
Parent Triggering Event. A Parent
Triggering Event shall be deemed to have occurred
if: (i) the board of directors of Parent shall have failed
to recommend that Parents stockholders vote to approve the
Merger, or shall for any reason have withdrawn or shall have
modified in a manner adverse to CancerVax the Parent Board
Recommendation; (ii) Parent shall have failed to include in
the Joint Proxy Statement/Prospectus the Parent Board
Recommendation; (iii) Parent shall have failed to hold the
Parent Stockholders Meeting within 45 days after the
Form S-4
Registration Statement is declared effective under the
Securities Act; (iv) the board of directors of Parent shall
have approved, endorsed or recommended any Acquisition Proposal;
(v) Parent shall have entered into any letter of intent or
similar document or any Contract relating to any Acquisition
Proposal; (vi) Parent or any director, officer or agent of
Parent shall have willfully and intentionally breached the
provisions set forth in Section 4.4 of the Agreement or
(v) Parent and Micromet shall have failed to consummate the
Micromet Recapitalization within seven days of the approval of
this Agreement and the Merger at the Parent Stockholders Meeting.
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Party. Party or
Parties shall mean Parent, Micromet,
Merger Sub and CancerVax. For purposes of Sections 4
through 10 Parent and Micromet shall collectively be deemed to
be a Party.
Person. Person shall mean
any individual, Entity or Governmental Body.
Representatives. Representatives
shall mean directors, officers, other employees, agents,
attorneys, accountants, advisors and representatives.
Reverse Split. Reverse
Split shall mean a reverse stock split of shares
of CancerVax capital stock in a range to be determined by the
Board of Directors of CancerVax prior to the Closing Date.
Sarbanes-Oxley Act. Sarbanes-Oxley
Act shall mean the Sarbanes-Oxley Act of 2002, as
it may be amended from time to time.
SEC. SEC shall mean the
United States Securities and Exchange Commission.
Securities Act. Securities
Act shall mean the Securities Act of 1933, as
amended.
Shareholders Agreement. Shareholders
Agreement shall mean that Shareholders
Agreement of Micromet AG dated as of October 11, 2005 by
and among Micromet AG and certain of its shareholders as
described therein.
Subsidiary. An entity shall be deemed to be a
Subsidiary of another Person if such
Person directly or indirectly owns or purports to own,
beneficially or of record, (a) an amount of voting
securities of other interests in such entity that is sufficient
to enable such Person to elect at least a majority of the
members of such entitys board of directors or other
governing body, or (b) at least 50% of the outstanding
equity, voting, beneficial or financial interests in such Entity.
Superior Offer. Superior
Offer shall mean an unsolicited bona fide written
offer by a third party to enter into (i) a merger,
consolidation, amalgamation, share exchange, business
combination, issuance of securities, acquisition of securities,
reorganization, recapitalization, tender offer, exchange offer
or other similar transaction as a result of which either
(A) the Partys stockholders prior to such transaction
in the aggregate cease to own at least 50% of the voting
securities of the entity surviving or resulting from such
transaction (or the ultimate parent entity thereof) or
(B) in which a Person or group (as defined in
the Exchange Act and the rules promulgated thereunder) directly
or indirectly acquires beneficial or record ownership of
securities representing 50% or more of the Partys capital
stock or (ii) a sale, lease, exchange transfer, license,
acquisition or disposition of any business or other disposition
of at least 50% of the assets of the Party or its Subsidiaries,
taken as a whole, in a single transaction or a series of related
transactions that: (a) was not obtained or made as a direct
or indirect result of a breach of (or in violation of) the
Agreement; and (b) is on terms and conditions that the
board of directors of CancerVax or Parent, as applicable,
determines, in its reasonable, good faith judgment, after
obtaining and taking into account such matters that its board of
directors deems relevant following consultation with its outside
legal counsel and financial advisor: (x) is reasonable
likely to be more favorable, from a financial point of view, to
CancerVaxs stockholders or Parents stockholders, as
applicable, than the terms of the Merger; and (y) is
reasonable capable of being consummated; provided,
however, that any such offer shall not be deemed to be a
Superior Offer if any financing required to
consummate the transaction contemplated by such offer is not
committed and is not reasonably capable of being obtained by
such third party, or if the consummation of such transaction is
contingent on any such financing being obtained.
Tax. Tax shall mean any
federal, state, local, foreign or other tax, including any
income tax, franchise tax, capital gains tax, gross receipts
tax, value-added tax, surtax, estimated tax, unemployment tax,
national health insurance tax, excise tax, ad valorem tax,
transfer tax, stamp tax, sales tax, use tax, property tax,
business tax, withholding tax, payroll tax, customs duty,
alternative or add-on minimum or other tax of any kind
whatsoever, and including any fine, penalty, addition to tax or
interest, whether disputed or not.
Tax Return. Tax Return
shall mean any return (including any information return),
report, statement, declaration, estimate, schedule, notice,
notification, form, election, certificate or other document or
information, and any amendment or supplement to any of the
foregoing, filed with or submitted to, or required to be filed
with or submitted to, any Governmental Body in connection with
the determination, assessment, collection or payment of any Tax
or in connection with the administration, implementation or
enforcement of or compliance with any Legal Requirement relating
to any Tax.
A-60
AMENDMENT
NO. 1 TO
AGREEMENT AND PLAN OF MERGER AND REORGANIZATION
This Amendment No. 1 to Agreement and Plan of Merger and
Reorganization
(this Amendment) is made and
entered into as of March 17, 2006, by and among
CancerVax
Corporation, a Delaware corporation
(CancerVax);
Carlsbad Acquisition
Corporation, a Delaware corporation
(Merger Sub);
Micromet,
Inc., a Delaware corporation
(Parent);
and Micromet
AG, a corporation organized under the laws of Germany
(Micromet). Capitalized terms used but
not defined in the Amendment shall have the meanings given to
them in the Merger Agreement.
BACKGROUND
The parties hereto have entered into that certain Agreement and
Plan of Merger and Reorganization, dated as of January 6,
2006 (the Merger Agreement), and deem
it to be in their respective best interests to amend the Merger
Agreement as provided below.
NOW, THEREFORE, in consideration of the foregoing premises and
for other good and valuable consideration, receipt and
sufficiency of which is hereby acknowledged, the parties hereto
agree as follows:
1. Clause (c) of Section 2.18 of the Merger
Agreement is hereby deleted and replaced with the following:
(c) recommended the adoption and approval of this
Agreement by the holder of Parent Common Stock and directed that
this Agreement and the Merger be submitted for approval by
Parents stockholder at a stockholder meeting or by a
written consent in lieu of such meeting;
2. Section 2.20 of the Merger Agreement is hereby
deleted and replaced with the following:
2.20 Vote Required. The
affirmative vote or written consent of the sole holder of shares
of Parent Common Stock outstanding on the date that the
Form S-4
Registration Statement is declared effective under the
Securities Act (the Required Parent Stockholder
Vote) is the only vote of the holders of any class
or series of any of the Micromet Parties capital stock
necessary to adopt or approve this Agreement and approve the
Merger.
3. Section 5.1(b) of the Merger Agreement is hereby
deleted and replaced with the following:
(b) Prior to the Effective Time, CancerVax shall use
commercially reasonable efforts to obtain all regulatory
approvals needed to ensure that the CancerVax Common Stock to be
issued in the Merger will (to the extent required) be registered
or qualified or exempt from registration or qualification under
the securities law of every jurisdiction of the United States in
which any registered holder of Micromet Common Stock or Micromet
Preferred Stock has an address of record on the date on which
the
Form S-4
Registration Statement is declared effective under the
Securities Act; provided, however, that CancerVax shall
not be required: (i) to qualify to do business as a foreign
corporation in any jurisdiction in which it is not now
qualified; or (ii) to file a general consent to service of
process in any jurisdiction.
4. Section 5.2 of the Merger Agreement is hereby
deleted and replaced with the following:
5.2 Parent Written Consent; Micromet
Recapitalization.
(a) Parent shall take all action necessary under all
applicable Legal Requirements to obtain and deliver, as promptly
as practicable after the
Form S-4
Registration Statement is declared effective under the
Securities Act, a written consent (the Parent
Written Consent) adopting and approving this
Agreement and the Merger, such consent to be executed at least
20 days prior to the Closing Date and in a form reasonably
acceptable to CancerVax.
(b) Parent and Micromet agree that, subject to
Section 5.2(c): (i) Parents board of directors
shall recommend that Parents sole stockholder vote to
adopt and approve this Agreement and the Merger and shall use
commercially reasonable efforts to solicit such approval;
(ii) the Joint Proxy Statement/Prospectus shall include a
statement to the effect that the board of directors of Parent
recommends that Parents stockholder vote to adopt and
approve this Agreement (the recommendation of Parents
board of
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directors that Parents stockholder vote to adopt and
approve this Agreement being referred to as the
Parent Board Recommendation); and
(iii) the Parent Board Recommendation shall not be
withdrawn or modified in a manner adverse to CancerVax, and no
resolution by the board of directors of Parent or any committee
thereof to withdraw or modify the Parent Board Recommendation in
a manner adverse to CancerVax shall be adopted or proposed.
(c) Notwithstanding anything to the contrary contained in
Section 5.2(b), at any time prior to the approval of this
Agreement by Parents sole stockholder, Parents board
of directors may withhold, amend, withdraw or modify the Parent
Board Recommendation in a manner adverse to CancerVax if, but
only if: (i) an unsolicited, bona fide written offer has
been made that it believes in good faith, based on such matters
as it deems relevant following consultation with its outside
legal counsel, is a Superior Offer and such offer is not
withdrawn; (ii) such unsolicited, bona fide written offer
was not obtained or made as a direct or indirect result of a
breach of this Agreement; (iii) Parents board of
directors determined in good faith, based on such matters as it
deems relevant following consultation with its outside legal
counsel, that the failure to withdraw, withhold, amend, or
modify such recommendation is reasonably likely to result in a
breach of its fiduciary duties under applicable Legal
Requirements; and (iv) the Parent Board Recommendation is
not withdrawn, withheld, amended or modified in a manner adverse
to CancerVax at any time within three Business Days after
CancerVax receives written notice from Parent confirming that
Parents board of directors has determined to change its
recommendation.
(d) Parents obligation to obtain the Parent Written
Consent in accordance with Section 5.2(a) shall not be
limited or otherwise affected by the commencement, disclosure,
announcement or submission of any Superior Offer or other
Acquisition Proposal, or by any withdrawal or modification of
the Parent Board Recommendation.
(e) Micromet and Parent shall take all necessary action to
effectuate the Micromet Recapitalization prior to the Closing
Date.
5. Section 9.1(d) of the Merger Agreement is hereby
deleted and replaced with the following:
(d) by CancerVax if this Agreement shall not have been
adopted and approved by the Required Parent Stockholder Vote in
accordance with Section 5.2(a).
6. Section 9.3(b)(ii) of the Merger Agreement is
hereby deleted and replaced with the following:
(ii) If this Agreement is terminated by CancerVax pursuant
to Section 9.1(d) or Section 9.1(g), in either case,
without duplication, Parent shall pay to CancerVax, within five
Business Days after termination, a nonrefundable fee in an
amount equal to $2,000,000.
7. The definition of Joint Proxy
Statement/Prospectus set forth in Exhibit A to the
Merger Agreement is hereby deleted and replaced with the
following:
Joint Proxy
Statement/Prospectus. Joint Proxy
Statement/Prospectus shall mean the proxy
statement/prospectus to be sent to CancerVaxs stockholders
in connection with the CancerVax Stockholders
Meeting.
8. The definition of Parent Triggering Event
set forth in Exhibit A to the Merger Agreement is hereby
deleted and replaced with the following:
Parent Triggering Event. A
Parent Triggering Event shall be
deemed to have occurred if: (i) the board of directors of
Parent shall have failed to recommend that Parents
stockholder vote to approve the Merger, or shall for any reason
have withdrawn or shall have modified in a manner adverse to
CancerVax the Parent Board Recommendation; (ii) Parent
shall have failed to include in the Joint Proxy
Statement/Prospectus the Parent Board Recommendation;
(iii) the board of directors of Parent shall have approved,
endorsed or recommended any Acquisition Proposal;
(iv) Parent shall have entered into any letter of intent or
similar document or any Contract relating to any Acquisition
Proposal; (v) Parent or any director, officer or agent of
Parent shall have willfully and intentionally breached the
provisions set forth in Section 4.4 of the Agreement or
(vi) Parent and Micromet shall have failed to consummate the
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Micromet Recapitalization within seven days of the approval of
the Merger at the CancerVax Stockholders Meeting.
9. Miscellaneous. Except as modified
hereby, all of the terms and conditions of the Merger Agreement
remain in full force and effect and are hereby reaffirmed,
ratified and approved. This Amendment, together with the Merger
Agreement, embodies the entire agreement and understanding
between the parties hereto with respect to the subject matter
hereof. No statement, representation, warranty, covenant or
agreement of any kind not expressly set forth in this Amendment
shall affect, or be used to interpret, change or restrict, the
express terms and conditions of this Amendment. Hereafter
references to the Merger Agreement in any document or other
agreement shall be deemed to constitute references to the Merger
Agreement as amended by this Amendment. This Amendment may be
executed in one or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute
one and the same instrument. Execution and delivery of this
Amendment may be made and evidenced by facsimile transmission.
[signature
pages follow]
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IN WITNESS WHEREOF, the parties have executed this
Amendment as of the date first above written.
CancerVax
Corporation
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Carlsbad Acquisition
Corporation
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Micromet,
Inc.
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Micromet AG
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A-64
VOTING
AGREEMENT
This Voting Agreement
(this Agreement) is entered
into as of January , 2006, by and between
Micromet, Inc., a Delaware corporation
(Parent), and
(Stockholder).
RECITALS
A. Stockholder is a holder of record and the
beneficial owner (within the meaning of
Rule 13d-3
under the Securities Exchange Act of 1934) of certain
shares of common stock of CancerVax Corporation, a Delaware
corporation (CancerVax).
B. CancerVax, Parent, Micromet AG and Carlsbad
Acquisition Corporation (CAC) are
entering into an Agreement and Plan of Merger and Reorganization
of even date herewith (the Merger
Agreement) which provides (subject to the
conditions set forth therein) for the merger of CAC into Parent
(the Merger).
C. In the Merger, the outstanding shares of
common stock of Parent are to be converted into the right to
receive shares of common stock of CancerVax.
D. In order to induce Parent to enter into the
Merger Agreement, Stockholder is entering into this Agreement.
E. The Merger Agreement has been approved by
the Board of Directors of CancerVax.
AGREEMENT
The parties to this Agreement, intending to be legally bound,
agree as follows:
Section 1. Certain
Definitions
For purposes of this Agreement:
(a) The terms Acquisition
Proposal and Acquisition
Transaction shall have the respective meanings
assigned to those terms in the Merger Agreement.
(b) CancerVax Common Stock shall
mean the common stock, par value $0.00004 per share, of
CancerVax.
(c) An Identified Termination
shall occur if the Merger Agreement is terminated (A) by
Parent or CancerVax pursuant to Section 9.1(e) of the
Merger Agreement or (B) by Parent pursuant to
Section 9.1(f) of the Merger Agreement.
(d) Stockholder shall be deemed to
Own or to have acquired
Ownership of a security if
Stockholder: (i) is the record owner of such security; or
(ii) is the beneficial owner (within the
meaning of
Rule 13d-3
under the Securities Exchange Act of 1934) of such security.
(e) Person shall mean any
(i) individual, (ii) corporation, limited liability
company, partnership or other entity, or (iii) governmental
authority.
(f) Subject Securities shall
mean: (i) all securities of CancerVax (including all shares
of CancerVax Common Stock and all options, warrants and other
rights to acquire shares of CancerVax Common Stock) Owned by
Stockholder as of the date of this Agreement; and (ii) all
additional securities of CancerVax (including all additional
shares of CancerVax Common Stock and all additional options,
warrants and other rights to acquire shares of CancerVax Common
Stock) of which Stockholder acquires Ownership during the period
from the date of this Agreement through the Voting Covenant
Expiration Date.
(g) A Person shall be deemed to have a effected a
Transfer of a security if such Person
directly or indirectly: (i) sells, pledges, encumbers,
grants an option with respect to, transfers or disposes of such
security or any interest in such security to any Person other
than Parent; (ii) enters into an agreement or commitment
B-1
contemplating the possible sale of, pledge of, encumbrance of,
grant of an option with respect to, transfer of or disposition
of such security or any interest therein to any Person other
than Parent; or (iii) reduces such Persons beneficial
ownership of, interest in or risk relating to such security.
(h) Voting Covenant Expiration
Date shall mean the earlier of the date upon which
the Merger Agreement is validly terminated, or the date upon
which the Merger is consummated; provided, however, that
the Voting Covenant Expiration Date shall be the
date 60 days following the date on which the Merger
Agreement is validly terminated, if an Identified Termination
occurs. Notwithstanding the foregoing, this Agreement may be
terminated for cause by either party, and if so terminated, the
date of any such termination shall be the Voting Covenant
Expiration Date.
Section 2. Transfer
of Subject Securities and Voting Rights
2.1 Restriction on Transfer of Subject
Securities. Subject to Section 2.3, during
the period from the date of this Agreement through the Voting
Covenant Expiration Date, Stockholder shall not, directly or
indirectly, cause or permit any Transfer of any of the Subject
Securities to be effected.
2.2 Restriction on Transfer of Voting
Rights. During the period from the date of this
Agreement through the Voting Covenant Expiration Date,
Stockholder shall ensure that: (a) none of the Subject
Securities is deposited into a voting trust; and (b) no
proxy is granted, and no voting agreement or similar agreement
is entered into, with respect to any of the Subject Securities.
2.3 Permitted
Transfers. Section 2.1 shall not prohibit a
transfer of CancerVax Common Stock by Stockholder (i) to
any member of his immediate family, or to a trust for the
benefit of Stockholder or any member of his immediate family,
(ii) upon the death of Stockholder, or (iii) if
Stockholder is a partnership or limited liability company, to
one or more partners or members of Stockholder or to an
affiliated corporation under common control with Stockholder,
or, after the liquidation or dissolution of such Stockholder, to
any of their partners, shareholders, unitholders or participants
in such funds or undertakings in the course of such liquidation
or dissolution; provided, however, that a transfer
referred to in this sentence shall be permitted only if, as a
precondition to such transfer, the transferee agrees in a
writing, reasonably satisfactory in form and substance to
Parent, to be bound by the terms of this Agreement.
Section 3. Voting
of Shares
3.1 Voting Covenant Prior to Termination of Merger
Agreement. Stockholder hereby agrees that, prior
to the earlier to occur of the valid termination of the Merger
Agreement or the consummation of the Merger, at any meeting of
the stockholders of CancerVax, however called, and in any
written action by consent of stockholders of CancerVax, unless
otherwise directed in writing by Parent, Stockholder shall, to
the extent legally permissible, cause the Subject Securities to
be voted:
(a) in favor of the Merger, the execution and delivery by
CancerVax of the Merger Agreement and the adoption and approval
of the Merger Agreement and the terms thereof, in favor of each
of the other actions contemplated by the Merger Agreement
(including but not limited to the issuance of CancerVax Common
Stock pursuant to the Merger and any amendment to the
Certificate of Incorporation of CancerVax contemplated by the
Merger Agreement) and in favor of any action in furtherance of
any of the foregoing; and
(b) against any action or agreement that would result in a
breach of any representation, warranty, covenant or obligation
of CancerVax or CAC in the Merger Agreement; and
(c) against the following actions (other than the Merger
and the transactions contemplated by the Merger Agreement):
(A) any extraordinary corporate transaction, such as a
merger, consolidation or other business combination involving
CancerVax or any subsidiary; (B) any sale, lease or
transfer of a material amount of assets of CancerVax or any
subsidiary; (C) any reorganization, recapitalization,
dissolution or liquidation of CancerVax or any subsidiary;
(D) any change in a majority of the board of directors of
CancerVax; (E) any amendment to CancerVaxs
Certificate of Incorporation or bylaws (other than as
contemplated by the Merger Agreement); (F) any material
change in the capitalization of CancerVax or CancerVaxs
corporate structure; and (G) any other action which is
intended, or would reasonably be expected, to impede, interfere
with, delay,
B-2
postpone, discourage or adversely affect the Merger or any of
the other transactions contemplated by the Merger Agreement or
this Agreement.
Prior to the earlier to occur of the valid termination of the
Merger Agreement or the consummation of the Merger, Stockholder
shall not enter into any agreement or understanding with any
Person to vote or give instructions in any manner inconsistent
with clause (a), (b) or (c)
of the preceding sentence.
3.2 Voting Covenant After Identified
Termination. If an Identified Termination occurs,
then, prior to the Voting Covenant Expiration Date, at any
meeting of the stockholders of CancerVax, however called, and in
any written action by consent of stockholders of CancerVax,
unless otherwise directed in writing by Parent, Stockholder
shall cause the Subject Securities to be voted (i) against
any Acquisition Proposal and any related transaction or
agreement and (ii) against any action which is intended, or
could reasonably be expected, to facilitate the consummation of
any Acquisition Transaction. Stockholder shall not enter into
any agreement or understanding with any Person prior to the
Voting Covenant Expiration Date to vote or give instructions in
any manner inconsistent with clause (i) or
(ii) of the preceding sentence.
3.3 Proxy; Further Assurances.
(a) Contemporaneously with the execution of this Agreement:
(i) Stockholder shall deliver to Parent a proxy in the form
attached to this Agreement as Exhibit A, which shall
be irrevocable to the fullest extent permitted by law (at all
times prior to the Voting Covenant Expiration Date) with respect
to the shares referred to therein (the
Proxy); and (ii) Stockholder
shall cause to be delivered to Parent an additional proxy (in
the form attached hereto as Exhibit A) executed on
behalf of the record owner of any outstanding shares of
CancerVax Common Stock that are owned beneficially (within the
meaning of
Rule 13d-3
under the Securities Exchange Act of 1934), but not of record,
by Stockholder.
(b) Stockholder shall, at his or its own expense, perform
such further acts and execute such further proxies and other
documents and instruments as may reasonably be required to vest
in Parent the power to carry out and give effect to the
provisions of this Agreement; provided, however, that nothing in
this Section 3 shall be deemed to obligate Stockholder to
vote in a manner contrary to such Stockholders fiduciary
duties or other than in good faith or in contravention of law or
public policy.
Section 4. No
Solicitation
Stockholder agrees that, during the period from the date of this
Agreement through the Voting Covenant Expiration Date,
Stockholder shall not, directly or indirectly, and Stockholder
shall ensure that his or its Representatives (as defined in the
Merger Agreement) do not, directly or indirectly:
(i) solicit, initiate, encourage, induce or facilitate the
making, submission or announcement of any Acquisition Proposal
or take any action that could reasonably be expected to lead to
an Acquisition Proposal; (ii) furnish any information
regarding CancerVax, Parent or any subsidiary to any Person in
connection with or in response to an Acquisition Proposal or an
inquiry or indication of interest that could lead to an
Acquisition Proposal; (iii) engage in discussions or
negotiations with any Person with respect to any Acquisition
Proposal; (iv) approve, endorse or recommend any
Acquisition Proposal; or (v) enter into any letter of
intent or similar document or any agreement or understanding
contemplating or otherwise relating to any Acquisition
Transaction. Stockholder shall immediately cease and
discontinue, and Stockholder shall ensure that his or its
Representatives immediately cease and discontinue, any existing
discussions with any Person that relate to any Acquisition
Proposal.
Section 5. Representations
and Warranties of Stockholder
Stockholder hereby represents and warrants to Parent as follows:
5.1 Authorization, etc. Stockholder
has the absolute and unrestricted right, power, authority and
capacity to execute and deliver this Agreement and the Proxy and
to perform his or its obligations hereunder and thereunder
except to the extent prohibited by law. This Agreement and the
Proxy have been duly executed and delivered by Stockholder and
constitute legal, valid and binding obligations of Stockholder,
enforceable against Stockholder in accordance with their terms,
subject to (i) laws of general application relating to
bankruptcy, insolvency and the relief of debtors,
(ii) rules of law governing specific performance,
injunctive relief and other equitable remedies and
(iii) laws of the jurisdictions of Stockholder or CancerVax
relating to
B-3
shareholder voting agreements. If Stockholder is a general or
limited partnership, then Stockholder is a partnership duly
organized, validly existing and in good standing under the laws
of the jurisdiction in which it was organized. If Stockholder is
a limited liability company, then Stockholder is a limited
liability company duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it was
organized.
5.2 No Conflicts or Consents.
(a) The execution and delivery of this Agreement and the
Proxy by Stockholder do not, and the performance of this
Agreement and the Proxy by Stockholder will not:
(i) conflict with or violate any law, rule, regulation,
order, decree or judgment applicable to Stockholder or by which
he or it or any of his or its properties is or may be bound or
affected; or (ii) result in or constitute (with or without
notice or lapse of time) any breach of or default under, or give
to any other Person (with or without notice or lapse of time)
any right of termination, amendment, acceleration or
cancellation of, or result (with or without notice or lapse of
time) in the creation of any encumbrance or restriction on any
of the Subject Securities pursuant to, any contract to which
Stockholder is a party or by which Stockholder or any of his or
its affiliates or properties is or may be bound or affected.
(b) The execution and delivery of this Agreement and the
Proxy by Stockholder do not, and the performance of this
Agreement and the Proxy by Stockholder will not, require any
consent or approval of any Person.
5.3 Title to Securities. As of the
date of this Agreement: (a) Stockholder holds of record
(free and clear of any encumbrances or restrictions) the number
of outstanding shares of CancerVax Common Stock set forth under
the heading Shares Held of Record on the
signature page hereof; (b) Stockholder holds (free and
clear of any encumbrances or restrictions) the options, warrants
and other rights to acquire shares of CancerVax Common Stock set
forth under the heading Options and Other Rights on
the signature page hereof; (c) Stockholder Owns the
additional securities of CancerVax set forth under the heading
Additional Securities Beneficially Owned on the
signature page hereof; and (d) Stockholder does not
directly or indirectly Own any shares of capital stock or other
securities of CancerVax, or any option, warrant or other right
to acquire (by purchase, conversion or otherwise) any shares of
capital stock or other securities of CancerVax, other than the
shares and options, warrants and other rights set forth on the
signature page hereof.
5.4 Accuracy of
Representations. The representations and
warranties contained in this Agreement are accurate in all
respects as of the date of this Agreement, will be accurate in
all respects at all times through the Voting Covenant Expiration
Date and will be accurate in all respects as of the date of the
consummation of the Merger as if made on that date.
Section 6. Additional
Covenants of Stockholder
6.1 Further Assurances. From time
to time and without additional consideration, Stockholder shall
(at Stockholders sole expense) execute and deliver, or
cause to be executed and delivered, such additional transfers,
assignments, endorsements, proxies, consents and other
instruments, and shall (at Stockholders sole expense) take
such further actions, as Parent may request for the purpose of
carrying out the intent of this Agreement.
6.2 Legends. If requested by
Parent, immediately after the execution of this Agreement (and
from time to time upon the acquisition by Stockholder of
Ownership of any shares of CancerVax Common Stock prior to the
Voting Covenant Expiration Date), Stockholder shall cause each
certificate evidencing any outstanding shares of CancerVax
Common Stock or other securities of CancerVax Owned by
Stockholder to be surrendered so that the transfer agent for
such securities may affix thereto a legend in the following form:
THE SECURITY OR SECURITIES REPRESENTED BY THIS CERTIFICATE MAY
NOT BE SOLD, EXCHANGED OR OTHERWISE TRANSFERRED OR DISPOSED OF
EXCEPT IN COMPLIANCE WITH THE TERMS AND PROVISIONS OF A VOTING
AGREEMENT DATED AS OF JANUARY , 2006, AS IT MAY
BE AMENDED, A COPY OF WHICH IS ON FILE AT THE PRINCIPAL
EXECUTIVE OFFICES OF THE ISSUER.
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Section 7. Miscellaneous
7.1 Survival of Representations, Warranties and
Agreements. All representations, warranties,
covenants and agreements made by Stockholder in this Agreement
shall terminate as of the Voting Covenant Expiration Date.
7.2 Expenses. All costs and
expenses incurred in connection with the transactions
contemplated by this Agreement shall be paid by the party
incurring such costs and expenses.
7.3 Notices. Any notice or other
communication required or permitted to be delivered to either
party under this Agreement shall be in writing and shall be
deemed properly delivered, given and received when delivered (by
hand, by registered mail, by courier or express delivery service
or by facsimile) to the address or facsimile telephone number
set forth beneath the name of such party below (or to such other
address or facsimile telephone number as such party shall have
specified in a written notice given to the other party):
if to Stockholder:
at the address set forth on the signature page hereof; and
if to Parent:
at the address set forth in the Merger Agreement
Copy to:
Cooley Godward LLP
One Freedom Square
11951 Freedom Drive
Reston, VA
20190-5656
Telephone:
(703) 456-8006
Fax:
(703) 456-8100
Attention: Christian E. Plaza, Esq.
7.4 Severability. Any term or
provision of this Agreement that is invalid or unenforceable in
any situation in any jurisdiction shall not affect the validity
or enforceability of the remaining terms and provisions hereof
or the validity or enforceability of the offending term or
provision in any other situation or in any other jurisdiction.
If the final judgment of a court of competent jurisdiction
declares that any term or provision hereof is invalid or
unenforceable, the parties hereto agree that the court making
such determination shall have the power to limit the term or
provision, to delete specific words or phrases, or to replace
any invalid or unenforceable term or provision with a term or
provision that is valid and enforceable and that comes closest
to expressing the intention of the invalid or unenforceable term
or provision, and this Agreement shall be enforceable as so
modified. In the event such court does not exercise the power
granted to it in the prior sentence, the parties hereto agree to
replace such invalid or unenforceable term or provision with a
valid and enforceable term or provision that will achieve, to
the extent possible, the economic, business and other purposes
of such invalid or unenforceable term.
7.5 Entire Agreement. This
Agreement, the Proxy and any other documents delivered by the
parties in connection herewith constitute the entire agreement
between the parties with respect to the subject matter hereof
and thereof and supersede all prior agreements and
understandings between the parties with respect thereto. No
addition to or modification of any provision of this Agreement
shall be binding upon either party unless made in writing and
signed by both parties.
7.6 Assignment; Binding
Effect. Except as provided herein, neither this
Agreement nor any of the interests or obligations hereunder may
be assigned or delegated by Stockholder, and any attempted or
purported assignment or delegation of any of such interests or
obligations shall be void. Subject to the preceding sentence,
this Agreement shall be binding upon Stockholder and his heirs,
estate, executors and personal representatives and his or its
successors and assigns, and shall inure to the benefit of Parent
and its successors and assigns. Without limiting any of the
restrictions set forth in Section 2 or elsewhere in this
Agreement, this Agreement shall be binding upon any Person to
whom any Subject Securities are transferred. Nothing in this
Agreement is intended to confer on any Person (other than Parent
and its successors and assigns) any rights or remedies of any
nature.
B-5
7.7 Indemnification. Stockholder
shall hold harmless and indemnify Parent and Parents
affiliates from and against, and shall compensate and reimburse
Parent and Parents affiliates for, any loss, damage,
claim, liability, fee (including reasonable attorneys
fees), demand, cost or expense (regardless of whether or not
such loss, damage, claim, liability, fee, demand, cost or
expense relates to a third-party claim) that is directly or
indirectly suffered or incurred by Parent or any of
Parents affiliates, or to which Parent or any of
Parents affiliates otherwise becomes subject, and that
arises directly or indirectly from, or relates directly or
indirectly to, (a) any inaccuracy in or breach of any
representation or warranty contained in this Agreement, or
(b) any failure on the part of Stockholder to observe,
perform or abide by, or any other breach of, any restriction,
covenant, obligation or other provision contained in this
Agreement or in the Proxy.
7.8 Specific Performance. The
parties agree that irreparable damage would occur in the event
that any of the provisions of this Agreement or the Proxy were
not performed in accordance with its specific terms or were
otherwise breached. Stockholder agrees that, in the event of any
breach or threatened breach by Stockholder of any covenant or
obligation contained in this Agreement or in the Proxy, Parent
shall be entitled (in addition to any other remedy that may be
available to it, including monetary damages) to seek and obtain
(a) a decree or order of specific performance to enforce
the observance and performance of such covenant or obligation,
and (b) an injunction restraining such breach or threatened
breach. Stockholder further agrees that neither Parent nor any
other Person shall be required to obtain, furnish or post any
bond or similar instrument in connection with or as a condition
to obtaining any remedy referred to in this Section 7.8,
and Stockholder irrevocably waives any right he or it may have
to require the obtaining, furnishing or posting of any such bond
or similar instrument.
7.9 Non-Exclusivity. The rights and
remedies of Parent under this Agreement are not exclusive of or
limited by any other rights or remedies which it may have,
whether at law, in equity, by contract or otherwise, all of
which shall be cumulative (and not alternative). Without
limiting the generality of the foregoing, the rights and
remedies of Parent under this Agreement, and the obligations and
liabilities of Stockholder under this Agreement, are in addition
to their respective rights, remedies, obligations and
liabilities under common law requirements and under all
applicable statutes, rules and regulations.
7.10 Governing Law; Venue.
(a) This Agreement and the Proxy shall be construed in
accordance with, and governed in all respects by, the laws of
the State of Delaware (without giving effect to principles of
conflicts of laws).
(b) Any legal action or other legal proceeding relating to
this Agreement or the Proxy or the enforcement of any provision
of this Agreement or the Proxy may be brought or otherwise
commenced in any state or federal court located in the State of
Delaware. Stockholder:
(i) expressly and irrevocably consents and submits to the
jurisdiction of each state and federal court located in the
State of Delaware in connection with any such legal proceeding;
(ii) agrees that service of any process, summons, notice or
document by U.S. mail addressed to him or it at the address
set forth on the signature page hereof shall constitute
effective service of such process, summons, notice or document
for purposes of any such legal proceeding;
(iii) agrees that each state and federal court located in
the State of Delaware shall be deemed to be a convenient
forum; and
(iv) agrees not to assert (by way of motion, as a defense
or otherwise), in any such legal proceeding commenced in any
state or federal court located in the State of Delaware, any
claim that Stockholder is not subject personally to the
jurisdiction of such court, that such legal proceeding has been
brought in an inconvenient forum, that the venue of such
proceeding is improper or that this Agreement or the subject
matter of this Agreement may not be enforced in or by such court.
Nothing contained in this Section 7.10 shall be deemed to
limit or otherwise affect the right of Parent to commence any
legal proceeding or otherwise proceed against Stockholder in any
other forum or jurisdiction.
B-6
(c) STOCKHOLDER IRREVOCABLY WAIVES THE RIGHT TO A JURY
TRIAL IN CONNECTION WITH ANY LEGAL PROCEEDING RELATING TO THIS
AGREEMENT OR THE PROXY OR THE ENFORCEMENT OF ANY PROVISION OF
THIS AGREEMENT OR THE PROXY.
7.11 Counterparts. This Agreement
may be executed in separate counterparts, each of which when so
executed and delivered shall be an original, but all such
counterparts shall together constitute one and the same
instrument.
7.12 Captions. The captions
contained in this Agreement are for convenience of reference
only, shall not be deemed to be a part of this Agreement and
shall not be referred to in connection with the construction or
interpretation of this Agreement.
7.13 Attorneys Fees. If any
legal action or other legal proceeding relating to this
Agreement or the enforcement of any provision of this Agreement
is brought against Stockholder, the prevailing party shall be
entitled to recover reasonable attorneys fees, costs and
disbursements (in addition to any other relief to which the
prevailing party may be entitled).
7.14 Waiver. No failure on the part
of Parent to exercise any power, right, privilege or remedy
under this Agreement, and no delay on the part of Parent in
exercising any power, right, privilege or remedy under this
Agreement, shall operate as a waiver of such power, right,
privilege or remedy; and no single or partial exercise of any
such power, right, privilege or remedy shall preclude any other
or further exercise thereof or of any other power, right,
privilege or remedy. Parent shall not be deemed to have waived
any claim available to Parent arising out of this Agreement, or
any power, right, privilege or remedy of Parent under this
Agreement, unless the waiver of such claim, power, right,
privilege or remedy is expressly set forth in a written
instrument duly executed and delivered on behalf of Parent; and
any such waiver shall not be applicable or have any effect
except in the specific instance in which it is given.
7.15 Construction.
(a) For purposes of this Agreement, whenever the context
requires: the singular number shall include the plural, and vice
versa; the masculine gender shall include the feminine and
neuter genders; the feminine gender shall include the masculine
and neuter genders; and the neuter gender shall include
masculine and feminine genders.
(b) The parties agree that any rule of construction to the
effect that ambiguities are to be resolved against the drafting
party shall not be applied in the construction or interpretation
of this Agreement.
(c) As used in this Agreement, the words
include and including, and variations
thereof, shall not be deemed to be terms of limitation, but
rather shall be deemed to be followed by the words without
limitation.
(d) Except as otherwise indicated, all references in this
Agreement to Sections and Exhibits are
intended to refer to Sections of this Agreement and Exhibits to
this Agreement.
B-7
In Witness
Whereof, Parent and Stockholder have caused this
Agreement to be executed as of the date first written above.
MICROMET, INC.
Stockholder
Name:
Address: _
_
_
_
Facsimile: _
_
|
|
|
Shares Held
of Record |
Options
and Other Rights |
Additional
Securities Beneficially Owned |
B-8
EXHIBIT A
FORM OF
IRREVOCABLE PROXY
The undersigned stockholder (the Stockholder)
of CancerVax Corporation, a Delaware corporation
(CancerVax), hereby irrevocably (to the
fullest extent permitted by law) appoints and constitutes
Christian Itin, Gregor Mirow and Micromet,
Inc., a Delaware
corporation (Parent), and each of
them, the attorneys and proxies of the Stockholder with full
power of substitution and resubstitution, to the full extent of
the Stockholders rights with respect to (i) the
outstanding shares of common stock of CancerVax owned of record
by the Stockholder as of the date of this proxy, which shares
are specified on the final page of this proxy, and (ii) any
and all other shares of capital stock of CancerVax which the
Stockholder may acquire on or after the date hereof. (The shares
of the common stock of CancerVax referred to in clauses
(i) and (ii) of the immediately
preceding sentence are collectively referred to as the
Shares.) Upon the execution hereof,
all prior proxies given by the Stockholder with respect to any
of the Shares are hereby revoked, and the Stockholder agrees
that no subsequent proxies will be given with respect to any of
the Shares.
This proxy is irrevocable to the fullest extent permitted by
law, is coupled with an interest and is granted in connection
with the Voting Agreement, dated as of the date hereof, between
Parent and the Stockholder (the Voting
Agreement), and is granted in consideration of
Parent entering into the Agreement and Plan of Merger and
Reorganization, dated as of the date hereof, among CancerVax,
Parent, Micromet AG and Carlsbad Acquisition Corporation (the
Merger Agreement). This proxy will
terminate on the Voting Covenant Expiration Date (as defined in
the Voting Agreement).
The attorneys and proxies named above will be empowered, and may
exercise this proxy, to vote the Shares at any time until the
earlier to occur of the Voting Covenant Expiration Date at any
meeting of the stockholders of CancerVax, however called, and in
connection with any written action by consent of stockholders of
Parent or CancerVax:
(i) in favor of the Merger (as defined in the Voting
Agreement), the execution and delivery by CancerVax of the
Merger Agreement and the adoption and approval of the Merger
Agreement and the terms thereof, in favor of each of the other
actions contemplated by the Merger Agreement (including but not
limited to the issuance of shares of CancerVax Common Stock
pursuant to the Merger and the amendment to CancerVaxs
Certificate of Incorporation contemplated by the Merger
Agreement) and in favor of any action in furtherance of any of
the foregoing; and
(ii) against any action or agreement that would result in a
breach of any representation, warranty, covenant or obligation
of CancerVax in the Merger Agreement; and
(iii) against the following actions, (other than the Merger
and the other transactions contemplated by the Merger
Agreement): (A) any extraordinary corporate transaction,
such as a merger, consolidation or other business combination
involving CancerVax or any subsidiary; (B) any sale, lease
or transfer of a material amount of assets of CancerVax or any
subsidiary; (C) any reorganization, recapitalization,
dissolution or liquidation of CancerVax or any subsidiary;
(D) any change in a majority of the board of directors of
CancerVax; (E) any amendment to CancerVaxs
certificate of incorporation or bylaws; (F) any material
change in the capitalization of CancerVax or CancerVaxs
corporate structure; and (G) any other action which is
intended, or would reasonably be expected to impede, interfere
with, delay, postpone, discourage or adversely affect the Merger
or any of the other transactions contemplated by the Merger
Agreement.
If an Identified Termination (as defined in the Voting
Agreement) occurs, then, during the
60-day
period commencing on the date of such Identified Termination, at
any meeting of the stockholders of CancerVax, however called,
and in connection with any written action by consent of
stockholders of CancerVax, the attorneys and proxies named above
will be empowered, and may exercise this proxy, to vote the
Shares in their discretion against or otherwise with respect to
(i) any Acquisition Proposal (as defined in the Voting
Agreement) and any related transaction or agreement and
(ii) any action which is intended, or could reasonably be
expected, to facilitate the consummation of any Acquisition
Transaction (as defined in the Voting Agreement).
B-9
The Stockholder may vote the Shares on all other matters not
referred to in this proxy, and the attorneys and proxies named
above may not exercise this proxy with respect to such other
matters.
This proxy shall be binding upon the heirs, estate, executors,
personal representatives, successors and assigns of the
Stockholder (including any transferee of any of the Shares).
Any term or provision of this proxy that is invalid or
unenforceable in any situation in any jurisdiction shall not
affect the validity or enforceability of the remaining terms and
provisions hereof or the validity or enforceability of the
offending term or provision in any other situation or in any
other jurisdiction. If the final judgment of a court of
competent jurisdiction declares that any term or provision
hereof is invalid or unenforceable, the Stockholder agrees that
the court making such determination shall have the power to
limit the term or provision, to delete specific words or
phrases, or to replace any invalid or unenforceable term or
provision with a term or provision that is valid and enforceable
and that comes closest to expressing the intention of the
invalid or unenforceable term or provision, and this proxy shall
be enforceable as so modified. In the event such court does not
exercise the power granted to it in the prior sentence, the
Stockholder agrees to replace such invalid or unenforceable term
or provision with a valid and enforceable term or provision that
will achieve, to the extent possible, the economic, business and
other purposes of such invalid or unenforceable term.
Name
Number of shares of CancerVax common stock owned of record as of
the date of this proxy:
Dated: January , 2006
B-10
VOTING
AGREEMENT
This Voting Agreement
(this Agreement) is entered
into as of January , 2006, by and between
CancerVax Corporation, a Delaware corporation
(CancerVax), and
(Stockholder).
Recitals
A. Stockholder is a holder of record and the
beneficial owner (within the meaning of
Rule 13d-3
under the Securities Exchange Act of 1934) of certain
ordinary shares and preference shares of Micromet AG, a
corporation organized under the laws of Germany
(Micromet). After the date of this
Agreement, Stockholder intends to exchange (the
Exchange) such shares of Micromet for
shares of Common Stock of Micromet, Inc., a Delaware corporation
(Parent) in connection with the
Micromet Recapitalization (defined below).
B. CancerVax, Parent, Micromet AG and Carlsbad
Acquisition Corporation (CAC) are
entering into an Agreement and Plan of Merger and Reorganization
of even date herewith (the Merger
Agreement) which provides (subject to the
conditions set forth therein) for the merger of CAC into Parent
(the Merger).
C. In the Merger, the outstanding shares of
common stock of Parent are to be converted into the right to
receive shares of common stock of CancerVax.
D. In order to induce CancerVax to enter into
the Merger Agreement, Stockholder is entering into this
Agreement.
E. This Agreement and the Merger have been
approved by the Board of Directors of Parent and by the
supervisory board and management board of Micromet.
Agreement
The parties to this Agreement, intending to be legally bound,
agree as follows:
Section 1. Certain
Definitions
For purposes of this Agreement:
(a) The terms Acquisition
Proposal and Acquisition
Transaction shall have the respective meanings
assigned to those terms in the Merger Agreement.
(b) An Identified Termination
shall occur if the Merger Agreement is terminated (A) by
CancerVax pursuant to Section 9.1(d) of the Merger
Agreement or (B) by CancerVax pursuant to
Section 9.1(g) of the Merger Agreement.
(c) Micromet Capital Stock shall
mean the ordinary shares and preference shares of Micromet, and
after the Exchange, the common stock of Parent.
(d) Micromet Recapitalization
shall have the meaning assigned to that term in the Merger
Agreement.
(e) Stockholder shall be deemed to
Own or to have acquired
Ownership of a security if
Stockholder: (i) is the record owner of such security; or
(ii) is the beneficial owner (within the
meaning of
Rule 13d-3
under the Securities Exchange Act of 1934) of such security.
(f) Person shall mean any
(i) individual, (ii) corporation, limited liability
company, partnership or other entity, or (iii) governmental
authority.
(g) Shareholders Agreement
shall mean that Shareholders Agreement of Micromet AG
dated as of October 11, 2005 by and among Micromet and
certain of its shareholders as described therein.
(h) Subject Securities shall
mean: (i) all securities of Micromet and Parent (including
all shares of Micromet Capital Stock and all options, warrants
and other rights to acquire shares of Micromet Capital Stock)
Owned by Stockholder as of the date of this Agreement; and
(ii) all additional securities of Micromet (including all
additional shares of Micromet Capital Stock and all additional
options, warrants and other rights
B-11
to acquire shares of Micromet Capital Stock) of which
Stockholder acquires Ownership during the period from the date
of this Agreement through the Voting Covenant Expiration Date.
(i) A Person shall be deemed to have effected a
Transfer of a security if such Person
directly or indirectly: (i) sells, pledges, encumbers,
grants an option with respect to, transfers or disposes of such
security or any interest in such security to any Person other
than CancerVax; (ii) enters into an agreement or commitment
contemplating the possible sale of, pledge of, encumbrance of,
grant of an option with respect to, transfer of or disposition
of such security or any interest therein to any Person other
than CancerVax; or (iii) reduces such Persons
beneficial ownership of, interest in or risk relating to such
security.
(j) Voting Covenant Expiration
Date shall mean the earlier of the date upon which
the Merger Agreement is validly terminated, or the date upon
which the Merger is consummated; provided, however, that
the Voting Covenant Expiration Date shall be the
date 60 days following the date on which the Merger
Agreement is validly terminated, if an Identified Termination
occurs. Notwithstanding the foregoing, this Agreement may be
terminated for cause by either party, and if so terminated, the
date of any such termination shall be the Voting Covenant
Expiration Date.
Section 2. Transfer
of Subject Securities and Voting Rights
2.1 Restriction on Transfer of Subject
Securities. Subject to Section 2.3, during
the period from the date of this Agreement through the Voting
Covenant Expiration Date, Stockholder shall not, directly or
indirectly, cause or permit any Transfer of any of the Subject
Securities to be effected.
2.2 Restriction on Transfer of Voting
Rights. During the period from the date of this
Agreement through the Voting Covenant Expiration Date,
Stockholder shall ensure that: (a) none of the Subject
Securities is deposited into a voting trust; and (b) no
proxy is granted, and no voting agreement or similar agreement
is entered into, with respect to any of the Subject Securities.
2.3 Permitted
Transfers. Section 2.1 shall not prohibit a
transfer of Micromet Capital Stock by Stockholder (i) to
any member of his immediate family, or to a trust for the
benefit of Stockholder or any member of his immediate family,
(ii) upon the death of Stockholder, (iii) if
Stockholder is a partnership or limited liability company, to
one or more partners or members of Stockholder or to an
affiliated corporation under common control with Stockholder or
(iv) to Stockholders associated
undertakings (within the meaning of §15 of the German
Stock Corporation Act), funds managed or advised by Stockholder
or any of the undertakings associated with Stockholder (within
the meaning of §15 of the German Stock Corporation Act),
or, after the liquidation or dissolution of such Stockholder or
referenced undertakings, to any of their partners, shareholders,
unitholders or participants in such funds or undertakings in the
course of such liquidation or dissolution; provided,
however, that a transfer referred to in this sentence shall
be permitted only if, as a precondition to such transfer, the
transferee agrees in a writing, reasonably satisfactory in form
and substance to CancerVax, to be bound by the terms of this
Agreement.
Section 3. Voting
of Shares
3.1 Voting Covenant Prior to Termination of Merger
Agreement. Stockholder hereby agrees that, prior
to the earlier to occur of the valid termination of the Merger
Agreement or the consummation of the Merger, at any meeting of
the stockholders of Parent or Micromet, however called, and in
any written action by consent of stockholders of Parent or
Micromet, unless otherwise directed in writing by CancerVax,
Stockholder shall, to the extent legally permissible, cause the
Subject Securities to be voted:
(a) in favor of the Merger and the Micromet
Recapitalization, the execution and delivery by Parent and
Micromet of the Merger Agreement and the adoption and approval
of the Merger Agreement and the terms thereof, in favor of each
of the other actions contemplated by the Merger Agreement
(including the Micromet Recapitalization) and in favor of any
action in furtherance of any of the foregoing; and
(b) in favor of any action of the stockholders of Micromet
to exercise, in connection with the Merger and Micromet
Recapitalization, the rights granted to the holders of the
preference shares series (B new) under Article 9 of the
Shareholders Agreement to demand from other stockholders
of Micromet the sale of such holders shares in accordance
with the terms of such Article 9; and
B-12
(c) against any action or agreement that would result in a
breach of any representation, warranty, covenant or obligation
of Parent or Micromet in the Merger Agreement; and
(d) against the following actions (other than the Exchange
and the Merger and the transactions contemplated by the Merger
Agreement): (A) any extraordinary corporate transaction,
such as a merger, consolidation or other business combination
involving Parent or Micromet or any subsidiary of such entities;
(B) any sale, lease or transfer of a material amount of
assets of Parent, Micromet or any subsidiary of such entities;
(C) any reorganization, recapitalization, dissolution or
liquidation of Parent, Micromet or any subsidiary of such
entities; (D) any change in a majority of the board of
directors of Parent or the supervisory board of Micromet;
(E) any amendment to Parents certificate of
incorporation or bylaws or Micromets charter documents;
(F) any material change in the capitalization of Parent or
Micromet or Parents corporate structure; and (G) any
other action which is intended, or would reasonably be expected,
to impede, interfere with, delay, postpone, discourage or
adversely affect the Merger or any of the other transactions
contemplated by the Merger Agreement or this Agreement.
Prior to the earlier to occur of the valid termination of the
Merger Agreement or the consummation of the Merger, Stockholder
shall not enter into any agreement or understanding with any
Person to vote or give instructions in any manner inconsistent
with clause (a), (b), (c) or
(d) of the preceding sentence.
3.2 Voting Covenant After Identified
Termination. If an Identified Termination occurs,
then, prior to the Voting Covenant Expiration Date, at any
meeting of the stockholders of Parent or Micromet, however
called, and in any written action by consent of stockholders of
Parent or Micromet, unless otherwise directed in writing by
CancerVax, Stockholder shall cause the Subject Securities to be
voted (i) against any Acquisition Proposal and any related
transaction or agreement and (ii) against any action which
is intended, or could reasonably be expected, to facilitate the
consummation of any Acquisition Transaction. Stockholder shall
not enter into any agreement or understanding with any Person
prior to the Voting Covenant Expiration Date to vote or give
instructions in any manner inconsistent with clause
(i) or (ii) of the preceding sentence.
3.3 Proxy; Further Assurances.
(a) Contemporaneously with the execution of this Agreement:
(i) Stockholder shall deliver to CancerVax a proxy in the
form attached to this Agreement as Exhibit A, which
shall be irrevocable to the fullest extent permitted by law (at
all times prior to the Voting Covenant Expiration Date) with
respect to the shares referred to therein (the
Proxy); and (ii) Stockholder
shall cause to be delivered to CancerVax an additional proxy (in
the form attached hereto as Exhibit A) executed on
behalf of the record owner of any outstanding shares of Micromet
Capital Stock that are owned beneficially (within the meaning of
Rule 13d-3
under the Securities Exchange Act of 1934), but not of record,
by Stockholder.
(b) Stockholder shall, at his, her or its own expense,
perform such further acts and execute such further proxies and
other documents and instruments as may reasonably be required to
vest in CancerVax the power to carry out and give effect to the
provisions of this Agreement; provided, however, that nothing in
this Section 3 shall be deemed to obligate Stockholder to
vote in a manner contrary to such Stockholders fiduciary
duties or other than in good faith or in contravention of law or
public policy.
Section 4. Waiver
of Appraisal Rights
Stockholder hereby irrevocably and unconditionally waives, and
agrees to cause to be waived and to prevent the exercise of, any
rights of appraisal, any dissenters rights and any similar
rights relating to the Merger or any related transaction that
Stockholder or any other Person may have by virtue of any
outstanding shares of Micromet Capital Stock Owned by
Stockholder.
Section 5. No
Solicitation
Stockholder agrees that, during the period from the date of this
Agreement through the Voting Covenant Expiration Date,
Stockholder shall not, directly or indirectly, and Stockholder
shall ensure that his or its Representatives (as defined in the
Merger Agreement) do not, directly or indirectly:
(i) solicit, initiate, encourage, induce or facilitate the
making, submission or announcement of any Acquisition Proposal
or take any action that could reasonably be expected to lead to
an Acquisition Proposal; (ii) furnish any information
regarding Parent,
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CancerVax or any subsidiary of such entities to any Person in
connection with or in response to an Acquisition Proposal or an
inquiry or indication of interest that could lead to an
Acquisition Proposal; (iii) engage in discussions or
negotiations with any Person with respect to any Acquisition
Proposal; (iv) approve, endorse or recommend any
Acquisition Proposal; or (v) enter into any letter of
intent or similar document or any agreement or understanding
contemplating or otherwise relating to any Acquisition
Transaction. Stockholder shall immediately cease and
discontinue, and Stockholder shall ensure that his or its
Representatives immediately cease and discontinue, any existing
discussions with any Person that relate to any Acquisition
Proposal.
Section 6. Representations
and Warranties of Stockholder
Stockholder hereby represents and warrants to CancerVax as
follows:
6.1 Authorization, etc. Stockholder
has the absolute and unrestricted right, power, authority and
capacity to execute and deliver this Agreement and the Proxy and
to perform his or its obligations hereunder and thereunder
except to the extent prohibited by law. This Agreement and the
Proxy have been duly executed and delivered by Stockholder and
constitute legal, valid and binding obligations of Stockholder,
enforceable against Stockholder in accordance with their terms,
subject to (i) laws of general application relating to
bankruptcy, insolvency and the relief of debtors,
(ii) rules of law governing specific performance,
injunctive relief and other equitable remedies and
(iii) laws of the jurisdictions of Stockholder or Micromet
relating to shareholder voting agreements. If Stockholder is a
general or limited partnership, then Stockholder is a
partnership duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it was
organized. If Stockholder is a limited liability company, then
Stockholder is a limited liability company duly organized,
validly existing and in good standing under the laws of the
jurisdiction in which it was organized.
6.2 No Conflicts or Consents.
(a) The execution and delivery of this Agreement and the
Proxy by Stockholder do not, and the performance of this
Agreement and the Proxy by Stockholder will not:
(i) conflict with or violate any law, rule, regulation,
order, decree or judgment applicable to Stockholder or by which
he or it or any of his or its properties is or may be bound or
affected; or (ii) result in or constitute (with or without
notice or lapse of time) any breach of or default under, or give
to any other Person (with or without notice or lapse of time)
any right of termination, amendment, acceleration or
cancellation of, or result (with or without notice or lapse of
time) in the creation of any encumbrance or restriction on any
of the Subject Securities pursuant to, any contract to which
Stockholder is a party or by which Stockholder or any of his,
her or its affiliates or properties is or may be bound or
affected. The parties acknowledge that the Stockholder is
subject to the terms of the Shareholders Agreement dated
as of October 11, 2005.
(b) The execution and delivery of this Agreement and the
Proxy by Stockholder do not, and the performance of this
Agreement and the Proxy by Stockholder will not, require any
consent or approval of any Person.
6.3 Title to Securities. As of the
date of this Agreement: (a) Stockholder holds of record
(free and clear of any encumbrances or restrictions other than
as set forth in the Shareholders Agreement
and/or the
Articles of Association of Micromet) the number of outstanding
shares of Micromet Capital Stock set forth under the heading
Shares Held of Record on the signature page
hereof; (b) Stockholder holds (free and clear of any
encumbrances or restrictions other than as set forth in the
Shareholders Agreement
and/or the
Articles of Association of Micromet) the options, warrants and
other rights to acquire shares of Micromet Capital Stock set
forth under the heading Options and Other Rights on
the signature page hereof; (c) Stockholder Owns the
additional securities of Micromet set forth under the heading
Additional Securities Beneficially Owned on the
signature page hereof; and (d) Stockholder does not
directly or indirectly Own any shares of capital stock or other
securities of Micromet, or any option, warrant or other right to
acquire (by purchase, conversion or otherwise) any shares of
capital stock or other securities of Micromet, other than the
shares and options, warrants and other rights set forth on the
signature page hereof.
6.4 Accuracy of
Representations. The representations and
warranties contained in this Agreement are accurate in all
respects as of the date of this Agreement, will be accurate in
all respects at all times through the
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Voting Covenant Expiration Date and will be accurate in all
respects as of the date of the consummation of the Merger as if
made on that date.
Section 7. Additional
Covenants of Stockholder
7.1 Further Assurances. From time
to time and without additional consideration, Stockholder shall
(at Stockholders sole expense) execute and deliver, or
cause to be executed and delivered, such additional transfers,
assignments, endorsements, proxies, consents and other
instruments, and shall (at Stockholders sole expense) take
such further actions, as CancerVax may request for the purpose
of carrying out the intent of this Agreement.
7.2 Legends. If requested by
CancerVax, immediately after the execution of this Agreement
(and from time to time upon the acquisition by Stockholder of
Ownership of any shares of Micromet Capital Stock prior to the
Voting Covenant Expiration Date), Stockholder shall cause each
certificate evidencing any outstanding shares of Micromet
Capital Stock or other securities of Micromet Owned by
Stockholder to be surrendered so that the transfer agent for
such securities may affix thereto a legend in the following form:
THE SECURITY OR SECURITIES REPRESENTED BY THIS CERTIFICATE MAY
NOT BE SOLD, EXCHANGED OR OTHERWISE TRANSFERRED OR DISPOSED OF
EXCEPT IN COMPLIANCE WITH THE TERMS AND PROVISIONS OF A VOTING
AGREEMENT DATED AS OF
JANUARY ,
2006, AS IT MAY BE AMENDED, A COPY OF WHICH IS ON FILE AT THE
PRINCIPAL EXECUTIVE OFFICES OF THE ISSUER.
Section 8. Miscellaneous
8.1 Survival of Representations, Warranties and
Agreements. All representations, warranties,
covenants and agreements made by Stockholder in this Agreement
shall terminate as of the Voting Covenant Expiration Date.
8.2 Expenses. All costs and
expenses incurred in connection with the transactions
contemplated by this Agreement shall be paid by the party
incurring such costs and expenses.
8.3 Notices. Any notice or other
communication required or permitted to be delivered to either
party under this Agreement shall be in writing and shall be
deemed properly delivered, given and received when delivered (by
hand, by registered mail, by courier or express delivery service
or by facsimile) to the address or facsimile telephone number
set forth beneath the name of such party below (or to such other
address or facsimile telephone number as such party shall have
specified in a written notice given to the other party):
if to Stockholder:
at the address set forth on the signature page hereof; and
if to CancerVax:
at the address set forth in the Merger Agreement
Copy to:
Latham & Watkins LLP
12636 High Bluff Drive, Suite 400
San Diego, CA 92130
ATTN: Scott N. Wolfe
8.4 Severability. Any term or
provision of this Agreement that is invalid or unenforceable in
any situation in any jurisdiction shall not affect the validity
or enforceability of the remaining terms and provisions hereof
or the validity or enforceability of the offending term or
provision in any other situation or in any other jurisdiction.
If the final judgment of a court of competent jurisdiction
declares that any term or provision hereof is invalid or
unenforceable, the parties hereto agree that the court making
such determination shall have the power to limit the term or
provision, to delete specific words or phrases, or to replace
any invalid or unenforceable term or provision with a term or
provision that is valid and enforceable and that comes closest
to expressing the intention of the invalid or unenforceable term
or provision, and this Agreement shall be enforceable as so
modified. In the event such court does not exercise the power
granted to it in the prior sentence, the parties hereto agree to
replace such invalid or unenforceable term or provision with a
valid and enforceable term or provision that will achieve, to
the extent possible, the economic, business and other purposes
of such invalid or unenforceable term.
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8.5 Entire Agreement. This
Agreement, the Proxy and any other documents delivered by the
parties in connection herewith constitute the entire agreement
between the parties with respect to the subject matter hereof
and thereof and supersede all prior agreements and
understandings between the parties with respect thereto. No
addition to or modification of any provision of this Agreement
shall be binding upon either party unless made in writing and
signed by both parties.
8.6 Assignment; Binding
Effect. Except as provided herein, neither this
Agreement nor any of the interests or obligations hereunder may
be assigned or delegated by Stockholder, and any attempted or
purported assignment or delegation of any of such interests or
obligations shall be void. Subject to the preceding sentence,
this Agreement shall be binding upon Stockholder and his heirs,
estate, executors and personal representatives and his or its
successors and assigns, and shall inure to the benefit of
CancerVax and its successors and assigns. Without limiting any
of the restrictions set forth in Section 2 or elsewhere in
this Agreement, this Agreement shall be binding upon any Person
to whom any Subject Securities are transferred. Nothing in this
Agreement is intended to confer on any Person (other than
CancerVax and its successors and assigns) any rights or remedies
of any nature.
8.7 Indemnification. Stockholder
shall hold harmless and indemnify CancerVax and CancerVaxs
affiliates from and against, and shall compensate and reimburse
CancerVax and CancerVaxs affiliates for, any loss, damage,
claim, liability, fee (including reasonable attorneys
fees), demand, cost or expense (regardless of whether or not
such loss, damage, claim, liability, fee, demand, cost or
expense relates to a third-party claim) that is directly or
indirectly suffered or incurred by CancerVax or any of
CancerVaxs affiliates, or to which CancerVax or any of
CancerVaxs affiliates otherwise becomes subject, and that
arises directly or indirectly from, or relates directly or
indirectly to, (a) any inaccuracy in or breach of any
representation or warranty contained in this Agreement, or
(b) any failure on the part of Stockholder to observe,
perform or abide by, or any other breach of, any restriction,
covenant, obligation or other provision contained in this
Agreement or in the Proxy.
8.8 Specific Performance. The
parties agree that irreparable damage would occur in the event
that any of the provisions of this Agreement or the Proxy were
not performed in accordance with its specific terms or were
otherwise breached. Stockholder agrees that, in the event of any
breach or threatened breach by Stockholder of any covenant or
obligation contained in this Agreement or in the Proxy,
CancerVax shall be entitled (in addition to any other remedy
that may be available to it, including monetary damages) to seek
and obtain (a) a decree or order of specific performance to
enforce the observance and performance of such covenant or
obligation, and (b) an injunction restraining such breach
or threatened breach. Stockholder further agrees that neither
CancerVax nor any other Person shall be required to obtain,
furnish or post any bond or similar instrument in connection
with or as a condition to obtaining any remedy referred to in
this Section 8.8, and Stockholder irrevocably waives any
right he, she or it may have to require the obtaining,
furnishing or posting of any such bond or similar instrument.
8.9 Non-Exclusivity. The rights and
remedies of CancerVax under this Agreement are not exclusive of
or limited by any other rights or remedies which it may have,
whether at law, in equity, by contract or otherwise, all of
which shall be cumulative (and not alternative). Without
limiting the generality of the foregoing, the rights and
remedies of CancerVax under this Agreement, and the obligations
and liabilities of Stockholder under this Agreement, are in
addition to their respective rights, remedies, obligations and
liabilities under common law requirements and under all
applicable statutes, rules and regulations. Nothing in this
Agreement shall limit any of Stockholders obligations, or
the rights or remedies of CancerVax, under any Affiliate
Agreement between CancerVax and Stockholder; and nothing in any
such Affiliate Agreement shall limit any of Stockholders
obligations, or any of the rights or remedies of CancerVax,
under this Agreement.
8.10 Governing Law; Venue.
(a) This Agreement and the Proxy shall be construed in
accordance with, and governed in all respects by, the laws of
the State of Delaware (without giving effect to principles of
conflicts of laws).
(b) Any legal action or other legal proceeding relating to
this Agreement or the Proxy or the enforcement of any provision
of this Agreement or the Proxy may be brought or otherwise
commenced in any state or federal court located in the State of
Delaware. Stockholder:
(i) expressly and irrevocably consents and submits to the
jurisdiction of each state and federal court located in the
State of Delaware in connection with any such legal proceeding;
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(ii) agrees that service of any process, summons, notice or
document by U.S. mail addressed to him or it at the address
set forth on the signature page hereof shall constitute
effective service of such process, summons, notice or document
for purposes of any such legal proceeding;
(iii) agrees that each state and federal court located in
the State of Delaware shall be deemed to be a convenient
forum; and
(iv) agrees not to assert (by way of motion, as a defense
or otherwise), in any such legal proceeding commenced in any
state or federal court located in the State of Delaware, any
claim that Stockholder is not subject personally to the
jurisdiction of such court, that such legal proceeding has been
brought in an inconvenient forum, that the venue of such
proceeding is improper or that this Agreement or the subject
matter of this Agreement may not be enforced in or by such court.
Nothing contained in this Section 8.10 shall be deemed to
limit or otherwise affect the right of CancerVax to commence any
legal proceeding or otherwise proceed against Stockholder in any
other forum or jurisdiction.
(c) STOCKHOLDER IRREVOCABLY WAIVES THE RIGHT TO A JURY
TRIAL IN CONNECTION WITH ANY LEGAL PROCEEDING RELATING TO THIS
AGREEMENT OR THE PROXY OR THE ENFORCEMENT OF ANY PROVISION OF
THIS AGREEMENT OR THE PROXY.
8.11 Counterparts. This Agreement
may be executed in separate counterparts, each of which when so
executed and delivered shall be an original, but all such
counterparts shall together constitute one and the same
instrument.
8.12 Captions. The captions
contained in this Agreement are for convenience of reference
only, shall not be deemed to be a part of this Agreement and
shall not be referred to in connection with the construction or
interpretation of this Agreement.
8.13 Attorneys Fees. If any
legal action or other legal proceeding relating to this
Agreement or the enforcement of any provision of this Agreement
is brought against Stockholder, the prevailing party shall be
entitled to recover reasonable attorneys fees, costs and
disbursements (in addition to any other relief to which the
prevailing party may be entitled).
8.14 Waiver. No failure on the part
of CancerVax to exercise any power, right, privilege or remedy
under this Agreement, and no delay on the part of CancerVax in
exercising any power, right, privilege or remedy under this
Agreement, shall operate as a waiver of such power, right,
privilege or remedy; and no single or partial exercise of any
such power, right, privilege or remedy shall preclude any other
or further exercise thereof or of any other power, right,
privilege or remedy. CancerVax shall not be deemed to have
waived any claim available to CancerVax arising out of this
Agreement, or any power, right, privilege or remedy of CancerVax
under this Agreement, unless the waiver of such claim, power,
right, privilege or remedy is expressly set forth in a written
instrument duly executed and delivered on behalf of CancerVax;
and any such waiver shall not be applicable or have any effect
except in the specific instance in which it is given.
8.15 Construction.
(a) For purposes of this Agreement, whenever the context
requires: the singular number shall include the plural, and vice
versa; the masculine gender shall include the feminine and
neuter genders; the feminine gender shall include the masculine
and neuter genders; and the neuter gender shall include
masculine and feminine genders.
(b) The parties agree that any rule of construction to the
effect that ambiguities are to be resolved against the drafting
party shall not be applied in the construction or interpretation
of this Agreement.
(c) As used in this Agreement, the words
include and including, and variations
thereof, shall not be deemed to be terms of limitation, but
rather shall be deemed to be followed by the words without
limitation.
(d) Except as otherwise indicated, all references in this
Agreement to Sections and Exhibits are
intended to refer to Sections of this Agreement and Exhibits to
this Agreement.
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In Witness Whereof,
CancerVax and Stockholder have caused this Agreement
to be executed as of the date first written above.
CancerVax Corporation
Stockholder
Name:
|
|
|
Shares Held
of Record |
Options
and Other Rights |
Additional
Securities Beneficially Owned |
B-18
EXHIBIT A
FORM OF
IRREVOCABLE PROXY
The undersigned stockholder (the
Stockholder) of Micromet AG, a
corporation organized under the laws of Germany
(Micromet), who will become a
stockholder of Micromet, Inc., a Delaware corporation
(Parent), hereby irrevocably (to the
fullest extent permitted by law) appoints and constitutes
[ ],
[ ]
and CancerVax
Corporation, a
Delaware corporation (CancerVax), and
each of them, the attorneys and proxies of the Stockholder with
full power of substitution and resubstitution, to the full
extent of the Stockholders rights with respect to
(i) the outstanding shares of capital stock of Micromet
owned of record by the Stockholder as of the date of this proxy,
which shares are specified on the final page of this proxy, and
(ii) any and all other shares of capital stock of Micromet
and Parent which the Stockholder may acquire on or after the
date hereof. (The shares of the capital stock of Micromet and
Parent referred to in clauses (i) and
(ii) of the immediately preceding sentence are
collectively referred to as the
Shares.) Upon the execution hereof,
all prior proxies given by the Stockholder with respect to any
of the Shares are hereby revoked, and the Stockholder agrees
that no subsequent proxies will be given with respect to any of
the Shares.
This proxy is irrevocable to the fullest extent permitted by
law, is coupled with an interest and is granted in connection
with the Voting Agreement, dated as of the date hereof, between
CancerVax and the Stockholder (the Voting
Agreement), and is granted in consideration of
CancerVax entering into the Agreement and Plan of Merger and
Reorganization, dated as of the date hereof, among CancerVax,
Parent, Micromet AG and Carlsbad Acquisition Corporation (the
Merger Agreement). This proxy will
terminate on the Voting Covenant Expiration Date (as defined in
the Voting Agreement).
The attorneys and proxies named above will be empowered, and may
exercise this proxy, to vote the Shares at any time until the
earlier to occur of the Voting Covenant Expiration Date at any
meeting of the stockholders of Parent or Micromet, however
called, and in connection with any written action by consent of
stockholders of Parent or Micromet:
(i) in favor of the Merger (as defined in the Voting
Agreement) and the Micromet Recapitalization (as defined in the
Voting Agreement), the execution and delivery by Parent and
Micromet of the Merger Agreement and the adoption and approval
of the Merger Agreement and the terms thereof, in favor of each
of the other actions contemplated by the Merger Agreement
(including the Micromet Recapitalization) and in favor of any
action in furtherance of any of the foregoing; and
(ii) in favor of any action of the stockholders of Micromet
to exercise, in connection with the Merger and Micromet
Recapitalization, the rights granted to the holders of the
preference shares series (B new) under Article 9 of the
Shareholders Agreement (as defined in the Voting
Agreement) to demand from other stockholders of Micromet the
sale of such holders shares in accordance with the terms
of such Article 9; and
(iii) against any action or agreement that would result in
a breach of any representation, warranty, covenant or obligation
of Parent or Micromet in the Merger Agreement; and
(iv) against the following actions (other than the Exchange
(as defined in the Voting Agreement), the Merger and the other
transactions contemplated by the Merger Agreement): (A) any
extraordinary corporate transaction, such as a merger,
consolidation or other business combination involving Parent,
Micromet or any subsidiary of such entities; (B) any sale,
lease or transfer of a material amount of assets of Parent,
Micromet or any subsidiary of such entities; (C) any
reorganization, recapitalization, dissolution or liquidation of
Parent, Micromet or any subsidiary of such entities;
(D) any change in a majority of the board of directors of
Parent or the supervisory board of Micromet; (E) any
amendment to Parents certificate of incorporation or
bylaws or Micromets charter documents; (F) any
material change in the capitalization of Parent or Micromet or
Parents corporate structure; and (G) any other action
which is intended, or would reasonably be expected to impede,
interfere with, delay, postpone, discourage or adversely affect
the Merger or any of the other transactions contemplated by the
Merger Agreement.
If an Identified Termination (as defined in the Voting
Agreement) occurs, then, during the
180-day
period commencing on the date of such Identified Termination, at
any meeting of the stockholders of Parent or Micromet,
B-19
however called, and in connection with any written action by
consent of stockholders of Parent or Micromet, the attorneys and
proxies named above will be empowered, and may exercise this
proxy, to vote the Shares in their discretion against or
otherwise with respect to (i) any Acquisition Proposal (as
defined in the Voting Agreement) and any related transaction or
agreement and (ii) any action which is intended, or could
reasonably be expected, to facilitate the consummation of any
Acquisition Transaction (as defined in the Voting Agreement).
The Stockholder may vote the Shares on all other matters not
referred to in this proxy, and the attorneys and proxies named
above may not exercise this proxy with respect to such other
matters.
This proxy shall be binding upon the heirs, estate, executors,
personal representatives, successors and assigns of the
Stockholder (including any transferee of any of the Shares).
Any term or provision of this proxy that is invalid or
unenforceable in any situation in any jurisdiction shall not
affect the validity or enforceability of the remaining terms and
provisions hereof or the validity or enforceability of the
offending term or provision in any other situation or in any
other jurisdiction. If the final judgment of a court of
competent jurisdiction declares that any term or provision
hereof is invalid or unenforceable, the Stockholder agrees that
the court making such determination shall have the power to
limit the term or provision, to delete specific words or
phrases, or to replace any invalid or unenforceable term or
provision with a term or provision that is valid and enforceable
and that comes closest to expressing the intention of the
invalid or unenforceable term or provision, and this proxy shall
be enforceable as so modified. In the event such court does not
exercise the power granted to it in the prior sentence, the
Stockholder agrees to replace such invalid or unenforceable term
or provision with a valid and enforceable term or provision that
will achieve, to the extent possible, the economic, business and
other purposes of such invalid or unenforceable term.
Name
Number of ordinary shares of Micromet owned
of record as of the date of this proxy:
Number and series of preference shares of
Micromet owned of record as of the date of this proxy:
Dated: January , 2006
B-20
ANNEX C
January 6, 2006
Personal and Confidential
Board of Directors
CancerVax Corporation
2110 Rutherford Road
Carlsbad, California 92008
Members of the Board:
You have requested our opinion as to the fairness, from a
financial point of view, to CancerVax Corporation (the
Company) of the Merger Consideration (as defined
below) to be paid by the Company to the holders of common stock
of Micromet US, Inc. (Parent) pursuant to the
Agreement and Plan of Merger and Reorganization (the
Agreement) to be entered into among the Company,
Carlsbad Acquisition Corporation (Merger Sub),
Parent and Micromet AG (Micromet).
The Agreement provides for the merger (the Merger)
of Merger Sub with and into Parent pursuant to which, among
other things, each share of common stock of Parent (subject to
certain exceptions) will, on the terms set forth in the
Agreement, be converted into the right to receive a number of
shares of Company common stock determined as set forth in
Section 1.6(a)(ii) of the Agreement (the shares of Company
common stock to be exchanged are referred to as the Merger
Consideration).
The terms and conditions of the Merger are more fully set forth
in the Agreement. Pursuant to the Agreement, immediately prior
to the closing of the Merger, Parent and Micromet will effect a
recapitalization whereby the stockholders of Micromet as of the
date of the Agreement will effect an exchange of their interests
for shares of common stock of Parent, as a result of which
Micromet will become a wholly owned subsidiary of Parent
(subject to the exception set forth in part 2.5(o) of the
Parent Disclosure Schedules (as defined in the Agreement)).
We, as a customary part of our investment banking business,
engage in the valuation of businesses and their securities in
connection with mergers and acquisitions, underwriting and
secondary distributions of securities, private placements and
valuations for estate, corporate and other purposes. We have
acted as financial advisor to the Company in connection with the
Merger and will receive a fee from the Company which is
contingent upon the consummation of the Merger. We will also
receive a fee from the Company for providing this opinion, which
will be credited against our fee for financial advisory
services. This opinion fee is not contingent upon the
consummation of the Merger. The Company has also agreed to
indemnify us against certain liabilities in connection with our
services. In the ordinary course of our business, we and our
affiliates may actively trade securities of the Company for our
own account or the account of our customers and, accordingly, we
may at any time hold a long or short position in such
securities. We have provided investment banking services to the
Company from time to time for compensation and we may seek to
provide investment banking services to the Company and Micromet
in the future for which we may receive compensation. We also
make a market in Company common stock.
In connection with our review of the Merger, and in arriving at
our opinion, we have:
(i) reviewed the financial terms of a draft of the
Agreement, dated January 5, 2006;
(ii) reviewed certain publicly available financial,
business and operating information related to the Company and
Micromet, respectively;
(iii) reviewed certain internal financial, operating and
other data with respect to Micromet prepared and furnished to us
by the management of Micromet;
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(iv) reviewed certain internal financial projections for
Micromet for the period ending December 31, 2020, which
were prepared for financial planning purposes (financial
projections for 2005 through 2010 were prepared by the
management of Micromet with certain adjustments based on
guidance from the management of the Company and financial
projections for 2011 through 2020 were prepared by the
management of the Company with guidance from the management of
Micromet);
(v) reviewed certain internal financial, operating and
other data with respect to the Company prepared and furnished to
us by the management of the Company;
(vi) reviewed certain internal financial projections for
the Company for the period ending December 31, 2006, which
were prepared for financial planning purposes and furnished to
us by the management of the Company;
(vii) conducted discussions with members of the senior
management of the Company and Micromet with respect to the
business and prospects of the Company and Micromet on a
stand-alone basis and on a combined basis following the Merger;
(viii) reviewed the reported prices and trading activity of
Company common stock and similar information for certain other
companies deemed by us to be comparable to the Company;
(ix) compared the financial performance of the Company and
Micromet with that of certain other publicly traded companies
deemed by us to be comparable;
(x) reviewed and compared the financial terms, to the
extent publicly available, of certain comparable merger
transactions; and
(xi) performed a discounted cash flows analysis for
Micromet on a stand-alone basis (information made available to
us was inadequate to perform a corresponding analysis for the
Company).
In addition, we have conducted such other analyses and
examinations and considered such other financial, economic and
market criteria as we have deemed necessary in arriving at our
opinion.
We have relied upon and assumed the accuracy and completeness of
the information provided by the Company and Micromet or
otherwise made available to us and have not assumed
responsibility independently to verify such information. Each of
Company and Micromet has advised us that they do not publicly
disclose internal financial information of the type provided to
us and that such information was prepared for financial planning
purposes and not with the expectation of public disclosure. We
have further relied upon the assurances of the Companys
and Micromets respective management that the information
provided has been prepared on a reasonable basis in accordance
with industry practice, and that they are not aware of any
information or facts that would make the information provided to
us incomplete or misleading. With respect to financial forecasts
and other estimates and business outlook information reviewed by
us, we have assumed that such information reflects the best
currently available estimates and judgments of the
Companys and Micromets management and is based on
reasonable assumptions. We express no opinion as to any
financial forecasts and other estimates and business outlook
information or the assumptions on which they were based. We have
relied, with your consent, on advice of the outside counsel and
the independent accountants to the Company and Micromet, and on
the assumptions of the Companys management, as to all
accounting, legal, tax and financial reporting matters with
respect to the Company, Micromet and the Agreement, including,
without limitation, the amount of the Merger Consideration.
We have also assumed, with your consent, the Merger will qualify
as a tax-free reorganization under the United States Internal
Revenue Code, the Merger will be consummated pursuant to the
terms of the Agreement without amendments thereto and without
waiver by any party of any conditions or obligations thereunder,
and that all the necessary regulatory approvals and consents
required for the Merger will be obtained in a manner that will
not adversely affect the Company, Micromet or the contemplated
benefits of the Merger.
In arriving at our opinion, we have not performed any appraisals
or valuations of any specific assets or liabilities (fixed,
contingent or other) of the Company or Micromet, and have not
been furnished with any such appraisals or valuations. We have
made no physical inspection of the facilities of either entity
in connection with this opinion. The analyses we performed in
connection with this opinion were going concern analyses. We
express
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no opinion regarding the liquidation value of any entity.
Without limiting the generality of the foregoing, we have
undertaken no independent analysis of any pending or threatened
litigation, regulatory action, possible unasserted claims or
other contingent liabilities, to which the Company, Micromet or
any of their respective affiliates is a party or may be subject,
and at the direction of the Company and with its consent, our
opinion makes no assumption concerning, and therefore does not
consider, the possible assertion of claims, outcomes or damages
arising out of any such matters. Further, for avoidance of doubt
and notwithstanding the analyses we performed were going concern
analyses, we express no opinion herein as to the viability of
the Company following the Merger, including the potential for or
timing of commercialization of any product or service, the
nature and extent of the Companys financing needs or the
ability of the Company to satisfy any such financing needs.
This opinion is necessarily based upon the information available
to us and facts and circumstances as they exist and are subject
to evaluation on the date hereof; events occurring after the
date hereof could materially affect the assumptions used in
preparing this opinion. We are not expressing any opinion herein
as to the price at which shares of common stock of the Company
or Micromet may trade following consummation of the Merger or at
any future time. We have not undertaken to reaffirm or revise
this opinion or otherwise comment upon any events occurring
after the date hereof and do not have any obligation to update,
revise or reaffirm this opinion.
This opinion is directed to the Board of Directors of the
Company in connection with its consideration of the Merger and
is not intended to be and does not constitute a recommendation
to any stockholder of the Company as to how such stockholder
should vote with respect to the Merger. This opinion shall not
be published or otherwise used, nor shall any public references
to us be made, without our prior written approval.
This opinion addresses solely the fairness, from a financial
point of view, to the Company of the proposed Merger
Consideration set forth in the Agreement and does not address
any other terms or agreement relating to the Merger. We were not
requested to opine as to, and this opinion does not address, the
basic business decision to proceed with or effect the Merger or
the merits of the Merger relative to any alternative transaction
or business strategy that may be available to the Company.
Although the Company engaged directly in an extensive effort to
solicit a business combination, except for a limited number of
parties with which we made contact about a possible business
combination transaction, we were not authorized to solicit, and
did not solicit, any business combination involving the Company
or any alternative transaction.
Based upon and subject to the foregoing and based upon such
other factors as we consider relevant, it is our opinion that
the Merger Consideration is fair, from a financial point of
view, to the Company as of the date hereof.
Sincerely,
PIPER JAFFRAY & CO.
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Annex
D
CERTIFICATE
OF AMENDMENT
OF THE AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION OF
CANCERVAX CORPORATION
CancerVax Corporation, a corporation organized and existing
under the laws of the State of Delaware, hereby certifies as
follows:
A. The name of the corporation is CancerVax Corporation.
The corporations original Certificate of Incorporation was
filed with the Delaware Secretary of State on June 12, 1998
and amended and restated on November 3, 2003.
B. This Certificate of Amendment was duly adopted by the
corporations directors and stockholders in accordance with
the applicable provisions of Sections 228 and 242 of the
Delaware General Corporation Law.
C. The Amended and Restated Certificate of Incorporation,
as heretofore amended, is hereby further amended by striking out
Article FIRST in its entirety and by substituting in lieu
of said Article the following new Article:
FIRST: The name of the Corporation (hereinafter the
Corporation) is Micromet, Inc.
D. The Amended and Restated Certificate of Incorporation,
as heretofore amended, is hereby further amended by changing
Article FOURTH so that, as amended, the first paragraph of
Article FOURTH shall be and read as follows:
FOURTH: The Corporation is authorized to issue two classes
of stock to be designated, respectively, Common Stock, par value
$0.00004 per share (Common Stock) and Preferred
Stock, par value $0.00004 per share (Preferred
Stock). The total number of shares of all classes of stock
that the Corporation shall have the authority to issue is
160,000,000 shares, 150,000,000 shares of which shall
be Common Stock and 10,000,000 shares of which shall be
Preferred Stock.
E. The Amended and Restated Certificate of Incorporation,
as heretofore amended, is hereby further amended by changing
Article FOURTH so that, as amended, the last paragraph of
Article FOURTH shall be and read as follows:
Upon the effectiveness of the certificate of amendment to
the amended and restated certificate of incorporation containing
this sentence, each
[ ] shares
of the Common Stock issued and outstanding as of the date and
time immediately preceding the effective date of a reverse stock
split, shall be automatically changed and reclassified, as of
the effective date of the split and without further action, into
one (1) fully paid and nonassessable share of Common Stock.
There shall be no fractional shares issued. A holder of record
of Common Stock on the effective date of the split who would
otherwise be entitled to a fraction of a share shall, in lieu
thereof, be entitled to receive a cash payment in an amount
equal to the fraction to which the stockholder would otherwise
be entitled multiplied by the closing price of the Common Stock,
as reported in the Wall Street Journal, on the last trading day
prior to the effective date of the split (or if such price is
not available, the average of the last bid and asked prices of
the Common Stock on such day or other price determined by the
Corporations board of directors).
IN WITNESS WHEREOF, the CancerVax Corporation has caused this
Certificate to be signed by David F. Hale, its President and
Chief Executive Officer, this day
of , 2006.
CANCERVAX CORPORATION
_
_
Name: David F. Hale
Title: President and Chief Executive Officer
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