Delaware
|
0-23047
|
13-3864870
|
(State or other jurisdiction of incorporation or organization)
|
(Commission file number)
|
(I.R.S. employer identification no.)
|
660 Madison Avenue, Suite 1700
New York, New York
|
|
10065
|
(Address of principal executive offices)
|
(Zip code)
|
☐
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
☐
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
☐
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
☐
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Item 1.01 | Entry into a Material Definitive Agreement. |
·
|
An increase of $36.20 per course in the payment for the manufacture and delivery of 1.7 million courses of TPOXX™. The increase in delivery payments will total $61.5 million and was accomplished by reducing the contractual holdback amount that is tied to FDA approval of TPOXX™ from $102.5 million to $41 million.
|
·
|
A change in the requirements for a $20.5 million (5% of contract price) milestone in the Contract. For payment, this milestone now requires SIGA to submit documentation to BARDA indicating that data covering the first 100 subjects enrolled in the phase III pivotal safety study have been submitted to and reviewed by a Data & Safety Monitoring Board (“DSMB”) and that such DSMB recommends continuation of the safety study, as well as submission of the final pivotal rabbit efficacy study report to the United States Food & Drug Administration (the “FDA”). Previously, this milestone required the successful submission to the FDA of a complete application for TPOXX™ regulatory approval.
|
Item 9.01. | Financial Statements and Exhibits. |
Exhibit No.
|
Description
|
|
Amendment of Solicitation/Modification of Contract 0013, dated June 28, 2016, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment).
|
SIGA TECHNOLOGIES, INC.
|
|||||
By:
|
/s/ Daniel J. Luckshire
|
||||
Name:
|
Daniel J. Luckshire
|
||||
Title:
|
Chief Financial Officer
|
||||
Date:
|
July 5, 2016
|