UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 9, 2013
NuPathe Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-34836 |
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20-2218246 |
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(State or other Jurisdiction of |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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7 Great Valley Parkway |
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19355 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (610) 232-0800
Not Applicable
(Former name or former address if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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.
On October 9, 2013, NuPathe Inc. (“NuPathe”) and LTS Lohmann Therapy Systems Corp. (“LTS”) entered into a commercial supply and license agreement (the “Commercial Supply Agreement”) pursuant to which LTS will be the exclusive manufacturer and supplier of drug product to be incorporated into Zecuity (“Zecuity Drug Product”). Subject to the terms and conditions of the Commercial Supply Agreement, NuPathe will purchase all of its commercial requirements of Zecuity Drug Product from LTS and LTS will supply Zecuity Drug Product to meet such requirements. Under certain specified circumstances, NuPathe may qualify, and obtain Zecuity Drug Product, from a back-up supplier.
There are no minimum purchase requirements under the Commercial Supply Agreement. At least 90 days prior to the beginning of each calendar quarter, NuPathe will deliver rolling forecasts to LTS which will include a good faith estimate of NuPathe’s Zecuity Drug Product requirements, on a monthly basis, for such calendar quarter and the subsequent three calendar quarters (“Rolling Forecasts”). Only the first three months of each Rolling Forecast will be binding, however, LTS may reject any portion of the binding forecast that exceeds the forecast for such three-month period contained in the immediately preceding Rolling Forecast by a specified percentage, or exceeds LTS’s annual capacities. NuPathe is required to place orders for Zecuity Drug Product in full batch amounts, on a monthly basis, at least 90 days before the month in which delivery of product is required. As a result, NuPathe will generally be committed for 6 months of Zecuity Drug Product.
The initial term of the Commercial Supply Agreement is 5 years from the date of delivery of the first order by LTS. The agreement will automatically renew for successive two year periods unless notice of termination is delivered by a party at least 2 years prior to the end of the initial term or any renewal term. Either party may terminate the agreement if the other party commits a material breach of its obligations which is not remedied within a specified period following receipt of written notice of such breach. NuPathe may also terminate the agreement upon certain specified breaches without providing LTS with an opportunity to remedy such breach and LTS may terminate the agreement if NuPathe does not order a specified minimum amount of Zecuity Drug Product during a calendar year — such minimum amount is currently one batch.
Upon termination of the Commercial Supply Agreement (other than by NuPathe for nonrenewal or by LTS for NuPathe’s breach), LTS shall, at NuPathe’s request and for compensation to be agreed upon by the parties, provide NuPathe or its back-up supplier such information and assistance a manufacturer would reasonably require to manufacturer Zecuity Drug Product and transfer ownership and possession of the commercial manufacturing equipment previously funded by NuPathe and used to manufacture Zecuity Drug Product, to NuPathe or its back-up supplier. In addition, under such circumstances, LTS grants to NuPathe, a worldwide, royalty-free license (including the right to sublicense) under applicable LTS intellectual property to use, import, sell, market and distribute, have imported, sold, marketed or distributed, the Zecuity Drug Product and Zecuity patch, and to make or have made the Zecuity Drug Product and Zecuity patch.
Concurrently with the execution of the Commercial Supply Agreement, NuPathe entered into an Interim Supply Agreement, dated October 9, 2013, with LTS and LTS Lohmann Therapie-Systeme AG (“LTS AG”). Pursuant to the Interim Supply Agreement, NuPathe shall purchase Zecuity Drug Product from LTS AG until LTS is qualified to manufacturer the Zecuity Drug Product (the “Interim Period”). The terms and conditions of the Commercial Supply Agreement shall apply to the purchase by NuPathe, and sale by LTS AG, of the Zecuity Drug Product during the Interim Period.
The foregoing is a summary description of certain terms of the Commercial Supply Agreement and Interim Supply Agreement and, by its nature, is incomplete. The Company intends to file copies of the Commercial Supply Agreement and Interim Supply Agreement as exhibits to its Quarterly Report on Form 10-Q for the period ended September 30, 2013. All readers are encouraged to read the entire text of the Commercial Supply Agreement and Interim Supply Agreement when they are filed.