10. Patent Rights
10.09 Preference for American Industry. Notwithstanding any other provision of the Article X, Patent Rights, the PAH is not to grant to any person the exclusive right to use or sell any Subject Invention in the United States or Canada unless such person agrees that any product embodying the Subject Invention or produced through the use of the Subject Invention shall be manufactured substantially in the United States or Canada. However, in individual cases, the requirements for such an agreement may be waived by the Government upon a showing by the PAH that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that, under the circumstances, domestic manufacture is not commercially feasible.
10.10 March–In Right. The PAH agrees that, with respect to any Subject Invention in which its PAH has retained title, the Government, through CMF, has the right to require the PAH to obtain and grant a non–exclusive license to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the PAH refuses such a request, the Government has the right to grant such a licensee itself if the Government determines that:
- Such action is necessary because the PAH or assignee has not taken effective steps, consistent with the intent of this Agreement, to achieve practical application of the Subject Invention;
- Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by the PAH, assignee, or their licensees;
- Such action is necessary to meet requirements for public use and such requirements are not reasonably satisfied by the PAH, assignee, or licensees; or
- Such action is necessary because the Agreement required by Section 10.09 of this Article X, Patent Rights, has not been obtained or waived or because a licensee who has the exclusive right to use or sell any Subject Invention in the United States is in the breach of such Agreement.
Statement of Work
10.0 Ensuring Sufficient Supply of the Product
a. In recognition of the Government’s significant funding for the development and manufacturing of the product in this Project Agreement and the Government’s need to provide sufficient quantities of a safe and effective COVID–19 vaccine to protect the United States population, the Government shall have the remedy described in this section to ensure sufficient supply of the product to meet the needs of the public health or national security. This remedy is not available to the Government unless and until both of the following conditions are met:
(i) Novavax gives written notice, required to be submitted to the Government no later than 15 business days, of:
a. any formal management decision to terminate manufacturing of the NVXCoV–2373 vaccine prior to delivery of 100 million doses to USG;
b. any formal management decision to discontinue sale of the NVX–CoV2373 vaccine to the Government prior to delivery of 100 million doses to USG; or
c. any filing that anticipates Federal bankruptcy protection; and
(ii) Novavax has submitted an Emergency Use Authorization under §564 of the FD&C Act or a biologics license application provisions of §351(a) of the Public Health Service Act (PHSA).
b. If both conditions listed in section (a) occur, Novavax, upon the request of the Government, shall provide the following items necessary for the Government to pursue manufacturing of the NVX–CoV–2373 vaccine with a third party for exclusive sale to the U.S. Government:
(i) a writing evidencing a non–exclusive, nontransferable, irrevocable (except for cause), royalty–free paid–up license to practice or have practiced for or on behalf of the U.S. Government any Background IP as defined in clause 7.1 necessary to manufacture or have manufactured the NVX–CoV2373 vaccine;
(ii) necessary FDA regulatory filings or authorizations owned or controlled by Novavax related to NVX–Cov2373 and any confirmatory instrument pertaining thereto; and
(iii) any outstanding Deliverables contemplated or materials purchased under this Project Agreement.
c. This Article shall be incorporated into any contract for follow–on activities for the Government to acquire and use additional doses of the product. Per section 1.3, the estimated quantity for follow–on production/procurement is approximately 560 million doses.
d. This Article will survive the acquisition or merger of the Contractor by or with a third party. This Article will survive the expiration of this agreement.