8.0 Ensuring Sufficient Supply Of The Product
1. 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 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:
- a. Sanofi gives written notice, required to be submitted to the Government no later than 15 business days, of:
- i. any formal management decision to terminate manufacturing of this product vaccine prior to delivery of 100 million doses to USG;
- ii. any formal management decision to discontinue sale of this product vaccine to the Government prior to delivery of 100 million doses to USG; or
- iii. any filing that anticipates Federal bankruptcy protection; and
- b. Sanofi 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).
2. If both conditions listed in section (a) occur, Sanofi, upon the request of the Government, shall provide the following items necessary for the Government to pursue manufacturing of this product vaccine with a third party for exclusive sale to the U.S. Government:
- a. 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 Sanofi Background Patent, Copyright, other Sanofi Intellectual Property, Sanofi Know-How, Sanofi Technical Data rights necessary to manufacture or have manufactured the vaccine;
- b. necessary FDA regulatory filings or authorizations owned or controlled by Sanofi related to this product vaccine and any confirmatory instrument pertaining thereto (excluding with respect to [redacted content]); and
- c. any outstanding Deliverables contemplated or materials purchased under this Project Agreement.
3. 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 sufficient quantities to vaccinate approximately 300 million people.
4. 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.