7.0 Intellectual Property and Regulatory Rights
7.1 Patent Rights
Patent rights and rights in any Subject Invention, as that term is defined in Article X Sections 10.01–10.13 of Other Transaction Agreement number WI5QKN–16–9–1002, shall be governed by Article X of the OTA and consistent with W15QKN–16–9–1002. These patent rights and rights in any Subject Invention include, but are not limited to, the Government’s retention of certain licensure rights in subject inventions and applicability of the Government’s March–In rights. Specifically, with respect to any Subject Invention in which Sanofi retains title and as set forth in Article X Section 10.02, the Government shall have a non–exclusive, nontransferable, irrevocable, paid–up license to practice or have practiced on behalf of the United States the Subject Invention throughout the world. Furthermore, Sanofi agrees that, with respect to any Subject Invention in which it has retained title, the Government, has the right to require Sanofi to obtain and grant a non–exclusive license to a responsible applicant or applicants, upon terms that are reasonable under the circumstances as set forth in Article X, Section 10.10.
7.4 Regulatory Rights
[…] The Parties agree that Contractor has invested significant time and resources in its platform and IP and is the best company situated to manage production of the Adjuvanted Recombinant COVID–19 Vaccine. At the same time, the Parties acknowledge that the Government has made significant investments in the prototype. Accordingly, the Contractor and the Government agree to the following:
c. Rights of Reference. To the extent necessary or useful to exercise the Government’s rights under the license grants in Section 7 of this Project Agreement and subject to the restrictions set forth in that section, Sanofi Pasteur hereby grants to the Government and its permitted sublicensees a limited “right of reference or use” (as that term is defined in 21 C.F.R. § 314.3(b), as amended from time to time) strictly for COVID–19 or other Material Threat (as defined at Section 319 of the Public Health Service Act) Purposes to Sanofi Pasteur’s filings to the FDA in connection with the Regulatory Application (excluding such right of reference or use for [redacted content] and Sanofi Pasteur shall provide appropriate notification of the Government’s access and reference rights to the applicable regulatory authorities requested by the Government for the limited purposes described above. Sanofi Pasteur agrees to provide a letter of cross–reference to the Government and file such letter with the appropriate FDA office. This provision is in addition to any rights in technical data described earlier in this document, excluding with respect to [redacted content].
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.