UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement.
On July 6, 2022, Modification No. 14 (the “Modification”) to Project Agreement No. 01 (“Project Agreement”), dated July 6, 2020, between Novavax, Inc. (the “Company”) and Advanced Technology International, the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed (“OWS”), was entered between the parties. The Modification amended the Project Agreement to provide for (i) an initial delivery to the United States Government (“USG”) of approximately 3 million doses of NVX-CoV2373, the Company’s vaccine candidate for the SARS-CoV-2 virus (the “Vaccine Product”), to be manufactured by Serum Institute of India Private Limited (Pune, India), or another location approved by the United States Food and Drug Administration (the “FDA”), contingent on the timing of Emergency Use Authorization (“EUA”) approval by the FDA, as well as the timing of label language and artwork approvals by the FDA and the recommendation of the Advisory Committee on Immunization Practices within the United States Centers for Disease Control and Prevention, and (ii) any additional manufacture and delivery of the Vaccine Product by the Company to the USG up to an aggregate of 100 million doses (inclusive of the initial lot of approximately 3 million doses) dependent on USG demand, FDA guidance on strain selection and agreement between the parties on price. OWS is a partnership among components of the U.S. Department of Health and Human Services and the U.S. Department of Defense working to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
The foregoing description of the material terms of the Modification does not purport to be complete and is qualified in its entirety by reference to the Modification, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Novavax, Inc. | ||
| Date: July 11, 2022 | By: | /s/ John A. Herrmann III |
| Name: | John A. Herrmann III | |
| Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary | |