SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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|Item 8.01|| |
On April 18, 2021, ModernaTX, Inc. (the “Company”), a wholly-owned subsidiary of Moderna, Inc. entered into an amendment (the “Amendment”) to its contract with the Biomedical Advanced Research and Development Authority (“BARDA”), dated April 16, 2020 (the “BARDA Contract”). BARDA is a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Under the BARDA Contract, BARDA has agreed to fund the advancement of mRNA-1273 (the “Moderna COVID-19 Vaccine”) to potential licensure, including funding for clinical studies and manufacturing scale-up.
The Amendment increases the maximum award from BARDA to the Company under the BARDA Contract by $236 million from approximately $1.0 billion to approximately $1.25 billion, and provides for additional reimbursement of costs associated with the Phase 3 clinical trial for the Moderna COVID-19 Vaccine and pharmacovigilance efforts. In accordance with the terms of the BARDA Contract and the applicable provisions of the Federal Acquisition Regulation, the Company submits expense requests regularly to BARDA for review and reimbursement. As set forth in the BARDA Contract, the Company’s requests for reimbursement relate only to matters that are subject to reimbursement by BARDA thereunder, and BARDA engages in an active and ongoing process under which all expense requests are reviewed in detail by BARDA prior to payment. As of March 31, 2021, the remaining available funding net of revenue earned under the BARDA Contract, prior to the Amendment, was $317 million.
The Amendment contains terms and conditions that are customary for government contracts of this nature, including provisions giving the government the right to terminate the contract at any time for its convenience.
The foregoing is a brief description of the material terms of the Amendment and does not purport to be a complete description of the rights and obligations of the parties thereunder. The foregoing description is qualified in its entirety by reference to the Amendment, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending June 30, 2021.
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.
|Date: April 28, 2021||MODERNA, INC.|
|General Counsel and Corporate Secretary|