What is the primary purpose of the agreement with the U.S. Department of Defense?

The primary purpose of the agreement is for Moderna to manufacture and supply its investigational COVID-19 vaccine candidate, mRNA-1273, to the U.S. Government. This is a key step in securing a significant supply of a potential vaccine for the U.S. population as part of Operation Warp Speed.

What is the total financial value of the agreement?

The U.S. Supply Agreement secures an initial 100 million doses for $1.225 billion. There is potential for an additional $300 million in performance incentives. Furthermore, the U.S. Government holds options for up to 400 million additional doses, each exercisable at $1.65 billion. Factoring in previous BARDA funding, the total potential commitment from the U.S. Government could reach up to $2.480 billion.

What are the conditions for receiving the additional $300 million?

The additional $300 million is contingent upon mRNA-1273 achieving either an Emergency Use Authorization (EUA) or an approved Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA) by January 31, 2021.

What are the implications of the U.S. Government's options to purchase more doses?

The options provide the U.S. Government with the flexibility to secure significant additional quantities of mRNA-1273 beyond the initial 100 million doses. This demonstrates a strong commitment and a potential long-term demand for Moderna's vaccine, offering substantial future revenue potential for the company if these options are exercised.

MRNA 8-K: Material Agreements & Regulation FD

01—Abstract

Summary

Summary of the 8-K filed August 12, 2020. Cited figures are marked; the original filing is the authoritative source.

Moderna, Inc. announced a significant material definitive agreement with the U.S. Department of Defense (DoD) on August 11, 2020, for the manufacturing and supply of its investigational COVID-19 vaccine candidate, mRNA-1273.

This agreement, facilitated through Operation Warp Speed and in collaboration with BARDA, represents a substantial financial commitment from the U.S. Government and provides considerable validation for Moderna's vaccine development efforts. The U.S. Supply Agreement secures an initial 100 million doses for $1.225 billion^a, with the potential for an additional $300 million if the vaccine achieves Emergency Use Authorization (EUA) or Biologics License Application (BLA) approval by January 31, 2021.

The agreement also includes options for the U.S. Government to purchase an additional 400 million doses. This substantial funding and commitment from a major governmental entity underscore the perceived importance and potential of mRNA-1273 in addressing the global pandemic.

02—Key points

Key Highlights

Moderna entered into a material definitive agreement with the U.S. Department of Defense (DoD) for the supply of its COVID-19 vaccine candidate, mRNA-1273.
The agreement includes an initial purchase of 100 million doses for $1.225 billion.
An additional $300 million is possible if mRNA-1273 receives Emergency Use Authorization (EUA) or Biologics License Application (BLA) by January 31, 2021.
The U.S. Government has options to purchase an additional 400 million doses, with each option valued at $1.65 billion.
The total potential commitment from the U.S. Government, including prior BARDA funding, could reach up to $2.480 billion.
The agreement provides for manufacturing and delivery, with a base performance period of nine months, extendable to 20 months if all options are exercised.
The company is eligible to receive approximately $600 million upon presentation of certain production documentation, independent of regulatory approval or dose delivery.

03—Questions

Frequently Asked Questions

What is the primary purpose of the agreement with the U.S. Department of Defense?
The primary purpose of the agreement is for Moderna to manufacture and supply its investigational COVID-19 vaccine candidate, mRNA-1273, to the U.S. Government. This is a key step in securing a significant supply of a potential vaccine for the U.S. population as part of Operation Warp Speed.
What is the total financial value of the agreement?
The U.S. Supply Agreement secures an initial 100 million doses for $1.225 billion. There is potential for an additional $300 million in performance incentives. Furthermore, the U.S. Government holds options for up to 400 million additional doses, each exercisable at $1.65 billion. Factoring in previous BARDA funding, the total potential commitment from the U.S. Government could reach up to $2.480 billion.
What are the conditions for receiving the additional $300 million?
The additional $300 million is contingent upon mRNA-1273 achieving either an Emergency Use Authorization (EUA) or an approved Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA) by January 31, 2021.
What are the implications of the U.S. Government's options to purchase more doses?
The options provide the U.S. Government with the flexibility to secure significant additional quantities of mRNA-1273 beyond the initial 100 million doses. This demonstrates a strong commitment and a potential long-term demand for Moderna's vaccine, offering substantial future revenue potential for the company if these options are exercised.

04—Continue

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