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Moderna, Inc. 8-K Report, Corporate Update (Apr 28, 2021)

Reports
Other Events
Filing Date
Filed April 28, 2021
Period End
April 18, 2021
Security
MRNA
In the record · 2018–202610-K910-Q238-K117

MRNA filed 9 annual reports (10-K), 23 quarterly reports (10-Q) and 117 current reports (8-K) between 2018 and 2026.

  1. Material agreement8-K · Aug ’20Aug ’20
  2. Leadership change8-K · Sep ’22Sep ’22
  3. Leadership change8-K · Sep ’26Sep ’26

01—Abstract

Summary

Summary of the 8-K filed April 28, 2021. Cited figures are marked; the original filing is the authoritative source.

Moderna, Inc. (MRNA), through its subsidiary ModernaTX, Inc., announced an amendment to its contract with the Biomedical Advanced Research and Development Authority (BARDA).

This amendment significantly increases BARDA's funding commitment for the development and potential licensure of the Moderna COVID-19 Vaccine (mRNA-1273). The total award under the BARDA contract now stands at approximately $1.25 billiona, an increase of $236 million from the previous $1.0 billion limit. This additional funding is earmarked for crucial stages of vaccine development, including reimbursement for costs associated with the Phase 3 clinical trial and pharmacovigilance activities.

Investors should note that BARDA has an ongoing, detailed review process for all expense requests submitted by Moderna, ensuring accountability and adherence to contract terms. As of March 31, 2021, approximately $317 millionb of the original BARDA funding remained available, indicating continued operational progress.

02—Key points

Key Highlights

  1. Moderna secures an additional $236 million in funding from BARDA, increasing the total contract value to approximately $1.25 billion.
  2. The increased funding is specifically allocated to support the Phase 3 clinical trial and pharmacovigilance efforts for the Moderna COVID-19 Vaccine (mRNA-1273).
  3. This amendment underscores BARDA's continued commitment to the advancement and potential licensure of Moderna's COVID-19 vaccine.
  4. BARDA employs a rigorous and ongoing review process for all expense reimbursements, ensuring oversight of fund utilization.
  5. As of March 31, 2021, a substantial $317 million of the prior BARDA funding was still available, demonstrating prudent use of allocated resources.
  6. The contract includes standard government clauses, such as the right for the government to terminate for convenience.

03—Questions

Frequently Asked Questions

  1. What is the primary purpose of this 8-K filing?

    The primary purpose of this 8-K filing is to announce an amendment to Moderna's contract with BARDA, which increases BARDA's funding for the development of the Moderna COVID-19 Vaccine by $236 million.

  2. How much total funding has BARDA committed to Moderna for the COVID-19 vaccine under this amended contract?

    Under the amended contract, BARDA has committed approximately $1.25 billion to Moderna for the advancement of the COVID-19 vaccine, an increase from the previous approximately $1.0 billion.

  3. What specific activities will the additional BARDA funding support?

    The additional $236 million will provide reimbursement for costs associated with the ongoing Phase 3 clinical trial for the Moderna COVID-19 Vaccine and for pharmacovigilance efforts.

  4. What are the implications of the government's right to terminate the contract for convenience?

    While standard in government contracts, the government's right to terminate for convenience means that BARDA can end the contract at any time for reasons of convenience, not necessarily due to any fault of Moderna. However, the significant ongoing funding suggests a strong current commitment.

04—Continue

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