Item 1.01. Entry into a Material Definitive Agreement.
On August 11, 2020, ModernaTX, Inc. ("Moderna"), a wholly-owned subsidiary of
Moderna, Inc. (the "Company"), entered into an agreement with the Army
Contracting Command of the U.S. Department of Defense ("DoD") for the supply of
mRNA-1273, the Company's investigational vaccine candidate against SARS-CoV-2,
the novel strain of coronavirus that causes COVID-19 (the "U.S. Supply
Agreement"). Moderna entered into the U.S. Supply Agreement as part of a
collaboration between DoD and the Biomedical Advanced Research and Development
Authority ("BARDA") of the U.S. Department of Health and Human Services in
connection with Operation Warp Speed.
The U.S. Supply Agreement provides for the manufacturing and delivery of an
initial 100 million doses of mRNA-1273 by the U.S. Government for $1.225
billion. Moderna is eligible to receive up to an additional $300 million upon
acceptance of the initial 100 million doses, if mRNA-1273 has achieved an
emergency use authorization ("EUA") or an approved biologics license application
("BLA") issued by the U.S. Food and Drug Administration ("FDA") on or before
January 31, 2021. With the award of the U.S. Supply Agreement, the U.S.
Government has committed up to $2.480 billion to the Company for mRNA-1273,
inclusive of the previous commitment of up to $955 million under a prior BARDA
award that is funding clinical development and associated manufacturing of
mRNA-1273. In addition, the U.S. Supply Agreement provides the U.S. Government
with four additional and separate options to purchase 100 million doses per
option of mRNA-1273. Each option is exercisable at the sole discretion of the
U.S. Government, following receipt of an EUA or BLA, at various times during the
first half of 2021. Upon exercise of each option, the U.S. Government will pay
Moderna $1.65 billion on the terms agreed to in the U.S. Supply Agreement.
If, following the filing of an application for an EUA or a BLA, but prior to
fulfilling its supply commitment under the U.S. Supply Agreement, the Company
either makes a formal management decision to terminate the manufacture or sale
of mRNA-1273 to the U.S. Government, or makes any filing that anticipates
Federal bankruptcy protection, then at the request of the U.S. Government, the
Company will provide the U.S. Government with certain items required for the
U.S. Government to have a third party manufacture mRNA-1273 exclusively for sale
to the U.S. Government, including 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 certain Moderna patent and other
intellectual property rights required to manufacture mRNA-1273; necessary FDA
regulatory filings or authorizations owned or controlled by Moderna related to
mRNA-1273; and any outstanding deliverables contemplated or materials purchased
under the U.S. Supply Agreement.
The U.S. Supply Agreement contains terms and conditions that are customary for
U.S. Government agreements of this nature, including provisions giving the U.S.
Government the right to terminate the agreement if the applicable Contracting
Officer determines that a termination is in the U.S. Government's interest.
Following any such termination, Moderna and the U.S. Government may agree upon
the amount to be paid or remaining to be paid to Moderna because of the
termination. The base period of performance under the U.S. Supply Agreement is
nine months, and may be extended to 20 months if all options are exercised by
the U.S. Government. Under the terms of the U.S. Supply Agreement, the Company
is entitled to receive approximately $600 million upon the presentation of
certain documentation regarding the production of mRNA-1273, which condition is
expected to be met prior to approval of mRNA-1273 or delivery of doses ordered
under the U.S. Supply Agreement. Additionally, the parties have agreed to novate
the agreement to another of the Company's wholly-owned subsidiaries.
The foregoing description of the material terms of the U.S. Supply Agreement
does not purport to be complete and is qualified in its entirety by reference to
the U.S. Supply Agreement, 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, 2020.
Item 7.01. Regulation FD Disclosure.
On August 11, 2020, the Company issued a press release announcing its entry into
the U.S. Supply Agreement, a copy of which is furnished as Exhibit 99.1 to this
Current Report on Form 8-K.
The information in this Item 7.01 to this Current Report on Form 8-K, and in
Exhibit 99.1 furnished herewith, shall not be deemed to be "filed" for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), or otherwise subject to the liabilities of that section, nor shall such
information be deemed incorporated by reference in any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as expressly set
forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. Description
99.1 Press release issued by Moderna, Inc. on August 11, 2020
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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