Current Report Filing (8-k)
11 Juli 2022 - 11:01PM
Edgar (US Regulatory)
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2022-07-06
2022-07-06
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event
reported): July 6, 2022
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
Delaware |
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0-26770 |
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22-2816046 |
(State or Other Jurisdiction
of Incorporation) |
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(Commission File Number) |
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(I.R.S. Employer
Identification No.) |
21 Firstfield Road
Gaithersburg, Maryland 20878
(Address of Principal Executive Offices,
including Zip Code)
(240) 268-2000
(Registrant’s telephone number,
including area code)
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
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¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
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Name of each exchange on which
registered |
Common Stock, Par Value $0.01 per share |
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NVAX |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
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.
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Novavax, Inc. |
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Date: July 11, 2022 |
By: |
/s/ John A. Herrmann III |
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Name: |
John A. Herrmann III |
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Title: |
Executive Vice President, Chief Legal Officer and Corporate Secretary |
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