Current Report Filing (8-k)
March 02 2021 - 5:16PM
Edgar (US Regulatory)
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2021-02-24
2021-02-24
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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): February 24, 2021
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
Delaware
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0-26770
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22-2816046
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(State or Other Jurisdiction
of Incorporation)
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(Commission File Number)
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(I.R.S. Employer
Identification No.)
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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.)
Securities registered pursuant to Section
12(b) of the Act:
Title of each class
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Trading
Symbol(s)
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Name of each exchange on which
registered
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Common Stock, Par Value $0.01 per share
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NVAX
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The Nasdaq Global Select Market
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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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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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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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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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 February 24, 2021, Novavax, Inc. (the
“Company”) entered into a collaboration and exclusive license agreement (the “Collaboration and Exclusive License
Agreement”) with Takeda Pharmaceutical Company Limited (“Takeda”) under which Takeda was granted an exclusive
license to develop, manufacture, and commercialize NVX-CoV2373, the Company’s vaccine candidate for the SARS-CoV-2 virus
(the “Vaccine Product”) in Japan. The Collaboration and Exclusive License Agreement anticipates the capacity to manufacture
by Takeda of 250 million doses of the Vaccine Product per year. The Government of Japan’s Ministry of Health, Labour and
Welfare (MHLW) will fund in part Takeda’s manufacturing activities under the Collaboration and Exclusive License Agreement.
Takeda will purchase doses of the
Company’s Matrix-M™ adjuvant to manufacture the doses of finished Vaccine Product. The Company will receive a low
to middle double digit percentage of Takeda’s net profit from the sale of the Vaccine Product. The Company is entitled
to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of net
profits from the sale of the Vaccine Product.
Takeda is solely responsible for obtaining
and maintaining all regulatory approvals required for the development, manufacture, and commercialization of the Vaccine Product
in Japan, with support from the Company. The regulatory and other activities of the collaboration will be overseen by a joint steering
committee composed of representatives of the Company and Takeda. The Collaboration and Exclusive License Agreement includes customary
representations and warranties of the Company and Takeda along with other customary provisions, including confidentiality, limitation
of liability, and indemnity provisions. The Collaboration and Exclusive License Agreement will remain in effect until terminated
by the Company or Takeda. Either party may terminate for (a) uncured material breach or (b) bankruptcy, and Takeda may terminate
for safety reasons. Upon the earlier of (a) December 31, 2022 and (b) the date during the post-pandemic period on which Takeda
receives regulatory approval for the Vaccine Product in Japan, Takeda has the right to terminate the Collaboration and Exclusive
License Agreement in its entirety for convenience by providing eighteen (18) months prior written notice to the Company.
The foregoing description of material terms of the Collaboration
and Exclusive License Agreement does not purport to be complete and is qualified in its entirety by reference to such 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 March 31, 2021.
Item 2.02. Results of Operations and Financial Condition.
Fourth Quarter Financial Results
On March 1, 2021,
the Company issued a press release announcing the Company’s financial results for the quarter and fiscal year ended December
31, 2020. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information
in Items 2.02 and 9.01 of this Form 8-K (including Exhibit 99.1) shall not be deemed “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 it 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.
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: March 2, 2021
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By:
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/s/ John A. Herrmann III
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Name:
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John A. Herrmann III
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Title:
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Executive Vice President, Chief Legal Officer
and Corporate Secretary
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