Item 5. Other Information
Item 5. Other Information
On May 5, 2021, the Company entered into an APA with Gavi (“Gavi APA”), an independent non-profit foundation organized under the laws of Switzerland, under which Gavi agreed to purchase 350 million doses of NVX-CoV2373, subject to certain conditions, solely for the purpose of vaccinating individuals within the countries participating in the COVAX Facility. The Company previously licensed its vaccine technology to SIIPL and under the Gavi APA is jointly committed with SIIPL to deliver approximately 1.1 billion doses to the countries participating under the COVAX Facility. The vaccine doses will be manufactured and distributed globally by the Company and SIIPL under an existing agreement between Gavi and SIIPL. The Company expects to supply significant doses on a first priority basis to low, middle and high income countries, as allocated by Gavi (subject to certain limitations), utilizing a tiered pricing schedule. Under the Gavi APA, the Company expects to deliver its committed doses with antigen manufactured at facilities funded in whole or in-part by the grant the Company received from
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CEPI, including Novavax CZ and production at commercial manufacturing partners, SK bioscience and BioFabri. Under the Gavi APA, the Company agreed to offer COVAX Facility buyers a designated number of doses constituting a significant majority of drug substance manufactured out of Novavax CZ, SK bioscience and BioFabri. Additionally, the Company may provide additional doses, to the extent available from CEPI funded manufacturing facilities, in the event that SIIPL cannot materially deliver expected vaccine doses to the COVAX Facility.
Under the Gavi APA , the Company expects to receive two (2) significant upfront payments, the first upon Novavax’ submission of a proposed timeline for clinical and regulatory submissions and the second after it secures emergency use listing of its vaccine by the WHO.
The Company will use best efforts to obtain emergency use authorization and emergency use listing for the Vaccine from the WHO, and use commercially reasonable efforts to obtain regulatory approval in each COVAX participant country where allocated COVAX doses are intended to be sold. Gavi will reasonably support the Company with obtaining regulatory approvals.
Gavi may terminate the Gavi APA if, among other reasons, (i) the purchase condition is not satisfied by December 31, 2021, (ii) the Company’s doses are not delivered by December 31, 2022, (iii) the Company withdraws its emergency use authorization or regulatory approval, or if the emergency use authorization or regulatory approval is revoked or materially changed, (iv) a material safety, regulatory or ethical issue pauses manufacturing, or (v) upon the occurrence of a material breach or certain adverse prohibited actions. Unless extended pursuant to the terms of the Gavi APA, the Gavi APA will terminate upon the later of (a) June 30, 2022 or (b) thirty (30) days after date all the binding purchase orders have been placed for the COVAX doses or the final balancing payment has been made.
The foregoing description of the material terms of the Gavi APA 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 June 30, 2021.
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Item 6. Exhibits
3.1
Second Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 3.1 to the Registra nt’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, filed on August 10, 2015 (File No. 000-26770))
3.2 Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on May 9, 2019 (File No. 000-26770))
3.3 Amended and Restated By-Laws of the Registrant (Incorporated by reference to Exhibit 3.2 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2012, filed on March 12, 2013 (File No. 000-26770))
3.4 Certificate of Designation of Series A Convertible Preferred Stock of the Registrant (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed June 19, 2020 (File No. 000-26770))
4.3 Form of Series A Convertible Preferred Stock Certificate of the Registrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed June 19, 2020 (File No. 000-26770))
10.1*± Collaboration and Exclusive License Agreement between Novavax, Inc. and SK Bioscience Company Limited, dated as of February 12, 2021
10.2*± Collaboration and Exclusive License Agreement between Novavax, Inc. and Takeda Pharmaceutical Company Limited, dated as of February 24, 2021
31.1* Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
31.2* Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
32.1* Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2* Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101 The following financial information from our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, formatted in Inline Extensible Business Reporting Language (Inline XBRL): (i) the Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020, (ii) the Consolidated Statements of Operations for the three-month period ended March 31, 2021 and 2020, (iii) the Consolidated Statements of Comprehensive Loss for the three-month period ended March 31, 2021 and 2020, (iv) the Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three-month period ended March 31, 2021 and 2020, (v) the Consolidated Statements of Cash Flows for the three-month period ended March 31, 2021 and 2020, and (vi) the Notes to Consolidated Financial Statements.
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
___________________________________
* Filed herewith or furnished.
± Certain portions of this exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NOVAVAX, INC.
Date: May 10, 2021 By: /s/ Stanley C. Erck
Stanley C. Erck
President and Chief Executive Officer
(Principal Executive Officer)
Date: May 10, 2021 By: /s/ John J. Trizzino
John J. Trizzino
Executive Vice President, Chief Commercial Officer, Chief Business Officer and Interim Chief Financial Officer
(Principal Financial and Accounting Officer)
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.