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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
☒    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2022
OR
☐    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to .
Commission File No. 000-26770
NOVAVAX, INC.
(Exact name of registrant as specified in its charter)
Delaware22-2816046
(State or other jurisdiction of
incorporation or organization)		(I.R.S. Employer
Identification No.)
21 Firstfield Road
GaithersburgMD20878
(Address of principal executive offices)(Zip code)
(240) 268-2000
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading
Symbol(s)		Name of each exchange on which registered
Common Stock, Par Value $0.01 per shareNVAXThe Nasdaq Global Select Market
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerxAccelerated Filero
Non-accelerated fileroSmaller reporting companyo
Emerging growth companyo 
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. o
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x
The number of shares outstanding of the Registrant's Common Stock, $0.01 par value, was 78,503,952 as of October 31, 2022.

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NOVAVAX, INC.
TABLE OF CONTENTS
Page No.
Item 1A.
Item 5.
Other Information

i
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PART I. FINANCIAL INFORMATION
Item 1.    Financial Statements
1
Table of Contents
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
For the Three Months Ended
September 30,		For the Nine Months Ended
September 30,
2022202120222021
Revenue:
Product sales$626,091 $— $1,267,174 $— 
Grants106,273 135,007 313,348 854,390 
Royalties and other2,213 43,837 43,951 69,700 
Total revenue734,577 178,844 1,624,473 924,090 
Expenses:
Cost of sales434,593 — 720,874 — 
Research and development304,297 408,195 977,428 1,571,551 
Selling, general, and administrative122,876 77,793 327,028 214,144 
Total expenses861,766 485,988 2,025,330 1,785,695 
Loss from operations(127,189)(307,144)(400,857)(861,605)
Other expense:
Interest expense(4,169)(5,182)(15,279)(15,989)
Other expense(34,783)(4,064)(53,002)(7,267)
Loss before income tax expense(166,141)(316,390)(469,138)(884,861)
Income tax expense2,472 6,041 6,552 12,606 
Net loss$(168,613)$(322,431)$(475,690)$(897,467)
Net loss per share:
Basic and diluted$(2.15)$(4.31)$(6.13)$(12.13)
Weighted average number of common shares outstanding
Basic and diluted78,274 74,745 77,631 73,972 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(unaudited)
For the Three Months Ended
September 30,		For the Nine Months Ended
September 30,
2022202120222021
Net loss$(168,613)$(322,431)$(475,690)$(897,467)
Other comprehensive loss:
Net unrealized losses on marketable securities available-for-sale, net of reclassifications— — — (9)
Foreign currency translation adjustment(12,924)(3,309)(22,441)(6,154)
Other comprehensive loss(12,924)(3,309)(22,441)(6,163)
Comprehensive loss$(181,537)$(325,740)$(498,131)$(903,630)
The accompanying notes are an integral part of these financial statements.
2
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NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
September 30,
2022		December 31,
2021
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents$1,280,581 $1,515,116 
Restricted cash10,785 11,490 
Accounts receivable111,645 454,993 
Inventory82,432 8,872 
Prepaid expenses and other current assets274,522 164,648 
Total current assets1,759,965 2,155,119 
Property and equipment, net255,532 228,696 
Right of use asset, net 108,543 40,123 
Intangible assets, net8,456 4,770 
Goodwill117,535 131,479 
Other non-current assets17,406 16,566 
Total assets$2,267,437 $2,576,753 
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable$144,997 $127,050 
Accrued expenses551,069 673,731 
Deferred revenue404,776 1,422,944 
Current portion of finance lease liabilities82,095 130,533 
Convertible notes payable324,525 — 
Other current liabilities160,499 36,061 
Total current liabilities1,667,961 2,390,319 
Deferred revenue1,035,418 172,528 
Convertible notes payable— 323,458 
Non-current finance lease liabilities31,474 — 
Other non-current liabilities98,569 42,121 
Total liabilities2,833,422 2,928,426 
Commitments and contingencies (Note 14)
Stockholders' equity (deficit):
Common stock, $0.01 par value, 600,000,000 shares authorized at September 30, 2022 and December 31, 2021; and 79,204,509 shares issued and 78,476,814 shares outstanding at September 30, 2022 and 76,433,151 shares issued and 75,841,171 shares outstanding at December 31, 2021
792 764 
Additional paid-in capital3,640,597 3,351,967 
Accumulated deficit(4,093,640)(3,617,950)
Treasury stock, cost basis, 727,695 shares at September 30, 2022 and 591,980 shares at December 31, 2021
(89,940)(85,101)
Accumulated other comprehensive loss(23,794)(1,353)
Total stockholders’ deficit(565,985)(351,673)
Total liabilities and stockholders’ deficit$2,267,437 $2,576,753 
The accompanying notes are an integral part of these financial statements.
3
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
Three and Nine Months Ended September 30, 2022 and 2021
(in thousands, except share information)
(unaudited)

Common StockAdditional
Paid-in
Capital		Accumulated
Deficit		Treasury
Stock		Accumulated Other
Comprehensive
Income (Loss)		Total Stockholders'
Equity (Deficit)
SharesAmount
Balance at June 30, 202278,776,234 $788 $3,604,614 $(3,925,027)$(86,455)$(10,870)$(416,950)
Stock-based compensation— — 33,386 — — — 33,386 
Stock issued under incentive programs428,275 4 2,597 — (3,485)— (884)
Foreign currency translation adjustment— — — — — (12,924)(12,924)
Net loss— — — (168,613)— — (168,613)
Balance at September 30, 202279,204,509 $792 $3,640,597 $(4,093,640)$(89,940)$(23,794)$(565,985)
Balance at June 30, 202174,672,351 $747 $3,237,085 $(2,449,235)$(47,205)$4,170 $745,562 
Stock-based compensation— — 45,274 — — — 45,274 
Stock issued under incentive programs1,301,172 13 28,154 — (31,927)— (3,760)
Foreign currency translation adjustment— — — — — (3,309)(3,309)
Net loss— — — (322,431)— — (322,431)
Balance at September 30, 202175,973,523 $760 $3,310,513 $(2,771,666)$(79,132)$861 $461,336 
                                                                                                                                                                                                                                                                                                                                                                                                                                            
Common StockAdditional
Paid-in
Capital		Accumulated
Deficit		Treasury
Stock		Accumulated Other
Comprehensive
Income (Loss)		Total Stockholders'
Equity (Deficit)
SharesAmount
Balance at December 31, 202176,433,151 $764 $3,351,967 $(3,617,950)$(85,101)$(1,353)$(351,673)
Stock-based compensation— — 104,367 — — — 104,367 
Stock issued under incentive programs573,960 6 4,900 — (4,839)— 67 
Issuance of common stock, net of issuance costs of $2,311
2,197,398 22 179,363 — — — 179,385 
Foreign currency translation adjustment— — — — — (22,441)(22,441)
Net loss— — — (475,690)— — (475,690)
Balance at September 30, 202279,204,509 $792 $3,640,597 $(4,093,640)$(89,940)$(23,794)$(565,985)
Balance at December 31, 202071,350,365 $714 $2,535,476 $(1,874,199)$(41,806)$7,024 $627,209 
Stock-based compensation— — 151,457 — — — 151,457 
Stock issued under incentive programs2,044,191 20 58,747 — (37,326)— 21,441 
Issuance of common stock, net of issuance costs of $7,292
2,578,967 26 564,833 — — — 564,859 
Unrealized loss on marketable securities— — — — — (9)(9)
Foreign currency translation adjustment— — — — — (6,154)(6,154)
Net loss— — — (897,467)— — (897,467)
Balance at September 30, 202175,973,523 $760 $3,310,513 $(2,771,666)$(79,132)$861 $461,336 
The accompanying notes are an integral part of these financial statements.




NOVAVAX, INC.
4
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Nine Months Ended September 30,
20222021
Operating Activities:
Net loss$(475,690)$(897,467)
Reconciliation of net loss to net cash provided by (used in) operating activities:
Depreciation and amortization21,832 8,989 
Non-cash stock-based compensation102,525 151,457 
Provision for excess and obsolete inventory358,075 — 
Right-of-use assets expensed, net of credits received40,187 17,117 
Other items, net(25,059)2,739 
Changes in operating assets and liabilities:
Inventory(426,466)— 
Accounts receivable, prepaid expenses, and other assets171,325 209,221 
Accounts payable, accrued expenses, and other liabilities90,418 180,708 
Deferred revenue(155,268)992,590 
Net cash provided by (used in) operating activities(298,121)665,354 
Investing Activities:
Purchases of property and equipment(66,033)(41,122)
Internal-use software development costs(4,888)— 
Purchases of marketable securities— (2,167)
Proceeds from maturities and sale of marketable securities— 159,807 
Net cash provided by (used in) investing activities(70,921)116,518 
Financing Activities:
Net proceeds from sales of common stock179,385 564,859 
Net proceeds from the exercise of stock-based awards67 21,441 
Finance lease payments(45,904)(63,876)
Net cash provided by financing activities133,548 522,424 
Effect of exchange rate on cash, cash equivalents, and restricted cash257 (6,208)
Net increase (decrease) in cash, cash equivalents, and restricted cash(235,237)1,298,088 
Cash, cash equivalents, and restricted cash at beginning of period1,528,259 648,738 
Cash, cash equivalents, and restricted cash at end of period$1,293,022 $1,946,826 
Supplemental disclosure of non-cash activities:
Right-of-use assets from new lease agreements$118,262 $34,914 
Capital expenditures included in accounts payable and accrued expenses$11,984 $7,884 
Supplemental disclosure of cash flow information:
Cash interest payments$17,260 $17,768 
Cash paid for income taxes$17,843 $6,041 
    
The accompanying notes are an integral part of these financial statements.
5
Table of Contents
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2022
(unaudited)
Note 1 – Organization and Business

Novavax, Inc. (“Novavax,” and together with its wholly owned subsidiaries, the “Company”) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The Company’s COVID-19 vaccine (“NVX-CoV2373,” “Nuvaxovid™,” “Covovax™,” “Novavax COVID-19 Vaccine, Adjuvanted”); influenza vaccine candidate; COVID-19-Influenza Combination (“CIC”) vaccine candidate; and additional vaccine candidates, including for Omicron subvariants and bivalent formulations with prototype vaccine (“NVX-CoV2373”), are genetically engineered nanostructures of conformationally correct recombinant proteins critical to disease pathogenesis and may elicit differentiated immune responses, which may be more efficacious than naturally occurring immunity or other vaccine approaches. NVX-CoV2373 and the Company’s other vaccine candidates incorporate the Company's proprietary Matrix-M™ adjuvant to enhance the immune response and stimulate higher levels of functional antibodies and induce a cellular immune response. The Company has announced data from its ongoing PREVENT-19 study supporting the use of NVX-CoV2373 for homologous boosting in adults and adolescents aged 12 through 17. Additional findings in Phase 3 COVID-19 Omicron (study 311) trial showed utility of the prototype vaccine as a heterologous booster, inducing broad immune responses against contemporary Omicron variants.

As of September 30, 2022, the Company had received approval, interim authorization, provisional approval, conditional marketing authorization, and emergency use authorization (“EUA”) from multiple regulatory authorities globally for NVX-CoV2373 for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications.

The Company commenced commercial shipments of NVX-CoV2373 doses under the name “Novavax COVID-19 Vaccine, Adjuvanted” and the brand name “Nuvaxovid™” in 2022.
Note 2 – Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. The consolidated financial statements are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, operating results, comprehensive loss, changes in stockholders’ equity (deficit), and cash flows for the periods presented. Although the Company believes that the disclosures in these unaudited consolidated financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the United States Securities and Exchange Commission (“SEC”).
The unaudited consolidated financial statements include the accounts of Novavax, Inc. and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Accumulated other comprehensive loss included a foreign currency translation loss of $23.8 million and $1.4 million as of September 30, 2022 and December 31, 2021, respectively.
The accompanying unaudited consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. Results for this or any interim period are not necessarily indicative of results for any future interim period or for the entire year. The Company operates in one business segment.
Reclassifications
Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation. These reclassifications have no material effect on previously reported financial position, cash flows, or results of operations.
6
Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates.
Revenue Recognition - Product Sales

Product sales are associated with the Company’s NVX-CoV2373 supply agreements, sometimes referred to as advance purchase agreements (“APAs”), with various international governments. The Company recognizes revenue from product sales based on the transaction price per dose calculated in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (Topic 606) when control of the product transfers to the customer and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory. If an APA includes a term that may have the effect of decreasing the price per dose of previously delivered shipments, the Company constrains the price until it is probable that a significant reversal in revenue recognized will not occur.
Cost of Sales
Cost of sales includes cost of raw materials, production, and manufacturing overhead costs associated with the Company’s product sales during the period. Cost of sales also includes adjustments for excess, obsolete, or expired inventory; idle capacity; and losses on firm purchase commitments to the extent the cost cannot be recovered based on estimates about future demand. Cost of sales does not include certain expenses related to raw materials, production, and manufacturing overhead costs that were expensed prior to regulatory authorization as described under the caption “Inventory” below.
Inventory

Inventory is recorded at the lower of cost or net realizable value under the First In, First Out (“FIFO”) methodology, taking into consideration the expiration of the inventory item (see Note 7). The Company determines the cost of raw materials using moving average costs and the cost of semi-finished and finished goods using a standard cost method adjusted on a periodic basis to reflect the deviation in the actual cost from the standard cost estimate. Standard costs consist primarily of the cost of manufacturing goods, including direct materials, direct labor, and the services and products of third-party suppliers. Manufacturing overhead costs are applied to semi-finished and finished goods based on expected production levels. The Company utilizes third-party contract manufacturing organizations (“CMOs”), contract development and manufacturing organizations (“CDMOs”), and other suppliers and service organizations to support the procurement and processing of raw materials, management of inventory, packaging, and the delivery process. Adjustments to reduce the cost of inventory to its net realizable value, if required, are made for estimated excess, obsolete, or expired inventory through cost of sales.

Prior to initial regulatory authorization for its product candidates, the Company expenses costs relating to raw materials, production, and manufacturing overhead costs as research and development expenses in the consolidated statements of operations, in the period incurred. Subsequent to initial regulatory authorization for a product candidate, the Company capitalizes the costs of production for a particular supply chain as inventory when the Company determines that it has a present right to the economic benefit associated with the product.
Recent Accounting Pronouncements
Not Yet Adopted
In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), with amendments in 2018, 2019, 2020, and 2022. The ASU sets forth a “current expected credit loss” (“CECL”) model that requires companies to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. ASU 2016-13 applies to financial instruments that are not measured at fair value, including receivables that result from revenue transactions. The ASU is effective for the Company beginning on January 1, 2023. Management is currently evaluating the effect of the guidance and does not expect it to have a material impact on the Company’s consolidated financial statements.
7
Adopted
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplified the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts in an entity’s own equity. Specifically, the new standard removed the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It also removed certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and simplified the diluted earnings per share calculation for convertible instruments. The Company adopted ASU 2020-06 on January 1, 2022 using a modified retrospective approach, which did not have a material impact on the Company’s consolidated financial statements.
Note 3 – Revenue
The Company's accounts receivable included $43.6 million and $419.7 million related to amounts that were billed to customers and $68.0 million and $35.3 million related to amounts which had not yet been billed to customers as of September 30, 2022 and December 31, 2021, respectively. During the nine months ended September 30, 2022, changes in the Company's accounts receivables and deferred revenue balances were as follows (in thousands):
December 31, 2021AdditionsDeductions September 30, 2022
Contract receivables:
Accounts receivable$454,993 1,519,345 (1,862,693)$111,645 
Contract liabilities:
Deferred revenue(1)
$1,595,472 96,298 
(251,576)(2)
$1,440,194 
(1)    Amount is comprised of $404.8 million and $1.4 billion of current Deferred revenue and $1.0 billion and $172.5 million of non-current Deferred revenue as of September 30, 2022 and December 31, 2021, respectively.
(2)    Deductions from Deferred revenue includes $202.5 million that was realized in Revenue and $49.1 million that was reclassified to Other liabilities.
The aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, was approximately $4 billion as of September 30, 2022. Failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under the Company’s APA agreements may require the Company to refund portions of upfront payments or result in reduced future payments, which could adversely impact the Company’s ability to realize revenue from its unsatisfied performance obligations. The timing to fulfill performance obligations related to grant agreements will depend on the results of the Company's research and development activities, including clinical trials, and delivery of doses. The timing to fulfill performance obligations related to APAs will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of the prototype NVX-CoV2373 vaccine under certain of our APAs. The remaining unfilled performance obligations not related to grant agreements or APAs are expected to be fulfilled in less than 12 months.
8
Grants
The Company recognized grant revenue as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2022202120222021
U.S. government partnership (“OWS”)$104,348 $96,215 $311,423 $699,268 
U.S. Department of Defense (“DoD”)1,925 1,287 1,925 21,472 
Coalition for Epidemic Preparedness Innovations (“CEPI”)— 37,505 — 131,022 
Bill & Melinda Gates Foundation (“BMGF”)
— — — 2,628 
Total grant revenue$106,273 $135,007 $313,348 $854,390 
U.S. Government
The Company’s U.S. government partnership consists of an agreement (the “OWS Agreement”) with 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”). In July 2022, the Company entered into a modification to the OWS Agreement that amended the terms of such agreement to provide for (i) an initial delivery to the U.S. government of approximately 3 million doses of NVX-CoV2373 and (ii) any additional manufacture and delivery to the U.S. government up to an aggregate of 100 million doses of NVX-CoV2373 contemplated by the original OWS Agreement (inclusive of the initial batch of approximately 3 million doses) dependent on U.S. government demand, FDA guidance on strain selection, agreement between the parties on the price of such doses, and available funding. The 3 million initial doses were delivered in July 2022. Additionally, in July 2022, the Company modified its existing agreement with the DoD and delivered 0.2 million doses of NVX-CoV2373 after receipt of EUA approval from the FDA, with delivery of the remaining 9.8 million doses of NVX-CoV2373 contemplated by the original agreement subject to DoD demand and available funding.
CEPI
The Company’s funding agreement with CEPI, under which CEPI has agreed to provide funding of up to $399.5 million to the Company to support the development of NVX-CoV2373, provides up to $257.0 million in grant funding and up to $142.5 million in forgivable no-interest term loans. These loans are only repayable if NVX-CoV2373 manufactured by the CMO network funded by CEPI is sold under the Company’s APA with Gavi, the Vaccine Alliance (“Gavi”), and such sales cover the Company’s costs of manufacturing the vaccine, not including manufacturing costs funded by CEPI. The timing of any loan repayments is currently uncertain given the timing and quantities of future orders under the Company’s APA with Gavi are unclear, as discussed below.

Royalties and Other
During the three and nine months ended September 30, 2022, the Company recognized $1.3 million and $10.5 million, respectively, in revenue related to sales-based royalties. During the three months ended June 30, 2022, the Company recognized a $20.0 million milestone payment upon the sale of NVX-CoV2373 in Japan. During the three and nine months ended September 30, 2021, the Company recognized $39.9 million and $63.4 million, respectively, in revenue related to sales-based royalties. During the three and nine months ended September 30, 2021, the Company did not recognize any revenue related to milestone payments.
9
Advance Purchase Agreements (APAs)
Under the terms of the Company’s supply commitment with Gavi, which includes both Novavax’ APA with Gavi and the supply obligation of its licensed partner, Serum Institute of India Private Limited (“SIIPL”), 1.1 billion doses of NVX-CoV2373 are to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. The Novavax APA contemplates that the Company will manufacture and distribute 350 million doses. Under that agreement with Gavi, the Company received an upfront payment of $350 million from Gavi in 2021 and an additional payment of $350 million in the first quarter of 2022 related to the Company’s achieving WHO Emergency Use Listing. Although Novavax continues to be prepared to deliver the quantities of NVX-CoV2373 doses to Gavi under the terms of the APA, the Company was notified by Gavi of its intent to seek to revise the number and timing of doses of NVX-CoV2373 supplied by Novavax under such agreement. Furthermore, Gavi may seek partial or full recovery of the prior nonrefundable payments it has made to Novavax. The Company’s position is that Gavi has no contractual right to recover prior nonrefundable payments if it fails to order the 350 million doses it committed to order. To date, except for an initial order of approximately 2 million doses, Novavax has not received an order from Gavi and the timing and quantities of future orders to deliver NVX-CoV2373 to the COVAX Facility are unclear.
Under the terms of the Company’s SARS-CoV-2 Vaccine Supply Agreement, originally entered into in October 2020 (the “Original UK Supply Agreement”) with The Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), the Authority agreed to purchase 60 million doses of NVX-CoV2373. In July 2022, the Company entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) with the Authority, under which the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses of NVX-CoV2373, with the number of additional doses contingent on the Company’s timely achievement of supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”). In the event that the Company is unable to achieve the JCVI supportive recommendations, it may have to repay up to $225.0 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement. As of September 30, 2022, the Company will be required to repay a minimum of $40.0 million related to the upfront payment, which is reflected in Other current liabilities, with the remaining balance of $185.0 million reflected in Deferred revenue. Under the Amended and Restated UK Supply Agreement, the Authority also has the option to purchase up to an additional 44 million doses, in one or more tranches, through 2024.
The Company has an APA with the European Commission (“EC”) acting on behalf of various European Union member states to supply a minimum of 20 million and up to 100 million initial doses of NVX-CoV2373, with the option for the EC to purchase an additional 100 million doses up to a maximum aggregate of 200 million doses in one or more tranches, through 2023. In July and August 2022, the Company was notified by the EC that it was cancelling 5 million doses of its prior commitment originally scheduled for delivery in the first and second quarters of 2022, in accordance with the APA, and reducing the order to 65 million doses. The Company is in the process of finalizing a revised delivery schedule for the remaining 23 million committed doses under the APA that were originally scheduled for delivery during the first and second quarters of 2022.
Note 4 – Collaboration, License, and Supply Agreements
Serum Institute
The Company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of NVX-CoV2373. SIIPL agreed to purchase the Company’s Matrix-MTM adjuvant and the Company granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of NVX-CoV2373 in SIIPL’s licensed territory solely for use in the manufacture of NVX-CoV2373. The Company and SIIPL equally split the revenue from SIIPL’s sale of NVX-CoV2373 in its licensed territory, net of agreed costs. The Company also has a supply agreement with SIIPL and Serum Life Sciences Limited (“SLS”) under which SIIPL and SLS supply the Company with NVX-CoV2373 for commercialization and sale in certain territories, as well as a contract development manufacture agreement with SLS, under which SLS manufactures and supplies finished vaccine product to the Company using antigen drug substance and Matrix-M™ adjuvant supplied by the Company. In May and August 2022, the Company expanded its license and supply arrangements with SIIPL to include its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate, so that SIIPL can manufacture and commercialize a vaccine targeting COVID-19 variants, including the Omicron subvariants, a quadrivalent influenza vaccine, and CIC vaccine, and supply such vaccines to the Company. In March 2020, the Company granted SIIPL a non-exclusive license for the use of Matrix-M™ adjuvant supplied by the Company to develop, manufacture, and commercialize R21, a malaria candidate developed by the Jenner Institute, University of Oxford.
10
Takeda Pharmaceutical Company Limited
The Company has a collaboration and license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) under which the Company granted Takeda an exclusive license to develop, manufacture, and commercialize NVX-CoV2373 in Japan. Under the agreement, Takeda purchases the Company’s Matrix-M™ adjuvant to manufacture NVX-CoV2373 and the Company is entitled to receive payments from Takeda based on the achievement of certain development and commercial milestones, as well as a portion of net profits from the sale of NVX-CoV2373 in the low to middle double-digit range. During the three months ended June 30, 2022, the Company recognized a milestone payment of $20.0 million upon the first sale in Japan.
SK bioscience Co., Ltd.
The Company has a collaboration and license agreement with SK bioscience Co., Ltd. (“SK bioscience”) to manufacture and commercialize NVX-CoV2373 for sale to the governments of South Korea, Thailand, and Vietnam. SK bioscience pays a royalty in the low to middle double-digit range. Additionally, the Company has a manufacturing supply arrangement with SK bioscience under which SK bioscience supplies the Company with the antigen component of NVX-CoV2373 for use in the final drug product globally, including product to be distributed by the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. In July 2022, the Company signed an additional agreement with SK bioscience for the technology transfer of the Company’s proprietary COVID-19 variant antigen materials so that SK bioscience can manufacture the drug substance targeting COVID-19 variants, including the Omicron subvariants. The companies also signed an agreement to manufacture and supply the Novavax COVID-19 vaccine in a prefilled syringe.
Other Supply Agreements
On September 30, 2022, the Company, FUJIFILM Diosynth Biotechnologies UK Limited (“FDBK”), FUJIFILM Diosynth Biotechnologies Texas, LLC (“FDBT”), and FUJIFILM Diosynth Biotechnologies USA, Inc. (“FDBU” and together with FDBK and FDBT, “Fujifilm”) entered into a Confidential Settlement Agreement and Release (the “Fujifilm Settlement Agreement”) regarding amounts due to Fujifilm in connection with the termination of manufacturing activity at FDBT under the Commercial Supply Agreement (the “CSA”) dated August 20, 2021 and Master Services Agreement dated June 30, 2020 and associated statements of work (the “MSA”) by and between the Company and Fujifilm. The MSA and CSA established the general terms and conditions applicable to Fujifilm’s manufacturing and supply activities related to NVX-CoV2373 under the associated statements of work.
Pursuant to the Fujifilm Settlement Agreement, the Company is responsible for payment of up to $185.0 million (the “Settlement Payment”) to Fujifilm in connection with cancellation of manufacturing activity at FDBT under the CSA, of which (i) $47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022 and (ii) the remaining balance is to be paid in four equal quarterly installments of $34.3 million each beginning March 31, 2023. As of September 30, 2022, $102.9 million of the remaining payment was reflected in Accrued expenses and $34.3 million was reflected in Other non-current liabilities. Under the Fujifilm Settlement Agreement, Fujifilm is required to use commercially reasonable efforts to mitigate the losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA, and the final two quarterly installments will be mitigated by any replacement revenue achieved by Fujifilm between July 1, 2023 and December 31, 2023. The Settlement Payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expense from FDBT manufacturing activity under the CSA prior to the Fujifilm Settlement Agreement and accordingly, during the three and nine months ended September 30, 2022, the Company recorded a benefit of $98.3 million as Research and development expense (see Note 9).
Except with respect to certain limited activities agreed upon by the parties, the MSA terminated with respect to all activities in FDBU and FDBT on October 21, 2022 and the impact of the termination was determined in accordance with the provisions of the MSA. The terms and conditions of the MSA and CSA will remain in full force and effect with respect to the ongoing activities at FDBK. In addition, the Company and Fujifilm mutually released all claims relating to (i) the cancellation of batches to be manufactured at FDBT under the MSA or CSA, (ii) FDBT facility idle time in 2022, (iii) failure to complete product performance qualification testing of batches manufactured by Fujifilm by December 2021, and (iv) any obligation by Fujifilm to reserve capacity or manufacture batches at FDBT for the benefit of the Company under the MSA or CSA.
The Company continues to assess its manufacturing needs and intends to modify its global manufacturing footprint consistent with its contractual obligations to supply, and anticipated demand for, NVX-CoV2373, and in doing so, recognizes that significant costs may be incurred.
11
Note 5 – Cash, Cash Equivalents, and Restricted Cash
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheets that sums to the total of such amounts shown in the statements of cash flows (in thousands):

September 30, 2022December 31, 2021
Cash and cash equivalents$1,280,581 $1,515,116 
Restricted cash, current10,785 11,490 
Restricted cash, non-current(1)
1,656 1,653 
Cash, cash equivalents, and restricted cash$1,293,022 $1,528,259 
(1)Classified as Other non-current assets as of September 30, 2022 and December 31, 2021, on the consolidated balance sheets.
Note 6 – Fair Value Measurements
The following table represents the Company’s fair value hierarchy for its financial assets and liabilities (in thousands):
Fair Value at September 30, 2022Fair Value at December 31, 2021
AssetsLevel 1Level 2Level 3Level 1Level 2Level 3
Money market funds(1)
$365,631 $— $— $361,822 $— $— 
Government-backed securities(1)
— 261,000 — — 266,250 — 
Corporate debt securities(1)
— 109,914 — — 790,672 — 
Agency securities(1)
— 42,777 — — — — 
Total cash equivalents$365,631 $413,691 $— $361,822 $1,056,922 $— 
Liabilities
Convertible notes payable$— $317,044 $— $— $447,509 $— 
(1)All investments are classified as Cash and cash equivalents as of September 30, 2022 and December 31, 2021, on the consolidated balance sheets.
Cash equivalents are recorded at cost, which approximate fair value due to their short-term nature. Pricing of the Company's Notes (see Note 10) has been estimated using other observable inputs, including the price of the Company's common stock, implied volatility, interest rates, and credit spreads.
During the nine months ended September 30, 2022 and 2021, the Company did not have any transfers between levels.
Note 7 – Inventory
Inventory consisted of the following (in thousands):
September 30, 2022December 31, 2021
Raw materials$17,557 $8,872 
Semi-finished goods33,030 — 
Finished goods31,845 — 
Total inventory$82,432 $8,872 
Inventory write-downs as a result of excess, obsolescence, expiry, or other reasons, and losses on firm purchase commitments are recorded as a component of cost of sales in our consolidated statements of operations. For the three and nine months ended September 30, 2022, inventory write-downs were $202.4 million and $358.1 million, respectively. For the three and nine months ended September 30, 2022, losses on firm purchase commitments were $46.6 million and $146.2 million, respectively. There were no inventory write-downs or losses on firm purchase commitments during 2021.
12
Note 8 – Intangible Assets and Goodwill
Identifiable Intangible Assets
Purchased intangible assets consisted of the following (in thousands):
September 30, 2022December 31, 2021
Gross
Carrying
Amount		Accumulated 
Amortization		Intangible
Assets, Net		Gross
Carrying
Amount		Accumulated 
Amortization		Intangible
Assets, Net
Finite-lived intangible assets:
Proprietary adjuvant technology$6,911 $(3,069)$3,842 $8,239 $(3,469)$4,770 
Internal-use software(1)
4,888 (274)4,614 — — — 
Total identifiable intangible assets$11,799 $(3,343)$8,456 $8,239 $(3,469)$4,770 
(1)As of September 30, 2022, internal-use software included $3.6 million for assets under development.
Amortization expense for the nine months ended September 30, 2022 and 2021 was $0.6 million and $0.3 million, respectively. Estimated amortization expense for existing in-use intangible assets for the remainder of 2022 and for each of the five succeeding years ending December 31 is estimated to be as follows (in thousands):
YearAmount
2022 (remainder)$189 
2023756 
2024740 
2025392 
2026335 
2027335 
Goodwill
The change in the carrying amounts of goodwill for the nine months ended September 30, 2022 was as follows (in thousands):
Amount
Balance at December 31, 2021$131,479 
Currency translation adjustments(13,944)
Balance at September 30, 2022$117,535 
Note 9 - Leases

During the nine months ended September 30, 2022, the Company concluded that changes in facts and circumstances on its CMO and CDMO agreements that had previously been determined to represent embedded lease arrangements resulted in the modification of existing leases and, in accordance with its policy, the Company remeasured and reallocated the remaining consideration in the contracts and reassessed the lease classification as of the effective date of the modification. As a result, during the nine months ended September 30, 2022, the Company recognized a Right-Of-Use (“ROU”) asset and a corresponding long-term operating lease liability of $44.0 million on the remeasurement of its long-term supply agreements using an average incremental borrowing rate of 5%. The Company expensed the ROU asset since it relates to research and development activities for the development of NVX-CoV2373 for which the Company does not have an alternative future use.
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During the three and nine months ended September 30, 2022, the Company recognized a short-term lease benefit of $46.6 million and expense of $37.3 million, respectively, related to its embedded leases, net of a benefit of $98.3 million related to the Fujifilm Settlement Agreement (see Note 4). During the three and nine months ended September 30, 2022, the Company expensed $24.2 million and $44.0 million, respectively, of ROU assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease. During the three and nine months ended September 30, 2021, the Company recognized a short-term lease expense of $111.3 million and $325.5 million, respectively, related to its embedded leases and expensed $4.4 million and $17.1 million, respectively, of ROU assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease. During the three and nine months ended September 30, 2022, the Company recognized $0.9 million and $4.3 million of interest expense, respectively, on its finance lease liabilities. During the three and nine months ended September 30, 2021, the Company recognized $1.6 million and $5.6 million of interest expense, respectively, on its finance lease liabilities.
During 2020, the Company entered into a lease agreement for the premises located at 700 Quince Orchard Road, Gaithersburg, Maryland. The lease is for approximately 170,000 square feet of space that the Company intends to use for manufacturing, research and development, and corporate offices. The term of the lease is 15 years with options to extend the lease. The lease provides for an annual base rent of $5.8 million that is subject to future rent increases and obligates the Company to pay building operating costs. During the nine months ended September 30, 2022, the Company obtained the right to direct the use of, and obtain substantially all of the benefit from, certain floors located at the premises and recognized an ROU asset and related lease obligation of $73.2 million as the lease commencement dates for accounting purposes had occurred.
Note 10 – Debt
Convertible Notes
The Company incurred approximately $10.0 million of debt issuance costs during the first quarter of 2016 relating to the issuance of $325 million aggregate principal amount of convertible senior unsecured notes that will mature on February 1, 2023 (the “Notes”), which were recorded as a reduction to the Notes on the consolidated balance sheet. The $10.0 million of debt issuance costs is being amortized and recognized as additional interest expense over the seven-year contractual term of the Notes on a straight-line basis, which approximates the effective interest rate method.
Total convertible notes payable consisted of the following (in thousands):
September 30, 2022December 31, 2021
Principal amount of Notes$325,000 $325,000 
Unamortized debt issuance costs(475)(1,542)
Total convertible notes payable(1)
$324,525 $323,458 
(1)    Convertible notes are classified as current liabilities and as non-current liabilities in the consolidated balance sheets as of September 30, 2022 and December 31, 2021, respectively.
The interest expense incurred in connection with the Notes consisted of the following (in thousands):
Three Months Ended
September 30,		Nine Months Ended
September 30,
2022202120222021
Coupon interest at 3.75%
$3,047 $3,047 $9,141 $9,141 
Amortization of debt issuance costs356 356 1,068 1,068 
Total interest expense on Notes$3,403 $3,403 $10,209 $10,209 
Note 11 – Stockholders' Equity (Deficit)
During the three months ended March 31, 2022, the Company sold 2.2 million of shares of its common stock resulting in net proceeds of approximately $179 million, under its most recent At Market Issuance Sales agreement entered in June 2021 (the “June 2021 Sales Agreement”), which allows it to issue and sell up to $500 million in gross proceeds of shares of its common stock. As of September 30, 2022, the remaining balance under the June 2021 Sales Agreement was approximately $318 million.
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During the nine months ended September 30, 2021, the Company sold 2.6 million shares of its common stock resulting in net proceeds of approximately $565 million, under its various At Market Issuance Sales agreements.
Note 12 – Stock-Based Compensation
Equity Plans
The 2015 Stock Incentive Plan, as amended (“2015 Plan”), was approved at the Company's annual meeting of stockholders in June 2015. Under the 2015 Plan, equity awards may be granted to officers, directors, employees, and consultants of and advisors to the Company and any present or future subsidiary.
The 2015 Plan authorizes the issuance of up to 14.8 million shares of common stock under equity awards granted under the 2015 Plan, which includes an increase of 2.4 million shares approved for issuance under the 2015 Plan at the Company's 2022 annual meeting of stockholders. All such shares authorized for issuance under the 2015 Plan have been reserved. The 2015 Plan will expire on March 4, 2025. As of September 30, 2022, there were 4.6 million shares available for issuance under the 2015 Plan.
The Amended and Restated 2005 Stock Incentive Plan (“2005 Plan”) expired in February 2015 and no new awards may be made under such plan, although awards will continue to be outstanding in accordance with their terms.
The 2015 Plan permits and the 2005 Plan permitted the grant of stock options (including incentive stock options), restricted stock, stock appreciation rights (“SARs”), and restricted stock units (“RSUs”). In addition, under the 2015 Plan, unrestricted stock, stock units, and performance awards may be granted. Stock options and SARs generally have a maximum term of ten years and may be or were granted with an exercise price that is no less than 100% of the fair market value of the Company's common stock at the time of grant. Grants of stock options are generally subject to vesting over periods ranging from one to four years.
The Company recorded all stock-based compensation expense in the consolidated statements of operations as follows (in thousands):
Three Months Ended
September 30,		Nine Months Ended
September 30,
2022202120222021
Cost of sales$51 $— $51 $— 
Research and development16,107 21,860 52,692 70,429 
General and administrative15,389 23,414 49,782 81,028 
Total stock-based compensation expense$31,547 $45,274 $102,525 $151,457 
Total stock-based compensation capitalized and included in inventory as of September 30, 2022 was $1.8 million. There was no stock-based compensation capitalized and included in inventory as of December 31, 2021.
As of September 30, 2022, there was approximately $189 million of total unrecognized compensation expense related to unvested stock options, SARs, RSUs, and the Company’s Employee Stock Purchase Plan, as amended (“ESPP”). This unrecognized non-cash compensation expense is expected to be recognized over a weighted-average period of approximately one year. This estimate does not include the impact of other possible stock-based awards that may be made during future periods.
The aggregate intrinsic value represents the total intrinsic value (the difference between the Company’s closing stock price on the last trading day of the period and the exercise price, multiplied by the number of in-the-money stock options and SARs) that would have been received by the holders had all stock option and SAR holders exercised their stock options and SARs on September 30, 2022. This amount is subject to change based on changes to the closing price of the Company's common stock. The aggregate intrinsic value of stock options and SARs exercises and vesting of RSUs for the nine months ended September 30, 2022 and 2021 was approximately $19 million and $381 million, respectively.
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Stock Options and Stock Appreciation Rights
The following is a summary of stock options and SARs activity under the 2015 Plan and 2005 Plan for the nine months ended September 30, 2022:
2015 Plan2005 Plan
Stock
Options		Weighted-Average
Exercise
Price		Stock
Options		Weighted-Average
Exercise
Price
Outstanding at December 31, 20213,635,837 $42.60 68,225 $109.52 
Granted558,181 71.21 — — 
Exercised(132,420)15.75 (3,000)31.10 
Canceled(61,364)88.58 (1,500)121.00 
Outstanding at September 30, 20224,000,234 $46.78 63,725 $112.94 
Shares exercisable at September 30, 20222,739,565 $39.72 63,725 $112.94 
The fair value of stock options granted under the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
Three Months Ended
September 30,		Nine Months Ended
September 30,
2022202120222021
Weighted average Black-Scholes fair value of stock options granted
$37.66
$203.51
$60.24
$156.86
Risk-free interest rate
3.0%-3.6%
0.6%-0.9%
1.4%-3.6%
0.5%-1.1%
Dividend yield—%—%—%—%
Volatility
122.2%-136.4%
126.4%-140.0%
120.5%-136.7%
124.7%-142.0%
Expected term (in years)
4.0-5.3
4.1-6.1
4.0-6.3
4.1-6.1
The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2015 Plan and 2005 Plan as of September 30, 2022 was approximately $9 million and 7.4 years, respectively. The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2015 Plan and 2005 Plan as of September 30, 2022 was approximately $5 million and 7.0 years, respectively.
Restricted Stock Units
The following is a summary of RSU activity for the nine months ended September 30, 2022:
Number of
Shares		Per Share
Weighted-
Average
Fair Value
Outstanding and unvested at December 31, 2021819,828 $116.70 
Granted1,113,958 68.49 
Vested(379,802)78.17 
Forfeited(114,976)110.59 
Outstanding and unvested at September 30, 20221,439,008 $90.03 
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Employee Stock Purchase Plan
The ESPP was approved at the Company's annual meeting of stockholders in June 2013. The ESPP currently authorizes an aggregate of 1.1 million shares of common stock to be purchased, and the aggregate amount of shares will continue to increase 5% on each anniversary of its adoption up to a maximum of 1.65 million shares. The ESPP allows employees to purchase shares of common stock of the Company at each purchase date through payroll deductions of up to a maximum of 15% of their compensation, at 85% of the lesser of the market price of the shares at the time of purchase or the market price on the beginning date of an option period (or, if later, the date during the option period when the employee was first eligible to participate). As of September 30, 2022, there were 0.7 million shares available for issuance under the ESPP.
The ESPP is considered compensatory for financial reporting purposes. As such, the fair value of ESPP shares was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
Three Months Ended
September 30,		Nine Months Ended
September 30,
2022202120222021
Range of Black-Scholes fair values of ESPP shares granted
$23.59-$39.73
$83.47-$152.11
$23.59-$79.74
$83.47-$238.85
Risk-free interest rate
3.2%-3.3%
0.1%-0.2%
0.6%-3.3%
0.1%-0.2%
Dividend yield—%—%—%—%
Volatility
103.0%-114.8%
114.9%-150.6%
103.0%-142.9%
114.9%-159.4%
Expected term (in years)
0.5-2.0
0.5-2.0
0.5-2.0
0.5-2.0
Note 13 – Income Taxes

The Company evaluates the available positive and negative evidence to estimate whether sufficient future taxable income will be generated to permit use of the existing deferred tax assets. A significant piece of objective evidence evaluated was the cumulative loss incurred over the three-year period ended September 30, 2022 and that the Company has historically generated pretax losses. Such objective evidence limits the ability to consider other subjective evidence, such as projections for future growth. On the basis of this evaluation, as of September 30, 2022, the Company continued to maintain a full valuation allowance against its deferred tax assets, except to the extent Net Operating Losses (“NOLs”) have been used to reduce taxable income. The Company’s remaining U.S. Federal NOLs are subject to limitation in accordance with the 2017 Tax Cuts and Jobs Act (“TCJA”), which limits allowable NOL deductions to 80% of federal taxable income.

Effective January 1, 2022, a provision of the TCJA has taken effect creating a significant change to the treatment of research and experimental expenditures under Section 174 of the IRC (“Sec. 174 expenses”). Historically, businesses have had the option of deducting Sec. 174 expenses in the year incurred or capitalizing and amortizing the costs over five years. The new TCJA provision, however, eliminates this option and will require Sec. 174 expenses associated with research conducted in the U.S. to be capitalized and amortized over a five-year period. For expenses associated with research outside of the U.S., Sec. 174 expenses will be capitalized and amortized over a 15-year period.
The Company recognized federal and state income tax expense of $2.4 million and $4.3 million, in total, for the three and nine months ended September 30, 2022, respectively, and did not recognize federal or state income tax expense for the three and nine months ended September 30, 2021. The Company recognized income tax expense related to foreign withholding tax on royalties of $0.1 million and $2.3 million, respectively, for the three and nine months ended September 30, 2022 and $6.0 million and $12.6 million for the three and nine months ended September 30, 2021, respectively.
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Note 14 – Commitments and Contingencies
Legal Matters

On November 12, 2021, Sothinathan Sinnathurai filed a purported securities class action in the U.S. District Court for the District of Maryland against the Company and certain members of senior management, captioned Sothinathan Sinnathurai v. Novavax, Inc., et al., No. 8:21-cv-02910-TDC (the “Sinnathurai Action”). On January 26, 2022, the court entered an order designating David Truong, Nuggehalli Balmukund Nandkumar, and Jeffrey Gabbert as co-lead plaintiffs in the Sinnathurai Action. The co-lead plaintiffs filed a consolidated amended complaint on March 11, 2022, alleging that the defendants made certain purportedly false and misleading statements concerning the Company’s ability to manufacture NVX-CoV2373 on a commercial scale and to secure the vaccine’s regulatory approval. The amended complaint defines the purported class as those stockholders who purchased the Company’s securities between February 24, 2021 and October 19, 2021. On April 25, 2022, defendants filed a motion to dismiss the consolidated amended complaint. On June 9, 2022, the co-lead plaintiffs filed an opposition to the motion to dismiss and on July 11, 2022, the Company filed a reply brief. The matter is now fully briefed. The Court has not indicated whether it intends to schedule any hearing on the motion before issuing a ruling.

After the Sinnathurai Action was filed, six derivative lawsuits were filed: (i) Robert E. Meyer v. Stanley C. Erck, et al., No. 8:21-cv-02996-TDC (the “Meyer Action”), (ii) Shui Shing Yung v. Stanley C. Erck, et al., No. 8:21-cv-03248-TDC (the “Yung Action”), (iii) William Kirst, et al. v. Stanley C. Erck, et al., No. 8:22-cv-00024-TDC (the “Kirst Action”), (iv) Amy Snyder v. Stanley C. Erck, et al., No. 8:22-cv-01415-TDC (the “Snyder Action”), (v) Charles R. Blackburn, et al. v. Stanley C. Erck, et al., No. 1:22-cv-01417-TDC (the “Blackburn Action”), and (vi) Diego J. Mesa v. Stanley C. Erck, et al. (the “Mesa Action”). The Meyer, Yung, Snyder, and Blackburn Actions were filed in the U.S. District Court for the District of Maryland. The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the U.S. District Court for the District of Maryland by the defendants. The Mesa Action was filed in the Delaware Court of Chancery. The derivative lawsuits name members of the board of directors and certain members of senior management as defendants. The Company is deemed a nominal defendant. The plaintiffs assert derivative claims arising out of substantially the same alleged facts and circumstances as the Sinnathurai Action. Collectively, the derivative complaints assert claims for breach of fiduciary duty, insider selling, unjust enrichment, violation of federal securities law, abuse of control, waste, and mismanagement. Plaintiffs seek declaratory and injunctive relief, as well as an award of monetary damages and attorneys’ fees.

On July 21, 2022, the Court issued a memorandum opinion and order remanding the Kirst Action to state court. On February 4, 2022, the Court entered an order consolidating the Meyer and Yung Actions (the “First Consolidated Derivative Action”). The plaintiffs in the First Consolidated Derivative Action filed their consolidated derivative complaint on April 25, 2022. On May 10, 2022, the Court entered an order in the First Consolidated Derivative Action granting the parties’ request to stay all proceedings and deadlines pending the earlier of dismissal or the filing of an answer in the Sinnathurai Action. On June 10, 2022, the Snyder and Blackburn Actions were filed. On October 5, 2022, the court entered an order granting a request by the plaintiffs in the First Consolidated Derivative Action and the Snyder and Blackburn Actions to consolidate all three actions and appoint co-lead plaintiffs and co-lead and liaison counsel (the “Second Consolidated Derivative Action”). The co-lead plaintiffs in the Second Consolidated Derivative Action will designate an operative complaint or file a consolidated amended complaint by November 21, 2022. On August 30, 2022, the Mesa Action was filed. On October 3, 2022, the court entered an order granting the parties’ request to stay all proceedings and deadlines in the Mesa Action pending the earlier of dismissal of the Sinnathurai Action or the filing of an answer to the operative complaint in the Sinnathurai Action. The financial impact of the claims is not estimable.

On February 26, 2021, a Novavax stockholder named Thomas Golubinski filed a derivative complaint against members of the Novavax board of directors and members of senior management in the Delaware Court of Chancery (the “Court”), captioned Thomas Golubinski v. Richard H. Douglas, et al., No. 2021-0172-JRS. The Company is deemed a nominal defendant. Golubinski challenged equity awards made in April 2020 and in June 2020 on the ground that they were “spring-loaded,” that is, made at a time when such board members or members of senior management allegedly possessed undisclosed positive material information concerning the Company. The complaint asserted claims for breach of fiduciary duty, waste, and unjust enrichment. The plaintiff sought an award of damages to the Company, an order rescinding both awards or requiring disgorgement, and an award of attorneys’ fees incurred in connection with the litigation. On May 10, 2021, the defendants moved to dismiss the complaint in its entirety. On June 17, 2021, the Company’s stockholders voted FOR ratification of the April 2020 awards and ratification of the June 2020 awards. Details of the ratification proposals are set forth in the Company’s Definitive Proxy Statement filed with the SEC on May 3, 2021. The results of the vote were disclosed in the Company’s Current Report on Form 8-K filed with the SEC on June 24, 2021. Thereafter, the plaintiff stipulated that, as a result of the outcome of the June 17, 2021 vote, the plaintiff no longer intends to pursue the lawsuit or any claim arising from the April 2020 and June 2020 awards. On August 23, 2021, the plaintiff filed a motion seeking an award of attorneys’ fees and expenses, to which the defendants filed an opposition. The motion was argued before the Court on October 18, 2022. The same day, the Court issued a bench ruling denying the plaintiff’s fee application in its entirety and entered an order to that effect. Under a prior Court order, the case was automatically dismissed with prejudice upon denial of the plaintiff’s fee application.

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On March 29, 2022, Par Sterile Products, LLC (“Par”) submitted a demand for arbitration against the Company with the American Arbitration Association, alleging that the Company breached certain provisions of the Manufacturing and Services Agreement (“MSA”) that the Company entered into with Par in September 2020 to provide fill-finish manufacturing services for NVX-CoV2373. The matter is at a preliminary stage and therefore the potential loss is not reasonably estimable. The parties are engaged in discovery and arbitration is scheduled for July 2023. While the Company maintains that no breach of the MSA has occurred and intends to vigorously defend the matter, if the final resolution of the matter is adverse to the Company, it could have a material impact on the Company’s financial position, results of operations, or cash flows.

The Company is also involved in various legal proceedings arising in the normal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, management does not expect the resolution of these legal proceedings to have a material adverse effect on the Company’s financial position, results of operations, or cash flows.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Any statements in the discussion below and elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) about expectations, beliefs, plans, objectives, assumptions, or future events or performance of Novavax, Inc. (“Novavax,” and together with its wholly owned subsidiaries, the “Company,” “we,” or “us”) are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements about our capabilities, goals, expectations regarding future revenue and expense levels, and capital raising activities; our operating plans and prospects; potential market sizes and demand for our product candidates; the efficacy, safety, and intended utilization of our product candidates; the development of our clinical-stage product candidates and our recombinant vaccine and adjuvant technologies; the development of our preclinical product candidates; our expectations related to enrollment in our clinical trials; the conduct, timing, and potential results from clinical trials and other preclinical studies; plans for and potential timing of regulatory filings; our expectation of manufacturing capacity, timing, production, distribution, and delivery for our coronavirus vaccine candidate (“NVX-CoV2373”) by us and our partners; our estimate of the number of individuals who may potentially be reached by NVX-CoV2373; our expectations with respect to the anticipated ongoing development and commercialization or licensure of NVX-CoV2373, including efforts to expand the NVX-CoV2373 label worldwide as a booster, and to various age groups and geographic locations, and our seasonal quadrivalent influenza vaccine, previously known as NanoFlu; the expected timing, content, and outcomes of regulatory actions; funding from the U.S. government partnership formerly known as Operation Warp Speed (“OWS”), the U.S. Department of Defense (“DoD”), and the Coalition for Epidemic Preparedness Innovations (“CEPI”), and payments from the Bill & Melinda Gates Foundation (“BMGF”); funding under our advance purchase agreements and supply agreements and amendments to, or termination of, any such agreement; our available cash resources and usage and the availability of financing generally; plans regarding partnering activities and business development initiatives; and other matters referenced herein. Generally, forward-looking statements can be identified through the use of words or phrases such as “believe,” “may,” “could,” “will,” “would,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,” “plan,” “project,” “expect,” “should,” “would,” “aim,” or “assume,” the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities, such as the U.S. Food and Drug Administration (“FDA”), World Health Organization (“WHO”), United Kingdom (“UK”) Medicines and Healthcare Products Regulatory Agency, the European Medicines Agency, the Republic of Korea’s Ministry of Food and Drug Safety, or Japan’s Ministry of Health, Labour and Welfare; unanticipated challenges or delays in conducting clinical trials; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, constraints on the ability of Novavax to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and other risks and uncertainties identified in Part I, Item 1A “Risk Factors” of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which may be detailed and modified or updated in other documents filed with the United States Securities and Exchange Commission (“SEC”) from time to time, and are available at www.sec.gov and at www.novavax.com. You are encouraged to read these filings as they are made.

Information in this Quarterly Report includes a financial measure that was not prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), which we refer to as adjusted cost of sales. We are presenting this non-GAAP financial measure to assist an understanding of our business and its performance. Adjusted cost of sales includes an estimate of standard manufacturing costs that were previously expensed to research and development prior to regulatory approvals for NVX-CoV2373 that would otherwise have been capitalized to inventory. Any non-GAAP financial measures presented are not, and should not be viewed as, substitutes for financial measures required by GAAP, have no standardized meaning prescribed by GAAP, and may not be comparable to the calculation of similar measures of other companies.

We cannot guarantee future results, events, level of activity, performance, or achievement. Any or all of our forward-looking statements in this Quarterly Report may turn out to be inaccurate or materially different from actual results. Further, any forward-looking statement speaks only as of the date when it is made, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
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Table of Contents
Overview

Novavax, Inc., together with our wholly-owned subsidiaries, is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Our proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticle vaccines designed to address urgent global health needs.

Our vaccine candidates are genetically engineered nanostructures of conformationally correct recombinant proteins that mimic those found on natural pathogens. This technology enables the immune system to recognize the right target proteins from different angles and develop protective antibodies. We believe that our vaccine technology may lead to the induction of a differentiated immune response that may be more efficacious than naturally occurring immunity or other vaccine approaches. Our vaccine candidates also incorporate our proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate higher levels of functional antibodies and induce a cellular immune response.

We have developed a COVID-19 vaccine (“NVX-CoV2373,” “Nuvaxovid™,” “Covovax™,” “Novavax COVID-19 Vaccine, Adjuvanted”), and are developing an influenza vaccine candidate, a COVID-19-Influenza Combination (“CIC”) vaccine candidate, and additional vaccine candidates, including for Omicron subvariants (NVX-CoV2515 for Omicron BA.1 specific vaccine), and bivalent formulations with prototype vaccine (“NVX-CoV2373”). NVX-CoV2373 has received approval, interim authorization, provisional approval, conditional marketing authorization (“CMA”), and emergency use authorization (“EUA”) from multiple regulatory authorities globally for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications. In addition to COVID-19 and seasonal influenza, our other areas of focus include respiratory syncytial virus (“RSV”) and malaria.

Technology Overview

We believe our recombinant nanoparticle vaccine technology together with our proprietary Matrix-M™ adjuvant is well-suited for the development and commercialization of vaccine candidates targeting a broad scope of respiratory and other emerging infectious diseases at scale.

Recombinant Nanoparticle Vaccine Technology

Once a pathogenic threat has been identified, the genetic sequence encoding the antigen is selected for subsequent use in developing the vaccine construct. The genetic sequence may be optimized to enhance protein stability or confer resistance to degradation. This genetic construct is inserted into the baculovirus Spodoptera frugiperda (“Sf9/BV”) insect cell-expression system, which enables efficient, large-scale expression of the optimized protein. The Sf9/BV system produces proteins that are properly folded and modified – which can be critical for functional, protective immunity – as the vaccine antigen. Protein antigens are purified and organized around a polysorbate-based nanoparticle core, in a configuration that resembles their native presentation. This results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M™ adjuvant.

Matrix-M™ Adjuvant

Our proprietary Matrix-M™ adjuvant has been a key differentiator within our platform. This adjuvant has demonstrated potent, well-tolerated, and durable efficacy by stimulating the entry of antigen presenting cells (“APCs”) into the injection site and enhancing antigen presentation in local lymph nodes. This in turn activates APCs, T-cell and B-cell populations, plasma cells, and high affinity antibodies, thereby boosting immune response. This potent mechanism of action enables a lower dose of antigen required to achieve the desired immune response and we believe thereby contributes to increased vaccine supply and manufacturing capacity. These immune-boosting and dose-sparing capabilities contribute to the adjuvant’s highly unique profile.
NVX-CoV2373 Regulatory and Licensure

We continue to make progress in advancing NVX-CoV2373 toward regulatory approvals. We have received numerous authorizations globally within the adult population, aged 18 and older, and the adolescent population, aged 12 through 17, for primary series and both homologous and heterologous booster indications. Collectively, these indications have the potential to reach over six billion individuals. To date, we have received approval, interim authorization, provisional approval, CMA, and EUA for both adult and adolescent populations, and we are working to expand our label worldwide. We continue to work closely with governments, regulatory authorities, and non-governmental organizations in our commitment to facilitate equitable global access to our COVID-19 vaccine.

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Table of Contents
For the territories in which our vaccine has gained authorization, NVX-CoV2373 is marketed under the brand names (i) Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS Recombinant, adjuvanted), (ii) Covovax™ (manufacturing and commercialization by the Serum Institute of India Pvt. Ltd. (“SIIPL”)), or (iii) Novavax COVID-19 Vaccine, Adjuvanted.
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Table of Contents
Through the date of filing this Quarterly Report, the below is a summary of regulatory authorizations for NVX-CoV2373:
nvax-20220930_g1.jpg
(1)    Regulatory approval received in partnership with SIIPL.
(2)    Regulatory manufacturing and marketing approval received by partner Takeda Pharmaceutical Company Limited (“Takeda”).

During the third quarter of 2022, we completed additional regulatory submissions in major markets for both adult and adolescent populations for primary and booster indications. We are in active discussions with regulatory authorities and remain focused on expanding our label in multiple countries for NVX-CoV2373.

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Table of Contents
Below is a summary and status of our regulatory submissions completed and awaiting authorization decisions, through the date of filing this Quarterly Report.
nvax-20220930_g2.jpg
(1)    Regulatory filing submitted by our partner, SK bioscience, Co., Ltd. (“SK bioscience”).

Clinical Pipeline

Our clinical pipeline encompasses vaccine candidates spanning multiple therapeutic areas including coronavirus, seasonal influenza, and RSV, in addition to providing Matrix-MTM adjuvant for collaborations investigating the prevention of malaria. Our COVID-19 vaccine candidate, NVX-CoV2373, is our leading product, having received approval, interim authorization, provisional approval, CMA, and EUA from multiple regulatory authorities globally.

We advanced NVX-CoV2373 through two pivotal Phase 3 clinical trials that demonstrated high efficacy against both the original COVID-19 strain and commonly circulating COVID-19 variants of concern, while displaying a favorable safety profile. In October 2022, we announced additional data from the Phase 3 PREVENT-19 trial and new results from a Lot Consistency Study (Study 307). New PREVENT-19 data added support for the use of prototype Novavax vaccine for homologous boosting in adults and adolescents aged 12 through 17. In all adults, boosted responses were long-lived and were demonstrated to be relevant against currently circulating variants such as Omicron. The Lot Consistency trial met its primary endpoint, showing that three lots of COVID-19 vaccine induced comparable immune responses in adults aged 18 through 49, thereby demonstrating the consistency of the commercial manufacturing process. Additional findings showed utility of the prototype vaccine as a heterologous booster, inducing broad immune responses against contemporary Omicron variants.

We remain focused on expanding our NVX-CoV2373 vaccine label within the booster and adolescent market following global regulatory authorizations. In August 2022, we initiated the Phase 2b/3 Hummingbird global clinical trial. The trial will evaluate the safety, effectiveness (immunogenicity), and efficacy of two primary doses of NVX-CoV2373 given 21 days apart in younger children (aged six to 11 years), followed by a booster dose at six months after the primary vaccination series. We enrolled the sentinel cohort in the first age group (aged six to 11 years) in the United States. Based on initial supportive safety and tolerability data analyzed by an independent Safety Monitoring Committee, we have progressed to recruiting the full age cohort. Furthermore, through ongoing booster studies in our clinical trials and continued development of our COVID-19 variant strain vaccine candidates, we continue to evaluate vaccine performance. We remain confident in the utility of our prototype vaccine against emerging variants, as we continue to respond to the evolving COVID landscape. We are currently analyzing preliminary clinical data from our ongoing Omicron BA.1 monovalent and bivalent strain change trial (study 311). Study 311 achieved its strain-change endpoint using BA.1 as the model omicron subvariant vaccine. However, the magnitude and breadth of the immune responses following boosting with the prototype vaccine reinforces our belief that a strain change may not be required for our technology. No significant benefit was observed for the bivalent formatted vaccine. When evaluating the response to the forward drifted BA.5 omicron subvariant, neither the BA.1 vaccine nor the prototype/BA.1 bivalent vaccine offered any advantage. We expect to leverage these clinical insights to advance additional regulatory approvals of our COVID-19 vaccine for primary, booster, and pediatric indications globally, amidst the ongoing and evolving COVID-19 pandemic.

Additionally, we are developing our quadrivalent nanoparticle influenza vaccine (qNIV) candidate, previously known as NanoFlu, which we previously advanced through a successful Phase 3 study announced in September 2021, demonstrating the utility for a stand-alone influenza vaccine or used in a combination vaccine. We continue to progress our CIC vaccine candidate, which combines NVX-CoV2373 and our qNIV approach. In October 2022, we announced positive results from the Phase 1/2 CIC clinical trial demonstrating the CIC vaccine’s ability to generate both antibody and polyfunctional CD4+ T-cell (lymphocytes that help coordinate the immune response) responses against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and homologous and heterologous influenza strains. We intend to continue the clinical development of CIC with a follow-up trial to begin in late 2022.

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Furthermore, we remain interested in continuing the development of both our RSV Program for respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”) and Matrix-MTM adjuvant collaborations for malaria. There is an ongoing Phase 3 trial being conducted by our partner, Jenner Institute, University of Oxford, for R21, a malaria candidate which is formulated using our Matrix-M™ adjuvant. In September 2022, positive results from an ongoing Phase 1/2b study were published in The Lancet Infectious Diseases reporting safety, immunogenicity, and efficacy results at 12 months following administration of a booster vaccination. A booster dose of R21 formulated with our Matrix-M™ adjuvant at one year following the primary three-dose regimen maintained high efficacy against first and multiple episodes of clinical malaria. The booster vaccine induced antibody concentrations that is related to vaccine efficacy. The trial is ongoing to assess long-term follow-up of the participants and the value of further booster vaccinations.

The pipeline chart below summarizes the core clinical and preclinical development programs that we are focusing on in the near-term.
nvax-20220930_g3.jpg
(1)    Supported by OWS, DoD, CEPI, and BMGF.
(2)    Authorized for provisional approval, CMA, or EUA in select geographies under trade names NuvaxovidTM and CovovaxTM. Received EUA from the U.S. FDA. PREVENT-19, a Phase 3 clinical trial in the U.S. and Mexico; Ongoing PREVENT-19 pediatric expansion in the U.S.; Phase 3 clinical trial in the UK; Ongoing Phase 2b clinical trial in South Africa. We, along with our partners, will have commercial rights in authorized geographies to sell and distribute NVX-CoV2373.
(3) Ongoing Phase 3 strain change trial.
Business Highlights
Third Quarter 2022 and Recent Highlights

Expanded COVID-19 Vaccine in Adult Population Aged 18 and Older

•Nuvaxovid™ booster authorized for emergency use in the U.S., European Union (“EU”), Switzerland, United Arab Emirates (UAE) and New Zealand, with submissions completed to WHO, as well as in Great Britain and South Korea

◦Recommendations provided by U.S. Centers for Disease Control and Prevention (“CDC”), E.U.’s Committee for Medicinal Products for Human Use and Switzerland’s Federal Office of Public Health

•Nuvaxovid™ granted import and use permit in Israel for primary series and as a booster

•Covovax™ granted full product registration in South Africa for primary series

Expanded COVID-19 Vaccine in Adolescent Population Aged 12 Through 17

•Nuvaxovid™ primary series authorized for emergency use in the U.S., EU, Japan, Great Britain, Australia, South Korea, Taiwan, Switzerland, Thailand, UAE and New Zealand, with submissions completed to WHO and in Singapore

◦Recommendation provided by U.S. CDC
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•Nuvaxovid™ granted import and use permit in Israel for primary series and as a booster

COVID-19 Vaccine Manufacturing and Supply

•Delivered over 94 million doses of NVX-CoV2373 globally to date

•Completed submission to add Novavax CZ as an EU manufacturing site

•Solidified manufacturing and supply network ensuring capacity to support ongoing global demand

COVID-19 Clinical Development Program

•Announced topline results from Phase 3 Boosting Trial for NVX-CoV2515, meeting the primary strain-change endpoint and reaffirming that prototype vaccine induces broadly cross-reactive responses, suggesting utility against current and future variants

•PREVENT-19 Phase 3 NVX-CoV2373 homologous booster data support benefits against variants

◦Following a single homologous booster dose, adult participants demonstrated increased anti-spike IgG levels and increased functional antibody levels measured by hACE2 receptor inhibition against Omicron BA.1, BA.2 and BA.5 variants, approximating levels observed in our Phase 3 efficacy studies

◦Robust booster responses were consistent between younger (less than 65 years of age) and older (greater than 65 years of age) adults, and independent of whether the booster dose was administered eight or 11 months after the primary series, offering further evidence of broad utility and duration of response with NVX-CoV2373

◦Adolescent participants following a single booster dose demonstrated neutralizing titers were 2.7-fold higher than those seen with primary vaccination and a broad antibody response against Omicron BA.1, BA.2 and BA.5 variants

•Demonstrated NVX-CoV2373 induced consistent immune responses when boosted on top of mRNA or AD26 vaccines, and achieved primary endpoint of Lot Consistency study for adults aged 18 through 49, demonstrating a consistent manufacturing process

◦When used as a heterologous boost (after either 2 or 3 doses of mRNA OR 1 or 2 doses of AD26) NVX-CoV2373 generated antibody levels previously found to be related to efficacy in the PREVENT-19 Phase 3 trial

•Initiated Phase 2b/3 Hummingbird global clinical trial for NVX-CoV2373 in younger children aged six months through 11 years, enrolling the sentinel cohort in the first group aged six through 11 years in the U.S.

◦Based on initial supportive safety and tolerability data analyzed by an independent Safety and Monitoring Committee, progressed to recruiting the full age cohort

COVID-19-Influenza Combination (CIC) Vaccine Candidate Clinical Development

•Announced positive cellular immunity results of CIC Phase 1/2 trial following initial results announced in April, demonstrating ability to generate immune responses, including both antibody and polyfunctional CD4+ T-cell responses, against SARS-CoV-2 and homologous and heterologous influenza strains

◦Generated robust antibody responses against both prototype and Omicron BA.1 strains of SARS-CoV-2 and influenza antigens

◦Safety and tolerability profile was consistent with standalone NVX-CoV2373 prototype vaccine and quadrivalent influenza vaccine candidate

◦Phase 2 trial expected to begin by the end of 2022

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Sales of Common Stock
During the three months ended March 31, 2022, we sold 2.2 million of shares of our common stock resulting in net proceeds of approximately $179 million, under our most recent At Market Issuance Sales agreement entered in June 2021 (the “June 2021 Sales Agreement”), which allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock. As of September 30, 2022, the remaining balance under our June 2021 Sales Agreement was approximately $318 million.
During the nine months ended September 30, 2021, we sold 2.6 million shares of our common stock resulting in net proceeds of approximately $565 million, under our various At Market Issuance Sales agreements then in effect.
Critical Accounting Policies and Use of Estimates

The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements (unaudited) and the accompanying notes, which have been prepared in accordance with generally accepted accounting principles in the United States.

The preparation of our consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Our critical accounting policies and estimates are included under Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC, and are updated for inventory valuation below.
Inventory Valuation
We periodically analyze our inventories for excess amounts or obsolescence and write down obsolete or otherwise unmarketable inventory to its estimated net realizable value based on assumptions about expected future demand and market conditions. Our assumptions about expected future demand are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory write down that we report in a particular period. Expense incurred related to excess inventory and obsolete inventory is recorded as a component of cost of sales in the consolidated statement of operations.
Recent Accounting Pronouncements Not Yet Adopted
See “Note 2―Summary of Significant Accounting Policies” included in our Notes to Consolidated Financial Statements (under the caption “Recent Accounting Pronouncements”).
Results of Operations
The following is a discussion of the historical financial condition and results of our operations that should be read in conjunction with the unaudited consolidated financial statements and notes set forth in this Quarterly Report.
Three Months Ended September 30, 2022 and 2021
Revenue
Three Months Ended September 30,
20222021Change
Revenue (in thousands):
Product sales$626,091 $— $626,091 
Grants106,273 135,007 (28,734)
Royalties and other2,213 43,837 (41,624)
Total revenue$734,577 $178,844 $555,733 
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Revenue for the three months ended September 30, 2022 was $734.6 million as compared to $178.8 million for the same period in 2021, an increase of $555.7 million. Revenue for the three months ended September 30, 2022 was primarily comprised of revenue from product sales of NVX-CoV2373 and revenue for services performed under the agreement with the U.S. government partnership formerly known as OWS (“OWS Agreement”). Revenue for the three months ended September 30, 2021 was primarily comprised of revenue for services performed under the OWS Agreement and our funding agreements with CEPI. The increase in revenue was due to the commencement of commercial sales of NVX-CoV2373 in 2022, partially offset by decreased development activities under our funding agreements with CEPI.
We expect revenue in 2022 to significantly increase as compared to 2021 due to product sales of NVX-CoV2373 under various supply agreements, sometimes referred to as advance purchase agreements (“APAs”), as a result of multiple global regulatory approvals.
Expenses
Three Months Ended September 30,
20222021Change
Expenses (in thousands):
Cost of sales$434,593 — $434,593 
Research and development304,297 408,195 (103,898)
Selling, general, and administrative122,876 77,793 45,083 
Total expenses$861,766 $485,988 $375,778 
Cost of Sales
Cost of sales was $434.6 million, or 69% of product sales, for the three months ended September 30, 2022, including expense of $249.0 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments. Prior to receiving regulatory approval, we expensed manufacturing costs as research and development expenses. After receiving regulatory approval, we capitalize the costs of production for a particular supply chain when we determine that we have a present right to the economic benefit associated with the product. While we tracked the quantities of our manufactured vaccine product and components, we did not track pre-approval manufacturing costs and therefore the manufacturing cost of our pre-launch inventory produced prior to approval is not reasonably determinable. However, based on our expectations for future manufacturing costs to produce our vaccine product and components inventory, we estimate at September 30, 2022 we had approximately $0.1 billion of commercial inventory that was expensed prior to approval. We expect to utilize the majority of our reduced-cost inventory through 2023. If inventory sold for the three months ended September 30, 2022 was valued at expected standard cost, including expenses related to excess and obsolete inventory, adjusted cost of sales for the period would have been approximately $444.0 million, or 71% of product sales, an adjustment of $9.4 million as compared to cost of sales recognized. The cost of sales to high income countries is expected to be between 15% and 30% of product sales based on our standard cost. The cost of sales as a percentage of product sales may fluctuate in the future as a result of changes to our customer mix or standard costs.
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Research and Development Expenses
Research and development expenses decreased to $304.3 million for the three months ended September 30, 2022 as compared to $408.2 million for the three months ended September 30, 2021, a decrease of $103.9 million primarily due to research and development of coronavirus vaccines, including NVX-CoV2373, NVX-CoV2515, bivalent formulations, and CIC, as summarized in the table below (in thousands):
Three Months Ended September 30,
20222021
Coronavirus vaccines $208,004 $341,600 
Influenza vaccine
3,011 1,656 
Other vaccine development programs843 126 
Total direct external research and development expense211,858 343,382 
Employee expenses45,150 36,574 
Stock-based compensation expense16,107 21,860 
Facility expenses16,770 4,983 
Other expenses14,412 1,396 
Total research and development expenses$304,297 $408,195 
Research and development expenses for coronavirus vaccines for the three months ended September 30, 2022 and 2021, included a benefit of $80.5 million related to previously accelerated manufacturing costs and an expense of $35.8 million related to the acceleration of manufacturing costs, respectively, for leases that we determined were embedded in multiple manufacturing supply agreements with Contract Manufacturing Organizations (“CMOs”) and contract manufacturing and development organizations (“CDMOs”). Pursuant to the Fujifilm Settlement Agreement (see Note 4 to our consolidated financial statements in this Quarterly Report), we are responsible for a Settlement Payment of up to $185.0 million to Fujifilm in connection with cancellation of manufacturing activity at FDBT under the CSA, of which $47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022. The Settlement Payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expense from FDBT manufacturing activity under the CSA prior to the Fujifilm Settlement Agreement and accordingly, during the three months ended September 30, 2022, we recorded a benefit of $98.3 million as Research and development expense. For 2022, we expect total research and development expenses to decrease as compared to 2021, primarily due to capitalization of manufacturing costs during 2022 that were previously recognized as research and development expenses in prior periods, partially offset by research and development expenses related to increased clinical activities as we continue to develop our coronavirus vaccines and other programs.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses increased to $122.9 million for the three months ended September 30, 2022 from $77.8 million for the same period in 2021, an increase of $45.1 million. The increase in selling, general, and administrative expenses is primarily due to an increase in professional fees and marketing costs in support of our NVX-CoV2373 program. For 2022, we expect selling, general, and administrative expenses to increase significantly as compared to 2021 due to increased activities related to supporting our NVX-CoV2373 program and increases in professional fees and marketing costs.
Other Expense
Three Months Ended September 30,
20222021Change
Other Expense (in thousands):
Interest expense$(4,169)$(5,182)$1,013 
Other expense(34,783)(4,064)(30,719)
Total other expense, net$(38,952)$(9,246)$(29,706)
We had total other expense, net, of $39.0 million for the three months ended September 30, 2022 as compared to $9.2 million for the same period in 2021. During the three months ended September 30, 2022 and 2021, other expense was primarily related to losses due to foreign exchange rate activity.
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Income Tax Expense
During the three months ended September 30, 2022 and 2021, we recognized $2.5 million and $6.0 million, respectively, of income tax expense related to federal and state income taxes and foreign withholding tax on royalties.
Net Loss
Three Months Ended September 30,
20222021Change
Net Loss (in thousands, except per share information):
Net loss$(168,613)$(322,431)$153,818 
Net loss per share, basic and diluted$(2.15)$(4.31)$2.16 
Weighted average shares outstanding, basic and diluted78,274 74,745 3,529 
Net loss for the three months ended September 30, 2022 was $168.6 million, or $2.15 per share, basic, as compared to $322.4 million, or $4.31 per share, basic, for the same period in 2021. The decrease in net loss during the three months ended September 30, 2022, was primarily due to the commencement of commercial sales of NVX-CoV2373 in 2022 and a decrease in research and development expense, partially offset by the write-down of excess, obsolete, or expired inventory and losses on firm purchase commitments.
The increase in weighted average shares outstanding for the three months ended September 30, 2022 is primarily a result of sales of our common stock and exercises of stock-based awards in 2022 and 2021.
Nine Months Ended September 30, 2022 and 2021
Revenue
Nine Months Ended September 30,
20222021Change
Revenue (in thousands):
Product sales$1,267,174 $— $1,267,174 
Grants313,348 854,390 (541,042)
Royalties and other43,951 69,700 (25,749)
Total revenue$1,624,473 $924,090 $700,383 
Revenue for the nine months ended September 30, 2022 was $1.6 billion as compared to $924.1 million for the same period in 2021, an increase of $700.4 million. Revenue for the nine months ended September 30, 2022 was primarily comprised of revenue from product sales of NVX-CoV2373 and, to a lesser extent, revenue for services performed under the OWS Agreement. Revenue for the nine months ended September 30, 2021 was primarily comprised of revenue for services performed under the OWS Agreement and our funding agreements with CEPI. The increase in revenue was due to the commencement of commercial sales of NVX-CoV2373 in 2022, partially offset by decreased development activities under the OWS Agreement and our funding agreements with CEPI.
Expenses
Nine Months Ended September 30,
20222021Change
Expenses (in thousands):
Cost of sales$720,874 $— $720,874 
Research and development977,428 1,571,551 (594,123)
Selling, general, and administrative327,028 214,144 112,884 
Total expenses$2,025,330 $1,785,695 $239,635 
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Cost of Sales
Cost of sales was $720.9 million, or 57% of product sales, for the nine months ended September 30, 2022, including expense of $504.3 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments. Prior to receiving approval, we expensed manufacturing costs as research and development expenses. After receiving approval, we capitalize the costs of production for a particular supply chain when we determine that we have a present right to the economic benefit associated with the product. While we tracked the quantities of our manufactured vaccine product and components, we did not track pre-approval manufacturing costs and therefore the manufacturing cost of our pre-launch inventory produced prior to approval is not reasonably determinable. However, based on our expectations for future manufacturing costs to produce our vaccine product and components inventory, we estimate at September 30, 2022 we had approximately $0.1 billion of commercial inventory that was expensed prior to approval. We expect to utilize the majority of our reduced-cost inventory through 2023. If inventory sold for the nine months ended September 30, 2022 was valued at expected standard cost, adjusted cost of sales for the period would have been approximately $883.5 million, or 70% of product sales, an adjustment of $162.6 million as compared to cost of sales recognized. The cost of sales to high income countries is expected to be between 15% and 30% of product sales based on our standard cost. The cost of sales as a percentage of product sales may fluctuate in the future as a result of changes to our customer mix or standard costs.
Research and Development Expenses
Research and development expenses decreased to $977.4 million for the nine months ended September 30, 2022 from $1.6 billion for the same period in 2021, a decrease of $594.1 million, primarily due to decreased development activities relating to coronavirus vaccines, including NVX-CoV2373, NVX-CoV2515, bivalent formulations, and CIC, as summarized in the table below (in thousands):
Nine Months Ended September 30,
20222021
Coronavirus vaccines $697,952 $1,376,921 
Influenza vaccine
6,581 5,950 
Other vaccine development programs1,156 641 
Total direct external research and development expense705,689 1,383,512 
Employee expenses132,069 86,085 
Stock-based compensation expense52,692 70,429 
Facility expenses40,842 11,387 
Other expenses46,136 20,138 
Total research and development expenses$977,428 $1,571,551 
Research and development expenses for coronavirus vaccines for the nine months ended September 30, 2022 and 2021, included a benefit of $147.8 million related to previously accelerated manufacturing costs and an expense of $78.8 million related to the acceleration of manufacturing costs, respectively, for leases that we determined were embedded in multiple manufacturing supply agreements with CMOs and CDMOs. Pursuant to the Fujifilm Settlement Agreement (see Note 4 to our consolidated financial statements in this Quarterly Report), we are responsible for a Settlement Payment of up to $185.0 million to Fujifilm in connection with cancellation of manufacturing activity at FDBT under the CSA, of which $47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022. The Settlement Payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expense from FDBT manufacturing activity under the CSA prior to the Fujifilm Settlement Agreement and accordingly, during the three months ended September 30, 2022, we recorded a benefit of $98.3 million as Research and development expense.

Selling, General, and Administrative Expenses
Selling, general, and administrative expenses increased to $327.0 million for the nine months ended September 30, 2022 from $214.1 million for the same period in 2021, an increase of $112.9 million. The increase in selling, general, and administrative expenses is primarily due to an increase in professional fees and marketing costs in support of our NVX-CoV2373 program.
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Other Expense
Nine Months Ended September 30,
20222021Change
Other Expense (in thousands):
Interest expense$(15,279)$(15,989)$710 
Other expense(53,002)(7,267)(45,735)
Total other expense, net$(68,281)$(23,256)$(45,025)
We had total other expense, net of $68.3 million for the nine months ended September 30, 2022 as compared to $23.3 million for the same period in 2021. During the nine months ended September 30, 2022 and 2021, other expense was primarily related to losses due to foreign exchange rate activity.
Income Tax Expense
During the nine months ended September 30, 2022 and 2021, we recognized $6.6 million and $12.6 million, respectively, of income tax expense related to federal and state income taxes and foreign withholding tax on royalties.
Net Loss
Nine Months Ended September 30,
20222021Change
Net Loss (in thousands, except per share information):
Net loss$(475,690)$(897,467)$421,777 
Net loss per share, basic and diluted$(6.13)$(12.13)$6.00 
Weighted average shares outstanding, basic and diluted77,631 73,972 3,659 
Net loss for the nine months ended September 30, 2022 was $475.7 million, or $6.13 per share, as compared to $897.5 million, or $12.13 per share, for the same period in 2021. The decrease in net loss during the nine months ended September 30, 2022 was primarily due to the commencement of commercial sales of NVX-CoV2373 in 2022 and a decrease in research and development expense, partially offset by decreased revenue under the OWS Agreement and the write-down of excess, obsolete, or expired inventory and losses on firm purchase commitments.
The increase in weighted average shares outstanding for the nine months ended September 30, 2022 is primarily a result of sales of our common stock in 2022 and 2021.
Liquidity Matters and Capital Resources
Our future capital requirements depend on numerous factors including, but not limited to, revenue from our product sales and royalties under licensing arrangements with our strategic partners; funding under our grant agreements; our projected activities related to the development and commercial support of NVX-CoV2373 and variant candidates, including significant commitments under various CRO, CMO, and CDMO agreements; the progress of preclinical studies and clinical trials; the time and costs involved in obtaining regulatory approvals; the costs of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights; and other manufacturing, sales, and distribution costs. We plan to continue developing other vaccines and product candidates, such as our influenza vaccine candidate and potential combination vaccines candidates, which are in various stages of development.
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We have entered into supply agreements, sometimes referred to as APAs, with Gavi, the Vaccine Alliance (“Gavi”); the European Commission (“EC”); and various countries globally. We also have grant and license agreements. As of September 30, 2022, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties under the license agreements, was approximately $4 billion. Failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under our APA agreements may require us to refund portions of upfront payments or result in reduced future payments, which could adversely impact our ability to realize revenue from our unsatisfied performance obligations. The timing to fulfill performance obligations related to grant agreements will depend on the results of our research and development activities, including clinical trials, and delivery of doses. The timing to fulfill performance obligations related to supply agreements will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of the prototype NVX-CoV2373 vaccine under certain of our APAs. The supply agreements typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment, and are applied to billings upon delivery of NVX-CoV2373. Such upfront payments under our supply agreements generally become non-refundable upon our achievement of certain development, regulatory, and commercial milestones.

In addition, we continue to assess our manufacturing needs and intend to modify our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, NVX-CoV2373, and in doing so recognize that significant costs may be incurred. Pursuant to the Fujifilm Settlement Agreement (see Note 4 to our consolidated financial statements in this Quarterly Report), we are responsible for a Settlement Payment of up to $185.0 million to Fujifilm in connection with cancellation of manufacturing activity at FDBT under the CSA, of which $47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022. The Settlement Payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expense from FDBT manufacturing activity under the CSA prior to the Fujifilm Settlement Agreement and accordingly, during the three months ended September 30, 2022, we recorded a benefit of $98.3 million as Research and development expense.

Under the terms of our supply commitment with Gavi, which includes both our APA and the supply obligation of our licensed partner, SIIPL, 1.1 billion doses of NVX-CoV2373 are to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. The Novavax APA contemplates that we will manufacture and distribute 350 million doses. Under that agreement with Gavi, we received an upfront payment of $350 million from Gavi in 2021 and an additional payment of $350 million in the first quarter of 2022 related to our achieving WHO Emergency Use Listing. Although Novavax continues to be prepared to deliver the quantities of NVX-CoV2373 doses to Gavi under the terms of the APA, we were notified by Gavi of its intent to seek to revise the number and timing of doses of NVX-CoV2373 supplied by Novavax under such agreement. Furthermore, Gavi may seek partial or full recovery of the prior nonrefundable payments it has made to Novavax. Our position is that Gavi has no contractual right to recover prior nonrefundable payments if it fails to order the 350 million doses it committed to order. To date, except for an initial order of approximately 2 million doses, Novavax has not received an order from Gavi and the timing and quantities of future orders to deliver NVX-CoV2373 to the COVAX facility are unclear.

In July 2022, we entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) with The Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), which amended and restated in its entirety the SARS-CoV-2 Vaccine Supply Agreement originally entered into in October 2020 (the “Original UK Supply Agreement”). Pursuant to the Original UK Supply Agreement, the Authority agreed to purchase 60 million doses of NVX-CoV2373. Under the Amended and Restated UK Supply Agreement, the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses of NVX-CoV2373, with the number of additional doses contingent on our timely achievement of supportive recommendations from the United Kingdom’s Joint Committee on Vaccination and Immunisation (the “JCVI”). In the event that we are unable to achieve the JCVI supportive recommendations, we may have to repay up to $225.0 million related to the upfront payment we received from the Authority under the Original UK Supply Agreement. As of September 30, 2022, we will be required to repay a minimum of $40.0 million related to the upfront payment. Under the Amended and Restated UK Supply Agreement, the Authority also has the option to purchase up to an additional 44 million doses, in one or more tranches, through 2024.

We have an APA with the EC acting on behalf of various EU member states to supply a minimum of 20 million and up to 100 million initial doses of NVX-CoV2373, with the option for the EC to purchase an additional 100 million doses up to a maximum aggregate of 200 million doses, in one or more tranches, through 2023. In July and August 2022, we were notified by the EC that it was cancelling 5 million doses of its prior commitment originally scheduled for delivery in the first and second quarters of 2022, in accordance with the APA, and reducing the order to 65 million doses. We are in the process of finalizing a revised delivery schedule for the remaining 23 million committed doses under our APA with the EC that were originally scheduled for delivery during the first and second quarters of 2022.

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In July 2022, we entered into a modification to the OWS Agreement that amended the terms of such agreement to provide for (i) an initial delivery to the U.S. government of approximately 3 million doses of NVX-CoV2373 and (ii) any additional manufacture and delivery to the U.S. government up to an aggregate of 100 million doses of NVX-CoV2373 contemplated by the original OWS Agreement (inclusive of the initial batch of approximately 3 million doses) dependent on U.S. government demand, FDA guidance on strain selection, agreement between the parties on the price of such doses, and available funding. Additionally, in July 2022, we entered into a modification to our existing agreement with the DoD that amended the terms of such agreement to provide for the initial delivery of 0.2 million doses of NVX-CoV2373 after receipt of EUA approval from the FDA, with delivery of the remaining 9.8 million doses of NVX-CoV2373 contemplated by the original agreement subject to DoD demand and available funding.

In the nine months ended September 30, 2022, we primarily funded our operations with cash and cash equivalents, upfront payments under APAs, revenue from product sales, royalties under licensing arrangements with our strategic partners, and proceeds from the sale of common stock, together with revenue under the OWS Agreement that supports our NVX-CoV2373 vaccine development activities. We anticipate our future operations to be funded by revenue from product sales, royalties under licensing arrangements with our strategic partners, revenue under our OWS Agreement, our cash and cash equivalents, and other potential funding sources.
We may from time to time seek to retire or purchase, directly or indirectly, our outstanding debt through cash purchases and/or exchanges for equity or debt, in open market purchases, privately negotiated transactions, or otherwise. Such purchases and/or exchanges, if any, will be on such terms and at such prices as we may determine, and will depend on prevailing market conditions, our liquidity requirements, contractual restrictions, and other factors. The amounts involved may be material, which could impact our capital structure, the market for our debt securities, and the price of the indebtedness being purchased and/or exchanged, and affect our liquidity.
As of September 30, 2022, we had $1.3 billion in cash and cash equivalents and restricted cash as compared to $1.5 billion as of December 31, 2021.
The following table summarizes cash flows for the nine months ended September 30, 2022 and 2021 (in thousands):
Nine Months Ended September 30,
20222021Change
Net cash provided by (used in):
Operating activities$(298,121)$665,354 $(963,475)
Investing activities(70,921)116,518 (187,439)
Financing activities133,548 522,424 (388,876)
Effect on exchange rate on cash, cash equivalents, and restricted cash257 (6,208)6,465 
Net increase (decrease) in cash, cash equivalents, and restricted cash(235,237)1,298,088 (1,533,325)
Cash, cash equivalents, and restricted cash at beginning of period1,528,259 648,738 879,521 
Cash, cash equivalents, and restricted cash at end of period$1,293,022 $1,946,826 $(653,804)
Net cash used in operating activities was $298.1 million for the nine months ended September 30, 2022, as compared to net cash provided by operating activities of $665.4 million for the same period in 2021. The decrease in cash provided is primarily due to the application of upfront payments under APAs resulting from sales of NVX-CoV2373 during the nine months ended September 30, 2022 as compared to an increase in cash due to the receipt of upfront payments under APAs during the nine months ended September 30, 2021.
During the nine months ended September 30, 2022 and 2021, our investing activities consisted primarily of capital expenditures and maturities and sale of marketable securities, net of purchases. Capital expenditures for the nine months ended September 30, 2022 and 2021 were $66.0 million and $41.1 million, respectively. For 2022, we expect our capital expenditures to continue to increase due to further development activities for our NVX-CoV2373 program, including the additional build-out of research and development and manufacturing facilities and related equipment, and the build-out of our new corporate office facility.
Our financing activities consisted primarily of sales of our common stock under our At Market Issuance Sales Agreements, payments of finance lease liabilities, and exercise of stock-based awards. In the nine months ended September 30, 2022 and 2021, we received net proceeds of approximately $179 million and $565 million, respectively, from selling shares of common stock through our At Market Issuance Sales Agreements.
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Item 3.    Quantitative and Qualitative Disclosures About Market Risk

We are subject to certain risks that may affect our results of operations, cash flows, and fair values of assets and liabilities, including volatility in foreign currency exchange rates and interest rate movements.

Foreign Currency Exchange Risk

Although we are headquartered in the U.S., our results of operations, including our foreign subsidiaries’ operations, are subject to foreign currency exchange rate fluctuations, primarily the U.S. dollar against the Euro, Pound Sterling, Swedish Krona, and Czech Koruna. This exchange exposure may have a material effect on our cash flow and results of operations, particularly in cases of revenue generated under APAs that include provisions that impact our and our counterparty’s currency exchange exposure. To date, we have not entered into any foreign currency hedging contracts, although we may do so in the future.

We also face foreign currency exchange exposure that arises from translating the results of our global operations to the U.S. dollar at exchange rates that have fluctuated from the beginning of the period. While the financial results of our global activities are reported in U.S. dollars, the functional currency of our foreign subsidiaries is generally their respective local currency. Fluctuations in the foreign currency exchange rates of the countries in which we do business will affect our operating results, often in ways that are difficult to predict. A 10% decline in the foreign exchange rates (primarily against the U.S. dollar) relating to our foreign consolidated subsidiaries would result in a decline of stockholders’ equity of approximately $17 million as of September 30, 2022.

Market and Interest Rate Risk

The primary objective of our investment activities is preservation of capital, with the secondary objective of maximizing income.

Our exposure to market risk is primarily confined to our investment portfolio, which historically has been classified as available-for-sale. We do not believe that a change in the market rates of interest would have any significant impact on the realizable value of our investment portfolio. Changes in interest rates may affect the investment income we earn on our marketable securities when they mature and the proceeds are reinvested into new marketable securities and, therefore, could impact our cash flows and results of operations.

Interest and dividend income is recorded when earned and included in investment income. Premiums and discounts, if any, on marketable securities are amortized or accreted to maturity and included in investment income. The specific identification method is used in computing realized gains and losses on the sale of our securities.

Our convertible senior unsecured notes have a fixed interest rate, and we have no additional material debt. As such, we do not believe that we are exposed to any material interest rate risk as a result of our borrowing activities.
Item 4.    Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the assistance of our chief executive officer and chief financial officer, has reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of September 30, 2022. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving such control objectives. Based on the evaluation of our disclosure controls and procedures as of September 30, 2022, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
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Changes in Internal Control over Financial Reporting

Our management, including our chief executive officer and chief financial officer, have evaluated changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2022, and have concluded that there have been no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1.    Legal Proceedings
Stockholder Litigation
On November 12, 2021, Sothinathan Sinnathurai filed a purported securities class action in the U.S. District Court for the District of Maryland against Novavax and certain members of senior management, captioned Sothinathan Sinnathurai v. Novavax, Inc., et al., No. 8:21-cv-02910-TDC (the “Sinnathurai Action”). On January 26, 2022, the court entered an order designating David Truong, Nuggehalli Balmukund Nandkumar, and Jeffrey Gabbert as co-lead plaintiffs in the Sinnathurai Action. The co-lead plaintiffs filed a consolidated amended complaint on March 11, 2022, alleging that the defendants made certain purportedly false and misleading statements concerning the Company’s ability to manufacture NVX-CoV2373 on a commercial scale and to secure the vaccine’s regulatory approval. The amended complaint defines the purported class as those stockholders who purchased Novavax securities between February 24, 2021 and October 19, 2021. On April 25, 2022, defendants filed a motion to dismiss the consolidated amended complaint. On June 9, 2022, the co-lead plaintiffs filed an opposition to the motion to dismiss and on July 11, 2022, the Company filed a reply brief. The matter is now fully briefed. The Court has not indicated whether it intends to schedule any hearing on the motion before issuing a ruling.

After the Sinnathurai Action was filed, six derivative lawsuits were filed: (i) Robert E. Meyer v. Stanley C. Erck, et al., No. 8:21-cv-02996-TDC (the “Meyer Action”), (ii) Shui Shing Yung v. Stanley C. Erck, et al., No. 8:21-cv-03248-TDC (the “Yung Action”), (iii) William Kirst, et al. v. Stanley C. Erck, et al., No. 8:22-cv-00024-TDC (the “Kirst Action”), (iv) Amy Snyder v. Stanley C. Erck, et al., No. 8:22-cv-01415-TDC (the “Snyder Action”), (v) Charles R. Blackburn, et al. v. Stanley C. Erck, et al., No. 1:22-cv-01417-TDC (the “Blackburn Action”), and (vi) Diego J. Mesa v. Stanley C. Erck, et al. (the “Mesa Action”). The Meyer, Yung, Snyder, and Blackburn Actions were filed in the U.S. District Court for the District of Maryland. The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the U.S. District Court for the District of Maryland by the defendants. The Mesa Action was filed in the Delaware Court of Chancery. The derivative lawsuits name members of the board of directors and certain members of senior management as defendants. Novavax is deemed a nominal defendant. The plaintiffs assert derivative claims arising out of substantially the same alleged facts and circumstances as the Sinnathurai Action. Collectively, the derivative complaints assert claims for breach of fiduciary duty, insider selling, unjust enrichment, violation of federal securities law, abuse of control, waste, and mismanagement. Plaintiffs seek declaratory and injunctive relief, as well as an award of monetary damages and attorneys’ fees.

On July 21, 2022, the Court issued a memorandum opinion and order remanding the Kirst Action to state court. On February 4, 2022, the Court entered an order consolidating the Meyer and Yung Actions (the “First Consolidated Derivative Action”). The plaintiffs in the First Consolidated Derivative Action filed their consolidated derivative complaint on April 25, 2022. On May 10, 2022, the Court entered an order in the First Consolidated Derivative Action granting the parties’ request to stay all proceedings and deadlines pending the earlier of dismissal or the filing of an answer in the Sinnathurai Action. On June 10, 2022, the Snyder and Blackburn Actions were filed. On October 5, 2022, the court entered an order granting a request by the plaintiffs in the First Consolidated Derivative Action and the Snyder and Blackburn Actions to consolidate all three actions and appoint co-lead plaintiffs and co-lead and liaison counsel (the “Second Consolidated Derivative Action”). The co-lead plaintiffs in the Second Consolidated Derivative Action will designate an operative complaint or file a consolidated amended complaint by November 21, 2022. On August 30, 2022, the Mesa Action was filed. On October 3, 2022, the court entered an order granting the parties’ request to stay all proceedings and deadlines in the Mesa Action pending the earlier of dismissal of the Sinnathurai Action or the filing of an answer to the operative complaint in the Sinnathurai Action.

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On February 26, 2021, a Novavax stockholder named Thomas Golubinski filed a derivative complaint against members of the Novavax board of directors and members of senior management in the Delaware Court of Chancery (the “Court”), captioned Thomas Golubinski v. Richard H. Douglas, et al., No. 2021-0172-JRS. Novavax is deemed a nominal defendant. Golubinski challenged equity awards made in April 2020 and in June 2020 on the ground that they were “spring-loaded,” that is, made at a time when such board members or members of senior management allegedly possessed undisclosed positive material information concerning the Company. The complaint asserted claims for breach of fiduciary duty, waste, and unjust enrichment. The plaintiff sought an award of damages to the Company, an order rescinding both awards or requiring disgorgement, and an award of attorneys’ fees incurred in connection with the litigation. On May 10, 2021, the defendants moved to dismiss the complaint in its entirety. On June 17, 2021, the Company’s stockholders voted FOR ratification of the April 2020 awards and ratification of the June 2020 awards. Details of the ratification proposals are set forth in the Company’s Definitive Proxy Statement filed with the SEC on May 3, 2021. The results of the vote were disclosed in the Company’s Current Report on Form 8-K filed with the SEC on June 24, 2021. Thereafter, the plaintiff stipulated that, as a result of the outcome of the June 17, 2021 vote, the plaintiff no longer intends to pursue the lawsuit or any claim arising from the April 2020 and June 2020 awards. On August 23, 2021, the plaintiff filed a motion seeking an award of attorneys’ fees and expenses, to which the defendants filed an opposition. The motion was argued before the Court on October 18, 2022. The same day, the Court issued a bench ruling denying the plaintiff’s fee application in its entirety and entered an order to that effect. Under a prior Court order, the case was automatically dismissed with prejudice upon denial of the plaintiff’s fee application.

Par Sterile Products, LLC Arbitration
On March 29, 2022, Par Sterile Products, LLC (“Par”) submitted a demand for arbitration against the Company with the American Arbitration Association, alleging that the Company breached certain provisions of the Manufacturing and Services Agreement (“MSA”) that the Company entered into with Par in September 2020 to provide fill-finish manufacturing services for NVX-CoV2373. The matter is at a preliminary stage and therefore the potential loss is not reasonably estimable. The parties are engaged in discovery and arbitration is scheduled for July 2023. While the Company maintains that no breach of the MSA has occurred and intends to vigorously defend the matter, if the final resolution of the matter is adverse to the Company, it could have a material impact on the Company's financial position, results of operations, or cash flows.

General

We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flows.
Item 1A.    Risk Factors
Information regarding risk and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the SEC on March 1, 2022, and Part II, Item 1A. “Risk Factors” of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022, which was filed with the SEC on August 9, 2022. There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022.
Item 5.    Other Information
On July 1, 2022, Novavax, Inc. (the “Company”) entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) with The Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), which amended and restated in its entirety the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the parties.
The description of the Amended and Restated UK Supply Agreement set forth in Part II, Item 5. “Other Information” of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 is incorporated herein by reference.
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Item 6.    Exhibits
3.1
3.2
3.3
3.4
10.1*±
10.2*±
10.3*±
10.4*±
10.5*±
10.6*±
10.7*±
10.8*±
31.1*
31.2*
32.1*
32.2*
101
The following financial information from our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, formatted in Inline Extensible Business Reporting Language (Inline XBRL): (i) the Consolidated Statements of Operations for the three- and nine-month periods ended September 30, 2022 and 2021, (ii) the Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021, (iii) the Consolidated Statements of Comprehensive Income (Loss) for the three- and nine-month periods ended September 30, 2022 and 2021, (iv) the Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three- and nine-month periods ended September 30, 2022 and 2021, (v) the Consolidated Statements of Cash Flows for the three- and nine-month periods ended September 30, 2022 and 2021, and (vi) the Notes to Consolidated Financial Statements.
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
___________________________________
*Filed or furnished herewith.
±    Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
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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: November 9, 2022By:/s/ Stanley C. Erck
Stanley C. Erck
President and Chief Executive Officer
(Principal Executive Officer)
Date: November 9, 2022By:/s/ James P. Kelly
James P. Kelly
Executive Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)



















40
Exhibit 10.1

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

[***]
[***]
EXECUTION VERSION

DATED 22 OCTOBER 2020
NOVAVAX, INC.
AND
THE SECRETARY OF STATE FOR BUSINESS, ENERGY AND INDUSTRIAL STRATEGY
AMENDED AND RESTATED
SARS-COV-2
VACCINE SUPPLY AGREEMENT AS OF 1 JULY
2022
** NON-BINDING/SUBJECT TO CONTRACT AND HMG APPROVALS PROCESS **


CONTENTS
Clause    Page
i

THIS AGREEMENT (“Agreement”) is amended, restated and entered into as of 1 July 2022 (the “Amendment Date”) but is made with effect from the Effective Date by and between:
(1)    NOVAVAX, INC., a corporation established under the laws of the state of Delaware in the US with its primary business address at 21 Firstfield Road, Gaithersburg, MD 20878 (“Novavax”); and
(2)    THE SECRETARY OF STATE FOR BUSINESS, ENERGY AND INDUSTRIAL STRATEGY, acting on behalf of the Crown, whose principal office is at 1 Victoria Street, London, SW1H 0ET (the “Authority”),
(each a “Party”, and collectively the “Parties”).
INTRODUCTION
(A)    Novavax has discovered and has been actively pursuing the clinical development of the Candidate within the Field in order to file for and secure a Marketing Authorisation for the Product with the indication in the Field before the Licensing Authority.
(B)    Novavax will establish a UK-located supply chain for the Product to the extent set forth in this Agreement, including the supply of Antigen from Fujifilm.
(C)    Fill/finish and labelling services for such Antigen manufactured by Fujifilm will be undertaken by any of the Facilities listed in Schedule 2, which may include [***] and [***].
(D)    The Authority, on behalf of the Crown, wishes to advance order and secure priority supplies of the Product, together with other vaccines and other therapeutic products, as part of its national and international strategy towards vaccination against, treatments for, and mitigation of the global impact arising from the spread of SARS-CoV-2.
(E)    Subject to Novavax actively pursuing Development of the Product, establishing the UK-located supply chain as set forth in this Agreement, and maintaining Marketing Authorisation for the Product in the Territory, the Authority wishes to have Novavax Manufacture and supply the Product in accordance with the Authority’s requirements as stated herein.
(F)    Novavax is willing and, notwithstanding Novavax’ other agreements or funding terms with any Third Party (including the Funding Entities), able to undertake the Development and Manufacture of the Products and supply to the Authority in accordance with the terms and conditions of this Agreement.
(G)    The Parties intend that this amended and restated Agreement replaces the version of the previous Agreement but that it has full force and effect as if it was entered into on 22 October 2020 in full substitution of the original version of the Agreement.



IT IS AGREED that:
1.DEFINITIONS
1.1In this Agreement, the following words and expressions shall have the following meanings:
“Additional Order” has the meaning given in clause 7.10;
“Adjuvant” means Novavax’ proprietary Matrix-M™ adjuvant;
“Administering Entity” means any person responsible for administering or having administered the Product including all Health Service Bodies;
“Affiliate” means, with respect to (i) Novavax, any Person that Controls, is Controlled by or is under common Control with Novavax from time to time; (ii) any Third Party, any Person that Controls, is Controlled by or is under common Control with that Third Party from time to time; and (iii) Authority, any Central Government Body;
“Antigen” means material made using Novavax’ technology intended to promote an immunological response or reaction within the Field which is incorporated in Novavax’ vaccine candidate NVX-CoV2373;
“Applicable Laws” means laws, rules, orders, regulations, ordinances, treaties, directives, Applicable Standards, rules of national stock exchanges and any other rules or regulations promulgated by or otherwise having the force of law of any Governmental Authority or Regulatory Authority in each case in any relevant or applicable geographical area and/or over any class of persons;
“Applicable Standards” shall mean all applicable cGxP requirements and guidelines including those issued by the Licensing Authority;
“Authorised Agent” means any authorised agent appointed by the Authority as notified to Novavax in writing;
“Baselines” means those baselines and targets set against the applicable KPIs set out in Schedule 5;
“Breaching Party” has the meaning given in clause 25.3.1;
“Business Continuity Event” means any event or issue that could impact on the operations of Novavax, its Affiliates and Subcontractors, and the ability of Novavax to supply the Product including, without limitation, any pandemic, any Force Majeure event, and any circumstances, events, changes or requirement related to the withdrawal of the UK (or any part of it) from the European Union;
“Business Continuity Plan” means Novavax’ business continuity plan which includes its plans for continuity of the Development, Manufacture and supply of the Product during any Business Continuity Event;
“Business Day” means any day that is not a Saturday, Sunday or public holiday in London, England or Washington, DC;
2

“Candidate” means Novavax’ vaccine candidate NVX-CoV2373, consisting of the Antigen and including the Adjuvant, as described more fully in Schedule 1, as intended for the prophylaxis and vaccination against SARS-CoV-2 in humans;
[***]
[***]
“Central Government Body” means a body listed in one of the following sub-categories of the UK’s Central Government classification of the Public Sector Classification Guide, as published and amended from time to time by the Office for National Statistics: (i) Government Department; (ii) Non-Departmental Public Body Assembly Sponsored Public Body (advisory, executive, or tribunal); (iii) Non- Ministerial Department; or (iv) Executive Agency;
“Certificate of Analysis” means the certificate of analysis to accompany each delivery of Product Delivered to the Authority or Authorised Agent, which certifies that the Product has been Manufactured, tested and released in compliance with its Specification, Applicable Standards and Applicable Laws.
“cGCP” or “GCP” means current good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of human clinical trials, including as described in the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), Directive 2001/20/EC and the standards required under Directive 2005/28/EC;
“cGLP” or “cGLP” means current good laboratory practices generally accepted within the pharmaceutical industry to promote the quality and integrity of data generated in laboratory testing and to prevent misleading or fraudulent practices, including those practices described in the Good Laboratory Practices Regulations 1999 and Directive 2004/10/EC;
“cGMP”, “GMP” or “Good Manufacturing Practice” means the then-current principles and guidelines of good manufacturing practice and general biologics products standards contained in Applicable Laws and guidance including: (i) Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use; (ii) Directive 2001/83/EC laying down the principles and guidelines of good manufacturing practice for medicinal products; (iii) further guidance as published by the European Commission in Volume 4 of “The Rules Governing Medical Products in the European Community”; and (iv) ICH Q7 Guideline, “The Rules Governing Medicinal Products in the European Union”, Volume 4, Part II, in each case as may be amended from time to time;
“cGVP” or “GVP” means current principles and guidelines of good pharmacovigilance practice for medicinal products for human use, as set forth in UK Human Medicines Regulation 2012, Directive 2001/83/EC, Commission Implementing Regulation No 520/2012 and the EMA’s Guideline on Good Pharmacovigilance Practice;
“cGxP” or “GxP” means cGMP, cGCP, cGLP and cGVP;
“Clinical Trials” means the clinical trials required to be undertaken for the purposes of securing a Marketing Authorisation for the Product in the Territory for the indication in the Field;
3

“Commercially Reasonable Efforts” means, with respect to the efforts, expertise and resources to be expended by (i) Novavax with respect to the achievement of an applicable obligation or objective under this Agreement, those diligent, professional and good faith efforts, expertise and resources that are normally and customarily used, engaged or otherwise expended or deployed by a competent pharmaceutical company of a similar size or resource as Novavax for the achievement of the same or similar objective on a timely basis having regard to the urgent need for a vaccine to end a global pandemic; or (ii) the Authority with respect to the achievement of an applicable obligation or objective under this Agreement, those diligent, professional and good faith efforts, expertise and resources that a diligent government, with similar resources as Authority, desirous of achieving a result would use to achieve the same or similar objective on a timely basis;
“Comparative Purchaser” means the following “high income economies” as defined by the World Bank as of the Effective Date: the member states of the European Union, Australia, Singapore and Saudi Arabia;
“Conditional Doses” has the meaning given in clause 7.4;
“Conditional Order” has the meaning given in clause 7.4;
“Confidential Information” means any business, commercial or technical information (in whatever form or media) of either Party that is marked or otherwise indicated as confidential when disclosed or would otherwise be regarded as confidential by a reasonable business person relating to the business, affairs, technologies, products, customers, clients or suppliers of that Party or its Affiliates which is provided by or on behalf of one Party to the other Party pursuant to this Agreement or to which a Party obtains access as a consequence of entering into or performing this Agreement (in each case whether before, on, or after the Effective Date).
For the avoidance of doubt, Confidential Information includes: (i) any information or materials possessed or developed by either Party or their respective Affiliates, whether possessed or developed before, on, or after the Effective Date, in relation to the Product and/or services provided hereunder (including know-how, processes, techniques, specifications, reports, analyses, sources of supply, marketing plans, sales strategies and pricing information), except for such information that is demonstrably non- confidential in nature; and (ii) any confidential information disclosed by a Party pursuant to the confidentiality agreement dated 1 June 2020, which shall be deemed Confidential Information of that Party disclosed under this Agreement. The terms of this Agreement (but not its existence) will be regarded as the Confidential Information of both Parties;
“Conforming Product” means Product that has been Manufactured in accordance with, and meets the requirements of, clause 5.14;
“Control” means: (i) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; (ii) to own, directly or indirectly, fifty per cent. (50%) or more of the outstanding voting securities or other ownership interest of such Person; or (iii) in the case of a partnership, control of the general partner, and “Controls” and “Controlled” shall be construed accordingly;
“Crown” means the government of the UK (including the Northern Ireland Assembly and Executive Committee, the Scottish Government and the Welsh Assembly Government), including, but not limited to, government ministers, government departments, government and particular bodies, and government agencies;
4

“Cure Period” has the meaning given in clause 25.3.1;
“Data Protection Act” means the Data Protection Act 2018 implementing the GDPR;
“Defect” or “Defective” means, in respect of a Product, that it is not compliant with the Specification, Marketing Authorisation (or Emergency Use Authorisation as applicable), Applicable Standards, Minimum Remaining Shelf Life at the time of Delivery, or Applicable Laws, Documentation, batch records, or Applicable Laws;
“Delivery” means delivery (by or on behalf of Novavax) of Conforming Product pursuant to an Order to the Delivery Location in accordance with clause 8.4.1 (and “Delivered” and “Deliver” shall be construed accordingly);
“Delivery Location” means the cold chain storage facility within the Territory, as such facility may be notified in writing to Novavax forty-five (45) days in advance;
“Delivery Schedule” means: (i) for the Firm Order, the quantities and dates for Delivery as set out in clause 7.3; (ii) for the Conditional Order, the quantities and dates for Delivery as set out in clauses 7.6 and 7.7; and (iii) for each Additional Order, the schedule for delivery by certain dates of the applicable quantities of Product agreed between the Parties pursuant to clause 7.11.1; in each of cases (i), (ii) and (iii) as may be updated by agreement between the Parties via the Overview Committee in accordance with clauses 8.2 and 8.5.
“Development” means all activities necessary to develop the Product and support and maintain the grant of a Marketing Authorisation (and, if applicable, Emergency Use Authorisation) for the Product in the Territory in the Field;
“Development Activities” means the development activities to be undertaken by or on behalf of Novavax in respect of the Product as set out in the Development and Manufacturing Plan;
“Development and Manufacturing Plan” means the plan and estimated timeline setting out in reasonable and appropriate detail the activities to be undertaken by or on behalf of Novavax in relation to the Development and Manufacture of Product as initially set out in Schedule 4 and as may be periodically updated from time to time in accordance with clauses 4.2.2 and 5.2.2 in each case to meet the objectives of this Agreement to deliver a safe and effective vaccine in the Field for the population in the Territory, including:
(a)a high-level clinical and regulatory plan;
(b)a high-level manufacturing plan including supply chain establishment and management;
(c)a high-level regulatory plan and pathway proposed to secure the Marketing Authorisation (including any Emergency Use Authorisation) for the Product in the Territory with the indication in the Field including estimated timelines; and
(d)the Key Performance Indicators in relation to the foregoing;
“Devolved Administrations” means the devolved administrations of Scotland, Wales and Northern Ireland (the Scottish Parliament, the Welsh Assembly and the Northern Ireland Assembly);
5

“Documentation” has the meaning given in clause 8.10;
“Dose” means a single individual dose of Product;
“DOTAS” means the Disclosure of Tax Avoidance Schemes rules which require a promoter of tax schemes to tell HM Revenue and Customs of any specified notifiable arrangements or proposals and to provide prescribed information on those arrangements or proposals within set time limits as contained in Part 7 of the Finance Act 2004 and in secondary legislation made under vires contained in Part 7 of the Finance Act 2004 and as extended to National Insurance Contributions by the National Insurance Contributions (Application of Part 7 of the Finance Act 2004) Regulations 2012, SI 2012/1868 made under S.132A Social Security Administration Act 1992;
“Early Pre-Payment Refund” has the meaning given in clause 14.2;
“Effective Date” means 22 October 2020;
“Emergency Use Authorisation” means any emergency use approval issued pursuant to Regulation 174 of the Human Medicines Regulations 2012 (or any replacement or superseding legislation);
“Facilities” means each and all of the facilities used in respect of the Manufacturing of the Product, including those identified in Schedule 2;
“Field” means the vaccination against SARS-CoV-2;
“Firm Order” has the meaning given in clause 7.3;
“Force Majeure” means any events beyond a Party’s reasonable control, subject to that Party having taken all reasonable steps (both anticipatory and reactionary) to avoid or mitigate such risks, such as labour disturbances or labour disputes of any kind, accidents, failure of any governmental approval required for full performance, civil disorders or commotions, war, acts of terrorism, acts of God, pandemics other than the SARS-CoV-2 Pandemic, energy or other conservation measures, explosions, failure of utilities, mechanical breakdowns, material shortages, default of suppliers or subcontractors, theft, or other occurrences. For the avoidance of doubt, (i) the withdrawal of the UK from the European Union and any related circumstances, events, changes or requirements; and (ii) the pandemic declared in respect of SARS-CoV-2; shall not be deemed an event of Force Majeure (the “SARS-CoV-2 Pandemic”);
“Fraud” any offence under Applicable Laws creating offences in respect of fraudulent acts, including any fraudulent acts in relation to this Agreement, or defrauding, attempting to defraud or conspiring to defraud the Crown;
“Fujifilm” means Fujifilm Diosynth Biotechnologies UK Limited having its facilities at Billingham, Teesside, UK;
“Funding Entity(ies)” means each of (i) The Coalition for Epidemic Preparedness Innovations and (ii) the U.S. Government;
“GDPR” means the General Data Protection Regulation (Regulation (EU) 2016/679);
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“General Anti-Abuse Rule” means: (i) the legislation in Part 5 of the Finance Act 2013; and (ii) any future legislation introduced into Parliament to counteract tax advantages arising from abusive arrangements to avoid national insurance contributions;
“Governmental Authority” means any government, supra-national, regional, regulatory or administrative body, authority, board, commission or agency, including any corresponding foreign agency or any instrumentality or officer acting in an official capacity of any of the foregoing, including any court, tribunal or judicial or arbitral body, or any committee exercising any executive, legislative, regulatory or administrative functions of government, whether local or national, including the Regulatory Authorities;
“Government Intervention” has the meaning given in clause 8.8;
“Halifax Abuse Principle” means the principle explained in the CJEU Case C-255/02 Halifax and others;
“Health Service Body” means, in so far as they are involved in the administration, distribution or handling of the Product:
(a)the Department of Health and all divisions and agencies thereof and any independent NHS board or similar body that may be established including regional agencies of such board;
(e)a GP (being a medical practitioner providing general medical services or personal medical services under the National Health Service Act 2006 (c.41) (whether operating in partnership with others or not));
(f)health service bodies referred to in section 9 of the National Health Service Act 2006 (c.41);
(g)the Secretary of State for Health;
(h)any care trust as defined in section 77 of the National Health Service Act 2006 (c.41);
(i)any NHS foundation trust listed in the register of NHS foundation trusts maintained pursuant to section 39 of the National Health Service act 2006 (c.41);
(j)any body replacing or providing similar or equivalent services to any of the above in any area of the UK including any bodies established pursuant to the Health and Social Care Act 2012 including but not limited to NHS England; and
(k)any statutory successor to any of the above;
“Indemnifying Party” has the meaning given in clause 21.7;
“Indemnitee” has the meaning given in clause 21.7;
“Indirect Tax” means value added, sales, consumption, goods and services taxes or other similar taxes required by Applicable Law to be disclosed as a separate item on the relevant invoice including, for the avoidance of doubt, any tax imposed in compliance with the Council Directive of 28 November 2006 on the common system of value added tax (Directive 2006/112);
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“Initial Term” has the meaning given in clause 25.1;
“Intellectual Property Rights” means all patent rights, supplemental protection certificates and patent term extensions, trademarks, copyrights, design rights, database rights, domain names, rights in inventions, confidential information, know-how, trade names, business names, get-up, logos and trade dress, and all other rights in the nature of intellectual property rights (whether registered or unregistered) and all applications and rights to apply for the above, anywhere in the world in each case for their full term and any extension thereto;
“IT Media” has the meaning given in clause 20.16;
“JCVI” means the Covid-19 subcommittee of the Joint Committee on Vaccination and Immunisation that is responsible for advising Health Service Bodies on immunisation, or any replacement or successor committee thereto;
“KPI” or “Key Performance Indicators” means the Key Performance Indicators set out in the Development and Manufacturing Plan, Schedule 3, Schedule 4 and Schedule 5;
“Labelling” means all labels, package inserts (including patient information leaflets), carton imprints and all other markings on packaging for the Product that are defined as labels or labelling under the Specifications or otherwise required under Applicable Laws to market or commercialise the Product for use;
“Licensing Authority” means: (i) the MHRA; and (ii) if it has authority under the Applicable Laws of the Territory to grant a Marketing Authorisation that has full legal force in the Territory to authorise commercial use of the Product in the Territory after its Delivery hereunder, the European Commission following assessment of the relevant Marketing Authorisation applicable by the European Medicine Agency (“EMA”) or any successor agency thereto with the same authority in the Territory;
“Losses” means any and all liabilities, claims, demands, causes of action, damages, losses, costs and expenses, including interest, penalties and reasonable legal and professional fees and disbursements;
“Loss of Supply” has the meaning given in clause 8.8;
“Manufacture”, “Manufactured” or “Manufacturing” means all activities involved in or relating to, as applicable, the manufacturing, quality control testing (including in- process, release and stability testing), processing, Labelling, releasing, packaging, storage and transport of the Product immediately prior to supply to the Authority hereunder;
“Marketing Authorisation” means the Regulatory Approval required under Applicable Laws in the Territory to place the Product on the market for human use outside of clinical trials but excluding any pricing or reimbursement approvals;
“MHRA” means the Medicines and Healthcare products Regulatory Agency or any successor agency thereto;
“Minimum Remaining Shelf Life” means the remaining period of time that the Product may be used pursuant to its Labelling at the date of Delivery of the Product to the Authority, which period shall be no less than the maximum shelf life of the Product as specified in the Marketing Authorisation less four (4) months;
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“Novavax Facilities” means those Facilities which are operated or owned by Novavax or its Affiliates as identified in Schedule 2 under the heading “Novavax Facilities”;
“Novavax Representatives” has the meaning given in clause 17.1;
“Occasion of Tax Non-Compliance” means:
(b)any tax return of Novavax submitted to a Relevant Tax Authority on or after 1 October 2012 is found, on or after 1 April 2013, to be incorrect as a result of:
(i)a Relevant Tax Authority successfully challenging Novavax under the General Anti-Abuse Rule or the Halifax Abuse Principle or under any tax rules or legislation that have an effect equivalent or similar to the General Anti-Abuse Rule or the Halifax Abuse Principle; or
(ii)the failure of an avoidance scheme which Novavax was involved in, and which was, or should have been, notified to a Relevant Tax Authority under the DOTAS or any equivalent or similar regime; or
(c)any tax return of the Novavax submitted to a Relevant Tax Authority on or after 1 October 2012 gives rise, on or after 1 April 2013, to a criminal conviction in any jurisdiction for tax related offences which is not spent at the Effective Date or to a civil penalty for fraud or evasion;
“Orders” means each of the Priority Order and any Additional Orders;
“Oversight Committee” means the joint committee established by the Parties in accordance with clause 2;
“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association joint venture, Governmental Authority, or similar entity, institution, body or organisation, including a Regulatory Authority;
“Personal Data” shall have the same meaning as defined in the Data Protection Act;
“Personnel” means the employees, officers, agents and contractors of a Party (or where the context requires, those of a Party’s Affiliates);
“Pre-Payment” means [***];
“Pre-Payment Refund” has the meaning given in clause 14.2.4;
“Price” means:
(l)[***]; and
(d)for any Doses beyond the first [***] Doses [***] of Conforming Product supplied pursuant to this Agreement, at a price per Dose to be agreed by the Parties (acting reasonably and in good faith) in writing in advance of an Additional Order being placed.
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(e)For clarity, the Price stated under clause (a) applies to any orders for the same Product as supplied under this Agreement, including any monovalent Variant Product that may be substituted for such Product under clause 7.13. For any multi-valent Variant Product or other dosage presentations of Product requested by the Authority other than in the presentation form (being number of Doses per vials) as specified in Schedule 1, the Parties will agree on a Price in writing. For the avoidance of doubt, other labelling changes, and secondary and tertiary packaging changes, or substitution of Variant Product for the Product shall not constitute a change in presentation form.
“Priority Order” has the meaning given in clause 7.1;
“Product” means the Candidate Developed and being Developed, including in accordance with the Development and Manufacturing Plan, and presented in final formulated, labelled and finished form, for the prophylaxis and vaccination against SARS-CoV-2 in humans, known as “NVX-CoV2373” or “Nuvaxovid”, as may be varied from time to time to mean any Variant Product specified under a Variant Substitution Notice in accordance with clause 7.13;
“Project Manager” has the meaning given in clause 2.1;
“Reduced Volume Refund” has the meaning given in clause 7.17;
“Regulatory Approval” means all licences, registrations, authorisations and approvals (including approvals of CTAs, MAAs, supplements and amendments, labelling approvals) issued by any Regulatory Authority which are required for the use, Development, Manufacture and commercialisation of the Product;
“Regulatory Authority” means any Governmental Authority that is concerned with the safety, efficacy, reliability, Manufacture, investigation, sale or marketing of the Product, including the MHRA and its successors and its equivalents and their successors in the Territory;
“Relevant Tax Authority” means HM Revenue & Customs;
“Representation” has the meaning given in clause 34.10;
“Representatives” has the meaning given in clause 20.2;
“Restrictive Population Group” means any population group that is considered, when compared to the general population as a whole, to be a minority group (being a group comprising less than one million (1,000,000) members in the UK), such as those groups of individuals who are intolerant to RNA-vaccines, or any group of individuals who, due to medical status, are considered immunosuppressed or immunocompromised;
“SARS-CoV-2 Pandemic” has the meaning given in the definition of “Force Majeure”;
“Specification” means the written specifications for the Manufacture, processing, packaging, labelling, testing and testing procedures, shipping, storage and supply of the Product, including characteristics, quality and processing of the Product as set out in Schedule 1, as such specifications may be amended or replaced from time to time as permitted under the Development and Manufacturing Plan or otherwise under this Agreement, and ultimately as compliant and set forth with the applicable Marketing
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Authorisation (and, if applicable, an Emergency Use Authorisation) for the Product granted by the Licensing Authority;
“Subcontractor” has the meaning given in clause 34.7.1;
“Term” has the meaning given in clause 25.1;
“Terminating Party” has the meaning given in clause 25.3;
“Territory” means the UK;
“Third Party” means any Person other than Novavax, the Authority and their respective Affiliates and permitted successors and assigns;
“Trigger” has the meaning given in clause 7.5;
“UK” means the United Kingdom of Great Britain and Northern Ireland;
“Variant Product” has the meaning given in clause 7.13;
“Variant Substitution Notice” has the meaning given in clause 7.13;
“VAT” means: (i) any Indirect Tax chargeable under or pursuant to Council Directive 2006/112/EC of the European Union; or (ii) any value added, turnover, sales, use or distribution Indirect Tax, or Indirect Tax of a like nature in any jurisdiction outside the European Union; and
“Wilful Misconduct” means conduct which constitutes an act or omission which is (i) reckless; (ii) intentionally aimed at achieving a wrongful purpose; or (iii) made in disregard of a known, reasonably anticipated or obvious risk.
1.1In this Agreement, the following rules of interpretation shall apply:
1.2.1the words “hereof”, “herein”, “hereto” and “hereunder”, and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement;
1.2.2when a reference is made in this Agreement to a clause or schedule, such reference is to a clause of or a schedule to this Agreement respectively, and all schedules to this Agreement form a part hereof for all purposes;
1.2.3the table of contents and headings of this Agreement are for convenience only and shall not affect the construction of this Agreement;
1.2.4any reference to an English statutory provision or English legal term for any action, remedy, method of judicial proceeding, document, legal status, court, official or any other legal concept or thing or Applicable Law shall, in respect of any jurisdiction other than England, be deemed to include what most nearly approximates in that jurisdiction to the English statutory provision or English legal term;
1.2.5any undertaking by, or obligation on, a Party to (i) do any act or thing includes an undertaking to procure the doing of that act or thing by a Party’s Affiliates;
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and, (ii) not do any act or thing includes an undertaking not to encourage, solicit, cause, or assist the doing of that act or thing by any Affiliate or other person;
1.2.6the words and expressions “holding company”, “parent undertaking”, “subsidiary” and “subsidiary undertaking” have the meanings given to them in the Companies Act 2006;
1.2.7any reference to a Party or the Parties is to a party or the parties (as the case may be) to this Agreement and shall include legal successors and/or any permitted assignees of a party;
1.2.8any use of the masculine, feminine or neuter gender respectively includes the other genders and any reference to the singular includes the plural (and vice versa)’,
1.2.9the words “other”, “include”, “including”, “such as” and “in particular” (and similar expressions) do not connote limitation in any way and will be deemed to be followed by the phrase “without limitation”;
1.2.10any reference to a “month” means a calendar month, any reference to a “day” means a calendar day;
1.2.11any reference to GBP, Pounds Sterling or £ is to the lawful currency from time to time of the UK and to US Dollars or US$ is to the lawful currency from time to time of the USA;
1.2.12any reference to a “statute” or “statutory provision” includes any successor legislation thereto, regulations promulgated thereunder, any consolidation or re-enactment, modification or replacement thereof, any statute or statutory provision of which it is a consolidation, re-enactment, modification or replacement and any subordinate legislation in force under any of the same from time to time except in each case to the extent that any consolidation, re-enactment, modification or replacement enacted after the date of this Agreement would extend or increase the obligations, in any manner (and whether financial obligations or otherwise), of either Party hereunder;
1.2.13provisions that require that a Party, the Parties or any committee hereunder to “agree”, “consent”, “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (excluding e-mail or instant messaging, but a signed PDF document being acceptable);
1.2.14the term “or” and “and/or” will be interpreted in the inclusive sense commonly associated with the term “and/or”;
1.2.15the words “notify” and “notification” in this Agreement shall, when referring to notifications as between the Parties to this Agreement (or their representatives), mean notify or notification in writing in accordance with clause 34.1 of this Agreement; and
1.2.16any reference to “writing” or “written” shall include any modes of reproducing words in a legible and non-transitory form (including email, but excluding SMS or temporary messages).
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1.1In case of a conflict between the provisions of any schedule and the provisions of the main body of this Agreement, the provisions of the main body of this Agreement shall prevail.
1.2In this Agreement, the Authority is acting as part of the Crown.
2.GOVERNANCE
Project Managers
2.1From the Effective Date each Party shall appoint, and provide details to the other Party, of its project manager (“Project Manager”) who shall be responsible for and represent the applicable Party in day-to-day liaison between the Parties concerning performance and progress under this Agreement against the KPIs and towards the Baselines. The Project Managers shall facilitate the relationship between the Parties under this Agreement and collate matters and issues that may be necessary for referral to the Oversight Committee. Each Party shall procure that its respective Project Manager shall:
2.1.1make themselves reasonably available to the other Project Manager for meetings in accordance with the provisions of this clause 2;
2.1.2co-operate fully, candidly and transparently with the other Project Manager to ensure that any actual or potential issues, difficulties or problems encountered in connection with the Product’s Development, supply chain infrastructure, Manufacture or supply under this Agreement, including as measured against the KPIs and towards the Baselines, are raised and discussed between Project Managers promptly and in a timely fashion;
2.1.3be a person of reasonable management seniority who is part of the relevant Party’s team working on and has good first-hand knowledge of the project concerning the Product from that Party’s perspective; and
2.1.4ensure that they appraise themselves and keep themselves appraised of all material matters and issues concerning the project relating to the Product.
2.2The Project Managers shall: (i) discuss and monitor progress of Development, Manufacturing and performance under this Agreement against the KPIs and towards achieving the Baselines; (ii) discuss any changes to the Development and Manufacturing Plan; (iii) discuss any issues or delays that will or might reasonably impact Novavax’ Delivery of Product in compliance with the Delivery Schedule, and seek to find solutions to the same; and (iv) escalate issues or matters to the Oversight Committee as appropriate.
2.3Each Party shall use reasonable efforts to minimise change of its Project Manager, but any change of a Project Manager shall be notified as soon as reasonably possible in writing and each Party shall use reasonable endeavours to ensure notice of any change on no less than two (2) weeks’ prior written notice.
Project Manager Meetings
2.4The Project Managers shall meet in accordance with the meeting schedule set forth in Schedule 3 or at such other times as they reasonably elect to do so, via a secure commercial digital platform (or physically, subject to observing then current social distancing and travel guidelines). Additionally, either Project Manager may call a special
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meeting at any time, provided that the requesting Party uses reasonable efforts to provide at least one (1) Business Days’ prior notice to the other Project Manager and, to the extent practicable, such notice includes a proposed agenda for such meeting. Each Party will be solely responsible for its own Project Manager’s expenses relating to attending and participating in the meetings. As appropriate, other representatives and consultants of the Parties may attend such meetings as non-voting participants.
Oversight Committee
2.5In addition to appointment of Project Managers, the Parties shall establish a wider oversight committee (“Oversight Committee”) that shall be responsible for overseeing the performance and supply contemplated by this Agreement and for making those decisions delegated to it in respect of the Delivery Schedule pursuant to this clause 2.
Oversight Committee Responsibilities
2.6The Oversight Committee shall have responsibility for:
2.6.1monitoring of, and to encourage and facilitate, ongoing communication and cooperation between the Parties with respect to the Product and performance under this Agreement;
2.6.2monitoring the progress of Development of the Product;
2.6.3monitoring the progress of Novavax in respect of establishing and validating the UK and EU supply chain required for the performance of this Agreement, and the status and operation of the UK and EU supply chain required for the performance of this Agreement (including attending meetings pursuant to clauses 5.5, 5.6.2, 5.7 and 5.8.3);
2.6.4overseeing, discussing, and providing input on managing and resolving any issues, concerns or delays in the Manufacturing or Delivery of Product;
2.6.5overseeing and reviewing any updates to the Development and Manufacturing Plan (which updates shall, subject to clause 4.2, be made by Novavax) and the Parties’ obligations pursuant to clauses 5.5 to 5.9;
2.6.6agreeing on the Baselines within sixty (60) days of the Effective Date (or such other period agreed by the Oversight Committee);
2.6.7agreeing in good faith any changes to the Delivery Schedule or any change to the Baselines;
2.6.8agreeing the specific quantities and dates for Delivery of Product pursuant to clause 8.5;
2.6.9agreeing to the arrangements for and access to any support or assistance agreed to be provided by the Authority in accordance with clause 2.16;
2.6.10resolving disputes referred to it by a Party or Project Manager; and
2.6.11monitoring Novavax’ performance against the Development and Manufacturing Plan, the KPIs and progress towards meeting the Baselines.
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Membership of the Oversight Committee
2.1The Oversight Committee shall comprise an equal number of representatives from each of the Parties and their Affiliates (collectively, the “Members”) initially set at three (3) Members per Party, or such other number as the Parties may mutually agree. Each Party may replace any or all of its Members at any time upon written notice to the other Party provided that any replacement Members are employees, officers or personnel of that Party (or its Affiliates), have the appropriate skill and experience to perform the duties of a Member, and sufficient seniority and authorisation on behalf of the applicable Party to take decisions arising within the scope of the Oversight Committee.
2.2Any Member may designate a suitable substitute who is an employee, officer or personnel of that Party (or its Affiliates) to temporarily attend and perform the functions of that Member. Each Party may, in its reasonable discretion, invite non-Member representatives of such Party to attend meetings of the Oversight Committee as a non-voting contributor, provided that such persons are bound by confidentiality obligations no less stringent than those of clause 20.
Meetings of the Oversight Committee
2.3The Oversight Committee shall meet monthly during the first six (6) months following the Effective Date (or, if later, until the supply chain for Manufacture under this Agreement is secured), and thereafter once every two (2) months or at such other times as the Members may mutually deem appropriate, provided that, the Oversight Committee shall meet within three (3) Business Days of referral of a dispute or issue to the Oversight Committee by a Project Manager in order to resolve the same (or sooner if required).
2.4The first Oversight Committee meeting shall be no later than ten (10) Business Days after the Effective Date.
2.5The Oversight Committee may meet virtually via a secured commercial digital platform, or where necessary it may meet physically subject to observing then current social distancing and travel guidelines. Either Party may also call a special meeting of the Oversight Committee (via a secure commercial digital platform) upon at least three (3) Business Days’ prior written notice to the other Party, or such shorter period as may be agreed on a meeting-by-meeting basis, if such Party reasonably believes that a significant matter must be addressed prior to the next regularly scheduled meeting, and such Party shall provide the Oversight Committee (as applicable) no later than two (2) Business Days prior to the special meeting with materials reasonably adequate to enable an informed understanding to be made by its Members. Each Party shall be responsible for its own expenses relating to such meetings. Novavax’ Project Manager shall be appointed and responsible for preparing reasonably detailed written minutes of all Oversight Committee meetings, provided that a Novavax Oversight Committee member will be responsible for keeping written minutes of any matters handled in executive session, which minutes will be circulated for comment and approval by the Authority.
Decision Making
2.6Except as otherwise expressly provided in this Agreement, decisions of the Oversight Committee shall be made by unanimous vote of a quorum of the Members, with each Party having one (1) vote. The presence of at least two (2) Members representing each Party (i.e. a total of at least four (4) Members) shall constitute a quorum of the Oversight Committee. The Members shall endeavour in good faith to reach agreement on any and all matters to be determined or resolved by the Oversight Committee. For clarity, subject
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to clause 4.2.2 and 5.2.2, Novavax shall have sole and final discretion on the contents of the Development and Manufacturing Plan and any amendments thereto.
2.7If at any time, the Oversight Committee is unable to reach a unanimous decision within three (3) Business Days (or sooner if required) after it has met and attempted to reach such decision, then either Party may, by written notice to the other, have such matter referred for resolution by an appropriate senior executive officer of each Party. Within three (3) Business Days (or sooner if required) of such notice, the relevant senior executives and member shall meet and attempt to resolve the dispute by good faith negotiations.
Information Disclosures
2.8Through the Project Managers and Oversight Committee, Novavax shall respond to reasonable requests and keep the Authority promptly informed of all events and issues that will or it may reasonably expect to materially impact the Development or Manufacture of the Product hereunder, its Delivery in accordance with the Delivery Schedule and/or any of the KPIs or progress towards achieving the Baselines.
Notifications
2.9Novavax shall ensure (through its Project Manager or the Oversight Committee) that it will notify the Authority or the Authority’s Project Manager within five (5) Business Days upon its knowledge of:
2.15.1any material adjustments or updates proposed to the Development and Manufacturing Plan;
2.15.2any material issues encountered in relation to sourcing, securing or purchasing (i) raw materials for, (ii) the Antigen or Adjuvant required for, or (iii) the Manufacture of, the Product to be supplied pursuant to this Agreement;
2.15.3any material adverse developments relevant to securing a timely agreement with, or under the agreement with, Fujifilm (or another CMO secured pursuant to clause 5.6) for the manufacture of Antigen at Fujifilm’s UK manufacturing facilities;
2.15.4any material adverse developments or issues under any agreement with any of the CMO partners listed under Schedule 2 (or another CMO secured pursuant to clause 5.8) for the co-formulation, fill/finish, and labelling of the Product to be supplied pursuant to this Agreement;
2.15.5the conclusion of any agreement in respect of the manufacture of Antigen or in respect of the co-formulation, fill/finish, and labelling of the Product, and provide the Authority with a copy of the same if permitted by the terms and conditions of such agreement;
2.15.6issues arising in relation to securing of, or Novavax loses or reasonably anticipates the loss of, any necessary consents, approvals, qualifications, or similar authorisations from any relevant Third Party (including the Licensing Authority) which are required to (i) permit Novavax, or Novavax’ Subcontractors, to handle, install, operate (or similar) any equipment or material as anticipated in the Development and Manufacturing Plan, or (ii) Manufacture and have Manufactured the Product;
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2.15.7any proposal to vary or amend any Marketing Authorisation (or, if applicable, an Emergency Use Authorisation) or any application for a Marketing Authorisation (or, if applicable, an Emergency Use Authorisation) for the Product in the Territory, or change the indications for the Product, or amend or change any Specification of the Product;
2.15.8any Clinical Trial results or findings that impact (or would reasonably be expected to impact) the efficacy or safety of the Product or the continuation of the Clinical Trial or Development of the Product; and
2.15.9any other issues that may negatively and materially impact the KPIs, achievement of the Baselines, the Development Plan, or performance under this Agreement.
Authority Support and Assistance
2.10Through the Oversight Committee or via its Project Manager, Novavax may request in writing to the Authority reasonable support or assistance from the Authority to facilitate (but not perform) Novavax’ performance of its obligations under this Agreement, including requests to receive support comprising: (i) access to consultants and personnel of the Authority which have local knowledge and experience in the Manufacture and regulatory approval of vaccine products in the UK, (ii) access to the Authority’s network of companies, stakeholders and other relevant subject matter experts who may help facilitate and assist Novavax in the Manufacture and Delivery of the Product, and (iii) guidance and other technical support that may be reasonably available from the Authority.
2.11The Authority shall act in good faith and use reasonable efforts to provide or facilitate introductions to those who can provide the support or assistance reasonably requested by Novavax pursuant to this Agreement. Notwithstanding the foregoing, the Authority shall not be obliged to incur, fund or pay for any costs or expenditure in respect of any such support or assistance that may be given (whether by the Authority or another), and the provision of, or failure to provide, any support or assistance shall not, in either case, relieve Novavax of its obligations under this Agreement, with Novavax remaining responsible at all times for the Development, Manufacture and Delivery of the Product. The Parties acknowledge and agree that, in respect of any such support or assistance:
2.17.1it is the Authority’s intent, wherever reasonably possible, to provide its support or assistance without cost to Novavax, but the Authority shall be entitled to charge Novavax (at a rate to be agreed between the Parties) if the request will require the Authority to make resources available to Novavax (including staff secondments or access to external consultants);
2.17.2unless otherwise agreed by the Parties in writing (whether in an amendment to this Agreement or in a separate agreement), and subject to clause 21.6, Novavax shall accept the Authority’s support and assistance on an “as is” basis and at its sole risk, and the Authority shall not in any circumstance be liable to Novavax for the delivery, or lack of delivery, of such support and assistance and Novavax shall not assert the provision or lack of provision of such support or assistance as a defence against the Authority for a failure to perform the Development and Manufacturing Plan, Manufacture the Product or meet the Delivery Schedule;
2.17.3the Authority may require Novavax to enter into a separate agreement in respect of such request at the Authority’s reasonable request; and
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2.17.4Novavax shall remain solely responsible for Manufacture and Delivery of Conforming Product to the Authority according to the Delivery Schedule, and Novavax shall not be entitled to rely upon the delivery, or lack of delivery, of such support and assistance by the Authority to excuse a failure to meet the Delivery Schedule.
Pharmacovigilance.
2.7The Authority will cooperate with regard to the reporting of safety information involving the Product supplied under this Agreement (including any Product donated or resold pursuant to clause 9.2) in accordance with Applicable Laws and Applicable Standards on pharmacovigilance and clinical safety, including, without limitation, entering into an appropriate pharmacovigilance agreement.
3.FACILITIES
Responsibility for establishing UK Supply Chain
3.1Novavax shall be responsible (at its own cost and expense) for securing Manufacturing Facilities for the Manufacture of Product, including those within the Territory. It is intended that such Manufacturing Facilities shall include those operated by Fujifilm (for the Antigen) in accordance with clause 5 below (“Primary Facilities”). Novavax shall prioritise production from the Primary Facilities in respect of the Priority Order. If, despite Novavax using Commercially Reasonable Efforts Novavax reasonably believes that Novavax cannot secure one or more of those Primary Facilities on commercially reasonable terms or that such facilities are not suitable for good demonstrable scientific and technical reasons, then Novavax will communicate the issue to the Oversight Committee for discussion. In connection with the foregoing, the Authority shall provide reasonable assistance to Novavax to facilitate establishment of the Primary Facilities as part of the supply chain (or, at the Authority’s discretion or upon agreement by the Oversight Committee, alternative Facilities to the extent that Fujifilm cannot achieve production), but for the avoidance of doubt, the Authority shall have no right (on behalf of Novavax) or obligation to contract with or perform any acts for the Facilities, or fund any activities in connection therewith, and Novavax shall have ultimate decision-making authority in regard to all matters related to the Facilities. Subject to the foregoing, Novavax may supply Antigen from any Facility set forth in Schedule 2 that is approved by the MHRA for the Product in the event of the failure of a Primary Facility during the period in which Novavax is discussing alternate Facilities with the Authority as set forth in this clause 3.1 until any such agreed alternate Facility has been approved by the MITRA, after which time Novavax shall use Commercially Reasonable Efforts to supply Antigen from such alternative Facility in the UK (but may nonetheless continue to supply Antigen from any such Facility set forth in Schedule 2). As of the Amendment Date, Novavax has entered into an agreement with Fujifilm to supply Antigen for use within the Territory.
Facilities for Manufacture of the Product
3.2Novavax represents to the Authority that Schedule 2 comprises the complete list of all Facilities that are or will be involved or required in any aspect of the Manufacturing of the Product (including the Adjuvant and Antigen) as of the Amendment Date, provided that Novavax shall ensure that all Product shall be finally released only from a Facility based in the European Economic Area (“EEA”) or the United Kingdom and that is approved by the MHRA and listed on the Marketing Authorisation for the Product as an approved manufacturing and release facility. Novavax agrees to notify the Oversight
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Committee should any change be made to or new facilities need to be added to Schedule 2. Any facility approved by the MHRA in a variation filing for the Product shall, following written notification by Novavax to the Authority, and subject to any [***] written objection issued by the Authority within [***] of receipt of such notification, be automatically deemed incorporated into Schedule 2, and Novavax may following the end of such [***] period, utilise such newly approved facility in the Manufacture of Product under this Agreement.
Validation Commitment
3.3Novavax shall ensure that pursuant to its (or its Affiliates’) applications for the Marketing Authorisation (and, if applicable, Emergency Use Authorisation) in respect of the Product, it and its Affiliates shall use Commercially Reasonable Efforts to qualify and validate in accordance with Applicable Laws and Applicable Standards (i) the Facilities necessary for the Manufacture of Product, including those Facilities set forth on Schedule 2; and (ii) any other necessary facilities being used by or on behalf of Novavax and its Affiliates for the Manufacture of Product based within the EEA but outside of the Territory, such that Product for the Territory could be sourced from and Manufactured within those other facilities.
Maintenance of Facilities
3.4Novavax shall:
3.4.1ensure that the Facilities have, and will throughout the Term continue to hold, all necessary Regulatory Approvals to operate and to Manufacture Conforming Product for supply and Delivery under and in accordance with this Agreement; and
3.4.2ensure that all Facilities shall meet and operate in accordance with all necessary Applicable Standards (including GxP) and Applicable Laws for the Manufacture of Conforming Product.
4.DEVELOPMENT, REGULATORY OBLIGATIONS AND INFORMATION REQUIREMENTS.
Developing the Product
4.1Novavax shall use Commercially Reasonable Efforts to Develop the Candidate in order to secure a Marketing Authorisation (and, if applicable, an Emergency Use Authorisation) in the Territory for the Product with the indication in the Field in accordance with the Development and Manufacturing Plan, Applicable Law and Applicable Standards. Novavax shall measure its progress against the Development and Manufacturing Plan using the KPIs and Baselines to communicate such progress to the Oversight Committee. The Development and Manufacturing Plan shall set forth reasonably-estimated timelines. The Parties agree that any failure to meet the reasonably estimated timelines in the Development and Manufacturing Plan shall not itself constitute a breach of this Agreement, provided that Novavax has used Commercially Reasonable Efforts to achieve the same.
Responsibility for Development and Execution of the Development and Manufacturing Plan
4.2The Development and Manufacturing Plan at Schedule 4 and any update thereto shall:
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4.2.1set out details and estimated timelines for the Development of the Product in accordance with this Agreement;
4.2.2be consistent with the provisions and objectives of this Agreement to Develop and Deliver Conforming Product to the Authority pursuant to a Marketing Authorisation granted in the Territory with an indication in the Field in accordance with the Delivery Schedule and Baselines; and
4.2.3not impose obligations on the Authority and/or Authority’s Affiliates unless the Authority has agreed in writing to assume responsibility for such obligations.
4.1Novavax shall be responsible, at its own cost, expense, and risk, for the Development of the Product, the implementation and execution of the Development and Manufacturing Plan and for undertaking, and having undertaken, all activities to Develop and Manufacture the Product and to file for and prosecute through to grant a Marketing Authorisation (including, if applicable, an Emergency Use Authorisation) in the UK for the Product for an indication within the Field, doing so in accordance with Applicable Standards and Applicable Law.
4.2For the avoidance of doubt, the Authority shall have no obligation or responsibility to perform any acts or fund any activities for Development of the Product or under the Development and Manufacturing Plan.
Updates to the Development and Manufacturing Plan
4.3The Development and Manufacturing Plan (except for the Delivery Schedule and Baselines which may only be adjusted in accordance with clause 2.6.6) may be adjusted and updated by Novavax, as Development progresses, on a reasonable basis and having regard to achievement of the objective under clause 4.1 and Novavax’ obligations in clause 4.2.
4.4Adjustments or updates proposed to the Development and Manufacturing Plan shall be notified to the Oversight Committee in accordance with clause 2.15.1 before being implemented.
Clinical Trials
4.5Novavax or its Affiliate shall fund and conduct the Clinical Trials at its own cost and risk, and shall take responsibility for all obligations imposed on the sponsor of the Clinical Trials undertaken in respect of the Product. The Authority shall use Commercially Reasonable Efforts to assist Novavax’ conduct of the UK-based Phase III Clinical Trial via facilitating access to the National Institute of Health Research to facilitate access to clinical trial sites in the UK, principle investigators, immunology lab testing facilities and personnel, and IRB(s), and by providing advice and Commercially Reasonable Efforts to facilitate streamlined Regulatory Approvals (via introductions to the Health Research Authority and MHRA only). In no event shall the Authority be responsible for funding or conducting any Clinical Trials.
4.6Novavax shall ensure that the Clinical Trials undertaken are performed in a professional and diligent manner, and in accordance with the Applicable Standards relevant to such trials, including securing all necessary Regulatory Approvals, consents and licences required for undertaking those Clinical Trials, including those of any ethics committee.
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Marketing Authorisation Commitments
4.7Novavax shall (itself or through its Affiliate) use Commercially Reasonable Efforts to secure a valid Marketing Authorisation from the Licensing Authority for the Product with the indication in the Field, and any other applicable Regulatory Approvals, each as required in the Territory for the Development, Manufacture and Delivery of the Product in the Territory. Once the Marketing Authorisation and any other applicable Regulatory Approvals are secured, Novavax shall maintain all such Regulatory Approvals until, at least, expiry of the shelf life of all Product supplied hereunder.
4.8Novavax shall ensure that the Marketing Authorisation granted for the Territory will include the Facilities as facilities qualified and validated for Manufacture of the Product to be supplied to the Authority under this Agreement.
4.9The obligations in clause 4.9 and clause 4.10 shall continue to apply after the expiry or termination of this Agreement until the earlier of (i) such time as the Authority notifies Novavax in writing that it has used or disposed of all units of the Product supplied under this Agreement, or (ii) expiry of the shelf life of the last batch of Doses delivered hereunder.
4.10Novavax shall, and shall procure that its Affiliates and Subcontractors shall, comply with all requests and recommendations of the Licensing Authorities and any other Regulatory Authority in connection with the Product and its Manufacture.
Product Information
4.11Where reasonably requested by the Authority, Novavax shall provide the Authority with Product description information (including Product photographs, SmPC information and descriptions, but not trade secrets of Novavax) in such manner and upon such media as requested. Novavax grants the Authority a perpetual, non-exclusive, royalty free licence to use and exploit such product information and any Intellectual Property Rights therein for the purpose of illustrating and describing the Product in product catalogues.
Emergency Use Authorisation
4.12The Parties acknowledge and agree that Novavax or the Authority may (but shall be under no obligation to) apply for an Emergency Use Authorisation for the Product with the Licensing Authority for the Territory for use with the indication in the Field. However, securing an Emergency Use Authorisation shall not relieve Novavax from the ongoing obligation to secure a Marketing Authorisation in the Territory for the Product with the indication in the Field.
Jurisdictional Limitations
4.13If due to its legal seat of incorporation Novavax is precluded or prevented from performing any obligations required of it pursuant to this Agreement due to Applicable Laws or Applicable Standards, including fulfilling any regulatory activities, applying for, maintaining or holding any Regulatory Approval, or Manufacturing or delivery of Product, then Novavax shall notify the Authority and shall procure that one or more of its Affiliates established within the Territory (or another acceptable jurisdiction) or, with the Authority’s prior written consent and solely in connection with holding a Marketing Authorisation and performing the obligations of a Marketing Authorisation holder, an approved Third Party service provider, shall fulfil those of Novavax’ obligations under this Agreement that Novavax is otherwise precluded or prevented from performing.
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Novavax shall be responsible to the Authority for any performance, non-performance, act or omission by such Affiliate(s) or Third Party service provider in connection with the foregoing. As at the Amendment Date, Novavax represents that Novavax CZ a.s. is the holder of the Marketing Authorisation, and Novavax shall procure that Novavax CZ a.s. shall continue to hold the Marketing Authorisation and shall fulfil those of Novavax’s obligations hereunder that are otherwise required to be performed by a Marketing Authorisation holder.
5.MANUFACTURE AND SUPPLY OF PRODUCT
Manufacturing and Supply Commitment
5.1Novavax shall, or shall procure its Affiliates shall, Manufacture and supply the Product to the Authority, and the Authority shall purchase the Product, subject to and in accordance with the terms and conditions of this Agreement.
Manufacturing Plan
5.2Novavax shall use Commercially Reasonable Efforts to implement the Manufacturing activities described in the Development and Manufacturing Plan in all material respects. Novavax’ progress against the Development and Manufacturing Plan shall be measured by reference to the KPIs and the Baselines, which shall be communicated to and discussed within the Oversight Committee. The Development and Manufacturing Plan at Schedule 4 and any update thereto shall:
5.2.1set out estimated timelines for technology transfer (if applicable), engineering and PPQ batches and the commercial Manufacture of the Product in accordance with this Agreement;
5.2.2be consistent with the provisions and objectives of this Agreement to Manufacture and Deliver commercial supplies of Conforming Product to the Authority pursuant to a Marketing Authorisation granted in the Territory for an indication within the Field and in accordance with the Priority Supply and the Delivery Schedule and Baselines; and
5.2.3not impose obligations on the Authority and/or the Authority’s Affiliates unless the Authority has agreed in writing to assume responsibility for such obligations.
5.3The Manufacturing activities in the Development and Manufacturing Plan may be adjusted and updated by Novavax on a reasonable basis. Novavax shall notify the Oversight Committee of any proposed material adjustment or amendment to the Development and Manufacturing Plan in accordance with clause 2.15 before being implemented.
Responsibility for Manufacturing and licensing obligations
5.4Novavax shall be responsible at its own cost and expense for establishing a supply chain for, and the Manufacture of, the Product, the implementation and execution of the Manufacturing under the Development and Manufacturing Plan, and for undertaking, and having undertaken, all activities required thereunder to Manufacture the Product as Conforming Product in compliance with Applicable Laws (including securing and maintaining applicable Regulatory Approvals). For the avoidance of doubt, and without prejudice to its obligation to pay the Price for Conforming Product, the Authority shall
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have no obligation to perform any acts or fund any activities under the Development and Manufacturing Plan.
Supply of Antigen
5.5The Parties agree that their preferred approach is for the Antigen to be manufactured on behalf of Novavax and its Affiliates by Fujifilm in the UK, but the Authority acknowledges and agrees that the responsibility for Manufacture of the Product resides with Novavax, who shall have ultimate decision-making authority in regard to Manufacture of the Product, including sourcing of Antigen to meet the Delivery Schedule and Baselines. [***]. Novavax shall use Commercially Reasonable Efforts to invite and permit representatives of the Authority to join meetings between Novavax and Fujifilm regarding Manufacturing and delivery schedule of the Antigen and if invited the Authority shall use Commercially Reasonable Efforts to join such meetings. As of the Amendment Date, Novavax has secured an agreement with Fujifilm in respect of the manufacture of the Antigen.
5.6If Novavax determines, acting reasonably and in good faith, that Fujifilm does not have sufficient capacity or capabilities to perform the activities contemplated by this Agreement within the period contemplated by the Delivery Schedule, Novavax shall use Commercially Reasonable Efforts to secure Antigen manufacturing services and facilities with the other CMOs set forth on Schedule 2 in order to fulfil Orders pursuant to this Agreement, provided that such facilities and other CMOs have been approved by the MHRA for the Manufacture of the Product. In selecting CMOs, Novavax shall give priority to securing authorised CMOs who can use their facilities based in the UK, and if none, then in the EEA, but the Parties acknowledge and agree that:
5.6.1Novavax shall (subject to same being approved under the Marketing Authorisation issued for the Territory) have the ultimate decision-making authority and responsibility in regard to where the Product is Manufactured in order to meet its obligations under this Agreement, including the Delivery Schedule and Baselines; and
5.6.2Novavax shall use Commercially Reasonable Efforts to invite and permit representatives of the Authority to join meetings between Novavax and the CMO regarding Manufacturing and delivery schedule of the Antigen and if invited the Authority shall use Commercially Reasonable Efforts to join such meetings.
Fill/Finish for Product
5.7The Product shall be supplied by Novavax (or its Affiliate) as finished, labelled and quality released drug product in accordance with the Marketing Authorisation. The Authority acknowledges and agrees that the responsibility for Manufacture of the Product resides with Novavax, who shall have ultimate decision-making authority and responsibility in regard to Manufacture of the Product, including sourcing of fill/finish contractors, in order to meet the Delivery Schedule and Baselines. As at the Amendment Date, the Authority acknowledges that fill/finish and labelling services are expected to be undertaken by the CMOs set forth on Schedule 2, subject to ensuring that all Product shall be finally released only from a Facility [***] that is approved by the MHRA and listed on the Marketing Authorisation for the Product as an approved manufacturing and release facility. [***]
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5.8With regard to each of co-formulation, fill/finish, and labelling services, if Novavax determines, acting reasonably and in good faith, that its preferred CMO does not have sufficient capacity or capabilities to perform the activities contemplated by this Agreement within the period contemplated by the Delivery Schedule, or that the terms offered by that CMO, despite having used Commercially Reasonable Efforts to negotiate the same, are not commercially reasonable, Novavax shall use Commercially Reasonable Efforts to secure co-formulation, fill/finish, and labelling services and facilities with other CMOs listed in Schedule 2 in order to fulfil Orders pursuant to this Agreement. In selecting CMOs from amongst those listed in Schedule 2, Novavax shall give reasonable priority to working with CMOs who can use their facilities based in the UK, and if none, then in the EEA, but the Parties acknowledge and agree that:
5.8.1Novavax shall (subject to same being approved under the Marketing Authorisation issued for the Territory) have the ultimate decision-making authority and responsibility in regard to where the Product is Manufactured in order to meet its obligations under this Agreement, including the Delivery Schedule and Baselines;
5.8.2Novavax shall ensure that all Product Delivered hereunder shall be finally released only by Novavax’s Responsible Person from a Facility based in [***] and that the Product is from a supply chain that is approved by the MHRA and listed on the Marketing Authorisation for the Product as an approved manufacturing and release facility; and
5.8.3Novavax shall use Commercially Reasonable Efforts to invite and permit representatives of the Authority to join meetings between Novavax and the CMO regarding Manufacturing and delivery schedule of finished Product and if invited the Authority shall use Commercially Reasonable Efforts to join such meetings.
Novavax’ Use of Excess Antigen Capacity
5.9Notwithstanding the provisions of clause 5.12 below, if Novavax can demonstrate to the Authority that, in respect of Antigen manufactured or to be manufactured by Fujifilm before [***], (i) it holds quantities of such Antigen that [***] exceed the requirements of the [***], or (ii) if use of such Antigen from Fujifilm for the [***] (in place of Antigen secured earlier for the [***] from another CMO in Schedule 2) would [***] delay the Delivery of the [***], then in either or both of cases (i) and (ii) Novavax shall be entitled to export such excess Antigen manufactured by Fujifilm from the UK provided that’.
5.9.1[***]; and
5.9.2[***]
Alternative Facilities
5.10Prior to commencement of the full-scale manufacturing of Antigen by Fujifilm (or such other CMO secured by Novavax pursuant to clause 3.1, 5.5 and 5.6), Novavax and the Authority, through the Oversight Committee, shall discuss, acting in good faith, an interim supply of Conforming Product from Novavax’ existing Manufacturing facilities. For clarity, Novavax has final-decision making authority regarding the choice of Manufacturing facility for the Product, provided that such facilities have been approved by the MHRA for the Manufacture of the Product. The Authority acknowledges that such supply is subject to Novavax’ obligations to CoVax and its Funding Entities.
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5.11If Novavax is delayed from fulfilling, or otherwise limited or unable to fulfil, Orders from any of the Facilities in the UK, then Novavax shall notify the Authority and use Commercially Reasonable Efforts to secure Manufacture of Product from other facilities within its and its Affiliates’ supply chain (as approved in the Marketing Authorisation) in order to fulfil Orders in accordance with the Delivery Schedule and Baselines hereunder, subject to (i) Novavax using Commercially Reasonable Efforts to procure Antigen from a [***] supplier; and (ii) all Product being finally released only from a Facility based in [***] and that is approved by the MHRA and listed on the Marketing Authorisation for the Product as an approved manufacturing and release facility.
Priority Supply
5.12[***] Furthermore, Novavax shall ensure that Conforming Product shall be supplied to the Authority on a priority supply basis, meaning that:
5.12.1Novavax will supply the Authority with Conforming Product in full to meet the total quantity required under the Priority Order prior to supplying any Product to any other Person in, or for use within, the Territory;
5.12.2Novavax shall not Manufacture or supply Product for any Third Party outside of the Territory using Antigen from Fujifilm until the Priority Order has been satisfied in accordance with this Agreement (each of clause 5.12.1 and this 5.12.2 being “First Priority Supply”); and
5.12.3with respect to (i) Additional Orders; or (ii) fulfilment of any Order to be made from Facilities other than Fujifilm (for Antigen); then in either case of (i) or (ii) such supply shall be:
(a)made to the Authority at a volume that is proportionately comparable on a pro-rated basis to each of the volumes being provided to each other Person being supplied Product (“Pro-Rated Formula”) on or broadly around the same time from the same facilities, such proportion being calculated by [***]; and
(b)notwithstanding (a) above, in the case of Additional Orders being Manufactured at the Facilities:
(i)fulfilment of such Orders shall be prioritised, having regard to meeting the applicable Delivery Schedule, following any other earlier and confirmed orders to Third Parties; and
(ii)supply of Product to fulfil such Additional Orders from the Facilities shall be made to the Authority based on the Pro-Rated Formula, at least as early, if not earlier, than any supply of Product being made available to any Third Party ordered at or around the same time as such Additional Orders from the same Facilities;
(collectively the provisions of this clause 5.12.3 being “Equal Priority Supply”); and
collectively the First Priority Supply and Equal Priority Supply being “Priority Supply”).
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5.13If Novavax proposes to supply Product to a Third Party outside, and for use outside, of the Territory before the grant or issuance of a Marketing Authorisation (and, if applicable, any Emergency Use Authorisation) for the Product in the Territory, then Novavax shall first notify the Authority of such decision and, subject to Priority Supply, Novavax shall, at Authority’s election (i) supply Product to the Authority pending grant of the Marketing Authorisation (and, if applicable, an Emergency Use Authorisation) and in quantities in compliance with the outstanding volume of Orders for the Authority; or (ii) reserve and allocate for the Authority physical volumes of Product in quantities in compliance with the outstanding volume of Orders for the Authority and hold the same for Delivery to the Authority immediately upon grant of the Marketing Authorisation (and, if applicable, Emergency Use Authorisation) or earlier upon the Authority’s written request; or (iii) not take any steps under (i) or (ii) above.
Product Conformance
5.14Novavax shall ensure that all Product supplied to the Authority (or its agent or designee) under this Agreement shall:
5.14.1be Manufactured (including being quality released) and labelled in accordance with Applicable Law, Applicable Standards, all Documentation and batch records, quality standards and all Regulatory Approvals;
5.14.2meet the Specification and shall, until expiry of the Minimum Remaining Shelf Life, continue to comply with the Specification, and meet the Marketing Authorisation and relevant Regulatory Approvals (subject to the proper storage and handling of the Product in accordance with the instructions in the SmPC by Authority or its designees or agents);
5.14.3be free of any identifiable Defect and shall be unadulterated;
5.14.4satisfy the Minimum Remaining Shelf Life at the time of Delivery; and
5.14.5be new and have not (i) previously left the control of Novavax or its Affiliates; (ii) been rejected or returned by any other entity; or (iii) been reprocessed or reworked; in each case of (i), (ii) and (iii) prior to their supply to the Authority under this Agreement.
No Exclusive Purchasing Arrangement
5.15Nothing in this Agreement shall amount to an exclusive purchasing obligation on the Authority or preclude or restrict the Authority from purchasing any products whatsoever from Third Parties, including any products that are complementary to, competitive to, equivalent to, or substitutable for the Product or that are indicated for or expected to be beneficial for use in the prophylaxis, treatment or vaccination against SARS-CoV-2.
Manufacturing Failures
5.16Without excusing or limiting the obligations under clause 5.14 and 8.8, and subject to notifying the Authority of the use of such alternative facilities, if for any reason related to the Facilities, Novavax is unable to supply Conforming Product to Authority in accordance with the Delivery obligations of this Agreement, then Novavax shall instead source and supply Product from its other supply chain arrangements involved in the Manufacture of Product for countries outside the Territory and shall ensure that such
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Product sourced from those other facilities may be supplied hereunder as Conforming Product.
6.PRODUCTION SCHEDULES AND BUSINESS CONTINUITY
Production Schedules
6.1On a rolling monthly basis Novavax shall provide the Oversight Committee with the then most current and accurate production schedule for the Manufacture of Product that is the subject of this Agreement, which shall include the status of Facility reservations and stock levels of Antigen, Adjuvant, formulated drug substance and final (but unlabelled) Product.
Business Continuity Plan
6.2Novavax and its Affiliates currently have in place and shall, in consultation with the Authority within ninety (90) days of the Effective Date, further develop, implement and thereafter keep current, a reasonable risk management programme for the Facilities and Manufacture and Delivery of the Product, including a Business Continuity Plan. At the Authority’s request, Novavax shall make a copy of the current Business Continuity Plan available to the Authority, or its representatives, for review. Novavax shall keep the Business Continuity Plan under review and shall update the same from time to time as reasonably appropriate.
6.3Novavax shall:
6.3.1test its Business Continuity Plan at reasonable intervals, and in any event no less than once every six (6) months, and update it to address any material failures; and
6.3.2use Commercially Reasonable Efforts to ensure that its and its Affiliates’ Business Continuity Plan complies, on an ongoing basis, with any specific and reasonable business continuity requirements, as may be discussed pursuant to the Oversight Committee.
6.1For the avoidance of doubt, having a Business Continuity Plan and its implementation does not relieve Novavax (or its Affiliates) from the Manufacturing and supply obligations under this Agreement.
7.ORDERING
Priority Order
7.1All orders placed by the Authority for Product prior to the Amendment Date are deemed withdrawn and void, without liability to either Party. Within [***] following the Amendment Date the Authority shall submit to Novavax a written order for sixteen million and one (16,000,001) Doses of the Product for Delivery in 2022-2023, consisting of (i) the Firm Order and (ii) the Conditional Order (together, the “Priority Order”), [***].
7.2Novavax shall accept the Priority Order in writing, and the confirmed Priority Order shall be binding upon the Parties subject to the terms and conditions set out in this Agreement. [***]
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Firm Order
7.3The first one million and one (1,000,001) Doses of the Priority Order (the “Firm Order”) represents a binding commitment between the Parties for Novavax to supply, and the Authority to purchase subject to Delivery being in accordance with the Delivery Schedule for the Firm Order. Pursuant to the Firm Order Novavax shall Deliver the Doses comprising the Firm Order to the Delivery Site on date(s), to be agreed between the Parties, falling between [***]. If Novavax does not Deliver all Doses included in the Firm Order on or prior to 30 September 2022, then the Authority may, at its option and without cost or liability, (i) terminate this Agreement; or (ii) cancel the Firm Order solely in respect of any of the volume of Doses outstanding at the later of 30 September 2022 or the date of notice from the Authority.
Booster and Adolescent Doses
7.4The remaining fifteen million (15,000,000) Doses of the Priority Order (the “Conditional Doses”) constitute a conditional order that, subject to clauses 7.6 and 7.7, only becomes binding on the Authority and Novavax (in whole, in part or potentially not at all) if and when one or more Triggers occur within a particular date range (the “Conditional Order”).
7.5Triggers.
7.5.1An “Adult Trigger” shall occur on the first date that the following two circumstances first exist together:
(a)the JCVI issues a supportive recommendation for the use of Product for the general adult population as part of a SARS-CoV-2 vaccine booster campaign in the UK, excluding where that recommendation relates only to one or more Restrictive Population Groups; and
(b)the Secretary of State for Health approves the JCVI recommendation referred to in clause 7.5.1(a).
7.5.2An “Adolescent Trigger” shall occur on the first date that one or both of the circumstances described in clause 7.5.2(a) and/or 7.5.2(b) first exist together with the circumstance described in clause 7.5.2(c):
(c)the JCVI issues a supportive recommendation for the use of Product for the general adolescent population as part of a SARS-CoV-2 vaccine booster campaign in the UK, excluding where that recommendation relates only to one or more Restrictive Population Groups; or
(d)the JCVI issues a supportive recommendation for the use of Product for the general adolescent population as a primary series SARS-CoV-2 vaccination, excluding where that recommendation relates only to one or more Restrictive Population Groups; and
(e)the Secretary of State for Health approves the JCVI recommendation referred to in clause 7.5.2(a) or 7.5.2(b).
7.5.1The Adolescent Trigger and the Adult Trigger are each a “Trigger” and collectively the “Triggers”. For the avoidance of doubt, Authority’s use or deployment of Product purchased under the Firm Order, even if used as a
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booster dose (whether for the adult or adolescent population, or both), shall not be considered a Trigger or construed to imply that a Trigger has occurred.
7.6If one or both Triggers occur prior to [***], the Authority’s obligation to purchase Conditional Doses pursuant to the Conditional Order shall become binding on both Parties on one, and one only, of the following scenarios (“Scenarios”) and for the following applicable volume of Doses:
7.6.1if (i) the Adult Trigger or (ii) both of the Adult Trigger and Adolescent Trigger, first occur on or prior to [***]:
(f)subject to clause 7.6.1 (e), Authority shall be obliged to purchase the full 15,000,000 Conditional Doses and shall notify Novavax in writing that it wishes to purchase all of the Conditional Doses;
(g)subject to clause 7.6.1(e), Novavax shall Deliver at least seven and a half million (7,500,000) Doses of the full volume of Conditional Doses between [***] (the seven and a half million (7,500,000) Doses being the “Initial Conditional Doses”);
(h)if Novavax fails to Deliver the Initial Conditional Doses in full by [***], Authority may, at its option and [***], cancel the Conditional Order solely in respect of any of the outstanding volume of Initial Conditional Doses not Delivered to the Authority by [***] or permit the same to carry over for Delivery in accordance with clause 7.6.1(d);
(i)Novavax shall Deliver the remaining volume of Conditional Doses (less any volume cancelled pursuant to clause 7.6.1(c)) in excess of the volume of Initial Conditional Doses Delivered by [***], failing which the Authority may, at its option and [***], cancel the Conditional Order solely in respect of any of the volume of Doses outstanding at that date; and
(j)if the Adolescent Trigger occurs only under clause 7.5.2(b) and 7.5.2(c), then the Authority shall only be obliged to purchase 3,750,000 Doses allocable to such Adolescent Trigger, thereby reducing the number of Conditional Doses that are binding on the Parties to a total of 11,250,000 Conditional Doses, and the Authority’s rights and obligations, including all remedies of this clause 7.6.1, will be adjusted to apply mutatis mutandis to the different volumes;
7.6.2if the Adolescent Trigger occurs on or prior to [***], but the Adult Trigger does not:
(k)subject to clause 7.6.2(c), Authority shall be obliged to purchase 50% of the full volume of Conditional Doses (i.e., seven and a half million (7,500,000) Doses) and shall notify Novavax in writing that it wishes to purchase such volume of Doses; and
(l)subject to clause 7.6.2(c), Novavax shall Deliver such volume of Conditional Doses (seven and a half million (7,500,000) Doses) in accordance with the timeframes set forth in clause 7.6.1, decreasing the applicable number of Doses by 50% (e.g., the Initial Conditional Doses to be delivered by [***] would be three million seven hundred fifty thousand (3,750,000) and the balancing volume of three million seven hundred fifty
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thousand (3,750,000) to be delivered by [***]), and the Authority’s rights and obligations, including all remedies under clause 7.6.1, shall be adjusted to apply mutatis mutandis to the different volumes;
(m)if the Adolescent Trigger occurs only under clause 7.5.2(b) and 7.5.2(c), the Authority shall only be obliged to purchase 3,750,000 Doses allocable to such Adolescent Trigger, clause 7.6.2(a) shall not apply, and the volume of Doses referred to in clause 7.6.2(b) shall be reduced by 50%, and the Authority’s associated rights and obligations, including all remedies, will apply mutatis mutandis to such reduced volume; and
(n)if .the Adult Trigger does not occur between [***] then the Conditional Order shall be automatically amended to reduce to (i) seven and a half million (7,500,000) Doses where the Adolescent Trigger occurs under clause 7.5.2(a) and 7.5.2(c), or (ii) three million seven hundred fifty thousand (3,750,000) Doses if such Adolescent Trigger was only under clause 7.5.2(b) and 7.5.2(c);
7.6.1if the Adolescent Trigger occurred on or prior to [***], and the Adult Trigger occurred between [***], clause 7.6.2 shall not apply and:
(o)the Conditional Order shall be automatically amended to reduce to (i) eleven million two hundred and fifty thousand (11,250,000) Doses where the Adolescent Trigger occurs under clause 7.5.2(a) and 7.5.2(c), or (ii) seven and a half million (7,500,000) Doses if the Adolescent Trigger is only under clause 7.5.2(b) and 7.5.2(c), as applicable; and
(p)the Authority shall be obliged to purchase, and shall notify Novavax in writing that it wishes to purchase:
(iii)seven and a half million (7,500,000) Doses to be delivered in accordance with the timelines specified under clause 7.6.2 (i.e. 3,750,000 Doses by [***] and 3,750,000 Doses by [***]), and for the avoidance of doubt, in respect of these Doses, all the provisions and remedies, including cancellation rights, of clause 7.6.2 shall apply); and
(iv)if the Adolescent Trigger occurs under clause 7.5.2(a) and 7.5.2(c), a further three million seven hundred fifty thousand (3,750,000) under this clause 7.6.3 provided that Delivery of all such Conditional Doses is made between [***], failing which the Authority may, at its option and [***], cancel the Conditional Order solely in respect of any of the volume of Doses outstanding on [***];
7.6.3if either the Adult Trigger or the Adolescent Trigger occurs between [***], but the other Trigger does not occur until after such time period (or not at all):
(q)subject to clause 7.6.4(c), the Conditional Order shall be automatically reduced to three million seven hundred fifty thousand (3,750,000);
(r)subject to clause 7.6.4(c), the Authority shall be obliged to purchase, and shall notify Novavax in writing that it wishes to purchase, three million seven hundred fifty thousand (3,750,000) Doses provided that Delivery of
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all such Conditional Doses is made between [***], failing which the Authority may, at its option and [***], cancel the Conditional Order solely in respect of any of the volume of Doses outstanding on [***]; and
(s)if the Adolescent Trigger is only under clause 7.5.2(b) and 7.5.2(c), then clause 7.6.4(a) shall not apply, the Authority shall only be obliged to purchase one million eight hundred and seventy five thousand (1,875,000) Doses, the volume of Doses referred to in clause 7.6.4(b) shall be reduced by 50%, the Conditional Order shall be reduced to such amount, and the Authority’s associated rights and obligations, including all remedies, will apply mutatis mutandis to such reduced volume;
7.6.2if both Triggers first occur between [***]:
(t)subject to clause 7.6.5(c), the Conditional Order shall be automatically reduced to seven and a half million (7,500,000) Doses;
(u)subject to clause 7.6.5(c), the Authority shall be obliged to purchase, and shall notify Novavax in writing that it wishes to purchase, seven and a half million (7,500,000) Doses; provided that Delivery of all such Conditional Doses is made between [***], failing which the Authority may, at its option and [***], cancel the Conditional Order solely in respect of any of the volume of Doses outstanding on [***]; and
(v)if the Adolescent Trigger is only under clause 7.5.2(b) and 7.5.2(c), the Authority shall be obliged to purchase 1,875,000 Doses allocable to such Adolescent Trigger thereby reducing the number of Conditional Doses that are binding on the Parties to a total of 5,625,000 Doses, and the Authority’s associated rights and obligations, including all remedies, will apply mutatis mutandis to such reduced volume.
For the avoidance of doubt, the maximum Doses allocable to the Adolescent Trigger under clause 7.6 is seven and a half million (7,500,000) Doses, and each of clause 7.5.2(a) and 7.5.2(b) of the Adolescent Trigger may each only be achieved a maximum of once for the purposes of clause 7.6. By way of non-limiting example only, if clause 7.5.2(a) and 7.5.2(c) are met on [***], then the Authority would purchase the full seven and a half million (7,500,000) Doses under clause 7.6.2(a), and any subsequent achievement of clause 7.5.2(b) would not give rise to any additional orders under this clause 7.6. The sub-clauses under clause 7.6 are mutually exclusive such that only one Scenario or no Scenarios under clause 7.6 may apply, it being acknowledged that if clause 7.6.2 first applies, but the Adult Trigger subsequently occurs between [***], then clause 7.6.3 shall apply in substitution of clause 7.6.2. With respect to the dates set forth in clause 7.6, time shall be of the essence.
7.7Following any notification by Authority that a Trigger has occurred prior to [***], the Parties shall, acting reasonably and in good faith taking into account the timing and circumstances of such Trigger, agree a mutually acceptable delivery schedule for the relevant volume of Conditional Doses to be Delivered, broken down on a [***] basis (which for the purposes of this Agreement shall become the Delivery Schedule applicable to those Conditional Doses). Such Delivery Schedule shall require the Delivery of the relevant volume of Conditional Doses to be before the applicable dates set forth above depending on the timing of the Conditional Trigger.
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7.8Subject to one of the Scenarios under clause 7.6 occurring, Novavax shall, on the Authority’s written request, replace [***] any Conditional Doses Delivered under clause 7.6 that are unused as of their labelled expiration date, up to [***] percent ([***]%) of such Conditional Doses Delivered under clause 7.6 (the “Replacement Offer”). If the Authority elects to enact the Replacement Offer, then the Authority will provide initial notice of the same within [***] of expiry of the applicable Doses, and will within [***] of the date of expiry provide a more detailed and organized accounting of Product for which replacement is requested to Novavax detailing the number of Doses, by lot number, that have expired as of the date of such election. As between the Parties, the Authority will be solely responsible, [***], for its disposal of all expired and undosed Product in accordance with applicable law and regulations. The Authority will provide a certified certificate of destruction to Novavax, including the number of Doses by lot that were destroyed, and the date upon which such destruction took place. If the Authority elects to enact the Replacement Offer, then Novavax will provide the Authority with a supply schedule of replacement Product, and Novavax will use Commercially Reasonable Efforts to Deliver or cause to be Delivered to the Authority the replacement Product no later than [***] after the original Product expiry date consistent with such supply schedule. For the avoidance of doubt, such delivery of replacement Product does not constitute any credit for future Product otherwise due under this Agreement.
7.9If neither Trigger occurs on or before [***] the Conditional Order shall automatically be cancelled without liability or costs to the Authority, and the Authority will not be obliged to purchase any of the Conditional Doses.
Additional Orders
7.10Up until 31 December 2024, the Authority may at its sole election and from time to time place one or more orders for additional volumes of Doses of the Product up to an aggregate maximum of forty four million (44,000,000) Doses (each order an “Additional Order”).
7.11If the Authority places an Additional Order:
7.11.1the Parties shall, acting reasonably and in good faith, agree a mutually acceptable delivery schedule for each Additional Order (which for the purposes of this Agreement shall become the Delivery Schedule applicable to such Additional Order) and in the absence of an agreement the Authority may withdraw and cancel [***] the Additional Order; and
7.11.2Novavax shall accept each Additional Order in writing.
7.12An Additional Order shall be binding upon the Parties in accordance with the terms and conditions set out in this Agreement. All other terms and conditions (including any terms and conditions which the Authority or Novavax purports to apply under any order, acceptance, specification or other document attached to any order or acceptance form) are hereby excluded.
Substitution of Doses
7.13The Authority may at any time, and from time to time, issue a written notice to Novavax requiring Novavax to substitute any volume of undelivered Doses of Product that are the subject of any Priority Order or Additional Order, for any new monovalent vaccine product that is Developed or being Developed by Novavax or its Affiliates that targets a different variant of SARS-CoV-2 (a “Variant Product”) and that has been granted or is
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expected to be granted a Marketing Authorisation in or for the Territory (a “Variant Substitution Notice”). For clarity, bivalent and multi-valent variant products shall not be Variant Products.
7.14Upon the Authority serving a Variant Substitution Notice:
7.14.1in respect of the volume of Doses of Product that are the subject of the Variant Substitution Notice, Novavax shall [***] cease and make no further deliveries of any equivalent volume of Doses of Product that are not the Variant Product;
7.14.2references in this Agreement to Product shall be read, with respect to the volume of Doses that are the subject of the Variant Substitution Notice, as references to the Variant Product that is the subject of the Variant Substitution Notice; and
7.14.3the Parties shall promptly discuss any reasonable adjustments to the timing of Deliveries of the volume of Doses of Product that are the subject of the relevant Variant Substitution Notice and Novavax shall use Commercially Reasonable Efforts to keep the Delivery dates for the applicable Variant Product as close as reasonably possible to the dates in the then current Delivery Schedule for those Doses of Product that have been substituted pursuant to the Variant Substitution Notice.
7.15For the avoidance of doubt, the obligations of Novavax under this Agreement with respect to Manufacturing, quality requirements, Delivery and shelf life shall apply, mutatis mutandis, to Variant Product that is the subject of a Variant Substitution Notice.
Reduced Volume
7.16Notwithstanding any other right it has under this Agreement, the Authority shall be entitled, on written notice to Novavax, to cancel or reduce (in whole or part) the volume of Doses of the Product that are ordered in [***] or any Additional Order (such reduction being the “Reduced Volume”):
(w)following any actual or reasonably threatened and/or reasonably anticipated material Loss of Supply (which will include for the avoidance of doubt an interruption in production which will reasonably be expected to result in a subsequent interruption in deliveries) which has not been remedied by Novavax within [***], by an amount equal to the amount subject to such Loss of Supply;
(x)as a result of any material adjustment or variation of the Development and Manufacturing Plan, or any adjustment or variation of the Specification or Marketing Authorisation after the Amendment Date; or
(y)in accordance with its rights pursuant to clauses 7.3 and 7.6; and
(z)subject to clause 8.6.2 and 8.6.3, any actual or reasonably threatened and/or anticipated failure to meet the Delivery Schedule for any Additional Order.
Following such adjustment the Parties shall agree in good faith a revised Delivery Schedule for the remaining volumes of Doses of Product to be Delivered, which shall be set as close in time to the original Delivery Schedule as is reasonably possible (and is compliant with principles of Priority Supply) and if agreement cannot be reasonably
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reached the Authority may further adjust [***] or Additional Order pursuant to this clause.
7.1The effect of the Reduced Volume shall be automatically binding on the Parties such that:
7.17.1Novavax shall, within [***] of the Authority’s written notice under clause 7.16 in respect of the Reduced Volume, refund to the Authority from the Pre-Payment a sum calculated as the Price per Dose (plus VAT if any was payable thereon) in respect of such Doses, multiplied by the number of Reduced Volume Doses (a “Reduced Volume Refund”); and
7.17.2Novavax shall have no further obligation to provide such Reduced Volume of Doses.
7.17Following any change in accordance with the foregoing or pursuant to clauses 8.8 or 12, each of the Orders shall thereafter reflect the new volume of Product adjusted according to this clause.
7.18If the Authority elects to receive a Reduced Volume, the sole and exclusive remedy of the Authority in respect of that Reduced Volume shall take the form of the Reduced Volume Refund provided that this shall not relieve Novavax for any liability in respect of any material breach (if applicable) of this Agreement, including its failure to use Commercially Reasonable Efforts where expressly required under this Agreement.
8.DELIVERY
Delivery Schedule
8.1Subject to the provisions of this clause 8, Novavax shall Deliver Conforming Product to the Authority or its Authorised Agent in the volumes and timelines set out in the applicable Delivery Schedule. For the purposes of the dates and timeframes set out in clauses 7.3, 7.6 and 7.7 [***].
8.2If due to events beyond Novavax’ reasonable control the Product is not going to be Delivered, in any material way, in accordance with the Delivery Schedule, then Novavax shall promptly notify the Oversight Committee and, subject to Authority’s exercise of any specific remedies or cancellation rights arising under this Agreement, and provided Novavax has used Commercially Reasonable Efforts to Deliver in accordance with the Delivery Schedule the Oversight Committee, the Oversight Committee shall discuss a reasonable and proportionate amendment to the applicable Delivery Schedule recognising that fast and early delivery of the Product is a fundamental requirement for the Authority. The Delivery Schedule may only be updated and refined during the Term with the written agreement of the Oversight Committee (such consent not to be unreasonably withheld or delayed), subject always to the Delivery Schedule conforming with Novavax’ obligations to supply Product in accordance with Priority Supply. For the avoidance of doubt, if a failure of Novavax not to use Commercially Reasonable Efforts in accordance with its obligations under this Agreement directly resulted in Novavax’ request for such change to the Delivery Schedule, such failure shall entitle the Authority to withhold its consent to any change to the Delivery Schedule. The foregoing shall not restrict or limit the Authority from exercising its rights under clauses 7.3 or 7.6, which rights have precedence over this clause.
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Authority’s Authorised Agents
8.3Where and insofar as expressly stated in writing by the Authority to Novavax, the Authority may appoint one or more Authorised Agents to act on the Authority’s behalf in relation to part or all of this Agreement, including to receive one or more Deliveries of any Product (or part thereof). Novavax shall work and co-operate reasonably with each Authorised Agent appointed by the Authority upon such notification.
Delivery
8.4Novavax shall:
8.4.1notify the Authority of the exact date of Delivery of specified quantities of Product no less than [***] in advance of such date;
8.4.2deliver the Product DAP (Incoterms 2020) at the Delivery Location (“Delivery”) with Delivery being complete upon the Product being unloaded and delivered into the cold chain storage facilities at the Delivery Location;
8.4.3ensure that the total volume of Doses of the Product set forth in the Orders (as may be amended) shall be Delivered;
8.4.4ensure that Delivery of Product shall not be made earlier than:
(a)subject to clause 8.6.2, the applicable dates set forth in the Delivery Schedule without the agreement of the Authority; or
(b)the date of grant or issuance of a Marketing Authorisation for the Product in the Territory, unless Delivery is requested earlier by the Authority,
and any Delivery (or attempted Delivery) of Product earlier than the applicable date set forth in the Delivery Schedule or before grant/issuance of a Marketing Authorisation (unless requested earlier by Authority) may be accepted or rejected (in whole or part) by Authority at its sole discretion and any rejection shall be at Novavax’ sole risk, cost and liability and Novavax shall remain responsible for effecting the subsequent Delivery of Conforming Product in accordance with the Delivery Schedule and provisions of this clause 8.4.
8.5Notwithstanding Novavax’ obligation to Deliver Product in the quantities and during the periods set forth in the Delivery Schedule, for each instalment set out in the applicable Delivery Schedule, the Oversight Committee may agree to further refine the timing for Delivery of that specific instalment and the quantities.
8.6Without prejudice to any of the Authority’s rights under clause 7 (including the right to cancel or reduce parts of the Priority Order), Novavax shall not be in breach of its obligation to comply with the Delivery Schedule if:
8.6.1there is a delay in Novavax securing the Marketing Authorisation (and, if applicable, any Emergency Use Authorisation) for the Product in the Territory provided that (i) Novavax, its Affiliates and Subcontractors used Commercially Reasonable Efforts in their respective activities to file for and secure the grant or issuance of the same; and (ii) delay was not caused by the breach of this Agreement or the negligence of, Novavax, its Affiliates or Subcontractors;
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8.6.2there is any minor variance of dates of Delivery compared to the Delivery Schedule of up to [***] due to the unpredictable nature of the Manufacturing of the Products, so long as such variance is agreed with the Authority in writing at least [***] prior to the scheduled Delivery date for such Products as set out in the Delivery Schedule (a “Grace Period”);
8.6.3there is any minor variance in quantity of Doses Delivered compared to the quantities in the Delivery Schedule of up to five per cent. (5%) provided any shortfall is fulfilled in the next Delivery (or if this is not possible, Novavax will use Commercially Reasonable Efforts to make up the shortfall in the earliest possible subsequent Delivery); or
8.6.4the Parties agree, from time to time and by mutual consent, to vary the Delivery Schedule.
Delays and Loss of Supply
8.7Novavax shall promptly (and [***] from the issue being identified) notify the Authority in writing of any actual or anticipated delay or change to the Delivery Schedule or any actual or anticipated delay in Delivery of Product against the Delivery Schedule.
8.8Without prejudice to clause 7.16, if the Authority’s supply is materially interrupted, delayed or deferred due to (i) any orders or directions pursuant to the US Defense Production Act, or as a consequence of any other government interventions (“Government Interventions”); (ii) demands or obligations from Funding Entities or other Third Parties; or (iii) commitments accepted by Novavax; (collectively a “Loss of Supply”) and such Loss of Supply is not promptly remedied by Novavax within twenty (20) Business Days, then in either case, the Authority shall be entitled:
8.8.1to terminate this Agreement pursuant to clause 25.4; and
8.8.2as its sole and exclusive remedy to recoup the Pre-Payment Refund provided to Novavax.
Receipt following Delivery
8.9The Authority or its Authorised Agent shall arrange for the Delivery Location to be ready for receipt of the Product in accordance with the Delivery Schedule. Delivery shall be deemed complete when the Product has been unloaded at the Delivery Location and stored in the cold chain facilities at such location. If the Delivery Location cannot receive the Product on the agreed Delivery date, then Novavax shall keep and store the same in accordance with the applicable storage guidelines and requirements for up to five (5) Business Days. Following that five (5) Business Day period, unless a further storage period is otherwise agreed between the Parties (at the Authority’s cost and risk), Novavax shall Deliver the Product to the Delivery Location (whether or not the Delivery Location can receive the Product).
8.10All Deliveries of the Product supplied hereunder shall, at the time of Delivery or reasonably in advance of the Delivery of the Product, be accompanied by the documentation specified in Schedule 8 (the “Documentation”).
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9.DISTRIBUTION
9.1Once Product is Delivered by Novavax in the UK, the Authority or its designees shall be responsible for and shall control and direct the onward distribution of the Product.
9.2Novavax agrees and acknowledges that the Authority may donate or resell Product Delivered to the Authority that is in excess of its requirements to other countries, governments and charitable organisations including the ACT Accelerator, but only if (i) the intended purpose of such donation or resale is to vaccinate individuals against SARS-CoV-2; (ii) such Product can be placed on the market in such country(ies) in accordance with Applicable Law (which for the avoidance of doubt does not require Novavax to seek any Regulatory Approval in such country(ies)); (iii) the Authority is not in material breach of this Agreement; and (iv) the Authority has paid to Novavax the Price for such Product. In addition, the Authority expressly acknowledges and agrees that, in connection with any donation or resale or Product to a country(ies) outside of the Territory as aforesaid, that (A) the Authority shall be solely responsible for shipping, transporting and otherwise delivering the donated or resold Product to such country(ies) (including the cost of importing, exporting and customs clearance) and that Novavax will have no obligation to assist the Authority with the foregoing or to otherwise assist the Authority with distribution of the Product within such country(ies), (B) the Authority shall be solely responsible for initiating and implementing any Product recalls in such country(ies), (C) the Product warranties set forth in this Agreement solely apply to the sale of Product to Authority under this Agreement, (D) the donation or reselling of any Product by Authority does not reduce or remove any obligation or right of the Authority or right or obligation of Novavax under this Agreement, and (E) Novavax shall have no indemnification obligation under this Agreement with respect to such Product once it is donated or resold, and (F) no Confidential Information of Novavax shall be disclosed.
10.RISK AND TITLE
10.1Risk of loss or damage and title to Products supplied under this Agreement shall pass to the Authority upon Delivery of the Product to the Authority pursuant to clause 8.
11.INSPECTION AND REJECTION OF PRODUCT
Inspection & Rejection
11.1Upon the later of Delivery of the Product and receipt of the Documentation, the Authority (or, on its behalf, its Authorised Agent) will inspect the Product and review the Documentation, and notify Novavax in writing (within ten (10) Business Days of the Delivery of the Product and receipt of the Documentation) if it rejects the Product (“Rejected Product”). Novavax agrees that the whole of any Delivery batch of Product may be rejected if a reasonable sample of the Products taken indiscriminately from that Delivery batch is found to have a Defect whereupon all Products from that Delivery batch shall be deemed Rejected Product. Notwithstanding the above:
11.1.1if a Defect in the Product was not reasonably ascertainable from a visual inspection of the Product and review of the accompanying Documentation; or
11.1.2any Defect was a latent or hidden defect;
then such ten (10) Business Day period shall not apply, provided that the Authority notifies Novavax in writing of its subsequent detection of the Defect within thirty (30) calendar days of the time the Authority first becomes aware of a Defect in the applicable
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Product (which may be prior to conducting root cause analysis) whereupon such Product shall be deemed a Rejected Product; provided, further, that such notice must be given before the expiration of the applicable initial shelf-life. Should the Authority notify Novavax pursuant to this clause 11.1, the Authority shall make available for collection by Novavax samples of the Rejected Product to Novavax (or its nominated agent) for collection and testing.
Independent Laboratory
11.2In the event of a disagreement concerning whether Product has any Defect or is Conforming Product, Novavax shall notify the Authority within fifteen (15) days of its receipt of the Authority’s notice of such Rejected Products. Novavax and the Authority shall use their respective reasonable endeavours to resolve such disagreement as promptly as possible. If the parties are unable to amicably resolve the disagreement, such dispute shall be resolved by having an independent, mutually acceptable, qualified third party expert (the “Independent Expert”) promptly examine the Product that is the subject of the dispute. The non-prevailing Party shall bear all out-of-pocket costs and expenses associated with the Independent Expert’s determination, including any reasonable out-of-pocket costs incurred by the prevailing Party in connection therewith. The findings of the Laboratory shall be final and binding on the Parties other than in the event of manifest error.
12.REMEDIES AND MITIGATION OF LOSSES
12.1Novavax acknowledges the critical importance that the Authority places on ensuring that Products are delivered free of Defect, in conformance with clause 5.14, and in accordance with Priority Supply and the Delivery Schedule.
Rejected Product
12.2In respect of any Rejected Product, provided that the Authority notifies Novavax of such Defect in accordance with clause 11.1, Novavax shall at the Authority’s election:
12.2.1upon such Rejected Product being made available for collection by Novavax or resolution of any disagreement as to whether or not the Rejected Product is Defective, refund the Authority’s payment for such Rejected Product calculated on a pro-rated basis according to the number of Product units returned as Rejected Product; or
12.2.2at no additional cost to the Authority, replace the Rejected Product with an identical quantity of Conforming Product, subject to the Parties agreeing on a Delivery date for such replacement Product, which Novavax shall use Commercially Reasonable Efforts to Deliver on an expedited basis, and
the Rejected Product shall be made available for collection and disposal by Novavax, which Novavax shall collect in accordance with Applicable Law and at Novavax’ sole expense and risk. Without prejudice to clause 12.3, the remedies set forth in this clause 12.2 shall be the sole and exclusive remedy of the Authority in regard to Rejected Product that has not been distributed, used or administered by the Authority.
Failure to Deliver Conforming Product
12.3If Novavax does not Deliver Conforming Products in accordance with the Delivery Schedule (or, where notified, but subject to clause 8.1, within the applicable Grace
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Period), other than where such failure to Deliver is due to the default of the Authority or its Authorised Agents, then the Authority shall, upon written notice to Novavax:
12.3.1be entitled to refuse or cancel Delivery of any such Products not Delivered in accordance with the Delivery Schedule and/or any future deliveries of Products; and
12.3.2be entitled to a refund, calculated on a pro-rated basis of the Price, for those Products (i) Delivered with a Defect (where the Authority elected to receive a replacement remedy pursuant to clause 12.2.2 but that replacement was not Conforming Product); (ii) not Delivered; or (iii) which have been refused Delivery or had their Delivery cancelled in accordance with clause 12.3.1.
12.3.3If Authority elects to exercise its remedy in this clause 12.3, and subject to clause 12.2.1, it shall be the sole and exclusive remedy of the Authority in regard to failure to Deliver Conforming Product provided that if Novavax fails to Deliver Conforming Products as a consequence of any unremedied material breach of this Agreement (such as failing to use Commercially Reasonable Efforts) then the foregoing shall be without prejudice to the Authority’s other remedies.
13.PRICE
[***]
13.1[***]
13.2[***]
13.3[***]
Currency
13.4The Price payable by the Authority under this Agreement shall be payable in US Dollars.
14.INVOICING AND PAYMENT
Pre-Payment
14.1The Parties acknowledge that as at the Amendment Date the Authority has paid the Pre-Payment, which amount Novavax holds on the Authority’s account and which Novavax shall off-set and apply as credit against payments due by the Authority to Novavax in respect of Conforming Product Delivered to the Authority to meet the Priority Order.
14.2In the following circumstances, Novavax shall provide a refund of part or all of the Pre-Payment:
14.2.1if Novavax fails to Deliver in full the Firm Order according to the applicable Delivery Schedule, Novavax shall refund to the Authority pro rata the Pre-Payment (plus any VAT if any was payable thereon) divided by sixteen million and one (16,000,001) Doses and multiplied by the number of Doses of the Firm Order which have not been fulfilled; and
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14.2.2Where one of the milestone dates referred to under clauses 7.6.1 to 7.6.5 passes without a Trigger event occurring (or where only one occurs) such that the Conditional Order is amended or cancelled, or the Conditional Order will never be for 15,000,000 Doses, or there is a cancellation of the Conditional Order (in whole or part) pursuant to clauses 7.6.1 to 7.6.5, Novavax shall within [***] of such event refund to the Authority pro rata the Pre-Payment (plus any VAT if any was payable thereon) divided by sixteen million and one (16,000,001) Doses and multiplied by the number of Doses of the Firm Order which have been reduced or cancelled (which in the case of clause 7.6.2 shall be an initial reduction of 3,750,000 Doses from [***] and a further reduction of 3,750,000 Doses from [***] if clause 7.6.3 is not triggered). By way of non-exhaustive example, this means:
(a)if on [***], the Adolescent Trigger occurs under both clause 7.5.2(a) and 7.5.2(c), but the Adult Trigger has not, the maximum possible number of Conditional Doses that may be Delivered is 11,250,000 (if clause 7.6.3 applies) or will otherwise be 7,500,000 if no Adult Trigger occurs before [***]. As such, a pro rata refund shall apply (assuming no other cancellations) as at [***] in respect of 3,750,000 Conditional Doses which may no longer be Delivered, and if the Adult Trigger does not apply before [***] a further pro rata refund shall apply (assuming no other cancellations) as at [***] in respect of 3,750,000 Conditional Doses;
(b)If on [***], neither the Adolescent Trigger nor the Adult Trigger has occurred, the maximum possible number of Conditional Doses that may be Delivered thereafter (assuming a Trigger occurs before [***]) is 7,500,000 (pursuant to clause 7.6.4(c)). As such, a pro rata refund shall apply as at [***] and in these circumstances in respect of the 7,500,000 Conditional Doses which may no longer be Delivered;
14.2.3subject to any reductions for cancellation or reductions pursuant to clause 14.2.2, if, pursuant to its rights under clause 7.6, 7.7 or 7.14, the Conditional Order is reduced, Novavax shall refund to the Authority pro rata the Pre-Payment (plus any VAT if any was payable thereon) divided by sixteen million and one (16,000,001) Doses and multiplied by the number of Conditional Doses which have been reduced or cancelled from the Conditional Order;
(each refund pursuant to clause 14.2.1 or 14.2.2 being an “Early Pre-Payment Refund”);
14.2.4on the date that sixteen million and one (16,000,001) Doses have been Delivered, the Cash Flow Advance shall be repaid in full by Novavax to the Authority (the “Cash Flow Advance Refund”); and
14.2.5should the Agreement expire or terminate, any balance of the Pre-Payment that has not been off-set and applied as a credit against the Price due for Conforming Product Delivered pursuant to this Agreement and has not been reimbursed pursuant to the foregoing provisions of this clause (the “Pre-Payment Refund”).
14.3Each Early Pre-Payment Refund and the Pre-Payment Refund shall be made by Novavax to the Authority within [***] of the occurrence of the applicable event triggering such refund, subject to a good faith discussion if the Authority has placed an Additional Order under clause 7.9 whether to apply the potential sum of such refund to an Additional
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Order. At the same time as Novavax issues such Early Pre-Payment Refund or Pre-Payment Refund, it shall provide the Authority with a written report detailing its calculation of such Early Pre-Payment Refund or Pre-Payment Refund accompanied by appropriate evidence (i.e. invoices, proof of payment of Early Pre-Payment Refunds etc.).
Invoicing
14.4Novavax shall invoice the Authority for all supplies of Conforming Product upon their [***].
Payment Terms
14.5Subject to any off-set and credit to be applied by Novavax in respect of the Pre-Payment, the Authority shall pay each invoice properly submitted in accordance with this Agreement and the invoice schedule within thirty (30) days after the date of the applicable invoice.
14.6All payments due to a Party under this Agreement:
14.6.1are exclusive of any VAT which may be chargeable, which, if properly chargeable, the paying Party shall pay in addition at the rate and in the manner for the time being prescribed by Applicable Law and subject to the other Party providing a valid and accurate VAT invoice;
14.6.2shall be made by transfer to such US or UK bank account as the receiving Party may from time to time notify in writing to the paying Party; and
14.6.3shall be made in full and cleared funds, subject to any deduction or withholding which must be made under Applicable Laws.
Disputes and Late Payments
14.7The Authority shall raise any queries with respect to an invoice within fifteen (15) days of receipt. Where Authority raises a query with respect to an invoice, the Parties shall liaise with each other and agree a resolution to such query within fifteen (15) days of the query being raised. If the Parties are unable to agree a resolution within fifteen (15) days of the query being raised, the dispute shall be referred to dispute resolution in accordance with the dispute resolution procedure prescribed in this Agreement. For the avoidance of doubt, the Authority shall not be in breach of any of any of its payment obligations under this Agreement in relation to any queried or disputed invoice sums unless the process referred to in this clause 14.7 has been followed and it has been determined that the queried or disputed invoice amount is properly due to Novavax and the Authority has then failed to pay such sum within fifteen (15) days following such determination.
14.8The Authority shall pay all amounts not in dispute. If the Authority fails to pay any amount payable under this Agreement by the due date for payment, then without prejudice to any other rights or remedies that Novavax may have interest shall accrue on that amount in accordance with the Late Payment of Commercial Debts (Interest) Act 1998.
15.WARRANTY AND UNDERTAKINGS
15.1Novavax warrants and undertakes to the Authority that:
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15.1.1it shall maintain a properly documented system of quality controls and processes (including quality management systems) covering all aspects of its obligations under this Agreement (including those it may subcontract to others) and shall at all times comply with such quality controls and processes and not amend them in material manner without notifying the Authority in writing at least five (5) Business Days in advance of such change (such notice to include the details of the consequences which follow such change being implemented).
15.2Novavax further represents, warrants, and undertakes to the Authority that:
15.2.1it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement;
15.2.2it is a properly constituted limited liability company and that it is fully empowered by the terms of its constitutional documents to enter into and to carry out its obligations under this Agreement and the documents referred to therein;
15.2.3to its knowledge there are no pending or threatened actions or proceedings before any court or administrative agency which would materially adversely affect the financial condition, business or operations of Novavax;
15.2.4there are no material agreements existing to which Novavax is a party which prevent Novavax from entering into this Agreement, or which would prevent Novavax from fulfilling [***] on the terms of this Agreement (including any agreement with a Funding Entity);
15.2.5all necessary actions to authorise the execution of and performance of its obligations under this Agreement have been taken before such execution; and
15.2.6it shall: (i) take reasonable steps to identify if there is any slavery or human trafficking in its supply chains accordingly to Applicable Law; (ii) notify the Authority promptly if it becomes aware of any actual or suspected incidents of slavery or human trafficking in its supply chains; and (iii) conduct its business without use of any slavery or human trafficking.
15.3Novavax also warrants that, at the time of their delivery, title to the Product supplied under this Agreement will pass to the Authority as provided in this Agreement free and clear of any security interest, lien, charge or other encumbrance.
Record Keeping
15.4Novavax shall (and shall procure that its Affiliates shall) maintain all records and reports with respect to the Manufacture and supply of the Product (and in relation to the provision of any other services) under this Agreement as required by Applicable Laws and in any event for a minimum period of six (6) years following the termination or expiry of this Agreement.
Product Recall
15.5Novavax and the Authority (or its designee) shall co-operate with respect to initiating and implementing any Product recalls (i) required by controlling Regulatory Authorities; (ii) that are precautionary withdrawals implemented due to an underlying concern regarding the Product; and (iii) voluntary withdrawals requested by the Authority for reasons other
42

than those under (i) or (ii). Novavax shall be responsible for implementing a recall required by the controlling Regulatory Authority or a precautionary recall under (ii) above, and the Authority shall be responsible for implementing any recall it voluntarily elects to make under (iii) above. Each Party, as applicable, shall (a) handle such matters in a timely, prudent and skilful manner, in compliance with all Applicable Law; and (b) keep the other Party informed in a timely manner with respect to the recalling Party’s activities in regard to all such recalls and market withdrawals.
15.6All costs incurred in responding to recalls and market withdrawals shall be borne:
15.6.1[***];
15.6.2[***], or
15.6.3[***].
16.FUTURE PREPAREDNESS
Through the Oversight Committee, the Parties shall discuss in good faith the terms and arrangements for a longer partnership with potential funding by the Authority for the development and supply of other potential pandemic preparedness vaccine products (including but not limited to Novavax’ seasonal influenza vaccine or a pandemic derivative thereof).
17.ANTI-BRIBERY
17.1Each Party represents:
17.1.1on behalf of itself, its Affiliates, and its and their respective Personnel (together with such Party, the “Party Representatives”) that its Party Representatives have not in relation to this Agreement:
(a)committed (directly or indirectly) any offence under any anti-bribery or anti-corruption laws (including the Bribery Act 2010 and/or the Foreign Corrupt Practices Act);
(b)offered, given or agreed to give any Personnel of the other Party any gift or consideration of any kind as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining or performance of this or any other agreement with the other Party; or
(c)in connection with this Agreement paid or agreed to pay any commission other than a payment, except as permitted under Applicable Law, (each of (a), (b) and (c) being a “Prohibited Act”).
17.2Each Party represents that:
17.2.1it has in place reasonably adequate training and compliance procedures to prevent bribery and corruption as contemplated by Applicable Laws; and
17.2.2it, its Affiliates, and their respective Personnel shall not knowingly take any action that will, or would reasonably be expected to, cause the other Party or its Affiliates to be in violation of any such laws or policies.
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17.3If a Party or its Party Representatives (or anyone acting on its or their behalf) has done or does any of the Prohibited Acts or has committed or commits any offence under any anti-bribery or anti-corruption laws in relation to this or any other agreement with the other Party:
17.3.1such act shall be treated as a material breach of this Agreement; and
17.3.2any termination under this clause 17.3 shall be without prejudice to any right or remedy that has already accrued, or subsequently accrues, to the non-breaching Party.
18.PRODUCT SECURITY
18.1Without prejudice to Novavax’s obligation to replace Doses [***] pursuant to clause 7.6 (which Doses to be replaced shall be destroyed by Novavax at its sole cost and responsibility), the Authority (or, on its behalf, its Authorised Agent) shall otherwise be responsible for destruction of all Conforming Product in its possession for which the shelf life has expired. Novavax shall be responsible for destruction of all Products that have Defects. In complying with its respective destruction obligations, the applicable Party shall undertake such destruction within mutually acceptable timelines, and prior to the destruction the applicable Party possessing the applicable Product shall hold the same securely pending destruction. Each Party shall keep a record of any destruction it undertakes and shall promptly issue certificates of destruction to the other Party upon request. Such records shall be kept for a period of the longer of five (5) years or the term required by Applicable Laws or Applicable Standards.
18.2The Authority shall comply with all Applicable Laws relating to the traceability of pharmaceutical products in accordance with Novavax’ specifications, standards, strategy and instructions applied by Novavax to all of its distributors of medicinal products from time to time. Any amendment to such specifications, standards, strategy or instructions shall be implied after a reasonable timeline agreed with the Authority.
18.3The Authority warrants and undertakes that it will not alter or modify any Product in any way (including Labelling and packaging but excluding any transportation packaging) after delivery to the Delivery Locations.
18.4After Delivery, all Products shall be: (i) stored securely by the Authority (or its Affiliate); and (ii) delivered, shipped and distributed by the Authority (or its Affiliate) in a secure manner appropriate to the transportation route and destination, in each case (i) and (ii) to guard against and deter theft, diversion, tampering or substitution (with, for example, counterfeits).
19.INTELLECTUAL PROPERTY
19.1Neither Party will gain any rights of ownership to or use of any property or Intellectual Property Rights owned by the other (whether by virtue of this Agreement, by implication or otherwise).
19.2Novavax warrants to the Authority that either it is the sole proprietor and legal and beneficial owner of all Intellectual Property Rights in the Product or it is licensed by the relevant owners to Manufacture and supply the Product in accordance with this Agreement.
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19.3Novavax warrants and represents to the Authority that, as of the Effective Date, it is not aware that any receipt, keeping, sale and use of the Product in the Territory in accordance with this Agreement would infringe any Intellectual Property Rights of any Third Party.
20.CONFIDENTIALITY
20.1Each Party shall treat the Confidential Information of the other Party as strictly confidential and not disclose it to any Third Party for any purpose whatsoever without obtaining the prior written consent of the other Party and not make use of the Confidential Information of the other Party or any part thereof other than as permitted under this Agreement, in each case other than to conduct its activities under this Agreement and as expressly permitted under this clause 20. Each Party agrees to treat such Confidential Information with at least the same care and in the same manner as its own secret and valuable information.
20.2Novavax may disclose all or any part of the Confidential Information to its Affiliates, and to its and its Affiliates’ respective Personnel and suppliers (“Representatives”) as necessary to enable Novavax’ performance under this Agreement, provided, however, that it ensures that such Representatives comply with the provisions of this clause 20. The Authority may disclose all or any part of the Confidential Information to Authorised Agents, Central Government Bodies and the Devolved Administrations (“Representatives”) as necessary to enable the Authority’s performance under this Agreement, provided, however, that it ensures that such Representatives comply with the provisions of this clause 20.
20.3The confidentiality obligations and use restrictions set forth in clause 20.1 shall not apply to:
20.3.1information that is or becomes generally available to the public (other than as a result of its disclosure by the receiving Party in breach of this clause 20);
20.3.2information that was available to the receiving Party or its Representatives on a non-confidential basis before disclosure by the disclosing Party;
20.3.3information that was, is or becomes available to the receiving Party or its Representatives on a non-confidential basis from a Third Party who, to the receiving Party’s or the relevant Representative’s knowledge, is not bound by a confidentiality agreement with the disclosing Party or otherwise prohibited from disclosing the information to the receiving Party or the Representative;
20.3.4information that is developed by or for the receiving Party or its Representatives independently of the information disclosed by the disclosing Party; or
20.3.5the disclosure of which is required to ensure the compliance of the Authority with any law including, but not limited to, the Freedom of Information Act 2000 (c.36) (“FOIA”), Codes of Practice on Access to Government Information, on the Discharge of Public Authorities’ Functions or on the Management of Records (“Codes of Practice”) or the Environmental Information Regulations 2004 (SI 2004/3391) (“Environmental Regulations”), provided, however, that the Authority has provided reasonable advance notice of the impending disclosure to Novavax and provided further that it shall only disclose the Confidential Information to the extent strictly necessary.
20.4Novavax agrees that:
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20.4.1without prejudice to the generality of clause 20.3.5, the provisions of this clause 20 are subject to the respective obligations and commitments of the Authority and any Authorised Agent, Central Government Body, Administering Entity and Devolved Administration (as the case may be) under the FOIA, the Codes of Practice and the Environmental Regulations;
20.4.2the decision on whether any exemption applies to a request for disclosure of recorded information is a decision solely for the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration (as the case may be); and
20.4.3where the Authority or an Administering Entity or Devolved Administration is managing a request as referred to in clause 20.4.2, Novavax shall co-operate with the Authority and any Authorised Agent, Central Government Body, Administering Entity or Devolved Administration making the request and shall respond within five (5) Business Days of any request by it for assistance in determining how to respond to a request for disclosure.
20.5Novavax shall:
20.5.1transfer any request for information, as defined under section 8 of the FOIA and/or the Environmental Regulations, to the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration as soon as practicable after receipt and in any event within five (5) Business Days of receiving a request for information;
20.5.2provide the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration with a copy of all information in its possession or power in the form that the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration requires within five (5) Business Days (or such other period as the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration may specify) of the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration requesting that information; and
20.5.3provide all necessary assistance as reasonably requested by the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration to enable the Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration to respond to a request for information within the time for compliance set out in section 10 of the FOIA.
20.6Subject to clause 20.5 above:
20.6.1Novavax hereby gives consent for the Authority to publish this Agreement in its entirety (but with any information which is exempt from disclosure in accordance with the provisions of the FOIA and or the Environmental Information Regulations redacted, and subject to clause 20.6.3 any other redactions agreed by the Parties), including from time to time agreed changes to this Agreement, to the general public; and
20.6.2the Authority hereby gives consent for Novavax to publish this Agreement as required by the SEC (but with any information which is exempt from disclosure
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redacted unless disclosure is required by the SEC, and subject to clause 20.6.3 any other redactions agreed by the Parties); and
20.6.3the Parties shall cooperate in good faith to agree the scope of redactions and to address each Party’s concerns as regards information which the other Party intends not to redact (but subject always to each Party’s obligations to disclose as set out above).
20.7The Authority may, at its sole discretion, redact information from this Agreement prior to publishing for one or more of the following reasons:
20.7.1national security;
20.7.2Personal Data;
20.7.3confidential information protected by Intellectual Property Rights;
20.7.4Third Party confidential information;
20.7.5IT security; or
20.7.6prevention of fraud.
20.8The Authority may consult with Novavax to inform its decision regarding any exemptions and/or redactions but the Authority shall have the final decision. Novavax shall assist and cooperate with the Authority to enable the Authority to publish this Agreement. The Authority will follow its own internal policies together with any applicable guidelines, including any published by the Treasury, the Cabinet Office or the Information Commissioner.
20.9The Authority or an Authorised Agent, Central Government Body, Administering Entity or Devolved Administration may consult Novavax in relation to any request for disclosure of Novavax’ Confidential Information in accordance with all applicable guidance.
20.10Each Party acknowledges that damages resulting from disclosure of the Confidential Information not permitted hereby would be an insufficient remedy. Novavax acknowledges and agrees that the Authority shall be the only Party entitled to seek, by way of private litigation, injunctive relief or other equitable relief in addition to any and all remedies available at law or in equity.
20.11Each Party may disclose Confidential Information (including this Agreement) of the other Party to the extent that such disclosure is:
20.11.1required by Applicable Laws, such as filing with securities regulators, or by an order of a Governmental Authority; provided that the receiving Party (where it is legally permitted to do so) shall first have given notice to the disclosing Party and given the disclosing Party a reasonable opportunity to seek a protective order or other form of confidential treatment for the information, or obtain assurances that the information be used only for the purposes for which the order was issued, and the receiving Party shall thereafter disclose only that portion of the information required to be disclosed in order to comply;
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20.11.2to a Regulatory Authority as reasonably necessary for the purposes of any filing, application or request for any marketing authorisation, licence or other Regulatory Approval made by or on behalf of Novavax or its Affiliates in respect of the Product;
20.11.3made by or on behalf of the receiving Party to legal, financial or other professional advisors, in each case for the purposes of advising on this Agreement and/or on the transactions contemplated hereby and thereby; provided however that, in each case, such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information and may only use such information for the purpose of assessing such transaction or providing such advice (as the case may be); or
20.11.4for the purposes of any legal proceedings brought pursuant to clause 34.11.2;
provided that the Party making disclosures to a Third Party (other than a Governmental Authority) pursuant to clause 20.11.3 or clause 20.11.4 shall ensure that each Third Party recipient is bound by obligations of confidentiality no less restrictive than those contained in this Agreement and shall be liable to the other Party for any breach of such confidentiality obligations by the relevant recipient.
20.12Nothing in this clause 20 shall prevent the Authority from disclosing Confidential Information where it is required to do so by judicial, administrative, governmental or regulatory process in connection with any action, suit, proceedings or claim or otherwise by Applicable Law. Nothing in this Agreement shall prevent the Authority from disclosing Confidential Information:
20.12.1to any contracting authority as defined in Regulation 2 of the Public Contracts Regulations 2015 (“Contracting Authority”). All Contracting Authorities receiving such Confidential Information shall be entitled to further disclose the Confidential Information to other Contracting Authorities on the basis that the information is confidential and is not to be disclosed to a Third Party which is not part of any Contracting Authority;
20.12.2to any consultant, contractor or other person engaged by the Authority or any person conducting an Office of Government Commerce gateway review;
20.12.3for the purpose of the examination and certification of the Authority’s accounts; or
20.12.4for any examination pursuant to Section 6(1) of the National Audit Act 1983 of the economy, efficiency and effectiveness with which the Authority has used its resources.
20.13The Authority may disclose the Confidential Information of Novavax:
20.13.1on a confidential basis to any Central Government Body for any proper purpose of the Authority or of the relevant Central Government Body;
20.13.2to Parliament and Parliamentary Committees or if required by any Parliamentary reporting requirement;
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20.13.3to the extent that the Authority (acting reasonably) deems disclosure necessary or appropriate in the course of carrying out its public functions;
20.13.4on a confidential basis to a professional adviser, consultant, supplier or other person engaged by any of the entities described in clause 20.13.1 (including any benchmarking organisation) for any purpose relating to or connected with this Agreement;
20.13.5on a confidential basis for the purpose of the exercise of its rights under this Supply Agreement, including the audit rights pursuant to clause 29; or
20.13.6on a confidential basis to a proposed successor body in connection with any assignment, novation or disposal of any of its rights, obligations or liabilities under this Agreement, and for the purposes of the foregoing, references to disclosure on a confidential basis shall mean disclosure subject to a confidentiality agreement or arrangement containing terms no less stringent than those placed on the Authority under this clause 20.
20.14The Authority and Novavax agree not to issue any press releases or public announcements concerning this Agreement or its terms without the prior written consent of the other Party as to the form, timing and content of any such release or announcement, except as required by Applicable Laws, including disclosure required by any securities exchange.
20.15Subject to clause 20.16, on expiry or termination of this Agreement or at any time at the disclosing Party’s request, the receiving Party shall return to the disclosing Party all copies containing Confidential Information of the disclosing Party or, at the disclosing Party’s option, destroy all copies of such Confidential Information. The return or destruction of the Confidential Information of the disclosing Party will not affect the receiving Party’s obligation to observe the confidentiality and non-use restrictions in respect of that Confidential Information set out in this Agreement.
20.16Each Party may keep one (1) copy of Confidential Information for evidence purposes at a secure place subject to the confidentiality and non-use obligations provided in this clause 20. The aforementioned return and destruction obligation shall not apply to electronic copies of Confidential Information which are rightfully contained in computers, word processors, communication systems and system-backup media (collectively “IT Media”) which do not need to be destroyed or returned, provided that such IT Media are: (i) overwritten in the ordinary course of their reuse; or (ii) at all times maintained in confidence and not readily accessible and the receiving Party shall treat such copies as confidential in accordance with this clause 20.
20.17This clause 20 shall remain in force without limit in time in respect of Confidential Information which comprises Personal Data or which relates to a patient, his or her treatment and/or medical records. Save as aforesaid, the obligations in this clause 20 shall last for the Term and for a period of ten (10) years thereafter.
21.INDEMNITIES
By Authority
21.1[***].
21.2[***]:
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21.2.1[***];
21.2.2[***]; or
21.2.3[***].
21.3[***]:
21.3.1[***]; or
21.3.2[***].
By Novavax
21.4[***]:
21.4.1[***];
21.4.2[***]; and
21.4.3[***].
21.5[***].
21.6[***].
Conduct of Claims
21.7[***]:
21.7.1[***];
21.7.2[***];
21.7.3[***];
21.7.4[***]; and
21.7.5[***].
[***].
22.LIABILITY
22.1[***].
22.2[***]:
22.2.1[***]; or
22.2.2[***].
22.3[***]:
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22.3.1[***];
22.3.2[***];
22.3.3[***];
22.3.4[***]; or
22.3.5[***].
22.4[***]:
22.4.1[***]; and,
22.4.2[***].
22.5[***].
22.6[***].
23.INSURANCE
Novavax shall take out and maintain with a reputable commercial insurer such types and amounts of liability insurance to cover liabilities related to its activities under this Agreement for product liability claims, and for such other losses as are normal and customary in the pharmaceutical industry generally for Persons similarly situated, and shall upon request provide to the Authority evidence of its insurance coverage. Such policies shall include product liability insurance, clinical trial insurance, manufacturing insurance and general liability insurance, and shall remain in effect throughout the Territory and the Term and for a period of three (3) years thereafter.
24.FORCE MAJEURE
24.1If a Party is prevented from or delayed in performing any of its obligations under the Agreement by a Force Majeure then:
24.1.1the relevant obligations under this Agreement shall be suspended for as long as the Force Majeure continues and the affected Party shall not be in breach of this Agreement or otherwise liable for any such failure or delay in the performance of such obligations;
24.1.2as soon as reasonably practicable after the start of the Force Majeure, the affected Party shall notify the other Party of the nature of the Force Majeure and the likely effects of the Force Majeure on its ability to perform its obligations under this Agreement; and
24.1.3as soon as reasonably practicable after the end of the Force Majeure, the affected Party shall notify the other Party that the Force Majeure has ended, and shall resume performance of its obligations under this Agreement.
25.DURATION AND TERMINATION
25.1This Agreement commences and takes effect on the Effective Date and shall continue until the later of (a) the date falling one hundred and twenty (120) days after the last date
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on which the total quantity of Conforming Product equal to the volumes to be purchased by the Authority under the Priority Order is last Delivered in full to the Authority or (b) 31 December 2024 (the “Initial Term”), unless and to the extent this Agreement is (i) extended under clause 25.2 or (ii) terminated earlier by a Party or the Parties in accordance with the provisions of this clause 25 (the “Term”).
25.2If an Additional Order is placed in accordance with clause 7.10, the term of this Agreement shall automatically be extended to [***].
25.3Either Party (the “Terminating Party”) shall be entitled to terminate this Agreement before the expiry of the Term in its sole discretion and upon written notice to that effect to the other Party, for material breach, if:
25.3.1subject to clause 25.3.2, the other Party (the “Breaching Party”) fails to materially comply with any of the obligations under this Agreement and fails to remedy the violation or breach within [***] (in each case, the “Cure Period”), after having been notified in advance in writing by the Terminating Party. In such event, the right of the Terminating Party to claim damages for breach of contract shall remain unaffected; and
25.3.2the Breaching Party may during the Cure Period commence legal proceedings to challenge the validity of the termination, in which case, termination shall not occur until the court makes a decision (which decision is not capable of appeal or which is not appealed within the time limited allowed for appeal) that the event(s) specified in the Terminating Party’s written notice does entitle the Terminating Party to terminate this Agreement.
25.4The Authority shall be entitled to terminate this Agreement before the expiry of the Term in its sole discretion and upon thirty (30) days’ written notice to that effect to Novavax:
25.4.1if the Authority, acting reasonably and in good faith, objects to any material change to the Development and Manufacturing Plan on the basis that such change will or is reasonably likely to result in (i) a material delay in securing a Marketing Authorisation for the Product in the Territory with an indication in the Field or (ii) a failure to Deliver quantities of the Confirming Product in all material respects to the Delivery Schedule or to Deliver the Firm Order by 1 October 2022 in accordance with clause 7.3;
25.4.2if there is any Loss of Supply; or
25.4.3the [***], to the extent it has not been fulfilled in full with Conforming Product, is cancelled or reduced such that there are no further volumes of Doses to be Delivered.
25.5The Authority shall be entitled to terminate this Agreement before the expiry of the Term in its sole discretion and upon written notice to that effect to Novavax, as detailed below and to the extent permitted by Applicable Laws, if:
25.5.1any resolution is passed, or application made, in relation to Novavax for a moratorium on the payment of its debts, or for its dissolution, liquidation, winding-up or administration; or
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25.5.2a receiver, liquidator, administrator or administrative receiver (or equivalent officer) is appointed over Novavax or its undertaking or all or a substantial part of its assets; or
25.5.3Novavax suffers any event in any jurisdiction to which it is subject that has an effect equivalent or similar to any of the events described in this clause 25.5; and/or
25.5.4Novavax ceases or threatens to cease to carry on business.
25.6The Authority shall be entitled to terminate this Agreement before the expiry of the Term in its sole discretion and upon written notice:
25.6.1if Novavax undergoes a change of control equivalent to or within the meaning of sections 450 and 451 of the Corporation Tax Act 2010 (other than for an intra-group change of control) without the prior written consent of the Authority and the Authority shall be entitled to withhold such consent if, in the reasonable opinion of the Authority, the proposed change of control will have a material impact on the performance of this Agreement or the reputation of the Authority;
25.6.2if Novavax purports to assign, subcontract, novate, create a trust in or otherwise transfer or dispose of this Agreement in breach of its terms, including those at clauses 34.5 and 34.7;
25.6.3Novavax commits a material breach of its obligation to notify the Authority of any Occasion of Tax Non-Compliance as required by clause 30, or Novavax fails to provide details of proposed mitigating factors as required by clause 30 that in the reasonable opinion of the Authority are acceptable; or
25.6.4the Agreement should not have been awarded to Novavax in view of a serious infringement of obligations under European law declared by the Court of Justice of the European Union under Article 258 of the Treaty on the Functioning of the EU.
26.CONSEQUENCES OF TERMINATION
26.1Upon expiry or termination of this Agreement:
26.1.1the proportion of the Order concerning Conforming Product that has not been Delivered at the date of termination shall be cancelled;
26.1.2Novavax shall be entitled to payment from the Authority for amounts that are due under this Agreement which have not otherwise been paid by the Authority in respect of the Price for Conforming Product that has been Delivered pursuant to this Agreement, which the Authority shall pay within thirty (30) days of the date of invoice for the same (to the extent the Authority has not already done so);
26.1.3Novavax shall make the Early Pre-Payment Refund and Pre-Payment Refund to the Authority in accordance with clause 14.2;
26.1.4each Party shall use Commercially Reasonable Efforts to mitigate both (i) the damages that would otherwise be recoverable from the other pursuant to this Agreement, and (ii) any costs, fees, expenses or losses that may be incurred by a
53

Party, or for which a Party may be responsible, under this Agreement, by taking appropriate and reasonable actions to reduce or limit the amount of such damages, costs, fees, expenses or losses; and
26.1.5any provision of this Agreement which expressly or by implication is intended to come into or continue in force, including clauses 1, 2.18, 4.9, 4.10, 4.11, 9, 11, 12, 13, 14, 18, 20, 21, 22, 23, 26, 29 and 34 shall remain in full force and effect.
26.2Expiry or termination of this Agreement for any reason shall be without prejudice to either Party’s other rights and remedies or to any accrued rights and liabilities as the date of such expiry or termination which shall survive such termination or expiry.
27.DATA PROTECTION
27.1The following shall apply if Novavax processes any Personal Data pursuant to this Agreement:
27.1.1Novavax shall comply with the Data Protection Act, the GDPR and any other applicable data protection legislation. In particular Novavax agrees to comply with the obligations placed on the Authority by the Principle (f) (the “Integrity Principle”) set out in the Data Protection Act and the GDPR, namely:
(a)to maintain technical and organisational security measures sufficient to comply at least with the obligations imposed on the Authority by the Integrity Principle;
(b)only to process Personal Data for and on behalf of the Authority, in accordance with the instructions of the Authority and for the purpose of performing its obligations under this Agreement and to ensure compliance with the Data Protection Act and GDPR; and
(c)to allow the Authority to audit Novavax’ compliance with the requirements of this clause 27 on reasonable notice and/or to provide the Authority with evidence of its compliance with the obligations set out in this clause 27.
27.2Both Parties agree to use all reasonable efforts to assist each other to comply with the Data Protection Act and the GDPR. For the avoidance of doubt, this includes Novavax providing the Authority with reasonable assistance in complying with subject access requests served on the Authority and Novavax consulting with the Authority prior to the disclosure by Novavax of any Personal Data in relation to such requests.
28.INDEPENDENT CONTRACTORS
Novavax is acting as an independent contractor under this Agreement. Nothing in this Agreement or any circumstances associated with it or its performance give rise to any relationship of agency, partnership or employer and employee between the Authority and Novavax or between the Authority and any Novavax Representative, nor authorise either Party to make or enter into any commitments for or on behalf of the other Party.
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29.RIGHT OF AUDIT, CONFLICTS OF INTEREST AND PREVENTION OF FRAUD
29.1Novavax shall keep secure and maintain for the Term of this Agreement and seven (7) years thereafter (or from the date of the last delivery, if later), or such longer period as may be agreed between the Parties, full and accurate records of all matters relating to this Agreement.
29.2Novavax shall grant to the Authority or its Authorised Agents, such access to those records as they may reasonably require in order to check Novavax’ compliance with this Agreement for the purposes of:
29.2.1the examination and certification of Novavax’ accounts; or
29.2.2any examination pursuant to section 6(1) of the National Audit Act 1983 of the economic efficiency and effectiveness with which the Authority has used its resources.
29.3The Comptroller and Auditor General may examine such documents as he may reasonably require which are owned, held or otherwise within the control of Novavax and may require Novavax to provide such oral and/or written explanations as he considers necessary. This clause does not constitute a requirement or agreement for the examination, certification or inspection of the accounts of Novavax under section 6(3)(d) and 6(5) of the National Audit Act 1983.
29.4The Authority shall have the right to audit Novavax’ compliance with this Agreement. Novavax shall permit or procure permission for the Authority or its authorised representative during normal business hours having given advance notice of no less than twenty (20) Business Days, access to any premises and facilities, books and records used in the performance of Novavax’ obligations under this Agreement.
29.5Should Novavax subcontract any of its obligations under this Agreement, Novavax shall use Commercially Reasonable Efforts to obtain for the Authority the right to audit (including but not limited to a financial audit and a full manufacturing audit) and inspect such Affiliate or Third Party. Novavax shall use Commercially Reasonable Efforts to procure permission for the Authority or its authorised representative during normal business hours no more than once in any twelve (12) months having given advance notice of no less than twenty (20) Business Days, access to any premises and facilities, books and records used in the performance of Novavax’ obligations under this Agreement, including any that are subcontracted to such Third Party. Novavax shall cooperate with such audit and inspection and accompany the Authority or its authorised representative if requested.
29.6Novavax shall take appropriate steps to ensure that neither Novavax nor any staff is placed in a position where, in the reasonable opinion of the Authority, there is or may be an actual conflict, or a potential conflict, between the pecuniary or personal interests of Novavax and the duties owed to the Authority under the provisions of this Agreement. Novavax will disclose to the Authority full particulars of any such conflict of interest which may arise.
29.7The Authority reserves the right to terminate this Agreement with immediate effect by giving notice in writing and/or to take such other steps it deems necessary where, in the reasonable opinion of the Authority, there is or may be an actual conflict, or a potential conflict, between the pecuniary or personal interests of Novavax and the duties owed to
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the Authority under the provisions of this Agreement. The actions of the Authority pursuant to this clause 29.7 shall not prejudice or affect any right of action or remedy which shall have accrued or shall thereafter accrue to the Authority.
29.8Novavax shall take all reasonable steps to prevent Fraud by staff and Novavax (including its shareholders, members and directors) in connection with the receipt of monies from the Authority. Novavax shall notify the Authority immediately if it has reason to suspect that any Fraud has occurred or is occurring or is likely to occur.
29.9If Novavax or its staff commits Fraud in relation to this or any other contract with the Crown (including the Authority) the Authority may:
29.9.1terminate this Agreement and recover from Novavax the amount of any loss suffered by the Authority resulting from the termination, including the cost reasonably incurred by the Authority of making other arrangements for the supply of the Product and any additional expenditure incurred by the Authority throughout the remainder of the Term of this Agreement; or
29.9.2recover in full from Novavax any other loss sustained by the Authority in consequence of any breach of clause 29.8.
30.TAX NON-COMPLIANCE
30.1If, at any point during the Term of this Agreement, an Occasion of Tax Non- Compliance occurs, Novavax shall:
30.1.1notify the Authority in writing of such fact within five (5) Business Days of its occurrence; and
30.1.2promptly provide to the Authority:
(a)details of the steps which Novavax is taking to address the Occasion of Tax Non-Compliance and to prevent the same from recurring, together with any mitigating factors that it considers relevant; and
(b)such other information in relation to the Occasion of Tax Non- Compliance as the Authority may reasonably require.
31.ENVIRONMENTAL CONSIDERATIONS
31.1Novavax shall comply in all material respects with applicable environmental laws and regulations in force from time to time in relation to the Product. Without prejudice to the generality of the foregoing, in respect of Product supplied in the Territory under this Agreement Novavax shall:
31.1.1comply with any obligations imposed on it in relation to the Product by the Producer Responsibility Obligations (Packaging Waste) Regulations 2007 (SI 2007/871) (or any other equivalent legislation giving effect in any part of the European Economic Area to the Packaging and Packaging Waste Directive 94/62/EC as amended); and
31.1.2without prejudice to the Novavax’ other obligations under this Agreement, label all units of the Product, and the packaging of those units, to highlight mandatory environmental and safety information as required by Applicable Laws.
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31.2Novavax shall promptly respond to and meet all reasonable requests by the Authority for information evidencing Novavax’ compliance with the provisions of this clause 31 in the Territory including the weight and type of packaging according to material types used in relation to the Product.
32.EQUALITY, NON-DISCRIMINATION AND HUMAN RIGHTS
32.1Novavax shall not, to the extent applicable to its activities in relation to this Agreement:
32.1.1engage in any prohibited conduct as defined in part 2 chapter 2 of the Equality Act 2010 (c.15) (the “Equality Act”) in relation to any protected characteristic (as defined in section 4 of the Equality Act) where this would contravene any provisions of the Equality Act, including part 3 (goods and services) and part 5 (employment);
32.1.2do (or omit to do) anything else that would amount to a contravention of the Equality Act including part 8 (prohibited conduct: ancillary) and chapter 3 part 5 (equality of terms); or
32.1.3do (or omit to do) anything else that would amount to a contravention of any equivalent legislation.
32.2Novavax shall notify the Authority promptly of any investigation of or proceedings against Novavax under the Equality Act or any predecessor legislation and shall cooperate fully and promptly with any requests of the person or body conducting such investigation or proceedings, including allowing access to any documents or data required, attending any meetings and providing any information requested.
32.3Novavax shall use Commercially Reasonable Efforts to include in any agreement with a Subcontractor entered into after the Effective Date to provide services or products solely in connection with this Agreement obligations substantially similar to those imposed on Novavax by this clause 32.
32.4Novavax shall: (i) comply in all material respects with applicable current employment legislation with respect to its employees engaged in relation to this Agreement; and (ii) ensure that its employees are provided with appropriate employment and equality training as required by Applicable Laws.
32.5Novavax shall, and shall use reasonable endeavours to ensure that its employees or agents and/or Subcontractors shall, at all times, act in a way which is compatible with the Convention rights within the meaning of Section 1 of the Human Rights Act 1998 (c.42).
33.SUPPLY CHAIN RIGHTS AND PROTECTION
33.1From the Effective Date, Novavax shall implement reasonable due diligence procedures prior to contracting with any Subcontractors or any other participants in its supply chains, in order to satisfy itself that there is no slavery or human trafficking in its supply chains.
33.2Novavax shall notify the Authority as soon as it becomes aware of any actual or suspected slavery or human trafficking in a supply chain which has a connection with this Agreement, and shall promptly use best efforts to remove any such slavery or human trafficking from its supply chain.
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33.3In relation to any contracts concluded by Novavax after the Effective Date with Subcontractors where the domicile of the Subcontractor is in the Territory, Novavax shall use Commercially Reasonable Efforts (i) to include payment terms that are no longer than thirty (30) days from the date of the receipt of a valid and undisputed invoice from the Subcontractor; and (ii) to agree late payment interest on the same terms as set forth herein.
34.MISCELLANEOUS
34.1Notices
34.1.1All communications relating to this Agreement shall be in writing and delivered by hand or sent by post to the Party concerned at the relevant address set out in this clause 34.1 below (or such other address as may be notified from time to time in accordance with this clause 34.1 by the relevant Party to the other Party). Any communication shall take effect:
(a)if hand delivered, upon being handed personally to the addressee (or, where the addressee is a corporation, any one of its directors or its secretary) or being left in a letter box or other appropriate place for the receipt of letters at the relevant Party’s address as set out below;
(b)if sent by first class registered post, at 10 a.m. on the second (2nd) Business Day after posting or if overseas by international recorded post, at 10 a.m. on the fifth (5th) Business Day after posting.
No notice served by email shall be effective.
34.1.2A notice sent by post (or the envelope containing it) shall not be deemed to be duly posted for the purposes of this clause 34.1 unless it is put into the post properly stamped or with all postal or other charges in respect of it otherwise prepaid.
For Notices to the Authority:
Secretary of State, Department for Business, Energy and Industrial Strategy
1 Victoria Street
Westminster
London
SW1H 0ET
Attn: Director General of the UK Vaccine Taskforce
With a copy to: Permanent Secretary, Department for Business, Energy & Industrial Strategy at the above address.
For Notices to Novavax:
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878 U.S.A.
Attn: EVP, Chief Legal Officer
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34.2Variation and Waiver
34.2.1No amendment or variation of the terms of this Agreement shall be effective unless it is made or confirmed in a written document signed by both Parties to this Agreement.
34.2.2Any waiver of any right, obligation or remedy under, or compliance with or breach of any provision of, this Agreement must be expressly stated in writing to be such a waiver, must specify the right, remedy, obligation, provision or breach to which it applies and must be signed by an authorised signatory of each of the Parties granting the waiver. If either Party waives any right, obligation or remedy under, or compliance with or breach of any provision of, this Agreement, it can still enforce that right, obligation or provision, or claim that remedy subsequently and that waiver shall not be deemed to be a waiver of any subsequent breach of that or any other provision or of any other right, obligation or remedy.
34.2.3The rights and remedies of either Party in respect of this Agreement shall not be diminished, waived or extinguished by the granting of any indulgence, forbearance or extension of time by either Party to the other nor by any failure to ascertain or exercise, or any delay in ascertaining or exercising, any such rights or remedies.
34.2.4The discontinuance, abandonment or adverse determination of any proceedings taken by either Party to enforce any right or any provision of this Agreement shall not operate as a waiver of, or preclude any exercise or enforcement or (as the case may be) further or other exercise or enforcement by that Party of, that or any other right or provision.
34.2.5Unless expressly provided otherwise in this Agreement, all references in this clause 34.2 to any right or remedy shall include any power, right or remedy conferred by this Agreement on, or provided by law or otherwise available to, the relevant Party; and any right not being exercised shall include any partial exercise of that right and any circumstances in which the relevant Party does not insist on the strict performance of any provision of this Agreement.
34.2.6The giving by either Party of any consent to any act which by the terms of this Agreement requires that consent shall not prejudice the right of that Party to withhold or give consent to the doing of any similar act.
34.3Counterparts
34.3.1This Agreement may be executed in any number of counterparts, and by the Parties on separate counterparts, but shall not be effective until each Party has executed at least one (1) counterpart. Each counterpart shall constitute an original of this Agreement, but all the counterparts shall together constitute the one agreement.
34.3.2Delivery of a copy of this Agreement together with an executed signature page of a counterpart in Adobe™ Portable Document Format (PDF) sent by electronic mail shall take effect (subject to clause 34.12) as delivery of an executed counterpart of this Agreement. If this method is adopted, without prejudice to the validity of this Agreement, each Party shall provide the other
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with a hard copy original of that executed counterpart as soon as reasonably practicable thereafter.
34.4Invalidity
Each provision of this Agreement is severable and distinct from the others. The Parties intend that each of those provisions shall be and remain valid and enforceable to the fullest extent permitted by Applicable Laws. If all or any part of any such provision is held to be, or at any time becomes to any extent invalid, illegal or unenforceable for any reason under any enactment or rule of law, it shall to that extent be deemed not to form part of this Agreement but (except to that extent in the case of that provision) it and all other provisions of this Agreement shall continue in full force and effect and their validity, legality and enforceability shall not be affected or impaired as a result, subject to the operation of this clause 34.4 not negating the commercial intent and purpose of the Parties under this Agreement.
34.5Assignment
34.5.1The Authority may assign or transfer, in whole or in part, this Agreement or any of its rights and obligations under this Agreement to one or more of its Affiliates; provided that if any such Affiliates fails to assume all obligations of Authority so assigned or transferred hereunder, Novavax shall have the right to terminate this Agreement by written notice with immediate effect.
34.5.2Novavax may, but only with the Authority’s prior written consent (which consent shall not be unreasonably withheld or delayed), assign or transfer, in whole or in part, this Agreement or any of its rights and obligations under this Agreement to one or more of its Affiliates. Novavax will procure that, before any assignee subsequently ceases to be a member of Novavax’ Group, the assignee shall assign back to Novavax for the purposes of this clause, as much of the benefit of this Agreement as has been assigned to it.
34.5.3Novavax may, but only with the Authority’s prior written consent (which consent shall not be unreasonably withheld or delayed), assign or transfer, in whole or in part, this Agreement or any of its rights and obligations under this Agreement to any Third Party, but otherwise may not assign this Agreement, in whole or part, to any Third Party.
34.5.4Any permitted assignment or transfer by one Party shall be effective only if the relevant assignee confirms in writing to, and upon receipt by, the other Party that it shall fully adhere to all the provisions of this Agreement as if it were an original party to this Agreement.
34.5.5This Agreement shall be binding on and inure for the benefit of the successors and permitted assignees of the Parties.
34.6Change of Control
34.6.1If Novavax undergoes a change of control equivalent to or within the meaning of sections 450 and 451 of the Corporation Tax Act 2010 (other than for an intra-group change of control) without the prior written consent of the Authority then, without prejudice to clause 25.6.1, upon the Authority’s request Novavax shall procure a legally binding guarantee from the parent entity of the party acquiring
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control of Novavax in favour of the Authority to guarantee and undertake to procure the continued performance by Novavax of this Agreement.
34.7Subcontracting
34.7.1Novavax may, without the need for the Authority’s consent but subject to clause 34.7.2, subcontract or delegate its obligations or services to be provided under this Agreement to one or more of its Affiliates and/or to any Third Party consultant or contractor, including Fujifilm (a “Subcontractor”).
34.7.2Novavax shall at all times remain responsible and liable to the Authority for the acts or omissions of Novavax’ Affiliates and Subcontractors to whom Novavax subcontracts or delegates any of its obligations, as if those acts or omissions were of its own.
34.8No Rights of Third Parties
Save as provided in this Agreement, including pursuant to clause 21.4, a person who is not a Party to this Agreement shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement. Notwithstanding any rights any third party may have by virtue of the foregoing, the Parties to this Agreement may vary, amend or terminate this Agreement without seeking the consent of any Third Party whose rights may be affected.
34.9Costs
Except as set forth herein, each Party will be responsible for all costs incurred by it or on its behalf in connection with this Agreement.
34.10Entire Agreement
This amended and restated Agreement, and any agreement or document referred to in it, together with the schedules herein, contains the entire agreement between the Parties with respect to the subject matter of this Agreement, and supersedes all previous agreements and understandings between the Parties with respect to that subject matter including the Heads of Terms between the Parties dated 13 August 2020. Each Party acknowledges that, in entering into this Agreement and the agreements and documents referred to in it, it does not rely on any statement, representation, assurance or warranty (whether it was made negligently or innocently) of any person (whether a Party to this Agreement or not) which is not expressly set out in this Agreement or those documents (a “Representation”), and that it shall have no cause of action against the other Party arising out of any Representation except in respect of any fraudulent misrepresentation by the other Party. Each Party agrees that the confidentiality agreement dated 1 June 2020 between the Parties is unaffected by this clause, provided that confidential information disclosed under that agreement may be used and deemed disclosed pursuant to this Agreement. For the avoidance of doubt, this Agreement supersedes the original agreement between the Parties dated 22 October 2020 with effect from the Amendment Date.
34.11Governing Law and Jurisdiction
34.11.1This Agreement and any issues, disputes or claims arising out of or in connection with it (whether contractual or non-contractual in nature, including
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claims in tort or for breach of any statute or Applicable Law) shall be governed by and construed in accordance with English law.
34.11.2If a dispute arises between the Parties in connection with or relating to this Agreement (a “Dispute”), either Party shall have the right to refer such Dispute to senior representatives (namely Executive Vice President, Chief Legal Officer for Novavax and Director General of the Vaccine Task Force for the Authority) for attempted resolution by good faith negotiations during a period of ten (10) Business Days. Any final decision mutually agreed to by such senior officers in writing shall be conclusive and binding on the Parties.
34.11.3Subject to clause 34.11.2, each Party irrevocably submits to the exclusive jurisdiction of the English courts to settle any dispute which may arise under or in connection with this Agreement or the legal relationships established by this Agreement.
34.12Delivery of Agreement
The Parties do not intend this Agreement to be delivered by, or to become legally binding on, any of them until the date of this Agreement is written at its head, notwithstanding that one or more of them may have executed this Agreement prior to that date being inserted.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed in two (2) counterparts by their respective duly authorised representatives as of the date set forth at the beginning of this Agreement.
SIGNED by John A. Herrmann III,    )
Authorised Signatory for and on behalf of    )
NOVAVAX, INC.    )
/s/ John A. Herrmann III        
SIGNED by [***]    )
Authorised Signatory for and on behalf of    )
THE SECRETARY OF STATE FOR    )
BUSINESS, ENERGY AND     )
INDUSTRIAL STRATEGY    )
/s/ [***]                

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SCHEDULE 1
CANDIDATE, PRODUCT AND SPECIFICATIONS
[Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the candidate, product and specifications has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]


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SCHEDULE 2
FACILITIES
[Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the facilities has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]

65

SCHEDULE 3
KEY PERFORMANCE INDICATORS AND MEETING SCHEDULES
[Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the key performance indicators and meeting schedules has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]


66

SCHEDULE 4
DEVELOPMENT AND MANUFACTURING PLAN
[Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the development and manufacturing plan has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]

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SCHEDULE 5
BASELINES
[Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the baselines has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]

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SCHEDULE 6
intentionally left blank

69

SCHEDULE 7
intentionally left blank

70

SCHEDULE 8
DOCUMENTATION TO ACCOMPANY DELIVERIES
[Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the documentation to accompany deliveries has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]

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Exhibit 10.2

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.


image_0.jpg
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878
United States of America

26th September 2022

Dear Novavax,
Letter of Amendment to the Amended and Restated SARS-COV-2 Vaccine Supply Agreement dated 1 July 2022
1.We refer to the Amended and Restated SARS-COV-2 Vaccine Supply Agreement dated 1 July 2022 (the “Amended and Restated Supply Agreement”) entered into between Novavax, Inc. (“Novavax”) and the Secretary of State for Business, Energy and Industrial Strategy (“BEIS”) acting on behalf of the Crown (the “Crown” or the “Authority”).
2.The Amended and Restated Supply Agreement was executed by BEIS acting on behalf of the Crown, but the Crown has subsequently determined, with effect from 1 October 2022, to place responsibility for managing the Amended and Restated Supply Agreement with the UK Health Security Agency (“UKHSA”), an executive agency of the Department for Health and Social Care (“DHSC”). Accordingly, although the Crown remains bound by the terms of the Amended and Restated Supply Agreement, going forwards the Amended and Restated Supply Agreement is to be considered to be between (i) the Crown (now with the UKHSA of DHSC acting on its behalf) and (ii) Novavax.
3.In addition to reflecting the change of responsibility and updating the applicable notice provisions, for practical purposes the Parties wish to simplify the precise number of Doses to be Delivered under the Agreement.
4.Capitalised words and expressions defined in the Amended and Restated Supply Agreement, where used in this letter of amendment (the “Amendment”), but not defined herein, shall have the same meaning set out in the Amended and Restated Supply Agreement as the context requires.
Page 1 of 4


5.The Parties hereby agree that, with effect from the date of this Amendment, the Amended and Restated Supply Agreement shall be amended to reflect and implement the following changes:
a.With respect to supply of the Product:
i.All references to “sixteen million and one Doses (16,000,001)” or “sixteen million and one (16,000,001) Doses” in the Amended and Restated Supply Agreement, including for the avoidance of doubt, in respect of the size of the Priority Order, shall be read as “sixteen million Doses (16,000,000)”; and
ii.The words “one million and one (1,000,001) Doses” in Clause 7.3 of the Amended and Restated Supply Agreement shall be read as “one million (1,000,000) Doses” and, for the avoidance of doubt, all references to the “Firm Volume” shall be construed accordingly.
b.With respect to the entity acting for the Authority:
iii.Paragraph (2) of the Parties Clause is deleted and replaced with:
“(2) The Secretary of State for Health and Social Care, acting as part of the Crown, through the UK Health Security Agency of Nobel House, 17 Smith Square, London, SW1P 3HX (the “Authority”)”
For the avoidance of doubt, all references to the “Authority”, the “Party” or the “Parties” in the Amended and Restated Supply Agreement shall be construed accordingly; and
iv.All other references to “the Secretary of State for Business, Energy & Industrial Strategy” shall be replaced with “The Secretary of State for Health and Social Care acting through the UK Health Security Agency”.
c.The Authority’s notice details as set out at Clause 34.1.2 shall be deleted and replaced by:
“For Notices to the Authority:

UK Health Security Agency Nobel House
17 Smith Square London
SW1P 3HX

Attn: UKHSA Vaccine Unit Commercial Lead

Page 2 of 4



With a copy to: The Director of the UKHSA Vaccines Unit at the above address.”

6.Except as expressly varied by this Amendment, the Amended and Restated Supply Agreement shall continue in full force and effect.
7.No provision of this Amendment will be modified or varied without the written consent, properly executed, of each Party.
8.The Parties hereby intend this Amendment to be legally binding on the Parties.
9.No Party has relied upon any statement, representation, warranty, understanding, undertaking, promise or assurance in entering into this Amendment and no warranties, representations, covenants or guarantees express or implied are given, made or renewed by entering into this Amendment.
10.Nothing in this Amendment, nor the amendment of the Documents, waives, discharges, releases or in any other way excuses or excludes any Party’s obligations or liabilities in respect of any accrued liabilities or breaches under the Documents.
11.This Amendment and any non-contractual or other obligations arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with English law and be subject to the exclusive jurisdiction of the Courts of England.
12.This Amendment may be signed in more than one counterpart and all counterparts shall together constitute one and the same document. By countersigning this Amendment, you agree that the shall be amended on the terms set out above and this Amendment shall be supplemental to the original Documents.
[Remainder of this page is intentionally left blank.]
Page 3 of 4



SIGNED by: /s/ [***]


[***]             (name)

[***] (position)

30th September 2022             (date)

for and on behalf
SECRETARY OF STATE FOR
BUSINESS, ENERGY AND INDUSTRIAL
STRATEGY
)

)

)

)

)

)

)



SIGNED by: /s/ Jonathan Wallinger


Jonathan Wallinger             (name)

SVP, General Counsel         (position)

10/13/2022                 (date)


for and on behalf
NOVAVAX, INC.
)


)

)

)


)
)

Page 4 of 4
Exhibit 10.3

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

image_0b.jpg

Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878

Attention:    [***], Senior Vice President
Subject:    Modification No. 02
Reference:    MCDC Base Agreement No. 2020-530 Dear [***]:
In accordance with the terms and conditions of the referenced MCDC Base Agreement, Modification No. 02 hereby amends the Base Agreement as follows:

DESCRIPTION OF MODIFICATION

1)References in the MCDC Base Agreement to 10 U.S.C. § 2371 are hereby replaced with 10 U.S.C. § 4022.

2)Article I: Scope of the Agreement, of the MCDC Base Agreement is modified as follows: Section 1.01 Background
The U.S. Army Contracting Command-New Jersey (ACC-NJ) is entering into an Other Transaction Agreement (OTA) under the authority of 10 U.S.C. § 4022(f), with the Medical CBRN Defense Consortium (MCDC). The Joint Project Manager for Chemical, Biological, Radiological, Nuclear - Medical (JPM-CBRN Medical), through the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), will collaborate with the MCDC to carry out a coordinated research and development program designed to develop prototype medical, pharmaceutical, and diagnostic technologies directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components or materials in use by the armed forces. An OTA is being proposed with the purpose of conducting Research and Development into medical, pharmaceutical, and diagnostic technologies to enhance the mission effectiveness of military personnel, collaborating with industry partners for the advanced development of Medical Countermeasures (MCM) for chemical and biological defense. The OTA will allow JPM-CBRN Medical to partner with other agencies in the Department of Defense (DoD) chemical and biological defense enterprise, as well as collaborate with industry on applied research on candidate MCMs and supporting technologies. The MCDC was formed in response to the Government's expressed interest to engage with an industry consortium comprised of traditional and nontraditional Government contractors, small and large business, for-profit and not-for-profit entities, academic organizations and their affiliates for the purpose of entering into an OTA to develop and mature medical, pharmaceutical, and diagnostic technologies through the execution of prototype projects.

Under the OTA and associated awards, the Government, along with the non-government members from the MCDC, shall perform coordinated planning and research and development prototype efforts designed to encompass the areas contained within the scope of the OTA as listed in Article I, Section 1.03 herein.

Section 1.02, Definitions


“Base Agreement” or “OTA” refers to the Prototype OTA under the authority of 10 U.S.C. § 4022(f), between the Government and the MCDC, Agreement No. W15QKN-16-9-1002.

“Other Transactions for Prototype Projects” refers to the type of OTA this MCDC Base Agreement is under. This type of OTA is authorized by Department of Defense (DoD) Authorization Acts, and is found in the U.S. Code as a Note in 10 U.S.C. § 4022. 10 U.S.C. § 4022, “Authority of the DoD to carry out certain prototype projects,” authorizes the Secretary of a military department to carry out prototype projects directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces. This type of OTA is treated by the DoD as an acquisition instrument, commonly referred to as an “other transaction” for a research prototype project or 4022 “other transaction.”

3)Article VI, Appropriate Use of Other Transaction Authority, of the MCDC Base Agreement is modified as follows: Article VI. APPROPRIATE USE OF OTHER TRANSACTION AUTHORITY
In accordance with provisions of 10 U.S.C. § 4022, the DoD has authority to enter into transactions other than contracts, grants, or cooperative agreements. The DoD has the authority to make awards that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the DoD, or the improvement of platforms, systems, components, or materials in use by the armed forces.

Per 10 U.S.C. § 4022, each prototype project awarded under this Base Agreement must meet one of the following conditions:

•There is at least one nontraditional defense contractor or nonprofit research institution participating to a significant extent in the prototype project.
•All significant participants in the transaction, other than the Federal Government, are small businesses (including small businesses participating in a program described under section 9 of the Small Business Act (15 U.S.C. 638)) or nontraditional defense contractors.
•At least one third of the total cost of the prototype project is to be paid out of funds provided by sources other than the Federal Government.
•The senior procurement executive for the agency determines in writing that exceptional circumstances justify the use of a transaction that provides for innovative business arrangements or structures that would not be feasible or appropriate under a contract, or would provide an opportunity to expand the defense supply base in a manner that would not be practical or feasible under a contract.

Throughout the period of performance of any PA, the AO and AOR will actively monitor projects to ensure compliance with this statutory requirement. The Government will take into account any implementation guidance from the Department of the Army and the Office of the Under Secretary of Defense for Acquisition and Sustainment, which includes but is not limited to, the most recent Other Transactions Guide. The MCDC Member awarded a PA will be given the opportunity to become compliant with this statutory requirement should they be found non-compliant by the AO and AOR and as communicated to the PAH by the CMF. Failure to comply may result in termination.



If significant nontraditional / nonprofit participation cannot be fulfilled, the PAH must provide at least one third cost share of the value of the PA awarded to the PAH. Proposals that fail to comply with this requirement, will not be awarded under the OTA.

Cost Sharing is not required under the OTA for projects that contain significant nontraditional / nonprofit participation. Where the Government and PAH agree, cost sharing may be considered on a per project basis under terms and conditions to be agreed to by them, and in accordance with the most recent Other Transactions Guide.

4)Article XXI: General Provisions, Section 21.15, Follow-On Production, of the MCDC Base Agreement is modified as follows:

Section 21.15 Follow-On Production

10 U.S.C. § 4022(f) authorizes the use of a follow-on production contract (FAR) or transaction (OTA). In order to be eligible for follow-on production, the following criteria is required: (1) the follow-on shall be awarded to the same participants named in the PA; (2) competitive procedures were used to award the PA in question; and (3) the PA was successfully completed. This MCDC Base Agreement was the result of competitive procedures, and competitive procedures are used to award individual projects under this MCDC Base Agreement. The AO shall be responsible for documenting whether or not a PA was successfully completed. Follow-on production efforts shall be strictly limited to the scope of the successfully completed prototype. This MCDC Base Agreement will not be used to award follow-on production efforts; Government customers will be responsible for working with their contracting personnel.

All PAs shall include the following statement:

"In accordance with 10 U.S.C. § 4022(f), and upon a determination that this competitively awarded prototype project has been successfully completed, this prototype project may result in the award of a follow-on production contract or transaction without the use of competitive procedures."


Except as provided herein, all Terms and Conditions of the referenced MCDC Base Agreement and preceding modifications remain unchanged and in full force and effect.

This modification is issued unilaterally. The Project Agreement Holder is not required to sign to finalize this action. Advanced Technology International
By:/s/ [***]
Name:[***]    
Title: Subcontracts Administrator 1
Date: Aug 2 2022    
Exhibit 10.4

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

image_01a.jpg

July 1, 2022
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878

Attention:    [***], Senior Vice President, Commercial Strategy
Subject:    Modification No. 14 to Project Agreement No. 01; MCDC2011-001
Reference:    MCDC Base Agreement No. 2020-530

Dear [***]:

In accordance with the terms and conditions of the referenced MCDC Base Agreement, Modification No. 14 hereby amends Project Agreement No. 01 as follows:

DESCRIPTION OF MODIFICATION


1) Attachment A, Statement of Work, of the Project Agreement is hereby amended as attached herein.


Except as provided herein, all Terms and Conditions of the referenced MCDC Base Agreement, Project Agreement, and preceding modifications remain unchanged and in full force and effect.

The Project Agreement Holder is required to sign this document and return to Advanced Technology International to finalize this action.


Novavax, Inc.        Advanced Technology International
By: /s/ John A. Herrmann III        By: /s/ [***]    
Name: John A. Herrmann III        Name: [***]    
Title: EVP, CLO        Title: Subcontracts Administrator I    
Date: July 2, 2022        Date: July 6, 2022    



Attachment A Statement of Work
(Incorporated as of Modification No. 14)

This page intentionally left blank. See separate document for Attachment A.


Attachment A
Statement of Work
(Incorporated as of Modification No. 14; Changes to Sections 1, 3, 4 and 5 are indicated in bold italics.)

For
Rapid (WF10) Advanced Research & Development to Large Scale Manufacturing of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus

RPP #: 20-11
Project Identifier: MCDC2011-001
Consortium Member: Novavax, Inc.
Title of Proposal: Rapid (WF10) Advanced Research & Development to Large Scale Manufacturing of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus
Requiring Activity: Joint Mission between the Department of Health and Human Services and Department of Defense to Combat COVID-19

1.0    INTRODUCTION, SCOPE, AND OBJECTIVES

1.1    Introduction

To meet the needs of the Coronavirus Disease 2019 (COVID-19) pandemic, the United States Government (USG) is identifying and will support development and at-scale manufacturing of selected vaccine candidates, to ensure timely availability to the US population when needed. This is the primary focus of the mission being executed by the Department of Health and Human Services (HHS) and Department of Defense (DoD), in support of Operation Warp Speed (OWS).

The USG is interested in pursuing prototype vaccines that are in an advanced stage of development, and will support companies that can, in parallel with nonclinical, clinical and regulatory development, rapidly establish the manufacturing capacity required to meet the USG’s objective of supplying a safe and effective Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccine to the entire US population. The USG is tasked with marshaling the efforts of the US biotechnology industry to achieve this goal.

1.2    Definition of the Prototype Project

Consistent with USG objectives, the “prototype project” under this agreement is defined as the ability to manufacture and deliver up to 100M doses of a SARS-CoV-2 vaccine, NVX-CoV-2373, which is suitable for use in humans under a sufficiently informed deployment strategy, and the advanced positioning of a stockpile of critical long lead raw materials for the Matrix-M adjuvant. As such, the “prototype project” will effectively demonstrate Novavax’s ability to rapidly stand up large scale manufacturing and seamlessly transition into ongoing production.

The NVX-CoV-2373 vaccine is comprised of the Matrix-M™ adjuvant, and antigen (SARS-CoV-2 spike protein). The vaccine is filled into a multi-dose vial ([***]) and is stored at refrigerated temperature (2-8oC).

Successful development of the prototype will demonstrate Novavax’s ability to rapidly stand up large scale manufacturing and seamlessly transition into ongoing production capability, in order to rapidly manufacture to meet surge requirements with little advance notification, and
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demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed, including in order to supply use in clinical studies, under an Emergency Use Authorization (EUA), or pursuant to other clearance from the U.S. Food and Drug Administration (FDA).

Successful completion of the prototype will require three coordinated and integrated lines of effort:

a)Large scale manufacturing, compliant with 21 CFR Parts 210 and 211, and the Drug Supply Chain Security Act (DSCA), to the extent applicable at the time of manufacturing by statute and FDA interpretive guidance thereof.
b)Parallel nonclinical and clinical studies required to determine if the vaccine is safe and effective.
c)Compliance with all applicable U.S. regulatory requirements.

It is important to note that while results of nonclinical and clinical studies are critical to develop use case scenarios and, in turn, inform the USG’s deployment strategy as it relates to product manufactured under this agreement, successful development of the prototype is dependent only on the validity of data from these studies. The degree to which the data are “positive” or “negative” is not a factor in demonstration of the prototype.

1.3    Follow-on Activity

This prototype project includes unpriced options for follow-on production/procurement. During the performance of the prototype, the USG and Novavax will negotiate the scope and price of production/procurement. If the prototype project is successful, the USG may then enter into follow-on production/procurement by executing these options through a separate stand-alone production/procurement agreement, to be negotiated in terms of scope and price as described in the following paragraph.

In accordance with 10 U.S.C. 4022(f), and upon demonstration of the prototype, or at the accomplishment of particularly favorable or unexpected results that would justify transitioning to production/procurement, EUA, or Biologics License Application (BLA) approved by the FDA, the USG and Novavax may enter into a non-competitive production/procurement follow-on agreement or contract for additional production/procurement, to partially or completely meet the USG objective of supplying a safe and effective SARS-CoV-2 vaccine to vaccinate up to 300M people in the targeted population (≈560M additional doses).

1.4    Scope

Novavax has defined a scope of activities in order to successfully develop the prototype, as defined above.

One lot will be manufactured initially, with approximately 3M doses delivered in support of this agreement.

Delivery of doses to the USG is contingent on the following:

1.Timing of EUA approval by FDA.
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2.Timing of label language and artwork approval by FDA.
3.Timing of Advisory Committee on Immunization Practices (ACIP) recommendation.

Any additional manufacturing and deliveries will be contingent on 1) USG demand, 2) FDA guidance on strain changes, and 3) agreement on price.

The scope includes the following activities:

oManufacturing
Manufacturing of up to 100M doses of NVX-CoV-2373 vaccine (or a variant construct if terms, including price, can be agreed upon) for distribution to the USG upon EUA under section 564 of the Food, Drug, and Cosmetic (FD&C) Act or a biologics licensure granted under Section 351(a) of the Public Health Service Act by the U.S. FDA.
Establishment of large-scale current Good Manufacturing Practice (cGMP) manufacturing capacity compliant with 21 CFR Parts 210 and 211, and the DSCA to the extent applicable at the time of manufacturing by statute and FDA interpretive guidance thereof.
Comparability among clinical vaccine lots and commercial lots using a comparability protocol.
Validation of manufacturing processes will be performed to cGMP standards.

oClinical
Phase 3 pivotal clinical trial harmonized with USG clinical strategies.
A Phase 3 clinical trial in pediatric populations (<18 years).
Phase 2 studies in at-risk subpopulations (e.g., co-morbidities, [***], immunocompromised), as well as studies to support manufacturing site comparability.

oNon-clinical
Studies to support EUA and regulatory approval (BLA).

oRegulatory
EUA submission when data supports it, while maintaining progress toward eventual BLA submission.
BLA submission when appropriate.
Regulatory support activities (Investigational New Drug (IND) submissions) for manufacturing, clinical, non-clinical studies.
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Meetings as-needed with regulators.

oProject Management
Mandatory reporting requirements, as described in the Base Agreement.
Submission of Quarterly Progress Reports. Format will be agreed on by the contractor and Agreements Officer’s Representative (AOR), and will include both technical and financial status and expenditure forecast.
Facilitation of biweekly teleconferences with Novavax and USG Subject Matter Experts.
Final prototype project report and applicable patents report(s).
Work Breakdown Structure (WBS) and Integrated Master Schedule (IMS).
All Regulatory correspondence relevant to the scope of work proposed, including communications with the FDA, and all submissions.

1.4.1    Novavax Project Plan

This is Novavax’s plan as of the date of the submission. Novavax desires to move quickly to large scale development as rapidly as possible, in order to meet the objectives of this proposal. As the COVID-19 pandemic is an evolving situation, Novavax may need to adapt its plan in response to FDA guidance, opportunities for manufacturing efficiencies, and clinical trial data.

1.5    Resolution of Conflicting Language

If there is a conflict between the Project Agreement (of which this Statement of Work is part) and the Base Agreement (Medical CBRN Consortium (MCDC) Base Agreement No.: 2020-530), the Project Agreement language will supersede and control the relationship of the parties.

2.0    APPLICABLE REFERENCES

N/A

3.0    REQUIREMENTS

3.1    Major Task: cGMP Manufacturing of NVX-CoV-2373 compliant with 21 CFR 210 and 211
3.1.1    Subtask: Raw Materials – Obtain Critical Starting Materials for Adjuvant Manufacturing
Sufficient Saponin to manufacture up to 100M vaccine doses will be purchased (Desert King, headquartered in San Diego, CA, facilities in Chile). Long-lead, critical, and limited-supply materials ([***]) will be purchased for the additional 560M vaccine doses to meet the contact requirement, in order to ensure capability to rapidly manufacture to meet surge requirements with little advance notification and demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed.
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3.1.2    Subtask: Raw Materials – Obtain Critical Starting Materials for Antigen and Fill/Finish Manufacturing
Sufficient materials (vials, stoppers, other consumables) to manufacture up to 100M vaccine doses will be purchased (sources TBD).
3.1.3    Subtask: Raw Materials – [***] Intermediates to Produce Matrix-M Adjuvant Matrix-M Adjuvant
[***] to supply large-scale manufacturing of vaccine doses will be manufactured at [***] and PolyPeptide (Torrance, CA & Malmö, Sweden). Technology transfer and start-up of the PolyPeptide facility in Torrance, CA will be completed. Long lead, critical, and limited supply materials will be purchased in order to achieve the goal of large-scale production.
3.1.4    Subtask: Matrix-M Adjuvant Manufacturing to Supply 100M Vaccine Doses
Matrix-M Adjuvant bulk components will be manufactured at ACG Biologics (Seattle, WA) to supply 100M vaccine doses. Technology transfer and start-up of the AGC Bio facility in Seattle will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site.
3.1.5    Subtask: Antigen Manufacturing to Supply up to 100M Vaccine Doses
Antigen will be manufactured to supply up to 100M vaccine doses. Technology transfer and scale-up activities will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site.
3.1.6    Subtask: Fill/Finish of up to 100M Vaccine Doses
Up to 100M doses of finished vaccine in [***] vials will be manufactured. This will include secondary packaging. Technology transfer and scale-up activities will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site.
3.1.7    Subtask: Shipping and Storage
Novavax assumes that it will maintain a Vendor Managed Inventory (VMI) system to enable shipment of product to the Biomedical Advanced Research and Development Authority (BARDA)-managed inventory system (McKesson depots). Novavax will perform activities to establish compliance with DSCA to the extent applicable at the time of manufacturing, by statute and FDA interpretive guidance thereof.
3.1.8    Subtask: Manufacture of 3M Doses and Subsequent Manufacturing
Approximately 3M doses will be manufactured at Serum Institute of India (Pune, India) or other FDA-approved location for delivery as soon as feasible after receipt of EUA from the FDA, at an agreed-upon price per dose. The manufacture and delivery of any doses beyond this initial quantity is dependent upon USG demand, FDA guidance on strain selection, and agreement between the parties on price, to be incorporated via a mutually agreed upon modification.

3.2    Major Task: Clinical Studies
Novavax will perform these clinical trials and deliver the results in an interim Clinical Study Report (CSR) at the completion of enrollment, and the final CSR when available. These trials will be conducted using a Clinical Research Organization (CRO) that is to be determined.
3.2.1    Subtask: Phase 3 US/Mexico Efficacy Study, Adults ≥ 18 and < 75 years
Study: Phase 3 – US/Mexico Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301. This includes a “crossover” component where patients that received placebo were offered the vaccine after [***].
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Population: Adults ≥ 18 years, inclusive of subjects with more severe co-morbid conditions.    
Locations: US/Mexico.    
Primary Objectives: Clinical efficacy, safety, immunogenicity.     
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M – dose determined by Phase 2 dose confirmation study, Placebo; ~0.5 mL dose Intramuscular (IM) injection, up to 2 doses at Day 0 and Day 21.
Enrollment: TOTAL N: ~30,000 (adjusted for expected endpoint incidence). [***].
3.2.1.1    Subtask: Phase 3 US/Mexico Efficacy Study, Adults ≥ 18, Booster Study
Study: Phase 3 – US/Mexico Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301. This includes a booster component where patients will receive a booster dose of vaccine approximately [***] after completion of the dose regimen.
Enrollment: TOTAL N: ~25,000 (adjusted for expected enrollment).
3.2.1.2    Subtask: Phase 3 US/Mexico Efficacy Study, Adolescents ≥ 12 and < 18 years, Adolescent/ Adolescent Booster Study
Study: Phase 3 – US/Mexico Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301. This includes a booster component where patients will receive a booster dose of vaccine approximately [***] after completion of the dose regimen.
Enrollment: TOTAL N: ~2500 (adjusted for expected enrollment).
3.2.2    Reserved
3.2.3    Reserved
3.2.4    Reserved
3.2.5    Subtask: Lot-to-Lot Consistency/Comparability Study (US or other)
Study: Phase 2 lot-to-lot consistency/comparability study (US or other), 2019nCoV-307.
Population: Adults ≥ 18 to < 50 years.    
Locations: USA.
Primary Objectives: Safety, immunogenicity.
Design: Randomized, observer-blinded.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; [***].
Enrollment: ~300 per cohort, each cohort having [***]. Study size may be adjusted to allow non-inferiority testing.
3.2.6    Reserved
3.2.7    Subtask: Pharmacovigilance; Establishment of Registration Safety Database
A registration safety database will be established to comply with FDA requirements for product safety and licensure.
3.2.8    Subtask: Phase 3 Pediatric Study
Study: Phase 2/3 pediatric study, 2019nCoV-503.
Population: Children ≥ 6 months to < 12 years (3 age cohorts).
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Locations: [***].
Primary Objectives: Safety, immunogenicity, effectiveness (determined by immunogenicity).
Design: Randomized, observer-blinded, placebo-controlled.          
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M [***].
Enrollment: N = 1,200 ([***]); N = 1,200 ([***]); N = 1,200 ([***]); TOTAL: N = 3,600; [***].

3.3    Major Task: Non-Clinical Studies
Novavax will perform these non-clinical studies and deliver the results in a study report at completion.
3.3.1    Mouse Study, Immunogenicity
Study 702-100. [***] in mice for vaccine efficacy profile to comply with FDA guidelines.
3.3.2    Rhesus Study, Immunogenicity
Study 702-099. [***] in rhesus monkeys for vaccine efficacy profile to comply with FDA guidelines.
3.3.3    Hamster Study, Immunogenicity
Study 702-102. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.4    Mouse Study, T-Cell Immunogenicity
Study 702-103. T-cell immunogenicity/challenge study in mice [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.5    Hamster Study, T-Cell Immunogenicity
Study 702-105. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.6    Mouse Study, T-Cell Immunogenicity
Study 702-104. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.7    Non-Clinical Studies: Collaboration with Univ. of Maryland School of Medicine
Three studies to study enhancement/inhibition and neutralization, and virus challenge of vaccinated mice:
1.Validation of Spike nanoparticles in cell inhibition studies: In vitro inhibition studies on cell line permissive to r2019-nCoV, readout TBD.
2.Neutralization studies with virus against bleeds from mice, In vitro microneutralization studies on cell line permissive to r2019-nCoV, TCID50 or fluorescence readout (TBD).
3.Virus challenge of vaccinated mice (mice vaccinated outside and shipped to UM for challenge), Challenge of vaccinated mice (shipped in for infection from Novavax), Lung pathology, Titer, viral Ribonucleic Acid (RNA) quantitation, pathology scoring and reports.
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3.3.8    Structural Study of COVID-19 Spike Protein and its Complex with Host Receptor (cooperation with Baylor College of Medicine)
Study to determine the structures of recombinant COVID-19. Spike protein in nanoparticles used in Novavax’s human vaccine and in complex with its host receptor ACE2. Will obtain a high-resolution cryoEM structure of full-length COVID-19 Spike protein and a high-resolution cryoEM structure of full-length COVID-19 Spike protein in complex with human receptor ACE2.
3.3.9    Neutralizing Assay Histopathology for On-going [***]
Histopathology readings for current neutralization studies in [***]. This will support the safety profile of the vaccine for FDA approval.
3.3.10    Mouse Study, Immunogenicity [***] Studies
Individual immunogenicity studies [***] in mice for vaccine efficacy profile in different sub-populations to comply with FDA guidelines.
3.3.11    Durability of NVX-CoV-2373 Vaccine Immunity and SARS-CoV-2 Protection at [***] in Rhesus Macaques
Study 702-110. This study is designed to evaluate the long-term immunogenicity and protective efficacy of NVX-CoV-2373 nanoparticle vaccine when administered with Matrix-MTM by IM injections on Study Days 0 and 21, to Non-Human Primates (NHP). Each study group will contain [***] NHPs ([***] per sex). Blood samples will be collected prior to vaccination and at multiple time points following vaccination as outlined below. Samples will be shipped to Novavax Inc. for performance of assays to determine the vaccine immunogenicity. Animals from placebo and active treatment groups will be challenged with SARS-CoV-2 virus at [***] following last treatment and monitored for clinical illness, viral RNA and sgRNA (nasal swabs, BAL) to assess the protective efficacy of the vaccine.
3.3.12    Immunogenicity and Protective Efficacy of Sub-Protective Doses of NVX-CoV-2373 in Rhesus Macaques
Study 702-111. This study is designed to evaluate the immunogenicity and protective efficacy of sub-optimal doses of NVX-CoV-2373 nanoparticle vaccine administered with a fixed dose of Matrix-MTM by IM injections on Study Days 0 and 21, to NHPs. Each study group will contain [***] NHPs ([***] per sex). Blood samples will be collected prior to vaccination and at various time points following vaccination as outlined below. Samples will be shipped to Novavax Inc. for performance of assays to determine the vaccine immunogenicity. Animals from placebo and active treatment groups will be challenged with SARS-CoV-2 virus at [***] following last treatment and monitored for clinical illness, viral RNA and sgRNA (nasal swabs, BAL) to assess the protective efficacy of the vaccine.
3.4    Major Task: Regulatory Affairs
Novavax will conduct the regulatory activities below, including BLA prep and submission, and provide the meeting minutes and applications to the USG.
3.4.1    Subtask: EUA Submission and Supporting Meetings and Regulatory Filings
An EUA will be submitted to the FDA upon obtaining sufficient clinical data. EUA, FDA meetings to support EUA, submission planning support for the Chemistry, Manufacturing, and Controls (CMC) team, EUA strategy and meeting support, and submission preparation support activities, will all be completed.
3.4.2    Subtask: IND Submission Updates and FDA Meetings
This task will include submissions to the IND and possible FDA meetings that will be required prior to the BLA submission.
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3.4.3    Subtask: BLA Submission
A BLA will be submitted to the FDA upon obtaining sufficient clinical data, FDA meetings to support BLA, submission planning support for the CMC team, BLA strategy and meeting support, and submission preparation support activities, will all be completed.

3.5    Major Task: Project Management and Reporting
3.5.1    Subtask: Kick-Off Meeting and Initial Baseline Review of IMS
Novavax shall conduct a Kick-Off Meeting and an initial review with the USG of the IMS, upon initiation of the program.
3.5.2    Subtask: Biweekly Meetings with OWS
Novavax shall submit the agenda in advance. Any technical updates shall be provided in advance for the USG team to review. Minutes shall be submitted after the biweekly meeting to the USG.
3.5.3    Subtask: Written Quarterly Reports
Novavax shall submit quarterly reports to the USG.
3.5.4    Subtask: Written Annual Reports
Novavax shall submit the annual reports to the USG.
3.5.5    Subtask: Written Final Report
Novavax shall submit the final report to the USG.

3.6    Optional Task: Follow-On Production
Follow-on production of finished doses of vaccine up to 560M doses.

4.0    DELIVERABLES

Del. #Deliverable DescriptionDue DateMilestone ReferenceSOW ReferenceGovernment RoleData Type/Data Rights
Manufacturing
4.01
[***]
[***]
5.13.1.1Reviewer
[***]
4.02
[***]
[***]
5.23.1.2Reviewer
[***]
4.03
[***]
[***]
5.33.1.3Reviewer
[***]
4.04
[***]
[***]
5.43.1.4Reviewer
[***]
4.05
[***]
[***]
5.53.1.5Reviewer
[***]
4.06
[***]
[***]
5.63.1.6Reviewer
[***]
4.07
[***]
[***]
5.73.1.7Reviewer
[***]
4.07a
[***]
[***]
5.7.13.1.8Reviewer
[***]
4.07b
[***]
[***]
TBDTBDReviewer
[***]
Clinical
4.08
[***]
[***]
5.83.2.1Reviewer[***]1
4.09Reserved
1 As used herein, “Government Purpose Rights“ has the meaning set forth in Article XI, Section 11.01(9) of the Base Agreement, as modified by Section 8.2(b) below.
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4.10Reserved
4.11Reserved
4.12
[***]
[***]
5.123.2.5Reviewer
[***]
4.13Reserved
4.14
[***]
[***]
5.143.2.7Reviewer
[***]
4.15
[***]
[***]
5.153.2.8Reviewer
[***]
Non- Clinical
4.16
[***]
[***]
5.163.3.1Reviewer
[***]
4.17
[***]
[***]
5.173.3.2Reviewer
[***]
4.18
[***]
[***]
5.183.3.3Reviewer
[***]
4.19
[***]
[***]
5.193.3.4Reviewer
[***]
4.20
[***]
[***]
5.203.3.5Reviewer
[***]
4.21
[***]
[***]
5.213.3.6Reviewer
[***]
4.22
[***]
[***]
5.223.3.7Reviewer
[***]
4.23
[***]
[***]
5.233.3.8Reviewer
[***]
4.24
[***]
[***]
5.243.3.9Reviewer
[***]
4.25
[***]
[***]
5.253.3.10Reviewer
[***]
4.26
[***]
[***]
5.263.3.11Reviewer
[***]
4.27
[***]
[***]
5.273.3.12Reviewer
[***]
Regulatory Affairs
4.28
[***]
[***]
5.283.4.1Reviewer
[***]
4.29
[***]
[***]
5.293.4.2Reviewer
[***]
4.30
[***]
[***]
5.303.4.3Reviewer
[***]
Project Management
4.31
[***]
[***]
5.313.5Reviewer
[***]
4.32
[***]
[***]
5.323.5.1Reviewer
[***]
4.33
[***]
[***]
5.333.5.2Reviewer
[***]
4.34
[***]
[***]
5.343.5.3Reviewer
[***]
4.35
[***]
[***]
5.353.5.4Reviewer
[***]
4.36
[***]
[***]
5.363.5.4Reviewer
[***]
4.36a
[***]
[***]
5.36a3.5.4Reviewer
[***]
4.36b
[***]
[***]
5.36b3.5.4Reviewer
[***]
4.37
[***]
[***]
5.373.5.5Reviewer
[***]
4.38
[***]
[***]
5.35N/AReviewer
[***]
TBD
[***]
[***]
Option 13.6Reviewer
[***]

Note 1: Attachment D of the Project Agreement shall be referenced for supplemental security requirements associated with deliverables under this project.

Note 2: The USG agrees to permanently transfer USG material, in the form of mutually agreed upon quantities of Clinical Drug Substance/Product, to Novavax for its own use in related drug trials. To enable the foregoing, the USG transfers all its right, title and interest in and to the Clinical Drug Substance/Product to Novavax. In consideration of such right, Novavax agrees (a)
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that Novavax shall [***]; (b) that Novavax agrees to [***]; and, (c) Novavax will, upon reasonable request from the USG, obtain and share data from the use of the Clinical Drug Substance/Product, in a mutually agreed upon format. All transfers of material produced under the project, shall obtain prior written approval by the Government, with material quantities, destinations, applications, and USG benefits clearly delineated in a mutually agreed upon format.

5.0    MILESTONE PAYMENT SCHEDULE
The milestones below are for reference and costs for the project will be invoiced monthly on a cost reimbursable basis as the work progresses.

MS #
Milestone Description
(Deliverable Reference)
Due DateTotal Program Funds
Manufacturing[***]
5.01
[***]
[***]
[***]
5.02
[***]
[***]
[***]
5.03
[***]
[***]
[***]
5.04
[***]
[***]
[***]
5.05
[***]
[***]
[***]
5.06
[***]
[***]
[***]
5.07
[***]
[***]
[***]
5.07a
[***]
[***]
[***]
5.07b
[***]
[***]
[***]
Clinical[***]
5.08
[***]
[***]
[***]
5.09Reserved
5.10Reserved
5.11Reserved
5.12
[***]
[***]
[***]
5.13Reserved
5.14
[***]
[***]
[***]
5.15
[***]
[***]
[***]
Non-Clinical[***]
5.16
[***]
[***]
[***]
5.17
[***]
[***]
[***]
5.18
[***]
[***]
[***]
5.19
[***]
[***]
[***]
5.20
[***]
[***]
[***]
5.21
[***]
[***]
[***]
5.22
[***]
[***]
[***]
5.23
[***]
[***]
[***]
5.24
[***]
[***]
[***]
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5.25
[***]
[***]
[***]
5.26
[***]
[***]
[***]
5.27
[***]
[***]
[***]
Regulatory Affairs[***]
5.28
[***]
[***]
[***]
5.29
[***]
[***]
[***]
5.30
[***]
[***]
[***]
Project Management[***]
5.31
[***]
[***]
[***]
5.32
[***]
[***]
[***]
5.33
[***]
[***]
[***]
5.34
[***]
[***]
[***]
5.35
[***]
[***]
[***]
5.36
[***]
[***]
[***]
5.36a
[***]
[***]
[***]
5.36b
[***]
[***]
[***]
5.37
[***]
[***]
[***]
5.38
[***]
[***]
[***]
Reservation Fees
5.39
[***]
[***]
[***]
5.40
[***]
[***]
[***]
5.41
[***]
[***]
[***]
Total (Cost Plus Fixed Fee)$1,800,670,981
Period of Performance (July 6, 2020 – December 31, 2023)42 Months (Base)
Option 1: Follow-On ProductionCost: [***]

6.0    INSPECTION, ACCEPTANCE, SHIPPING, AND DELIVERY PROVISIONS

The shipment of physical deliverables shall be coordinated with the AOR. Data deliverables shall be provided in accordance with the agreement, and in coordination with the AOR. Further details are provided below.

A. Inspection. Quality inspection of Filled Drug Product (FDP) shall occur when Novavax performs release testing, in order to confirm that the product complies with Novavax’s release specifications and criteria. Novavax will submit the Certificate of Analysis, Certificate of Compliance, examples of actual printed labels with lot number, and examples of printed carton labels for quality inspection of all drug product lots via the BARDA Data Infrastructure (BDI) system.

B. Delivery and Acceptance. Novavax shall notify the AOR (via update to BARDA-managed inventory system) at least [***] prior to initial delivery of NVX-CoV-2373 product. Exceptions are permitted if approved by the AOR. Upon notification, the AOR will instruct Novavax to deliver doses either to VMI or one or more, centralized USG-designated distribution sites within the USA.
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Upon delivery of product, notification of delivery quantities shall be made to the AOR via the Dose Tracking Tool in accordance with the reporting requirements. Both parties acknowledge that doses delivered under this agreement are intended for clinical use or use under an EUA or a BLA (once such EUA or BLA is received).

Upon receipt of the provided certificates and any inspection of product at the destination site(s) that was timely requested (physical or representative, i.e., pictures), the AOR will review and recommend acceptance or rejection. Inspections may be made by the AOR or a duly authorized USG representative. The USG shall accept or reject product (through the BARDA-managed inventory system) that conforms to agreement requirements based on Certificates of Analysis and Certificate(s) of Compliance, provided by Novavax, and review of temperature monitoring data. The AOR will correspondingly notify Novavax of acceptance or rejection. However, the USG’s acceptance of product will be deemed to have occurred if the USG does not provide written notice of acceptance or rejection within [***] of Novavax’s provision of all applicable certificates.

C. Vendor Managed Inventory. Product to be stored as VMI will be shipped to [***], in order to enable shipment to designated site(s). When held in VMI, these materials will be maintained in Novavax’s or its designated representative’s quality and inventory systems. Product held in VMI is subject to the following requirements:

i. Provide temperature controlled storage at the manufacturer’s site, approved by the USG, according to cGMP and product specifications.

ii. Where possible, store agreement products physically segregated from other products. If physical separation is not possible, separation of agreement products must be controlled by a logical Warehouse Management System (WMS) at the case and pallet level.

iii. Ensure proper labeling of stored materials as USG property.

iv. Provide the USG access to review the security systems in place and request updates as needed, in accordance with the Security Plan.

v. Include in the Government’s dose tracking tool, inventory for drug product (number of vials), including inventory quantity changes, current quantity, storage facility/location, manufacturing date, latest stability result for potency, date of next expected stability result, and the current expiration date (if applicable).

vii. Conduct testing necessary to ensure continued use of the stored material for pandemic response.

vii. Make appropriate updates to the regulatory documentation, supporting the continued use of the stored material for pandemic response.

viii. If using a storage site, provide the quality agreement, specify the location and terms of the storage contract.

For accepted product in VMI, Novavax must notify the AOR of any proposed movement of the product within the BARDA-managed inventory tracking system. Any deviations, Out of Specification (OOS) results, or other product issues, shall be reported to the USG within [***] of Novavax identification.
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D. Government Sites. Product to be shipped to USG-designated distribution sites shall be shipped trackable by GPS. Novavax will include the following information on the packing lists provided with bulk shipments to the centralized depots:

i. Transaction Information (TI)

ii. Transaction History (TH)

iii. Transaction Statement (TS)

iv. Centers for Disease Control (CDC) Purchase Order (PO) Number

Novavax will also transmit bulk shipment Advance Shipment Notices (ASN) to the CDC via Electronic Data Interchange (EDI).

E. Title and Physical Risk of Loss. Title to product will transfer upon [***]. Novavax will [***]. If product is initially delivered to a [***], risk of loss will transfer upon [***].

Novavax will notify the AOR (via e-mail or phone) of any storage or quality deviation for product held in VMI, within [***]. To the extent that Novavax is responsible for the correction, repair or replacement of USG property held in VMI, and replacement upon loss or damage of such product is feasible, the USG will accept replacement of such property.

7.0    INTELLECTUAL PROPERTY, DATA RIGHTS, AND COPYRIGHTS

7.1    BACKGROUND IP

(a)    Ownership. Prior to June 8, 2020, Novavax had funded the development of NVX-CoV-2373, and other antecedent vaccine programs relevant to Novavax’ proprietary position in the development of NVX-CoV-2373, as well as its sf9/baculovirus manufacturing platform, (all “Background IP”) through private funding or in collaboration with a funding partner other than the U.S. Government. Such private and non-governmental funding has continued since June 8, 2020 and is expected to continue during the performance of the Project Agreement. A list of all patents and patent applications included in the Background IP is provided below as Enclosure 4. Background IP also consists of (a) manufacturing know-how, including, without limitation, the NVAX-Cov-2373 manufacturing process definitions, process development/characterization reports, laboratory scale process procedures, manufacturing records, analytical test methods, product quality target ranges/specifications, quality target product profile, critical quality attributes (collectively “Background Know-How”), (b) data from pre-clinical and clinical research studies, analytical and process development research, and data related to, or generated using, the Background Know-How (collectively, “Background Data”), and (c) proprietary manufacturing materials, including, without limitation, sf9 cell banks (master and working), baculovirus virus stock (master and working), product standards, reference standards, and critical reagents (“Background Materials”). On June 8, 2020, Novavax and the U.S. Department of Defense entered into a Letter Contract for specified U.S.-based clinical and manufacturing development of NVX-CoV-2373 which acknowledged Background IP and made no explicit U.S. Government claims to Background IP or subsequent data arising therefrom. The U.S. Government hereby acknowledges such Background IP in full and further acknowledges that it has no ownership rights to Novavax Background IP under this Project Agreement.

(b)     Background IP Limited License to Government. Subject to the terms of the Project Agreement, Novavax grants the U.S. Government a nonexclusive, worldwide, nontransferable,
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non-sublicenseable license to use the Background IP to the limited extent necessary for the U.S. Government to review and use the Deliverables tendered by Novavax under this Agreement identified in Section 4.0 above, and for no other purpose; provided that the U.S. Government agrees that it may not disclose the Background IP to third parties, or allow third parties to have access to, use, practice or have practiced the Background IP, without Novavax’s prior written consent. To the extent that a Deliverable with Foreground IP incorporates or uses Background IP, the Deliverable shall be deemed and considered to comprise Background IP and shall be used by the U.S. Government in accordance with this Background IP Limited License.

(c)     Background IP License to Novavax. Subject to the terms of the Project Agreement, the U.S. Government grants to Novavax a nonexclusive, worldwide, nontransferable, irrevocable, paid-up license to any intellectual property (including patents and patent applications) to which the U.S. Government has rights thereto, provided that such license is limited to such intellectual property rights necessary to perform Novavax’s obligations under the Project Agreement. 

7.2    FOREGROUND IP

(a)    Ownership.    Notwithstanding anything in the Base Agreement to the contrary, Novavax owns all rights, title and interest in and to any development, modification, discovery, invention or improvement, whether or not patentable, conceived, made, reduced to practice, or created in connection with activities funded under the Project Agreement, including, without limitation, all data and inventions, and intellectual property rights in any of the foregoing (“Foreground IP”).

(b)    Foreground IP Special License. Subject to the terms of the Project Agreement, Novavax grants the U.S. Government a nonexclusive, worldwide, nontransferable, irrevocable, paid-up license to practice or have practiced the Foreground IP for or on behalf of the U.S. Government (“Foreground IP Special License”).

8.0     DATA RIGHTS

Article XI, §11.03 of the Base Agreement is hereby amended, consistent with the “Specifically Negotiated License Rights” capability at Article XI, §§11.01(12) and 11.03(4), as follows:

8.1 Data Ownership.

Novavax owns all rights, title and interest to all Data (as defined in Article XI, Section 11.01(7) of the Base Agreement) generated as a result of the work performed under this Project Agreement, including Subject Data.

8.2 Rights to Data.

(a)    Subject Data. Subject to the terms of the Project Agreement, Novavax grants to the U.S. Government a Government purpose rights license to Subject Data that will convert to an unlimited rights license (as the term is defined in Article XI, Section 11.01(14) of the Base Agreement)2 after three (3) years from the date of delivery. As used herein, “Subject Data” shall mean Technical Data under Article XI, §11.01(13) of the Base Agreement Deliverables that are considered Subject Data are identified in the Deliverable Table set forth in Section 4.0 above.

(b)    Transfer of Data. Each party, upon written request to the other party, shall have the right to review and to request delivery of Subject Data, and delivery of such Data shall be
2 As used herein, “Government Use” as used “Purpose Rights“ has the meaning set forth in this Section 4.0 means Government purpose rights as defined in the Base Agreement, Article XI, Section 11.01(9).) of the Base Agreement, as modified by Section 8.2(b) below.
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made to the requesting party within two weeks of the request, except to the extent that such Data are subject to a claim of confidentiality or privilege by a third party.

(c)    Background IP Limited License. To the extent that Subject Data incorporates or uses Background IP, the data shall be deemed and considered to comprise Background IP and shall be used by the U.S. Government in accordance with the Background IP Limited License set forth in Section 7.3 above.

8.3 Background Technical Data Rights Assertions.

Novavax asserts background technical data rights as follows:

The Background Data, as defined in Section 7.1 above, was developed through private funding or in collaboration with a funding partner other than the U.S. Government. Such funding is expected to continue; accordingly, Novavax asserts Background Data as Category A Data pursuant to section 11.02(1) of the Base Agreement and the U.S. Government shall have no rights therein.

9.0     REGULATORY RIGHTS

This agreement includes research with an investigational drug, biologic or medical device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance before commercial marketing may begin. It is expected that this agreement will result in the FDA authorization, clearance and commercialization of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus (the “Technology”). Novavax is the Sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), emergency use authorization (EUA), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted to the FDA) that controls research under this contract. As the Sponsor of the Regulatory Application to the FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), Novavax has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application. This clause protects the return on research and development investment made by the U.S. Government in the event of certain regulatory product development failures related to the Technology.

Novavax agrees to the following:

a. Communications. Novavax will provide the U.S. Government with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that the U.S. Government representatives are invited to participate in any formal or informal Sponsor meetings with FDA;

b. Rights of Reference. The U.S. Government is hereby granted a right of reference as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous applicable law recognized outside of the U.S.) to any Regulatory Application submitted in support of the statement of work for the Project Agreement. When it desires to exercise this right, the U.S. Government agrees to notify Novavax in writing describing the request along with sufficient details for Novavax to generate a letter of cross-reference for the U.S. Government to file with the appropriate FDA office. The U.S. Government agrees that such letters of cross-reference may contain reporting requirements to enable Novavax to comply with its own pharmacovigilance reporting obligations to the FDA and other regulatory agencies. Nothing in this paragraph reduces the U.S. Government’s data rights as articulated in other provisions of the Project Agreement.
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c. DoD Medical Product Priority. PL-115-92 allows the DoD to request, and FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. Novavax recognizes that only the DoD can utilize PL 115-92. As such, Novavax will work proactively with the DoD to leverage this this law to its maximal potential under this Project Agreement. Novavax shall submit a mutually agreed upon Public Law 115-92 Sponsor Authorization Letter to the U.S. Government within 30 days of award.

10.0    ENSURING SUFFICIENT SUPPLY OF THE PRODUCT

a. In recognition of the Government’s significant funding for the development and manufacturing of the product in this Project Agreement and the Government’s need to provide sufficient quantities of a safe and effective COVID-19 vaccine to protect the United States population, the Government shall have the remedy described in this section to ensure sufficient supply of the product to meet the needs of the public health or national security. This remedy is not available to the Government unless and until both of the following conditions are met:

i.Novavax gives written notice, required to be submitted to the Government no later than 15 business days, of:
a.any formal management decision to terminate manufacturing of the NVX-CoV-2373 vaccine prior to delivery of 100 million doses to USG;
b.any formal management decision to discontinue sale of the NVX-CoV-2373 vaccine to the Government prior to delivery of 100 million doses to USG; or
c.any filing that anticipates Federal bankruptcy protection; and
ii.Novavax has submitted an Emergency Use Authorization under §564 of the FD&C Act or a biologics license application under the provisions of §351(a) of the Public Health Service Act (PHSA).

b. If both conditions listed in section (a) occur, Novavax, upon the request of the Government, shall provide the following items necessary for the Government to pursue manufacturing of the NVX-CoV-2373 vaccine with a third party for exclusive sale to the U.S. Government:

i.a writing evidencing 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 any Background IP as defined in clause 7.1 necessary to manufacture or have manufactured the NVX-CoV-2373 vaccine;
ii.necessary FDA regulatory filings or authorizations owned or controlled by Novavax related to NVX-CoV-2373 and any confirmatory instrument pertaining thereto; and
iii.any outstanding Deliverables contemplated or materials purchased under this Project Agreement.
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c. This Article shall be incorporated into any contract for follow-on activities for the Government to acquire and use additional doses of the product. Per section 1.3, the estimated quantity for follow-on production/procurement is approximately 560 million doses.

d. This Article will survive the acquisition or merger of the Contractor by or with a third party. This Article will survive the expiration of this agreement.

11.    SECURITY

The security classification level for this effort is UNCLASSIFIED. Attachment D of the Project Agreement shall be referenced for supplemental security requirements associated with the execution of this project.

12.0     MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)
    
N/A

13.0     GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION

14.0    AGREEMENTS OFFICER’S REPRESENTATIVE (AOR) AND ALTERNATE AOR CONTACT INFORMATION

AOR

NAME: [***]                
EMAIL: [***]            
PHONE: [***]    
AGENCY NAME/DIVISION/SECTION: Joint Program Executive Office, Joint Program Lead-Enabling Biotechnologies

Alternate AOR

NAME: [***]                 
EMAIL: [***]            
PHONE: [***]            
AGENCY NAME/DIVISION/SECTION: HHS

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ENCLOSURE 3: (SUPERSEDED)

N/A – this enclosure has been superseded from the original and is no longer applicable.


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ENCLOSURE 4: PATENT LISTING
[Pursuant to Regulation S-K, Item 601(a)(5), this enclosure setting forth the patent listing has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted exhibits to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]
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Exhibit 10.5

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

image_02.jpg

August 9, 2022

Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878

Attention:    [***], Senior Vice President, Commercial Strategy

Subject:    Modification No. 15 to Project Agreement No. 01; MCDC2011-001

Reference:    MCDC Base Agreement No. 2020-530

Dear [***]:        

In accordance with the terms and conditions of the referenced MCDC Base Agreement, Modification No. 15 hereby amends Project Agreement No. 01 as follows:

DESCRIPTION OF MODIFICATION

1)Attachment A, Statement of Work, of the Project Agreement is hereby amended as attached herein.


Except as provided herein, all Terms and Conditions of the referenced MCDC Base Agreement, Project Agreement, and preceding modifications remain unchanged and in full force and effect.
    
The Project Agreement Holder is required to sign this document and return to Advanced Technology International to finalize this action.


Novavax, Inc.                                            Advanced Technology International

By: /s/ John A. Herrmann III                By: /s/ [***]                

Name: John A. Herrmann III                Name: [***]                

Title: EVP, CLO                    Title: Subcontracts Administrator I        

Date: August 10, 2022                    Date: August 10, 2022                



Attachment A
Statement of Work
(Incorporated as of Modification No. 15)

This page intentionally left blank. See separate document for Attachment A.


Attachment A
Statement of Work
(Incorporated as of Modification No. 15; Changes to Sections 3, 4, and 5 are indicated in bold italics.)

For
Rapid (WF10) Advanced Research & Development to Large Scale Manufacturing of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus

RPP #: 20-11
Project Identifier: MCDC2011-001
Consortium Member: Novavax, Inc.
Title of Proposal: Rapid (WF10) Advanced Research & Development to Large Scale Manufacturing of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus
Requiring Activity: Joint Mission between the Department of Health and Human Services and Department of Defense to Combat COVID-19

1.0    INTRODUCTION, SCOPE, AND OBJECTIVES

1.1    Introduction

To meet the needs of the Coronavirus Disease 2019 (COVID-19) pandemic, the United States Government (USG) is identifying and will support development and at-scale manufacturing of selected vaccine candidates, to ensure timely availability to the US population when needed. This is the primary focus of the mission being executed by the Department of Health and Human Services (HHS) and Department of Defense (DoD), in support of Operation Warp Speed (OWS).

The USG is interested in pursuing prototype vaccines that are in an advanced stage of development, and will support companies that can, in parallel with nonclinical, clinical and regulatory development, rapidly establish the manufacturing capacity required to meet the USG’s objective of supplying a safe and effective Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccine to the entire US population. The USG is tasked with marshaling the efforts of the US biotechnology industry to achieve this goal.

1.2    Definition of the Prototype Project

Consistent with USG objectives, the “prototype project” under this agreement is defined as the ability to manufacture and deliver up to 100M doses of a SARS-CoV-2 vaccine, NVX-CoV-2373, which is suitable for use in humans under a sufficiently informed deployment strategy, and the advanced positioning of a stockpile of critical long lead raw materials for the Matrix-M adjuvant. As such, the “prototype project” will effectively demonstrate Novavax’s ability to rapidly stand up large scale manufacturing and seamlessly transition into ongoing production.

The NVX-CoV-2373 vaccine is comprised of the Matrix-M™ adjuvant, and antigen (SARS-CoV-2 spike protein). The vaccine is filled into a multi-dose vial ([***]) and is stored at refrigerated temperature (2-8oC).

Successful development of the prototype will demonstrate Novavax’s ability to rapidly stand up large scale manufacturing and seamlessly transition into ongoing production capability, in order to rapidly manufacture to meet surge requirements with little advance notification, and
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demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed, including in order to supply use in clinical studies, under an Emergency Use Authorization (EUA), or pursuant to other clearance from the U.S. Food and Drug Administration (FDA).

Successful completion of the prototype will require three coordinated and integrated lines of effort:

a)Large scale manufacturing, compliant with 21 CFR Parts 210 and 211, and the Drug Supply Chain Security Act (DSCA), to the extent applicable at the time of manufacturing by statute and FDA interpretive guidance thereof.
b)Parallel nonclinical and clinical studies required to determine if the vaccine is safe and effective.
c)Compliance with all applicable U.S. regulatory requirements.

It is important to note that while results of nonclinical and clinical studies are critical to develop use case scenarios and, in turn, inform the USG’s deployment strategy as it relates to product manufactured under this agreement, successful development of the prototype is dependent only on the validity of data from these studies. The degree to which the data are “positive” or “negative” is not a factor in demonstration of the prototype.

1.3    Follow-on Activity

This prototype project includes unpriced options for follow-on production/procurement. During the performance of the prototype, the USG and Novavax will negotiate the scope and price of production/procurement. If the prototype project is successful, the USG may then enter into follow-on production/procurement by executing these options through a separate stand-alone production/procurement agreement, to be negotiated in terms of scope and price as described in the following paragraph.

In accordance with 10 U.S.C. 4022(f), and upon demonstration of the prototype, or at the accomplishment of particularly favorable or unexpected results that would justify transitioning to production/procurement, EUA, or Biologics License Application (BLA) approved by the FDA, the USG and Novavax may enter into a non-competitive production/procurement follow-on agreement or contract for additional production/procurement, to partially or completely meet the USG objective of supplying a safe and effective SARS-CoV-2 vaccine to vaccinate up to 300M people in the targeted population (≈560M additional doses).

1.4    Scope

Novavax has defined a scope of activities in order to successfully develop the prototype, as defined above.
One lot will be manufactured initially, with approximately 3M doses delivered in support of this agreement.

Delivery of doses to the USG is contingent on the following:

1.Timing of EUA approval by FDA.
2.Timing of label language and artwork approval by FDA.
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3.Timing of Advisory Committee on Immunization Practices (ACIP) recommendation.

Any additional manufacturing and deliveries will be contingent on 1) USG demand, 2) FDA guidance on strain changes, and 3) agreement on price.

The scope includes the following activities:

oManufacturing
Manufacturing of up to 100M doses of NVX-CoV-2373 vaccine (or a variant construct if terms, including price, can be agreed upon) for distribution to the USG upon EUA under section 564 of the Food, Drug, and Cosmetic (FD&C) Act or a biologics licensure granted under Section 351(a) of the Public Health Service Act by the U.S. FDA.
Establishment of large-scale current Good Manufacturing Practice (cGMP) manufacturing capacity compliant with 21 CFR Parts 210 and 211, and the DSCA to the extent applicable at the time of manufacturing by statute and FDA interpretive guidance thereof.
Comparability among clinical vaccine lots and commercial lots using a comparability protocol.
Validation of manufacturing processes will be performed to cGMP standards.

oClinical
Phase 3 pivotal clinical trial harmonized with USG clinical strategies.
A Phase 3 clinical trial in pediatric populations (<18 years).
Phase 2 studies in at-risk subpopulations (e.g., co-morbidities, [***], immunocompromised), as well as studies to support manufacturing site comparability.

oNon-clinical
Studies to support EUA and regulatory approval (BLA).

oRegulatory
EUA submission when data supports it, while maintaining progress toward eventual BLA submission.
BLA submission when appropriate.
Regulatory support activities (Investigational New Drug (IND) submissions) for manufacturing, clinical, non-clinical studies.
Meetings as-needed with regulators.
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oProject Management
Mandatory reporting requirements, as described in the Base Agreement.
Submission of Quarterly Progress Reports. Format will be agreed on by the contractor and Agreements Officer’s Representative (AOR), and will include both technical and financial status and expenditure forecast.
Facilitation of biweekly teleconferences with Novavax and USG Subject Matter Experts.
Final prototype project report and applicable patents report(s).
Work Breakdown Structure (WBS) and Integrated Master Schedule (IMS).
All Regulatory correspondence relevant to the scope of work proposed, including communications with the FDA, and all submissions.

1.4.1    Novavax Project Plan

This is Novavax’s plan as of the date of the submission. Novavax desires to move quickly to large scale development as rapidly as possible, in order to meet the objectives of this proposal. As the COVID-19 pandemic is an evolving situation, Novavax may need to adapt its plan in response to FDA guidance, opportunities for manufacturing efficiencies, and clinical trial data.

1.5    Resolution of Conflicting Language

If there is a conflict between the Project Agreement (of which this Statement of Work is part) and the Base Agreement (Medical CBRN Consortium (MCDC) Base Agreement No.: 2020-530), the Project Agreement language will supersede and control the relationship of the parties.

2.0    APPLICABLE REFERENCES

N/A

3.0    REQUIREMENTS

3.1    Major Task: cGMP Manufacturing of NVX-CoV-2373 compliant with 21 CFR 210 and 211
3.1.1    Subtask: Raw Materials – Obtain Critical Starting Materials for Adjuvant Manufacturing
Sufficient Saponin to manufacture up to 100M vaccine doses will be purchased (Desert King, headquartered in San Diego, CA, facilities in Chile). Long-lead, critical, and limited-supply materials ([***]) will be purchased for the additional 560M vaccine doses to meet the contact requirement, in order to ensure capability to rapidly manufacture to meet surge requirements with little advance notification and demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed.
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3.1.2    Subtask: Raw Materials – Obtain Critical Starting Materials for Antigen and Fill/Finish Manufacturing
Sufficient materials (vials, stoppers, other consumables) to manufacture up to 100M vaccine doses will be purchased (sources TBD).
3.1.3    Subtask: Raw Materials – [***] Intermediates to Produce Matrix-M Adjuvant Matrix-M Adjuvant
[***] to supply large-scale manufacturing of vaccine doses will be manufactured at [***] and PolyPeptide (Torrance, CA & Malmö, Sweden). Technology transfer and start-up of the PolyPeptide facility in Torrance, CA will be completed. Long lead, critical, and limited supply materials will be purchased in order to achieve the goal of large-scale production.
3.1.4    Subtask: Matrix-M Adjuvant Manufacturing to Supply up to 100M Vaccine Doses
Matrix-M Adjuvant bulk components will be manufactured at ACG Biologics (Seattle, WA) to supply up to 100M vaccine doses. Technology transfer and start-up of the AGC Bio facility in Seattle will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site.
3.1.5    Subtask: Antigen Manufacturing to Supply up to 100M Vaccine Doses
Antigen will be manufactured to supply up to 100M vaccine doses. Technology transfer and scale-up activities will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site.
3.1.6    Subtask: Fill/Finish of up to 100M Vaccine Doses
Up to 100M doses of finished vaccine in [***] will be manufactured. This will include secondary packaging. Technology transfer and scale-up activities will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site.
3.1.7    Subtask: Shipping and Storage
Novavax assumes that it will maintain a Vendor Managed Inventory (VMI) system to enable shipment of product to the Biomedical Advanced Research and Development Authority (BARDA)-managed inventory system (McKesson depots). Novavax will perform activities to establish compliance with DSCA to the extent applicable at the time of manufacturing, by statute and FDA interpretive guidance thereof.
3.1.8    Subtask: Manufacture of 3M Doses and Subsequent Manufacturing
Approximately 3M doses will be manufactured at Serum Institute of India (Pune, India) or other FDA-approved location for delivery as soon as feasible after receipt of EUA from the FDA, at an agreed-upon price per dose. The manufacture and delivery of any doses beyond this initial quantity is dependent upon USG demand, FDA guidance on strain selection, and agreement between the parties on price, to be incorporated via a mutually agreed upon modification.

3.2    Major Task: Clinical Studies
Novavax will perform these clinical trials and deliver the results in an interim Clinical Study Report (CSR) at the completion of enrollment, and the final CSR when available. These trials will be conducted using a Clinical Research Organization (CRO) that is to be determined.
3.2.1    Subtask: Phase 3 US/Mexico Efficacy Study, Adults ≥ 18 and < 75 years
Study: Phase 3 – US/Mexico Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301. This includes a “crossover” component where patients that received placebo were offered the vaccine after [***].
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Population: Adults ≥ 18 years, inclusive of subjects with more severe co-morbid conditions.    
Locations: US/Mexico.    
Primary Objectives: Clinical efficacy, safety, immunogenicity.     
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M – dose determined by Phase 2 dose confirmation study, Placebo; ~0.5 mL dose Intramuscular (IM) injection, up to 2 doses at Day 0 and Day 21.
Enrollment: TOTAL N: ~30,000 (adjusted for expected endpoint incidence). [***].
3.2.1.1    Subtask: Phase 3 US/Mexico Efficacy Study, Adults ≥ 18, Booster Study
Study: Phase 3 – US/Mexico Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301. This includes a booster component where patients will receive a booster dose of vaccine approximately [***] after completion of the dose regimen, and a second booster dose no less than [***] after the previous booster.
Enrollment: TOTAL N: ~25,000 (adjusted for expected enrollment).
3.2.1.2    Subtask: Phase 3 US/Mexico Efficacy Study, Adolescents ≥ 12 and < 18 years, Adolescent/Adolescent Booster Study
Study: Phase 3 – US/Mexico Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301. This includes a booster component where patients will receive a booster dose of vaccine approximately [***] after completion of the dose regimen.
Enrollment: TOTAL N: ~2500 (adjusted for expected enrollment).
3.2.2    Reserved
3.2.3    Reserved
3.2.4    Reserved
3.2.5    Subtask: Lot-to-Lot Consistency/Comparability Study (US or other)
Study: Phase 2 lot-to-lot consistency/comparability study (US or other), 2019nCoV-307.
Population: Adults ≥ 18 to < 50 years.    
Locations: USA.
Primary Objectives: Safety, immunogenicity.
Design: Randomized, observer-blinded.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; [***].
Enrollment: ~300 per cohort, each cohort having [***]. Study size may be adjusted to allow non-inferiority testing.
3.2.6    Reserved
3.2.7    Subtask: Pharmacovigilance; Establishment of Registration Safety Database
A registration safety database will be established to comply with FDA requirements for product safety and licensure.
3.2.8    Subtask: Phase 3 Pediatric Study
Study: Phase 2/3 pediatric study, 2019nCoV-503. 
Population: Children ≥ 6 months to < 12 years (3 age cohorts).   
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Locations: [***].      
Primary Objectives: Safety, immunogenicity, effectiveness (determined by immunogenicity).
Design: Randomized, observer-blinded, placebo-controlled.          
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M [***].
Enrollment: N = 1,200 ([***]); N = 1,200 ([***]); N = 1,200 ([***]); TOTAL: N = 3,600; [***].

3.3    Major Task: Non-Clinical Studies
Novavax will perform these non-clinical studies and deliver the results in a study report at completion.
3.3.1    Mouse Study, Immunogenicity
Study 702-100. [***] in mice for vaccine efficacy profile to comply with FDA guidelines.
3.3.2    Rhesus Study, Immunogenicity
Study 702-099. [***] in rhesus monkeys for vaccine efficacy profile to comply with FDA guidelines.
3.3.3    Hamster Study, Immunogenicity
Study 702-102. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.4    Mouse Study, T-Cell Immunogenicity
Study 702-103. T-cell immunogenicity/challenge study in mice [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.5    Hamster Study, T-Cell Immunogenicity
Study 702-105. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.6    Mouse Study, T-Cell Immunogenicity
Study 702-104. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.7    Non-Clinical Studies: Collaboration with Univ. of Maryland School of Medicine
Three studies to study enhancement/inhibition and neutralization, and virus challenge of vaccinated mice:
1.Validation of Spike nanoparticles in cell inhibition studies: In vitro inhibition studies on cell line permissive to r2019-nCoV, readout TBD.
2.Neutralization studies with virus against bleeds from mice, In vitro microneutralization studies on cell line permissive to r2019-nCoV, TCID50 or fluorescence readout (TBD).
3.Virus challenge of vaccinated mice (mice vaccinated outside and shipped to UM for challenge), Challenge of vaccinated mice (shipped in for infection from Novavax), Lung pathology, Titer, viral Ribonucleic Acid (RNA) quantitation, pathology scoring and reports.
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3.3.8    Structural Study of COVID-19 Spike Protein and its Complex with Host Receptor (cooperation with Baylor College of Medicine)
Study to determine the structures of recombinant COVID-19. Spike protein in nanoparticles used in Novavax’s human vaccine and in complex with its host receptor ACE2. Will obtain a high-resolution cryoEM structure of full-length COVID-19 Spike protein and a high-resolution cryoEM structure of full-length COVID-19 Spike protein in complex with human receptor ACE2.
3.3.9    Neutralizing Assay Histopathology for On-going [***]
Histopathology readings for current neutralization studies in [***]. This will support the safety profile of the vaccine for FDA approval.
3.3.10    Mouse Study, Immunogenicity [***] Studies
Individual immunogenicity studies [***] in mice for vaccine efficacy profile in different sub-populations to comply with FDA guidelines.
3.3.11    Durability of NVX-CoV-2373 Vaccine Immunity and SARS-CoV-2 Protection at [***] in Rhesus Macaques
Study 702-110. This study is designed to evaluate the long-term immunogenicity and protective efficacy of NVX-CoV-2373 nanoparticle vaccine when administered with Matrix-MTM by IM injections on Study Days 0 and 21, to Non-Human Primates (NHP). Each study group will contain [***] NHPs ([***] per sex). Blood samples will be collected prior to vaccination and at multiple time points following vaccination as outlined below. Samples will be shipped to Novavax Inc. for performance of assays to determine the vaccine immunogenicity. Animals from placebo and active treatment groups will be challenged with SARS-CoV-2 virus at [***] following last treatment and monitored for clinical illness, viral RNA and sgRNA (nasal swabs, BAL) to assess the protective efficacy of the vaccine.
3.3.12    Immunogenicity and Protective Efficacy of Sub-Protective Doses of NVX-CoV-2373 in Rhesus Macaques
Study 702-111. This study is designed to evaluate the immunogenicity and protective efficacy of sub-optimal doses of NVX-CoV-2373 nanoparticle vaccine administered with a fixed dose of Matrix-MTM by IM injections on Study Days 0 and 21, to NHPs. Each study group will contain [***] NHPs ([***] per sex). Blood samples will be collected prior to vaccination and at various time points following vaccination as outlined below. Samples will be shipped to Novavax Inc. for performance of assays to determine the vaccine immunogenicity. Animals from placebo and active treatment groups will be challenged with SARS-CoV-2 virus at [***] following last treatment and monitored for clinical illness, viral RNA and sgRNA (nasal swabs, BAL) to assess the protective efficacy of the vaccine.
3.4    Major Task: Regulatory Affairs
Novavax will conduct the regulatory activities below, including BLA prep and submission, and provide the meeting minutes and applications to the USG.
3.4.1    Subtask: EUA Submission and Supporting Meetings and Regulatory Filings
An EUA will be submitted to the FDA upon obtaining sufficient clinical data. EUA, FDA meetings to support EUA, submission planning support for the Chemistry, Manufacturing, and Controls (CMC) team, EUA strategy and meeting support, and submission preparation support activities, will all be completed.
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3.4.2    Subtask: IND Submission Updates and FDA Meetings
This task will include submissions to the IND and possible FDA meetings that will be required prior to the BLA submission.
3.4.3    Subtask: BLA Submission
A BLA will be submitted to the FDA upon obtaining sufficient clinical data, FDA meetings to support BLA, submission planning support for the CMC team, BLA strategy and meeting support, and submission preparation support activities, will all be completed.

3.5    Major Task: Project Management and Reporting
3.5.1    Subtask: Kick-Off Meeting and Initial Baseline Review of IMS
Novavax shall conduct a Kick-Off Meeting and an initial review with the USG of the IMS, upon initiation of the program.
3.5.2    Subtask: Biweekly Meetings with OWS
Novavax shall submit the agenda in advance. Any technical updates shall be provided in advance for the USG team to review. Minutes shall be submitted after the biweekly meeting to the USG.
3.5.3    Subtask: Written Quarterly Reports
Novavax shall submit quarterly reports to the USG.
3.5.4    Subtask: Written Annual Reports
Novavax shall submit the annual reports to the USG.
3.5.5    Subtask: Written Final Report
Novavax shall submit the final report to the USG.

3.6    Optional Task: Follow-On Production
Follow-on production of finished doses of vaccine up to 560M doses.

4.0    DELIVERABLES

Del. #Deliverable DescriptionDue DateMilestone ReferenceSOW ReferenceGovernment RoleData Type/Data Rights
Manufacturing
4.01[***][***]5.13.1.1Reviewer[***]
4.02[***][***]5.23.1.2Reviewer[***]
4.03[***][***]5.33.1.3Reviewer[***]
4.04[***][***]5.43.1.4Reviewer[***]
4.05[***][***]5.53.1.5Reviewer[***]
4.06[***][***]5.63.1.6Reviewer[***]
4.07[***][***]5.73.1.7Reviewer[***]
4.07a[***][***]5.7.13.1.8Reviewer[***]
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4.07b[***][***]TBDTBDReviewer[***]
Clinical
4.08[***][***]5.83.2.1.1Reviewer[***]1
4.09Reserved
4.10Reserved
4.11Reserved
4.12[***][***]5.123.2.5Reviewer[***]
4.13Reserved
4.14[***][***]5.143.2.7Reviewer[***]
4.15[***][***]5.15
3.2.1.2 3.2.8
Reviewer[***]
Non- Clinical
4.16[***][***]5.163.3.1Reviewer[***]
4.17[***][***]5.173.3.2Reviewer[***]
4.18[***][***]5.183.3.3Reviewer[***]
4.19[***][***]5.193.3.4Reviewer[***]
4.20[***][***]5.203.3.5Reviewer[***]
4.21[***][***]5.213.3.6Reviewer[***]
4.22[***][***]5.223.3.7Reviewer[***]
4.23[***][***]5.233.3.8Reviewer[***]
4.24[***][***]5.243.3.9Reviewer[***]
4.25[***][***]5.253.3.10Reviewer[***]
4.26[***][***]5.263.3.11Reviewer[***]
4.27[***][***]5.273.3.12Reviewer[***]
Regulatory Affairs
4.28[***][***]5.283.4.1Reviewer[***]
4.29[***][***]5.293.4.2Reviewer[***]
4.30[***][***]5.303.4.3Reviewer[***]
Project Management
4.31[***][***]5.313.5Reviewer[***]
4.32[***][***]5.323.5.1Reviewer[***]
4.33[***][***]5.333.5.2Reviewer[***]
4.34[***][***]5.343.5.3Reviewer[***]
4.35[***][***]5.353.5.4Reviewer[***]
4.36[***][***]5.363.5.4Reviewer[***]
1 As used herein, “Government Purpose Rights“ has the meaning set forth in Article XI, Section 11.01(9) of the Base Agreement, as modified by Section 8.2(b) below.
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4.36a[***][***]5.36a3.5.4Reviewer[***]
4.36b[***][***]5.36b3.5.4Reviewer[***]
4.37[***][***]5.373.5.5Reviewer[***]
4.38[***][***]5.35N/AReviewer[***]
TBD[***][***]Option 13.6Reviewer[***]

Note 1: Attachment D of the Project Agreement shall be referenced for supplemental security requirements associated with deliverables under this project.

Note 2: The USG agrees to permanently transfer USG material, in the form of mutually agreed upon quantities of Clinical Drug Substance/Product, to Novavax for its own use in related drug trials. To enable the foregoing, the USG transfers all its right, title and interest in and to the Clinical Drug Substance/Product to Novavax. In consideration of such right, Novavax agrees (a) that Novavax shall [***]; (b) that Novavax agrees to [***]; and, (c) Novavax will, upon reasonable request from the USG, obtain and share data from the use of the Clinical Drug Substance/Product, in a mutually agreed upon format. All transfers of material produced under the project, shall obtain prior written approval by the Government, with material quantities, destinations, applications, and USG benefits clearly delineated in a mutually agreed upon format.

5.0    MILESTONE PAYMENT SCHEDULE
The milestones below are for reference and costs for the project will be invoiced monthly on a cost reimbursable basis as the work progresses.

MS #
Milestone Description
(Deliverable Reference)
Due DateTotal Program Funds
Manufacturing[***]
5.01[***][***][***]
5.02[***][***][***]
5.03[***][***][***]
5.04[***][***][***]
5.05[***][***][***]
5.06[***][***][***]
5.07[***][***][***]
5.07a[***][***][***]
5.07b[***][***][***]
Clinical[***]
5.08[***][***][***]
5.09Reserved[***]
5.10Reserved[***]
5.11Reserved[***]
5.12[***][***][***]
5.13Reserved[***]
5.14[***][***][***]
5.15[***][***][***]
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Non-Clinical[***]
5.16[***][***][***]
5.17[***][***][***]
5.18[***][***][***]
5.19[***][***][***]
5.20[***][***][***]
5.21[***][***][***]
5.22[***][***][***]
5.23[***][***][***]
5.24[***][***][***]
5.25[***][***][***]
5.26[***][***][***]
5.27[***][***][***]
Regulatory Affairs[***]
5.28[***][***][***]
5.29[***][***][***]
5.30[***][***][***]
Project Management[***]
5.31[***][***][***]
5.32[***][***][***]
5.33[***][***][***]
5.34[***][***][***]
5.35[***][***][***]
5.36[***][***][***]
5.36a[***][***][***]
5.36b[***][***][***]
5.37[***][***][***]
5.38[***][***][***]
Reservation Fees
5.39[***][***][***]
5.40[***][***][***]
5.41[***][***][***]
Total (Cost Plus Fixed Fee)$1,800,670,981
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Period of Performance (July 6, 2020 – December 31, 2023)42 Months (Base)
Option 1: Follow-On ProductionCost: [***]

The USG and Novavax agree that billable costs for the duration of the agreement will not exceed the total amount of $1,800,670,981, as shown in the functional areas set forth in the table below. Novavax acknowledges that any costs above the contract ceiling amounts, to include potential indirect rate adjustments, will be the sole responsibility of Novavax.

Functional AreaCeiling
Manufacturing[***]
Clinical[***]
Non-Clinical[***]
Regulatory Affairs[***]
Project Management[***]
Total:$1,800,670,981

6.0    INSPECTION, ACCEPTANCE, SHIPPING, AND DELIVERY PROVISIONS

The shipment of physical deliverables shall be coordinated with the AOR. Data deliverables shall be provided in accordance with the agreement, and in coordination with the AOR. Further details are provided below.

A. Inspection. Quality inspection of Filled Drug Product (FDP) shall occur when Novavax performs release testing, in order to confirm that the product complies with Novavax’s release specifications and criteria. Novavax will submit the Certificate of Analysis, Certificate of Compliance, examples of actual printed labels with lot number, and examples of printed carton labels for quality inspection of all drug product lots via the BARDA Data Infrastructure (BDI) system.

B. Delivery and Acceptance. Novavax shall notify the AOR (via update to BARDA-managed inventory system) at least [***] prior to initial delivery of NVX-CoV-2373 product. Exceptions are permitted if approved by the AOR. Upon notification, the AOR will instruct Novavax to deliver doses either to VMI or one or more, centralized USG-designated distribution sites within the USA.

Upon delivery of product, notification of delivery quantities shall be made to the AOR via the Dose Tracking Tool in accordance with the reporting requirements. Both parties acknowledge that doses delivered under this agreement are intended for clinical use or use under an EUA or a BLA (once such EUA or BLA is received).

Upon receipt of the provided certificates and any inspection of product at the destination site(s) that was timely requested (physical or representative, i.e., pictures), the AOR will review and recommend acceptance or rejection. Inspections may be made by the AOR or a duly authorized USG representative. The USG shall accept or reject product (through the BARDA-managed inventory system) that conforms to agreement requirements based on Certificates of Analysis and Certificate(s) of Compliance, provided by Novavax, and review of temperature monitoring data. The AOR will correspondingly notify Novavax of acceptance or rejection. However, the
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USG’s acceptance of product will be deemed to have occurred if the USG does not provide written notice of acceptance or rejection within [***] of Novavax’s provision of all applicable certificates.

C. Vendor Managed Inventory. Product to be stored as VMI will be shipped to [***], in order to enable shipment to designated site(s). When held in VMI, these materials will be maintained in Novavax’s or its designated representative’s quality and inventory systems. Product held in VMI is subject to the following requirements:

i. Provide temperature controlled storage at the manufacturer’s site, approved by the USG, according to cGMP and product specifications.

ii. Where possible, store agreement products physically segregated from other products. If physical separation is not possible, separation of agreement products must be controlled by a logical Warehouse Management System (WMS) at the case and pallet level.

iii. Ensure proper labeling of stored materials as USG property.

iv. Provide the USG access to review the security systems in place and request updates as needed, in accordance with the Security Plan.

v. Include in the Government’s dose tracking tool, inventory for drug product (number of vials), including inventory quantity changes, current quantity, storage facility/location, manufacturing date, latest stability result for potency, date of next expected stability result, and the current expiration date (if applicable).

vii. Conduct testing necessary to ensure continued use of the stored material for pandemic response.

vii. Make appropriate updates to the regulatory documentation, supporting the continued use of the stored material for pandemic response.

viii. If using a storage site, provide the quality agreement, specify the location and terms of the storage contract.

For accepted product in VMI, Novavax must notify the AOR of any proposed movement of the product within the BARDA-managed inventory tracking system. Any deviations, Out of Specification (OOS) results, or other product issues, shall be reported to the USG within [***] of Novavax identification.

D. Government Sites. Product to be shipped to USG-designated distribution sites shall be shipped trackable by GPS. Novavax will include the following information on the packing lists provided with bulk shipments to the centralized depots:

i. Transaction Information (TI)

ii. Transaction History (TH)

iii. Transaction Statement (TS)

iv. Centers for Disease Control (CDC) Purchase Order (PO) Number

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Novavax will also transmit bulk shipment Advance Shipment Notices (ASN) to the CDC via Electronic Data Interchange (EDI).

E. Title and Physical Risk of Loss. Title to product will transfer upon [***]. Novavax will [***]. If product is initially delivered to a [***], risk of loss will transfer upon [***].

Novavax will notify the AOR (via e-mail or phone) of any storage or quality deviation for product held in VMI, within [***]. To the extent that Novavax is responsible for the correction, repair or replacement of USG property held in VMI, and replacement upon loss or damage of such product is feasible, the USG will accept replacement of such property.

7.0    INTELLECTUAL PROPERTY, DATA RIGHTS, AND COPYRIGHTS

7.1    BACKGROUND IP

(a)    Ownership. Prior to June 8, 2020, Novavax had funded the development of NVX-CoV-2373, and other antecedent vaccine programs relevant to Novavax’ proprietary position in the development of NVX-CoV-2373, as well as its sf9/baculovirus manufacturing platform, (all “Background IP”) through private funding or in collaboration with a funding partner other than the U.S. Government. Such private and non-governmental funding has continued since June 8, 2020 and is expected to continue during the performance of the Project Agreement. A list of all patents and patent applications included in the Background IP is provided below as Enclosure 4. Background IP also consists of (a) manufacturing know-how, including, without limitation, the NVAX-Cov-2373 manufacturing process definitions, process development/characterization reports, laboratory scale process procedures, manufacturing records, analytical test methods, product quality target ranges/specifications, quality target product profile, critical quality attributes (collectively “Background Know-How”), (b) data from pre-clinical and clinical research studies, analytical and process development research, and data related to, or generated using, the Background Know-How (collectively, “Background Data”), and (c) proprietary manufacturing materials, including, without limitation, sf9 cell banks (master and working), baculovirus virus stock (master and working), product standards, reference standards, and critical reagents (“Background Materials”). On June 8, 2020, Novavax and the U.S. Department of Defense entered into a Letter Contract for specified U.S.-based clinical and manufacturing development of NVX-CoV-2373 which acknowledged Background IP and made no explicit U.S. Government claims to Background IP or subsequent data arising therefrom. The U.S. Government hereby acknowledges such Background IP in full and further acknowledges that it has no ownership rights to Novavax Background IP under this Project Agreement.

(b)     Background IP Limited License to Government. Subject to the terms of the Project Agreement, Novavax grants the U.S. Government a nonexclusive, worldwide, nontransferable, non-sublicenseable license to use the Background IP to the limited extent necessary for the U.S. Government to review and use the Deliverables tendered by Novavax under this Agreement identified in Section 4.0 above, and for no other purpose; provided that the U.S. Government agrees that it may not disclose the Background IP to third parties, or allow third parties to have access to, use, practice or have practiced the Background IP, without Novavax’s prior written consent. To the extent that a Deliverable with Foreground IP incorporates or uses Background IP, the Deliverable shall be deemed and considered to comprise Background IP and shall be used by the U.S. Government in accordance with this Background IP Limited License.

(c)     Background IP License to Novavax. Subject to the terms of the Project Agreement, the U.S. Government grants to Novavax a nonexclusive, worldwide, nontransferable, irrevocable, paid-up license to any intellectual property (including patents and patent applications) to which
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the U.S. Government has rights thereto, provided that such license is limited to such intellectual property rights necessary to perform Novavax’s obligations under the Project Agreement. 

7.2    FOREGROUND IP

(a)    Ownership.    Notwithstanding anything in the Base Agreement to the contrary, Novavax owns all rights, title and interest in and to any development, modification, discovery, invention or improvement, whether or not patentable, conceived, made, reduced to practice, or created in connection with activities funded under the Project Agreement, including, without limitation, all data and inventions, and intellectual property rights in any of the foregoing (“Foreground IP”).

(b)    Foreground IP Special License. Subject to the terms of the Project Agreement, Novavax grants the U.S. Government a nonexclusive, worldwide, nontransferable, irrevocable, paid-up license to practice or have practiced the Foreground IP for or on behalf of the U.S. Government (“Foreground IP Special License”).

8.0     DATA RIGHTS

Article XI, §11.03 of the Base Agreement is hereby amended, consistent with the “Specifically Negotiated License Rights” capability at Article XI, §§11.01(12) and 11.03(4), as follows:

8.1 Data Ownership.

Novavax owns all rights, title and interest to all Data (as defined in Article XI, Section 11.01(7) of the Base Agreement) generated as a result of the work performed under this Project Agreement, including Subject Data.

8.2 Rights to Data.

(a)    Subject Data. Subject to the terms of the Project Agreement, Novavax grants to the U.S. Government a Government purpose rights license to Subject Data that will convert to an unlimited rights license (as the term is defined in Article XI, Section 11.01(14) of the Base Agreement)2 after three (3) years from the date of delivery. As used herein, “Subject Data” shall mean Technical Data under Article XI, §11.01(13) of the Base Agreement Deliverables that are considered Subject Data are identified in the Deliverable Table set forth in Section 4.0 above.

(b)    Transfer of Data. Each party, upon written request to the other party, shall have the right to review and to request delivery of Subject Data, and delivery of such Data shall be made to the requesting party within two weeks of the request, except to the extent that such Data are subject to a claim of confidentiality or privilege by a third party.

(c)    Background IP Limited License. To the extent that Subject Data incorporates or uses Background IP, the data shall be deemed and considered to comprise Background IP and shall be used by the U.S. Government in accordance with the Background IP Limited License set forth in Section 7.3 above.

8.3 Background Technical Data Rights Assertions.

Novavax asserts background technical data rights as follows:

2 As used herein, “Government Use” as used “Purpose Rights“ has the meaning set forth in this Section 4.0 means Government purpose rights as defined in the Base Agreement, Article XI, Section 11.01(9).) of the Base Agreement, as modified by Section 8.2(b) below.
18

FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE

The Background Data, as defined in Section 7.1 above, was developed through private funding or in collaboration with a funding partner other than the U.S. Government. Such funding is expected to continue; accordingly, Novavax asserts Background Data as Category A Data pursuant to section 11.02(1) of the Base Agreement and the U.S. Government shall have no rights therein.

9.0     REGULATORY RIGHTS

This agreement includes research with an investigational drug, biologic or medical device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance before commercial marketing may begin. It is expected that this agreement will result in the FDA authorization, clearance and commercialization of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus (the “Technology”). Novavax is the Sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), emergency use authorization (EUA), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted to the FDA) that controls research under this contract. As the Sponsor of the Regulatory Application to the FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), Novavax has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application. This clause protects the return on research and development investment made by the U.S. Government in the event of certain regulatory product development failures related to the Technology.

Novavax agrees to the following:

a. Communications. Novavax will provide the U.S. Government with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that the U.S. Government representatives are invited to participate in any formal or informal Sponsor meetings with FDA;

b. Rights of Reference. The U.S. Government is hereby granted a right of reference as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous applicable law recognized outside of the U.S.) to any Regulatory Application submitted in support of the statement of work for the Project Agreement. When it desires to exercise this right, the U.S. Government agrees to notify Novavax in writing describing the request along with sufficient details for Novavax to generate a letter of cross-reference for the U.S. Government to file with the appropriate FDA office. The U.S. Government agrees that such letters of cross-reference may contain reporting requirements to enable Novavax to comply with its own pharmacovigilance reporting obligations to the FDA and other regulatory agencies. Nothing in this paragraph reduces the U.S. Government’s data rights as articulated in other provisions of the Project Agreement.

c. DoD Medical Product Priority. PL-115-92 allows the DoD to request, and FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. Novavax recognizes that only the DoD can utilize PL 115-92. As such, Novavax will work proactively with the DoD to leverage this this law to its maximal potential under this Project Agreement. Novavax shall submit a mutually agreed upon Public Law 115-92 Sponsor Authorization Letter to the U.S. Government within 30 days of award.

10.0    ENSURING SUFFICIENT SUPPLY OF THE PRODUCT

19

FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE

a. In recognition of the Government’s significant funding for the development and manufacturing of the product in this Project Agreement and the Government’s need to provide sufficient quantities of a safe and effective COVID-19 vaccine to protect the United States population, the Government shall have the remedy described in this section to ensure sufficient supply of the product to meet the needs of the public health or national security. This remedy is not available to the Government unless and until both of the following conditions are met:

i.Novavax gives written notice, required to be submitted to the Government no later than 15 business days, of:
a.any formal management decision to terminate manufacturing of the NVX-CoV-2373 vaccine prior to delivery of 100 million doses to USG;
b.any formal management decision to discontinue sale of the NVX-CoV-2373 vaccine to the Government prior to delivery of 100 million doses to USG; or
c.any filing that anticipates Federal bankruptcy protection; and
ii.Novavax has submitted an Emergency Use Authorization under §564 of the FD&C Act or a biologics license application under the provisions of §351(a) of the Public Health Service Act (PHSA).

b. If both conditions listed in section (a) occur, Novavax, upon the request of the Government, shall provide the following items necessary for the Government to pursue manufacturing of the NVX-CoV-2373 vaccine with a third party for exclusive sale to the U.S. Government:

i.a writing evidencing 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 any Background IP as defined in clause 7.1 necessary to manufacture or have manufactured the NVX-CoV-2373 vaccine;
ii.necessary FDA regulatory filings or authorizations owned or controlled by Novavax related to NVX-CoV-2373 and any confirmatory instrument pertaining thereto; and
iii.any outstanding Deliverables contemplated or materials purchased under this Project Agreement.

c. This Article shall be incorporated into any contract for follow-on activities for the Government to acquire and use additional doses of the product. Per section 1.3, the estimated quantity for follow-on production/procurement is approximately 560 million doses.

d. This Article will survive the acquisition or merger of the Contractor by or with a third party. This Article will survive the expiration of this agreement.

11.    SECURITY

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FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE

The security classification level for this effort is UNCLASSIFIED. Attachment D of the Project Agreement shall be referenced for supplemental security requirements associated with the execution of this project.

12.0     MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)
    
N/A

13.0     GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION

14.0    AGREEMENTS OFFICER’S REPRESENTATIVE (AOR) AND ALTERNATE AOR CONTACT INFORMATION

AOR

NAME: [***]
EMAIL: [***]
PHONE: [***]
AGENCY NAME/DIVISION/SECTION: Joint Program Executive Office, Joint Program Lead-Enabling Biotechnologies

Alternate AOR

NAME: [***]
EMAIL: [***]
PHONE: [***]
AGENCY NAME/DIVISION/SECTION: HHS

21

FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE

ENCLOSURE 3: (SUPERSEDED)

N/A – this enclosure has been superseded from the original and is no longer applicable.


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FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE

ENCLOSURE 4: PATENT LISTING
[Pursuant to Regulation S-K, Item 601(a)(5), this enclosure setting forth the patent listing has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted exhibits to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]

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FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE
Exhibit 10.6

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

image_03.jpg
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878

Attention:    [***]
Subject:    Modification No. 16 to Project Agreement No. 01; MCDC2011-001 Reference:    MCDC Base Agreement No. 2020-530
Dear [***]:

In accordance with the terms and conditions of the referenced MCDC Base Agreement, Modification No. 16 hereby amends Project Agreement No. 01 as follows:

DESCRIPTION OF MODIFICATION

1) The Limitations of Costs clause of the Project Agreement hereby replaces the Incremental Funding clause as indicated below:

5. LIMITATION OF COSTS
The total amount of funding currently available for payment and allotted to this Project Agreement is
$1,800,670,981 (this is an increase of $52,981,653). If at any time the Project Agreement Holder has reason to believe that the Total Estimated Cost which will accrue in the performance of this Project Agreement in the next succeeding [***], when added to all other payments previously accrued, will exceed [***] of the then current total authorized funding, the Project Agreement Holder shall notify the MCDC CMF to that effect, advising the estimate of additional funds required for the period specified. The Project Agreement Holder is not obligated to continue performance under this Project Agreement (including actions under the Termination clause of the MCDC Base Agreement) or otherwise incur costs in excess of the amount allotted to the Project Agreement by the MCDC CMF.


Except as provided herein, all Terms and Conditions of the referenced MCDC Base Agreement, Project Agreement and preceding modifications remain unchanged and in full force and effect.

This modification is issued unilaterally. The Project Agreement Holder is not required to sign to finalize this
action.

Advanced Technology International

By: /s/ [***]    

Name: [***]     

Title: Vice President Contracts and Procurement    

Date: Sep 1 2022    
Exhibit 10.7

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
1.CONTRACT ID CODE
PAGE OF PAGES
13
1.AMENDMENT/MODIFICATION NO.
1.EFFECTIVE DATE
1.REQUISITION/PURCHASE REQ. NO.
1.PROJECT NO.(If applicable)
P0000629-Jul-2022SEE SCHEDULE
1.ISSUED BY
CODEW911SR
1.ADMINISTERED BY (If other than item 6)
CODEW911SR
ACC-APG EDGEWOOD
[***]
ACC-APG EDGEWOOD
[***]
SCD: A
1.NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)
9A. AMENDMENT OF SOLICITATION NO.
NOVAVAX, INC.
20 FIRSTFIELD RD
GAITHERSBURG MD 20878-1760
9B. DATED (SEE ITEM 11)
X10A. MOD. OF CONTRACT/ORDER NO.
W911QY20C007
X10B. DATED (SEE ITEM 13)
CODE1UCZ4FACILITY CODE
11.THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
☐    The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer ☐ is extended, ☐ is not extended.
Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:
(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
12.ACCOUNTING AND APPROPRIATION DATA (If required)
1.THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
A.THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
A.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).
X
A.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: 52.243-2 Changes Cost Reimbursement.
A.OTHER (Specify type of modification and authority)
A.IMPORTANT: Contractor ☐ is not, ☒ is required to sign this document and return      1      copies to the issuing office.
14.DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Modification Control Number:[***]
The purpose of this modification is as follows:
a.    Provide for the delivery of 200,000 dose of drug product at the price set forth in the contractors July 8, 2022 proposal,
b.    Incorporate FAR Clause 52.243-2, Changes Cost Reimbursement.
c.    Incorporate Section H terms specific to patent infringement.
All other terms and conditions remain the same and in full force and effect.

**** Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A.    NAME AND TITLE OF SIGNER (Type or Print)

John A Herrmann III    EVP, CLO
16A.    NAME AND TITLE OF CONTRACTING OFFICER (Type or Print)

TEL: [***]    EMAIL: [***]
15B. CONTRACTOR/OFFEROR

/s/ John A. Herrmann III    
(Signature of person authorized to sign)
15C. DATE SIGNED

July 28, 2022
16B. UNITED STATES OF AMERICA

BY /s/ [***]    
(Signature of Contracting Officer)
16C. DATE SIGNED

29 July, 2022
EXCEPTION TO SF    30 30-105-04    STANDARD FORM 30 (Rev. 10-83)
APPROVED BY OIRM 11-84    Prescribed by GSA
    FAR (48 CFR) 53.243

W911QY20C0077
[***]
Page 2 of 3
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGES
SECTION SF 30 - BLOCK 14 CONTINUATION PAGE
The following have been added by full text:
P00006
A.The purpose of this modification is as follows:
a.CLIN 0001 is hereby revised to provide for the delivery and acceptance of 200,000 doses of FDA authorized final drug product, subject to the terms of the Contractors July 11, 2022 Price Proposal, at the dose price stated in [***]. The cost of the 200,000 doses shall not exceed [***]. Delivery of any remaining doses shall be directed by the DoD and set forth in a modification signed by both parties.
b.Section I is hereby revised to include FAR Clause 52.243-2 Changes Cost Reimbursement by reference.
c.The total cost of the contract remains unchanged.
d.The total funding of the contract remains unchanged
e.Delivery and acceptance shall be performed under the terms of this contract. The COR shall notify the contractor upon acceptance, thereby authorizing invoicing.
f.Section H of the contract is hereby revised to incorporate additional terms specific to patent infringement.
B.The parties hereby agree that changes effected by this modification constitute both the consideration and the equitable adjustment due under any clause of this contract resulting from the incorporation of the changes denoted in paragraph A of this modification.
C.All other terms and conditions remain the same and in full force and effect.
SECTION B - SUPPLIES OR SERVICES AND PRICES
CLIN 0001
The CLIN extended description has changed from:
The contractor shall complete development and production of the Novavax nanoparticle vaccine against COVID-19, to include, production of the M matrix adjuvant and the fill/finish capability, in accordance with the Performance Work Statement (PWS) attached in Section C. Deliverables shall be completed in accordance with the following schedule: [***]


W911QY20C0077
[***]
Page 3 of 3
To:
The contractor shall complete development and production of the Novavax nanoparticle vaccine against COVID-19, to include, production of the M matrix adjuvant and the fill/finish capability, in accordance with the Performance Work Statement (PWS) attached in Section C. Deliverables shall be completed in accordance with the following schedule: [***]
SECTION H    - SPECIAL CONTRACT REQUIREMENTS
The following have been added by full text:
SECTION H:
The parties agree and acknowledge that the USG does not authorize or consent to any Contractor infringement of a valid U.S. patent. The parties further acknowledge that 28 USC Section 1498, regarding patent indemnity by the USG government to the Contractor, does not apply to this contract.
SECTION I - CONTRACT CLAUSES
The following have been added by reference:
52.243-2    Changes--Cost-Reimbursement    AUG 1987
(End of Summary of Changes)
Exhibit 10.8

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

CONFIDENTIAL SETTLEMENT AGREEMENT AND RELEASE
This CONFIDENTIAL SETTLEMENT AGREEMENT AND RELEASE (the “Agreement”), effective as of September 30, 2022 (the “Effective Date”), is made by and between Novavax, Inc. (“Novavax”) on the one hand, and FUJIFILM Diosynth Biotechnologies UK Limited (“FDBK”), FUJIFILM Diosynth Biotechnologies Texas, LLC (“FDBT”), and FUJIFILM Diosynth Biotechnologies USA, Inc. (“FDBU”), on the other. FDBK, FDBT and FDBU shall individually and/or collectively, as the context requires, be referred to herein as “Fujifilm”. Novavax and Fujifilm are referred to herein together, as the “Parties,” and each, as a “Party.”
RECITALS
WHEREAS, Novavax and Fujifilm are parties to a Master Services Agreement dated June 20, 2020 and associated statements of work (collectively, the “MSA”) and a Commercial Supply Agreement dated August 20, 2021 (“CSA”), both of which have been modified by amendments and change orders and pursuant to which Fujifilm provides manufacturing and other agreed upon services to Novavax;
WHEREAS, Novavax instructed Fujifilm to stop manufacturing activities at FDBT and the parties have since agreed to terminate all manufacturing activity at FDBT under the CSA;
WHEREAS, the Parties disagree about the amount due to Fujifilm under the CSA in connection with the termination of services and cancellation of batches forecasted to be manufactured at FDBT;
WHEREAS, this Agreement is intended to resolve the disagreements of the Parties regarding the amounts due under the CSA in connection with the termination of services at FDBT;
NOW, THEREFORE, in consideration of the promises and the mutual covenants of the Parties herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1.Recitations. The above recitals are true and correct and are incorporated herein by reference.
2.Non-Admission of Liability. The Parties understand and agree that this is a compromise and settlement of disputed claims. Each of the Parties specifically denies any liability or wrongdoing whatsoever on their part. Nothing in this Agreement shall constitute or be construed as an admission of liability on behalf of the Parties or their agents, affiliates, assigns, parents, subsidiaries, and/or successors, or an admission as to the validity of the claims.
3.Attorney Representation. This Agreement is entered into voluntarily by the Parties who stipulate and agree that they are under no duress or undue influence. The Parties represent that in the execution of this Agreement, they had the opportunity to consult legal counsel of their own selection and that the said attorneys have reviewed this Agreement, made any desired changes, and advised their respective clients with respect to the advisability of making the settlement and releases provided herein and of executing this Agreement.
4.Terms. As full and final settlement of the Released Claims (defined herein), the Parties agree as follows:


(a)Novavax shall be liable to Fujifilm for payment of $185,000,000.00 in connection with the cancellation of batches to be manufactured at FDBT under the CSA and all FDBT facility idle fees that Fujifilm claims to be due and owing, subject to the following terms and payment schedule (“CSA Settlement Payment”):
•On September 30, 2022, Fujifilm shall apply and credit the Initial Reservation Fee in the amount of $47,812,500.00 paid by Novavax and referenced in Section 5 of the CSA against the CSA Settlement Payment.
•Fujifilm will raise one invoice consistent with the terms of this Agreement for the balance of the CSA Settlement Payment after the application of the Initial Reservation Fee. The balance shall be paid in four equal installments of $34,296,875.00, provided that the final two installments shall be subject to the mitigation clause set forth below.
•The first two installment payments, due by no later than March 31, 2023 and June 30, 2023, shall be paid by Novavax in full and are not subject to reduction based on any mitigation efforts by Fujifilm.
•The final two installment payments shall be subject to the mitigation clause set forth in Section 4(b) of this Agreement. All replacement revenue achieved by Fujifilm in connection with manufacturing that occurs between July 1, 2023 and December 31, 2023 (the “Mitigation Period”) and encompassed by the mitigation clause set forth below shall be credited against the final two installment payments due as part of the CSA Settlement Payment. To the extent any balance remains after application of the mitigation savings, Novavax shall pay such amounts by no later than September 30, 2023 and December 31, 2023, provided that Fujifilm has timely delivered the reports set forth below to calculate any mitigation savings.
•All payments made pursuant to this Agreement shall be made according to the following wire payment information:
[***]

(b)Fujifilm shall use commercially reasonable efforts to mitigate the losses associated with vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Such mitigation shall encompass any cost savings achieved through replacement revenue recognized from fees received from third-parties for Fujifilm manufacturing services during the Mitigation Period as a result of Fujifilm selling vacant capacity in [***] at FDBT [***]. As of the Effective Date, Fujifilm has not identified any programs for manufacture in [***]. However, prior to the Effective Date, Fujifilm identified two programs [***] that have been sited for manufacture in idle capacity in [***]. In addition, to the extent Fujifilm identifies third-party manufacturing services for delivery in FDBT during the Mitigation Period, such manufacturing services shall be sited appropriately by Fujifilm within the FDBT facilities with [***] being prioritized over [***]. For the avoidance of doubt, [***] in Texas are designed to support technology and programs that are different from that of the [***] and, as such, [***] cannot be prioritized over these facilities with respect to such programs.
    -2-

(c)To facilitate the computation of any mitigation savings due under Section 4, Fujifilm shall provide Novavax with [***] reports to be delivered by the [***] commencing on [***]. Each report shall include sufficient information to allow the Parties to determine and assess any mitigation savings to be credited to Novavax under this Section, including, but not limited to, the following information:
(i)An anonymized pipeline summary of proposals issued by Fujifilm to prospective third-party clients where the program may be manufactured in [***]. Such summary will be [***];
(ii)A summary of all current and new manufacturing activity planned to occur in [***] during the Mitigation Period. Such summary should include, at a minimum, [***]; and
(iii)A detailed report of the actual mitigation in applicable fees in light of the signed and delivered manufacturing services that have been performed by Fujifilm in [***] during the Mitigation Period. The Parties acknowledge and agree that application of this mitigation provision shall not apply to fees that Fujifilm has received but are subject to refund to the third-party.
To the extent Novavax has questions or concerns regarding Fujifilm’s prioritization of [***], the Parties will work together in good faith to address these questions or concerns, including, but not limited to, discussing whether Fujifilm will provide additional information.
The identity of any third-party who has contracted with Fujifilm and all confidential information that is not relevant to computing the mitigation savings will not be provided by Fujifilm to Novavax and, if applicable, may be redacted.
It is recognized and understood by both parties that Fujifilm is a Contract Development and Manufacturing Organization and has established business processes that will be followed for the identification, contracting and delivery of third-party business. Fujifilm shall use commercially reasonable efforts to identify applicable projects to utilize [***] during the Mitigation Period.
(d)With respect to the MSA, the Parties agree that no further manufacturing work shall be performed and the Parties shall work together in good faith to resolve all open invoices, reconcile open but not yet raised invoices for work completed, reconcile raw material and consumables, identify any credits due to Novavax or invoices to be raised to Novavax accounting for any pre-payments or in connection with any change orders, and determine disposition of the equipment held by Fujifilm, by [***]. To the extent the Parties are unable to achieve resolution of all or part of this section by [***], the Parties agree to resolve any disputes according to Section 16.3 of the MSA. Novavax shall notify Fujifilm within [***] of the Effective Date whether any services being performed by Fujifilm at its facility in North Carolina or Texas should be terminated. Absent such notification, Fujifilm will consider the MSA terminated with respect to all activities in FDBU and FDBT and determine the impact of such termination in accordance with the provisions of the MSA.
(e)With respect to the CSA, the parties shall work together in good faith to resolve all raw material and consumables reconciliation and disposition by [***]. It being
    -3-

Fujifilm’s position that it ordered materials in good faith to deliver on the commitments of the CSA and as such, save for any mitigation proposed by Fujifilm, such materials shall be for the account of Novavax.
(f)The terms and conditions of the MSA and CSA shall remain in full force and effect with respect to the ongoing activities at FDBK. Except as expressly set forth herein, nothing in this Agreement modifies the MSA or CSA. To the extent any terms of this Agreement conflict with the MSA or CSA, the terms of this Agreement shall control with respect to the matters addressed herein.
5.Releases. In consideration of Paragraph 4 herein, including, without limitation, Novavax’s agreement to pay the CSA Settlement Payment, the Parties hereby remise, release, acquit, satisfy, and forever discharge each Party and their past, present and future officers, directors, heirs, agents, servants, employees, legal representatives, assigns, successors, affiliates, shareholders, beneficiaries, predecessors, insurers, administrators, and successors in interest; their parent, holding, subsidiary, affiliated, and related entities; any business entity or division owning or controlling the Parties in whole or in part; any business entity or division owned or controlled in whole or in part by the Parties (all of the foregoing persons and entities are hereinafter collectively referred to as the “Released Parties”), of and from all claims, liabilities, obligations, promises, agreements, damages, actions, demands, costs, losses, fees and expenses as of the Effective Date relating to (a) the cancellation of batches to be manufactured at FDBT under the MSA or CSA; (b) FDBT facility idle time in 2022; (c) the Parties failure to complete Product PPQ by December 2021; and (d) any obligation by Fujifilm to reserve capacity or manufacture batches at FDBT for the benefit of Novavax under the MSA or CSA (collectively, the “Released Claims”). For the avoidance of doubt, nothing in this Agreement terminates the MSA or CSA with respect to FDBK, nor releases either Party’s claims or obligations with respect to the items identified in Paragraphs 4(d) and 4(e).
6.Representations and Warranties, Each Party hereby represents and warrants to the other Party that:
(g)It has the full right, power, and authority to enter into this Release, to grant the release contained herein and to perform its obligations hereunder;
(h)The execution of this Release by the individual whose signature is set out at the end of this Release on behalf of such Party, and the delivery of this Release by such Party, have been duly authorized by all necessary corporate action on the part of such Party;
(i)This Release has been executed and delivered by each Party and constitutes the legal, valid, and binding obligation of each Party, enforceable against each Party in accordance with its terms; and
(j)Neither Party has assigned nor transferred any of the Released Claims herein to any person or entity and no person or entity has subrogated to or has any interest or rights in any Released Claims.
7.Confidentiality. Each Party acknowledges the confidential nature of the terms and conditions of this Agreement, as well as the Confidentiality terms that remain in full force and effect in the MSA and the CSA (collectively, the “Confidential Information”) and, except as set forth below or in Section 8(a) of this Agreement, each Party agrees that it shall not (a) disclose any Confidential Information to any person or entity, except to such Party’s and its affiliates’ employees, advisors, and other representatives who need to know the Confidential
    -4-

Information to assist such Party, or act on its behalf, to exercise its rights or perform its obligations under this Agreement or the CSA, or (b) use the Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement or the CSA. Each Party shall be responsible for any breach of this Section 7 caused by any of its and its affiliates’ employees, advisors, or other representatives. Notwithstanding the foregoing, if any Confidential Information is permissibly disclosed under Section 8(a), such information will no longer be deemed “Confidential Information” for the purposes of this Section 7.
In the event that either Party receives a request to produce Confidential Information of the other Party pursuant to an order of a court of competent jurisdiction or a facially valid administrative, Congressional, state or local legislative or other subpoena or believes that such Party is otherwise required by law to disclose Confidential Information, then such Party shall [***] notify the other Party prior to making such disclosure, unless prior notification is precluded by law or regulation or where enforcement action by applicable authority precludes prior notification, in which case the Party will notify the other Party [***], and shall provide the other Party the opportunity to challenge or otherwise lawfully seek limits upon such disclosure of Confidential Information.
8.Publicity and Announcements.
(k)Neither Party shall (orally or in writing) publicly disclose or issue any press release, make any other public statement, or otherwise communicate with the media, concerning the termination of the MSA or CSA, the existence of this Agreement or the subject matter hereof, without the prior written approval of the other Party, except to the extent that such Party is required to make any public disclosure or filing regarding the subject matter of this Agreement by applicable laws or regulations, or in connection with enforcing its rights under this Agreement.
(l)Neither Party shall make, publish, or communicate to any person or entity or in any public forum any comments or statements (written or oral) that denigrate or disparage, or are detrimental to, the reputation or stature of the other Party or its businesses, or any of its employees, officers, directors, and existing and prospective customers, suppliers, investors, and other associated third parties.
9.Entire Agreement. This Agreement is the sole and entire agreement of the Parties regarding the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations, and warranties, both written and oral, regarding such subject matter.
10.Amendments. This Agreement may not be amended, modified or altered at any time without the approval of the Parties; however, any such amendment must be in writing and signed by all Parties for such amendment to be of any force and effect.
11.Survival. All representations and warranties contained herein shall survive the execution and delivery of this Agreement, and the execution and delivery of any other document or instrument referred to herein.
12.Governing Law and Dispute Resolution. The laws of [***] (without giving effect to its conflict of law principles) govern all matters arising out of or relating to this Agreement, including, without limitation, its validity, interpretation, construction, performance and enforcement. The dispute resolution provisions in Section 16 of the CSA shall apply to any and all disputes arising under this Agreement.
    -5-

13.Costs. The Parties have agreed to bear their own attorneys’ fees and costs with respect to the preparation of any and all documents necessary to enter into this Agreement.
14.Counterparts. This Agreement may be signed and executed in one or more counterparts, each of which shall be deemed an original and all of which together shall constitute one Agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or email shall be effective as delivery of an originally executed counterpart of this Agreement.
15.No Adverse Construction. The Parties acknowledge that this Agreement has been prepared by each of them through counsel. In the event any part of this Agreement is found to be ambiguous, such ambiguity shall not be construed against any Party.

[INTENTIONALLY LEFT BLANK]

    IN WITNESS WHEREOF, The Parties have executed this Agreement as of the date set forth below.
On behalf of Novavax, Inc.
    By:    /s/ John A. Herrmann III        
    Printed Name:    John A. Herrmann III        
    Title:    EVP, CLO                
    Date:    9/30/2022                

On behalf of FUJIFILM Diosynth Biotechnologies Texas, LLC
    By:    [***]            
    Printed Name:    [***]            
    Title:    [***]                
    Date:    30 Sep 2022            

On behalf of FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
    By:    [***]            
    Printed Name:    [***]            
    Title:    [***]                
    -6-

    Date:    30 Sep 2022            

On behalf of FUJIFILM Diosynth Biotechnologies UK Limited
    By:    [***]            
    Printed Name:    [***]            
    Title:    [***]                
    Date:    30 Sep 2022            

    -7-

    Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

I, Stanley C. Erck, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of Novavax, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
e)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and


f)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 9, 2022
By:
/s/ Stanley C. Erck
Stanley C. Erck
President and Chief Executive Officer

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

I, James P. Kelly, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of Novavax, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 9, 2022
By:
/s/ James P. Kelly
James P. Kelly
Executive Vice President, Chief
Financial Officer and Treasurer

Exhibit 32.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO 18 UNITED STATES CODE §1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)

In connection with the Quarterly Report of Novavax, Inc. (the “Company”) on Form 10-Q for the fiscal period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Stanley C. Erck, President and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by this Report.

Date: November 9, 2022
By:
/s/ Stanley C. Erck
Stanley C. Erck
President and Chief Executive Officer

This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Company specifically incorporates it by reference.

Exhibit 32.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 UNITED STATES CODE §1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)

In connection with the Quarterly Report of Novavax, Inc. (the “Company”) on Form 10-Q for the fiscal period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James P. Kelly, Executive Vice President and Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by this Report.

Date: November 9, 2022
By:
/s/ James P. Kelly
James P. Kelly
Executive Vice President, Chief
Financial Officer and Treasurer

This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Company specifically incorporates it by reference.