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Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2021
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 of incorporation)
(I.R.S. Employer Identification No.)




21 Firstfield Road,
Gaithersburg,Maryland20878
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (240) 268-2000
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading SymbolName of each exchange on which registered
Common Stock, Par Value $0.01 per shareNVAXThe Nasdaq Global Select Market
Securities registered pursuant to Section 12(g) of the Act: Not Applicable
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
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 ☒ No ☐
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 ☒ No ☐
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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. (Check one):
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant had elected not to use the extended transition period for complying with any new or revised financial accounting standards provide pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.     ☒

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant (based on the last reported sale price of Registrants common stock on June 30, 2021 on the Nasdaq Global Select Market) was approximately $15,697,000,000.
As of February 21, 2022, there were 76,282,986 shares of the Registrant’s common stock outstanding.
Documents incorporated by reference: Portions of the Registrant’s Definitive Proxy Statement to be filed no later than 120 days after the fiscal year ended December 31, 2021 in connection with the Registrant’s 2020 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent indicated herein.



Table of Contents
NOVAVAX, INC.
TABLE OF CONTENTS
Page
PART I
PART II
PART III
PART IV
Item 16.
FORM 10-K SUMMARY
2

Table of Contents
CERTAIN DEFINITIONS

All references in this Annual Report on Form 10-K to “Novavax,” the “Company,” “we,” “us” and “our” refer to Novavax, Inc. including its wholly-owned subsidiaries, Novavax AB and Novavax CZ (unless the context otherwise indicates).
NOTE REGARDING TRADEMARKS
Novavax™, Nuvaxovid™, Matrix-M™, Matrix™, Prepare™, Resolve™, and ResVax™ are trademarks of Novavax. Any other trademarks referred to in this Annual Report on Form 10-K are the property of their owners. All rights reserved. We do not intend our use or display of other companies’ trade names or trademarks to imply an endorsement or sponsorship of us by such companies, or any relationship with any of these companies.
FORWARD-LOOKING INFORMATION
This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K, our actual results may differ materially from those anticipated in these forward-looking statements. Please also see the disclaimer under the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS

Our business is subject to numerous risks which are discussed more fully under the heading “Risk Factors” in this Annual Report on Form 10-K. These risks include, but are not limited to, the following:

We have a history of losses and our future profitability is uncertain.

We will continue to require significant funding to maintain our current level of operations and fund the further development of our vaccine candidates.

Because our vaccine product development efforts depend on new and rapidly evolving technologies, we cannot be certain that our efforts will be successful.

The regulatory and commercial success of our COVID-19 vaccine candidate, NVX-CoV2373, remains uncertain. While we have received provisional registration, conditional marketing authorization, or emergency use authorization for NVX-CoV2373 in a number of jurisdictions, we may be unable to obtain regulatory approvals in the United States ("U.S.") or in any other jurisdiction or produce a successful vaccine in a timely manner, if at all.

We are a biotechnology company and face significant risk in developing, manufacturing, and commercializing our products.

Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products.

Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees.

There is significant competition in the development of a vaccine against COVID-19, influenza, and respiratory syncytial virus (“RSV”) and we may never see returns on the significant resources we are devoting to our vaccine candidates.

We may not succeed in obtaining the U.S. Food and Drug Administration (“FDA”) licensure or foreign regulatory approvals necessary to sell our vaccine candidates.

Our products might fail to meet their primary endpoints in clinical trials, meaning that we will not have the clinical data required to support regulatory obligations.

The regulatory pathway for NVX-CoV2373 is continually evolving, and may result in unexpected or unforeseen challenges.
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We have conducted, are conducting, and plan to conduct in the future, a number of clinical trials for NVX-CoV2373 at sites outside the U.S. and the FDA may not accept data from trials conducted in such locations.

The later discovery of previously unknown problems with a product, manufacturer, or facility may result in restrictions, including withdrawal of a vaccine that had previously received regulatory approval in certain jurisdictions from the market.

Our success depends on our ability to maintain the proprietary nature of our technology.

Our business may be adversely affected if we do not successfully execute our business development initiatives.

Servicing our 3.75% convertible senior unsecured notes due 2023 (the “Notes”) requires a significant amount of cash, and we may not have sufficient cash flow resources to pay our debt.

Because our stock price has been and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected.

Litigation could have a material adverse impact on our results of operation and financial condition.

We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies, such as the COVID-19 pandemic.
PART I
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Item 1.    BUSINESS

Overview

Novavax, Inc., together with our wholly-owned subsidiaries, Novavax AB and Novavax CZ, 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 nanoparticles designed to address urgent global health needs.

The vaccine candidates in our near-term pipeline, including both our coronavirus vaccine candidate (“NVX-CoV2373”) and our seasonal quadrivalent influenza vaccine candidate (“NanoFlu”), are genetically engineered, three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. NVX-CoV2373 has received provisional approval, conditional marketing authorization (“CMA”) and emergency use authorization (“EUA”) from multiple regulatory authorities globally. In January 2022, we also submitted a request to the U.S. Food and Drug Administration (“FDA”) for EUA of NVX-CoV2373. We also advanced our NanoFlu Program vaccine program through a Phase 3 clinical trial, which demonstrated positive top-line results and achieved statistical significance in key secondary endpoints. Additionally, we are exploring a number of combination vaccine candidates including a COVID-Influenza combination vaccine currently in a Phase 1/2 clinical trial. We believe that our protein-subunit-based candidates elicit differentiated immune responses that may be more efficacious than naturally occurring immunity or other vaccine approaches. These vaccine candidates incorporate our proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate higher levels of neutralizing antibodies.

We were incorporated in 1987 under the laws of the State of Delaware. Our principal executive offices are located at 21 Firstfield Road, Gaithersburg, Maryland, 20878, and our telephone number is (240) 268-2000. Our common stock is listed on the Nasdaq Global Select Market under the symbol “NVAX.”

NVX-CoV2373 Regulatory and Licensure

We have made substantial progress in advancing NVX-CoV2373 toward regulatory approvals. We have received several authorizations, which collectively have the potential to reach over six billion individuals, and we have completed additional regulatory submissions in other major markets. We are in active discussions with regulatory authorities and remain focused on seeking additional authorizations for NVX-CoV2373. We continue to work closely with governments, regulatory authorities, and non-governmental organizations in our commitment to facilitating equitable global access to our COVID-19 vaccine.

For the territories in which our vaccine has gained authorization, NVX-CoV2373 is marketed under the brand name of Covovax™ (manufacturing and commercialization by the Serum Institute of India Pvt. Ltd. (“SIIPL”)) or as Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]).

Through the date of filing this Annual Report on Form 10-K, the below is a summary of regulatory authorizations for NVX-CoV2373, the first protein-based COVID-19 vaccine to be approved for commercial use based on Phase 3 data:
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(1) Regulatory approval received in partnership with SIIPL

In February 2022, in partnership with SIIPL, the Directorate General of Drug Administration granted EUA for NVX-CoV2373 in Bangladesh, in individuals aged 18 years and older, which will be manufactured and marketed in India by SIIPL under the brand name CovovaxTM. Within the same month, Health Canada granted authorization for NVX-CoV2373 in individuals aged 18 years and older, to be marketed under Nuvaxovid™. The Singapore Health Authority also issued interim authorization for NVX-CoV2373 in individuals aged 18 years and older, to be marketed under Nuvaxovid™. New Zealand’s Medsafe granted provisional approval for NVX-CoV2373 in individuals aged 18 years and older, to be supplied to New Zealand under the brand name Nuvaxovid™. Additionally, in February 2022, the Medicines and Healthcare products Regulatory Agency (“MHRA”) in Great Britain granted CMA for NVX-CoV2373 in individuals aged 18 years and older, to be authorized for use in Great Britain marketed under the brand name Nuvaxovid™.

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In January 2022, the Australia’s Therapeutic Goods Administration (“TGA”) granted provisional registration for NVX-CoV2373 in individuals aged 18 years and older, to be supplied to Australia under the brand name Nuvaxovid™. Additionally, in January 2022, South Korea’s Ministry of Food and Drug Safety approved a Biologics License Application (“BLA”) from SK bioscience for NuvaxovidTM, to be manufactured and marketed in the country by SK bioscience.

In December 2021, the Ministry of Health Prevention granted EUA for NVX-CoV2373 in the United Arab Emirates (“UAE”) in individuals aged 18 years and older under the brand name Nuvaxovid™.

Additionally, in December 2021, in partnership with SIIPL, the Drugs Controller General of India granted EUA for NVX-CoV2373 in individuals aged 18 years and older, which will be manufactured and marketed in India by SIIPL under the brand name CovovaxTM. In the same month, the World Health Organization (“WHO”) granted EUL for NVX-CoV2373 to be manufactured and marketed by SIIPL as CovovaxTM. The WHO then granted a second EUL for NVX-CoV2373 to be marketed by us as NuvaxovidTM in Europe and other markets. This second EUL by the WHO followed the recommendation of the WHO Strategic Advisory Group of Experts on Immunization (“SAGE”) for a primary two-dose vaccination series of NVX-CoV2373 in persons aged 18 years and older and a third dose of NVX-CoV2373 administered to immunocompromised persons.

Within the same month, the European Commission (“EC”) granted CMA for NuvaxovidTM, in individuals aged 18 years and older, which prequalifies NVX-CoV2373 as meeting WHO standards for quality, safety and efficacy. The authorization follows the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use recommendation to authorize the vaccine and is applicable in all 27 European Union (E.U.) member states.

In November 2021, in partnership with SIIPL, we received EUA in individuals aged 18 years and older from the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Pengawas Obat dan Makanan. NVX-CoV2373 will be manufactured in India and marketed in Indonesia by SIIPL under the brand name CovovaxTM.

Additionally, in November 2021, in partnership with SIIPL, the Philippine Food and Drug Administration granted EUA for NVX-CoV2373 in individuals aged 18 years and older to be manufactured in India and marketed in the Philippines by SIIPL under the brand name CovovaxTM.

Below is a summary and status of our regulatory submissions completed through the date of filing this Annual Report on Form 10-K.
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(1) Regulatory filing submitted in partnership with SIIPL
(2) Regulatory filing submitted in partnership with Takeda Pharmaceutical Company Limited (“Takeda”)

In February 2022, we completed submission to Swissmedic, the Swiss Agency for Therapeutic Products for CMA for NVX-CoV2373.

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In January 2022, we completed submission to the FDA for EUA for NVX-CoV2373. This submission follows the December 2021 submission of the final data package including the complete chemistry, manufacturing, and controls module, to the U.S. FDA.

In January 2022, in partnership with SIIPL, we completed submission to the South African Health Products Regulatory Agency for EUA of NVX-CoV2373. If authorized, NVX-CoV2373 will be manufactured by and commercialized by SIIPL in South Africa under the brand name Covovax™.

In December 2021, our partner Takeda completed submission of a New Drug Application to the Ministry of Healthy, Labour and Welfare (“MHLW”) in Japan for NVX-CoV2373. With the support of the MHLW, the companies are working to establish the capability to manufacture TAK-019 at Takeda's facilities in Japan and aim to begin distribution in early 2022, pending regulatory approval.

Product Pipeline

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(1) Supported by funding from the U.S. government partnership formerly known as Operation Warp Speed (“OWS”), U.S. Department of Defense (“DoD”), Coalition for Epidemic Preparedness Innovations (“CEPI”), and Bill & Melinda Gates Foundation (“BMGF”).
(2) Authorized for provisional approval, CMA or EUA in select geographies under trade names CovovaxTM and NuvaxovidTM. Request submitted to the FDA for EUA. 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 United Kingdom (“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) Reflects malaria vaccine candidate (“R21”) created by the University of Oxford and formulated with Matrix-M adjuvant; Ongoing Phase 3 clinical trial in Africa; R21 is licensed to SIIPL; we will have commercial rights to sell and distribute R21 in certain countries, primarily in travelers' and military vaccine markets.

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Technology Overview

Recombinant Nanoparticle Vaccine Technology

Our recombinant nanoparticle vaccines combine the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic vaccines that target a variety of viral pathogens.

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 presentation results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M adjuvant. We believe our vaccine technology is well-suited for the development of additional vaccine candidates targeting a broad scope of respiratory and other emerging infectious diseases.

Matrix-M Adjuvant

Our proprietary Matrix-M™ adjuvant has been a key differentiator within our platform. This adjuvant has demonstrated potent and well-tolerated efficacy by stimulating the entry of antigen presenting cells (“APCs”) into the injection site and enhancing antigen presentation in local lymph nodes, which in turn activates APC cells, T-cells, and B-cell populations, thereby boosting immune response. Matrix-M™ adjuvant has been shown to produce a long-lasting memory response, through the production of plasma cells, memory B-cells, high affinity antibodies, and CD4+ T-cells. 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.

We continue to evaluate commercial opportunities for the use of our Matrix-M™ adjuvant alongside vaccine antigens produced by other manufacturers. Matrix-M™ is being evaluated in combination with several partner-led malaria vaccine candidates, including in a Phase 3 trial for R21, a malaria vaccine candidate created by the Jenner Institute, University of Oxford. The University of Oxford has partnered with SIIPL for commercial development of R21 and has granted SIIPL a license for R21. We expect to manufacture and supply the Matrix-M™ adjuvant component of R21 to SIIPL, which represents a significant commercial opportunity for our adjuvant, pending possible licensure. We have commercial rights to sell and distribute the SIIPL-manufactured R21 in certain countries, primarily in the travelers’ and military vaccine markets.

We are also supplying Matrix-M™ adjuvant for two Phase 1 clinical trials led by National Institutes of Health teams, focused on Epstein-Barr virus and Malaria transmission blocking.

Pipeline Overview

Our development pipeline encompasses vaccine candidates spanning multiple therapeutic areas, with our COVID-19 vaccine candidate, NVX-CoV2373, as the leading product candidate, which has received provisional registration, CMA, or EUA in a number of jurisdictions. We have also submitted a request to the FDA for EUA of NVX-CoV2373. Beyond COVID-19, our pipeline includes programs for seasonal influenza, a combination vaccine consisting of NanoFlu and NVX-CoV2373, RSV, and Matrix-MTM adjuvant collaborations for the treatment of malaria. 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 (“VoC”), while maintaining a favorable safety profile. We also advanced our NanoFlu Program through a Phase 3 clinical trial, which demonstrated positive top-line results and achieved statistical significance in key secondary endpoints. We initiated a trial of a combination vaccine consisting of our NanoFlu Program and NVX-CoV2373 and remain interested in further development of our RSV Program for respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”). Ongoing Phase 3 trials are being conducted for R21, a malaria candidate, by our partners, Jenner Institute, University of Oxford, which is formulated with our Matrix-M adjuvant.

We remain focused on bringing our NVX-CoV2373 vaccine candidate to market following global regulatory authorizations. Through ongoing booster studies in our clinical trials, as well as the development of COVID-19 variant strain vaccine candidates, we continue to collect data to characterize and improve vaccine performance. We expect to leverage these clinical insights to advance the use and additional regulatory approvals of our COVID-19 vaccine for both primary
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vaccination around the globe, to use within a booster setting, and for the pediatric population amidst the ongoing and evolving COVID-19 pandemic.

Although NVX-CoV2373 and our NanoFlu Program are our near-term priorities, we remain optimistic that the additional programs in our pipeline, including our RSV Program, and our partner-led malaria candidate, present strong opportunities for future development.

Coronavirus

NVX-CoV2373 Clinical Development

NVX-CoV2373 has progressed through multiple clinical trials, including two Phase 3 trials, one Phase 2b trial, and one Phase 1/2 trial. We have completed crossover arms in our Phase 3 UK, Phase 2b South Africa, PREVENT-19 Phase 3 U.S. and Mexico, and PREVENT-19 pediatric expansion trials. Through our clinical development program to date, we have established a dose of 5 micrograms of NVX-CoV2373 with Matrix-M adjuvant for late-stage development. We have collected data that indicates a reassuring safety profile and statistically significant levels of efficacy for NVX-CoV2373 against the original COVID-19 strain and commonly circulating VOC.

A summary and status of our clinical development of NVX-CoV2373 by trial is as follows:

PREVENT-19 Phase 3 U.S. and Mexico

PREVENT-19 was a randomized, placebo-controlled, observer-blinded Phase 3 trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in 29,960 participants aged 18 years or older across 119 sites in the U.S. and Mexico. Enrollment for PREVENT-19 emphasized recruiting high-risk groups most impacted by COVID-19.

In December 2021, the full results from the PREVENT-19 Phase 3 trial in the U.S. and Mexico were published in The New England Journal of Medicine. The analysis, previously announced in June 2021, was conducted on events accrued prior to participants receiving crossover vaccine. NVX-CoV2373 achieved 100% protection against moderate and severe disease, 92.6% efficacy against any VOC and variants of interest (“VOI”), and the primary endpoint of 90.4% efficacy against COVID-19 of any severity during the time period evaluated, despite the majority (79%) of the sequenced cases of illness being attributed to VOC and VOI. PREVENT-19 was conducted with support and funding from OWS.

In November 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) provided guidance stating that our PREVENT-19 participants from sites outside the U.S., as well as previously stated guidance stating participants from within the U.S., are considered fully vaccinated. In January 2022, we also submitted a request to the FDA for EUA of NVX-CoV2373.

PREVENT-19 Pediatric Expansion

In February 2022, we announced positive results from our Phase 3 PREVENT-19 pediatric expansion in adolescents aged 12 to 17, for which we completed enrollment in June 2021. The study results achieved their primary effectiveness endpoint and demonstrated 80% efficacy overall, with 82% clinical efficacy against the Delta (B.1.617.2) variant, as the trial was conducted when the Delta (B.1.617.2) variant was the predominant circulating strain in the U.S. Immune responses were two-to-three-fold higher in adolescents than in adults against all variants studied. NVX-CoV2373 was well-tolerated with no safety signals identified.

The study enrolled 2,247 adolescents across 73 sites in the U.S. to evaluate safety, effectiveness (immunogenicity), and efficacy, with an emphasis on ensuring well-balanced racial and ethnic representation among participants. Participants randomly received either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of participants received intramuscular injections of the vaccine and one-third received placebo. Participants are being monitored for safety for up to two years following the final administered dose.

We expect to submit our regulatory filing to global regulatory authorities during the first quarter of 2022. The subsequent pediatric clinical development plan has been agreed to by the FDA, the MHRA, and EMA and we expect to initiate additional studies globally evaluating younger age groups during the second quarter of 2022.

In December 2021, we announced initial data evaluating the immune response of NVX-CoV2373 against the Omicron (B.1.1.529) variant strain from our ongoing PREVENT-19 pediatric expansion. Data from this study showed immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern.
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Phase 3 UK

In February 2022, we announced extended analysis from our pivotal Phase 3 UK trial showing that a high level of efficacy for NVX-CoV2373 was maintained over a 6-month period of surveillance. The analysis showed vaccine efficacy of 82.5% in protection against all COVID-19 infection, both symptomatic and asymptomatic, as measured by PCR+ or anti-N seroconversion. NVX-CoV2373 showed a reassuring safety profile during over the 6-month period, with adverse events that were balanced between vaccine and placebo groups. Additionally, the trial demonstrated continued protection with an overall vaccine efficacy of 82.7% and vaccine efficacy against severe disease was 100% during the 6-month efficacy collection window, in line with the initial analysis.

This data builds upon the final analysis of our Phase 3 UK trial was published in The New England Journal of Medicine in June 2021. The publication of the final analysis highlights the robust safety and efficacy data for NVX-CoV2373. The final analysis confirmed 89.7% overall efficacy, with over 60% of the cases caused by the Alpha (B.1.1.7) variant strain. The analysis also confirmed 96.4% efficacy against non-Alpha (non-B.1.1.7) variant strains present at the time of the study, which represents strains most similar to the original COVID-19 virus. The trial was a randomized, observer-blinded, placebo-controlled study that enrolled 15,203 adults aged 18 to 84. The trial was conducted in partnership with the UK government Vaccines Taskforce (“VTF”) and led by researchers at St George’s, University of London, and St George’s Hospital, London.

In June 2021, the National Health Service (“NHS”), UK government VTF, and National Institute for Health Research determined participants in our Phase 3 UK trial may be considered fully vaccinated under the standard NHS program.

Phase 3 UK Influenza Co-Administration Sub-Study

In November 2021, positive results from our Phase 3 UK influenza co-administration sub-study, the first co-administration study of a SARS-CoV2 vaccine candidate and an approved influenza vaccine were published in The Lancet Respiratory Medicine. In the sub-study, with initial data announced in June 2021, 431 participants from our Phase 3 UK trial received an approved seasonal influenza vaccine (Seqirus, adjuvanted, trivalent seasonal influenza vaccine or a cell-based quadrivalent seasonal influenza vaccine). Approximately half of the participants in the study were co-vaccinated with NVX-CoV2373, while the remainder received placebo. Results demonstrated a robust immune response and a favorable safety and reactogenicity profile. Immunogenicity of the influenza vaccine was preserved with concomitant administration, while a modest decrease in the immunogenicity of NVX-CoV2373 was found. There was an adequate number of participants aged 18 to 64 years to confirm an efficacy trend of 87.5% against COVID-19. The co-administration sub-study represents the first study of a SARS-CoV-2 vaccine candidate and an approved influenza vaccine, and was led by researchers at St George’s, University of London and St George’s Hospital, London.

Phase 2b South Africa

In May 2021, results from the initial primary analysis of our Phase 2b South Africa trial were published in The New England Journal of Medicine. The publication of the initial primary analysis, which was previously announced in January 2021, highlights NVX-CoV2373’s cross-protection against the Beta (B.1.351) variant strain prevalent in South Africa during the study.

The Phase 2b South Africa trial was a randomized, observer-blinded, placebo-controlled study that enrolled 4,404 participants. Half of the trial participants received two intramuscular injections of NVX-CoV2373, administered 21 days apart, while the other half of the trial participants received placebo.

In the complete analysis announced in March 2021, NVX-CoV2373 demonstrated 55.4% efficacy for the prevention of mild, moderate, and severe COVID-19 disease in the 95% of the trial population that was HIV-negative. Overall efficacy, including both HIV-positive and HIV-negative participants, was 48.6% predominantly against the Beta (B.1.351) variant strain, with the complete analysis showing that NVX-CoV2373 achieved its primary efficacy endpoint in the overall trial population. During the efficacy analysis, the Beta (B.1.351) variant strain circulating in South Africa accounted for approximately 93% of sequenced cases in our Phase 2b trial. There were no cases of severe disease in the NVX-CoV2373 group, and all hospitalization and death occurred in the placebo group. This trial also showed that the vaccine is well-tolerated, with low levels of serious adverse events, or SAEs, through day 35, balanced between vaccine and placebo groups. CEPI funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial, which was also supported in part by a $15.0 million grant from BMGF.

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NVX-CoV2373 Clinical Development Conducted by Partners

Phase 2/3 India

SIIPL has expanded their Phase 2/3 clinical trial of NVX-CoV2373 in India to include a pediatric cohort. In the pediatric cohort, SIIPL has initiated recruitment of participants aged 2-17 years, with the intention of completing enrollment of 920 total participants. Previously, in April 2021, SIIPL completed enrollment of approximately 1,600 participants aged 18 years and older in their initial cohort. This study, which was initiated in March 2021, will evaluate the safety and immune response of NVX-CoV2373.

Phase 1/2 Japan

In March 2021, Takeda completed enrollment of a Phase 1/2 clinical trial of NVX-CoV2373 in Japan. This placebo-controlled trial will evaluate the immunogenicity and safety of NVX-CoV2373 in 200 participants aged 20 years and older. The interim clinical study report has been completed with the safety and immunogenicity data needed to support the Japan Pharmaceuticals and Medical Device Agency application. Participants are currently in their twelve-month safety follow-up.

Variant Strain (Monovalent and/or Bivalent) Vaccine Development

Our nanoparticle vaccine technology is purpose-built to rapidly address evolving infectious disease threats. As variants of COVID-19 emerge, we proactively evaluate NVX-CoV2373’s ability to protect against variant strains and evaluate the potential need for variant-specific vaccine constructs.

COVID-19 Omicron (B.1.1.529) Variant Strain Vaccine

In December 2021, we began development of an Omicron-specific vaccine construct of the SARS-CoV-2 Spike protein (rS) antigen, currently in use in NVX-CoV2373, and initiated GMP manufacturing. We expect delivery towards the end of the first quarter of 2022.

NVX-CoV2373 Booster Studies

PREVENT-19 Booster Study

In December 2021, we initiated PREVENT-19 Phase 3 trial booster study for NVX-CoV2373. The study will evaluate the safety the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373. All the PREVENT-19 trial participants are eligible to receive a third booster dose. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant Spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least six months after receipt of active vaccine. The primary endpoint is the first occurrence of polymerase chain reaction (PCR)-confirmed mild, moderate or severe COVID-19 with onset at least seven days after the third (booster) vaccine dose. Two additional groups will be evaluated in this portion of the trial. Trial participants who initially received placebo and subsequently received a different COVID-19 vaccine are also eligible for a booster dose of NVX-CoV2373. Participants who were unblinded after initially receiving active vaccine and did not subsequently receive another vaccine will also be eligible to be boosted with NVX-CoV2373.

Phase 2 U.S. and Australia Booster Study - Including Omicron (B.1.1.529) Variant Results

In December 2021, we announced initial data evaluating the immune response of NVX-CoV2373 against the Omicron (B.1.1.529) variant strain as well as additional data from our ongoing Phase 2 booster study. These results demonstrated broad cross-reactivity against the Omicron variant and other circulating variants for primary 2-dose regimen, with enhanced responses following a third dose at six months. The third dose produced increased immune responses to the Omicron (B.1.1.529) variant strain comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold increase in hACE2 inhibition increase after booster dose. Data from this study are available ahead of publication via the preprint server for biology on medRxiv.

In September 2021, we initiated a twelve-month booster dose for select participants in the Phase 2 portion of our U.S. and Australia Phase 1/2 trial. Select participants received a fourth 5 microgram dose at twelve months to examine the immune responses produced by our vaccine candidate.

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In August 2021, we announced data from our six-month booster study in the Phase 2 portion of our U.S. and Australia Phase 1/2 trial, which we initiated in March 2021. Select participants in the 5 microgram dose cohort received a third 5 microgram dose (booster dose) at six months to examine the immune responses of our vaccine candidate. Analysis of sera from primary vaccination series notably showed cross-reactive, functional antibodies to Alpha (B.1.1.7), Beta (B.1.351) and Delta (B.1.617.2) variant spike proteins, all of which increased 6- to 10-fold with the booster dose.

NVX-CoV2373: Partner-Led Vaccine Mix and Match Clinical Study

Mix-and-Match COVID-19 Vaccine Booster Trial ("Cov-Boost") – Led by University Hospital Southampton NHS

In December 2021, the UK government VTF announced top-line data from the heterologous boosting, Phase 2 Cov-Boost study published in The Lancet from the University Hospital Southampton NHS Foundation Trust. NVX-CoV2373 was one of seven COVID-19 vaccines studied for the potential to provide a booster dose from a different manufacturer for individuals who previously received two doses of an authorized vaccine. The results demonstrated that administration of NVX-CoV2373 among other studied COVID-19 vaccines, resulted in substantial increases in functional antibody titers when given as a third dose in two heterologous vaccination regiments. This study reinforces our confidence in the potential for NVX-CoV2373 to serve as a well-tolerated third dose to boost immune levels and provide broad protection against disease without a burdensome side effect profile.
The trial, which was initiated in June 2021, completed enrollment in July of 2,886 participants aged 30 years and older. NVX-CoV2373 is one of seven COVID-19 vaccines evaluating the potential for providing a booster dose from different manufacturers to individuals who have previously received two doses of an authorized vaccine. The trial assesses the safety and immune response against COVID-19 provided by the various vaccine schedules. The trial is led by the University Hospital Southampton NHS Foundation Trust and other UK National Institute for Health Research sites. Cov-Boost is receiving support from the UK government VTF and Department of Health and Social Care.

COVID-19 Vaccine Funding

We have secured critical funding to support the development of NVX-CoV2373. Through the date of filing this Annual Report on Form 10-K, funding for NVX-CoV2373 encompasses over $2 billion from sources including CEPI, DoD, and OWS.

In April 2021, our Base Agreement and a Project Agreement (together, as amended and supplemented, the “OWS Agreement”) entered into with Advanced Technology International, Inc., the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with OWS, was amended to fully fund the agreement up to $1.75 billion to support certain activities related to the development of NVX-CoV2373. This includes the manufacture and delivery of 100 million doses of NVX-CoV2373 to the U.S. government. We expect this funding will assist in rapidly developing our large-scale manufacturing capacity and transitioning into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 for use in clinical trials and for commercial sale. The OWS Agreement is funding the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including PREVENT-19. Funding under the OWS Agreement supported our file submission for EUA with the FDA and is expected to support our plans to submit a BLA with the FDA. Accepted analytical methods that we can use to demonstrate our vaccine’s purity, potency, and consistent lot manufacturing are critical to attaining licensure in all the territories we intend to sell our vaccine. In the U.S., these analytical methods will be reviewed and approved by the FDA. As of December 31, 2021, the Company's OWS agreement was amended to increase the contract ceiling by $52.9 million for a revised total of $1.8 billion. The agreement’s authorized funding and scope remains unchanged at $1.75 billion for support of certain activities related to the development of NVX-CoV2373 and the manufacture and delivery of 100 million doses of the vaccine candidate to the U.S. government. The Company and the U.S. government will determine the timing and amounts for delivery of NVX-CoV2373 doses upon U.S authorization and the Company intends to pursue additional U.S. procurement agreements for supply of NVX-CoV2373 doses. In July 2021, the U.S. government instructed us to prioritize alignment with the FDA on our analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made. The U.S. government also instructed us to proceed with work under the OWS Agreement related to all other activities including ongoing clinical trials and nonclinical studies, regulatory interactions, analytics/assays, and characterization of manufactured vaccine and project management. In October 2021 and January 2022, the U.S. government extended the prescribed time to meet its July 2021 instructions until April 2022.

In February 2022, the Company’s Project Agreement with ATI was modified to include a Phase 3 efficacy study with respect to 2019n-CoV-301 in adolescents with a booster component and accordingly, the performance period under the Project Agreement was extended to December 31, 2023.

A summary and status of our historical COVID-19 funding developments follows:
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Seasonal Influenza

NanoFlu Program (Older Adults)

Influenza is a world-wide infectious disease with serious illness generally occurring in more susceptible populations such as children under and older adults, but also occurring in the general population. According to a 2021 Fortune Business Insights research report forecast of influenza vaccines, the market for seasonal influenza vaccines is expected to grow from approximately $6.6 billion in 2021 to approximately $10.73 billion in 2028.

In September 2021, the final analysis of the primary endpoint of our pivotal Phase 3 clinical trial for the NanoFlu Program was published in The Lancet Infectious Diseases. We previously announced that the NanoFlu Program achieved the trial’s primary endpoints, demonstrating non-inferior immunogenicity to Fluzone® Quadrivalent against all four influenza virus strains included in the vaccine, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous strains (22-66% increased) and six heterologous A/H3N2 strains (34-46% increased) as compared to Fluzone® Quadrivalent. Additionally, the NanoFlu Program showed potent induction of polyfunctional antigen-specific CD4+ T-cells against A(H3N2) and B/Victoria strains, with a 126–189% increase in various post vaccination cell-mediated immunity markers as compared to Fluzone® Quadrivalent.

Combination Vaccines

Our NanoFlu Program team remains focused on advancing combination vaccine candidates. With the ongoing development of NanoFlu Program, NVX-CoV2373, and our RSV Program, a strong rationale exists for developing combination respiratory vaccines designed to protect susceptible populations against these diseases.

COVID / Influenza Combination Vaccine

Phase 1/2 Clinical Trial of COVID-Influenza Combination Vaccine

In October 2021, we completed enrollment of our Phase 1/2 study in Australia, which we initiated in September 2021. The trial enrolled 642 healthy adults aged 50 to 70 years across 10 sites and will evaluate the safety, tolerability and immune response of a combination vaccine using NanoFlu Program and NVX-CoV2373, combined with our Matrix-M™ adjuvant. Participants have been either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through an authorized vaccine at least eight weeks prior to enrollment. All participants will be randomly assigned to cohorts to evaluate multiple formulations and will be administered doses on Day 0 and again at Day 56. Data from this Phase 1/2 trial are expected in the second quarter of 2022. Data from this Phase 1/2 trial are expected in April of 2022. We expect to initiate a Phase 2 clinical trial for the COVID-Influenza combination vaccine and NanoFlu Program as a standalone vaccine in the second half of 2022.

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In May 2021, we announced data from a preclinical study of qNIV/CoV2373 to assess its immunogenicity and protective efficacy in animal models. Preclinical data from this study showed that qNIV/CoV2373 induced functional influenza and COVID-19 antibody responses, with hemagglutination inhibition and ACE2 receptor-inhibiting titers that were comparable between immunization with the combination vaccine and with its respective component vaccines. qNIV/CoV2373 also induced elevated levels of SARS-CoV-2 anti-S IgG two weeks after the first immunization, which increased significantly after the second dose, with levels comparable to animals that received NVX-CoV2373 alone. Human ACE2 receptor inhibiting antibody levels responded similarly. qNIV/CoV2373 also induced antibodies against SARS-CoV-2 neutralizing epitopes that are common between the original COVID-19 strain and the Beta (B.1.351) variant strain. When challenged with SARS-CoV-2, examination of viral load in the upper and lower respiratory tract showed little or no virus was detected four days after infection in animals immunized with either qNIV/CoV2373 or with NVX-CoV2373 alone. Data from this study are available ahead of publication via the preprint server for biology on bioRxiv.

Respiratory Syncytial Virus ("RSV")

Currently, there is no approved RSV vaccine available to combat the estimated 64 million RSV infections that occur globally each year. Older adults (60 years and older) are at increased risk for RSV disease due in part to immunosenescence, the age-related decline in the human immune system. RSV infection can also lead to exacerbation of underlying co-morbidities such as chronic obstructive pulmonary disease, asthma and congestive heart failure.

RSV Program (Older Adults)

Previous clinical development through a Phase 2 clinical trial demonstrated that our RSV Program for older adults with either aluminum phosphate or our proprietary Matrix-MTM adjuvant increased the magnitude, duration and quality of the immune response versus the non-adjuvanted RSV F Vaccine. We continue to assess the development opportunities for our RSV Program for older adults.

Malaria

Malaria is a life-threatening disease caused by a parasite that infects mosquitos subsequently transmitted to humans. According to the 2021 WHO World Malaria Report, in 2020, there was an estimated 241 million malaria cases and 627 thousand deaths worldwide in 2020. We believe malaria has the potential to be preventable through the R21 vaccine candidate, which is being developed through several partner-led trials and is formulated with our Matrix-MTM adjuvant.

R21 - Malaria Vaccine

R21 is a malaria vaccine candidate created by the Jenner Institute, University of Oxford, and formulated with our Matrix-M adjuvant. The University of Oxford has granted SIIPL a license for R21. We expect to manufacture and supply the Matrix-M adjuvant component of R21 to SIIPL. SIIPL has committed to manufacture at least 200 million doses per year of R21 after licensure, if granted. Additionally, SIIPL has rights to use Matrix-M adjuvant in R21 in regions where the disease is endemic and will pay royalties to us on its market sales of the vaccine. We will have commercial rights to sell and distribute the SIIPL-manufactured R21 in certain countries, primarily in the travelers’ and military vaccine markets.

R21 Clinical Development

R21 is currently being evaluated in a Phase 3 licensure trial initiated in May 2021. Data from this trial are expected in the second half of 2022. Previously, in April 2021, data from the Phase 2b trial evaluating R21 was published in The Lancet, demonstrating 77% efficacy when formulated with 50 micrograms of Matrix-MTM adjuvant and 71% efficacy when formulated with 25 micrograms of Matrix-MTM adjuvant. Both adjuvant dose levels were well tolerated in young children, with no severe reactions to R21 reported.

Advance Purchase Agreements (“APA”)

We have entered into APAs (also referred to as “supply agreements” throughout this Annual Report on Form 10-K) with Gavi, the Vaccine Alliance (“Gavi”), the EC, and various countries globally. The APAs 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. Such upfront payments generally become non-refundable upon our achievement of certain development milestones. We expect to sign additional APAs that are currently in active discussions and negotiations.

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A summary of our APAs follows:

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(1) The APA includes an option to order additional doses as may be required from time to time.

Under the terms of our APA with Gavi, 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. We expect to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility. Under a separate purchase agreement with Gavi, SIIPL is expected to manufacture and deliver the balance of the 1.1 billion doses of NVX-CoV2373 for low- and middle-income countries participating in the COVAX Facility. We expect to deliver doses with antigen and Matrix-MTM adjuvant manufactured at facilities directly funded by the investments previously received from CEPI (the “CEPI Funding Agreement”). We expect to supply significant doses that Gavi would allocate to low-, middle-, and high-income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi may prioritize such doses to low- and middle-income countries at lower prices. Additionally, we may provide additional doses of NVX-CoV2373, to the extent available from CEPI-funded manufacturing facilities, in the event that SIIPL cannot materially deliver expected vaccine doses to the COVAX Facility. Together with SIIPL, we expect to initiate delivery of doses following receipt of appropriate regulatory authorizations. Under the agreement, we received an upfront payment from Gavi of $350 million in 2021 and recorded a receivable as of December 31, 2021, for an additional payment of $350 million because we secured EUL for NVX-CoV2373 from the WHO in December 2021.

Under the terms of our APA with the EC, acting on behalf of various E.U. member states, we are committed 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 through 2023. We have received orders for 69 million doses under this agreement.

License and Collaboration
Our commitment to partnering globally in efforts to end the COVID-19 pandemic is demonstrated through our partnership with SIIPL to supply NVX-CoV2373 to India and low- and middle-income countries. In August 2020, we expanded upon our manufacturing and supply capabilities to include partnerships with both Takeda in Japan and SK bioscience in South Korea and furthered these collaborations in February and December 2021. These additional partnerships will increase our production capacity and are expected to support a rapid roll-out of NVX-CoV2373 globally.
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(1) Geographies pending regulatory authorizations and not yet authorized under the brand name
(2) SK bioscience received non-exclusive licenses in Thailand and Vietnam
A summary of our license and collaboration agreements follows:

SIIPL

In July 2020, we entered into a supply and license agreement with SIIPL, which was amended in September 2020 and amended and restated in July 2021, under which we granted exclusive and non-exclusive licenses to SIIPL for the development, co-formulation, filling and finishing, registration, and commercialization of NVX-CoV2373. SIIPL agreed to purchase our Matrix-MTM adjuvant and we 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. We will equally split the revenue from SIIPL's sale of NVX-CoV2373 in its licensed territory, net of agreed costs. We granted to SIIPL (i) an exclusive license in India during the agreement, and (ii) a non-exclusive license (a) during the “Pandemic Period” (as declared by the World Health Organization), in all countries other than specified countries designated by the World Bank as upper-middle or high-income countries, with respect to which we retains rights, and (b) after the Pandemic Period, in only those countries designated as low or middle-income by the World Bank. Following the Pandemic Period, we may notify SIIPL of any bona fide opportunities for us to license NVX-CoV2373 to a third party in such low and middle-income countries and SIIPL would have an opportunity to match or improve such third-party terms, failing which, we would have the discretion to remove one or more non-exclusive countries from SIIPL’s license. In October 2021, we entered into a supply agreement and a contract development manufacturing agreement with SIIPL and Serum Life Sciences Limited (“SLS”) under which SIIPL and SLS will supply us with NVX-CoV2373 for commercialization and sale in certain territories.

Takeda

In February 2021, we finalized a collaboration and license agreement with Takeda under which we granted Takeda an exclusive license to develop, manufacture and commercialize NVX-CoV2373 in Japan. Under the agreement, Takeda purchases Matrix-M™ adjuvant from us to manufacture doses of finished NVX-CoV2373 and we are 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 September 2021, Takeda finalized an agreement with MHLW for the purchase of 150 million doses of NVX-CoV2373. The announcement followed an update from MHLW on its ongoing efforts to secure coronavirus vaccine for the citizens of Japan. These efforts include vaccine procurement by Takeda pursuant to the terms of the collaboration and license agreement we entered into with Takeda in February 2021. Distribution of our vaccine in Japan by Takeda is expected to begin in 2022, pending regulatory approval. Takeda anticipates the capacity to manufacture 150 million doses of NVX-CoV2373 per year.

SK bioscience

In February 2021, we finalized an expanded collaboration and license agreement with SK bioscience to manufacture and commercialize NVX-CoV2373 for sale to the government of Korea. Concurrently, SK bioscience finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021. Our agreement is in addition to our existing manufacturing arrangement with SK bioscience entered into in August 2020. Under the collaboration agreement, SK bioscience was granted an exclusive license to develop, manufacture, and commercialize NVX-CoV2373 in the Republic of Korea. SK bioscience will pay a tiered royalty in the low to middle double-digit range on the sale of NVX-CoV2373 in the Republic of Korea. In May 2021, we entered a non-binding
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Memorandum of Understanding (“MOU”) with the Ministry of Health and Welfare of Korea and SK bioscience to explore further cooperation in the development and manufacturing of vaccines, including NVX-CoV2373 and to potentially explore the development of new vaccine products with SK bioscience, including COVID-19 variant vaccines and/or an influenza/COVID-19 combination vaccine. In December 2021, we amended the collaboration and license agreement to grant a non-exclusive license to cover Thailand and Vietnam, subject to a low to middle double-digit royalty, and for SK biosciences to supply the antigen component of NVX-CoV2373 to us for use in the final drug product globally, including product distributed by the COVAX Facility.

Manufacturing and Supply
We are committed to discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases and are exploring a number of combination vaccine candidates, including a COVID-influenza combination vaccine directly and by leveraging our strategic global partnerships. In 2021 and 2020, we established a global supply chain to support the commercialization of NVX-CoV2373. The acquisition of Novavax CZ (formerly Praha Vaccines, a.s.) in the Czech Republic in May 2020 demonstrated the Company’s first major step toward building out our global manufacturing capabilities. Since May 2020, we have established partnerships worldwide to amplify and solidify our global reach.

To date, we have increased our projected global manufacturing production rate of NVX-CoV2373 to be over two billion annualized doses when we are at full capacity. Of this anticipated capacity, approximately one billion doses will be manufactured by SIIPL.

A summary of our key manufacturing and supply arrangements follows:
Matrix-MTM Adjuvant
We manufacture our proprietary saponin-based Matrix-M™ adjuvant at our Novavax AB facility in Uppsala, Sweden.
In June 2020, we entered into contract manufacturing arrangements with AGC Biologics and the Polypeptide Group to provide contract development and manufacturing services, supplying us with large-scale production of Matrix-M™ adjuvant.
Antigen Component of NVX-CoV2373
In October 2021, we entered into a supply agreement with SIIPL and SLS, an affiliate of SIIPL, for the manufacture of NVX-CoV2373. In October 2021, we also entered into a contract development manufacture agreement with SLS, where SLS will manufacture and supply finished vaccine product to us using antigen drug substance and Matrix-M™ adjuvant supplied by us.
In October 2021, we entered into a contract manufacturing agreement with Mabion S.A. (“Mabion”) for the large-scale manufacturing of NVX-CoV2373 through 2026. This agreement follows the successful completion of technology transfer to Mabion for antigen production of NVX-CoV2373. We are scaling up manufacturing of NVX-CoV2373 at Mabion’s Good Manufacturing Practice-certified facility located near Warsaw, Poland.
In August 2021, we extended our partnership with FUJIFILM Diosynth Biotechnologies through an agreement for long-term commercial manufacturing of NVX-CoV2373 through 2025. Under this agreement, FUJIFILM Diosynth Biotechnologies has continued to manufacture the antigen component of NVX-CoV2373 at its sites in Morrisville, North Carolina, College Station, Texas, and Billingham, UK. This development follows a previous manufacturing agreement with FUJIFILM Diosynth Biotechnologies, which we entered into in July 2020.
In June 2021, we announced the completion of construction of the National Research Council of Canada’s Biologics Manufacturing Centre and ongoing technology transfer for the production of NVX-CoV2373. Technology transfer to establish a step-by-step process of producing NVX-CoV2373 at the Biologics Manufacturing Centre began in April 2021 following a collaboration agreement entered into with the National Research Council of Canada in March 2021. These developments build upon a MOU entered into in February 2021 with the Canadian government to produce NVX-CoV2373 at
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the Biologics Manufacturing Centre in Canada. Large-scale GMP production is expected to begin once the facility has received Health Canada approval.
Pursuant to our APA with Gavi, we have licensed our NVX-CoV2373 technology to SIIPL and are jointly committed with SIIPL to deliver the 1.1 billion doses to the COVAX Facility. We expect to supply doses to Gavi utilizing a tiered pricing schedule.
In July 2020, we announced a manufacturing agreement with FDB allowing for the large-scale contract production of NVX-CoV2373 in connection with our OWS Agreement, beginning at FDB’s North Carolina facility.

Competition in COVID-19, Influenza, and RSV

The vaccine market is intensely competitive, characterized by rapid technological progress. Our technology is based upon utilizing the baculovirus expression system in insect cells to make recombinant vaccines. Our Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. We believe this baculovirus expression system offers many advantages when compared to other technologies and is uniquely well-suited for developing COVID-19, influenza, and RSV vaccines, as well as vaccines against a number of other infectious diseases.

A number of vaccine manufacturers, research institutions, and other organizations are developing a vaccine for SARS-CoV-2, the virus that causes COVID-19 disease. A variety of different vaccine technologies are being studied, including nucleic acid (RNA/DNA), viral vectors, live attenuated or inactivated, and protein-based vaccines. According to a coronavirus vaccine tracker published by The New York Times, updated as of February 23, 2022, there are 115 vaccines in clinical trials and 49 have reached the final stages of testing. As of January 2022, Novavax is one of five manufacturers that have a COVID-19 vaccine that has received Conditional Marketing Authorization by the EMA in the European Union, with the other manufacturers being Pfizer, Moderna, Johnson & Johnson and AstraZeneca. As of January 2022, Pfizer has received BLA approval and Moderna and Johnson & Johnson have each received EUA by the FDA in the U.S for their COVID-19 vaccines. As of January 2022, we submitted for EUA by the FDA for NVX-CoV2373, marking the first protein-based COVID-19 vaccine filing. Based on NVX-CoV2373’s high efficacy against both the original and variant strains and its well-tolerated profile demonstrated in clinical trials, including two pivotal Phase 3 trials in the U.K. and U.S., we believe our vaccine candidate will play an important role in addressing this global public health crisis.

A number of companies are developing and selling vaccines for seasonal influenza employing both traditional (egg-based) and new vaccine technologies (cell-based). Many seasonal influenza vaccines are currently approved and marketed, and most of these are marketed by major pharmaceutical companies such as Sanofi Pasteur, GSK and Seqirus. Competition in the sale of seasonal influenza vaccines is intense. For the older adult segment, Sanofi currently supplies Fluzone-HD® and Flublok® to the majority of older adults in the U.S. Therefore, newly developed and approved products must be differentiated from existing vaccines in order to have commercial success. In order to show differentiation in the seasonal influenza market, a product may need to be more efficacious and/or be less expensive and quicker to manufacture, all while still showing a comparable or improved tolerability profile. Many of our competitors are working on new products and new generations of current products, some by adding an adjuvant that is used to increase the immunogenicity of that product, each of which is intended to be more efficacious than currently marketed products. Several competitors are working on developing seasonal influenza vaccines using different technologies than those in existing marketed vaccines, the most notable being mRNA. Despite the significant competition and advancing technologies, based on our completed Phase 3 trial results, we believe that NanoFlu Program, our adjuvanted nanoparticle seasonal influenza product could be as efficacious as, or more so than, current products or products being developed by our competitors.

There is currently no approved RSV vaccine for sale in the world; however, a number of vaccine manufacturers, academic institutions and other organizations currently have, or have had, programs to develop such a vaccine. These groups are developing products to prevent disease caused by RSV using a variety of technology platforms, including viral vectors, nucleic acid (RNA/DNA), live attenuated chimeric, antigens or monoclonal antibodies (“Mab”) and competitive recombinant technologies. We continue to believe that our RSV F Vaccine candidate, which is a recombinant prefusogenic F-protein nanoparticle, is likely to be as effective as other RSV vaccine candidates or other products in development by our competitors. At this time, there are a number of companies and other organizations with vaccine candidates in late-stage clinical trials. In older adults, GSK, Pfizer, and Janssen are in Phase 3 trials. GSK and Pfizer both are in Phase 3 trials for infants via maternal immunization. Additionally, both the AstraZeneca / Sanofi partnered monoclonal antibody and Merck monoclonal antibody are in Phase 3 trials in infants.

In general, competition among pharmaceutical products is based in part on product efficacy, safety, reliability, availability, price and patent position. An important factor is the relative timing of the market introduction of our products and our competitors’ products. Accordingly, the speed with which we can develop products, complete the clinical trials and
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approval processes and supply commercial quantities of the products to the market is an important competitive factor. Our competitive position also may depend upon our ability to show differentiation with a product that is more efficacious and/or less expensive and quicker to manufacture. Other factors affecting our competitive position include our ability to attract and retain qualified personnel, obtain patent protection or otherwise develop proprietary products or processes and secure sufficient capital resources for the lengthy period between technological conception and commercial sale.
Patents and Proprietary Rights
We generally seek patent protection for our technology and product candidates in the U.S. and abroad. The patent position of biotechnology and pharmaceutical firms generally is highly uncertain and involves complex legal and factual questions. Our success will depend, in part, on whether we can:
obtain patents to protect our own technologies and product candidates;
obtain licenses to use the technologies of third-parties, which may be protected by patents;
protect our trade secrets and know-how; and
operate without infringing the intellectual property and proprietary rights of others.
Patent Rights; Licenses.
We have intellectual property (patents, licenses, know-how) related to our vaccines, manufacturing processes and other technologies. Currently, we have or have rights to over 550 U.S. and foreign patents and patent applications relating to vaccines and vaccine-related technologies.
Patents related to our Virus-Like Particle (“VLP”) program include U.S. Patent No. 7,763,450, which covers, in part, the use of influenza gene sequences for high-yield production of consistent influenza VLP vaccines to protect against current and future seasonal and pandemic strains of influenza viruses. Corresponding European patent, European Patent No. 1644037 also covers this technology. U.S. Patent Nos. 8,080,255, 8,551,756, 8,506,967 and 8,592,197 are directed to methods of producing VLPs and inducing substantial immunity to an influenza virus infection by administering VLPs comprising HA and NA proteins, and our M1 protein derived from the avian influenza strain, A/Indonesia/5/05. Certain claims also encompass similar methods and compositions where the M1 protein is from a different strain of influenza virus than the influenza HA protein and the influenza NA protein. Related patent protection in Europe is provided by European Patent No. 2343084, which covers, in part, vaccine compositions containing VLPs that contain M1, HA, and NA proteins. Our VLP patent portfolio contains many other patents, including U.S. Patent Nos. 8,951,537, 8,992,939, 9,144,607, 9,050,290, 9,180,180, 9,381,239, 9,464,276, 9,474,799, and other patents in multiple ex-U.S. jurisdictions.
We also have been issued patents directed to other core programs, including our RSV and influenza programs. Issued patents directed to various aspects of the RSV program include U.S. Patent Nos. 8,715,692, 9,675,685, 9,731,000, 9,717,786, 10,022,437, and 10,426,829. Additional patents in the family include EP237009 in Europe, as well as others throughout the world. Patents related to our rabies program include 9,724,405 and 10,086,065 in the U.S., and EP2635257 and EP3246019 in Europe. Related patents have been issued in other world markets. Issued patents in our influenza nanoparticle program include US Patent No. 10,426,829. In addition to our focus on vaccine programs, we also pursue patent protection for our Matrix Adjuvant program. Issued U.S. Patent Nos. 7,838,019, 9,205,147, 9,901,634, 8,821,881, and 10,729,764 provide examples of patents related to our Matrix Adjuvant program.
We pursue patents related to NVX-CoV2373, our COVID-19 vaccine candidate. Our applications include PCT/US2021/015220 and U.S. Serial No. 16,997,001, which the U.S Patent Office has allowed.
We continue to prepare, file, and prosecute patent applications to provide broad and strong protection of our proprietary rights, including next generation applications focused on our RSV Program, our influenza nanoparticle program, and our adjuvant program.
The Federal Technology Transfer Act of 1986 and related statutory guidance encourages the dissemination of science and technology innovation. While our expired contract with the U.S. Department of Health and Human Services, (“DHHS”), Biomedical Advanced Research and Development Authority (“HHS BARDA”) provided us with the right to retain ownership in our inventions that may have arisen during performance of that contract, with respect to certain other collaborative research efforts with the U.S. government, certain developments and results that may have commercial potential are to be freely published, not treated as confidential, and we may be required to negotiate a license to developments and results in order to commercialize products. There can be no assurance that we will be able to successfully obtain any such license at a reasonable cost, or that such development and results will not be made available to our competitors on an exclusive or non-exclusive basis.
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Trade Secrets
We also rely significantly on trade secret protection and confidentiality agreements to protect our interests. It is our policy to require employees, consultants, contractors, manufacturers, collaborators and other advisors to execute confidentiality agreements upon the commencement of employment, consulting or collaborative relationships with us. We also require confidentiality agreements from any entity that is to receive confidential information from us. With respect to employees, consultants and contractors, the agreements generally provide that all inventions made by the individual while rendering services to us shall be assigned to us as our property.
Government Regulations
The development, production and marketing of biological products, which include the vaccine candidates being developed by Novavax or our collaborators, are subject to regulation for safety, efficacy and quality by numerous governmental authorities in the U.S. and other countries. Although we focus on the U.S. regulatory process and the standards imposed by the FDA, the International Conference on Harmonisation (“ICH”) and other agencies because we believe meeting U.S. and ICH standards generally allows us to satisfy regulatory agencies in other countries where we intend to do business; however, we are mindful that expectations in some venues, notably in the European Union and the United Kingdom (in relation to Great Britain), differ to some degree and we take proactive steps to address such differences by maintaining regular filings and correspondence and attending regular meetings with many other non-U.S. regulatory agencies. In the U.S., the development, manufacturing and marketing of human pharmaceuticals and vaccines are subject to extensive regulation under the Federal Food, Drug, and Cosmetic Act, and biological products are subject to regulation under provisions of that act and the Public Health Service Act. The FDA not only assesses the safety and efficacy of these products but it also regulates, among other things, the testing, manufacture, labeling, storage, record-keeping, advertising and promotion of such products. The process of obtaining FDA licensure for a new vaccine is costly and time-consuming.
Vaccine clinical development in most countries follows the same general regulatory pathway as drugs and other biologics. Before applying for FDA licensure to market any new vaccine candidate, we expect to first submit an investigational new drug application (“IND”) that explains to the FDA, among other things, the results of preclinical toxicology testing conducted in laboratory animals, the method of manufacture, quality control tests for release, the stability of the investigational product and what we propose to do for human testing. At this stage, the FDA decides whether it is reasonably safe to move forward with testing the vaccine candidate in humans. We must then conduct Phase 1 clinical trials and larger-scale Phase 2 and 3 clinical trials that demonstrate the safety, immunogenicity and efficacy of our vaccine candidate to the satisfaction of the FDA. Following successful completion of all three phases of clinical development, a BLA can be submitted to the FDA requesting licensure of the vaccine for marketing based on the vaccine’s safety and efficacy. Similar pathways exist in Europe and other geographies.
The FDA will only approve a BLA if the vaccine is demonstrated to be safe, pure and potent. During the FDA’s review of a BLA, the proposed manufacturing facility undergoes a pre-approval inspection during which the FDA examines in detail the production of the vaccine, the manufacturing facility and the quality documentation related to the vaccine. Vaccine licensure also requires the provision of adequate product labeling to allow health care providers to understand the vaccine’s proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public. Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, the FDA typically requires Phase 4 post-marketing clinical trials for vaccines after licensure to continue gathering safety, and sometimes effectiveness/efficacy data in the indicated and additional populations.
The Commissioner of the FDA may, under delegated authority from the Secretary of the DHHS, and under certain circumstances, issue an EUA, that would permit the use of an unapproved medical product or unapproved use of an approved medical product to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. When issuing an EUA, the FDA imposes conditions of authorization, with which the EUA holder must comply. Such conditions include, but may not be limited to, compliance with labeling, distribution of materials designed to ensure proper use, reporting obligations, and restrictions on advertising and promotion. The EUA is only effective for the duration of the public health emergency. The FDA may also revise or revoke the EUA sooner if, the criteria for issuance are no longer met or other circumstances make a revision or revocation appropriate to protect the public health or safety. For example, an EUA may be revoked when the FDA determines that the underlying public health emergency no longer exists or warrants such authorization, or for reasons such as significant adverse inspectional findings, reports of adverse events linked to or suspected of being caused by the EUA product, or newly emerging data that may demonstrate the product may not be effective.
In order to ensure continuing safety, the FDA and most other non-U.S. based regulatory agencies continue to oversee the production of vaccines even after the vaccine and manufacturing processes are approved. For example, monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. Manufacturers may also be required to submit the results of their own tests for
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potency, safety and purity for each vaccine lot, if requested by the relevant regulatory agency. They may also be required to submit samples of each vaccine lot to the agency for testing.
In addition to obtaining FDA licensure for each product, each domestic manufacturing establishment must be registered with the FDA, is subject to FDA inspection and must comply with current Good Manufacturing Practices (“GMP”) regulations. To supply products for use either in the U.S. or outside the U.S., including clinical trials, U.S. and foreign manufacturing establishments, including third-party facilities, must comply with GMP regulations and are subject to periodic inspection by the FDA or by corresponding regulatory agencies in their home country.
The EU and the U.K. similarly provide a faster means to achieve approval by offering conditional marketing authorizations which are granted with the proviso of obtaining additional data to eventually become unconditional, but which allow authorization to be granted earlier albeit with a more limited set of clinical data.
The FDA has several programs designed to expedite the development and approval of drugs and biological products intended to treat serious or life-threatening diseases or conditions, including fast track designation, breakthrough therapy designation, priority review designation, and accelerated approval. First, the FDA may designate a product for Fast Track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for such a disease or condition. For Fast Track products, sponsors may have more frequent interactions with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete. The FDA granted Fast Track Designation for NVX-CoV2373 in November 2020 and for NanoFlu, our recombinant quadrivalent seasonal influenza vaccine candidate, in January 2020.
Second, a product may be designated as a Breakthrough Therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The FDA may hold meetings with the sponsor throughout the development process; provide timely advice to the product sponsor regarding development and approval; involve more senior staff in the review process; assign a cross-disciplinary project lead for the review team; and take other steps to design the clinical trials in an efficient manner.

Third, the FDA may designate a product for priority review if it is a product that treats a serious disease or life-threatening condition and, if approved, would provide a significant improvement in safety or effectiveness over available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and, for a drug product (including a vaccine), to shorten the FDA’s goal for taking action on a marketing application from ten months to six months.

Fourth, a product may be eligible for accelerated approval, if it treats a serious or life-threatening condition and generally provides a meaningful advantage over available therapies. In addition, it must demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, or IMM that is reasonably likely to predict an effect on IMM or other clinical benefit. As a condition of approval, the FDA may require that a sponsor of a drug or biologic receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials to confirm efficacy using a clinically meaningful endpoint, thereby confirming efficacy observed pre-approval using a surrogate endpoint. In June 2019, we announced that the FDA acknowledged that the accelerated approval pathway is available for NanoFlu.

In addition to regulatory approvals that must be obtained in the U.S., an investigational product is also subject to regulatory approval in other countries in which it is intended to be marketed. No such product can be marketed in a country until the regulatory authorities of that country have approved an appropriate marketing application. FDA licensure does not guarantee approval by other regulatory authorities. In addition, in many countries, the government is involved in the pricing of the product. In such cases, the pricing review period often begins after market approval is granted.
We are also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential federal, state or local regulations, including national and local regulations that govern our facility in Sweden. These and other laws govern our use, handling and disposal of various biological and chemical substances used in, and waste generated by our operations. Our research and development involves the controlled use of hazardous materials, chemicals and viruses. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated.
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In the event of such an accident, we could be held liable for any damages that result and any such liability could exceed our resources. Additionally, for formulations containing controlled substances, we are subject to Drug Enforcement Act regulations.

In both domestic and foreign markets, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payers. Third-party payers include government authorities or programs, private health insurers (including managed care plans) and other organizations. These third-party payers are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of our products. There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the indications for which the product is approved by the FDA or similar regulatory authorities outside the United States. Our product candidates may not be considered cost-effective at certain prices. Adequate third-party reimbursement may not be available in certain markets to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. Third-party payors may also control access to, or manage utilization of, our products with various utilization management techniques. Decreases in third-party reimbursement for our product candidates or a decision by a third-party payer to not cover our product candidates could reduce physician utilization of our products and have a material adverse effect on our sales, results of operations and financial condition.
Within the U.S., if we obtain appropriate approval in the future to market any of our product candidates, those products could potentially be covered by various government health benefit programs as well as purchased by government agencies. The participation in such programs or the sale of products to such agencies is subject to regulation. In exchange for coverage, we may be obligated to provide rebates or offer discounts under government health programs or to government and private purchasers.

The U.S. and state governments continue to propose and pass legislation designed to reform delivery of, or payment for, health care, including initiatives to reduce the cost of healthcare. For example, in March 2010, the U.S. Congress enacted the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (“Healthcare Reform Act”) which includes changes to the coverage and reimbursement of drug products under government health care programs. Under the Trump administration, there were several efforts to modify or repeal all or certain provisions of the Healthcare Reform Act, and some modifications were implemented. Adoption of price controls and cost-containment measures and adoption of more restrictive policies in jurisdictions with existing controls and measures could further limit our net revenue and results.

Other legislative changes have been proposed and adopted in the United States since the Healthcare Reform Act was enacted. For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2030 due to subsequent legislative amendments contained in the Coronavirus Aid, Relief, and Economic Security Act, commonly referred to as the “CARES Act”. In November 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued an interim final rule that seeks to lower prescription drug costs by paying no more for certain Medicare Part B drugs than the lowest price paid for such drugs in certain other countries (the "Most Favored Nation Rule”). Under the rule, the lower payment rates for affected drugs would be phased in over a period of four years, beginning in 2021. The rule has been challenged by industry associations on a number of grounds. On December 28, 2020, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction in Biotechnology Innovation Organization v. Azar, No. 3:20-cv-08603, which preliminarily enjoins CMS from implementing the Most Favored Nation Rule. Given this preliminary injunction, the Most Favored Nation Rule was not implemented on January 1, 2021 and will not be implemented without further rule-making. However, this interim final rule or any similar type of reference pricing regulation could potentially harm our business if expanded to include our products.

Recently, there has been considerable public and government scrutiny in the U.S. of pharmaceutical pricing and proposals to address the perceived high cost of pharmaceuticals. There have also been several recent state legislative efforts to address drug costs, which generally have focused on increasing transparency around drug costs or limiting drug prices or price increases. Adoption of new legislation at the federal or state level could affect demand for, or pricing of, our product candidates if approved for sale. It is also possible that additional governmental action will be taken in response to the COVID-19 pandemic. We cannot predict the ultimate content, timing or effect of any federal and state reform efforts. There is no assurance that federal or state health care reform will not adversely affect our future business and financial results.

Similarly, in many countries outside the U.S., pharmaceutical pricing is subject to regulatory control, particularly in countries where healthcare is provided mainly through government funding or government backed insurers. In such countries governmental organizations will generally determine firstly if a medicinal product might be reimbursed and secondly the maximum price payable.
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Within the U.S., we may be subject to various federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims laws, for activities related to future sales of any of our product candidates that may in the future receive regulatory and marketing approval. Anti-kickback laws generally prohibit a pharmaceutical manufacturer from soliciting, offering, receiving or paying any remuneration to generate business, including the purchase, prescription or use of a particular drug. Although the specific provisions of these laws vary, their scope is generally broad and there may not be regulations, guidance or court decisions that apply the laws to particular industry practices. There is therefore a possibility that our practices might be challenged under such anti-kickback laws. False claims laws, including the federal False Claims Act (“FCA”), prohibit anyone from knowingly and willingly presenting, or causing to be presented, any claims for payment for reimbursed drugs or services to third party payers (including Medicare and Medicaid) that are false or fraudulent. Our activities relating to the sale and marketing of our products may be subject to scrutiny under these laws. Violations of fraud and abuse laws may be punishable by criminal or civil sanctions, including fines and civil monetary penalties, and exclusion from federal health care programs (including Medicare and Medicaid). In the U.S., federal and state authorities are paying increased attention to enforcement of these laws within the pharmaceutical industry and private individuals have been active in alleging violations of the laws and bringing suits on behalf of the government under the FCA. If we were subject to allegations concerning, or were convicted of violating, these laws, our business could be harmed.

On November 20, 2020, the DHHS published a Final Rule entitled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection,” commonly referred to as the “Rebate Rule”, which amends the federal Anti-Kickback Statute discount safe harbor by eliminating protection for price concessions, including rebates, that are offered by pharmaceutical manufacturers to plan sponsors, or pharmacy benefit managers under contract with them, under the Medicare Part D program and Medicare Advantage Plans, unless the price reduction is one required by law. Effective January 1, 2022, in advance of the calendar year 2022 Part D plan year, safe harbor protection will be eliminated for manufacturer rebates paid directly (or indirectly through a pharmacy benefit manager) to Part D prescription drug plans and Medicare Advantage prescription drug plans. Effective December 30, 2020, the Rebate Rule established two new safe harbors. The first new safe harbor protects price reductions paid by manufacturers to prescription drug plans (including prescription drug plans offered by Medicare Advantage organizations) and Medicaid managed care organizations, which are fully reflected at the point-of-sale. The second new safe harbor protects fair-market-value service fees paid to pharmacy benefit managers by manufacturers. This new rule could result in a change in incentives for health plans and pharmacy benefit managers in negotiating rebates and discounts with manufactures for preferred formulary placement. At this time we cannot predict how these changes will impact our business and operations once our product candidates are commercialized.

Within the European Union and the United Kingdom, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is prohibited. The provision of benefits or advantages to physicians is also governed by the national anti-bribery laws of EU Member States and the United Kingdom, such as the U.K. Bribery Act 2010. Infringement of these laws could result in substantial fines and imprisonment.

We are also subject to the U.S. Foreign Corrupt Practices Act (“FCPA”), which prohibits any U.S. individual or business from paying, offering, authorizing payment or offering anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the U.S. to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions. Various laws, regulations and executive orders also restrict the use and dissemination outside the U.S. or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. As we expand our presence outside the U.S., it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside the United States, which could limit our growth potential and increase our development costs. We cannot guarantee that we, our employees, our consultants, or our third-party contractors are or will be in compliance with all federal, state, and foreign regulations regarding bribery and corruption. Moreover, our strategic collaborators and third-party contractors located outside the U.S. may have inadequate compliance programs or may fail to respect the laws and guidance of the territories in which they operate. The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The Securities and Exchange Commission (“SEC”) also may suspend or bar issuers from trading securities on
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U.S. exchanges for violations of the FCPA’s accounting provisions. Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could also have an adverse effect on our business, financial condition, and results of operations.

The Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), created additional federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, impose requirements regarding the privacy and security of individually identifiable health information, including mandatory contractual terms, for covered entities, or certain healthcare providers, health plans, and healthcare clearinghouses, and their business associates that provide services to the covered entity that involve individually identifiable health information and their subcontractors that use, disclose or otherwise process individually identifiable health information. HITECH also increased the civil and criminal penalties that may be imposed against covered entities and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA. While pharmaceutical and biotechnology companies are typically not directly regulated by HIPAA, our business may be indirectly impacted by HIPAA in our interactions with providers, payors, and others that have HIPAA compliance obligations. We are also subject to state and foreign laws governing the privacy and security of health or personal information such as the European Union General Data Protection Regulation (“GDPR”) and the California Consumer Privacy Act of 2018 (“CCPA”).

There has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers. The Physician Payments Sunshine Act imposes annual reporting requirements on certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, for payments made by them to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers will also be required to report information related to payments and other transfers of value provided in the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.

Within the European Union and the United Kingdom, payments made to physicians must be publicly disclosed. Moreover, agreements with physicians must in some countries be the subject of prior notification and approval by the physician’s employer, their competent professional organization, or the regulatory authorities of the individual country. These requirements are provided in the national laws, industry codes, or professional codes of conduct, applicable in the European Union Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines, or imprisonment.

Laws and regulations have been enacted by the federal government and various states to regulate the sales and marketing practices of pharmaceutical manufacturers with marketed products. The laws and regulations generally limit financial interactions between manufacturers and health care providers and/or require disclosure to the government and public of such interactions. Many of these laws and regulations contain ambiguous requirements or require administrative guidance for implementation. Given the lack of clarity in laws and their implementation, any future activities (if we obtain approval and/or reimbursement from federal healthcare programs for our product candidates) could be subject to challenge.

Given the significant global impact of the COVID-19 pandemic, it is possible that one or more government entities may take actions, including the U.S. government under the Defense Production Act of 1950, as amended, which could directly or indirectly have the effect of diminishing some of our rights or opportunities with respect to NVX-CoV2373 and the economic value of a COVID-19 vaccine to us could be limited. In addition, during a global health crisis, such as the COVID-19 pandemic, where the spread of a disease needs to be controlled, closed or heavily regulated national borders will create challenges and potential delays in our development and production activities and may necessitate that we pursue strategies to develop and produce our vaccine candidates within self-contained national or international borders, at potentially much greater expense and with longer timeframes for public distribution.

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. In the United States, the Public
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Readiness and Emergency Preparedness Act (the “PREP Act”), provides immunity for manufacturers from all claims under state or federal law for "loss" arising out of the administration or use of a “covered countermeasure.” However, injured persons may still bring a suit for "willful misconduct" against the manufacturer under some circumstances. "Covered countermeasures" include security countermeasures and "qualified pandemic or epidemic products", including products intended to diagnose or treat pandemic or epidemic disease, such as pandemic vaccines, as well as treatments intended to address conditions caused by such products. For these immunities to apply, the Secretary of DHHS must issue a declaration in cases of public health emergency or “credible risk” of a future public health emergency. On March 17, 2020, the Secretary of DHHS issued a declaration under the PREP Act and has issued subsequent amendments thereto since then to provide liability immunity for activities related to certain countermeasures against the ongoing COVID-19 pandemic. While we believe our products would be covered under the provisions of the PREP Act, this cannot be assured.

Also, there can be no assurance that the Secretary of the HHS will make other declarations in the future that cover any of our other product candidates or that the U.S. Congress will not act in the future to reduce coverage under the PREP Act or to repeal it altogether. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
Human Capital

Employees

As of February 21, 2022, we have 1,541 full-time employees, of whom 198 hold M.D. or Ph.D. degrees and 499 of whom hold other advanced degrees. Of our total workforce, 1,088 employees are engaged primarily in research, development, and manufacturing activities and 453 employees are engaged primarily in executive, business development, commercial, finance and accounting, legal, and administrative functions. None of our U.S. or Czech employees are represented by labor unions or covered by collective bargaining agreements; 135 of our 136 Swedish employees are covered by typical collective bargaining agreements.

To nurture, grow, and treat our employees fairly is imbued in our culture. We are proud to have been recognized in the 2021 Top Workplaces USA list based on employee surveys. We believe this award reflects our investment in an exceptional work culture.

Employee Safety and Benefits

Employee safety is our highest priority. As we moved through the pandemic in 2021, we continued to encourage employees who were able to work from home to do so. We implemented a Covid Resources page on our intranet, which provides employees with information on Covid-19 safety, both inside and outside of the workplace. Resources on this site include our Covid-19 Protocols and Guide, our policies on face coverings and social distancing, a list of infection control measures, and mental wellness support resources. We implemented temperature screenings for everyone who enters our facilities and require visitors to complete a health assessment before entering.

Our 700 Quince Orchard office space located in Gaithersburg, Maryland is on track to receive WELL Platinum certification. WELL is the leading tool for advancing health and well-being in buildings globally. As one of 35 WELL certified buildings in North America, this building will meet rigorous standards for materials selection, indoor air quality, and acoustics. In addition, our operations and policies contribute to earning high marks in all the 10 WELL Concepts: Air, Water, Nourishment, Light, Movement, Thermal Comfort, Sound, Materials, Mind, and Community.

Compensation and Benefits; Health and Wellness

Our total rewards package is designed to attract, engage, motivate, and retain top talent. We strive to provide compensation, benefits, and services that help meet the varying needs of our employees. Our generous total rewards package includes competitive market pay and comprehensive benefits that are among the best in our industry, including insurance to protect and maintain health, income protection through our short- and long-term disability programs, adoption assistance and paid parental leave programs, and services to assist in balancing work and personal life, such as backup child, adult, and elder care, and financial wellbeing programs, including monthly financial wellness seminars, one-on-one financial planning sessions, and debt and credit management support.

Our wellness initiatives include a monthly newsletter, which highlights organizations and partners, tools, and resources intended to help our employees lead healthier and happier lives. We offer several digital apps that allow our employees to connect to an online licensed therapist or to access activities that are designed to reduce stress and anxiety and
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increase mindfulness and emotional well-being. We have a robust employee assistance program for employees to access support for a variety of life events.

To assist employees with work/life balance, we provide employees with a concierge service to assist employees with tasks including, but not limited to:
finding and booking auto services;
sourcing pet sitters and boarders;
researching online and in-person tutors;
suggesting community events;
providing vacation ideas;
finding and booking home cleaners, plumbers, HVAC, and landscaping services;
finding and booking yoga, personal training sessions, and spin classes;
suggesting nutritional meals and recipes; and
researching day care center availability and ratings.

In addition, we offer every employee the benefit of equity ownership in the company through equity grants and participation in our employee stock purchase plan. We believe that equity compensation has been, and will continue to be, a critical component of our compensation package because it develops a culture of ownership among our employees and aligns their interests with the interests of our stockholders.

Recruitment, Development and Training

The attraction, development, and retention of employees is a critical success factor for our success. We utilize a variety of recruitment vehicles to source top talent, including strategic partnerships with search firms, leveraging social media channels, and a robust employee referral program.

To support the growth and advancement of our employees, we offer tuition and continuing education reimbursement, and an array of training and professional development opportunities, including on-the-spot coaching with executive coaches and access to the LinkedIn Learning library of over 16,000 on-demand video tutorials that address skills, knowledge, and behaviors related to business, leadership, technology, and innovation. In the last 12 months, videos were viewed and completed over 25,000 times by our employees. We provide an Executive Development Program for employees identified as having high potential and for employees who have been identified as potential successors to leadership positions. Our Executive Development Program includes executive coaching engagements and leadership development programs designed to strengthen our leadership bench and accelerate and prepare our top talent for future growth. Professional development learning series are available to all employees and focus on self-awareness, collaboration, hybrid working, and business acumen.

Internal Communications

We employ a variety of tools to facilitate open and direct communication, including global forums with executives, employee surveys, and engagement through forums and committees. Our executive leadership team continues to recognize the importance of increased employee engagement.

Diversity and Inclusion

Our culture of diversity, equity, and inclusion (“DEI”) enables us to create, develop, and fully leverage the strengths of our workforce to meet our growth objectives. We recently completed an evidence-based analysis of our current DEI state, resulting in a multi-year road map and strategy to drive diversity and inclusion by developing inclusive leaders, enabling an inclusive culture, and building diverse teams. The first annual Novavax Women’s Leadership Forum was successfully
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launched and resulted in building networks, developing skills, sharing voices and ideas, and becoming agents of positive change. We are focused on growing and maintaining our diverse workforce and we believe our DEI strategy will enable us to continuously improve and excel. In 2022, we hired a DEI and Employee Engagement Manager focused on actions to build an inclusive workforce, and we are investing in training to develop our leaders to access different perspectives when generating ideas and decision making.

Availability of Information
Our website address is www.novavax.com. We make available, free of charge and through our website, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and our other filings with the SEC, and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after filed with or furnished to the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov.
We use our website (www.novavax.com) as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation Fair Disclosure promulgated by the SEC. These disclosures are included on our website (www.novavax.com) in the “Investors” or “News” sections. Accordingly, investors should monitor these portions of our website (www.novavax.com), in addition to following our press releases, SEC filings and public conference calls and webcasts.
Also available on our website is information relating to corporate governance at Novavax and our Board of Directors, including our Code of Conduct. We intend to disclose on our website any future amendments to and waivers from this code that apply to our Chief Executive Officer, Principal Financial Officer, Principal Accounting Officer and Controller, and persons performing similar functions, as promptly as practicable, as may be required under applicable SEC and Nasdaq rules.
We webcast our earnings calls and certain events we participate in or host with members of the investment community on the investor relations section of our website. Additionally, we provide notifications of news or announcements regarding press and earnings releases as part of the investor relations section of our website. The contents of our website are not part of this Annual Report on Form 10-K, or any other report we file with, or furnish to, the SEC.
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Item 1A.    RISK FACTORS

You should carefully consider the following risk factors in evaluating our business. A number of risks could cause our actual results to differ materially from those that are indicated by forward-looking statements. Some risks relate principally to our business and the industry in which we operate. Others relate principally to the securities market and ownership of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties of which we are unaware, or that we currently deem immaterial, also may become important factors that affect us. Any of the following risks could result in material adverse impacts on our business, financial condition, or results of operations. You also should consider the other information included in this Annual Report on Form 10-K as well as our other filings with the SEC.

Summary of Risk Factors

Our business is subject to numerous risks. The following is a summary of the principal risk factors described in this section:

We have a history of losses and our future profitability is uncertain.

We will continue to require significant funding to maintain our current level of operations and fund the further development of our vaccine candidates.

Because our vaccine product development efforts depend on new and rapidly evolving technologies, our efforts may not succeed.

The regulatory and commercial success of our COVID-19 vaccine candidate, NVX-CoV2373, remains uncertain. While we have received provisional registration, conditional marketing authorization, or emergency use authorization for NVX-CoV2373 in a number of jurisdictions, we may be unable to obtain regulatory approvals in the United States or in any other jurisdiction or produce a successful vaccine in a timely manner, if at all.

We are a biotechnology company and face significant risk in developing, manufacturing, and commercializing our products.

Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products.

Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees.

There is significant competition in the development of a vaccine against COVID-19, influenza, and RSV and we may never see returns on the significant resources we are devoting to our vaccine candidates.

We may not succeed in obtaining the FDA licensure or foreign regulatory approvals necessary to sell our vaccine candidates.

Our products might fail to meet their primary endpoints in clinical trials, meaning that we will not have the clinical data required to support regulatory obligations.

The regulatory pathway for NVX-CoV2373 is continually evolving, and may result in unexpected or unforeseen challenges.

We have conducted, are conducting, and plan to conduct in the future, a number of clinical trials for NVX-CoV2373 at sites outside the United States and the FDA may not accept data from trials conducted in such locations.

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The later discovery of previously unknown problems with a product, manufacturer, or facility may result in restrictions, including withdrawal of a vaccine that had previously received regulatory approval in certain jurisdictions from the market.

Our success depends on our ability to maintain the proprietary nature of our technology.

Our business may be adversely affected if we do not successfully execute our business development initiatives.

Servicing our 3.75% convertible senior unsecured notes due 2023 (the “Notes”) requires a significant amount of cash, and we may not have sufficient cash flow resources to pay our debt.

Because our stock price has been and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected.

Litigation or regulatory investigations could have a material adverse impact on our results of operation and financial condition.

We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies, such as the COVID-19 pandemic.

Risks Related to Our Financial Condition and Capital Requirements

We have a history of losses and our future profitability is uncertain.

Our expenses have exceeded our revenue since our formation in 1987, and our accumulated deficit at December 31, 2021 was $3.6 billion. Our revenue and expenses fluctuate significantly from period to period. For most of our history our expenses have exceeded our revenue, which may occur during most periods in the foreseeable future. Our net losses for the last three fiscal years were $1.7 billion in 2021, $418.3 million in 2020, and $132.7 million in 2019.

Historically, our losses have resulted predominantly from research and development expenses for our vaccine candidates, manufacturing-related expenses, expenses associated with efforts to obtain regulatory approvals, costs related to protection of our intellectual property, and other general and administrative operating expenses, a significant portion of which have been noncash. Our expenses have exceeded our revenue since inception, and we believe our expenses will fluctuate over time, and may substantially increase in some years, as a result of continuing efforts to develop, test, manufacture, and make regulatory filings for our vaccine candidates, and, if our product candidates are approved, commercialization efforts.

As of the end of fiscal year 2021, our investment in the development and manufacture of NVX-CoV2373 has been substantial, and we expect such levels of investment to continue for the rest of 2022 and beyond, although the precise magnitude of our total investment will depend on the duration of the COVID-19 pandemic, the competitive landscape, the timing and results of our applications for regulatory approvals, the availability of funding, and whether and what booster shot protocols are recommended by governments, regulatory authorities, and healthcare providers. If we are unable to timely commercialize a vaccine against COVID-19 in sufficient jurisdictions, we likely would never recoup our investments. We expect to continue to incur significant operating expenses and anticipate significant losses over time as we seek to:

conduct additional clinical trials and seek regulatory approvals for NVX-CoV2373 and other potential vaccine candidates;

conduct preclinical studies for other potential vaccine candidates;

expand our global manufacturing and distribution capacity; and

maintain, expand and protect our intellectual property portfolio.

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As a result, we expect our cumulative operating losses to increase until such time, if ever, that product sales, licensing fees, royalties, milestones, contract research and other sources generate sufficient revenue to fully fund our operations. We may never achieve profitability and may not sustain profitability, if achieved.

We will continue to require significant funding to maintain our current level of operations and fund the further development of our vaccine candidates.

We do not currently generate sufficient revenue from product sales, licensing fees, royalties, milestones, contract research or other sources to fully fund our operations. We, therefore, will use our cash resources, and expect to require additional funds, to maintain our operations, continue our research and development programs, commence future preclinical studies and clinical trials, seek regulatory approvals and manufacture and market any products that are approved for commercialization.

To date, we have financed our operations primarily through the sale of equity and debt securities, government funding and grant agreements, and additional funding may not be available to us on favorable terms, or at all. Although we have entered into supply agreements for NVX-CoV2373 that include prepayments from the purchasers, until we can generate sufficient product revenue in amounts sufficient to fully fund our operations, which we may never do, we expect to finance our cash needs through a combination of additional public or private equity or debt financings, as well as existing cash, potential collaborations, strategic alliances and marketing, distribution or licensing arrangements, funding from governmental and non-governmental funding entities, and potentially other sources. While we may continue to apply for contracts or grants from academic institutions, non-profit organizations and governmental entities, we may not be successful. Adequate additional funding may not be available to us on acceptable terms, if at all. Furthermore, negative interpretations of clinical trial data or setbacks, or perceived setbacks, with respect to manufacturing ability and/or capacity or regulatory filing timelines for NVX-CoV2373 or our other vaccine candidates, as well as the competitive landscape posed by other COVID-19 vaccines, may impair our ability to raise additional financing on favorable terms, or at all. Additionally, certain of the supply agreements for NVX-CoV2373 may be terminated by the counterparty if we do not timely achieve requisite regulatory approval for NVX-CoV2373 in the relevant jurisdictions under such agreements. If we cannot raise the additional funds required for our anticipated operations, we may be required to delay significantly, reduce the scope of or eliminate one or more of our research or development programs, downsize our organization, or seek alternative measures to avoid insolvency, including arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies or vaccine candidates. If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings also could have a material and adverse effect on the price of our common stock.

Economic uncertainty may adversely affect our access to capital, cost of capital and ability to execute our business plan as scheduled.

Generally, worldwide economic conditions remain uncertain, particularly due to the COVID-19 pandemic. Access to capital markets is critical to our ability to operate. Traditionally, biotechnology companies have funded their research and development expenditures by raising capital in the equity markets. Declines and uncertainties in these markets in the past have severely restricted raising new capital and have affected companies’ ability to continue to expand or fund existing development, manufacturing, regulatory and commercialization efforts. We require significant capital for our current and expected operations. The general economic and capital market conditions, both in the U.S. and worldwide, have been volatile in the past and at times have adversely affected our access to capital and increased the cost of capital. The capital and credit markets may not be available to support future capital raising activity on favorable terms. If economic conditions decline, our future cost of equity or debt capital and access to the capital markets could be adversely affected. In addition, if we are unable to access the capital markets on favorable terms, our ability to execute our business plan as contemplated would be compromised. Moreover, we rely and intend to rely on third parties, including clinical research organizations, contract manufacturing organizations and other important vendors and consultants. Global economic conditions may result in a disruption or delay in the performance of our third-party contractors and suppliers. If such third parties are unable to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.

Our existing funding and supply agreements do not assure success of our vaccine candidates or that we will be able to fully fund our vaccine candidates.

The OWS Agreement, the DoD Agreement and the CEPI funding agreement each reimburse a portion of the expenses associated with the development and commercialization of NVX-CoV2373. To the extent funding commitments in such agreements are conditioned on our meeting certain milestones or conditions, including regulatory approval in applicable jurisdictions, we may not ultimately receive the full amount of committed funds and could be exposed to urgent need for additional funding to support our NVX-CoV2373 development, manufacturing and distribution activities. For example, in
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connection with the OWS Agreement, the USG has instructed us to prioritize alignment with the FDA on our analytic methods before conducting additional U.S. manufacturing and further indicated that the USG will not fund additional U.S. manufacturing until such agreement has been made. The OWS Agreement includes provisions giving the USG termination rights based on a determination that the funded project will not produce beneficial results commensurate with the expenditure of resources and that termination would be in the USG’s interest. Such a determination would result in the loss of funding under that agreement and could result in other actions by the U.S. government. The CEPI funding agreement provides CEPI certain “march-in” rights in the event of certain breaches of that agreement. We may be unable to timely obtain additional government or private funding, if at all. Additionally, we have entered into, and plan to continue entering into, supply agreements for NVX-CoV2373 that include prepayments from the purchasers. Certain of the supply agreements may be terminated by the counterparty if we do not timely achieve requisite regulatory approval for NVX-CoV2373 in the relevant jurisdictions under such agreements. In the event we are unable to successfully develop and commercialize NVX-CoV2373 or fail to meet certain regulatory milestones or product volume or delivery timing obligations under our supply agreements, we may be required to refund significant portions of the prepayments, which could have a material and adverse effect on our financial condition. Our inability to succeed with key clinical or development activities could jeopardize our ability to obtain licensure from the FDA or other regulatory authorities to sell NVX-CoV2373. As a result, our existing funding and supply agreements may be insufficient to fund our commercial launch.

Risks Related to Product Development and Commercialization

Because our vaccine product development efforts depend on new and rapidly evolving technologies, our efforts may not succeed.

Our vaccine development efforts depend on new, rapidly evolving technologies and on the marketability and profitability of our products. Our development efforts and, if those are successful, commercialization of NVX-CoV2373 and our other vaccines could fail for a variety of reasons, including if:

our recombinant nanoparticle vaccine technologies, any or all of the products based on such technologies or our proprietary manufacturing process prove ineffective or unsafe;

new strains of COVID-19 evolve, with respect to which NVX-CoV2373 proves less effective;

we or our third-party manufacturer facilities fail to reproducibly scale-up manufacturing with sufficiently high yields at reasonable cost and on projected timelines, or such manufacturing fails to generate product that consistently satisfies purity, potency, quality, stability, and shelf-life standards necessary for obtaining regulatory approvals or achieving commercial viability;

the products are difficult to manufacture on a large-scale or uneconomical to market;

some or all of the products that we or our third-party partners have manufactured may be determined to be unsalable based on criteria imposed by regulators as they complete regulatory approvals;

our in-house or third-party manufacturing facilities fail regulatory inspections;

proprietary rights of third-parties prevent us or our collaborators from exploiting technologies, and manufacturing or marketing products; or

third-party competitors achieve and maintain greater market share due to earlier approvals or superior marketing capabilities.

The regulatory and commercial success of our COVID-19 vaccine candidate, NVX-CoV2373, remains uncertain. While we have received provisional registration, conditional marketing authorization or emergency use authorization for NVX-CoV2373 in a number of jurisdictions, we may be unable to obtain any other regulatory approvals in the United States or other jurisdictions or produce a successful vaccine in a timely manner, if at all.

In response to the outbreak of COVID-19, we are pursuing the development and manufacture of our vaccine candidate, NVX-CoV2373. Even though we have reported positive data from Phase 1, 2 and 3 clinical trials, and have
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received provisional registration, conditional marketing authorization, or emergency use authorization from the World Health Organization and in Canada, Australia, New Zealand, the E.U., the United Kingdom, India, Indonesia, the Philippines, and Singapore, as well as full approval in South Korea, such results may not be sufficient to support regulatory submissions, authorizations and approvals, accelerated or otherwise, in any other relevant jurisdictions on our projected timelines, if at all.

Additionally, even though NVX-CoV2373 has received regulatory approval in certain jurisdictions and may receive further regulatory approval in others, successful commercialization depends on our ability to effectively scale up manufacturing capabilities at our own locations and those of our manufacturing partners and contractors. In May 2020, we acquired Novavax CZ (formerly Praha Vaccines, a.s.) including its vaccine manufacturing facility in Bohumil, Czech Republic and approximately 150 of its employees. We also are actively entering into agreements with third parties to manufacture the antigen component of NVAX-CoV2373 and our proprietary Matrix-Madjuvant, as well as to distribute NVX-CoV2373. Because of contractual restraints and the limited number of third-party manufacturers with the expertise, required regulatory approvals and facilities to manufacture NVX-CoV2373 and its components at commercial scale, replacement of a manufacturer may be expensive and time-consuming and may cause interruptions in production. Manufacturing of NVX-CoV2373 and its components involves a complicated process that will require significant investments of time and financial resources to implement, and our efforts to establish manufacturing capabilities may not meet expectations as to timing, scale-up, reproducibility, yields, purity, cost, potency or quality. Shortages of raw materials and supplies also negatively impact our manufacturing efforts. We may not be able to timely and effectively produce NVX-CoV2373 in adequate quantities to address global demand.

We have not previously had a commercial launch of any vaccine product, and doing so in a pandemic environment with an urgent, critical global need creates additional challenges. In addition to scaling up our manufacturing capabilities, we need to develop global distribution channels and form partnerships with third parties worldwide, as well as hire, train and integrate additional management, administrative and sales and marketing personnel. Rapid and significant growth may strain our administrative and operational infrastructure, imposing significant additional responsibilities on our organization, and our efforts to establish these capabilities may not meet expectations as to timing, scale-up, reproducibility, yields, purity, cost, potency or quality. If we fail to successfully manage our growth and the increased complexity of our operations, our business, financial position, results of operations and prospects may be materially and adversely affected.

We are a biotechnology company and face significant risk in developing, manufacturing and commercializing our products.

We focus our research and development activities on vaccines, an area in which we believe we have particular strengths and a technology that appears promising. The outcome of any research and development program is highly uncertain. Only a small fraction of biopharmaceutical development programs ultimately result in commercial products or even product candidates and a number of events could delay our development efforts and negatively impact our ability to make regulatory submissions or obtain regulatory approval for, and to manufacture, market and sell, NVX-CoV2373 or any other vaccine on our projected timelines, if at all. Vaccine candidates that initially appear promising often fail to yield successful products, and we may not ultimately be able to demonstrate the safety, potency, purity, stability and efficacy necessary to obtain or maintain regulatory authorization to market our product candidates. In many cases, preclinical studies or clinical trials will show that a product candidate is not efficacious or that it raises safety concerns or has other side effects that outweigh its intended benefit. Success in preclinical or early clinical trials may not translate into success in large-scale clinical trials. Further, success in clinical trials often leads to increased investment, accelerating cumulative losses. Even if clinical trial results appear positive, regulatory approval may not be obtained if the FDA, or a foreign equivalent, does not agree with our interpretation of the results, and we may face challenges when scaling-up the production process to commercial levels. Even after a product is approved and launched, general usage or post-marketing clinical trials may identify safety or other previously unknown problems with the product, or manufacturing issues may emerge, either of which may result in regulatory approvals being suspended, limited to narrow the scope of the approval, or revoked, which may otherwise prevent successful commercialization. Intense competition in the vaccine industry could also limit the successful commercialization of any products for which we receive commercial approval.

We will require approval from the FDA of any name we intend to use for our products regardless of whether we have secured a trademark registration from the USPTO. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. The FDA may object to any product name we submit if it believes the name inappropriately implies medical claims. If the FDA objects to any of our proposed product names, we may be required to adopt an alternative name for our proposed products. If we adopt an alternative name, we would lose the benefit of any existing trademark applications for such developmental candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. We may be unable to build a
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successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our products, if approved.

Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products.

We are highly dependent on third-party organizations to conduct some of our laboratory testing and clinical trials and a significant amount of our vaccine manufacturing activities and distribution. If we are unable to obtain any necessary services on acceptable terms, we may not complete our product development or commercialization efforts in a timely manner. We may lose control over these activities or become too dependent upon these parties. These third parties may not complete testing, manufacturing or distribution activities on schedule, or in satisfaction of regulatory or commercial requirements. Certain of our facilities are also contracted for defined time frames and through association with OWS and CEPI, and we may not be able to access those facilities for sufficient periods of time to provide adequate supply.

We are responsible for confirming that each of our clinical trials is conducted in accordance with its general investigational plan and protocol. Moreover, the FDA and foreign regulatory agencies require us to comply with regulations and standards, commonly referred to as good clinical practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, safety and welfare of clinical trial participants are adequately protected. The FDA and foreign regulatory agencies also require us to comply with good manufacturing practices. Our reliance on third parties does not relieve us of these responsibilities and requirements. These third parties may not successfully carry out their contractual duties or regulatory obligations. Furthermore, if a third-party manufacturer is producing materials or products for themselves or other companies, that manufacturer is exposed to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements for the production of those materials and products may generally affect the regulatory status of the third-party manufacturer’s facility, which could impact its ability to produce our materials and products. Any of our third-party service providers may need to be replaced, the quality or accuracy of the data they obtain may be compromised, the services provided to us may be delayed, or the product they manufacture may be contaminated due to the failure to adhere to our clinical and manufacturing protocols, regulatory requirements or for other reasons. In any such event, our preclinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval of, or successfully commercially manufacture on a timely basis, our vaccine candidates.

The results from the Prepare trial, including that ResVax failed to meet the primary endpoint of the trial, will likely create challenges, some of which may be significant, around further development of that vaccine.

While the Prepare results suggest that ResVax, the project name for the RSV vaccine candidate, is safe and is likely efficacious in more serious manifestations of RSV disease, the trial failed to achieve its primary clinical endpoint. Not achieving the primary clinical endpoint has been viewed negatively by our investors. Although the failure to achieve the primary endpoint in the trial is not evidence that the vaccine is ineffective, it means that regulatory agencies like the FDA and EMA are likely to require additional clinical trial data prior to licensure. This development may be viewed negatively by our potential collaborators and partners, which may make the ongoing development of ResVax, and any other RSV F Vaccine candidates, more challenging.

We may have product liability exposure.

The administration of drugs or vaccines to humans, whether in clinical trials or after marketing approval, can result in product liability claims. We maintain product liability insurance coverage for our current clinical programs, including our NVX-CoV2373 trials, and we have expanded our insurance coverage to include the sale of commercial products. However, we may not be able to obtain additional insurance coverage or maintain insurance coverage on commercially reasonable terms, at a reasonable cost or in sufficient amounts to protect us against losses due to liability. Furthermore, such insurance coverage and our resources may not be sufficient to satisfy all liabilities that result from product liability claims. A successful claim may prevent us from obtaining adequate product liability insurance in the future on commercially desirable terms, if at all. Even if a claim is not successful, defending such a claim would be time- consuming and expensive, may damage our reputation in the marketplace and would likely divert management’s attention.

In addition, because we are developing NVX-CoV2373 in response to the outbreak of COVID-19, a global pandemic, we have received provisional registration, conditional marketing authorization or emergency use authorization from the World Health Organization and in Canada, Australia, New Zealand, the E.U., the United Kingdom, India, Indonesia, the Philippines, and Singapore, as well as full authorization in South Korea, and we may have a widely used vaccine as an investigational vaccine or a product authorized for temporary or emergency use prior to our receipt of marketing approval in
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other jurisdictions as well. Unexpected safety issues in these circumstances could lead to product liability claims and our existing insurance may not be adequate for such claims.

Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for our products;

withdrawal of regulatory approvals;

voluntary or mandatory recalls of our products;

necessity for additional nonclinical or clinical studies, changes in labeling, or changes to manufacturing processes, specifications and/or facilities;

impairment of our business reputation and negative media attention;

withdrawal of clinical trial participants;

costs of related litigation;

substantial monetary awards to participants or other claimants;

loss of revenue; and

inability to commercialize our vaccine candidates.

In the United States, the PREP Act provides immunity for manufacturers from all claims under state or federal law for “loss” arising out of the administration or use of a “covered countermeasure.” However, injured persons may still bring a suit for “willful misconduct” against the manufacturer under some circumstances. “Covered countermeasures” include security countermeasures and “qualified pandemic or epidemic products”, including products intended to diagnose or treat pandemic or epidemic disease, such as pandemic vaccines, as well as treatments intended to address conditions caused by such products. For these immunities to apply, the Secretary of DHHS must issue a declaration in cases of public health emergency or “credible risk” of a future public health emergency. On March 17, 2020, the Secretary of DHHS issued a declaration under the PREP Act and has issued subsequent amendments thereto to provide liability immunity for activities related to certain countermeasures against the ongoing COVID-19 pandemic. While we believe our products would be covered under the provisions of the PREP Act, this cannot be assured. Also, the Secretary of the HHS may not make other declarations in the future that cover any of our other product candidates, and the U.S. Congress may reduce coverage under the PREP Act or repeal it altogether. Product liability lawsuits may result in substantial liabilities and may require us to limit commercialization of our product candidates.

If we are unable to effectively manufacture our vaccines in sufficient quantities, at sufficient yields or are unable to obtain regulatory approvals for a manufacturing facility for our vaccines, we may experience delays or an adverse impact on product development, clinical trials, regulatory approval and commercial distribution.

Completion of our clinical trials and commercialization of our vaccine candidates require access to, or development of, facilities to effectively manufacture our vaccine candidates at sufficient yields and at commercial-scale. We have limited experience manufacturing any of our vaccine candidates in the volumes necessary to support commercial sales. While we have recently increased our projected global manufacturing capacity for NVX-CoV2373, our efforts to establish manufacturing capabilities may not meet expectations as to timing, scale-up, reproducibility, yields, purity, cost, potency or quality. The antigen component of NVX-CoV2373 is currently being manufactured at Novavax CZ, as well as numerous partnered manufacturing sites, including FUJIFILM in the United States, SIIPL in India, SK bioscience in Korea, and Takeda in Japan, among others. Challenges manufacturing either the antigen component or the adjuvant, or issues in later manufacturing stages, could compromise production of NVX-CoV2373.

Manufacturing our vaccine candidates involves a complicated process with which we have limited experience. We are highly dependent on third-party organizations to conduct a significant amount of our vaccine manufacturing activities. If
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we and our third-party manufacturing organizations are unable to manufacture our vaccine candidates in clinical quantities or, if and when necessary, in commercial quantities and at sufficient yields and at required specifications, then commercialization will be delayed, and we will need to identify and reach supply arrangements with additional third parties. Third-party manufacturers also must receive FDA or equivalent foreign regulatory body approval before they can produce clinical material or commercial product. Our vaccines are in competition with other products for access to these third-party facilities and may be subject to delays in manufacture if third parties prioritize other products. We may not be able to enter into any necessary additional third-party manufacturing arrangements on acceptable terms, or on a timely basis. In addition, we have to enter into technical transfer agreements and share our know-how with the third-party manufacturers, which can be time-consuming and may result in delays.

Because of contractual restraints and the limited number of third-party manufacturers with the expertise, required regulatory approvals and facilities to manufacture our bulk vaccines at commercial-scale, replacement of a manufacturer may be expensive and time-consuming and may cause interruptions in the production of our vaccine. We and our third-party manufacturers may also encounter production challenges related to:

costs, scale up, and yields;

shortages of raw materials and supplies;

quality control and assurance;

contamination, lot consistency, potency, and purity;

shortages of qualified personnel and other capacity constraints;

compliance with strictly enforced and evolving federal, state and foreign regulations that vary in each country where products might be sold including nationalization or other territory restrictions placed on our owned and third-party manufacturing sites; and

capital funding.

Delays or interruptions could have a material adverse effect on our business, financial condition, results of operations and cash flows.

We must identify vaccines for development with our technologies and establish successful third-party relationships.

The near and long-term viability of our vaccine candidates depend in part on our ability to successfully establish new strategic collaborations with pharmaceutical and biotechnology companies, non-profit organizations and government agencies. Establishing strategic collaborations and obtaining government funding is difficult and time-consuming. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position or based on their internal pipelines; government agencies may reject contract or grant applications based on their assessment of public need, the public interest, our products’ ability to address these areas, or other reasons beyond our expectations or control. Collaborators also may seek to modify or terminate relationships. Past success in establishing strategic collaborations with pharmaceutical and biotechnology companies, non-profit organizations and government agencies in the past is no guarantee of future success in entering into new relationships or in performing under existing relationships. If we fail to establish a sufficient number of collaborations or government relationships on acceptable terms, or fail to perform under collaborations or relationships to the satisfaction of counter-parties, we may not be able to commercialize our vaccine candidates or generate sufficient revenue to fund further research and development efforts.

The collaborations we have established or may establish may not result in the successful development or commercialization of any vaccine candidates for several reasons, including the fact that:

we may not have the ability to control the activities of our partners and cannot provide assurance that they will fulfill their obligations to us, including with respect to the license, development and commercialization of vaccine candidates, in a timely manner or at all;
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such partners may not devote sufficient resources to our vaccine candidates or properly maintain or defend our intellectual property rights;

our partners could independently develop, or develop with third parties, products that compete directly or indirectly with our vaccine candidates if such partners believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

any failure on the part of our partners to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our vaccine candidates and affect our ability to realize product revenue; and

disagreements, including disputes over the ownership of technology developed with such collaborators, could result in litigation, which would be time consuming and expensive, and may delay or terminate research and development efforts, regulatory approvals and commercialization activities.

If we or our collaborators fail to maintain our existing agreements or in the event we fail to establish agreements as necessary, we could be required to undertake research, development, manufacturing and commercialization activities solely at our own expense. These activities would significantly increase our capital requirements and, given our lack of sales, marketing and distribution capabilities, significantly delay the commercialization of our vaccine candidates.

Even though we have received provisional registration, conditional marketing authorization or emergency use authorization in certain jurisdictions for NVX-CoV2373, and even if we have products licensed in additional markets, our vaccine products may not be initially or ever profitable.

Whether we make a profit from the sale of our vaccine products is dependent on a number of variables, including the costs we incur manufacturing, testing and releasing, packaging and shipping such vaccine product. Additionally, the CEPI funding agreement necessitates that we allocate a certain number of doses of NVX-CoV2373 to certain middle and lower income countries, and the Grant Agreement with BMGF necessitates that we commit to a specific amount of sales in certain specified middle and lower income countries, which may impact negatively our ability to generate profit. We cannot predict when, if at all, our approved vaccine products will be profitable to the Company.

Even if we successfully commercialize any of our vaccine candidates, either alone or in collaboration, we face uncertainty with respect to pricing, third-party reimbursement and healthcare reform, all of which could adversely affect any commercial success of our vaccine candidates.

Our ability to collect revenue from the commercial sale of our vaccines may depend on our ability, and that of any current or potential future collaboration partners or customers, to obtain adequate levels of approval, coverage and reimbursement for such products from third-party payers such as:

government health administration authorities such as the Advisory Committee for Immunization Practices of the Centers for Disease Control and Prevention;

private health insurers;

managed care organizations;

pharmacy benefit management companies; and

other healthcare related organizations.

Third-party payers are increasingly challenging the prices charged for medical products and may deny coverage or offer inadequate levels of reimbursement if they determine that a prescribed product has not received appropriate clearances from the FDA, or foreign equivalent, or other government regulators; is not used in accordance with cost-effective treatment methods as determined by the third-party payer; or is experimental, unnecessary or inappropriate. Prices could also be driven down by managed care organizations that control or significantly influence utilization of healthcare products.
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In both the U.S. and some foreign jurisdictions, there have been a number of legislative and regulatory proposals and initiatives to change the health care system in ways that could affect our ability to sell vaccines and could adversely affect the prices that we receive for our vaccine candidates, if approved. Some of these proposed and implemented reforms could result in reduced pharmaceutical pricing or reimbursement rates for medical products, and while we have no current vaccines available for commercial sale other than subject to provisional registration, conditional marketing authorization or emergency use authorization in certain foreign jurisdictions, the impact of such reform could nevertheless adversely affect our business strategy, operations and financial results. For example, the Affordable Care Act (“ACA”) contained several cost containment measures that could adversely affect our future revenue, including, for example, increased drug rebates under Medicaid for brand name prescription drugs, extension of Medicaid rebates to Medicaid managed care organizations, and extension of so-called 340B discounted pricing on pharmaceuticals sold to certain healthcare providers. Additional provisions of the healthcare reform laws that may negatively affect our future revenue and prospects for profitability include the assessment of an annual fee based on our proportionate share of sales of brand name prescription drugs to certain government programs, including Medicare and Medicaid. The ACA also established a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of-sale discounts off negotiated prices of applicable branded on drugs (including vaccines) to eligible beneficiaries during their coverage gap period (the so-called “donut hole”), as condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. Other aspects of healthcare reform, such as expanded government enforcement authority and heightened standards that could increase compliance-related costs, could also affect our business.

Further, we face uncertainties because of occasional political, legislative, and administrative efforts to substantially modify or invalidate some or all of the provisions of the ACA. For example, in 2017, the Trump administration withheld the cost-sharing subsidies paid to ACA health insurance exchange plans serving low-income enrollees. The Tax Cut and Jobs Act (“TCJA”) was also enacted at the end of 2017 and included provisions that affected healthcare insurance coverage and payment, such as the elimination of the tax penalty for individuals who do not maintain sufficient health insurance coverage beginning in 2019 (the so-called “individual mandate”).

More recently, the Biden administration, through the American Rescue Plan Act of 2021, increased subsidies for coverage purchased through ACA health insurance exchanges and extended eligibility for subsidies to higher income levels. On December 14, 2018, a U.S. District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the TCJA, the remaining provisions of the ACA are invalid as well. On December 18, 2019, the U.S. Court of Appeals for the 5th Circuit ruled that the individual mandate was unconstitutional but remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. On March 2, 2020, the U.S. Supreme Court granted the petitions for writs of certiorari to review the case, and oral arguments were heard on November 10, 2020. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. Separately, President Biden issued an Executive Order to initiate a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The Executive Order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is also unclear how these and other healthcare reform measures of the Biden administration or other efforts, if any, to challenge, repeal or replace the ACA, will impact our business.

Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011 and subsequent laws, which began in 2013 and, due to subsequent legislative amendments, will stay in effect through 2030 unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. New laws may result in additional reductions in Medicare and other healthcare funding, which may materially adversely affect customer demand and affordability for our products and, accordingly, the results of our financial operations. Additionally, the pharmaceutical industry has also been the subject of significant publicity in recent years regarding the pricing of pharmaceutical products, including publicity and pressure resulting from prices charged by pharmaceutical companies for new products as well as price increases by pharmaceutical companies on older products that some people have deemed excessive. As a result, pharmaceutical product prices have been the focus of increased scrutiny by the U.S. government, including certain state attorneys general, members of congress, presidential candidates and the United States Department of Justice. If reforms in the health care industry make reimbursement for our potential products less likely, the market for our potential products will be reduced, and we could lose potential sources of revenue. The existence or threat of cost control measures could cause our corporate collaborators to be less willing or able to pursue research and development programs related to our vaccine candidates. Further, it is also possible
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that additional governmental action is taken in response to the COVID-19 pandemic. We cannot predict the ultimate content, timing or effect of any healthcare reform legislation or the impact of potential legislation on us.

Even if we receive regulatory approvals for our vaccine candidates, including NVX-CoV2373, coverage and reimbursement may be subject to unique regulatory policies. For example, under the ACA preventive care mandate, non-grandfathered group health plans and health insurance coverage offered in the individual or group market typically have at least one year before they must provide first-dollar coverage for a newly issued preventive care requirement or guideline. However, pursuant to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), non-grandfathered group health plans and health insurance coverage offered in the individual or group market must cover any qualifying coronavirus preventive service 15 business days after the United States Preventive Services Task Force, or Advisory Committee on Immunization Practices (ACIP) designates such service as preventive. Further, third-party reimbursement for providers administering COVID-19 vaccines may affect market acceptance of NVX-CoV2373, if we receive regulatory approval. Currently, the CARES Act and its implementing regulations state that (i) providers that participate in the U.S. Centers for Disease Control and Prevention’s COVID-19 Vaccination Program must administer a COVID-19 immunization regardless of an individual’s ability to pay or health insurance coverage status, (ii) providers may not seek any reimbursement, including through balance billing, from an immunization recipient, (iii) coverage is required, without cost-sharing, for the administration of the immunization even if a third party, such as the federal government, pays for the cost of the immunization, and (iv) private health insurance plans must cover COVID-19 immunizations and their administration even when provided by out-of-network providers for the duration of the public health emergency for COVID-19. Even if we receive regulatory approvals for NVX-CoV2373, there is no guarantee payors will provide coverage and reimbursement for our product after the termination of the public health emergency, nor can we guarantee that even if coverage is provided, the reimbursement amount will be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment. We cannot predict continued prevalence of COVID-19, whether herd immunity will be achieved (which would affect the need for future administration of COVID-19 vaccines), or whether NVX-CoV2373 will be effective against continuing mutations or variants of the SARS-CoV-2 virus.

We have limited marketing capabilities, and if we are unable to enter into collaborations with marketing partners or develop our own sales and marketing capability, we may not be successful in commercializing any approved products.

Although we have initiated preliminary activities in anticipation of commercialization of our vaccine candidates, we currently have limited dedicated sales, marketing or distribution capabilities. As a result, we depend on collaborations with third parties that have established distribution systems and sales forces, including our collaboration with SIIPL, among others. To the extent that we enter into co-promotion or other licensing arrangements, our revenue will depend upon the efforts of third parties, over which we may have little or no control. If we are unable to reach and maintain agreements with one or more pharmaceutical companies or collaborators, we may be required to market our products directly. Developing a marketing and sales force is expensive and time-consuming and could delay a product launch. We may not be able to attract and retain qualified sales personnel or otherwise develop this capability.

Our vaccine candidates may never achieve market acceptance even if we obtain regulatory approvals.

Even if we receive regulatory approvals for the commercial sale of our vaccine candidates, the commercial success of these vaccine candidates will depend on, among other things, their acceptance by physicians, patients and third-party payers, such as health insurance companies and other members of the medical community, as a vaccine and cost-effective alternative to competing products. If our vaccine candidates fail to gain market acceptance, we may be unable to earn sufficient revenue to continue our business. Market acceptance of, and demand for, any product that we may develop and commercialize will depend on many factors, including:

our ability to provide acceptable evidence of safety and efficacy (including against emerging COVID-19 variants);

the prevalence and severity of adverse side effects;

whether our vaccines are differentiated from other vaccines;

availability, relative cost and relative efficacy of alternative and competing treatments;

the effectiveness of our marketing and distribution strategy;

publicity concerning our products or competing products and treatments; and
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our ability to obtain sufficient third party insurance coverage or reimbursement.

If our vaccine candidates do not become widely accepted by physicians, patients, third-party payers and other members of the medical community, our business, financial condition and results of operations could be materially and adversely affected.

We may not be able to secure sufficient supplies of a key component of our adjuvant technology.

Because an important component of our adjuvant technology is extracted from a species of soap-bark tree (Quillaja saponaria) grown in Chile, we need long term access to quillaja extract with a consistent and sufficiently high quality. We need a secure supply of raw material, as well as back-up suppliers, or our adjuvant products may be delayed and we may not be able to meet our obligations under our various collaboration and supply agreements.

Current or future regional relationships may hinder our ability to engage in larger transactions.

We have entered into regional collaborations to develop, manufacture and distribute our vaccine candidates in certain parts of the world, and we anticipate entering into additional regional collaborations. Our relationships with SIIPL, Takeda, SK bioscience and BMGF are examples of these regional relationships. These relationships often involve the licensing of our technology to our partner or entering into a distribution agreement, frequently on an exclusive basis. Generally, exclusive agreements are restricted to certain territories. Because we have entered into exclusive license and distribution agreements, larger companies may not be interested, or able, to enter into collaborations with us on a worldwide-scale. Also, these regional relationships may make us an unattractive target for an acquisition.

Our product candidates are sensitive to shipping and storage conditions, which could subject our vaccine candidates to risk of loss or damage.

Our vaccine candidates are sensitive to storage and handling conditions. Loss in vaccine candidates could occur if the product or product intermediates are not stored or handled properly. It is possible that our vaccine candidates could be lost due to expiration prior to use. If we do not effectively maintain our supply logistics, then we may experience an unusual number of returned or out of date products. Failure to effectively maintain our supply logistics, by us or third parties, could lead to additional manufacturing costs and delays in our ability to supply required quantities for clinical trials or otherwise.

Our vaccine candidates could become subject to a product recall which could harm our reputation, business, and financial results.

The FDA and similar foreign governmental authorities have the authority to require the recall of certain vaccine candidates. Manufacturers may, under their own initiative, recall a product if any material deficiency in a product is found. A government-mandated or voluntary recall by us or our strategic collaborators could occur as a result of manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our vaccine candidates would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations. A recall announcement could harm our reputation with customers and negatively affect our sales, if any.

Risks Related to Our Industry and Competition

Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees.

The biotechnology and pharmaceutical industries are subject to intense competition and rapid and significant technological change. We have many potential competitors, including major pharmaceutical companies, specialized biotechnology firms, academic institutions, government agencies and private and public research institutions. Many of our competitors have significantly greater financial and technical resources, experience and expertise in:

research and development;

preclinical testing;

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designing and implementing clinical trials;

regulatory processes and approvals;

production and manufacturing; and

sales and marketing of approved products.

Principal competitive factors in our industry include:

the quality and breadth of an organization’s technology;

management of the organization and the execution of the organization’s strategy;

the skill and experience of an organization’s employees and its ability to recruit and retain skilled and experienced employees;

an organization’s intellectual property portfolio;

the range of capabilities, from target identification and validation to drug discovery and development to manufacturing and marketing; and

the availability of substantial capital resources to fund discovery, development and commercialization activities.

Large and established companies, such as Merck & Co., Inc., GlaxoSmithKline plc, CSL Ltd., Sanofi Pasteur, SA, Pfizer Inc., Johnson & Johnson, AstraZeneca, and Moderna, among others, compete in the vaccine market. In particular, these companies have greater experience and expertise in securing government contracts and grants to support their research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products, manufacturing such products on a broad scale and marketing approved products.

Regardless of the disease, smaller or early-stage companies and research institutions also may prove to be significant competitors, particularly through collaborative arrangements with large and established pharmaceutical companies. As these companies develop their technologies, they may develop proprietary positions, which may prevent or limit our product development and commercialization efforts. We will also face competition from these parties in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and participant registration for clinical trials and in acquiring and in-licensing technologies and products complementary to our programs or potentially advantageous to our business. If any of our competitors succeed in obtaining approval from the FDA or other regulatory authorities for their products sooner than we do or for products that are more effective or less costly than ours, our commercial opportunity could be significantly reduced.

In order to effectively compete, we will have to make substantial investments in development, testing, manufacturing and sales and marketing or partner with one or more established companies. We may not be successful in gaining significant market share for any vaccine. Our technologies and vaccines also may be rendered obsolete or non-competitive as a result of products introduced by our competitors to the marketplace more rapidly and at a lower cost.

There is significant competition in the development of a vaccine against COVID-19, influenza, and RSV and we may never see returns on the significant resources we are devoting to our vaccine candidates.

We may be unable to produce a successful COVID-19 vaccine, and establish a competitive market share for our vaccine before the COVID-19 outbreak is contained or significantly diminished. A large number of vaccine manufacturers, academic institutions and other organizations have developed COVID-19 vaccines or are developing COVID-19 vaccine candidates. In particular, Moderna, Pfizer/BioNTech, and Johnson & Johnson have received emergency use authorizations for their COVID-19 vaccines in the U.S. and other countries, and many other companies, including AstraZeneca, Sinovac Biotech, Sinopharm, and Inovio are in various stages of developing and obtaining marketing authorization for COVID-19 vaccine candidates. Despite funding provided to us to date, many of our competitors pursuing vaccine candidates have significantly greater product candidate development, manufacturing and marketing resources than we do. Larger
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pharmaceutical and biotechnology companies have extensive experience in clinical testing and obtaining regulatory approval for their products and may have the resources to heavily invest to accelerate discovery and development of their vaccine candidates. The success of our COVID-19 vaccine will depend, in part, on its relative safety, efficacy (including against emerging variant strains), side effect profile, convenience, and cost. COVID-19 vaccines approved prior to our vaccine satisfy a portion of the demand for initial vaccinations, and we no longer have access to that opportunity. In addition, COVID-19 vaccines approved prior to our vaccine may develop broad market acceptance that we are challenged to overcome. For example, in the U.S. the FDA amended the Pfizer-BioNTech EUA on September 22, 2021, and the Moderna EUA and Johnson & Johnson EUA on October 20, 2021, to authorize the use of a single booster dose for certain populations after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The FDA then amended both of these Pfizer-BioNTech EUA and the Moderna EUA again on November 19, 2021, to authorize the use of such a single booster dose for all patients 18 years and older. On December 9, 2021, the FDA amended only the Pfizer-BioNTech EUA to authorize the use of the single booster dose for all patients 16 years and older. On January 3, 2022, the FDA further amended the Pfizer-BioNTech EUA again to authorize the use of the single booster dose for all patients 12 years and older and third pediatric doses for 5–11-year-old solid organ transplant patients or patients with a similar level of immunocompromise. Furthermore, if any competitors are successful in producing a more efficacious vaccine or other treatment for COVID-19 (including against emerging variant strains), or if any competitors are able to manufacture and distribute any such vaccines or treatments with greater efficiency there may be a diversion of potential governmental and other funding away from us and toward such other parties.

We are allocating significant financial and personnel resources to the development of NVX-CoV2373, which may cause delays in or otherwise negatively impact our other development programs. Our business could be negatively impacted by our allocation of significant resources to combating a global health threat that is unpredictable or against which our vaccine, if commercialized, may ultimately prove unsuccessful or unprofitable.

Many seasonal influenza vaccines are currently approved and marketed. Competition in the sale of these seasonal influenza vaccines is intense. Therefore, newly developed and approved products must be differentiated from existing vaccines in order to have commercial success. In order to show differentiation in the seasonal influenza market, a product may need to be more efficacious, particularly in older adults, and/or be less expensive or quicker to manufacture. Many competitors are working on new products and new generations of current products, intended to be more efficacious than those currently marketed. Our nanoparticle seasonal influenza vaccine candidate may not prove to be more efficacious than current products or products under development by our competitors. Further, our in-house or third-party manufacturing arrangements may not provide enough savings of time or money to provide the required differentiation for commercial success.

We are also aware that there are multiple companies with active RSV vaccine programs at various stages of development. Thus, while there is no RSV vaccine currently on the market, there is likely to be significant and consistent competition as these active programs mature. Different RSV vaccines may work better for different segments of the population, so it may be difficult for a single RSV vaccine manufacturer to provide vaccines that are marketable to multiple population segments. Geographic markets are also likely to vary significantly, which may make it difficult to market a single RSV vaccine worldwide. Even if a manufacturer brings an RSV vaccine to license, it is likely that competitors will continue to work on new products that could be more efficacious and/or less expensive. Our RSV vaccine candidate may not be as far along in development as other active RSV vaccine programs about which we are not aware, nor as efficacious as products under development by competing companies. Even if our RSV vaccine candidate receives regulatory approval, it may not achieve significant sales if other, more effective vaccines under development by our competitors are also approved.

Risks Related to Regulatory and Compliance Matters

We may not succeed in obtaining the FDA licensure or foreign regulatory approvals necessary to sell our vaccine candidates.

The development, manufacture and marketing of our pharmaceutical and biological products are subject to government regulation by the U.S. FDA and regulatory authorities in other jurisdictions, including the European Medicines Agency (EMA), the Czech Republic’s State Institute for Drug Control (SUKL) with respect to our manufacturing facility in the Czech Republic and the Swedish Medical Products Agency (Läkemedelsverket, LV) with respect to our adjuvant product being developed in Sweden, as well as other country authorities into which active pharmaceutical ingredients and excipients are imported and/or manufactured by us or our sub-contracted manufacturers. In the U.S. and most foreign countries, we must complete rigorous preclinical testing and extensive clinical trials that demonstrate the safety and efficacy of a product in order to apply for regulatory approval to market the product. Additionally, we must demonstrate that our manufacturing facilities, processes and controls are adequate with respect to such product to assure safety, purity and potency and comply with applicable good manufacturing practice requirements. None of our vaccine candidates has yet gained regulatory approval in the U.S., although NVX-CoV2373 has received provisional registration, conditional marketing authorization or emergency
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use authorization in certain other jurisdictions. We also have vaccine candidates in clinical trials and preclinical laboratory or animal studies.

Our products might fail to meet their primary endpoints in clinical trials, meaning that we will not have the clinical data required to support regulatory obligations.

The steps generally required by the FDA before our proposed investigational products may be marketed in the U.S. include:

performance of preclinical (animal and laboratory) tests;

submission to the FDA of an IND, which must become effective before clinical trials may commence;

performance of adequate and well controlled clinical trials to establish the safety and efficacy of the investigational product in the intended target population;

performance of a consistent and reproducible manufacturing process at commercial scale capable of passing FDA inspection;

submission to the FDA of a BLA or a NDA; and

FDA approval of the BLA or NDA before any commercial sale or shipment of the product.

Clinical trials that we undertake in other countries will be subject to similar or equivalent processes and requirements, In Europe, as well as an authorization for the trial itself, it is necessary to obtain the consent of a local ethics committee for each trial site and to provide for publication specific information about the trial and its outcome. If endpoints are not met, this information will be made publicly available and could be damaging to the reputation of the Company.

These processes are expensive and can take many years to complete, and we may not be able to demonstrate the safety, purity, potency and efficacy of our vaccine candidates to the satisfaction of regulatory authorities. The start of clinical trials can be delayed or take longer than anticipated for many and varied reasons, many of which are out of our control. Safety concerns may emerge that could lengthen the ongoing clinical trials or require additional clinical trials to be conducted. Promising results in early clinical trials may not be replicated in subsequent clinical trials. Regulatory authorities may also require additional testing, and we may be required to demonstrate that our proposed products represent an improved form of treatment over existing therapies, which we may be unable to do without conducting further clinical trials. Moreover, if a regulatory authority grants regulatory approval of a product, the approval may be limited to specific indications or limited with respect to its distribution. Expanded or additional indications for approved products may not be approved, which could limit our revenue. Foreign regulatory authorities may apply similar limitations or may refuse to grant any approval. Consequently, even if we believe that preclinical and clinical data are sufficient to support regulatory approval for our vaccine candidates, the FDA and foreign regulatory authorities ultimately may not grant approval for commercial sale in their applicable jurisdiction, or may impose regulatory requirements that make further pursuit of approval uneconomical in one or more jurisdictions. If our vaccine candidates are not approved, our ability to generate revenue will be limited, and our business will be adversely affected.

We may fail to obtain regulatory approval for our products on a timely basis or comply with our continuing regulatory obligations after approval is obtained.

Delays in obtaining regulatory approval can be extremely costly in terms of lost sales opportunities, loss of any potential marketing advantage of being early to market and increased clinical trial costs. For example, certain of our APAs and supply agreements may be terminated by the counterparty if we do not timely achieve requisite regulatory approval for NVX-CoV2373 in the relevant jurisdictions under such agreements. The speed with which we begin and complete the preclinical studies necessary to begin clinical trials, the clinical trials themselves and our applications for marketing approval will depend on several factors, including the following:

our ability to scale-up manufacturing capability that reproducibly generates consistent yields of product with required purity, potency and quality; that such scale-up occurs on a timely basis; and that we have access to sufficient quantities of materials for use in necessary preclinical studies and clinical trials;
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regulatory authority review and approval of proposed clinical trial protocols;

approval of clinical trials protocols and informed consent forms by institutional review boards responsible for overseeing the ethical conduct of the trial;

the rate of participant enrollment and retention, which is a function of many factors, including the size of the participant population, the proximity of participants to clinical sites, the eligibility criteria for the clinical trial and the nature of the protocol;

unfavorable test results or side effects experienced by clinical trial participants;

analysis of data obtained from preclinical and clinical activities, which are susceptible to varying interpretations and which interpretations could delay, limit, result in the suspension or termination of, or prevent further conduct of clinical studies or regulatory approval;

the availability of skilled and experienced staff to conduct and monitor clinical trials and to prepare the appropriate regulatory applications; and

changes in the policies of regulatory authorities for drug or vaccine approval during the period of product development.

We have limited experience in conducting and managing the preclinical studies and clinical trials necessary to obtain regulatory marketing approvals. We may not be permitted to continue or commence additional clinical trials. We also face the risk that the results of our clinical trials may be inconsistent with the results obtained in preclinical studies or clinical trials of similar products or that the results obtained in later phases of clinical trials may be inconsistent with those obtained in earlier phases. A number of companies in the biotechnology and product development industry have suffered significant setbacks in advanced clinical trials, even after experiencing promising results in early animal and human testing.

Regulatory agencies may require us or our collaborators to delay, restrict or discontinue clinical trials on various grounds, including a finding that the participants are being exposed to an unacceptable health risk. In addition, we or our collaborators may be unable to submit applications to regulatory agencies within the time frame we currently expect. Once submitted, applications must be approved by various regulatory agencies before we or our collaborators can commercialize the product described in the application. All statutes and regulations governing the conduct of clinical trials are subject to change in the future, which could affect the cost of such clinical trials. Any unanticipated costs or delays in our clinical trials or regulatory submissions could delay our ability to generate revenue and harm our financial condition and results of operations.

Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products internationally.

We intend to have our vaccine candidates marketed outside the U.S. In furtherance of this objective, we have entered into supply agreements with various foreign governments and international distribution agreements with commercial entities. In order to market our products in the European Union, United Kingdom, India, Asia and many other non-U.S. jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing and data review. The time required to obtain foreign regulatory approval may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. Additionally, regulatory authorities outside the United States might not accept data from trials conducted in other countries. Although NVX-CoV2373 has received provisional registration, conditional marketing authorization or emergency use authorization in a number of jurisdictions, we may not obtain regulatory approvals in other relevant jurisdictions on a timely basis, if at all. Approval by one regulatory agency does not ensure approval by regulatory agencies in other jurisdictions. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in other jurisdictions, including approval by the FDA. The failure to obtain regulatory approval in foreign jurisdictions could harm our business.

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The regulatory pathway for NVX-CoV2373 is continually evolving and may result in unexpected or unforeseen challenges.

The regulatory pathway for NVX-CoV2373 is evolving and failure by us to comply with any laws, rules and standards, some of which may not exist yet or are subject to interpretation and may be subject to change, could result in a variety of adverse consequences, including penalties, fines and delays in vaccine licensure. Efforts to comply with evolving laws, regulations and standards have resulted in, and are likely to continue to result in, increased general and administrative expenses and a diversion of management time and attention to regulatory compliance activities. For example, the rules, regulations and standards governing OWS are uncertain and may evolve as the program progresses. Such rules or standards may adversely affect our plans to develop NVX-CoV2373 and failure by us to comply with any laws, rules or standards, some of which may not exist yet or may change, could result in a range of adverse consequences, such as penalties, fines or failure to receive funding.

The speed at which multiple stakeholders are moving to create, test and approve vaccines for COVID-19 is highly unusual and may increase the risks associated with traditional vaccine development, which typically takes between eight and ten years. Given this accelerated timeline, we and regulators, such as the FDA, the EMA, and the MHRA may make decisions more rapidly than is typical. Evolving or changing plans or priorities at the FDA or other regulatory bodies to whom we wish to apply for authorization, including based on new knowledge of COVID-19 and how the disease affects the human body, and new variants of the virus, may significantly affect the regulatory pathway for NVX-CoV2373. Results from clinical testing may raise new questions and require us to redesign proposed clinical trials, including revising proposed endpoints or adding new clinical trial sites or cohorts of subjects. In addition, the FDA’s or other regulatory authorities’ analysis of clinical data may differ from our interpretation, or regulators’ requirements and expectations for vaccine authorization or approval may change over time, with the result that the FDA or other regulators may require that we conduct additional clinical trials or non-clinical studies. The evolving regulatory pathway may impede the development, commercialization and/or licensure of NVX-CoV2373.

In addition, because the path to licensure of any vaccine against COVID-19 is unclear, we may have a widely used vaccine in circulation in certain countries as an investigational vaccine or a product authorized for temporary or emergency use prior to our receipt of full marketing approval. Unexpected safety issues in these circumstances could lead to significant reputational damage for Novavax and our technology platform going forward and other issues, including delays in our other programs, the need for re-design of our clinical trials and the need for significant additional financial resources.

We have conducted, continue to conduct and plan to conduct in the future, a number of clinical trials for NVX-CoV2373 at sites outside the United States and the FDA may not accept data from trials conducted in such locations.

We are currently conducting several clinical trials of NVX-CoV2373 at sites outside the U.S., including a Phase 3 trial partially in Mexico, a Phase 3 trial in the U.K., a Phase 2b trial in South Africa, a Phase 1/2 trial partially in Australia, a Phase 2/3 trial in India, and a Phase 1/2 trial in Japan. Although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of these data is subject to conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and be performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. Other regulatory authorities impose equivalent requirements for their countries. In addition, while these clinical trials are subject to the applicable local laws, where the data is to be used to support our U.S. NDA, FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S. laws and regulations. If the FDA does not accept the data from any trial that we conduct outside the U.S., it could result in delay pending completion of our trials conducted in the U.S. or result in the need for additional trials, which would be costly and time-consuming and could delay or permanently halt our development of NVX-CoV2373.

The later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions, including withdrawal of a vaccine that had previously received regulatory approval in certain jurisdictions from the market.

Even after a product gains regulatory approval, the product and the manufacturer of the product will be subject to continuing regulatory review, including adverse event reporting requirements and prohibitions against promoting products for unapproved uses. Failure to comply with any post-approval requirements can, among other things, result in warning letters, product seizures, recalls, substantial fines, injunctions, suspensions or revocations of marketing authorizations or licenses, operating restrictions and criminal prosecutions. Any such enforcement actions, any unanticipated changes in existing regulatory requirements or the adoption of new requirements, or any safety issues that arise with any approved products,
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could adversely affect our ability to market products and generate revenue and thus adversely affect our ability to continue our business.

We also may be restricted or prohibited from marketing or manufacturing a product, even after obtaining product approval, if previously unknown problems with the product or its manufacture are subsequently discovered. We cannot provide assurance that newly discovered or developed safety issues will not arise following regulatory approval. With the use of any vaccine by a wide patient population, serious adverse events may occur from time to time that did not arise in the clinical trials of the product or that initially appeared to be unrelated to the vaccine itself and only with the collection of subsequent information were found to be causally related to the product. Any such safety issues could cause us to suspend or cease marketing of our approved products, possibly subject us to substantial liabilities, and adversely affect our ability to generate revenue and our financial condition.

Our ability to produce a successful vaccine may be curtailed by one or more government actions or interventions, which may be more likely during a global health crisis such as COVID-19.

Given the significant global impact of the COVID-19 pandemic, it is possible that one or more government entities may take actions, including under the U.S. government under the Defense Production Act of 1950, as amended, that directly or indirectly have the effect of diminishing some of our rights or opportunities with respect to NVX-CoV2373, and the economic value of a COVID-19 vaccine to us could be limited. In addition, during a global health crisis, such as the COVID-19 pandemic, where the spread of a disease needs to be controlled, closed or heavily regulated national borders create challenges and delays in our development, production and distribution activities and may necessitate that we pursue strategies to develop, produce and distribute our vaccine candidates within self-contained national or international borders or with additional safety measures or checks in place, at potentially much greater expense and with longer timeframes for public distribution.

Inadequate funding for the FDA, the SEC and other regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, or otherwise perform their normal functions on which the operation of our business may rely, which could negatively impact our ability to develop or commercialize new products or services, access capital markets, or otherwise operate our business.

The ability of the FDA and other regulatory authorities to review and approve new product applications is affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. For example, average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough employees and stop or slow the pace of critical activities. Equally, the move of the EMA to the Netherlands from London caused a significant loss of experienced staff and the UK’s MHRA’s loss of funding from the E.U. has caused a loss of funding and consequently of staff. If a prolonged government shutdown or slowdown of the relevant regulatory authority occurs, it could significantly impact the ability of that Authority to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Fast Track Designation by the FDA, the issue of conditional marketing authorizations by the EMA or MHRA, or other regulatory acceleration options may not actually lead to a faster development or regulatory review or approval process and does not assure approval.

If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address an unmet medical need for this condition, the drug sponsor may apply for FDA Fast Track Designation or similar fast track processes with other regulatory agencies, such as conditional marketing authorizations from the EMA or MHRA. However, Fast Track Designation or conditional authorizations do not ensure that the drug sponsor will receive marketing approval or that approval will be granted within any particular timeframe. The FDA granted Fast Track Designation for NVX-CoV2373 in November 2020 and for NanoFlu, our recombinant quadrivalent seasonal influenza vaccine candidate, in January 2020. We may also seek Fast Track Designation for more of our other vaccine candidates. If we do seek Fast Track Designation for our other vaccine candidates, we may not receive it, and even if we receive Fast Track
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Designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. Fast Track Designation alone does not guarantee qualification for the FDA’s priority review procedures.

Obtaining a Fast Track Designation does not change the standards for product approval, but may expedite the development or approval process. Even though the FDA has granted such designation for NVX-CoV2373 and NanoFlu, it may not actually result in faster clinical development or regulatory review or approval. Furthermore, such a designation does not increase the likelihood that NVX-CoV2373 or NanoFlu will receive marketing approval in the U.S.

Because we are subject to environmental, health and safety laws, we may be unable to conduct our business in the most advantageous manner.

We are subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, emissions and wastewater discharges, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research, including infectious disease agents. We also cannot accurately predict the extent of regulations that might result from any future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our operations.

Our facilities in Maryland are subject to various local, state and federal laws and regulations relating to safe working conditions, laboratory practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including chemicals, microorganisms and various hazardous compounds used in connection with our research and development activities. In the U.S., these laws include the Occupational Safety and Health Act, the Toxic Test Substances Control Act and the Resource Conservation and Recovery Act. Similar national and local regulations govern our facilities in Sweden and the Czech Republic. We cannot eliminate the risk of accidental contamination or discharge or injury from these materials. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of these materials. We could be subject to civil damages in the event of an improper or unauthorized release of, or exposure of individuals to, these hazardous materials. In addition, claimants may sue us for injury or contamination that results from our use or the use by third parties of these materials, and our liability may exceed our total assets. Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development or production efforts.

Although we have general liability insurance, these policies contain exclusions from insurance against claims arising from pollution from chemicals or pollution from conditions arising from our operations. Our collaborators are working with these types of hazardous materials in connection with our collaborations. In the event of a lawsuit or investigation, we could be held responsible for any injury we or our collaborators cause to persons or property by exposure to, or release of, any hazardous materials. However, we believe that we are currently in compliance with all material applicable environmental and occupational health and safety regulations.

For our product candidates, we will be subject to additional healthcare laws and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.

Within the U.S. (and within foreign countries), if we obtain approval for any of our product candidates and begin commercializing them, our operations may be directly, or indirectly through our arrangements with third-party payors and customers, subject to additional healthcare regulation and enforcement by the federal and state governments (or the regulatory bodies or governments of foreign countries), which may constrain the business or financial arrangements and relationships through which we sell, market and distribute our products. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials. The applicable U.S. federal and state healthcare laws and regulations (which may be comparable to foreign laws existing in foreign countries) that may affect our ability to operate include:

the Federal Food, Drug and Cosmetic Act, which among other things, strictly regulates drug product marketing and promotion and prohibits manufacturers from marketing such products for unapproved uses;

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving or providing remuneration, directly or indirectly, to induce the referral for an item or service or
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the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;

federal false claims laws, including the False Claims Act (“FCA”), which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, information or claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;

manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims; the FCA also permits a private individual acting as whistleblower to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;

federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs;

the federal Physician Payment Sunshine Act and its implementing regulations, which require manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the DHHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners; similar reporting requirements have also been enacted on the state level in the United States, and an increasing number of countries worldwide either have adopted or are considering similar laws requiring disclosure of interactions with health care professionals;

the federal law known as HIPAA, which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

state law equivalents of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state gift ban and transparency laws, many of which state laws differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts; and

state laws restricting interactions with healthcare providers and other members of the healthcare community or requiring pharmaceutical manufacturers to implement certain compliance standards.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to, on a corporate or individual basis, penalties, including civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, the exclusion from participation in federal and state healthcare programs and even imprisonment, any of which could materially adversely affect our ability to operate our business and our financial results. In addition, the cost of implementing sufficient systems, controls, and processes to ensure compliance with all of the aforementioned laws could be significant. Any action for violation of these laws, even if successfully defended, could cause us to incur significant legal expenses and divert management’s attention from the operation of the company’s business. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, that person or entity may be subject to criminal, civil or administrative sanctions, including
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exclusions from government funded healthcare programs. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights those actions, our business may be impaired.

We are also subject to anti-bribery and anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, and other similar worldwide anti-bribery laws, as well as various trade laws and regulations (including economic sanctions, export laws, and customs laws), and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.

The FCPA and similar worldwide anti-bribery and anti-corruption laws prohibit companies and their intermediaries from corruptly providing any payments or other benefits to foreign government officials for the purpose of obtaining or retaining business. The U.S. Departments of Justice, Securities & Exchange Commission, Commerce, State and Treasury and other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for violations of the FCPA, economic sanctions laws, export control laws, and other federal statutes and regulations, including those established by the Office of Foreign Assets Control, or OFAC. In addition, the U.K. Bribery Act of 2010, or the Bribery Act, prohibits both domestic and international bribery, as well as bribery across both private and public sectors. An organization that fails to prevent bribery by anyone associated with the organization can be charged under the Bribery Act unless the organization can establish the defense of having implemented adequate procedures to prevent bribery.

Similarly, U.S. and similar worldwide trade laws, including economic sanctions, export laws, and customs laws, regulate our ability to conduct business with certain jurisdictions and counterparties, and regulate the ways in which we may export and import products around the world. In connection with these laws, various government agencies may require us to obtain export licenses, may seek to impose modifications to business practices, including cessation of business activities in or with countries, entities, and individuals targeted with sanctions. The breadth and dynamic nature of these laws and regulations may increase compliance costs, and may subject us to fines, penalties and other sanctions.

Novavax has received a number of regulatory approvals in ex-U.S. jurisdictions and has commenced commercial operations in these international locations. Further, a portion of our business with respect to our manufacturing is conducted outside of the United States. We expect our international activities to increase in the future. Though we maintain policies, internal controls and other measures reasonably designed to promote compliance with applicable anti-corruption and trade laws and regulations, our employees or agents may nevertheless engage in improper conduct for which we might be held responsible. Any violations of these anti-corruption or trade laws, or even allegations of such violations, can lead to an investigation and/or enforcement action, which could disrupt our operations, involve significant management distraction, and lead to significant costs and expenses, including legal fees. If we, or our employees or agents acting on our behalf, are found to have engaged in practices that violate these laws and regulations, we could be subject to criminal and civil enforcement action, suffer severe fines and penalties, profit disgorgement, injunctions on future conduct, securities litigation, bans on transacting government business, delisting from securities exchanges and other consequences that may have a material adverse effect on our business, financial condition and results of operations. In addition, our reputation, our revenue or our stock price could be adversely affected if we become the subject of any negative publicity related to actual or potential violations of anti-corruption or trade laws and regulations.

Risks Related to our Intellectual Property

Our success depends on our ability to maintain the proprietary nature of our technology.

Our success in large part depends on our ability to maintain the proprietary nature of our technology and other trade secrets. To do so, we must prosecute and maintain existing patents, obtain new patents and pursue trade secret and other intellectual property protection. We also must operate without infringing the proprietary rights of third-parties or allowing third-parties to infringe our rights. We currently have or have rights to over 550 U.S. and foreign patents and patent applications covering our technologies. However, patent issues relating to pharmaceuticals and biologics involve complex legal, scientific and factual questions. To date, no consistent policy has emerged regarding the breadth of biotechnology
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patent claims that are granted by the U.S. Patent and Trademark Office (“USPTO”) or enforced by the federal courts. Therefore, we do not know whether any particular patent applications will result in the issuance of patents, or that any patents issued to us will provide us with any competitive advantage. We also cannot be sure that we will develop additional proprietary products that are patentable. Furthermore, there is a risk that others will independently develop or duplicate similar technology or products or circumvent the patents issued to us.

Although our patent filings include claims covering various features of our vaccine candidates, including composition, methods of manufacture and use, our patents do not provide us with complete protection against the development of competing products. Some of our know-how and technology is not patentable. To protect our proprietary rights in unpatentable intellectual property and trade secrets, we require employees, consultants, advisors and collaborators to enter into confidentiality agreements. These agreements may not provide meaningful protection for our trade secrets, know-how or other proprietary information.

Failure to obtain trademark registrations for proposed product names/brands, in the U.S. or abroad, may adversely impact our business.

Trademark registration to protect the trademarks for our proposed products will require approval from the USPTO in the United States and in trademark offices throughout the world in our key markets. The USPTO or a trademark office in a key international jurisdiction may refuse registration of any of our trademarks on a variety of potential grounds. If registration is not granted to one of our trademarks in the United States or in another key international jurisdiction, we may be required to adopt an alternative name for that proposed product. If we adopt an alternative name, we would lose the benefit of any existing trademark applications for such developmental candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA and other regulatory authorities.

Third parties may claim we infringe their intellectual property rights.

Our research, development and commercialization activities, including any vaccine candidates resulting from these activities, may be found to infringe patents or trademarks owned by third-parties and to which we do not hold licenses or other rights. There may be rights we are not aware of, including applications that have been filed, but not published that, when issued, could be asserted against us. These third-parties could bring claims against us, and that may cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages. Further, if a patent or trademark infringement suit were brought against us, we could be forced to stop or delay research, development, manufacturing or sales of the product or biologic drug candidate that is the subject of the suit.

As a result of patent or trademark infringement claims, or in order to avoid potential claims, we may choose or be required to seek a license from the third party. These licenses may not be available on acceptable terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be non- exclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patent or trademark infringement claims, we are unable to enter into licenses on acceptable terms. All of the issues described above could also impact our collaborators, which would also impact the success of the collaboration and therefore us.

There has been substantial litigation and other proceedings regarding patent, trademark, and other intellectual property rights in the pharmaceutical and biotechnology industries.

We may become involved in litigation to defend or enforce our intellectual property or the intellectual property of our collaborators or licensors, which could be expensive and time-consuming.

Competitors may infringe our patents or the patents of our collaborators or licensors. As a result, we may be required to file patent infringement suits to prevent unauthorized uses. This can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover its technology. An adverse determination of any litigation or defense proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at the risk of not issuing. Competitors may infringe our trademarks or the trademarks of collaborators or licensors. As a result, we may be required to file suit to counter infringement for unauthorized use of an identical or confusingly similar trademark. This can be expensive and time-consuming.

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Even if we are successful, litigation may result in substantial costs and distraction to our management. Even with a broad portfolio, we may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the U.S.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If investors perceive these results to be negative, the market price for our common stock could be significantly harmed.

The scope, validity, and ownership of our patent claims may be challenged in various venues and, if we do not prevail, our ability to exclude competitors may be harmed, potentially reducing our ability to succeed commercially.

We may be subject to a variety of challenges from third parties that relate to the scope of the claims or to their validity. Such challenges can be mounted in post-grant review, ex parte re-examination, and inter partes review proceedings before the USPTO, or similar adversarial proceedings in other jurisdictions. If we are unsuccessful in any such challenge, the scope of our claims could be narrowed or could be invalidated. Any such outcome could impair our ability to exclude competitors from the market in those countries, potentially impacting our commercial success.

Our patents may be subject to various challenges related to ownership and inventorship, including interference or derivation proceedings. Third parties may assert that they are inventors on our patents or that they are owners of the patents. While we perform inventorship analyses to insure that the correct inventors are listed on our patents, we cannot be certain that a court of competent jurisdiction would arrive at the same conclusions we do. If we are unsuccessful in defending against ownership or inventorship challenges, a court may require us to list additional inventors, may invalidate the patent, or may transfer ownership of the patent to a third party. Any of these outcomes may harm our ability to exclude competitors and potentially impact our commercial success. Further, if ownership is transferred to a third party we may be required to seek a license to those rights to preserve our exclusive ability to practice the invention. Such a license may not be available on commercially reasonable terms, or at all. If we are unable to obtain a license, we may be required to expend time, effort, and other resources to design around the patent. Any such license may be non-exclusive and if a competitor is able to obtain a license from the third party, our ability to exclude that competitor from the market may be negatively impacted.

Even if we are ultimately successful, defending any such challenges may cause us to incur substantial expenses and may require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

The scope, validity, and ownership of our trademark rights/registrations may be challenged in various venues in the U.S. and abroad and, if we do not prevail, our ability to exclude competitors from using and registering confusingly similar trademarks may be harmed, potentially reducing our ability to succeed commercially.

We may be subject to a variety of challenges from third parties that relate to the validity of our trademark registrations in the U.S. and internationally. Such challenges can be mounted in trademark cancellation and opposition proceedings before the USPTO, or similar adversarial proceedings in other jurisdictions. If we are unsuccessful in any such challenge, our trademark registrations could be narrowed or could be refused or canceled. Any such outcome could impair our ability to exclude competitors from using a confusingly similar mark, potentially impacting our commercial success.

Our trademark registrations may be subject to various challenges related to likelihood of confusion, use of a trademark in commerce, or other grounds in the U.S. and internationally. Third parties may assert that our trademarks infringe on their prior rights or that we are not using a trademark in a particular jurisdiction in connection with the goods/services identified in the trademark registration. While we perform trademark clearance searches and analysis to determine that we are not infringing upon the trademark rights of others, we cannot be certain that a court of competent jurisdiction would arrive at the same conclusions we do. If we are unsuccessful in defending against such challenges, a court may cancel our trademark registration and/or issue an injunction requiring that we cease use of the trademark. We may also not be able to rely on common law rights that we may have in any trademark. Any of these outcomes may potentially impact our commercial success.

Even if we are ultimately successful, defending any such challenges may cause us to incur substantial expenses and may require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

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We may need to license intellectual property from third parties and, if our right to use the intellectual property we license is affected, our ability to develop and commercialize our vaccine candidates may be harmed.

We have in the past, and we expect in the future to license intellectual property from third parties and that these licenses will be material to our business. We will not own the patents or patent applications that underlie these licenses, and we may not control either the prosecution or the enforcement of the patents. Under such circumstances, we may be forced to rely upon our licensors to properly prosecute and file those patent applications and prevent infringement of those patents.

While many of the licenses under which we have rights provide us with rights in specified fields, the scope of our rights under these and other licenses may be subject to dispute by our licensors or third parties. In addition, our rights to use these technologies and practice the inventions claimed in the licensed patents and patent applications are subject to our licensors abiding by the terms of those licenses and not terminating them. Any of our licenses may be terminated by the licensor if we are in breach of a term or condition of the license agreement, or in certain other circumstances.

Further, any disputes regarding obligations in licenses may require us to take expensive and time-consuming legal action to resolve, and, even if we are successful, may delay our ability to commercialize products and generate revenue. Further, if we are unable to resolve license issues that arise we may lose rights to practice intellectual property that is required to make, use, or sell products. Any such loss could compromise our development and commercialization efforts for current or future product candidates and/or may require additional effort and expense to design around.

Our vaccine candidates and potential vaccine candidates will require several components that may each be the subject of a license agreement. The cumulative license fees and royalties for these components may make the commercialization of these vaccine candidates uneconomical.

If patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize our discoveries.

Important legal issues remain to be resolved as to the extent and scope of available patent protection for biopharmaceutical products and processes in the U.S. and other important markets outside the U.S., such as Europe and Japan. In addition, foreign markets may not provide the same level of patent protection as provided under the U.S. patent system. Litigation or administrative proceedings may be necessary to determine the validity and scope of certain of our and others’ proprietary rights. Any such litigation or proceeding may result in a significant commitment of resources in the future and could force us to do one or more of the following: cease selling or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue; obtain a license from the holder of the intellectual property right alleged to have been infringed, which license may not be available on reasonable terms, if at all; and redesign our products to avoid infringing the intellectual property rights of third parties, which may be time-consuming or impossible to do. In addition, changes in, or different interpretations of, patent laws in the U.S. and other countries may result in patent laws that allow others to use our discoveries or develop and commercialize our products. We cannot provide assurance that the patents we obtain or the unpatented technology we hold will afford us significant commercial protection.

If we do not obtain patent term extension and/or patent term adjustment in the United States under the Hatch- Waxman Act and similar extensions in foreign countries, our ability to exclude competitors may be harmed.

In the United States, the patent term is 20 years from the earliest U.S. non-provisional filing date. Extensions of patent term may be available under certain circumstances. Depending upon the timing, duration and conditions of FDA marketing approval of our product candidates, we may be able to extend the term of one patent that covers a marketed product under the Drug Price Competition and Patent Term Restoration Act of 1984, (the “Hatch-Waxman Amendments”) and similar legislation in the European Union.

The Hatch-Waxman Amendments permit patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. We may not receive any extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner.

Patent term covering our products may also be extended for time spent during the prosecution of the patent application in the USPTO. This extension is referred to as Patent Term Adjustment (“PTA”). The laws and regulations
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governing how the USPTO calculates the PTA is subject to change and changes in the law can reduce or increase any such PTA. Further, the PTA granted by the USPTO may be challenged by a third party. If we do not prevail under such a challenge, the PTA may be reduced or eliminated, shortening the patent term, which may negatively impact our ability to exclude competitors.

Risks Related to Employee Matters, Managing Growth and Information Technology

Our business may be adversely affected if we do not successfully execute our business development initiatives.

We anticipate growing through both internal development projects, as well as external opportunities, which include the acquisition, partnering and in-licensing of products, technologies and companies or the entry into strategic alliances and collaborations. The availability of high quality opportunities is limited, and we may fail to identify candidates that we and our stockholders consider suitable or complete transactions on terms that prove advantageous. In order to pursue such opportunities, we may require significant additional financing, which may not be available to us on favorable terms, if at all. Even if we are able to successfully identify and complete acquisitions, like our business combinations with Novavax CZ (formerly Praha Vaccines) and Novavax AB, strategic transactions involve many risks, including, among others, those related to diversion of management’s attention from other business concerns, unanticipated expenses and liabilities, and increased complexity of our operations, which could prevent us from effectively exploiting acquired facilities, successfully integrating the acquired business and personnel, or fully realizing expected synergies.

To effectively manage our current and future potential growth, we will need to continue to enhance our operational, financial and management processes and to effectively expand, train and manage our employee base. Supporting our growth initiatives will require significant expenditures and management resources, including investments in research and development, manufacturing in-house and through third-party manufacturers and other areas of our business. If we do not successfully manage our growth and do not successfully execute our growth initiatives, then our business and financial results may be adversely impacted, and we may incur asset impairment or restructuring charges.

Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely could compromise our information and expose us to liability, reputational damage, or other costs.

In the ordinary course of our business, we and many of our current and future strategic partners, vendors, contractors, and consultants collect and store sensitive data, including intellectual property, our proprietary business information and data about our clinical participants, suppliers and business partners and personally identifiable information. The secure maintenance of this information is critical to our operations and business strategy. Some of this information represents an attractive target of criminal attack by malicious third parties with a wide range of motives and expertise, including nation-states, organized criminal groups, “hacktivists,” patient groups, disgruntled current or former employees and others. Our ongoing operating activities also depend on functioning information technology systems. Cyber attacks are of ever-increasing levels of sophistication, and, despite our security measures, our information technology systems and infrastructure and those of our vendors and partners are not immune to such attacks or breaches. In 2020, several domestic and foreign security agencies announced that government actors or government-affiliated actors were specifically targeting organizations engaging in COVID-19 vaccine development and research. Our profile as an OWS recipient and our development of NVX-CoV2373 may result in greater risk of cyber attack. Any such attack could result in a material compromise of our networks, and the information stored there could be accessed, publicly disclosed, lost, rendered, permanently or temporarily, inaccessible. Furthermore, we may not promptly discover a system intrusion. Like other companies in our industry, we have and third parties with connections to our systems or with data relevant to our business have experienced attacks to our data and systems, including malware and computer viruses. Additionally, we partner with sites that store our clinical trial data. Attacks could have a material impact on our business, operations or financial results. Any access, disclosure or other loss of information, whether stored by us or our partners, or other cyberattack causing disruption to our business, including ransomware, could result in reputational, business, and competitive harms, significant costs related to remediation and strengthening our cyber defenses, legal claims or proceedings, government investigations, liability including under laws that protect the privacy of personal information, and increased insurance premium, all of which could adversely affect our business. We also may need to pay a ransom if a “ransomware” infection prevents access or use of our systems and we may face reputational and other harms in addition to the cost of the ransom if an attacker steals certain critical data in the course of such an attack.

Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and our failure to comply with data protection laws and regulations could lead to government enforcement actions, which would cause our business and reputation to suffer.

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Evolving state, federal and foreign laws, regulations and industry standards regarding privacy and security apply to our collection, use, retention, protection, disclosure, transfer and other processing of personal data. Privacy and data protection laws may be interpreted and applied differently from country to country and may create inconsistent or conflicting requirements, which increases the costs incurred by us in complying with such laws, which may be substantial. For example, the European Union’s General Data Protection Regulation 2016/679 (“GDPR”), which became effective in May 2018, imposes a broad array of requirements for processing personal data, including elevated disclosure requirements regarding collection and use of such data, requirements that companies allow individuals to obtain copies or demand deletion of personal data held by those companies, limitations on retention of information, and public disclosure of significant data breaches, among other things. The GDPR provides for substantial penalties for non-compliance of up to the greater of €20 million or 4% of global annual revenue for the preceding financial year. From January 1, 2021 the GDPR has been retained in U.K., as it forms part of the law of England and Wales, Scotland and Northern Ireland by virtue of section 3 of the European Union (Withdrawal) Act 2018, as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (SI 2019/419) (“UK GDPR”), alongside the U.K.’s Data Protection Act 2018. Our efforts to comply with GDPR, the UK GDPR and other privacy and data protection laws impose significant costs and challenges that are likely to increase over time, and we are exposed to substantial penalties or litigation related to violations of existing or future data privacy laws and regulations.

Furthermore, the GDPR and UK GDPR impose strict restrictions surrounding the transfer of personal data to countries outside the EEA and the U.K., including to the United States. In 2016, the EU and United States agreed to a transfer framework for data transferred from the European Union to the United States, called the EU-US Privacy Shield. On July 16, 2020, however, the Court of Justice of the European Union issued a decision that declared the Privacy Shield framework invalid and raised questions about whether the European Commission’s Standard Contractual Clauses (“SCCs”), an alternative to the Privacy Shield, can lawfully be used for cross-border data transfers. On June 4, 2021, the European Commission adopted new SCCs under the GDPR for personal data transfers outside of the EEA. Under this legal mechanism, we may have obligations to conduct transfer impact assessments for such cross-border data transfers and implement additional security measures. As we incorporate the new SCCs into our contractual arrangements, we may be required to expend significant resources to update our contractual arrangements and to comply with the new obligations. If we are unable to implement a valid compliance mechanism for cross-border personal information transfers, we may face increased exposure to regulatory actions, substantial fines and injunctions against processing or transferring personal information from Europe to the United States. An inability to import personal information from Europe to the United States may significantly and negatively impact our business operations, including by limiting our ability to conduct clinical trials in Europe; limiting our ability to collaborate with contract research organizations, service providers, contractors and other companies subject to the GDPR; or requiring us to increase our data processing capabilities in Europe at significant expense.

Privacy laws and regulations are also expanding in the United States. The California Consumer Privacy Act (“CCPA”), which became effective January 1, 2020, substantially expands privacy obligations of many businesses, requiring new disclosures to California consumers, imposing new rules for collecting or using information about minors and affording consumers new abilities, such as the right to know whether their data is sold or disclosed and to whom, the right to request that a company delete their personal information, the right to opt-out of the sale of personal information and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right. Like the GDPR, the CCPA establishes potentially significant penalties for violation. The CCPA also provides a private right of action along with statutory damages for certain data breaches, which is expected to increase risks related to data breach litigation. The California Privacy Rights Act (“CPRA”), which will become operational in 2023, expands on the CCPA, creating new consumer rights and protections, including the right to correct personal information, the right to opt out of the use of personal information in automated decision making, the right to opt out of “sharing” consumer’s personal information for cross-context behavioral advertising, and the right to restrict use of and disclosure of sensitive personal information, including geolocation data to third parties. Similar restrictions are also included in the Virginia Consumer Data Protection Act (“VCDPA”) and the Colorado Privacy Act (“CPA”), the first comprehensive state privacy statutes to follow the CCPA. We will need to evaluate and potentially update our privacy program to seek to comply with the CPRA, VCDPA, CPA and other US privacy laws, and we expect to incur additional expense in our effort to comply.

There is also a likelihood that other states will follow California, Colorado and Virginia in enacting more comprehensive privacy laws. Such legislation, if enacted, may add additional complexity, variation in requirements, restrictions and potential legal risk, and may require additional investment of resources in compliance programs, impact strategies, reduce the availability of previously useful data and result in increased compliance costs and/or changes in business practices and policies.

Collaborations and contracts of our wholly owned subsidiaries Novavax AB and Novavax CZ, with regional partners, such as SIIPL, Takeda and SK bioscience, as well as with international providers, expose us to additional risks associated with doing business outside the U.S.
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Swedish-based Novavax AB and Czech Republic-based Novavax CZ are wholly owned subsidiaries of Novavax, Inc. We also have entered into a supply and license agreement with SIIPL, collaboration and license agreements with each of Takeda and SK bioscience and other agreements and arrangements with foreign governments and companies in other countries. We plan to continue to enter into collaborations or partnerships with companies, non-profit organizations and local governments in various parts of the world. Risks of conducting business outside the U.S. include negative consequences of:

the costs associated with seeking to comply with multiple regulatory requirements that govern our ability to develop, manufacture and sell products in local markets;

failure to comply with anti-bribery laws such as the U.S. Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions;

new or changes in interpretations of existing trade protections measures, including tariffs, embargoes and import and export licensing requirements;

difficulties in and costs of staffing, managing and operating our international operations;

changes in environmental, health and safety laws;

fluctuations in foreign currency exchange rates;

new or changes in interpretations of existing tax laws;

political instability and actual or anticipated military or potential conflicts (including, without limitation, the ongoing conflict between Russia and Ukraine, and a wider European or global conflict);

economic instability, inflation, recession and interest rate fluctuations;

minimal or diminished protection of intellectual property in many jurisdictions; and

possible nationalization and expropriation.

These risks, individually or in the aggregate, could have a material adverse effect on our business, financial conditions, results of operations and cash flows.

If we are unable to attract or retain key management or other personnel, our business, operating results and financial condition could be materially adversely affected.

We depend on our senior executive officers, as well as key scientific and other personnel. The loss of these individuals could harm our business and significantly delay or prevent the achievement of research, development or business objectives. Turnover in key executive positions resulting in lack of management continuity and long-term history with our Company could result in operational and administrative inefficiencies and added costs.

We may not be able to attract qualified individuals for key positions on terms acceptable to us. Competition for qualified employees is intense among pharmaceutical and biotechnology companies, and the loss of qualified employees, or an inability to attract, retain and motivate additional highly skilled employees could hinder our ability to complete clinical trials successfully and otherwise develop marketable products.

We also rely from time to time on outside advisors who assist us in formulating our research and development and clinical strategy. We may not be able to attract and retain these individuals on acceptable terms, which could delay our development efforts.

Risks Related to Our Convertible Senior Notes
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Servicing our 3.75% convertible senior unsecured notes due 2023 requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt.

In 2016, we issued $325 million aggregate principal amount of Notes. Our ability to make scheduled payments of the principal of, to pay interest on, or to refinance our indebtedness, including the Notes, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. We do not expect our business to be able to generate cash flow from operations sufficient to service our debt and make necessary capital expenditures and may therefore be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinance our indebtedness, which is non-callable and matures in 2023, will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations, and limit our flexibility in planning for and reacting to changes in our business.

We may not have the ability to raise the funds necessary to repurchase the Notes as required upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the Notes.

Holders of the Notes will have the right to require us to repurchase their Notes for cash upon the occurrence of a fundamental change at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any. A fundamental change may also constitute an event of default or prepayment under, and result in the acceleration of the maturity of, our then-existing indebtedness. We cannot assure that we will have sufficient financial resources, or will be able to arrange financing, to pay the fundamental change repurchase price in cash with respect to any Notes surrendered by holders for repurchase upon a fundamental change. In addition, restrictions in our then existing credit facilities or other indebtedness, if any, may not allow us to repurchase the Notes upon a fundamental change. Our failure to repurchase the Notes upon a fundamental change when required would result in an event of default with respect to the Notes which could, in turn, constitute a default under the terms of our other indebtedness, if any. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes.

Capped call transactions entered into in connection with our Notes may affect the value of our common stock.

In connection with our Notes, we entered into capped call transactions (the “capped call transactions”) with certain financial institutions. The capped call transactions are expected to generally reduce the potential dilution upon conversion of the Notes into shares of our common stock.

In connection with establishing their initial hedges of the capped call transactions, these financial institutions or their respective affiliates entered into various derivative transactions with respect to our common stock and/or to purchase our common stock. The financial institutions, or their respective affiliates, may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock or other securities of ours in secondary market transactions prior to the maturity of the Notes. This activity could also cause or avoid an increase or a decrease in the market price of our common stock or the Notes, which could affect the value of our common stock.

Risks Related to Ownership of Our Common Stock

Because our stock price has been and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected.

Our stock price has been highly volatile. From January 1, 2021 through December 31, 2021, the closing sale price of our common stock has been as low as $112.98 per share and as high as $319.93 per share. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad market fluctuations may cause the market price of our common stock to be lower or more volatile than expected.

Furthermore, given the global focus on the COVID-19 pandemic and our investment in developing a COVID-19 vaccine, information in the public arena on this topic, whether or not accurate, has had and will likely continue to have an outsized impact (positive or negative) on our stock price. Information related to our development, manufacturing, regulatory and commercialization efforts with respect to NVX-CoV2373, or information regarding such efforts by competitors with respect to their COVID-19 vaccines and vaccine candidates, may meaningfully impact our stock price. As a result of this
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volatility, you may not be able to sell your common stock at or above your initial purchase price. The market price of our common stock may be influenced by many other factors, including:

future announcements about us or our collaborators or competitors, including the results of testing, technological innovations or new commercial products;

clinical trial results;

delays in making regulatory submissions;

depletion of our cash reserves;

sale of equity securities or issuance of additional debt;

announcement by us of significant strategic partnerships, collaborations, joint ventures, capital commitments or acquisitions;

changes in government regulations;

impact of competitor successes and in particular development success of vaccine candidates that compete with our own vaccine candidates;

developments in our relationships with our collaboration and funding partners;

announcements relating to health care reform and reimbursement levels for new vaccines and other matters affecting our business and results, regardless of accuracy;

sales of substantial amounts of our stock by us or existing stockholders (including stock by insiders or 5% stockholders);

development, spread or new announcements related to pandemic diseases;

litigation;

public concern as to the safety of our products;

significant set-backs or concerns with the industry or the market as a whole;

regulatory inquiries, reviews and potential action, including from the FDA or the SEC;

recommendations by securities analysts or changes in earnings estimates; and

the other factors described in this Risk Factors section.

In the past, following periods of volatility in the market price of a company’s securities, securities class-action litigation often has been instituted against that company. Such litigation, if instituted against us, could cause us to incur substantial costs to defend such claims and divert management’s attention and resources, which could seriously harm our business, financial condition, and results of operations, and prospects.

Raising additional capital by issuing securities or through collaboration and licensing arrangements may cause dilution to existing stockholders or require us to relinquish rights to our technologies or vaccine candidates.

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If we are unable to partner with a third-party to advance the development of one or more of our vaccine candidates, we will need to raise money through additional debt or equity financings. To the extent that we raise additional capital by issuing equity securities, our stockholders will experience immediate dilution, which may be significant. There is also a risk that such equity issuances may cause an ownership change under the Internal Revenue Code of 1986, as amended, and similar state provisions, thus limiting our ability to use our net operating loss carryforwards and credits. To the extent that we raise additional capital through licensing arrangements or arrangements with collaborative partners, we may be required to relinquish, on terms that may not be favorable to us, rights to some of our technologies or vaccine candidates that we would otherwise seek to develop or commercialize ourselves. In addition, economic conditions may also negatively affect the desire or ability of potential collaborators to enter into transactions with us. They may also have to delay or cancel research and development projects or reduce their overall budgets.

Provisions of our Second Amended and Restated Certificate of Incorporation and Amended and Restated By-Laws and Delaware law could delay or prevent the acquisition of the Company, even if such acquisition would be beneficial to stockholders, and could impede changes in our Board.

Provisions in our organizational documents could hamper a third party’s attempt to acquire, or discourage a third-party from attempting to acquire control of, the Company. Stockholders who wish to participate in these transactions may not have the opportunity to do so. Our organizational documents also could limit the price investors are willing to pay in the future for our securities and make it more difficult to change the composition of our Board in any one year. For example, our organizational documents provide for a staggered board with three classes of directors serving staggered three-year terms and advance notice requirements for stockholders to nominate directors and make proposals.

As a Delaware corporation, we are also afforded the protections of Section 203 of the Delaware General Corporation Law, which will prevent us from engaging in a business combination with a person who acquires at least 15% of our common stock for a period of three years from the date such person acquired such common stock, unless advance board or stockholder approval was obtained.

Any delay or prevention of a change of control transaction or changes in our Board or management could deter potential acquirers or prevent the completion of a transaction in which our stockholders could receive a substantial premium over the then current market price for their shares.

We have never paid dividends on our capital stock, and we do not anticipate paying any such dividends in the foreseeable future.

We have never paid cash dividends on our common stock. We currently anticipate that we will retain all of our earnings for use in the development of our business and do not anticipate paying any cash dividends in the foreseeable future. As a result, capital appreciation, if any, of our common stock would be the only source of gain for stockholders until dividends are paid, if at all.

General Risk Factors

Litigation or regulatory investigations could have a material adverse impact on our results of operation and financial condition.

In addition to intellectual property litigation, from time to time, we may be subject to other litigation or regulatory investigations. Regardless of the merits of any claims that may be brought against us, litigation or regulatory investigations could result in a diversion of management’s attention and resources and we may be required to incur significant expenses defending against these claims. If we are unable to prevail in litigation or regulatory investigations, we could incur substantial liabilities. Where we can make a reasonable estimate of the liability relating to pending litigation and determine that it is probable, we record a related liability. As additional information becomes available, we assess the potential liability and revise estimates as appropriate. However, because of uncertainties relating to litigation, the amount of our estimates could be wrong.

We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies, such as the COVID-19 pandemic.

Our operations, and those of our clinical research organizations, contract manufacturing organizations, vendors of materials needed in manufacturing, collaboration partners, distributors and other third parties upon whom we depend, could be subject to fires, extreme weather conditions, earthquakes, power shortages, telecommunications failures, water shortages,
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floods, hurricanes, typhoons, war, political unrest, sabotage or terrorism and other natural or man-made disasters, as well as public health emergencies, such as the COVID-19 pandemic. The occurrence of any of these business disruptions could prevent us from using all or a significant portion of our facilities and it may be difficult or impossible for us to continue certain activities for a substantial period of time. The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event and we may incur substantial expenses and delays as a result. Our ability to manufacture our product candidates and obtain necessary clinical supplies for our product candidates could be disrupted if the operations of our contract manufacturing organizations or suppliers are affected by a natural or man-made disaster, or a public health emergency.

The outbreak of COVID-19 may materially and adversely affect our business and our financial results.

The COVID-19 pandemic continues to present substantial global economic and public health challenges, which may materially and adversely impact our business, financial condition and results of operations. In response to COVID-19, various aspects of our business operations have been, and could continue to be, disrupted. We continue to implement a work from home policy, with our administrative employees working outside of our offices, and on-site staff restricted to only those required to execute certain laboratory and related support activities. Working remotely could increase our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. In addition, as a result of state or local restrictions, our on-site staff conducting research and development may not be able to access our laboratories, and these core activities may be significantly limited or curtailed, possibly for extended periods of time. Travel restrictions and other governmental measures may also result in a disruption or delay in the performance of our third-party contractors and suppliers. If such third parties are unable to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected. Furthermore, while some jurisdictions have recently started to phase out restrictions imposed on commercial activities at varying degrees, a resurgence of COVID-19, coupled with a potential surge in variant strains of COVID-19, in certain geographies could result in restrictions being reinstated.

Our clinical trials, whether planned or ongoing, may be affected by the COVID-19 pandemic. Study procedures (particularly any procedures that may be deemed non-essential), site initiation, participant recruitment and enrollment, participant dosing, shipment of our product candidates, distribution of clinical trial materials, study monitoring, site inspections and data analysis may be paused or delayed due to changes in hospital or research institution policies, federal, state or local regulations, prioritization of hospital and other medical resources toward efforts to treat or prevent COVID-19, or other reasons related to the pandemic. In addition, there could be a potential effect of COVID-19 to the operations of the FDA or other health authorities, which could result in delays of reviews and approvals, including with respect to our product candidates. Any prolongation or de-prioritization of our clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

The trading prices for our common stock and that of other biopharmaceutical companies have been highly volatile due to the COVID-19 pandemic, especially as a result of investor concerns and uncertainty related to the impact of the outbreak on the economies of countries worldwide. These broad market and industry fluctuations, as well as general economic, political and market conditions, may negatively impact the market price of shares of our common stock.

The COVID-19 pandemic continues to rapidly evolve. The extent to which the outbreak impacts our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the emergence of variant strains, the duration of the pandemic, travel restrictions and social distancing in the U.S. and other countries, business closures or business disruptions and the effectiveness of actions taken in the U.S. and other countries to contain and treat the disease.

The United Kingdom’s withdrawal from the European Union could result in increased regulatory and legal complexity, which may make it more difficult for us to do business in the UK and/or Europe and impose additional challenges in securing regulatory approval of our product candidates in the UK and/or Europe.

The United Kingdom’s exit from the European Union as of January 31, 2020, with a transitional period up to December 31, 2020, commonly referred to as “Brexit”, has caused political and economic uncertainty, including in the regulatory framework applicable to our operations and vaccine candidates in the United Kingdom and the European Union, and this uncertainty may persist for years. Brexit could, among other outcomes, disrupt the free movement of goods, services and people between the United Kingdom and the European Union, and result in increased legal and regulatory complexities, as well as potential higher costs of conducting business in Europe. As one of the Brexit consequences, the EMA has relocated from the United Kingdom to the Netherlands. This has led to a significant reduction of the EMA workforce, which has resulted and could further result in significant disruption and delays in its administrative procedures, such as granting clinical trial authorization or opinions for marketing authorization, disruption of importation and export of active substance and other
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components of new drug formulations, and disruption of the supply chain for clinical trial product and final authorized formulations. As the European Union granted conditional marketing authorization for NVX-CoV2373 after January 1, 2021, it is not grandfathered in the UK. We therefore must seek to obtain a separate marketing authorization for the UK, increasing our regulatory burden.

The cumulative effects of the disruption to the regulatory framework may add considerably to the development lead time to marketing authorization and commercialization of products in the European Union and/or the United Kingdom. It is possible that there will be increased regulatory complexities, which can disrupt the timing of our clinical trials and regulatory approvals. In addition, changes in, and legal uncertainty with regard to, national and international laws and regulations may present difficulties for our clinical and regulatory strategy. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, would prevent us from commercializing our product candidates in the United Kingdom and/or the European Union and restrict our ability to generate revenues and achieve and sustain profitability.

In addition, as a result of Brexit, other European countries may seek to conduct referenda with respect to their continuing membership with the European Union. Given these possibilities and others we may not anticipate, as well as the absence of comparable precedent, it is unclear what financial, regulatory and legal implications the withdrawal of the United Kingdom from the European Union will have, how such withdrawal will affect us, and the full extent to which our business could be adversely affected.

We are increasingly a target for public scrutiny, and our business may be impacted by unfavorable publicity.

Given that COVID-19 represents an unprecedented urgent public health crisis, that we are developing NVX-CoV2373 as a COVID-19 vaccine candidate, and that we have received significant funding from the U.S. and foreign governments and other sources to support the development and potential commercialization of NVX-CoV2373, we have observed and are likely to continue to face significant public attention and scrutiny over the complex decisions we have made and will be making regarding the development, testing, manufacturing, allocation and pricing of NVX-CoV2373. If we are unable to successfully manage these risks, we could face significant reputational harm, which could negatively affect our stock price. The intense public interest, including speculation by the media, in the development of NVX-CoV2373 has caused significant volatility in our stock price, which we expect to continue as data and other information from our ongoing clinical trials become publicly available. If concerns should arise about the actual or anticipated efficacy or safety of any of our product candidates, such concerns could adversely affect the market’s perception of these candidates, which could lead to a decline in investors’ expectations and a decline in the price of our common stock.

The increasing use of social media platforms presents new risks and challenges to our business.

Social media is increasingly being used to communicate about pharmaceutical companies’ research, product candidates, and the diseases such product candidates are being developed to prevent. Social media practices in the pharmaceutical industry continue to evolve and regulations relating to such use are not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business, resulting in potential regulatory actions against us. For example, subjects may use social media channels to comment on their experience in an ongoing blinded clinical trial or to report an alleged adverse event. When such events occur, there is a risk that we fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our investigational product candidates. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social media or networking website. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions, or incur reputational or other harm to our business.
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Item 1B. UNRESOLVED STAFF COMMENTS
None.
Item 2. PROPERTIES

As of December 31, 2021, we leased approximately 40,000 square feet of office space in Gaithersburg, Maryland that serves as our corporate headquarters, and approximately 170,000 square feet of office space in Gaithersburg, Maryland (“700QO”) which the Company intends to use for manufacturing, research and development, and offices. The term of the 700QO lease agreement is approximately 15 years, and the Company has the option to extend the Lease Agreement for two successive five-year terms.

In addition, we lease offices in the United States and foreign locations for our services and support, commercial, research and development, manufacturing, and administrative personnel. As of December 31, 2021, we leased approximately 184,000 square feet of office and other space in the United States, in addition to our corporate headquarters, and approximately 176,000 square feet of office space in various foreign locations. Although we believe that our facilities are suitable and adequate for our present needs, the Company’s management continues to review and assess real property requirements that may be necessary to address our current business plan.

Item 3. LEGAL PROCEEDINGS

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, 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 action is currently stayed, and upon final resolution of the plaintiff’s motion for an award of fees and expenses, the action will be automatically dismissed.

On November 12, 2021, Sothinathan Sinnathurai filed a purported 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”). The complaint in the Sinnathurai Action alleges that the defendants made certain purportedly false and misleading statements concerning NVX-CoV2373, including with respect to the Company’s manufacturing capabilities and NVX-CoV2373’s regulatory and commercial prospects. The purported class is defined as those who purchased or otherwise acquired Novavax securities between March 2, 2021 and October 19, 2021. The complaint demands an award of damages on behalf of the purported class and attorneys’ fees incurred in connection with the litigation. 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 court has ordered the co-lead plaintiffs to file an amended complaint by March 11, 2022. The Company’s response to the amended complaint is due April 25, 2022.

After the Sinnathurai Action was filed, three derivative lawsuits were filed and are currently pending in the U.S. District Court for the District of Maryland: Robert E. Meyer v. Stanley C. Erck, et al., No. 8:21-cv-02996-TDC (the “Meyer Action”), Shui Shing Yung v. Stanley C. Erck, et al., No. 8:21-cv-03248-TDC (the “Yung Action”), and William Kirst, et al. v. Stanley C. Erck, et al., No. 8:22-cv-00024-TDC (the “Kirst Action”). 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 derivative 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. Novavax removed the Kirst Action from the Circuit Court for Montgomery County, Maryland. On February 7, 2022, the plaintiffs in the Kirst Action filed a motion to remand the action to state court and, in response, the Company has filed an opposition. The Court also entered an order tolling the defendants’ time to respond to the complaints in the Meyer and Yung Actions pending submission of a joint proposed briefing schedule on any
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anticipated motion practice in those cases by March 25, 2022. On February 4, 2022, the Court entered an order consolidating the Meyer and Yung Actions.

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 4. MINE SAFETY DISCLOSURES
Not applicable.
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PART II
Item 5.    MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Our common stock trades on the Nasdaq Global Select Market under the symbol “NVAX.” Our common stock was held by approximately 133 stockholders of record as of February 21, 2022, one of which is Cede & Co., a nominee for Depository Trust Company (“DTC”). All of the shares of common stock held by brokerage firms, banks and other financial institutions as nominees for beneficial owners are deposited into participant accounts at DTC, and are therefore considered to be held of record by Cede & Co. as one stockholder. We do not anticipate declaring or paying any cash dividends in the foreseeable future.
Securities Authorized for Issuance under our Equity Compensation Plans
Information regarding our equity compensation plans, including both stockholder approved plans and non-stockholder approved plans, is included in Item 12 of this Annual Report on Form 10-K.
Performance Graph
The graph below matches Novavax, Inc.'s cumulative 5-Year total shareholder return on common stock with the cumulative total returns of the Nasdaq Composite Index and the Russell 2000 Growth Biotechnology Index. The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from December 31, 2016 to December 31, 2021.
COMPARISON OF 5 YEAR CUMULATIVE RETURN*
Among Novavax Inc., the NASDAQ Composite index
and the Russell2000 Growth Biotechnology Index
nvax-20211231_g7.jpg
*$100 invested on 12/31/16 in stock or index, including reinvestment of dividends.
Fiscal year ending December 31.


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Value of $100 invested on December 31, 2016 in stock or index, including reinvestment of dividends, for fiscal years ended December 31:
12/30/1612/29/1712/31/1812/31/1912/31/2012/31/21
Novavax, Inc.$100 $98.41 $146.03 $15.79 $442.5 $567.74 
NASDAQ Composite$100 $129.64 $125.96 $172.17 $249.51 $304.85 
Russell 2000 Growth Biotechnology$100 $159.84 $131.82 $192.39 $299.05 $208.12 
This graph is not “soliciting material,” is not deemed “filed” with the SEC, and is not to be incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
Item 6.    RESERVED
Item 7.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Any statements in the discussion below and elsewhere in this Annual Report on Form 10-K about expectations, beliefs, plans, objectives, assumptions or future events or performance of Novavax, Inc. (“Novavax,” together with its wholly owned subsidiaries Novavax AB and Novavax CZ, 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 NVX-CoV2373 by us and our partners; our expectations with respect to the anticipated ongoing development and commercialization or licensure of NVX-CoV2373 and NanoFlu Program; 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; 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 (“MHRA”), the European Medicines Agency (“EMA”), the Republic of Korea’s Ministry of Food and Drug Safety (“MFDS”), or Japan’s Ministry of Health, Labour and Welfare (“MHLW”); 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 this Annual Report on Form 10-K, 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.

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We cannot guarantee future results, events, level of activity, performance, or achievement. Any or all of our forward-looking statements in this Annual Report on Form 10-K 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.
Overview

We are 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 proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs.

Our vaccine candidates in our near-term pipeline, including both NVX-CoV2373 and the NanoFlu Program, are genetically engineered, three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. At the forefront of our pipeline is our COVID-19 vaccine candidate, NVX-CoV2373. NVX-CoV2373 has received provisional approval, conditional marketing authorization (“CMA”) and emergency use authorization (“EUA") from multiple regulatory authorities globally. In January 2022, we also submitted a request to the FDA for emergency use authorization of NVX-CoV2373. We also advanced our NanoFlu Program vaccine program through a Phase 3 clinical trial, which demonstrated positive top-line results and achieved statistical significance in key secondary endpoints. Additionally, we are currently evaluating a COVID-influenza combination vaccine in a Phase 1/2 clinical trial, which combines the company's NVX-CoV2373 and our NanoFlu Program vaccine candidates. We believe that our protein-subunit-based candidates elicit differentiated immune responses that may be more efficacious than naturally occurring immunity or other vaccine approaches. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

We remain focused on the manufacturing and distribution to bring our NVX-CoV2373 vaccine candidate to market following global regulatory authorizations. Through ongoing booster studies in our clinical trials, as well as the development of COVID-19 variant strain vaccine candidates, we continue to collect data to characterize and optimize vaccine performance. We expect to leverage these clinical insights to advance the use of our COVID-19 vaccine for both primary vaccination around the globe, to use within a booster setting, and for the pediatric population amidst the ongoing and evolving COVID-19 pandemic.

Although NVX-CoV2373 and the NanoFlu Program are our near-term priorities, we remain optimistic that the additional programs in our pipeline, including our vaccine candidates in our RSV Program, and our partner-led malaria candidates, present strong opportunities for future development.

Business Highlights

Fourth Quarter 2021 and Recent Highlights

Achieved Multiple Regulatory Authorizations Globally for COVID-19 Vaccine

Nuvaxovid was granted authorization (emergency, provisional, interim conditional or emergency use listing) in Great Britain, the European Union, the WHO, Canada, Australia, United Arab Emirates, Singapore, and New Zealand; received Biologics License Application approval in South Korea with our partner, SK bioscience

Covovaxwas granted emergency use authorization in India, Indonesia, Philippines, Bangladesh, and emergency use listing from the WHO with our partner, SIIPL

Completed Multiple Regulatory Submissions Globally for COVID-19 Vaccine

Completed regulatory submissions for authorization for NVX-CoV2373 in the U.S. and Switzerland

SIIPL completed submission to South Africa, for NVX-CoV2373 to be marketed as CovovaxTM

Takeda, our partner, completed submission to Japan for a New Drug Application
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COVID-19 Vaccine Advanced Purchase Agreement
Executed APA with Israel’s Ministry of Health to supply a minimum of 5 million vaccine doses
Option to purchase an additional 5 million doses
COVID-19 Vaccine Manufacturing, Supply and Distribution
Built manufacturing and robust supply network to support over 2 billion annual doses of capacity and initiated distribution of NVX-CoV2373 to begin fulfillment of our commitments
Expanded partnership with SIIPL through new supply agreement
Reserved significant additional manufacturing capacity with SK bioscience to produce antigen, and SK bioscience acquired non-exclusive rights to sell to governments in Thailand and Vietnam
Entered into a contract manufacturing agreement with Mabion for the large-scale manufacturing of NVX-CoV2373 through 2026
COVID-19 Vaccine Clinical Development
Announced data from extended analysis of our UK Phase 3 study demonstrating ongoing durability of protection against infection and disease
82.5% vaccine efficacy in protection against all COVID-19 infection, both symptomatic and asymptomatic, as measured by PCR+ or anti-N seroconversion
82.7% overall vaccine efficacy against disease over a 6-month data collection period (median of 101 days of surveillance)
100% vaccine efficacy against severe disease
Announced data from PREVENT-19 Phase 3 pediatric expansion in adolescents aged 12 through 17, achieving primary effectiveness endpoint and comparability to adult population
Adolescent neutralization responses ~1.5-fold higher than adults
82% clinical efficacy against Delta variant
IgG and functional immune responses against variants were higher than in adults
Generally well-tolerated with no safety signals
Expect to supplement global regulatory filings in the first quarter of 2022
Expect to initiate a pediatric study in younger children in the second quarter of 2022
Initiated PREVENT-19 Phase 3 booster study to evaluate safety and efficacy of a third dose of NVX-CoV2373
Heterologous boosting data announced in COV-Boost Phase 2 Study, with NVX-CoV2373 demonstrating its ability to serve as a well-tolerated third dose to boost immune levels

Announced immunologic cross-reactivity data from vaccine booster and adolescent studies to highlight potential utility of NVX-CoV2373 against Omicron variant (B.1.1.529)
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Demonstrated broad IgG antibody cross-reactivity against Omicron and other circulating variants with primary 2-dose regimen
Third dose at 6-months produced increased immune response showing 9.3-fold IgG rise and 19.9-fold functional ACE2 inhibition increase
Ongoing PREVENT-19 Phase 3 pediatric expansion showed robust immune response 2-to-4-fold higher than adults against evaluated variants, including Omicron following primary 2-dose regimen

Developed Omicron-specific vaccine with GMP manufacturing and lab-based assessments underway
Expect delivery toward the end of the first quarter of 2022

COVID-Influenza Combination Vaccine Clinical Development
Ongoing Phase 1/2 trial for COVID-influenza combination vaccine
Data is expected in April 2022
Expect to initiate Phase 2 clinical trial for COVID-influenza combination vaccine and NanoFlu standalone in the second half of 2022

Publication Highlights

Final analysis from PREVENT-19 Phase 3 trial in U.S. and Mexico published in The New England Journal of Medicine

Final analysis from UK Phase 3 influenza co-administration sub-study published in The Lancet Respiratory Medicine

Final analysis of COV-Boost study led by University of Southampton NHS published in The Lancet
Sales of Common Stock
During 2021, we issued and sold 2.6 million of shares of our common stock resulting in net proceeds of approximately $565 million under our various At Market Issuance Sales Agreements. The most recent At Market Issuance Sales Agreement, which we entered into in June 2021 (the “June 2021 Sales Agreement”) and is currently in effect, allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock. In January 2022, we sold 0.4 million shares of our common stock resulting in net proceeds of $34.7 million under the June 2021 Sales Agreement, with a remaining balance of $464.9 million available thereafter.
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, which have been prepared in accordance with generally accepted accounting principles in the U.S.
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 as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. These estimates, particularly estimates relating to accounting for revenue, lease accounting, pre-launch inventory, and accounting for research and development expenses have a material impact on our consolidated financial statements and are discussed in detail throughout our analysis of the results of operations discussed below.
We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities and equity that are not readily apparent from other sources. Actual results and outcomes could differ from these estimates and assumptions.
Revenue Recognition
We perform research and development under government funding, grant, license and clinical development agreements. Our revenue primarily consists of funding under U.S. government contracts and other arrangements to advance the clinical
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development and manufacturing of NVX-CoV2373. Our U.S. government contracts include the DoD Contract and the OWS Agreement. Other funding arrangements primarily include a grant and forgivable loan funding from CEPI.
At contract inception, we analyze our revenue arrangements to determine the appropriate accounting under generally accepted accounting principles in the United States (“U.S. GAAP”). Currently, our revenue arrangements represent customer contracts within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (Topic 606) (“ASC 606”) or are subject to the contribution guidance in ASC Topic 958-605, Not-for-Profit Entities – Revenue Recognition (“ASC 958-605”), which applies to business entities that receive contributions within the scope of ASC 958-605. We recognize revenue from arrangements within the scope of ASC 606 following the five-step model: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to our customer. We recognize contribution revenue within the scope of ASC 958-605 when the funder-imposed conditions have been substantially met. Contributions are recorded as deferred revenue until the period in which research and development activities are performed that satisfy the funder-imposed conditions.
Under our U.S government contracts, we are entitled to receive funding, on a cost-reimbursable or cost-reimbursable-plus-fixed-fee basis, to support certain activities related to the development, manufacture, and delivery of NVX-CoV2373 to the U.S. government. We analyzed these contracts and determined that they are within the scope of ASC 606. Our obligations under each of the contracts are not distinct in the context of the contract as they are highly interdependent or interrelated and, as such, they are accounted for as a single performance obligation. The transaction price under these arrangements is the consideration we expect to receive and consists of the funded contract amount and the unfunded variable amount to the extent that it is probable that a significant reversal of revenue will not occur. We recognize revenue for these contracts over time as we transfer control over the goods and services and satisfy our performance obligation. We measure progress toward satisfaction of our performance obligation using an Estimate-at-Completion (“EAC”) process, which is a cost-based input method that reviews and monitors the progress towards the completion of our performance obligation. Under this process, we consider the costs that have been incurred to-date, as well as projections to completion using various inputs and assumptions, including, but not limited to, progress towards completion, labor costs and level of effort, material and subcontractor costs, indirect administrative costs, and other identified risks. Estimating the total allowable cost at completion of our performance obligation under a contract is subjective and requires us to make assumptions about future activity and cost drivers. Changes in these estimates can occur for a variety of reasons and, if significant, may impact the timing of revenue and fee recognition on our contracts. Allowable contract costs include direct costs incurred on the contract and indirect costs that are applied in the form of rates to the direct costs. Progress billings under the contracts are initially based on provisional indirect billing rates, agreed upon between us and the U.S. government. These indirect rates are subject to review on an annual basis. The impact of changes in the indirect billing rates are recorded in the period when such changes are identified and reflect the difference between actual indirect costs incurred compared to the estimated amounts used to determine the provisional indirect billing rates agreed upon with the U.S. government. We recognize revenue on our U.S government contracts based on reimbursable allowable contract costs incurred in the period up to the transaction price. For our cost-reimbursable-plus-fixed-fee contracts, we recognize the fixed fee based on the proportion of reimbursable contract costs incurred to total estimated allowable contract costs expected to be incurred on completion of the underlying performance obligation as determined under the EAC process. Changes in estimates related to the EAC process are recognized in the period when such changes are made on a cumulative catch-up basis. We include the transaction price comprising both funded and unfunded portions of customer contracts, in this estimate. We have not experienced any material difference as a result of change in estimate arising from the EAC process.
Our other funding arrangements primarily include the CEPI Grant Funding and CEPI Forgivable Loan Funding (each as defined in “Note 2―Summary of Significant Accounting Policies” included in our Notes to Consolidated Financial Statements). The CEPI Forgivable Loan Funding is designated for the prepayment of certain manufacturing activities. We analyzed these other funding arrangements and determined that they are not within the scope of ASC 606 as they do not provide a direct economic benefit to the grantor. Payments received under the grant funding arrangements are considered conditional contributions under the scope of ASC 958-605 and are recorded as deferred revenue until the period in which such research and development activities are actually performed that satisfy the funder-imposed conditions. Payments received under the CEPI Forgivable Loan Funding are only repayable if the proceeds of sales to one or more third parties of NVX-CoV2373 cover our costs of manufacturing such vaccine candidate, not including manufacturing costs funded by CEPI. As the financial risk remains with CEPI, we have determined that the use of the CEPI Forgivable Loan Funding is outside the scope of ASC Topic 470, Debt. The research and development risk is considered substantive, such that it was not probable that the development would be successful at the inception of the contract. Therefore, we have concluded that ASC Topic 730, Research and Development is considered applicable and most appropriate. Given the financial risk associated with the research and development activities lies with CEPI because repayment of any funds provided by CEPI depends solely on the results of the research and development activities having future economic benefit, we account for our obligation under the CEPI Forgivable
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Loan Funding as a contract to perform research and development for others. We have determined that payments received under these agreements should be recorded as revenue under ASC 958-605 rather than a reduction to research and development expenses. This is consistent with our policy of presenting such amounts as revenue. In reaching this determination, we considered a number of factors, including whether we are principal under the arrangement, and whether the arrangement is significant to, and part of, our core operations. We will record revenue as we perform the contractual research and development services.
We have manufacturing and supply arrangements that include a license to use our intellectual property. The licensing arrangements include sales-based royalties, certain development and commercial milestone payments, and the sale of proprietary Matrix-MTM adjuvant. The license is deemed to be the predominant item to which the milestone payments and sales-based royalties relate. Because development milestone payments are contingent on the achievement of milestones that are not within our control or the control of the licensee, such as regulatory approvals, the payments are not considered probable of being achieved and are excluded from the transaction price until the milestone is achieved. We recognize revenue when the development milestone is achieved. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, we recognize revenue on the satisfaction (or partial satisfaction) of the performance obligation to which some or all of the payment has been allocated, which is normally when the related sales occur.

We generally allocate the transaction price to each performance obligation based on a relative standalone selling price basis. We develop assumptions that require judgment to determine the standalone selling price for each performance obligation in consideration of applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer.

Lease Accounting

We enter into manufacturing supply agreements with CMOs and CDMOs to manufacture our vaccine candidates. Certain of these manufacturing supply agreements include the use of identified manufacturing facilities and equipment that are controlled by us and for which we obtain substantially all the output and may qualify as an embedded lease. We treat manufacturing supply agreements that contain a lease as lease arrangements in their entirety. The evaluation of leases that are embedded in our CMO and CDMO agreements is complex and requires judgment in determining whether the contract, either explicitly or implicitly, is for the use of an identified asset, which generally is the use of a portion of the manufacturing facility, whether we have the right to direct the use of, and obtain substantially all of the benefit from, the identified asset, the term of the lease and the fixed lease payments under the contract. Depending on the contract, the lease commencement date, defined as the date on which the lessor makes the underlying asset available for use by the lessee and is the date on which the Company is required to accrue lease expenses, may be different than the inception date of the contract. We determine the non-cancellable lease term of our embedded leases based on the impact of certain expected milestones on our option to terminate the lease where we are reasonably certain to not exercise that option. We evaluate changes to the terms and conditions of a lease contract to determine if they result in a new lease or a modification of an existing lease. For lease modifications, we remeasure and reallocate the remaining consideration in the contract and reassess the lease classification at the effective date of the modification. We classify leases as either operating or finance leases based on the economic substance of the agreement. We also enter into non-cancelable lease agreements for facilities and certain equipment.

For leases that have a lease term of more than 12 months at the lease commencement date, we recognize lease liabilities, which represent our obligation to make lease payments arising from the lease, and corresponding right-of-use (“ROU”) assets, which represent the right to use an underlying asset for the lease term, based on the present value of the fixed future payments over the lease term. We calculate the present value of future payments using the discount rate implicit in the lease, if available, or our incremental borrowing rate. For all leases that have a lease term of 12 months or less at the commencement date (referred to as “short-term” leases), we have elected to apply the practical expedient in ASC Topic 842, Leases (“ASC 842”) to not recognize a lease liability or ROU asset but instead, recognize lease payments as an expense on a straight-line basis over the lease term and variable lease payments that do not depend on an index or rate, as an expense in the period in which the variable lease costs are incurred based on performance or usage in accordance with contractual agreements. In determining the lease period, we evaluate facts and circumstances that could affect the period over which we are reasonably certain to use the underlying asset while taking into consideration the non-cancelable period over which we have the right to use the underlying asset and any option period to extend or terminate the lease if we are reasonably certain to exercise the option. We re-evaluate short-term leases that are modified and if they no longer meet the requirements to be treated as a short-term lease, we recognize and measure the lease liability and ROU asset as if the date of the modification is the lease commencement date (see Note 7 to the accompanying consolidated financial statements). For short-term leases that are modified and continue to meet the requirements to be treated as a short-term lease, we remeasure the fixed lease payments under the modified lease, and recognize lease payments as an expense on a straight-line basis over the modified lease term.

For operating leases, we recognize lease expense related to fixed payments on a straight-line basis over the lease term and lease expense related to variable payments as incurred based on performance or usage in accordance with the contractual agreements. For finance leases, we recognize the amortization of the ROU asset over the shorter of the lease term or useful life
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of the underlying asset. We expense ROU assets acquired for research and development activities under ASC Topic 730, Research and Development, if they do not have an alternative future use, in research and development projects or otherwise.

We use significant assumptions and judgment in evaluating our lease contracts and other agreements under ASC 842, including the determination of whether an agreement is or contains a lease, whether a change in the terms and conditions of a lease contract represent a new or modified lease, whether a lease represents an operating or finance lease, the discount rate used to determine the present value of lease obligations and the term of embedded leases in our manufacturing supply agreements.
Pre-Launch Inventory
Prior to an initial regulatory authorization for our product candidates, we expense costs relating to raw materials and inventory production as research and development expenses in our consolidated statements of operations in the period incurred. We capitalize the costs of production as inventory when we believe regulatory authorization and subsequent commercialization is considered probable and we expect to realize future economic benefit from the sales of the product candidate.
Upon the authorization of distribution and use of NVX-CoV2373 following regulatory authorization by EMA and the WHO in December 2021, we began to capitalize inventory costs associated with the related supply of NVX-CoV2373, as it was determined that inventory costs subsequently incurred had a probable future economic benefit.
Accounting for Research and Development Expenses
We estimate our prepaid and accrued expenses related to our research and development activities using a process that involves reviewing contracts and purchase orders, communicating with our project managers and service providers to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or for which we have been invoiced in advance of the service. This estimation process includes a review of:
expenses incurred under agreements with contract research organizations (“CROs”) that conduct our clinical trials and third party consultants; and
the cost of developing and manufacturing vaccine components under third-party CMOs and CDMOs agreements, including expenses incurred for the procurement of raw materials, laboratory supplies and equipment.
We base our expenses on our estimates of the services provided and efforts expended pursuant to contracts, statements of work and related change orders with the service provider, as well as discussion with internal personnel and external service providers as to the progress of the services and the agreed-upon fee to be paid for such services. The financial terms of these agreements are based on negotiated terms, vary from contract to contract and may result in an uneven level of activity over time. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Additionally, invoicing from third-party service providers may not coincide with actual work performed and can result in a prepaid or an accrual position at the end of the period. The estimation process requires us to make significant judgments and estimates in determining the services incurred as of the balance sheet date, which may result in either a prepaid or an accrual balance. As actual costs become known, we adjust our estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed may vary from the related estimates and could result in us reporting amounts that are too high or too low in a particular period. Our prepaid and accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from CROs, CMOs, CDMOs, and third-party service providers. Due to the nature of the estimation process, there may be a difference between estimated costs and actual costs incurred. Historically, we have not experienced any material differences in prior periods.
Recent Accounting Pronouncements
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 for Fiscal Years 2021 and 2020
The following is a discussion of our historical consolidated financial condition and results of operations, and should be read in conjunction with the consolidated financial statements and notes thereto set forth in this Annual Report on Form 10-K. Additional information concerning factors that could cause actual results to differ materially from those in our forward-looking statements is described under Part I, Item 1A, “Risk Factors” of this Annual Report on Form 10-K.
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For our discussion of the year ended December 31, 2020, compared to the year ended December 31, 2019, please read Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations located in Annual Report on Form 10-K for the year ended December 31, 2020.
Revenue
20212020Change
Revenue (in thousands):
Grants$948,709 $453,210 $495,499 
Royalties and other197,581 22,388 175,193 
Total revenue$1,146,290 $475,598 $670,692 
Grants
The Company recognized grant revenue as follows:
20212020Change
Grant Revenue (in thousands)
U.S. Government Partnership (a)
$788,953 $204,727 $584,226 
U.S. DoD
21,683 12,519 9,164 
CEPI
135,445 223,158 (87,713)
BMGF
2,628 12,806 (10,178)
Total grant revenue$948,709 $453,210 $495,499 
(a) U.S. government partnership formerly known as Operation Warp Speed
Grant revenue for 2021 was $948.7 million as compared to $453.2 million for 2020, an increase of $495.5 million. Grant revenue for 2021 and 2020 primarily comprised revenue for services performed under the OWS Agreement and CEPI Funding Agreement. The increase in revenue was primarily due to increased development activities related to NVX-CoV2373 under the OWS Agreement.
Royalties and Other
Royalties and other revenue for 2021 was $197.6 million as compared to $22.4 million for 2020, an increase of $175.2 million. Royalties and other revenue primarily comprised royalties under our licensing arrangements, and the increase in revenue was due to increased sales-based royalties by our license partners to South Korea and Indonesia.
We expect revenue in 2022 to significantly increase as compared to 2021 due to our NVX-CoV2373 program, which we anticipate will continue to be funded by OWS and/or other revenue sources. Further, we anticipate bringing our NVX-CoV2373 vaccine candidate to market following receipt of global regulatory authorizations, and potential approvals that should significantly increase revenue (also see below under Liquidity and Capital Resources in this Management's Discussion and Analysis). In anticipation, we have entered into various APAs, as well as multiple collaboration and license agreements with strategic partners, to supply NVX-CoV2373 in their specified territories under which we are entitled to receive royalty revenue from the sale of NVX-CoV2373 by such partners.
Expenses:
20212020Change
Expenses (in thousands):
Research and development$2,534,508 $747,027 $1,787,481 
General and administrative298,358 145,290 153,068 
Total expenses$2,832,866 $892,317 $1,940,549 
Research and Development Expenses
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Research and development expenses increased to approximately $2.5 billion for 2021 as compared to $747.0 million for 2020, an increase of $1.8 billion, due to increased development activities relating to NVX-CoV2373, as summarized in the table below.
20212020
Research and Development Expenses (in thousands)
NVX-CoV2373 $2,245,935 $609,401 
NanoFlu7,761 14,802 
Other vaccine development programs818 2,651 
Total direct external research and development expense2,254,514 626,854 
Employee expenses130,576 45,882 
Stock-based compensation expense86,928 55,955 
Facility expenses26,100 7,232 
Other expenses36,390 11,104 
Total research and development expenses$2,534,508 $747,027 

Research and development expenses for NVX-CoV2373 for 2021 and 2020 included approximately $239 million and $217 million, respectively, related to the acceleration of manufacturing costs for leases that we determined were embedded in multiple manufacturing supply agreements with CMOs and CDMOs.
During 2021 and 2020, our research and development activities were primarily focused on the development of NVX-CoV2373 and included direct external research and development expenses related to NVX-CoV2373 of $2.2 billion and $609.4 million, respectively, primarily comprised of costs related to the following:
expenses incurred under agreements with CROs that conduct our clinical trials and third-party consultants related to the development of NVX-CoV2373;

expenses incurred on developing and manufacturing the antigen drug substance and Matrix-Madjuvant components of NVX-CoV2373 under agreements that we established with third-party CMOs and CDMOs;

expenses incurred for the procurement of raw materials, laboratory supplies, and equipment; and

other costs related to preclinical studies and regulatory consulting, as well as related program management activities to support our growing global operations.
We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with vaccine development. As we obtain data from preclinical studies and clinical trials, we may elect to discontinue or delay clinical trials in order to focus our resources on more promising vaccine candidates. Completion of clinical trials may take several years or more, but the length of time can vary substantially depending upon the phase, size of clinical trial, primary and secondary endpoints, and the intended use of the vaccine candidate. The cost of clinical trials may vary significantly over the life of a project as a result of a variety of factors, including:
the number of participants who participate in the clinical trials;
the number of sites included in the clinical trials;
if clinical trial locations are domestic, international, or both;
the time to enroll participants;
the duration of treatment and follow-up;
the safety and efficacy profile of the vaccine candidate; and
the cost and timing of, and the ability to secure, regulatory approvals.
As a result of these uncertainties, we are unable to determine the duration and completion costs of our research and development projects or when, and to what extent, we will generate future cash flows from our research projects.

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For 2022, we expect total research and development expenses to decrease significantly as compared to 2021. The decline in 2022 is anticipated to result from expected 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 NVX-CoV2373 and other programs. Our cost of goods sold expenses could be significant depending on our commercial shipment levels and timing of deliveries. However, we anticipate initially recognizing a lower cost of goods sold expense as a result of pre-launch inventory previously recognized as research and development expenses.

General and Administrative Expenses

General and administrative expenses increased to $298.4 million for 2021 from $145.3 million for 2020, an increase of $153.1 million. The increase in general and administrative expenses is primarily due to increased employee-related costs, including stock-based compensation expense, and an increase in professional fees in support of our NVX-CoV2373 program.

For 2022, we expect 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 employee-related costs and professional fees. We also expect to incur selling and marketing expenses following regulatory authorizations, and potential approvals, of NVX-CoV2373.
Other Income (Expense):
20212020Change 
Other Income (Expense) (in thousands):
Investment income$1,364 $1,014 $350 
Interest expense(21,127)(15,145)(5,982)
Other income (expense)(8,197)12,591 (20,788)
Total other income (expense), net$(27,960)$(1,540)$(26,420)

We had total other expense, net of $28.0 million for 2021 compared to total other expense, net of $1.5 million for 2020, an increase of $26.4 million. In 2021 and 2020, interest expense included $7.2 million and $3.1 million, respectively, related to finance leases. In 2021 and 2020, other income included a loss of $7.2 million and a gain of $12.6 million, respectively, due to changes in the foreign exchange rates, primarily on an intercompany loan with Novavax CZ.
Income Tax Expense:
During the year ended December 31, 2021, we recognized $29.2 million of income tax expense related to foreign withholding tax on royalties. We did not recognize any income tax expense for the year ended December 31, 2020.
Net Loss:
20212020Change 
Net Loss (in thousands, except per share information):
Net loss$(1,743,751)$(418,259)$(1,325,492)
Net loss per share$(23.44)$(7.27)$(16.17)
Weighted average shares outstanding74,400 57,554 16,846 

Net loss for 2021 was $1.7 billion, or $23.44 per share, as compared to $418.3 million, or $7.27 per share, for 2020, an increase of $1.3 billion. The increase in net loss was primarily due to increased development activities relating to NVX-CoV2373, partially offset by increased revenue under the OWS Agreement and, to a lesser extent, royalties under our licensing arrangements.

The increase in weighted average shares outstanding for 2021 is primarily a result of sales of our common stock in 2021 and 2020.
Liquidity Matters and Capital Resources
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Our future capital requirements depend on numerous factors including, but not limited to, our projected activities related to the development of NVX-CoV2373, 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 NanoFlu vaccine candidate and potential combination vaccines candidates, which are in various stages of development. We believe our operating expenses and capital requirements will fluctuate depending upon the timing of events, such as the progress of our NVX-CoV2373 clinical trials and regulatory approval for the use of NVX-CoV2373 in the U.S. and internationally, as well as the scope, initiation and progress of our preclinical studies and clinical trials related to other research and development activities.
We have entered into APAs or supply agreements with Gavi, the EC, and various countries globally. We also have grant and license agreements. As of December 31, 2021, 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 licensing agreements, was approximately $8 billion. The timing to fulfill performance obligations related to grant agreements will depend on the results of our research and development activities, including clinical trials. The timing to fulfill performance obligations related to APAs will depend on timing of product manufacturing, delivery, and receipt of marketing authorizations. The remaining unfilled performance obligations are expected to be fulfilled in less than one year. The APAs or 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. Such upfront payments generally become non-refundable upon our achievement of certain development and commercial milestones. However, certain of the APAs and supply agreements may be terminated by the counterparty if we do not timely achieve requisite regulatory approval for NVX-CoV2373 in the relevant jurisdictions under such agreements. If the APAs or supply agreements were terminated, the refundable portion of the upfront payments will be repaid. We expect to sign additional APAs or supply agreements that are currently in active discussions and negotiations.
In May 2021, we finalized an APA with Gavi, building upon our MOU previously announced in February 2021. Under the terms of the agreement, 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. We expect to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility. Under a separate purchase agreement with Gavi, SIIPL is expected to manufacture and deliver the balance of the 1.1 billion doses of NVX-CoV2373 for low- and middle-income countries participating in the COVAX Facility. We expect to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the investments previously received from CEPI. In October 2021, we entered into a supply agreement and a contract development manufacturing agreement with SIIPL and SLS under which SIIPL and SLS will supply us with NVX-CoV2373. We expect to deliver doses with antigen and adjuvant manufactured at facilities directly funded under the funding agreement with CEPI, with initial doses supplied by SIIPL and SLS under the supply agreement. We expect to supply significant doses that Gavi would allocate to low-, middle- and high-income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi may prioritize such doses to low- and middle- income countries, at lower prices. Additionally, we may provide additional doses, to the extent available from CEPI-funded manufacturing facilities, in the event that SIIPL cannot materially deliver expected vaccine doses to the COVAX Facility. Together with SIIPL, we expect to initiate delivery of doses following receipt of appropriate regulatory authorizations. Under the APA, we received an upfront payment of $350 million from Gavi in 2021 and recorded a receivable as of December 31, 2021, for an additional $350 million because the Company secured EUL for NVX-CoV2373 by the WHO in December 2021, which are recorded as deferred revenue.
We have also entered into supply and license agreements with strategic partners to supply NVX-CoV2373 in their specified territories under which we are entitled to receive royalties primarily from the sale of NVX-CoV2373 by our partners, such as SIIPL in India, Takeda in Japan, and SK bioscience in the Republic of Korea. During 2021, we received royalties of $195.8 million under these licensing arrangements.
We funded our operations in 2021 with cash and marketable securities on hand, upfront payments under APAs, and proceeds from the sale of common stock, together with revenue under the OWS Agreement and CEPI Funding Agreement that support our NVX-CoV2373 vaccine development activities. We anticipate our future operations to be funded by our cash, cash equivalents and marketable securities, upfront payments under our APAs and revenue under our OWS Agreement, and, following receipt of global regulatory authorizations, and potential approvals, revenue from product sales, royalties under licensing arrangements with our strategic partners, and/or other potential funding sources.
As of December 31, 2021, we had $1.5 billion in cash and cash equivalents, marketable securities, and restricted cash as compared to $806.4 million as of December 31, 2020. These amounts consisted of $1.5 billion in cash and cash equivalents,
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no marketable securities, and $13.1 million in restricted cash as of December 31, 2021 as compared to $553.4 million in cash and cash equivalents, $157.6 million in marketable securities, and $95.3 million in restricted cash as of December 31, 2020.
The following table summarizes cash flows for 2021 and 2020:
20212020Change
Summary of Cash Flows (in thousands):
Net cash (used in) provided by:
Operating activities$322,946 $(42,541)$365,487 
Investing activities100,154 (377,778)477,932 
Financing activities461,713 984,762 (523,049)
Effect on exchange rate on cash, cash equivalents and restricted cash(5,292)2,115 (7,407)
Net increase in cash, cash equivalents and restricted cash879,521 566,558 312,963 
Cash, cash equivalents and restricted cash at beginning of year648,738 82,180 566,558 
Cash, cash equivalents and restricted cash at end of year$1,528,259 $648,738 $879,521 
Net cash provided by operating activities increased to $322.9 million for 2021, as compared to $42.5 million used in 2020. The increase in cash provided is primarily due to payments under APAs recorded as deferred revenue, partially offset by funding of our increased net loss and the timing of payments to third parties.
During 2021, our investing activities primarily consisted of capital expenditures and purchases and maturities of marketable securities. During 2020, our investing activities primarily consisted of capital expenditures, purchases and maturities of marketable securities, and our acquisition of Novavax CZ. Capital expenditures for the years ended December 31, 2021 and 2020 were $57.5 million and $54.6 million, respectively. For 2022, we expect an increase in our capital expenditures 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 to accommodate anticipated increases in headcount.
Our financing activities consisted primarily of sales of our common stock under our At Market Issuance Sales Agreements, finance lease payments related to embedded leases and, to a much lesser extent, exercises of stock-based awards and purchases under our employee stock purchase plan. In 2021, we received net proceeds of approximately $565 million from the sale of shares of common stock through our At Market Issuance Sales Agreements. In 2020, we received net proceeds of approximately $877 million (this amount excludes $3.2 million received in the first quarter of 2021 for shares traded in late December 2020) from selling shares of common stock through our various At Market Issuance Sales Agreements and approximately $200 million through the issuance of preferred stock in a private placement.
Contractual Obligations
The following table summarizes our contractual obligations as of December 31, 2021 (in thousands):
Contractual Obligations:TotalLess than 
One Year
1 – 3
Years
3 – 5
Years
More than
5 Years
Operating leases$81,191 $32,959 $14,342 $14,705 $19,185 
Finance leases obligation133,286 133,286 — — — 
Convertible notes (a)325,000 — 325,000 — — 
Contractual obligations recognized as of December 31, 2021539,477 166,245 339,342 14,705 19,185 
Purchase commitments (b)826,112 826,112 — — — 
Facilities lease agreement (c)104,249 5,814 12,067 12,678 73,690 
Total contractual obligations$1,469,838 $998,171 $351,409 $27,383 $92,875 
(a)    See Note 8 to the consolidated financial statements included in this Annual Report on Form 10-K regarding our Notes, which will mature on February 1, 2023, and bear cash interest of 3.75%, payable February 1 and August 1 of each year.
(b)    This amount primarily represents our non-cancelable fixed payment obligations under certain CMO, CDMO, and lab supply agreements that we are not contractually able to terminate for convenience. Certain agreements provide for termination rights subject to termination fees. Under such agreements, we are contractually obligated to make payments to vendors, mainly to reimburse them for their estimated unrecoverable expenses incurred. As of December 31, 2021, these agreements are active
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ongoing arrangements and the Company expects to receive value from these arrangements in the future. The exact amount of such obligations is dependent on the timing of termination, and the exact terms of the relevant agreement, and cannot be reasonably estimated.
(c)    This relates to the lease of 700 Quince Orchard that did not commence as of December 31, 2021 (see Note 7 to the consolidated financial statements).
In addition to the above obligations, we enter into a variety of agreements and financial commitments in the normal course of business. The terms generally allow us the option to cancel, reschedule, and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. It is not possible to predict the maximum potential amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement.
Item 7A.    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. where we conduct the vast majority of our business activities, our results of operations are subject to foreign currency exchange rate fluctuations, including our foreign subsidiaries’ operations. We have two foreign consolidated subsidiaries, Novavax AB, which is located in Sweden, and Novavax CZ, which is located in the Czech Republic.

While the financial results of our global activities are reported in U.S. dollars, the functional currency for our foreign subsidiaries is 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 exchange rate between the U.S. dollar and Swedish Krona would result in a decline of stockholders’ equity (deficit) of approximately $4 million as of December 31, 2021. A 10% decline in the exchange rate between the U.S. dollar and Czech Koruna would result in a decline of stockholders’ equity (deficit) of approximately $4 million as of December 31, 2021.

Interest Rate Risk
Our exposure to interest rate risk is primarily confined to our investment portfolio. 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.
Our 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 8.    FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by this item is set forth on pages F-1 to F-34.
Item 9.    CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.

Item 9A.    CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures” (defined in SEC Rule 13a-15(e)) refers to the controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Securities Exchange Act of 1934 (the “Exchange Act”) is recorded, processed, summarized and reported, within time periods specified in the rules and forms of the Securities and Exchange Commission. “Disclosure controls and
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procedures” include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
The Company’s management, with the participation of the chief executive officer and the chief financial officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K (the “Evaluation Date”). Based on that evaluation, the Company’s chief executive officer and chief financial officer have concluded that, as of the Evaluation Date, such controls and procedures were effective at the reasonable assurance level.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act, as a process designed by, or under the supervision of, the Company’s principal executive officer and principal financial officer and effected by the Company’s board of directors, management and other personnel, 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 in the United States (“GAAP”). Such internal control includes those policies and procedures that:
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and
provide reasonable assurance regarding prevention or timely detection of an unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2021. In making this assessment, our management used the criteria set forth in the 2013 Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on its assessment, our management has determined that, as of December 31, 2021, our internal controls over financial reporting are effective based on those criteria.
Ernst & Young LLP has issued a report on our internal control over financial reporting. This report is included in the Reports of Independent Registered Public Accounting Firm in Item 15.(a)(1).
Changes in Internal Control over Financial Reporting
Our management, including our chief executive officer and chief financial officer, has evaluated any changes in our internal control over financial reporting that occurred during the quarterly period ended December 31, 2021 and has concluded that there was no change that occurred during the quarterly period ended December 31, 2021 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B.    OTHER INFORMATION
None.
Item 9C.    DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
PART III
Item 10.    DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
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The information required by this item is incorporated by reference from our definitive Proxy Statement for our 2022 Annual Meeting of Stockholders scheduled to be held in June 2022 (the “2022 Proxy Statement”). We expect to file the 2022 Proxy Statement within 120 days after the close of the fiscal year ended December 31, 2021.
Item 11.    EXECUTIVE COMPENSATION
We incorporate herein by reference the information required by this item concerning executive compensation to be contained in the 2022 Proxy Statement.
Item 12.    SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
We incorporate herein by reference the information required by this item concerning security ownership of certain beneficial owners and management and related stockholder matters to be contained in the 2022 Proxy Statement.
The following table provides our equity compensation plan information as of December 31, 2021. Under these plans, our common stock may be issued upon the exercise and/or vesting of equity awards and purchases under our Employee Stock Purchase Plan (“ESPP”). See also the information regarding our equity awards and ESPP in Note 13 to the consolidated financial statements included herewith.
Equity Compensation Plan Information
Plan CategoryNumber of Securities
to be Issued
Upon Exercise of
Outstanding Options,
Warrants and Rights
(a)
Weighted-Average
Exercise Price of
Outstanding
Options, Warrants
and Rights
(b)
Number of Securities
Remaining Available for
Future Issuance Under
Equity Compensation
Plans (Excluding
Securities Reflected in
Column (a))
(c)
Equity compensation plans approved by security holders (1)4,523,890$43.843,881,131
Equity compensation plans not approved by security holdersN/AN/AN/A
(1)Includes our 2015 Stock Incentive Plan, 2005 Stock Incentive Plan, and ESPP. The weighted-average exercise price in column (b) excludes restricted stock units, which are not subject to an exercise price.
Item 13.    CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
We incorporate herein by reference the information required by this item concerning certain related party transactions set forth in Note 16 to our consolidated financial statements included herewith. We incorporate herein by reference other information required by this item concerning certain other relationships and related transactions and director independence to be contained in the 2022 Proxy Statement.
Item 14.    PRINCIPAL ACCOUNTING FEES AND SERVICES
We incorporate herein by reference the information required by this item concerning principal accountant fees and services to be contained in the 2022 Proxy Statement.
PART IV
Item 15.    EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)The following documents are filed as part of the Annual Report on Form 10-K:
(1)Index to Financial Statements
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F- 2
F- 5
F- 6
F- 7
F- 8
F- 9
(2)Financial Statement Schedules
Financial statement schedules are omitted because they are not applicable, not required under the instructions or all the information required is set forth in the financial statements or notes thereto.
(3)Exhibits

Exhibits marked with a single asterisk (*) are filed herewith.

Exhibits marked with a double plus sign (††) refer to management contracts, compensatory plans, or arrangements.
Confidential treatment has been granted for portions of exhibits marked with a double asterisk (**).
Confidential information contained in exhibits marked with a caret (^) has been omitted because it (i) is not material and/or (ii) would be competitively harmful if publicly disclosed.

All other exhibits listed have previously been filed with the SEC and are incorporated herein by reference.

Exhibit
Number
Description
3.1
3.2
3.3
3.4
4.1
4.2
4.3
4.4*
10.1††
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10.2††
10.3††
10.4††
10.5††
10.6††
10.7††
10.8††
10.9††
10.10††
10.11††
10.12††
10.13††
10.14††
10.15††
10.16††
10.17††
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10.18††
10.19††
10.20††
10.21††
10.22††
10.23††
10.24††
10.25††

10.26††
10.27††
10.28
10.29
10.30
10.31
10.32
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10.33*
10.34**
10.35**
10.36^
10.37^*
10.38^
10.39^*
10.40^*
10.41^
10.42**
10.43**
10.44^
10.45^
10.46^
10.47^*
10.48^
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10.49^
10.50^
10.51^
10.52^
10.53^
10.54^
10.55^
10.56^
10.57^
10.58^
10.59^
10.60^
10.61^
10.62^
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10.63^
10.64^*
10.65^*
10.66
10.67
10.68^
10.69^
10.70
10.71
10.72
10.73
10.74
10.75
10.76^
10.77
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14*
21*
23.1*
31.1*
31.2*
32.1*
32.2*
101The following financial information from our Annual Report on Form 10-K for the year ended December 31, 2021, formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated Balance Sheets as of December 31, 2021 and 2020, (ii) the Consolidated Statements of Operations for the three years in the period ended December 31, 2021, (iii) the Consolidated Statements of Comprehensive Loss for the three years in the period ended December 31, 2021, (iv) the Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three years in the period ended December 31, 2021, (v) the Consolidated Statements of Cash Flows for the three years in the period ended December 31, 2021, and (vi) the Notes to Consolidated Financial Statements.
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Item 16.    FORM 10-K SUMMARY
Not applicable.
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.
By: /s/ Stanley C. Erck
Stanley C. Erck
President and Chief Executive Officer
Date: February 28, 2022
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:

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NameTitleDate
/s/ Stanley C. ErckPresident and Chief Executive Officer and Director (Principal Executive Officer)February 28, 2022
Stanley C. Erck
/s/ James P. Kelly
Executive Vice President, Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer)
February 28, 2022
James P. Kelly
/s/ James F. YoungChairman of the Board of DirectorsFebruary 28, 2022
James F. Young
/s/ Gregg H. AltonDirectorFebruary 28, 2022
Gregg H. Alton
/s/ Richard H. DouglasDirectorFebruary 28, 2022
Richard H. Douglas
/s/ Rachel K. KingDirectorFebruary 28, 2022
Rachel K. King
/s/ Margaret G. McGlynnDirectorFebruary 28, 2022
Margaret G. McGlynn
/s/ Michael A. McManusDirectorFebruary 28, 2022
Michael A. McManus
/s/ Rajiv I. ModiDirectorFebruary 28, 2022
Rajiv I. Modi
/s/ David M. MottDirectorFebruary 28, 2022
David M. Mott

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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Years ended December 31, 2021, 2020, and 2019
Contents
F- 2
F- 5
F- 6
F- 7
F- 8
F- 9

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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Novavax, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Novavax, Inc. (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 28, 2022 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing a separate opinion on the critical audit matters or on the account or disclosures to which they relate.

Revenue recognition related to the cost-based input method for U.S. government contracts
Description of the Matter
As described in Note 12 to the consolidated financial statements, the Company recorded approximately $811 million of revenue from U.S. government contracts to advance the clinical development and manufacturing of NVX-CoV2373 on a reimbursable-cost or reimbursable-cost-plus fixed fee basis. The Company measures progress toward satisfaction of its performance obligations using a cost-based input method that requires an estimate of total allowable cost at completion. Estimating the total allowable costs at completion is highly subjective. Changes in the estimated total allowable cost at completion could materially impact the timing of revenue recognition. Allowable contract costs include direct costs incurred on the contract and indirect costs that are applied in the form of rates to the direct costs.

Auditing revenue recognition based on the cost-based input method involved subjective auditor judgment. The estimates of costs at completion are based on management’s assessment of the costs necessary to fulfill its performance obligations under the contracts. Auditing allowable contract costs was complex due to the specialized knowledge needed to evaluate the costs included in the calculation of indirect rates and the contract terms.
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How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over recognition of revenue under the cost-based input method. For example, we tested controls over the appropriateness of significant assumptions regarding the estimation of allowable costs to be incurred for the performance obligations and controls over the appropriateness of the indirect rate calculation.

To test the recognition of revenue under the cost-based input method, our audit procedures included among others, reviewing management’s estimate to total allowable costs at completion for consistency with contract terms, obtaining an understanding of the stage of completion through review of project deliverables, evidence of stage of completion including discussion with clinical research and manufacturing teams, and comparing actual results to prior management estimates. To test the recognition of revenue related to indirect rates, our audit procedures included among others, testing the allowability of the underlying costs used in the Company’s calculation of indirect rates. We utilized specialists to evaluate the treatment of significant indirect cost types.
Identification of embedded leases related to manufacturing supply agreements
Description of the Matter
As described in Note 7 to the consolidated financial statements, the Company entered into multiple supply agreements with contract manufacturing organizations and contract development and manufacturing organizations. The Company determined that certain of these arrangements contain embedded leases as it has the exclusive use of, and control over, a portion of the manufacturing facility or equipment of the contract manufacturing organization during the contractual term of the arrangements. As a result of identifying embedded leases in certain of these arrangements, the Company immediately expensed approximately $144 million, which represented the right of use assets related to these arrangements that did not have an alternative future use.

Auditing embedded leases within supply agreements was complex due to the judgment required to evaluate whether each arrangement included a lease and the related lease term. This significant auditor judgment involves the assessment of whether the Company has the right to obtain substantially all of the economic benefits from the use of identified assets and an assessment of the lease term, including whether the Company is reasonably certain not to exercise its termination provisions within the arrangements.

How We Addressed the Matter in Our Audit
We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over the identification of embedded leases in supply agreements. For example, we tested controls over management’s review of the supply agreements that evaluated whether management was entitled to substantially all of the economic benefits, as well as management’s assessment of the various termination provisions.

To test the Company’s identification of embedded leases, our audit procedures included among others, reviewing the terms of supply agreements with contract manufacturing organizations, obtaining an understanding of the facilities and equipment subject to the arrangements through discussions with representatives of the counterparties, and evaluating the identification of embedded leases and determination of the lease term.

/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2014.
Tysons, Virginia
February 28, 2022
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Novavax, Inc.
Opinion on Internal Control over Financial Reporting
We have audited Novavax, Inc.’s internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Novavax, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2021, and the related notes and our report dated February 28, 2022 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting included in Item 9A. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed 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. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Tysons, Virginia
February 28, 2022
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NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
December 31,
20212020
ASSETS
Current assets:
Cash and cash equivalents$1,515,116 $553,398 
Marketable securities— 157,649 
Restricted cash11,490 93,880 
Accounts receivable454,993 262,012 
Prepaid expenses and other current assets173,520 181,264 
Total current assets2,155,119 1,248,203 
Property and equipment, net228,696 179,954 
Intangible assets, net4,770 5,725 
Goodwill131,479 135,379 
Other non-current assets56,689 13,218 
Total assets$2,576,753 $1,582,479 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:  
Accounts payable$127,050 $54,332 
Accrued expenses673,731 137,390 
Deferred revenue1,422,944 273,228 
Current portion of finance lease liabilities130,533 105,862 
Other current liabilities36,061 8,860 
Total current liabilities2,390,319 579,672 
Deferred revenue172,528 — 
Convertible notes payable323,458 322,035 
Non-current finance lease liabilities— 40,083 
Other non-current liabilities42,121 13,480 
Total liabilities2,928,426 955,270 
Commitments and contingencies
Preferred stock, $0.01 par value, 2,000,000 shares authorized at December 31, 2021 and 2020; no shares issued and outstanding at December 31, 2021 and 2020
— — 
Stockholders’ equity (deficit):
Common stock, $0.01 par value, 600,000,000 shares authorized at December 31, 2021 and 2020; and 76,433,151 shares issued and 75,841,171 shares outstanding at December 31, 2021 and 71,350,365 shares issued and 70,953,739 shares outstanding at December 31, 2020
764 714 
Additional paid-in capital3,351,967 2,535,476 
Accumulated deficit(3,617,950)(1,874,199)
Treasury stock, 591,980 shares, cost basis at December 31, 2021 and 396,626 shares, cost basis at December 31, 2020
(85,101)(41,806)
Accumulated other comprehensive income (loss)(1,353)7,024 
Total stockholders’ equity (deficit)(351,673)627,209 
Total liabilities and stockholders’ equity (deficit)$2,576,753 $1,582,479 
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
 Year Ended December 31,
 202120202019
Revenue:   
Grants$948,709 $453,210 $15,937 
Royalties and other197,581 22,388 2,725 
Total revenue1,146,290 475,598 18,662 
Expenses:
Research and development2,534,508 747,027 113,842 
Gain on sale of assets— — (9,016)
General and administrative298,358 145,290 34,417 
Total expenses2,832,866 892,317 139,243 
Loss from operations(1,686,576)(416,719)(120,581)
Other income (expense):
Investment income1,364 1,014 1,512 
Interest expense(21,127)(15,145)(13,612)
Other income (expense)(8,197)12,591 (13)
Loss before income tax expense(1,714,536)(418,259)(132,694)
Income tax expense29,215 — — 
Net loss$(1,743,751)$(418,259)$(132,694)
Basic and diluted net loss per share$(23.44)$(7.27)$(5.51)
Basic and diluted weighted average number of common shares outstanding74,400 57,554 24,100 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
 Year Ended December 31,
 202120202019
Net loss$(1,743,751)$(418,259)$(132,694)
Other comprehensive income (loss):
Net unrealized gains (losses) on marketable securities available-for-sale, net of reclassifications(9)
Foreign currency translation adjustment(8,368)19,523 (1,322)
Other comprehensive income (loss)(8,377)19,532 (1,317)
Comprehensive loss$(1,752,128)$(398,727)$(134,011)
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
(in thousands, except share information)
 Common StockAdditional
Paid-in
Capital
Accumulated
Deficit
Treasury
Stock
Accumulated
Other
Comprehensive
Income (Loss)
Total
Stockholders’ Equity (Deficit)
 SharesAmount
Balance at December 31, 201819,245,302 $192 $1,144,621 $(1,299,107)$(2,450)$(11,191)$(167,935)
Stock-based compensation— — 17,048 — — — 17,048 
Stock issued under incentive programs173,873 1,122 — (132)— 992 
Fractional shares purchased in stock split— — — — (1)— (1)
Issuance of common stock, net of issuance costs of $1,655
12,980,177 130 97,760 — — — 97,890 
Unrealized gain on marketable securities— — — — — 
Foreign currency translation adjustment— — — — — (1,322)(1,322)
Net loss— — — (132,694)— — (132,694)
Balance at December 31, 201932,399,352 324 1,260,551 (1,431,801)(2,583)(12,508)(186,017)
Preferred stock beneficial conversion feature
— — 24,139 (24,139)— — — 
Conversion of preferred stock4,388,850 44 199,778 — — — 199,822 
Stock-based compensation— — 128,035 — — — 128,035 
Stock issued under incentive programs2,168,725 22 44,447 — (39,223)— 5,246 
Issuance of common stock, net of issuance costs of $11,416
32,393,438 324 878,526 — — — 878,850 
Unrealized gain on marketable securities— — — — — 
Foreign currency translation adjustment— — — — — 19,523 19,523 
Net loss— — — (418,259)— — (418,259)
Balance at December 31, 202071,350,365 714 2,535,476 (1,874,199)(41,806)7,024 627,209 
Stock-based compensation— — 183,626 — — — 183,626 
Stock issued under incentive programs2,503,819 24 68,032 — (43,295)— 24,761 
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— — — — — (8,368)(8,368)
Net loss— — — (1,743,751)— — (1,743,751)
Balance at December 31, 202176,433,151 $764 $3,351,967 $(3,617,950)$(85,101)$(1,353)$(351,673)
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
 Year Ended December 31,
 202120202019
Operating Activities:   
Net loss$(1,743,751)$(418,259)$(132,694)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization12,661 4,885 5,676 
Gain on sale of assets— — (9,016)
Right-of-use assets expensed144,433 245,861 — 
Non-cash stock-based compensation183,626 128,035 17,048 
Other items, net(7,641)(15,080)6,381 
Changes in operating assets and liabilities:
Accounts receivable, prepaid expenses, and other assets(192,265)(422,689)(4,202)
Accounts payable and accrued expenses600,326 163,161 (11,485)
Deferred revenue1,325,557 271,545 (8,331)
Net cash provided by (used in) operating activities322,946 (42,541)(136,623)
Investing Activities:
Capital expenditures(57,486)(54,622)(1,857)
Acquisition of Novavax CZ, net of cash acquired— (165,516)— 
Proceeds from sale of assets— — 18,333 
Purchases of marketable securities(2,167)(363,202)(17,484)
Proceeds from maturities of marketable securities159,807 205,562 39,500 
Net cash provided by (used in) investing activities100,154 (377,778)38,492 
Financing Activities:
Net proceeds from sale of preferred stock
— 199,822 — 
Net proceeds from sales of common stock564,859 875,623 97,392 
Net proceeds from the exercise of stock-based awards24,761 5,382 992 
Finance lease payments(127,907)(96,065)— 
Net cash provided by financing activities461,713 984,762 98,384 
Effect of exchange rate on cash, cash equivalents, and restricted cash(5,292)2,115 (32)
Net increase in cash, cash equivalents, and restricted cash879,521 566,558 221 
Cash, cash equivalents, and restricted cash at beginning of year648,738 82,180 81,959 
Cash, cash equivalents, and restricted cash at end of year$1,528,259 $648,738 $82,180 
Supplemental disclosure of non-cash activities:
Sale of common stock under the Sales Agreement not settled at year-end$— $3,227 $497 
Capital expenditures included in accounts payable and accrued expenses$10,338 $9,255 $49 
Right-of-use assets from new lease agreements
$179,210 $247,599 $— 
Supplemental disclosure of cash flow information:
Cash interest payments, net of amounts capitalized$19,428 $13,705 $12,188 
Cash paid for income taxes$12,606 $— $— 
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Note 1 – Organization

Novavax, Inc. (“Novavax,” and together with its wholly owned subsidiaries, including Novavax AB and Novavax CZ, the “Company”) is a biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The Company’s vaccine candidates, including both its coronavirus vaccine candidate, NVX-CoV2373, and its lead influenza vaccine candidate, NanoFlu, are genetically engineered, three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis and may elicit differentiated immune responses, which may be more efficacious than naturally occurring immunity or traditional vaccines. NVX-CoV2373 and NanoFlu include the use of the Company's proprietary Matrix-MTM adjuvant.

In December 2021, the Company was granted emergency use listing (“EUL”) for NVX-CoV2373 by the World Health Organization (“WHO”), to be marketed as NuvaxovidTM in Europe and other markets and conditional marketing authorization for NuvaxovidTM, which prequalifies NVX-CoV2373 as meeting WHO standards for quality, safety, and efficacy. The authorization follows the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use recommendation to authorize the vaccine and is applicable in all 27 European Union member states.

During the fourth quarter of 2021, in partnership with Serum Institute of India Private Limited (“SIIPL”), the WHO granted EUL for NVX-CoV2373 to be manufactured and marketed by SIIPL as CovovaxTM, the Drugs Controller General of India granted emergency use authorization (“EUA”) for NVX-CoV2373, which will be manufactured and marketed in India by SIIPL under the brand name CovovaxTM, the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Pengawas Obat dan Makanan, granted EUA for NVX-CoV2373, to be manufactured and marketed in Indonesia by SIIPL under the brand name Covovax™, and the Philippine Food and Drug Administration granted EUA for NVX-CoV2373, to be manufactured and marketed in the Philippines by SIIPL under the brand name CovovaxTM.
Note 2 – Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements include the accounts of Novavax, Inc. and its wholly owned subsidiaries, including Novavax AB and Novavax CZ. All intercompany accounts and transactions have been eliminated in consolidation.
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.
The Company combined amounts previously reported as Government contracts revenue of $217.2 million and Grants revenue of $236.0 million for the year ended December 31, 2020, and Government contracts revenue of $7.5 million and Grants revenue of $8.4 million for the year ended December 31, 2019 into a single financial statement line item, Grants, in the consolidated statements of operations. Other revenue of $22.4 million for the year ended December 31, 2020, and $2.7 million for the year ended December 31, 2019 was reclassified to Royalties and other.
Use of Estimates
The preparation of the consolidated financial statements in conformity with generally accepted accounting principles in the United States (“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.
Cash and Cash Equivalents
Cash and cash equivalents consist of highly liquid investments with maturities of three months or less from the date of purchase. Cash and cash equivalents consist of the following (in thousands):
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December 31,
 20212020
Cash$96,372 $122,312 
Money market funds 361,822 96,116 
Government-backed securities266,250 44,250 
Treasury securities— 44,052 
Corporate debt securities790,672 246,668 
Cash and cash equivalents$1,515,116 $553,398 
Cash equivalents are recorded at cost, which approximate fair value due to their short-term nature.
Marketable Securities
Marketable securities consist of debt securities with maturities greater than three months from the date of purchase that have historically included commercial paper, government-backed securities, treasury securities, corporate notes, and agency securities. Classification of marketable securities between current and non-current is dependent upon the maturity date at the balance sheet date taking into consideration the Company’s ability and intent to hold the investment to maturity.
Interest and dividend income are recorded when earned and included in investment income in the consolidated statements of operations. Premiums and discounts, if any, on marketable securities are amortized or accreted to maturity and included in investment income in the consolidated statements of operations. The specific identification method is used in computing realized gains and losses on the sale of the Company’s securities.
The Company classifies its marketable securities with readily determinable fair values as “available-for-sale.” Investments in securities that are classified as available-for-sale are measured at fair market value in the consolidated balance sheets, and unrealized gains and losses on marketable securities are reported as a separate component of stockholders’ equity (deficit) until realized. Marketable securities are evaluated periodically to determine whether a decline in value is “other-than-temporary.” The term “other-than-temporary” is not intended to indicate a permanent decline in value. Rather, it means that the prospects for a near term recovery of value are not necessarily favorable, or that there is a lack of evidence to support fair values equal to, or greater than, the carrying value of the security. Management reviews criteria, such as the magnitude and duration of the decline, as well as the Company’s ability to hold the securities, including whether the Company will be required to sell a security prior to recovery of its amortized cost basis, the investment issuer’s financial condition and business outlook to predict whether the loss in value is other-than-temporary. If a decline in value is determined to be other-than-temporary, the value of the security is reduced and the impairment is recorded as other income (expense) in the consolidated statements of operations.
Fair Value Measurements
The Company applies Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), for financial and non-financial assets and liabilities.
ASC 820 discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The statement utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:
Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions.
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Restricted Cash

The Company’s current and non-current restricted cash includes payments received under the Coalition for Epidemic Preparedness Innovations (“CEPI”) funding agreements, payments received under the Bill & Melinda Gates Foundation (“BMGF”) grant agreements, and cash collateral accounts under letters of credit that serve as security deposits for certain facility leases. CEPI and BMGF funds become unrestricted as the Company incurs expenses for services performed under these agreements. As of December 31, 2021 and 2020, the restricted cash balances (both current and non-current) consisted primarily of $10.4 million and $92.4 million, respectively, of payments under the CEPI funding agreements.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheets that sum to the total of the same such amounts shown in the statement of cash flows (in thousands):
December 31,
 20212020
Cash and cash equivalents$1,515,116 $553,398 
Restricted cash current11,490 93,880 
Restricted cash non-current (1)1,653 1,460 
Cash, cash equivalents and restricted cash$1,528,259 $648,738 
(1) Classified as Other non-current assets as of December 31, 2021 and 2020
Accounts Receivable
The Company recognizes amounts due from customers as accounts receivable when its right to payment is unconditional. The Company has evaluated outstanding receivables to assess collectability, with consideration given to economic conditions, the aging of receivables, and customer-specific risks. There was no allowance for doubtful accounts as of December 31, 2021, and 2020. There was no bad debt expense for the years ended December 31, 2021, 2020 or 2019.
Concentration of Credit Risk
Financial instruments expose the Company to concentration of credit risk and consist primarily of cash and cash equivalents and marketable securities. The Company’s investment policy limits investments to certain types of instruments, including asset-backed securities, high-grade corporate debt securities, and money market funds, places restrictions on maturities and concentrations in certain industries and requires the Company to maintain a certain level of liquidity. At times, the Company maintains cash balances in financial institutions, which may exceed federally insured limits. The Company has not experienced any losses relating to such accounts and believes it is not exposed to a significant credit risk on its cash and cash equivalents.
The Company's accounts receivable arise from revenue arrangements with customers in different countries. The Company's revenue is primarily due to grants made by government-sponsored and private organizations, as well as royalties from our collaboration and license partners. The following entities accounted for more than 10% of total revenue or accounts receivable for the periods presented:
Percentage of Revenue
 for Year Ended December 31,
Percentage of Accounts Receivable as of December 31,
20212020201920212020
U.S. government (a)71 %46 %40 %*78 %
CEPI12 %47 %***
BMGF
**45 %**
SK bioscience, Co., Ltd.14 %****
Gavi, the Vaccine Alliance***77 %*
Government of New Zealand****17 %

*Amounts represent less than 10%
(a)    Including U.S. government partnership formerly known as Operation Warp Speed, Department of Defense, and Biomedical Advanced Research and Development Authority
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Pre-Launch Inventory
Prior to initial regulatory authorizations for its product candidates, the Company expenses costs relating to raw materials and inventory production as research and development expenses in the consolidated statements of operations, in the period incurred. The Company capitalizes the costs of production as inventory when regulatory authorization and subsequent commercialization are considered probable and the Company expects to realize future economic benefit from the sales of the product candidate.
Upon the authorization of distribution and use of NVX-CoV2373 following regulatory authorizations by EMA and the WHO in December 2021, the Company began to capitalize inventory costs associated with the related supply of NVX-CoV2373, as it was determined that inventory costs subsequently incurred had a probable future economic benefit.
Property and Equipment
Property and equipment are stated at cost, net of accumulated depreciation. and are depreciated using the straight-line method over the estimated useful lives of the assets. Repairs and maintenance costs are expensed as incurred. The estimated useful lives of property and equipment are described below:
Useful Life
Buildings25 years
Machinery and equipment
5 - 7 years
Computer hardware3 years
Leasehold improvements
Shorter of useful life or remaining term of the lease
Lease Accounting

The Company enters into manufacturing supply agreements with contract manufacturing organizations (“CMO”) and contract development and manufacturing organizations (“CDMO”) to manufacture its vaccine candidates. Certain of these manufacturing supply agreements include the use of identified manufacturing facilities and equipment that are controlled by the Company and for which the Company obtains substantially all the output and may qualify as an embedded lease. The Company treats manufacturing supply agreements that contain a lease as lease arrangements in their entirety. The evaluation of leases that are embedded in the Company’s CMO and CDMO agreements is complex and requires judgment in determining whether the contract, either explicitly or implicitly, is for the use of an identified asset and the Company has the right to direct the use of, and obtain substantially all of the benefit from, the identified asset which generally, is the use of a portion of the manufacturing facility of the CMO or CDMO, whether the Company has the right to direct the use of, and obtain substantially all of the benefit from, the identified asset, the term of the lease, and the fixed lease payments under the contract. Depending on the contract, the lease commencement date, defined as the date on which the lessor makes the underlying asset available for use by the lessee and is the date on which the Company is required to accrue lease expenses, may be different than the inception date of the contract. The Company determines the non-cancellable lease term of its embedded leases based on the impact of certain expected milestones on its option to terminate the lease where it is reasonably certain to not exercise that option. The Company evaluates changes to the terms and conditions of a lease contract to determine if they result in a new lease or a modification of an existing lease. For lease modifications, the Company remeasures and reallocates the remaining consideration in the contract and reassesses the lease classification at the effective date of the modification. Leases are classified as either operating or finance leases based on the economic substance of the agreement. The Company also enters into non-cancelable lease agreements for facilities and certain equipment.

For leases that have a lease term of more than 12 months at the lease commencement date, the Company recognizes lease liabilities, which represent the Company’s obligation to make lease payments arising from the lease, and corresponding right-of-use (“ROU”) assets, which represent the right to use an underlying asset for the lease term, based on the present value of the fixed future payments over the lease term. The Company calculates the present value of future payments using the discount rate implicit in the lease, if available, or the Company’s incremental borrowing rate. For all leases that have a lease term of 12 months or less at the commencement date (referred to as “short-term” leases), the Company has elected to apply the practical expedient in ASC Topic 842, Leases (“ASC 842”), to not recognize a lease liability or ROU asset but, instead, recognize lease payments as an expense on a straight-line basis over the lease term and variable lease payments that do not depend on an index or rate as an expense in the period in which the variable lease costs are incurred based on performance or usage in accordance with contractual agreements. In determining the lease period, the Company evaluates facts and circumstances that could affect the period over which it is reasonably certain to use the underlying asset while taking into consideration the non-cancelable period over which it has the right to use the underlying asset and any option period to extend or terminate the lease if it is reasonably certain to exercise the option. The Company re-evaluates short-term leases that are modified and if they no longer meet the requirements to be treated as a short-term lease, recognizes and measures the lease
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liability and ROU asset as if the date of the modification is the lease commencement date. For short-term leases that are modified and continue to meet the requirements to be treated as a short-term lease, the Company remeasures the fixed lease payments under the modified lease and recognize lease payments as an expense on a straight-line basis over the modified lease term.

For operating leases, the Company recognizes lease expense related to fixed payments on a straight-line basis over the lease term and lease expense related to variable payments as incurred based on performance or usage in accordance with the contractual agreements. For finance leases, the Company recognizes the amortization of the ROU asset over the shorter of the lease term or useful life of the underlying asset. The Company expenses ROU assets acquired for research and development activities under ASC Topic 730, Research and Development, if they do not have an alternative future use, in research and development projects or otherwise.

The Company uses significant assumptions and judgment in evaluating its lease contracts and other agreements under ASC 842, including the determination of whether an agreement is or contains a lease, whether a change in the terms and conditions of a lease contract represent a new or modified lease, whether a lease represents an operating or finance lease, the discount rate used to determine the present value of lease obligations, and the term of a lease embedded in its manufacturing supply agreements.

Intangible Assets
The Company’s intangible assets include proprietary adjuvant technology and collaboration agreements, which were measured at the estimated fair values as of their acquisition dates. Amortization expense for intangible assets is recorded on a straight-line basis over the expected useful lives of the assets, ranging from 7 years to 20 years.
Impairment of Long-Lived Assets
Long-lived assets, including property and equipment and finite-lived intangible and right-of-use assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable based on the criteria for accounting for the impairment or disposal of long-lived assets under ASC Topic 360, Property, Plant and Equipment. The Company calculates the estimated fair value of a long-lived asset (group) using the income approach. Impairment losses are recognized when the sum of expected future cash flows is less than the assets’ (group’s) carrying value.
Goodwill
Goodwill is subject to impairment tests annually or more frequently should indicators of impairment arise. The Company has determined that, because its only business is the development of recombinant vaccines, it operates as a single operating segment and has one reporting unit. The Company primarily utilizes the market approach and, if considered necessary, the income approach to determine if it has an impairment of its goodwill. The market approach is based on market value of invested capital. To ensure that the Company’s capital stock is the appropriate measurement of fair value, the Company considers factors such as its trading volume, diversity of investors, and analyst coverage. If considered necessary, the income approach is used to corroborate the results of the market approach. Goodwill impairment may exist if the carrying value of the reporting unit exceeds its estimated fair value. If the carrying value of the reporting unit exceeds its fair value, step two of the impairment analysis is performed. In step two of the analysis, an impairment loss is recorded equal to the excess of the carrying value of the reporting unit’s goodwill over its implied fair value, should such a circumstance arise.
At October 1, 2021 and 2020, the fair value of the Company’s single reporting unit was substantially higher than its carrying value, resulting in no impairment to goodwill as of October 1, 2021 and 2020.
Revenue Recognition
At contract inception, the Company analyzes its revenue arrangements to determine the appropriate accounting under U.S. GAAP. Currently, the Company’s revenue arrangements represent customer contracts within the scope of ASC Topic 606, Revenue from Contracts with Customers (Topic 606) (“ASC 606”), or are subject to the contribution guidance in ASC Topic 958-605, Not-for-Profit Entities – Revenue Recognition (“ASC 958-605”), which applies to business entities that receive contributions within the scope of ASC 958-605. The Company recognizes revenue from arrangements within the scope of ASC 606 following the five-step model: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) it satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it
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transfers to its customer. The Company recognizes contribution revenue within the scope of ASC 958-605 when the funder-imposed conditions have been substantially met. Contributions are recorded as deferred revenue until the period in which research and development activities are performed that satisfy the funder-imposed conditions.
Grants

Grant revenue includes both revenue from government contracts and grants from organizations such as CEPI. The Company performs research and development under government funding, grant, license, and clinical development agreements. The revenue primarily consists of funding under U.S. government contracts and other arrangements to advance the clinical development and manufacturing of NVX-CoV2373. The Company’s U.S. government contracts are with the U.S. Department of Defense (the “DoD”) and the U.S. government partnership formerly known as Operation Warp Speed (“OWS”) (see Note 12). Other funding arrangements primarily include a grant and forgivable loan funding from CEPI (see Note 12).

Under the U.S. government contracts, the Company is entitled to receive funding on a cost-reimbursable or cost-reimbursable-plus-fixed-fee basis, to support certain activities related to the development, manufacture, and delivery of NVX-CoV2373 to the U.S. government. The Company analyzed these contracts and determined that they are within the scope of ASC 606. The obligations under each of the contracts are not distinct in the context of the contract as they are highly interdependent or interrelated and, as such, they are accounted for as a single performance obligation. The transaction price under these arrangements is the consideration the Company is expecting to receive and consists of the funded contract amount and the unfunded variable amount to the extent that it is probable that a significant reversal of revenue will not occur. The Company recognizes revenue for these contracts over time as the Company transfers control over the goods and services and satisfies the performance obligation. The Company measures progress toward satisfaction of the performance obligation using an Estimate-at-Completion (“EAC”) process, which is a cost-based input method that reviews and monitors the progress towards the completion of the Company’s performance obligation. Under this process, management considers the costs that have been incurred to-date, as well as projections to completion using various inputs and assumptions, including, but not limited to, progress towards completion, labor costs and level of effort, material and subcontractor costs, indirect administrative costs, and other identified risks. Estimating the total allowable cost at completion of the performance obligation under a contract is subjective and requires the Company to make assumptions about future activity and cost drivers. Changes in these estimates can occur for a variety of reasons and, if significant, may impact the timing of revenue and fee recognition on the Company’s contracts. Allowable contract costs include direct costs incurred on the contract and indirect costs that are applied in the form of rates to the direct costs. Progress billings under the contracts are initially based on provisional indirect billing rates, agreed upon between the Company and the U.S. government. These indirect rates are subject to review on an annual basis. The Company records the impact of changes in the indirect billing rates in the period when such changes are identified. These changes reflect the difference between actual indirect costs incurred compared to the estimated amounts used to determine the provisional indirect billing rates agreed upon with the U.S. government. The Company recognizes revenue on the U.S government contracts based on reimbursable allowable contract costs incurred in the period up to the transaction price. For cost-reimbursable-plus-fixed-fee contracts, the Company recognizes the fixed-fee based on the proportion of reimbursable contract costs incurred to total estimated allowable contract costs expected to be incurred on completion of the underlying performance obligation as determined under the EAC process. The Company recognizes changes in estimates related to the EAC process in the period when such changes are made on a cumulative catch-up basis. The Company includes the transaction price comprising both funded and unfunded portions of customer contracts in this estimate.

The Company’s other funding agreements currently include funding from CEPI in the form of a grant (“CEPI Grant Funding”) and one or more forgivable no interest term loans (“CEPI Forgivable Loan Funding”). Under the Company’s grant funding arrangements, currently including the CEPI and BMGF arrangements, the Company is primarily entitled to reimbursement for costs that support development related activities of NVX-CoV2373. The Company analyzed these other funding arrangements and determined that they are not within the scope of ASC 606 as they do not provide a direct economic benefit to the grantor. Payments received under the grant funding arrangements are considered conditional contributions under the scope of ASC 958-605 and are recorded as deferred revenue until the period in which such research and development activities are actually performed in a manner that satisfies the funder-imposed conditions. Payments received under the CEPI Forgivable Loan Funding agreement are only repayable if the proceeds of sales to one or more third parties of NVX-CoV2373 cover the Company’s costs of manufacturing such vaccine candidate, not including manufacturing costs funded by CEPI. As the financial risk remains with CEPI, the Company determined that the use of the funds from the CEPI agreement is outside the scope of ASC Topic 470, Debt. The research and development risk was considered substantive, such that it was not probable that the development would be successful at the inception of the contract. Therefore, the Company concluded that ASC 730 was considered applicable and most appropriate. Given the financial risk associated with the research and development activities lies with CEPI because repayment of any funds provided by CEPI depends solely on the results of the research and development activities having future economic benefit, the Company has accounted for the obligation under the CEPI Forgivable Loan Funding as a contract to perform research and development for others. The Company has determined that payments received under these agreements should be recorded as revenue under ASC 958-605 rather than a reduction to research and development
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expenses. This is consistent with the Company’s policy of presenting such amounts as revenue. In reaching this determination, the Company considered a number of factors, including whether it is principal under the arrangement, and whether the arrangement is significant to, and part of, the Company’s core operations. The Company will record revenue as it performs the contractual research and development services.
Royalties and Other
The Company also has various arrangements that include a right for a third party to use the Company's intellectual property as a functional license. These licensing arrangements include sales-based royalties, certain development and commercial milestone payments, and the sale of proprietary Matrix-MTM adjuvant. The license is deemed to be the predominant item to which the sales-based royalties or milestone payments relate. Because development milestone payments are contingent on the achievement of milestones, such as regulatory approvals, that are not within the Company or licensee's control, the payments are not considered probable of being achieved and are excluded from the transaction price until the milestone is achieved. The Company recognizes revenue when the development milestone is achieved. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item, the Company recognizes revenue on the satisfaction (or partial satisfaction) of the performance obligation, which is when the related sales occur.
The Company allocates the transaction price to each performance obligation based on a relative standalone selling price basis. It develops assumptions that require judgment to determine the standalone selling price for each performance obligation in consideration of applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer.
Research and Development Expenses
Research and development expenses include salaries, stock-based compensation, laboratory supplies, consultants and subcontractors, including external contract research organizations (“CROs”), CMOs, and CDMOs and other expenses associated with the Company’s process development, manufacturing, clinical, regulatory, and quality assurance activities for its clinical development programs. In addition, related indirect costs such as fringe benefits and overhead expenses are also included in research and development expenses.
The Company estimates its research and development expense related to services performed under its contracts with external service providers based on an estimate of the level of service performed in the period. Research and development activities are expensed as incurred.
Accrued Research and Development Expenses
The Company accrues research and development expenses, including clinical trial-related expenses, as the services are performed, which may include estimates of those expenses incurred, but not invoiced. The Company uses information provided by third-party service providers and CROs, CMOs, and CDMOs invoices and internal estimates to determine the progress of work performed on the Company’s behalf. Assumptions based on clinical trial protocols, contracts, and participant enrollment data are also developed to determine and analyze these estimates and accruals.
Stock-Based Compensation
The Company accounts for stock-based compensation related to grants of stock options, stock appreciation rights, restricted stock awards, and purchases under the Company’s Employee Stock Purchase Plan, as amended and restated (the “ESPP”), at fair value. The Company recognizes compensation expense related to such awards on a straight-line basis over the requisite service period (generally the vesting period) of the equity awards, based on the award's fair value at the grant date. The requisite service period is typically one to four years. Forfeitures for all awards are recognized as incurred.
The expected term of stock options and stock appreciation rights granted is based on the Company’s historical option exercise experience and post-vesting forfeiture experience using the historical expected term from the vesting date, whereas the expected term for purchases under the ESPP is based on the purchase periods included in the offering. The expected volatility is determined using historical volatilities based on stock prices over a look-back period corresponding to the expected term. The risk-free interest rate is determined using the yield available for zero-coupon U.S. government issues with a remaining term equal to the expected term. The Company has never paid a dividend, and as such, the dividend yield is zero, and the Company does not intend to pay dividends in the foreseeable future.
See Note 13 for a further discussion on stock-based compensation.
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Income Taxes
The Company accounts for income taxes in accordance with ASC Topic 740, Income Taxes. Under the liability method, deferred income taxes are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect of changes in tax rates on deferred tax assets and liabilities is recognized in income in the period such changes are enacted. A valuation allowance is established when necessary to reduce net deferred tax assets to the amount expected to be realized.
Tax benefits associated with uncertain tax positions are recognized in the period in which one of the following conditions is satisfied: (1) the more likely than not recognition threshold is satisfied; (2) the position is ultimately settled through negotiation or litigation; or (3) the statute of limitations for the taxing authority to examine and challenge the position has expired. Tax benefits associated with an uncertain tax position are reversed in the period in which the more likely than not recognition threshold is no longer satisfied.
The Company has historically generated significant federal, state, and foreign tax net operating losses, which may be subject to limitation in future periods. Management has fully reserved the related deferred tax assets with a valuation allowance in the current reporting period as it is more likely than not that the related benefit will not be realized. The Company is currently subject to examination in all open tax years.
During the year ended December 31, 2021, the Company recognized $29.2 million in income tax expense related to foreign withholding tax on royalties. During the years ended December 31, 2020 and 2019, the Company recognized no income tax expense.
Net Loss per Share
Net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding after giving consideration to the dilutive effect of certain securities outstanding during the period. At December 31, 2021, 2020, and 2019, the Company had potentially dilutive outstanding stock options, stock appreciation rights, and unvested restricted stock units. The Company has generated a net loss in all periods presented; therefore the basic and diluted net loss per share are the same because the inclusion of the potentially dilutive securities would be anti-dilutive. As of December 31, 2021, the Company's Notes (see Note 8) would have been convertible into approximately 2,385,800 shares of the Company's common stock assuming a common stock price of $136.20 or higher. These shares, after giving effect to the add back of interest expense and unamortized debt issuance costs on the Notes and any shares due to the Company upon settlement of its capped call transactions, are excluded from the computation, as their effect is antidilutive.
Foreign Currency
The accompanying consolidated financial statements are presented in U.S. dollars. The functional currency of Novavax AB, which is located in Sweden, is the local currency (Swedish Krona) and the functional currency of Novavax CZ, which is located in the Czech Republic, is the local currency (Czech Koruna). The translation of assets and liabilities of Novavax AB and Novavax CZ to U.S. dollars are made at the exchange rate in effect at the consolidated balance sheet date, while equity accounts are translated at historical rates. The translation of the statement of operations data is made at the average exchange rate in effect for the period. The translation of operating cash flow data is made at the average exchange rate in effect for the period, and investing and financing cash flow data is translated at the exchange rate in effect at the date of the underlying transaction. Translation gains and losses are recognized as a component of accumulated other comprehensive income (loss) in the accompanying consolidated balance sheets. The foreign currency translation adjustment balance included in accumulated other comprehensive income (loss) was $(1.4) million and $7.0 million at December 31, 2021 and 2020, respectively.
Segment Information
The Company manages its business as one operating segment: the development of recombinant vaccines. The Company does not operate separate lines of business with respect to its vaccine candidates. Accordingly, the Company does not have separately reportable segments as defined by ASC Topic 280, Segment Reporting.
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Recent Accounting Pronouncements
Not Yet Adopted

In August 2020, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("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 will simplify the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts on an entity’s own equity. Specifically, the new standard will remove the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It will also remove certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and will simplify the diluted earnings per share calculation for convertible instruments. ASU 2020-06 will be effective January 1, 2022 for the Company and will be applied using a modified retrospective approach. Management has evaluated the impact of adopting ASU 2020-06 and has determined that it will not have a material impact on the Company’s consolidated financial statements.
Note 3 – Marketable Securities
The Company had no marketable securities classified as available-for-sale as of December 31, 2021 as all of the Company's investments were in securities classified as cash and cash equivalents. Marketable securities classified as available-for-sale as of December 31, 2020 were comprised of (in thousands):
December 31, 2020
Amortized CostGross Unrealized
Gains
Gross Unrealized LossesFair Value
Treasury securities$10,038 $— $(2)$10,036 
Corporate debt securities127,003 13 (3)127,013 
Agency securities20,599 — 20,600 
Total$157,640 $14 $(5)$157,649 

Note 4 – Fair Value Measurements
The following table represents the estimated fair value of the Company’s financial assets and liabilities (in thousands):
Fair Value at December 31, 2021Fair Value at December 31, 2020
AssetsLevel 1Level 2Level 3Level 1Level 2Level 3
Money market funds (1)$361,822 $— $$96,116 $$
Government-backed securities (1)266,250 44,250 
Treasury securities (2)— 54,088 
Corporate debt securities (3)790,672 373,681 
Agency securities— 20,600 
Total cash equivalents and marketable securities$361,822 $1,056,922 $$96,116 $492,619 $
Liabilities
Convertible notes payable$— $447,509 $$$407,238 $
(1)Classified as cash and cash equivalents as of December 31, 2021 and 2020 (see Note 2).
(2)Includes $44,052 classified as cash and cash equivalents as of December 31, 2020 on the consolidated balance sheets.
(3)Includes $790,672 and $246,668 classified as cash and cash equivalents as of December 31, 2021 and 2020, respectively, on the consolidated balance sheets.
Fixed-income investments categorized as Level 2 are valued at the custodian bank by a third-party pricing vendor’s valuation models that use verifiable observable market data, such as interest rates and yield curves observable at commonly quoted intervals and credit spreads, bids provided by brokers or dealers, or quoted prices of securities with similar
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characteristics. Pricing of the Company’s Notes (as defined in Note 8) has been estimated using other observable inputs, including the price of the Company’s common stock, implied volatility, interest rates, and credit spreads among others.
During the years ended December 31, 2021 and 2020, the Company did not have any transfers between Levels.
The amount in the Company’s consolidated balance sheets for accounts payable and accrued expenses approximates its fair value due to its short-term nature.
Note 5 – Intangible Assets and Goodwill
Identifiable Intangible Assets
Purchased intangible assets consisted of the following as of December 31, 2021 and 2020 (in thousands):
December 31, 2021December 31, 2020
Gross Carrying AmountAccumulated AmortizationIntangible Assets, NetGross Carrying AmountAccumulated AmortizationIntangible Assets, Net
Finite-lived intangible assets:
Proprietary adjuvant technology$8,239 $(3,469)$4,770 $9,099 $(3,374)$5,725 
Collaboration agreements3,722 (3,722)— 4,109 (4,109)— 
Total identifiable intangible assets$11,961 $(7,191)$4,770 $13,208 $(7,483)$5,725 
Amortization expense for the years ended December 2021, 2020, and 2019 was $0.4 million, $0.6 million, and $0.7 million, respectively. Estimated amortization expense for existing intangible assets for each of the five succeeding years ending December 31 is as follows (in thousands):
YearAmount
2022$412 
2023412 
2024412 
2025412 
2026412 
Goodwill
The change in the carrying amounts of goodwill was as follows (in thousands):
Year Ended December 31,
20212020
Beginning balance$135,379 $51,154 
Goodwill resulting from the acquisition of Novavax CZ— 70,662 
Currency translation adjustments(3,900)13,563 
Ending balance$131,479 $135,379 
Note 6 – Acquisition of Novavax CZ

On May 27, 2020 (the “Acquisition Date”), the Company entered into a Share Purchase Agreement (the “Deed”) by and among Novavax AB, the Company’s wholly-owned Swedish subsidiary (the “Buyer”), and De Bilt Holdings B.V., Poonawalla Science Park B.V., and Bilthoven Biologicals B.V. (collectively, the “Sellers”) and, solely as guarantors, each of Serum International B.V. and the Company. Pursuant to the terms and conditions of the Deed, the Buyer acquired all the issued and outstanding shares of Novavax CZ (formerly, Praha Vaccines a.s.), a vaccine manufacturing company (the “Acquisition”). The assets of Novavax CZ acquired as part of the Acquisition include a biologics manufacturing facility and associated assets in Bohumil, Czech Republic and will be used by the Company to expand its manufacturing capacity.

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Allocation of Purchase Price to Assets Acquired and Liabilities Assumed

The Company has accounted for the Acquisition as a business combination using the acquisition method of accounting, with the Company as the acquirer. The acquisition method requires the Company to record the assets acquired and liabilities assumed at fair value. The amount by which the purchase price exceeds the fair value of net assets acquired is recorded as goodwill. The Company completed the appraisal process necessary to assess the fair values of the assets acquired and liabilities assumed to determine the amount of goodwill to be recognized as of the Acquisition Date. The final determination of the fair value of all assets and liabilities was completed in 2020 and is presented in the table below.

The table below summarizes the final allocation of the purchase price based upon the fair values of assets acquired and liabilities assumed (in thousands):

May 27, 2020
Prepaid expense and other current assets$326 
Property and equipment96,739 
Goodwill70,662 
Accounts payable(1,193)
Accrued expenses(205)
Other non-current liabilities(813)
Purchase price, net of cash acquired$165,516 

The fair value of the assets acquired and liabilities assumed was determined using market and cost valuation methodologies. The fair value measurements were based on significant unobservable inputs that were developed by the Company using publicly available information, market participant assumptions, and cost and development assumptions. Because of the use of significant unobservable inputs, the fair value measurements represent a Level 3 measurement as defined in ASC 820. The market approach is a valuation technique that uses prices and other relevant information generated by market transactions involving identical or comparable assets, liabilities, or a group of assets or liabilities. The cost approach estimates value by determining the current cost of replacing an asset with another of equivalent utility. The cost to replace a given asset reflects the estimated reproduction or replacement cost for the property, less an allowance for loss in value due to depreciation.

The cost approach was the primary approach used to value fixed assets, including the real property. Fixed assets are depreciated on a straight-line basis over their expected remaining useful lives, ranging from four years to 25 years.

The Company recorded $70.7 million in goodwill related to the Acquisition representing the purchase price that was in excess of the fair value of the assets acquired and liabilities assumed. The goodwill generated from the Acquisition is not expected to be deductible for U.S. federal income tax purposes. The goodwill recognized is attributable to intangible assets that do not qualify for separate recognition, such as the assembled workforce of Novavax CZ.

Current assets and current liabilities were recorded at their contractual or historical acquisition amounts, which approximate their fair value.

Impact to Financial Results for the Year Ended December 31, 2020

The results of operations from Novavax CZ have been included in the consolidated financial statements since the Acquisition Date. As a result, the consolidated financial results for the year ended December 31, 2020 does not reflect a full twelve months of Novavax CZ results. From the Acquisition Date through December 31, 2020, Novavax CZ did not recognize any revenue and recorded a net loss from operations of $11.3 million.

The Company incurred approximately $2.7 million of costs related to the Acquisition in the year ended December 31, 2020, which are included within general and administrative expenses in the consolidated statements of operations.

Supplemental Pro Forma Financial Information (Unaudited)

The unaudited pro forma financial information below gives effect to the Acquisition as if it had occurred as of January 1, 2019. The pro forma financial information is presented for informational purposes only and is not necessarily indicative of the results of operations that would have been achieved had the Acquisition been consummated as of that time. The unaudited pro forma financial information combines the historical results of operations of the Company and Novavax CZ and reflects the application of certain pro forma adjustments (in thousands, except per share amounts):
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Year Ended December 31,
20202019
Revenue$475,598 $18,662 
Net loss(419,896)(142,210)
Basic and diluted net loss per share$(7.04)$(3.22)

Pro forma adjustments include the recognition of depreciation expense based on the Acquisition Date fair value and remaining useful lives of Novavax CZ fixed assets (net of historical depreciation expense) and the elimination of costs related to the Acquisition, which are non-recurring in nature.
Note 7 – Leases

The Company has embedded leases related to multiple manufacturing supply agreements with CMOs and CDMOs to manufacture the Company’s COVID-19 vaccine candidate, NVX-CoV2373, as well as operating leases for its research and development and manufacturing facilities, corporate headquarters and offices, and certain equipment.

During 2021 and 2020, the Company entered into various CMO and CDMO manufacturing supply agreements that include the use of identified manufacturing facilities and contain fixed or minimum commitments. The Company evaluated the agreements at inception and determined that certain of these arrangements contain an embedded lease under ASC 842 as it has the exclusive use of, and control over, a portion of the manufacturing facility and equipment of the supplier during the contractual term of the arrangement. The Company classified the CMO and CDMO arrangements as operating and finance leases based on the terms of the agreement. The Company recognized lease expense related to fixed payments for its short-term operating leases on a straight-line basis over the lease term and lease expense related to variable payments as incurred based on performance or usage in accordance with the contractual agreements. Additionally, during 2021, the Company amended its various CMO and CDMO agreements that modified existing embedded leases under ASC 842 as the Company continued to have the exclusive use of, and control over, a portion of manufacturing facilities and equipment of the supplier during the contractual term of the new arrangement. For leases that were previously determined to represent short-term embedded leases, the modifications did not result in a change in lease classification.

During 2021 and 2020, the Company recognized ROU assets of $144.4 million and $245.9 million, respectively, for its finance leases and long-term operating related to leases embedded in CMO and CDMO manufacturing supply agreements. The Company expensed the ROU assets since they relate to research and development activities for the development of NVX-CoV2373 for which the Company does not have an alternative future use.

During 2021, the Company entered into and extended various facility lease agreements related to research and development facilities and office space. During 2020, the Company entered into a lease agreement for the premises located at 700 Quince Orchard Road, Gaithersburg, Maryland ("700QO"). The lease is for approximately 170,000 square feet of space that the Company intends to use for manufacturing, research and development, and 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. The Company incurred $36.4 million in 2021 related to tenant improvement costs and anticipates that it will incur substantial additional tenant improvement costs, net of total landlord contribution of $30.6 million, through 2023 to bring the building to the condition necessary for its intended use. The Company is anticipated to occupy the premises in phases and occupied the third floor during the first quarter of 2022.

As of December 31, 2021, the facility leases, excluding the 700QO lease, have expirations that range from approximately three to nine years, some of which include options to extend the lease term. The Company includes the option to extend the lease in determining the lease term if it is reasonably certain that the option will be exercised. The facility leases contain provisions for future rent increases and obligate the Company to pay building operating costs. The Company records operating lease expense for each of its operating leases on a straight-line basis from lease commencement date through the end of the lease term.

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The Company uses its incremental borrowing rate in determining its ROU assets and long-term lease obligations. The Company uses significant judgment and estimates, including the estimated value of the underlying leased asset and financial profile of comparable companies, to analyze the credit spread as of the lease inception date.

Supplemental balance sheet information related to leases as of December 31, 2021 and 2020 was as follows (in thousands, except weighted-average remaining lease term and discount rate):
December 31,
Lease Assets and LiabilitiesClassification20212020
Assets:
ROU assets, operating, netOther non-current assets$40,123$7,794
Liabilities:
Current portion of operating lease liabilitiesOther current liabilities$30,983$3,782
Current portion of finance lease liabilitiesCurrent portion of finance lease liabilities130,533105,862
Total current lease liabilities$161,516$109,644
Non-current portion of operating lease liabilitiesOther non-current liabilities $39,116$10,122
Non-current portion of finance lease liabilitiesNon-current finance lease liabilities40,083
Total non-current lease liabilities$39,116$50,205
Weighted-average remaining lease term (years):
Operating leases5.04.5
Finance leases3.74.7
Weighted-average discount rate:
Operating leases6.0%13.8%
Finance leases5.2%6.4%
Lease expense for the operating and short-term leases for the years ended December 31, 2021 and 2020 was as follows (in thousands):
Year Ended December 31,
20212020
Operating lease expense$37,027 $2,462 
Short-term lease expense468,210 66,805 
Variable lease expense116,435 4,854 
Finance lease expense:
ROU assets expensed$112,528 $242,009 
Interest expense7,241 3,097 
Total finance lease expense$119,769 $245,106 
Supplemental cash flow information related to leases for the year ended December 31, 2021 and 2020 was as follows (in thousands):
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Year Ended December 31,
20212020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating leases$203,991 $63,634 
Operating cash flows used in finance leases7,241 3,097 
Financing cash flows used in finance leases127,907 96,065 
ROU assets obtained in exchange for operating lease obligations$66,682 $5,590 
ROU assets obtained in exchange for finance lease obligations112,528 242,009 
As of December 31, 2021, maturities of lease liabilities were as follows (in thousands):
YearAmount
2022$166,244 
20237,104 
20247,238 
20257,361 
20267,344 
Thereafter19,186 
Total minimum lease payments214,477 
Less: imputed interest(13,845)
Total lease liabilities$200,632 
Note 8 – Long-Term Debt
Convertible Notes
In 2016, the Company issued $325 million aggregate principal amount of convertible senior unsecured notes that will mature on February 1, 2023 (the “Notes”). The Notes are senior unsecured debt obligations and were issued at par. The Notes were issued pursuant to an indenture dated January 29, 2016 (the “Indenture”) between the Company and the trustee. The Company received $315.0 million in net proceeds from the offering after deducting underwriting fees and offering expenses. The Notes bear cash interest at a rate of 3.75%, payable on February 1 and August 1 of each year, beginning on August 1, 2016. The Notes are not redeemable prior to maturity and are convertible into shares of the Company’s common stock. As a result of the Company’s one-for-twenty reverse stock split in 2019 and pursuant to Section 14.04(a) of the Indenture, the Notes are initially convertible into approximately 2,385,800 shares of the Company’s common stock based on the initial conversion rate of 7.3411 shares of the Company’s common stock per $1,000 principal amount of the Notes. This represents an initial conversion price of approximately $136.20 per share of the Company’s common stock, representing an approximate 22.5% conversion premium based on the last reported sale price of the Company’s common stock of $111.20 per share on January 25, 2016. In addition, the holders of the Notes may require the Company to repurchase the Notes at par value plus accrued and unpaid interest following the occurrence of a Fundamental Change (as described in the Indenture). If a holder of the Notes converts upon a Make-Whole Adjustment Event (as described in the Indenture), they may be eligible to receive a make-whole premium through an increase to the conversion rate up to a maximum of 8.9928 shares per $1,000 principal amount of Notes (subject to other adjustments as described in the Indenture).
The Notes are accounted for in accordance with ASC 470-20, Debt with Conversion and Other Options (“ASC 470-20”) and ASC 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 815-40, to qualify for equity classification (or non-bifurcation, if embedded) the instrument (or embedded feature) must be both (1) indexed to the issuer’s stock and (2) meet the requirements of the equity classification guidance. Based upon the Company’s analysis, it was determined the Notes do contain embedded features indexed to its own stock, but do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component. Since the embedded conversion feature meets the equity scope exception from derivative accounting, and also since the embedded conversion option does not need to be separately accounted for as an equity component under ASC 470-20, the proceeds received from the issuance of the convertible debt were recorded as a liability on the consolidated balance sheets.
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In connection with the issuance of the Notes, the Company also paid $38.5 million, including expenses, to enter into privately negotiated capped call transactions with certain financial institutions (the “capped call transactions”). The capped call transactions are generally expected to reduce the potential dilution upon conversion of the Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the Notes. The cap price of the capped call transactions will initially be $194.60 per share, which represented a premium of approximately 75% based on the last reported sale price of the Company’s common stock of $111.20 per share on January 25, 2016, and is subject to certain adjustments under the terms of the capped call transactions. If, however, the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, exceeds the cap price, there would nevertheless be dilution upon conversion of the Notes to the extent that such market price exceeds the cap price. The Company evaluated the capped call transactions under ASC 815-10, Derivatives and Hedging – Overall and determined that it should be accounted for as a separate transaction and that the capped call transactions will be classified as an equity instrument.
The Company incurred approximately $10.0 million of debt issuance costs in 2016 relating to the issuance of 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. The Company also incurred $0.9 million of expenses related to the capped call transactions, which were recorded as a reduction to additional paid-in-capital.
Total convertible notes payable consisted of the following at (in thousands):
December 31,
 20212020
Principal amount of Notes$325,000 $325,000 
Unamortized debt issuance costs(1,542)(2,965)
Total convertible notes payable$323,458 $322,035 
Interest expense incurred in connection with the Notes consisted of the following (in thousands):
Year Ended December 31,
 202120202019
Coupon interest at 3.75%
$12,188 $12,188 $12,188 
Amortization of debt issuance costs1,424 1,424 1,424 
Total interest expense on Notes$13,612 $13,612 $13,612 

Note 9 – Preferred Stock

In June 2020, the Company entered into a redeemable Series A Convertible Preferred Stock Subscription Agreement, pursuant to which the Company agreed to issue and sell in a private placement 438,885 shares of its newly designated redeemable Series A Convertible Preferred Stock, par value $0.01 per share (“Preferred Stock”), at a purchase price of $455.70 per share, for total gross proceeds of $200.0 million. During the fourth quarter of 2020, all outstanding shares of Preferred Stock were converted and the Company issued 4,388,850 shares of common stock, par value $0.01 per share, and reclassified $199.8 million from Preferred stock to additional paid in capital. The Company recognized a beneficial conversion feature of approximately $24.1 million at the time of issuance of the Preferred Stock that was recorded in additional paid-in capital and accumulated deficit as the Preferred Stock issuance was contingently redeemable and convertible at any time at the option of the holder.
Note 10 – Stockholders’ Equity
In June 2021, the Company entered into an At Market Issuance Sales Agreement (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, and terminated its existing At Market Issuance Sales agreement. As of December 31, 2021, no shares had been sold under the June 2021 Sales Agreement.
During 2021 and 2020, the Company sold 2.6 million and 32.4 million, respectively, of shares of its common stock resulting in net proceeds of approximately $565 million and $877 million, respectively, under its various At Market Issuance Sales Agreement.
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Note 11 – Other Financial Information
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following at December 31 (in thousands):
December 31,
20212020
Prepaid expenses$120,029 $171,602 
Other current assets53,491 9,662 
Prepaid expenses and other current assets$173,520 $181,264 
Property and Equipment, net
Property and equipment is comprised of the following at December 31 (in thousands):
December 31,
20212020
Land and buildings$83,534 $79,096 
Machinery and equipment119,998 31,609 
Leasehold improvements10,282 9,684 
Computer hardware9,670 6,126 
Construction in progress35,114 71,232 
258,598 197,747 
Less: accumulated depreciation(29,902)(17,793)
Property and equipment, net$228,696 $179,954 
Approximately $168.0 million of net assets used in operations were located in the Czech Republic. Depreciation expense was approximately $12.5 million, $4.3 million, and $5.1 million for the years ended December 31, 2021, 2020, and 2019, respectively.
Accrued Expenses
Accrued expenses consist of the following at December 31 (in thousands):
December 31,
20212020
Employee benefits and compensation$38,419 $20,752 
Research and development accruals577,100 99,994 
Other accrued expenses58,212 16,644 
Accrued expenses$673,731 $137,390 

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Note 12 – Revenue
The Company recognizes revenue from the performance of research and development activities under government contracts and grant, license, and clinical development agreements, and from royalties under its collaboration and license agreements that include the sale of Matrix-MTM adjuvant.
The Company's accounts receivable included $419.7 million and $262.0 million related to amounts that were billed to customers as of December 31, 2021 and December 31, 2020, respectively. Accounts receivable also included $35.3 million related to amounts which had not yet been billed to customers as of December 31, 2021. There were no amounts which had not yet been billed to customers as of December 31, 2020. During the year ended December 31, 2021, changes in the Company's accounts receivables and deferred revenue balances were as follows (in thousands):
December 31, 2020AdditionsDeductions December 31, 2021
Contract receivables:
Accounts receivable$262,012 2,432,268 (2,239,287)$454,993 
Contract liabilities
Deferred revenue(1)
$273,228 1,598,152 (275,908)$1,595,472 
(1) Amount is comprised of $1.4 billion of current Deferred revenue and $172.5 million of non-current Deferred revenue.
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 $8 billion as of December 31, 2021. 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. The timing to fulfill performance obligations related to advance purchase agreements (“APAs”) will depend on timing of product manufacturing, delivery, and receipt of marketing authorizations. The remaining unfilled performance obligations are expected to be fulfilled in less than one year.
As of December 31, 2021, deferred revenue of $1.6 billion primarily related to upfront payments under APAs. The upfront payments are intended to assist the Company in funding investments related to building out and operating its manufacturing and distribution network, among other expenses, in support of its global supply commitment. Such upfront payments generally become non-refundable upon our achievement of certain development and commercial milestones. However, certain of the APAs may be terminated by the counterparty if the Company does not timely achieve requisite regulatory approval for NVX-CoV2373 in the relevant jurisdictions under such agreements. If the APAs were terminated, the refundable portion of the upfront payments would be repaid.
Grants
The Company recognized grant revenue as follows (in thousands):
Year Ended December 31,
20212020
U.S. government partnership (a)
$788,953 $204,727 
U.S. DoD
21,683 12,519 
CEPI
135,445 223,158 
BMGF
2,628 12,806 
Total grant revenue$948,709 $453,210 

(a) U.S. government partnership formerly known as OWS

U.S. Government Partnership

In July 2020, the Company entered into a Project Agreement (the “Project Agreement”) with Advanced Technology International, Inc. (“ATI”), the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with OWS. OWS is a partnership among components of the U.S. Department of Health and Human Services and the U.S. Department of Defense working to accelerate the development, manufacturing, and distribution of COVID-19 vaccines,
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therapeutics, and diagnostics. The Project Agreement relates to the Base Agreement the Company entered into with ATI in June 2020 (the “Base Agreement,” together with the Project Agreement, the “OWS Agreement”). The OWS Agreement requires the Company to conduct certain clinical, regulatory, and other activities, including a pivotal Phase 3 clinical trial to determine the safety and efficacy of NVX-CoV2373, and to manufacture and deliver to the U.S. government 100 million doses of the vaccine candidate. Funding under the OWS Agreement is payable to the Company for various development, clinical trial, manufacturing, regulatory, and other activities. The OWS Agreement contains terms and conditions that are customary for U.S. government agreements of this nature, including provisions giving the U.S. government the right to terminate the Base Agreement and/or the Project Agreement based on a reasonable determination that the funded project will not produce beneficial results commensurate with the expenditure of resources and that termination would be in the U.S. government’s interest. If the Project Agreement is terminated prior to completion, the Company is entitled to be paid for work performed and costs or obligations incurred prior to termination and consistent with the terms of the OWS Agreement. In July 2021, the U.S. government instructed the Company to prioritize alignment with the U.S. Food and Drug Administration (“FDA”) on the Company's analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made. In the third quarter of 2021, the Company updated its estimate-at-completion to reflect the impact of the change to the recognition of the fixed fee under the contract. The U.S. government also instructed the Company to proceed with work under the OWS Agreement related to all other activities, including ongoing clinical trials and nonclinical studies, regulatory interactions, analytics/assays and characterization of manufactured vaccine, and project management. In October 2021 and January 2022, the U.S. government extended the prescribed time to meet its July 2021 instructions until April 2022. The performance period under the Project Agreement extends through 2023 to cover clinical trial activities, subject to early termination by the U.S. government or extension by mutual agreement of the parties.

Under the OWS Agreement, the Company was originally entitled to receive funding of up to $1.75 billion to support certain activities related to the development of NVX-CoV2373 and the manufacture and delivery of the vaccine candidate to the U.S. government. Pursuant to the OWS Agreement, the Company is authorized to make expenditures or incur obligations of up to $1.75 billion. In August 2021, the Company's OWS agreement was amended to increase the contract ceiling by $52.9 million for a revised total of $1.8 billion. The agreement’s authorized funding remains unchanged at $1.75 billion for support of certain activities related to the development of NVX-CoV2373 and the manufacture and delivery of 100 million doses of the vaccine candidate to the U.S. government. As of December 31, 2021, the Company had recognized $1.0 billion in revenue related to the OWS Agreement since the inception of the contract, leaving $0.8 billion remaining to spend. The Company and the U.S. government will determine the timing and amounts for delivery of NVX-CoV2373 doses upon U.S authorization and the Company intends to pursue additional U.S. procurement agreements for supply of NVX-CoV2373 doses.

U.S. Department of Defense

In June 2020, the Company entered into a letter contract that was later amended in January 2021 (the “DoD Contract”) with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (“JPEO-CRBND-EB”), under which JPEO-CRBND-EB agreed to provide funding of up to $45.7 million to the Company to support the manufacture of NVX-CoV2373. Under the DoD Contract, the Company is authorized to make expenditures or incur obligations up to the full amount of the funding.

Under the DoD Contract, the Company is expected to deliver 10 million doses of NVX-CoV2373 to the DoD. The 10 million doses of NVX-CoV2373 may be used in Phase 2/3 clinical trials or under an EUA, if approved by the FDA. Pursuant to the DoD Contract, if NVX-CoV2373 is approved by the FDA, the DoD is entitled to most-favored customer status for a period of five years from the award of the DoD Contract, meaning that the Company cannot give any comparable commercial client in the United States more favorable pricing than the DoD under similar transactional circumstances.

Coalition for Epidemic Preparedness Innovations
In May 2020, the Company entered into a restated funding agreement which was amended in November 2020 (the “CEPI Funding Agreement”) with CEPI, under which CEPI agreed to provide funding of up to $399.5 million to the Company to support the development of NVX-CoV2373. The CEPI Funding Agreement provides up to $257.0 million in Grant Funding and up to $142.5 million in Forgivable Loan Funding, which are loans in the form of one or more forgivable no-interest term loans in order to prepay certain manufacturing activities and are not subject to restrictive or financial covenants. Payments received under the CEPI Forgivable Loan Funding are only repayable if the proceeds of sales to one or more third parties of NVX-CoV2373 cover the Company’s costs of manufacturing such vaccine candidate, not including manufacturing costs funded by CEPI. The Company anticipates making repayments starting in 2022.

Under the terms of the CEPI Funding Agreement, among other things, the Company and CEPI agreed on the importance of global equitable access to any vaccines produced pursuant to the CEPI Funding Agreement. Any such vaccines,
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if approved, are expected to be procured and allocated through global mechanisms under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the World Health Organization (“WHO”), Gavi the Vaccine Alliance, CEPI, and other global non-governmental organizations and governmental leaders in 2020.

The scope and continuation of the CEPI Funding Agreement may be amended depending on ongoing developments of the COVID-19 outbreak and the success of NVX-CoV2373 relative to other third-party COVID-19 vaccine candidates or treatments. If the WHO, CEPI, or a regulatory authority having jurisdiction over a clinical trial of NVX-CoV2373 determines that a third-party product candidate has substantially greater potential than a Company vaccine product, the Company must cease its clinical trial in the relevant region, and will be reimbursed for any costs incurred as a result thereof. In addition, CEPI has the right to unilaterally terminate the CEPI Funding Agreement if CEPI reasonably determines that (i) there are material safety, regulatory, or ethical issues with the development of NVX-CoV2373, (ii) NVX-CoV2373 development should be limited in scope or terminated, (iii) the Company becomes unable to discharge its obligations under the agreement, (iv) the Company fails to meet certain milestones, or (v) the Company commits fraud or a financial irregularity.

Payments received in advance that are related to future performance are deferred and recognized as revenue when the research and development activities are performed. Cash payments received under the CEPI Funding Agreement are restricted as to their use until expenditures contemplated in the funding agreements are incurred.

Bill & Melinda Gates Foundation

In support of the Company's development of ResVax, the project name for the respiratory syncytial virus (“RSV”) vaccine candidate, in September 2015, the Company entered into the grant agreement with BMGF (the “BMGF Grant Agreement”), under which it was awarded a grant totaling up to $89.1 million (the “Grant”). The Grant supported ResVax development activities, including the Company's global Phase 3 clinical trial in pregnant women in their third trimester and other regulatory efforts. The BMGF Grant Agreement was completed as of December 31, 2021. The Company concurrently entered into a Global Access Commitments Agreement (“GACA”) with BMGF as a part of the BMGF Grant Agreement. Under the terms of the GACA, among other things, the Company agreed to make a certain amount of ResVax available and accessible at affordable pricing to people in certain low- and middle-income countries. Unless terminated earlier by BMGF, the GACA will continue in effect until the later of 15 years from its effective date, or 10 years after the first sale of a product under defined circumstances. The term of the GACA may be extended in certain circumstances, by a period of up to five additional years.

In July 2020, the Company entered into a grant agreement with BMGF (the “BMGF SA Grant Agreement”) under which it was awarded and received a grant of $15.0 million to support a Phase 2b clinical trial in the Republic of South Africa to evaluate the safety, immunogenicity, and potential efficacy of NVX-CoV2373. As of December 31, 2021, the Company had recognized the full amount of the grant as revenue.

Payments received in advance that are related to future performance are deferred and recognized as revenue when the research and development activities are performed. Cash payments received under the BMGF Grant Agreement and the BMGF SA Grant Agreement are restricted as to their use until expenditures contemplated in the agreements are incurred.
Royalties and Other

For the year ended December 31, 2021, the Company recognized $178.6 million in revenue related to sales-based royalties. For the year ended December 31, 2020, the Company recognized $20.0 million related to a development and commercial milestone payment.

Serum Institute of India Private Limited

In July 2020, the Company entered into a supply and license agreement with Serum Institute of India Private Limited (“SIIPL”), which was amended in September 2020 and amended and restated in July 2021, under which the Company granted exclusive and non-exclusive licenses to SIIPL for the development, co-formulation, filling and finishing, registration, and commercialization by SIIPL of NVX-CoV2373. SIIPL agreed to purchase Matrix-M™ adjuvant from the Company 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 under the terms of the agreement. The parties will equally split the revenue from sale of NVX-CoV2373 by SIIPL in its licensed territory, net of agreed costs. The Company granted to SIIPL (i) an exclusive license in India during the agreement and (ii) a non-exclusive license (a) during the “Pandemic Period” (as declared by the WHO) in all countries other than specified countries designated by the World Bank as upper-middle or high-income countries, with respect to which the Company retains rights, and (b) after the Pandemic Period, in only those countries designated as low or middle-income by the World Bank. Following the Pandemic Period, the Company may notify SIIPL of any bona fide opportunities for the Company to license NVX-CoV2373 to a third party in such low and middle-
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income countries and SIIPL would have an opportunity to match or improve such third-party terms, failing which, the Company would have the discretion to remove one or more non-exclusive countries from SIIPL’s license. In October 2021, the Company entered into a supply agreement and a contract development manufacturing agreement with SIIPL and Serum Life Sciences Limited ("SLS") under which SIIPL and SLS will supply the Company with NVX-CoV2373 for commercialization in certain territories.

Takeda Pharmaceutical Company Limited

In February 2021, the Company finalized 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 Matrix-M™ adjuvant from the Company to manufacture doses of 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 September 2021, Takeda finalized an agreement with the Government of Japan’s Ministry of Health, Labour and Welfare ("MHLW") for the purchase of 150 million doses of NVX-CoV2373. The announcement followed an update from MHLW on its ongoing efforts to secure coronavirus vaccine for the citizens of Japan. These efforts include vaccine procurement by Takeda pursuant to the terms of the collaboration and license agreement that the Company entered into with Takeda in February 2021. In 2020, the Company recognized revenue as a result of achieving a development milestone from the Takeda arrangement in the amount of $20.0 million, which is included in Royalties and other revenue on the Statements of Operations. The Company is eligible for a future milestone payment of an additional $20.0 million upon regulatory approval in Japan.

SK bioscience, Co., Ltd.

In February 2021, the Company finalized an expanded collaboration and license agreement with SK bioscience, Co., Ltd. ("SK bioscience") to manufacture and commercialize NVX-CoV2373 for sale to the government of Korea. Concurrently, SK bioscience finalized an APA with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021. The agreement is in addition to the Company's existing manufacturing arrangement with SK bioscience entered into in August 2020. Under the collaboration agreement, SK bioscience was granted an exclusive license to develop, manufacture, and commercialize NVX-CoV2373 in the Republic of Korea. SK bioscience will pay the Company a tiered royalty in the low to middle double-digit range on the sale of NVX-CoV2373. In May 2021, the Company entered a non-binding Memorandum of Understanding with the Ministry of Health and Welfare of Korea and SK bioscience to explore further cooperation in the development and manufacturing of vaccines, including NVX-CoV2373, and to potentially explore the development of new vaccine products with SK bioscience, including COVID-19 variant vaccines and/or an influenza/COVID-19 combination vaccine. SK bioscience expanded its capacity to manufacture the antigen component of NVX-CoV2373 and, in December 2021, the Company amended the collaboration and license agreement to grant a non-exclusive license to cover Thailand and Vietnam, subject to a low to middle double-digit royalty, and for SK biosciences to supply the antigen component of NVX-CoV2373 to the Company for use in the final drug product globally, including product distributed by the COVAX Facility.
Advance Purchase Agreements (APAs)
During the years ended December 31, 2021 and 2020, the Company entered into various APAs for NVX-CoV2373. Under the terms of the Company's advance purchase agreements, government counterparties make upfront payments and have certain termination rights, or rights to reduce or cancel orders, if regulatory approval for the vaccine is not received or if supply is materially interrupted, delayed, or deferred. The Company records such upfront payments as deferred revenue and will recognize revenue when the vaccine is delivered to its customers. As of December 31, 2021 and 2020, the Company had deferred revenue related to APAs of $1.6 billion and $45.0 million, respectively.
Under the terms of the APA with Gavi and a separate purchase agreement between Gavi and SIIPL, 1.1 billion doses of NVX-CoV2373 are to be made available to countries participating in the COVAX Facility. The Company expects to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility. Under a separate purchase agreement with Gavi, SIIPL is expected to manufacture and deliver the balance of the 1.1 billion doses of NVX-CoV2373 for low- and middle-income countries participating in the COVAX Facility. The Company expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded under the Company's funding agreement with CEPI, with initial doses supplied by SIIPL and SLS under a supply agreement. The Company expects to supply significant doses that Gavi would allocate to low-, middle- and high-income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi may prioritize such doses to low- and middle- income countries, at lower prices. Additionally, the Company may provide additional doses of NVX-CoV2373, to the extent available from CEPI funded manufacturing facilities, in the event that SIIPL cannot materially deliver expected vaccine doses to the COVAX Facility. Under the agreement, the Company received an upfront payment from Gavi of $350.0 million in 2021 and has recorded a receivable as of December 31, 2021, for
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an additional $350.0 million because the Company secured EUL for NVX-CoV2373 by the WHO in December 2021, which are recorded as deferred revenue.
The Company also has an APA with the European Commission 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 Commission to purchase an additional 100 million doses up to a maximum aggregate of 200 million doses in one or more tranches, through 2023. Under the terms of the APA, the Company agreed to manufacture the vaccine in facilities located in the European Union and ensure continued efficacy of the vaccine against variants of the SARS-CoV-2 virus. Pursuant to the terms of the APA, the Company is prohibited from supplying NVX-CoV2373 to any third party if such delivery would impede or limit the fulfillment of the Company’s obligations to the European Commission under the APA, except with respect to the Company’s obligations under its APA with Gavi.
Note 13 – 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 12.4 million shares of common stock under equity awards granted under the 2015 Plan, which includes an increase of 1.5 million shares approved for issuance under the 2015 Plan at the Company’s 2021 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.
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, and restricted stock units. In addition, under the 2015 Plan, unrestricted stock, stock units, and performance awards may be granted. Stock options and stock appreciation rights generally have a maximum term of 10 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 stock-based compensation expense in the consolidated statements of operations as follows (in thousands):
Year Ended December 31,
202120202019
Research and development$86,928 $55,955 $8,436 
General and administrative96,698 72,080 8,612 
Total stock-based compensation expense$183,626 $128,035 $17,048 
As of December 31, 2021, there was approximately $190 million of total unrecognized compensation expense related to unvested stock options, stock appreciation rights, restricted stock units and the Employee Stock Purchase Plan, as amended (the “ESPP”). This unrecognized non-cash compensation expense is expected to be recognized over a weighted-average period of 1.2 years and will be allocated between research and development and general and administrative expenses accordingly. This estimate does not include the impact of other possible stock-based awards that may be made during future periods and awards that require approval by the stockholders.
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 stock appreciation rights) that would have been received by the holders had all stock option and stock appreciation rights holders exercised their stock options and stock appreciation rights on December 31, 2021. 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 stock appreciation rights exercises and vesting of restricted stock units for 2021, 2020, and 2019 was $453.8 million, $187.3 million, and $0.5 million, respectively.
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Stock Options and Stock Appreciation Rights
The following is a summary of stock options and stock appreciation rights activity under the 2015 Plan and the 2005 Plan for the year ended December 31, 2021:
 2015 Plan2005 Plan
 Stock OptionsWeighted-
Average
Exercise
Price
Stock
Options
Weighted-
Average
Exercise
Price
Outstanding at January 1, 20215,420,463 $38.05 214,186 $88.11 
Granted81,959 $177.84 — $— 
Exercised(1,778,688)$31.11 (145,961)$78.11 
Canceled(87,897)$120.62 — $— 
Outstanding at December 31, 20213,635,837 $42.60 68,225 $109.52 
Shares exercisable at December 31, 20211,170,259 $57.01 68,225 $109.52 
Shares available for grant at December 31, 20213,716,636 

The fair value of stock options granted under the 2015 Plan was estimated at the date of grant or the date upon which the 2015 Plan was approved by the Company’s stockholders for certain stock options granted in 2020 and 2019 using the Black-Scholes option-pricing model with the following assumptions:
Year Ended December 31,
 202120202019
Weighted average Black-Scholes fair value of stock
options and SARs granted
$158.02$80.48$4.98
Risk-free interest rate
0.5%-1.3%
0.2%-1.5%
1.5%-2.6%
Dividend yield—%—%—%
Volatility
124.7%-142.0%
116.0%-152.2%
105.4%-134.1%
Expected term (in years)
4.1-6.1
3.9-7.6
3.9-7.5
The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and stock appreciation rights outstanding under the 2015 Plan and 2005 Plan as of December 31, 2021 was approximately $376 million and 7.7 years, respectively. The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and stock appreciation rights exercisable under the 2015 Plan and 2005 Plan as of December 31, 2020 was approximately $108 million and 6.8 years, respectively.
Restricted Stock Units
The following is a summary of restricted stock units activity for the year ended December 31, 2021:
 Number of
Shares
Per Share
Weighted-
Average
Fair Value
Outstanding and unvested at January 1, 20211,044,980 $72.59 
Restricted stock units granted316,571 $191.82 
Restricted stock units vested(488,370)$69.02 
Restricted stock units forfeited(53,353)$141.01 
Outstanding and unvested at December 31, 2021819,828 $116.70 
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 600,000 shares of common stock to be purchased. 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
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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). At December 31, 2021, there were 164,495 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:
Year Ended December 31,
 202120202019
Range of Black-Scholes fair values of ESPP
shares granted
$83.47-$238.85
$2.57-$92.67
$2.57-$35.00
Risk-free interest rate
0.1%-0.2%
0.2%-2.6%
1.2%-2.6%
Dividend yield—%—%—%
Volatility
114.9%-159.4%
66.6%-189.7%
52.2%-171.6%
Expected term (in years)
0.5-2.0
0.5-2.0
0.5-2.0
Note 14 – Employee Benefits
The Company maintains a defined contribution 401(k) retirement plan, pursuant to which employees may elect to contribute up to 100% of their compensation on a tax deferred basis up to the maximum amount permitted by the Internal Revenue Code of 1986, as amended.
The Company matches 100% of the first 3% of the participants’ deferral, and 50% on the next 2% of the participants’ deferral, up to a potential 4% Company match. The Company’s matching contributions to the 401(k) plan vest immediately. Under its 401(k) plan, the Company has recorded expense of $3.4 million, $0.9 million, and $1.0 million in 2021, 2020, and 2019, respectively.
The Company’s foreign subsidiaries have pension plans under local tax and labor laws and are obligated to make contributions to the plan. Contributions and other expenses related to this plan were $1.7 million, $1.0 million, and $0.7 million in 2021, 2020, and 2019, respectively.
Note 15 – Income Taxes
The Company’s income (loss) from operations before income tax expense by jurisdiction for the years ended December 31 are as follows (in thousands):
Year Ended December 31,
202120202019
Domestic$(1,633,016)$(455,253)$(124,189)
Foreign(81,520)36,994 (8,505)
Loss before income tax expense$(1,714,536)$(418,259)$(132,694)
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During the year ended December 31, 2021, the Company recognized $29.2 million of income tax expense related to foreign withholding tax on royalties. During the years ended December 31, 2020 and 2019, the Company recognized no income tax expense.
A reconciliation of the provision for income tax to the amount computed by applying the U.S. federal statutory tax rate to the Company’s effective tax rate is as follows:
Year Ended December 31,
202120202019
Statutory federal tax rate(21)%(21)%(21)%
State income taxes, net of federal benefit(6)%(3)%(2)%
Research and development and other tax credits(1)%— %(3)%
Non-deductible expenses
%%— %
Non-cash stock-based compensation(4)%(7)%— %
Foreign tax expense%— %— %
Other%%%
Change in tax rate— %(5)%%
Change in valuation allowance30 %31 %22 %
Income tax provision%— %— %

As of December 31, 2021, the Company has available federal, state, and foreign net operating losses of $3.2 billion, $2.8 billion, and $127.6 million, respectively, that may be applied against future taxable income. Federal net operating losses of $0.9 billion will expire in the years 2022 to 2037. The remaining $2.3 billion of federal net operating losses can be carried forward indefinitely. A portion of the foreign net operating losses will begin to expire in 2023. The Company also has research tax credits of $44.6 million that continue to expire in 2022. Utilization of the net operating loss carryforwards and credits may be subject to an annual limitation due to ownership changes of the Company. As of December 31, 2021, the Company does not expect such limitation, if any, to impact the use of the net operating losses and business tax credits.
The Company files income tax returns in the U.S. federal jurisdiction and in various states, as well as in Sweden and the Czech Republic. The Company has U.S. tax net operating losses and credit carryforwards that are subject to examination from 2002 through 2021. The returns in Sweden are subject to examination from 2015 through 2021 and the returns for the Czech Republic are subject to examination from 2018 through 2021.
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The significant components of the Company’s deferred tax assets and liabilities as of December 31 were as follows (in thousands):
December 31,
20212020
Deferred tax assets:
Federal and state net operating loss carryforward$845,731 $325,655 
Foreign net operating loss carryforward25,625 8,620 
Research tax credits44,618 35,065 
Lease liability 52,852 39,548 
Deferred revenue20,262 60,657 
Non-cash stock-based compensation24,698 22,577 
Original discount interest1,729 3,177 
Other11,801 12,019 
Total deferred tax assets1,027,316 507,318 
Valuation allowance(1,015,333)(504,788)
Net deferred tax assets$11,983 $2,530 
Deferred tax liabilities:
ROU assets(10,071)(1,253)
Intangibles(1,034)(1,198)
Other(878)(79)
Total deferred tax liabilities$(11,983)$(2,530)
Net deferred tax assets$— $— 
The Company has evaluated the positive and negative evidence bearing upon the realization of its deferred tax assets, including its history of significant losses in every year since inception and, in accordance with U.S GAAP, has fully reserved the net deferred tax asset. The Company concluded that realization of its net deferred tax assets is not more-likely-than-not to be realized as of December 31, 2021. The valuation allowance increased by $510.5 million and $139.0 million for the years ended December 31, 2021 and 2020, respectively, primarily due to the increase in net operating loss carry-forwards and research and development tax credits.
On a periodic basis, the Company reassesses the valuation allowance on its deferred income tax assets, weighing positive and negative evidence to assess the recoverability of the deferred tax assets. In 2021, the Company reassessed the valuation allowance and considered negative evidence, including its cumulative losses over the three years ended December 31, 2021, and positive evidence, including its recent regulatory authorizations for NVX-CoV2373. After assessing both the negative and positive evidence, the Company concluded that it should maintain the valuation allowance on its net operating losses and its other deferred tax assets as of December 31, 2021. The release of the valuation allowance, as well as the exact timing and the amount of such release, continue to be subject to, among other things, the Company's level of profitability, revenue growth, clinical program progression, and expectations regarding future profitability. The Company's total deferred tax asset balance subject to the valuation allowance was $1.0 billion at December 31, 2021.
The Company recognizes the effect of a tax position when it is more likely than not, based on the technical merits, that the tax position will be sustained upon examination. A reconciliation of the beginning and ending amounts of unrecognized tax benefits in the year ended December 31, 2021, 2020, and 2019 is as follows (in thousands):
Year Ended December 31,
202120202019
Unrecognized tax benefits balance at January 1,$8,766 $— $— 
Additions for tax positions of current year4,158 1,413 — 
Additions for tax positions of prior years— 7,353 — 
Reductions for tax positions of prior year(1,770)— — 
Settlements of tax positions of prior years— — — 
Unrecognized tax benefits balance at December 31,$11,154 $8,766 $— 
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The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2021 and 2020, the Company had no accruals for interest or penalties related to income tax matters. The total amount of unrecognized tax benefits that, if recognized, would affect the effective tax rate is $11.2 million.
Note 16 – Related Party Transaction
In June 2020, in advance of David M. Mott joining the Company’s Board of Directors, the Company agreed to sell 32,916 shares of common stock to him at a purchase price of $45.57 per share, reflecting the closing price of the Company’s common stock on the trading date prior to the date the parties’ agreement regarding the sale, for total gross proceeds of $1.5 million. Mr. Mott joined the Company’s Board of Directors later in the same month.

Note 17 – Commitment and Contingencies

Legal Matters

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, 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 action is currently stayed, and upon final resolution of the plaintiff’s motion for an award of fees and expenses, the action will be automatically dismissed. As such, the Company is not expecting any material estimable financial impact of the plaintiff's claim.

On November 12, 2021, Sothinathan Sinnathurai filed a purported 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”). The complaint in the Sinnathurai Action alleges that the defendants made certain purportedly false and misleading statements concerning NVX-CoV2373, including with respect to the Company’s manufacturing capabilities and NVX-CoV2373’s regulatory and commercial prospects. The purported class is defined as those who purchased or otherwise acquired Novavax securities between March 2, 2021 and October 19, 2021. The complaint demands an award of damages on behalf of the purported class and attorneys’ fees incurred in connection with the litigation. 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 court has ordered the co-lead plaintiffs to file an amended complaint by March 11, 2022. The Company’s response to the amended complaint is due April 25, 2022.

After the Sinnathurai Action was filed, three derivative lawsuits were filed and are currently pending in the U.S. District Court for the District of Maryland: Robert E. Meyer v. Stanley C. Erck, et al., No. 8:21-cv-02996-TDC (the “Meyer Action”), Shui Shing Yung v. Stanley C. Erck, et al., No. 8:21-cv-03248-TDC (the “Yung Action”), and William Kirst, et al. v. Stanley C. Erck, et al., No. 8:22-cv-00024-TDC (the “Kirst Action”). 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 derivative 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. Novavax removed the Kirst Action from the Circuit Court for Montgomery County, Maryland. On February 7, 2022, the plaintiffs in the Kirst Action filed a motion to remand the action to state court and, in response, the Company has filed an opposition. The Court also entered an order tolling the defendants’ time to respond to the complaints in the Meyer and Yung Actions pending submission of a joint proposed briefing schedule on any anticipated motion practice in those cases by March 25, 2022. On February 4, 2022, the Court entered an order consolidating the Meyer and Yung Actions. The financial impact of the claims is not estimable.

F- 34

Table of Contents
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.

Purchase Commitments

The Company has entered into agreements in the normal course of business with CMOs and CDMOs supplying the Company with production capabilities, and with vendors for preclinical studies, clinical trials, and other goods or services. A number of these arrangements are within the scope of lease accounting (see Note 7). Certain agreements provide for termination rights subject to termination fees. Under such agreements, the Company is contractually obligated to make payments to vendors, mainly to reimburse them for their estimated unrecoverable expenses. The exact amount of such obligations are dependent on the timing of termination, and the terms of the relevant agreement, and cannot be reasonably estimated. As of December 31, 2021, most of these agreements were active ongoing arrangements and the Company expects to receive value from these arrangements in the future. The Company recognizes fees related to obligations for terminated contracts where such fees are reasonably estimable. The Company did not accrue obligations that were not reasonably estimable.

As of December 31, 2021, the Company had no non-cancelable purchase commitments with a remaining term of more than one year as compared with approximately $117 million as of December 31, 2020.
Note 18 – Subsequent Events
In January 2022, the Company sold 0.4 million shares of its common stock resulting in net proceeds of $34.7 million under the June 2021 Sales Agreement, with a remaining balance of $464.9 million available thereafter.
In January and February 2022, the Company received authorization for NuvaxovidTM from the regulatory authorities in Canada, Singapore, New Zealand, Great Britain, Australia, and South Korea.
In January 2022, the Company submitted a request to the FDA for EUA of NVX-CoV2373.
In February 2022, the Company’s Project Agreement with ATI was modified to include a Phase 3 efficacy study with respect to 2019n-CoV-301 in adolescents with a booster component and accordingly, the performance period under the Project Agreement was extended to December 31, 2023.
F- 35
Exhibit 4.4
DESCRIPTION OF THE REGISTRANT’S SECURITIES
REGISTERED PURSUANT TO SECTION 12 OF THE
SECURITIES EXCHANGE ACT OF 1934

As of December 31, 2021, Novavax, Inc. (the “Company”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

Description of Common Stock

The following description of the Company’s Common Stock is a summary and does not purport to be complete. It is subject to and qualified in its entirety by reference to the Company’s Second Amended and Restated Certificate of Incorporation, as amended, (the “Certificate of Incorporation”), Certificate of Designation of Series A Convertible Preferred Stock (the “Certificate of Designation”) and Amended and Restated By-Laws (the “By-Laws”), each of which is incorporated by reference as an exhibit to this Annual Report on Form 10-K. The Company encourages you to read the Certificate of Incorporation, the Certificate of Designation, the By-Laws, and the applicable provisions of the Delaware General Corporation Law for additional information.

Authorized Capital Shares

The Certificate of Incorporation authorizes the issuance of 600,000,000 shares of common stock, $0.01 par value per share (“Common Stock”), and 2,000,000 shares of preferred stock, $0.01 par value per share (“Preferred Stock”), of which 438,885 shares of Preferred Stock have been designated as Series A Convertible Preferred Stock, par value $0.01 per share, pursuant to the Certificate of Designation (“Series A Convertible Preferred Stock”). The outstanding shares of Common Stock are fully paid and nonassessable. As of December 31, 2021, there are no shares of Preferred Stock outstanding.

Preferred Stock

Authorized but Unissued Preferred Stock

The Board of Directors (the “Board”), without further stockholder approval, has the power to issue Preferred Stock in one or more series and determine certain terms relative to any Preferred Stock to be issued, such as the power to establish different series and to set voting rights, the dividend rights and dates, conversion rights, redemption privileges and liquidation preferences.

Series A Convertible Preferred Stock

    Each share of Series A Convertible Preferred Stock is convertible into ten shares of Common Stock, subject to mandatory conversion upon the earlier of (1) the tenth anniversary of the issuance date or (2) immediately prior to the effectiveness of certain change of control transactions.

Holders of Series A Convertible Preferred Stock are not entitled to vote on matters submitted to the holders of Common Stock and do not have the right to cumulative dividends. In the event that the Company declares a dividend upon Common Stock, a holder of the Series A Convertible Preferred Stock is entitled to receive the amount of dividends per share of Series A Convertible Preferred Stock that such holder would have been entitled to receive if it had converted such Series A Convertible Preferred Stock into Common Stock immediately prior to such declaration of a dividend.

In the event of a liquidation, dissolution or winding up of the Company that does not constitute a change of control transaction triggering mandatory conversion of the Series A Convertible Preferred Stock, any holder of Series A Convertible Preferred Stock will be entitled to receive, in preference to the holders of Common Stock and any junior Preferred Stock, an amount per share equal to the greater of (1) the sum of the purchase price plus an amount equal to any declared and unpaid dividends on the Series A Convertible Preferred Stock, or (2) the amount that such shares of Series A Convertible Preferred Stock would have been entitled to receive if they had converted into Common Stock immediately prior to such liquidation, dissolution or winding up.



Exhibit 4.4
As of December 31, 2021, there are no shares of the Series A Convertible Preferred Stock outstanding.

Common Stock

Dividend Rights

Subject to the rights of holders of outstanding shares of Preferred Stock, if any, the holders of Common Stock are entitled to receive dividends, if any, as may be declared from time to time by the Board in its discretion out of funds legally available for the payment of dividends.

Voting Rights

The holders of Common Stock are entitled to one vote per share on all matters voted on by the stockholders, including the election of directors, and do not have cumulative voting rights.

Classified Board

The members of the Board are divided into three classes, designated as Class I, Class II, and Class III, each serving staggered three-year terms, with no one class having more than one more director than any other class. The By-Laws provide for directors in director elections to be elected by a plurality of the votes entitled to vote.

Liquidation Rights

Subject to any preferential rights of outstanding shares of Preferred Stock, holders of Common Stock will share ratably in all assets legally available for distribution to the Company’s stockholders in the event of dissolution.

Other Rights and Preferences

The Common Stock has no redemption provisions or preemptive, conversion or exchange rights. No shares of any class of the Company’s capital stock are subject to any sinking fund provisions, restrictions on the alienability of securities to be registered, calls, assessments by, or liabilities of the Company. Holders of Common Stock may act by written consent.

Certain Provisions of the Certificate of Incorporation, By-laws, and Delaware Law

Certain provisions of the Certificate of Incorporation and By-Laws may be deemed to have an anti-takeover effect and may prevent, delay, or defer a tender offer or takeover attempt, including:

Classified Board, Removal of Directors, and Charter Amendments relating to the Board

The Certificate of Incorporation and the By-Laws provide for the division of members of the Board into three classes, with no one class having more than one more director than any other class, serving staggered three-year terms. The Certificate of Incorporation provides that any amendments to the charter relating to the number, classes, election, term, removal, vacancies, and related provisions with respect to the Board may only be made by the affirmative vote of the holders of at least 75% of the shares of capital stock issued and outstanding and entitled to vote. These provisions may have the effect of making it more difficult for a third party to acquire control of the Company, or of discouraging a third party from attempting to acquire control of the Company.

Authorized but Unissued Shares

The authorized but unissued shares of Common Stock and Preferred Stock are available for future issuance without stockholder approval, subject to any limitations imposed by the Nasdaq Stock Market. These additional shares may be utilized for a variety of corporate purposes. In particular, the Board could issue shares of Preferred Stock that could, depending on the terms of the series, impede the completion of a takeover effort. The Board may determine that the issuance of such shares of Preferred Stock is in the


Exhibit 4.4
best interest of the Company and its stockholders. Such issuance could discourage a potential acquiror from making an unsolicited acquisition attempt through which such acquiror may be able to change the composition of the Board, including a tender offer or other transaction a majority of the Company’s stockholders might believe to be in their best interest or in which stockholders might receive a substantial premium for their stock over the then-current market price.

Advance Notice Requirements for Stockholder Proposals and Director Nominations

The By-Laws provide that a stockholder seeking to bring business before an annual meeting of stockholders, or to nominate candidates for election as directors, must provide timely notice of such stockholder’s intention in writing. To be timely, a stockholder nominating individuals for election to the Board or proposing business must provide advanced notice to the Company not less than 60 days nor more than 90 days prior to the anniversary date of the prior year’s annual meeting of stockholders or, in the case of any special meeting, not less than 60 days nor more than 90 days prior to the special meeting, unless, in the case of annual meeting, such meeting occurs more than 30 days before or after such anniversary date, or, in the case of a special meeting, such meeting occurs less than 100 days after notice or public disclosure of the date of the special meeting is given or made, in which cases notice will be timely if received not later than the close of business on the tenth day after the day on which notice or public announcement of the date of such meeting was made.

Limits on Ability of Stockholders to Act by Written Consent

The Certificate of Incorporation provides that the stockholders may not act by written consent. In addition, the Certificate of Incorporation requires that special meetings of stockholders be called only by the Board, the Company’s chief executive officer, or the Company’s president if there is no chief executive officer. Further, business transacted at any special meeting of stockholders is limited to matters relating to the purpose or purposes stated in the notice of meeting. This limit on the ability of the Company’s stockholders to act by written consent or to call a special meeting may lengthen the amount of time required to take stockholder proposed actions.

Section 203 of the General Corporation Law of the State of Delaware

The Company is subject to Section 203 of the Delaware General Corporation Law. This statute regulating corporate takeovers prohibits a Delaware corporation from engaging in any business combination with an interested stockholder for three years following the date that the stockholder became an interested stockholder, unless:

prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

upon completion of the transaction that resulted in the interested stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding (1) shares owned by persons who are directors and also officers, and (2) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or

the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder.

Generally, a business combination includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. An interested stockholder is any person who, together with such person’s affiliates and associates (1) owns 15% or more of a corporation’s voting securities or (2) is an affiliate or associate of a corporation and was the owner of 15% or more of the corporation’s voting securities at any time within the three year period immediately preceding a business combination


Exhibit 4.4
governed by Section 203. The existence of this provision may have an anti-takeover effect with respect to transactions the Board does not approve.

Listing

The Company’s Common Stock is traded on The Nasdaq Global Select Market under the trading symbol “NVAX.”

Exhibit 10.33

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

FIRST AMENDMENT TO LEASE AGREEMENT
THIS FIRST AMENDMENT TO LEASE AGREEMENT (“this First Amendment”) is dated as of June 22, 2021 (“Effective Date”), by and between ARE-MARYLAND NO. 51, LLC, a Delaware limited liability company, having an address at 26 North Euclid Avenue, Pasadena, California 91101 (“Landlord”), and NOVAVAX, INC., a Delaware corporation, having an address at 21 Firstfield Road, Gaithersburg, Maryland 20878 (“Tenant”).
RECITALS
A.    Landlord and Tenant have entered into that certain Lease Agreement (“Lease”) dated as of October 22, 2020, wherein Landlord leased to Tenant certain premises containing approximately 169,420 rentable square feet (“Existing Premises”) located at 700 Quince Orchard Road, Gaithersburg, Maryland 20878, as more particularly described in the Lease.
B.    The Project includes an unenclosed loading dock area adjoining the Building that Tenant proposes to enclose and improve and thereby form a part of the Existing Premises. Once enclosed, the former loading dock area will contain approximately 1,819 rentable square feet of space (“Expansion Premises”).
C.    Landlord and Tenant desire to amend the Lease, among other things, to expand the Existing Premises to include the Expansion Premises, and increase the Tenant Improvement Allowance so that it includes the Expansion Premises, all on the terms and conditions set forth in this First Amendment.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing Recitals, the mutual promises and conditions contained herein, and for other good and valuable consideration, the receipt and legal sufficiency of which are hereby acknowledged, Landlord and Tenant hereby agree that the Lease is amended as follows:
1.Definitions; Recitals. Terms used in this First Amendment but not otherwise defined shall have the meanings set forth in the Lease. The Recitals form an integral part of this First Amendment and are hereby incorporated by reference.
2.Expansion Premises. Effective as of the Effective Date, the Existing Premises shall be expanded to include the Expansion Premises (the Expansion Premises and the Existing Premises are collectively referred to herein as the “Premises”). Exhibit A-1 attached hereto, which depicts the Expansion Premises as the area labeled “Expansion Premises,” shall be added as an integral part of Exhibit A to the Lease.
a.Tenant Improvements. Tenant shall improve the Expansion Premises in accordance with Tl Construction Drawings approved by Landlord under the Work Letter attached to the Lease as Exhibit C, and Landlord shall provide Tenant with the Tenant Allowance as described in the Work Letter. To the extent Tenant has not submitted and received approval of the Tl Design Drawings or Tl Construction Drawings for the Tenant Improvements
117566588_3


to be made within the Expansion Premises, Tenant shall do so in accordance with the terms and conditions of the Work Letter.
3.Expansion Premises. Tenant accepted possession of the Expansion Premises on the Commencement Date of the Lease in its then “as is” condition. Landlord shall have no obligation for any defects in the Expansion Premises.
a.Condition. Neither Landlord nor any of its agents has made any representation or warranty with respect to the condition of all or any portion of the Expansion Premises and/or the suitability of the Expansion Premises for the conduct of Tenant’s business, and Tenant waives any implied warranty that the Expansion Premises are suitable for the Permitted Use. Tenant shall use the Expansion Premises only for the Permitted Use under the Lease in compliance with the provisions of Section 7 of the Lease.
b.Permits. Landlord shall have no obligation to perform any work at the Building in connection with Tenant’s occupancy of the Expansion Premises or obtain any permits, approvals, or entitlements related to Tenant’s specific use of the Expansion Premises or Tenant’s business operations therein.
4.Base Rent for Expansion Premises. (a) Tenant shall continue to pay Base Rent with respect to the Existing Premises at the rates set forth in the Lease, and (b) commencing on the Rent Commencement Date (i.e., January 1, 2022), Base Rent for the Expansion Premises shall be payable at the rate of $5,146.25 per month. During the Term, the Base Rent for the Expansion Premises shall be increased on the Adjustment Date, by multiplying the monthly Base Rent payable immediately before such Adjustment Date for the Expansion Premises by the Rent Adjustment Percentage (i.e., [***]%) and adding the resulting amount to the monthly Base Rent payable immediately before such Adjustment Date. Base Rent, as so adjusted, shall thereafter be due as provided in Section 4 of the Lease. On the Effective Date, Tenant shall deliver to Landlord an amount equal to the first monthly installment of Base Rent payable for the Expansion Premises.
5.Changes to Defined Terms. Effective as of the Effective Date (except as otherwise specified below), the following amendments are hereby made to the definitions contained in the Basic Lease Provisions.
a.The defined term “Premises” shall be deleted in its entirety and replaced with the following:
“Premises:    That portion of the Project, containing approximately 171,239 rentable square feet, as determined by Landlord, consisting of (i) approximately 169,420 rentable square feet of space as shown as the hatched area on Exhibit A attached hereto (“Existing Premises”), and (ii) approximately 1,819 rentable square feet of space as shown as the area labeled “Expansion Premises” on Exhibit A-1 attached hereto (“Expansion Premises”; together with the Existing Premises, the “Premises”). The area of the Premises has been measured pursuant to Method A of the BOMA 2017 for Office Buildings: Standard Methods of Measurement as
    -2-
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adopted by the Building Owners and Managers Association International (ANSI/BOMA 265.1-2017) Tenant acknowledges that such measurement shall be conclusive as to the area of the Premises.
b.The defined term “Rentable Area of Premises” shall mean approximately 171,239 rentable square feet.
6.Amendments to Work Letter. Effective as of the Effective Date, the Work Letter is amended as follows:
a.[***]
b.[***]:
[***][***][***]
[***][***][***]
[***][***][***]
[***][***][***]
[***][***][***]
[***][***]

7.Miscellaneous.
a.Entire Agreement. The Lease, as amended by this First Amendment, is the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous oral and written agreements and discussions. The Lease, as so amended by this First Amendment, may be amended only by an agreement in writing, signed by the parties hereto.
b.Binding Effect. This First Amendment is binding upon and shall inure to the benefit of the parties hereto, their respective agents, employees, members, representatives, officers, directors, divisions, subsidiaries, affiliates, assigns, heirs, successors in interest and shareholders.
c.Broker. Landlord and Tenant each represents and warrants that it has not dealt with any broker, agent, or other person (collectively, “Broker”) in connection with this First Amendment and that no Broker brought about this transaction, other than Jones Lang LaSalle Brokerage, Inc. (“JLL”). JLL shall be paid by Landlord pursuant to a separate agreement between Landlord and JLL. Landlord and Tenant each hereby agree to indemnify and hold the other harmless from and against any claims by any Broker, other than JLL, claiming a commission or other form of compensation by virtue of having dealt with Tenant or Landlord, as applicable, with regard to this First Amendment.
    -3-
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d.Ratification; Conflicts. Except as amended and/or modified by this First Amendment, the Lease is hereby ratified and confirmed and all other terms of the Lease shall remain in full force and effect, unaltered and unchanged by this First Amendment. In the event of any conflict between the provisions of this First Amendment and the provisions of the Lease, the provisions of this First Amendment shall prevail. Regardless of whether specifically amended by this First Amendment, all of the terms and provisions of the Lease are hereby amended to the extent necessary to give effect to the purpose and intent of this First Amendment.
e.Counterparts/Electronic Signatures. This First Amendment may be executed in 2 or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signature process complying with the U.S. federal ESIGN Act of 2000, such as DocuSign) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes. Electronic signatures shall be deemed original signatures for purposes of this First Amendment and all matters related thereto, with such electronic signatures having the same legal effect as original signatures.

[SIGNATURES APPEAR ON NEXT PAGE]

    -4-
117566588_3


IN WITNESS WHEREOF, the parties hereto have executed this First Amendment under seal as of the day and year first above written.
TENANT:
NOVAVAX, INC.,
a Delaware corporation

By: /s/ John A. Herrmann III (SEAL)            
Name:
John A. Herrmann III                
Title:
EVP, CLO                    
LANDLORD:
ARE-MARYLAND NO. 51, LLC,
a Delaware limited liability company
By:    Alexandria Real Estate Equities, L.P. ,
a Delaware limited partnership,
as its managing member
By:    ARE-QRS CORP.,
a Maryland corporation,
general partner
By:    [***]        
Name:    [***]        
Title:     Senior Vice President Real Estate Legal Affairs



117566588_3



EXHIBIT A-1
EXPANSION PREMISES
[Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit setting forth the expansion premises 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.]
    -6-
117566588_3
Exhibit 10.37

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
SUPPLY AGREEMENT
BETWEEN
NOVAVAX INC
AND
SERUM INSTITUTE OF INDIA PVT. LTD.
AND
SERUM LIFE SCIENCES LIMITED

1

110826759_7


This Supply Agreement (“Supply Agreement”) is made effective as of 25 October 2021 (“Effective Date of the Supply Agreement”) by and between Novavax, Inc., a Delaware USA corporation having a place of business at 21 Firstfield Rd., Gaithersburg, MD 20878 (“Novavax”, which expression shall, unless repugnant to the context thereof, mean and include its Affiliates, successors and permitted assigns), Serum Institute of India Private Limited, a company incorporated under the Companies Act, 1956 of India with registration number U80903PN1984PTC03294, and having its registered address as 212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028 India (“SIIPL”, which expression shall, unless repugnant to the context thereof, mean and include its Affiliates, successors and permitted assigns), and Serum Life Sciences Limited, a company duly incorporated having its registered office situated in England and Wales, formerly known as Covicure Holdings Limited having its principal office at 12 New Fetter Lane, London, United Kingdom, EC4A 1JP (“SLS”). Novavax, SLS and SIIPL may each be referred to herein individually as a “Party” and collectively as the “Parties.” All capitalized terms, which are not defined under this Supply Agreement, shall have the same meaning ascribed to them in the Amended and Restated License and Supply agreement between the Parties, dated as on July 1, 2021 (the “License Agreement”).
RECITALS
WHEREAS, Under the License Agreement, Novavax has granted SIIPL an exclusive license [for the SIIPL Exclusive Territory (as defined in the License Agreement)] and a non-exclusive license [for the SIIPL Non-Exclusive Territory (as defined in the License Agreement)] to Manufacture and use the Drug Substance along with the Adjuvant (supplied by Novavax) and the Novavax Know-How to Develop, Manufacture, and Commercialize a Product;
AND WHEREAS, under Section 14.2 (Supply and Purchase of Drug Substance and / or Product by SIIPL) of the License Agreement, Parties have agreed that SIIPL shall, on mutually agreed terms and conditions, supply the Drug Substance and / or Product to Novavax in such quantities as may be required by Novavax for further commercialisation by Novavax in the Novavax Exclusive Territory and/or the SIIPL Non-Exclusive Territory (each, as defined in the License Agreement) as the case may be;
AND WHEREAS, SIIPL and SLS are Affiliates are each other and it is agreed between the Parties that SLS shall supply the Product Manufactured by SIIPL;
AND WHEREAS, the Parties wish to record in writing the technical and commercial terms for such supply by SLS of the Product Manufactured by SIIPL to Novavax for further commercialisation by Novavax in the Novavax Exclusive Territory and/or the SIIPL Non-Exclusive Territory;
AND WHEREAS, the Parties agree and accept that the Recitals stated above shall form an integral and enforceable part of the Supply Agreement, just like any other provision contained hereunder.
NOW THEREFORE, the Parties covenant to each other as under –
Article 1.Definitions
1.1“Business Day” means any day other than a Sunday, or bank or other public holiday in either Washington D.C., U.S.A, or Pune, India
1.2“cGMPs” means current Good Manufacturing Practices regulations and standards enforced by the U.S. Food and Drug Administration, European Medicines Agency, Medicines & Healthcare products Regulatory Agency (MHRA) in the
2
110826759_4
110826759_7


United Kingdom or other applicable regulatory bod(ies) in other jurisdictions and which apply to the Manufacturing of the Product under this Supply Agreement.
1.3“Certificate of Analysis” or “CoA” means, with respect to a Supply Batch, a certificate in the applicable format for the applicable Product manufactured under cGMP, from time to time during the term of Supply Agreement, issued by SIIPL, either itself, or through an Affiliate or Subcontractor, and executed by SIIPL’s responsible person certifying that a Supply Batch meets the Product Requirements and such other criteria as identified in the Certificate of Analysis.
1.4“Certificate of Conformance” or “CoC” means, with respect to a Supply Batch, a certificate in the applicable format for the applicable Product from time to time during the Term of the Supply Agreement, issued by SIIPL, either itself or through an Affiliate’s or Subcontractor’s, quality department and executed by SIIPL’s responsible person (a) listing the date of manufacture, unique Supply Batch number, and quantity of Product in such Supply Batch, (b) certifying that such Batch was Manufactured in compliance with the applicable Product Requirements, and (c) certifying that all investigative and corrective action reports are completed and approved.
1.5“Commercialize”, “Commercializing” or “Commercialization” or “Commercialized” for the purpose of this Supply Agreement, means any and all activities undertaken by Novavax in and limited to Novavax Exclusive Territory or SIIPL Non-Exclusive Territory which are directed to the marketing, promotion, distribution, pricing, reimbursement, offering for sale, and sale of the Product and interacting with Governmental Authority in the applicable country or region for the Product, but excluding activities directed to Manufacturing, Medical Affairs, or Development.
1.6“Commercially Reasonable Efforts” means, [***].
1.7“Facility” means any facility set forth on Exhibit A (Facilities) in which Product is Manufactured, either by SIIPL (itself or through an Affiliate or Subcontractor). For the purpose of clarity, consent of Novavax is hereby deemed granted for the Facilities listed in the Exhibit A as of the Effective Date.
1.8“Latent Defect” means [***].
1.9“Manufacturing Defect” means [***].
1.10“Manufacturing Process” means the process, or applicable portion(s) thereof for the Manufacture, analysis, documentation, quality evaluation, storage, and shipping of components, intermediates, and Product.
1.11“Product Requirements” means the applicable Certificate of Analysis, and Certificate of Conformance, cGMP, any applicable Regulatory Approval, the requirements of all applicable Regulatory Authorities, the Quality Agreement and the Applicable Law.
1.12“Regulatory Approval” shall mean (i) with respect to Novavax, all necessary approvals, authorizations, licenses or permissions under the Applicable Law or by the applicable Government / Regulatory / other concerned Authority, towards import into, and sale and commercialization of the Product in, each country in the Novavax Exclusive Territory and/or the SIIPL Non-Exclusive Territory, and (ii)
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with respect to SIIPL, all necessary approvals, authorizations, licenses or permissions under the Applicable Law or by the applicable Government / Regulatory / other concerned Authority towards Manufacture of the Products.
1.13“Regulatory Authority” means any governmental agency or authority, responsible for granting Regulatory Approvals for the Product in a country within the Novavax Exclusive Territory or the SIIPL Non-Exclusive Territory, and including, without limitation, the FDA in the United States, the EMA in the European Union and the MHRA in the United Kingdom.
1.14“Statement of Work” or “SOW” means a mutually agreed upon document setting forth the pricing, INCOTERMS, delivery details and payments and other pertinent information, in order to prepare for, initiate and conduct the activities contemplated under this Supply Agreement, for the Development and Manufacture and supply of the Product.
1.15“Supply Batch” means a quantity of Product supplied to Novavax under any Firm Purchase Order under this Supply Agreement, that is intended to have uniform character and quality and that has been or is being supplied in accordance with the applicable Specifications during the same cycle of Manufacturing.
Article 2.Delivery, Inspection and Recall for Product to be supplied by SIIPL to Novavax
2.1Statement of Work.
Novavax will provide SIIPL and SLS a Statement of Work in the form and format mutually agreed between the Parties setting out, among other details, the quantity of the Product to be supplied, the desired destination of delivery of the Product, [***] agreed for the delivery. Such a SOW shall be provided by Novavax at least [***] before issuing a Proposed Purchase Order (as defined hereunder). For the sake of clarity, the SOW is not binding on SIIPL or SLS until the same is executed by the Parties.
2.2Firm Purchase Orders.
Subsequent to SIIPL and SLS accepting the SOW, Novavax will issue a proposed written purchase order to SIIPL and SLS (each a “Proposed Purchase Order”) specifying the quantity of Product being ordered [***], the price per dose [***], the requested delivery date (“Product Delivery Date”), Novavax Purchase Order number, place of delivery (“Product Delivery Destination”), and any other information necessary for the [***] delivery of such Product.
2.2.1Acceptance of Firm Purchase Orders.
SIIPL and SLS will review each Proposed Purchase Order and will, no later than [***] after SIIPL’s and SLS’ receipt of each such Proposed Purchase Order, notify Novavax in writing of SIIPL’s / SLS’ acceptance, rejection or proposed modification of such Proposed Purchase Order; provided that neither SIIPL nor SLS may reject any Proposed Purchase Order that sets forth the same quantities and deliver dates set forth in the applicable SOW, unless Novavax is unable to provide the necessary quantities of Adjuvant required for such volumes (each a “Firm Purchase Order”).
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2.2.2No Other Terms.
No terms, provisions, or conditions of any Firm Purchase Order that conflict with the terms of this Supply Agreement or License Agreement or terms, provisions or conditions of any other business form or written authorization used by Novavax or SIIPL will have any effect on the rights, duties, or obligations of the Parties under or otherwise modify this Supply Agreement, License Agreement, any other Proposed Purchase Order or any other Firm Purchase Order, regardless of any failure of Novavax or SIIPL to object to such terms, provisions, or conditions.
2.3Subcontracting.
2.3.1The Parties agree that SIIPL / SLS can subcontract or have the SIIPL’ / SLS’ obligations subcontracted provided that the Subcontractors have been appointed in accordance with the Quality Agreement.
2.3.2[***].
2.3.3[***].
2.4Product Delivery.
SLS will deliver Products to the Product Delivery Destination and in accordance with the [***] specified in the applicable Firm Purchase Order (“Product Delivery”). Title and risk of loss or damage to Products will [***]. SIIPL will Manufacture or have Manufactured, either itself or through an Affiliate or Subcontractor approved under this Supply Agreement, and deliver the Product, either itself, or through SLS, specified in an accepted Firm Purchase Order for delivery on the applicable Product Delivery Date, or such other extended delivery date mutually agreed to between the Parties.
2.4.1Delivery Responsibilities.
SIIPL/SLS will notify Novavax when a Batch of the Product is ready to be shipped. SIIPL/SLS or another Affiliate or Subcontractor under this Supply Agreement, will be responsible for appropriate packaging, labelling, and issuance of carrier’s declaration for all Products shipped under this Supply Agreement. SIIPL/SLS and Novavax will ensure that each of their respective employees involved in activities related to shipments (and in the case of Novavax, receipt of shipments) of Product have received [***] training to properly handle such Product.
If it is mutually agreed between the Parties that SIIPL/SLS will deliver the Product to a designee of Novavax in certain specified countries, then the quantities and delivery obligations for such supply of Product shall be recorded under the relevant SOW.
2.4.2Storage.
Novavax shall [***] take delivery of Batches of the Product at the Product Delivery Destination [***]. If Novavax fails to make arrangements to take delivery of any Products on the applicable Product Delivery Date, [***].
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2.4.3Failure to Satisfy Product Delivery Date.
If SIIPL fails to deliver the full quantity of the Product ordered in a Firm Purchase Order on the delivery date set forth in such Purchase Order (“Supply Failure”), then SIIPL shall not be held liable for any Supply Failure to the extent due to [***].
2.5Product Labelling.
Since the Product shall be Manufactured by SIIPL and supplied to Novavax by SLS / SIIPL for sale and Commercialisation by Novavax in the Novavax Exclusive Territory and SIIPL Non-Exclusive Territory, the Parties shall mutually agree [***] on the Product packaging and labelling requirements on a country-to-country basis. Accordingly, the Firm Purchase Order, as may be applicable, shall specify and include all packaging and labeling requirements for the Product to be supplied by SIIPL/SLS, or another Affiliate or Subcontractor approved under this Supply Agreement, under such Firm Purchase Order.
2.6Non-Conforming Batches of the Product.
Novavax will have the right to inspect and determine whether each Batch conforms to the applicable Product Requirements and the quantity of supplied Product as per the Firm Purchase Order and/or the Quality Agreement. In case of [***] nonconformance of a particular batch as per the applicable Firm Purchase Order and/or the Quality Agreement, then SIIPL will [***].
2.6.1Product Non-Conformance Disputes.
In the event of a disagreement between the Parties concerning whether or not a Batch meets the applicable Product Requirements, Novavax and SIIPL will appoint [***] to undertake analysis of the Batch to determine whether or not it meets the applicable Product Requirements. Each Party will [***] cooperate with and provide [***] information, documentation, and materials [***] relevant to the disagreement to the [***]. [***]. All costs and expenses incurred by the [***] (Non-Conformance Disputes) shall be borne by [***].
2.7Latent Defects, Pharmacovigilance, Adverse Events and Recalls.
All Parties confirm that since -
(i)SIIPL and SLS or other Affiliates or Subcontractors are performing this Supply Agreement solely for Novavax;
(ii)Novavax owns, controls and shall sell Adjuvant to SIIPL/SLS under the Supply Agreement; and
(iii)Novavax shall have the right to inspect and determine whether each Batch conforms to the applicable Product Requirements
hence, Novavax will have [***], over handling any and all claims related to (a) any Latent Defects in the Products, (b) all pharmacovigilance activities, (b) any adverse events notifications and complaints, and (c) whether and under what circumstances to require a Recall of the Product in a country in the Novavax Exclusive Territory and SIIPL Non-Exclusive Territory. [***].
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2.8Conditions for Manufacture, Supply and Delivery of Product by SIIPL/SLS.
2.8.1SIIPL shall commence Manufacturing operations, either itself or through an Affiliate or Subcontractor, and shall supply and deliver the Product only after it receives all Regulatory Approvals and [***] approvals, authorizations, permissions, licenses or any other requirements, conditions or approvals of the Regulatory Authority / Government Authority in [***].
2.8.2Novavax confirms that the Manufacture, supply and Product Delivery obligations of SIIPL/SLS in relation to the Product under each and every Firm Purchase Order are entirely subject to receipt by SIIPL and SLS of all Regulatory Approvals and any [***] authorisations from the Regulatory Authority / Government Authority, including any export permissions and / or any other requirements, conditions or approvals in [***].
2.8.3[***].
Article 3.Regulatory matters for the Supply Agreement
3.1Regulatory Approvals.
Specific and restricted to the context of this Supply Agreement, SIIPL, either itself or through an Affiliate or Subcontractor, will be [***] for obtaining and maintaining any permits or other Regulatory Approvals required under Applicable Law to Manufacture or have Manufactured the Product. [***]. All such documents shall be available in English. If Novavax requires such documentation to be translated into a non-English language, then SIIPL will provide a certified translation in the language requested by Novavax [***].
3.2Documentation for Product Master File.
[***], SIIPL, either itself or through an Affiliate or Subcontractor approved under this Supply Agreement, will maintain and keep updated drug master files for the Product. SIIPL shall provide all [***] documentation to Novavax [***]. At Novavax [***] request, SIIPL will take other [***] as may be requested by any Regulatory Authorities to give Novavax the benefit of such master files.
3.3Records and Accounting by SIIPL.
SIIPL/SLS will keep and shall ensure that any other Affiliates and Subcontractors engaged in this Supply Agreement keeps records of the Manufacture (including production data), testing, and shipping of each Batch and retain samples of all Batches in accordance with the applicable quality agreement executed by all Parties for the Product being supplied under this Supply Agreement (the “Quality Agreement”).
3.4Audits and Regulatory Inspections.
Audits and regulatory inspection of SIIPL’s manufacturing facility / those of SLS/ of any Subcontractor’s facilities approved for use under this Supply Agreement, as the case may be, shall be conducted in accordance with the Quality Agreement. Novavax agrees to execute [***] confidentiality agreement required by any Affiliate or Subcontractor of SIIPL (including SLS) in connection with such visit,
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audit or inspection of the facilities of such Affiliate or Subcontractor, and will comply with such Affiliate’s or Subcontractor’s reasonable rules and regulations. In the event Novavax foresees the existence of an operational issue in the Manufacture of any component of the Product that Novavax [***] believes [***] may result in a cGMP or other regulatory deficiency or failure of SIIPL to meet its obligations under this Supply Agreement or the Quality Agreement (such as failure of a Product to meet the Product Requirements), then Parties shall agree [***] to conduct joint inspections.
3.5Notification of Regulatory Inspections.
If any Governmental Authority provides SIIPL notice of its intent to conduct an inspection or investigation, or to take any other type of regulatory action with respect to any facility where the Product is manufactured under this Supply Agreement, then SIIPL will give Novavax notice [***] of its receipt of such notice. SIIPL will provide to Novavax information and findings pertaining thereto [***] after receipt. [***], then Novavax shall be entitled to be present during any such inspection or investigation.
3.6Reports.
SIIPL/SLS will supply [***] data [***] relating to the Products, [***], that Novavax requires or otherwise requests[***]. Further, SIIPL/SLS will provide Novavax with written reports in the format [***] required by Novavax and hold meetings with Novavax’ representatives [***] on the progress of their performances under this Supply Agreement [***].
3.7Complaints.
In connection with any Product complaints or customer communications [***] relating to the Product that are received by SIIPL/SLS, SIIPL/SLS will ***] report such to Novavax. In addition to what is agreed between the Parties under the Quality Agreement, for the sake of clarity, it is reiterated that Novavax shall be [***] to conduct investigation of any such complaints and otherwise handle all claims or complaints towards any Latent Defects in the Products, or any adverse events notifications, or any Product recalls.
Article 4.Payments; Invoicing; Taxes; Financial Reports
4.1Invoice and Payment.
4.1.1SLS will issue to Novavax a written invoice (i) in accordance with each Firm Purchase Order or (ii) upon Product Delivery set forth in a Firm Purchase Order, and Novavax will pay SLS all undisputed amounts set forth in such Firm Purchase Order within [***] of receipt of each such invoice.
4.1.2All invoices issued and payments to be made between the Parties under this Supply Agreement shall be made in U.S. dollars and shall be paid by wire transfer in immediately available funds to a bank account designated by SLS.
4.1.3If, due to restrictions or prohibitions imposed by national or international authority, a given payment cannot be made as provided in this Section 4.1,
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then the Parties will consult with a view to finding a [***] acceptable solution. Upon agreement of the Parties in a Firm Purchase Order, Novavax may deliver such payment in the relevant country and in the local currency of the relevant country.
4.2Taxes
4.2.1Responsibility.
Except as expressly set forth in Section 4.2.2 (Withholding Taxes) and stated below, each Party will pay any and all taxes levied by Applicable Law on account of all payments received by such Party from the other Party or any third party as a result of this Agreement, including all taxes based on any net income of such Party.
4.2.2Withholding Taxes.
SLS will provide such information and documentation to Novavax as are [***] requested by Novavax to determine if any withholding taxes apply to any payments to be made by Novavax to SLS under this Agreement. If any taxes are required to be withheld with respect to any such payments to be made by Novavax to SLS under this Agreement, Novavax will: (a) deduct those taxes from the remittable payment, (b) pay the taxes to the proper taxing authority, (c) send evidence of the obligation together with proof of tax payment to SLS [***], and (d) [***]. [***]. [***].
4.2.3No other Taxes.
No other taxes would be levied/withheld by either Party other than the taxes mentioned specifically above.
4.2.4[***].
[***]. [***].
Article 5.Intellectual Property
5.1Background Intellectual Property.
Each Party retains its respective ownership (a) in its Background IP or (b) in intellectual property determined to be owned by such Party in accordance with the License Agreement (collectively, “Background Intellectual Property”).
5.2Ownership of Improvements.
5.2.1Novavax shall own all right in and title to improvements made to [***]. [***]. In the event SIIPL, either itself or through an Affiliate or Subcontractor, conceives, develops or reduces to practice during the Term of this Supply Agreement any improvements to [***], then SIIPL shall [***] disclose in writing to Novavax any such improvements and the same shall form part and parcel of [***].
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Ownership in all right in and title to all improvements other than [***] shall be determined in accordance with all applicable provisions of the License Agreement, including, but not limited to, Article 9 of the License Agreement.
5.3Covenant Not to Sue.
Each Party acknowledges and agrees that the covenant not to sue described in Section 6.2 (Covenant Not to Sue) of License Agreement applies to the performance under and activities contemplated by this Supply Agreement.
Article 6.Confidentiality
6.1Definition.
“Confidential Information” means the terms and provisions of this Supply Agreement and other Know-How, trade secrets, inventions, materials, and other proprietary information and data of a financial, commercial, or technical nature (in whatever form) that a Party (“Disclosing Party”) or any of its Affiliates has supplied or otherwise made available to the other Party (“Receiving Party”) or its Affiliates, which are disclosed in writing or orally and whether or not specifically marked or designated by the Disclosing Party as confidential. For clarity, Novavax Confidential Information includes Adjuvant and all other data, information and Know-How associated therewith. For clarity, SIIPL’s /SLS’ Confidential Information includes (i) all data, information and Know-How owned or controlled by SIIPL /SLS in relation to any Development or Manufacturing activities conducted hereunder this Supply Agreement, (ii) all Records, reports books of accounts maintained by SIIPL/SLS in the performance of this Supply Agreement, and (iii) any nonpublic information or data that may be disclosed to or shared with, or to which Novavax or any of its Affiliates or any other Third Party acting on its behalf (including any auditors appointed by Novavax) may be exposed to during any site visits or inspection visits or regulatory visits at any of SIIPL’ / SLS’ and / or a Subcontractor’s facilities (as the case may be).
6.2Obligations on Receiving Party.
The Receiving Party will (a) protect all Confidential Information of the Disclosing Party against unauthorized disclosure to Third Parties and (b) not use or disclose the Confidential Information of the Disclosing Party, except as permitted by or in furtherance of exercising rights or carrying out obligations hereunder. The Receiving Party will treat all Confidential Information provided by the Disclosing Party with the same degree of care as the Receiving Party uses for its own similar information, but in no event less than a reasonable degree of care. The Receiving Party may disclose the terms and conditions of this Supply Agreement and the Confidential Information to its Affiliates, and their respective directors, officers, employees, Subcontractors, sublicensees, consultants, attorneys, accountants, banks, financial advisors, funders and investors (collectively, “Representatives”) who have an absolute need-to-know such information to carry out the activities and transactions or to exercise its rights contemplated by this Supply Agreement, provided that the such Representatives are bound by written obligations of confidentiality at least as restrictive as those set forth in this Supply Agreement. Each Party will promptly notify the other Party of any misuse or unauthorized disclosure of the other Party’s Confidential Information.
6.3Exceptions to Confidentiality.
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The obligations under this Article 6 (Confidentiality) will not apply to any information to the extent the Receiving Party [***]:
6.3.1is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Supply Agreement by the Receiving Party or any Representatives to whom it disclosed such information;
6.3.2was known to, or was otherwise in the possession of, the Receiving Party prior to the time of disclosure by the Disclosing Party;
6.3.3is disclosed to the Receiving Party on a non-confidential basis by a Third Party who is entitled to disclose it without breaching any confidentiality obligation to the Disclosing Party; or
6.3.4is independently developed by or on behalf of the Receiving Party or any of its Affiliates, as evidenced by its written records, without use or access to the Confidential Information.
6.4Permitted Disclosures.
6.4.1Compliance with Law.
The Receiving Party may disclose Confidential Information of the Disclosing Party that the Receiving Party is required to disclose under Applicable Laws or a court order or other governmental order, [***].
6.4.2SEC Filings and Other Disclosures.
Novavax may disclose such [***] redacted terms of this Supply Agreement [***] only to the extent [***] required to comply with the rules and regulations promulgated by the United States Securities and Exchange Commission or similar security regulatory authorities in other countries. [***].
6.4.3Other Permitted Disclosure.
Notwithstanding the restrictions set forth in this Article 6 (Confidentiality), Novavax may disclose the terms and provisions of this Supply Agreement to any Third Party in connection with any actual or bona fide prospective acquisition, merger, financing, transfer or sale of all or substantially all of the assets of the business of Novavax to which this Supply Agreement relates as permitted under Section 11.3 (Assignment); provided that such Third Party is bound by written obligations of confidentiality at least as restrictive as those set forth in this Supply Agreement. Novavax agrees that in the event it is requested to disclose any portion of SIIPL’ Confidential Information to such Third Party for the context laid out above, then, it must secure [***] consent from SIIPL, [***].
6.4.4Continuing Confidentiality Obligations.
If and whenever any Confidential Information is disclosed in accordance with this Section 6.4 (Permitted Disclosures), such disclosure shall not
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cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Supply Agreement).
6.5Ongoing Obligation for Confidentiality.
Upon expiration or termination of this Supply Agreement, the Receiving Party will, and will [***] its Representatives to, destroy, delete, or return [***] any Confidential Information of the Disclosing Party, [***]. [***].
Article 7.Representations, Warranties and Covenants
7.1Representations, Warranties and Covenants of Each Party.
Each Party represents, warrants and covenants that:
7.1.1it is a corporation duly organized, validly existing, and in good standing under the laws of its jurisdiction of formation;
7.1.2it has full corporate power and authority to execute, deliver, and perform under this Supply Agreement, and has taken all corporate action required by Applicable Laws and its organizational documents to authorize the execution and delivery of this Supply Agreement and the consummation of the transactions contemplated by this Supply Agreement;
7.1.3this Supply Agreement constitutes a valid and binding agreement enforceable against it in accordance with its terms;
7.1.4all consents, approvals, and authorizations from all Governmental Authorities or other Third Parties required to be obtained in connection with this Supply Agreement have been obtained; and
7.1.5the execution and delivery of this Supply Agreement and all other instruments and documents required to be executed pursuant to this Supply Agreement, and the consummation of the transactions contemplated hereby do not and will not: (a) conflict with or result in a breach of any provision of its organizational documents; (b) result in a breach of any agreement to which it is a party that would impair the performance of its obligations hereunder; or (c) violate any Applicable Laws.
7.2Representations, Warranties and Covenants of SIIPL and SLS.
SIIPL and SLS, jointly, represent, warrant and covenant that:
7.2.1neither they nor any person or entity acting for or on behalf of SIIPL / SLS will, in connection with the performance of this Supply Agreement, (i) use any funds for contributions, gifts, entertainment, or other payments related to political activity or (ii) make any payment to any government official, in each case in violation of any Applicable Law;
7.2.2(i) neither they nor any Affiliate / Subcontractor has been debarred under the provisions of the Applicable Law, or by any Regulatory Authority, (ii) neither they nor any Affiliate / Subcontractor will use in any capacity, in
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connection with the performance of this Agreement, any person or entity who has been debarred pursuant to the foregoing, and (iii) if at any time during the term of this Supply Agreement, they or any person or entity engaged by SIIPL /SLS to perform this Supply Agreement (a) becomes debarred, or (b) receives notice of action or threat of action with respect to its debarment, SIIPL /SLS shall notify Novavax immediately, and Novavax shall have the right to terminate this Supply Agreement immediately.
7.3Batch Warranties.
SIIPL warrants that all Batches Manufactured, either by itself or through Subcontractor, under this Supply Agreement will:
7.3.1for Batches delivered for Commercial use, be Delivered with full title and with the applicable Certificate of Analysis, Certificate of Conformance, Master Batch Record, applicable master safety data sheet, and additional Batch-related documentation identified in the Quality Agreement;
7.3.2be Manufactured in accordance with cGMP or otherwise in accordance with all Applicable Law and the terms of the applicable Quality Agreement;
7.3.3at the time of the Product Delivery, conform to the applicable Product Specifications in all respects.
7.4Representations, Warranties and Covenants of Novavax.
Novavax represents, warrants and covenants that:
7.4.1All Novavax Background Intellectual Property, Adjuvant and any Novavax Know-How provided to SIIPL under this Supply Agreement or under any Firm Purchase Order have been Manufactured by Novavax (or procured from a Third Party manufacturing them, as the case may be), strictly in accordance with all Applicable Laws and cGMP;
7.4.2Novavax controls or has all such right title and interest in the Novavax Background Intellectual Property, Adjuvant, and any Novavax Know-How, as may necessary for supply to and use by SIIPL, either itself or through an Affiliate or Subcontractor, thereof, for the performance of SIIPL’s obligations under this Supply Agreement; and
7.4.3Supply to and use by SIIPL, either itself or through an Affiliate or Subcontractor, of any Novavax Background Intellectual Property, Adjuvant and any Novavax Know-How for the Development or Manufacture of the Product under this Supply Agreement or any Firm Purchase Order (i) is free of any Third Party lien, (ii) does not infringe any valid Third Party Intellectual Property Rights, (iii) is not in violation of any agreement or other contractual arrangement by which Novavax may be bound and (iv) is compliant with all Applicable Laws which may apply the Agreement.
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7.4.4Novavax assures and warrants that it shall sell the Adjuvant to SIIPL/SLS at an agreed price no higher than the price recorded under Exhibit B hereunder.
7.5DISCLAIMER OF WARRANTIES.
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE.
7.6[***].
EXCEPT FOR DAMAGES RESULTING FROM [***], IN NO EVENT WILL EITHER PARTY HAVE ANY CLAIMS AGAINST OR LIABILITY TO THE OTHER PARTY WITH RESPECT TO ANY[***].
Article 8.Indemnification and Insurance
8.1Indemnification by SIIPL and SLS.
SIIPL and SLS, jointly, will indemnify, defend, and hold harmless Novavax and its Affiliates and their respective officers, directors, employees, successors, and permitted assigns, (each a “Novavax Indemnified Party”) from and against any and all losses, liabilities, damages, costs, fees, and expenses (including reasonable attorneys’ fees) (collectively, “Losses”) suffered by any Novavax Indemnified Party in connection with any suits or claims brought by any Third Party (“Claims”) arising out of or resulting from (in each case, [***]:
8.1.1[***]
8.1.2[***]
8.1.3[***]
8.1.4[***]
8.1.5[***].
8.2Indemnification by Novavax.
Novavax will indemnify, defend, and hold harmless SIIPL, SLS and their Affiliates and their respective officers, Subcontractors, directors, employees, successors, and permitted assigns (each, a “SIIPL Indemnified Party”) from and against Losses suffered by any SIIPL Indemnified Party in connection with any Claims arising out of or resulting from [***]:
8.2.1[***]
8.2.2[***]
8.2.3[***]
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8.2.4[***]
8.2.5[***]
8.2.6[***]
8.2.7[***]
8.3Indemnification Procedure.
In connection with any Claim for which an Indemnified Party seeks indemnification from the other Party pursuant to this Supply Agreement, the Indemnified Party will: (a) give the other Party [***] written notice of the Claim; provided, [***]; (b) cooperate with the other Party, at the other Party’s expense, in connection with the defense and settlement of the Claim; and (c) permit the other Party to control the defense and settlement of the Claim; provided, however, that the other Party may not settle the Claim without the Indemnified Party’s prior written consent [***]. Further, the Indemnified Party will have the right to participate (but not control) and be represented in any suit or action by counsel of its selection and at its own expense.
8.4Insurance.
SIIPL (for itself and SLS) and Novavax, each at their own expense, shall obtain and thereafter maintain during the term of the Supply Agreement [***] all [***] insurance covering each Party’s performance under this Supply Agreement, as may be applicable to each Party under the respective Applicable Law. Each Party shall provide the other a certificate of insurance upon the written request of the other Party.
Article 9.Term and Termination
9.1Term.
This Supply Agreement will commence upon the Effective Date of the Supply Agreement and, if not otherwise terminated earlier pursuant to this Article 9, will continue in full force and effect until three (03) years or until two (2) years after the date of expiration or termination of the last Firm Purchase Order, whichever is later (“Term”).
9.2Termination for Cause.
9.2.1Either Party (“Non-Breaching Party”) will have the right, without prejudice to any other remedies available to it at law or in equity, to terminate this Agreement in the event the other Party breaches (“Breaching Party”) any of its material obligations hereunder and fails to cure such breach within [***] after receiving notice thereof; provided, however, that (a) if the breach by its nature is not curable, then the Non-Breaching Party will be entitled to seek such relief within [***] of providing written notice to the Breaching Party, and (b) [***] (“Cure Period”), in each case (a) and (b), at the end of which such termination shall become effective, unless, such allegedly breaching Party disputes such breach in accordance with Section 9.2.2 below. Any termination by a Party under this Section 9.2 (Termination for Cause) will be without
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prejudice to any damages or other legal or equitable remedies to which it may be entitled from the other Party.
9.2.2If the Parties [***] disagree as to whether there has been a material breach, including whether such breach was material or curable, the Party that disputes whether there has been a material / curable breach may contest the allegation in accordance with Section 11.2 (Dispute Resolution). Notwithstanding anything to the contrary in Section 9.2.1, if a Party contests the allegation in accordance with Section 11.2, the Cure Period for any dispute will extend from the date that written notice was first provided to the Breaching Party by the Non-Breaching Party until the end of the escalation period stipulated under Section 11.2, and it is understood and acknowledged that, during such period, all of the terms and conditions of this Agreement will remain in effect, and the Parties will continue to perform all of their respective obligations under this Agreement.
9.3Termination and Bankruptcy.
This Supply Agreement may be terminated by a Party [***] upon written notice to the other Party if the other Party files a petition in bankruptcy or of insolvency, or is adjudicated insolvent, or takes advantage of the insolvency law in any state or country, or makes an assignment for the benefit of creditors, or a receiver, trustee or other court officer is applied for or appointed for its property.
9.4Termination for Change of Control of Novavax.
SIIPL and SLS shall have the right, in their sole discretion to terminate this Supply Agreement by a written notice of [***] to Novavax, in the event Novavax undergoes a change of control event as stipulated under Section 11.3.2 and the party acquiring or merging with or in any other manner controlling Novavax (i) refuses to be bound by the terms and conditions of this Supply Agreement, or (ii) does not perform the obligations of Novavax under this Supply Agreement.
9.5Termination by Mutual Consent.
In the event the applicable Regulatory Authority in the Novavax Exclusive Territory or the SIIPL Non-Exclusive Territory does not approve any of the Products (or any other product containing or comprised of any of the Products) for marketing or distribution or withdraws marketing or distribution approval, or SIIPL/SLS fails to maintain the consents, approvals, and authorizations from all Governmental Authorities or other Third Parties required to Manufacture the Products then all Parties may mutually agree in good faith to decide the path forward, including modifications of the commercial terms and/or termination.
Article 10.Effects of Expiry / Termination
10.1Accrued Rights.
Expiration or termination of this Supply Agreement will not relieve the Parties of any liability that accrued hereunder prior to the effective date of such expiration or termination, nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this
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Supply Agreement, and any such expiration or termination will be without prejudice to the rights of either Party against the other.
10.2Return of Confidential Information.
Upon the expiration or termination of this Supply Agreement, the Receiving Party will [***] to the Disclosing Party [***] all Confidential Information of the Disclosing Party that is in the Receiving Party’s possession or under its control (other than any Confidential Information required to continue to exercise a Party’s rights that survive termination of this Supply Agreement). Notwithstanding the foregoing, the Receiving Party shall not be required to return or destroy Confidential Information contained in any computer system back-up records made in the ordinary course of business and shall be entitled to retain [***] Confidential Information, [***] to comply with Applicable Law and to monitor its continuing obligations under the Agreement, [***].
10.3Survival.
The following provisions, as well as any other provisions which by their nature are intended to survive termination or expiration, will survive termination or expiration of this Supply Agreement: Section 2.7 ( Latent Defects, Pharmacovigilance, Adverse Events and Recalls); Article 5 (Intellectual Property Rights); Article 6 (Confidential Information); Article 7 (Representations and Warranties); Article 8 (Indemnification and Insurance); Article 10 (Effects of Expiry / Termination) and Article 11 (Miscellaneous).
Article 11.Miscellaneous
11.1No Third Party Obligation on SIIPL / SLS
11.1.1Novavax expressly agrees that SIIPL and SLS are performing their obligations under this Supply Agreement, either themselves or through another Affiliate or Subcontractor, solely in the capacity of suppliers the Product in mutually agreed quantities between the Parties under any and all Firm Purchase Orders issued hereunder. SIIPL /SLS shall not be bound by or obligated to any Third Party to fulfill any Product supply commitments or assurances or covenants as a result of this Supply Agreement, whether as of Effective Date of this Supply Agreement, or at any time during the Term, which are given by Novavax to any Third Party, including without limitation to any Government Authority / Regulatory Authority in any country within the Novavax Exclusive Territory or the SIIPL Non-Exclusive Territory, or any international for-profit organization or any international non-profit organization or any statutory or governmental entity or any other private or public corporation (other than an Affiliate of Novavax), and Novavax shall be solely obligated to fulfill any and all of its covenants to any such Third Party without any recourse to SIIPL/SLS.
11.1.2For the sake of clarity, by executing this Supply Agreement, SIIPL/SLS shall not, either directly, or by any implication, be responsible for or become to a party to, any obligations, commitments, promises or other assurances by Novavax to any Third Party in relation to the supply of the Product, [***].
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11.2Dispute Resolution and Escalation.
The Parties recognize that a dispute may arise relating to this Supply Agreement. In the event of such a dispute, the authorized officers from each Party will negotiate [***] to settle any such dispute within [***]. If such officers are unable to resolve the dispute, then either Party may commence legal proceedings in accordance with Section 11.5 below.
11.3Assignment.
11.3.1Assigning to Affiliates.
No Party hereto may assign any right or obligation hereunder to a Third Party without the [***] consent of the other Party hereto. Notwithstanding the foregoing, either Party may assign this Agreement, or all of its rights or obligations hereunder to any Affiliate of such Party [***].
11.3.2Change of Control.
Subject to [***], Novavax may assign this Supply Agreement, or all of its rights or obligations hereunder and thereunder to any Affiliate of Novavax, or to any Person that acquires all or substantially all of the stock or assets of the business to which this Supply Agreement relates (by merger, stock or asset purchase, operation of law, or otherwise), provided that such Third Party acquiring Novavax shall be bound by the terms and conditions of this Supply Agreement and accordingly be obligated to perform all the obligations and responsibilities of Novavax under this Supply Agreement, and provided further that, in the event of any failure of any such party acquiring or merging with Novavax to comply with the provisions of this Section 11.3.2, SIIPL and SLS reserve their right to [***].
11.3.3Successors and Assigns.
This Supply Agreement will be binding on and insure to the benefit of the Parties, their executors, administrators, successors and permitted assigns.
11.4Severability.
Should one or more of the provisions of this Supply Agreement become void or unenforceable as a matter of law, then such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Supply Agreement, and the Parties agree to substitute a valid and enforceable provision therefor which, as nearly as possible, achieves the desired economic effect and mutual understanding of the Parties under this Supply Agreement.
11.5Governing Law and Legal Proceedings.
This Supply Agreement, and all claims arising under or in connection therewith, will be governed by and interpreted in accordance with the substantive laws of [***] without regard to conflict of law principles thereof. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to any Purchase Order made pursuant to this Supply Agreement.
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11.6Waivers and Amendments.
The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Supply Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver will be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Supply Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.
11.7Relationship of the Parties.
SIIPL and SLS are Affiliates of each other, however, nothing contained in this Supply Agreement will be deemed to constitute a partnership, joint venture, or legal entity of any type between SIIPL/SLS and Novavax, or to constitute one as the agent of the other. Moreover, as between SLS/SIIPL on the one hand, and Novavax on the other, this Supply Agreement, or any of the transactions contemplated hereby are not to be construed, as a partnership for any tax purposes and each Party will act solely as an independent contractor, and nothing in this Supply Agreement will be construed to give one the power or authority to act for, bind, or commit the other.
11.8Notices.
All notices, consents, waivers, and other communications under this Supply Agreement must be in writing and will be deemed to have been duly given when: (a) delivered by hand (with written confirmation of receipt); (b) sent by fax (with written confirmation of receipt), provided that a copy is sent by an internationally recognized overnight delivery service (receipt requested); or (c) sent by email to the addressee, and marked as “Notice” under this Section 11.8, provided sender receives electronic confirmation of receipt by such recipient, or (d) when received by the addressee, if sent by an internationally recognized overnight delivery service, receipt requested, in each case to the appropriate addresses and fax numbers set forth below (or to such other addresses and fax numbers as a Party may designate by written notice):
If to SIIPL:
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road,
Hadapsar, Pune, India - 411028
E: [***]
If to Novavax:
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878
Attn:    [***]
E: [***]
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If to SLS:
Serum Life Sciences Ltd.
12 New Fetter Lane, London,
United Kingdom, EC4A 1JP
Attention: [***]
E: [***]
11.9Further Assurances.
Novavax, SLS and SIIPL hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge, and deliver any and all such other documents and take any such other action as may be reasonably necessary or appropriate to carry out the intent and purposes of this Supply Agreement.
11.10No Third Party Beneficiary Rights.
Except as expressly provided in this Supply Agreement, this Supply Agreement is not intended to and will not be construed to give any Third Party any interest or rights (including any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby.
11.11Entire Agreement. This Supply Agreement, the Exhibit(s), Firm Purchase Orders, and the Quality Agreement, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter. In the event of any conflict between a material provision of this Supply Agreement and any Firm Purchase Order, the order of precedence shall be as follows: Supply Agreement, the Exhibit(s) and the Firm Purchase Order, unless any such conflict is specifically and expressly identified in the applicable a Firm Purchase Order, in which case, such conflicting provision in the Firm Purchase Order shall control. Notwithstanding the foregoing, the Quality Agreement shall control with respect to all quality matters. Nothing stated herein this Supply Agreement shall derogate, or be interpreted to derogate from any provision of the License Agreement and the Parties agree that the License Agreement and Supply Agreement shall be read compositely. For the sake of clarity, the termination or expiry of this Supply Agreement shall not affect, and shall not mean (or be interpreted as to mean) expiry or termination of the License Agreement.
11.12Force Majeure.
Neither Party will be liable or deemed in default for failure to perform any duty or obligation that such Party may have under this Supply Agreement where such failure has been occasioned by any act of God, fires, earthquakes, strikes and labor disputes, acts of war, terrorism, civil unrest, other factors that affect the supply or procurement of Raw Materials, or intervention of any Governmental Authority (“Force Majeure”), and which is beyond its reasonable control; [***].
11.13Cumulative Remedies.
Except as otherwise set forth in this Supply Agreement, no remedy referred to in this Supply Agreement is intended to be exclusive, but each will be cumulative
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and in addition to any other remedy referred to in this Supply Agreement or otherwise available under Applicable Law.
11.14Waiver of Rule of Construction.
Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Supply Agreement. Accordingly, any rule of construction that any ambiguity in this Supply Agreement will be construed against the drafting Party will not apply.
11.15Construction; Rules of Construction.
Interpretation of this Supply Agreement will be governed by the following rules of construction: (a) words in the singular will be held to include the plural and vice versa, and words of one gender will be held to include the other gender as the context requires; (b) references to the terms “Section,” or “clause” are to a Section of this Supply Agreement unless otherwise specified; (c) the terms “hereof,” “hereby,” “hereto,” and derivative or clause or similar words refer to this entire Supply Agreement; (d) the word “including” and words of similar import when used in this Supply Agreement will mean “including without limitation,” unless otherwise specified; (e) the word “or” will not be exclusive; (f) references to “written” or “in writing” include in electronic form; (g) the titles and headings contained in this Supply Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this Supply Agreement; (h) the word “will” will be construed to have the same meaning and effect as the word “shall”; (i) references to “days” will mean calendar days, unless otherwise specified; and (j) a reference to any Person includes such Person’s successors and permitted assigns.
11.16Counterparts.
This Supply Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. This Supply Agreement may be executed by facsimile, PDF format via email or other electronically transmitted signatures and such signatures will be deemed to bind each Party as if they were original signatures.
-------------[Signature page follows on the next page]-------------

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image_0a.jpgIn Witness Whereof, the Parties have caused this Supply Agreement to be executed by their respective duly authorized officers as of the Effective Date.
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SERUM INSTITUTE OF INDIA PVT. LTD.
By:/s/ [***]
(Signature)
Name:[***]
Title:[***]
NOVAVAX, INC.
By:/s/ John A. Herrmann III
(Signature)
Name:John A. Herrmann III
Title:EVP, CLO


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SERUM LIFE SCIENCES LIMITED.
By:/s/ [***]
(Signature)
Name:[***]
Title:[***]


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EXHIBIT A
FACILITIES
[Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit A 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.]
[***]

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EXHIBIT B
PRICING AND PAYMENTS
[Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit B setting forth the Pricing and Payments 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 10.39

CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
First Amendment to Collaboration and License Agreement
This First Amendment to Collaboration and License Agreement (the “First Amendment’) is made effective as of December 23, 2021 (the “First Amendment Effective Date”) by and between Novavax, Inc., a Delaware corporation having a place of business at 21 Firstfield Rd., Gaithersburg, MD 20878 (“Novavax”) and SK bioscience Co., Ltd., a company incorporated in the Republic of Korea having a place of business at 310 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 13494, Republic of Korea (“SK”).
RECITALS
WHEREAS, the Parties have entered into a Collaboration and License Agreement, effective as of February 12, 2021 (the “Collaboration and License Agreement”), in which Novavax has granted to SK, and SK has accepted a license to Develop, Manufacture and/or Commercialize Novavax’ coronavirus vaccine candidate, NVX-CoV2373, comprised of its proprietary BV2373 antigen (“Original Antigen”) and formulated with Novavax’ Matrix-M™ adjuvant (“Original Vaccine Product”);
WHEREAS, Novavax is developing one or more coronavirus vaccine candidates comprised of a variant antigen (“Variant Antigen”) formulated with Matrix-M™ adjuvant that targets a variant COVID-19 virus (Original Antigen and Variant Antigen are hereinafter collectively referred to as “Antigen”);
WHEREAS, SK and the Korean Government have entered into an Advance Purchase and Supply Agreement, effective as of February 16, 2021 (the “First Korean APA”) under which the Korean Government may purchase forty million (40,000,000) doses of Original Vaccine Product (the “First Korean APA Doses”);
WHEREAS, SK and the Korean Government may enter into a second advance purchase agreement under which the Korean Government may purchase up to an additional five million (5,000,000) doses of Vaccine Product Manufactured from [***] in the second half of Calendar Year 2022 [***] (the “Second Korean APA Doses”) (the “Second Korean APA”) (the First Korean APA Doses and the Second Korean APA Doses, if any, are hereinafter collectively referred to as the “Korean APA Doses and the First Korean APA and the Second Korean APA, if any, are hereinafter collectively referred to as the “Korean APAs”);
WHEREAS, SK desires to enter into advance purchase agreements with the governments of Thailand and Vietnam, under which such governments may purchase up to a total of [***] doses of Vaccine Product [***] (the “Ex-Korea APA Doses”)(which Ex-Korea Doses and Second Korean APA Doses shall not exceed [***] doses in total) (the Korean Government and the governments of Thailand and Vietnam (and/or their local representatives designated by the governments, who would be responsible for Commercialization of Vaccine Product on behalf of such governments) are hereinafter collectively referred to as the “National Governments”);
WHEREAS, in accordance with the terms and conditions set forth below, Novavax and SK desire to reserve the entire capacity of SK’s [***] for the Manufacture of Antigen Product during the remainder of 2021 and for the entirety of Calendar Year 2022 and, potentially, Calendar Year 2023 and Novavax wishes to purchase such Antigen Product for use as Collaboration Antigen Product;
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WHEREAS, Novavax desires to purchase any and all Antigen that SK Manufactures in 2021 and 2022 for use as Collaboration Antigen Product pursuant to an allocation formula set forth in the amended and restated Section 5.3 below;
WHEREAS, the Parties desire to convert doses of Novavax Vaccine Product to doses of SK Vaccine Product under financial terms that differ from the other doses of SK Vaccine Product;
WHEREAS, subject to the terms and conditions set forth below, the Parties desire to extend the Term for Korea to the twentieth (20th) anniversary date of the Effective Date of the Collaboration and License Agreement and the term for Thailand and Vietnam to the fifth (5th) anniversary date of the Effective Date of the Collaboration and License Agreement; and
WHEREAS, the Parties wish to enter into this First Amendment to set forth the terms and conditions under which (i) SK may Develop, Manufacture and/or Commercialize the Second Korean APA Doses, the Ex-Korea APA Doses and/or Vaccine Product to other potential purchasers and (ii) Novavax may purchase Collaboration Antigen Product Manufactured by SK in the SK Facility from the First Amendment Effective Date through December 31, 2022 (with an option to discuss possible extension until December 31, 2023 if Novavax exercises its option set forth in Section 5.2).
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1.Definitions
All capitalized terms used in this First Amendment shall have the same meanings as defined in the Collaboration and License Agreement unless otherwise specifically indicated herein.
2.Amendment
(1)Except as set forth in this First Amendment, all references to “Korean Government” in the Collaboration and License Agreement shall be replaced with “National Governments”.
(2)Except as set forth in this First Amendment, all references to “Antigen” in the Collaboration and License Agreement shall be replaced with “Original Antigen” as defined under this First Amendment.
(3)Section 1.9 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 1.9:
1.9    Background Intellectual Property means any and all Intellectual Property of a Party, which, as demonstrated by admissible evidence, (i) already existed as of the Effective Date (February 12, 2021) of this Agreement or (ii) was developed or obtained by or on behalf of such Party independent of this Agreement, and without reliance upon the Confidential Information of the other Party. Notwithstanding the foregoing, any and all Intellectual Property developed or obtained by or on behalf of Novavax in relation to the Variant Antigen as of the First Amendment Effective Date shall be deemed as Background Intellectual Property of Novavax.”
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(4)All references to “Novavax Vaccine Product” in the Collaboration and License Agreement shall be deleted and Section 1.61 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 1.6.1:
1.61    [Intentionally Left Blank to Preserve Numbering]
(5)Section 1.79 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 1.79:
1.79    SK Facility means [***] of the manufacturing facility at SK which shall be fully dedicated to the Manufacture of SK Antigen Product and/or Collaboration Antigen Product until December 31, 2022 and/or during the entirety of Calendar Year 2023 (if the Parties execute an applicable SOW pursuant to Section 5.2).”
(6)Section 1.82 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 1.82:
1.82    SK Territory means the Republic of Korea, Thailand, and Vietnam, which may only be extended by prior mutual written agreement between the Parties.”
(7)Section 1.98 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 1.98:
1.98    Vaccine Product means a finished coronavirus vaccine product formulated with Adjuvant Components [***]. The final form (e.g., [***]) of the Vaccine Product and the specific Antigen(s) incorporated therein (e.g., [***]) shall be determined by Novavax and SK, based on the mutual good-faith discussions between the Parties, provided that such Vaccine Product is in compliance with the Applicable Laws in the Territory and in alignment with Novavax’ Variant Antigen development strategy as determined by Novavax in its sole discretion.”
(8)The following new Section 1.102 shall be inserted into the Collaboration and License Agreement:
1.102    Technology Transfer means, subject to the licenses granted in Section 12.4.1 (Novavax as Licensor) the transfer from Novavax to SK of Intellectual Property, including Novavax Supplied Items as set forth in the SOW(s), in Novavax’ possession and control that is [***] for SK to perform Process Development and scale-up related to the planned Manufacture of Antigen Product and Vaccine Product.”
(9)The following new Section 2.2.5 shall be inserted into the Collaboration and License Agreement:
2.2.5 oversee and discuss allocation of the Antigen Product under Section 5.3.2 of the Collaboration and License Agreement or relevant SOW, including facilitating remedial an action plan in case of any Antigen Product Manufactured is determined to be non-conforming in accordance with Article 6 and the applicable Quality Agreement.”
(10)The following new Section 2.7 shall be inserted into the Collaboration and License Agreement:
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2.7    Joint Commercialization Committee.
2.7.1    Formation and Purpose. The Parties agree to establish a Joint Commercialization Committee (“JCC”) which shall be composed of [***] representatives from each Party, each of whom shall have the appropriate knowledge and expertise and requisite decision-making authority. The role of the JCC shall be:
(i)    monitor and coordinate communication and operations regarding SK’s efforts with respect to its Commercialization activities in connection with any and all SK Antigen Products and SK Vaccine Products in the SK Territory;
(ii)    review the global Commercialization (including branding) and pricing strategy and updates thereto, provide feedback to the Parties, and submit the final Commercialization strategy and any updates thereto for the SK Antigen Products and SK Vaccine Products for review and approval by the JSC;
(iii)    determine SK’s Commercialization diligence efforts and objectives for SK Antigen Product and SK Vaccine Product for each Calendar Year basis by December 31 of the preceding Calendar Year, which efforts and objectives shall including annual sales targets, detailing obligations and other customary and industry standard measurements and objectives; and
(iv)    be notified by SK [***] in advance of the completion date of clinical study, filing date, including initial and completed filing dates of any rolling submission, and anticipated approval date for Regulatory Approval and the anticipated First Launch Date (as defined below) in relation to any Competing Vaccine (as defined below) in the SK Territory.
2.7.2    JCC Decisions and Actions. All JCC decisions shall be taken following [***], with each Party having one (1) vote. If the JCC fails to reach unanimous agreement on a matter for a period in excess of [***] from the date first presented to the JCC in writing, the matter shall be referred immediately to the JSC in accordance with Section 2.2.2.
2.7.3    JCC Meetings. Meetings of the JCC shall be held in the same manner and follow the same procedures for the JSC as set forth in Section 2.3.”
(11)Section 3.1 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 3.1:
3.1    Antigen Product Technology Transfer. As of the Effective Date, the Parties hereby acknowledge they are completing Antigen Product Technology Transfer with respect to Manufacture of Original Antigen Product [***]. On a date to be agreed by the Parties, the Parties shall perform the Technology Transfer with respect to Manufacture of any Antigen Product of Variant Antigen (“Variant Antigen Product”) selected in accordance with Section 1.98. Novavax agrees to provide the additional materials, data, information, and/or documentations required for SK’s performance under this Agreement as specified in the attached Exhibit A (Product Deliverables) and Exhibit C (Variant Antigen Product Deliverables), which content shall be agreed to by the Parties upon the selection of Variant Antigen Product in accordance with Section 1.98. To the extent
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mutually agreed by the Parties, Novavax shall provide additional information, data, or material required for SK’s performance under this Agreement. Each of the Parties shall bear their own respective internal costs associated with execution of the Antigen Product Technology Transfer under this Section 3.1.”
(12)Section 4.4 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 4.4:
4.4    Development Support. Novavax will provide information, data and assistance (to the extent it has resources to do so and reasonably requested by SK) relating to adjuvanted formulation Development including any data pertaining to the Adjuvant, instructions for the formulation process, information about any necessary equipment required for such formulation. SK shall have access to reasonable quantities of excess Antigen Product Manufactured under the Supply Agreement that will not be used by Novavax for its commercial supply or any other purpose, for purposes of formulation Development by SK under this Agreement. Novavax shall provide SK with [***], and any regulatory activities relating thereof, (i) promptly after Effective Date, as specified in Exhibit A (Product Deliverables) with respect to Antigen Product comprised of the Original Antigen and (ii) promptly after the Parties have agreed to the contents of Exhibit C (Variant Antigen Product Deliverables) in accordance with Section 3.1 with respect to Antigen Product comprised of a Variant Antigen.”
(13)Section 5.1 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 5.1:
5.1    Antigen Product Supply. The Parties anticipate that a total of approximately [***] Batches of Antigen Product will be Manufactured in the SK Facility in [***] and on condition that there will be no constraint on Manufacturing the Antigen Product beyond SK’s reasonable control, including any unreasonable constraint in procuring Raw Materials, unexpected issues in Manufacturing of the Antigen Product or any regulatory issues that may adversely affect the Manufacturing of the Antigen Product. Subject to Section 5.3 (Allocation of Antigen Product), SK shall supply, and Novavax shall Purchase, an anticipated [***] Batches of such Antigen Product produced in [***], subject to a corresponding SOW, for use as Collaboration Antigen Product after SK’s fulfillment of its obligation to supply the First Korean APA Doses to the Korean Government under the First Korean APA.
As of the First Amendment Effective Date, SK plans to Manufacture Antigen Product commencing in [***]. The Parties anticipate that approximately [***] Batches, of Antigen Product (which may include SK Antigen Product) will be Manufactured at SK Facility during such period on condition that (i) the Manufacturing yield for any Variant Antigen, if applicable, will be similar to that of Original Antigen and (ii) there will be no constraint on Manufacturing the Antigen Product beyond SK’s reasonable control, including any unreasonable constraint in procuring Raw Materials, unexpected issues in Manufacturing of Antigen Product (including possible conversion to a variant of the Antigen Product) or any regulatory issues that may adversely affect the Manufacturing of the Antigen Product. The allocation of such Antigen Product for use as Collaboration Antigen Product is set forth in Section 5.3 below.”
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(14)The following new Section 5.1.1 shall be inserted into the Collaboration and License Agreement:
5.1.1    Price and Fee Incentive Terms. The Collaboration Antigen Price for the Collaboration Antigen Product supplied by SK under Section 5.1 and all other terms and conditions applicable to the purchase of Collaboration Antigen Product shall be mutually agreed in good faith by the Parties and set forth in an SOW.”
(15)Section 5.2 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 5.2:
5.2    Option for Supply in 2023.
SK grants an exclusive option and right to Novavax, exercisable at Novavax’ sole discretion until [***], to negotiate the terms and conditions of the use of the entire or a portion of the capacity of [***] for the Manufacture of Collaboration Antigen Product in Calendar Year 2023 (the “2023 Option”). If Novavax exercises the 2023 Option, the Parties shall have until [***] to negotiate in good faith and execute an SOW under this Agreement setting forth the agreed upon terms and conditions. Until the later of [***] if Novavax does not exercise 2023 Option or [***] if Novavax does exercise the 2023 Option, (a) SK may not enter into discussions or negotiations with any Third Party regarding the use of the SK Facility to manufacture any other product and (b) SK shall reserve the use of SK Facility solely for the Manufacture of the Collaboration Antigen Product in Calendar Year 2023 to the exclusion of all other products.
Upon the expiration of the 2023 Option, SK may enter into discussions or negotiations with any Third Party regarding the use of the SK Facility in Calendar Year 2023; provided, however, if SK receives a bona fide offer(s) from a Third Party prior to [***], SK shall notify Novavax in writing setting forth the material terms of any such Third Party offer(s). Novavax shall have [***] from the receipt of SK’s notice to notify that it wishes to match such terms, in which case the Parties shall have until [***] to negotiate in good faith and execute an SOW setting forth such terms.”
(16)Section 5.3 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 5.3
5.3    Allocation of Antigen Product.
5.3.1    Remainder of Calendar Year 2021. The First Korean APA Doses of SK Antigen Product to be supplied to the Korean Government shall be prioritized among any other allocation of any supply of Antigen Product Manufactured in SK Facility in Calendar Year 2021, and all remaining allocation from such facility in Calendar Year 2021 shall be made available for use as Collaboration Antigen Product. For the sake of clarity, SK shall bear the entire cost of Manufacture of any Antigen Product allocated for supply under the Korea APAs and the Ex-Korea APAs, including without limitation the cost of relevant Raw Materials.
5.3.2    Calendar Year 2022. SK will allocate and deliver to Novavax the entire quantity of the Antigen Product Manufactured in the SK Facility in Calendar Year 2022 provided that if SK has entered into the Second Korean APA and/or one or more Ex-
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Korea APAs, SK (i) may allocate and deliver [***] of such Antigen Product Manufactured [***] for supply under one or more Ex-Korea APAs; (ii) may only allocate and deliver Antigen Product Manufactured [***] for supply under the Second Korean APA, in which case, such allocation will be [***] of such Antigen Product Manufactured [***], and (iii) shall allocate and deliver the remaining Antigen Product to Novavax for use as Collaboration Antigen Product. For the sake of clarity, SK shall bear the entire cost of Manufacture of any Antigen Product allocated for supply under the Korea APAs and the Ex-Korea APAs, including without limitation the cost of relevant Raw Materials. For further clarity, no Antigen Product Manufactured in any given month in Calendar Year 2022 may be allocated for use as Second Korean APA Doses or Ex-Korea APA Doses unless SK is obligated to Manufacture Antigen Product in such month under an executed Second Korean APA and/or one or more Ex-Korea APAs.”
(17)Section 7.1 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 7.1:
7.1    General. Unless otherwise specified in this Agreement, this Article 7 governs the procedures and the Parties’ rights and obligations with respect to forecasts, purchase orders and delivery for Collaboration Antigen Product to applicable Product Requirements. The Parties agree that SK will sell, and Novavax will buy, [***] of Collaboration Antigen Product Manufactured in the SK Facility in [***] (if the Parties execute an applicable SOW pursuant to Section 5.2) and allocated to Novavax in accordance with Article 5 (Commercial Manufacture and Supply of Antigen Product).”
(18)Section 7.2 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 7.2:
7.2    Forecast Beyond [***]. As soon as [***] and subject to Article 5, the JSC will discuss and approve a mutually developed initial non-binding forecast of Novavax’ anticipated demand for Collaboration Antigen Product for commercial sale in the Novavax Territory in [***], which will be non-binding and for planning purpose only (the “Initial Forecast”). The JSC will update the Initial Forecast on a [***] rolling basis no less than [***] before the beginning of each Calendar Quarter (an “Updated Forecast”). Subject to the applicable SOW, the quantities forecasted for [***] in each Updated Forecast shall be binding [***] on Novavax and SK (each a “Binding Forecast”). Notwithstanding the foregoing, the Parties shall [***] upon completion of process validation or process performance qualification of the Collaboration Antigen Product and pursuant to the relating to SOW(s).”
(19)The following new Section 7.8 shall be added to the Collaboration and License Agreement:
7.8    Reporting. SK shall provide Novavax with a breakdown of the costs and utilization/consumption of Raw Materials and/or Novavax Supplied Items per Batch. Additionally, SK shall provide [***] assistance, including records and reporting, as required, to permit Novavax to confirm the accuracy of such breakdown of costs. SK shall also provide [***] assistance to allow Novavax or its representatives to inspect/verify quantities and cost balances of Batches, Raw Materials and/or Novavax Supplied Items on hand at SK in order to satisfy Novavax’ requirements under US GAAP.”
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(20)Section 8.1 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 8.1:
8.1    Forecast. Within [***] of the Effective Date, SK will provide Novavax with a [***] forecast of SK’s anticipated demand for the Adjuvant Components for Manufacture of the SK Vaccine Product in the SK Territory (the “Initial Adjuvant Forecast”) for Novavax’ review and acceptance at its discretion. The Parties agree that SK will purchase from Novavax and Novavax will accept to supply to SK, the quantity of Adjuvant Components sufficient to Manufacture: (i) [***] doses of Adjuvant for Manufacture of the First Korean APA Doses of SK Vaccine Product, such quantity to be included in the Initial Adjuvant Forecast (the “Minimum Order’’); (ii) [***] doses of Adjuvant for Manufacture of the Second Korean APA Doses of SK Vaccine Product, if any, such quantity to be included in the Updated Adjuvant Forecast (as defined below); and/or (iii) [***] doses of Adjuvant for Manufacture of the Ex-Korea APA Doses of SK Vaccine Product, if any, such quantity to be included in the Updated Adjuvant Forecast (which Ex-Korea APA Doses and the Second Korean APA Doses will not exceed [***] doses in total). SK will update the Initial Adjuvant Forecast on a [***] rolling basis [***] each [***] (the “Updated Adjuvant Forecast’) for Novavax’ review and acceptance at its discretion (the Initial Adjuvant Forecast and Updated Adjuvant forecast are collectively referred to as the “Adjuvant Forecast’), which Updated Adjuvant Forecasts submitted by SK following the First Amendment Effective Date shall include the full [***] doses of Adjuvant referenced above in this Section 8.1 (Forecast). Upon Novavax’ acceptance, the forecast for the first [***] of the Initial Adjuvant Forecast and any and all Updated Adjuvant Forecast(s) will be binding upon both Parties and not subject to change (a “Firm Order”), unless otherwise agreed by the Parties through the good faith discussion regarding change of a Firm Order to reflect the quantity of Adjuvant necessary for Manufacture for the Second Korean APA Doses and/or the Ex-Korea APA Doses, if any. Notwithstanding the foregoing, upon request by SK, the Parties will discuss in good faith to modify any Initial Adjuvant Forecast, Updated Adjuvant Forecast, and Firm Order, except for the purchase orders subject to Section 8.3 (Purchase Order), within [***] of the close of [***] only to the extent that aggregated quantity of Adjuvant Component in [***] set forth in the Firm Order shall remain the same.”
(21)Article 9 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Article 9:
Article 9
[Intentionally Left Blank to Preserve Numbering]
(22)Section 10.1.3 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 10.1.3:
10.1.3 For the greater clarity, the Parties will cooperate to file and obtain Regulatory Approvals in SK Territory necessary for the Development, Manufacture and/or Commercialization of the Vaccine Product [***]. Subject to 12.4.1 (d)(Sublicensing), SK or its sublicensee will be responsible with respect to all regulatory activities for the SK Vaccine Product in the SK Territory, as applicable, including performing nonclinical or clinical development to the extent required by relevant Regulatory Authority, including Korea MFDS, Thailand FDA, and/or Vietnam Drug Administration, for the purpose of
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obtaining relevant licenses (including any post Emergency Use Listing or any other Regulatory Approval clinical requirements), and maintaining, in its name or the name of its designee or Affiliates, all Regulatory Approvals required to Manufacture and Commercialize the Vaccine Product in SK Territory, and any correspondence or meetings with the relevant Governmental Authority regarding any of the foregoing. At SK’s reasonable request, Novavax will support SK as may be reasonably necessary, and to the extent Novavax has resources to do so, to obtain such Regulatory Approval including participation in any scheduled meeting with a Regulatory Authority regarding any Regulatory Approval of the SK Vaccine Product in SK Territory.”
(23)The following new Section 10.1.4 shall be added to the Collaboration and License Agreement:
10.1.4 Within [***] of its receipt of a request from Novavax, unless otherwise agreed between the Parties in good faith, SK shall provide copies of all then-existing Regulatory Filings (as defined below) or any drafts thereof to Novavax. SK hereby grants Novavax a right of reference to and under any such Regulatory Filings. “Regulatory Filing means any submission to a Regulatory Authority of any appropriate regulatory application, including any submission to a regulatory advisory board, and any supplement, amendment, variations, extensions and renewals thereof.”
(24)Section 11.1.1(b) of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 11.1.1 (b):
(b) SK Antigen Product Fee Incentive (Korea Only).
(i)    First Korean APA. Subject to Sections 11.1.1(f) (Modified Pricing for Certain SK Products) and 11.1.2 (Pricing of SK Products), for sales made by SK to the Korean Government under the First Korean APA, SK shall pay Novavax a fee incentive of (a) [***] on Net Sales of SK Antigen Product if total sales of SK Antigen Product to the Korean Government equals or exceeds [***] doses or (b) [***] on Net Sales of SK Antigen Product if total sales of SK Antigen Product to the Korean Government is less than [***] doses. SK will issue a written invoice to the Korean Government (which will be denominated [***]) and simultaneously provide a copy to Novavax, on a [***] basis for the accumulated SK Antigen Product batches released with the issuance of CoAs during the given [***]. Upon [***], SK will [***], make payment to Novavax for the corresponding fee incentive.
(ii)    Second Korean APA. Subject to Sections 11.1.1 (f) (Modified Pricing for Certain SK Products) and 11.1.2 (Pricing of SK Products), for sales made by SK to the Korean Government under the Second Korean APA, SK shall pay Novavax a fee incentive of [***] on Net Sales of SK Antigen Product. SK will issue a written invoice to the Korean Government (which will be denominated [***]) and simultaneously provide a copy to Novavax, on a [***] for the accumulated SK Antigen Product batches released with the issuance of CoAs during the given [***]. Upon [***], SK will [***], make payment to Novavax for the corresponding fee incentive.
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(iii)    Advance Payment Credits. Any fee incentive payments payable under this Section 11.1.1 (b) may be reduced on a pro rata basis by any non-refundable advance payments actually received by Novavax pursuant to Section 11.1.1 (d) for the applicable Korean APA, but only to the extent any such advance payment amount was not already credited against prior fee incentive payments paid under this Section 11.1.1 (b) or Section 11.1.1 (c).”
(25)Section 11.1.1(c) of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 11.1.1 (c):
(c) SK Vaccine Product Fee Incentive (Korea, Thailand and Vietnam) and other Purchasers.
(i)    Korea.
(1)    First Korean APA. Subject to Sections 11.1.1(f) (Modified Pricing for Certain SK Products) and 11.1.2 (Pricing of SK Products), for sales made by SK to the Korean Government under the First Korean APA, SK shall pay Novavax a fee incentive of (a) [***] on Net Sales of SK Vaccine Product if total sales of SK Vaccine Product to the Korean Government equals or exceeds [***] doses or (b) [***] on Net Sales of SK Vaccine Product if total sales of SK Vaccine Product to the Korean Government is less than [***] doses. SK will issue a written invoice to the Korean Government (which will be denominated [***]) and [***] provide a copy to Novavax, upon [***]. Upon [***], SK will [***] make payment to Novavax for the corresponding sales fee incentive.
(2)    Second Korean APA. Subject to Sections 11.1.1(f) (Modified Pricing for Certain SK Products) and 11.1.2 (Pricing of SK Products), for sales made by SK to the Korean Government under the Second Korean APA, SK shall pay Novavax a fee incentive of [***] on Net Sales of SK Vaccine Product. SK will issue a written invoice to the Korean Government (which will be denominated [***]) and [***] provide a copy to Novavax, [***]. Upon [***], SK will [***] make payment to Novavax for the corresponding fee incentive.
(3)    Advance Payment Credits. Any fee incentive payments payable under this Section 11.1.1(c)(i) may be reduced on a pro rata basis by any non-refundable advance payments actually received by Novavax pursuant to Section 11.1.1 (d) for the applicable Korean APA, but only to the extent any such advance payment amount was not already credited against prior fee incentive payments paid under this Section 11.1.1(b) or Section 11.11.1(c).
(ii)    Thailand and Vietnam. Subject to Section 11.1.2 (Pricing of SK Products), SK shall pay Novavax a fee incentive of [***] on Net Sales of SK Vaccine Product to either the Thai or Vietnamese government. SK will issue a written invoice to either Thai or Vietnamese government, as appropriate, and [***] provide a copy to Novavax, on a [***] basis for the accumulated SK Vaccine Product batches released with the issuance of CoAs during the given [***]. Upon [***], SK will [***] make payment to Novavax for the corresponding sales fee incentive. Any fee incentive payments
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payable under this Section 11.1.1(c)(ii) may be reduced on a pro rata basis by any non-refundable advance payments actually received by Novavax pursuant to Section 11.1.1(d) for the applicable Ex-Korea APA, but only to the extent any such advance payment amount was not already credited against prior fee incentive payments paid under this Section 11.1.1(b) or Section 11.11.1(c).”
(iii)    Other Purchasers. In the event SK decides to sell SK Products to purchasers other than the National Governments in the SK Territory, SK shall pay Novavax an incentive fee of [***] on Net Sales to any such purchaser. [***] prior to any such sale, the Parties shall enter into an amendment to this Agreement setting forth the term governing other compensation such as advance payments, payment term, sales reporting obligations, commercial diligence efforts and other reasonable and customary terms associated with such sales; provided that such terms shall be consistent with the terms of this Agreement and its SOWs.”
(26)Sections of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Sections 11.1.1 (d), 11.1.1 (e), 11.1.1 (f) and 11.1.1 (g):
(d)    Advance Payment For SK Products. If SK receives an advance payment from any National Government for the sales of SK Antigen Product or SK Vaccine Product in the SK Territory, SK shall pay Novavax [***] of such advance payment. Upon [***], SK will [***] pay to Novavax [***]. Within [***], SK will pay Novavax for [***]. Any non-refundable amount received by Novavax under this Section 11.1.1(d) is creditable one time for each non-refundable payment against fee incentives payable by SK under Section 11.1.1(b) or Section 11.1.1(c) on a pro rata basis.
(e)    Adjuvant. SK shall pay Novavax [***] for the quantity of Adjuvant Components required to Manufacture each dose of Adjuvant delivered by Novavax in [***] and [***] for the quantity of Adjuvant Components required to Manufacture each dose of Adjuvant delivered by Novavax in [***], if any. Novavax shall issue a written invoice upon delivery of the Adjuvant Components. SK will pay Novavax all undisputed amounts within [***] of receipt of each such invoice.
(f)    Modified Pricing for Certain SK Products. Notwithstanding the fee incentive percentage figures in Sections 11.1.1(b)(SK Antigen Product Fee Incentive) and (c)(SK Vaccine Product Fee Incentive), SK shall pay Novavax a fee incentive of [***] on the Net Sales of (i) the first [***] doses SK Antigen Product and (ii) the first [***] doses of SK Vaccine Product to be supplied to the Korean Government under the First Korean APA and invoiced after the First Amendment Effective Date in accordance with Section 11.1.1(b) (SK Antigen Product Fee Incentive) or Section 11.1.1 (c) (SK Vaccine Product Fee Incentive) as applicable.”
(g)    Other Purchasers. Advance payments and other forms of compensation to be paid to SK by purchasers other than National Governments for SK Products shall be made in accordance with Section 11.1.1 (c)(iii).”
(27)Section 11.1.2 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 11.1.2:
11.1.2 Pricing of SK Products. [***].
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(a)    Korea. As of the effective date of the First Korean APA, such supply price per dose shall be [***] and comprise of the following components:
(i)    SK Antigen Product [***]: [***] per dose
(ii)    Formulation, fill and finish of SK Antigen Product into SK Vaccine Product [***]: [***] per dose
(iii)    The total price per dose of SK Vaccine Product [***] shall be [***] per dose.
(b)    Thailand. For Thailand, SK anticipates that the total price per dose of SK Vaccine Product [***] shall be [***] per dose.
(c)    Vietnam. For Vietnam, SK anticipates that the total price per dose of SK Vaccine Product [***] shall be [***] per dose.
Formulation, fill and finish and the total prices per dose of SK Vaccine Product [***] shall be agreed by the Parties and set forth in an SOW.”
(28)The first paragraph of Section 11.2 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following paragraph (the second paragraph of Section 11.2 shall remain unchanged):
11.2. Form of Payments. All payments to be made between the Parties under this Agreement shall be made in Dollars and shall be paid by wire transfer in immediately available funds to a bank account designated by the receiving Party. Notwithstanding the fact that the invoices issued in accordance with Section 11.1.1(b) (SK Antigen Product Fee Incentive) and Section 11.1.1(c) (SK Vaccine Product Fee Incentive) to the National Governments may be denominated in [***], all prices set forth in this Agreement shall be in [***]. [***].”
(29)Section 11.4.1 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 11.4.1:
11.4.1. Record Retention; Audits. SK will maintain (and will cause its Affiliates to maintain) complete and accurate records of (i) in the case of Collaboration Antigen Product, SK’s and its Affiliates’ costs of Raw Materials used to Manufacture such product if Novavax is required to pay for the cost of such Raw Materials pursuant to an applicable SOW and (ii) sales of SK Antigen Products and SK Vaccine Products (the “Records”), in reasonable detail to permit Novavax to confirm the accuracy of such sales for the preceding [***]. SK will permit (and will cause its Affiliates to permit) Novavax’ representatives (including an independent certified public accounting firm) to inspect and audit the Records reasonably acceptable to SK (and who are bound by written obligations of non-use and nondisclosure no less stringent than those set forth in the Collaboration and License Agreement) during the business hours of SK or the applicable Affiliates. Such inspection or audit will be limited to a maximum of [***], and Novavax will notify SK thereof in writing at least [***].”
(30)Section 12.4.1 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 12.4.1:
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12.4.1 Novavax as Licensor.
(a)    Korea. Subject to the other terms and conditions set forth in this Agreement, Novavax hereby grants an exclusive, nontransferable (except in conjunction with a permitted assignment under Section 18.2 (Assignment), fee incentive-bearing license to SK and its Affiliates under Novavax’ Background Intellectual Property (including the items listed in Exhibit A and B) and Novavax Improvements, only to the extent necessary to distribute, offer for sale, sell, import, export, make, have made, Commercialize and otherwise Exploit the Vaccine Product in the Republic of Korea and to supply the Collaboration Antigen Product to Novavax.
(b)    Thailand and Vietnam. Subject to the other terms and conditions set forth in this Agreement, Novavax hereby grants a non-exclusive, nontransferable (except in conjunction with a permitted assignment under Section 18.2 (Assignment)), fee incentive-bearing license to SK and its Affiliates under Novavax’ Background Intellectual Property (including the items listed in Exhibit A and B) and Novavax Improvements, only to the extent necessary to distribute, offer for sale, and sell the Vaccine Product, to the governments of Thailand and/or Vietnam, or their local representatives designated by the governments, who would be responsible for Commercialization of Vaccine Product on behalf of such governments or purchasers other than the National Governments. In case SK engages with such local representatives or other purchasers for Commercialization of Vaccine Product, SK will notify Novavax in advance, and give Novavax an opportunity to confirm that such local representatives or other purchasers are not prohibited under any Applicable Laws, including sanctions administered by the U.S. Office of Foreign Asset Control, from engaging in such transaction, provided that such confirmation by Novavax shall not be unreasonably delayed or withheld.
(c)    Limitation Regarding Adjuvant and Adjuvant Components. The licenses granted by Novavax in Section 12.4.1(a) and (b), do not include the right to, and SK shall not, offer to sell, sell, make, have made, Manufacture or reverse engineer the Adjuvant or Adjuvant Components.
(d)    Sublicensing. In order to perform its obligations and exercise its rights under this Agreement, SK may grant a sublicense to a Third Party in the SK Territory under Novavax’ Background Intellectual Property and Novavax Improvements with prior written consent of Novavax, which consent shall not be unreasonably withheld. Notwithstanding the foregoing, Novavax’ prior consent is hereby deemed to have been given for the sublicenses necessary to obtain the Regulatory Approval as required under Section 10.1.3, in performance of the Ex-Korea APAs.”
(31)Section 13.4.3 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 13.4.3:
13.4.3.    Other Permitted Disclosure. Notwithstanding the restrictions set forth in this Article 13 (Confidentiality), Novavax may, [***], disclose the terms and provisions of this Agreement and Confidential Information belonging to SK to any Third Party in connection with any actual or bona fide prospective acquisition, merger, financing transfer or sale of all or substantially all of the stock, assets of the business to which this
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Agreement relates permitted under Section 18.2(Assignment) of Novavax, provided that such Third Party is bound by written obligations of confidentiality at least as restrictive as those set forth in this Agreement. Subject to the terms and conditions set forth in Section 13.4.1 (Compliance with Law), SK may, [***], disclose to the National Governments the term and conditions of this Agreement that are reasonably necessary for discussion, negotiation and execution of the Korean APA and/or Ex-Korea APAs; provided that SK shall first enter into a CDA with each National Government with obligations of confidentiality at least as restrictive as those set forth in this Agreement.”
(32)Section 14.5 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 14.5:
14.5    Novavax’ Covenant. Novavax hereby covenants that Adjuvant Components supplied to SK by Novavax hereunder will:
14.5.1.    be delivered with full title and with the applicable Certificate of Analysis, Certificate of Conformance, applicable master safety data sheet, and additional Batch-related documentation identified in the Quality Agreement;
14.5.2.    be Manufactured in accordance with all Applicable Laws, GMP and the terms of the Quality Agreement; and
14.5.3.    conform to the applicable Product Requirements in all respects at the time of delivery.”
(33)Section 16.1 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 16.1:
16.1    Term. Subject to the other terms and conditions elsewhere in this Agreement, this Agreement will commence upon the Effective Date and, if not otherwise terminated earlier pursuant to this Article 16 (Term and Termination) or not extended by mutual agreement between the Parties, will continue in full force and effect until the later of: (i) twentieth (20th) anniversary date of the Effective Date of this Agreement; (ii) the completion of duties and obligations of this Agreement, any SOW, the Korean APAs, and any Ex-Korea APAs, including sell off of any remaining SK Product in its inventory; (iii) the day that the WHO declares that there is no longer a COVID-19 pandemic; or (iv) termination in accordance of Section 16.4 (the “Term”). [***].
16.1.1    Thailand and Vietnam. Notwithstanding the foregoing Section 16.1, the term of the non-exclusive license granted under Section 12.4.1(b)(Thailand and Vietnam) shall expire on the fifth (5th) anniversary date of the Effective Date of this Agreement, provided that such term shall expire earlier on March 31, 2022 with respect to either Thailand or Vietnam or both countries if SK has not executed an Ex-Korea APA with such country(ies) by March 31, 2022.”
(34)Section 16.4 of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 16.4:
16.4    Non-Exclusive License-Competing Vaccine. For the purpose of this Section, “First Launch Date” shall mean the date of the first sale by SK of another vaccine product
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for the prevention of COVID-19 to a Third Party (a “Competing Vaccine”) in a country in the SK Territory following the grant of any Regulatory Approval necessary for distribution and sale of such Competing Vaccine in such country.
16.4.1    Korea. On the First Launch Date in Korea, the exclusive license granted to SK under Section 12.4.1 (a) (Novavax as Licensor: Korea) shall convert to a non-exclusive license solely to allow SK to Exploit SK Antigen Product and/or SK Vaccine Product to the National Governments in Korea, which non-exclusive license shall expire on the later of (a) the third (3rd) anniversary date of the Effective Date of this Agreement or (b) the first (1st) anniversary date of the First Launch Date in Korea.
16.4.2    Thailand and Vietnam. On the First Launch Date in Thailand or Vietnam, the nonexclusive license granted to SK under Section 12.4.1 (b) (Novavax as Licensor: Thailand/ Vietnam) for such country shall expire on the earlier of (i) the first (1st) anniversary date of the First Launch Date in such country or (ii) the fifth (5th) anniversary date of the Effective Date of this Agreement.
16.4.3    Filing of Regulatory Approval by Novavax in Korea. Prior to the First Launch Date in Korea, Novavax, itself or through its Affiliate or a local sponsor as required by Applicable Law, which local sponsor is directly engaged by Novavax solely for the purpose of provision of service to file and hold Regulatory Approval and to perform other regulatory activities on behalf of Novavax, without any other service relating to Commercialization of the Vaccine Product (“Local Sponsor”), shall be entitled to file for its own Regulatory Approval of Vaccine Product with the Regulatory Authority in Korea (“the Novavax BLA”) [only after SK’s initial filing for Regulatory Approval of the Competing Vaccine with the Regulatory Authority in Korea]. For clarity, after the First Launch Date, the restrictions set forth in the preceding sentence shall not apply to Novavax. Further, Novavax may not disclose or transfer the Novavax BLA including any contents thereof to any Third Party (other than its Affiliate or the Local Sponsor as required by Applicable Law) until SK’s license converts to non-exclusive license pursuant to Section 16.4.1 above. Upon the conversion of SK’s license to non-exclusive license, Novavax may share the information or data of SK’s dossier with Third Party under [reasonable] confidentiality obligations.”
(35)The Parties agree that new exhibit, Exhibit C, as attached to this First Amendment shall be added to the Collaboration and License Agreement.
(36)Section 17.2. of the Collaboration and License Agreement shall be deleted in its entirety and replaced with following Section 17.2:
17.2    Expiration or Termination for Product Safety or Efficacy Failure or Competing Vaccine. Upon the expiration of this Agreement in accordance with Section 16.1, termination in accordance with Section 16.3 (Termination for Product Safety or Efficacy Failure) or upon the expiration of all licenses within the corresponding country in SK Territory in accordance with Section 16.4 (Non-exclusive License-Competitive Vaccine):
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17.2.1    The licenses granted by Novavax to SK under Section 12.4.1 (Novavax as Licensor) hereunder shall [***] revert to Novavax; provided, however, that in case of termination as a result of failure to obtain the necessary Regulatory Approvals for the Vaccine Product as provided under Section 16.3, the foregoing licenses granted shall revert to Novavax only with respect to such countries where the necessary Regulatory Approvals for the Vaccine Product cannot or will not be obtained; and
17.2.2.    Upon Novavax’ request, JSC shall coordinate the wind-down of SK’s efforts under this Agreement, and SK, [***] after the effective date of such expiration or termination, shall transfer and assign to Novavax or its designee (i) any and all regulatory materials including any regulatory filings or dossiers or Regulatory Approvals related to the SK Vaccine Product , (ii) any information, materials, and data, including copies of all clinical trial data and results, if any, and all other information developed by or for the benefit of SK relating to the SK Vaccine Product, including control of, and all information relating to, the global safety database, (iii) any applicable Third Party contract(s) and (iv) other documents and reports relating to the SK Vaccine Product that are developed by or for the benefit of SK, and necessary or reasonably useful to continue Development, Commercialization and Manufacture of the SK Vaccine Product (including material documents and agreements relating to the sourcing and Manufacture of the SK Vaccine Product) throughout the SK Territory, to the extent, for the transfer and assignment set forth in the foregoing (i), (ii), (iii) and (iv), that (a) it does not include SK’s Background Intellectual Property and/or SK Improvements and (b) SK has the legal right to transfer to Novavax such materials, information or documents, and provided further that Novavax reimburses SK for all the [***] costs and expenses for the transfer as mutually agreed by the Parties. If SK does not have such legal right, SK shall use its [***] to provide or transfer to Novavax such materials, information or documents and to cooperate with Novavax in connection with such transfer. “
(37)The term “exclusive license” used in Section 17.3. shall be replaced with the term, “licenses.
(38)The words “and assign” shall be inserted after the first reference to “provide” in Section 17.4.3.
3.Miscellaneous
(1)This First Amendment shall come into force on the First Amendment Effective Date.
(2)On and after the First Amendment Effective Date, each reference in the Collaboration and License Agreement to “this Agreement”, “hereof’, “herein”, “herewith”, “hereunder” and words of similar import shall, unless otherwise stated, be construed to refer to the Collaboration and License Agreement as amended by this First Amendment. No reference to this First Amendment need be made in any instrument or document at any time referring to the Collaboration and License Agreement.
(3)Except as expressly amended or modified in this First Amendment, all other terms, conditions and provisions contained in the Collaboration and License Agreement shall
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remain in full force and effect and apply fully to the terms of this First Amendment as if part of the Collaboration and License Agreement.
[Signature page follows on the next page]
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IN WITNESS WHEREOF, the Parties have executed this First Amendment in two (2) copies through their duly authorized officers or representatives as of the First Amendment Effective Date.

Novavax, Inc.SK bioscience Co., Ltd.
/s/ John Herrmann III/s/ [***]
Name:    John A. Herrmann III
Name:    [***]
Title:    Executive Vice President,
    Chief Legal Officer
    and Corporate Secretary
Title:    [***]

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Exhibit C
VARIANT ANTIGEN PRODUCT DELIVERABLES
[Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit C setting forth the variant antigen product deliverables 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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Confidential
Exhibit 10.40


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

STATEMENT OF WORK No. 1
This Statement of Work No. 1 (hereinafter “SOW”) is entered into as of December 23, 2021 (the “SOW Effective Date”) by and between Novavax, Inc., a Delaware corporation having a place of business at 21 Firstfield Rd., Gaithersburg, MD 20878 (“NovavaxorPurchaser”) and SK bioscience Co., Ltd., a company incorporated in the Republic of Korea having a place of business at 310 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13494 Korea (“SKorSupplier”), as envisaged by Sections 5.1 and 5.2 of the Collaboration and License Agreement, dated 12 February, 2021 and as amended on December 23, 2021 (hereinafter the “Collaboration and License Agreement”), and will be incorporated into the Collaboration and License Agreement upon execution.
This SOW shall commence as of the SOW Effective Date and shall be valid until completion of services set forth hereunder (“Services”), unless this SOW or the Collaboration and License Agreement is terminated earlier in accordance with Article 16 of the Collaboration and License Agreement. Capitalized terms used in this SOW without definition shall have the same meanings as set forth in the Collaboration and License Agreement. Any Change Order executed between the Parties under this SOW shall be subject to the Section 2.3 (Change Orders) of the Supply Agreement.
1.GENERAL PROVISIONS:
1.1Purchaser shall provide to Supplier Novavax Supplied Items ([***] SK facility and for which [***] will serve as the importer of record) necessary and sufficient for Supplier to perform the Services, including but not limited to the following:
1.1.1Bill of materials for all materials required to Develop and Manufacture the Collaboration Antigen Product as specified in Attachment A (Bill of Materials) of this SOW which material shall be procured by [***] in accordance with the terms and conditions of the Collaboration and License Agreement and this SOW); and
1.1.2Novavax’s materials, including the sufficient quantities of cell bank, seed virus stock, reference standards and any additional materials as agreed to be supplied by Novavax.
1.2SK will perform Services in accordance with or based on the following:
1.2.1Novavax’s and SK’s Background Intellectual Property and any Novavax Improvements and SK Improvements (collectively, the “Project Intellectual Property”), including Purchaser Supplied Items;
1.2.2Applicable Law and requirements including GMP in the Territory (defined hereunder);
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1.2.3Quality Agreement - Contract Manufacture between SK Bioscience Co., Ltd. and Novavax, Inc. and its Affiliate Novavax CZ, a.s. ([***]), which may be amended from time to time; and
1.2.4Pertinent provisions of the Collaboration and License Agreement and this SOW.
2.SERVICES:
2.1SK will render Novavax the Services as set forth below based on the Project Intellectual Property, including Novavax Supplied Items as may be necessary to complete the Technology Transfer, Development, Manufacture and supply of the Collaboration Antigen Product in the Novavax Territory in a professional manner;
2.1.1Perform activities related to commercial Manufacture of the Collaboration Antigen Product including the Manufacture of Collaboration Antigen Product under emergency use authorizations or approvals;
2.1.2[***] other than Purchaser Supplied Items, which are outlined and agreed between the Parties as set forth in Attachment A (Bill of Materials) and
2.1.3Prepare and provide documents related to the Services as outlined in Attachment B (Project Plan).
3.TERRITORY:
Subject to the second paragraph of this Section below, the Parties acknowledge and agree that the Collaboration Antigen Product delivered hereunder shall be compliant with the Applicable Law, including without limitation applicable GMP, with regard to obtaining and maintaining applicable Regulatory Approval of [***] (the “SOW Territory”).
Notwithstanding the foregoing, the Parties acknowledge that [***] has not been certified under the GMP requirements of [***]. Supplier agrees to use Commercially Reasonable Efforts to cooperate with Purchaser to achieve compliance with the Applicable Law of [***], for which SK expects to have [***] inspected for [***] GMP in [***] or on another date as may be adjusted upon mutual agreement with Novavax; [***].
For clarity, nothing herein shall limit Purchaser’s right and ability to use Collaboration Antigen Product delivered hereunder anywhere in the world, provided, however, Supplier does not guarantee that it will comply with the Applicable Law or any other regulations or guidance of the countries outside of the SOW Territory.
4.PROJECT PLAN: The scope of work, key activities, estimated timelines, budgets and deliverables are described in Attachment B (Project Plan) to this SOW (hereinafter “Project Plan”) and any modifications may be made in an applicable Change Order to
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this SOW. Both Parties agree that the timeline for the Services to be performed as set forth in the Project Plan is reasonably estimated as of SOW Effective Date and the Parties will put forth all [***] efforts to comply with such timeline.
5.SUBCONTRACTED SERVICES: Following the instruction of Novavax, both Parties hereby agree to engage [***], to perform certain [***] testing of the Collaboration Antigen Product, [***], and [***] testing (“Testing Services”) on behalf of SK under the agreement between SK and [***] for the provision of Testing Services by [***]. The Parties hereby agree that any costs or fees incurred by [***] for the aforementioned Testing Services (the “[***] Fee”) shall be charged to Novavax through SK under this SOW as necessary to cover the [***] Fee. Novavax agrees that the invoice for [***] Fee shall also include any relevant reference documents such as invoices or quotes from [***]. Invoices shall be issued on a [***] basis by SK to Novavax on the date of invoice for the Release of Batches in accordance with Attachment B (Project Plan) of this SOW and the terms as set forth in Section 6.1 (Payments) of the Supply Agreement shall apply in relation to invoicing and payment for [***] Fee.
6.PAYMENT: Novavax shall make the payment to SK for the Services in accordance with the payment schedule described in Attachment C (Payment Schedule) of this SOW and pursuant to Section 11.1.1 (Payment and Invoice) of the Collaboration and License Agreement; provided, if an applicable executed Change Order results in an increased total payment amount, such increased amount payable by Novavax shall be reflected in the remaining unpaid, due and payable corresponding milestone payment amount, if any, or a separate payment amount. If such Change Order results in a reduced payment amount, such reduced amount will be either (i) deducted from any remaining unpaid, due and payable corresponding milestone payment amount, if any, or (ii) refunded by SK to Novavax if Novavax has already paid such amount or if there is no remaining unpaid, due and payable corresponding milestone payment.
SK bank account
Beneficiary Account Name: [***]
Beneficiary Account #: [***]
Beneficiary Bank: [***]
Beneficiary Bank Address: [***]
SWIFT (international wire): [***]
7.DELIVERY: Subject to Section 7.5 (Delivery) of the Collaboration and License Agreement, Collaboration Antigen Product will be delivered by air [***]. Title and risk of loss to Collaboration Antigen Products shall pass to Novavax in accordance with the [***] herein.
[Signature page follows on the next page]

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IN WITNESS WHEREOF, the Parties have caused this SOW to be executed by their respective duly authorized officers as of the SOW Effective Date.
SK BIOSCIENCE CO., LTD.
By:/s/ [***]
(Signature)
Name:[***]
Title:[***]
NOVAVAX, INC.
By:/s/ John A. Herrmann III
(Signature)
Name:John A. Herrmann III
Title:Executive Vice President, Chief Legal Officer and Corporate Secretary


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ATTACHMENT A

Bill of Materials (BOM)
The BOM to be agreed by the Parties as of this SOW Effective Date, will serve as a basis for [***]. The BOM may be amended from time to time on a technical need basis through discussion and written agreement between the Parties.

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ATTACHMENT B

Project Plan
[Pursuant to Regulation S-K, Item 601(a)(5), this Attachment B setting forth the project plan 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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ATTACHMENT C

Payment Schedule
This Attachment defines the payment schedules for Service fees, [***] payable by Novavax to SK for Batches produced in the remaining period of [***] and [***] under the Collaboration and License Agreement. The terms of Section 11.1.1 (Payment and Invoice) of the Collaboration and License Agreement shall apply in relation to invoicing and payment thereof.
1.Service Fees
Novavax shall pay the Batch fee for SK’s Services in accordance with the payment schedule as set forth in the table below.
The Service fees set forth in the table below do not include [***] of the Collaboration and License Agreement and Section 5 of this Attachment C.
Invoice MilestonesInvoice Amount (USD)
For each Batch Released in 2021 and 2022[***] per Batch

1)For the Manufacturing and Release of such Batches, SK will invoice Novavax on a [***] basis for the actual Batches Released in a given [***] based on the relevant per-Batch price.
2)[***].
2.Binding Forecast
Within [***] of the execution of this SOW, Novavax shall provide SK with the forecast of Novavax’s anticipated demand for Collaboration Antigen Product to be Manufactured (or already Manufactured) for the remaining period of [***]. For the purposes of this SOW only, the term “Binding Forecast” defined in Section 7.2 of the Collaboration and License Agreement shall mean [***] and any Updated Forecast thereto. The [***] for each calendar month shall be [***] of the maximum number of Batches of Collaboration Antigen Product that [***] is capable of Manufacturing in such calendar month as set forth in Annex 1 to Attachment B. The [***] or any Updated Forecast for each calendar month shall be [***] of the maximum number of Batches of Collaboration Antigen Product that [***] is capable of Manufacturing in such calendar month as set forth in Annex 1 to Attachment B; provided that any allocation made to supply the [***] shall be automatically deducted from any forecast hereunder and Novavax shall have no obligation to pay any [***]. For greater clarity, and subject to the last sentence of this Section 2, the Purchase Orders issued under this SOW shall not be less than the quantity as specified in the corresponding month of the Binding Forecast. The Parties agree to modify the Binding Forecast and/or the Purchase Order issued under this SOW to reflect the quantity of the Antigen Product allocated for the supply under [***]. Notwithstanding the above and anything to the contrary herein, upon execution of this SOW, Novavax shall issue to SK a Purchase Order for [***] of the quantity of Collaboration Antigen Product in the [***] and [***] of the quantity of Collaboration Antigen Product in the [***], and make [***].
3.Fee Incentive
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3.1Fee Incentive. Novavax shall pay SK a fee incentive in accordance with the following schedule based on Novavax Net Sales (as defined below) of Vaccine Product Manufactured incorporating Collaboration Antigen Product (“Collaboration Vaccine Product”):
Calendar Novavax Net SalesFee Incentive Rate
For Novavax Net Sales during any [***][***]

3.2Novavax Net Sales” means, [***].
3.3Fee Incentive Payment. Any fee incentive payable under this SOW shall be calculated [***], for the [***] ending on that date (each a “Fee Incentive Payment”). Novavax shall submit the Fee Incentive Payment together with the delivery of a written sales report to SK within [***] after the end of each [***] that shows, with respect to each country in the SOW Territory, the Novavax Net Sales recognized during such [***], stating gross sales (including, number of doses and price per dose) and Novavax Net Sales of the Collaboration Vaccine Products (including reasonable details relating to the deductions made in determining the Novavax Net Sales and the corresponding Collaboration Antigen Product Batch information thereof) (the “Sales Report”). All such Fee Incentive Payments shall be made in [***]. For the purpose of computing the Novavax Net Sales of Collaboration Vaccines Products sold in a currency other than [***], such currency shall be converted from local currency to [***] by Novavax in accordance with [***].
3.4Financial Audits.
3.4.1Record Retention; Audits. Novavax will maintain (and will cause its Affiliates to maintain) complete and accurate records of sales of Collaboration Vaccine Products (the “Records”), including the Sales Report, in reasonable detail to permit SK to confirm the accuracy of such sales for the preceding [***]. Novavax will permit (and will cause its Affiliates to permit) SK’s representatives (including an independent certified public accounting firm) to inspect and audit the Records reasonably acceptable to Novavax (and who are bound by written obligations of non-use and non-disclosure no less stringent than those set forth in the Collaboration and License Agreement) during the business hours of Novavax or the applicable Affiliates. Such inspection or audit will be limited to a maximum of [***], and Novavax will notify SK thereof in writing at least [***] in advance.
3.4.2Audit Report. Upon completion of any audit or inspection pursuant to Section 3.4.1 (Record Retention; Audits) SK or its independent certified public accounting firm, as applicable, will provide Novavax a written report disclosing any discrepancies between the Records and any Fee Incentive Payments to SK under this SOW. If such report determines that either Party has underpaid any amounts payable to the other Party hereunder, then the paying Party will pay the other Party any such undisputed discrepancy no later than [***] after delivery of such report. If such report determines that either Party has overpaid any amounts payable
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to the other Party hereunder, then such other Party will refund any such undisputed discrepancy no later than [***] after delivery of such report. The fees charged by any such accounting firm will be paid by [***]; provided, however, that if any audit or inspection discloses a net overpayment of payments by or underpayments to SK of more than [***] of the total amounts owed or paid by or to SK for any [***] covered by the audit, then [***] will pay the reasonable fees and expenses charged by such accounting firm.
3.4.3Audit Disputes. Either Party may refer any disputes with respect to the findings of the report set forth in Section 3.4.2 (Audit Report) for resolution pursuant to the dispute resolution procedures set forth in Section 18.1 (Dispute Resolution) of the Collaboration and License Agreement.
4.[***]
[***];
4.1[***].
4.2[***].
4.3[***].
[***]
[***]
[***]
[***]
[***][***][***][***]

[***].
[***].
4.4[***].
5.Raw Material Costs
Subject to Section 3.2 (Raw Materials) of the Collaboration and License Agreement, [***]. [***]. The costs of such Raw Materials, including acquisition and handling costs, shall be invoiced [***] as set forth in the table below.
Invoice MilestonesInvoice Amount
[***][***].
[***][***].

1)The Parties acknowledge that the timely procurement and acquisition of Raw Materials sufficient enough for SK to perform the Services is important in consideration of the urgency of the current COVID-19 pandemic. The Parties shall discuss and confirm the BOM including the list of the Raw Materials and quantities to be procured by [***]. The BOM including quantity of the Raw
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Materials may be updated from time to time by mutual consent of the Parties. [***].
2)[***].
3)[***].
6.Storage Fee
In accordance with Section 7.6 (Storage) of Collaboration and License Agreement, Collaboration Antigen Product will be stored [***] for up to [***] from date of Manufacturing (“DoM”); provided that for the purposes of this Section 6, the preceding [***] period for the Batches Manufactured [in 2021] shall not commence until the SOW Effective Date. However, in case a Batch has not completed the quality assurance Release within [***] from DoM, Batch will be stored [***] to Novavax until a formal disposition (quality assurance Release or rejection). Novavax may request from time to time to store Collaboration Antigen Product beyond the time specified [***] (on a per [***] and per Batch bases). In such case, a storage fee of [***] shall be charged to Novavax by SK separately.


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Exhibit 10.47
CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
AMENDMENT
THIS AMENDMENT TO ADVANCED PURCHASE AGREEMENT (“Amendment”) is made effective as of the last date of signature (the “Amendment Effective Date”) by and between NOVAVAX, INC, a Delaware corporation with offices at 21 Firstfield Road, Gaithersburg, MD 20878 U.S.A. (“Novavax”), and the Commonwealth of Australia as Represented by the Department of Health, with offices at Scarborough House 1 Atlantic Street, Woden, ACT 2606, Australia (collectively, “Customer”).
RECITALS
WHEREAS, Novavax and Customer entered into that certain Advanced Purchase Agreement dated effective 31 December 2020 (as amended) (the “Agreement”); and
WHEREAS, the Parties desire to amend certain provisions of the Agreement.

NOW THEREFORE, in consideration of the mutual promises and covenants hereinafter set forth and other good and valuable consideration, the receipt of which is hereby acknowledged by the Parties, the Parties hereto agree that the Agreement is amended by this Amendment as follows:
1.Recitals. The Recitals shall be amended by the addition of the following new recital:
WHEREAS, the Parties agree that if Novavax decides to commercialize any Variant Vaccine(s), Customer wishes to have the option to purchase an amount of the Variant Vaccine(s) ([***]).
2.Section 2.1. (Sale of Product) shall be amended by adding a new Section 2.1.1 as follows:
Section 2.1.1. Option to purchase Vaccine Variants. The Parties acknowledge that Novavax may develop one or more alternative formulations of the Vaccine that are [***] different to the Vaccine [***] to target any current or future variants or strains of COVID-19 (each a “Variant Vaccine”). The Parties agree that any [***] variations of the Vaccine are not considered a Variant Vaccine. Novavax may elect to commercialize a Variant Vaccine and if so, shall [***], notify Customer in writing of such proposed commercialization plans. If Novavax provides such notice to the Customer or the Customer otherwise becomes aware that Novavax intends to commercialize any Variant Vaccine, the Customer may, [***], provide Novavax with one or more written notices electing to purchase any Variant Vaccine ([***]) (each notice an “Option Notice”). Each Option Notice will provide for the number of Variant Vaccine doses the Customer wishes to be supplied and, [***]. Terms of Agreement and variation. The Variant Vaccine will be supplied pursuant to the applicable terms of the Agreement, including Sections 2.2, 2.4, 2.5, 2.6, 3, 4, 8, 14 and 15, and the terms “Vaccine” and “Product” in the Agreement will be deemed (as applicable and except as the context otherwise requires) to include any Variant Vaccine (howsoever it may be packaged) ordered by the Customer in accordance with this clause; except that on receipt of each Option Notice, the Parties agree to negotiate, [***], the amount of Variant Vaccine doses to be supplied, the price of such Variant Vaccine (provided that the price of each Variant Vaccine dose must be no more than [***]) and the estimated delivery schedule for the Variant Vaccines. If the Parties agree on the matters set out above, the Parties will enter into a variation to the Agreement to include the agreed quantity and price of ([***]), and delivery schedule for, the Variant Vaccine. Aggregate Amount and Advance Payment. Any Variant Vaccine will count towards the Aggregate Amount ([***]). On execution of the variation by both parties, Novavax will [***]. [***]. Within [***] after execution of the variation by both parties, the Customer will deliver to Novavax (i) a Purchase Order for the agreed quantity of Variant Vaccine together with the Customer’s order number and invoice address and (ii) [***].
3.Section 2.4. (Delivery) shall be deleted in its entirety and replaced with the following:
Delivery. Novavax will use reasonable endeavours to meet the quarterly delivery schedule for the Product set forth in Exhibit B (“Delivery Schedule”). Novavax will deliver, or ensure that the Sponsor delivers: (a) [***]: (i) if the Vaccine receives Regulatory Approval in the Territory before [***], or (ii) if the Vaccine receives Regulatory Approval in the Territory on or after [***] (in each case (i) and (ii), [***]); and (b) [***] shipments of Product to Customer thereafter until the Aggregate Amount is supplied in accordance with the quantities of Vaccine specified in the Delivery Schedule, and otherwise in accordance with Section 3.1. Customer acknowledges that initiation of deliveries is dependent on Regulatory Approval in the Territory and that delivery of the first shipment of Product is expected to be a date as soon as practicable after receipt of
CONFIDENTIAL


Regulatory Approval in the Territory. On at least a [***] basis, Novavax shall communicate any anticipated changes to the Delivery Schedule to Customer. Any changes to the Delivery Schedule must be made in accordance with Section 13.4. At least [***] in advance of each anticipated shipment under the Delivery Schedule, Novavax will confirm to the Customer in writing the date of delivery of the Product and the quantities of Product to be delivered. [***], Novavax will notify Customer in writing by email when the Product is available for Delivery. [***] (“Delivery Change Request”). Within [***] of receipt of such Delivery Change Request, Novavax shall provide a proposed delivery schedule reflecting the Delivery Change Request or that portion of the Delivery Change Request which Novavax can, acting reasonably, accommodate. The Parties may discuss in [***] any changes to the proposed delivery schedule. If a proposed delivery schedule is agreed upon, the Parties shall make any necessary changes to the Delivery Schedule in accordance with Section 13.4. Novavax will notify Customer in writing by email when the Product is available for Customer’s inspections.
4.Section 2.5. (Variance) shall be deleted in its entirety and replaced with the following:
Not used.
5.Section 2.6. (Short Supply) shall be deleted in its entirety and replaced with the following:
Short Supply. If Novavax receives Regulatory Approval in the Territory, but reasonably believes that it will not be able to supply Customer with quantities of Vaccine specified in the Delivery Schedule, then Novavax shall [***] notify Customer in writing of such circumstances (Short Supply Notice), [***].
2.6.1.    Without prejudice to any other rights that the Customer may have under this Agreement, the Customer may, by giving Novavax written notice no later than [***] after receipt of the Short Supply Notice from Novavax: (a) elect to cancel delivery of the Product that was scheduled for delivery during the duration of the supply failure; or (b) where Novavax’s inability to supply results from Novavax’s inability to manufacture or source sufficient quantities of Vaccine doses to supply all of its customers, elect for Novavax to deliver to Customer [***] for the period of short supply, on any conditions [***] notified by Customer (including as to how any short supply should be made up in the future).
2.6.2.    If Novavax’s failure to supply is still ongoing after [***] of each initial missed or under delivery, Customer may, by giving Novavax written notice no later than [***] after such [***] period has passed, cancel future deliveries of Product and terminate the Agreement.
2.6.3.    For avoidance of doubt, Product may not be cancelled under this Section 2.6 if, at the time of receipt of a cancellation notice given by the Customer under Section 2.6.1 or Section 2.6.2, such Product (a) has arrived in Australia but is still under quarantine awaiting TGA release, or (b) has passed TGA release, but not been delivered to Customer in accordance with Section 3.1.
2.6.4.    If Customer elects to cancel delivery of Product pursuant to this Section 2.6, [***]. [***].
6.Section 7.2.2. (Regulatory Approval) shall be deleted in its entirety and replaced with the following:
Regulatory Approval. If Novavax fails to receive Regulatory Approval of the Vaccine in the Territory on or before [***] then Customer may terminate this Agreement [***] upon written notice to Novavax. Customer’s sole and exclusive remedy for Novavax’s failure to receive Regulatory Approval of the Vaccine in the Territory are those set out in this Section 7.2.2 and Section 7.5.
7.Section 18.57 shall be deleted in its entirety and replaced with the following:
Not used.
8.Exhibit B. Exhibit B in the Agreement is hereby deleted and replaced with the attached Exhibit B.
9.Exhibit D. Exhibit D in the Agreement is hereby deleted and replaced with the attached Exhibit D.
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10.Effectiveness of Amendment. Except as amended hereby, the Agreement shall remain in full force and effect. Capitalized terms used in this Amendment and not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement.
11.Counterparts. This Amendment may be executed in counterparts, each of which shall be deemed an original, and all of which, taken together, shall constitute one and the same instrument. This Amendment shall be effective upon full execution by electronic transmission or original, and an electronically transmitted signature shall be deemed to be and shall be as effective as an original signature.
12.IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed by their duly authorized representatives as of the last date of signature written below.

[Remainder of page intentionally blank.]
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NOVAVAX, INC.

By:    /s/ John A. Herrmann III        Signature

Name:    John A. Herrmann III

Title:    EVP, Chief Legal Officer

Date:    12/20/2021    


SIGNED by an authorised representative for and on behalf of the Commonwealth of Australia acting through and represented by the Department of Health [***] in the presence of:


/s/ [***]                    
Signature of witness


[***]                    
Name of Witness (block letters)


Date: 23 December 2021            







/s/ [***]                    
Signature of authorised signatory


[***]                
Name of authorised signatory (block letters)


[***]    
Position of authorised signatory





Exhibit B

Delivery Schedule
[Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit B setting forth the Delivery Schedule 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.]




Exhibit D

Manufacturing Facilities:
[Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit D setting forth the Manufacturing 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.]


Exhibit 10.64

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_0c.jpg

December 20, 2021
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878

Attention:    [***], Senior Vice President, Commercial Strategy
Subject:    Modification No. 12 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. 12 hereby amends Project Agreement No. 01 as follows:
DESCRIPTION OF MODIFICATION
1)The Term of the Project Agreement clause of the Project Agreement is hereby amended to read as indicated in bold below:
2. TERM OF THE PROJECT AGREEMENT
The period of performance for this Project Agreement is from July 06, 2020 through January 31, 2022 (this is a one
(1) month no-cost extension).
2)The Technical and Administrative Representatives clause of the Project Agreement is hereby amended to read as indicated in bold below:
10. TECHNICAL AND ADMINISTRATIVE REPRESENTATIVES
The following technical and contractual representatives of the Parties are hereby designated for this Project Agreement. Either party may change their designated representatives by written notification to the other.
MCDC CMF Contractual Representative:
MCDC Contracts
Advanced Technology
International 315 Sigma Drive
Summerville, SC 29486
Email: [***]
Phone: [***]
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Government Technical Representatives:
Agreements Officer Representative (AOR):        Alternate
AOR: [***]                        [***]
Email: [***]                    Email: [***]
Phone: [***]                    Phone: [***]
Project Agreement Holder’s Representatives:
Technical Representative:                Contractual Representative:
[***]                        [***]
21 Firstfield Road                    21 Firstfield Road
Gaithersburg, MD 20878                Gaithersburg, MD 20878
Email: [***]                    Email: [***]
Phone: [***]                    Phone: [***]
3)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 II
Date: 12/21/2021                        Date: 12/22/2021
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Attachment A
Statement of Work

(Incorporated as of Modification No. 12)

This page is intentionally blank. See separate Attachment A.
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Attachment A
Statement of Work
(Incorporated as of Modification No. 12; Changes to Sections 3, 4, 5 and 14 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 manufacture and delivery of 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 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
4

FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE
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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. 2371b(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. The scope is based on the following assumptions regarding manufacturing and clinical dose:

Manufacturing Assumptions and Clinical Dose
The NVX-CoV-2373 vaccine is comprised of the Matrix-M™ adjuvant, and antigen (SARS-CoV-2 spike protein).
A dose range of 5-25 µg of antigen is under clinical study. The anticipated dose based on clinical data obtained to date is [***]µg of antigen with [***]µg of Matrix-M adjuvant.
For planning purposes, the [***] ([***]µg antigen/dose) has been used and the calculations in this scope of work have been based on this dose.
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The antigen production is the rate-limiting step in vaccine production. The Matrix-M adjuvant will be available prior to antigen production. Dose production has been calculated based on the availability of antigen. Novavax is planning on a batch-by-batch rapid fill/finish once antigen is manufactured and available.
The estimated production schedule based on the [***]µg antigen/dose (base case) and [***] µg antigen /dose (anticipated case) is in the table below:

Estimated Schedule of Cumulative Doses Manufactured by Month
DosageOct 2020Nov 2020Dec 2020Jan 2021Feb 2021
[***] µg/dose (base case)[***][***][***][***][***]**
[***] µg/dose (anticipated case)[***][***]100,000,000*
*Actual cumulative projected production at [***] µg/dose is [***] in December 2020. Some doses may be in progress at the end of December 2020.
**Actual cumulative projected production at [***] µg/dose is [***] in February 2021.

The scope includes the following activities:

Manufacturing
Manufacturing of 100M doses (at [***]µg/dose, ≈[***]) of NVX-CoV-2373 vaccine in 2020 for distribution to the Government 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 linked to the product associated with the Phase 1 clinical study. For adjuvant components, the same raw material lot(s) will be used for the current and new Contract Manufacturing Organization (CMO) processes for the comparability protocol, and the same test lab will be used to ensure only process differences are being evaluated.
Validation of manufacturing processes will be performed to cGMP standards.

Clinical
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 (co-morbidities, [***], immunocompromised), as well as studies to support manufacturing site comparability.

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

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Regulatory
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.

Project 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
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with little advance notification and demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed.
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 100M Vaccine Doses
Antigen will be manufactured at Fuji (2 sites – College Station, TX and Research Triangle Park, NC) to supply 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 100M Vaccine Doses
100M doses of finished vaccine in [***] vials will be manufactured at Baxter (Bloomington, IN, USA). 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 for a period of 12 months, with shipments to 10 geographic zones in the USA. 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.

3.2    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 Global Efficacy Study, Adults ≥ 18 and < 75 years
Study: Phase 3 – Global 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 [***].
Population: Adults ≥ 18 years, inclusive of subjects with more severe co-morbid conditions.    
Locations: North America, Europe; may include Africa, Asia, Oceania, South America.    
Primary Objectives: Clinical efficacy, safety, immunogenicity.     
Design: Randomized, observer-blinded, placebo-controlled.    
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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 Global Efficacy Study, Adults ≥ 18 and < 75 years, Booster Study
Study: Phase 3 – Global 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)
3.2.2    Subtask: Phase 2 Efficacy Expansion (US), Adults ≥ 18 and < 75 years
Study: Phase 2 - Part 3 efficacy expansion (US), 2019nCoV-204.
Population: Adults ≥ 18 and < 75 years.     
Locations: USA.
Primary Objectives: Clinical efficacy, safety, immunogenicity.     
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M – [***]; not greater than 25 µg antigen + 50 µg adjuvant, [***] to allow for rapid initiation. Placebo. ~0.5 mL dose IM injection, up to 2 doses at Day 0 and Day 21.
Enrollment: TOTAL: [***]. [***]. Adjusted for expected event occurrence. Event driven analysis. Initiation of study gated on completion of Phase 1 study, dose-selection and regulatory approval.
3.2.3    Subtask: Phase 2 Study in Immunocompromised Persons (HIV-positive adult subjects) (Africa)
Study: Phase 2 study in immunocompromised persons (HIV-positive adult subjects) (Africa).
Population: Adults ≥ 18 and < 65 years.     
Locations: Republic of South Africa (RSA)
Primary Objectives: Safety, immunogenicity (serum and cellular).
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; Placebo, 0.5 mL dose IM injection, up to 2 doses at Day 0 and Day 21.
Enrollment: Total N = 2,640 – 2,880 (with n=240 - 480 HIV+); 1:1 Vaccine to placebo. Initiation gated on completion of Phase 1 study, dose selection, and regulatory approval.
3.2.4    Subtask: [***]
Study: [***].
Population: [***].    
Locations: [***].    
Primary Objectives: [***].
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M [***].
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Enrollment: [***]. Initiation gated on benefit:risk assessment (derived from Task 2.3.1 and/or 2.3.2 and/or other Phase 2 studies) and regulatory approval to conduct studies in this vulnerable population.
3.2.5    Subtask: Phase 2 Manufacturing Site Lot Consistency/Comparability Study (US or other)
Study: Phase 2 manufacturing site lot consistency/comparability study (US or other), 2019nCoV-201.
Population: Adults ≥ 18 to < 50 years.    
Locations: USA.
Primary Objectives: Safety, immunogenicity.
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; [***].
Enrollment: ~600 per cohort, each cohort having [***]. Study size may be adjusted to allow non-inferiority testing.
3.2.6    Subtask: [***]
Study: [***].
Population: [***].    
Locations: [***].
Primary Objectives: [***].
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; [***].
Enrollment: Total = 800 mothers + baby. Initiation gated on benefit:risk assessment (derived from Task 2.3.1 and/or 2.3.2 and/or other Phase 2 studies) and regulatory approval to conduct studies in this vulnerable population.
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: [***]
Study: [***].
Population: [***].
Location: [***].
Primary Objective: [***].
Design: Randomized, observer-blinded, placebo (or active vaccine) control.
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M – [***].
Enrollment: TOTAL: N ~12,500 (based on agreed VE, power, and LBCI). [***]. Adjusted for expected event occurrence if robust demonstration of clinical efficacy is required by the FDA. Event driven analysis for study termination.

3.3    Major Task: Non-Clinical Studies
Novavax will perform these non-clinical studies and deliver the results in a study report at completion.
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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.
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
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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.
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 Government 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.
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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
4.1[***][***]5.13.1.1Reviewer[***]
4.2[***][***]5.23.1.2Reviewer[***]
4.3[***][***]5.33.1.3Reviewer[***]
4.4[***][***]5.43.1.4Reviewer[***]
4.5[***][***]5.53.1.5Reviewer[***]
4.6[***][***]5.63.1.6Reviewer[***]
4.7[***][***]5.73.1.7Reviewer[***]
Clinical
4.8[***][***]5.83.2.1Reviewer[***]1
4.9[***][***]5.93.2.2Reviewer[***]
4.10[***][***]5.103.2.3Reviewer[***]
4.11[***][***]5.113.2.4Reviewer[***]
4.12[***][***]5.123.2.5Reviewer[***]
4.13[***][***]5.133.2.6Reviewer[***]
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
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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4.28
[***]

[***]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[***]
4.37[***][***]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.

Milestone #
Milestone Description
(Deliverable Reference)
Due DateTotal Program Funds
Manufacturing[***]
5.1[***][***][***]
5.2[***][***][***]
5.3[***][***][***]
5.4[***][***][***]
5.5[***][***][***]
5.6[***][***][***]
5.7[***][***][***]
Clinical[***]
5.8[***][***][***]
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5.9[***][***][***]
5.10[***][***][***]
5.11[***][***][***]
5.12[***][***][***]
5.13[***][***][***]
5.14[***][***][***]
5.15[***][***][***]
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[***][***][***]
5.37[***][***][***]
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 – January 31, 2022)
19 Months (Base)
Option 1: Follow-On ProductionCost: [***]

6.0    SHIPPING 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.

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 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. 
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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.
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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

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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 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

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
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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 10.65

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

January 31, 2022

Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878

Attention:    [***], Senior Vice President, Commercial Strategy
Subject:    Modification No. 13 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. 13 hereby amends Project Agreement No. 01 as follows:

DESCRIPTION OF MODIFICATION

1)The Term of the Project Agreement clause of the Project Agreement is hereby amended to read as indicated in bold below:

2. TERM OF THE PROJECT AGREEMENT
The period of performance for this Project Agreement is from July 06, 2020 through December 31, 2023 (this is a 23 month no-cost extension).

2)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.
119011951_4



Novavax, Inc.

By:    /s/ John A. Herrmann III    

Name:    John A. Herrmann III    

Title:    EVP, CLO    

Date    1/31/22    

Advanced Technology International

By:    /s/ [***]    

Name:    [***]    

Title:    Sr. Contracts Administrator    

Date    2/1/22    

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Attachment A
Statement of Work

(Incorporated as of Modification No. 13)

This page is intentionally blank. See separate Attachment A.

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Attachment A
Statement of Work
(Incorporated as of Modification No. 13; 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 manufacture and delivery of 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. 2371b(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. The scope is based on the following assumptions regarding manufacturing and clinical dose:

Manufacturing Assumptions and Clinical Dose
The NVX-CoV-2373 vaccine is comprised of the Matrix-M™ adjuvant, and antigen (SARS-CoV-2 spike protein).
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A dose range of 5-25 µg of antigen is under clinical study. The anticipated dose based on clinical data obtained to date is [***]µg of antigen with [***]µg of Matrix-M adjuvant.
For planning purposes, the [***] ([***]µg antigen/dose) has been used and the calculations in this scope of work have been based on this dose.
The antigen production is the rate-limiting step in vaccine production. The Matrix-M adjuvant will be available prior to antigen production. Dose production has been calculated based on the availability of antigen. Novavax is planning on a batch-by-batch rapid fill/finish once antigen is manufactured and available.
The estimated production schedule based on the [***]µg antigen/dose (base case) and [***] µg antigen /dose (anticipated case) is in the table below:

Estimated Schedule of Cumulative Doses Manufactured by Month
DosageOct 2020Nov 2020Dec 2020Jan 2021Feb 2021
[***] µg/dose (base case)[***][***][***][***][***]**
[***] µg/dose (anticipated case)[***][***]100,000,000*
*Actual cumulative projected production at [**] µg/dose is [***] in December 2020. Some doses may be in progress at the end of December 2020.
**Actual cumulative projected production at [***] µg/dose is [***] in February 2021.

The scope includes the following activities:

Manufacturing
Manufacturing of 100M doses (at [***]µg/dose, ≈[***]) of NVX-CoV-2373 vaccine in 2020 for distribution to the Government 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 linked to the product associated with the Phase 1 clinical study. For adjuvant components, the same raw material lot(s) will be used for the current and new Contract Manufacturing Organization (CMO) processes for the comparability protocol, and the same test lab will be used to ensure only process differences are being evaluated.
Validation of manufacturing processes will be performed to cGMP standards.
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Clinical
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 (co-morbidities, [***], immunocompromised), as well as studies to support manufacturing site comparability.

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

Regulatory
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.

Project 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,
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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.
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 100M Vaccine Doses
Antigen will be manufactured at Fuji (2 sites – College Station, TX and Research Triangle Park, NC) to supply 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.
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3.1.6    Subtask: Fill/Finish of 100M Vaccine Doses
100M doses of finished vaccine in [***] vials will be manufactured at Baxter (Bloomington, IN, USA). 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 for a period of 12 months, with shipments to 10 geographic zones in the USA. 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.

3.2    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 Global Efficacy Study, Adults ≥ 18 and < 75 years
Study: Phase 3 – Global 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 [***].
Population: Adults ≥ 18 years, inclusive of subjects with more severe co-morbid conditions.    
Locations: North America, Europe; may include Africa, Asia, Oceania, South America.    
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 Global Efficacy Study, Adults ≥ 18 and < 75 years, Booster Study
Study: Phase 3 – Global 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 Global Efficacy Study, Adolescents ≥ 12 and < 18 years, Adolescent/ Adolescent Booster Study
Study: Phase 3 – Global 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    Subtask: Phase 2 Efficacy Expansion (US), Adults ≥ 18 and < 75 years
Study: Phase 2 - Part 3 efficacy expansion (US), 2019nCoV-204.
Population: Adults ≥ 18 and < 75 years.     
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Locations: USA.
Primary Objectives: Clinical efficacy, safety, immunogenicity.     
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M – [***]; not greater than 25 µg antigen + 50 µg adjuvant, [***] to allow for rapid initiation. Placebo. ~0.5 mL dose IM injection, up to 2 doses at Day 0 and Day 21.
Enrollment: TOTAL: [***]. [***]. Adjusted for expected event occurrence. Event driven analysis. Initiation of study gated on completion of Phase 1 study, dose-selection and regulatory approval.
3.2.3    Subtask: Phase 2 Study in Immunocompromised Persons (HIV-positive adult subjects) (Africa)
Study: Phase 2 study in immunocompromised persons (HIV-positive adult subjects) (Africa).
Population: Adults ≥ 18 and < 65 years.     
Locations: Republic of South Africa (RSA)
Primary Objectives: Safety, immunogenicity (serum and cellular).
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; Placebo, 0.5 mL dose IM injection, up to 2 doses at Day 0 and Day 21.
Enrollment: Total N = 2,640 – 2,880 (with n=240 - 480 HIV+); 1:1 Vaccine to placebo. Initiation gated on completion of Phase 1 study, dose selection, and regulatory approval.
3.2.4    Subtask: [***]
Study: [***].
Population: [***].    
Locations: [***].    
Primary Objectives: [***].
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M [***].
Enrollment: [***]. Initiation gated on benefit:risk assessment (derived from Task 2.3.1 and/or 2.3.2 and/or other Phase 2 studies) and regulatory approval to conduct studies in this vulnerable population.
3.2.5    Subtask: Phase 2 Manufacturing Site Lot Consistency/Comparability Study (US or other)
Study: Phase 2 manufacturing site lot consistency/comparability study (US or other), 2019nCoV-201.
Population: Adults ≥ 18 to < 50 years.    
Locations: USA.
Primary Objectives: Safety, immunogenicity.
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; [***].
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Enrollment: ~600 per cohort, each cohort having [***]. Study size may be adjusted to allow non-inferiority testing.
3.2.6    Subtask: [***]
Study: [***].
Population: [***].    
Locations: [***].
Primary Objectives: [***].
Design: Randomized, observer-blinded, placebo-controlled.    
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M; [***].
Enrollment: Total = 800 mothers + baby. Initiation gated on benefit:risk assessment (derived from Task 2.3.1 and/or 2.3.2 and/or other Phase 2 studies) and regulatory approval to conduct studies in this vulnerable population.
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: [***]
Study: [***].
Population: [***].
Location: [***].
Primary Objective: [***].
Design: Randomized, observer-blinded, placebo (or active vaccine) control.
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M – [***].
Enrollment: TOTAL: N ~12,500 (based on agreed VE, power, and LBCI). [***]. Adjusted for expected event occurrence if robust demonstration of clinical efficacy is required by the FDA. Event driven analysis for study termination.

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.
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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.
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
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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.
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 Government 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.
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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[***]
Clinical
4.08[***][***]5.83.2.1Reviewer[***]1
4.09[***][***]5.93.2.2Reviewer[***]
4.10[***][***]5.103.2.3Reviewer[***]
4.11[***][***]5.113.2.4Reviewer[***]
4.12[***][***]5.123.2.5Reviewer[***]
4.13[***][***]5.133.2.6Reviewer[***]
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[***]
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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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) 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[***][***][***]
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Clinical[***]
5.08[***][***][***]
5.09[***][***][***]
5.10[***][***][***]
5.11[***][***][***]
5.12[***][***][***]
5.13[***][***][***]
5.14[***][***][***]
5.15[***][***][***]
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
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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    SHIPPING 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.

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.

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(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 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.

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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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.

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
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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 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.

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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 14 The NovaCode Our Code of Conduct


 
Contents INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 A Message From Our CEO . . . . . . . . . . . . . . . . . . . . . . 4 OUR CODE OF CONDUCT . . . . . . . . . . . . . . . . . . . . . . 5 Our Core Principles . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Employee Responsibilities . . . . . . . . . . . . . . . . . . . . . 7 Managers Have Additional Responsibilities . . . . . 8 Interactions with Our Communities . . . . . . . . . . . . 8 Marketing and Business Practices . . . . . . . . . . . . . . 8 Fair Competition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Business Intelligence . . . . . . . . . . . . . . . . . . . . . . . . . 9 Ethical Business Partners . . . . . . . . . . . . . . . . . . . . . . 9 Conflicts of Interests . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Gifts and Hospitality . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Political Activity & Involvement . . . . . . . . . . . . . . . . 9 Government Relations and Lobbying . . . . . . . . . . . 9 Excellence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Quality and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 11 International Trade . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Clinical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Pharmacovigilance . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Safety and Health . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Interactions with Our Customers and Stakeholders . . . . . . . . . . . . . . . . . 13 Respect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Human Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Anti-Discrimination . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Harassment-free Workplace . . . . . . . . . . . . . . . . . . 15 Zero Tolerance for Retaliation . . . . . . . . . . . . . . . . 15 Disability Accommodations . . . . . . . . . . . . . . . . . . 15 Drug-free Workplace . . . . . . . . . . . . . . . . . . . . . . . . 15 Accountability and Discipline . . . . . . . . . . . . . . . . . 15 Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Using and Protecting Company Assets . . . . . . . . 16 Confidential Information . . . . . . . . . . . . . . . . . . . . . 17 Data Privacy and Personal Privacy . . . . . . . . . . . . 17 Intellectual Property . . . . . . . . . . . . . . . . . . . . . . . . . 17 Records and Disclosure . . . . . . . . . . . . . . . . . . . . . . 17 Accurate Information for Investors . . . . . . . . . . . 17 Responsible Communications . . . . . . . . . . . . . . . . . 18 Communications With the Public . . . . . . . . . . . . . . 18 Insider Trading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 RESOURCES FOR TAKING ACTION . . . . . . . . . . . 19 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 The Compliance Helpline . . . . . . . . . . . . . . . . . . . . .20 Disciplinary Actions . . . . . . . . . . . . . . . . . . . . . . . . . .20 WAIVERS AND AMENDMENT . . . . . . . . . . . . . . . . . 21 ADDITIONAL RESOURCES . . . . . . . . . . . . . . . . . . . 21


 
rs, oint s, INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect Responsibility Introduction OUR CODE OF BUSINESS CONDUCT (the “Code”) provides guidance to help us make the right decisions and sets the highest standards of ethical business conduct at Novavax . It outlines expectations for our employees when dealing with strategic partners, healthcare professionals, and the communities we serve . Except as otherwise required by applicable laws, this Code applies to Novavax, Inc . and all of its subsidiaries and other business entities worldwide (collectively, “Novavax”) . The Code is not intended to be an exhaustive list of Novavax’s policies and procedures . Supplementary information on a number of topics may be found by referring to our global policies and to local policies and procedures . While the Code applies to all employees, office and directors, certain business partners, such as j ventures, agents, consultants, distributors, supplier vendors, independent contractors, and temporary employees, are also expected to live up to the principles of the Code . Managers who supervise our external business partners are responsible for ensuring that they understand and adhere to our standards. Our Code is available on our corporate website, Novavax .com, and our internal intranet under Compliance . Please refer to these sites for the most up-to-date version of our Code . ● 3


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect Responsibility A Message from Our CEO NOVAVAX DOES IMPORTANT AND ESSENTIAL WORK. Every day, we work to create vaccines to address unmet medical needs and improve the lives of people all over the world . But equally important to what we do, is how we do it . We’ve always prided ourselves on being a company built on principles of integrity, responsibility, and trust . We must comply not only with the spirit of the law, but with the letter of the law, by following all applicable legal standards and regulations that govern our industry, in every country we do business . Which is why we ask every employee to complete our required compliance training and certify that you have read and understand our compliance policies and Code of Business Conduct . Meeting the highest ethical standards is both an individual and shared responsibility — let’s work together as a team to help one another, to make good decisions and protect our company’s reputation . If you ever have any questions or concerns regarding our compliance program, reach out to your manager, HR business partner, or a member of our legal or compliance team . However, if you prefer to raise a concern anonymously, you can reach out to our ethics and compliance hotline . Thank you for upholding our “Nova Code” and making Integrity a part of everything we do. Stanley C . Erck President and CEO 4


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect Responsibility Code of Conduct Our Core Principles 5


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect Responsibility Our Core Principles INTEGRITY We are honest and transparent in all that we do and adhere to laws, industry regulations, and internal policies and conduct our business with the highest level of integrity and ethics . EXCELLENCE We strive for excellence in all of our business activities and never compromise quality and safety in developing, manufacturing, marketing, and distributing our therapies . COMMITMENT We are committed to improving lives and global public health and we always put the needs of the communities we serve first. RESPECT We are globally inclusive, bias-free, and work together as a team by embracing diversity and treating everyone with respect and dignity . RESPONSIBILITY We are responsible for protecting Novavax’s assets, information, and reputation, and reducing the impact of our operations on the environment every day . 6


 
INTRODUCTION CODE OF CONDUCT RESOURCES INTEGRITY Excellence Commitment Respect Responsibility 1 INTEGRITY We are honest and transparent in all we do. At Novavax, we understand and accept our responsibility to provide effective and accessible vaccines to populations throughout the globe in accordance with our Core Principles, and in compliance with all applicable laws and regulations . We recognize that healthcare laws, regulations, and situations involving compliance can be complicated . When faced with a tough decision, we must always consider if the activity is legal, ethical, and consistent with our Core Principles—and if we don’t know or are unsure, we ask . This is why we have a Code of Business Conduct and provide you with resources to help you understand our standards and expectations, to help you exercise sound judgment and make good choices for not only Novavax but also all the communities we serve . Please know that you are never alone in making these decisions . We are One Team, and your manager, Human Resources, Legal, Compliance, and colleagues are here to support you every step of the way . 7


 
INTRODUCTION CODE OF CONDUCT RESOURCES 8 INTEGRITY Excellence Commitment Respect Responsibility Employee Responsibilities • Always act in a professional, honest, and ethical manner when acting on behalf of Novavax . • Be familiar with the information contained in this Code as well as Novavax policies . • Complete all required training in a timely manner and keep up to date on current standards and expectations. • Promptly report concerns about possible violations of laws, regulations, this Code and policies to your supervisor, the Corporate Compliance Hotline, or to any of the resources listed in this Code . • Remember: No reason, including the desire to meet business goals, is an excuse for compromising our ethics or violating laws, regulations, the Code, or other policies . Managers Have Additional Responsibilities If you are in a leadership position you are expected to meet the following additional responsibilities: • Lead by example: Managers are expected to exemplify the highest standards of ethical business conduct. • Be a proactive resource for others . • Communicate to employees and business partners about how the Code and policies apply to their daily work. • Look for opportunities to discuss and address ethics and ethically challenging situations with others. • Create an environment where compliance is recognized and valued and where everyone feels comfortable asking questions . • If you supervise external business partners, ensure that they understand their ethics and compliance obligations. Interactions with Our Communities The healthcare community who influence, recommend, and administer our vaccines as well as those individuals throughout the world who use our vaccines, have placed their trust in us . We work hard every day to deserve that trust and will do business with honesty and integrity—and will comply with all applicable ethical and legal standards . We do not offer or provide bribes or kickbacks to win or influence a business or prescribing decision, or to advance our interests with government authorities . The countries in which we operate have strict anti- corruption rules and regulations that prohibit giving, getting, offering, or asking for anything of value in return for business or for bribing government officials (e .g ., The U .S . Foreign Corrupt Practices Act (FCPA), U .S . Anti-Kickback Statute, Canada’s Corruption of Foreign Public Officials Act (CFPOA), Ireland’s Corruption Offences Act 2018, Germany’s Act on Combating International Bribery, and the U .K . Bribery Act that extends anti-bribery claims to private individuals) . Many countries also have additional directives such as the European anti-money laundering directives (AMLD) that fight against money laundering and terrorist financing. In addition to these laws and directives, we are also responsible for third parties acting on Novavax’s behalf, and we must perform our due diligence, carefully monitor our business partners, and require them to operate in compliance with our Code and our standards . Due to the complexity of anti-corruption and anti-bribery laws worldwide, it is important that we are all aware of our policies and ask questions if we have any doubts about the proper course of action . If you have questions, contact your supervisor, Corporate Compliance, or any of the resources listed in this Code . Please refer to our Global Anti-Bribery and Anti-Corruption Policy (CORP-POL-001) for additional information . Marketing and Business Practices To help ensure the safe and proper use of our vaccines, information provided to healthcare professionals must be in compliance with all applicable laws and must be approved and reviewed appropriately . We promote our vaccines only for the uses that have been approved, cleared, or authorized by the relevant governmental agency . Healthcare professionals must determine the best course of care for their patients, and Novavax is committed to providing timely, fair, accurate, and balanced information to assist them with these important treatment decisions . We never look to gain competitive advantages through unethical or illegal business practices . We do not enter into agreements with competitors to engage in any anti-competitive behavior, including setting prices or dividing markets . We do not engage in unfair or deceptive acts or practices, such as false or misleading advertising or other misrepresentation . Additionally, all materials used in the public and with our customers and stakeholders, must be approved internally for the specific audience and use and follow all internal guidelines, including our Global Material Review Policy (Legal-POL-002). For additional information please contact Legal or Corporate Compliance. Fair Competition Novavax expects openness, honesty, and courtesy from all employees in their business dealings . Every employee must act ethically and with respect for others, and endeavor to deal fairly and honestly with all vendors, partners, competitors, and the general public. Each employee is also responsible for creating and sustaining a pleasant, secure, and productive working environment . No employee should take unfair advantage of anyone through manipulation, concealment, abuse or disclosure of privileged information, misrepresentation, or any other unfair dealing practice .


 
INTRODUCTION CODE OF CONDUCT RESOURCES 9 INTEGRITY Excellence Commitment Respect Responsibility Novavax also abides by and adheres to fair competition standards that are a matter of law in virtually every jurisdiction in which we conduct business . Novavax expects employees to act in accordance with such standards, which include compliance with: • all antitrust rules and regulations, including rules against agreements or understandings between Novavax and its competitors that affect the process, terms, or conditions of sale; • prohibitions against unfair methods of competition and unfair and deceptive acts or practices in commerce; and, • all foreign corrupt practices laws, including those making illegal any offer, payment, promise to pay or authorization to pay any money, gift, or anything of value to foreign officials, political parties, or candidates for improper purposes Business Intelligence We will never engage in deception or unethical behavior to obtain information about competitors . We should also be careful when accepting information from third parties . We should know and trust their sources and be sure that the knowledge they provide is not protected by trade-secret laws or confidentiality agreements. When Novavax employs former employees of competitors, we recognize and respect the obligations of those employees not to use or disclose the confidential information of their former employers. Make sure you only obtain competitive information through legal and ethical means and respect the confidentiality obligations of others. Additionally, ensure that you avoid using or disclosing confidential information unless you have obtained the appropriate approvals . Ethical Business Partners Novavax only works with business partners (e .g ., vendors, consultants, distributors) who conduct their business with integrity . Every vendor we hire must uphold our principles and may not engage in unethical or illegal business practices . Before entering into a business relationship, you must ensure that the appropriate due diligence screening has occurred, and that the vendor meets our standards of excellence . Only approve transactions once you fully understand them and are certain that they comply with our policies . Only make payments in accordance with the payment terms as defined in the agreement or invoice . Communicate any issues that are identified to appropriate Novavax personnel, including Legal, Corporate Compliance, and Finance . Conflicts of Interests While Novavax does not wish to infringe on the personal lives of its employees, employees must not have personal activities or relationships, including commercial interests, that conflict or appear to conflict with the interests of the Company. A conflict of interest develops any time an employee faces a choice between what is in his or her personal interest (financial or otherwise) and the interest of the Company . Novavax expects that the interests of the Company will take precedence over an employee’s personal interests and that our employees will act only for the benefit of the Company. A conflict of interest occurs when a person has a competing interest that may interfere with their ability to make an objective decision . Each of us is expected to use good judgment and avoid situations that can lead to even the appearance of a conflict. Where there is any question as to whether a conflict of interest exists, we should always look to be transparent and disclose such issues or interests . Situations like non-Novavax outside employment, serving on external for-profit or non-profit committees or other advisory capacity, receiving gifts or benefits from any third party should be disclosed . Since these situations are not always clear-cut, make sure that you disclose any situation that could be perceived as a potential conflict of interest to your manager . Always avoid using your position with Novavax for personal advantage . Please refer to our Supernova Handbook or speak with your HR partner for additional information . Gifts and Hospitality Under appropriate circumstances, a modest gift or a meal to our business partners, healthcare professionals, or the populations we serve may be locally acceptable and compliant . However, if not handled carefully, the exchange of gifts and hospitality can create the appearance of an inducement or a conflict of interest, especially if it happens frequently or if the value is significant under local standards . When it comes to gifts and hospitality, Novavax’s position is straightforward: we do not accept or provide gifts or hospitality or any other item of value if the intent is to improperly influence a business decision. Gifts of cash or cash equivalents are never allowed . Use sound judgment; only provide and accept gifts or hospitality that are permissible by law and policy . Please remember, providing hospitality and gifts to government employees is strictly prohibited or limited in many jurisdictions . For more information, please speak with your manager, Corporate Compliance, or Legal . Political Activity & Involvement You have the right to voluntarily and freely participate in your country’s political processes, including making personal political contributions . However, you must always make it clear that your personal views and actions are not those of Novavax .


 
INTRODUCTION CODE OF CONDUCT RESOURCES INTEGRITY Excellence Commitment Respect Responsibility Avoid even the appearance that you are making contributions or campaigning to gain favor or as an attempt to exert influence. Also, never use Novavax’s funds, assets, services, or facilities to support any political candidate or party, or engage in any lobbying activity unless specifically authorized by Novavax Government Affairs. Discuss any questions or concerns about political contributions or political activities, with the government affairs team. Government Relations and Lobbying Novavax will deal with all government agencies in a direct, open, and honest manner . Most contact with government personnel for the purpose of influencing legislation or rulemaking, including such activity in connection with marketing or procurement matters, is considered lobbying . Some laws also define lobbying even more broadly to include our normal marketing activities . If your job responsibility is to make marketing contacts on behalf of Novavax, you are responsible for knowing and adhering to all the relevant lobbying laws and associated gift laws, if applicable, and for compliance with all reporting requirements . Please refer to our Lobbying, Political Activities, and Government Interactions Policy (CORP-POL-003) for additional information . ● 10


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity EXCELLENCE Commitment Respect Responsibility 2 EXCELLENCE We strive for excellence and never compromise quality and safety. Quality and Safety Novavax trusts and empowers its employees to uphold quality as an integral part of their responsibilities in developing, manufacturing, and marketing new and existing therapies . Quality is part of our culture and is integrated into all critical business and decision–making processes . The safety and well-being of our vaccine recipients is Novavax’s top priority . As such, we maintain a demonstrable commitment to the quality, efficacy, and safety of our vaccines in compliance with all applicable global requirements regulating their development, manufacturing, and distribution . Novavax closely monitors the quality and safety of its vaccines . Unfavorable results or adverse events involving our vaccines must be reported to regulatory authorities appropriately . Make sure you know and comply with quality and safety policies and report any quality or safety related matter immediately to our quality and safety departments . 11


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity EXCELLENCE Commitment Respect Responsibility International Trade We comply with all import/export control laws, trade restrictions, and anti-boycott laws without limitation, and we expect our business partners to do the same . You should make sure that you know and comply with these laws when engaging in an international transaction or when releasing certain types of technical data or information to any person . Export control restrictions apply not only to international shipments of tangible materials and equipment, but also to the transfer of intangible technical data to some foreign countries or citizens of those countries . Many countries also have prohibitions against dealing with specifically identified countries, persons, or organizations which must be observed as well as any trade sanctions, embargoes, or other government orders . Employees should consult with a designated Trade Compliance Leader or Legal as early as possible about applicable laws on exporting goods, information, and technology . For more information please refer to the Global Trade Control Policy (GSC-POL-001) or reach out to tradecompliance@novavax .com . Clinical Research We are proud of our work to advance healthcare through the clinical research we conduct . To ensure that we abide by all laws, regulations, and our own high ethical standards, we follow all review and approval procedures before initiating research . We will protect the safety of our research participants through appropriate informed consent procedures and good clinical practices, and we will comply with all applicable privacy-related policies and regulations . Anywhere we do clinical research we will ensure that participants are not exposed to unnecessary risk; that they understand the nature and purpose of the research through informed consent procedures; and privacy and confidentiality rules are applied, and the information gathered enables transparent and accurate reporting, interpretation, and verification of clinical results. Pharmacovigilance To ensure that every Novavax vaccine is both effective and safe, we have systematic, stringent processes designed to improve patient safety . The benefit-risk profiles of our vaccines are derived from efficacy and safety data that is collected both throughout the development of our vaccines and after they go to market . Novavax is mandated by Worldwide Health Authorities (e .g . Food and Drug Administration [FDA]; European Medicines Agency [EMA]) to collect, evaluate, and report any Adverse Event (AE) associated with the use of a Novavax product . All Novavax employees are required to report any Adverse Event associated with a Novavax product within one business day of becoming aware of the event . If you become aware of any adverse event relating to our vaccines, please immediately access NovavaxMedInfo .com for reporting options and instructions . Quality We comply with all governmental and regulatory agency requirements and industry standards relating to the manufacturing of our vaccines including good laboratory practices (GLP), current good manufacturing practices (cGMP), and good distribution practices (GDP) to ensure that our vaccines are manufactured according to the highest standards and are safe and effective. All Novavax employees are required to report any quality issues associated with a Novavax product within one business day of becoming aware of the event . If you become aware of any quality issue relating to our vaccines, please immediately report this matter to qualitycompliance@novavax .com . Safety and Health Novavax is committed to providing a safe and healthy workplace . Situations that may pose a health or safety hazard must be reported immediately . We can only achieve our goal of a safe and healthy workplace through the proactive participation and support of everyone . Make sure you know and comply with safety and health policies and procedures and report all injuries, hazards, and property damage to your manager within 24 hours. Security Novavax is committed to providing a secure workplace for its employees, contractors, and visitors . Any situation that may pose a security risk must be reported immediately . Security is a shared responsibility . Make sure you always visibly wear your ID card on campus and never allow anyone to “piggy-back” behind you into a facility or restricted area . Notify Security if your ID card is lost or stolen . Immediately report any suspicious persons or activity to Security at security@novavax .com . Conduct by a Novavax employee that threatens, intimidates, or coerces another will not be tolerated . This prohibition includes all acts of harassment, including harassment that is based on an individual’s race, color, religion, gender, gender identity or expression, age, sexual orientation, national origin, disability, pregnancy, genetic information, military status, employment or marital status or any characteristic protected by law . All threats of (or actual) violence, both direct and indirect, should be reported as soon as possible to Security, Human Resources, Corporate Compliance, or your manager . This includes threats by employees, as well as threats by business partners, vendors, solicitors, or other members of the public . Weapons are prohibited on Novavax property, which includes designated employee parking areas and Novavax sponsored events. ● 12


 
INTRODUCTION CODE OF CONDUCT RESOURCES s Integrity Excellence COMMITMENT Respect Responsibility 3 COMMITMENT We are committed to improving public health and ethically supporting communities in need. Interactions with Our Customers and Stakeholders As part of our commitment to help address unmet medical needs and support optimal healthcare, we recognize the importance of fully understanding the public health needs of the individuals and communities we serve . In our interactions with government agencies, advocacy groups and other stakeholders, we strive to build relationships based on mutual respect and integrity, and we are transparent in our interactions . Additionally, we only interact with individuals according to the principle and circumstances permitted by company policy and local rules and regulations. Please ensure that our communications and interactions with our stakeholders are appropriate and consistent with applicable company policies and regulatory standards . ● 13


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment RESPECT Responsibility 4 RESPECT We are globally committed to a workplace where everyone is treated fairly, respectfully, and with dignity. We are committed to a workplace where employees feel respected and appreciated . We treat our employees with respect and dignity . We owe each other honesty, respect, and fair treatment—this means we treat others as they want to be treated . It’s also the basis of our commitment to one another and the key to building successful teams . Keeping this commitment allows us to attract and keep talented individuals in a supportive, professional, and respectful work environment. Maintaining this environment helps Novavax succeed and creates the setting for each of us to thrive and to reach our full potential . What follows are some of the key areas where we shall be guided by our commitment to our Core Principles . 14


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment RESPECT Responsibility Human Rights We support fundamental human rights and will champion these rights . We will not work with business partners who employ children or forced labor . We will not tolerate violence or abuse . In every country where we operate, Novavax follows all laws, regulations, and international conventions related to human rights . Our medical and research activities follow the principles outlined in the Declaration of Helsinki . Anti-Discrimination Novavax brings together employees with a wide variety of backgrounds, skills, and cultures . Combining this wealth of talent and resources creates our diverse and dynamic teams that drive excellence . All of our colleagues, job applicants, and business partners will be treated with respect and judged solely on the basis of their qualifications, demonstrated skills, and achievements . We comply with and uphold laws prohibiting discrimination based on any protected characteristic, including non-discrimination based upon a person’s race, color, religion, gender, gender identity or expression, age, sexual orientation, national origin, disability, pregnancy, genetic information, military status, and employment or marital status . Harassment-free Workplace We all have the right to work in an environment that is free from intimidation and harassment . Novavax expects all personnel to adhere to a simple standard: all employees will be treated with respect . Verbal or physical conduct by any employee that harasses or disrupts another’s work performance or creates an intimidating or hostile work environment will not be tolerated. Our Code also prohibits conduct that, although perhaps not unwelcome to the participants, creates an intimidating, hostile or offensive environment for others who observe the conduct . Zero Tolerance for Retaliation Novavax strictly prohibits reprisals or retaliation against anyone who raises a business practice, ethical or legal issue or cooperates in the investigation of such an issue . This is a cornerstone of our Corporate Culture . We do not tolerate any form of retaliation, whether by a manager or co-worker, against an individual because he or she made a good faith report of a legal or ethical concern . This extends to anyone who assists with or cooperates in an investigation or reports a legal or ethical concern or question . Regardless of the type of misconduct reported, we will not tolerate retaliation against anyone who makes a good faith report of an alleged violation . If you believe you have been retaliated against, you should notify Corporate Compliance or the Helpline immediately. Disability Accommodations Novavax is committed to complying with the Americans with Disabilities Act and other applicable laws in markets where we operate to ensure equal opportunity in employment for qualified persons with disabilities . All employment practices and activities are conducted on a non- discriminatory basis . We will make reasonable accommodations for qualified individuals with known disabilities unless doing so would result in a hardship for Novavax . Please contact your HR partner if you have any questions or need additional support . Drug-free Workplace Novavax is committed to maintaining a drug- free workplace . Employees who use illegal drugs may be subject to disciplinary action, up to and including termination. Accountability and Discipline Violating relevant laws, regulations, or the Code, or encouraging others to do so, exposes Novavax to liability and puts both your own and Novavax’s reputation at risk . Novavax will take appropriate disciplinary action against any employee or business partner whose actions are found to violate these policies or any other policies of Novavax . ● 15


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect RESPONSIBILITY 5 RESPONSIBILITY We are responsible for protecting Novavax’s assets, information, and reputation. Using and Protecting Company Assets We are each personally responsible for protecting Company assets and using them with care . Company assets include funds, facilities, equipment, information systems, intellectual property, and confidential information. Personal use of Company assets is discouraged . All information that is sent or received through our computer or phone systems is part of official Company records, and we can be legally required to show those records . Make sure that business information you process is accurate, appropriate, ethical, and legal . Novavax also believes that every employee is responsible for appropriately securing all Company property within his or her control to prevent its unauthorized use . You must not allow Company property to be used to help carry out illegal or improper activities such as outside employment . Novavax requires a workplace free of harassment and strives to be sensitive to the diversity of its employees . We also prohibit the use of all computers and communication systems in ways that are disruptive, offensive to others, or harmful to morale. 16


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect RESPONSIBILITY Confidential Information Employees, officers, and directors must maintain the confidentiality of confidential information entrusted to them by Novavax or other companies, including our suppliers and vaccine recipients, except when disclosure is authorized by a supervisor or legally permitted in connection with reporting illegal activity to the appropriate regulatory authority . Unauthorized disclosure and use of any confidential information is prohibited. Additionally, employees should take appropriate precautions to ensure that confidential or sensitive business information, whether proprietary to Novavax or another company, is not communicated within Novavax except to employees who have a need to know such information to perform their responsibilities for Novavax . Employees should also remember that their obligation to protect the Company’s confidential information continues even after their employment with Novavax ends . Employees and former employees who improperly use or disclose confidential information will be subject to disciplinary action and legal action, even if they do not actually benefit from the disclosed information. THIRD-PARTY CONFIDENTIAL INFORMATION We are also often in receipt or possession of the confidential information of other parties, including our vendors, vaccine recipients, business partners and competitors . Often this information is protected, and its use governed, by confidentiality agreements with those parties . You must treat this information in the same way you treat Novavax’s confidential information. You therefore should refuse unsolicited third-party confidential information or, if inadvertently received, should return such information unopened to the third party or transfer it to your Legal partner for appropriate disposition. Data Privacy and Personal Privacy Many of us have access to personal information related to our vaccine recipients, healthcare professionals, employees, and others . This information is considered sensitive information and is protected by laws and regulations and must be secured and kept confidential. Protecting personal information that we have been entrusted is not only a legal requirement, but also our commitment and responsibility . If you have any questions about privacy requirements, contact your manager, the Legal, Corporate Compliance, or Human Resources departments . Please refer to our Global Personal Information Privacy Policy (LGL-POL-003) for additional information. Intellectual Property Novavax’s intellectual property (IP) is an important asset that must be protected . Some examples of our IP are trade secrets, patents, trademarks, copyrights, discoveries, methods, know-how and techniques, innovations, designs, systems, software, data, and technology . Please remember to protect our IP by sharing it only with authorized parties . Additionally, ensure that you only use or disclose confidential or proprietary information with appropriate approvals . Properly label confidential information to indicate how it should be handled, distributed, and destroyed . You should also promptly disclose to Novavax any inventions or other IP that you create while you are employed by Novavax . Novavax respects the intellectual property rights of others . Unauthorized use of the intellectual property rights of others may expose Novavax to civil lawsuits and damages . Therefore, do not use the patents, copyrights, trademarks, trade secrets or other intellectual property of third parties without first ensuring that Novavax has obtained permission to do so, whether pursuant to a license or otherwise . For more information, please speak with your Legal partner. Records and Disclosure Our Company is subject to extensive and complex reporting requirements . Our operations must comply with all applicable regulatory, accounting, financial and other rules, and regulations of the jurisdictions in which we operate. All of our financial records, accounts, and financial statements must be clear and complete, maintained in reasonable detail, and appropriately reflect our Company’s transactions and activities. It is the policy of Novavax to provide full, fair, accurate, timely, and understandable disclosure in reports and documents filed with or submitted to the U .S . Securities and Exchange Commission (SEC) and other regulatory authorities and in other public communications. Each of us is responsible for information and records under our control so we need to be familiar with the procedures that apply to our jobs . Documents should be reported, disclosed, and retained in accordance with our internal policies and regulatory requirements . Do not hesitate to contact Legal if there is any doubt or if you have any questions. Accurate Information for Investors Further, as a publicly-traded company, all employees have a responsibility to ensure that the Company provides the investing public with information that reflects the Company’s business transactions. Therefore, all of our public disclosures that are filed with government agencies or communicated to the public must be complete, fair, accurate, timely, and understandable . In addition, they must be prepared, reported, and maintained in accordance with all applicable laws and accounting standards . This obligation applies to all employees, including all executives, with any responsibility for preparing such reports, including drafting, reviewing, and signing or certifying the information they contain . 17


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect RESPONSIBILITY The Company must communicate to the extent required by government agencies about its operations, without compromising proprietary and confidential information. Responsible Communications Write carefully and clearly in all your business communications, including emails, with the understanding that someday what you write may become a public document . Use common sense when communicating . Be truthful, accurate, and don’t embellish with unnecessary opinion . Be clear and avoid ambiguity and always consider how a future reader would interpret your communication . Don’t include sensitive information unless it is absolutely necessary and consider a face-to-face meeting or a phone call as an alternative . Remember, emails and texts are forever . Manage and secure records based on the sensitivity of the information they contain and always comply with instructions from Legal to retain records pursuant to a litigation or investigation hold . COMMUNICATIONS WITH THE PUBLIC To achieve a consistent voice and message when making disclosures or providing information to the public, only authorized persons may speak on behalf of Novavax . Please note that only designated employees in Corporate Affairs and Executive Management are authorized to speak on behalf of the company to the media and the financial community. We expect all employees to be careful when using any social media . If you participate in online forums, blogs, or bulletin boards, avoid discussing Novavax, do not discuss internal or confidential business information, and never give the impression that you are speaking on behalf of Novavax without prior authorization. Don’t send emails or post confidential information or material that could damage Novavax’s reputation . Make sure you never speak publicly on issues involving Novavax without prior authorization . For additional information, please refer to our Social Media Policy (CAFF-POL-001) or reach out to a member of our corporate affairs team at digital@novavax .com . COMMUNICATIONS TO OUR INVESTORS We are required under U .S . federal securities laws and European laws to provide our stockholders and the public with periodic disclosure regarding our business and financial condition (such as quarterly and annual reports and materials for our annual stockholders meeting) . We provide additional disclosures through our quarterly earnings calls and press releases . All Novavax employees who participate in the preparation or dissemination of these disclosures, or who provide information that they know may be used in the preparation of these disclosures, have a legal and ethical duty to ensure that the content of the disclosures is accurate, complete, and timely . We have developed disclosure controls and procedures that are designed to ensure that all public disclosures are accurate, complete, and timely . If you become aware that our public disclosures are not accurate, complete, and timely, or become aware of a transaction or development you believe may require disclosure, you should report the matter immediately to Legal and Corporate Compliance . Insider Trading Novavax is proud when our employees choose to invest in the Company . Personal investment is an effective way to align the interests of employees with the interests of our stockholders . When buying or selling Company shares, all employees, directors, officers, and other “insiders” should be mindful of the legal and policy limitations on trading . We will not use information concerning Novavax or information from our business partners for personal benefit. To help ensure that you do not engage in prohibited insider trading and avoid even the appearance of an improper transaction, Novavax has adopted an Insider Trading Policy, which is available on our intranet site or from Legal . Our Insider Trading Policy prohibits all of our directors, officers, employees, and temporary staff worldwide, as well as their immediate family members, from trading securities, or disclosing or passing along information to others who then trade on the basis of material nonpublic information . You may only purchase or sell a company’s securities if you are not in possession of material non-public information about such company . Certain individuals are subject to additional trading restrictions, which limit those individuals to trading in the Company’s securities only during certain open trading windows . Material information is information that a reasonable investor would consider important in deciding whether to buy, sell, or hold a security . Information is generally considered “public” after it has been publicly available for at least one business day after disclosure . Violations of the insider trading laws are severe and include civil and criminal fines and penalties . It is your responsibility to ensure that you do not violate the insider trading laws or our Global Insider Trading Policy (LGL-POL-001). ● 18


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect Responsibility Resources for Taking Action 19


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect Responsibility General Novavax is committed to creating a workplace conducive to the open discussion of its business practices . If you see or suspect any illegal or unethical behavior or policy violation, or you have a question about what to do in a certain situation, you have a responsibility to speak up . Remember, an issue cannot be addressed unless it is brought to someone’s attention . Examples of matters that should be reported include violations of accepted industry codes, bribery or corruption, inappropriate financial reporting, or harassment. You are encouraged to share your concerns with any person with whom you feel most comfortable, including your manager or any other member of management, Corporate Compliance, Human Resources, Legal, or Finance . Please feel free to go to the resource that you are most comfortable with, but keep in mind that your best resource is often your immediate supervisor or manager. Any report or information that you submit must be made in good faith . This does not mean that you must be certain or correct when you raise a concern, but it does mean that you believe the concern you are raising is legitimate and the information you are providing is accurate . For general compliance questions or for questions relating to raising a concern, please feel free to contact us at CorporateCompliance@novavax .com . Concerns about improprieties and wrongdoing involving our and matters involving the Securities and Exchange Commission (“SEC”) should be reported directly to our Chief Financial Officer (“CFO”) and Legal . Concerns about Human Resources related policies, procedures or regulations or matters regarding personal conduct should be brought to the immediate attention of Human Resources . Suspected Code violations that relate to financial statement disclosures or accounting, internal control, or auditing matters, should be reported directly to Corporate Compliance and the Chairman of the Audit Committee of our Board . If an employee feels uncomfortable speaking with any of the above resources for any reason, the Company has established a “Whistleblower” procedure by which confidential complaints may be raised anonymously to Novavax .ethicspoint .com . Complaints submitted through this confidential process will be presented to the Chairman of the Audit Committee, if they involve the Company’s accounting, auditing and internal controls and disclosure practices, or to our Board for other non- financial related matters. Anyone may utilize this confidential and anonymous process either to raise new concerns or complaints or if they feel that a concern or complaint previously raised has not been appropriately handled . NOTE: If you have a question or concern regarding human resources matters that do not fall within the scope of this Code or the related policies and procedures of Novavax, please refer such question or concern to the Human Resources department . The Compliance Helpline However, you choose to raise your concern, please do not hesitate to use the Corporate Compliance Helpline . Our helpline is available 24 hours a day and language translation is available . All calls and reports submitted are handled promptly and discreetly, and Novavax will review and investigate each matter promptly and accordingly . You may call or submit your concern online . You may report your concern anonymously, although it is most helpful for Compliance to be able to communicate freely with you . In any case, please know that your confidentiality will be maintained to the fullest extent possible and Novavax strictly prohibits any form of retaliation . All employees may access the Helpline online at Novavax .ethicspoint .com . If you prefer to call: IN THE US 844-612-0252 IN SWEDEN 020-12 72-95 IN CZECH REPUBLIC 800-144-499 Disciplinary Actions The Company shall determine whether violations of this Code have occurred and, if so, shall determine the disciplinary measures to be taken against any employee who has violated this Code . In the event that the alleged violation involves an executive officer or board member, the Legal Matters Committee of the Board of Directors, shall determine whether a violation of this Code has occurred and, if so, shall determine the disciplinary measures to be taken against such officer or director. ● 20


 
INTRODUCTION CODE OF CONDUCT RESOURCES Integrity Excellence Commitment Respect Responsibility Waivers and Amendment Generally, the policies contained in this Code must be strictly adhered to and no exceptions can be allowed; however, there may be some cases where an exception may be appropriate . Any employee or officer who believes that a waiver of any of these policies is appropriate in their case should first contact their immediate supervisor . If the supervisor agrees that a waiver is appropriate, the approval of the Chief Compliance Officer must be obtained. The Company reserves the right to amend, alter, or terminate this Code at any time for any reason . Additional Resources Supplementary information on a number of topics may be found by referring to our global policies and resources page on the intranet under Compliance . In addition, be sure to consult your country specific policies and procedures related to each of the sections referenced in the Code . If your questions are not fully addressed by these resources, please discuss your questions with your manager, Compliance, Legal or Human Resources partner, or otherwise email Compliance at CorporateCompliance@novavax .com . You can use any of these resources when you need clarification of policies, or assistance in dealing with “gray areas” or when you are concerned about possible violations of our Code, policies, applicable laws, or regulations . ● Thanks once again for upholding our Novacode and making Integrity a part of everything we do. 21


 
VERSION #3 REVISED SEPTEMBER 2021


 

Exhibit 21
LIST OF SUBSIDIARIES

The following is a list of subsidiaries of the Company as of December 31, 2021

Name of Subsidiary             Jurisdiction of Incorporation or Organization
         
Novavax AB                         Sweden

Novavax CZ (formerly Praha Vaccines a.s.)         The Czech Republic

image_0.jpg Exhibit 23.1
        
Consent of Independent Registered Public Accounting Firm
 
We consent to the incorporation by reference in the following Registration Statements:
    
(1)Registration Statement (Form S-8 No. 333-258517) pertaining to the Novavax, Inc. stock incentive plan,
(2)Registration Statement (Form S-8 No. 333-243758) pertaining to the Novavax, Inc. stock incentive plan,
(3)Registration Statement (Form S-3 No. 333-237094) pertaining to Novavax, Inc. common stock, preferred stock, warrants and units,
(4)Registration Statement (Form S-3 No. 333-235761) pertaining to Novavax, Inc. common stock, preferred stock, warrants and units,
(5)Registration Statement (Form S-8 No. 333-233133) pertaining to the Novavax, Inc. stock incentive plan and 2013 employee stock purchase plan,
(6)Registration Statement (Form S-8 No. 333-226498) pertaining to the Novavax, Inc. stock incentive plan and 2013 employee stock purchase plan,
(7)Registration Statement (Form S-8 No. 333-219829) pertaining to the Novavax, Inc. stock incentive plan,
(8)Registration Statement (Form S-8 No. 333-213069) pertaining to the Novavax, Inc. stock incentive plan and 2013 employee stock purchase plan,
(9)Registration Statement (Form S-8 No. 333-206354) pertaining to the Novavax, Inc. stock incentive plan,
(10)Registration Statement (Form S-8 No. 333-198121) pertaining to the Novavax, Inc. stock incentive plan,
(11)Registration Statement (Form S-8 No. 333-190600) pertaining to the Novavax, Inc. stock incentive plan,
(12)Registration Statement (Form S-8 No. 333-190599) pertaining to the Novavax, Inc. 2013 employee stock purchase plan,
(13)Registration Statement (Form S-8 No. 333-183113) pertaining to the Novavax, Inc. stock incentive plan,
(14)Registration Statement (Form S-8 No. 333-145298) pertaining to the Novavax, Inc. stock incentive plan,
(15)Registration Statement (Form S-8 No. 333-130990) pertaining to the Novavax, Inc. stock incentive plan,
(16)Registration Statement (Form S-8 No. 333-110401) pertaining to the Novavax, Inc. stock incentive plan,
(17)Registration Statement (Form S-8 No. 333-97931) pertaining to the Novavax, Inc. stock incentive plan,
(18)Registration Statement (Form S-8 No. 333-46000) pertaining to the Novavax, Inc. stock incentive plan,
(19)Registration Statement (Form S-8 No. 333-77611) pertaining to the Novavax, Inc. stock incentive plan,
(20)Registration Statement (Form S-8 No. 333-03384) pertaining to the Novavax, Inc. stock incentive plan,
(21)Registration Statement (Form S-8 No. 33-80279) pertaining to the Novavax, Inc. stock incentive plan, and
(22)Registration Statement (Form S-8 No. 33-80277) pertaining to the Novavax, Inc. stock incentive plan







image_0.jpg Exhibit 23.1
        
of our reports dated February 28, 2022, with respect to the consolidated financial statements of Novavax, Inc., and the effectiveness of internal control over financial reporting of Novavax, Inc., included in this Annual Report (Form 10-K) of Novavax, Inc. for the year ended December 31, 2021.

/s/ Ernst & Young LLP

Tysons, Virginia
February 28, 2022




    Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

I, Stanley C. Erck, certify that:

1.I have reviewed this Annual Report on Form 10-K 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: February 28, 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 Annual Report on Form 10-K 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: February 28, 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 Annual Report of Novavax, Inc. (the “Company”) on Form 10-K for the fiscal period ended December 31, 2021 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: February 28, 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 Annual Report of Novavax, Inc. (the “Company”) on Form 10-K for the fiscal period ended December 31, 2021 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: February 28, 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.