exhibit1045






Exhibit 10.45    CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS  EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE COMPETITIVELY  HARMFUL IF PUBLICLY DISCLOSED.       Applied Technologies Center  315 Sigma Drive  Summerville, SC  29486  www.ati.org      92962494_6  January 19, 2021  Novavax, Inc.  21 Firstfield Road  Gaithersburg, MD 20878  Attention: [***]  Subject: Modification No. 06 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. 06 hereby amends the Project Agreement No. 01 as follows:  DESCRIPTION OF MODIFICATION  1) Attachment A, Statement of Work, of the Project Agreement is hereby amended as  attached herein.  Except as provided herein, all Terms and Conditions of the referenced MCDC Base  Agreement, Project Agreement, and preceding modifications remain unchanged and in full force  and effect.  The Project Agreement Holder is required to sign this document and return to Advanced  Technology International to finalize this action.  Novavax, Inc. Advanced Technology International  By: /s/ John A. Herrmann III By: /s/ [***]  Name: John A. Herrmann III Name: [***]  Title: EVP, Chief Legal Officer Title: Contracts Administrator  Date: 01/21/2021 Date: Jan 22 2021  





 






  92962494_6  Attachment A  Statement of Work  This page intentionally left blank. See separate document for Attachment A.     





 






   -3-  92962494_6  Attachment A  Statement of Work  (Incorporated as of Modification No. 06; changes to Section 4 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-CoV2373, 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-MTM 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).  





 






   -4-  92962494_6  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 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:  





 






   -5-  92962494_6  o Manufacturing Assumptions and Clinical Dose   The NVX-CoV-2373 vaccine is comprised of the Matrix-MTM 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.   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  Dosage Oct 2020 Nov 2020 Dec 2020 Jan 2021 Feb 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:  o 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  





 






   -6-  92962494_6  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.  o 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.  o Non-clinical   Studies to support EUA and regulatory approval (BLA).  o 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.  o 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.  





 






   -7-  92962494_6   Final prototype project report and applicable patents report(s).   Work Breakdown Structure (WBS) and Integrated Master Schedule (IMS).   All Regulatory correspondence relevant to the scope of work proposed,  including communications with the FDA, and all submissions.  1.4.1 Novavax Project Plan  This is Novavax’s plan as of the date of the submission. Novavax desires to move  quickly to large scale development as rapidly as possible, in order to meet the  objectives of this proposal. As the COVID-19 pandemic is an evolving situation,  Novavax may need to adapt its plan in response to FDA guidance, opportunities for  manufacturing efficiencies, and clinical trial data.  1.5 Resolution of Conflicting Language  If there is a conflict between the Project Agreement (of which this Statement of Work is part) and  the Base Agreement (Medical CBRN Consortium (MCDC) Base Agreement No.: 2020-530), the  Project Agreement language will supersede and control the relationship of the parties.  2.0 APPLICABLE REFERENCES  N/A  3.0 REQUIREMENTS  3.1 Major Task: cGMP Manufacturing of NVX-CoV-2373 compliant with 21 CFR 210  and 211  3.1.1 Subtask: Raw Materials – Obtain Critical Starting Materials for Adjuvant  Manufacturing  Sufficient Saponin to manufacture up to 100M vaccine doses will be purchased (Desert King,  headquartered in San Diego, CA, facilities in Chile). Long-lead, critical, and limited-supply  materials ([***]) will be purchased for the additional 560M vaccine doses to meet the contact  requirement, in order to ensure capability to rapidly manufacture to meet surge requirements with  little advance notification and demonstrate capability to stockpile and distribute large quantities of  the vaccine to respond when needed.  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).  





 






   -8-  92962494_6  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.  Population: Adults ≥ 18 years, inclusive of subjects with more severe co-morbid conditions.  





 






   -9-  92962494_6  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). [***].  3.2.2 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.  





 






   -10-  92962494_6  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; [***].  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: [***].  





 






   -11-  92962494_6  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.  





 






   -12-  92962494_6  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.  





 






   -13-  92962494_6  3.3.11 Durability of NVX-CoV2373 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-CoV2373 nanoparticle vaccine when administered with Matrix-MTM by IM  injections on Study Days 0 and 21, to Non-Human Primates (NHP). Each study group will contain  [***] NHPs ([***] per sex). Blood samples will be collected prior to vaccination and at multiple  time points following vaccination as outlined below. Samples will be shipped to Novavax Inc. for  performance of assays to determine the vaccine immunogenicity. Animals from placebo and active  treatment groups will be challenged with SARS-CoV-2 virus at [***] following last treatment and  monitored for clinical illness, viral RNA and sgRNA (nasal swabs, BAL) to assess the protective  efficacy of the vaccine.  3.3.12 Immunogenicity and Protective Efficacy of Sub-Protective Doses of NVX- CoV2373 in Rhesus Macaques  Study 702-111. This study is designed to evaluate the immunogenicity and protective efficacy of  sub-optimal doses of NVX-CoV2373 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.  





 






   -14-  92962494_6  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.  3.6 Optional Task: Follow-On Production  Follow-on production of finished doses of vaccine up to 560M doses.  4.0 DELIVERABLES  Del. #  Deliverable  Description Due Date  Mileston e  Referenc e  SOW  Reference  Government  Role  Data Type/Data  Rights   Manufacturing       4.1 [***] [***] 5.1 3.1.1 Reviewer [***]  4.2 [***] [***] 5.2 3.1.2 Reviewer [***]  4.3 [***] [***] 5.3 3.1.3 Reviewer [***]  4.4 [***] [***] 5.4 3.1.4 Reviewer [***]  4.5 [***] [***] 5.5 3.1.5 Reviewer [***]  4.6 [***] [***] 5.6 3.1.6 Reviewer [***]  4.7 [***] [***] 5.7 3.1.7 Reviewer [***]   Clinical       4.8 [***] [***] 5.8 3.2.1 Reviewer [***]  4.9 [***] [***] 5.9 3.2.2 Reviewer [***]  4.10 [***] [***] 5.10 3.2.3 Reviewer [***]  4.11 [***] [***] 5.11 3.2.4 Reviewer [***]  





 






   -15-  92962494_6  Del. #  Deliverable  Description Due Date  Mileston e  Referenc e  SOW  Reference  Government  Role  Data Type/Data  Rights  4.12 [***] [***] 5.12 3.2.5 Reviewer [***]  4.13 [***] [***] 5.13 3.2.6 Reviewer [***]  4.14 [***] [***] 5.14 3.2.7 Reviewer [***]  4.15 [***] [***] 5.15 3.2.8 Reviewer [***]   Non-Clinical       4.16 [***] [***] 5.16 3.3.1 Reviewer [***]  4.17 [***] [***] 5.17 3.3.2 Reviewer [***]  4.18 [***] [***] 5.18 3.3.3 Reviewer [***]  4.19 [***] [***] 5.19 3.3.4 Reviewer [***]  4.20 [***] [***] 5.20 3.3.5 Reviewer [***]  4.21 [***] [***] 5.21 3.3.6 Reviewer [***]  4.22 [***] [***] 5.22 3.3.7 Reviewer [***]  4.23 [***] [***] 5.23 3.3.8 Reviewer [***]  4.24 [***] [***] 5.24 3.3.9 Reviewer [***]  4.25 [***] [***] 5.25 3.3.10 Reviewer [***]  4.26 [***] [***] 5.26 3.3.11 Reviewer [***]  4.27 [***] [***] 5.27 3.3.12 Reviewer [***]   Regulatory Affairs       4.28 [***] [***] 5.28 3.4.1 Reviewer [***]  4.29 [***] [***] 5.29 3.4.2 Reviewer [***]  4.30 [***] [***] 5.30 3.4.3 Reviewer [***]   Project  Management        4.31 [***] [***] 5.31 3.5 Reviewer [***]  4.32 [***] [***] 5.32 3.5.1 Reviewer [***]  4.33 [***] [***] 5.33 3.5.2 Reviewer [***]  4.34 [***] [***] 5.34 3.5.3 Reviewer [***]  4.35 [***] [***] 5.35 3.5.4 Reviewer [***]  4.36 [***] [***] 5.36 3.5.4 Reviewer [***]  4.37 [***] [***] 5.37 3.5.5 Reviewer [***]  4.38 [***] [***] 5.35 N/A Reviewer [***]  TBD [***] [***] Option  1  3.6 Reviewer [***]  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)  





 






   -16-  92962494_6  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 Date  Total Program  Funds   Manufacturing  [***]  5.1 [***] [***] [***]  5.2 [***] [***] [***]  5.3 [***] [***] [***]  5.4 [***] [***] [***]  5.5 [***] [***] [***]  5.6 [***] [***] [***]  5.7 [***] [***] [***]   Clinical  [***]  5.8 [***] [***] [***]  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 [***] [***] [***]  





 






   -17-  92962494_6  Milestone #  Milestone Description  (Deliverable Reference) Due Date  Total Program  Funds  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) $1,747,689,328   Period of Performance (July 6, 2020 – December 31,  2021)  18 Months (Base)   Option 1: Follow-On Production Cost: [***]  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- CoV2373, and other antecedent vaccine programs relevant to Novavax’ proprietary position in the  development of NVX-CoV2373, 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-Cov2373 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  





 






   -18-  92962494_6  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- CoV2373 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.  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:  





 






   -19-  92962494_6  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)1 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:  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                                                    1 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.  





 






   -20-  92962494_6  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  (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:  





 






   -21-  92962494_6  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-CoV2373  vaccine;  ii. necessary FDA regulatory filings or authorizations owned or controlled by  Novavax related to NVX-Cov2373 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.  11.0 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  





 






   -22-  92962494_6  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: TBD  MAILING ADDRESS:   EMAIL:  PHONE:  AGENCY NAME/DIVISION/SECTION: HHS/ASPR/BARDA    





 






  92962494_6  ENCLOSURE 3: (SUPERSEDED)  N/A – this enclosure has been superseded from the original and is no longer applicable.    





 






  Page 1 of 4  FOR OFFICIAL USE ONLY / PROCUREMENT SENSITIVE  92962494_6  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.]