exhibit1042






Exhibit 10.42    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    92635035_6  September 18, 2020  Novavax, Inc.  21 Firstfield Road  Gaithersburg, MD  20878  Attention: Mr. [***]  Subject:  Modification No. 03 to Project Agreement No. 01; MCDC2011-001  Reference: MCDC Base Agreement No. 2020-530  Dear [***]:  THIS MODIFICATION NO. 03 TO UNDEFINITIZED PROJECT AGREEMENT (UPA) NO. 01  (“Modification”) is made effective as of the later date of signature below (the “Modification Effective Date”) by and  between Novavax, Inc. (“Project Agreement Holder”) and Advanced Technology International (“MCDC CMF”).  WHEREAS, Project Agreement Holder and MCDC CMF are parties to that certain Undefinitized Project  Agreement No. 01 (“UPA”) under MCDC Base Agreement No:  2020-530 (“Base Agreement”); and  WHEREAS, Project Agreement Holder and MCDC CMF desire to modify and clarify certain provisions of  the UPA.  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 UPA is amended by this Modification as follows:  DESCRIPTION OF MODIFICATION  1) Attachment A, Statement of Work, is hereby amended to read as attached herein.  2) Attachment D, Clause for MCDC Consortium Other Transaction Authority Agreements Standard  Language OWS for Consortium OTA, is hereby incorporated into the Project Agreement 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.  





 






  92635035_6  Novavax, Inc. Advanced Technology International  By: /s/ John Herrmann III By: /s/ [***]  Name: John Herrmann III Name: [***]  Title: EVP, CLO Title: Contracts Administrator  Date: 09/21/2020 Date: 22 Sep 2020 1:39 PM    





 






  92635035_6  Attachment A  Statement of Work  This page is intentionally left blank.  Please see separate Attachment A.    





 






  1  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  Attachment A  Statement of Work  (Incorporated as of Modification No. 03; changes to Sections 4, 5, and 11 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 (2-8°C).  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).  





 






  2  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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:  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  





 






  3  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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 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.  





 






  4  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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 Monthly 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  





 






  5  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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.  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  





 






  6  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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.  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-M1 - 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-M1 – [***]; 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.  





 






  7  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  Test Product(s); Dose Regimen; Route of Administration:  Vaccine + Matrix-M1; 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-M1 [***].  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-M1; [***].  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.  





 






  8  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  Test Product(s); Dose Regimen; Route of Administration:  Vaccine + Matrix-M1; [***]  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-M1 – [***].  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.  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  





 






  9  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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.  3.4 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.  





 






  10  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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.  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  Milestone  Reference  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 [***]  





 






  11  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  Del. #  Deliverable  Description  Due Date  Milestone  Reference  SOW  Reference  Government  Role  Data  Type/Data  Rights  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 [***]  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 [***]   Regulatory Affairs       4.26 [***] [***] 5.26 3.4.1 Reviewer [***]  4.27 [***] [***] 5.27 3.4.2 Reviewer [***]  4.28 [***] [***] 5.28 3.4.3 Reviewer [***]   Project Management       4.29 [***] [***] 5.29 3.5.1 Reviewer [***]  4.30 [***] [***] 5.30 3.5.2 Reviewer [***]  4.31 [***] [***] 5.31 3.5.3 Reviewer [***]  4.32 [***] [***] 5.32 3.5.4 Reviewer [***]  4.33 [***] [***] 5.33 3.5.4 Reviewer [***]  4.34 [***] [***] 5.34 3.5.5 Reviewer [***]  4.35 [***] [***] 5.35 N/A Reviewer [***]  TBD [***] [***] Option 1 3.6 Reviewer [***]    Note:  Attachment D of the Project Agreement shall be referenced for supplemental security  requirements associated with deliverables under this project.  





 






  12  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  5.0 MILESTONE PAYMENT SCHEDULE  Milestone #  Milestone Description  (Deliverable Reference)  Due Date  Total Program  Funds   Manufacturing    [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]   Clinical     [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]   Non-Clinical    [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]   Regulatory Affairs  $10,362,788  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]   Project Management  $8,303,163  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  





 






  13  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  Milestone #  Milestone Description  (Deliverable Reference)  Due Date  Total Program  Funds  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]   Advanced Material Purchases    [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]   Reservation Fees    [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***]   Acceleration Fees    [***] [***] [***] [***]  Total (Cost Plus Fixed Fee) $1,600,434,522  Period of Performance (July 6, 2020 - December 31, 2021) 18 Months (Base)  Option 1:  Follow-On Production Cost:  [***]    Simplified Table:  Estimated Cost by Project Areas  Area Cost  Manufacturing (100M doses) $418,151,118  Non-Clinical $5,092,957  Clinical $1,158,524,498  Regulatory $10,362,788  Project Management $8,303,163  Total Project Cost $1,600,434,523    Simplified Table:  Selected Estimated Costs for Key Deliverables*  Area Milestone/Deliverable Start Finish Cost  [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***]  





 






  14  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  Area Milestone/Deliverable Start Finish Cost  [***] [***] [***] [***] [***]  [***] [***] [***] [***]    * For key deliverables only; does not encompass total project costs.  ** Time to obtaining vaccine efficacy data.  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  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,  





 






  15  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  the Deliverable shall be deemed and considered to comprise Background IP and shall be used by  the U.S. Government in accordance with this Background IP Limited License.  (c) Background IP License to Novavax.  Subject to the terms of the Project Agreement, the  U.S. Government grants to Novavax a nonexclusive, worldwide, nontransferable, irrevocable,  paid-up license to any intellectual property (including patents and patent applications) to which  the U.S. Government has rights thereto, provided that such license is limited to such intellectual  property rights necessary to perform Novavax’s obligations under the Project Agreement.  7.2 FOREGROUND IP  (a) Ownership.  Notwithstanding anything in the Base Agreement to the contrary, Novavax  owns all rights, title and interest in and to any development, modification, discovery, invention or  improvement, whether or not patentable, conceived, made, reduced to practice, or created in  connection with activities funded under the Project Agreement, including, without limitation, all  data and inventions, and intellectual property rights in any of the foregoing (“Foreground IP”).  (b) Foreground IP Special License.  Subject to the terms of the Project Agreement, Novavax  grants the U.S. Government a nonexclusive, worldwide, nontransferable, irrevocable, paid-up  license to practice or have practiced the Foreground IP for or on behalf of the U.S. Government  (“Foreground IP Special License”).  8.0 DATA RIGHTS  Article XI, §11.03 of the Base Agreement is hereby amended, consistent with the “Specifically Negotiated  License Rights” capability at Article XI, §§11.01(12) and 11.03(4), as follows:  8.1 Data Ownership.  Novavax owns all rights, title and interest to all Data (as defined in Article XI, Section 11.01(7) of  the Base Agreement) generated as a result of the work performed under this Project Agreement, including  Subject Data.  8.2 Rights to Data.  (a) Subject Data.  Subject to the terms of the Project Agreement, Novavax grants to the U.S.  Government a Government purpose rights license to Subject Data that will convert to an unlimited  rights license (as the term is defined in Article XI, Section 11.01(14) of the Base Agreement)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                                                        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.  





 






  16  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  requesting party within two weeks of the request, except to the extent that such Data are subject to  a claim of confidentiality or privilege by a third party.  (c) Background IP Limited License.  To the extent that Subject Data incorporates or uses  Background IP, the data shall be deemed and considered to comprise Background IP and shall be  used by the U.S. Government in accordance with the Background IP Limited License set forth in  Section 7.3 above.  8.3 Background Technical Data Rights Assertions.  Novavax asserts background technical data rights as follows:  The Background Data, as defined in Section 7.1 above, was developed through private funding or  in collaboration with a funding partner other than the U.S. Government.  Such funding is expected to  continue; accordingly, Novavax asserts Background Data as Category A Data pursuant to section 11.02(1)  of the Base Agreement and the U.S. Government shall have no rights therein.  9.0 REGULATORY RIGHTS  This agreement includes research with an investigational drug, biologic or medical device that is regulated  by the U.S. Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance  before commercial marketing may begin.  It is expected that this agreement will result in the FDA  authorization, clearance and commercialization of NVX-CoV-2373 as a Vaccine for SARS-CoV-2  Coronavirus (the “Technology”).  Novavax is the Sponsor of the Regulatory Application (an investigational  new drug application (IND), investigational device exemption (IDE), emergency use authorization (EUA),  new drug application (NDA), biologics license application (BLA), premarket approval application (PMA),  or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted to the FDA) that  controls research under this contract.  As the Sponsor of the Regulatory Application to the FDA (as the  terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812  Subpart C, or 814.20), Novavax has certain standing before the FDA that entitles it to exclusive  communications related to the Regulatory Application.  This clause protects the return on research and  development investment made by the U.S. Government in the event of certain regulatory product  development failures related to the Technology.  Novavax agrees to the following:  a. Communications.  Novavax will provide the U.S. Government with all communications and  summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that  the U.S. Government representatives are invited to participate in any formal or informal Sponsor meetings  with FDA;  b. Rights of Reference.  The U.S. Government is hereby granted a right of reference as that term is  defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous applicable law recognized outside of  the U.S.) to any Regulatory Application submitted in support of the statement of work for the Project  Agreement.  When it desires to exercise this right, the U.S. Government agrees to notify Novavax in writing  describing the request along with sufficient details for Novavax to generate a letter of cross-reference for  the U.S. Government to file with the appropriate FDA office.  The U.S. Government agrees that such letters  of cross-reference may contain reporting requirements to enable Novavax to comply with its own  pharmacovigilance reporting obligations to the FDA and other regulatory agencies.  Nothing in this  paragraph reduces the U.S. Government’s data rights as articulated in other provisions of the Project  Agreement.  





 






  17  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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 law to its maximal potential under this Project Agreement.  Novavax shall submit a mutually agreed  upon Public Law 115-92 Sponsor Authorization Letter to the U.S. Government within 30 days of award.  10.0 ENSURING SUFFICIENT SUPPLY OF THE PRODUCT  a. In recognition of the Government’s significant funding for the development and manufacturing of  the product in this Project Agreement and the Government’s need to provide sufficient quantities of a safe  and effective COVID-19 vaccine to protect the United States population, the Government shall have the  remedy described in this section to ensure sufficient supply of the product to meet the needs of the public  health or national security.  This remedy is not available to the Government unless and until both of the  following conditions are met:  i. Novavax gives written notice, required to be submitted to the Government no later  than 15 business days, of:  a. any formal management decision to terminate manufacturing of the  NVX-CoV-2373 vaccine prior to delivery of 100 million doses to USG;  b. any formal management decision to discontinue sale of the  NVX-CoV-2373 vaccine to the Government prior to delivery of 100  million doses to USG; or  c. any filing that anticipates Federal bankruptcy protection; and  ii. Novavax has submitted an Emergency Use Authorization under §564 of the FD&C  Act or a biologics license application 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.  





 






  18  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  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  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         





 






  19  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  ENCLOSURE 3:  PAYMENT REQUEST INFORMATION  Novavax, Inc. is requesting a payment upon incurring costs, for a total of [***] to support the development  of NVX-CoV2373 as a vaccine for SARS-CoV-2 Coronavirus.  The costs, as outlined below, are  incorporated into estimates from subcontractors under milestones associated with manufacture.  Novavax  will work with subcontractors to ensure the appropriate accounting for pre-award costs during subcontract  finalization and subsequent billing.  Projected Expenditures  Cost Element Task/Purpose Amount  Materials  Antigen [***] [***]  Adjuvant [***] [***]  Adjuvant [***] [***]  Reservations Fees  AGC Bio Seattle [***] [***]  PolyPeptide [***] [***]  Fuji RTP [***] [***]  Fuji Texas [***] [***]  Acceleration Fee  Fuji [***] [***]  Subtotal  [***]      Indirect + Fee Burden  [***]  Total Requested Amount [***]    I. Financial Institution Information   Novavax, Inc.   21 Firstfield Road   Gaithersburg, MD  20878   Name of Bank: [***]   Address: [***]    [***]   ABA #:  [***], Checking Account #:  [***]   Swift:  [***]    II. Justification for Requesting the Payment   Materials Costs:  - [***] Direct Costs  Procurement and qualification of critical long lead raw materials needed to produce 100M  doses of NVX-CoV-2373 in 2020 and to ensure availability of 100M additional doses of  NVX-CoV-2373 in 2021.  This also includes materials for the purchase of a stockpile of  certain critical long lead raw materials for the Matrix-M Adjuvant, necessary to rapidly  





 






  20  FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE  92635035_6  initiate large-scale manufacturing without a delay.  This will ensure timely availability of  the vaccine candidate to the US population when needed, a primary mission of HHS in  support of OWS.   Reservation and Acceleration Fees:  - [***] Direct Costs  To quickly address the urgent need presented by the COVID-19 pandemic, Novavax will  rely on the reservation of dedicated capacity from manufacturing service provides to be  able to produce NVX-CoV-2373.  This will ensure timely availability of the vaccine  candidate to the US population when needed, a primary mission of HHS in support of  OWS.    





 






  92635035_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.]    





 






  92635035_6  Attachment D  Clause for MCDC Consortium Other Transaction Authority Agreements Standard Language OWS  for Consortium OTA  This page is intentionally left blank.  Please see separate Attachment D.    





 






  92635035_6    Attachment D  Clause for MCDC Consortium Other Transaction Authority Agreements  Standard Language OWS for Consortium OTA  (Incorporated as of Modification No. 03)  Required MCDC Base Agreement Modifications  The Medical CBRN Consortium (MCDC) Base Agreement, Article XVII, SECURITY & OPSEC shall  apply to this Project Agreement.  In addition, the below language shall replace Paragraph 6 of Article XVII  of the MCDC Base Agreement, in regard to this Project Agreement.  (6) Access and General Protection/Security Policy and Procedures.  This standard language text is  applicable to ALL PAH employees working on critical program information or covered defense information  related to Operation Warp Speed (OWS), and to those with an area of performance within an Army  controlled installation, facility or area.  PAH employees shall comply with applicable installation, facility  and area commander installation/facility access and local security policies and procedures (provided by  government representative).  The PAH also shall provide all information required for background checks  necessary to access critical program information or covered defense information related to OWS, and to  meet installation access requirements to be accomplished by installation Provost Marshal Office, Director  of Emergency Services or Security Office.  The PAH workforce must comply with all personal identity  verification requirements as directed by DOD, HQDA and/or local policy.  In addition to the changes  otherwise authorized by the changes clause of this agreement, should the Force Protection Condition  (FPCON) at any individual facility or installation change, the Government may require changes in PAH  security matters or processes.  Required SOW Language for Deliverables  (in body of SOW or Deliverables Section)  Information Security  Classification guidance for Operation Warp Speed - The security level for this agreement is  UNCLASSIFIED. “Controlled technical information,” “covered contractor information system,” “covered  defense information,” “cyber incident,” “information system,” and “technical information” are defined in  DFARS Clause 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting.    Personnel Security  In addition to the industry standards for employment background checks, Novavax must be willing to have  key individuals, in exceptionally sensitive positions, identified for additional vetting by the United States  Government.  Supply Chain Resiliency Plan  Novavax shall develop and submit within [***] after execution of this Modification [#3], a comprehensive  Supply Chain Resiliency Program that provides identification and reporting of critical components  associated with the secure supply of drug substance, drug product, and work-in-process through to finished  goods.  a) A critical component is defined as any material that is essential to the product or the  manufacturing process associated with that product.  Included in the definition are  





 






  92635035_6  consumables and disposables associated with manufacturing.  NOT included in the  definition are facility and capital equipment.  Consideration of critical components includes the evaluation and potential impact of raw materials,  excipients, active ingredients, substances, pieces, parts, software, firmware, labeling, assembly, testing,  analytical and environmental componentry, reagents, or utility materials which are used in the  manufacturing of a drug, cell banks, seed stocks, devices and key processing components and equipment.   A clear example of a critical component is one where a sole supplier is utilized.  Novavax shall identify key equipment suppliers, their locations, local resources, and the associated control  processes at the time of award.  This document shall address planning and scheduling for active  pharmaceutical ingredients, upstream, downstream, component assembly, finished drug product and  delivery events as necessary for the delivery of product.  a) Communication for these requirements shall be updated as part of an annual review, or as  necessary, as part of regular contractual communications.  b) For upstream and downstream processing, both single-use and re-usable in-place  processing equipment, and manufacturing disposables also shall be addressed.  For finished  goods, the inspection, labeling, packaging, and associated machinery shall be addressed  taking into account capacity capabilities.  c) The focus on the aspects of resiliency shall be on critical components and aspects of  complying with the contractual delivery schedule.  Delivery methods shall be addressed,  inclusive of items that are foreign-sourced, both high and low volume, which would  significantly affect throughput and adherence to the contractually agreed deliveries.  Novavax shall articulate in the plan, the methodology for inventory control, production planning,  scheduling processes and ordering mechanisms, as part of those agreed deliveries.  a) Production rates and lead times shall be understood and communicated to the  Contracting/Agreement Officer or the Contracting/Agreement Officer’s Representative as  necessary.  b) Production throughput critical constraints should be well understood by activity and by  design, and communicated to contractual personnel.  As necessary, communication should  focus on identification, exploitation, elevation, and secondary constraints of throughput, as  appropriate.  Reports for critical items should include the following information:  a) Critical Material  b) Vendor  c) Supplier, Manufacturing / Distribution Location  d) Supplier Lead Time  e) Shelf Life  f) Transportation / Shipping restrictions  The CO and COR reserve the right to request un-redacted copies of technical documents, during the period  of performance, for distribution within the Government.  Documents shall be provided within [***] after  CO issues the request in writing.  Novavax may arrange for additional time if deemed necessary, and agreed  to by the CO.  





 






  92635035_6  Manufacturing Data Requirements:  Novavax shall submit within [***] after execution of this Modification [#3], detailed data regarding project  materials, sources, and manufacturing sites, including but not limited to:  physical locations of sources of  raw and processed material by type of material; location and nature of work performed at manufacturing,  processing, and fill/finish sites; and location and nature of non-clinical and clinical studies sites.  The  Government may provide a table in tabular format for Novavax, to be used to submit such data which would  include but not be limited to the following:   Storage/inventory of ancillary materials (vials, needles, syringes, etc.)   Shipment of ancillary materials (vials, needles, syringes, etc.)   Disposal of ancillary materials (vials, needles, syringes, etc.)   Seed development or other starting material manufacturing   Bulk drug substance and/or adjuvant production   Fill, finish, and release of product or adjuvant   Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant   Stability information of bulk substance and/or finished product   Shipment of bulk substance of final product   Disposal of bulk substance or final product  Product Development Source Material and Manufacturing Reports and Projections:  Novavax shall submit a detailed spreadsheet regarding critical project materials that are sourced from a  location other than the United States, sources, and manufacturing sites, including but not limited to:   physical locations of sources of raw and processed material by type of material; location and nature of work  performed at manufacturing sites; and location and nature of non-clinical and clinical study sites.  Novavax will provide manufacturing reports and manufacturing dose tracking projections/actuals utilizing  the “COVID-19 Dose Tracking Templates”, on any contract/agreement that is manufacturing product   Novavax will submit Product Development Source Material Report  o Within [***] of execution of this Modification [#3]   o Within [***] of substantive changes are made to sources and/or materials  o Or on the [***] contract anniversary.   Novavax will update the Dose Tracking Template [***] during manufacturing campaigns  and daily during response operations (where a Public Health Emergency has been declared)  and COVID-19 response, with the first deliverable submission within [***] of this  Modification [#3].  Updates to be provided weekly in advance of commercial-scale  manufacturing and daily once material for use in response operations begins manufacture   The Government will provide written comments to the Product Development Source  Material and Manufacturing Report within [***] after the submission   If corrective action is recommended, Novavax must address all concerns raised by the  Government in writing  Novavax Locations:  Novavax shall submit detailed data regarding locations where work will be performed under this contract,  including addresses, points of contact, and work performed per location, to include sub-contractors.  Contractor will submit Work Locations Report:   Within [***] of execution of this Modification [#3]  





 






  92635035_6   Within [***] after a substantive location or capabilities change   Within [***] of a substantive change if the work performed supports medical  countermeasure development that addresses a threat that has been declared a Public Health  Emergency by the HHS Secretary or a Public Health Emergency of International Concern  (PHEIC) by the WHO  Required SOW Language for Security Section  This project requires an OPSEC Plan and a Security Plan.  Novavax shall develop a comprehensive security program that provides overall protection of personnel,  information, data, and facilities associated with fulfilling the Government requirement.  This plan shall  establish security practices and procedures that demonstrate how Novavax will meet and adhere to the  security requirements outlined below prior to the commencement of product manufacturing, and shall be  delivered to the Government within [***] of execution of this Modification [#3].  Novavax shall provide a  Risk Assessment to evaluate which subcontractors, consultants, researchers, etc. performing work on behalf  of this effort, are required to comply with all Operation Warp Speed and Project Agreement security  requirements and prime contractor security plans.  a) The Government will review the plan and Risk Assessment in detail and submit comments  within [***] to the Contracting Officer (CO) to be forwarded to Novavax.  Novavax shall  review the Draft Security Plan comments, and, submit a Final Security Plan to the U.S.  Government within [***] after receipt of the comments.  b) The Security Plan shall include a timeline for compliance of all the required security  measures outlined by the Government.  c) Upon completion of initiating all security measures, Novavax shall supply to the  Contracting Officer a letter certifying compliance to the elements outlined in the Final  Security Plan.  d) The OPSEC plan will include identifying the critical information related to this contract,  why it needs to be protected, where it is located, who is responsible for it, and how to  protect it.  At a minimum, the Final Security Plan shall address the following items:  Security Requirements:  1. Facility Security Plan  Description:  As part of the partner facility’s overall security program, Novavax shall submit a written  security plan with their proposal to the Agreement Officer for review and approval by Operation Warp  Speed security subject matter experts.  The performance of work under the Project Agreement will be  in accordance with the approved security plan.  The security plan will include the following processes  and procedures at a minimum:  Security Administration  organization chart and responsibilities   written security risk assessment for site   threat levels with identification matrix (High, Medium, or  Low)   enhanced security procedures during elevated threats   liaison procedures with law enforcement   annual employee security education and training program  





 






  92635035_6  Personnel Security  policies and procedures   candidate recruitment process   background investigations process   employment suitability policy   employee access determination   rules of behavior/ conduct   termination procedures   non-disclosure agreements  Physical Security Policies  and Procedures   internal/external access control   protective services   identification/badging   employee and visitor access controls   parking areas and access control   perimeter fencing/barriers   product shipping, receiving and transport security  procedures   facility security lighting   restricted areas   signage   intrusion detection systems   alarm monitoring/response   closed circuit television   product storage security   other control measures as identified  Information Security  identification and marking of sensitive information   access control   storage of information   document control procedures   retention/ destruction requirements  Information  Technology/Cyber  Security Policies and  Procedures   intrusion detection and prevention systems   threat identification   employee training (initial and annual)   encryption systems   identification of sensitive information/media   password policy (max days 90)   lock screen time out policy (minimum time 20 minutes)   removable media policy   laptop policy   removal of IT assets for domestic/foreign travel  





 






  92635035_6   access control and determination   VPN procedures   WiFi and Bluetooth disabled when not in use   system document control   system backup   system disaster recovery   incident response   system audit procedures   property accountability  2. Site Security Master Plan  Description:  The partner facility shall provide a site schematic for security systems which includes:   main access points; security cameras; electronic access points; IT Server Room; Product Storage  Freezer/Room; and bio-containment laboratories.     3. Site Threat / Vulnerability / Risk Assessment  Description:  The partner facility shall provide a written risk assessment for the facility addressing:   criminal threat, including crime data; foreign/domestic terrorist threat; industrial espionage; insider  threats; natural disasters; and potential loss of critical infrastructure (power/water/natural gas, etc.) This  assessment shall include recent data obtained from local law enforcement agencies.  The assessment  should be updated annually.     4. Physical Security  Description:  Closed Circuit Television  (CCTV) Monitoring  a) Layered (internal/external) CCTV coverage with time-lapse  video recording for buildings and areas where critical assets  are processed or stored.  b) CCTV coverage must include entry and exits to critical  facilities, perimeters, and areas within the facility deemed  critical to the execution of the contract.  c) Video recordings must be maintained for a minimum of 30  days.  d) CCTV surveillance system must be on emergency power  backup.  e) CCTV coverage must include entry and exits to critical  facilities, perimeters, and areas within the facility deemed  critical to the execution of the contract.  f) Video recordings must be maintained for a minimum of 30  days.  g) CCTV surveillance system must be on emergency power  backup.  Facility Lighting a) Lighting must cover facility perimeter, parking areas, critical  infrastructure, and entrances and exits to buildings.  b) Lighting must have emergency power backup.  





 






  92635035_6  c) Lighting must be sufficient for the effective operation of the  CCTV surveillance system during hours of darkness.  Shipping and Receiving a) Must have CCTV coverage and an electronic access control  system.  b) Must have procedures in place to control access and  movement of drivers picking up or delivering shipments.  c) Must identify drivers picking up Government products by  government issued photo identification.  Access Control a) Must have an electronic intrusion detection system with  centralized monitoring.  b) Responses to alarms must be immediate and documented in  writing.  c) Employ an electronic system (i.e., card key) to control access  to areas where assets critical to the contract are located  (facilities, laboratories, clean rooms, production facilities,  warehouses, server rooms, records storage, etc.).  d) The electronic access control should signal an alarm  notification of unauthorized attempts to access restricted  areas.  e) Must have a system that provides a historical log of all key  access transactions and kept on record for a minimum of 12  months.  f) Must have procedures in place to track issuance of access  cards to employees and the ability to deactivate cards when  they are lost or an employee leaves the company.  g) Response to electronic access control alarms must be  immediate and documented in writing and kept on record for a  minimum of 12 months.  h) Should have written procedures to prevent employee  piggybacking access  i) to critical infrastructure (generators, air handlers, fuel storage,  etc.) should be controlled and limited to those with a  legitimate need for access.  j) Must have a written manual key accountability and inventory  process.  k) Physical access controls should present a layered approach to  critical assets within the facility.  Employee/Visitor  Identification  a) Should issue company photo identification to all employees.  b) Photo identification should be displayed above the waist  anytime the employee is on company property.  c) Visitors should be sponsored by an employee and must  present government issued photo identification to enter the  property.  d) Visitors should be logged in and out of the facility and should  be escorted by an employee while on the premises at all times.  





 






  92635035_6  Security Fencing Requirements for security fencing will be determined by the criticality of  the program, review of the security plan, threat assessment, and onsite  security assessment.  Protective Security Forces Requirements for security officers will be determined by the criticality of  the program, review of the security plan, threat assessment, and onsite  security assessment.  Protective Security Forces  Operations  a) Must have in-service training program.  b) Must have Use of Force Continuum.  c) Must have communication systems available (i.e., landline on  post, cell phones, handheld radio, and desktop computer).  d) Must have Standing Post Orders.  e) Must wear distinct uniform identifying them as security  officers.  5. Security Operations  Description:  Information Sharing a) Establish formal liaison with law enforcement.  b) Meet in person at a minimum annually.  Document meeting  notes and keep them on file for a, minimum of 12 months.   POC information for LE Officer that attended the meeting  must be documented.  c) Implement procedures for receiving and disseminating threat  information.  Training a) Conduct new employee security awareness training.  b) Conduct and maintain records of annual security awareness  training.  Security Management a) Designate a knowledgeable security professional to manage  the security of the facility.  b) Ensure subcontractor compliance with all Government  security requirements.  6. Personnel Security  Description:  Records Checks Verification of social security number, date of birth, citizenship,  education credentials, five-year previous employment history, five-year  previous residence history, FDA disbarment, sex offender registry, credit  check based upon position within the company; motor vehicle records  check as appropriate; and local/national criminal history search.  Hiring and Retention  Standards  a) Detailed policies and procedures concerning hiring and  retention of employees, employee conduct, and off boarding  procedures.  b) Off Boarding procedures should be accomplished within 24  hour of employee leaving the company.  This includes  termination of all network access.  





 






  92635035_6  7. Information Security  Description:  Physical Document  Control  a) Applicable documents shall be identified and marked as  procurement sensitive, proprietary, or with appropriate  government markings.  b) Sensitive, proprietary, and government documents should be  maintained in a lockable filing cabinet/desk or other storage  device and not be left unattended.  c) Access to sensitive information should be restricted to those  with a need to know.  Document Destruction Documents must be destroyed using approved destruction measures (i.e.,  shredders/approved third party vendors / pulverizing / incinerating).  8. Information Technology & Cybersecurity  Description:  Identity Management a) Physical devices and systems within the organization are  inventoried and accounted for annually.  b) Organizational cybersecurity policy is established and  communicated.  c) Asset vulnerabilities are identified and documented.  d) Cyber threat intelligence is received from information sharing  forums and sources.  e) Threats, vulnerabilities, likelihoods, and impacts are used to  determine risk.  f) Identities and credentials are issued, managed, verified,  revoked, and audited for authorized devices, users and  processes.  g) Users, devices, and other assets are authenticated (e.g.,  single-factor, multifactor) commensurate with the risk of the  transaction (e.g., individuals’ security and privacy risks and  other organizational risks)  Access Control a) Limit information system access to authorized users.  b) Identify information system users, processes acting on behalf  of users, or devices and authenticate identities before allowing  access.  c) Limit physical access to information systems, equipment, and  server rooms with electronic access controls.  d) Limit access to/ verify access to use of external information  systems.  Training a) Ensure that personnel are trained and are made aware of the  security risks associated with their activities and of the  applicable laws, policies, standards, regulations, or procedures  related to information technology systems.  Audit and Accountability a) Create, protect, and retain information system audit records to  the extent needed to enable the monitoring, analysis,  investigation, and reporting of unlawful, unauthorized, or  





 






  92635035_6  inappropriate system activity.  Records must be kept for  minimum must be kept for 12 months.  b) Ensure the actions of individual information system users can  be uniquely traced to those users.  c) Update malicious code mechanisms when new releases are  available.  d) Perform periodic scans of the information system and real  time scans of files from external sources as files are  downloaded, opened, or executed.  Configuration  Management  a) Establish and enforce security configuration settings.  b) Implement sub networks for publically accessible system  components that are physically or logically separated from  internal networks.  Contingency Planning a) Establish, implement, and maintain plans for emergency  response, backup operations, and post-disaster recovery for  information systems to ensure the availability of critical  information resources at all times.  Incident Response a) Establish an operational incident handling capability for  information systems that includes adequate preparation,  detection, analysis, containment, and recovery of  cybersecurity incidents.  Exercise this capability annually.  Media and Information  Protection  a) Protect information system media, both paper and digital.  b) Limit access to information on information systems media to  authorized users.  c) Sanitize and destroy media no longer in use.  d) Control the use of removable media through technology or  policy.  Physical and  Environmental Protection  a) Limit access to information systems, equipment, and the  respective operating environments to authorized individuals.  b) Intrusion detection and prevention system employed on IT  networks.  c) Protect the physical and support infrastructure for all  information systems.  d) Protect information systems against environmental hazards.  e) Escort visitors and monitor visitor activity.  Network Protection Employ intrusion prevention and detection technology with immediate  analysis capabilities.  9. Transportation Security  Description:  Adequate security controls must be implemented to protect materials while in transit from  theft, destruction, manipulation, or damage.  Drivers a) Drivers must be vetted in accordance with the Government  Personnel Security Requirements.  b) Drivers must be trained on specific security and emergency  procedures.  c) Drivers must be equipped with backup communications.  





 






  92635035_6  d) Driver identity must be 100 percent confirmed before the  pick-up of any Government product.  e) Drivers must never leave Government products unattended,  and two drivers may be required for longer transport routes or  critical products during times of emergency.  f) Truck pickup and deliveries must be logged and kept on  record for a minimum of 12 months.  Transport Routes a) Transport routes should be pre-planned and never deviated  from except when approved or in the event of an emergency.  b) Transport routes should be continuously evaluated based upon  new threats, significant planned events, weather, and other  situations that may delay or disrupt transport.  Product Security a) Government products must be secured with tamper resistant  seals during transport, and the transport trailer must be locked  and sealed.   Tamper resistant seals must be verified as “secure”  after the product is placed in the transport vehicle.  b) Government products should be continually monitored by  GPS technology while in transport, and any deviations from  planned routes should be investigated and documented.  c) Contingency plans should be in place to keep the product  secure during emergencies such as accidents and transport  vehicle breakdowns.  10. Security Reporting Requirements  Description:  The partner facility shall notify the Agreement Officer within 24 hours of any activity or  incident that is in violation of established security standards or indicates the loss or theft of government  products.  The facts and circumstances associated with these incidents will be documented in writing  for government review.     11. Security Audits  Description:  The partner facility agrees to formal security audits conducted at the discretion of the  government.  Security audits may include both prime and subcontractor.