Document:

EXHIBIT 10.2
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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.
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UNDEFINITIZED PROJECT AGREEMENT NO.:                   1
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MCDC BASE AGREEMENT NO.:                    2020-530
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	PROJECT TITLE:
	MCDC2011-0011; Rapid Advanced Development to Large Scale

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	                        Manufacturing of NVX-CoV-2373

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PARTIES:      Advanced Technology International (“MCDC CMF”) and Novavax, Inc. (“Project Agreement Holder”)
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This Undefinitized Project Agreement is awarded under the authority of MCDC Base Agreement No. 2020-530, and herein incorporates all the terms and conditions thereof.
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1.   PAYMENT METHOD
The Payment Method for this Undefinitized Project Agreement is Cost Plus Fixed Fee with a not to exceed ceiling.
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2.   TERM OF THE PROJECT AGREEMENT
The period of performance for this Project Agreement is from the effective date, which is the date of the last signature through December 31, 2021.
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3.   OBLIGATION
The MCDC CMF’s liability to make payments to the Project Agreement Holder is limited to only those funds obligated under this Undefinitized Project Agreement or by modification to the Undefintized Project Agreement. MCDC CMF may incrementally fund this Undefintized Project Agreement.
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4.   UNDEFINITIZED PROJECT AGREEMENT (UPA)
MCDC2011-001 is a Cost Plus Fixed Fee (CPFF) Agreement that will be awarded under W15QKN-16-9-1002 (hereinafter “Agreement”). Due to urgency concerns, this Undefinitized Project Action (UPA) is being issued to the Project Agreement Holder for Rapid (WF10) Advanced Research & Development to Large Scale Manufacturing of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus. The following is hereby incorporated as part of this Agreement.
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1.   DEFINITIZATION:
a)   This Agreement covers a CPFF UPA that awards prototype project MCDC2011-001. The Project Agreement Holder agrees to promptly begin negotiating with the Agreements Officer on the terms of a definitive Agreement for the project, which will include: (1) all mutually agreeable terms and conditions related to this Agreement, and (2) all other terms and conditions required by law. The Project Agreement Holder will be
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required to submit a qualifying cost proposal with all necessary supporting documentation, in order to allow for a full evaluation of costs.
b)   The schedule for definitizing this Agreement is as follows:
i.          Receipt of Qualifying Proposal: 10 September 2020
ii.         Estimated Start of Negotiations: 01 October 2020
iii.        Estimated Date of Definitization: 09 December 2020
c)   The Parties will use best efforts to finalize the definitive agreement. If a definitive Agreement is not finalized to supersede this UPA by the target date in paragraph 2(b)(iii), or within any extension granted in writing by the Agreements Officer, the Agreements Officer may, with the approval of the Army Contracting Command-New Jersey, Senior Contracting Official, unilaterally determine a fair and reasonable price. This determination is subject to Project Agreement Holder appeal, as provided for in the Disputes article of W15QKN-16-9-1002, but the Project Agreement Holder shall not cease performance of this Agreement while proceeding through the dispute process.
d)   After the Agreements Officer’s determination of a fair and reasonable price, the Agreement shall be governed by all of the terms and conditions of the definitive Agreement. Furthermore, all the terms and conditions of this UPA shall continue in effect, except for those that by their nature apply only to UPAs.
e)   The Government and Project Agreement Holder agree that this UPA will include a ceiling in the amount of $1,600,434,522.00. This ceiling may be adjusted only by the written agreement of both parties.
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2.   PAYMENT OF ALLOWABLE COSTS BEFORE DEFINITZATION:
Prior to definitization of this Agreement, the Government will reimburse the Project Agreement Holder for all allowable and allocable costs up to 50% of the approved Not- To-Exceed (NTE) Price of $1,600,434,522.00. At any time before a payment, the Agreements Officer may have the Project Agreement Holder's invoices or vouchers audited. Any payment may be (1) reduced by any amounts found by the Agreements Officer not deemed authorized in accordance with the Statement of Work, or (2) adjusted for overpayments made on preceding invoices or vouchers.
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3.   LIMITATIONS ON OBLIGATIONS:
The Government will not obligate more than 50 percent of the NTE Price before definitization.
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4.   LIMITATION OF GOVERNMENT LIABILITY:
a)   In performance of this Agreement, the Project Agreement Holder is not authorized to make expenditures or incur obligations exceeding $800,217,261.00 dollars.
b)   The maximum amount for which the Government shall be liable if this Agreement is terminated is $800,217,261.00 dollars.
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5.   EXECUTION AND COMMENCEMENT OF WORK:
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Upon acceptance by both parties, the Project Agreement Holder shall proceed with performance of the Statement of Work, including the purchase of any necessary materials.
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5.   MILESTONE PAYMENT SCHEDULE
The Project Agreement Holder shall segregate and track all Undefinitized Project Agreement costs separately and shall document the accomplishments of each Project Payable Milestone under each
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Project Agreement. Acceptance of Milestones shall be contingent upon approval from the government Agreements Officer Representative (AOR) detailed in Clause No. 9, Technical and Administrative Representatives. Milestone payments will be paid in the amount indicated in the attached Milestone Payment Schedule (Attachment A) and are adjustable based on actual expenditures.
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6.   PAYMENT OF FIXED FEE
The fixed fee specified herein, subject to any adjustments required by other provisions of this Undefinitized Project Agreement will be paid in installments at the time of each provisional payment on account of the allowable costs. The amount of fixed fee paid will be based upon the ratio that the Project Agreement Holder's incurred allowable costs bear to the total estimated cost. In the event the work cannot be completed within the estimated cost, the MCDC CMF may increase the estimated cost without increasing the fixed fee.
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7.   APPROACH TO MEETING THE OTHER TRANSACTION AUTHORITY
In accordance with provision contained in 10 USC 2371b governing the use Other Transaction Agreements each MCDC Member Organization must meet at least one of the following conditions: have at least one nontraditional defense contractor or nonprofit research institution participating to a significant extent in the performance of an awarded Project Agreement; all significant participants in the Project Agreement other than the Federal Government are small businesses (including small businesses participating in a program described under section 9 of the Small Business Act (15 U.S.C. 638)) or nontraditional defense contractors; or provide a cost share of no less than one third of the value of the Project Agreement awarded to the Member Organization. The Project Agreement Holder’s approach to meeting the Other Transaction Authority requirement is identified below. Throughout the period of performance of any Project Agreement, the CMF and the Government will actively monitor the award to ensure compliance with this provision in accordance with implementation guidance from Headquarters – Department of the Army (HQDA) and/or Office of the Secretary of Defense (OSD). The Project Agreement Holder will be given the opportunity to become compliant with the guidance should they be found non-compliant. Failure to comply may result in termination.
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The warranties and representations submitted as part of the proposal are hereby incorporated into this Undefinitized Project Agreement. The Project Agreement Holder was proposed as a nontraditional defense contractor and determined to be providing a significant contribution.
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8.   STATEMENT OF WORK
The Statement of Work, Attachment A, provides a detailed description of the work to be accomplished and reports and deliverables required by this Undefinitized Project Agreement. All changes to Attachment A must be incorporated via written modification to this Project Agreement. Additional guidance on report requirements is in Attachment B, Report Requirements.
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9.   TECHNICAL AND ADMINISTRATIVE REPRESENTATIVES
The following technical and contractual representatives of the Parties are hereby designated for this Undefinitized Project Agreement. Either party may change their designated representatives by written notification to the other.
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	MCDC CMF Contractual Representative:
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	[***], Contracts Administrator
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	Advanced Technology International
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	315 Sigma Drive
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	Summerville, SC 29486
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	Email: [***]
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	Phone: [***]
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	Government Technical Representatives:
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	Agreements Officer Representative (AOR):
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	[***]
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	Email: [***]
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	Phone: [***]
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	Project Agreement Holder’s Representatives:
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	Technical Representative:
	Contractual Representative:

	[***]
	[***]

	21 Firstfield Road
	21 Firstfield Road

	Gaithersburg, MD 20878
	Gaithersburg, MD 20878

	Email: [***]
	Email: [***]

	Phone: [***]
	Phone: [***]

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10. MARKING OF DELIVERABLES
Any Data delivered under this Undefinitized Project Agreement, by the Project Agreement Holder, shall be marked with a suitable notice or legend.
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11. SECURITY ADMINISTRATION
The security level for this project is UNCLASSIFIED.
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12. ATTACHMENTS
Attachments listed herein are hereby incorporated by reference into this Project Agreement.
A.  Statement of Work, “Rapid Advanced Development to Large Scale Manufacturing of NVX- CoV-2373”
B.   Report Requirements
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13. GOVERNMENT FURNISHED PROPERTY
At this time, Government Furnished Property is not provided for use under this Project Agreement.
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14. DATA RIGHTS
Please reference Section 8 of Attachment A, Statement of Work.
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15. FOLLOW-ON PRODUCTION PROVISION
In accordance with 10.U.S.C. 2371b(f), and upon a determination that this competitively awarded prototype project has been successfully completed, this prototype project may result in the award
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of a follow-on production contract or transaction without the use of competitive procedures.
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16. SECURITY & OPSEC
The below language shall be used as Paragraph 6 of Article XVII in the Project Agreement Holder's Base Agreement:
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Access and General Protection/Security Policy and Procedures. This standard language text is applicable to ALL Project Agreement Holder 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. Project Agreement Holder employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The Project Agreement Holder 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 Project Agreement Holder 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 Project Agreement Holder security matters or processes.
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17. ENTIRE AGREEMENT
This Project Agreement and the MCDC Base Agreement under which it is issued constitute the entire understanding and agreement between the parties with respect to the subject matter hereof.
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Except as provided herein, all Terms and Conditions of the MCDC Base Agreement and its modifications remain unchanged and in full force and effect.
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The Project Agreement Holder is required to sign this document and return to Advanced Technology International to finalize this action.
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	Novavax, Inc.
	    
	Advanced Technology International

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

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

	Title:
	EVP, Chief Legal Officer
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	Title:
	[***]

	Date:
	06 July 2020
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	Date:
	06 July 2020

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Attachment A
Statement of Work
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This page intentionally left blank. See separate document for Attachment A.
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Attachment B
Report Requirements
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This page intentionally left blank. See separate document for Attachment B.Exhibit 10.3
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.
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	Applied Technologies Center
315 Sigma Drive
Summerville, SC 29486
www.ati.org
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July 8, 2020
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878
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Attention:        [***]
Subject:           Modification No. 01 to Project Agreement No. 01; MCDC2011-001
Reference:       MCDC Base Agreement No. 2020-530
Dear [***]:
THIS MODIFICATION NO. 01 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. 1 (“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)         The Milestone Payment Schedule clause of the Undefinitized Project Agreement is hereby replaced in its entirety as indicated below:
5. MILESTONE PAYMENT SCHEDULE
The parties have established Project milestones to identify key project objectives and measure the progress toward completion of such objectives. The amounts of payments associated with each Milestone are indicated in Section 5 (Milestone Payment Schedule) of Attachment A (Statement of Work), and are adjustable based on actual expenditures. Notwithstanding anything in the Base Agreement, UPA or Attachment A to the contrary, the parties agree that (a) the Project Agreement Holder shall invoice the MCDC CMF on a monthly basis for actual costs incurred by Project
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Agreement Holder in performing activities and tasks for each Milestone under the Project, up to the maximum amount allowable under the applicable Project milestones (as such, maximum amount may be adjusted over time); and (b) Project Agreement Holder shall not be required to complete performance of a Milestone, or receive the MCDC CMF’s acceptance of a Deliverable, to invoice or receive payment from the MCDC CMF each month. To support its invoices, the Project Agreement Holder shall segregate and track all UPA costs separately and shall document its progress towards the accomplishment of each Project milestone under this UPA. Payment to the Project Agreement Holder of a monthly invoice is contingent upon the Project Agreement Holder’s satisfactory performance of tasks and activities towards completion of a Project milestone; acceptance by the MCDC CMF of the Project Agreement Holder’s monthly invoices for payment of amounts under the UPA, shall be contingent upon approval from the Government Agreements Officer’s Representative (AOR) detailed in Clause No. 9, Technical and Administrative Representatives.
2)         Effectiveness of Modification. Except as modified hereby, the UPA shall remain in full force and effect. Capitalized terms used in this Modification and not otherwise defined herein shall have the meanings ascribed to such terms in the UPA or Base Agreement.
3)         Counterparts. This Modification may be executed in separate counterparts, and by facsimile, each of which when so executed and delivered shall be an original and all such counterparts shall together constitute one and the same instrument.
4)         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.
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	Novavax, Inc.
	    
	Advanced Technology International

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

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

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	Title: 
	EVP Chief Legal Officer
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	Title: 
	Contracts Administrator

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	Date: 
	07/09/2020
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	Date: 
	09 Jul 2020 10:56 AM

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Attachment A
Statement of Work
(Incorporated as of Modification No. 01; changes to Section 5 are indicated in bold italics.)
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For
Rapid (WF10) Advanced Research & Development to Large Scale Manufacturing of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus
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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
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1.0       INTRODUCTION, SCOPE, AND OBJECTIVES
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1.1       Introduction
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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).
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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.
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1.2       Definition of the Prototype Project
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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.
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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).
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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
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studies, under an Emergency Use Authorization (EUA), or pursuant to other clearance from the U.S. Food and Drug Administration (FDA).
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Successful completion of the prototype will require three coordinated and integrated lines of effort:
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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.
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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.
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1.3       Follow-on Activity
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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.
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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).
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1.4       Scope
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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:
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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
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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:
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	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*
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*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.
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The scope includes the following activities:
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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.
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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.
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o    Non-clinical
·     Studies to support EUA and regulatory approval (BLA).
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o    Regulatory
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·     EUA submission when data supports it, while maintaining progress toward eventual BLA submission.
·     BLA submission when appropriate.
·     Regulatory support activities (Investigational New Drug (IND) submissions) for manufacturing, clinical, non-clinical studies.
·     Meetings as-needed with regulators.
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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.
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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.
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1.5       Resolution of Conflicting Language
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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.
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2.0       APPLICABLE REFERENCES
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N/A
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3.0       REQUIREMENTS
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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
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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.
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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.
Locations: North America, Europe; may include Africa, Asia, Oceania, South America.
Primary Objectives: Clinical efficacy, safety, immunogenicity.
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Design: Randomized, observer-blinded, placebo-controlled.
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix[***] – dose determined by Phase 2 dose confirmation study, Placebo; [***].
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-[***]; not greater than [***], [***] to allow for rapid initiation. Placebo.  ~0.5 mL dose IM injection, up to 2 doses at Day 0 and Day 21.
Enrollment: TOTAL: N [***] 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-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-[***].
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-[***].
Enrollment: ~600 per cohort, each cohort having [***]. Study size may be adjusted to allow non-inferiority testing.
3.2.6    Subtask: [***]
Study: [***]
Population: [***]
Locations: [***]
Primary Objectives: [***]
Design: Randomized, observer-blinded, placebo-controlled.
Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-[***].
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[***].
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. Immunogenicity [***] in mice for vaccine efficacy profile to comply with FDA guidelines.
​

​
3.3.2    Rhesus Study, Immunogenicity
Study 702-099. Immunogenicity/challenge [***] in rhesus monkeys for vaccine efficacy profile to comply with FDA guidelines.
3.3.3    Hamster Study, Immunogenicity
Study 702-102. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.4    Mouse Study, T-Cell Immunogenicity
Study 702-103. T-cell immunogenicity/challenge study in mice [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.5    Hamster Study, T-Cell Immunogenicity
Study 702-105. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.6    Mouse Study, T-Cell Immunogenicity
Study 702-104. Immunogenicity/challenge study in hamster [***] for vaccine efficacy profile to comply with FDA guidelines.
3.3.7    Non-Clinical Studies: Collaboration with Univ. of Maryland School of Medicine
Three studies to study enhancement/inhibition and neutralization, and virus challenge of vaccinated mice:
1.   Validation of Spike nanoparticles in cell inhibition studies: In vitro inhibition studies on cell line permissive to r2019-nCoV, readout TBD.
2.   Neutralization studies with virus against bleeds from mice, In vitro microneutralization studies on cell line permissive to r2019-nCoV, TCID50 or fluorescence readout (TBD).
3.   Virus challenge of vaccinated mice (mice vaccinated outside and shipped to UM for challenge), Challenge of vaccinated mice (shipped in for infection from Novavax), Lung pathology, Titer, viral Ribonucleic Acid (RNA) quantitation, pathology scoring and reports.
3.3.8    Structural Study of COVID-19 Spike Protein and its Complex with Host Receptor (cooperation with Baylor College of Medicine)
Study to determine the structures of recombinant COVID-19.  Spike protein in nanoparticles used in Novavax’s human vaccine and in complex with its host receptor ACE2. Will obtain a high-resolution cryoEM structure of full-length COVID-19 Spike protein and a high-resolution cryoEM structure of full-length COVID-19 Spike protein in complex with human receptor ACE2.
3.3.9    Neutralizing Assay Histopathology for On-going [***]
Histopathology readings for current neutralization studies in [***]. This will support the safety profile of the vaccine for FDA approval.
3.3.10  Mouse Study, Immunogenicity [***] Studies
Individual immunogenicity studies [***] in mice for vaccine efficacy profile in different sub-populations to comply with FDA guidelines.
​
3.4       Major Task: Regulatory Affairs
Novavax will conduct the regulatory activities below, including BLA prep and submission, and provide the meeting minutes and applications to the USG.
​

​
3.4.1    Subtask: EUA Submission and Supporting Meetings and Regulatory Filings
An EUA will be submitted to the FDA upon obtaining sufficient clinical data. EUA, FDA meetings to support EUA, submission planning support for the Chemistry, Manufacturing, and Controls (CMC) team, EUA strategy and meeting support, and submission preparation support activities, will all be completed.
3.4.2    Subtask: IND Submission Updates and FDA Meetings
This task will include submissions to the IND and possible FDA meetings that will be required prior to the BLA submission.
3.4.3    Subtask: BLA Submission
A BLA will be submitted to the FDA upon obtaining sufficient clinical data, FDA meetings to support BLA, submission planning support for the CMC team, BLA strategy and meeting support, and submission preparation support activities, will all be completed.
​
3.5       Major Task: Project Management and Reporting
3.5.1    Subtask: Kick-Off Meeting and Initial Baseline Review of IMS
Novavax shall conduct a Kick-Off Meeting and an initial review with the USG of the IMS, upon initiation of the program.
3.5.2    Subtask: Biweekly Meetings with OWS
Novavax shall submit the agenda in advance.  Any technical updates shall be provided in advance for the Government team to review.   Minutes shall be submitted after the biweekly meeting to the USG.
3.5.3    Subtask: Written Quarterly Reports
Novavax shall submit quarterly reports to the USG.
3.5.4    Subtask: Written Annual Reports
Novavax shall submit the annual reports to the USG.
3.5.5    Subtask: Written Final Report
Novavax shall submit the final report to the USG.
​
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
	[***]

	4.6
	[***]
	[***]
	5.6
	3.1.6
	Reviewer
	[***]

	4.7
	[***]
	[***]
	5.7
	3.1.7
	Reviewer
	[***]

​
​

​
​
	​

	​

	​

	​

	​

	​

	​

	Del. #
	Deliverable
Description
	Due Date
	Milestone
Reference
	SOW
Reference
	Government
Role
	Data Type/Data Rights

	​
	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
	[***]

	TBD
	[***]
	[***]
	Option 1
	3.6
	Reviewer
	[***]

​
5.0       MILESTONE PAYMENT SCHEDULE
​
	​

	​
​

	

	​

	Milestone #
	Milestone Description
(Deliverable Reference)
	Due Date
	Total Program
Funds

	​
	Manufacturing
	​
	​

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

​
​

​
​
	​

	​
​

	​

	​

	Milestone #
	Milestone Description
(Deliverable Reference)
	Due Date
	Total Program
Funds

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	​
	Clinical
	​
	​

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	​
	Non- Clinical
	​
	​

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	​
	Regulatory Affairs
	​
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	​
	Project Management
	​
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	​
	Advanced Material Purchases 
	​
	​

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	​
	Reservation Fees
	​
	​

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	​
	Acceleration Fees
	​
	​

	[***]
	[***]
	[***]
	[***]

​
​

​
	​

	​
​

	

	​

	Milestone #
	Milestone Description
(Deliverable Reference)
	Due Date
	Total Program
Funds

	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

	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	​

* 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, 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 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:
​
​

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.
​

​
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:
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).
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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:
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​

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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.
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c. This Article shall be incorporated into any contract for follow-on activities for the Government to acquire and use additional doses of the product.  Per section 1.3, the estimated quantity for follow-on production/procurement is approximately 560 million doses.
​
d. This Article will survive the acquisition or merger of the Contractor by or with a third party.  This Article will survive the expiration of this agreement.
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11.       SECURITY
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The security classification level for this effort is UNCLASSIFIED.
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12.0     MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)
​
N/A
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13.0     GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION
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14.0     AGREEMENTS OFFICER’S REPRESENTATIVE (AOR) AND ALTERNATE AOR CONTACT INFORMATION
​
AOR
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NAME: [***]
EMAIL: [***]
PHONE: [***]
AGENCY NAME/DIVISION/SECTION: Joint Program Executive Office, Joint Program Lead-Enabling Biotechnologies
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Alternate AOR
​
NAME: TBD
MAILING ADDRESS:
EMAIL:
PHONE:
AGENCY NAME/DIVISION/SECTION: HHS/ASPR/BARDA
​
​

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ENCLOSURE 3: PAYMENT REQUEST INFORMATION
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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
 
	[***]

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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 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.
​
​

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ENCLOSURE 4: PATENT LISTING
[***]

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