Exhibit 10.1


 


[**] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request.


An unredacted version of this exhibit has been
filed separately with the Commission.


 


		


 


GRANT AGREEMENT


Investment ID OPP1127647


 


AGREEMENT SUMMARY & SIGNATURE PAGE


 


	GRANTEE INFORMATION


 


	Name:	 	Novavax, Inc.
	Tax Status:	 	Not exempt from federal income tax under U.S. IRC § 501(c)(3). You confirm that the above information is correct and agree to notify the Foundation immediately of any change.
	Expenditure Responsibility:	 	This Grant Agreement is subject to "expenditure responsibility" requirements under the U.S. Internal Revenue Code.
	Mailing Address:	 	
        20 Firstfield Road

        Gaithersburg, MD, 20878

	Primary Contact:	 	Russell Wilson, Senior Vice President, Business Development, rwilson@novavax.com


 


	FOUNDATION INFORMATION


 


	Mailing Address:	 	P. O. Box 23350, Seattle, WA 98102, U.S.A.
	Primary Contact:	 	
        Niteen Wairagkar, Senior Program Officer, Pneumonia

        Niteen.Wairagkar@gatesfoundation.org



 


	AGREEMENT INFORMATION


 


	Title:	 	Advancing the development of a maternally-administered RSV vaccine candidate to licensure and WHO prequalification
	"Charitable Purpose":	 	To advance to WHO Pre-Qualification the development of a respiratory syncytial virus (RSV) vaccine for maternal immunization to reduce the burden of RSV disease in infants less than six months of age in developing countries.
	"Start Date":	 	Date of last signature
	"End Date":	 	December 31, 2021
	This Grant Agreement includes and incorporates by this reference:	 	
        This Grant Agreement Summary & Signature Page and:

        ● Grant Amount and Reporting & Payment Schedule
        (Attachment A)

        ● Terms and Conditions (Attachment B)

        ● Project Governance Plan (Appendix C)

        ● Global Access Commitments Agreement (“GACA”)
        (Attachment D)

        ● Proposal Narrative (date submitted September 8,
        2015)

        ● Budget (date submitted June 22, 2015)

        ● Vaccine – Target Product Profile (date submitted
        June 17, 2015)

        ● Integrated Product Development Plan (IPDP) (date
        submitted May 29, 2015)

        ● IPDP Executive Summary (updated September 10,
        2015)

        ● Product Development (PD) Workbook (date submitted
        June 17, 2015)

        ● Investment Guidelines (date submitted July 23,
        2015)



 




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[**] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request.


An unredacted version of this exhibit has been
filed separately with the Commission.


 


THIS AGREEMENT is between Novavax,
Inc. ("You" or "Grantee") and the Bill & Melinda Gates Foundation ("Foundation"),
and is effective as of the date of last signature. Each party to the Agreement may be referred to individually as a "Party"
and together as the "Parties." As a condition of this grant, the Parties enter into this Agreement by having their
authorized representatives sign below.


 


	BILL & MELINDA GATES FOUNDATION	 	NOVAVAX, INC.
	 	 	 
	/s/ Sue Desmond-Hellmann	 	/s/ Stanley C. Erck
	 	 	 
	Sue Desmond-Hellmann	 	Stanley Erck
	Chief Executive Officer	 	President and Chief Executive Officer
	 	 	 
	September 18, 2015	 	September 25, 2015
	 	 	 
	Date	 	Date


 


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[**] = Portions of this exhibit have been omitted
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filed separately with the Commission.


 


GRANT AGREEMENT


Investment ID OPP1127647


 


ATTACHMENT A


GRANT AMOUNT AND REPORTING & PAYMENT SCHEDULE


 


GRANT AMOUNT


The Foundation will pay You up to the total
grant amount specified in the Reporting & Payment Schedule below. The Foundation’s Primary Contact must approve in writing
any Budget cost category change of more than 10%.


 


PAYMENTS


The Foundation will make payments according
to the Reporting & Payment Schedule and, where specified, contingent on Your completion of the applicable target, milestone,
or reporting deliverable as well as compliance with this Grant Agreement and the Global Access Commitments Agreement. The Foundation
may approve changes to the schedule from time to time, and will confirm any such changes in writing. Specific subsequent payment
amounts will be decided by the Foundation, based upon actual financial information reported to the Foundation in Expenditure Responsibility
reports.


 


REPORTING


You will submit reports according to the Reporting
& Payment Schedule using the Foundation's templates or forms, which the Foundation will make available to You and which may
be modified from time to time. For a progress or final report to be considered satisfactory, it must demonstrate meaningful progress
against the targets or milestones for that investment period. If meaningful progress has not been made, the report should explain
why not and what adjustments You are making to get back on track. Please notify the Foundation's Primary Contact if You need to
add or modify any targets or milestones. The Foundation must approve any such changes in writing. You agree to submit other reports
the Foundation may reasonably request.


 


ACCOUNTING FOR PERSONNEL TIME


You agree to track the time of all employees,
contingent workers, and any other compensated individuals whose compensation will be paid in part by Grant Funds. Such individuals
will keep timesheets that will track actual time worked on the Project in increments of sixty minutes or less and will include
brief descriptions of tasks performed. You will report actual time worked consistent with those timesheets in Your progress and
final budget reports. You will submit copies of timesheets to the Foundation upon request.


 


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[**] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request.


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filed separately with the Commission.


 


REPORTING & PAYMENT SCHEDULE


 


	Investment


Period	 	Target, Milestone, or 

Reporting Deliverable	 	
        

        Due By
	 	
        Payment Date
	 	Payment

 Amount (U.S.$)
	—	 	Countersigned Grant Agreement and Global Access Commitments Agreement	 	—	 	[**]	 	[**]
	 	 	 	 	 	 	 	 	 
	[**]	 	
        Go/No-Go Milestone 1:

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


 


 






1 The results of the Go/No-Go Milestone
are expected to be available by the due date listed above. For this and all other Stage Gates, the Foundation will then determine,
in its sole discretion, whether to provide continued funding under this Grant Agreement. If the Foundation determines that it will
not provide continued funding for the remainder of the proposed work, the Project will be terminated. To the extent that there
is any inconsistency between the Proposal and the Grant Agreement on this issue, the Grant Agreement shall govern.


 




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	[**]	 	[**]	 	[**]	 	[**]	 	[**]
	 	 	 	 	 	 	 	 	 
	[**]	 	[**]	 	[**]	 	[**]	 	[**]
	 	 	 	 	 	 	 	 	 
	[**]	 	[**]	 	[**]	 	[**]	 	[**]
	 	 	 	 	 	 	 	 	 
	[**]	 	[**]	 	[**]	 	[**]	 	[**]
	 	 	 	 	 	 	 	 	 
	[**]	 	[**]	 	[**] days of End Date	 	—	 	—
	 	 	 	 	 	 	 	 	 
	 	 	 	 	Total Grant Amount	 	Up to $89,083,312.00


 


UPDATES TO REPORTING & PAYMENT
SCHEDULE


You acknowledge and agree that all
payments under this grant are subject to your achievement of any go/no-go milestones, the Foundation’s approval of the Milestones,
Deliverables and Reports in Reporting & Payment Schedule, compliance with the Global Access Commitments Agreement set forth
at Attachment D and your compliance with this Grant Agreement (including any Attachments, Appendices or Schedules). From time to
time the Foundation may update the Payment & Reporting Schedule to reflect actual payments and/or update payment dates or milestones,
and you agree to cooperate to revise this Grant Agreement accordingly as well as execute an amendment to this Grant Agreement reflecting
any such changes. If requested by the Foundation, You agree to update Your proposal narrative, budget and/or other Project documentation
(including IPDP) to reflect activities under the Project.


 




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[**] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request.


An unredacted version of this exhibit has been
filed separately with the Commission.


 


GRANT AGREEMENT


Investment ID OPP1127647


 


ATTACHMENT B


TERMS & CONDITIONS


 


This Grant Agreement is subject to the following terms and conditions.


 


PROJECT SUPPORT


 


PROJECT DESCRIPTION AND CHARITABLE PURPOSE


The Foundation is awarding You this
grant to carry out the project described in the Proposal Narrative, IPDP, and PD Workbook (collectively, "Project")
in order to further the Charitable Purpose.


 


MANAGEMENT
OF FUNDS


 


USE OF FUNDS


You may not use funds provided under
this Grant Agreement ("Grant Funds") for any purpose other than the Project. You may not use Grant Funds to reimburse
any expenses You incurred prior to the Start Date.


 


INVESTMENT OF FUNDS


You must invest Grant Funds in accordance
with the Investment Guidelines. You must provide the Foundation with 30 days' prior written notice before making any changes to
the Investment Guidelines. Together with any progress or final reports required under this Grant Agreement, You must report investment
activities and the amount of any currency conversion gains (or losses) and the amount of any interest, or other income generated
by the Grant Funds (collectively "Income"). Any Income must be used for the Project.


 


SEGREGATION OF FUNDS


You must maintain Grant Funds in
a physically separate bank account or a separate bookkeeping account maintained as part of Your financial records and dedicated
to the Project.


 


GLOBAL
ACCESS


 


GLOBAL ACCESS COMMITMENT


You will conduct and manage the
Project and the Funded Developments in a manner that ensures Global Access. Your Global Access commitments will survive the term
of this Grant Agreement. “Funded Developments” means the products, services, processes, technologies, materials,
software, data, other innovations, and intellectual property resulting from the Project (including modifications, improvements,
and further developments to Background Technology). “Background Technology” means any and all products, services,
processes, technologies, materials, software, data, or other innovations, and intellectual property created by You or a third party
prior to or outside of the Project used as part of the Project. “Global Access” means: (a) the knowledge and
information gained from the Project will be promptly and broadly disseminated; and (b) the Funded Developments will be made available
and accessible at an affordable price (i) to people most in need within developing countries, or (ii) in support of the U.S. educational
system and public libraries, as applicable to the Project.


 


GLOBAL ACCESS MILESTONES


In order to further define Your
Global Access commitments, You agree to the terms and conditions set out in the Global Access Commitments Agreement set
forth in Attachment D. In the event of any conflict between this Global Access section of this Grant Agreement and the Global Access
Commitments Agreement, the Global Access Commitments Agreement shall control.


 


You may not materially change the
plans and strategies contained in any Global Access Commitments Agreement without the Foundation’s prior written approval.
Upon request of the Foundation, You will provide the Foundation with progress updates evidencing your progress to attain Your the
Global Access Commitments.


 




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[**] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request.


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filed separately with the Commission.


 


PUBLICATION


For the purpose of achieving Global
Access, You will seek prompt publication of any Funded Developments consisting of data and results in a peer-reviewed journal,
treatise, or trade publication, as applicable, consistent with the Global Access Commitments Agreement. Publication may be delayed
for a reasonable period for the sole purpose of seeking patent protection, provided the patent application is drafted, filed, and
managed in a manner that best furthers the Charitable Purpose. You will also use good faith efforts to ensure that Your subcontractors,
agents, and affiliates, as applicable, likewise seek prompt publication of any Funded Developments consisting of data and results.


 


PUBLICATION IN PEER-REVIEWED
JOURNALS


If
You seek publication of Funded Developments in a peer-reviewed journal, such publication shall be under “open access”
terms and conditions consistent with the Foundation’s Open Access Policy available at: www.gatesfoundation.org/How-We-Work/General-Information/Open-Access-Policy,
which may be modified from time to time.


 


INTELLECTUAL PROPERTY REPORTING


During the term of this Grant Agreement
and for 5 years after, You will submit upon request annual intellectual property reports related to the Funded Developments, Background
Technology, and any related agreements using the Foundation’s templates or forms, which the Foundation may modify from time
to time.


 


SUBGRANTS
AND SUBCONTRACTS


 


SUBGRANTS AND SUBCONTRACTS


You may not make subgrants under
this Grant Agreement. You have the exclusive right to select subcontractors to assist with the Project.


 


RESPONSIBILITY FOR OTHERS


You are responsible for (a) all
acts and omissions of any of Your trustees, directors, officers, employees, subgrantees, subcontractors, contingent workers, agents,
and affiliates assisting with the Project, and (b) ensuring their compliance with the terms of this Grant Agreement and the Global
Access Commitments Agreement.


 


PROHIBITED
ACTIVITIES


 


ANTI-TERRORISM


You will not use funds provided
under this Grant Agreement, directly or indirectly, in support of activities (a) prohibited by U.S. laws related to combatting
terrorism; (b) with persons on the List of Specially Designated Nationals (www.treasury.gov/sdn) or entities owned or controlled
by such persons; or (c) with countries against which the U.S. maintains comprehensive or targeted sanctions (currently, Cuba,
Iran, (North) Sudan, Syria, North Korea, Russia and Ukraine), unless such activities are fully authorized by the U.S. government
under applicable law and specifically approved by the Foundation in its sole discretion.


 


ANTI-CORRUPTION; ANTI-BRIBERY


You will not offer or provide money,
gifts, or any other things of value directly or indirectly to anyone in order to improperly influence any act or decision relating
to the Foundation or the Project, including by assisting any party to secure an improper advantage. Training and information on
compliance with these requirements are available at www.learnfoundationlaw.org.


 


POLITICAL ACTIVITY AND ADVOCACY


You may not use Grant Funds to influence
the outcome of any election for public office or to carry on any voter registration drive. You may not use Grant Funds to support
lobbying activity or to otherwise support attempts to influence local, state, federal, or foreign legislation. Your strategies
and activities, and any materials produced with Grant Funds, must comply with applicable local, state, federal, or foreign lobbying
law. You agree to comply with lobbying, gift, and ethics rules applicable to the Project.


 




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[**] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request.


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REGULATED
ACTIVITIES


 


INSURANCE


You will maintain sufficient insurance
coverage including general liability and other coverage, as applicable (such as clinical trial insurance, product liability, medical
malpractice, workers compensation, or otherwise) to address the risks, activities and/or omissions applicable to the Project.


 


CLINICAL TRIALS


Since the Project will involve clinical
trials on human subjects, a condition of this grant is Your agreement that the appropriate Institutional Review Boards (“IRBs”)
and ethical committees will review and approve the clinical protocols prior to trial initiation. You further agree to conduct clinical
trials associated with the Project under the generally accepted principles of “Good Clinical Practices” as defined
by the International Conference on Harmonization (ICH) E-6 Standard, the United States Food and Drug Administration (FDA) or the
European Agency for the Evaluation of Medicinal Products (EMEA), as applicable. You acknowledge and agree that, as between You
and the Foundation, You take and will have full responsibility for all compliance, data safety, monitoring, and audit requirements
of the relevant regulatory agencies, both for Yourself and all other sites included in the Project, including those activities
conducted through subgrants, subcontracts or other collaborative efforts. You acknowledge and agree that any activities by the
Foundation as the grantor funding the Project, including its review of the Proposal Narrative and PD Workbook or suggested modifications
to the Project, does not modify the provisions of this paragraph or constitute the basis for any claim by You against the Foundation.


 


COVERAGE FOR ALL SITES


You agree that for each venue in
which any part of the Project is conducted (either by Your organization or a subgrantee or subcontractor) all legal and regulatory
approvals for the activities being conducted will be obtained in advance of commencing the regulated activity. You further specifically
agree that no funds will be expended to enroll human subjects until the necessary regulatory and ethical bodies’ approvals
are obtained.


 


INSTITUTIONAL REVIEW BOARD (IRB)
AND OTHER ETHICAL COMMITTEE APPROVAL


You agree to obtain the review and
approval of all final protocols by the appropriate IRBs and ethical committees prior to enrollment of the first human subject.
A similar provision applies to Institutional Animal Care and Use Committee approval of studies involving animals, and Institutional
Biosafety Committee for biohazards and recombinant DNA. You agree to provide prompt notice to the Foundation if the facts and circumstances
change regarding the approval status of the IRBs or ethical committees for any final protocol(s).


 


PROVISION OF CARE FOR HUMAN SUBJECTS
RESEARCH


In keeping with “Good Clinical
Practice” standards, You will disclose to subjects and the IRBs what care and/or referrals will be available through participation
in the study. Institutional policies regarding what care will be provided to personnel who are injured as a result of their work
on the Project should similarly be developed, approved and implemented with notice to the employees.


 


PUBLICITY


 


PUBLICITY BY THE FOUNDATION


The Foundation may include information
about the award of this grant, including Your name, in its periodic public reports and may make such information available on its
website and as part of press releases, public reports, speeches, newsletters, tax returns and other public disclosure.


 


PUBLICITY BY YOU


You
must obtain the Foundation’s prior written approval before: (a) issuing a press release or other public announcement regarding
this grant; and (b) any other public use of the Foundation’s name or logo. Please email Your request to: grantee.comms@gatesfoundation.org
two weeks in advance to provide the Foundation an opportunity to review and comment. Detailed guidelines are available at:
www.gatesfoundation.org/grantseeker/documents/guidelines_communications_for_grantees.doc.


 




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PUBLICITY BY OTHERS


You and Your subgrantees, subcontractors,
contingent workers, agents, or affiliates may not state or otherwise imply to third parties that the Foundation directly funds
or otherwise endorses their activities.


 


OTHER


 


COMPLIANCE WITH LAWS


In carrying out the Project and
activities under the Global Access Commitments Agreement, You will comply with all applicable laws, regulations, and rules and
will not infringe, misappropriate, or violate the intellectual property rights of any third party.


 


RELIANCE


You acknowledge that the Foundation
is relying on the information You provide in reports and during the course of any due diligence conducted prior to the Start Date
and during the term of this Grant Agreement and Global Access Commitments Agreement. You represent that the Foundation may continue
to rely on this information and on any additional information You provide regarding activities, progress, and Funded Developments.


 


INDEMNIFICATION


You will indemnify, defend, and
hold harmless the Foundation and its trustees, employees, and agents (“Indemnified Parties”) from and against
any and all demands, claims, actions, suits, losses, damages (including property damage, bodily injury, and wrongful death), arbitration
and legal proceedings, judgments, settlements, or costs or expenses (including reasonable attorneys’ fees and expenses) (collectively,
“Claims”) arising out of or relating to the acts or omissions, actual or alleged, of You or your employees,
subcontractors, contingent workers, agents, and affiliates with respect to the Project, the Product, the Global Access Commitments
Agreement or the Grant Agreement. You agree that any activities by the Foundation in connection with the Project or Product, such
as its review or proposal, input, or suggested modifications to the Project or Product, will not modify or waive the Foundation’s
rights under this paragraph. An Indemnified Party may, at its own expense, employ separate counsel to monitor and participate in
the defense of any Claim.


 


TERM AND TERMINATION


 


TERM


This Grant Agreement commences on
the Start Date and continues until the End Date, unless terminated earlier as provided in this Grant Agreement.


 


TERMINATION


The Foundation may modify, suspend,
or discontinue any payment of Grant Funds or terminate this Grant Agreement if: (a) the Foundation is not reasonably satisfied
with Your progress on the Project; (b) there are significant changes to Your leadership or other factors that the Foundation reasonably
believes may threaten the Project’s success; (c) there is a change in Your control; or (d) You fail to comply with this Grant
Agreement or the Global Access Commitments Agreement.


 


RETURN OF FUNDS


Any Grant Funds, plus any Income,
that have not been used for, or committed to, the Project upon expiration or termination of this Grant Agreement, must be returned
promptly to the Foundation.


 


RECORD KEEPING


You will maintain adequate accounting
records and copies of any reports submitted to the Foundation related to the Project. You will retain such records and reports
for 4 years after Grant Funds are fully spent and as set forth in the Global Access Commitments Agreement, and will make such records
and reports available to enable the Foundation to monitor and evaluate how Grant Funds have been used and as otherwise described
in the Global Access Commitment Agreement.


 


SURVIVAL


A Party’s obligations under
this Grant Agreement will be continuous and survive expiration or termination of this Grant Agreement as expressly provided in
this Grant Agreement or otherwise required by law or intended by their nature. For the avoidance of doubt, the parties intend that
the following sections survive the term of this Grant Agreement: Reporting, Accounting for Personnel Time, Use of Funds, Investment
of Funds (as applicable to any Grant Funds that have not been used for or committed to the Project), Segregation of Funds, Responsibility
for Others, Global Access, Regulated Activities, Publicity, Compliance, Reliance, Indemnification, Termination, Return of Funds,
Record Keeping, Survival and Notice and Approvals, Severability and the entirety of the Global Access Commitments Agreement (Appendix
D).


 




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GENERAL


 


ENTIRE AGREEMENT AND AMENDMENTS


This Grant Agreement together with
all attachments thereto, including the Global Access Commitments Agreement together with the CDA between the parties dated March
26, 2013, amended as of April 29, 2015 (and further amended from time to time as agreed in a signed writing by the parties) contains
the entire agreement of the Parties and supersedes all prior and contemporaneous agreements concerning its subject matter. Except
as specifically permitted in this Agreement, no modification, amendment, or waiver of any provision of this Grant Agreement or
the Global Access Commitments Agreement will be effective unless in writing and signed by authorized representatives of both Parties.


 


NOTICES AND APPROVALS


Except as to ordinary programmatic
communications (which may be delivered by email), any notices, requests, and approvals under this Grant Agreement or the Global
Access Commitments Agreement must be delivered in writing as set forth in the Notice provision of the Global Access Commitments
Agreement.


 


SEVERABILITY


Each provision of this Grant Agreement
and the Global Access Commitments Agreement must be interpreted in a way that is enforceable under applicable law. If any provision
is held unenforceable, the rest of the agreement will remain in effect.


 


ASSIGNMENT


You may not assign, or transfer
by operation of law or court order, any of Your rights or obligations under this Agreement or the Global Access Commitments Agreement
without the Foundation’s prior written approval. This Grant Agreement and the Global Access Commitments Agreement will bind
and benefit any permitted successors and assigns.


 


COUNTERPARTS


Except as may be prohibited by applicable
law or regulation, this Grant Agreement and the Global Access Commitments Agreement and any amendment(s) thereto may each be signed
in counterparts, delivered by facsimile, PDF, or other electronic means, each counterpart of which will be deemed an original and
all of which when taken together will constitute one agreement.


 


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GRANT AGREEMENT


Investment ID OPP1127647


 


ATTACHMENT C


Project Governance Plan


 


Unless otherwise agreed by the parties, governance shall be as follows:


 


Meetings of the Parties


1) Monthly conference calls


		o	Parties will meet monthly via teleconference calls at which Novavax will provide updates from each functional area (clinical,
regulatory, CMC) along with any new issues and a review of key risks and mitigations.



		o	These monthly meetings will also be a key opportunity to share relevant data as it emerges, such as enrollment figures, investigator
site updates, manufacturing progress, DSMB feedback, and status of regulatory filings and communications.



2) Stage Gate Reviews and Annual Project Reviews


		o	In addition, parties will meet in person for Stage Gate Reviews or Annual Project Reviews if the interval between successive
Stage Gates is more than one year. Stage Gate Meetings will be held at each of the Stage Gates identified in the PD Workbook:



§      [**]


§      [**]


§      [**]


§      [**]


		o	The date for the Stage Gate Review meeting (or Annual Review meeting) will be set by the parties three months in advance.



		o	Novavax will use reasonable good faith efforts to provide prereading materials approximately six weeks prior to the Stage Gate
Review meeting; Progress Narrative including key new data, updated PDSS, IPDP, cTPP and PD Workbook with milestones tracked and
funding plans.



		o	Foundation will provide an agenda for the Stage Gate Review focusing on key data and issues four weeks prior to the meeting.



		o	At the meeting, Novavax will present key data and receive
live feedback.



		o	After the meeting, Foundation will in a closed session determine whether to fund the next stage of development based on alignment
of cTPP, timelines and development plans with Foundation strategy.



		o	Within one week of the meeting, Foundation will provide Novavax with a summary of key decisions (i.e. Go, Rework, NoGo), next
steps and action items.



 


3) Advisory Committee


		o	Novavax will convene an Advisory Committee, which will include a variety of members with scientific and/or technical expertise.
Thea Foundation may serve as a member. The committee meetings will be convened at least on an annual basis to review, evaluate
and offer guidance and input with respect to implementation of the IPDP and achieving the milestones and deliverables.



		o	The committee may also be convened on an ad hoc basis as needed.



 


Project Monitoring


		·	In addition to the activities and reports set forth in the Grant Agreement
and GACA, joint visits to clinical sites to be arranged from time to time during the Phase 3 study. For the avoidance of doubt,
Foundation’s role in such sites visits is observational only and for informational purposes only.



 


Other


		·	As agreed by the parties



 




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GRANT AGREEMENT


Investment ID OPP1127647


 


ATTACHMENT D


 


GLOBAL ACCESS COMMITMENTS AGREEMENT (GACA)


 


GACA attached as separately numbered pages 1-28.


 


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