[***]
Certain information has been excluded pursuant to Regulation S-K, Item 601(b)(10)(iv) from this Document because it is both not material
and is the type that the registrant treats as private or confidential.


 


Exhibit
10.38


 





 


COVID-19
Outbreak Response Agreement (ver 3.1)


Agreement
Summary


 


	AWARDEE
    INFORMATION
	Name:
    	 	Variation
    Biotechnologies Inc. (“Awardee”)
	Mailing
    Address: 	 	 
	Project
    Lead:	 	David
    Anderson
	Management
    Contact:	 	Adam
    Buckley
	Bank
    Account Details:	 	Account
    Name: USD

    Account
    Number: **

    Routing/ABA
    Number: **

    Swift
    Code: **

    Bank:
    **

    Bank
    Address: **



 


	CEPI
    INFORMATION
	Mailing
    Address:	 	Coalition
    for Epidemic Preparedness Innovations, PO Box 123 Torshov, N-0412 Oslo, Norway
	Project
    Lead:	 	 
	Management
    Contact:	 	 


 


	AGREEMENT
    INFORMATION
	Project
    Name	 	Development
    of SA-Variant Monovalent & Multivalent SARS-CoV2 Vaccine Candidates
	CEPI
    Programme Name	 	Outbreak
    Response To Novel Coronavirus (COVID-19)
	Effective
    Date	 	Date
    of last signature below
	Expiry
    Date	 	As
    described in Clause 20.1 of the Terms and Conditions in Annex A.
	This
    Agreement includes and incorporates by reference: 	 	The
    agreement (the “Agreement”) means this Agreement Summary together with the following: - Terms and Conditions (Annex
    A)

    -
    Team Charter (Annex B)

    -
    iPDP for Work Package(s) (Annex C)

    -
    Budget for Work Package(s) (Annex D)

    -
    List of AMC Countries, UMICs and HICs as at the Effective Date (Annex E)

    -
    List of Sub-Contractors (Annex F)

    -
    List of Pre-existing Agreements (Annex G)



 




    	 



    	 



    

 


THIS
AGREEMENT (the “Agreement”) is between Awardee and the Coalition for Epidemic Preparedness Innovations (“CEPI”)
and is effective as of the date of the last signature, below (the “Effective Date”).
Each party to this Agreement may be referred to individually as a “Party” and together
as the “Parties.” This Agreement sets out the terms and conditions governing the
performance and funding of the Project (as defined herein). It also reflects the Parties’ mutual commitment to develop a safe and
effective vaccine against SARS-CoV-2, to test and obtain regulatory approval for the vaccine as rapidly as possible, consistent with
patient safety and achieving vaccine quality, and to ensure the manufacture and distribution of sufficient quantities of the vaccine
to meet global demand at affordable prices in the country of use. As a condition of this funding award, the Parties enter into this Agreement
by having their authorised representatives sign below.


 


Signed
for and on behalf of:


 


	COALITION
    FOR EPIDEMIC PREPAREDNESS INNOVATIONS	 
	 	 
	Signature:
    	/s/
    Richard Hatchett	 
	Name:
    	Richard
    Hatchett	 
	Title:
    	Chief
    Executive Officer	 
	Date.
    	March 9, 2021	 


 


	VBI
    Vaccines Inc.	 
	 	 
	Signature:
    	/s/ Jeffrey Baxter 	 
	Name:
    	Jeffrey Baxter 	 
	Title:
    	Chief
    Executive Officer	 
	Date:
    	March 8, 2021 	 


 




    	2



    	 



    

 


Annex
A: Terms and Conditions


 


Definitions:


 


		1.1	“Additional
                                            COVID-19 Candidate” means any of Awardee’s vaccine candidates against SARS-CoV-2
                                            containing antigens from only SARS-CoV-2 and not from any other viruses, other than the Project
                                            Vaccine or VBI-2902 (as defined herein), in any form or dosage of pharmaceutical composition
                                            or preparation.



 


		1.2	“Additional
                                            COVID-19 Candidate Notice” has
                                            the meaning described in Clause 14.1.



 


		1.3	“Affiliate”
                                            means any business entity controlled by, controlling or under common control with, a Party.
                                            For clarity, “control” shall exist through the ability to directly or indirectly
                                            control the management and/or business of the other entity, whether through ownership of
                                            voting stock or the power to appoint a majority of the Party’s governing board.



 


		1.4	“Agreement
                                            Summary” means the signature page that identifies the Parties and to which this
                                            Annex A
                                            and other annexes are attached.



 


		1.5	“AMC
                                            Countries” means those countries which are eligible to participate in the COVAX
                                            AMC from time to time (listed in Annex E as at the Effective Date). 



 


		1.6	“Background
                                            Intellectual Property” (or “Background IP”) means any and all
                                            Intellectual Property that is owned or controlled by Awardee during the Term of this Agreement,
                                            whether existing as of the Effective Date or later developed or acquired independently of
                                            the Project. For clarity, Background IP includes commercial freedom-to-operate licences obtained
                                            by Awardee.



 


		1.7	“Budget”
                                            means the schedule of funds identified in Annex
                                            D to be paid by CEPI to the Awardee for the Project
                                            activities in the Work Packages, as may be amended from time to time by the written agreement
                                            of both Parties.



 


		1.8	“Business
                                            Days” means any day, other than (a) a Saturday or Sunday; and (b) any public holiday
                                            in London England, Oslo Norway or Massachusetts United States. 



 


		1.9	“Canada
                                            Agreement” means the agreements between the Strategic Innovation Fund of Canada
                                            and Variation Biotechnologies Inc. executed Sept 16th 2020 including any extensions
                                            or amendments thereto, provided that any such amendment is consistent with CEPI’s rights
                                            hereunder. 



 


		1.10	“CEPI
                                            Service Provider” means a third party contracted and funded directly by CEPI, which
                                            CEPI, at its discretion, may make available to Awardee to support its activities under the
                                            Project.



 


		1.11	“Commercial
                                            Benefits” means any economically quantifiable benefits that arise from the commercial
                                            exploitation of the Project Results (including the Project Vaccine).



 


		1.12	“Commercially
                                            Reasonable Efforts” means the carrying out of such obligations or tasks with a
                                            level of efforts and resources (including departmental budget resources) consistent with
                                            the efforts and resources that Awardee commits to other products at a similar stage of development,
                                            life cycle and potential for impacting subject outcomes, taking into account all relevant
                                            factors, including issues of safety and efficacy, product profile, difficulty in developing
                                            or manufacturing products, the regulatory requirements involved (including the likelihood
                                            of receipt of approval by the relevant governmental authorities) and the potential marketability
                                            for a product intended to address the global urgent medical need, serious public health issues
                                            and economic impact created by the COVID-19 pandemic and potential market demand of the product.



 




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		1.13	“Cost
                                            Guidance” means CEPI’s explanatory document regarding eligible direct and
                                            indirect costs, non-eligible costs, and valuation of in-kind contributions, as further described
                                            in Clause 11.2.



 


		1.14	“Cost
                                            of Goods” (or “COGs”) means the actual costs of manufacturing
                                            and supplying the Project Vaccine incurred by Awardee or its designee, the scope of which
                                            shall be determined pursuant to Section 15.3 and shall include the following costs to the
                                            extent attributable to the manufacture and supply of the Project Vaccine (unless otherwise
                                            agreed by the Parties):



 


		(a)	direct
                                            costs of raw materials, intermediates and components, reference materials or standards required
                                            for release testing and materials necessary to support stability studies (including methods
                                            and consumables);



 


		(b)	fully
                                            loaded direct labour costs;



 


		(c)	direct
                                            costs of drug substance and drug product manufacturing, quality assurance and stability testing,
                                            characterisation testing, quality control release testing of drug substance and drug product,
                                            quality assurance batch record review and release;



 


		(d)	costs
                                            of interim packaging and labelling;



 


		(e)	direct
                                            costs of insurance, storage and freight and shipping costs;



 


		(f)	tariffs,
                                            sales and excise taxes, customs and duty and charges levied by governmental entities (including
                                            export fees) on the Project Vaccine; 



 


		(g)	a
                                            fair and reasonable allocation of identifiable internal and indirect costs incurred by Awardee
                                            in connection with and attributable to such manufacturing of the Project Vaccine, including,
                                            at a minimum, for process development, project management, manufacturing oversight, facilities,
                                            depreciation, utilities, insurance, and quality control and assurance, in conformity with
                                            relevant U.S. GAAP, IFRS or other local GAAP accounting principles, in each case, calculated
                                            by Awardee in a manner consistent with its treatment of such costs (including idle capacity)
                                            with respect to other products and without disadvantaging the Project Vaccine on account
                                            of the terms of this Agreement or otherwise;



 


		(h)	royalties,
                                            licensing fees, milestone fees and other costs and expenses directly attributable to rights
                                            to use the Intellectual Property and technology associated with the Project Vaccines and
                                            the Project Materials;



 


		(i)	costs
                                            of compliance with regulatory requirements including reporting, audits and updates;



 


		(j)	direct
                                            costs of product liability insurance, if not otherwise provided; and



 


		(k)	costs
                                            and expenses for pharmacovigilance and medical affairs directly incurred for, or fairly allocable
                                            to, the Project Vaccine supplied pursuant to this Agreement.



 


		1.15	“COVID-19
                                            Global Vaccine Access Facility” or “COVAX” means the global
                                            umbrella mechanism developed and managed under the auspices of the Vaccine Task Force, a
                                            component of the Access to COVID-19 Tools (ACT) Accelerator, that shall pool funding commitments
                                            and incentivise scale-up of research and development, clinical trial investments, and manufacturing
                                            for a portfolio of vaccine candidates.



 




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		1.16	“Enabling
                                            Rights” means rights to Background Intellectual Property, Project Intellectual
                                            Property and Project Results that could be asserted by Awardee or a Subawardee to block CEPI
                                            from exercising the Public Health Licence to make, have made, use, have used, import, sell
                                            or otherwise exploit the Project Vaccine. For purposes of this Agreement, Enabling Rights
                                            also includes the contractual rights that control the use of such items as, for example,
                                            rights to use biological materials covered in material transfer agreements entered into between
                                            Awardee and third parties.



 


		1.17	“Equitable
                                            Access” has the meaning given to it in Clause 15.1.



 


		1.18	“Equitable
                                            Access Plan” means the principles of Equitable Access under this Agreement including
                                            those set out in Clause 15 and the Equitable Access Policy (as defined in Clause 15.1).



 


		1.19	“Field”
                                            means the public health response to the Outbreak and to other coronaviruses against which
                                            a Project Vaccine may be at least partially cross-protective or as otherwise agreed by the
                                            Parties from time to time in accordance with Clause 22.6.



 


		1.20	“Financial
                                            Report” has the meaning described in Clause 3.9.



 


		1.21	“Further
                                            Funding Notice” has the meaning described in Clause 4.1.



 


		1.22	“Gavi”
                                            means the Gavi Vaccine Alliance, an independent non-profit foundation within the meaning
                                            of Articles 80 et seq. of the Swiss Civil Code with a registered address at Chemin
                                            du Pommier 40, 1218 Le Grand-Saconnex, Geneva, Switzerland and any procurement agent that
                                            may be appointed by Gavi from time to time. 



 


		1.23	“HICs”
                                            or “Higher Income Countries” means the countries identified in Annex E.



 


		1.24	“Integrated
                                            Product Development Plan” (or “iPDP”) means the document setting
                                            out details of one or more Work Packages that collectively describe the various activities,
                                            deliverables, milestones, phases, risks and timelines associated with the Project, as may
                                            be amended from time to time by the written agreement of both Parties. The initial iPDP is
                                            set forth as Annex
                                            C.



 


		1.25	“Intellectual
                                            Property” or “IP” means (a) inventions, patents, utility models,
                                            and rights in the foregoing; (b) trade marks, trade names, geographical indications and appellations
                                            of origin, rights under the law of passing off, unfair competition and equivalents; (c) copyright,
                                            rights in software, rights in performances and in recordings, moral rights, and database
                                            rights; (d) designs, design patents, registered and unregistered designs and design rights;
                                            (e) confidential information consisting of trade secrets and rights under the law of breach
                                            of confidence and equivalents; and all other intellectual property rights of any kind however
                                            designated that may subsist anywhere in the world whether arising by operation of law, treaty,
                                            contract, conduct or otherwise, together with all registrations, applications, rights to
                                            priority, renewals, extensions, continuations, divisions or reissues thereof and all rights
                                            to bring action for infringement past, present and future.



 


		1.26	“Joint
                                            Monitoring and Advisory Group” or “JMAG”
                                            has the meaning described in Clause 2.3.



 


		1.27	“LMICs”
                                            or “Low and Middle Income Countries” means the countries identified by
                                            the Organisation for Economic Co-operation and Development (or “OECD”)
                                            as having low-income or middle-income economies, as may be updated from time-to-time by the
                                            OECD.



 




    	5



    	 



    

 


		1.28	“Lowest
                                            Tier Countries” means in the case of any
                                            matter relating to COVID-19, the AMC Countries and in the case of all other diseases, the
                                            Low and Middle Income Countries.



 


		1.29	“NRC
                                            Agreement” means the Collaboration Agreement with the NRC dated March 30, 2020
                                            and the first Amendment dated December 21, 2020, as may be amended from time to time provided
                                            that any such amendment is consistent with CEPI’s rights hereunder.



 


		1.30	“Outbreak”
                                            means the COVID-19 outbreak caused by the SARS-CoV-2 virus or any
                                            strain, mutations and related recurrences
                                            of such virus.



 


		1.31	“Pandemic
                                            Period” means the period of time beginning on 30 January 2020, when the World Health
                                            Organization (or “WHO”) declared COVID-19 to be a Public Health Emergency
                                            of International Concern (or “PHEIC”), and ending on the earlier of (1)
                                            the date on which WHO declares that the COVID-19 PHEIC is over or (2) the date determined
                                            by CEPI, in its reasonable discretion in consultation with the Awardee and based on epidemiological
                                            data published by WHO, including. 



 


		1.32	“Pre-existing
                                            Agreements” means the agreements entered into by the Awardee prior to the Effective
                                            Date details of which are set out in Exhibit H.



 


		1.33	“Project”
                                            means the activities under this Agreement, as are described in the Team Charter, iPDP and
                                            Budget, to be performed by or on behalf of the Awardee and/or any Subawardee. 



 


		1.34	“Project
                                            Continuity Plan” has
                                            the meaning described in Clause 13.2. 



 


		1.35	“Project
                                            Data” has the meaning described in Clause 9.1.



 


		1.36	“Project
                                            Intellectual Property” (or “Project IP”) means the Intellectual
                                            Property discovered or made by or on behalf of the Awardee and/or any Subawardee in the performance
                                            of the Project.



 


		1.37	“Project
                                            Materials” has the meaning described in Clause 9.2.



 


		1.38	“Project
                                            Results” means all of the tangible materials and other results that are made or
                                            developed by or on behalf of Awardee and/or any Subawardee under the Project, including the
                                            Project Vaccine and assays developed by or on behalf of the Awardee or any Subawardee that
                                            are necessary for Project Vaccine production, whether in whole or in components, serum samples
                                            collected, protocols used in clinical or non-clinical evaluation of the Project Vaccine,
                                            Project Data, and Project Materials.



 


		1.39	“Project
                                            Vaccine” means one or more of Awardee’s vaccine candidates *** 
                                            (as described in the iPDP) and any other of the Awardee’s
                                            vaccine candidates expressly identified in the iPDP, in any form or dosage of pharmaceutical
                                            composition or preparation (including any ***  candidate
                                            vaccines of any of the foregoing which are included in the iPDP and Budget from time to time).



 


		1.40	“Public
                                            Health Licence” means a grant by Awardee to CEPI of all relevant Enabling Rights
                                            for use in the Field by CEPI as described in Clause 13.4. 



 


		1.41	“Ready
                                            Reserve of Clinical Trial Material” has the meaning described in Clause 12.1.



 


		1.42	“Stage
                                            Gate” means a mutually agreed “go/no go” decision point to continue
                                            a given Work Package or to commence activities in another Work Package, as set out in the
                                            iPDP.



 




    	6



    	 



    

 


		1.43	“Stage
                                            Gate Review Committee” has the meaning described in Clause 2.5.



 


		1.44	“Subawardee”
                                            means a third party that is contracted by and receives CEPI funds from Awardee to perform
                                            activities or provide support under the Project. For clarity, Subawardees include both “Sub-Grantees”
                                            and “Sub-Contractors” described in Clauses 3.3 and 3.2, respectively.



 


		1.45	“Sub-Contractor”
                                            has the meaning described in Clause 3.2. 



 


		1.46	“Team
                                            Charter” has the meaning described in Clause 2.1.



 


		1.47	“Technical
                                            Report(s)” has the meaning described in Clause 2.4.



 


		1.48	“Term”
                                            has the meaning described in Clause 20.1.



 


		1.49	“Third
                                            Party Code” (or “Code”) means the periodically updated, consolidated
                                            statement of CEPI’s values and of the policies, practices and principles described
                                            in Clause 11.2.



 


		1.50	“Trusted
                                            Collaborator” is a component of the Project Continuity Plan and has the meaning
                                            described in Clause 13.2.



 


		1.51	“Trusted
                                            Manufacturer” is a component of the Project Continuity Plan and has the meaning
                                            described in Clause 13.2.



 


		1.52	“UMICs”
                                            or “Upper and Middle Income Countries” means the countries identified
                                            in Annex E.



 


		1.53	“VBI-2902”
                                            means Awardee’s clinical stage monovalent vaccine against the L-strain of reference
                                            for SARS-COV2.



 


		1.54	“Volume
Commitment Percentage” means the relevant percentage of the Awardee’s capacity to produce Project Vaccine together with
Trusted Manufacturer, where the relevant percentage shall be calculated as follows: **% for any Project Vaccine for which CEPI provides
preclinical funding, **% for any Project Vaccine for which CEPI funds through Phase 1 clinical study, **% for any Project Vaccine for
which CEPI funds through Phase 2 clinical study, **% for any Project Vaccine for which CEPI funds through Phase 3 clinical study, and
**% for any Project Vaccine for which CEPI funds through to (i) approval and registration as set out in the iPDP; (ii) WHO pre-qualification
or emergency use listing; and (ii) reasonably sufficient commercial manufacturing capabilities as required to meet Awardee’s obligations
hereunder. In the event that CEPI co-funds with a third party organization, VBI, CEPI and the third party organization will negotiate
an appropriate Volume Commitment Percentage commensurate with the respective interests of the party, funding contributions and stage
of investment (provided always that such Volume Commitment Percentage shall be no lower than the Volume Commitment Percentage applicable
to the funding stage immediately prior to the latest stage to which CEPI has provided funding).



 


		1.55	“Work
                                            Package(s)” means a discrete set of Project activities described in the iPDP.



 


		2	Project
                                            Organisation and Management:



 


		2.1	Team
                                            Charter. The Project shall be managed by the Parties as described in the Team Charter
                                            in Annex B.



 




    	7



    	 



    

 


		2.2	iPDP
                                            and Work Packages. Awardee shall use Commercially Reasonable Efforts to undertake the
                                            Project as described in the iPDP, including achieving the milestones and timelines of each
                                            Work Package and achieving each Stage Gate within the agreed timeframe, it being understood
                                            that neither Party can assure a positive technical outcome for any Work Package. The Project
                                            is organised into one or more Work Packages and each Work Package has an associated budget
                                            as set out in the Budget. The Work Packages shall be pursued and performed by Awardee in
                                            accordance with the Budget and the iPDP. CEPI will pay the Awardee in accordance with the
                                            Budget and the iPDP and, where applicable, upon completion of a Stage Gate (as determined
                                            pursuant to Clause 2.5). Additional Work Package(s) may be agreed in writing by the Parties
                                            after the Effective Date, which, upon execution by both Parties, shall be annexed to and
                                            become a part of this Agreement. Work Packages may also be modified or extended with the
                                            mutual written consent of both Parties in accordance with Clause 22.6.



 


		2.3	Joint
                                            Monitoring and Advisory Group. Promptly following the Effective Date, the Parties will
                                            establish a joint monitoring and advisory group (“JMAG”) that shall meet
                                            regularly as specified in the Team Charter to monitor progress of and advance the Project.
                                            The JMAG shall coordinate the efforts of CEPI and Awardee to:



 


		(a)	facilitate
                                            communications
                                            between the Parties;



 


		(b)	review
                                            the progress of the Project;



 


		(c)	discuss
                                            substantial proposed changes in the scope or conduct of applicable clinical and animal studies;



 


		(d)	discuss
                                            clinical trial protocols, publications and regulatory submissions;



 


		(e)	coordinate
                                            the sharing of any Project Results identified in a Work Package as intended for use by other
                                            CEPI awardees;



 


		(f)	review
                                            and update the Project Continuity Plan;



 


		(g)	review
                                            and update the Equitable Access Plan; and



 


		(h)	discuss
                                            plans, as appropriate, for the development of manufacturing and its scale-up and scale-out.



 


		2.4	Technical
                                            Reports and Access to Project Results.
                                            Awardee shall disclose all Project Results to CEPI’s Project Lead, at meetings of the
                                            JMAG and shall provide written reports of progress made under the iPDP using a template provided
                                            by CEPI (“Technical Reports”), within twenty (20) Business Days of the
                                            end of each calendar quarter during the term of the Project as set out in the iPDP. In addition,
                                            the Awardee shall make Project Results available to CEPI as described in the iPDP or otherwise
                                            as may reasonably be requested from time to time by CEPI.



 


		2.5	Stage
                                            Gate Review. Unless otherwise addressed in a Work Package for a given Stage Gate, when
                                            Awardee believes that a Stage Gate in a Work Package will be achieved in the near term, Awardee
                                            shall notify the JMAG promptly and provide relevant information (including the completion
                                            of a form provided by CEPI) and request a meeting of CEPI’s committee authorised to
                                            assess whether Stage Gates have been completed (the “Stage Gate Review Committee”).
                                            Awardee’s Project Manager shall coordinate with CEPI’s Project Manager to schedule
                                            a Stage Gate Review Committee meeting as early as possible, but no later than fifteen (15)
                                            Business Days before the planned meeting date. CEPI shall notify Awardee of the Stage Gate
                                            Review Committee’s decision as soon as possible, but no later than twenty (20) Business
                                            Days after the meeting date.. If the Stage Gate Review Committee determines that the Stage
                                            Gate was not completed, CEPI shall promptly discuss with Awardee potential actions to be
                                            taken in order to complete such Stage Gate.



 




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		2.6	Subawardees.
                                            Project activities may be undertaken by Subawardees that are identified in a Work Package
                                            and associated Budget as of the Effective Date or are proposed by Awardee and reasonably
                                            approved by CEPI in writing after the Effective Date.



 


		2.7	CEPI
                                            Service Providers. CEPI has entered into certain service agreements with CEPI Service
                                            Providers that have agreed to provide preferential charging to CEPI awardees. CEPI shall
                                            make available various laboratory services or other support to Awardee provided by a CEPI
                                            Service Provider, for example, by providing testing of clinical serum samples, evaluation
                                            of immunity of Project Vaccine in animal models and various analytical services. Awardee
                                            agrees to make Commercially Reasonable Efforts to utilise any CEPI Service Provider for the
                                            provision of services as may be specified in a Work Package and agreed in writing between
                                            the Parties. Awardee and the CEPI Service Provider may, at their own discretion, enter directly
                                            into an appropriate agreement between themselves setting out the terms on which the services
                                            will be provided. CEPI shall, through the JMAG or otherwise, discuss with Awardee protocols
                                            and data management related to any services provided by any CEPI Service Provider.



 


		3	Use
                                            of Funds; Procurement; Project Records:



 


		3.1	Use
                                            and Management of Funds. The Budget sets out the total funding to be provided by CEPI
                                            to Awardee for each Work Package. Awardee shall use this funding only in accordance with
                                            a Work Package unless otherwise agreed in writing by CEPI in advance. Awardee shall manage
                                            all funds received by Awardee for the Project (whether CEPI funds or funds provided by a
                                            third party) with financial controls and practices consistent with U.S. GAAP, IFRS or local
                                            GAAP, and further in compliance with applicable CEPI policies and procedures as described
                                            in Clause 11.2 of this Agreement.



 


		3.2	Use
                                            of Sub-Contractors. 



 


		(a)	Awardee
                                            may use sub-contractors to undertake work pursuant to the Work Packages on its behalf provided
                                            that such sub-contractors are listed in Annex F or they have been approved by CEPI in advance
                                            in writing (“Sub-Contractors”). Such Sub-Contractors may be retained without
                                            a tender process.



 


		(b)	The
                                            use of any Sub-Contractors that are not included in the iPDP and Budget as of the Effective
                                            Date must be approved in advance in writing by CEPI and managed by Awardee in compliance
                                            with Clause 11.2. Awardee’s selection and use of Sub-Contractors must be undertaken
                                            in compliance with Section 14 of the Third Party Code and Cost Guidance. 



 


		(c)	If
                                            Awardee is using a Sub-Contractor to undertake work pursuant to a Work Package, the funding
                                            allocated for the Sub-Contractor will be determined based on costs pre-approved in writing
                                            by CEPI, which may include a modest profit. 



 


		(d)	Awardee
                                            shall ensure that each Sub-Contractor is subject to all of the obligations, as between the
                                            Awardee and the Sub-Contractor, applicable to Awardee under this Agreement, including the
                                            obligations relating to auditing, inspection, record keeping, use of funds, compliance obligations
                                            analogous to those in the Third Party Code and Cost Guidance, and all other compliance obligations
                                            as are applicable to Awardee under this Agreement. Awardee shall be responsible for the acts
                                            and omissions of its Sub-Contractors that participate in the Project as if such acts and
                                            omissions were those of the Awardee itself.



 




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		(e)	Awardee
                                            shall ensure that each Sub-Contractor (i) assigns or grants a licence in respect of all Enabling
                                            Rights to the Awardee in order to enable the grant of the Public Health License to CEPI pursuant
                                            to Clause 13.4 of this Agreement; or (ii) directly grants the Public Health License to CEPI
                                            pursuant to Clause 13.4 of this Agreement.



 


		(f)	Awardee
                                            shall notify CEPI promptly in writing if any Sub-Contractor is not in compliance with the
                                            representations and warranties in Clause 17 or any other terms of this Agreement.



 


		3.3	Use
                                            of Sub-Grantees. 



 


		(a)	Subawardees
                                            that are “Sub-Grantees” will be identified as such in the iPDP and will
                                            be funded using the same grant structure as the grant received by Awardee under this Agreement.
                                            



 


		(b)	Awardee
                                            shall ensure that Sub-Grantees only appoint Sub-Contractors in accordance with the provisions
                                            of Clause 3.2. 



 


		(c)	The
                                            funding allocted to a Sub-Grantee will be based on actual costs incurred in line with a budget
                                            approved by CEPI in writing and determined on a without-profit basis. 



 


		(d)	The
                                            use of any Sub-Grantees that are not included in the iPDP and Budget as of the Effective
                                            Date must be approved in writing in advance by CEPI and managed by Awardee in accordance
                                            with Clause 11.2 of this Agreement, Section 15 of the Third Party Code, and Cost Guidance.
                                            



 


		(e)	Awardee
                                            shall ensure that each Sub-Grantee agrees in writing to be subject to all of the obligations
                                            applicable to Awardee under this Agreement, including the obligations relating to auditing,
                                            inspection, record keeping, use of funds, compliance with the Third Party Code and Cost Guidance,
                                            and all other compliance obligations as are applicable to Awardee under this Agreement. Awardee
                                            shall be responsible for the acts and omissions of its Sub-Grantees that participate in the
                                            Project as if such acts and omissions were those of the Awardee itself.



 


		(f)	Awardee
                                            shall ensure that each Sub-Grantee (i) assigns or grants a licence in respect of all Enabling
                                            Rights to the Awardee in order to enable the grant of the Public Health License to CEPI pursuant
                                            to Clause 13.4 of this Agreement; or (ii) directly grants the Public Health License to CEPI
                                            pursuant to Clause 13.4 of this Agreement.



 


		(g)	Awardee
                                            shall notify CEPI promptly in writing if any Sub-Grantee is not in compliance with the representations
                                            and warranties in Clause 17 or any other terms of this Agreement.



 


		3.4	Payments.
                                            Payments to Awardee under this Agreement shall be made in U.S. dollars (US$) to Awardee’s
                                            bank account identified on the Agreement Summary. CEPI shall make payments in tranches covering
                                            six (6) month periods as set out in the Budget. Awardee
                                            shall be entitled to submit a payment request form to CEPI upon execution of this Agreement
                                            and thereafter at the same time as the semiannual financial reporting. Tranches
                                            of funding for each payment request submitted under this Agreement in accordance with the
                                            Budget shall be paid by CEPI within twenty (20) Business Days after receipt and approval
                                            by CEPI of all of the following: (i) payment request by Awardee; (ii) any quarterly Technical
                                            Report due at the time of the payment request; and (iii) any quarterly Financial Report due
                                            at the time of the payment request; each to be submitted using templates provided by CEPI.
                                            Payments may be adjusted by CEPI to reflect any underspend as well as any interest earned
                                            on unutilised funds as noted in the Financial Report.



 




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		3.5	Delayed
                                            Payments.
                                            CEPI may delay or condition a payment if:



 


		(a)	Awardee
                                            has not
                                            achieved a material milestone in accordance with the iPDP by the agreed time, unless such
                                            delay has been approved in writing by the JMAG in accordance with the Team Charter or otherwise
                                            by CEPI;



 


		(b)	The
                                            Awardee or any
                                            Subawardees are no longer in compliance with the representations and warranties in Clause
                                            17 at the time the payment tranche is requested; or



 


		(c)	Awardee
                                            has not
                                            reasonably completed the payment request form or submitted reasonably satisfactory Technical
                                            Reports and Financial Reports.



 


		3.6	Hold
                                            on Payment During a Material Breach. CEPI
                                            is not obliged to pay any tranches of funding for any Work Package for so long as Awardee
                                            is in breach of a material obligation under this Agreement.



 


		3.7	Retained
                                            Final Payment.
                                            CEPI shall retain ten percent (10%) of the payment tranche in respect of the final 6 months’
                                            of the term of the Project and release it within twenty (20) Business Days after approving
                                            Awardee’s final Technical Report and Financial Report for the final Work Package.



 


		3.8	Financial
                                            Reports. Awardee shall provide reports of its expenditure under the Budget with supporting
                                            documentation and using a template provided by CEPI (“Financial Reports”)
                                            within thirty
                                            (30) Business Days of the end of each calendar quarter
                                            during the term of the Project or such other date(s) as may be identified in the Budget.
                                            Awardee shall submit a final Financial Report for a Work Package within sixty (60) days after
                                            the completion of any Work Package.



 


		3.9	Project
                                            Records. Awardee shall keep accurate records of its Project activities and expenditure
                                            under each Work Package and retain them for a period of five (5) years from the end of the
                                            term of the applicable Project.



 


		3.10	Access
                                            to Financial Records. During the Term and for a period of five (5) years after expiration
                                            or termination of this Agreement, CEPI, or its designee (which shall be an internationally
                                            recognised certified public accounting firm, not engaged on a contingent basis), and at CEPI’s
                                            reasonable cost, shall have on-site access to inspect Awardee’s Project-related financial
                                            records once annually upon at least fifteen (15) Business Days’ advance written notice.
                                            Such inspections shall be conducted during normal operating hours in a manner to minimise
                                            disruption to Awardee’s and/or Sub-Grantee’s business. For clarity, access to
                                            such records also shall be provided to records related to Cost of Goods as described in Clause
                                            15.



 


		3.11	ProjectFinancial
                                            Audits. During the Term and for a period of five (5) years after expiration or termination
                                            of this Agreement, if requested by CEPI, and at CEPI’s reasonable cost, once annually
                                            upon at least fifteen (15) Business Days’ notice, Awardee’s external auditors
                                            shall conduct a Project audit in accordance with ISA800 and/or ISA805 and like standards
                                            and provide CEPI with audited statements. Such inspections shall be conducted during normal
                                            operating hours in a manner to minimise disruption to Awardee’s business.



 




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		4	Further
                                            Funding:



 


		4.1	First
                                            Right to Fund. Where practicable CEPI likes to continue to participate in its programmes
                                            throughout their life cycle. In the event that (a) Awardee reasonably requires any funding
                                            for the development, manufacture and/or deployment
                                            of a Project Vaccine in addition to the funding to be provided by CEPI pursuant to the Budget;
                                            or (b) Awardee receives any offer or indication of interest from a third party to
                                            provide funding support for the development, manufacture
                                            and/or deployment of a Project Vaccine; Awardee shall provide prompt written notice to CEPI,
                                            including a summary of the amount of funding required or offered and the terms (if any) offered
                                            by any potential third party funder (each a “Further Funding Notice”).
                                            CEPI shall have the first right (but not the obligation), at CEPI’s sole discretion,
                                            to provide such further funding support to the Awardee for the development, manufacture and
                                            deployment of the Project Vaccine and shall provide written notice to the Awardee of any
                                            such election within thirty (30) days of receipt by CEPI of a Further Funding Notice. The
                                            Awardee shall not accept any third party funding support in respect of the development, manufacture
                                            and/or deployment of a Project Vaccine unless and until the earlier of (i) CEPI has provided
                                            written notice that it does not wish to provide such further funding; or (ii) Awardee has
                                            not received an election from CEPI to provide such further funding within thirty (30) days
                                            of receipt by CEPI of a Further Funding Notice.



 


		4.2	Participation
                                            By Other Funders.
                                            Each Party acknowledges that additional third party funding support for the Project may become
                                            available to either Party. For example, other funders may offer to fund certain activities
                                            under a Work Package or the scale-up and scale-out of Project Vaccine production. Subject
                                            to Clause 4.1 and Awardee’s representations in Clause 17.2, the Parties shall, in good
                                            faith, use reasonable endeavours to facilitate such participation and make appropriate revisions
                                            to relevant Work Packages and the Budget, as well as managing any potentially conflicting
                                            commitments.



 


		5	Ownership
                                            of Project Results; Intellectual Property:



 


		5.1	Awardee’s
                                            Background IP. Awardee
                                            shall retain ownership of its Background IP. Nothing in this Agreement shall be deemed to
                                            assign any ownership interest in such Background IP to CEPI, without prejudice to the licence
                                            rights of CEPI expressly set out in this Agreement.



 


		5.2	Ownership
                                            of Project Intellectual Property. Awardee shall own any Intellectual Property invented
                                            by either Party and arising under the Project, subject to the rights of CEPI to use Project
                                            Intellectual Property expressly set out in this Agreement. Awardee shall have the right,
                                            but not the obligation, to seek IP protection in respect of any Project Intellectual Property
                                            at its own cost. Upon request, but no less than annually, Awardee
                                            shall provide a written update to CEPI regarding the status of Project Intellectual Property
                                            rights sought and obtained.



 


		5.3	Ownership
                                            of Project Results. Awardee shall own the Project Results, subject to the rights of CEPI
                                            to use Project Results expressly set out in this Agreement.



 


		5.4	Third
                                            Party IP. The Parties shall notify each other promptly regarding any third party IP they
                                            become aware of that might impact Awardee’s ability to perform its obligations under
                                            this Agreement and activities contemplated under the Project Continuity Plan and Equitable
                                            Access Plan. The Parties shall cooperate in good faith to resolve any such matters.



 




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		6	Clinical
                                            Trials:



 


		6.1	Clinical
                                            Trials. Awardee shall undertake the clinical trials
                                            as described in the clinical development plan in the iPDP (the “Project Clinical
                                            Trials”), in compliance with all applicable laws and regulations, including requirements
                                            related to use of clinical data outside of the country in which a given Project Clinical
                                            Trial is conducted. Awardee shall ensure that all Project Clinical Trials comply with CEPI’s
                                            Clinical Trial Policy referred to in Clause 11.2.



 


		6.2	Clinical
                                            Trial Protocols: Preparation. Awardee shall
                                            be responsible for the preparation of clinical trial protocols for the Project Clinical Trials.
                                            Awardee shall provide CEPI and/or CEPI’s designee with
                                            a draft of each clinical trial protocol for the Project Clinical Trials and shall consult
                                            with and consider any reasonable suggestions made by CEPI and/or its designee regarding the
                                            clinical trial protocols reasonably in advance of finalising the relevant clinical trial
                                            protocol and submitting it to the institutional review boards, ethics committees, and/or
                                            regulatory authorities.



 


		6.3	Clinical
                                            Trial Protocols: Reporting of Submitted Versions.
                                            Awardee shall provide to CEPI a copy of all clinical trial protocols as submitted to institutional
                                            review boards, ethics committees and regulatory authorities in respect of the Project Clinical
                                            Trials.



 


		6.4	Clinical
                                            Data. Informed consent shall be obtained from each
                                            clinical trial subject to allow, to the extent permitted by law:



 


		(a)	the
                                            transfer of anonymised or pseudonymised data to CEPI and/or CEPI’s designee; and



 


		(b)	the
                                            collection and use of biological samples and the use of data (duly anonymised or pseudonymised
                                            (at CEPI’s discretion) and, at CEPI’s request, blinded) derived from such samples
                                            by CEPI or its designated Assessors (as defined herein) for the purposes of this Agreement.



 


		6.5	Sponsorship
                                            and Management of Clinical Trials.



 


		(a)	Awardee
                                            shall be the sponsor of any clinical trial (unless CEPI and Awardee otherwise agree in writing),
                                            and shall be responsible for obtaining and maintaining all regulatory and ethical committee
                                            approvals necessary or reasonably useful for the conduct of the Project Clinical Trials.
                                            



 


		(b)	In
                                            respect of each Project Clinical Trial, Awardee shall establish an internal Trial Steering
                                            Committee (“TSC”)
                                            and either a Safety Monitoring Committee or Data Safety Monitoring Board, as applicable (each,
                                            a “DSMB”). CEPI shall be
                                            entitled to appoint, and Awardee shall permit, a CEPI representative or designee to attend
                                            all meetings of each Project Clinical Trial’s TSC and/or DSMB as an observer (either
                                            in person or by telephone, video or other electronic means). Subject to Clause 6.5(c) below,
                                            Awardee shall provide a copy to CEPI of all papers that a member of the TSC and/or DSMB would
                                            be entitled to receive at the same time as any such papers are provided to the members of
                                            the TSC and/or DSMB (as applicable). 



 


		(c)	In
                                            the event that CEPI’s attendance at a meeting of the TSC and/or DSMB or receipt of
                                            papers would, in the Awardee’s reasonable discretion acting in good faith, jeopardise
                                            the integrity/blinded nature of an ongoing Project Clinical Trial, the Awardee shall promptly
                                            notify CEPI of such fact and CEPI shall not be entitled to, and Awardee shall not be required
                                            to permit CEPI to, attend such meeting or receive such papers at that time. During an ongoing
                                            Project Clinical Trial, Awardee will continue to provide CEPI with all open session DSMB
                                            documents, DSMB recommendation forms and other “open” documents identified by
                                            both Parties in the iPDP and/or protocol for such Project Clinical Trial. After a Project
                                            Clinical Trial l is unblinded, Awardee shall provide a copy of all papers that were provided
                                            to the members of the TSC and/or DSMB and/or that a member of the TSC and/or DSMB would be
                                            entitled to receive.



 




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		6.6	Safety
                                            Notifications. Awardee shall notify the JMAG in
                                            writing promptly following any single safety event of concern or a series of safety
                                            events considered by the DSMB as relevant in relation to the Project Vaccine and
                                            within 48 hours from the time when such event or series of events becomes known to Awardee.



 


		6.7	Records
                                            and Reporting. Awardee shall ensure that all data in relation to the Project Clinical
                                            Trials and any other clinical trials undertaken by or on behalf of Awardee or Subawardee
                                            with respect to the Project Vaccine are appropriately recorded and that all such records
                                            are kept up to date and maintained in accordance with applicable laws and regulations. Awardee
                                            will ensure that CEPI is able to review and verify all anonymised or pseudonymised data at
                                            the end of the relevant Project Clinical Trial or other clinical trial and will promptly
                                            following the end of such Project Clinical Trial or such other clinical trial provide a copy
                                            of, or access to, such anonymised or pseudonymised data to CEPI in such form as CEPI may
                                            reasonably require.



 


		6.8	Priority
                                            for Clinical Trials. Awardee acknowledges that
                                            the pool of subjects available in areas of Outbreak to participate in a clinical trial to
                                            test the Project Vaccine may be limited. Accordingly, if WHO, CEPI or a regulatory authority
                                            in the area where the clinical trial is to be conducted determines that a product other than
                                            a Project Vaccine has substantially greater potential and should be prioritised instead for
                                            a particular clinical trial, Awardee shall not unreasonably proceed with a clinical trial
                                            of such Project Vaccine unless required to do so by a relevant regulatory authority or a
                                            Pre-existing Agreement. Awardee shall be reimbursed for its reasonable, non-cancellable costs
                                            incurred resulting from such determination to not proceed.



 


		6.9	Potential
                                            WHO Clinical Trials.



 


		(a)	Awardee
                                            shall not unreasonably decline to participate in a Phase IIb or III clinical trial as requested
                                            and funded by WHO and/or CEPI to compare the Project Vaccine with other COVID-19 vaccine
                                            candidates. 



 


		(b)	In
                                            the event of such participation by Awardee, Awardee will, promptly following the end of such
                                            clinical trial, provide a copy of the final study report to CEPI.



 


		7	Regulatory
                                            Activities:



 


		7.1	Regulatory
                                            Activities. Awardee shall pursue the regulatory
                                            activities described in the iPDP.



 


		7.2	Meetings
                                            with Regulatory Authorities. Awardee shall notify
                                            CEPI in writing of any material meetings with regulatory authorities at least five (5) Business
                                            Days in advance of such meetings, or if Awardee itself receives less than five (5) Business
                                            Days notice of such a meeting, as soon as practicable. CEPI or its designee may, at CEPI’s
                                            option, observe all material interactions between Awardee and regulatory authorities relating
                                            to the Project Vaccine. At CEPI’s reasonable request, Awardee shall request a meeting
                                            with regulatory authorities to address any significant unresolved issues.



 


		7.3	Regulatory
                                            Filings. Awardee shall consult regularly with CEPI
                                            regarding regulatory strategy for a Project Vaccine and shall provide advance copies of all
                                            material regulatory submissions for review and comment by CEPI no later than ninety-six (96)
                                            hours prior to their contemplated submission to a regulatory authority. If a final version
                                            is not available by ninety-six (96) hours prior to submission, then a mature draft version
                                            may be electronically delivered to CEPI for review at that time. Additionally, Awardee shall
                                            upload copies of the following to a confidential electronic archiving service designated
                                            by CEPI: 



 




    	14



    	 



    

 


		(a)	all
                                            submissions to regulatory authorities and regulatory filings in respect of a Project Vaccine
                                            together with all data included or referenced therein (other than ministerial or routine
                                            submissions that do not involve safety or efficacy issues); and 



 


		(b)	material
                                            documents and information exchanged between any regulatory authority and the Awardee relating
                                            to a Project Vaccine including official meeting minutes.



 


		8	Animal
                                            Studies:



 


		8.1	Animal
                                            Studies. Awardee shall pursue studies involving
                                            animals as described in the iPDP, in compliance with all applicable laws and regulations
                                            and further in compliance with Clause 11.2.



 


		9	Dissemination
                                            of Project Results; Publication:



 


		9.1	Dissemination
                                            of Project Data. Awardee shall disseminate pre-clinical
                                            and clinical trial data (including any negative results, model animal Project Vaccine-related
                                            deaths and any toxicology study issues) produced under the Project (collectively, “Project
                                            Data”), as described in the iPDP and this Agreement or as otherwise agreed by the
                                            JMAG.



 


		9.2	Dissemination
                                            of Project Materials. Awardee shall disseminate biological samples, Project Vaccines,
                                            and other tangible materials produced under the Project (collectively, “Project
                                            Materials”) as described in the iPDP and this Agreement or as otherwise agreed
                                            by the JMAG. If Awardee develops animal models under the Project, they shall also be considered
                                            Project Materials and disseminated as described in the iPDP and this Agreement or as otherwise
                                            agreed by the JMAG.



 


		9.3	Publication
                                            of Project Data for the Outbreak Research Community.
                                            Project Data shall be shared by the Awardee and CEPI openly and rapidly with the broader
                                            community to inform the public health response and help save lives. Key principles of this
                                            sharing of data have been agreed to by funders, research organisations, government agencies,
                                            civil society organisations and for-profit life science enterprises, as described in the
                                            Wellcome Trust’s Statement on Sharing Research Data and Findings Relevant to the Coronavirus
                                            (COVID-19) Outbreak to which CEPI is a signatory. Additional guidance is provided in (i)
                                            WHO’s 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks; and
                                            (ii) WHO’s 2016 Guidance on Good Participatory Practices in Trials of Interventions
                                            Against Emerging Pathogens.



 


		9.4	Clinical
                                            Trial Registration and Results:



 


		(a)	Clinical
                                            trials must be registered through an easily discoverable
                                            existing public route such as clinicaltrials.gov, The EU Clinical Trials Register, and/or
                                            the International Clinical Trials Registry Platform, in accordance with all applicable laws
                                            and regulations. The information provided shall follow the current WHO Trial Registration
                                            Data Set. The clinical trial ID or registry identifier code/number shall be included in all
                                            publications of clinical trials.



 




    	15



    	 



    

 


		(b)	Clinical
                                            trial results (including negative results) must be disclosed publicly following database
                                            lock in as close to real time as is possible. Publication should be made through an easily
                                            discoverable existing public route (website or system) that includes a metadata description,
                                            where patient privacy is upheld, and the system follows a request-for-information approach
                                            (where requests are fulfilled subject to an independent review and approval step). Clinical
                                            trial data shall be submitted for publication within four (4) months after each final study
                                            report or comparable report is submitted to CEPI. During the same time period, Awardee shall
                                            make the results available to the national Ministry of Health or equivalent in the countries
                                            where trials are held. Related clinical trial data shall be deposited in an open sharing
                                            platform such as ClinicalStudyDataRequest.com, Vivli Center for Global Clinical Research
                                            Data, or an equivalent service.



 


		9.5	Open
                                            Access. CEPI requires “Open Access”
                                            for all Project Results. This means that the Awardee must ensure that a copy of the final
                                            manuscript of all research publications, journal articles, scholarly monologues and book
                                            chapters published under this Clause 9 is deposited into PubMed Central (or Europe PubMed
                                            Central) or otherwise made freely available upon acceptance for publication or immediately
                                            after the publisher’s official date of final publication. Moreover, Awardee shall ensure
                                            that all peer-reviewed published research that is funded, in whole or in part, by CEPI shall
                                            be published in accordance with the principles of Plan S (“Accelerating the transition
                                            to full and immediate Open Access to scientific publications”), a UK and European data
                                            sharing initiative for research funded by public grants. Awardee shall comply with CEPI’s
                                            reasonable requests to share information in a preprint service such as bioRxiv.



 


		9.6	Statement
                                            of Support in Publications. All such publications
                                            shall include a statement that the work was “supported, in whole or in part, by funding
                                            from CEPI” (or such other words to the same effect) and shall credit, where appropriate,
                                            the country in which any clinical trials were performed.



 


		10	Independent
                                            Assessors:



 


		10.1	Independent
                                            Assessors. As required in a Work Package or as
                                            otherwise reasonably requested by CEPI, Awardee shall cooperate with and provide reasonable
                                            assistance to independent third-party laboratories or consultants (“Assessors”)
                                            (which may include but is not limited to the Task Force for Global Health and its Safety
                                            Platform for Emergency vACcines (SPEAC) Project), retained in confidence and at CEPI’s
                                            expense, to consult on development of clinical trial protocols, explore development strategies,
                                            and evaluate Project Results, including the Project Vaccine. Awardee acknowledges that such
                                            Assessors may provide CEPI with directly comparable evaluations of similar materials developed
                                            under CEPI’s portfolio of awarded projects. The results of the testing, analysis, meta-analysis
                                            or other assessments by such Assessor(s) shall be subject to the confidentiality obligations
                                            of this Agreement. At Awardee’s reasonable request, CEPI shall provide Awardee with
                                            access to the results of any evaluation of Project Results by an Assessor solely to the extent
                                            such assessment directly relates to the Project Results and Project Vacine. For clarity,
                                            CEPI shall not be required to grant access to any information regarding CEPI’s portfolio
                                            of other awarded projects.



 


		10.2	Awardee
                                            and the Assessor(s) may, at their own discretion, enter directly into an appropriate agreement
                                            between themselves to the extent necessary to facilitate any Assessor’s activities
                                            under Clause 10.1, such as a non-disclosure agreement or material transfer agreement. CEPI
                                            shall, through the JMAG or otherwise, discuss with Awardee protocols and data management
                                            related to any Assessor’s activities under Clause 10.1.



 




    	16



    	 



    

 


		10.3	Awardee
                                            Cooperation. Awardee shall provide reasonable assistance
                                            to CEPI and any designated Assessor to facilitate any Assessor’s activities under Clause
                                            10.1, including:



 


		(a)	ensuring
                                            that any samples to be transferred or exported by or on behalf of Awardee from a clinical
                                            trial site or sample storage site are transferred and/or exported pursuant to the terms and
                                            conditions of a material transfer agreement to be entered into between Awardee and the Assessor
                                            in a form reasonably acceptable to CEPI, the Awardee and the Assessor, in addition to any
                                            other applicable laws and regulations.



 


		(b)	cooperating
                                            with regard to any data analysis, to the extent relevant under a given Work Package or otherwise
                                            reasonably requested by CEPI by:



 


		(i)	providing
                                            data or other information generated under this Agreement to CEPI’s designated Assessor
                                            as CEPI may instruct, including data regarding CMC, formulation or the results of any of
                                            its pre-clinical or clinical trials (duly anonymised and, upon CEPI’s request, blinded)
                                            and other documents and information such as study protocols, case report forms needed to
                                            develop standardised approaches and tools for safety data management;



 


		(ii)	providing
                                            CEPI’s designated Assessor with other data (duly anonymised and, upon CEPI’s
                                            request, blinded) as CEPI may reasonably request in order to conduct comparative assessments;
                                            and



 


		(iii)	providing
                                            CEPI’s designated Assessor with clinical trial data (duly anonymised and, at CEPI’s
                                            request, blinded) for the purposes of signal detection or meta-analyses of safety data (including
                                            across product candidates).



 


		11	Compliance:



 


		11.1	Compliance
                                            with applicable laws. Awardee shall comply with
                                            all laws and regulations that are applicable to its activities, operations and use of CEPI
                                            funds under the Project.



 


		11.2	CEPI’s
                                            Third Party Code and Cost Guidance. The Third Party
                                            Code is a statement of CEPI’s values and of the policies, practices and principles
                                            applicable to recipients of CEPI funding. CEPI shall notify Awardee of material changes to
                                            the Code without undue delay. CEPI’s Cost Guidance provides additional information
                                            regarding the treatment of costs.



 


		(a)	Awardee
                                            acknowledges the statement of CEPI’s values in Section 1 of the Code.



 


		(b)	Awardee
                                            shall adhere to business practices, ethical principles and legal requirements that are at
                                            least substantially similar to those described in Sections 2 to 10 of the Code.



 


		(c)	Awardee
                                            confirms that it has understood and will comply with the provisions of the ‘Accurate
                                            Records and Documentation’ paragraph in Section 10 of the Code, which may entail obtaining
                                            records and financial documentation from Sub-Contractors and Sub-Grantees to be provided
                                            to CEPI or its designated auditor.



 


		(d)	Awardee
                                            shall comply with the requirements for reporting compliance concerns and misconduct
                                            to CEPI subject to applicable law (Sections 4 and 11
                                            of the Code).



 




    	17



    	 



    

 


		(e)	Awardee
                                            shall cooperate as may be requested by CEPI in the submission of information related to Project
                                            activities and expenditures in accordance with the International Aid Transparency Initiative
                                            (Section 12 of the Code).



 


		(f)	Awardee
                                            shall comply with CEPI’s Equitable Access Policy, which is further described
                                            in Clause 14 of this Agreement.



 


		(g)	To
                                            the extent applicable to the Project, Awardee shall comply with CEPI’s Animals in Research
                                            Policy.



 


		(h)	To
                                            the extent applicable to the Project, Awardee may rely upon its own substantially similar
                                            policies and principles so as to comply with: (i) CEPI’s Clinical Trials Policy; (ii)
                                            CEPI’s Managing Conflicts of Interest Policy; (iii) CEPI’s Scientific Integrity
                                            Policy; and (iv) CEPI’s Travel and Expenses Policy.



 


		(i)	Awardee
                                            shall comply with the provisions of the Third Party
                                            Code related to Sub-Contracts (Section 14 of the Code) and to Sub-Grants (Section 15 of the
                                            Code).



 


		11.3	Compliance
                                            Audit. During the Term and for a period of five
                                            (5) years after expiration or termination of this Agreement, CEPI, or an auditor appointed
                                            by CEPI, shall be entitled to audit Awardee’s performance of its compliance obligations
                                            under this Agreement, upon reasonable notice. Such audits may include requests for documentation
                                            concerning Awardee’s own costs as well as Subawardees’ costs in connection with
                                            the Project, and Awardee shall use all reasonable endeavours to provide such documentation
                                            to CEPI without undue delay.



 


		11.4	Compliance
                                            by Sub-Contractors and Sub-Grantees. CEPI’s
                                            Third Party Code and Cost Guidance apply to all third parties which receive funds from CEPI,
                                            either directly or indirectly. The compliance obligations in this Clause 11 of the Agreement
                                            therefore also apply to all Sub-Contractors and Sub-Grantees and Awardee shall ensure that
                                            all such Sub-Contractors and Sub-Grantees comply in full with the obligations set out in
                                            this Clause 11.



 


		12	Ready
                                            Reserve of Clinical Trial Material:



 


		12.1	Ready
                                            Reserve. CEPI may instruct and fund Awardee to undertake
                                            the manufacturing and maintenance of a Ready Reserve of Clinical Trial Material through an
                                            additional Work Package, which may include doses from consistency batches if so directed
                                            by CEPI. For purposes of this Agreement, a “Ready Reserve of Clinical Trial Material”
                                            means a quantity of doses for potential use in a clinical trial, which Project Vaccine has
                                            not yet received a marketing approval. Such Ready Reserve of Clinical Trial Material may
                                            be used for further clinical trials, to advance product development and for emergency use
                                            subject to obtaining all necessary regulatory approvals and consents, in each case in emergency
                                            situations based on national or international guidance (such as from WHO) or in such other
                                            manner, in each case as CEPI may reasonably determine. If required by CEPI, an additional
                                            Work Package covering such activities shall be negotiated expeditiously and in good faith
                                            by the Parties.



 


		12.2	Management
                                            of Ready Reserve. The Parties agree that CEPI may
                                            delegate the management of the Ready Reserve of Clinical Trial Material to WHO or another
                                            CEPI designee, at its discretion.



 




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		13	Project
                                            Continuity:



 


		13.1	Awardee
                                            Contingency Plan. Awardee shall prepare and maintain
                                            a contingency plan to minimise any potential disruption to the Project, and provide a copy
                                            of the plan to CEPI in confidence as it relates to the Project as required under the iPDP.



 


		13.2	Project
                                            Continuity Plan. Because of the exigent nature
                                            of the Outbreak, the iPDP shall include a Project Continuity Plan that, at a minimum, shall
                                            address the following items:



 


		(a)	responsibilities
                                            and level of access on the part of other collaborators, Subawardees and consortium members,
                                            if any, to Project Results and Enabling Rights;



 


		(b)	management
                                            of key Project Materials through participants in the Project and other entities such as the
                                            BioEscrow® deposit service of the American Type Culture Collection;



 


		(c)	identification
                                            of a proposed third party, within a timeframe to be established in the iPDP, such as a Subawardee,
                                            under contract to Awardee, which is capable of performing the activities in agreed Work Packages,
                                            any additional Work Packages or a Project expansion (“Trusted Collaborator”),
                                            in the event that Awardee is unable to continue its activities under this Agreement or declines
                                            CEPI’s request to undertake additional Work Packages or a Project expansion. Awardee’s
                                            Subawardee agreement(s) with Trusted Collaborator shall expressly permit Awardee to assign
                                            the agreement to CEPI if so requested by CEPI pursuant to Clause 13.6; and



 


		(d)	requirement
                                            for the Awardee to use its reasonable endeavours to sign Subawardee agreement(s) with one
                                            or more operational manufacturing facilities at one or more geographically dispersed manufacturing
                                            sites located in LMICs, within a timeframe to be established in the iPDP, or
                                            within such other time period as may be set out in the iPDP from time to time, which
                                            Awardee will contract with as described in the iPDP to
                                            produce Project Vaccine for use in the Field (“Trusted Manufacturer”).
                                            Awardee’s Subawardee agreement(s) with Trusted Manufacturer(s) shall (i) comply with
                                            the relevant requirements of this Agreement; (ii) enable Awardee to use the Trusted
                                            Manufacturers to produce the Project Vaccine for supply in accordance with Clause 15.5 (Volume
                                            Commitment); (iii) shall include a right for CEPI to
                                            reserve manufacturing capacity with the Trusted Manufacturer; and (iv) shall expressly permit
                                            Awardee to assign the agreement to CEPI if so requested by CEPI pursuant to Clause 13.6.
                                            The terms of such Subawardee agreement shall be subject to CEPI’s prior written consent.
                                            Awardee shall notify CEPI of the identity of the Trusted Manufacturer(s) and provide
                                            a copy of the relevant final Subawardee agreement(s) to CEPI without undue delay after the
                                            entry into the Subawardee agreement(s).



 


		13.3	Alternative
                                            Designations by CEPI. If Awardee does not designate
                                            a Trusted Collaborator and/or Trusted Manufacturer, or a designated Trusted Collaborator
                                            and/or Trusted Manufacturer notifies Awardee that they are no longer available, then CEPI
                                            may propose a Trusted Collaborator or Trusted Manufacturer to Awardee. Neither Party may
                                            unreasonably decline to accept the designation of a proposed Trusted Collaborator under Clause
                                            13.2 or this Clause 13.3. Once designated and under contract to pursue Project activities,
                                            a Trusted Collaborator and Trusted Manufacturer shall be a Subawardee for the purposes of
                                            this Agreement.



 


		13.4	Public
                                            Health Licence. Subject to the terms of this Agreement,
                                            Awardee hereby grants (and shall ensure that each Subawardee grants) a worldwide, non-exclusive,
                                            irrevocable, fully paid up, royalty free Public Health Licence to CEPI, on the condition
                                            that CEPI may only exercise the rights granted under the Public Health Licence in the event
                                            that:



 




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		(a)	CEPI
                                            is not in material breach of its obligations under this Agreement; and



 


		(b)	one
                                            or more of the triggers set out in Clause 13.5 has occurred.



 


CEPI
shall be entitled to sublicense Project Results and Enabling Rights included in the Public Health Licence in accordance with this Clause
13. Each sublicence shall be in writing and CEPI
shall require that each sublicensee complies with the terms of the Public Health Licence.


 


		13.5	Public
                                            Health Licence Triggers. Consistent with Clause
                                            13.4, CEPI shall have the right to exercise the Public Health Licence in the event that any
                                            one or more of the following events occurs:



 


		(a)	Awardee
                                            declines
                                            to participate in an additional Work Package or Project expansion that CEPI has offered to
                                            fund, either directly or indirectly through a Subawardee;



 


		(b)	CEPI
                                            and Awardee
                                            agree, in good faith, that Awardee shall not be able to perform the activities under an agreed
                                            Work Package, either directly or indirectly through a Subawardee;



 


		(c)	Awardee
                                            is in material
                                            breach of this Agreement or the Equitable Access Plan and has not cured such breach within
                                            thirty (30) Business Days of notification of such breach by CEPI, unless otherwise mutually
                                            agreed in writing; or



 


		(d)	the
                                            Agreement
                                            is terminated by CEPI pursuant to Clause 20.2(a)-(b) (default or insolvency) or 20.3(c) –
                                            (e) (unavailability to perform Project activities, failure to satisfy payment criteria or
                                            fraud).



 


For
clarity, CEPI shall only have the right to exercise the Public Health Licence in the events set out in Clauses 13.5(a) and (b) during
the Term.


 


In
the event that CEPI exercises the Public Health Licence, CEPI shall provide prompt written notice of such exercise to VBI and shall use
its reasonable endeavours to exploit the rights granted to it under such Public Health Licence. On expiry of the later of (i) the Term;
(ii) the date that is five years from the end of the Pandemic Period; or (ii) ten years from the Effective Date; and provided that CEPI
has not exercised its rights under the Public Health License in accordance with this Clause 13.5, the Public Health License granted pursuant
to Clause 13.4 shall lapse and be of no further force and effect.


 


		13.6	Agreement
                                            between CEPI and the Trusted Collaborator or Trusted Manufacturer. In the event that
                                            the Public Health Licence is exercised, CEPI may request assignment of the relevant Trusted
                                            Collaborator or Trusted Manufacturer contracts from Awardee to CEPI or, at CEPI’s discretion,
                                            CEPI may endeavour to reach agreement directly with the Trusted Collaborator and/or Trusted
                                            Manufacturer, as the case may be, to perform such activities as CEPI may deem necessary.
                                            At CEPI’s request, Awardee shall use all reasonable endeavours to facilitate the conclusion
                                            of a direct contractual relationship between the Trusted Collaborator or Trusted Manufacturer,
                                            as the case may be, and CEPI. If those negotiations do not result in an agreement within
                                            twenty (20) Business Days from the initiation of negotiations, then CEPI may grant rights
                                            under its Public Health Licence to a third party unilaterally designated by CEPI as a Trusted
                                            Collaborator or Trusted Manufacturer, without approval from Awardee.



 


		13.7	Effects
                                            of Exercise of the Public Health Licence. Upon
                                            exercise of the Public Health Licence by CEPI and provision of written notice to Awardee,
                                            Awardee shall promptly:



 




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		(a)	provide
                                            CEPI with an up-to-date list of Enabling Rights and applicable Background IP, along with
                                            an invoice for any payments due under any licence agreement for Third Party Background IP
                                            attributable to the grant of the Public Health Licence to CEPI or a sublicensee;



 


		(b)	provide
                                            CEPI with a good faith schedule of key technology transfer activities and estimated direct
                                            costs for the technology transfer in Clause 13.6;



 


		(c)	promptly
                                            and diligently transfer to the Trusted Collaborator and/or
                                            Trusted Manufacturer, as the case may be,
                                            all Project Results, Project Materials described in Clause 13.2(b), all guidance, information,
                                            materials and assistance reasonably required to accomplish the Project activities identified
                                            by CEPI. Such transfer shall be (i) in the event the Public Health Licence is exercised by
                                            CEPI pursuant to Clause 13.5(a) or (b), at CEPI’s reasonable cost; or (ii) in the event
                                            the Public Health Licence is exercised by CEPI pursuant to Clause 13.5(c) or (d), at Awardee’s
                                            cost; and



 


		(d)	and
                                            Awardee hereby does undertake not to sue CEPI or its designee for the exercise of the Public
                                            Health Licence.



 


		14	Further
                                            Development Projects:



 


		14.1	Additional
                                            COVID-19 Candidate. During the Term (including any period of continued funding), CEPI
                                            shall have the first right (but not the obligation), at CEPI’s sole discretion, to
                                            elect to contribute funding to support the Awardee for the development, manufacture and deployment
                                            of any Additional COVID-19 Candidate. In the event that Awardee identifies any Additional
                                            COVID-19 Candidate, Awardee shall provide prompt written notice to CEPI of the existence
                                            of such Additional COVID-19 Candidate (an “Additional COVID-19 Candidate Notice”)
                                            and shall provide to CEPI a summary of all material information and data regarding such Additional
                                            COVID-19 Candidate available to Awardee. Awardee shall further provide to CEPI all such information
                                            as CEPI may reasonably request regarding such Additional COVID-19 Candidate in order for
                                            CEPI to evaluate its interest in providing funding support for the development, manufacture
                                            and/or deployment of such Additional COVID-19 Candidate. Within thirty (30) days of receipt
                                            by CEPI of any Additional COVID-19 Candidate Notice, CEPI shall provide written notice to
                                            Awardee of its desire to provide funding support to Awardee for the development, manufacture
                                            and deployment of such Additional COVID-19 Candidate. If CEPI elects to provide such funding
                                            support to Awardee, Awardee and CEPI shall discuss and agree, in good faith, a Work Package
                                            detailing the rapid development, manufacture and deployment of the Additional COVID-19 Candidate
                                            and, following the written agreement of both Parties to the Work Package and updated iPDP,
                                            such Additional COVID-19 Candidate shall become a Project Vaccine. If CEPI does not elect
                                            to provide funding support in respect of any Additional COVID-19 Candidate within thirty
                                            (30) days of receipt by CEPI of any Additional COVID-19 Candidate Notice, then Awardee shall
                                            be free to develop and seek funding from any third party for such development of the relevant
                                            Additional COVID-19 Candidate.



 


		14.2	Disease
                                            X Project. During the Term and for a period of five (5) years after expiration or termination
                                            of this Agreement, CEPI may provide written notice to the Awardee at any time if it wishes
                                            to discuss the funding of a further project to be performed by Awardee for the development,
                                            manufacture and/or deployment of a platform technology which could be used in respect of
                                            any unknown “disease X” that poses (or has the potential to pose) an increased
                                            public health risk due to its epidemic potential, as may be identified by CEPI or listed
                                            on the WHO Blueprint from time to time. For a period of five (5) years after expiration or
                                            termination of this Agreement, CEPI may also provide written notice to the Awardee at any
                                            time if it wishes to discuss the funding of any Additional COVID-19 Candidate. Following
                                            receipt of any such written notice by Awardee, CEPI and Awardee shall negotiate expeditiously
                                            and in good faith the terms of a new agreement for any such further project, and any funding
                                            to be provided by CEPI to Awardee in respect of such project for a period of up to ninety
                                            (90) days. Both Parties shall use their reasonable endeavours to agree to terms relating
                                            to any such further project within ninety (90) days but neither party shall be obligated
                                            to enter into an agreement. For clarity, neither Party shall be deemed to have defaulted
                                            under or to be in breach of this Section
                                            14.2 for failure to agree such terms within the ninety
                                            (90) day period, provided that the relevant Party has used its commercially reasonable endeavours
                                            to do so.



 




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		15	Equitable
                                            Access:



 


		15.1	Commitment
                                            to Equitable Access. The Awardee and CEPI each confirm that they are committed to achieving
                                            “Equitable Access” to the results of all CEPI-supported programmes whether in
                                            an outbreak or pandemic situation in accordance with the “Equitable Access Policy”
                                            referenced in CEPI’s Third Party Code and in Clause 11.2. Equitable Access means that
                                            a Project Vaccine will be made available first to populations at risk when and where they
                                            are needed at affordable prices.



 


		15.2	Project
                                            Vaccine Registration. Awardee shall cooperate
                                            with CEPI or CEPI’s designee to take such actions as are reasonably agreed and funded
                                            as agreed between the Parties in the Budget to register Project Vaccines in countries identified
                                            as priorities which are set out in the iPDP or as may be mutually agreed by the Parties in
                                            an advanced purchase agreement or otherwise.
                                            If Awardee is not the licence holder for the purposes of registration in a given country,
                                            then Awardee shall be responsible for ensuring that any applicable Subawardee facilitates
                                            such registrations as instructed by and funded as agreed between the Parties in the Budget.
                                            As soon as practicable, Awardee shall liaise with WHO to apply for WHO pre-qualification
                                            or a similar registration system to the extent available and shall implement such systems
                                            as soon as they have been approved by WHO.



 


		15.3	Global
                                            Allocation and Purchase. It is the Parties’ expectation that Gavi, pursuant to
                                            COVAX (or a similar purchasing entity as otherwise reasonably directed by CEPI), shall provide
                                            funding to purchase the Project Vaccine and be responsible for its allocation. Awardee shall
                                            respond promptly to any Gavi or UNICEF or CEPI identified Request for Proposal for a COVID-19
                                            vaccine. Awardee shall negotiate in good faith with Gavi (or as otherwise reasonably directed
                                            by CEPI) to sign a purchase commitment or purchase order to supply Project Vaccine as may
                                            be required by Gavi, CEPI or any designee of Gavi or CEPI whether during or after a Pandemic
                                            Period, in accordance with and subject to the provisions of Clauses 15.5 and 15.7. As part
                                            of the good faith negotiation, the Parties shall negotiate and settle the costs, expenses
                                            and other factors to be used in the calculation of COGs, such negotiation and settlement
                                            to, at all times, be guided by and reflect the principle that Awardee shall not suffer financial
                                            losses when supplying Project Vaccine to any market and take into account the amount of funding
                                            provided by CEPI and any other grants or public funding received by Awardee or Subawardee
                                            from third parties.



 


		15.4	Pandemic
                                            Period Production Reporting. During the Pandemic Period, Awardee shall:



 


		(a)	provide
                                            the JMAG with a regularly updated quarterly statement of its actual capacity and a forecast
                                            of its planned capacity for the following four (4) calendar quarters for the manufacturing
                                            of Project Vaccine under this Agreement and otherwise;



 


		(b)	provide
                                            the JMAG with advance notice in writing of all manufacturing runs for the Project Vaccine
                                            in accordance with agreed forcasting;



 


		(c)	discuss
                                            in good faith with the JMAG how to achieve its requirements for doses of Project Vaccine,
                                            including any potential increase in Awardee’s manufacturing capacity.



 




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		15.5	Volume
                                            Commitment. Awardee shall:



 


		(a)	during
                                            the Pandemic Period, produce Project Vaccine in quantities which shall be at least equal
                                            to the quantities described in the Work Package(s);



 


		(b)	during
                                            the Pandemic Period, subject only to the Awardee’s supply obligations under the Pre-existing
                                            Agreements (including Section 6.3.1 of the Canada Agreement) which have been communicated
                                            to CEPI as required under the iPDP, offer the Volume Commitment Percentage of the Project
                                            Vaccine produced pursuant to Clause 15.5(a) for purchase by Gavi, CEPI or their respective
                                            designees pursuant to Clause 15.3 during the Pandemic Period. For clarity, Awardee may not
                                            allocate or agree to supply such Project Vaccine doses to other third parties, other than
                                            as required pursuant to the Pre-existing Agreements, during the Pandemic Period without the
                                            express written permission of Gavi, CEPI or their respective designee;



 


		(c)	After
                                            the Pandemic Period, for a period lasting until the later of (i) five years from the end
                                            of the Pandemic Period; or (ii) ten years from the Effective Date; subject
                                            to the same limitations as Section 15.5(b), if CEPI determines in its reasonable discretion
                                            in consultation with the Awardee that a regional but not a global Outbreak exists, then Awardee
                                            shall offer a percent of the total quantity of the Project Vaccine produced for purchase
                                            by Gavi, CEPI or their respective designees pursuant to Clause 15.3 equal to the Volume Commitment
                                            Percentage multiplied by the percentage of the world population that resides in the region
                                            in which the Outbreak exists; save that where a regional Outbreak exists in a relatively
                                            small population (as reasonably determined by CEPI), the Parties shall discuss in good faith
                                            an increase in the Volume Commitment Percentage in order to adequately address such an Outbreak.
                                            For example, if the Volume Commitment Percentage was ** and there was an Outbreak in Africa,
                                            then, based on 2020 census data, approximately ** of Project Vaccine would be offered for
                                            purchase by Gavi;



 


		(d)	supply
                                            Project Vaccine doses to COVAX in a timely manner that enables COVAX represented economies
                                            to receive Project Vaccine in a similar timeframe to other third party customers;



 


		(e)	consistent
                                            with the commitments in Clauses 15.4 to 15.6, subject only to the Awardee’s supply
                                            obligations under the Pre-existing Agreements (including Section 6.3.1 of the Canada Agreement)
                                            which have been communicated to CEPI as required under the iPDP, sell the Project Vaccine
                                            doses to Gavi, CEPI or their respective designees during and after the Pandemic Period pursuant
                                            to Clause 15.3; and



 


		(f)	upon
                                            receipt of written request from CEPI, provide reasonable information to CEPI about its production,
                                            supply, pricing and sales of Project Vaccine which is sufficient for CEPI to evaluate whether
                                            such activities are in accordance with Awardee’s obligations under this Agreement;
                                            



 


		(g)	subject
                                            only to the Awardee’s supply obligations under the Pre-existing Agreements (including
                                            Section 6.3.1 of the Canada Agreement) which have been communicated to CEPI as required under
                                            the iPDP, use its Commercially Reasonable Efforts to provide an amount of doses to be reasonably
                                            determined by CEPI based on the Awardee’s worldwide supply capacity and the level and
                                            timing of CEPI’s funding contribution to the global initiative “Access to COVID-19
                                            Tools (act) Accelerator” so as to ensure availability for all, subject to the inclusion
                                            of satisfactory liability protection (which may include participation in the Gavi no fault
                                            compensation programme) and regulatory conditions. This Agreement does not cover specific
                                            details with regard to the provision of doses to the COVID-19 Tools (act) Accelerator to
                                            be concluded and agreed separately with the relevant parties involved.



 




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		15.6	Commercially
                                            Reasonable Efforts. With regard to its obligations
                                            under this Agreement, Awardee shall use its Commercially Reasonable Efforts to address the
                                            urgent medical need created by the COVID-19 pandemic by fulfilling such obligations, including
                                            achieving the objectives and timelines of each Work Package (including each Stage Gate in
                                            a Work Package) within the agreed timeframe, it being agreed that Awardee does not represent
                                            or warrant any particular outcome for any Work Package or any activity described in a Work
                                            Package or this Agreement.



 


		15.7	Post-Pandemic
                                            Period Production and Supply. After the Pandemic Period, for a period lasting until the
                                            later of (i) five years from the end of the Pandemic Period; or (ii) ten years from the Effective
                                            Date, Awardee shall continue to produce and supply the Project Vaccine for purchase by Gavi,
                                            CEPI or their respective designees pursuant to Clause 15.3, as is required by Gavi, CEPI
                                            or their respective designees to meet the needs of AMC Countries for so long as there is
                                            demand for such supply, which quantity shall be set out in an advanced purchase agreement
                                            between the Awardee and Gavi, CEPI or their respective designees. Awardee shall negotiate
                                            and agree on the terms of any such advanced purchase agreement with Gavi, CEPI or their respective
                                            designees expeditiously and in good faith but Awardee shall not, for greater certainty, be
                                            subject to any commitments regarding volume save as otherwise set forth in Clause 15.5(c).
                                            Awardee undertakes to continue to sell Project Vaccine after the Pandemic Period for a period
                                            lasting until the later of (i) five years from the end of the Pandemic Period; or (ii) ten
                                            years from the Effective Date, to AMC Countries and to public sector entities that procure
                                            the Project Vaccine for use in AMC Countries (if there is a demand for such supply), at a
                                            reasonable price to achieve Equitable Access for populations in need of a Project Vaccine
                                            as well as an appropriate return on investment for
                                            vaccine manufacturers, and ensuring that on-going supply is commercially sustainable.



 


		15.8	Re-emergence
                                            of Pandemic: In the event that the Pandemic Period has ended but there is a re-emergent
                                            pandemic caused by SARS-CoV-2, then the Parties shall negotiate in good faith to amend the
                                            agreement to address the Parties obligations during that period, in a manner consistent with
                                            the principles of Equitable Access applicable to the Pandemic Period set out in this Clause
                                            15 (including in respect of timelines, supply volume and access).



 


		15.9	Pricing
                                            Objectives. The Parties acknowledge that the price
                                            of the Project Vaccine is critical to achieving Equitable Access. Accordingly, Awardee agrees
                                            that its pricing shall be as reasonably required to achieve both Equitable Access for populations
                                            in need of a Project Vaccine as well as an appropriate return on investment for vaccine manufacturers,
                                            and ensuring that on-going supply is commercially sustainable. The Parties acknowledge that
                                            the availability of pandemic insurance as described in Clause 18.7 shall be relevant to pricing.
                                            For clarity the following shall be considered to have satisfied the Equitable Access Plan
                                            for the relevant doses of Project Vaccine:



 


		(a)	the
                                            purchase of Project Vaccine by Gavi, CEPI or their respective designee during the Pandemic
                                            Period as described above in this Clause 15;



 




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		(b)	during
                                            the Pandemic Period, and in respect of any region in which an epidemic is determined to exist
                                            according to Section 15.5(c), the sale of the Project Vaccine to Gavi, CEPI or their respective
                                            designee at no more than (i) ** 
                                            for allocation to LMICs; (ii) ** for allocation to
                                            UMICs and (iii) ** for allocation to HICs; provided always that in each case the sale of
                                            the Project Vaccine to Gavi, CEPI or their respective designee shall be at a price that is
                                            no higher than the lowest price at which Awardee sells the Project Vaccine to any third party
                                            in respect of the relevant country other than as contemplated by the Canada Agreement;



 


		(c)	after
                                            the Pandemic Period for
                                            a period ending on the later of (i) five years from the end of the Pandemic Period; or (ii)
                                            ten years from the Effective Date, the sale of the
                                            Project Vaccine to Gavi, CEPI or their respective designee at no more than ** for allocation
                                            to LMICs, provided always that in each case the sale of the Project Vaccine to Gavi, CEPI
                                            or their respective designee shall be at a price that is no higher than the lowest price
                                            at which Awardee sells the Project Vaccine to any third party in respect of the relevant
                                            country; and 



 


		(d)	during
                                            the Pandemic Period and after the Pandemic Period for
                                            a period ending on the later of (i) five years from the end of the Pandemic Period; or (ii)
                                            ten years from the Effective Date, the sale of the
                                            Project Vaccine not acquired by Gavi, CEPI or their respective designee at no more than **
                                            for allocation to LMICs.



 


		15.10	Costs
                                            and Sales.
                                            Consistent with the commitments and limitations in Clauses 15.4 to 15.9, Awardee shall:



 


		(a)	provide
                                            written quarterly updates to the JMAG during the Term and to CEPI during any period after
                                            the expiry of the Term that Awardee is making sales of Project Vaccine pursuant to Section
                                            15.3 regarding its COGs for Project Vaccines and discuss relevant product development decisions
                                            that could affect COGs; and



 


		(b)	sell
                                            the Project Vaccine doses to Gavi, CEPI, or CEPI’s designee during and after the Pandemic
                                            Period pursuant to Clause 15.3.



 


		15.11	Information
                                            about Production, Supply, Pricing and Sales.
                                            At any time during the Term, and during any period after expiry of the Term that Awardee
                                            is making sales of Project Vaccine pursuant to Section 15.3, upon written request by CEPI,
                                            Awardee shall provide reasonable information
                                            about its COGs, production, supply, pricing and sales of Project Vaccine sufficient to enable
                                            CEPI to evaluate whether such activities meet the Equitable Access Policy.



 


		15.12	Audit
                                            of Cost of Goods.
                                            At any time during the Term, and during any period after expiry of the Term until the date
                                            that is five (5) years after the expiry of any pricing obligations pursuant to Clause 15.9,
                                            no more than once per twelve (12) month period and
                                            at CEPI’s reasonable cost, CEPI shall have the right to review or to designate
                                            an external auditor (which shall be an internationally
                                            recognised certified public accounting firm, not engaged on a contingent basis) to
                                            review Awardee’s financial records relevant to the information provided in Clause 15.9.
                                            Such audits will be conducted during normal operating
                                            hours in a manner which minimises disruption to Awardee’s business. In the event
                                            that the audit concludes that the COGs and production, allocation, supply or pricing of Project
                                            Vaccine doses are not substantially in accordance with the pricing obligations in Clause
                                            15, then Awardee shall: (i) reimburse the reasonable costs of the audit; and (ii) take immediate
                                            steps, as advised by the auditors, to comply with the requirements of this Clause 5. The
                                            provisions of this Clause 15.12 shall also apply to any Subawardees and Trusted Collaborators.



 




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		15.13	Equitable
                                            Access Plan.
                                            The Equitable Access Plan shall be reviewed by JMAG no less than every six (6) months and
                                            shall take into account changes in COGs over time, production yield and volume and production
                                            economics. The Equitable Access Plan shall be regularly updated during the Term of this Agreement.



 


		15.14	Alternative
                                            to Purchase by Gavi.
                                            In the event that Gavi does not procure Project Vaccine as set out by the Parties in Clause
                                            15.3, or does not continue such activities after the Pandemic Period relevant to this Clause
                                            15, then CEPI, or its designee or their designated purchasing agent(s), shall have the rights
                                            accorded to Gavi in this Clause 15.



 


		16	Commercial
                                            Benefits:



 


		16.1	Commercial
                                            Benefits. CEPI is required by its own funders to
                                            obtain a share of any Awardee’s Commercial Benefits as a contribution to support CEPI’s
                                            programme activities. For clarity, examples of Commercial Benefits include the sales of a
                                            Project Vaccine at market prices, commercial licensing of Project IP, receipt of government-granted
                                            incentives such as Priority Review Vouchers and revenue from the commercialisation of combination,
                                            derivative or follow-on products (including antibody products, assays and vaccines) or application
                                            of production technology resulting in whole or part from CEPI funding.



 


		16.2	Waiver
                                            of Commercial Benefits. In consideration for Awardee’s acceptance and compliance
                                            with the provisions of Clause 15, CEPI agrees to forgo any share of potential Commercial
                                            Benefits otherwise applicable under Sub-Clause 16.1 during the Pandemic Period. Following
                                            the Pandemic Period and except during a period of regional Outbreak pursuant to Section 15.5.(c),
                                            the Awardee shall promptly notify CEPI of any Commercial Benefits in respect of any sales
                                            of a Project Vaccine for which CEPI provides funding through Phase 2 clinical studies (or
                                            any Project Vaccine if (i) this Agreement is terminated by CEPI pursuant to Clause 20.2 or
                                            Clause 20.3(c) – (e); or (ii) Awardee does not accept further funding from CEPI offered
                                            on similar terms to those set out in this Agreement) in any country other than an AMC Country.
                                            Following receipt by CEPI of any such notice, Awardee and CEPI shall discuss the sharing
                                            of such Commercial Benefits in the Field, commensurate with CEPI’s funding contributions
                                            and stage of investment, through an appropriate mechanism agreed in good faith by the Parties
                                            within ninety (90) days.



 


		17	Representations
                                            and Warranties:



 


		17.1	Awardee
                                            Warranties. Awardee warrants that the following
                                            statements are true and correct to its reasonable knowledge and belief in so far as they
                                            relate to the Project as of the Effective Date:



 


		(a)	it
                                            has the full power and authority to enter into and assume its obligations under this Agreement;



 


		(b)	this
                                            Agreement has been duly executed and is legally binding and enforceable in accordance with
                                            its terms:



 


		(c)	it
                                            is in material compliance with all statutes, regulations, directives and requirements of
                                            any governmental entity;



 


		(d)	it
                                            does not infringe, misappropriate or violate the intellectual property, privacy or publicity
                                            rights of any third party;



 




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		(e)	it
                                            is not under any obligation, contractual or otherwise, to any person or third party in respect
                                            of the Enabling Rights that conflicts with or is inconsistent in any material respect with
                                            the terms of this Agreement or that would impede the complete fulfillment of its obligations
                                            under this Agreement;



 


		(f)	it
                                            has disclosed in writing to CEPI any actual or contemplated commitments or obligations to
                                            third parties for Project Vaccine doses;



 


		(g)	it
                                            has identified Enabling Rights in writing to CEPI;



 


		(h)	neither
                                            Awardee nor agreed Subawardees, if any, nor any officer or employee of the foregoing has
                                            been debarred or is subject to debarment by a regulatory authority or funding agency anywhere
                                            in the world;



 


		(i)	all
                                            financial and other information submitted to CEPI in relation to this Agreement is true,
                                            complete and accurate in all material respects; and



 


		(j)	to
                                            the extent that Awardee relies upon its own processes, procedures and policies to the extent
                                            specifically permitted for purposes of compliance with Clause 11.2, such processes, procedures
                                            and policies are substantially similar to those of CEPI.



 


		17.2	Awardee
                                            Representations. During the Term of this Agreement,
                                            Awardee shall:



 


		(a)	notify
                                            CEPI promptly in writing in the event that any of the warranties set out in Sub-Clause 17.1
                                            are no longer true and correct, and shall so notify CEPI at least at the time that Awardee
                                            requests any disbursement of Project funds;



 


		(b)	provide
                                            written updates to the JMAG regarding Enabling Rights acquired or created during the course
                                            of the Project;



 


		(c)	notify
                                            CEPI before accepting third-party funds related to the Project (not including public financings
                                            on a stock exchange, receipt of funds pursuant to the Canada Agreement or receipt of funds
                                            pursuant to the Loan and Guaranty Agreement dated May 22, 2020 between Variation Biotechnologies
                                            Inc., the Awardee and K2 Health Ventures LLC ); 



 


		(d)	make
                                            no encumbrances over, dispose of, or otherwise deal with the Project Results,
                                            Project Intellectual Property and/or Enabling Rights in any way that could be reasonably
                                            deemed inconsistent with this Agreement, including the Public Health
                                            Licence, or that could impede the complete fulfillment of its obligations under this
                                            Agreement, without the express written permission of
                                            CEPI; and



 


		(e)	notify
                                            CEPI promptly if it becomes aware that any actions are likely or have already been taken
                                            by the government of any country in which Awardee shall conduct Project activities that may
                                            adversely affect Awardee’s commitments in this Agreement, including Equitable Access.
                                            For clarity, such government actions may relate, for example, to the exercise of eminent
                                            domain or sovereign rights over Project Vaccine doses.



 




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		17.3	Additional
                                            Awardee Representation. In the event that the Public
                                            Health Licence becomes exercisable and irrespective
                                            of whether the Agreement has expired or been terminated, Awardee shall make no encumbrances
                                            over, dispose of, or otherwise deal with the Project Results, Project Intellectual Property
                                            and/or Enabling Rights, in any way that may be inconsistent with the Public Health Licence,
                                            without the express written permission of CEPI.



 


		17.4	CEPI
                                            Warranties. CEPI warrants that the following
                                            statements are true and correct to its reasonable knowledge and belief, in so far as they
                                            relate to the Project:



 


		(a)	it
                                            has the full power and authority to enter into and assume its obligations under this Agreement;



 


		(b)	it
                                            is in material compliance with all statutes, regulations, directives and requirements
                                            of any governmental entity; and



 


		(c)	it
                                            has not granted rights to any third party in respect of Project Results (other than in accordance
                                            with the terms of this Agreement).



 


		17.5	No
                                            Other Warranties.
                                            EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NO PARTY MAKES, AND EACH PARTY EXPRESSLY
                                            DISCLAIMS, ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES
                                            OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENTS, NON-INFRINGEMENT
                                            OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING,
                                            USAGE OR TRADE PRACTICES.



 


		18	Insurance,
                                            Liability and Indemnification:



 


		18.1	Insurance.
                                            Awardee shall maintain insurance sufficient to cover the activities, risks, and potential
                                            omissions relevant to the Project, including clinical trial liability insurance cover, in
                                            accordance with generally accepted industry standards and as required by law. Awardee
                                            shall provide CEPI with a certificate confirming such
                                            insurance upon request. In the event that the Public Health Licence becomes exercisable and
                                            CEPI exercises such rights, CEPI shall maintain comparable insurance protection.



 


		18.2	Indemnification
                                            for Third Party Claims.
                                            Awardee shall indemnify and defend CEPI, its Affiliates, officers, directors, third party
                                            contractors, and employees, from and against any and all damages, and liabilities arising
                                            from claims asserted by third parties (including claims for negligence) which arise directly
                                            or indirectly out of or in connection with: (i) a breach of Awardee’s, or its Affiliate’s
                                            or Subawardee’s obligations under this Agreement; (ii) the research, development, manufacture,
                                            promotion or use of any Project Vaccine, Project Results or Enabling Rights (including for
                                            clarity, the use of any Project Results in development activities and clinical studies) conducted
                                            by Awardee, or its Affiliates or Subawardees; or (iii) any claim that the use of Awardee’s
                                            Intellectual Property Rights infringe the intellectual property rights of any third party,
                                            except to the extent such claim, damage or liability is caused by CEPI’s negligence
                                            or intentional misconduct. In the event that the Public Health Licence becomes exercisable
                                            and CEPI exercises such rights, the obligations of this Clause 18.2 shall apply to CEPI mutatis
                                            mutandis.



 




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		18.3	Conduct
                                            of Responses to Third Party Claims. Each Party
                                            shall use all reasonable endeavours to inform the other Party promptly of any circumstances
                                            that are likely to give rise to a third party claim which may be covered by Clause 18.2 together
                                            with copies of all relevant papers and official documents. The indemnified party shall not
                                            take any material action in respect of any third party claim which is covered by Clause 18.2
                                            without the consent of the indemnifying party, including any settlement of any such third
                                            party claim, provided such consent is not unreasonably conditioned, withheld or delayed.
                                            The indemnifying party shall have the right to assume control of defence of the claim and
                                            shall keep the indemnified party fully informed of the progress of all relevant third party
                                            claims which are covered by Clause 18.2 and shall fully consult with the indemnified party
                                            on the nature of any defence to be advanced in advance. The indemnified party may have its
                                            counsel participate in (but not control) the defence of a claim, at the indemnified party’s
                                            own expense.



 


		18.4	Exclusions.
                                            Except in the event of a breach of a Party’s confidentiality obligations under Clause
                                            19, neither Party shall be liable to the other Party for any loss of profits or economic
                                            loss; or indirect, incidental or consequential damages, whether in contract, warranty, negligence,
                                            tort, strict liability or otherwise, arising out of or in connection with any breach of or
                                            failure to perform any of the provisions of this Agreement.



 


		18.5	Liability
                                            Cap. CEPI’s maximum liability in aggregate
                                            to Awardee arising out of this Agreement shall not exceed the aggregate of the total Work
                                            Package budget unless CEPI has exercised the Public Health Licence in which event CEPI’s
                                            maximum liability to Awardee arising out of this Agreement shall not exceed the greater of:
                                            (i) the aggregate of the total Work Package budget or (ii) CEPI’s total insurance cover
                                            for any clinical trials or provision of Project Vaccine under the Public Health Licence.
                                            



 


		18.6	Exclusions
                                            from Liability Cap. Notwithstanding the foregoing,
                                            nothing in this Agreement shall limit the liability
                                            of either Party in respect of: (i) personal injury or death arising out of that Party’s
                                            negligence or intentional misconduct; or (ii) fraud or fraudulent misrepresentation or intentional
                                            misconduct.



 


		18.7	Pandemic
                                            Insurance.
                                            The Parties acknowledge that, as of the Effective Date, WHO is considering an insurance mechanism
                                            that would provide insurance cover for the suppliers of investigational products for use
                                            in the case of a PHEIC declared by WHO. The Parties agree that, if and when this mechanism
                                            is established, they shall discuss in good faith the impact of such arrangements on the Parties’
                                            obligations under this Agreement and how it would apply to the supply of Project Vaccines.



 


		19	Confidentiality:



 


		19.1	Confidential
                                            Information. Confidential Information means non-public
                                            information disclosed by one Party to the other and includes, in the case of Awardee, non-public
                                            information relating to its products, inventions, clinical trials and data. For avoidance
                                            of doubt, for so long as none of the exceptions in Clause 19.2 apply, COGs, production,
                                            supply, pricing and sales of Project Vaccine shall
                                            be deemed Confidential Information of Awardee, provided however that CEPI shall have the
                                            right to use and disclose such Confidential Information in a manner that anonymises Awardee’s
                                            identity by aggregating it with similar information from other of CEPI’s awardees or
                                            third parties. Each Party undertakes that during the Term of this Agreement as defined in
                                            Sub-Clause 20.1 and for five (5) years after its expiry or termination, it shall keep confidential
                                            and not disclose the other Party’s Confidential Information to any person other than
                                            its employees, agents, consultants, contractors, professional advisers, Subawardees and regulatory
                                            authorities and, in the case of CEPI, Gavi, COVAX, its funders and Assessors, who have a
                                            need to know and agree to respect its confidentiality. Each Party shall take commercially
                                            reasonable precautions to protect against unauthorised disclosure and shall use the other
                                            Party’s Confidential Information only for the purposes of carrying out is obligations
                                            under, and achieving this objectives of, this Agreement. For clarity, Project Results may
                                            be disclosed and utilised by the Parties as set out in and subject to the terms of this Agreement.



 




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		19.2	Confidentiality
                                            Limitations. Confidential Information shall not
                                            include:



 


		(a)	information
                                            already known to the receiving Party or its Affiliates and which is not subject to pre-existing
                                            obligations of confidentiality;



 


		(b)	information
                                            that is independently developed by the receiving Party or its Affiliates;



 


		(c)	information
                                            that is or becomes part of the public domain other
                                            than by unauthorised disclosure by receiving Party;



 


		(d)	information
                                            properly obtained by the receiving Party or its Affiliates
                                            from a source that, to the best knowledge of the receiving Party, is not bound by a confidentiality
                                            obligation to the disclosing Party; and 



 


		(e)	information
                                            to the limited extent that is required to be disclosed by a competent legal authority; provided
                                            that, where it is free to do so, the receiving Party shall give notice of such disclosure
                                            requirement to the disclosing Party as soon as reasonably practicable.



 


		20	Term
                                            and Termination:



 


		20.1	Term.
                                            This Agreement shall commence on the Effective Date identified in the Agreement Summary and
                                            shall continue in full force and effect until the earlier of: (i) five (5) years from the
                                            Effective Date; (ii) the time that all activities set out in any active Work Packages, including
                                            any additional Work Packages, have been completed including delivery of any payments; and
                                            (iii) the termination of this Agreement pursuant to this Clause 20 (the “Term”).



 


		20.2	Termination
                                            by Either Party for Default or Insolvency. Either
                                            Party (the “Terminating Party”)
                                            may terminate this Agreement by giving written notice of termination, effective immediately,
                                            if the other Party (the “Defaulting Party”):



 


		(a)	breaches
                                            a material obligation in this Agreement and either fails to cure that breach within a cure
                                            period of thirty (30) Business Days after notice from the Terminating Party or such longer
                                            time if agreed in writing or, if the breach is not reasonably capable of cure within thirty
                                            (30) Business Days, fails to take prompt and reasonable steps to cure the breach and maintain
                                            such diligent efforts until cure is achieved; or



 


		(b)	makes
                                            any statutory arrangement with its creditors, resolves to or undergoes any insolvency proceeding
                                            anywhere in the world (except for the purpose of solvent amalgamation or reconstruction).



 


		20.3	Other
                                            Termination by CEPI. CEPI shall be entitled, in
                                            its sole discretion, to terminate this Agreement by
                                            providing written notice of termination to Awardee in the following circumstances:



 


		(a)	with
                                            immediate effect if CEPI notifies Awardee that there are material safety, regulatory, scientific
                                            misconduct or ethical issues associated with continuing the Project, as reasonably determined
                                            by CEPI and, if such issue is capable of remedy, Awardee has failed to remedy such issue
                                            within ten (10) Business Days;



 




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		(b)	upon
                                            thirty (30) Business Days’ prior notice in writing, if CEPI determines that the
                                            Project must be
                                            materially limited in scope or terminated;



 


		(c)	CEPI
                                            reasonably determines that Awardee is unable to discharge its obligations under this Agreement,
                                            for example if key personnel or technology resources required for successful completion of
                                            the Project become unavailable to Awardee permanently or for a material period of time, and
                                            Awardee does not reasonably alleviate CEPI’s concerns within a cure period of thirty
                                            (30) Business Days or such longer time as may be agreed by the Parties in writing;



 


		(d)	Awardee
                                            does not satisfy the criteria in Clause 3.4 required for CEPI to pay funding tranches under
                                            a Work Package and fails to satisfy those criteria in full within a cure period of forty
                                            (40) Business Days or such longer time as may be agreed by the Parties in writing; or



 


		(e)	Awardee
                                            has committed fraud or a Financial Irregularity. For purposes of this Agreement, “Financial
                                            Irregularity” includes any and all kinds of corruption, including bribery, nepotism
                                            and illegal gratuities; misappropriation of cash, inventory and all other kinds of assets;
                                            and making fraudulent financial and non-financial statements to CEPI.



 


		20.4	Payments
                                            After Certain Terminations by Awardee. If this
                                            Agreement is terminated by Awardee pursuant
                                            to Clause 20.2(a) - (b) (default or insolvency on the part of CEPI) or terminated by CEPI
                                            pursuant to Clause 20.3(a) – (b) (issues precluding continuation of the Project or
                                            limiting of Project Scope by CEPI), then CEPI shall reimburse Awardee for all reasonably
                                            incurred expenses through termination and any non-cancellable expenses relating to Project
                                            activities that were included in the iPDP and/or authorised in writing by CEPI and including
                                            those that arise through termination and after the termination date, solely to the extent
                                            they are not otherwise covered by CEPI funding and provided always that Awardee uses all
                                            reasonable endeavours to minimise and mitigate any such expenses.



 


		20.5	Effects
                                            of Termination by CEPI under Clause 20.2(a) - (b) or 20.3(c) - (d). If
                                            this Agreement is terminated by CEPI pursuant to Clause 20.2(a) - (b) (default or insolvency
                                            on the part of Awardee) or 20.3(c) - (d) (inability to proceed or financial issues with Awardee),
                                            then CEPI shall reimburse Awardee for all expenses reasonably incurred prior to termination
                                            and any non-cancellable expenses relating to the Project activities that were included in
                                            the iPDP and/or authorised in writing by CEPI and that arise either before or after the date
                                            of termination, provided always that Awardee uses all reasonable endeavours to minimise and
                                            mitigate any such expenses. Additionally, Awardee shall use all reasonable endeavours to,
                                            and only to the extent required to practice CEPI Public Health License, at CEPI’s expense:



 


		(a)	make
                                            all Project Data publicly available in such manner as CEPI may direct, except to the extent
                                            that to do so would result in the public disclosure of Enabling Rights or Awardee Confidential
                                            Information or Confidential Information of a third party that would not otherwise reasonably
                                            be publicly disclosed;



 




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		(b)	at
                                            CEPI’s sole discretion, either authorize access to or dispatch to CEPI (or its designee)
                                            by registered post or reputable courier services all Project Materials within twenty (20)
                                            Business Days of CEPI requesting
                                            such Project Materials in writing;



 


		(c)	grant
                                            rights to CEPI (or its designee) to any regulatory approvals and applications for regulatory
                                            approvals relating to the Project Vaccine;



 


		(d)	within
                                            twenty (20) Business Days of the date of termination, provide CEPI with an up-to-date list
                                            of all sublicence, contract manufacturing agreements and other third party agreements and
                                            arrangements to which Awardee is a party that solely relate to the development of the Project
                                            Vaccine and have deliverables or work outstanding as at the date of termination (the “Contracts”);



 


		(e)	as
                                            requested by CEPI, and to the extent it has the legal right to do so (i) assign the benefit
                                            (subject to the assumption of the burden) of one or more Contracts to CEPI (or its designee)
                                            and, where consent of a third party is required, seek to obtain such consent; (ii) novate
                                            one or more Contracts to CEPI (or its designee); or (iii) terminate one or more Contracts
                                            in accordance with its terms at Awardee’s cost;



 


		(f)	as
                                            requested by CEPI, perform technology transfer, on an expedited basis, to a Trusted Collaborator
                                            or Trusted Manufacturer, as the case may be; and



 


		(g)	as
                                            requested by CEPI, provide written confirmation or ratification in the event that CEPI exercises
                                            the Public Health Licence.



 


		20.6	Additional
                                            Effects of Termination. Irrespective of the grounds
                                            for CEPI’s termination of the Agreement:



 


		(a)	CEPI
                                            shall not be required to make any further payments to Awardee under this Agreement or any
                                            Work Package other than as specified in this Clause 20;



 


		(b)	Awardee
                                            shall return any CEPI funds within twenty (20) Business Days from the date of termination
                                            that are unspent, if any, after deducting reimbursement to Awardee for all reasonably incurred
                                            expenses incurred prior to the termination date and any non-cancellable expenses relating
                                            to the Project activities that were included in the iPDP and/or authorised in writing by
                                            CEPI and that arise before or after the date of termination, provided always that Awardee
                                            uses all reasonable endeavours to minimise and mitigate any such expenses;



 


		(c)	each
                                            Party shall return or destroy, as requested by the other Party, the Confidential Information
                                            of the other Party, except that: (i) CEPI may retain the Project Results subject to the obligations
                                            of confidentiality set out in Clause 19, (ii) each Party may keep one (1) copy of such Confidential
                                            Information for monitoring compliance, and (iii) solely in the event that the Public Health
                                            Licence has been exercised, CEPI may retain such other Confidential Information reasonably
                                            required by CEPI to exercise and benefit from the Public Health Licence. Neither Party shall
                                            be required to delete copies of Confidential Information stored on automatic electronic backup
                                            systems;



 


		(d)	if
                                            there is an on-going clinical trial, unless agreed otherwise by the Parties in writing, Awardee
                                            shall ensure that no additional trial subjects are enrolled and the Parties shall work together
                                            to plan and implement a wind-down of the study in an orderly fashion, with due regard for
                                            patient safety and the rights of any participating subjects.



 




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		20.7	Repayment
                                            of Funds for Financial Irregularity. Where termination
                                            is due to any Financial Irregularity or fraudulent
                                            or illegal activity by Awardee, Awardee shall repay to CEPI the amount of funds related to
                                            such Financial Irregularity or fraudulent or illegal activity within twenty (20) Business
                                            Days of the notice of termination.



 


		20.8	Survival
                                            of Rights and Identified Clauses. Termination of
                                            this Agreement shall be without prejudice to the rights and duties of either Party accrued
                                            prior to termination or expiry of the Agreement. The following sections shall continue to
                                            be enforceable notwithstanding termination or expiry: Clauses 3.8-3.11, 5.1-5.3, 6.7, 6.9(b),
                                            9, 11.2 (solely to the extent applicable to any surviving obligations under this Agreement),
                                            11.3, 11.4, 13.4, 13.5, 13.6, 13.7, 14.2, 15.1, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9,
                                            15.10, 15.11, 15.12, 15.14, 16, 17.3, 18, 19, 20, 21, 22.1, 22.2, 22.3, 22.4, 22.5, 22.7,
                                            22.9, 22.10, 22.11, 22.12, 22.14, 22.16, 22.17 as well as any other provision, which by its
                                            nature, is intended to survive termination.



 


		21	Resolving
                                            Differences:



 


		21.1	Resolution
                                            by
                                            the JMAG.
                                            Awardee and CEPI shall cooperate in good faith to resolve differences and disputes about
                                            the Project (including any disputes under Clause 15.3) at the JMAG.



 


		21.2	Escalation
                                            to Senior Management of the Parties. Any difference
                                            or dispute that cannot be resolved by the JMAG shall be submitted to the Parties’ respective
                                            Chief Executive Officers or designees for resolution. If the Parties remain unable to resolve
                                            such dispute within sixty (60) days of referral to the Chief Executive Officers or designees
                                            for resolution (or such additional time as mutually agreed in writing), then, with the exception
                                            of disputes relating to intellectual property, the Parties irrevocably submit to arbitration
                                            for its resolution upon referral of such dispute by either Party pursuant to Clause 21.3.



 


		21.3	Arbitration.
                                            Any disputes to be resolved by binding arbitration (including any question regarding its
                                            existence, validity or termination or this Agreement), shall be referred to and finally resolved
                                            by arbitration under the Rules of the London Court of International Arbitration, which Rules
                                            are incorporated by reference into this Clause. The number of arbitrators shall be three
                                            (3). The seat, or legal place, of arbitration shall be London, England. The language to be
                                            used in the arbitral proceedings shall be English. Notwithstanding the foregoing, any Party
                                            may seek specific performance, interim or final injunctive relief or any other relief of
                                            similar nature or effect in any court of competent jurisdiction. This Clause shall be governed
                                            by and construed in accordance with the law of England and Wales without giving effect to
                                            any choice of law or conflict of law provisions or rules that would cause the application
                                            of the laws of any other jurisdiction.



 


		21.4	Public
                                            Health Licence.
                                            If CEPI invokes its rights under a Public Health Licence under Clause 13, then the Parties
                                            shall pursue an expedited resolution of any differences under Clause 21.2 within fourteen
                                            (14) days. However, because of the exigent circumstances in the Outbreak, Awardee agrees
                                            that CEPI may proceed under a Public Health Licence and the ultimate resolution of any dispute
                                            shall be limited to the recovery of monetary damages by Awardee under Clause 21.3 rather
                                            than any injunctive relief except to the extent that the dispute relates to disclosure of
                                            Confidential Information or to public safety.



 




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		22	Miscellaneous:



 


		22.1	Relationship
                                            of
                                            the Parties.
                                            Neither Party shall by reason of this Agreement be empowered to act as agent for the other
                                            Party or to pledge the credit of the other Party. Neither Party shall be held liable for
                                            or incur liability in respect of the acts or defaults of the other Party.



 


		22.2	Announcements
                                            and Use of Names. Neither Party shall issue any
                                            press release, public statement or public announcement with respect to this Agreement without
                                            the prior written consent of the other Party except to the extent required by applicable
                                            law or the rules of any public stock exchange. Neither Party shall use the name or trademarks
                                            of the other Party or its Affiliates in any press release, public statement or publication
                                            without the named Party’s prior express written consent except to the extent required
                                            by applicable law or the rules of any public stock exchange. After the initial announcement,
                                            or as required by law, either Party may disclose a description of the Project, the names
                                            of each Party and its Project Lead, and the amount of the CEPI funding without the prior
                                            consent of the other Party.



 


		22.3	Assignment.
                                            Neither Party shall, without the prior written
                                            consent of the other Party, such consent not to be unreasonably withheld or delayed, assign
                                            its rights or obligations under this Agreement to any third party, except that CEPI may do
                                            so to an organisation of equivalent charitable mission and Awardee may do so to an Affiliate
                                            or as part of a sale of the entire business consistent with the satisfaction of Awardee’s
                                            obligations under this Agreement, provided that in each instance, such permitted assignee
                                            assumes all rights and obligations under this Agreement. This Agreement will be binding
                                            upon, inure solely to the benefit of and be enforceable by each Party and their respective
                                            permitted successors and assigns.



 


		22.4	Notice.
                                            Any notice to be given pursuant to this Agreement shall be in writing in the English language
                                            and shall be delivered by overnight courier, by registered, recorded delivery or certified
                                            mail (postage prepaid) to the address of the recipient Party provided in the Agreement Summary
                                            or such other address as a Party may from time to time designate by notice in writing. Any
                                            notice given pursuant to this Clause shall be deemed to have been received on the day of
                                            receipt, provided receipt occurs on a Business Day of the recipient Party or otherwise on
                                            the next following Business Day of the recipient.



 


		22.5	Entire
                                            Agreement.
                                            This Agreement, including the Agreement Summary and Annexes, constitutes the entire agreement
                                            and understanding between the Parties relating to its subject matter and together they supersede
                                            and replace all prior arrangements, whether written or oral, between the Parties relating
                                            to the subject matter of this Agreement.



 


		22.6	Amendments
                                            to this Agreement. No variation, amendment, modification
                                            or supplement to this Agreement, including its
                                            Annexes, shall be valid unless and until it is made in writing and signed by a duly authorised
                                            representative of each Party provided that minor amendments to administrative provisions
                                            of this Agreement may be made by exchange of emails between the Parties.



 


		22.7	Order
                                            of Precedence. If there is any conflict between
                                            the provisions of this Agreement, the Third
                                            Party Code and any Work Package, then the provisions of this Agreement shall prevail, followed
                                            by the provisions of the Third Party Code, and finally by the provisions of the Work Package.



 


		22.8	Force
                                            Majeure. Neither Party shall be deemed to have
                                            defaulted under or to be in breach of this Agreement for
                                            failure or delay in fulfilling material obligations when such failure or delay is directly
                                            caused by an event outside of their reasonable control which was not reasonably foreseeable
                                            on the Effective Date, including but not limited to acts of war, insurrections, acts of terrorism,
                                            acts of God or acts, omissions or delays in acting or failure to act by any of CEPI’s
                                            funders (collectively a “Force Majeure Event”).
                                            Each Party shall inform the other promptly and in writing of any Force Majeure Event and
                                            the Parties shall seek to agree on the appropriate course of action under the circumstances.
                                            In the case of an Outbreak, the Parties shall be expected to continue to carry out their
                                            obligations pursuant to applicable Work Packages with all due health and safety precautions.



 




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		22.9	No
                                            Rights
                                            for Third Parties.
                                            A person who is not a Party to this Agreement has no right under the Contracts (Rights of
                                            Third Parties) Act of 1999 or otherwise to enforce or to enjoy the benefit of any term of
                                            this Agreement except that Gavi shall have the right to enforce its rights under Clause 15
                                            and Clause 19.



 


		22.10	No
                                            Waiver.
                                            Neither Party shall be deemed to have waived any of its rights or remedies under this Agreement
                                            unless the waiver is expressly made in writing and signed by a duly authorised representative
                                            of that Party.



 


		22.11	Headings.
                                            The captions to the clauses, subclauses and paragraphs are not a part of this Agreement but
                                            are merely for convenience to assist in locating and reading this Agreement.



 


		22.12	Waiver
                                            of Rule of Construction. Each Party has had the
                                            opportunity to consult with counsel in connection
                                            with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction
                                            that any ambiguity in this Agreement shall be construed against the drafting Party shall
                                            not apply.



 


		22.13	Business
                                            Day Requirements. In the event that any notice
                                            or other action or omission is required to be taken by a Party under this Agreement on a
                                            day that is not a Business Day then such notice or other action or omission shall be deemed
                                            to be required to be taken on the next occurring Business Day.



 


		22.14	Further
                                            Assurances. Each Party shall duly execute and deliver,
                                            or cause to be duly executed and delivered,
                                            such further instruments and do and cause to be done such further acts and things, including
                                            the filing of such assignments, agreements, documents and instruments, as may be necessary
                                            or as the other Party may reasonably request in connection with this Agreement or to carry
                                            out more effectively the provisions and purposes hereof or to better assure and confirm unto
                                            such other Party its rights and remedies under this Agreement.



 


		22.15	Counterparts
                                            and Electronic Signing. This Agreement may be executed
                                            in two or more counterparts, each of which shall
                                            be deemed an original, but all of which together shall constitute one and the same instrument.
                                            Additionally, this Agreement may be signed electronically by exchanging signed PDF versions
                                            or by using an electronic signature platform which meets the European Union requirements
                                            for valid electronic signatures (such as DocuSign®).



 


		22.16	Choice
                                            of Law. This Agreement shall be governed by and
                                            construed in accordance with the laws of England and Wales without giving effect to any choice
                                            of law or conflict of law provisions or rules that would cause the application of the laws
                                            of any other jurisdiction.



 


		22.17	Interpretation.
                                            In this Agreement: 



 


		(a)	any
                                            headings in this Agreement shall not affect the interpretation of this Agreement; 



 


		(b)	unless
                                            the context otherwise requires, reference to the singular includes the plural and vice versa,
                                            any reference to a person includes a body corporate and words importing one gender include
                                            both genders; 



 


		(c)	a
                                            reference to a statute or statutory provision is (unless otherwise stated) a reference to
                                            the applicable UK or other country’s statute as it is in force for the time being,
                                            taking account of any amendment, extension, or re-enactment and includes any subordinate
                                            legislation for the time being in force made under it, and reference to a policy, procedure
                                            or protocol of CEPI is a reference to the version of the policy, procedure or protocol from
                                            time to time in force and duly communicated to the Awardee, provided that CEPI has
                                            not received any objection to any updated policy, procedure or protocol within ten (10) Business
                                            Days of receipt of notice by Awardee. In the event that CEPI receives any objection to any
                                            updated policy, procedure or protocol within thirty (30) days of receipt of notice by Awardee,
                                            the Parties shall discuss in good faith the reasons for such objection and determine the
                                            applicability of any such updates; and



 


		(d)	where
                                            the words “include(s)” or “including” are used in this Agreement,
                                            they are deemed to have the words “without limitation” following them, and are
                                            illustrative and shall not limit the sense of the words preceding them.



 




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Annex
B: Team Charter


 


** 


 




    	36



    	 



    

 


Annex
C: Integrated Product Development Plan


 


** 


 




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Annex
D: Budget


 


** 


 




    	38



    	 



    

 


Annex
E: List of AMC Countries, UMICs and HICs as at the Effective Date 


 


1.
AMC Countries


 


The
92 Gavi COVAX AMC-eligible countries and economies (based
on 2018 and 2019 World Bank GNI data) which as at the Effective Date are:


 


		●	Low
                                            income: Afghanistan, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Congo,
                                            Dem. Rep., Eritrea, Ethiopia, Gambia, The Guinea, Guinea-Bissau, Haiti, Korea, Dem. People’s
                                            Rep., Liberia, Madagascar, Malawi, Mali, Mozambique, Nepal, Niger, Rwanda, Sierra Leone,
                                            Somalia, South Sudan, Syrian Arab Republic, Tajikistan, Tanzania, Togo, Uganda, Yemen, Rep.,
	 	 	 
		●	Lower-middle
                                            income: Angola, Algeria, Bangladesh, Bhutan, Bolivia, Cabo Verde, Cambodia, Cameroon,
                                            Comoros, Congo, Rep. Côte d’Ivoire, Djibouti, Egypt, Arab Rep., El Salvador,
                                            Eswatini, Ghana, Honduras, India, Indonesia, Kenya, Kiribati, Kyrgyz Republic Lao PDR, Lesotho,
                                            Mauritania, Micronesia, Fed. Sts., Moldova, Mongolia, Morocco, Myanmar, Nicaragua, Nigeria,
                                            Pakistan, Papua New Guinea, Philippines, São Tomé and Principe, Senegal, Solomon
                                            Islands, Sri Lanka, Sudan, Timor-Leste, Tunisia, Ukraine, Uzbekistan, Vanuatu, Vietnam, West
                                            Bank and Gaza, Zambia, Zimbabwe
	 	 	 
		●	Additional
                                            IDA eligible: Dominica, Fiji, Grenada, Guyana, Kosovo, Maldives, Marshall Islands, Samoa,
                                            St. Lucia, St. Vincent and the Grenadines, Tonga, Tuvalu.



 


2.
Upper Middle Income Countries


 


Those
countries identified by the OECD as having upper middle income economies, as may be updated from time-to-time by the OECD. As at the
Effective Date the list is set out at under the column ‘Upper Middle Income Countries’.


 


http://www.oecd.org/dac/financing-sustainable-development/development-finance-standards/DAC-List-of-ODA-Recipients-for-reporting-2020-flows.pdf


 


3.
High Income Countries 


 


Those
countries identified by the Organisation for Economic Co-operation and Development (or “OECD”) as having high income
economies, as may be updated from time-to-time by the OECD. As at the Effective Date the list is set out at: 


 


http://www.oecd.org/dac/financing-sustainable-development/development-finance-standards/DAC-List-of-ODA-Recipients-for-reporting-2020-flows.pdf


 




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Annex
F: Sub-Contractors


 


[To
to be updated during the term of the Agreement]


 




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Annex
G: Pre-existing Agreements


 


The
Canada Agreement


 


The
NRC Agreement


 




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