Exhibit 10.6


 


CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT
HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS
(I) NOT MATERIAL AND (II) THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS THAT INFORMATION AS PRIVATE OR CONFIDENTIAL.


 


LICENCE AGREEMENT


 


THIS AGREEMENT is made on 27
September 2018 (“Effective Date”)


 


BETWEEN


 


		(1)	VACCITECH LIMITED, a company registered in England and Wales under number 09973585, the
registered office of which is at Magdalen Centre 1 Robert Robinson Avenue, The Oxford Science Park, Oxford, Oxfordshire, 0X4 4GA,
United Kingdom (“Vaccitech”);



 


		(2)	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD, with offices at
University of Oxford, University Offices, Wellington Square, Oxford, 0X1 2JD (“Oxford”); and



 


		(3)	OXFORD UNIVERSITY INNOVATION LIMITED (previously known as Isis Innovation Limited), a company
registered in England and Wales under number 02199542, the registered office of which is at University Offices, Wellington Square,
Oxford, 0X1 2JD (“OUI”).



 


Each of Vaccitech, Oxford and OUI is referred
to as a “Party” and together as the “Parties”; save that OUI shall only be a Party to this
Agreement for the purposes of clause 3.


 


INTRODUCTION


 


		(A)	Vaccitech has a licence under the Licensed Technology pursuant to the Head Licence (both as defined
below).



 


		(B)	Pursuant to the Head Licence, Oxford has a licence for Non-Commercial Use (as defined in the Head
Licence) under the Licensed Technology (as defined in the Head Licence) and Licensee Improvements (as defined in the Head Licence).



 


		(C)	To the extent such rights are not already retained pursuant to the Head Licence, Oxford wishes
to acquire a sub-licence under the Licensed Technology and Vaccitech is willing to grant such rights, all in accordance with the
provisions of this Agreement.



 


		(D)	OUI wishes to waive certain provisions of the Head Licence with respect to such sub-licence, in
accordance with the provisions of this Agreement.



 


AGREED TERMS


 


		1.	Definitions and interpretation



 


		1.1	In this Agreement, including the introduction:



 


		(a)	“Affiliate” means any corporation
or other business entity that directly or indirectly controls or is controlled by or is under common control with the relevant
Party. For the purposes of this definition only, “control”, or “controlled”
shall mean: (i) direct or indirect beneficial ownership of fifty percent (50%) or more of the voting interest in an entity; or
(ii) possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of that entity
(whether through ownership of securities or other ownership interests, by contract or otherwise);



 









     


     


    

 


		(b)	“CEPI” means Coalition for Epidemic
Preparedness Innovations, a not-for-profit international association existing under Norwegian law;



 


		(c)	“CEPI Agreement” means the framework
agreement between Oxford, CEPI and Janssen Vaccines & Prevention B.V., entered into on or about the same date as the present
Agreement;



 


		(d)	“CEPI Licence” has the meaning given
in Schedule 1 of this Agreement;



 


		(e)	“Control” and with correlative meaning,
 “Controlled by” means the possession of the right (directly or indirectly, and by ownership, licence or otherwise)
to grant a licence, sub-licence or other right as required in this Agreement, to or under any know how or intellectual property
right, without violating the terms of any agreement or other arrangement with any third party;



 


		(f)	“Field” means the diagnosis, prevention
or treatment of Middle Eastern Respiratory Syndrome (“MERS”) in humans;



 


		(g)	“Head Licence” means the licence agreement
between OUI and Vaccitech dated 4 March 2016 set out, in redacted form, in Schedule 2;



 


		(h)	“Licensed Product” means any product,
process, service or composition for use in the Field which is entirely or partially produced by means of or with the use of, or
within the scope of, the Licensed Technology, or any part of it;



 


		(i)	“Licensed Technology” means the Licensed
Technology (as defined in in the Head Licence) and all developments and improvements to the Licensed Technology that are Controlled
by Vaccitech during the term of the Head Licence;



 


		(j)	“Public Sector Agency” means a public
government or government department or agency or a recognised not-for-profit organisation or entity, such as registered charities
or registered faith-based organisations, including:



 


		(A)	government or department or agency thereof, including
ministries of health;



 


		(B)	intergovernmental organisations such as the United Nations,
its specialised agencies including the World Health Organisation and its programmes or funds such as the United Nations Children’s
Fund;



 


		(C)	not-for-profit organisations or entities organised under
the laws of a government or department or agency thereof, such as Medecins Sans Frontieres and faith-based organisations; and



 


		(D)	not -for-profit organisations or foundations that are
funded by governments or other non-profit organisations such as the World Bank, UNITAID or the US Agency for International Development
or the GAVI Alliance, but specifically excluding hospitals and clinics who wish to purchase the Licensed Product directly for
their own use;



 


The term “Public Sector Agency”
excludes any military organisations except for: (a) any military organisation operating in the area affected or likely to be affected
by the Outbreak or Increased Outbreak Preparation Need (each as defined in Schedule 1) at the date the Affected Territory (as defined
in Schedule 1) is declared; and (b) any military personnel providing healthcare or healthcare related services to the population
affected by or at risk of the Outbreak or Increased Outbreak Preparation Need;


 


		(k)	“Representatives” in relation to a
Party, means the directors, officers, employees, consultants and advisers of that Party or its Affiliates, and with respect to
Oxford means its sub-licensees under a sub-licence granted pursuant to clause 2.2; and



 









    2


     


    

 


		(l)	“Sell”, “Sale”
and or “Selling” means sale to Public Sector Agencies on a “cost plus” basis (where “cost
plus” means the cost of manufacturing and supply plus a reasonable margin of [***] on such cost reflecting the limited volume
of manufacture and episodic demand), and for the purposes of this definition, the pre-margin “cost” element shall
be determined in accordance with the formula for calculating the production economics cost of goods set by the Bill and Melinda
Gates Foundation but specifically excluding from such formula any funding provided to the manufacturer or supplier by any charitable
or other public sources, including CEPI and its own funders.



 


		1.2	In this Agreement:



 


		(a)	the singular includes the plural and vice versa, any
gender includes other genders, and a “person” includes a natural person, corporate or unincorporated body (whether
or not having separate legal personality);



 


		(b)	“this Agreement” includes this Agreement
as amended or supplemented from time to time;



 


		(c)	the headings to clauses and schedules are to be ignored
in construing this Agreement; and



 


		(d)	the schedules form part of this Agreement as if set out
in full in this Agreement and a reference to “this Agreement” includes a reference to the schedules.



 


		2.	Grant of rights



 


		2.1	Subject to the provisions of this Agreement, in addition
to and to the extent such rights are not already retained under the Licensed Technology pursuant to the Head Licence, Vaccitech
hereby grants to Oxford a perpetual, worldwide, fully-paid up non-exclusive licence, under the Licensed Technology in the Field
of the same scope as the CEPI License, for the sole purpose of:



 


		(a)	enabling Oxford to grant a sublicense to CEPI of the
scope of the CEPI Licence, ; and



 


		(b)	enabling Oxford to Develop the Licensed Product (including
generation of investigational stockpiles but excluding any commercial use or Sale of the same). This license shall be sublicensible
by Oxford solely to Oxford’s collaborators under the CEPI Agreement.



 


		2.2	Notwithstanding clause 2.1, Oxford shall only grant CEPI
a sub-licence of the rights granted under clause 2.1(a) if:



 


		(a)	such sub-licence contains legally binding provisions
that require that CEPI shall promptly communicate to Oxford in writing: (A) any safety information requested by a regulatory authority
in respect of a Licensed Product; and (B) any clinical data relating to a Licensed Product of which it becomes aware and which
has a material implication for the safety of the Licensed Product or which may otherwise materially affect the regulatory treatment
or pathway of any product candidate utilising the Licensed Technology;



 


		(b)	such sub-licence contains legally binding provisions
that (A) require that CEPI and its sublicensees shall only sell the Licensed Product in accordance with the definition of Sell,
(B) require CEPI to keep proper records and books of account showing the description and price of Licensed Products supplied or
put into use by CEPI, the cost of manufacturing and supply of such Licensed Products and any margin obtained by CEPI on sales
of such Licensed Products; and (C) permit Vaccitech by itself or through a third party (provided that such third party has entered
into legally binding confidentiality obligations to CEPI), upon reasonable prior written notice to CEPI, during normal business
hours and not more than once per calendar year, to audit such records and books of account of CEPI to verify CEPI’s compliance
with clause 2.2(b)(A); and



 









    3


     


    

 


		(c)	such sub-licence shall automatically terminate upon termination
of this Agreement and, provided that CEPI is not in breach of the terms of its sub-licence, Vaccitech shall, if requested by CEPI,
grant CEPI, with effect from the date of termination of this Agreement, a sub-licence under the Licensed Technology in the Field
solely of the scope of the CEPI Licence and on materially the same terms (including as to scope of rights under such intellectual
property and financial terms) to those contained in such sub-licence, to the extent that Vaccitech is able to grant such a sub-licence.



 


		(d)	no sub-licence granted pursuant to this clause 2.2 shall
relieve Oxford of its obligations to Vaccitech under this Agreement.



 


		2.3	Oxford shall remain fully liable to Vaccitech in respect
of any acts or omissions of CEPI, that would, if effected by Oxford, constitute a breach of this Agreement.



 


		3.	Head Licence



 


		3.1	OUI hereby acknowledges and agrees that, notwithstanding
any other provision of the Head Licence:



 


		(a)	clauses 2.3, 2.4, 2.5, 8.2, 9, 11, 12.3 (with respect
to the termination of sublicenses), 12.5(a) and 13.3 of the Head Licence shall not apply with respect to the licence granted under
clause 2.1 or to any sublicense granted pursuant to clause 2.2; and



 


		(b)	Vaccitech shall be permitted to disclose the Licensed
Technology to Oxford, and Oxford shall be permitted to disclose the Licensed Technology to its sub-licensees, subject to the provisions
of this Agreement;



 


		(c)	Vaccitech shall not be required to make any payment (whether
in royalties, milestone payments or otherwise) to OUI in respect to any amounts received by Vaccitech from Oxford pursuant to
this Agreement or in connection with the exercise by Oxford or its sub-licensees of rights granted pursuant to this Agreement;
and



 


		(d)	Vaccitech is released from and shall not be required
to provide any indemnity to OUI or any other party in relation to the use of the Licensed Technology or the commercialisation
of Licensed Products by Oxford or its sub-licensees.



 


		3.2	OUI hereby acknowledges and agrees that Vaccitech has
complied with the requirements of clause 2.1.1 (c)(i) of the Head Licence.



 


		3.3	Nothing in this agreement shall affect the intellectual
property management provisions as set out in the Head Licence.



 


		3.4	Vaccitech hereby acknowledges and agrees that:



 


		(a)	nothing in this Agreement shall limit the rights retained
by OUI in respect of Non-commercial Use under the Head Licence;



 


		(b)	the rights retained by OUI in respect of Non-Commercial
Use under the Head License allows Oxford to carry out research activities (including in collaboration with other parties) up to
and including the performance of Phase l/ll clinical trials and related activities, and the generation of Licensed Product for
research use (but excluding any commercial use or Sale of such Licensed Product)



 


		4.	Adverse event information



 


		4.1	Oxford shall promptly communicate to Vaccitech in writing:
(i) any safety information requested by a regulatory authority in respect of a Licensed Product; and (ii) any clinical data relating
to a Licensed Product of which it becomes aware which has a material implication for the safety of the Licensed Technology or
which may otherwise materially affect the regulatory treatment or pathway of any product candidate utilising the Licensed Technology.



 









    4


     


    

 


		4.2	Vaccitech’s sole right under this Agreement to
all information provided to it in accordance with clause 4.1 shall be to utilise such information in its regulatory submissions
and correspondence with regulatory authorities.



 


		5.	Confidentiality



 


		5.1	“Confidential Information” shall mean
all information of a confidential or proprietary nature disclosed by a Party or its Representatives to the other Party under or
in connection with this Agreement, and any information (whether or not technical) disclosed under or in connection with this Agreement
that would be regarded as confidential by a reasonable business person.



 


		5.2	Each Party undertakes that it shall keep the other Party’s
Confidential Information confidential and shall not:



 


		(a)	use such Confidential Information except for the purpose
of exercising or performing its rights and obligations under this Agreement; or



 


		(b)	disclose such Confidential Information in whole or in
part to any third party, except as expressly permitted by this clause 5 (or in the case of Vaccitech, as expressly permitted under
clause 4.2).



 


		5.3	The provisions of this clause shall not apply to any
Confidential Information that:



 


		(a)	is or becomes generally available to the public (other
than as a result of its disclosure by the receiving Party or its Representatives in breach of this clause);



 


		(b)	was available to the receiving Party on a non-confidential
basis before disclosure by the disclosing Party;



 


		(c)	was, is or becomes available to the receiving Party on
a non-confidential basis from a person who, to the receiving Party’s knowledge, is not bound by a confidentiality agreement
with the disclosing Party or otherwise prohibited from disclosing the information to the receiving Party; or



 


		(d)	the Parties agree in writing is not confidential or may
be disclosed.



 


		5.4	A Party may disclose the other Party’s Confidential
Information:



 


		(a)	to those of its Representatives who need to know such
information for the purpose of exercising or performing its rights and obligations under this Agreement provided that it shall
ensure that they comply with this clause 5; and



 


		(b)	as may be required by law, a court of competent jurisdiction
or any governmental or regulatory authority, provided that, to the extent it is legally permitted to do so, it gives the other
Party as much notice of such disclosure as possible.



 


		5.5	The provisions of this clause shall continue to apply
after the expiry or earlier termination of this Agreement.



 


		6.	Warranties and liability



 


		6.1	Each Party acknowledges that, in entering into this Agreement,
it does not do so in reliance on any representation, warranty, or other provision except as expressly provided in this Agreement,
and any conditions, warranties or other terms implied by statute or common law are excluded from this Agreement to the fullest
extent permitted by law.



 


		6.2	Except in relation to any claims, damages and liabilities
arising directly from a breach of this Agreement by Vaccitech and/or the fraud, negligence or wilful misconduct of Vaccitech,
Oxford agrees to indemnify Vaccitech from and against any and all claims (including claims for negligence) actions, damages and
liabilities asserted by any third- party (each such claim a “Third Party Claim”), which arise from: (a) CEPI’s
or its Affiliates’ or sublicensees’, use of the Licensed Technology or Licensed Product (including without limitation
any investigational stockpile of the Licensed Product); and (b) Oxford or its sublicensees’ use of the Licensed Technology
or Licensed Product pursuant to the rights granted in 2.1 (b) This indemnity will extend to activities carried out by any third
parties on behalf of CEPI or CEPI’s Affiliates or sublicensees, or pursuant to any downstream grant of rights or transfer
of Licensed Technology or Licensed Product originating from CEPI or its Affiliates or sublicensees.



 






    5


     


    

 


		6.3	Vaccitech shall provide prompt written notice to Oxford
of the assertion or commencement of any Third Party Claim in respect of which it seeks indemnification pursuant to clause 6.2.
Oxford (or its appointee) shall have the right to assume the defence and/or settlement of the same and shall not be liable for
any settlement made by Vaccitech without Oxford’s consent, provided that Oxford (or its appointee) may not use any defence
or agree to any settlement that would materially prejudice Vaccitech. Vaccitech shall:



 


		(a)	notify Oxford as soon as possible after becoming aware
of the relevant Third Party Claim (or the likelihood of such a claim arising);



 


		(b)	promptly provide all assistance and information (including
access to documents and personnel) reasonably required by Oxford for the purposes of assessing and handling the Third Party Claim;
and



 


		(c)	not make any admission of liability, conclude any agreement
or make any compromise with any person in relation to such Third Party Claim without the prior written consent of Oxford.



 


		6.4	Subject to clause 6.5, the liability of either Party
for any breach of this Agreement, in negligence or arising in any other way out of the subject-matter of this Agreement, will
not extend to incidental, indirect or consequential damages or loss of profits.



 


		6.5	Notwithstanding any other provision of this Agreement,
neither Party’s liability under or in connection with this Agreement shall be excluded or reduced to the extent that it
arises in respect of the following matters:



 


		(a)	for death or personal injury caused by negligence;



 


		(b)	for fraud or fraudulent misrepresentation; or



 


		(c)	any other liability which may not lawfully be excluded
or reduced.



 


		7.	Term and termination



 


		7.1	This Agreement shall come into force on the Effective
Date and, unless terminated earlier in accordance with clause 7.2, shall remain in force until the expiry or termination of the
Head Licence.



 


		7.2	Vaccitech may terminate this Agreement immediately by
giving notice to Oxford if Oxford is in material breach of this Agreement and such breach has not been remedied within a period
of [***] from the receipt by Oxford of a notice specifying the breach and requiring its remedy.



 


		7.3	On expiry or termination of this Agreement for any reason,
all rights and licences granted pursuant to this Agreement shall cease.



 


		7.4	The termination or expiry of this Agreement shall be
without prejudice to any obligations, rights or liabilities of any of the Parties which have accrued before such termination or
expiry.



 









    6


     


    

 


		8.	General



 


		8.1	Amendment. This Agreement may only be amended
in writing signed by duly authorized representatives of Oxford, OUI and Vaccitech.



 


		8.2	Assignment. Vaccitech shall not assign, transfer,
novate, encumber or otherwise deal with the Licensed Technology if such assignment, transfer, novation, encumbrance or dealing
would conflict with the rights granted to Oxford under this Agreement, save with Oxford’s prior written consent.



 


		8.3	Waiver. No failure or delay on the part of a Party
to exercise any right or remedy under this Agreement shall be construed or operate as a waiver thereof, nor shall any single or
partial exercise of any right or remedy preclude the further exercise of such right or remedy.



 


		8.4	Invalid clauses. If any provision or part of this
Agreement is held to be invalid, amendments to this Agreement may be made by the addition or deletion of wording as appropriate
to remove the invalid part or provision but otherwise retain the provision and the other provisions of this Agreement to the maximum
extent permissible under applicable law.



 


		8.5	No agency. Neither Party shall act or describe
itself as the agent of the other, nor shall it make or represent that it has authority to make any commitments on the other’s
behalf.



 


		8.6	Notices. Any notice to be given under this Agreement
must be in writing, and be delivered to the other Party by hand or courier. Any notice shall be deemed to have been received on
the day of delivery. Until changed by notice given in accordance with this clause, all notices should be addressed as follows:



 


	 	For Vaccitech:	 	For Oxford:
	 	 	 	 
	 	Name:  Dr Thomas Evans	 	Name:  The Director, Research Services
	 	 	 	 
	 	
        Address:

        Vaccitech Limited, The Schrodinger

 Building, 2nd
        Floor, Science Park, 

Heatley Road, Oxford 0X4 4GE
	 	
        Address:

        University Offices, Wellington Square, Oxford 0X1 2JD



 


		8.7	Further action. Each Party agrees to execute,
acknowledge and deliver such further instruments, and do all reasonable further similar acts, as may be necessary or appropriate
to carry out the purposes and intent of this Agreement



 


		8.8	Entire Agreement. This Agreement constitutes the
entire agreement between the Parties about the subject matter of this Agreement and (in relation to such subject matter) supersedes
and extinguishes all earlier understandings and agreements between any of the parties and all earlier representations by any Party.



 


		8.9	Third parties. A person who is not a Party has
no right to enforce any term of this Agreement.



 


		8.10	Counterparts. This Agreement may be executed in
any number of counterparts, each of which is an original but all of which together will constitute one document. The Parties may
execute this Agreement and any amendment thereto by exchanging signed electronic copies thereof (PDF) and the Parties agree that
for the purposes of executing this Agreement copies of signatures will constitute valid signatures,



 


		8.11	Law and jurisdiction. This Agreement (and any
claim relating to it, its subject matter, its enforceability or its termination, including non-contractual claims) is governed
by and construed in accordance with English law and the courts of England and Wales shall have non-exclusive jurisdiction to resolve
any such claim.



 


This Agreement has been entered into on
the Effective Date.


 









    7


     


    

 


	
        SIGNED by

        for and on behalf of VACCITECH LIMITED
	 	)

)	
        /s/ Tom Evans 

        Tom Evans

        Director

         

	
        SIGNED by

        for and on behalf of THE CHANCELLOR, MASTERS AND SCHOLARS
        OF THE UNIVERSITY OF OXFORD
	 	)

)

)

)	
        

         

         

        

        /s/ Dennis Murphy 

        27 September 2018

        Authorised signatory

         

	
        SIGNED by

        for and on behalf of OXFORD UNIVERSITY INNOVATION LIMITED
	 	)

)

)	
         

        

        /s/ Matthew Perkins 

        Matthew Perkins

        Director



 









    8


     


    

 


SCHEDULE 1 - CEPI LICENCE


 


“CEPI Licence” means:


 


		(i)	A non-exclusive, irrevocable (other than as set out in clause 2.2(c) of this Agreement), perpetual,
worldwide, fully paid-up licence for the purpose of addressing Increased Outbreak Preparation Needs and/or Outbreaks under the
Licensed Technology with the right to grant sub-licences to Develop, Manufacture and Market (where selling and commercial exploitation
are limited to Selling) the Licensed Product in the Field for use in the Affected Territory or to treat Healthcare Workers.



 


For clarity, such license:


 


		a.	shall include the right to Develop, Manufacture and Sell the Licensed Product in the Field anywhere
in the world, provided that all end users of any Licensed Products are in the Affected Territory or are Healthcare Workers.



 


		b.	shall exclude the right to sell or otherwise commercially exploit the Licensed Product other than
in accordance with the definition for Sell; and



 


		c.	shall exclude the right to apply for or obtain any Marketing Approval or any post marketing activities.



 


The licence shall only be sub-licensible
to CEPI’s Affiliates and/or to Public Sector Agencies and their appointees and designees for the purpose of accelerating
epidemic preparedness for public health applications and for no other purpose.


 


		(ii)	The right to Sell, replenish, export or import the investigational stockpile of the Licensed Product,
or have any of the foregoing done for it, provided such use is for the purpose of addressing Increased Outbreak Preparation needs
and/or Outbreaks and in strict accordance with CEPI’s Mission.



 


In the interpretation of the “CEPI
License” (and this Agreement) the following additional definitions apply:


 


“Affected Territory”
means a geographic area: (i) where there is an Outbreak; (ii) for which there is an Increased Outbreak Preparation Need; or (iii)
any other area CEPI and the parties to the CEPI Agreement agree in writing will be treated as an Affected Territory;


 


“Approved Regulatory Authority”
means the EU European Medicines Agency, the US Food and Drug Administration, SwissMedic, Japanese PMDA, Australian Therapeutic
Goods Agency, South Korean Ministry of Drug Safety, Health Canada or Singapore Health Sciences Authority and in each case any successor
authority, including, if applicable, the UK Medicines & Healthcare products Regulatory Agency;


 


“CEPI’s Mission”
is defined with reference to the following activities:


 


		(i)	fund, co-fund, co-ordinate and support the development of new vaccines with chosen partners to
prevent and contain infectious disease epidemics;



 


		(ii)	work with its partners and relevant agencies to ensure the vaccines developed are provided to all
populations who need them on an equitable basis; and



 


		(iii)	work with its partners and relevant agencies to ensure adequate stockpiles and manufacturing capacity
of vaccines developed for epidemic situations;



 


“Develop” or
 “Development” means, with respect to the Licensed Product, those pre-clinical and clinical vaccine
development activities that are necessary or useful to obtain Marketing Approval from at least one Approved Regulatory
Authority and in applicable regulatory jurisdictions including stability testing, toxicology, formulation and process
development, Manufacturing activities, statistical analysis, pre-clinical and clinical studies, regulatory filing submissions
and approval, pharmacovigilance and post-marketing activities, but in all cases excluding the actual application for or
obtaining of any Marketing Approval;


 






    9


     


    

 


“Healthcare Workers”
means any healthcare worker going to an Affected Territory under the direction of one or more Public Sector Agencies in order to
help address a public healthcare issue regardless of the fact that they may, from time to time, be located outside of the geographic
area of the Affected Territory or may not yet have arrived in the Affected Territory;


 


“Increased Outbreak Preparation
Need” means, when having considered all reasonably accessible and relevant information including epidemiological data,
travel and migration patterns and the likely availability of other products or product candidates in the Field and following consultation
with the CEPI scientific advisory board and/or CEPI’s Board of Directors, CEPI determines that there is a heightened need
for the Licensed Product, and that steps should be taken to prepare for such need;


 


“Manufacturing” or “Manufacture”
means the production, subject to GMP, of Licensed Product or constituents thereof, including active ingredients, excipients, adjuvants,
preservatives or other additives, for use in clinical trials or finished dosage form of the Licensed Product as well as the fill
and finish or packaging;


 


“Marketing Approval”
means a marketing authorisation granted by the European Commission in accordance with the procedure for the authorisation and supervision
of medicinal products for human use set forth in Regulation (EC) No. 726/2004, or any Approved Regulatory Authority and any corresponding
regulatory approval necessary to manufacture, use, sell or store a Licensed Product in any other country or jurisdiction, but not
including pricing and reimbursement approvals;


 


“Marketing” or “Market”
means, in relation to the Licensed Product, importing, exporting, marketing, selling, promoting, distributing or otherwise utilising
or commercially exploiting the Licensed Product, but in all cases excluding applying for or obtaining any Marketing Approval.


 


“Outbreak” means where
there has been a material increase in the number of cases of people infected in the Field in a particular locality, region or territory
that has: (i) been declared a Public Health Emergency of International Concern by WHO; (ii) been declared a public health emergency
on a national or regional scale by one or more national governments; or (iii) been declared a public health emergency by CEPI following
consultation with the CEPI scientific advisory board and/or CEPI’s Board of Directors;


 


“Public Sector Agency”
means a public government or a government department or agency or a recognised not-for-profit organisation or entity, such as registered
charities or registered faith-based organisations, including:


 


		(a)	government or department or agency thereof, including ministries of health;



 


		(b)	intergovernmental organisations such as the United Nations, its specialised agencies including
the World Health Organisation and its programmes or funds such as the United Nations Children’s Fund;



 


		(c)	not-for-profit organisations or entities organised under the laws of a government or department
or agency thereof, such as Medecins Sans Frontieres and faith-based organisations; and



 


		(d)	not-for-profit organisations or foundations that are funded by governments or other not-for-profit
organisations such as the World Bank, UNITAID or the US Agency for International Development or the GAVI Alliance, but specifically
excluding hospitals and clinics who wish to purchase the Product directly for their own use.



 


The term “Public Sector
Agency” excludes any military organisations except for: (a) any military organisation operating in the area affected or
likely to be affected by the Outbreak or Increased Outbreak Preparation Need at the date the Affected Territory is declared;
and (b) any military personnel providing healthcare or healthcare related services to the population affected by or at risk
of the Outbreak or Increased Outbreak Preparation Need;


 


“Sell”, “Sale”
and or “Selling” means sale to Public Sector Agencies on a “cost plus” basis (where “cost
plus” means the cost of manufacturing and supply plus a reasonable margin of [***] on such cost reflecting the limited volume
of manufacture and episodic demand), and for the purposes of this definition, the pre-margin “cost” element shall be
determined in accordance with the formula for calculating the production economics cost of goods set by the Bill and Melinda Gates
Foundation but specifically excluding from such formula any funding provided to the manufacturer or supplier by any charitable
or other public sources, including CEPI and its own funders.


 









    10


     


    

 


SCHEDULE 2 - THE HEAD LICENCE


 


[Redacted copy of the Head Licence to be
attached]


 






    11