Valneva SE 6-K


 


Exhibit 10.7


 


[***]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT
MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL.


 


Amendment
No. 3 to

Research Collaboration and License Agreement

(“Amendment No. 3”)


 


	Date:	June 19, 2022
	 	 
	Name of Agreement:	Research Collaboration and License Agreement
    (“Original Agreement”), as amended by Amendment No. 1 to Agreement dated as of 14 July 2021 and Amendment
    No. 2 to Agreement dated as of 10 November 2021 (the “Agreement”)
	 	 
	Effective Date of Original Agreement:	April 29, 2020
	 	 
	Parties:	Pfizer Inc. (“Pfizer”) and Valneva
    Austria GmbH (“Company”)


 


WHEREAS,
the parties have entered into a Subscription Agreement dated as of the date of this Amendment No. 3 (the “Subscription Agreement”)
pursuant to which, among other things, Pfizer is obligated to acquire the euro equivalent of $95 million of certain securities
of the Company, in accordance with the terms and conditions of the Subscription Agreement; and


 


WHEREAS,
the parties hereto desire to amend, among other things, certain terms of the Agreement, subject to the terms and conditions of
this Amendment No. 3.


 


NOW,
THEREFORE, in order to accommodate the desired amendment(s), the parties hereby agree as follows:


 


		1.	Defined
                                         Terms. Capitalized terms used but not defined herein shall have the respective meanings
                                         ascribed to such terms in the Agreement.



 


		2.	Amendment(s)
                                         to the Agreement. Each of the amendments referenced below in this Section 2 shall
                                         become effective only as of the sale of the certain securities of the Company described
                                         in the Subscription Agreement resulting in at least the euro equivalent of $95 million
                                         of gross cash proceeds paid by Pfizer to the Company pursuant to the Subscription Agreement
                                         (the “Subscription Closing”):



 


		2.1	The
                                         first sentence of Section 3.2 of the Agreement will be replaced in its entirety as follows:



 


“Subject
to the terms and conditions of this Agreement, the Development Costs incurred by the Parties pursuant to the Development Plan
in accordance with the Development Budget (“Shared Costs”) from the Effective Date through April 30, 2022 will
be borne seventy percent (70%) by Pfizer and thirty percent (30%) by Valneva. Shared Costs incurred after April 30, 2022 will
be borne sixty percent (60%) by Pfizer and forty percent (40%) by Valneva, subject to the terms and conditions of this Section
3.2 (the “60/40 Shared Cost Split”). Notwithstanding the 60/40 Shared Cost Split after April 30, 2022, beginning
on May 1, 2022 with respect to Shared Costs incurred on or after May 1, 2022:



 






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(a)
until the occurrence of any Phase 3 Clinical Trial Cessation, with respect to a maximum aggregate of [***] of such Shared Costs,
(i) Valneva shall bear the first [***] of such Shared Costs, then Pfizer shall bear the subsequent [***] of such Shared Costs,
then Valneva shall bear the subsequent [***] of such Shared Costs and then Pfizer shall bear the subsequent [***] of such Shared
Costs, and (ii) with respect to all such Shared Costs in excess of [***], the 60/40 Cost Sharing Split shall be applied to any
such additional Shared Costs incurred following the exhaustion of such total [***] as allocated above; and


 


(b)
effective upon the occurrence of any Phase 3 Clinical Trial Cessation, the Parties understand and agree that all Shared Costs
incurred on or after May 1, 2022 shall be borne sixty percent (60%) by Pfizer and forty percent (40%) by Valneva.


 


As
used herein (i) “Phase 3 Clinical Trial Cessation” shall mean any (x) termination of any Phase 3 Clinical Trial prior
to completion in accordance with the terms of the protocol for such Phase 3 Clinical Trial or (y) any temporary halt or Clinical
Hold of any Phase 3 Clinical Trial which lasts for longer than 180 days; and (ii) “Clinical Hold” shall mean (x) an
order issued by the FDA pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical
investigation of the Combined Therapy or such Party’s Single Agent Compound in the United States or (y) an equivalent order
issued by a Regulatory Authority other than the FDA in any other country or group of countries.”


 


		2.2	A
                                         new Section 3.3.1 would be added to the Agreement in its entirety as follows:



 


“Sales
Milestone Payments. Pfizer would pay to Valneva the following one-time sales milestone payments within sixty (60) days following
the Pfizer Quarter in which the corresponding cumulative Net Sales threshold for all Products is first achieved.


 


	Cumulative
    Territory-Wide Net Sales Milestones	Payment
	[***]	[***]
	[***]	[***]
	[***]	[***]
	[***]	[***]


“


 


		2.3	The
                                         table in Section 3.4.1 of the Agreement would be revised in its entirety as follows:



 


	Per
    Product Annual Territory- Wide Net Sales	Marginal
    Royalty Rate (% of Per Product Annual Net Sales)
	[***]	14.0%
	[***]	16.0%
	[***]	18.0%
	[***]	20.0%
	[***]	22.0%


 






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2.4       Exhibit
A to the Agreement is hereby amended and replaced in its entirety to include the Development Budget set forth on Exhibit A to
this Amendment No. 3.


 


2.5       Exhibit
B to the Agreement is hereby amended and replaced in its entirety to include the Development Plan set forth on Exhibit B to this
Amendment No. 3.


 


		3.	Phase
                                         3 Clinical Trial Start Timing. Effective as of the Subscription Closing, the Parties
                                         agree to use good faith efforts to initiate the Phase 3 Clinical Trial described in the
                                         Development Plan no later than [***].



 


		4.	Ratification
                                         of the Agreement. Except as expressly set forth in Articles 2 and 3 above, the Agreement
                                         shall remain unmodified and in full force and effect. The execution, delivery and effectiveness
                                         of this Amendment No. 1 shall not, except as expressly provided herein, operate as a
                                         waiver of any right, power or remedy of the parties to the Agreement, nor constitute
                                         a waiver of any provision of the Agreement.



 


		5.	Counterparts.
                                         This Amendment No. 3 may be executed in any number of counterparts, each of which shall
                                         be an original instrument and all of which, when taken together, shall constitute one
                                         and the same agreement.



 




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IN
WITNESS WHEREOF, the duly authorized representatives of Pfizer and Company have executed this Amendment No. 3 as of the date first
above written.


 





	Valneva Austria GmbH	 	Pfizer Inc.
	 	 	 
	/s/ [***]	 	/s/ [***]
	 	 	 
	By:
           [***]

         

        Title:
        Managing Director

         

        (Duly
authorized)
	 	By:
           [***]

         

        Title:
        Senior Vice President, Worldwide Business Development

         

        (Duly
authorized)





 





	/s/ [***]	 	 
	 	 	 
	By:
           [***]

         

        Title:
        Managing Director

         

        (Duly
authorized)
	 	 


  




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Exhibit
A


 


Development
Budget


 


[***]


 




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Exhibit
B


 


Development
Plan


 


[***]


 



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