Valneva SE 6-K


 


Exhibit 10.5


 





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= 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. 1 to Research Collaboration and License Agreement


 


	Amendment
    No. 1 Date:	July
    14, 2021
	Name
    of Original Agreement:	Research
    Collaboration and License Agreement (the “License Agreement”) (the “Original Agreement,” and together
    with any previous amendments which may be described below, the “Agreement”)
	Effective
    Date of Original Agreement:	April
    29, 2020 (“Effective Date”)
	Parties:	Pfizer
    Inc. (“Pfizer”) and Valneva Austria GmbH (“Valneva”)
	Dates
    of Previous Amendment(s):	None


WHEREAS,
the parties hereto desire to amend, among other things, certain terms of the Agreement including to provide for the transfer of
Pfizer Materials to Valneva to support Development activities.


 


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.



 


		2.1.	Section
                                         1 of the Agreement is hereby amended to add new definitions 1.103 Pfizer Materials as
                                         follows:



 


1.103
“Pfizer Materials” means the OspA Humabs (human monoclonal B cell antibodies), and non-human primate sera (including
in all cases, without limitation, derivatives, progeny, conjugates, compositions, formulations, salts, prodrugs, metabolites,
polymorphs, and isomers thereof), together with all reagents, chemical compounds, biological materials or other materials, which
are provided by Pfizer to Valneva pursuant to or otherwise in connection with the Agreement.


 


		2.	Section
                                         4 of the Agreement is hereby amended to add new Section 4.5 as follows:



 


4.5.       Transfer
and Use of Pfizer Materials.


 


4.5.1
Transfer. From time to time, pursuant to the Development Plan, or otherwise, Pfizer may provide Valneva with Pfizer Materials
for use in the Development Plan. The Pfizer Materials are provided on an “as-is” basis without representation or warranty
of any type, express or implied, including any representation or warranty of merchantability, non-infringement, title or fitness
for a particular purpose, each of which is hereby disclaimed by such providing Party.


 


4.5.2
Use of Pfizer Materials. Valneva shall use the Pfizer Materials solely in connection with conducting the specific activities under
the Development Plan for which the Pfizer Materials are being provided and for no other purpose. Without limiting the generality
of the foregoing, except as expressly set forth in this Agreement, Valneva shall not make or attempt to make analogues, progeny
or derivatives of, or modifications to, the Pfizer Materials, and Valneva shall not use the Pfizer Materials for the benefit of
any Third Party or of its own internal research programs outside of the Development Program. Valneva shall not administer any
of the Pfizer Materials to any human. Valneva shall comply with all Applicable Laws regarding the handling and use of the Pfizer
Materials. Each Party agrees to retain possession over the other Party’s Proprietary Materials and not to provide the Pfizer
Materials to any Third Party without Pfizer’s prior written consent.


 






     


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4.5.3
Unauthorized Use of Pfizer Materials. The Parties acknowledge and agree that all results from the use of the Pfizer Materials
shall be Development Program Know-How and Development Program Patent Rights. In the event that Valneva uses the Pfizer Materials
for any purpose other than the purposes authorized herein, the results of such unauthorized research, and any discoveries or inventions
that arise from such unauthorized research, whether patentable or not, shall belong solely and exclusively to Pfizer. If required
in order to perfect or enforce Pfizer’s ownership of such results, discoveries or inventions, each hereby assigns and agrees
to assign to Pfizer all of its right, title and interest in and to all such results, discoveries or inventions made through unauthorized
research. Valneva hereby agrees to cooperate with Pfizer, and to execute and deliver any and all documents that Pfizer reasonably
deems necessary, to perfect and enforce its rights hereunder.


 


4.5.4
Title to Pfizer Materials. All right, title and interest in the Pfizer Materials shall remain the sole property of Pfizer notwithstanding
the transfer to and use by Valneva of the same.


 


4.5.5
Return of Pfizer Materials. Upon completion of the activities for which the Pfizer Materials have been provided, or upon expiration
or termination of the Agreement, if earlier, Valneva shall, at Pfizer’s option, either destroy or return to Pfizer all unused
Pfizer Materials.


 


		3.	Ratification
                                         of the Agreement. Except as expressly set forth in Article 2 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.



 


		4.	Counterparts.
                                         This Amendment No. 1 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.



 


[Signatures
on following page]


 




     


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IN
WITNESS WHEREOF, authorized representatives of the Parties have duly executed this Agreement to be effective as of the Effective
Date.


 


Valneva
Austria GmbH


 





	By:	/s/[***]	 



 

	Name:	[***]	 


 


	Title:	[***]	 


 


	By:	/s/[***]	 


 


	Name:	[***]	 



 

	Title:	Managing Director	 




 


Pfizer
Inc.


 





	By:	/s/[***]	 


 


	Name:	[***]	 



 

	Title:	SVP and Head of Vaccine Research & Development