Document:

Valneva SE 6-K

 

Exhibit
10.6 

 

[***]
= 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. 2 to Agreement 

(“Amendment No. 2”)

 

	Amendment
    No. 2 Date:	10
    November 2021
	Name
    of Original Agreement:	The
    Research Collaboration and 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):	14
    July 2021

WHEREAS,
On 14 July 2021, the Parties entered into an amendment to the Agreement (“Amendment No. 1”). On 10 November the Parties
entered into another amendment to the Agreement and this second amendment was incorrectly headed “Amendment No. 1”
and the Parties now wish to delete the Amendment No. 1 dated 10 November 2021 in its entirety and replace it with this Amendment
No. 2;

 

WHEREAS,
As a result of updated set-up/timelines for the New Phase 2 Clinical Trial (VLA15-221) the parties have agreed to transfer the
IND on a date certain to help support Pfizer’s future development and planning of Clinical Trials of the Vaccine (each as
defined in the Agreement);

 

WHEREAS,
the parties hereto desire to amend, among other things, certain terms of the Agreement reflecting the accelerated timing of the
transfer of the IND.

 

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
                                         4.2.6(e) of the Agreement is hereby amended and replaced in its entirety with the following
                                         new Section 4.2.6(e):

 

4.2.6(e).
transfer the IND for the Vaccine to Pfizer not later than [***];

 

		2.2.	Section
                                         5.2 of the Agreement is hereby amended and replaced in its entirety with the following
                                         new Section 5.2:

 

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5.2.
Valneva Phase 2 Clinical Trials.

 

5.2.1.
Valneva shall continue to act as the sponsor of the Valneva On-Going Phase 2 Clinical Trials until such time as Valneva transfers
the IND relating to the Vaccine to Pfizer pursuant to Section 4.2.6(e). Valneva will be solely responsible for all Costs associated
with the Valneva On-Going Phase 2 Clinical Trials incurred prior to, and after IND transfer.

 

5.2.1(a).       Upon
Valneva transferring the IND relating to the Valneva Phase 2 Clinical Trials to Pfizer, Pfizer shall become the regulatory sponsor
of such IND and any and all clinical trials conducted in relation to the IND or to the Vaccine.

 

5.2.1(b).       Subject
to the terms of this Agreement, coincident with Valneva transferring the IND relating to the Valneva Phase 2 Clinical Trials to
Pfizer, Pfizer will transfer to Valneva responsibility for such obligations of sponsorship as are mutually agreed between the
Parties, to enable Valenva’s uninterrupted conduct of the Valneva Phase 2 Clinical Trials.

 

5.2.1(c)       Prior
to Pfizer transferring to Valneva any obligations of sponsorship, the Parties will mutually agree upon a plan (“Transfer
Plan”) which will set forth in detail the nature and scope of each Party’s responsibilities with respect to the Valneva
Phase 2 Clinical Trials following transfer of the IND. Once agreed upon, the Transfer Plan will be incorporated by reference into
this Agreement and may only be amended with the unanimous consent of both parties, which may be provided either in writing, or
orally at a meeting of the Joint Development Committee and recorded in the minutes thereof. The head terms of such Transfer Plan
is attached hereto as Exhibit A.

 

5.2.2.
After transfer of the IND pursuant to Section 4.2.6(e), Valneva shall ensure that the Valneva Phase 2 Clinical Trials are performed
in accordance with this Agreement, the applicable protocols and all Applicable Law, including GCP. In the event that any Regulatory
Authority, ethics committee or institutional review board makes inquiries relating to any aspect of the Valneva Phase 2 Clinical
Trials, including but not limited to any aspect of the protocol, data quality, manufacturing or study conduct, Valneva will immediately
notify Pfizer of such inquiries and provide reasonable assistance to Pfizer in responding.

 

5.2.3.
After transfer of the IND pursuant to Section 4.2.6(e), Valneva shall ensure that: (i) all directions from any Regulatory Authority
and/or ethics committee with jurisdiction over the Valneva Phase 2 Clinical Trials are followed; (ii) all Regulatory Approvals
from any Regulatory Authority and/or ethics committee with jurisdiction over the New Phase 2 Clinical Trial are maintained; and
(iii) all reports and related documentation relating to the Valneva Phase 2 Clinical Trials are maintained in good scientific
manner and in compliance with Applicable Law, including any revisions to reports and related documentation as are necessary to
fulfill Pfizer’s obligations as sponsor of the Valneva Phase 2 Clincial Trials upon transfer of the IND from Valneva to
Pfizer. Pfizer, as the sponsor, shall lead any discussions with a Regulatory Authority regarding the Valneva Phase 2 Clinical
Trials, with Valneva having the right to participate in any such discussions. Prior to any such discussions Pfizer and Valneva
shall jointly discuss strategies and content of information to be provided to, and/or discussed with the relevant Regulatory Authority.

 

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		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. 2 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. 2 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
IMMEDIATELY FOLLOWING ON NEXT PAGE

 

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IN
WITNESS WHEREOF, the duly authorized representatives of Pfizer and Valneva have executed this Amendment No. 2 as of the date first
above written.

 

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

         

        By:
[***]

        [***]
	By:
    /s/[***]
	Print
    Name:	Print
    Name: [***]
	Title:
[***]
	Title:
    SVP and Head of Vaccine Research & Development
	Date:
March 21, 2022

        mars
22, 2022

        (Duly
authorized)
	Date:
                                         March 21, 2022

         

        (Duly
authorized)

         

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EXHIBIT
A

 

Head
terms to be detailed in the Transfer Plan:

 

[***]

 

    5Valneva 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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