Document:

Valneva SE 6-K

 

Exhibit 10.4

 

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Strictly confidential 

 

Amendment to the APA No: SANTE/2020/C3/089

 

This Amendment to the Advance Purchase
Agreement (“Amendment”) is made effective as of the last date of signature (the “Amendment Effective
Date”) by and between Valneva Austria GmbH, a limited liability company (Gesellschaft mit beschränkter Haftung)
incorporated under company [***], whose registered office is at Campus Vienna Biocenter 3, 1030 Vienna, Austria (the “contractor”),
and the European Commission (the “Commission”), acting on behalf and in the name of the Participating Member
States to the APA.

 

WHEREAS, contractor and the Commission
entered into Advanced Purchase Agreement dated effective on 23 November 2021 (the “APA”); and

 

WHEREAS, the Product has not received
a Marketing Authorisation for the Product on or before 30 April 2022, which, pursuant to Article II.16.1 of the APA, provided a
legal ground for the Commission to terminate the APA in the absence of an acceptable remedial plan;

 

WHEREAS on 13 May 2022 the Commission
has sent to the contractor a Termination Intent Notice;

 

WHEREAS, on 18 May 2022, the contractor
proposed a remedial plan to the Commission and the Participating Member States consisting of a draft amendment to the APA offering
the Participating Member States, depending on their choices, the possibility to withdraw from the APA, adjust their orders or maintain
their initial orders.

 

WHEREAS on 23 June 2022 the Product
received a positive opinion by EMA, recommending issuance of an unconditional marketing authorisation;

 

WHEREAS the Commission decision
to grant an unconditional Marketing Authorisation was adopted on 24 June 2022;

 

WHEREAS, following the discussions
on the remedial plan proposed by the contractor on 18 May 2022, and updates thereto of 7 and 9 June 2022, the Parties desire to
amend certain provisions of the Agreement, in particular to allow the Participating Member States to opt 1) to pursue the implementation
of the APA, without any modification to the volumes ordered under their respective Vaccine Order Forms; 2) to pursue the implementation
of the APA, with a reduction of the volumes under their respective Vaccine Order Forms; or 3) to terminate the APA and their respective
Vaccine Order Forms.

 

The Parties hereto agree that the APA shall
be amended.

 

		1.	Scope of the Amendment

 

		1.1.	The Parties hereby agree to (i) formalize the justified termination of the APA for certain Participating
Member States pursuant to Article II.16.1 of the APA on the ground that the long stop date relating to Marketing Authorisation
of 30 April 2022 was not met (ii) reduce the volume of Doses under their respective Vaccine Order Forms for certain other Participating
Member States, (iii) amend the timelines of the implementation of the APA with respect to the Remaining Member States (as defined
in Article 3.3 of the Amendment) and, as a result of the preceding changes, (iv) amend the rights and obligations of the Parties
with respect to the delivery of the Doses.

 

		1.2.	Except as set forth in this Amendment, all other articles and annexes of the APA shall remain unchanged
and unaffected. This Amendment has been prepared and entered into in accordance with Article II.10.2 of the APA and forms an integral
part of the APA.

 

    
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		1.3.	Capitalized terms used in this Amendment that are defined in the APA have the same meaning in this
Amendment.

 

		2.	Options for the implementation of the APA 

 

		2.1.	The Parties have agreed that each of the Participating Member States has the option to:

 

		2.1.1.	pursue the implementation of the APA, without any modification to the volumes ordered under their
respective Vaccine Order Forms, subject to the provisions of Articles 3 and 4 of this Amendment (“Option 1”);

 

		2.1.2.	pursue the implementation of the APA, with a reduction of the volumes under their respective Vaccine
Order Forms, subject to the provisions of Articles 3, 5 and 7 of this Amendment (“Option 2”); or

 

		2.1.3.	terminate the APA and their respective Vaccine Order Forms, subject to the provisions of Article
6 and 7 of this Amendment (“Option 3”).

 

The Participating
Member States having chosen Option 1 or Option 2 are collectively referred to as the “Remaining Member States”.

 

		2.2.	According to the options in Article 2.1 of this Amendment selected by the respective Participating
Member States, all of the references to the volume and allocation of the Doses under the APA and the Vaccine Order Forms are corrected
according to Annex I of this Amendment, which replaces Annex I of the APA.

 

		2.3.	The Parties agree that no suspension and cancellation of Doses and reimbursement of Down Payment
can occur under:

 

		2.3.1.	Article I.4.7.2.a) of the APA on the grounds of the new Delivery Schedule being adopted under Article
3.3 of this Amendment; or

 

		2.3.2.	Article I.4.7.4 of the APA.

 

		3.	The implementation of the APA under Option 1 and Option 2

 

		3.1.	The Remaining Member States:

 

		3.1.1.	will not terminate the APA despite the fact that the contractor failed to receive a Marketing Authorisation
for the Product on or before 30 April 2022, which is one of the long stop dates described in Article II.16.1 of the APA; and

 

		3.1.2.	will amend their Vaccine Order Forms to adjust to the adapted volumes and allocations in Annex
I of this Amendment, which replaces Annex I of the APA in accordance with Article 2.2 of this Amendment.

 

		3.2.	The contractor shall make the first delivery upon the signature of this Amendment as early as possible
from a regulatory process perspective and in accordance with the agreed Delivery Schedule.

 

    
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		3.3.	As of the Amendment Effective Date, the Delivery Schedule set out in Article I.4.7.1 of the APA
is replaced by the Delivery Schedule set out below:

 

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		4.	Rights of the Participating Member States having opted for Option 1

 

Subject to
the other provisions of this Amendment, the rights and obligations of the Participating Member States under Option 1 shall remain
unchanged and unaffected.

 

		5.	Rights of the Participating Member States having opted for Option 2

 

		5.1.	The contractor commits to deliver the updated volume of the Doses indicated in Annex I of this
Amendment (“New Allocated Doses”) in accordance with the Delivery Schedule as set out under Article 3.3 of the
Amendment.

 

		6.	Rights of the Participating Member States having opted for Option 3

 

		6.1.	For the purposes of this Amendment, Option 3 shall be considered as a justified termination due
to the failure to meet one of the long stop dates described in Article II.16.1 of the APA.

 

		6.2.	The Participating Member States having opted for Option 3 will no longer be considered as a “Participating
Member State” or a “Party” to the APA from the Amendment Effective Date.

 

		7.	Effect of Options 2 and 3 as regards the Down Payments

 

		7.1.	Within 30 days of the Amendment Effective Date, the contractor shall provide a Financial Statement
to the Commission drawn up in accordance with Article II.16.5.b) of the APA describing the use of the Down Payments, for the purpose
of assessing the entitlement of Participating Member States choosing Option 2 or Option 3 to the reimbursement of Unspent Amounts.

 

		7.2.	[***]

 

    
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		7.3.	In accordance with provision of Article II.16.5.c) of the APA, the contractor will clarify whether
any Refundable Items remain at its disposal and Parties will discuss in good faith the implementation of this provision with regard
to the reduced volume of Doses.

 

		8.	Additional Supply Option

 

Article I.4.4
of the APA relating to the 2023 Option is deleted. Nevertheless, the Remaining Member States shall have the option to purchase
additional Doses under the following conditions:

 

		8.1.	each Remaining Member State shall have the right, at its discretion, to purchase one additional
Dose for each Dose purchased under Annex I of this Amendment (the "Additional Supply Option");

 

		8.2.	a Remaining Member State electing to purchase additional Doses under the Additional Supply Option
must notify its decision to contractor, at the latest on [***], by issuing a new Vaccine Order Form to this end;

 

		8.3.	such Doses shall be invoiced upon delivery and paid for in accordance with the APA;

 

		8.4.	[***]; and

 

		8.5.	the additional Doses ordered shall be delivered [***].

 

		9.	Order of priority of provisions

 

If there is any conflict between
different provisions in the APA, as amended by this Amendment, the provisions set out in this Amendment take precedence over those
in the APA.

 

		10.	Applicable law

 

		10.1.	This Amendment shall be governed by the laws of [***].

 

		10.2.	For avoidance of doubt, Article I.10 (Applicable law and settlement of disputes) of the
APA shall apply to this Amendment.

 

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	SIGNATURES	 
	 	 
	For the contractor,	For the Commission, on behalf and in the name of the Participating Member States,
	 	 
	[***]	[***]
	 	 
	 	Signature:	
    /s/ [***]	 
	Signature: 	/s/
    [***]	 	 
	 	Done at [***]
	Done at [***]	 
	 	 
	AND	 
	 	 
	[***]	 
	 	 
	Signature:	 
	 	 
	Done at [***] In duplicate in English.	 
	 	 	 	 	 	 

 

    
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Annex I: Participating Member States
and allocated volumes

 

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 Page 6 of 6Valneva SE 6-K

 

Exhibit 10.5

 

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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

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