Document:

EX-10.2

  Exhibit 10.2

   

  CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [[***]], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL, AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED AND is the type that the registrant treats as private or confidential.

  Termination, AMENDMENT and Program Transfer AGREEMENT

  This Termination, Amendment and Program Transfer Agreement (“Agreement”) is entered into as of the date of the last signature below (“Agreement Effective Date”) by and between:

  Bayer AG (“Bayer”), a company organized under the Laws of Germany, whose office is situated at Müllerstraße 178, 13353 Berlin, Germany,

  and

  Atara Biotherapeutics, Inc. (“Atara”), a company organized under the Laws of Delaware, whose office is situated at 611 Gateway Blvd, Suite 900, South San Francisco, CA 94080, U.S.A.

  Bayer and Atara shall also each individually be referred to herein as a “Party”, and shall be referred to collectively as the “Parties”.

   

  Recitals

  WHEREAS, Bayer is engaged in the development, commercialization and manufacture of pharmaceutical products;

  WHEREAS, Atara owns - partly through ownership, partly through acquired license - certain patent rights, know how and other intellectual property relating to Licensed Cell Therapeutics (as defined in the License Agreement), and is developing the Licensed Cell Therapeutics for the treatment or prevention of cancer;

  WHEREAS, Atara and Bayer entered into a Research, Development and License Agreement dated as of December 4, 2020 (the “License Agreement”) to collaborate on the research, Development and Commercialization of Licensed Cell Therapeutics and Licensed Products (as defined in the License Agreement) and under which Bayer obtained an exclusive license and sublicense under certain intellectual property rights Controlled by Atara to Develop, Commercialize and Manufacture the Licensed Cell Therapeutics in the Field in the Territory on the terms and subject to the conditions of the License Agreement;

  WHEREAS, Atara and Bayer entered into a Phase 1-2 Manufacturing and Supply Agreement dated as of March 3, 2021 (the “MSA”), pursuant to which Atara Manufactures, stores and distributes for Bayer quantities of clinical supplies of the allogeneic Licensed Product for the Phase 1 Clinical Trial and the Phase 2 Clinical Trial of Bayer conducted in the United States, and Bayer purchases from Atara such quantities of clinical supply of the allogeneic Licensed Product and receives such storage and distribution services in connection with such clinical supply;

   

  

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  WHEREAS, Atara and Bayer entered into a Quality Assurance Agreement dated as of March 3, 2021 (the “Quality Agreement”), which governs quality-related terms associated with the supply of the allogeneic Licensed Product detailed in the MSA;

  WHEREAS, Atara and Bayer entered into a Technology Transfer Agreement dated as of March 3, 2021 (the “Tech Transfer Agreement”) which governs the transfer of the PV1 Manufacturing Technology (as defined in the Tech Transfer Agreement) to Bayer;

  WHEREAS, Atara and Bayer entered into a Pharmacovigilance Agreement dated as of March 3, 2021 (the “PV Agreement”), which details each Party’s pharmacovigilance obligations in relation to Licensed Products under the License Agreement;

  [[***]];

  WHEREAS, on May 11, 2022, Bayer provided to Atara a written notice to terminate the License Agreement, with effectiveness of termination on September 13, 2022 in accordance with the terms of the License Agreement;

  WHEREAS, the Parties want to mutually agree on an earlier effectiveness of the termination of the License Agreement including, for clarity, the other Atara-Bayer Agreements;

  WHEREAS, in view of the termination of the Atara-Bayer Agreements the Parties want to amend certain terms, in particular regarding the surviving provisions, of the Atara-Bayer-Agreements;

  WHEREAS, Atara requested a Program Transfer (as defined in the License Agreement) and the Parties wish to agree on such Program Transfer; 

  NOW, THEREFORE, in consideration of the recitals above and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

   

  Article 1
DEFINITIONS

  1.1Unless expressly stated otherwise in this Agreement, all defined terms used in this Agreement shall have the meaning ascribed to them in the applicable Atara-Bayer Agreement or, if not used specifically regarding one of the Atara-Bayer Agreements but regarding this Agreement, then as ascribed to such term in the License Agreement.

  1.2“Atara-Bayer Agreement” means the License Agreement, the MSA, the Quality Agreement, the Tech Transfer Agreement, and/or the PV Agreement, as applicable.

   

   

   

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  Article 2
TERMINATION

  2.1Termination of the License Agreement. 

  2.1.1The Parties hereby agree that as of July 31, 2022 (the “Termination Effective Date”), the License Agreement shall stand terminated and thereafter it shall have no future force or effect.

  2.1.2It is agreed that the provisions in the License Agreement regarding the termination notice are specifically waived by the Parties for the purposes of this Agreement.

  2.1.3For clarity, upon the termination of the License Agreement, the MSA, the Quality Agreement and the Tech Transfer Agreement automatically terminate as agreed in the respective Atara-Bayer Agreement.

  2.2Termination of the PV Agreement. The Parties hereby agree that as of the Termination Effective Date, the PV Agreement shall stand terminated and thereafter it shall have no future force or effect. 

  2.3Termination of the Binding Purchase Order. The Parties hereby agree that as of the Termination Effective Date the only existing Binding Purchase Order of March 3, 2021 (Exhibit A-1 to the MSA) shall stand terminated and thereafter it shall have no future force or effect.

   

  Article 3
AMENDMENTS

  3.1Amendment to the License Agreement. Section 18.6 of the License Agreement shall be deleted in its entirety and be replaced as follows:

  “18.6.	Survival. The provisions of Sections 2.1.2, 2.1.3, 2.2.2, 2.2.3, 2.8, 3.3.4, 9.6.4 (solely with respect to payments that are accrued but unpaid at the time of expiration or termination), 9.7, 11.2, 13.1 and 13.2 (solely with respect to Public Communication), 13.3, 13.7, 14.1-14.2 (solely with respect to claims arising from a breach of warranty, subject to applicable statute of limitation), 14.3, 17.4, 18.3, and 18.6 and Article 1, Article 10, Article 12 (but not Section 12.3), Article 16 (but not Section 16.5), Article 20 and Article 21 shall survive the termination of this Agreement.  For the avoidance of doubt, Sections 8.1, 12.3, 13.4, 13.5, 13.6 and 18.4-18.5 of the License Agreement shall terminate as of the Termination Date. Further, notwithstanding anything to the contrary in the License Agreement, Bayer shall not be permitted to make any Scientific Communications, and Atara shall be free to make Scientific Communications of any kind without any restrictions.”

  3.2Amendment to the MSA. Section 11.3.2 of the MSA shall be deleted in its entirety and be replaced as follows:

   

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  “11.3.2  Upon the expiration or termination of this Agreement, the rights and obligations of each of the Parties thereunder shall terminate. The provisions of Article 1, Article 7, Article 8, Article 12 and Sections 2.7, 4.3, and 11.3 shall survive any termination of this Agreement. 

  3.3Amendment to the Quality Agreement. Section 10.4 of the Quality Agreement shall be deleted in its entirety and be replaced as follows:

  “10.4	Upon termination of the QAA, all rights and obligations of the Parties under this QAA shall cease immediately.”

  3.4Amendment to the Tech Transfer Agreement. Section 5.3 of the Tech Transfer Agreement shall be deleted in its entirety and be replaced as follows:

  “5.3	Survival. The following provisions of this Agreement will survive its termination or expiration: Sections 1, 5.3 and 6.”

  3.5Amendment to the PV Agreement. The last paragraph of Section 18 of the PV Agreement (starting with “In addition, for the avoidance of doubt...”) shall be deleted in its entirety and shall not be replaced.

   

  Article 4
PAYMENT

  4.1Payment Amount. As consideration for the termination of the contractual relationship established by the Atara-Bayer Agreements including the Binding Purchase Order of March 3, 2021 (Exhibit A-1 to the MSA), Bayer agrees to pay to Atara and Atara agrees to accept the sum of US$4,210,000 (in words: four million two hundred ten thousand U.S. dollars)  which breaks down as follows:

  •[[***]].

  •[[***]].

  The Parties agree that except for the payment set forth in this Section 4.1, neither Bayer nor Atara shall have any further obligations to make any payments in connection with the Atara-Bayer Agreements, the Binding Purchase Order of March 3, 2021 (Exhibit A-1 to the MSA) and/or this Agreement.

  4.2Invoicing and Payment Date. Atara may invoice the payment amount set out in Section 4.1 after the Termination Effective Date. Payment shall be made by Bayer to Atara within [[***]] after receipt of an invoice.

  4.3Other Payment Terms and Taxes. Sections 9.6.1, 9.6.3 – 9.7 of the License Agreement shall apply mutatis mutandis to the payment obligation under Section 4.1 in this Agreement.

   

   

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  Article 5
PROGRAM TRANSFER

  5.1Program Transfer Items. Bayer herewith makes the following Program Transfer in accordance with Section 18.3.4 of the License Agreement:

  5.1.1Regulatory Documentation. Bayer herewith transfers and assigns to Atara the Regulatory Documentation owned by Bayer or its Affiliates that is listed in Exhibit 5.1.1. 

  5.1.2Inventory and other material. Bayer shall transfer to Atara the remaining inventory of Licensed Cell Therapeutics or Licensed Product (including work-in-progress) [[***]] listed in Exhibit 5.1.2. Further, Bayer shall transfer or destroy [[***]] material that is also listed in Exhibit 5.1.2.

  5.1.3Licenses.  Bayer hereby grants, on behalf of itself and its Affiliates to Atara under the Bayer Results, Joint Results, Bayer Background Technology, Bayer Background Improvements, and Bayer Improvement IP listed in Exhibit 5.1.3, in each case, with a right to grant and authorize sublicenses through multiple tiers, a worldwide, non-exclusive, perpetual, irrevocable, royalty- and milestone-free, fully paid-up license to import, use, Manufacture, have Manufactured, sell, have sold, offer to sell and otherwise commercialize the Terminated Product in the Field. In addition, the licenses and provisions set forth in Section 2.2.2 of the License Agreement shall survive with respect to the Terminated Product and any other products in the Field in the Territory comprising a Licensed Cell Therapeutic or Licensed Product (alone or with other ingredients), provided that, for clarity, the exclusive licenses granted to Bayer under Section 2.1.1 of the License Agreement will, at such time, be terminated, and therefore such licenses and provisions set forth in Section 2.2.2 shall no longer be subject to any exclusive license to Bayer under the License Agreement. 

  5.1.4No other Items.  The Parties mutually agree that Sections 18.3.4.2 (ii), (iii) and (vi) are not applicable.

   

   

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  5.2Copies; Shipment. 

  5.2.1Atara confirms to already have received copies of the items listed in Exhibits 5.1.1 and 5.1.3, unless otherwise indicated in Exhibit 5.1.3. The copies that have not yet been transferred will be transferred within the timelines indicated in Exhibit 5.1.3.

  5.2.2Bayer shall dispatch the inventory to be transferred to Atara under Section 5.1.2 [[***]].

  5.3As Is; No Consideration. The Parties agree that Bayer makes the transfers under this Agreement on an “as is” basis and that the Program Transfer shall be made without any consideration.

  5.4Agreement on Completeness. The Parties agree that the items listed in Section 5.1 including Exhibits 5.1.1, 5.1.2 and 5.1.3 cover conclusively the items that need to be transferred in accordance with Section 18.3.4 of the License Agreement. However, if within [[***]] as of the Agreement Effective Date Atara identifies additional (i) Regulatory Documentation, (ii) remaining inventory of Licensed Cell Therapeutics or Licensed Product (including work-in-progress), (iii) Bayer Background Technology or Bayer Improvement IP, in each case (i) – (iii) only to the extent covered by Section 18.3.4 of the License Agreement, then the Parties shall coordinate a [[***]] transfer of such additional items in accordance with Section 18.3.4.2 to Atara.

   

  Article 6
RELEASE

  The Parties, on behalf of itself and its Affiliates, do hereby mutually remise, release and forever discharge each other and their respective administrators, executors, representatives, successors and assigns, from any and all actions, causes of action, suits, debts, accounts, covenants, disputes, agreements, promises, damages, judgments, executions, claims, and demands whatsoever that they ever had, now has, or that they or their administrators, executors, representatives, successors and assigns hereafter can or may have, by reason of any act, omission, matter, cause or thing whatsoever occurring at any time prior to the execution of this Agreement, whether known or unknown, suspected or unsuspected, foreseen or unforeseen, arising from or related to (i) the Atara-Bayer Agreements and/or the Binding Purchase Order of March 3, 2021 (Exhibit A-1 to the MSA) and (ii) the negotiations before the Agreement Effective Date.

   

  Article 7
CONFIDENTIALITY 

  7.1Destruction of Confidential Information. Within [[***]] upon the Agreement Effective Date, each Party will destroy all of the other Party’s Confidential Information received under any of the Atara-Bayer Agreements, except to the 

   

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  extent such first Party has the right to retain any such Confidential Information pursuant to such Section 18.3.3 of the License Agreement which shall apply mutatis mutandis to all Atara-Bayer Agreements.

  7.2Confidentiality of Terms. Article 12 of the License Agreement shall apply mutatis mutandis to this Agreement and the terms and conditions of this Agreement shall be deemed both Parties’ Confidential Information under the License Agreement and, with regard thereto, both Parties shall be subject to the obligations of confidentiality and non-use as per Section 12.2 of the License Agreement.

   

  Article 8
MUTUAL REPRESENTATIONS AND WARRANTIES

  8.1Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party that as of the Agreement Effective Date of this Agreement:

  8.1.1It is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation;

  8.1.2It has full corporate right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement;

  8.1.3It is duly authorized to execute and deliver this Agreement, and the person or persons executing this Agreement on its behalf have been duly authorized to do so by all requisite corporate action; and

  8.1.4This Agreement is legally binding upon it, enforceable in accordance with its terms.

  8.2Disclaimer of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY, AND, WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY, INCLUDING ANY WARRANTY OF ACCURACY, SAFETY, QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OF ANY KNOW-HOW, LICENSES, DOCUMENTS, MATERIAL, ETC., OR ANY WARRANTY AS TO THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

   

  Article 9
TERM

   

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  9.1Term. The term of this Agreement will commence on the Agreement Effective Date and will end upon the later of (i) receipt of the payment by Atara under Section 4.1, (ii) receipt of the inventory by Atara listed in Exhibit 5.1.2, (iii) receipt of copies of all items listed in Exhibit 5.1.3, and (iv) fulfillment of the obligations under Section 7.1 by either Party.

  9.2Survival. Sections 5.1.3, 7.2 and 9.2 and Articles 1, 3, 6, 8 and 10 of this Agreement will survive any expiration of this Agreement. 

   

  Article 10
MISCELLANEOUS

  10.1In the event of a conflict between the terms and conditions of this Agreement and the exhibits, the terms and conditions of this Agreement shall prevail, unless explicitly stated otherwise by the Parties in the exhibits.

  10.2Articles 20 and 21 of the License Agreement shall apply mutatis mutandis to this Agreement.

  10.3In the event of any inconsistencies or conflict between the Atara-Bayer Agreements and this Agreement, the provisions of this Agreement shall govern and control.

   

  Exhibits

  Exhibit 4.1:	Atara’s Incurred Fees under the Binding Purchase Order of March 3, 2021 under the MSA

   

  Exhibit 5.1.1:	Regulatory Documentation

   

  Exhibit 5.1.2:	Inventory and other material

   

  Exhibit 5.1.3:	Bayer Results / Joint Results / Bayer Background Technology / Bayer Background Improvements / Bayer Improvement IP

   

   

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  IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Agreement Effective Date.

   

  		
	Berlin, Germany
	San Francisco, California, U.S.A.

	BAYER AG
 
 
 
ppa. /s/ Marianne De Backer 
Dr. Marianne De Backer
Head of Business Dev. & Licensing & OI, PH
 
 
 
ppa. /s/ Dominik Rüttinger
Prof. Dr. Dominik Rüttinger
Global Head Research & Early Development (RED) Oncology
	ATARA BIOTHERAPEUTICS, INC
 
 
/s/ Pascal Touchon
Pascal Touchon
President and Chief Executive Officer

   

   

   

   

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  Exhibit 4.1

   

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  Exhibit 10.2

  Exhibit 5.1.1

  Regulatory Documentation

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  Exhibit 5.1.2

  [[***]]

   

   

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  Exhibit 10.2

  Exhibit 5.1.3

  [[***]]EX-10.3

  Exhibit 10.3

  CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [[***]], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL, AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED AND is the type that the registrant treats as private or confidential.

  AMENDMENT NO. 1 TO THE COMMERCIALIZATION AGREEMENT

  This Amendment No. 1 to the Commercialization Agreement (this “Amendment”) is made and entered into, effective as of September 27, 2022 (“Amendment Effective Date”), by and between Atara Biotherapeutics, Inc. (“Atara”), a Delaware corporation with offices at 611 Gateway Blvd, Suite 900, South San Francisco, CA 94080 and Pierre Fabre Medicament (“Partner”), having its registered office at Les Cauquillous, 81500 Lavaur, France. Atara and Partner are sometimes referred to singly as “Party” and collectively as “Parties.”

  Background

  WHEREAS, the Parties have entered into that certain Commercialization Agreement (the “Agreement”) effective as of October 2, 2021 (the “Effective Date”), pursuant to which the Parties are conducting certain development and/or commercialization activities in regards to tabelecleucel, an allogeneic T-cell immunotherapy selective for the tumor-associated antigens expressed by EBV;

  WHEREAS, the Parties desire to amend the Agreement to incorporate the various changes set forth in this Amendment; 

  WHEREAS, the Parties agree that the amendments specified herein are to become effective on the Amendment Effective Date, unless otherwise herein specified; and 

  WHEREAS, Section 17.1 of the Agreement provides that the Agreement may only be modified by a writing signed by each Party to the Agreement.

  NOW, THEREFORE, the Parties desire, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, to amend the Agreement as set forth in this Amendment.

  Article 1
DEFINITIONS

  1.1Capitalized Terms.  Capitalized terms used in this Amendment shall have the meanings set forth in the Agreement unless otherwise defined and set forth in this Amendment.  Except as expressly modified by this Amendment, the remainder of the Agreement shall remain in force in accordance with its terms and without any modification.

  Article 2
AMENDMENTS

  2.1Amendment of Section 1.12.  Section 1.12 of the Agreement is hereby deleted in its entirety.

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  2.2Amendment of Section 1.13.  Section 1.13 of the Agreement is hereby renumbered as Section 1.12.

  2.3Amendment of Section 1.14.  Section 1.14 of the Agreement is hereby amended and restated in its entirety as follows:

  1.13 “Atara Manufacturing Facility” means one or more facilities of (a) [[***]] or (h) any other facility of an Atara Affiliate or Third Party subcontractor designated after the Effective Date by Atara, in each case (i) subject to prior notice to Partner sufficiently in advance if the use of any such Atara Manufacturing Facility will require a change to any Regulatory Filing, Regulatory Approval, or Marketing Authorization for the Product in the Territory, and (ii) subject to Partner’s prior written consent in the event that Atara’s use of such other facility in connection with the performance of its obligations under this Agreement would adversely impact in any material respect a Regulatory Filing, Regulatory Approval, or Marketing Authorization, in each case, in the Territory, which consent shall not be unreasonably withheld or delayed, or in accordance with Section 9.5.

  2.4Amendment of Sections 1.15 – 1.35.  Sections 1.15 – 1.35 of the Agreement are hereby renumbered as Sections 1.14 – 1.34, respectively.

  2.5Amendment of Section 1.36. Section 1.36 of the Agreement is hereby renumbered as Section 1.35, and amended and restated in its entirety as follows:

  1.35 “Cost-Plus” means the actual cost incurred by Atara for Manufacturing Product (including intermediates), plus [[***]], where actual costs include, without limitation, the following:

   	[[***]]

  2.6Amendment of Sections 1.37 – 1.59.  Sections 1.37 – 1.59 of the Agreement are hereby renumbered as Sections 1.36 – 1.58, respectively

  2.7Amendment of Section 1.60.  Section 1.60 of the Agreement is hereby renumbered as Section 1.59, [[***]].

  2.8Amendment of Sections 1.61 and 1.62.  Sections 1.61 and 1.62 of the Agreement are hereby renumbered as Sections 1.60 and 1.61, respectively, and then solely upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, said sections shall be immediately and automatically renumbered as Sections 1.59 and 1.60, respectively.

  2.9Amendment of Section 1.63.  Section 1.63 of the Agreement is hereby renumbered as Section 1.62, and then solely upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, said section shall be immediately and automatically deleted in its entirety.

  2.10Amendment of Sections 1.64 – 1.136. Sections 1.64 – 1.136 of the Agreement are hereby renumbered as Sections 1.63 and 1.135, respectively, and then solely upon achievement of the 

   

  

   

  developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, said sections shall be immediately and automatically renumbered as Sections 1.61 – 1.133, respectively.

  2.11Amendment of Section 1.137. Section 1.137 of the Agreement is hereby renumbered as Section 1.136, and then solely upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, said section shall be immediately and automatically amended and restated in its entirety as follows:

  1.134 “Royalty Term” means, on a country-by-country-basis within the Territory, the period beginning on the date of the First Commercial Sale of Product in such country and ending on the last to occur of (a) [[***]] after the First Commercial Sale in the applicable country; (b) the expiration or abandonment of the last Valid Claim of the Patent Rights within the Atara Intellectual Property that Covers any aspect of the Commercialization of the Product in the Field in such country; or (c) the expiration of all Regulatory Exclusivity for such Product in the Field in such country. 

  2.12Amendment of Sections 1.138 – 1.152.  Sections 1.138 – 1.153 of the Agreement are hereby renumbered as Sections 1.137 and 1.151, respectively, and then solely upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, said sections shall be immediately and automatically renumbered as Sections 1.135 – 1.149, respectively.

  2.13Amendment of Section 7.3. Section 7.3 of the Agreement is hereby amended and restated in its entirety as follows:

  7.3 Pharmacovigilance. At a mutually agreeable time prior to the transfer of the Regulatory Approval or MA for the Product in Europe and the UK for the Primary Indication, the Parties will negotiate and execute in good faith a mutually agreed pharmacovigilance agreement in customary form (the “Pharmacovigilance Agreement”) delineating the processes and procedures for sharing safety information with respect to the Product that are customary for agreements of this type.  The Pharmacovigilance Agreement shall, among other things, require each of Atara and Partner to inform the other as soon as is practicable of any observed significant safety issue considered likely to have an adverse impact on Commercialization of the Product. 

  2.14Amendment of Section 8.10. Solely upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, Section 8.10 of the Agreement shall be immediately and automatically amended and restated in its entirety as follows:

  8.10 Cell Selection. Upon grant of a Marketing Authorization, and prior to [[***]], Atara shall provide Cell Selection services for the Product in the Field for Commercialization in the Territory, to Partner and its Affiliates and their Approved Sublicensees, at the sole and exclusive cost of Atara.  [[***]].  If the Parties mutually agree that Atara shall continue to provide such Cell Selection services to Partner on or after [[***]], Atara’s provision of such Cell Selection services shall be at the sole and exclusive cost and expense of Partner, in accordance with Exhibit F attached hereto.  [[***]]. 

   

  

   

  2.15Amendment of Section 9.1. Section 9.1 of the Agreement is hereby amended and restated in its entirety as follows:

  9.1 Manufacturing and Supply Agreement. At a mutually agreeable time prior to the transfer of the Regulatory Approval or MA for the Product in Europe and the UK for the Primary Indication and at the latest by October 31, 2022, the Parties will negotiate and execute a manufacturing and supply agreement (the “Manufacturing and Supply Agreement” or “MSA”) on mutually agreed terms and conditions for the Manufacture and supply of the Product that are customary for agreements of this type.  Partner shall purchase from Atara or its Affiliates all of Partner’s, and its Affiliates’ and Approved Sublicensees’ requirements of Product in the Field in the Territory pursuant to the terms and conditions of the MSA. Key terms relating to Atara’s Manufacture and supply of Product for Partner that are to be incorporated into the Ancillary Agreements are summarized in Exhibit C attached hereto.

  2.16Amendment of Section 9.3.  Section 9.3 of the Agreement is hereby amended and restated in its entirety as follows:

  9.3 Quality Agreement. At a mutually agreeable time prior to the transfer of the Regulatory Approval or MA for the Product in Europe and the UK for the Primary Indication and concomitant with the MSA at the latest by October 31, 2022, the Parties will negotiate and execute a quality agreement (the “Quality Agreement”) on mutually agreed terms and conditions for the manufacture and supply of the Product that are customary for agreements of this type, including customary audit rights of Atara Manufacturing Facility.

  2.17Amendment of Section 9.5. Section 9.5 of the Agreement is hereby amended and restated in its entirety as follows:

  9.5. Atara Supply Obligation. 

  (a) 	The obligations of Atara under this Article 9, including the obligations to Manufacture (or have Manufactured by an Atara Manufacturing Facility) and supply Product to Partner hereunder, shall continue (on a country-by-country and Product-by-Product basis) through to the end of the Term with respect to such Product in such country. 

  (b)	At any time after a period of [[***]] from the First Commercial Sale of the Product in the Territory, upon Atara’s delivery of formal written notice to Partner, Atara may elect to transfer to Partner the responsibility for Manufacturing Product, or having Product Manufactured, for use in the Territory. At least [[***]] before Atara’s delivery of such formal written notice, Atara shall inform Partner of its intent to deliver such formal written notice, at which time Partner shall choose to assume directly, or through an Atara Manufacturing Facility, or through any other qualified designee of Partner approved in advance by Atara, the Manufacturing of the Product for the Territory (the supplier so elected by Partner in this Section 9.5(b) being referred to as the “Selected Manufacturer”).  Partner’s choice of Selected Manufacturer shall be delivered to Atara in writing no later than [[***]] after Atara notifies Partner of its intent to deliver the formal 

   

  

   

  written notice in this Section 9.5(b). If so elected by Partner, Atara shall use Commercially Reasonable Efforts to enable Partner to negotiate with the Atara Manufacturing Facility for the supply of the Product for the Territory at terms and conditions substantially as favorable as those of Atara. As soon as reasonably practicable after receipt of Partner’s choice of Selected Manufacturer, if required, Atara shall use Commercially Reasonable Efforts to (i) transfer to the Selected Manufacturer technology, materials, and other Know-How required to enable them to Manufacture Product for all of Partner’s authorized uses in the Field and in the Territory under this Agreement (the “Technology Transfer”) and (ii) complete the Technology Transfer within [[***]] of Partner’s choice of the Selected Manufacturer. Except in the case where the Selected Manufacturer is [[***]], [[***]] shall bear the associated costs for such Technology Transfer under this Section 9.5(b). 

  (c)	Upon completion of any Technology Transfer pursuant to Section 9.5(b), as soon as reasonably practicable, Partner shall seek revision of all Regulatory Approvals related to the Commercialization of the Product in the Territory to reflect such Selected Manufacturer as the Manufacturer. Until completion of any Technology Transfer to the Selected Manufacturer pursuant to Section 9.5(b) and revision of all Regulatory Approvals related to the Commercialization of the Product in the Territory to reflect such Selected Manufacturer as the Manufacturer, Atara shall continue to (i) Manufacture, or have Manufactured by an Atara Manufacturing Facility, and (ii) supply Product to Partner pursuant to the provisions of this Article 9, Exhibit C, and the associated MSA.  In the event that a Technology Transfer to a Selected Manufacturer occurs, upon its completion, Section 2.1 of this Agreement shall be amended to grant the Selected Manufacturer a non-exclusive, non-sublicensable, fully paid-up license under the Atara Intellectual Property existing as of the completion date of the Technology Transfer to Manufacture the Product for all of Partner’s authorized uses in the Field and in the Territory under this Agreement.  Atara shall have no further obligation to Manufacture and supply Product for any Partner, Partner’s Affiliate, or Approved Sublicensee use under this Agreement.

   

  2.18Amendment of Section 11.2.  Section 11.2 of the Agreement is hereby amended and restated in its entirety as follows:

  11.2 Development Milestones. Partner shall make the following one-time milestone payments to Atara for the milestone events set forth in this Section 11.2:

  (a)	[[***]].

  (b)	Following grant of Centralized Marketing Authorization in the European Union of the Product for EBV+ PTLD [[***]], Atara’s filing of an application for transfer of the associated Marketing Authorization to Partner: Thirty Million Dollars ($30,000,000).

   

  (c)	[[***]].

   

  (d)	[[***]].

   

   

  

   

  2.19Amendment of Section 11.4. Upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, Section 11.4 of the Agreement shall be immediately and automatically amended and restated in its entirety as follows:

  11.4	Royalties on Net Sales. From the Effective Date [[***]], on a country-by-country basis [[***]], Partner shall make the following royalty payments to Atara on Net Sales of Product at a rate of: 

  (i)	[[***]] on the portion of annual aggregate Net Sales less than or equal to [[***]]. 

  (ii)	[[***]] on the portion of annual aggregate Net Sales greater than [[***]] and less than or equal to [[***]]. 

  (iii)	[[***]] on the portion of annual aggregate Net Sales greater than [[***]]) and less than or equal to [[***]].

  (iv)	[[***]] on the portion of annual aggregate Net Sales greater than [[***]].

  2.20Amendment of Section 11.5. Upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, Section 11.5 of the Agreement shall be immediately and automatically amended and restated in its entirety as follows:

  11.5 	Third Party Licenses.  In the event that Partner determines in its good faith judgment with advice from independent legal counsel that it is necessary to obtain a license to any Third Party Patent Rights in the Territory, wherein Partner’s Commercialization of the Product in the Field in the Territory would infringe such Third Party Patent Rights absent a license thereunder, and Partner obtains a license under such Patent Rights, Partner may deduct from the amounts due to Atara during the Royalty Term under Section 11.4(a) an amount equal to [[***]] of any royalty payments on net sales actually paid to any such Third Party as consideration solely for any such license to such Patent Rights in the Territory; provided, however, that in no event shall the royalties owed to Atara under Section 11.4(a) be reduced, in the aggregate, by more than [[***]].  Partner agrees to provide Atara a true, complete and unredacted copy of any license or other agreement subject to this Section 11.5 within [[***]] of entering into such license agreement.

   

  2.21Amendment of Section 11.6. Upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, Section 11.6 of the Agreement shall be immediately and automatically amended and restated in its entirety as follows:

  11.6	Generic Competitor. If during the Royalty Term, a Third Party Generic Competitor receives Regulatory Approval, enters the market for sale in the Territory, and (i) achieves a Generic Market Share of at least [[***]] in any particular Calendar Quarter in any country(ies) of the Territory, in lieu of the royalty rates specified in Section 11.4 hereto, the royalty rate applicable to Net Sales of Product by Partner, its Affiliates, and Approved Sublicensees in such country(ies) in that Calendar Quarter shall be reduced by [[***]], or (ii) achieves a Generic Market Share of greater than [[***]] in any particular Calendar Quarter in any country(ies) in the Territory, in lieu of the royalty rates specified 

   

  

   

  in Section 11.4 hereto, the royalty rate applicable to Net Sales of Product by Partner, its Affiliates, and Approved Sublicensees in such county(ies) in that Calendar Quarter shall be [[***]].  

  2.22Amendment of Section 11.7. Upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, Section 11.7 of the Agreement shall be immediately and automatically amended and restated in its entirety as follows:

  11.7	Academic Hospital Manufacturer. If during the Royalty Term, on a country-by-country basis in the Territory, a product meeting the requirements of clause (a) and (b) of the defined term “Generic Competitor” is manufactured and sold by an academic hospital in a country in the Territory, Partner shall provide written notice to Atara of the sales of such product in such country and if the Parties mutually agree that the impact of such sales by the academic hospital is material, [[***]].

  2.23Amendment of Exhibit C. Exhibit C of the Agreement is hereby deleted and replaced in its entirety with new Exhibit C appended to this Amendment.

  2.24Amendment of Exhibit F. Upon achievement of the developmental milestone set forth in Section 11.2(b) of the Agreement as amended herein, Exhibit F of the Agreement shall be immediately and automatically deleted and replaced in its entirety with new Exhibit F appended to this Amendment.

   

  Article 3
MISCELLANEOUS

  3.1No Waiver. Nothing in this Amendment is intended to operate as a waiver of any claims either Party may have against the other Party arising prior to the date of this Amendment, including any claims arising prior to the date of this Amendment with respect to the performance of the Parties under the Agreement. Any delay in enforcing a Party’s rights under this Amendment or the Agreement, or any waiver as to a particular default or other matter, will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Amendment or the Agreement, except with respect to an express written waiver relating to a particular matter for a particular period of time signed by an authorized representative of the waiving Party, as applicable.

  3.2Miscellaneous. This Amendment shall be governed by and interpreted in accordance with the laws of the State of Switzerland, without giving effect to any choice of law principles that would require the application of the laws of a different jurisdiction. Except as specifically amended by this Amendment, the terms and conditions of the Agreement shall remain in full force and effect. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Except to the extent expressly provided herein, the Agreement, as amended by this Amendment, including all appendices, exhibits and schedules to each of the foregoing, constitute the entire agreement between the Parties relating to the subject matter of the Agreement and supersedes all previous oral and written communications, including all previous agreements, between the Parties.

   

   

  

   

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  Exhibit 10.3

  IN WITNESS WHEREOF, Atara and Partner have executed this Amendment by their respective officers hereunto duly authorized, on the day and year hereinafter written. The Parties acknowledge and agree that the signature date may not be the Amendment Effective Date.

  PIERRE FABRE MEDICAMENT

  By: /s/ Jean-Luc Lowinski	

  Name:  Jean-Luc Lowinski	

  Title:  President  	

  ATARA BIOTHERAPEUTICS, INC.

  By: /s/ Pascal Touchon	

  Name:  Pascal Touchon	

  Title:  President and Chief Executive Officer  

   

   

   

  9

   

  

   

  EXHIBIT C (Key Manufacturing and Supply Terms)

  [[***]] 

   

   

  

   

  EXHIBIT F (Cell Selection Services)

  [[***]]

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