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AMENDED AND RESTATED NON EXCLUSIVE LICENSE AGREEMENT

License Agreement

AMENDED AND RESTATED NON EXCLUSIVE LICENSE AGREEMENT | Document Parties: REGENERON PHARMACEUTICALS INC You are currently viewing:
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REGENERON PHARMACEUTICALS INC

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Title: AMENDED AND RESTATED NON EXCLUSIVE LICENSE AGREEMENT
Governing Law: New York     Date: 8/1/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDED AND RESTATED NON EXCLUSIVE LICENSE AGREEMENT, Parties: regeneron pharmaceuticals inc
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Exhibit 10.2

Portions of this Exhibit Have Been

Omitted and Separately Filed with the Securities

And Exchange Commission with a Request

For Confidential Treatment

AMENDED AND RESTATED NON EXCLUSIVE LICENSE AGREEMENT

This agreement is made this 1st day of July, 2008 (hereinafter “the DATE OF SIGNATURE ”)

By and between

CELLECTIS , a French Société Anonyme, registered under the Registre de commerce et des Sociétés de Paris under n° B 428 859 052, having its registered office at 102 avenue Gaston Roussel – 93235 Romainville, France, represented by its legal representative, Mr. André CHOULIKA, Directeur Général (hereinafter “ CELLECTIS ”)

and

REGENERON PHARMACEUTICALS, INC. , a company organized and existing under the laws of the State of New York, having a principal place of business at 777 Old Saw Mill River Road, Tarrytown, NY 10591 U.S.A. (United States of America), represented by its legal representative, Mr. Stuart Kolinski, Senior Vice President & General Counsel (hereinafter “ REGENERON ”).

REGENERON and CELLECTIS hereinafter individually or collectively referred to as the PARTY(IES).

WITNESSETH

WHEREAS , CELLECTIS is a biotechnology company specialized in rational genome engineering. CELLECTIS controls and develops tools and methods to rewrite DNA sequences in genomes of living organisms. With these technologies, CELLECTIS develops therapeutic drugs, as well as industrial tools to develop animal models and to engineer protein producer strains, animals or plants;

WHEREAS, CELLECTIS has exclusive rights, including the right to grant sublicenses, from INSTITUT PASTEUR, a French foundation located at 25 Rue du Docteur Roux – 75015 Paris France, the owner of PATENTS (as defined below), relating to a process for the specific replacement or insertion of a gene in the receiver genome by homologous recombination;

WHEREAS, REGENERON is a biopharmaceutical company that has developed technologies and know-how to generate genetically modified animals, and that discovers, develops, and commercializes therapeutic medicines for the treatment of serious medical conditions;

WHEREAS, REGENERON and CELLECTIS, parties to a Non-Exclusive License Agreement dated as of December 12, 2003 (as the same has been amended, modified, and

July 1, 2008

 


 

supplemented, the “Original Agreement”) wish to amend and restate the Original Agreement on the terms and conditions set forth herein;

WHEREAS REGENERON accepts to enter into this AGREEMENT *****

NOW, THEREFORE , in consideration of the mutual undertakings contained herein and other good and valuable consideration, the Parties intending to be legally bound, hereby agree as follows:

 

 

ARTICLE 1 – DEFINITIONS

For the purpose of this Agreement, the following terms shall have the meanings defined herein:

1.1.

 

“AFFILIATE” means a legal entity that indirectly or directly controls, is controlled by, or is under common control with, a PARTY hereto or a THIRD PARTY, as the case may be (where control means direct or indirect legal or beneficial ownership of 50% or more of the issued shares or voting rights).

 

 

 

1.2.

 

“AGREEMENT” means this Amended and Restated Non Exclusive License Agreement, which includes the Exhibits as well as any amendments thereto signed by duly authorized officers of the PARTIES.

 

 

 

1.3.

 

“ASTELLAS” means Astellas Pharma Inc., a Japanese company with a principal place of business located at 2-3-11 Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan, and its AFFILIATES.

 

 

 

1.4.

 

“ASTRAZENECA” means AstraZeneca UK Limited, a company incorporated in England with a registered office at 15 Stanhope Gate, London W1K 1lN and its AFFILIATES.

 

 

 

1.5.

 

“CLAIMS” shall mean any and all claims, actions, causes of action, demands, costs, and charges of whatever nature .

 

 

 

1.6.

 

“DERIVED PRODUCT” means any nucleic acid material (including that coding for a protein, including an antibody), cells containing the foregoing in which the method of inserting the nucleic acid is not a LICENSED PROCESS, and proteins (including antibodies), in all cases that are both: (i) derived, developed or discovered from a LICENSED PRODUCT, and (ii) whose manufacture, use, sale, offer to sell, lease, transfer, import or export infringes a VALID CLAIM of a PATENT.

 

 

 

1.7.

 

“FIELD OF USE” means the in vitro and/or in vivo modification and manipulation of the genetic material and/or of the pluripotent, embryonic, or other cells of a rodent using VELOCIGENE and/or VELOCIMMUNE, and the research, development, production and/or commercialization of LICENSED PRODUCTS, LICENSED SERVICES, and DERIVED PRODUCTS.

 

 

 

1.8.

 

“IMPROVEMENT” means any improvement, addition, enhancement, modification, development, invention, alteration and/or technical advance, whether patentable or

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not, relating to any of the PATENTS whose exploitation is dependent on at least one claim of the PATENTS.

 

 

 

1.9.

 

“LICENSED PRODUCT” means any and all VELOCIGENE PRODUCTS and VELOCIMMUNE PRODUCTS.

 

 

 

1.10.

 

“LICENSED PROCESS” means any process which infringes a VALID CLAIM.

 

 

 

1.11.

 

“LICENSED SERVICES” means any and all VELOCIGENE SERVICES and VELOCIMMUNE SERVICES.

 

 

 

1.12.

 

“NET SALES” means with respect to a LICENSED PRODUCT and/or LICENSED SERVICES, the gross amount invoiced by REGENERON or its AFFILIATES for the sales of LICENSED PRODUCTS and/or the performance of LICENSED SERVICES to a THIRD PARTY, less:

 

(a)

 

trade, quantity and cash discounts actually allowed;

 

 

 

 

 

(b)

 

discounts, refunds, rebates, charge backs, retroactive price adjustments, and any other allowances actually granted which effectively reduce the net selling price;

 

 

 

 

 

(c)

 

product returns and allowances actually granted;

 

 

 

 

 

(d)

 

any tax, tariff or duty imposed on the production, sale, delivery or use of the product (excluding federal, state or local taxes based on income); and

 

 

 

 

 

(e)

 

freight, postage, shipping, customs duties, excises and insurance charges actually allowed or paid for delivery of LICENSED PRODUCTS, to the extent billed.

 

 

 

For the avoidance of doubt, sales and/or performances, as the case may be, of LICENSED PRODUCTS and/or LICENSED SERVICES between REGENERON and either (i) ASTELLAS, ASTRAZENECA, or SANOFI-AVENTIS under the SPECIAL AGREEMENTS, or (ii) REGENERON’s AFFILIATES shall be disregarded for purposes of calculating NET SALES.

 

 

 

1.13.

 

“NIH GRANT” shall mean the research grant number 5UO1HJ004085/02 dated September 7, 2006 (and any extensions or continuation thereof) from the National Institutes of Health of the United States government for creating and developing animals for use in research efforts to the extent REGENERON supplies LICENSED PRODUCTS or performs LICENSED SERVICES under said grant or contract.

 

 

 

1.14.

 

“PATENTS” means (i) all patent applications and issued patents claiming the priority date of the French application published as FR 2 646 438 relating to a PROCESS FOR THE SPECIFIC REPLACEMENT OF A COPY OF A GENE PRESENT IN THE RECEIVER GENOME VIA THE INTEGRATION OF A GENE, including but not limited to those referenced in Exhibit A; (ii) any application or patent corresponding to the national or regional phases of the PCT international application WO 90/11354; (iii) the European Patent EP 419 621 as well as any divisional applications; (iv) any US and other foreign patents and patent applications corresponding to any of the foregoing in (i), (ii), (iii) and/or (iv), and/or any divisions, continuations, continuations-in-part, extensions or reissues thereof; and (v) all patent applications

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and issued patents claiming priority to any of the patents or patent applications referenced in Exhibit A.

 

 

 

1.15.

 

“REGENERON PRODUCTS” means any and all LICENSED PRODUCTS and LICENSED SERVICES made (or was made for), used, leased, transferred, imported, exported, or sold by REGENERON or any of its AFFILIATES to or for THIRD PARTIES.

 

 

 

1.16.

 

“SANOFI-AVENTIS” means Aventis Pharmaceuticals Inc., a corporation organized under the laws of the state of Delaware, having a principal place of business at 55 Corporate Drive, Bridgewater, New Jersey 08807 and its AFFILIATES.

 

 

 

1.17.

 

“SPECIAL AGREEMENTS” means each of (i) the Non-Exclusive License and Material Transfer Agreement, dated as of February 5, 2007, by and between REGENERON and ASTRAZENECA, (ii) the Non-Exclusive License and Material Transfer Agreement, dated as of March 30, 2007, by and between REGENERON and ASTELLAS, (iii) the Discovery and Preclinical Development Agreement, the License and Collaboration Agreement, and the Stock Purchase Agreement, each dated as of November 28, 2007, between REGENERON and SANOFI-AVENTIS, (iv) with respect to each agreement described in (i), (ii) and (iii) above, any amendments, modifications, or extensions thereof, and (v) all other agreements in the FIELD OF USE entered into with these parties, including without limitation, any license or material transfer agreement with SANOFI-AVENTIS, including those agreements contemplated in sections 2.15, 2.16 and 2.17 of the November 28, 2007 Discovery and Preclinical Development Agreement between REGENERON and SANOFI-AVENTIS.

 

 

 

1.18.

 

“THIRD PARTY (IES)” means any and all persons, partnerships, corporations, joint ventures, companies, firms, or any other entities other than CELLECTIS, *****, REGENERON or any of their respective AFFILIATES.

 

 

 

1.19.

 

“TERRITORY” means any and all countries throughout the world.

 

 

 

1.20.

 

“VALID CLAIM” means a claim in an issued and unexpired patent under the PATENTS, which has not been held unenforceable, invalid or unpatentable by a court or other government body having competent jurisdiction, and which has not been rendered unenforceable through disclaimer or otherwise.

 

 

 

1.21.

 

“VELOCIGENE” means any technology and know-how for genetically engineering pluripotent, embryonic stem, or other cells that involve the deletion, modification, and/or insertion of genetic material from or into such cells.

 

 

 

1.22.

 

“VELOCIGENE PRODUCT” means, *********************************** in each case, the manufacture, use, sale, offer to sell, lease, transfer, import or export of which infringes a VALID CLAIM. For the purpose of this AGREEMENT, neither a VELOCIMMUNE PRODUCT nor a DERIVED PRODUCT shall be considered a VELOCIGENE PRODUCT.

 

 

 

1.23.

 

“VELOCIGENE SERVICE” means a contract with a THIRD PARTY pursuant to which REGENERON or its AFFILIATE is engaged specifically to make or use a

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VELOCIGENE PRODUCT. For the purpose of this AGREEMENT, a VELOCIMMUNE SERVICE shall not be considered a VELOCIGENE SERVICE.

 

 

 

1.24.

 

“VELOCIMMUNE” means ***************************************.

 

 

 

1.25.

 

“VELOCIMMUNE PRODUCT” means *********************************************, the manufacture, use, sale, offer to sell, lease, transfer, import or export of which infringes a VALID CLAIM. For the purposes of this AGREEMENT, neither a VELOCIGENE PRODUCT nor a DERIVED PRODUCT shall be considered a VELOCIMMUNE PRODUCT.

 

 

 

1.26.

 

“VELOCIMMUNE SERVICE” means a contract with a THIRD PARTY pursuant to which REGENERON or its AFFILIATES is engaged specifically to make or use a VELOCIMMUNE PRODUCT. For the purpose of this AGREEMENT, a VELOCIGENE SERVICE shall not be considered a VELOCIMMUNE SERVICE.

The trademarks “VELOCIGENE” and “VELOCIMMUNE” are used in these defined terms for convenience only, it being understood that REGENERON may use any other brand name for the products and technologies referred to in this AGREEMENT.

 

 

ARTICLE 2 – LICENSE GRANT

 

 

 

2.1.

 

 

 

(a)

 

Subject to the terms and conditions of this AGREEMENT, CELLECTIS hereby grants to REGENERON and its AFFILIATES a non-transferable, non-exclusive license under the PATENTS in the FIELD OF USE in the TERRITORY to practice the PATENTS, including to make, have made, use, transfer, offer to sell, sell, lease, import, or export LICENSED PRODUCTS, the LICENSED PROCESS and LICENSED SERVICES, without the right to grant sub-licenses under the PATENTS, except as set forth in Section 2.2.

 

 

 

 

 

(b)

 

For the avoidance of doubt it is understood and agreed that the license right granted in Section 2.1(a) includes: (1) the right for REGENERON to make, have made, use, transfer, offer to sell, sell, lease, import or export LICENSED PRODUCTS and LICENSED SERVICES to or for THIRD PARTIES in the FIELD OF USE to enable such THIRD PARTIES to make, have made, use, transfer, offer to sell, sell, lease, import or export REGENERON PRODUCTS, or DERIVED PRODUCTS; and (2) the right for REGENERON to make, have made, use, transfer, offer to sell, sell, lease, import or export DERIVED PRODUCTS on or behalf of THIRD PARTIES in the FIELD OF USE.

 

 

 

 

 

(c)

 

In case REGENERON grants to THIRD PARTIES a license (or sublicense) of other patents controlled by REGENERON, solely for use in connection with establishing a VELOCIGENE platform, CELLECTIS will offer such THIRD PARTIES a non exclusive license under the PATENTS with the same terms and conditions as granted to REGENERON in the ORIGINAL AGREEMENT.

July 1, 2008

 


 

2.2.

 

Unless the contrary is clearly indicated by the text hereof, in every instance of this AGREEMENT, it is understood that reference to REGENERON includes AFFILIATES of REGENERON as well and that REGENERON may extend to its AFFILIATES by sublicense the benefits of this LICENSE provided that REGENERON remains responsible to CELLECTIS with regard to all obligations placed upon REGENERON pursuant to this AGREEMENT.

 

 

 

2.3.

 

For the purpose of this AGREEMENT, it is understood and agreed that the license grant in this Article 2 includes the following:

 

 

 

2.3.1

 

REGENERON is entitled to make, have made, use, transfer, offer to sell, sell, lease, import or export DERIVED PRODUCTS;

 

 

 

2.3.2

 

REGENERON is entitled to grant licenses on its intellectual property covering DERIVED PRODUCTS and LICENSED PRODUCTS and to sell DERIVED PRODUCTS and LICENSED PRODUCTS;

 

 

 

2.3.3

 

REGENERON, ASTELLAS, ASTRAZENECA, and SANOFI-AVENTIS, as well as the THIRD PARTIES having received REGENERON PRODUCTS or DERIVED PRODUCTS in accordance with the terms of this AGREEMENT shall have the right (i) to make, have made, use, transfer, offer to sell, sell, lease, import or export DERIVED PRODUCTS and (ii) to practice the LICENSED PROCESS to use, breed, derive and replicate REGENERON PRODUCTS.

 

 

 

2.4.

 

For the purposes of settlement of the dispute between the PARTIES regarding the interpretation of the commitments made and rights granted in the ORIGINAL AGREEMENT, and based on the representations made by REGENERON in Section 10.8 of this AGREEMENT, it is agreed that the rights and licenses set forth in this AGREEMENT were included in the ORIGINAL AGREEMENT. Therefore the rights and licenses set forth in this AGREEMENT were granted as of December 12, 2003 and continue to exist through the duration specified in Article 11.

 

 

 

2.5.

 

No Other Licenses. No right or licenses are granted hereunder, except as expressly and specifically set forth in this Section 2.

 

 

 

 

 

ARTICLE 3– FINANCIAL CONDITIONS

In full consideration of the rights and privileges granted under this AGREEMENT, REGENERON agrees to pay to CELLECTIS any and all of the amounts provided under this Article according to the terms of payment provided here below.

 

(a)

 

REGENERON shall pay to CELLECTIS a fixed, non-refundable lump sum payment of US$12,450,000 (TWELVE MILLION FOUR HUNDRED FIFTY THOUSAND DOLLARS), within ten (10) days from its receipt of the signed INSTITUT PASTEUR Letter. It is agreed that this lump sum payment shall satisfy any and all payment obligations to CELLECTIS arising under this AGREEMENT with respect to the SPECIAL AGREEMENTS and that notwithstanding anything herein to the contrary, REGENERON shall not be required to make any further royalty or other payments hereunder, under the ORIGINAL AGREEMENT, or otherwise (whether under contract or law) with respect to the SPECIAL AGREEMENTS.

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(b)

 

REGENERON shall pay to CELLECTIS a royalty of **************************** made after December 31, 2007 of any VELOCIGENE PRODUCTS and/or VELOCIGENE SERVICES by REGENERON within the TERRITORY. Notwithstanding the foregoing no royalties shall be payable to CELLECTIS under this subsection (b) under the following circumstances: NET SALES of VELOCIGENE PRODUCTS or VELOCIGENE SERVICES (i) pursuant to any agreement made with THIRD PARTIES receiving VELOCIMMUNE PRODUCTS or VELOCIMMUNE SERVICES subject to the royalty obligations in subsection 3(c) below, or (ii) pursuant to any of the SPECIAL AGREEMENTS. The payments specified in this subsection (b) are subject to and limited by subsection 3(1).

 

 

 

 

 

(c)

 

Subject to the terms of the second sentence of this subsection (c), REGENERON shall pay to CELLECTIS a royalty of ******************************* made after December 31, 2007 of any VELOCIMMUNE PRODUCTS and/or VELOCIMMUNE SERVICES by REGENERON made within the TERRITORY (other than any such NET SALE pursuant to any of the SPECIAL AGREEMENTS). Notwithstanding the foregoing, if under an agreement with THIRD PARTIES, REGENERON provides services or sells, licenses, leases, or transfers rights in addition to a VELOCIMMUNE PRODUCT or VELOCIMMUNE SERVICE, then REGENERON, at its option, may satisfy its obligations under this subsection (c) with respect to such agreement(s) either (i) by making within thirty (30) days from the effective date of such agreement (s) ***************************************** in consideration of the rights granted on the LICENSED PROCESS and the payments attributable to the NET SALES of the applicable VELOCIMMUNE PRODUCTS or VELOCIMMUNE SERVICES. By way of example, it is understood and agreed that VELOCIMMUNE SERVICES may be sold on a fee-for-service basis or as part of a collaboration agreement where REGENERON is being paid to provide VELOCIMMUNE SERVICES along with other rights and services. The payments specified in this subsection (c) are subject to and limited by subsection 3(1).

 

 

 

 

 

(d)

 

Notwithstanding anything to the contrary in this AGREEMENT, if under any agreement with a THIRD PARTY, *********************

 

(i)

 

************************************, or

 

 

 

 

 

(ii)      ********************************** then REGENERON shall pay to CELLECTIS *************************************************. The payments specified in this subsection (d) are subject to and limited by subsection 3(1).

 

 

(e)

 

REGENERON shall pay to CELLECTIS a fee of ******************* for any transfer free of charge of VELOCIGENE PRODUCTS and/or VELOCIGENE SERVICE to any academic, non-profit entity within the TERRITORY. The transfer fee(s) shall be payable to CELLECTIS annually in accordance with Section 5.1.

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(f)

 

REGENERON shall pay to CELLECTIS an annual success fee :

 

 

 

 

 

 

over *** VELOCIGENE PRODUCTS developed and produced by REGENERON in any calendar year and transferred to a THIRD PARTY and/or academic within one calendar year, REGENERON will pay to CELLECTIS a success fee of *******

 

 

 

 

 

 

between ************* VELOCIGENE PRODUCTS developed and produced by REGENERON in any calendar year and transferred to a THIRD PARTY and/or academic within one calendar year, REGENERON will pay to CELLECTIS a success fee of ********

 

 

 

 

 

 

between ******* VELOCIGENE PRODUCTS developed and produced by REGENERON in any calendar year and transferred to a THIRD PARTY and/or academic within one calendar year, REGENERON will pay to CELLECTIS a success fee of ********

 

 

 

 

 

 

between ********* VELOCIGENE PRODUCTS developed and produced by REGENERON in any calendar year and transferred to a THIRD PARTY and/or academic within one calendar year, REGENERON w


 
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