SETTLEMENT AND LICENSE AGREEMENT
EXHIBIT 10.1
[***] Certain information in this exhibit has been omitted because it is permitted to be omitted by applicable regulatory guidance.
SETTLEMENT AND LICENSE AGREEMENT
THIS SETTLEMENT AND LICENSE AGREEMENT ("Agreement"), effective January 24,
2019 ("Effective Date"), is entered into by and among AbbVie Inc., a corporation organized
and existing under the laws of Delaware, having its corporate headquarters at 0 Xxxxx Xxxxxxxx Xxxx, Xxxxx Xxxxxxx, Xxxxxxxx 00000, on behalf of itself and its Affiliates, and AbbVie Biotechnology Ltd, a corporation organized and existing under the laws of Bermuda with a place of business at Clarendon House, 0 Xxxxxx Xxxxxx, Xxxxxxxx XXx 0 Bermuda (collectively and including their Affiliates, "AbbVie"); and Coherus BioSciences, Inc., a corporation organized and existing under the laws of Delaware, having a place of business at 000 Xxxx Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxxx Xxxx, XX 00000, on behalf of itself and its Affiliates (including its Affiliates, "Coherus").
WHEREAS, AbbVie manufactures and markets a fully human anti-TNFa monoclonal antibody with the brand name HUMIRA® and international non-proprietary name adalimumab (the "Humira Product"), which was invented by AbbVie (or its predecessors);
WHEREAS, AbbVie Inc. owns or has exclusively licensed from AbbVie Biotechnology Ltd more than [***] issued U.S. Patents related to the Humira Product, the last of which will expire in [***];
WHEREAS, AbbVie Biotechnology Ltd owns or has licensed from AbbVie Inc. more than [***] issued U.S. Patents related to the Humira Product, the last of which will expire in [***];
WHEREAS, AbbVie markets the Humira Product in the Territory pursuant to Biologics License Application No. 125057 (together with any replacements or supplements thereto, as amended now or in the future, the "Humira BLA");
WHEREAS, Xxxxxxx seeks to market a biosimilar version of the Humira Product pursuant to a marketing authorization to be obtained under the Biologics Price Competition and Innovation Act ("BPCIA");
WHEREAS, Xxxxxxx intends to file, but has not yet filed, a Biologics License Application pursuant to 42 U.S.C. § 262(k) of the BPCIA seeking approval to market a biosimilar of the Humira Product (together with any supplements and replacement thereto, as amended now or in the future, the "Coherus BLA ") prior to the expiration of at least one of the
U.S. Patents related to the Humira Product;
WHEREAS, the biosimilar of the Humira Product that will be the subject of the Coherus BLA may be labeled for indications including, but not limited to, [***] and for each indication will have the same route of administration and dosing regimen as the Humira Product;
WHEREAS, AbbVie previously asserted in litigation pursuant to the BPCIA [***] U.S. Patents related to the Humira Product that AbbVie asserted were infringed by biosimilar products of adalimumab sought to be marketed by Amgen Inc. and Amgen Manufacturing
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Limited (collectively and including their respective Affiliates, "Amgen") and reserved the right to assert at least an additional [***] patents if and when Amgen provided commercial notice of its intent to market its biosimilar adalimumab product;
WHEREAS, AbbVie and Amgen resolved all pending BPCIA and future patent litigation related to its biosimilar adalimumab product in the U.S. via a settlement announced publicly on September 28, 2017;
WHEREAS, AbbVie has filed litigation pursuant to the BPCIA against Boehringer lngelheim International GmbH, Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer lngelheim Fremont, Inc. (collectively, "BI") asserting BI's biosimilar adalimumab product infringes [***] U.S. Patents related to the Humira Product and has reserved the right to assert at least an additional [***] patents if and when BI provides commercial notice of its intent to market its biosimilar adalimumab product;
WHEREAS, Samsung Bioepis Co., Ltd. (including its Affiliates, "Samsung") intends to market a biosimilar version of the Humira Product pursuant to the BPCIA, which it identifies as SB5; AbbVie and Samsung resolved all BPCIA disputes related to Samsung's biosimilar adalimumab product in the U.S. via a settlement announced publicly on April 5, 2018;
WHEREAS, AbbVie previously asserted in litigation pursuant to the BPCIA [***] U.S. Patents related to the Humira Product that AbbVie asserted were infringed by biosimilar products of adalimumab sought to be marketed by Sandoz Inc., Sandoz International GmbH, and Sandoz GmbH (collectively, "Sandoz") and reserved the right to assert at least an additional [***] patents if and when Sandoz provided commercial notice of its intent to market its biosimilar adalimumab product;
WHEREAS, AbbVie and Sandoz resolved all pending BPCIA litigation, any pending inter partes review proceedings, and future patent litigation related to its biosimilar adalimumab product in the U.S. via a settlement announced publicly on October 11, 2018;
WHEREAS, Mylan Pharmaceuticals, Inc. (including its Affiliates, "Mylan") intends to market a biosimilar version of the Humira Product pursuant to the BPCIA; AbbVie and Mylan resolved all BPCIA disputes related to the Mylan biosimilar adalimumab product in the U.S. via a settlement announced publicly on July 17, 2018;
WHEREAS, Fresenius Kabi Deutschland GmbH (including its Affiliates, "Fresenius") intends to market a biosimilar version of the Humira Product pursuant to the BPCIA; AbbVie and Fresenius resolved all BPCIA disputes related to the Fresenius biosimilar adalimumab product in the U.S. via a settlement announced publicly on October 18, 2018;
WHEREAS, Momenta Pharmaceuticals, Inc. (including its Affiliates, "Momenta") intends to market a biosimilar version of the Humira Product pursuant to the BPCIA; AbbVie and Momenta resolved all BPCIA disputes related to the Momenta biosimilar adalimumab product in the U.S. via a settlement announced publicly on November 6, 2018;
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WHEREAS, Pfizer Inc. (including its Affiliates, "Pfizer") intends to market a biosimilar version of the Humira Product pursuant to the BPCIA; AbbVie and Pfizer resolved all BPCIA disputes related to the Pfizer biosimilar adalimumab product in the U.S. via a settlement announced publicly on November 30, 2018;
WHEREAS, Amgen filed two petitions seeking inter partes review of U.S. Patent Nos. [***], which cover formulations comprising adalimumab; and on January 14, 2016 the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ("PTAB") denied institution, holding that Amgen failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
WHEREAS, Xxxxxxx filed a petition seeking inter partes review of U.S. Patent No.
[***], which covers formulations comprising adalimumab; and on November 7, 2016 the PTAB denied institution, holding that Xxxxxxx failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
WHEREAS, Xxxxxxx filed four petitions seeking inter partes review of U.S. Patent No. [***], which covers formulations comprising adalimumab; and on September 7, 2017 the PTAB denied institution, holding that Xxxxxxx failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
WHEREAS, Sandoz Inc. filed a petition seeking inter partes review of U.S. Patent No.
[***], which covers formulations comprising adalimumab; and on February 9, 2018 the PTAB denied institution, holding that Sandoz failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
WHEREAS, Sandoz Inc. filed two petitions seeking inter partes review of U.S. Patent No. [***], which covers methods of treating chronic plaque psoriasis with adalimumab, which method would be included in the instructions for use for the biosimilar of the Humira Product that will be the subject of the Coherus BLA; and on February 9, 2018 and May 3, 2018 the PTAB denied institution, holding that Sandoz failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
WHEREAS, Sandoz Inc. filed a petition seeking inter partes review of U.S. Patent No. [***], which covers methods of treating ulcerative colitis with adalimumab, which method would be included in the instructions for use for the biosimilar of the Humira Product that will be the subject of the Coherus BLA; and on March 9, 2018 the PTAB denied institution, holding that Sandoz failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
WHEREAS, Sandoz Inc. filed a petition seeking inter partes review of U.S. Patent No. [***], which covers methods of treating Crohn's disease with adalimumab, which method would be included in the instructions for use for the biosimilar of the Humira Product that will be the subject of the Coherus BLA; and on March 9, 2018 the PTAB denied institution, holding that Sandoz failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
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WHEREAS, Sandoz Inc. filed a petition seeking inter partes review of U.S. Patent No.
[***], which covers methods of treating Crohn's disease and ulcerative colitis with adalimumab, which method would be included in the instructions for use for the biosimilar of the Humira Product that will be the subject of the Coherus BLA; and on June 5, 2018 the PTAB denied institution, holding that Sandoz failed to establish a reasonable likelihood that any challenged claim would be held unpatentable;
WHEREAS, Xxxxxxx filed three petitions seeking inter partes review of U.S. Patent Nos.
[***] in IPR 2016-00172; IPR 2016-00188; IPR 2016-00189,
respectively, each of which covers methods of treating rheumatoid arthritis with adalimumab, which method would be included in the instructions for use for the biosimilar of the Humira Product that will be the subject of the Coherus BLA;
WHEREAS, the PTAB instituted the inter partes review proceedings for each of U.S. Patent Nos. [***], and held the claims of those patents unpatentable in final decisions issued May 16, 2017 and June 9, 2017; and where AbbVie has appealed said decisions to the U.S. Court of Appeals for the Federal Circuit, which appeals were docketed as Nos. 2017-2304, -2305, -2306, which appeals remain pending ("Federal Circuit Appeals");
WHEREAS, in the absence of this settlement and license agreement, upon filing of the Coherus BLA, Xxxxxxx would comply with the patent identification provisions of the BPCIA, which the Parties agree would culminate in litigation under the BPCIA ("BPCIA Litigation");
WHEREAS, the Parties wish to settle the Federal Circuit Appeals (as between the Parties), the BPCIA Litigation and any related disputes between them in the Territory;
WHEREAS, no Party has received any consideration from the other Party for its entry into this Agreement other than that which is described in this Agreement.
NOW, THEREFORE, in consideration of the mutual promises and covenants contained in this Agreement and for other good and valuable consideration, the receipt of and sufficiency of which is hereby acknowledged, the Parties agree as follows:
ARTICLE 1: DEFINITIONS
Terms when used herein with initial capital letters shall have the meanings set forth below or as otherwise defined in this Agreement.
1.2 | ''AbbVie Releasees" has the meaning set forth in Section 3.2. |
1.3 | "AbbVie Releasors" has the meaning set forth in Section 3.1. |
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1.6 | "Amgen" has the meaning set forth in the WHEREAS clauses. |
1.7 | "BPCIA" has the meaning set forth in the WHEREAS clauses. |
1.8 | "BPCIA Litigation" has the meaning set forth in the WHEREAS clauses. |
1.9 | "BI" has the meaning set forth in the WHEREAS clauses. |
1.13 | "Coherus BLA" has the meaning set forth in the WHEREAS clauses. |
1.14 | "Coherus Releasees" has the meaning set forth in Section 3.1. |
1.15 | "Coherus Releasors" has the meaning set forth in Section 3.2. |
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1.20 | "Federal Circuit Appeals" has the meaning set forth in the WHEREAS clauses. |
1.21 | "Fresenius" has the meaning set forth in the WHEREAS clauses. |
1.23 | "Humira BLA" has the meaning set forth in the WHEREAS clauses. |
1.24 | "Humira Product" has the meaning set forth in the WHEREAS clauses. |
1.25 | "IPR" means Inter Partes Review pursuant to 35 U.S.C. § 311 et seq. |
1.26 | "License Entry Date" has the meaning set forth in Section 6.1. |
1.28 | "License Term(s)" has the meaning set forth in Section 5.5. |
1.29 | "Momenta" has the meaning set forth in the WHEREAS clauses. |
1.30 | "Mylan" has the meaning set forth in the WHEREAS clauses. |
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1.32 | "Party" means AbbVie or Coherus, and "Parties" means all of the foregoing. |
1.34 | "Pfizer" has the meaning set forth in the WHEREAS clauses. |
1.35 | "PGR" means post-grant review pursuant to 35 U.S.C. § 321 et seq. |
1.36 | "PTAB" has the meaning set forth in the WHEREAS clauses. |
1.37 | "Royalty Rate" has the meaning set forth in Section 5.4. |
1.38 | "Royalty Termination Date" has the meaning set forth in Section 5.6. |
1.39 | "Samsung" has the meaning set forth in the WHEREAS clauses. |
1.40 | "Sandoz" has the meaning set forth in the WHEREAS clauses. |
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9.2(c), 9.2(d) and 9.2(e), as applicable. [***]. For the avoidance of doubt, prior to the Royalty Termination Date, no Sublicensee has any rights under this Agreement until AbbVie approves the sublicense in writing and the executed sublicense is provided to AbbVie in accordance with Section 9.2(e).
1.46 | "Third Party Rate" has the meaning set forth in Section 5.4(b). |
ARTICLE 2: TERMINATION OF LITIGATION
2.1 Withdrawal from Federal Circuit Appeals. Within [***] of execution of this Agreement, Licensee shall cause its attorneys to file a motion in the U.S. Court of Appeals for the Federal Circuit seeking to withdraw Licensee from the Federal Circuit Appeals. As of the date of filing such motion to withdraw, Licensee will cease all participation in all of the Federal Circuit Appeals (other than cooperating to take any necessary steps to effect its withdrawal) and will not assist any third party directly or indirectly in any way in the Federal Circuit Appeals. It is understood and agreed that such Federal Circuit Appeals will not be dismissed and that Licensor may continue to proceed with and participate in such Federal Circuit Appeals notwithstanding the withdrawal of Licensee. For clarity, if in any of the Federal Circuit Appeals, the U.S. Court of Appeals for the Federal Circuit remands any of the cases to the PTAB for further proceedings, Licensee's obligation not to participate in the Federal Circuit Appeals or to assist any third party with respect to such Federal Circuit Appeals will extend to those further proceedings on remand and any subsequent appeals thereof.
ARTICLE 3: RELEASE
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successors, and assigns, [***].
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ARTICLE 4: PATENT ENFORCEABILITY
4.1Enforceability of Licensed Humira Patents. Xxxxxxx admits that the Licensed Humira Patents are valid and enforceable.
ARTICLE 5: GRANT OF LICENSE AND ROYALTIES
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Patents, except as expressly set forth in Section 5.3, [***].
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Agreement. Coherus and its Sublicensees will accommodate such an audit and use reasonable efforts to accommodate such request within [***] of AbbVie's request; provided however, any audit under this Section 5.8 shall be conducted during normal business hours of Coherus and its Sublicensees. The audit will be at AbbVie's sole expense unless the audit shows an underpayment in the royalties due to AbbVie of [***] or more in any calendar quarter in which case Coherus will pay for the audit. In the event that an audit reveals any underpayment in royalties due to AbbVie, Xxxxxxx shall promptly, but in no event later than [***] after receipt of written notice thereof, pay such underpayment to AbbVie.
AbbVie's audit rights may only be exercised once during any [***] period. No set of books and records for any given period shall be audited more than once. Notwithstanding any provision herein to the contrary, Coherus and its Sublicensees shall not have the right to audit any books and records of AbbVie or any of its agents.
ARTICLE 6: LICENSE ENTRY DATE FOR THE COHERUS BIOSIMILAR PRODUCT
ARTICLE 7: ADDITIONAL COVENANTS
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other Party as soon as practicable and, if at all possible, in sufficient time to allow the other Party to oppose disclosure or seek an appropriate protective order.
ARTICLE 8: REPRESENTATIONS AND WARRANTIES
8.2 | Additional AbbVie Representations and Warranties. |
8.3 | Additional Coherus Representations and Warranties. |
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ARTICLE 9: SCOPE OF THE PARTIES' AGREEMENT
9.2 | Sublicensing. |
(iv) of Section 9.2(d) are met by any Sublicensee granted license rights under this Section 9.2(b).
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withheld, delayed or conditioned, except that each Party may upon notice to the other Party but without obtaining the consent of the other Party, assign or sublicense any or all of its rights and obligations under this Agreement to any one or more of its Affiliates or assign to any successor in interest to such Party's or assignee's business relating to this Agreement in connection with a merger, reorganization, change of control, or sale of all or substantially all of its assets to which this Agreement relates. Any purported assignment or transfer in violation of the foregoing shall be null and void ab initio and of no force or effect. In the event of a permitted assignment, this Agreement shall be binding upon and inure solely to the benefit of the Parties and their respective successors and permitted assigns.
ARTICLE 10: GENERAL PROVISIONS
10.1 | Termination. |
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I 0.2Governing Law; Venue. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to its conflicts of law principles that would result in the application of the laws of any other jurisdiction. The Parties hereby consent to the exclusive jurisdiction of the courts located in the State of Delaware in connection with any dispute arising out of or relating to this Agreement and expressly waive any objections or defenses based on lack of personal jurisdiction or venue.
I 0.3Severability. If a court of competent jurisdiction holds any provision of this Agreement to be illegal, unenforceable, or invalid, in whole or in part for any reason: (a) all other provisions hereof shall remain in full force and effect and shall be liberally construed in order to carry out the intent of the Parties as near as possible, and (b) the Parties agree to use their commercially reasonable efforts to negotiate a provision, in replacement of the provision held illegal, unenforceable, or invalid, that is consistent with applicable law and accomplishes, as nearly as possible, the original intention of the Parties with respect thereto and without materially changing the economic value of the transactions contemplated hereby.
I0.4Entire Agreement. This Agreement and any exhibits, appendices, and attachments to this Agreement, constitute the final, complete, and exclusive statement of the terms of the agreement among the Parties pertaining to the subject matter of this Agreement and supersedes all prior and contemporaneous understandings or agreements of the Parties (other than those referenced in this Agreement). No Party has been induced to enter into this Agreement by, nor is any Party relying on, any representation or warranty outside those expressly set forth in this Agreement.
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Parties may supplement, amend, or modify this Agreement by a subsequent written agreement executed by the Parties through their authorized representatives.
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10.13 | Notices. |
(b) | Addresses for purpose of giving notice are as follows: |
If to AbbVie:
Attention: [***] and Attention: [***]
0 X. Xxxxxxxx Xxxx, Xxxxxxxx XX-00 Xxxxx Xxxxxxx, XX 00000
If to Coherus:
Attention: [***]
000 Xxxx Xxxxxxx Xxxxx, Xxxxx 000 Xxxxxxx Xxxx, XX 00000
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IN WITNESS WHEREOF, the Parties, through their authorized officers, have executed this Agreement as of the Effective Date.
AbbVie Inc.Coherus BioSciences, Inc.
By: /s/ Xxxxxxx X. Xxxxx By: /s/ Xxxxxx X. Xxxxxxx
Name: Xxxxxxx X. Xxxxx Name: Xxxxxx X. Xxxxxxx
Title: Executive Vice President,Title: Chairman & Chief
Finance and AdministrationExecutive Officer
Date: January 24, 2019Date: January 24, 2019
AbbVie Biotechnology Ltd
By: /s/ Xxxxxxx X. Xxxxx
Name: Xxxxxxx X. Xxxxx
Title: Executive Vice President,
Finance and Administration
Date: January 24, 2019