Exhibit 10.1
Execution Version
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
CONFIDENTIAL SETTLEMENT AND LICENSE AGREEMENT
This Confidential Settlement And License Agreement (the “Settlement Agreement”) is hereby entered into on August 29, 2023 (“Execution Date”) by and among
ALKERMES, INC., a Pennsylvania corporation with a place of business at 852 Winter Street, Waltham, MA 02451,
ALKERMES PHARMA IRELAND LIMITED, an entity organized and existing under the laws of Ireland, with a place of business at Connaught House, 1 Burlington Road, Dublin 4, Ireland, D04 C5Y6,
(ALKERMES, INC. and ALKERMES PHARMA IRELAND LIMITED collectively, “Alkermes” or “Plaintiffs”) and
TEVA PHARMACEUTICALS USA, INC., a Delaware corporation, having a place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054 (“Teva” or “Defendant”);
(each individually a “Party” and, collectively, the “Parties”).
RECITALS
WHEREAS Alkermes, Inc. is the registered holder of U.S. Food & Drug Administration approved New Drug Application No. 021897 for VIVITROL® (naltrexone for extended-release injectable suspension) 380mg/vial (“VIVITROL”);
WHEREAS Alkermes Pharma Ireland Limited is the owner of U.S. Patent No. 7,919,499 (the “ʼ499 Patent”);
WHEREAS Teva is the owner of ANDA No. 213195 for generic naltrexone for extended-release injectable suspension, 380 mg/vial;
WHEREAS Plaintiffs have filed a lawsuit against Teva in the United States District Court for the District of New Jersey (Case No. 1:20-cv-12470), alleging that the filing of ANDA No. 213195 infringes the ’499 Patent (“Lawsuit”);
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WHEREAS the Parties wish to avoid the significant legal expense and legal risks involved in continuing the Lawsuit by settling the Lawsuit on the terms and conditions set forth in this Settlement Agreement;
WHEREAS as a result of this Settlement Agreement, Teva will be permitted to make sales in the Territory of the generic form of VIVITROL for human use in advance of the expiration of the ‘499 Patent, upon the dates and terms specified herein, which sales otherwise may not have been made until after the expiration of the ’499 Patent;
NOW, THEREFORE, in consideration of the mutual execution of this Settlement Agreement and the promises made herein, the Parties agree as follows:
“Affiliate” of a Party means any person or entity that controls, is controlled by or is under common control with such Party. As used in this definition, “control” of an entity means: (a) direct or indirect ownership of more than fifty percent (50%) of the outstanding stock or shares having the right to vote for the election of directors of such entity; or (b) the direct or indirect power to either: (i) direct the management and policies of the entity; or (ii) elect at least fifty percent (50%) of the members of the governing body of such entity.
“Alkermes NDA” means NDA No. 021897 for VIVITROL.
“ANDA” means an Abbreviated New Drug Application as defined in the U.S. Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder filed with the FDA under 21 U.S.C. § 355(j).
“Applicable Law” means all applicable provisions of constitutions, statutes, rules, regulations, ordinances and orders of all Governmental Entities and all orders and decrees of all courts and tribunals.
[**]
“Confidential Information” means the terms of this Settlement Agreement and any information furnished in connection with this Settlement Agreement, including any and all know-how, trade secrets, formulae, data, inventions, technology and other information, including manufacturing techniques, processes, trade and financial
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information, related to the manufacture, use, sale, offer for sale, or marketing of any products that are the subject of this Settlement Agreement, currently in the possession of, or developed during the term of this Settlement Agreement by, Teva, Plaintiffs or any of their respective Affiliates.
“FDA” means the United States Food and Drug Administration and any successor agency having the same functions.
“Final Court Decision” means a decision by a U.S. court or the U.S. Patent Trial and Appeal Board that is no longer subject to a right of appeal (other than by a petition to the United States Supreme Court for a writ of certiorari).
“Generic Extended Release Naltrexone Product” means a product that has been approved by or submitted for approval to the FDA under an ANDA that relied in whole or in part on data developed for, or the approval of, the NDA Product and that is listed in FDA’s Orange Book as a generic version of the NDA Product.
“Governmental Entity” means any (i) nation, state, county, city, town, village, district, or other jurisdiction of any nature, (ii) federal, state, local, municipal, foreign, or other government, (iii) governmental or quasi-governmental authority of any nature (including any governmental agency, branch, department, official, or entity and any court or other tribunal), (iv) multi-national organization or body, or (v) body exercising, or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory, or taxing authority or power of any nature.
“Licensed Patent” means the ’499 Patent, and any extensions, pediatric exclusivities, divisionals, continuations, continuations-in-part, reissues, reexaminations, inter partes reviews, and post-grant reviews thereof, and any other patents prospectively listed in the Orange Book for the NDA Product.
“Market” and “Marketing” means to sell or distribute a product.
“NDA” means a new drug application as defined in the U.S. Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder and filed with the FDA under 21 U.S.C. § 355.
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“NDA Product” means the naltrexone for extended-release injectable suspension product approved under the Alkermes NDA.
“Orange Book” means the FDA’s publication “Approved Drug Products With Therapeutic Equivalence Evaluations.”
“Paragraph IV Certification” means certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) to any patents listed in the Orange Book in connection with the Alkermes NDA.
“Proceeding” means any administrative, judicial or legislative action, audit, litigation, investigation, suit or other proceeding in any court or tribunal.
“Section 505(b)(2) Applicant” means a Third Party that has sought approval or has received approval for a Section 505(b)(2) Product.
“Section 505(b)(2) Application” means an application as defined in the U.S. Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder filed with the FDA under 21 U.S.C. § 355(b)(2).
“Section 505(b)(2) Product” means a product that has been approved by or submitted for approval to the FDA under a Section 505(b)(2) Application for naltrexone for extended-release injectable suspension and for which VIVITROL is the listed drug.
“Territory” means the United States of America and its territories, commonwealths and possessions, including the Commonwealth of Puerto Rico and the District of Columbia.
“Teva ANDA” means ANDA No. 213195 for a Generic Extended Release Naltrexone Product.
“Teva Product” means the Generic Extended Release Naltrexone Product approved under the Teva ANDA. For the sake of clarity, Teva Product does not include any product that is used, sold, offered for sale or marketed outside of the Territory, even if it is the same as the Teva Product covered herein.
“Teva’s Consent Decree” means the Stipulated Revised Order for Permanent Injunction and Equitable Monetary Relief entered by the United States District Court of
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the Eastern District of Pennsylvania on February 21, 2019, in Federal Trade Commission v. Cephalon, Inc., No. 2:08-cv-2141 (MSG), D.I. 409.
“Third Party” means any person or entity other than the Parties and their respective Affiliates.
Final Dismissal of Lawsuit. Within five (5) business days of the Execution Date, the Parties shall enter into and cause to be filed in the Lawsuit a Stipulated Consent Judgment and Injunction in the form attached as Exhibit A hereto. The date upon which the Lawsuit is dismissed against all Parties pursuant to the Stipulated Consent Judgment and Injunction shall be the “Effective Date.”
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More Favorable Terms or Conditions. Alkermes represent that they have not, prior to the Effective Date of this Settlement Agreement, entered into an agreement, license or other authorization with any Third Party granting such Third Party a license or other authorization under Licensed Patent containing any terms or conditions more favorable than those provided to Teva herein, [**]. In the event that, subsequent to the Effective Date, Alkermes, or any of their Affiliates, enter into any agreement, license, or other authorization of any kind with any Third Party granting such Third Party a license or other authorization under the Licensed Patent containing any terms or conditions more favorable than those provided to Teva herein, [**], Alkermes shall, within ten (10) business days of entering into any such agreement, give Teva notice of such agreement specifying the new, more favorable conditions, subject to written confidentiality obligations, and, if Teva accepts all of those more favorable terms, this Settlement Agreement shall be automatically amended to include such more favorable terms, [**].
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For Alkermes:
Chief Legal Officer
Alkermes, Inc.
900 Winter Street
Waltham, MA 02451
External Counsel
Isaac S. Ashkenazi, Esq.
Paul Hastings LLP
200 Park Avenue
New York, NY 10166
Email:isaacashkenazi@paulhastings.com
For Teva:
General Counsel
Teva Pharmaceuticals USA, Inc.
Morris Corporate Center III
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400 Interpace Parkway, Bldg. A.
Parsippany, NJ 07054
Email: USLegalNotices@tevapharm.com
External Counsel
John Christopher Rozendaal, Esq.
Sterne, Kessler, Goldstein & Fox
1100 New York Avenue, Suite 600
Washington, DC 20005
Email: jcrozendaal@sternekessler.com
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Delisting. From and after the Effective Date, prior to the License Effective Date, unless required, requested or recommended by the FDA or other Governmental Entity or Applicable Law or to address toxicity, efficacy or safety concerns, Plaintiffs shall not (a)
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delist the NDA Product with the FDA; (b) seek or otherwise undertake any action with the FDA to withdraw the NDA Product from the market; and/or (c) delete, remove, designate as “obsolete” or cancel any National Drug Code(s) or any other relevant code(s) for the NDA Product from the applicable National Drug Data File maintained by First Databank (or any successor or equivalent organization), or from any other future comparable pricing database. For the avoidance of doubt, nothing in this Article XVI obligates Alkermes to engage in any marketing, sales or other activities with respect to the NDA Product and shall not prohibit Alkermes from taking any action it deems reasonably necessary for the safety or efficacy of the NDA Product.
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IN WITNESS HEREOF, the Parties have caused their duly authorized representatives to execute this Settlement Agreement to be effective as of the Effective Date.
ALKERMES, INC.
By: /s/ Michael Landine Name: Michael Landine Title: Senior Vice President Date: August 29, 2023
| TEVA PHARMACEUTICALS USA, INC.
By: /s/ Carrie Groff Name: Carrie Groff Title: VP, Portfolio and New Product Strategy Date: August 29, 2023
|
ALKERMES PHARMA IRELAND LIMITED
By: /s/ Richie Paul Name: Richie Paul Title: Director Date: August 29, 2023
| TEVA PHARMACEUTICALS USA, INC.
By: /s/ Colman Ragan Name: Colman Ragan Title: VP & GC North America IP Litigation Date: August 29, 2023
|
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