Item 1.01 Entry into a Material Definitive Agreement.
Collaboration and License Agreement
On January 28, 2019 (the “Agreement Date”), Neurocrine Biosciences, Inc. (the “Company”) entered into a Collaboration and License Agreement (the “Collaboration Agreement”) with Voyager Therapeutics, Inc. (“Voyager”) for the research, development and commercialization of adeno-associated virus (“AAV”)-based gene therapy products.
Collaboration and Licenses. Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any required approvals or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the “Effective Date” and such clearance, “Antitrust Clearance”), the Company and Voyager have agreed to collaborate on the conduct of four collaboration programs (the “Programs”): Voyager’sVY-AADC program, intended to advance Voyager’sVY-AADC product candidate for the treatment of Parkinson’s disease, which is currently in an ongoing Phase 2 trial (the “AADC Program”); Voyager’s program intended to generate gene therapy product candidates for the treatment of Friedreich’s ataxia, including Voyager’sVY-FXN01 product candidate (the “FA Program” and, collectively with the AADC Program, the “Existing Programs”); and two programs to be determined by the Company and Voyager at a later date, as described below (each a “Discovery Program” and, collectively, the “Discovery Programs”).
Under the terms of the Collaboration Agreement, subject to the rights retained by Voyager thereunder, Voyager has agreed to collaborate with the Company on, and to grant, as of the Effective Date, exclusive, royalty-bearing,non-transferable, sublicensable licenses to certain of Voyager’s intellectual property rights, for all human and veterinary diagnostic, prophylactic, and therapeutic uses, for the research, development, and commercialization of gene therapy products (the “Collaboration Products”) under (i) the AADC Program, on a worldwide basis; (ii) the FA program, for the United States and, upon expiration of Sanofi Genzyme’s option to the FA Program pursuant to its ongoing collaboration with Voyager (the “Sanofi Genzyme Collaboration”) without exercise of such option, all countries in the world in which the Collaboration Agreement remained in effect with respect to the FA Program; and (iii) each Discovery Program, on a worldwide basis.
Pursuant to development plans agreed to by the Company and Voyager, and as overseen by a joint steering committee (“JSC”), Voyager has operational responsibility, subject to certain exceptions, for the conduct of each Program (prior to the Transition Event (as defined below) for each Program) and is required to use commercially reasonable efforts to develop the Collaboration Products. The Company has agreed to be responsible for all costs incurred by Voyager in conducting these activities for each Program, in accordance with an agreed budget. If Voyager breaches its development responsibilities or in certain circumstances upon a change in control of Voyager, the Company has the right but not the obligation to assume the activities under such Program.
Upon the occurrence of a specified event for each Program (a “Transition Event”), the Company agrees to assume responsibility for development, manufacturing and commercialization activities for such Program from Voyager and to pay milestones and royalties on future net sales as described further below. For each Existing Program, Voyager has the option (a “Co-Co Option”) toco-develop andco-commercialize such Program upon the occurrence of a specified event (a “Co-Co Trigger Event”). Should Voyager elect to exercise itsCo-Co Option, the Company and Voyager agree to enter into a cost- and profit-sharing arrangement (a “Co-Co Agreement”) whereby the Company and Voyager agree to jointly develop and commercialize Collaboration Products for such Program (“Co-Co Products”) and share in its costs, profits and losses, and Voyager agrees to forfeit certain milestones and royalties on net sales in the United States during the effective period of the applicableCo-Co Agreement. The Transition Events are (i) with respect to the AADC Program, Voyager’s receipt of topline data for the ongoing Phase 2 clinical trial forVY-AADC; (ii) with respect to the FA Program, Voyager’s receipt of topline data for the initial Phase 1 clinical trial for an FA Program product candidate; and (iii) with respect to each Discovery Program, the preparation by Voyager and the approval by the Company of an investigational new drug application to be filed with the U.S. Food and Drug Administration (“FDA”) by the Company for the first development candidate in such Discovery Program. TheCo-Co Trigger Events are (i) with respect to the AADC Program, Voyager’s receipt of topline data for the ongoing Phase 2 clinical trial forVY-AADC and (ii) with respect to the FA Program, the achievement of milestones or metrics specified in the applicable development plan, as determined by the JSC.
Subject to exceptions specified in the Collaboration Agreement, profits and losses under Voyager’sCo-Co Option are agreed to be allocated (i) 50% to the Company and 50% to Voyager for a Collaboration Product from the AADC Program and (ii) 60% to the Company and 40% to Voyager for a Collaboration Product from the FA Program; provided, however, that the Company may elect, within a specified period following the acceptance for filing of a biologics license application from the FDA, to pay a $35 million rate-shifting fee to Voyager to change the allocation for the AADC Program to 55% to the Company and 45% to Voyager. The parties have agreed that eachCo-Co Agreement will provide Voyager the right to terminate for any reason upon prior written notice to the Company, and the Company the right to terminate in certain circumstances upon a change of control of Voyager.
