GBA1 Program Clause Samples
GBA1 Program. Voyager shall conduct Discovery Activities for the GBA1 Program pursuant to the GBA1 Program Development Plan. Promptly following the Effective Date, the Parties shall prepare the initial draft of the GBA1 Program Development Plan and submit it to the JSC for review and approval. The JSC shall approve the GBA1 Program Development Plan and Development Candidate Criteria for the GBA1 Program in accordance with Section 3.1.2(e) and Section 3.6.
1. The JSC shall, prior to the end of each Calendar Year during the Discovery Period, review the GBA1 Program Development Plan and determine whether to update such plan, and shall prepare a detailed budget for Voyager’s activities under the GBA1 Program Development Plan for the subsequent Calendar Year. A Party may also develop and submit to the JSC from time to time proposed substantive amendments to the GBA1 Program Development Plan. The JSC shall review such proposed amendments and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion and, upon any such approval by the JSC, the GBA1 Development Plan shall be deemed amended accordingly.
GBA1 Program. Subject to the limitations set forth in Section 3.6.3(c), with respect to the GBA1 Program, such matters will be resolved as follows: (i) Prior to the exercise by Voyager of the Co-Co Option for the GBA1 Program, or if Voyager does not exercise the Co-Co Option, Neurocrine shall have the right to finally decide any unresolved matter relating to the GBA1 Program that is within the scope of the JSC’s authority except with respect to the establishment of the GBA1 Program Development Plan or the determination of the Development Candidate Criteria for the GBA1 Program as set forth in Section 3.6.1; and (ii) From and after the timely exercise by Voyager of its Co-Co Option for the GBA1 Program: (A) to the extent any unresolved matter within the scope of the JSC’s authority relates to the Development or Manufacturing of Co-Co Products for the Co-Co Territory prior to commercial launch of any Co-Co Product in the Co-Co Territory, neither Party shall have the right to decide such unresolved matter and such unresolved matter shall be deadlocked until resolved by mutual agreement of the Parties or the JSC; and (B) to the extent any unresolved matter within the scope of the JSC’s authority relates to the Development or Manufacturing of Co-Co Products following commercial launch of any Co-Co Product in the Co- Co Territory, or relates to Commercialization of Co-Co Products, or relates to the Development outside of the Co-Co Territory of Products in the GBA1 Program, Neurocrine shall have the right to decide such unresolved matter, subject to Section 4.1.2(a). EXECUTION COPY CONFIDENTIAL 30 (b) New Discovery Programs. Subject to the limitations set forth in Section 3.6.3(c), Neurocrine will have the right to finally decide any unresolved matters relating to the New Discovery Programs that is within the scope of the JSC’s authority.