Joint CMC Working Group Sample Clauses
The Joint CMC Working Group clause establishes a collaborative committee composed of representatives from both parties to oversee and coordinate activities related to the contract. This group typically meets regularly to discuss project progress, resolve issues, and make joint decisions on matters affecting both sides, such as changes in scope or addressing unforeseen challenges. By formalizing this working group, the clause ensures ongoing communication, facilitates joint problem-solving, and helps prevent misunderstandings or disputes during the course of the agreement.
Joint CMC Working Group. The Parties shall establish a joint Manufacturing working group (the “Joint CMC Working Group”) within [**] following the Effective Date. The Joint CMC Working Group will be responsible for providing the JSC and the Parties with guidance with respect to matters relating to the generation and maintenance of chemistry, manufacturing and controls (CMC) data required by applicable Law to be included or referenced in, or otherwise support, an IND or Regulatory Approval Application and coordinating the sharing and exchange of such data between Voyager and Neurocrine. The Joint CMC Working Group will report to the JSC.
Joint CMC Working Group. The Parties shall establish a joint Manufacturing working group (the “Joint CMC Working Group”) within [**] following the Effective Date. The Joint CMC Working Group will be responsible for providing the JGC and the Parties with guidance with respect to matters relating to the generation and maintenance of chemistry, manufacturing and controls (CMC) data required by applicable Law to be included or referenced in, or otherwise support, an IND or Regulatory Approval Application and coordinating the sharing and exchange of such data between Voyager and AbbVie. The Joint CMC Working Group will report to the JGC. AbbVie shall have the right to disband the Joint CMC Working Group at any time after the License Option Effective Date upon written notice to Voyager.
Joint CMC Working Group. The Parties shall establish a joint Manufacturing working group (the “Joint CMC Working Group”) within [Redacted] following the Effective Date. The Joint CMC Working Group will be responsible for providing the JGC and the Parties with guidance with respect to matters relating to the Manufacturing of Licensed Compounds and Licensed Products, including the generation and maintenance of CMC Data and subject to Section 8.8, coordinating the sharing and exchange of such CMC Data between I-Mab and AbbVie. Without limiting the foregoing, the Joint CMC Working Group shall be responsible for (a) reviewing and approving the timeline for AbbVie’s Manufacturing Development for the Existing Product (the “Manufacturing Timeline”) based on the I-Mab Territory Development Plan and the AbbVie Territory Development Plan and (b) overseeing and coordinating the global Manufacture of the Licensed Products to be supplied by or on behalf of one Party to the other Party in accordance with Section 7.1. The Joint CMC Working Group will report to the JGC, and the JGC shall have the right to disband the Joint CMC Working Group at any time.