Development Candidate Identification Plans Clause Samples
The Development Candidate Identification Plans clause outlines the procedures and criteria for selecting and designating potential candidates for development within a project or collaboration. Typically, this clause specifies the responsibilities of each party in proposing, evaluating, and prioritizing candidates, as well as the timelines and documentation required for the identification process. Its core function is to ensure a structured and transparent approach to candidate selection, minimizing misunderstandings and aligning both parties on the development pipeline.
Development Candidate Identification Plans. Promptly after the Effective Date, but in any event within [***] thereafter, Ionis will submit to the JSC for its review and approval an initial draft plan to identify a Development Candidate (such plan, as may be modified by the JSC from time to time to address the discovery activities to be conducted by Ionis, the “Development Candidate Identification Plan”‘). No later than [***] after submission of the Development Candidate Identification Plan to the JSC, the JSC will agree on the final Development Candidate Identification Plan, which plan will be consistent with Ionis’ other plans for other gene targets. From time to time during the Collaboration Term Ionis will update the Development Candidate Identification Plan as needed and submit it to the JSC for its review and approval in accordance with Section 4.1.2. If the JSC cannot agree upon any aspect of the final Development Candidate Identification Plan or any update thereto proposed by Ionis within [***] following discussion at the meeting of the JSC, then either Party may refer the matter to the Senior Representatives for resolution. If the Senior Representatives cannot agree on any aspect of the final Development Candidate Identification Plan or any proposed update thereto within an additional [***] after the matter is so referred, then Ionis will have final decision-making authority with respect to any elements of the Development Candidate CONFIDENTIAL Identification Plan to which the Senior Representatives cannot agree. Ionis will carry out its drug discovery efforts in accordance with the Development Candidate Identification Plan and in a manner consistent with its internal practices for other gene targets with the goal of identifying the optimal Compound as the Development Candidate and at least one Related Compound as soon as practicable.
Development Candidate Identification Plans. Neither Party will have any further obligations with respect to the terminated Development Candidate Identification Plan(s).
Development Candidate Identification Plans. After Bayer delivers a Drug Discovery Request Notice to Isis under Section 2.1, the Parties will discuss [***]. For each New Drug Option Program, Isis will provide Bayer an initial draft plan to identify a Development Candidate under the applicable New Drug Option Program (the “Development Candidate Identification Plan”). Bayer will review such plan with Isis and the Parties will agree on a final Development Candidate Identification Plan for such New Drug Option Program. Isis will use Commercially Reasonable Efforts to complete the activities for each New Drug Option Program set forth in the applicable Development Candidate Identification Plan [***] in a manner consistent with its internal practices for other gene targets with the goal of identifying a Development Candidate for the applicable New Drug Option Program as soon as possible. If the Parties cannot mutually agree on a final Development Candidate Identification Plan for a given New Drug Option Program, Isis will perform such New Drug Option Program under a plan consistent with Isis’ other plans to create Development Candidates for other gene targets in Isis’ own internal programs. Bayer may propose changes to the Development Candidate Identification Plan, and Isis will consider Bayer’s comments and proposals in good faith [***] regarding the conduct of the Development Candidate Identification Plan so long as [***].
Development Candidate Identification Plans. Within [***] days after the designation of each Collaboration Program, Ionis will submit to the Neurology JRC for its review and approval an initial draft plan to identify Development Candidates under such Collaboration Program, which plan may include activities related to the identification of biomarkers if determined by the Neurology JRC, shall take into account any recommendations of the [***] in relation to [***] considerations for such potential Development Candidates and shall include a list prepared by Biogen of any [***] that the [***] agrees to include in such plan (such plan, as may be modified from time to time to address the discovery, research and optimization activities to be conducted under such Collaboration Program, a “Development Candidate Identification Plan”). No later than [***] days after the designation of each Collaboration Program, or if the Parties mutually agree, at the next Neurology JRC meeting, the Parties or the Neurology JRC will agree on all other aspects of such final Development Candidate Identification Plan, which plan (and the Key Criteria set forth therein) will be generally consistent with Ionis’ other plans for other gene targets and which plan will include any other activities that should be initiated during the Development Candidate Identification Term, such as natural history studies and endpoint development. Ionis will update each Development Candidate Identification Plan as needed and submit it to the Neurology JRC for its review and approval. In addition, either Party may propose updates to the Development Candidate Identification Plan and submit such proposed updates to the Neurology JRC for its review and approval. If the Neurology JRC cannot agree upon any aspect of a final Development Candidate Identification Plan for a Collaboration Program (or any proposed updates thereto) within [***] days following discussion at the meeting of the Neurology JRC, then either Party may refer the matter to the CSC for resolution. If the CSC cannot agree on any aspect of a final Development Candidate Identification Plan for a Collaboration Program or a proposed update thereto within an additional [***] days after the matter is so referred, then Ionis will have final decision-making authority with respect to any other elements of the applicable Development Candidate Identification Plan to which the Neurology JRC or the CSC (as applicable) cannot agree; provided, however, that Ionis shall not (i) include any Biogen Background...