Initial Development Plan definition

Initial Development Plan has the meaning set forth in Section 3.2(b).

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Initial Development Plan shall have the meaning set forth in Section 2.1.1.

Initial Development Plan has the meaning set forth in Section 4.2(b).

Examples of Initial Development Plan in a sentence

• The Initial Development Plan shall be provided by Licensee to Mount Sinai within thirty (30) days of the Effective Date and become a part of this Agreement upon the written consent of the Parties.

• The Initial Development Plan shall serve as the Development Plan for the first full Calendar Year of this Agreement and the period from the Effective Date through the end of the initial partial Calendar Year.

• Celgene will have the right to exercise the Celgene Program Option with respect to any Drug Candidate Program (including any Follow-On Compound in such Drug Candidate Program) upon Completion of the Clinical Trials set forth in the Initial Development Plan for such Drug Candidate Program (or, with respect to the GI-4000 Program, at such time as is provided in Section 3.3.

• In accordance with the process described below, the Parties intend to select one of ALN-PCS02 or ALN-PSCsc for ongoing Development prior to the initiation of IND-enabling studies described in the Initial Development Plan.

• Without limiting the generality of the foregoing, the JRC shall have no power to amend this Agreement or the Initial Development Plan.

More Definitions of Initial Development Plan

Initial Development Plan means the initial development plan prepared by representatives of Symphony Dynamo and Dynavax prior to the Closing Date, and attached to the Amended and Restated Research and Development Agreement as Annex C thereto.

Initial Development Plan means the initial Development Plan (including the Development budget) attached hereto as Schedule 1.33 covering the initial Development activities, as the same may be amended from time to time in accordance with the terms hereof.

Initial Development Plan means the initial Development Plan for the Exploitation by Licensee of the Exclusively Licensed Technical Information, to be provided by Licensee to Mount Sinai within thirty (30) days of the Effective Date, which Development Plan shall be attached at Exhibit D, incorporated into and made part of this Agreement, upon written consent of Mount Sinai.

Initial Development Plan means the initial Development Plan for the Product attached to this Agreement as Exhibit A.

Initial Development Plan means, with respect to any Program, a plan that describes the plan for conducting Development with respect to each Drug Candidate, including by specifying clinical and nonclinical studies and activities to be conducted and anticipated Development activities for each Drug Candidate (including the following anticipated activities or events: a description of the indication targeted, timelines, phasing of Development, study treatments, major inclusion and exclusion criteria, primary endpoints, study size, timelines for data preparation and filing of regulatory submissions, toxicology and a plan for selecting appropriate species for toxicology studies, ADME, and pharmacology studies and manufacturing process development). The Initial Development Plan will include drug design and Development activities that are in keeping with the Parties’ current drug design and Development practices and that are reasonably calculated to result in the Development of the Drug Candidates that may be progressed through to Commercialization. The Initial Development Plan as of the Effective Date is set forth on Exhibit 1.68, which may be amended from time to time in accordance with Section 3.2.5.

Initial Development Plan shall have the meaning given to such term in Section 4.3.1.

Initial Development Plan means the initial development plan for the Product, as outlined in Schedule 2 attached hereto.