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 5.2.

Examples of Initial Development Plan in a sentence

MannKind shall not assign, delegate, or subcontract to a Third Party any of the development or regulatory activities assigned to it under the Development Plan without the prior written approval of United Therapeutics, provided that the Parties agree that the subcontractors listed in the Initial Development Plan (“Approved Suppliers”) shall be deemed pre-approved for the tasks indicated therein.
MannKind shall be responsible for performing those tasks with respect to the development of the Initial Product that are set forth in the Initial Development Plan and those tasks with respect to the development of any additional Product(s) that are set forth in any Additional Development Plans mutually agreed by the Parties.
Notwithstanding the foregoing, in the event that MannKind is required to have its personnel visit United Therapeutics’ facilities in connection with the manufacturing technology transfer activities contemplated in the Initial Development Plan, United Therapeutics agrees to reimburse MannKind for the reasonable travel and lodging expenses incurred in connection therewith.

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.