Additional Development Proposal definition

Additional Development Proposal has the meaning set forth in Section 5.2.5.1 (Additional Development Proposals).
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Additional Development Proposal has the meaning set forth in Section 3.3.2 (Additional Indications Development).
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Examples of Additional Development Proposal in a sentence

  • The JDC will approve or reject an Additional Development Proposal within [***] days after receipt thereof from the Proposing Party as set forth in this Section 5.2.2.4.

  • If the JSC approves an Additional Development Proposal, the Development Plan shall be deemed to be amended to include the Additional Development Activities and associated budget upon approval of such Additional Development Proposal by the JSC.

  • The PSC shall vote on whether to approve an Additional Development Proposal within [***] after receipt thereof from the Proposing Party as set forth in this Section 5.2.5.2 (PSC Decision Regarding Additional Development Activities).

  • Each Additional Development Proposal shall describe in reasonable detail the Secondary Indication Study(ies) that the Proposing Party desires to conduct, including a synopsis of the trial, the proposed enrollment criteria, number of patients to be included, endpoints to be measured, and statistical design and powering (the “Additional Development Activities”), as CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • The Proposing Party will submit each Additional Development Proposal to the JDC to review and discuss and then the JDC will submit each Additional Development Proposal (as may be revised by the JDC) to the JSC to review, discuss and determine whether to approve in accordance with Section 2.3.2.1 (Specific Responsibilities of the JDC).

  • If the JPT and JSC do not timely approve an Additional Development Proposal within the time periods set forth in Section 4.2.4(b), the other Party (the “Declining Party”) may, within [***] Business Days of the JSC’s final vote with respect to the Additional Development Proposal, initiate the dispute resolution arbitration procedures set forth in Section 16.6.4, if, and only if, the Declining Party determines reasonably and in good faith that (i) [***] or (ii) [***].

  • If the JPT approves an Additional Development Proposal, such Additional Development Proposal shall be submitted promptly to the JSC for review.

  • The Proposing Party shall provide the JPT with any additional Information related to the Additional Development Proposal reasonably requested by the JPT.

  • If the JSC does not approve the Additional Development Proposal, inclusion of the Additional Development Activities within the Development Plan shall not be subject to resolution under Section 2.3.6, and instead the provisions of Sections 4.2.4(c)–(e) shall apply.

  • If the JSC cannot reach consensus on approving any aspect of an Additional Development Proposal or the update to the Joint Development Plan related thereto (e.g., the additional Indication proposed to be included for Development and Regulatory Approval, [**].

Related to Additional Development Proposal