Development and Regulatory Plan definition

Development and Regulatory Plan means the plan for the Development of the Licensed Compound for Regulatory Approval and Post-Approval Research prepared by Astellas and approved by the JSC and as amended or updated from time to time in accordance with this Agreement.
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Development and Regulatory Plan has the meaning set forth in Section 6.2(a).
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Development and Regulatory Plan means the plan for the Development of the Licensed Compound for Regulatory Approval and Post-Approval Research prepared by Astellas and approved by the JSC and as amended or updated from time to time in accordance with this Agreement. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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Examples of Development and Regulatory Plan in a sentence

  • Astellas will be responsible for the payment of all of the expenses incurred after the Effective Date in connection with the Development of the Product exclusively for the Territory and pursuant to the Development and Regulatory Plan.

  • Any amendment to the Initial Development and Regulatory Plan or any subsequent Development and Regulatory Plan will contain least that level of detail and cover at least the same matters as the Initial Development Plan.

  • In addition, the JSC will meet within seven Business Days of a proposal by either Party to amend the Development and Regulatory Plan to consider such amendment.

  • Astellas will implement and conduct the Development activities in accordance with the Development and Regulatory Plan and Applicable Law.

  • Each Party will report on Development activities, if any, undertaken by it in accordance with Development and Regulatory Plan in connection with meetings of the JSC, including by providing a reasonably detailed summary of all results, data, and material inventions, if any, obtained from such activities.

  • During the Term, Astellas may amend the Development and Regulatory Plan on an ongoing basis as necessary, any modifications being subject to approval by the JSC, [**] as necessary to comply with Applicable Laws or requirements imposed by Regulatory Authorities, [**], and such amendment and modification shall be deemed approved by the JSC.

  • During the Term, the JSC will review the Development and Regulatory Plan at least once per year, and will amend the Development and Regulatory Plan as necessary pursuant to such review.

  • If approved by the JSC, such additional Development activities will become part of the Development and Regulatory Plan.

  • Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development and Regulatory Plan.

  • The Development and Regulatory Plan for the Product will include, among other things, the indications in the Field for which the Product is to be Developed and other exploratory indications in the Field for which the Product may be developed, critical activities to be undertaken, certain timelines, go/no go decision points and relevant decision criteria and certain allocations of responsibilities between the Parties for the various activities to be undertaken under the Development and Regulatory Plan.


More Definitions of Development and Regulatory Plan

Development and Regulatory Plan means the plan for the Development of the Licensed Compound for Regulatory Approval and Post- Approval Research prepared by Astellas and approved by the JSC and as amended or updated from time to time in accordance with this Agreement.
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Related to Development and Regulatory Plan