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

  • 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.

  • 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.

  • Astellas will direct, coordinate, and manage the Development of the Product in the Field, according 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.

  • 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.

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

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

  • 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.


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.
Sample 1

Related to Development and Regulatory Plan

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Development Program means the implementation of the development plan.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Project Plan means the document to be developed by the Contractor and approved by WTL, based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalised Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by WTL. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Development Project means a project for the development of land within a project area.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Development Phase means the period before a vehicle type is type approved.

  • The Project Plan means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Marketing Plan has the meaning set forth in Section 4.3(a).

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Development Area means that area to which a development plan is applicable.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Project Plans mean the plans for the Project that are attached to this Agreement as Exhibit “B.”

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

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

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;