Joint Development Plan and Budget definition

Joint Development Plan and Budget has the meaning set forth in Section 4.3(c)(i).
Sample 1Sample 2Sample 3
Joint Development Plan and Budget means an annual plan developed by the JDC and approved by the JSC describing the Development activities, including Clinical Trials, for the Compound and Product which are necessary for obtaining or maintaining Regulatory Approvals for the Product both inside and outside the Territory, as further specified in Article 4.2.
Sample 1
Joint Development Plan and Budget has the meaning set forth in Section 5.2.1(b)(i) (Initial Development Plan and Budget).
Sample 1

Examples of Joint Development Plan and Budget in a sentence

  • Each Party shall keep records associated with Development Costs incurred through performance of the Joint Development Plan and Budget for the applicable Program strictly separate from records associated with Development Costs incurred through performance of an Independent Additional Study Development Plan.

  • At the reasonable request of the other Party, a Party will supply the other Party Materials Controlled by such Party for Research consistent with and in furtherance of the POC Plan, Joint Development Plan and Budget or Additional Research Plan for a given Program, as applicable.

  • The purpose of the Joint Development Plan and Budget for the applicable Program is to set forth the specific Development activities to be performed by the Parties in support of such Joint Development Program, [***].

  • Each Joint Development Plan and Budget for the applicable Program shall set forth activities that are similar in nature to those contained in the applicable POC Plan.

  • Before the Commencement of the first Registrational Study for any Collaboration Product following the exercise of the Merck Participation Election for the applicable Program, Merck shall provide, and within [***] days after such provision the JCC will review and update for approval by the JSC, a written summary of the global Commercialization strategy for all Collaboration Products included in the Joint Development Plan and Budget for the applicable Program in the Territory.

  • For clarity, any costs incurred by or on behalf of a Party (or its Affiliates) that are in excess of the budget (plus the Permitted Overage) for such costs as set forth in the applicable Joint Development Plan and Budget, Global Commercialization Plan, Incremental Capacity Buildup Plan, Additional Research Plan or Commercial Capacity Buildup Plan, in each case, for the applicable Program, shall be [***].

  • Each Party shall conduct the Internal SAV Programs, POC Programs, Additional Research Programs, Joint Development Programs and Independent Additional Studies and other activities under the Internal SAV Program Plans, POC Plans, Additional Research Plans, Joint Development Plan and Budget for the applicable Program or Independent Additional Study Development Plans in compliance with all applicable Laws.

  • Subject to the remainder of this Section 6.2(b), to the extent supply of Collaboration SAV Products (including mRNA Constructs therefor) is anticipated to be required to perform the activities under any Joint Development Plan and Budget, concurrent with Merck’s review of Moderna’s Manufacturing operations and the Parties’ preparation of a plan for correcting observations for such SAV Program as set forth in Section 6.1(d)(ii), the Parties shall discuss in good faith and mutually agree on [***].

  • If the Parties mutually agree upon a new Joint Development Plan and Budget for such Joint SAV Program, then the Parties will perform the Collaboration Activities (including any nonclinical studies or Clinical Studies) under the new Joint Development Plan and Budget for such Joint SAV Program in accordance with this Agreement.

  • For clarity, if Merck proposes a reasonable Joint Development Plan and Budget to resolve such Safety Issue within such [***] period, (A) Moderna shall [***] and (B) the preparation and initiation of activities under such Joint Development Plan and Budget shall be deemed [***].

Related to Joint Development Plan and Budget

  • 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;

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

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

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

  • Development Budget has the meaning set forth in Section 3.1.

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

  • Research Budget has the meaning set forth in Section 2.2.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • 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.

  • Development Program means the implementation of the development plan.

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

  • 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;

  • Global Development Plan has the meaning set forth in Section 3.1.

  • 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;

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

  • Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.

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

  • 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;

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • Work Plan means a plan that describes each individual activity to be conducted to complete eligible activities and the associated costs of each individual activity.

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

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