Development Plan/Budget definition

Development Plan/Budget means (a) the comprehensive plan for the Development of any Licensed Compound or Licensed Product for the purpose of obtaining Regulatory Approval in the Territory, including activities designed to generate the preclinical, process development/manufacturing scale-up, clinical and regulatory information required for filing NDAs in the Territory, and (b) a budget setting forth the internal and external resources and expenses, including the maximum costs to be incurred in a particular Contract Year, for such Development activities.
Development Plan/Budget means (a) the comprehensive plan for the Development of any Licensed Compound or Licensed Product for the purpose of obtaining Regulatory Approval in North America and Europe, including activities designed to generate the preclinical, process development/manufacturing scale-up, clinical and regulatory information required for filing NDAs in North America and Europe, and (b) a budget setting forth the internal and external resources and expenses, including the maximum costs to be incurred in a particular Contract Year, for such Development activities.
Development Plan/Budget shall have the meaning set forth in Article 4.4.

Examples of Development Plan/Budget in a sentence

  • With respect to the initial Development Plan/Budget, the Joint Development Committee shall, within sixty (60) days after the Effective Date, approve and submit to the Parties the initial Development Plan/Budget.

  • Celgene shall use Commercially Reasonable Efforts to carry out the Celgene Development Activities as set forth in the applicable Development Plan/Budget to Develop Licensed Compounds and Licensed Products.

  • During the Agreement Term, the Joint Development Committee shall, at least ninety (90) days prior to the commencement of any Contract Year during the Agreement Term, approve and submit to the Parties the Development Plan/Budget.

  • Thereafter, the Joint Development Committee shall prepare a draft of the Development Plan/Budget at least one hundred twenty (120) days prior to the commencement of any Contract Year.

  • Acceleron shall prepare the first draft of the initial Development Plan/Budget and present it to Celgene at least 15 days prior to the first meeting of the Joint Development Committee.

  • Each Development Plan/Budget shall contain the specific Development and Manufacturing objectives to be achieved by Celgene during the Contract Year, the specific Development and Manufacturing objectives to be achieved by Acceleron during the Contract Year, and the timeline for performing such Development objectives.

  • Each Party shall keep the Joint Development Committee or the Joint Commercialization Committee fully informed about the status of the activities performed pursuant to the Development Plan/Budget, including providing the Joint Development Committee with copies of the final form of all written reports that relate to such activities, or pursuant to the Commercialization Plan/Budget, as applicable.

  • Acceleron shall use Commercially Reasonable Efforts to carry out the Acceleron Development Activities as set forth in the applicable Development Plan/Budget to Develop Licensed Compounds and Licensed Products.

  • Upon Celgene’s exercise of an Option, the initial Development Plan/Budget proposed by Acceleron (including the proposed Initial Development Diseases), with such changes as are determined by Celgene, in its sole discretion, shall be deemed part of the Development Plan/Budget and deemed approved by the Joint Development Committee.

  • The Development Plan/Budget for the first two (2) Contract Years shall include activities to optimize the current Manufacturing process and undertake analytical method development activities for ACE-536.


More Definitions of Development Plan/Budget

Development Plan/Budget means either or both of the Celgene Development Plan/Budget or the PH Field Development Plan/Budget.
Development Plan/Budget. Section 4.2
Development Plan/Budget means the budget(s) set forth in Exhibit A in the Development Plan.
Development Plan/Budget means the budget for activities related to seeking, obtaining or maintaining Regulatory Approval in the United States and EU as set forth in the Development Plan on a rolling [***] Calendar Year basis. [***]
Development Plan/Budget in Section 1.30 and all references to the “Development Plan” and “Development Plan Budget” in the Agreement be replaced with “Development Plan or Co-Development Plan, as applicable” and “Development Plan Budget or Co-Development Plan Budget, as applicable” respectively.

Related to Development Plan/Budget

  • Development Budget means the cost categories listed on Pages 8 - 11 in Form 3 that are directly related to the proposed Project as submitted in the Application. Indirect or off-site costs not directly related to the development of the project are not valid or eligible costs.

  • 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;

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

  • 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.

  • 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.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., 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 Finalized 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 Webel Technology Ltd. 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.

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

  • Project area budget means a multiyear projection of annual or cumulative

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

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

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

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

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

  • Project Budget means the budget and project description included in the grant application. The Project Budget must succinctly describe all major elements of project work, the estimated cost of each, and clearly allocate requested grant funding and match contributions to each.

  • Budget means a resource, expressed in financial terms, proposed by the Board for the purpose of carrying out, for a specific period, any or all of the functions of the Trust.

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

  • Development Program means the implementation of the development plan.

  • 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.

  • Timeline means the list of critical dates and actions included in the Introductory Materials.

  • 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.

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

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Approved Project Budget means the most recent statement, approved by the FTA, of the costs of the Project, the maximum amount of Federal assistance for which the TJPA is currently eligible, the specific tasks (including specified contingencies) covered, and the estimated cost of each task.

  • 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.