Joint Global Development Plan definition

Joint Global Development Plan means the joint global development plan for any Joint Global Study mutually agreed by the Parties to be conducted jointly pursuant to the terms and conditions of this Collaboration Agreement. The Joint Global Development Plan should also include a budget and timeline, to be prepared by the Parties and reviewed and approved by the Collaboration Committee, as such plan may be amended from time to time in accordance with this Collaboration Agreement.
Sample 1Sample 2Sample 3
Joint Global Development Plan means the plan setting forth (a) all Clinical Trials for any Licensed Products and corresponding Sarepta Diagnostic Products, in each case, through the completion of Pivotal Clinical Trials and any other Development activities necessary to obtain and maintain Regulatory Approvals for such Licensed Products and corresponding Sarepta Diagnostic Products in the U.S. and the European Union, including process development activities and any post-Regulatory Approval studies, the data from which may be used in both the U.S. and the European Union to obtain or maintain Regulatory Approval, (b) the timelines for such activities, and (c) the Joint Global Development Budget, in each case ((a) through (c)), as the same may be amended from time-to-time in accordance with this Agreement. The initial Joint Global Development Plan is attached as Schedule 4.3.1 of this Agreement.
Sample 1
Joint Global Development Plan has the meaning set forth in Section ‎4.2(a).
Sample 1

Examples of Joint Global Development Plan in a sentence

  • For clarity, nothing in this Collaboration Agreement will be construed as limiting either Party’s right to develop Licensed Product as set forth in the License Agreement outside the scope of the Joint Global Development Plan and this Collaboration Agreement, or as requiring either Party to participate in any Joint Global Study under the Joint Global Development Plan.

  • The Collaborative Cost Model will be based on the Shared Costs and the Collaborative Model shall be reviewed and approved by CC and appended to the Joint Global Development Plan.

  • The Project Team will be responsible for the preparation of the budget, actuals required to conduct each Joint Global Study under the Joint Global Development Plan.

  • The Joint Global Development Plan shall include the allocation of Sponsorship and all items (i) through (iii) as set out in Section 2.3 below, all of which the Parties shall agree on.

  • Notwithstanding anything herein, if any cost is incurred (i) for a Global Study that is conducted by Allist and not part of the Joint Global Development Plan, Allist shall be solely responsible for such cost; (ii) if any cost is incurred for a Global Study that is conducted by AxxxXxxx and not part of the Joint Global Development Plan, then ArriVent shall be solely responsible for such cost.

  • This Collaboration Agreement, including the Exhibits hereto and together with the Joint Global Development Plan, License Agreement, the Quality Agreement, and Pharmacovigilance Agreement, sets forth the complete, final, and exclusive agreement between the Parties concerning the subject matter hereof and supersedes all prior agreements and understandings between the Parties with respect to such subject matter.

  • If CC agrees on a written development plan for such proposed Global Study, such proposed Global Study shall become a “Joint Global Study” and such plan a Joint Global Development Plan.

  • The Joint Global Development Plan and each Joint Global Study shall be approved by the CC.

  • However, the CC shall have decision-making authority and will have the right, power, and authority under this Collaboration Agreement to approve the Joint Global Development Plan.

  • Each Party shall have the right to engage subcontractors (including consultants, agents, vendors, and the like) to conduct activities assigned to it under such Joint Global Development Plan (collectively, “Subcontractors”) so long as such Party remain primarily responsible for the performance of such Subcontractors it engages and the compliance of such Subcontractors with the terms and conditions of this Collaboration Agreement.

Related to Joint Global Development Plan

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

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

  • Initial Development Plan has the meaning set forth in Section 3.2(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;

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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.

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

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • 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.

  • 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.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • 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.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Individual development account means a contract between an account holder and a fiduciary organization, for the deposit of funds into a financial institution by the account holder, and the deposit of matching funds into the financial institution by the fiduciary organization, to allow the account holder to accumulate assets for use toward achieving a specific purpose approved by the fiduciary organization.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Development Program means the implementation of the development plan.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Michigan economic development corporation means the public body corporate created under section 28 of article VII of the state constitution of 1963 and the urban cooperation act of 1967, 1967 (Ex Sess) PA 7, MCL 124.501 to 124.512, by a contractual interlocal agreement effective April 5, 1999, as amended, between local participating economic development corporations formed under the economic development corporations act, 1974 PA 338, MCL 125.1601 to 125.1636, and the Michigan strategic fund. If the Michigan economic development corporation is unable for any reason to perform its duties under this act, those duties may be exercised by the Michigan strategic fund.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

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

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

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Economic development means all powers expressly granted and reasonably inferred pursuant to SDCL § 9-54.