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.
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Joint Global Development Plan has the meaning set forth in Section ‎4.2(a).
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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.
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Examples of Joint Global Development Plan in a sentence

  • Prior to the Opt-In/Out Date, Protagonist will lead CMC Development in preparation for the submission of the Rusfertide NDA to the FDA, with guidance from and in consultation with Takeda, in accordance with and as set forth in its Joint Global Development Plan.

  • In accordance with the reporting format and schedule approved by the JDC, each Party shall promptly disclose to the other Party in writing all data, including pre-clinical data, formulation data and manufacturing data, generated by or on behalf of such Party under the applicable Joint Global Development Plan.

  • Takeda shall have the right, in its sole discretion, to utilize the services of CROs or other Third Party subcontractors to perform its activities under the applicable Joint Global Development Plan and this ‎Article IV.

  • A.If Protagonist has not exercised the Rusfertide Opt-Out Right or a Partial Opt-Out Right with respect to the Licensed Product for which the New Technology is being proposed, the JSC will determine whether to approve the inclusion of such New Technology under this Agreement with respect to activities under the Joint Global Development Plan or the Joint Commercialization Plan corresponding to such Licensed Product.

  • Except as provided in the foregoing sentence and in Section ‎5.1(a)(ii), each Party will be solely responsible for all costs and expenses incurred by or on behalf of such Party and its Affiliates in connection with the performance of regulatory activities for the Licensed Products in the Territory if any of those activities are not referenced in such Joint Global Development Plan or Joint Commercialization Plan.

  • Provided Protagonist has not exercised the Rusfertide Opt-Out Right, then, for any other Licensed Product for which Xxxxxxxxxx has not already exercised a Partial Opt-Out Right, Takeda will prepare a proposed draft Joint Global Development Plan (inclusive of a proposed Shared Development Budget) for such Licensed Product, and submit such Joint Global Development Plan to the JDC to review, discuss and determine whether to submit to the JSC for approval.

  • In addition, at the first JDC meeting in the following Calendar Year, each Party will provide an annual review for the Calendar Year-ended of results versus goals of Development activities for the Licensed Products under the applicable Joint Global Development Plan.

  • Unless agreed in the applicable Joint Global Development Plan, Protagonist may not engage a Third Party subcontractor that is not an Approved Development Subcontractor to conduct any of the activities assigned to Protagonist under such Joint Global Development Plan without Takeda’s prior approval through the JDC.

  • In the event of any inconsistency between a Joint Global Development Plan and this Agreement, the terms of this Agreement will prevail.

  • The initial Joint Global Development Plan (and Shared Development Budget) for Xxxxxxxxxx as agreed upon by the Parties is attached hereto as Schedule ‎4.2(a).

Related to Joint Global Development Plan

  • 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;

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

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

  • 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.

  • 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 management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • 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.

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

  • Development Committee shall have the meaning set forth in Section 3.4.1.

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

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.