Initial Global Development Plan definition

Initial Global Development Plan means the initial global Development plan for the Development of Licensed Products, as such plan may be amended from time to time in accordance with this Agreement. The Initial Global Development Plan as of the Execution Date is attached hereto as Exhibit A.
Initial Global Development Plan means the Global Development Plan as of the Execution Date, which is attached to this Agreement as Exhibit C and includes the following: [**] [**]. The Parties will add Development Budgets for [**] to the Initial Global Development Plan within [**] days after the Execution Date.
Initial Global Development Plan has the meaning set forth in Section 5.2 (Initial Global Development Plan).

Examples of Initial Global Development Plan in a sentence

  • The Parties acknowledge that the Initial Global Development Plan is preliminary and provides high-level Work Plans for initial Development activities.

  • The Initial Global Development Plan as of the Effective Date (attached hereto as Exhibit C) includes: (a) the Work Plan for the Initial Study; (b) the Work Plan for each Ongoing Study that will continue (if any); (c) the Work Plan for each Ongoing Study that will be wound down; and (d) the Work Plan for any other clinical study of Licensed Products.

  • Each Party will conduct, and ensure that each of its Affiliates and Third Parties engaged by such Party conducts, all of its and their activities with respect to the development, registration, manufacture, distribution, promotion and Commercialization of the Product in accordance with this Agreement, the Initial Global Development Plan, the Global Development Plan, the Global Pricing Policy, the Quality and Compliance Standards, Proper Conduct Practices, and all Applicable Law.

  • The initial global development plan and corresponding budget for the Licensed Compounds and Licensed Products is set forth on Schedule 5.2 (Initial Global Development Plan and Budget) (such global development plan attached as of signing, the “Initial Global Development Plan” and as it may be modified in accordance with the terms and conditions of this Agreement, the “Global Development Plan” and such corresponding budget, the “Global Development Budget”).

  • The initial Global Development Budget is attached hereto in Schedule 4.4.1 (Initial Global Development Plan and Initial Global Development Budget).

  • As promptly as possible following the Execution Date, Novartis shall (a) sponsor, communicate with Regulatory Authorities, initiate, operationalize and conduct […***…] in accordance with the Initial Global Development Plan and under an IND prepared and filed by Novartis and (b) sponsor, initiate, operationalize and conduct […***…]; provided, that, […***…].

  • The Initial Global Development Plan, which is attached hereto as Exhibit A, includes a detailed Clinical Trial plan which describes (a) the Initial Global Studies being conducted by XxxXxxx, (b) the Novartis-Initiated Trials conducted by Novartis, and (c) all other Clinical Trials, including data-generation Clinical Trials, to be conducted by Novartis.

  • List of Exhibits: Exhibit A: Chemical Structure of cabozantinib Exhibit B: Exelixis Patents Exhibit C: Approved Distributors Exhibit D: Initial Global Development Plan and Budget Exhibit E: Press Release [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  • During the Term, the JDC shall review, discuss and approve potential amendments to the Initial Global Development Plan, at least […***…].

  • The initial Global Development Plan (including the initial Global Development Budget) is attached hereto as Schedule 4.4.1 (Initial Global Development Plan and Initial Global Development Budget).


More Definitions of Initial Global Development Plan

Initial Global Development Plan means the Global Development Plan to be approved by the JCC on or before December 31, 1995 as provided in Section 3.3;
Initial Global Development Plan means the Global Development Plan as of the Execution Date, which is attached to this Agreement as Exhibit C and includes: (a) the initial CDP including the Work Plan and Development Budget for each of the Initial Studies; and (b) Additional Studies that are US Studies planned as of the Execution Date, which shall be incorporated into the CDP if Geron exercises it US Opt-In Rights pursuant to Section 2.2.2, and which shall be incorporated into a Xxxxxxx IDP if Geron does not so exercise such rights.
Initial Global Development Plan means that certain Global Development Plan prepared by Amgen and KKC and separately agreed upon by the Parties as of the Effective Date.

Related to Initial Global Development Plan

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

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

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

  • 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.

  • 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;

  • 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.

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

  • 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;

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

  • Economic development incentive means a financial incentive,

  • Development Plan 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.

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

  • 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.

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

  • 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;

  • 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.

  • Existing development means development, other than that associated with agricultural or forest management activities, that meets one of the following criteria:

  • 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.

  • 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.

  • 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.

  • Planned unit development means a subdivision characterized by a unified site design, clustered residential units and/or commercial units, and areas of common open space.

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

  • 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.

  • 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.