Annual Global Development Plan definition

Annual Global Development Plan means, with respect to each Product and Calendar Year, the written plan for the Development Program to be conducted for such Product for such Calendar Year, as such written plan may be amended, modified or updated in accordance with Section 3.1.2(b); provided, however, that the initial Annual Global Development Plan shall cover the period from the Effective Date through December 31, 2008.
Sample 1

Examples of Annual Global Development Plan in a sentence

  • The JDC shall meet to consider such Clinical Trial Proposal within sixty (60) days, and shall promptly integrate, or direct the integration of, such Clinical Trial Proposal into the Annual Global Development Plan.

  • During the Opt-Out Notice Period, the Parties shall continue to Develop the Product in accordance with the applicable Annual Global Development Plan.

  • Each Party shall perform its obligations under each Annual Global Development Plan and Product Commercialization Plan in good scientific manner and in compliance in all material respects with all Applicable Laws.

  • Scientists at ARIAD and MERCK shall cooperate in the performance of the Development Program and, subject to the terms of this Agreement and any confidentiality obligations to Third Parties, shall exchange such data, information and materials as is reasonably necessary for the other Party to perform its obligations under any Annual Global Development Plan and Product Commercialization Plan.

  • The first Amplixa Annual Global Development Plan, which covers the period from the Effective Date through December 31, 2010, and the Amplixa Global Development Outline have been agreed upon by the Parties as of the Execution Date.

  • Each amendment, modification or update to any Amplixa Annual Global Development Plan or the Amplixa Global Development Outline shall: (x) except as set forth in the immediately preceding sentence, be set forth in a written document that specifically states that it is an amendment, modification or update to such Amplixa Annual Global Development Plan or the Amplixa Global Development Outline, as applicable, and be subject to approval by the JDC, and (y) include the resulting changes to the budget, if any.

  • For Clinical Trials conducted in both the U.S. Territory and the ROW Territory or in the U.S. Territory only for an Indication other than Sarcoma, the Parties will be jointly responsible for the conduct of all activities related to such Clinical Trials except as set forth in the Annual Global Development Plan.

  • Unless expressly contemplated by an Amplixa Annual Global Development Plan, Targacept may subcontract with a Third Party to perform any or all of its obligations hereunder only with the prior written consent of AstraZeneca, such consent not to be unreasonably withheld, conditioned or delayed.

  • An initial Annual Global Development Plan and budget for the period from the Effective Date through December 31, 2008 for each Product and Indication shall be prepared by the Parties at the direction of the JDC, and submitted to the JSC for approval within ninety (90) days after the Effective Date.

  • Except as set forth in any Annual Global Development Plan, the Responsible Party for Development of a Product shall have the primary right and responsibility for the conduct of all non-clinical studies for such Product for use in seeking Regulatory Approvals in its Territory.

Related to Annual 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.

  • 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;

  • Economic development incentive means a financial incentive,

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

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

  • 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.

  • spatial development framework means the Kouga 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.

  • 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, multi-apartment buildings, 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;

  • 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;

  • 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.

  • 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.

  • 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.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • 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.

  • 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;

  • 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.

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

  • Next Michigan development corporation means that term as defined in section 3 of the next Michigan development act, 2010 PA 275, MCL 125.2953.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

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

  • Community Development Director means the Director of City’s Department of Community Development or his or her designee.