PH Field Development Plan/Budget definition

PH Field Development Plan/Budget means (a) the comprehensive plan for the Development of any Sotatercept Licensed Compound or Sotatercept Licensed Product for the purpose of obtaining Regulatory Approval in the PH Field 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 for such Development activities. Solely if and to the extent that Celgene agrees in writing to perform any Development activities in the PH Field which constitute Celgene Development Activities, the PH Field Development Plan/Budget shall be amended by the Parties to provide for such Development activities and a budget setting forth the internal and external resources and expenses therefor.
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Examples of PH Field Development Plan/Budget in a sentence

  • Celgene shall use Commercially Reasonable Efforts to carry out (a) the Celgene Development Activities as set forth in the Celgene Development Plan/Budget to Develop Licensed Compounds and Licensed Products in the Celgene Field and (b) any Celgene Development Activities in the PH Field as set forth in the PH Field Development Plan/Budget.

  • With the exception of the PH Field Development Plan/Budget for Contract Year 2018, the Joint Development Committee shall prepare a draft of a revised Development Plan/Budget for each 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 PH Field Development Plan/Budget and present it to Celgene at the first Joint Development Committee meeting in Contract Year 2018, and the Parties agree that (a) Acceleron may conduct all PH Field Development Activities that are Acceleron Development Activities prior to such meeting and (b) Celgene will conduct all PH Field Development Activities that have been designated in writing previously as Celgene Development Activities prior to such meeting.

  • Each PH Field Development Plan/Budget shall contain the specific Development and Manufacturing objectives in the PH Field to be achieved by each Party during the applicable Contract Year, and the timeline for performing such Development objectives.

Related to PH Field Development Plan/Budget

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

  • 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).

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

  • 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;

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

  • 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;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • 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.

  • 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 Program means the implementation of the development plan.

  • 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.

  • Development Phase means the period before a vehicle type is type approved.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • 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 Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • 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.

  • Development Works means the external development works and internal development works on immovable property;

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

  • 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;

  • Development Area means that area to which a development plan is applicable.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

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

  • 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.