Core Development Activities definition

Core Development Activities means: [***]
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Core Development Activities means all activities regardless of where they are performed which are part of a Development Program for a Drug Product Candidate and which the Development Committee believes are reasonably necessary in order to obtain Regulatory Approval from the [***]. Notwithstanding the foregoing, "Core Development Activities" shall not include studies required by the regulatory authority of a particular country with respect to a particular geographic or ethnic population, or a subset thereof, and not otherwise required by the FDA.
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Core Development Activities shall have the meaning ascribed to it in Section 2.8(c) hereof.
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Examples of Core Development Activities in a sentence

  • The VERTEX Development Plan will be updated by VERTEX annually thereafter to describe the VERTEX Development Activities (other than Core Development Activities) that VERTEX then intends will be conducted during the subsequent year and the remainder of the development period.

  • The Core Development Plan will be updated by VERTEX annually thereafter to describe the Core Development Activities that VERTEX then intends will be conducted during the subsequent year and the remainder of the development period.

  • For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50).

  • UGNX shall be solely responsible for one hundred percent (100%) of the Development Costs for Development activities (other than Core Development Activities) with respect to Licensed Products in the Field (including Development Costs for Phase 4 Clinical Trials) conducted in Latin America.

  • As soon as practicable after the Effective Date, VERTEX will prepare a development plan for the conduct of the Core Development Activities (the “Core Development Plan”), including an accompanying budget, and will provide a copy of such Plan to the JDC.

  • As soon as practicable after the Effective Date, VERTEX will prepare a development plan for the conduct of the VERTEX Development Activities in the VERTEX Territory, other than the Core Development Activities (the “VERTEX Development Plan”), and will provide a copy of such Plan to the JDC.

  • The results of all Core Development Activities, including all data collected or analyzed with respect thereto, and all study reports analyzing such data (collectively, “UGNX Clinical Data”) will be jointly owned by UGNX and KHK.

  • For clarity, the Core Development Plan and Core Development Activities shall cover the 001 and 002 Studies.

  • Beginning on the Profit Share Transition Date (in the Profit Share Territory) or the applicable European Transition Date (in the European Territory), KHK will be responsible for [***] ([***]%) of the Development Costs for the Core Development Activities conducted in the Profit Share Territory and the European Territory, respectively, excluding, for clarity, any On-Going Clinical Trials.

  • UGNX shall keep KHK reasonably informed of its anticipated requirements of the Licensed Products for Core Development Activities and Non-Core Development Activities through the JDC and the Core Development Plan and Non-Core Development Plan by providing a good faith estimate of such requirements on a [***] basis, the first [***] months of which shall be binding, to be updated [***], (collectively, the “UGNX Forecast”).


More Definitions of Core Development Activities

Core Development Activities means all activities regardless of where they are performed which are part of a Development Program for the Drug Product Candidate and which the JDC believes are reasonably necessary in order to obtain Regulatory Approval from the FDA and the EMEA or its comparable successor for marketing the corresponding Drug Product in the United States and the European Union for the Indications selected.
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Related to Core Development Activities

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • 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.

  • Project Activities means the activities to be undertaken or Works to be delivered or Property to be contributed or provided by you, your approved Sub-Grantees or your approved sub- contractors as summarised in the Particulars and more particularly described in the Agreed Proposal for which Xxxxx is payable under this Agreement;

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Development Program means the implementation of the development plan.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • 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.

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

  • licensed activities means things authorised to be done by the licence

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

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

  • Motorsport Activities means any motorsport activities or Recreational Services which are permitted or approved which Motorsport Australia regulates or administers or otherwise are under the responsibility / control of Motorsport Australia;

  • Research Program has the meaning set forth in Section 2.1.

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

  • 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;

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • Development Project means a project for the development of land within a

  • Motor Sport Activities means any motor sport activities or Recreational Services which are permitted or approved which CAMS regulates or administers by CAMS or otherwise under the responsibility / control of CAMS;

  • Research Program Term has the meaning set forth in Section 2.2.

  • 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.

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Research Budget has the meaning set forth in Section 3.2.

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