GSK Development Activities definition

GSK Development Activities has the meaning set forth in Section 3.2.
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GSK Development Activities has the meaning set forth in Section 5.5 (GSK Development Activities).
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GSK Development Activities means the Development activities specified to be conducted by GSK in any Global Development Plan.
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Examples of GSK Development Activities in a sentence

  • GSK will be responsible for completing the GSK Development Activities as outlined in the Development Plan.

  • The Formulation Development Timeline is the timeline associated with the GSK Development Activities and incorporated as part of the Development Timeline shown in Figure 1.

  • During the period between Joint Project Team meetings, POZEN may reasonably request additional information and materials from GSK reasonably related to the content of such presentations, including the underlying data for such results and to consult with GSK regarding the implementation of the GSK Development Activities and the Formulation Development Timeline.

  • In order to facilitate the flow of information, GSK will permit one employee of POZEN to attend one scheduled meeting of the project team that is performing the GSK Development Activities per month.

  • At each meeting of the Joint Project Team, GSK will make a presentation summarizing the results of the GSK Development Activities.

  • In addition, when the GSK Development Activities have been completed, GSK will provide POZEN with a complete copy of the results of the GSK Development Activities, any final reports describing such results, as well as the underlying data including a copy of the final authorized dataset including all data listings and tables.

  • The POZEN Development Activities (for which POZEN is responsible) are detailed in Section 1, and the GSK Development Activities (for which GSK is responsible) are detailed in Section 2.

  • GSK shall be responsible for the conduct of the GSK Development Activities set forth in the Global Development Plans which shall include the Development of Products for all Indications in the ROW Territory.

  • For the avoidance of doubt, as between the Parties, GSK shall have sole responsibility for any regulatory matters in connection with any GSK Development Activities or Independent Registration Studies, including any Regulatory Approvals or any communications, filings, submissions or interactions with any Regulatory Authority, and will own, all Regulatory Filings in the Territory, in connection therewith.

  • Notwithstanding the foregoing, from time to time during the Development Term, GSK shall keep the JDC reasonably informed with respect to any material GSK Development Activities, including providing periodic updates with respect thereto.

Related to GSK Development Activities

  • Development Activities means those activities which are normally undertaken for the development, construction, 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.

  • 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.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

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

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

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

  • 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.

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

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

  • Project Activities means activities related to the design, the construction, operation and maintenance of the Facility, including the sale of Energy Output to the Buyer and for purposes of the Job Creation Element, shall include the Employment of people to manage, within the Project, activities required to comply with the obligations related to Economic Development;

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

  • 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.

  • 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.

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

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

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • 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:

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

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

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

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

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

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.