Egalet Development Activities definition

Egalet Development Activities means any Development and Manufacturing activities which are assigned to Egalet by the JDC in accordance with Section 3.1. 5

Examples of Egalet Development Activities in a sentence

  • After the end of each Calendar Quarter during which Egalet has performed Egalet Development Activities pursuant to Section 4.1.1, Egalet shall deliver to Shionogi an invoice of Egalet Development Costs.

  • Subject to Section 4.1.4 and Section 4.2.2, Shionogi shall be responsible for all aspects of the Development of Products in the Territory, including conducting all Clinical Trials for Products for the purpose of obtaining Regulatory Approval for Products in the Territory; provided, however, that Egalet shall be responsible for Egalet Development Activities.

  • Subject to the terms and conditions of this Agreement, Egalet hereby grants, on behalf of itself and its Affiliates, to Shionogi, effective 16 on the Effective Date, a royalty-bearing, exclusive (even as to Egalet (except to the extent necessary for Egalet to perform the Egalet Development Activities)) worldwide license, with the right to sublicense as set forth in Section 2.3.1, under the Egalet Technology to Manufacture, Develop and Commercialize the Products in the Field in the Territory.

  • Egalet shall promptly report and provide to Shionogi any and all raw data, results and other information related to the Egalet Development Activities in Egalet’s possession or control.

  • Within thirty (30) days after the Effective Date, the Parties shall establish a joint development committee (the “JDC”) that will serve as a forum to facilitate the Parties’ collaboration, particularly regarding the generation of Product formulations, and to define and agree upon the Egalet Development Activities.

  • Without limiting the generality of the foregoing, the Parties acknowledge and agree that the initial meeting of the JDC shall be held within forty-five (45) days of the Effective Date and shall be devoted to determining the scope of the Egalet Development Activities.

  • Egalet shall, upon the request of Shionogi, make appropriate scientific and regulatory personnel available to Shionogi, either by telephone or in person as the Parties may mutually agree, as reasonably required to keep Shionogi informed of such Egalet Development Activities.

Related to Egalet 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.

  • 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.

  • 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 Program means the implementation of the development plan.

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

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

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

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

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

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • 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.

  • 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.

  • 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 means a methodical investigation into a subject.

  • 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;

  • 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.

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

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

  • 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.

  • 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.

  • 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;

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

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