Additional Development Activities definition

Additional Development Activities has the meaning set forth in Section 5.2.5.1 (Additional Development Proposals).
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Additional Development Activities shall have the meaning assigned thereto in Section 3.1.2.
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Additional Development Activities has the meaning set forth in Section 3.4.1 (Additional Development Proposals).
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Examples of Additional Development Activities in a sentence

  • If the JSC approves an Additional Development Proposal, the Development Plan shall be deemed to be amended to include the Additional Development Activities and associated budget upon approval of such Additional Development Proposal by the JSC.

  • The PSC shall vote on whether to approve an Additional Development Proposal within [***] after receipt thereof from the Proposing Party as set forth in this Section 5.2.5.2 (PSC Decision Regarding Additional Development Activities).

  • The Proposing Party shall also provide the JPT with any other Information related to the Additional Development Activities which is reasonably requested by the JPT and available to the Proposing Party.

  • Additional Development Activities are “Successful” if such activities (1) produce data or results that satisfy the relevant endpoints, in the case of a clinical trial, (2) otherwise achieve the desired goals of such Additional Development Activities that are specified by Jazz in writing before it initiates such activities, or (3) produce data that is incorporated into an approved label or result in a compendia listing.

  • Subject to any Supply Agreement, any Losses arising out of Third Party product liability claims arising from the Development of Regional Licensed Products will be treated as Development Costs in accordance with Section 5.2.4; provided that (x) with respect to any Additional Development Activities, the CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • For clarity, a Licensed Product that is the subject of Additional Development Activities shall continue to be a “Licensed Product” for all purposes of this Agreement.

  • Product Candidates will be Developed in the Territory and in North America pursuant to a Global Development Plan and in connection with any Additional Development Activities that may be undertaken by either Party.

  • To the extent not provided pursuant to Section 4.3.1, the JPT shall establish a process pursuant to which each Party shall promptly provide to the other Party copies of or access to non-clinical data and Clinical Data, and other Information, results, and analyses with respect to any Development activities for a Collaboration Program and its Additional Development Activities (collectively, “Regulatory Data”).

  • Lyell and GSK will each provide an update at each JSC meeting detailing the current status of each Lyell Development Program or Development Program, as applicable, and in the case of Lyell, Additional Development Activities, including in each case a summary in reasonable detail of the Collaboration Programs and the Additional Development Activities (as applicable), results obtained therein and future plans with respect thereto.

  • Lyell shall keep GSK reasonably informed of its or its academic partner’s interactions with Regulatory Authorities regarding Regulatory Materials for Lyell PoC Development Programs and Additional Development Activities, to the extent such interactions reasonably relate to a Compound or Product.


More Definitions of Additional Development Activities

Additional Development Activities means, with respect to an Additional Development Project, all Development activities related to obtaining and maintaining Regulatory/Pricing Approval in the Territory with respect to the form, formulation, method of delivery or Indication that is the subject of such Additional Development Project.
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Related to Additional 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.

  • 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).

  • 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;

  • Development Program means the implementation of the development plan.

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

  • 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.

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

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

  • 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.

  • 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.

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

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

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

  • Funded Activities means the activities set out in Annex 2 of these Conditions; Funding Period means the period for which the Grant is awarded starting on the Commencement Date and ending on [INSERT PROJECT END DATE]; General Data Protection Regulations and GDPR means (Regulation (EU) 2016/679); Grant means the sum or sums the Authority will pay to the Grant Recipient in accordance with paragraph 4 of these Conditions and subject to the provisions set out at paragraph 26.