Additional Development Activities definition

Additional Development Activities has the meaning set forth in Section 5.2.2.4(a).
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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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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 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.

  • Any Additional Development Activities included in a Split Territory Global Development Plan pursuant to this Section 5.2.5.2 (PSC Decision Regarding Additional Development Activities) shall be deemed to be Split Territory Global Development Activities for all purposes under this Agreement (including the definition of Global Development Costs).

  • 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).

  • Any Additional Development Activities included in a RLP Development Plan pursuant to this Section 5.2.2.4 will be deemed to be RLP Development Activities for all purposes under Section 5.2.3.2. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • 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 “[***]”.

  • 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.

  • If a Party (the “Proposing Party”) wishes to conduct Development Activities that are not covered by an approved Product Work Plan (“Additional Development Activities”), then the Proposing Party shall provide the JSC with a proposal for such Additional Development Activities, including a description of, and rationale for, the activities, timelines for the activities and a projected budget for such activities, for review and approval, and shall incorporate reasonable comments from the JSC.

  • Upon such an election, such Additional Development Activities shall be deemed the “Independent Development Activities” of the Proposing Party and the Proposing Party may pursue such work subject to the remainder of this Section 4.3, and the Development Costs with respect thereto shall be Independent Development Costs subject to Section 8.2(b).

  • Except as expressly set forth in this Section 4.2.4(d), the conduct of the Additional Development Activities will be subject to all terms and conditions of this Agreement relating to Development of Optioned Products.


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 Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • 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.

  • Professional development plan means a plan specifically designed to identify goals, activities and measurable objectives that will support continuous learning related to professional knowledge, skills and abilities.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.