Global Phase 3 Study definition

Global Phase 3 Study means that certain Phase 3 Clinical Trial described in Schedule 1.39, attached hereto, to be conducted by Inovio and Advaccine (other than in Greater China, where such Phase 3 Clinical Trial will be conducted by Advaccine). For clarity, Global
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Global Phase 3 Study means that certain Phase 3 Clinical Trial described in Schedule 1.39, attached hereto, to be conducted by Inovio and Advaccine (other than in Greater China, where such Phase 3 Clinical Trial will be conducted by Advaccine). For clarity, Global Phase 3 Study does not include any Clinical Trials not specifically described in Global Phase 3 Study Plan and does not include any Clinical Trial that will be conducted by Each Party independently. For additional clarity, Global Phase 3 Study does include any Clinical Trial conducted by a Global Purchasing Entity.
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Examples of Global Phase 3 Study in a sentence

  • Inovio shall keep Advaccine reasonably informed as to the progress and results of Inovio’s Development activities under the Global Phase 3 Study (including prompt reporting of available clinical Data).

  • Notwithstanding the foregoing to the contrary, any Remedial Action in connection with the Global Phase 3 Study in the Advaccine Territory (other than Greater China) shall be jointly decided by the Parties.

  • Notwithstanding the foregoing to the contrary, Inovio shall be responsible for the pharmacovigilance activities in the Advaccine Territory (other than Greater China) in connection with the Global Phase 3 Study, provided however that, a copy of any pharmacovigilance-related filings or reporting for the Global Phase 3 Study shall be provided to Advaccine for review and comment pursuant to the Pharmacovigilance Agreement.

  • At such JSC meeting, the Parties shall discuss the status, progress and results of the Global Phase 3 Study, and Inovio shall promptly respond to Advaccine’s reasonable questions or requests for additional information relating to such activities.

  • Notwithstanding the foregoing to the contrary, Inovio shall have the right to lead all interactions with Regulatory Authorities in the Advaccine Territory (other than in Greater China) with respect to the Global Phase 3 Study, and Inovio shall keep Advaccine reasonably informed of such regulatory activities in a manner similar to Advaccine’s obligations to Inovio under this Section 5.3 mutatis mutandis.

  • For clarity, the Parties desire Advaccine to make payments directly to Third Party service providers of the Global Phase 3 Study, however, in the event that such direct payments are not feasible or permitted by such Third Party service provider, Advaccine shall pay its share of the Global Development Costs directly to Inovio.

  • In addition and to the extent applicable, within thirty (30) days after the end of each Fiscal Year, Inovio shall provide Advaccine with a detailed written report regarding the progress of the Global Phase 3 Study and any results therefrom.

  • Upon completion of the Global Phase 3 Study, Inovio will promptly transfer to Advaccine (including its Affiliate or Sublicensee) all Regulatory Materials related to the Global Phase 3 Study that are specific to the Advaccine Territory.

  • In the event that Inovio enters into an agreement with a Global Purchasing Entity that authorizes such Global Purchasing Entity to conduct a portion of the Global Phase 3 Study in the Advaccine Territory (other than Greater China) in accordance with Section 6.6, then Inovio will work directly with such Global Purchasing Entity regarding such portion of the Global Phase 3 Study and will update the JSC with respect to such Development activities.

  • Advaccine shall be solely responsible for the day-to-day conduct of Development within the Advaccine Territory and all decisions associated therewith, except for the Global Phase 3 Study as otherwise provided in this Agreement.