Phase III Plan definition

Phase III Plan means the plan of subdivision prepared by ▇▇▇▇▇ ▇. ▇▇▇▇▇, O.L.S. and dated  , 2017 [NTD: Need to complete particulars] a photographic reduction of which is attached to this Agreement as Schedule “B” to this Agreement;
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Phase III Plan means that plan for the development and completion of the plan relating to the Phase III Assets set forth on Exhibit G attached hereto.
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Phase III Plan. Section 4.2 "Phase I Project Team" Section 2.1 "Phase II Project Team" Section 3.1 "Purchase Pro" Preamble "Purchase Pro Technical Problem" Exhibit A "Restrictions" Section 4.2(c) "Suppliers" Section 2.2(g) "Term" Section 8.1
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Examples of Phase III Plan in a sentence

  • If the JEC cannot agree on such Phase III Plan within a [***]-day period, then such matter shall be referred to the Senior Officers of the Parties for resolution.

  • The final Phase III Plan (along with supporting documentation) is available publicly as described in Appendix B.

  • If such Senior Officers cannot agree on such Phase III Plan within a [***].

  • The Participating Phase III Party under a Unilateral Phase III Plan shall have the right to amend such Unilateral Phase III Plan, [***].

  • On October 2, 2014 after considering all public comments received on the draft plan, the Trustees adopted a final Phase III Plan that included the Early Restoration Project.

  • If the JDC cannot agree on such Phase III Plan within [***] days after submission of such plan by the Participating Phase III Party, the matter shall be referred to the JEC for resolution.

  • With respect to a Unilateral Phase III Plan for a Unilateral Product in an Indication for a Royalty Region, the applicable Participating Phase III Party shall be the Lead Development Party and Lead Regulatory Party with respect to the Development activities under such Unilateral Phase III Plan (including with respect to the preparation and filing of all Drug Approval Applications for such Unilateral Product in such Indication in such Royalty Region).

  • If such Senior Officers cannot resolve such matter within a [***]-day period, the Lead Development Party shall have the final decision-making authority, exercising reasonable good faith judgment consistent with the Principles; provided that such Lead Development Party shall not have the right, without the other Party’s written consent, to make any Material Amendment to the Joint Phase III Plan.

  • The Participating Phase III Party shall pay for one hundred percent (100%) of all Development Costs incurred in connection with its activities under such Unilateral Phase III Plan.

  • Either Party may propose to the applicable JDC an amendment to the Joint Phase III Plan from time to time, including adding Development activities required to obtain Regulatory Approval in the applicable Indication in the Profit Share Region.

Related to Phase III Plan

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase III means a human clinical trial of a Licensed Product, which trial is designed to: (a) establish that a Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; (c) support regulatory approval of such Licensed Product; and (d) be generally consistent with 21 CFR § 312.21(c). Said trial may be conducted in any country.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.