Proposed Studies definition

Proposed Studies means the list of clinical studies proposed to be undertaken by ARIAD US in the Territory and the Reserved Territory, the name, protocol synopses for which are as set forth in Appendix 1.138.
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Examples of Proposed Studies in a sentence

  • ARIAD US and ARIAD SWISSCO shall use good faith efforts to coordinate and liaise, through the JSC, concerning continued Development of the Product with respect to (i) Development being Global Studies, Ongoing Studies and Proposed Studies and (ii) each Party’s separate plans for Development in its respective territory.

  • ARIAD US may in its sole discretion commence and conduct the Proposed Studies and the provisions of Sections 5.6 or 5.7.2 shall not apply to the Proposed Studies but otherwise all provisions of this ARTICLE 5 shall apply as appropriate to a Proposed Study.

  • The Proposed Studies and, if a Party does not veto a clinical study under Sections 5.6 or 5.7.2, the clinical studies the subject of (ii), in each case once initiated, shall be listed in a Development register (“Development Register”) maintained by the JSC.

  • ARIAD US shall report the results of each of the Proposed Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within six (6) months of database lock for the applicable study.

  • A Clinical Development Plan also may include information with respect to Proposed Studies, provided that the Parties shall not be obligated to conduct any such Proposed Studies and references in this Agreement to the Clinical Development Plan shall not be deemed to include any such Proposed Studies.

  • Notwithstanding anything to the contrary in this Agreement, Spectrum shall be entitled to conduct any development studies in relation to the Licensed Products in the Licensed Territory and Purchaser shall be entitled to conduct Spectrum-approved Proposed Studies in Spectrum Territory.

  • As between the Parties, subject to Section 4.2 (Xencor Proposed Studies), Genentech shall have sole decision-making authority over all Development matters for Collaboration Products.

  • Subject to Section 4.2 (Xencor Proposed Studies), Genentech (itself or through its Affiliates or sublicensees) shall have the sole and exclusive right, at its sole cost and expense, to Develop any and all Collaboration Products in the Territory.

  • Any (a) material modifications to the GDP approved at a JDC meeting shall constitute an amendment to the GDP, and (b) decisions by the JDC related to any Proposed Studies shall be made, in each case upon approval by both Parties of the meeting minutes related thereto.

  • Milestone payments from Mundipharma to Allos in respect of any of the solid tumor and hematology Indications listed in Exhibit A will be discussed and agreed between the Parties at the time any Proposed Studies in respect of such solid tumor and hematology Indications are discussed.

Related to Proposed Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]