Phase 3 Clinical Trials definition

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Phase 3 Clinical Trials means a human clinical trial that satisfies the requirements for a Phase 3 study as defined in 21 C.F.R. Part 312.21(c) (or its successor regulation) or the equivalent human clinical trial outside the U.S. For purposes of Section 3.2, a Phase 3 Clinical Trial shall include any pivotal trial that is officially designated as a phase 3 trial with the Regulatory Authority having jurisdiction, or that is intended to serve to gather any of the pivotal data that (if favorable) would support Regulatory Approval (regardless of whether such trial is denominated “Phase 2”, “Phase 3”, “Phase 2/3” or otherwise denominated).

Phase 3 Clinical Trials means a human clinical trial of a Product or New Collaboration Compound on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Product or New Collaboration Compound, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise.

Examples of Phase 3 Clinical Trials in a sentence

Notwithstanding any other provision of this Agreement, Acceleron shall not be obligated to reimburse or share with Celgene any capital expenditures costs required for Celgene to Manufacture and supply Clinical Supplies for Phase 3 Clinical Trials or Post-Approval Clinical Trials.
Acceleron shall not unreasonably refuse such request; provided that, notwithstanding any other provision of this Agreement, Celgene shall fully reimburse Acceleron for agreed upon capital expenditures reasonably required for Acceleron to Manufacture and supply such Clinical Supplies for Phase 3 Clinical Trials, and otherwise the Costs of Clinical Supplies shall be allocated in accordance with Article 5, including Section 5.5.
The Initial Development Plan shall further outline such additional Phase 3 Clinical Trials as the Parties have agreed to conduct (i.e. in addition to those being conducted under the TCDP).
The Parties will discuss global Phase 3 Clinical Trials of the Licensed Product in good faith and consider [***] into such clinical trials, and, if they mutually agree to do so, MPI shall be responsible for operational control of such [***] and shall [***] exclusively attributable to the conduct of such [***].
The Initial Development Plan includes and shall be integrated with those Phase 3 Clinical Trials that are currently being conducted by FibroGen or Astellas under the U.S. and EU plan for conducting Phase 3 Clinical Trials of the Product for the CKD Indications under the Astellas EU Agreement (the “Transatlantic Clinical Development Plan” or the “TCDP”).
Except as contemplated by the Global Studies and such other Phase 3 Clinical Trials being conducted by or on behalf of Coherus in support of Regulatory Approvals or Pricing and Reimbursement Approvals in the Territory, [***].
Celgene shall Manufacture and supply all Clinical Supplies for Phase 3 Clinical Trials and Post-Approval Clinical Trials; provided, however, that the Joint Development Committee may request, at least one (1) year prior to the anticipated launch of the first Phase 3 Clinical Trial or Post-Approval Clinical Trials, as applicable, that Acceleron Manufacture and supply such Clinical Supplies on terms to be agreed.
Zosano shall be responsible for development and scale up of the manufacturing process and for the manufacturing of clinical supply of the Licensed Product for Novo Nordisk until completion of the Technology Transfer (i.e., for the preclinical studies, Phase 1 Clinical Trial(s), Phase 2 Clinical Trial(s) and, at Novo Nordisk’s option, Phase 3 Clinical Trial(s), including any necessary validation studies).
FibroGen shall manufacture and supply an appropriate amount (currently estimated at up to approximately 3 million units of Product (i.e. 3 million tablets of active drug) and approximately 1.5 million tablets of placebo) for the conduct of the Phase 3 Clinical Trials sponsored by AstraZeneca as well as the amount required to support FibroGen’s studies and regulatory submissions.
Upon Beijing SL’s reasonable request, and at Beijing SL’s cost and expense, Gemphire shall provide Beijing SL with reasonable assistance in conducting the Beijing SL Development Work, including without limitation, consultation with respect to the submission of IND and NDA to the NMPA, the design and analysis of Phase 2 Clinical Trials and Phase 3 Clinical Trials, the end of Phase 2 meeting with the NMPA, and life cycle management for the Licensed Product.

More Definitions of Phase 3 Clinical Trials

Phase 3 Clinical Trials has the meaning set forth in 21 CFR 312.21(c), as amended.

Phase 3 Clinical Trials means large scale human clinical trials conducted in patients anywhere in the world in accordance with cGCP and intended to demonstrate efficacy and a level of safety in the particular indication tested sufficient to obtain Marketing Approval of Product. Phase 3 Clinical Trials include "bridging studies" which allow submission in a target country of clinical data generated from Phase 3 studies completed in other countries to be submitted in lieu of repeating Phase 3 studies in the target country.

Phase 3 Clinical Trials has the same meaning as that term has in the United States of America Government's Food and Drug Code of Federal Regulations (edition of 1 April 1993), 21CFR CH.1S 312.21. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Phase 3 Clinical Trials means those clinical trial(s) that satisfy the provisions of 21 CFR 321.21(c) and any successor regulation, or the equivalent thereof in any jurisdiction outside the United States, and are designed to gather additional evidence of safety and efficacy of Licensed Product to support Regulatory Approval and to evaluate the overall risks and benefits of a Licensed Product.

Phase 3 Clinical Trials means the on-going studies of the Primary Product with ClinicalTrials.gov identifiers (a) NCT02534844 Study VTS301 (the “301 Clinical Trial”) and Study VTS-270-302 (the “302 Clinical Trial”) and (b) NCT03643562 (Study VTS-270-001 (the “001 Clinical Trial”)).

Phase 3 Clinical Trials shall have the meaning described in the ICH Harmonised Tripartite Guideline entitled “General Considerations for Clinical Trials,” as amended.