Phase 1 Clinical Trials definition

Phase 1 Clinical Trials means a human clinical trial of a Licensed Product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients or similar clinical study prescribed by the FDA or a comparable foreign regulatory authority, including the trials referred to in 21 C.F.R. §312.21(a), as amended.

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Phase 1 Clinical Trials. “Phase 2 Clinical Trials” and “Phase 3 Clinical Trials” have the same meanings as those terms have in Part 21 of the United States Code of Federal Regulations §312.21, or foreign equivalents thereof. For the avoidance of doubt, `initiation’ of ▇▇▇▇▇ ▇, ▇▇▇▇▇ 2 or Phase 3 trials (or the ‘entry’ of a Licensed Product into such trials) occurs at the time of dosing of the first human subject in the first ▇▇▇▇▇ ▇, ▇▇▇▇▇ 2 or Phase 3 trial (as applicable), in any given Therapeutic Area.

Phase 1 Clinical Trials means human clinical trials conducted anywhere in the world in accordance with cGCP in a small number of healthy volunteers or patients intended to establish an initial safety profile and the pharmacokinetics and/or pharmacodynamics of a Product.

Examples of Phase 1 Clinical Trials in a sentence

Notwithstanding any other provision of this Agreement, Celgene shall not be obligated to reimburse or share with Acceleron any capital expenditures costs required for Acceleron to Manufacture and supply such Clinical Supplies for Phase 1 Clinical Trials or Phase 2 Clinical Trials.
Subject to Section 2.4.2, Acceleron shall Manufacture all Clinical Supplies for Phase 1 Clinical Trials and Phase 2 Clinical Trials.
For purposes of clarification, upon transition of Manufacturing and supply obligations to Celgene pursuant to this Section 2.4.2 for a particular Licensed Compound or related Licensed Product, if any Clinical Supplies are needed for additional Phase 1 Clinical Trials or Phase 2 Clinical Trials for the same Licensed Compound or Licensed Product, such Manufacturing and supply responsibilities will be undertaken by Celgene in the same manner as set forth in this Section 2.4.2.
Notwithstanding the foregoing, Genocea, in its sole discretion, may determine the timing and content of any press release with respect to activities conducted hereunder beginning with the Phase 1 Clinical Trials with respect to each Licensed Product and all activities thereafter; provided that Genocea may not use Isconova’s name in any such press release without the prior written consent of Isconova, except for the limited purpose of identifying Isconova as the licensor of the Licensed Technology.
Acceleron shall Manufacture all Clinical Supplies for Phase 1 Clinical Trials, Phase 2A Clinical Trials and Phase 2B Clinical Trials.
Notwithstanding any other provision of this Agreement, Celgene shall not be obligated to reimburse or share with Acceleron any capital expenditures costs required for Acceleron to Manufacture and supply such Clinical Supplies for Phase 1 Clinical Trials, Phase 2A Clinical Trials and Phase 2B Clinical Trials.
Zosano shall comply with U.S. cGMP for clinical supplies and all other governmental laws and regulations applicable in the U.S. in manufacturing and supplying Licensed Product for Phase 1 Clinical Trial(s) and Phase 2 Clinical Trial(s), as may be further set forth in the Quality Agreement.
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).
Subject to Section 2.5, Prothena shall be responsible for the clinical strategy and conduct of such Phase 1 Clinical Trials.
Regulus shall have the right, but not the obligation, to reasonably rely on such Preliminary PoC Plan in undertaking any Phase 1 Clinical Trials of such Development Candidate under any Early Development Program for such Development Candidate.

More Definitions of Phase 1 Clinical Trials

Phase 1 Clinical Trials has the same meaning as the term has in the United States Code of Federal Regulations or its foreign equivalent in a Major Country.

Phase 1 Clinical Trials shall have the meaning described in the ICH Harmonised Tripartite Guideline entitled “General Considerations for Clinical Trials,” as amended.