Phase 1 Trial. The term “Phase 1 Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 1 study as defined in 21 CFR § 312.21(a) (or its successor regulation).
Appears in 3 contracts
Samples: License Agreement (Synthorx, Inc.), License Agreement (Synthorx, Inc.), License Agreement (Vividion Therapeutics, Inc.)
Phase 1 Trial. The term “Phase 1 Trial” shall mean a human clinical trial that would satisfy conducted on a limited number of study subjects for the requirements for purpose of gaining evidence of the safety and tolerability of, and information regarding pharmacokinetics and potential pharmacological activity for, a Phase 1 study product or compound, as defined described in 21 CFR C.F.R. § 312.21(a) (or its successor regulationincluding any such clinical study in any country other than the United States).
Appears in 2 contracts
Samples: Research Funding and Option Agreement (aTYR PHARMA INC), Research Funding and Option Agreement (aTYR PHARMA INC)
