Phase II Study. The term “Phase II Study” shall mean 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.
Appears in 2 contracts
Samples: Collaboration and License Agreement (C4 Therapeutics, Inc.), Collaboration and License Agreement (C4 Therapeutics, Inc.)
Phase II Study. The term “Phase II Study” shall mean a human clinical trial, 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 equivalents thereof.
Appears in 2 contracts
Samples: Option and License Agreement (Magenta Therapeutics, Inc.), Option and License Agreement (Magenta Therapeutics, Inc.)
Phase II Study. The term “Phase II Study” shall mean (a) a human dose exploration, dose response, duration of effect, kinetics, dynamic relationship or preliminary efficacy and safety study of a Licensed Product in the target patient population, or (b) a controlled dose ranging clinical trial, for which trial to evaluate further the primary endpoints include efficacy and safety of a determination of dose ranges and/or a preliminary determination of efficacy Licensed Product in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time the target patient population and to time, and define the foreign equivalent thereofoptimal dosing regimen.
Appears in 1 contract
Samples: PSMP License Agreement (Progenics Pharmaceuticals Inc)
