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: Exclusive Research, Development Option and License Agreement (Magenta Therapeutics, Inc.), Exclusive Research, Development 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: Psma/PSMP License Agreement (Progenics Pharmaceuticals Inc)
