Phase III Study. The term “Phase III Study” shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (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 III Study. The term “Phase III Study” shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval Regulatory Approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (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.)
