Clinical Trial. “Phase 2 Clinical Trial” shall mean any controlled human clinical trial designed to: (a) evaluate the effectiveness of the intended use of the therapeutic agent for a particular indication or indications; (b) identify short-term side effects and risks that are associated with the therapeutic agent in the dosage range to be prescribed; and (c) satisfy the requirements of 21 CFR § 312.21(b).
Appears in 2 contracts
Sources: Asset Purchase Agreement (Eiger BioPharmaceuticals, Inc.), Asset Purchase Agreement (Celladon Corp)