Phase III. The term “Phase III” shall mean an expanded human clinical study in any country on a sufficient number of subjects that is designated to establish that a Product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions, if any, that are associated with Product in the dosage range to be prescribed, which trial is designed to result in regulatory approval of such Product, including all tests, studies, or a similar clinical study prescribed by the regulatory authorities, from time to time, pursuant to applicable law or otherwise including for example trials referred to in 21 C.F.R. 312.21(c).
Appears in 3 contracts
Sources: License Agreement (Neumora Therapeutics, Inc.), License Agreement (Neumora Therapeutics, Inc.), License Agreement (Neumora Therapeutics, Inc.)