Common use of Clinical Trial Clause in Contracts

Clinical Trial. The term “Phase III Clinical Trial” shall mean a controlled study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an NDA to obtain Regulatory Approval to market the product, as further defined in 21 C.F.R. § 312.21(c), as amended (or its successor regulation or comparable Laws in countries outside the United States). [**] or [**]. The term “[**]” or “[**]” shall mean the applicable compound identified in Exhibit E.