Phase III Study

Phase III Study. Means, as to a particular Licensed Product, a clinical trial in patients in any country conducted to evaluate further the efficacy and safety of a Licensed Product in order to assess the overall benefit-risk relationship of the Licensed Product and to provide an adequate basis for physician labeling, in conformance with the requirements of 21 C.F.R. 312.21(b) (or any successor or substitute provision) or similar foreign requirements.