Phase II Study

Phase II Study. Means, as to a particular Licensed Product, a clinical trial in patients in any country having a treatment phase with a duration of at least thirty (30) days conducted to evaluate further the efficacy and safety of a Licensed Product for an indication or indications of use in the patient population with the disease or condition under study, in conformance with the requirements of 21 C.F.R. 312.21(b) (or any successor or substitute provision) or similar foreign requirements.