definiens: shall mean expanded controlled and uncontrolled human clinical trials pursuant to a randomized study with endpoints agreed upon by regulatory bodies for regulatory approval performed after PHASE II CLINICAL TRlAL(S ) evidence suggesting effectiveness of a LICENSED PRODUCT has been obtained, and intended to gather additional infonnati on about effectiveness and safety -4 - BN\931485.4 [COMPANY] Confidential that is needed to evaluate the overall benefit - risk relationship for a LICENSED PRODUCT and to provide an adequate basis for labeling of a LtCENSED PRODUCT, as required by 21 C.F.R § 312 or a LICENSED : tvIETHOD that is being tested in the first patient in a clinical trial of a LICENSED PRODUCT or a LICENSED METHOD according to the standards of the phannaceutical industry for a Phase III clinical trial and prior to the filing of an NDA or comparable request for marketing approval