definiens: means a clinical trial in humans of a pharmaceutical or biological product conducted under anIND that is performed to gain evidence with statistical si gniﬁcance of the eﬃcacy of such product for particular indicat ion(s)in patients with the disease or condition for which the product is intended, and to obtain expanded evidence of safety forsuch product that is needed to evaluate the overall beneﬁt -risk relationship of such product, to form the basis for a pprovalof a BLA by a Regulatory Authority and to provide an ad equate basis for physician labeling, in a manner that is generallyconsistent with 21 C.F.R. § 312.21(c ), as amended ( or it s successor regulation ), or, with respect to any other countr y orregion, the equivalent of such a clinical trial in such ot her country or region . Notwithstanding anything to the contrary setforth in this Agreement, treatment of patients as part of [ * ]