definiens: means a pivotal human clinical trial of a Product ( whether or not denominated a clinical trial underapplicable regulations ) with a deﬁned dose or a set of deﬁned doses of such Product designed to ascertain eﬃcacy and safety of such Product for thepurpose of enabling, without the performance of additional human clinical trials, the preparation and submission of an MAA to the applicable RegulatoryAuthorities in a country of the Licensed Territory, as further deﬁned in 21 C.F.R. § 312.21(c ) for the U.S., as amended from time to time, or thecorresponding foreign regulations . In the ﬁeld of oncology, Pivotal ( Phase III ) Clinical Trials test if a new Product is better than standard treatment andmay include hundreds to thousands of patients around the country or world . The control group receives the standard treatment and the study groupreceives the new Product being investigated