definiens: means a human clinical trial of a Product in any country, and which is:(a ) a controlled study of a product in patients of the efficacy and safety of such product which isprospectively designed to demonstrate statistically whether such product is effective and safe foruse in a particular indication in a manner sufficient to obtain Regulatory Approval to market suchProduct ; ( b ) a clinical trial that the sponsoring Party or its Affiliate refers to in a press release as aPhase III Study ; or ( c ) a trial that is intended to form the primary basis for Regulatory Approval forCommercialization of a Product in one or more countries in the Territory ; provided that, if a PhaseII Study has not previously been completed with respect to such Product, then a clinical trial shallnot be deemed a until the design of such clinical trial is acknowledged in writingby a Regulatory Authority ( either prospectively or following completion of the clinical trial ) to besufficient for such clinical trial to be included as a pivotal efficacy and safety clinical trial in anapplication for marketing authorization, or equivalent, filed with the applicable RegulatoryAuthority in the applicable country or jurisdiction