definiens: means all rights related to human interferon alpha under patents and patent applications, and any and all patents issuing there from ( including utility, model and design patents and certificates of invention ), together with any and all substitutions, extensions ( including supplemental protection certificates ), registrations, confinnations, reissues, divisional, continuations, continuations - in - part, re - examinations, renewals and foreign counterparts of the foregoing and all improvements, supplements, modifications or additions, means a well - controlled study of sufficient size and appropriate design to demonstrate the safety and efficacy of the Product for its intended use, 9 means, as applicable, a study or program designed to obtain additional safety or efficacy data, detect new uses for a drug, or to detemline effectiveness for labeled indications under conditions of widespread usage, which is commenced after Government Approval of the Product in the applicable country in the Territory or any such study or program required by the FDA or other applicable Governmental Authority