definiens: means any written app lication, submission, notice or other filing made t o an applicable Regulatory Authority in a country in the Territory : ( i ) seeking Marketing Approval for the commercial manufacture, use, storage, import, expor t, transport, distribution, marketing or sale of a Product, as well as an Investigational New Drug Application ( as defined in the Federal Food, Drug and Cosmetics Ac t, as amended from time to time, and the rules, regulatio ns and guidelines promulgated thereunder ) ; or ( 2 ) t hat is required to be filed with the FDA before beginning clinical testing of a pharmaceutical product in hum an subjects ; or ( 3 ) any successor application or proce dure ; or ( 4 ) non - U.S. equivalents to any of the for egoing ; and ( 5 ) all supplements and amendments that may be file d with respect to any of the foregoing