definiens: shall mean an investigational new drug application filed with the United States Food and Drug Administration prior to beginning clinical trials in humans in the United States or any comparable application filed with regulatory authorities in or for a country or group of countries other than the United States 2.10 are IPdR composition, as covered by United States Patent 4,895,937 entitled, and use for the treatment of cancers as covered by a United States Patent 5,728,684 and related pending or issued foreign applications, together with any continuations, continuations - in - part, and any divisional, or substitute patents, any reissues or re - examinations of any such applications or patents, and any extension of the term of any such patent 2.11 are defined in Article 1.1 2.12 shall have the meaning ascribed to such term in the United States Federal Bankruptcy Law, as amended from time to time, or has commenced bankruptcy, reorganization or insolvency proceedings, or any other proceeding under any federal, state or other law for the relief of debtors