definiens: means all technical, scientific and other know - how and information, trade secrets, knowledge, technology, inventions, means, methods, processes, practices, formulas, instructions, skill s, techniques, procedures, experiences, ideas, technic al assistance, designs, drawings, assembly procedur es, computer programs, apparatuses, specifications, dat a, results and other material, and other drug disco very and development technology, pre - clinical and clinical t rial results, manufacturing procedures, test proced ures and purification and isolation techniques, ( whether or not confidential, proprietary, patented or patentab le ) in written, electronic or any other form now known or hereafter developed, and all improvements, whether to the fo regoing or otherwise, and other discoveries, developments i nventions and other intellectual property ( whether or not confidential, proprietary, patented or patentable ), provided that Know - How shall not include Patents 1.31 means a new drug application ( as defi ned in Title 21 of the United States Code of Federa l Regulations, as amended from time to time ) submitte d to the FDA seeking regulatory approval to market and sell the Product for human therapeutic use in the United States ( including a new drug application submitted under Section 505(b)(2 ) of the Act )