definiens: means all technical, scientific and other know - how and information, trade secrets, knowledge, technology, inventions, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, and other drug discovery and development technology, pre - clinical andclinical trial results, manufacturing procedures, test procedures and purification and isolation techniques, ( whether or notconfidential, proprietary, patented or patentable ) in written, electronic or any other form now known or hereafter developed, and all improvements, whether to the foregoing or otherwise, and other discoveries, developments inventions and otherintellectual property ( whether or not confidential, proprietary, patented or patentable ), provided that Know - How shall notinclude Patents1.44 means a new drug application ( as defined in Title 21 of the United States Code of Federal Regulations, asamended from time to time ) submitted to the FDA seeking regulatory approval to market and sell the Product for humantherapeutic use in the United States ( including a new drug application submitted under Section 505(b)(2 ) of the Act )