definiens: means ( i ) research and development information, unpatented inventions, trade secrets, proprietary materials, or any other type of proprietary or confidential technical data or information, including, without limitation, methods, techniques, processes, specifications, recipes, formulae, designs, plans, drawings, data, protocols, or preclinical and clinical studies, which are Controlled by BIAL as of the Effective Date and ( a ) reasonably necessary for the development, commercialization, importation, use, sale, or offer for sale of the Licensed Products, or ( b ) useful for the development, commercialization, importation, use, sale, or offer for sale of the Licensed Products to the extent that BIAL has developed or uses such know - how in connection with the Licensed Products ; and ( ii ) subject to the provisions in Section 6.7, the BIA 2 - 093 IND and any other regulatory filings and correspondence and all data : and information submitted in support of such filings or correspondence, which are Controlled by BIAL as of the Effective Date and relate solely to BIA 2 - 093 and/or the Licensed Products . The term BIAL Know - How includes any items encompassed by ( i ) and ( ii ) in the preceding sentence created after the Effective Date and during the Term of this Agreement and Controlled by BIAL