definiens: means any and all research and development informa tion, unpatented inventions, trade secrets, proprietary materials, o r any other type of proprietary or confidential tec hnical data or information, including without limitation, products, methods, techniques, processes, specifications, r ecipes, formulae, designs, plans, drawings, data, protocols, or non - clinical and clinical data ( including, wit hout limitation, Data ), which are Controlled by BIAL or its Affiliates as of the Effective Date or during t he Term and are either ( i ) reasonably necessary for the use, development mark eting, distribution, importation, commercialization, manufacture ( other than the Manu facturing Know - How ), offer for sale or sale of the Licensed Products, or ( ii ) useful for the use, development marketing, distrib ution, importation, commercialization, manufacture ( other than the Manu facturing Know - How ), offer for sale or sale of the Licensed Products, and in such case ( i ) or ( ii ) to the extent that BIAL or its Affiliates have develop ed or used such know - how in connection with the Licensed Produ cts . The term includes, without limitation, all proprietary and confidential inform ation included in INDs / NDAs and any other regulator y filings and correspondence related to any Licensed Product and all Data and information to be submitted in sup port of such filings or correspondence, and information rel ating to marketing and commercialization, to the ex tent Controlled by BIAL or its Affiliates during the Ter m and related to Licensed Products, and BIAL ’s inte rest in Development Intellectual Property jointly owned by the Parties ; provided however that in the event tha t any Third Party becomes a BIAL Affiliate by merger with or by acquisition of BIAL or any of its Affiliates, any know - how of such Third Party in existence as of the effective date of such merger or acquisition shall not be included in BIAL Know - How so long as it is not used and was not generated in connection with the development, manufacture or commercialization of an y Licensed Product . For greater certainty, the term does not include the Manufacturing Know - H ow