definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any other similar provisionunder Applicable Law outside the US ) to all Regulatory Filings and Regulatory Approvalsheld by the Licensee or its Affiliates or Sublicensees that are necessary for BioMedica’sresearch, development, manufacture, use, sale, import and export of the Products butthat do not solely and specifically relate to the Product;(vi)the Licensee shall and shall procure that its Affiliates and Sublicensees shall grant toBioMedica an exclusive licence under ( 1 ) all Patents that Cover the Product as thenbeing developed or commercialised by the Licensee and ( 2 ) the Know - How that isnecessary or reasonably useful for the research, development, manufacture, use, sale, import and export of the Products, in each case that are Controlled by the Licensee, itsAffiliates, and Sublicensees as of the effective date of termination, solely to research, develop, manufacture, have manufactured, use, sell, have sold, import and export suchProducts ; and(vii)the Licensee shall and shall procure that its Affiliates and Sublicensees shall, promptlytransfer to BioMedica or its nominee a copy of all Know- How licensed under Clause15.3(c)(vi ) ( Termination ), provided that BioMedica shall reimburse the Licensee, at thethen - current Licensee FTE rate, for time spent in connection with such transfer toBioMedica