definiens: as that term is defined in 21C.F.R. § 314.3(b ) ( or any other similar provision under Applicable Law outside the US ) to allregulatory documents, dossiers and filings that relate to the Product or any lentiviral vector genetherapy product manufactured by BioMedica, provided that:(i)such right shall apply only to such regulatory documents, dossiers or filings to whichBioMedica is able to grant such without violating the terms of anyagreement or other arrangements with any Third Party or misappropriating the proprietaryor trade secret information of a Third Party ; and(ii)such right shall be for the sole purpose of enabling the Licensee its Affiliates, andSublicensees to file, obtain approval and maintain any Regulatory Filings with respect tothe Products or exercise any of its license rights to Products