definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any successor rule oranalogous Law recognized outside of the United States ), to, and a right to copy, access, and otherwise use, all information anddata ( including all CMC information as well as data made, collected or otherwise generated in the conduct of any ClinicalStudies or Post - Approval Studies or early access / named patient programs for the Licensed Products ) included in anyregulatory filing, Regulatory Approval, drug master file or other regulatory documentation ( including orphan drugapplications and designations ) owned or controlled by such Party or its Related Parties that relates to ( a ) any Licensed Productor ( b ) with respect to such information and materials provided to [COMPANY], to the extent necessary or useful to obtainRegulatory Approval of a Licensed Product in the [COMPANY] Territory, the siRNA Product Controlled by [COMPANY] and knownas ALN - TTR01, and such Party shall provide a signed statement to this effect, if requested by the other Party, in accordancewith 21 C.F.R. § 314.50(g)(3 ) ( or any successor or analogous Law outside of the United States )