definiens: , as that term is defined in 21 C.F.R. § 314.3(b)(or any successor rule or analogous law recognized outside of the United States ), to, and a rightto copy, access, and otherwise use, all information and data ( including all CMC information aswell as data made, collected or otherwise generated in the conduct of any Clinical Studies orupon exercise of the Supplemental Study Opt - In Right, Supplemental Studies, or earlyaccess / named patient programs for the applicable Products or Licensed Products ) included inor used in support of any regulatory filing, Regulatory Approval, drug master file or otherregulatory documentation ( including orphan drug applications and designations ) maintained onbehalf of such Party ( or its Affiliates ) that relates to any Product or Licensed Product, to theextent necessary or useful to obtain Regulatory Approval of a Product or Licensed Product inthe BPM Territory or the [COMPANY] Territory, as applicable, and such Party will provide a signedstatement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3 ) ( or any successor or analogous law outside of the United States )