definiens: as that term is defined in 21 C.F.R. 314.3(b ) ( or any successor rule or ana logous Law recognized outside of the United States ), to, and a right to copy, access, and otherwise use, all information and data ( including all CMC information as well as data made, collected or othe rwise generated in the conduct of any Clinical Stud ies or upon exercise of the Additional Development Opt- In Right, Supplemental Studies, or early access / named patient programs for the Regional Lice nsed Products ) included in or used in support of an y regulatory filing, Regulatory Approval, drug master file or other regulatory documentation ( including pediatric and orphan drug applications and designat ions ) maintained on behalf of such Party ( or its Related Parties ) that relates to any Regional Licen sed Product, to the extent necessary or useful to o btain Regulatory Approval of a Regional Licensed Product in the [COMPANY] Territory or the [COMPANY] Territory, as applicable, and such Party will provide a signed statement to this effect, if requested by the othe r Party, in accordance with 21 C.F.R. 314.50(g)(3 ) ( o r any successor or analogous Law outside of the United States )