definiens: as that term isdefined in 21 C.F.R. § 314.3(b ) ( or any successor rule or analogous Law recognized outside of the UnitedStates ), to, and a right to copy, access, and otherwise use, all information and data ( including all CMCinformation as well as data made, collected or otherwise generated in the conduct of any Clinical Studiesor of any Supplemental Studies or early access / named patient programs for the Licensed Products)included in or used in support of any Regulatory Filing, Regulatory Approval, drug master file or otherregulatory documentation ( including orphan drug applications and designations ) maintained on behalf ofsuch Party ( or its Related Parties ) that relates to any Licensed Product, to the extent necessary to obtainRegulatory Approval of a Licensed Product in the [COMPANY] Territory or the aTyr Territory, as applicable, andsuch Party will 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 )