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 right to c opy, access and otherwise use, all information and data ( including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or early access / nam ed p atient programs for the Licensed Products ) included in any regulatory filing, Regulatory Appro val, drug master file or other regulatory documenta tion ( including orphan drug applications and designation s ) owned or controlled by such Party or its Related Par ties that relates to any Licensed Product, and such Party shall provide a signed statement to this eff ect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3 ) ( or any successor rule or analogous Law outside of the United States )