definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any successor rule or a nalogous Law recognized outside of the United States ), to, and a right to copy, access and otherwis e use, all information and data ( including all chemistry, manufacturing and control s information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or early access / named patient programs for the Licensed Products ) included in any regulatory filing, Regulatory Approval, drug master file or other regulatory docu mentation ( including orphan drug applications and designations ) owned or controlled by Eurofarma or its Related Parties that relates to any Licensed Product, in each case in connection with Summit ’s or its Rel ated Parties ’ ( a ) Development and Manufacture of License d Products throughout the Summit Territory and the Eurofarma Territory and ( b ) Comme rcialization of Licensed Products throughout the Summit Territory, and Eurofarma shall provide a signed statement to this effect, if requested by Summit, in accordance with 21 C.F.R. § 314.50(g)(3 ) ( or any successor rule or analogous Law outside of the United States ) . Summit may extend the rights granted by Eurofarma to Summit under this Section 3.5.1 to its Related Parties