definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any successor rule or analogous Law recognized outs ide 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 mad e, collected or otherwise generated in the conduct of any Clinical Studies or early access / named patient programs for the T1 Licensed Products ) included in or used in support of any drug master file maintain ed by or on behalf of Surface ( including its Related P arties ) that relates to any T1 Licensed Product to the extent necessary or useful to Research, Develop, Ma nufacture or Commercialize T1 Licensed Products in the [COMPANY] Territory . Notwithstanding anything to the contrary in this Agreement, Surface will not withdraw or inactivate any regulatory filing that N ovartis or its Related Parties reference or otherwi se use pursuant to this Section 7.1.3