definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any successor rule or analogo us Law recognized outside of the United States ), to, and a right to copy, access, and otherwise use, all information and data ( including all CMC informatio n as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exe rcise of the Additional Development Opt - In Right, Supplem ental Studies or Regional [ * * * ] Activities, or earl y 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 orphan drug applications and designations ) maintain ed on behalf of such Party ( or its Related Parties ) that relates to any Regional Licensed Product, to the ex tent necessary or useful to obtain Regulatory Appro val of a Regional Licensed Product in the [COMPANY] Terr itory or the Surface Territory, as applicable, and such Party will provide a signed statement to this Confidential - 82 - CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH . A COMPLETE VERSION OF THIS EXHIBIT HAS BEE N FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSU ANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AM ENDED