definiens: as that term is defined in21 C.F.R. § 314.3(b ) ( or any Applicable Law recognized outside 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 made, collected orotherwise generated in the conduct of any Clinical Trials or early access / named patient programs for the LicensedProducts ) included in or used in support of any Regulatory Approval, drug master file or other RegulatoryDocumentation ( including Assigned Regulatory Documentation, Assigned Regulatory Approvals and orphan drugapplications and designations ) maintained on behalf of, or Controlled by, [COMPANY] ( or its Sublicensees ) that relates to anyLicensed Product, in each case to the extent necessary to perform ACI ’s Development obligations under thisAgreement, including in connection with any conduct of any Unilateral Activities ( it being understood that ( i ) [COMPANY] willprovide a signed statement to this effect, if requested in writing by ACI, in accordance with 21 C.F.R. § 314.50(g)(3)(or any Applicable Law outside of the United States ) and ( ii ) upon the reasonable written request of ACI, [COMPANY] will, andwill cause its Sublicensees to, obtain and provide to ACI certificates or other formal or official attestations concerningthe regulatory status of the Licensed Products ( e.g