definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any successor rule or analo gous law recognized outside of the United States ), to, and a right to copy, access, and otherwise use, all infor mation and data included in the BMF, IB, IND and Re gulatory Approval for the [COMPANY] Antibody controlled by Agen us solely as required for filing and approval of an IND for the Licensed Product, and [COMPANY] will provide, and will cause its Affiliates and Third Party contracto rs, as applicable, to provide, a signed statement or lette r of authorization to this effect, if requested by UroGen, in accordance with 21 C.F.R. § 314.50(g)(3 ) ( or any suc cessor or analogous law outside of the United State s ) . For purposes of clarity, UroGen may use and permit refe rence to such data as UroGen reasonably determines to be required by the applicable Regulatory Authority in respect of the UroGen Improvements