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, Regul atory Approval or other regulatory documentation for the Licensed Product, but excluding UroGen proprietary information which is formulation specific as develo ped in the Licensed Products, and UroGen will provi de, and will cause its Affiliates and Third Party licensees and sublicensees to provide, a signed statement or letter of authorization to this effect, if requested by Agenu s, in accordance with 21 C.F.R. § 314.50(g)(3 ) ( or a ny successor or analogous law outside of the United St ates )