definiens: means a human clinical study designed as a pivota l study to confirm with statistical significance the efficacy and safety of a Licensed Product or Buck L icensed Product with respect to a given indication, which s tudy is performed for purposes of filing an MAA for such Product for such indication as described under 21 C .F.R. § 312.21(c ) with respect to the United States, or, with respect to a jurisdiction other than the United Sta tes, a similar clinical study, in each case which s hall be deemed commenced when the third patient in such study has received his or her initial dose of such Licensed P roduct or Buck Licensed Product ; and ( vi ) ( Marketing Approval Application ) shall mean a new drug application filed with the FDA as more fully defined in 21 C.F. R. § 314.50 et . seq ., or similar application or subm ission filed with or submitted to any Regulatory Authority to ob tain permission to initiate marketing and sales of a Licensed Product or Buck Licensed Product for a particular i ndication . An MAA shall be deemed to be if it has been accepted for substantive review by the FDA or other applicable Regulatory Authority ; ( vii ) means Japan ’s Ministry of Health, Labor and Welfa re ( also known as ) or any successor agency thereto