definiens: ( all the ease may be ) sh.all mean the notification in .... Titing to Yanda, its Affiliate or .sublicensee from the FDA or Wl ~uivalen\ EUrOpClI.ll Union ~gu!atory authority ( via the Centralized Procedure or the mutual recognition proeedur~ ) that the NDA or Inhial Filing in Europe ( as1he case may be ) is sufficien lly complete to permit a substantive ~view . Such milestone payment shall be paid in cash by VilIlda di«<'t1y to No\'ani ~ witllin seven ( 7 ) blJ1;jness days of the date of such first filmg . The Five Million Doll : v p~)'TIlcn t provided fOI herein wall, unless otherwise cxpu, ssly provided fOI herein, be non·refundable