definiens: as defined in the protocol, and at least[illi}J@ eligible patients per siudy protocol in each treatment group have been enrolled in the study, and provided that [COMPANY] docs not terminate the study early ) ; ( b ) US$ SO, oog drwo Hundred and Fifty Thousand!United States Dollars ) within thirty ( 30 ) days of data analysis of the completed Phase lIb Siudy which demonstrates a statistically significant improvement over placebo sufficient to meet the primary efficacy endpoint!(p < O.Osj for at leastfme active dose]as set out in the current protocol in the Phase rIb Study ; ( c ) US~12s.0001tJne Hundred and Twenty Five ThousandlUnited States Dollars ) within thirty ( 30 ) days ofVivus ' data analysis of the completed Phase lIb Study showing a skin irritation rate being achieved in each treatment group in the Phase lib Study at the application site, regardless of severity, offlP / o or less of the total number of patients III the particular treatment group ; ( d ) USQ2S0,OOO]dTwo Hundred and Fifty ThousandlUnited States Dollars ) within thirty ( 30 ) days of a Product Patent ( as defined bclow ) issuing in the United States of America, where a means any Patent that is entitled to the effective filing date of US Patent Application Numbe~20029S34811and that includes ( i ) one or more apparatus claims that claim the spray apparatus used in the Product being devdoped ( or sold ) by [COMPANY] ( or its Affiliate or sublicensee ) at the time of is sua nee, and ( ii ) one or more composition of matter claims that claim the formulation ofthe Acrux Penetration Enhancer together with one or more hormones, which include at least the active ingredient in the Product being dcvelopcd ( or sold ) by [COMPANY] ( or its Affiliate C \])()o, i S · . .Tcrnrm, ci hlc,\Ol . KAl'\HN·4407~.1·v1 2·ACHX .. ViVLJ ' Tosto, lorono Licon « Agr, DOr ( 154HM ) 4411763 \'12/]]1 ' > ~(;:1)12 I ] ) ( ) ( • 18 or suhlicensee ) at the time of is sua nee . It is understood that no claims ofa Patent issued as of the Effective Date satisfy this milestone ; ( e ) US$ b, OOO.OOO]Vne Million]United States Dollars ) \vithin thirty ( 30 ) days of Yivus ( or its Affiliate or sub - licensee ) commencing in the United States the first Phase 1lI study in respect of the Produl : t ( such commencement being defined as the date when the first patient has been dosed in accordance " ' ith the Phase III protocol ): and ( f ) IJS.~1, 500,0001 dOne Million Five Hundred ' [ ' housandIUnited States Dollars ) within thirty ( 30 ) days of submission hy ' or under authority ofYivus or its Affiliate or sublicensee in the United States of the first new drug : application to the FDA ( as ne\v drug application is defined in 21 c.r . R. ~ J 14.50 et . Seq, as updatcd or amended from time to time ), or such other equivalent regulatOl ) ' application in the United States for approval of marketing of the Product . ( the ) in respect of the Product : and ( g ) lJS$r, OOO.OOO!drhree Million!Unired States Dollars ) within thirty ( 30 ) days of the first FDA marketing approval in the United States in respect of the Product ( the marketing approval being defined as approval by the FDA ofYivus ' or its Affiliate 's or suhl1censee 's J\'DA for the Product . permitting the Product to he marketed In the United States )