definiens: with respect to an y acti vit y means the efforts and resources that would be used in the developmen t, regi stration, Reimbu rsement authori zation, market l aunch, manufacturing and/or performance of the relevant acti vity in compliance wi th Applicable Law b y a Person ( engaged in t he developm ent or comm ercia li zation of pharmaceutical products ) of comparabl e si ze and resources as the applica bl e Part y wit h rega rd to CONFIDENTIAL 3 NSD \189959 .3 a _ prod uct at a s imilar stage in its prod u ct life ta king into account the fo llow ing factors to the ex tent reasona bl e and relevant : issues of sa fety and effi cacy, prod u ct profile, mar ket potentia l, competiti ve market conditions, d urati on of exclus i vit y or other proprietary _ posi tion of the rod u ct and the otcnti a l _ P.rofitabi lit y and economi c return of the prod u cn, a ll as measured by t he facts and circumstan ces at t he tim e su ch efforts are due