definiens: shall mean any [ til pharmaceUt!Galllre aration In Ii a form eonla mg an LICensed Produ to sale b rescri bon over - the - counter or an other meth, i sag rod e ' eveloll ent where : : : ;, ! ~= : s : o==~~g . uires I tlils AgrElement ( i ) .Q@gnostie pIQ.!l ~ n.!<!!nlng allY L'cense f'iOducts 10 ny . elhod, I, a y. form 0 co figu tlens IncluCllng . such f ' Oduct I Deve 0 men ! ere ! Ii tlOntelrt so egu res In this A reement OF ( iill vaeclne fe · arallo 10 mal to cont 100ng an~ [ cens re uets or sale I : i~ an~ method in any dosa e arm formu]atio, esenlatio \ ne xtensio 0 = : : : : : ; ~ ~!!.I!.!.J > O ' _ ~~!JJ ing such Pro uet IA develollment wee ! lie context so J1 ulres i IS 1.41 . shall mean any approvals, licences, registrations or authorisations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, department, bureau or governmental entity, necessary for the manufacture, marketing or sale of the Product or conduct of clinical trials in a regulatory jurisdiction, excluding Price and Reimbursement Approval