definiens: means, with respect to a Licensed Product, [COMPANY] 's [ direc ., actual ] costs to [ launch, market, promote, and advertise .su ~ hLicensed PrO.duct ] in[theLJ~ ], but [ excluding ] costs associated with t ~ l1esales.fQf : c ~ J9r.si~~1 ! Llc ~ nsed p.roduct ] and [ its : management ] . rvlarketing Costs for a given Licensed Product include, [ f9~ clarity, ] the [ dir'ect costs ] of [ ( a ) .. activities ] related to [ Q ~ t ~ ining relU.lb ~ r$ements ] from [ payers ] and [ costs of salescand m'arketing::~'ata, ] and [ ( bl.s(il co.s~ ] of [ a~~i",tie~ ] that [ promote · : Roche'sbusinessin general ] without [ referencing ] Lic.ensed Product, [ ( ii ) ilnyadministrative, ( ) v ~ rheacl ] or [ I~~or ' co ~ t~, assp ~ i ~ ted wlttf~,otivlties ] for which [ direct cpsts ] are [ includc:.d ] under the foregoing[sent ~ hce or.(~lortrials . ] 1.33 means a New Drug Application filed with the FDA for approval to market and sell a drug