definiens: shall mean, with respect to each Collaboration Antibody, One Hundred Percent ( 100 % ) of the consolidated fully burdened cost of Producti on Process Development of such Collaboration Antibody, which shall include ( a ) direct labor and material costs, ( b ) substrate and product quality assurance / control costs, ( c ) costs of any stability studies, ( d ) cos ts of losses or wastage in process development, to the extent not t he result of negligence or the use of non - standard operating procedures, ( e ) facility and equipment depreciation costs, ( f ) facility and equipment validation and c ontrol costs, ( g ) costs associated with evaluation of safety prof ile, activity and quality of material in in vitro and in vivo uses, ( g ) costs required for manufacturing material for in vitro and in vivo uses, ( h ) costs associated with submission and maintenance of regulatory documentation, ( i ) sh ipping costs, ( j ) costs related to subcontracted wo rk, ( k ) expenses with respect to each of the foregoing, and ( l ) applicable allocable overhead, as determin ed in accordance with GAAP as applied by [COMPANY] ; ( m ) [ * ] percent ( [ * ] % ) of the sum of the components ( a ) th rough ( l ) ; ( n ) all of the manufacturer 's allocable intell ectual property and technology acquisition and lice nse costs and expenses ( including royalties, license fees, milest one payments and other payment obligations ) paid to Third Parties with respect to Production Process Developm ent of a Collaboration Antibody