definiens: shall mean with respect to any Drug Product or Drug Substance, thefully - burdened costs of producing ( including the costs associated with product testing and releaseactivities ) and packaging of such Drug Product or Drug Substance, including the sum of thefollowing components : ( a ) the direct costs, including direct labor and materials, of producing andpackaging such Drug Product or Drug Substance ; ( b ) all manufacturing overhead costs incurredby InununoGen attributable to the cost of goods under the foregoing clause ( a ), includingsupervisory services, occupancy costs, purchasing, human resources, payroll, information systemand accounting which are allocable to company departments based on space occupied orheadcount or another activity - based method ; ( c ) any other costs borne by [COMPANY] for thetransport, customs clearance, duty, insurance and/or storage of Drug Product or Drug Substance;and ( d ) general and administrative costs which are allocable to company departments based onspace occupied or headcount or another activity - based method . In no event shall the indirectmanufacturing cost allocated to BI Phamla exceed $ 175,000 per Batch Run . Notwithstandingthe foregoing, Direct Cost of Drug Product or Drug Substance shall not include ( i ) the cost ofpurchasing any Dedicated Equipment to the extent reimbursed by BI Pharma pursuant to Section5.5 of this Agreement, ( ii ) the cost of failed batches other than pursuant to Section 6.4 of thisAgreement, ( iii ) the cost of DM I Inventory acquired at BI Pharma 's expense pursuant to Section- G2 - 6.8 of this Agreement, or ( iv ) any indirect costs allocable to batches produced for third parties inthe Facility . If BI or BI Pharma as the case may be can reasonably demonstrate to ImmunoGenthat any equivalent materials, components or equipment used for the production of DrugSubstance and/or Drug Product of the same quality, quantity and timing can be purchased at alower price than [COMPANY] 's Direct Cost and such materials or components, or that equipmentcan be supplied on a reasonably consistent and reliable basis, then [COMPANY] shall accept suchlower price for the calculation of the Direct Cost