definiens: means the cost of Manufacturing the Product . Fully Burdened Manufacturing Costs shall be a per unit ( calculated annually ), comprised of the following elements calculated in accordance with GAAP : ( a ) direct labor ( the actual cost of employees engaged in direct manufacturing activities and quality control and quali ty assurance activities who are directly employed in manufacturing the Product ), ( b ) direct materials ( the actual costs incurred in manufacturing or purchasing materials for manufacture, including freight -in costs, sales and excise taxes imposed thereon an d customs duty and charges levied by government authorities, and all costs of packaging components ), ( c ) pro -rata facility costs ( meaning rent, property taxes, depreciation of leaseholds, utilities, spare parts, maintenance contracts ) for the manufacture o f the Product but not including construction nor capital improvement and without regard to idle space, ( d ) manufacturing equipment depreciation, ( e ) document control, purchasing, warehouse management ( with such allocations to be based on estimated service levels, headcount or square footage occupancy depending on the category ), ( f ) quality assurance / quality control, and ( g ) indirect charges and overheads reasonable allocable to the provision of the Products . To the extent that Products are sourced from one or more CMOs by Cullinan, Fully Burdened Manufacturing Costs shall be the actual invoiced price paid by Cullinan to such CMO(s ) for the manufacture and supply of a Product