definiens: means with respect to any Product supplied within the scope of this Agreement the unit cost of Manufactureconsisting of ( a ) Direct Material Costs, ( b ) Direct Operating Labor Costs and ( c ) Indirect Expenses ( Indirect Expensesshall be billed separately ), each as defined below, all as fairly and reasonably attributable to Product within the scopeof this Agreement : ( a ) means the cost of purchased materials used in the manufacture orpackaging of Product, including costs of Materials ; ( b ) means the personnel cost of employees directly employed in themanufacturing, Packaging, quality testing or release of Product, including basic wages, labor and relatedpayroll taxes and benefits ; and ( c ) means, collectively : ( i ) Costs of quality assurance activities ( excluding labor costs ) relating to Products ; ( ii ) Interim transportation, or any related transportation cost including tertiary packaging and storage ofProduct, as incurred or spent in connection with this Agreement ; ( iii ) Costs of Products as actually invoiced by Contract Manufacturers for applicable Products suppliedto Licensee, including the benefit of any price reductions, payment or terms discounts or otherreimbursements, such as volume discounts, that may be applicable to purchased Products ) ; ( iv ) Costs associated with changes of the Product Specifications or the Manufacturing Process ; 3 ( v ) Costs and expenses relating to registration and maintenance of Drug Master Files ; and ( vi ) Product validation costs ( including manufacturing, testing, and stability ) for the Territory, Territory - specific testing requirements, and annual stability testing for the Products in the Territory