definiens: means, with respect to Eagle ’s Manufacture and/or acquisition of Supplied Items and supplythereof as referred to in Section 6.2, Eagle ’s fully - loaded internal and external costs applicable to the Supplied Items, determined in accordance with GAAP by Eagle and consistent with Eagle ’s financial reports in the ordinary course of itsbusiness, which costs shall include, without limitation : ( a ) the cost of goods produced, which shall include direct labor, material, overhead and Third Party expenses, but shall not include any intellectual property acquisition or licensing costs or royalties directly allocable tothe Manufacture, use or sale of the Supplied Items ; ( b ) costs incurred by Eagle for the packaging, transport, customs clearance, and storage of such Supplied Itemsdirectly allocable to the Manufacture of the Supplied Items ( including the costs for containers, freight, duties, insurance, and warehousing ) ; ( c ) costs incurred by Eagle associated with ( i ) stability and other product testing and activities relating toquality assurance and quality control, ( ii ) regulatory affairs activities and/or ( iii ) product liability and lossinsurance ; provided that, in each case such costs are directly applicable to the Supplied Items ; and ( d ) logistics costs ( including labor costs ) incurred by Eagle that are directly allocable to the Manufacture of theSupplied Items ( including, for example, a percentage of Eagle Manufacturing department salary and salary - related costs allocated directly to the Supplied Items )