definiens: means the costs incurred ( i.e., paidor accrued ) by a Party, its Affiliates or agents in the Manufacture ( including shipping or storage costs ) of a Product orPlacebo, as applicable, which shall be the sum of direct labor, direct material and Allocable Overhead incurred in theManufacture of such Product or Placebo as determined in accordance with GAAP as consistently applied by such Partyor its Affiliates . Notwithstanding the foregoing, Fully Burdened Manufacturing Costs exclude ( i ) all payments ( includingupfront fees, milestones and royalties ) to any Third Party to obtain rights ( whether by acquisition, license or otherwise ) toany intellectual property that is necessary or useful to Manufacture Clinical Supplies or Commercial Supplies in anycountry and ( ii ) any and all costs and expenses incurred in connection with the acquisition of any such rights