definiens: means with respect to either Party, * * * % of the actual, fully - burdened cost ofall Manufacturing activities, including raw materials, direct labor and benefits, and the proportionate share ( asdetermined pursuant to the subsequent sentence ) of indirect manufacturing costs, including third party manufacturingcosts . For clarity, such fully - burdened cost shall be calculated ( i ) on a theoretical full - capacity basis ( with reasonabledeductions for changeover and maintenance downtime ) with the percentage allocable to Manufacturing Costsrepresenting the number of units or runs of Product produced or performed as a percentage of the total number ofunits or runs, including those of other products, that could be manufactured in such facility during a calendar year and(ii ) in accordance with GAAP, consistently applied . Costs that can not be identified to a specific activity supportingproduct manufacturing, such as charges for central corporate overhead that are not controllable by the manufacturingplant, shall not be included in the determination of Manufacturing Costs . For avoidance of doubt, Manufacturing Costsdo not include any margin or mark - up relating to inter - company supply between the manufacturing Party and itsAffiliates ( or among such Affiliates )