definiens: means, with respect to a Shared Product, the aggregate of internal and external costs of Infinity and Infinity RelatedParties to manufacture such Shared Product for the United States ( including any drug delivery device sold, or, as applicable, reasonably intended to be sold, for a single price with such Oncology Product ), calculated as follows : ( a ) to the extent thatInfinity or Infinity Related Parties performs all or any part of the manufacturing of such Shared Product for the United States, the direct material costs and direct labor costs for, plus manufacturing overhead reasonably allocable to, such manufacturingof such Shared Product ( which may include facilities ’ start - up costs, the costs of audits, all directly incurred manufacturingvariances, the costs of failed batches of such Shared Product, manufacturing administrative and facilities costs ( includingdepreciation ) ), all calculated in accordance with GAAP ; and ( b ) to the extent that manufacturing of such Shared Product forthe United States is performed by a Third Party, the Out - of - Pocket Expenses of Infinity or Infinity Related Parties for suchmanufacturing activities ( including, to the extent included in the fees charged by such Third Party, costs for failed batches ofsuch Shared Product ) for the United States from such Third Party, and the reasonably allocated direct labor costs incurred byInfinity or any Infinity Related Parties in managing and overseeing the Third Party relationship, determined in accordancewith GAAP . COGS shall also include royalties, license or other fees paid by Infinity or Infinity Related Parties to Third Partiesto license Patent Rights or other intellectual property rights specifically for the manufacture of such Shared Product for theUnited States ( to the extent not already included in the Out - of - Pocket Expenses under clause ( b ) above ) ; provided, that anysuch amounts that are included in COGS will not be included in any other category of Shared Commercial Expenses so as notto double count such amounts . This definition shall also apply to Reverted Products, for purposes of Section 15.2(f ) of theAgreement, as if references herein to Shared Product were references to Reverted Products