definiens: means, with respect to a Collaboration Product, s ubject to this Agreement ( including Sections 8.4.1, 8.4.2, and 8.6 ), the fol lowing FTE Costs incurred, and any direct out - of- pocket costs or expenses paid or accrued in accordance with the app licable Accounting Standard(s ), by or on behalf of a Party or any of its Affiliates during the Term that are spec ifically identifiable or reasonably allocable to th e Commercialization of such Collaboration Product, or the Manufacture of such Collaboration Product in support of such Commercialization : ( i)Fixed SG&A ; ( ii)Cost of Manufacture ( except for Costs of Manufa cture of Collaboration Products subject to subclauses ( i)- ( iv ), inclusive, in Section 1.167(b ) ) ; ( iii)costs or expenses for Medical Affairs Activiti es incurred or accrued after the First Commercial S ale of such Collaboration Product in the Territory ; ( iv ) Patent costs following the First Commercial Sa le of such Collaboration Product in the Territory ( to the extent not otherwise reimbursed, including thro ugh recoveries obtained in connection with any liti gation, as contemplated under Sections 10.4 and 10.9 ) ; ( v)costs or expenses incurred or accrued for Produc t Trademarks of such Collaboration Product following the First Commercial Sale of such Collabo ration Product in the Territory ; ( vi)Third Party IP Payments ; ( vii)costs or expenses associated with recall or wi thdrawal of such Collaboration Product, other than those as to which a Party has an obligation of inde mnification under ARTICLE 14 ; ( viii)Losses specifically identifiable or reasonabl y allocable to the Commercialization of such Collaboration Product, or the Manufacture of such C ollaboration Product in support of such Commerciali zation, other than those as to which a Party has an obligat ion of indemnification under ARTICLE 14 ; 3 CONFIDENTIALEXECUTION COPY ( ix)any other costs or expenses of [COMPANY], its A ffiliates, and its sublicensees specifically identi fiable or reasonably allocable to the Commercialization of such Collaboration Product as consistently applied across its portfolio