definiens: means, subject to the other provisions of this Agreement, the FTE Costs, if applicable, anddirect out - of - pocket costs recorded as an expense in accordance with Accounting Standards, in each case, that areincurred by [COMPANY] or any of its Affiliates or any of its ( Sub)licensees and are specifically identifiable or reasonablyallocable to the Commercialization of the [ * * * ] Products in the United States, or the Manufacture of the [ * * * ] Productsfor use in such Commercialization activities, including in each case in accordance with Accounting Standards, thefollowing expenses : a)Sales and Marketing Costs ; b)Distribution Costs ; c)Manufacturing Costs ( including for inventory build - up in advance of the launch of the [ * * * ] Products and forsamples of [ * * * ] Products distributed for use in the United States ) ; d)Regulatory Expenses ; e ) [ * * * ] Post - Approval Development Costs ; f)Medical Affairs Costs ; g)costs associated with patient assistance programs ; h)Patent and Trademark Costs ( to the extent not otherwise reimbursed through recoveries obtained inconnection with any litigation as contemplated under Section 10.4 and Section 10.5 ) ; i)product liability insurance with respect to the [ * * * ] Products in the United States in the event the Partiesobtain a joint policy ; j)Third Party Payments ; k)costs associated with recall or withdrawal of a [ * * * ] Product, to the extent treated as Allowable Expensespursuant to Section 6.7 ; and l)Losses specifically identifiable or reasonably allocable to the Commercialization of a [ * * * ] Product in theUnited States, or the Manufacture of a [ * * * ] Product in support of such Commercialization, to the extenttreated as Allowable Expenses pursuant to Article 14