definiens: means all actual cost s and expenses ( including labor ) that are attributable to Commercialization activities, inclu ding Allocable Overhead . Commercialization Expenses shall include : ( i ) costs and expenses related to Phase II I(b)/IV Studies related to Product, ( ii ) infrastruc ture required to support and maintain patient / safety surveillance as required by applicable Regulatory Authorities attr ibutable to Product, including medical staff support and pharma covigilence systems and procedures ; ( iii ) out - of - po cket patent prosecution, enforcement and/or defense cost s and expenses incurred by a Party in connection wi th claims instituted by either Party pursuant to Article 9 he reof, ( iv ) out - of - pocket costs and expenses of main taining Regulatory Approvals in the Territory, ( v ) royalty and other amounts paid by a Party to Third Parties in connection with the use of Third Party technology r elated to the use or sale of Product, and all payme nts made to XOMA Ireland Limited under the Non - Exclusive XOMA I reland License by [COMPANY] ( net of any amounts paid to [COMPANY] by XOMA in respect thereof ), ( vi ) the co sts of product recalls, product liability claims, a wards and damages, and Product liability insurance premiums, and ( vii ) costs and expenses incurred in connection with pricing and reimbursement matters, managed care and formulary management, and governmental affairs activities directly relating to a Product