definiens: means the following expenses, to the extent incurred and reasonable, without anyduplication, and specifically identifiable or reasonably allocable to the commercialization of a Net Profit / Loss Split Product, or the manufacture thereof for use in such commercialization : ( i ) Sales and Marketing Costs ; ( ii ) Distribution Costs ; ( iii ) Manufacturing Costs for sale or distribution ( including samples ) ; ( iv ) Regulatory Expenses that are specifically identifiable or reasonably allocable to the Exploitationand pharmacovigilance and safety expenses ; ( v ) Development Costs after First Commercial Sale, including Phase IV Costs or new tests of studiesfor Additional Indications, or formulations ; ( vi ) Medical Affairs Costs ; ( vii ) costs associated with patient assistance programs ; ( viii ) Patent Costs ; ( ix ) Trademark Costs ; ( x ) product liability insurance in the event the Parties obtain a joint policy ; ( xi ) Third Party Payments ; ( xii ) costs associated with recall or withdrawal ; 1 * * * Confidential material redacted and filed separately with the Commission