definiens: shall mean the direct out of pocket costs ( other than Development Costs ) that arerecorded as an expense in accordance with GAAP and incurred during the Co - Promotion Period by or on behalf of a Party orany of its Affiliates substantially in accordance with the Americas / Europe Commercialization Plan ( and the budget containedtherein ) to the extent incurred in performing tasks that are specifically identified in the Americas / Europe CommercializationPlan for Europe or reasonably allocable to the Commercialization of a Licensed Product in Europe . Commercialization Costsshall include only the following costs, in each case solely with respect to Europe : ( a ) Manufacturing Costs of Licensed Products sold in Europe plus any inventory losses incurred ( except to the extentcaused by the gross negligence or willful misconduct of a Party),- 3 - ( b ) marketing expenses specifically attributable to a Licensed Product, including costs incurred in connection with thepreparation of a commercial launch, market research, Post Approval Studies, costs associated with marketing personnel(including compensation, benefits, travel, supervision, and training ) advertising, advertising agencies, producing LicensedProduct Promotional Materials, sponsoring seminars and symposia ( including continuing medical education programs),reimbursement and other patient support services, allocated based upon the proportion of such expenses directly attributableto such Licensed Product or the activities of the Parties in connection with the conduct of the Americas / EuropeCommercialization Plan specifically with respect to Europe, ( c ) costs specifically identifiable to the sales force and, to the extent the Parties agree to use Third Party contract salesorganizations, the cost of such CSO sales representatives, and medical science liaison ( ) activities of Licensed Productsin Europe, including the managed care market, including costs associated with sales and MSL representatives, includingcompensation, benefits, travel, supervision and training, and sales meetings, consultants, call reporting and othermonitoring / tracking costs, district, regional and national sales management, but excluding hiring and termination costsassociated with either Party ’s sales personnel ( including recruiting, relocation, severance and other similar costs ) ; all suchcosts for personnel who are not 100 % dedicated to the Licensed Product shall be allocable by the relative position of theproducts detailed, ( d ) to the extent not included in the Manufacturing Costs of a Licensed Product, license fees, milestone payments andother amounts required to be paid to Third Parties in consideration for rights required to conduct activities under theAmericas / Europe Commercialization Plan solely with respect to Europe as agreed to pursuant to this Agreement, allocatedbased on the proportion of such costs directly attributable to such Licensed Product, ( e ) notwithstanding Sections 8.2 and 8.3, costs associated with prosecution, maintenance and enforcement of Patentsand Product Trademarks in Europe pursuant to Sections 8.2 and 8.3 covering any Licensed Product and defense of Third Partyintellectual property claims in Europe pursuant to Section 8.4.3 incurred after the Regulatory Approval of such LicensedProduct, ( f ) product liability insurance premiums and, except to the extent required to be indemnified by a Party underSections 13.1(a ) or ( b ) or 13.2(a ) or ( b ), product liability claims, market withdrawals, field adjustments or recalls in respect ofLicensed Products sold in Europe, ( g ) post - Regulatory Approval regulatory expenses directly related to the Licensed Product, including costs tomaintain such Regulatory Approval ( including user fees paid after Regulatory Approval ), medical and safety activities(including, if required, the design, testing and ongoing implementation of a risk management program for a Licensed Product)and adverse event reporting, ( h ) to the extent previously included in Net Sales, bad debt expense associated with accounts receivable deemed to beuncollectible, only after using reasonable efforts to pursue and collect such amounts, and- 4 - ( i ) such other costs that the Parties agree shall be required for the Commercialization of the Licensed Products inEurope