definiens: shall mean, with respect to a Product Co - Promoted in North America, the variablecosts and fixed costs properly incurred by each Party with respect to work performed by the Parties and theirsubcontractors in connection with the conduct of the applicable Commercialization Plan for such Product, and inaccordance with the budget contained therein, including ( a ) the Fully Absorbed Cost of Goods for batches of suchProduct sold, ( b ) marketing, distribution and sales expenses attributable to a Product, including costs incurred inconnection with commercial launch, market research, post - approval marketing studies, advertising, producing ProductPromotional Materials, sponsoring seminars and symposia ( including continuing medical education sponsored by theMarketing Party ), sales training meetings and seminars specific to the Product, reimbursement and other patientsupport services, distribution costs, product liability insurance, transportation expenses including insurance ( but onlyto the extent not charged to customers ), inventory losses ( except to the extent caused by the gross negligence orwillful misconduct of a Party ), allocated based upon the proportion of such expenses directly attributable to suchProduct or the activities of the Parties in connection with the conduct of the Commercialization Plan, ( c ) to the extentnot included in the Fully Absorbed Cost of Goods of a Product, license fees, milestone payments and other amountsrequired to be paid to Third Parties in consideration for rights required to conduct activities under the applicableCommercialization Plan as agreed to pursuant to this Agreement, allocated based on the proportion of such costsdirectly attributable to such Product, ( d ) costs associated with Prosecution and enforcement of Licensed Patents inNorth America pursuant to Sections 17.4 and 17.6 covering any Co - Promoted Products and defense of Third Partyintellectual property claims in North America pursuant to Section 17.5 incurred after the Marketing Approval of suchProduct, and ( e ) post - Marketing Approval regulatory expenses directly related to the Product, including costs tomaintain such Marketing Approval ( including user fees paid after Marketing Approval ), medical and safety activities, adverse event reporting, market withdrawals, field adjustments or recalls . For purposes of this paragraph and to theextent agreed upon by the JSC and included in the applicable Commercialization Plan, shall bedeemed to be the cost of labor ( calculated on a full - time equivalent basis ) and other material resources directlyconsumed in the execution of the applicable Commercialization Plan and shall be deemed to be the fixedcosts directly related to the execution of the applicable Commercialization Plan, allocated based upon the proportionof such costs directly attributable to support of the applicable Commercialization Plan or by such other method of costallocation as may be approved by the JSC . A Party ’s internal costs associated with efforts of sales representativesshall be allocated to Commercialization Costs based on reasonable metrics established by the JSC prior to obtainingMarketing Approval of a Product . Except as otherwise provided in this Agreement, all cost determinations madehereunder shall be made in accordance with GAAP