definiens: . Commercialization Costs means, with respect to Licensed Product in theField in the Profit - Share Territory, whether or not occurring during Development or Commercialization ( a ) the costs andexpenses incurred by a Party or any of its Related Parties in the Commercialization of Licensed Product, including thecosts of advertising, detailing, sales, marketing and promotion of Licensed Product and medical, customer orregulatory support and a reasonable allocation ( subject to the oversight of the JCT ) of [ * * ] for sales force managementand support, ( b ) infrastructure required to support and maintain patient / safety surveillance as required by applicableRegulatory Authorities directly attributable to Licensed Product, including the costs of maintaining the global safetydatabase contemplated under Section 5.9, ( c ) reasonable out - of - pocket [ * * ] costs and expenses incurred by a Party orany of its Related Parties with respect to [ * * ], ( d ) reasonable out - of - pocket [ * * ] incurred by a Party or any of itsRelated Parties regarding [ * * ] under Section 8.4 to the extent such enforcement action is approved by the JSC andreasonable out - of - pocket costs and expenses incurred by a Party or any of its Related Parties and included inCommercialization Costs pursuant to Section [ * * ], in each case with respect to [ * * ] in the Field in the Profit - ShareTerritory, ( e ) the reasonable out - of - pocket costs and expenses of maintaining Regulatory Approval for LicensedProduct, ( f ) except for those obligations to be paid fully by [COMPANY] under Section 7.7, [ * * ] to the extent reasonablyallocable to the Profit - Share Territory, ( g ) the costs of product recalls, withdrawals, insurance, [ * * ] and returnedproduct destruction, and ( h ) the cost of [ * * ] . In calculated Commercialization Costs, the costs of internal personnelengaged in Commercialization efforts shall be based on the FTE Cost applicable to such efforts, unless another basisis otherwise agreed by the Parties in writing . For sake of clarity, the FTE Cost of a sales representative does notinclude [ * * ] based on sales of Licensed Product in the Profit - Share Territory, which such [ * * ] shall be separatelyincluded as a Commercialization Costs budget item . For purposes of clarity, costs and expenses included in thecalculation of N.A. Pre - Tax Profit or Loss, and the deductions specified in the definition of Net Sales or inDevelopment Costs, shall not be double - counted, and shall be determined from the books and records of theapplicable Party and its Affiliates maintained in accordance with GAAP, consistently applied