definiens: means the approval of the applicable Regulatory Authority necessary for themarketing and sale of a pharmaceutical or drug product for an indication in the Field in a country, including any and allapprovals that are required by Applicable Law in such country for pricing and reimbursement . For purposes ofillustration, in addition to approval of a Drug Application : Regulatory Approval in France includes approval of a DrugApplication and publication of the reimbursed price level in the official journal and registration on a reimbursement listby or on behalf of Comité Economique des Produits de Santé or Haute Autorité de Santé ( or a successor agency);Regulatory Approval in Italy includes publication of reimbursement in the Government ’s Offical Gazette ( by AgenziaItaliana del Farmaco or a successor agency ) ; Regulatory Approval in Germany includes execution of contract with thehead association of sick funds ( GKV - Spitzenverband, Gesetzlichen Krankenversicherung, or a successor agency);Regulatory Approval in Spain includes authorization by La Comisión Interministerial de Precios de los Medicamentosor La Comisión Nacional para el Uso Racional de los Medicamentos, or a successor agency ) for national patientaccess to reimbursement by or on behalf of a Governmental Authority ; and Regulatory Approval in the UnitedKingdom includes approval by the National Institute for Health and Care Excellence ( or a successor agency ) to obtainmandatory funding to enable broad market access