definiens: means any and all Regulatory Licenses that are ne cessary to market and/or sell a drug, biological product, cell therapy or gene therapy in a country or jurisdicti on for one or more uses, including any pricing and reimbursement approvals that are necessary to conduct a launch of such drug, biological product, cell therapy or gene ther apy in such country or jurisdiction ( even if such p ricing and reimbursement approvals are not legally required to launch such drug, biological product, cell therapy or gene therapy in such country or jurisdiction ) . For purpo ses of illustration with respect to the Major Europ ean Countries, the following pricing and reimbursement approvals are examples of those that are necessary to conduct a launch of a drug, biological product, cel l therapy or gene therapy : in France, publication o f the reimbursed price level in the official journal and registration on a reimbursement list by or on behal f of Comité Economique des Produits de Santé or Haute Autorité de Santé ( or a successor agency ) ; in Italy, publica tion of reimbursement in the Government ’s Official Gazette ( by Agenzia Italiana del Farmaco or a successor age ncy ) ; in Germany, execution of contract with the head associ ation of sick funds ( GKV - Spitzenverband, Gesetzlich en Krankenversicherung, or a successor agency ) ; in Spa in, authorization by La Comisión Interministerial d e Precios de los Medicamentos or La Comisión Nacional para el Uso Racional de los Medicamentos ( or a successor agency ) for national patient access to reimbursemen t by or on behalf of a Governmental Authority ; and in the United Kingdom, a recommendation by the National In stitute for Health and Care Excellence ( or a succes sor agency ) to obtain mandatory funding to enable broad market access . For clarity, as of the Effective Da te, no pricing or reimbursement approval as described abov e is required to launch a drug, biological product, cell therapy or gene therapy in the United States