definiens: means any Clinical Study, patient registry or other data collection effort for theProduct with respect to the Development Indication that is initiated in one or more countries after receipt ofRegulatory Approval for such Development Indication and not to support or obtain an application forRegulatory Approval for another indication, which Clinical Study is required by the FDA, Health Canada or theEMA as a post - approval commitment or other condition to receiving Regulatory Approval for the Product inthe Development Indication by the FDA, Health Canada or the EMA including but not limited to clinicalexperience trials, * Confidential Treatment Requested 18 post - approval studies intended to evaluate clinical outcomes or the risk / benefits of the Product, paediatricstudies ( including Paediatric Plans ) and studies that are required by a Regulatory Authority as post - approvalcommitments or other conditions to receiving Regulatory Approval for the Product in the DevelopmentIndication by the FDA, Health Canada or the EMA