Definition of Post-Marketing Surveillance

  1. Post-Marketing Surveillance means post-marketing surveillance required by a Regulatory Authority in Japan to ensure the efficacy and safety of Products after Marketing Approval of such Products and to establish proper methods of use of Product, consisting of three systems: the adverse drug reactions and infections collection and reporting system, the reexamination system, and the reevaluation system in Japan. 12 Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets and three asterisks [***], have been separately filed with the Commission.

Definition of Post-Marketing Surveillance in Collaboration Agreement

Post-Marketing Surveillance means post-marketing surveillance required by a Regulatory Authority in Japan to ensure the efficacy and safety of Products after Marketing Approval of such Products and to establish proper methods of use of Product, consisting of three systems: the adverse drug reactions and infections collection and reporting system, the reexamination system, and the reevaluation system in Japan. 12 Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets and three asterisks [***], have been separately filed with the Commission.