Safety Data Exchange. In accordance with the provisions of the Safety Data Exchange Agreement dated September 19, 2014 between the Parties, as amended (the “Safety Data Exchange Agreement”), no later than March 1, 2016, Merck Serono shall transfer and deliver to BioMarin or its designated Affiliate the Products’ global safety database maintained by or on the behalf of Merck Serono or any of its Affiliates, in electronic format, as well as any compilations of such data in non-electronic formats[*], together with information relating to the collection and reporting of all Adverse Events to any Governmental Body as required by such Governmental Body regarding the Products prior to the Transfer Time. From and after the Transfer Time, BioMarin shall assume responsibility for all pharmacovigilance activities relating to the Products as set forth in Section 6.06(h).
Appears in 2 contracts
Samples: Termination and Transition Agreement (Biomarin Pharmaceutical Inc), Termination and Transition Agreement (Biomarin Pharmaceutical Inc)
Safety Data Exchange. In accordance with the provisions of the Safety Data Exchange Agreement dated September 19, 2014 between the Parties, as amended Parties (the “Safety Data Exchange Agreement”), no later than March 1, 2016, Merck Serono shall transfer and deliver to BioMarin or its designated Affiliate the Products’ global safety database maintained by or on the behalf of Merck Serono or any of its Affiliates, in electronic format, as well as any compilations of such data in non-electronic formats[*], together with information relating to the collection and reporting of all Adverse Events to any Governmental Body as required by such Governmental Body regarding the Products prior to the Transfer Time. From and after the Transfer Time, BioMarin shall assume responsibility for all pharmacovigilance activities relating to the Products as set forth in Section 6.06(h).
Appears in 2 contracts
Samples: Termination and Transition Agreement (Biomarin Pharmaceutical Inc), Termination and Transition Agreement (Biomarin Pharmaceutical Inc)