Global Safety Database. Mereo shall establish, hold and maintain (at Mereo’s sole cost and expense) the global safety database for Products as required under Applicable Law. Mereo shall provide AstraZeneca with such safety information, including adverse event reports, relating to the Products as AstraZeneca reasonably requires, including to enable AstraZeneca to respond to a request from any applicable Regulatory Authority. To the extent that AstraZeneca requires Mereo to provide AstraZeneca with safety information that constitutes personal data under Applicable Laws relating to privacy pursuant to this Section 6.3, the Parties will agree on reasonable terms for such disclosure in order to ensure compliance with the requirements of Applicable Laws relating to privacy on each Party.
Appears in 5 contracts
Sources: Amendment and Restatement Agreement (Mereo BioPharma Group PLC), Exclusive License and Option Agreement, Exclusive License and Option Agreement (Mereo Biopharma Group PLC)