definiens: means, with respect to the Product, any of the fo llowing : ( a ) an adverse safety profile of the Product, or receipt or genera tion by a Party of any safety, tolerability or othe r data, indicating or signaling, as measured by safety and efficacy ev aluation criteria and methodology customarily used by a majority of clinicians conducting studies on simila r products in the applicable region or country, tha t the Product has or would have serious enough risks for medical applications in humans to require a recall, withdra wal, or similar action ; or ( b ) any notice, information or c orrespondence received by a Party from a Regulatory Authority, or any action taken by a Regulatory Authority, in e ach case, that would reasonably be expected to resu lt in Regulatory Approval not being granted therefor or, if already granted, the Regulatory Approval therefo r being revoked or materially and adversely amended, or cau ses the Regulatory Approval therefor not to be gran ted or, if already granted, to be revoked or materially and ad versely amended