definiens: means, with respect to a Product, any of the foll owing : ( a ) an adverse safety profile of a Product, or receipt or generation by a Party of any safety, tolerability or other data, i ndicating or signaling, as measured by safety and efficacy evalu ation criteria and methodology customarily used by a majority of clinicians conducting studies on similar product s in the applicable region ( including Region ) or co untry ( including Country ), that such Product has or would have serious risks for medical applications in hum ans to require a recall, withdrawal, or similar action ; or ( b ) any notice, information or correspondence rece ived by a Party from a Regulatory Authority, or any action taken by a Regulatory Authority, in each case, indicates th at Regulatory Approval is unlikely to be granted therefor or, if already granted, the Regulatory Approval therefor w ould likely be revoked or materially amended, or causes the Reg ulatory Approval therefor not to be granted or, if already granted, to be revoked or materially amended