definiens: means, with respect to a Product, any of the foll owing : ( a ) an [ * * * ] of a Product, or receipt or generation by a Party of any [ * * * ] or other data, indicating or signaling, as m easured by [ * * * ] and methodology customarily used by a majorit y of clinicians conducting studies on similar produ cts in the applicable region ( including Region ) or country ( including Country ), that such Product has or woul d have serious enough risks for medical applications in hu mans to require a [ * * * ] ; or ( b ) any notice, informa tion or correspondence received by a Party from a Regulator y Authority, or any action taken by a Regulatory Au thority, in each case, indicates that [ * * * ] or, if [ * * * ], th e [ * * * ] therefor would [ * * * ], or causes the [ * * * ] o r, if [ * * * ], to be [ * * * ]