definiens: shall mean, with respect to a given Program Compo und or Product : ( a ) an effect that is considered to be generally related to either the me chanism of action or the basic chemical structure o f such Program Compound or Product which has led or i s reasonably expected to lead to ( i ) the issuance by the FDA or the EMA of a non - approvable letter or non - approval letter to a Third Party for such Third Party ’s compound with the same mechanism of a ction or the basic chemical structure of such Program Compound or Product or ( ii ) the required wi thdrawal from the market of any compound with the same mechanism of action or the basic chemical structure of such Program Compound or Product ; ( b ) a Regulatory Authority or safety data review bo ard for a Clinical Study or Studies of such Program Compound or Product has required termination or sus pension of a Clinical Study or Studies of such Program Compound or Product ; or ( c ) [COMPANY] or its Affiliate reasonably believes in good faith, after due inquiry and in a manner consistent with [COMPANY] ’s the n - current decision - making policies and procedures with respect to such a determination, that terminat ion of the further Development of such Program Compound or Product is warranted because there is a n unacceptable risk for harm in humans either based upon the observation of serious adverse effec ts in humans after such Program Compound or Product has been administered to or taken by humans or based upon pre - clinical in vitro or animal data that is predictive of serious adverse effects in hu ma ns