definiens: means the existence or occurrence of one ormore of the following events or justifications : ( i ) the occurrence of an event of Force Majeure ; ( ii ) the adoption by aRegulatory Authority of any one or more regulations that become effective after the Effective Date and that materially affectthe Development or clinical testing of the Product or the process for obtaining any Regulatory Approval for the Product ; and(iii ) the occurrence of any event, condition or circumstance ( including an event, condition or circumstance related to themanufacture or supply of the Product ( or any material component thereof ) for clinical studies or a regulatory action by anyRegulatory Authority ) with respect to the Product ( or any material component thereof ) that ( A ) involves the safety, toxicity, efficacy or pharmacokinetics of the Product or ( B ) prevents the use of the Product in humans ( including, without limitation, asa result of patent or other blocking rights ) and, in the case of clauses ( A ) or ( B ) above, is not attributable to ( 1 ) a breach by TGof any obligation under this Agreement, ( 2 ) the failure of TG to comply with any protocol, development plan or ApplicableLaws with respect to the development of the Product, or ( 3 ) any grossly negligent or willful act or omission of TG ; or ( C ) thatthe TG Diligence Failure is caused by TG ’s failure to take actions that would be in excess of Commercially ReasonableEfforts ; provided, that, in any such case, TG shall use Commercially Reasonable Efforts to mitigate the effect and duration ofany such acceptable delay with respect to the Product that is the subject of the Diligence Failure Notice