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, Pricing Approval, orReimbursement Approval for the Product ; and ( iii ) the occurrence of any event, condition or circumstance ( including anevent, condition or circumstance related to the manufacture or supply of the Product ( or any material component thereof ) forclinical studies or a regulatory action by any Regulatory Authority ) with respect to the Product ( or any material componentthereof ) that ( A ) involves the safety, toxicity, efficacy or pharmacokinetics of the Product or ( B ) prevents the use of theProduct in humans ( including, without limitation, as a 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 ILDONG of any obligation under this Agreement, ( 2 ) the failure of ILDONGto comply with any protocol, development plan or Applicable Laws with respect to the development of the Product, or ( 3 ) anygrossly negligent or willful act or omission of ILDONG ; or ( C ) that the ILDONG Diligence Failure is caused by ILDONG’sfailure to take actions that would be in excess of Commercially Reasonable Efforts ; provided, that, in any such case, ILDONGshall use Commercially Reasonable Efforts to mitigate the effect and duration of any such acceptable delay with respect to theProduct that is the subject of the Diligence Failure Notice