definiens: means, when used in connection with the Company or Parent, any change, effect orcircumstance that : ( i ) has or would reasonably be expected to have a material adverse effect on the business, financialcondition or results of operations of such party and its Subsidiaries taken as a whole, other than such changes, effects orcircumstances reasonably attributable to : ( A ) economic conditions generally in the United States or foreign economies in anylocations where such party has material operations or sales ; ( B ) conditions generally affecting the industries in which suchparty participates ; ( C ) the announcement or 67pendency of the Merger ; ( D ) legislative or regulatory changes in the industries in which such party participates following theannouncement of the transactions contemplated by this Agreement ; ( E ) any attack on or by, outbreak or escalation ofhostilities or acts of terrorism involving, the United States, any declaration of war by Congress or any other national orinternational calamity or emergency ; ( F ) compliance with the terms of, or the taking of any action required by, or the failure totake any action prohibited by, this Agreement ; ( G ) the failure of any nonclinical or clinical trial to demonstrate the desiredsafety and efficacy of any Medical Device, Biologic or Drug ; or ( H ) the denial, delay or limitation of approval of, or taking ofany other regulatory action by, the FDA or any other Governmental Entity with respect to any Medical Device, Biologic orDrug ; provided, that with respect to clauses ( A ), ( B ) and ( D ) the changes, effects or circumstances do not have a materiallydisproportionate effect ( relative to other industry participants ) on such party ; or ( ii ) prevents the Company or Parent, asapplicable, from consummating the Merger and the other transactions contemplated by this Agreement