definiens: means, when used in connection with the Company or Parent, any cha nge, effect or circumstance that : ( i ) has or would reasonably be expected to have a material adverse effect on the business, financial condition or results of operations of such party and its Subsidiaries taken as a whole, other than such changes, effects or circumstances reasonably attributable to : ( A ) economic conditions generally in the United States or foreign economies in any locations where such party has material operations or sales ; ( B ) conditions generally affecting the industries in which such par ty participates ; ( C ) the announcement or pendency of the Merger ; ( D ) legislative or regulatory changes in the industries in which such party participates following the announcement of the transactions contemplated by this Agreement ; ( E ) any attack on or by, outbreak or escalation of hostilities or acts of terrorism involving, the United States, any declaration of war by Congress or any other national or international calamity or emergency ; ( F ) compliance with the terms of, or the taking of any action requir ed by, or the failure to take any action prohibited by, this Agreement ; ( G ) the failure of any nonclinical or clinical trial to demonstrate the desired safety and efficacy of any Biologic or Drug ; or ( H ) the denial, delay or limitation of approval of, or t aking of any other regulatory action by, the FDA or any other Governmental Entity with respect to any Biologic or Drug ; provided, that with respect to clauses ( A ), ( B ) and ( D ) the changes, effects or circumstances do not have a materially disproportionate effect ( relative to other industry participants ) on such party ; or ( ii ) prevents the Company or Parent, as applicable, from consummating the Merger and the other transactions contemplated by this Agreement