definiens: means any material adverse effect on ( i ) the business, condition ( financial orotherwise ) or results of operations of the Company and its Subsidiaries, taken as a whole, or ( ii ) the ability of the Company toperform its obligations under this Agreement or to effect the Merger, excluding for the purpose of clause ( i ) any such adverseeffect resulting from or arising out of : ( A ) the announcement, pendency or consummation of the Offer or the Merger(including any loss of or adverse change in the relationship of the Company and its Subsidiaries with their respectiveemployees, customers, partners or suppliers related thereto ) ; ( B ) the identity of Parent or any of its Affiliates as the acquirer ofthe Company or any facts or circumstances concerning Parent or any of its Affiliates ; ( C ) general economic, financial marketor political conditions ; ( D ) general conditions in the industry in which the Company and its Subsidiaries operate or in anyspecific jurisdiction or geographical area in the United States or elsewhere in the world ; ( E ) any changes ( after the date hereof)in GAAP or Applicable Law ( or interpretations thereof ) ; ( F ) any adoption, implementation, repeal, modification, reinterpretation or proposal of any law, regulation or policy by, the FDA or any other Governmental Authority, or any panelor advisory body empowered or appointed thereby, in each case, after the date hereof ; ( G ) the determination by, or the delayof a determination by, any Governmental Authority ( other than the FDA ), or any panel or advisory body empowered orappointed thereby, in each case, after the date of this Agreement, with respect to the approval or non - approval of any of theCompany ’s or its Subsidiaries ’ products which have not, as of the date of this hereof, been approved or cleared by suchGovernmental Authority ; ( H ) ( 1 ) any recall of any Medical Device by the FDA, other than any recall that has resulted in orwould reasonably be expected to result in the incurrence by the Company of direct costs ( as determined in accordance withGAAP consistently applied ) exceeding $ 7,500,000, in which case the full extent of the effects of such recall shall be takeninto account in determining whether or not there has been a Company Material Adverse Effect, and ( 2 ) any issuance of awarning letter by the FDA or the receipt of Form 483 observations from the FDA, other than a corporate - wide warning letterfrom the FDA ; 3(I ) the taking of any specific action, or refraining from taking any specific action, in each case at the written direction of Parentor as expressly required by this Agreement ; ( J ) any Stockholder Litigation ; ( K ) any acts of terrorism or war or any weather - related event, fire or natural disaster or any escalation thereof ; or ( L ) any failure by the Company to meet internal or analysts’estimates or projections, performance measures, operating statistics or revenue or earnings predictions for any period or adecline in the price or trading volume of the Shares ( provided, however, that, except as otherwise provided in this definition, the underlying causes of such failure or decline may be taken into account in determining whether there is a CompanyMaterial Adverse Effect has occurred ) ; provided, further, in the case of clauses ( C ), ( D ) and ( E ), such effect may be taken intoaccount in determining whether or not there has been a Company Material Adverse Effect to the extent such effect has amaterially disproportionate adverse effect on the Company and its Subsidiaries, taken as a whole, as compared to otherparticipants in the industry in which the Company and its Subsidiaries operate, in which case the entire incrementaldisproportionate impact or impacts may be taken into account in determining whether or not there has been a CompanyMaterial Adverse Effect