definiens: means any event, change, development or occurrence that, either individually or in theaggregate with all other events, changes, developments or occurrences, would have, or would reasonably be expected to have, a material adverse effect on : ( i ) the properties, assets, liabilities, business, results of operations, financial condition of theCompany and its Subsidiaries, taken as a whole, but excluding any such event, change, development or occurrence resultingfrom or arising out of : ( A ) changes in the financial markets generally in the United States or that are the result of acts of war orterrorism ; ( B ) general national, international or regional economic, financial, political or business conditions ( includingchanges in Law or GAAP or the interpretation thereof ) affecting generally the generic pharmaceutical industry or thepharmaceutical industry, which do not have a materially disproportionate effect ( relative to other industry participants ) on theCompany and its Subsidiaries taken as a whole ; ( C ) the execution, announcement and performance of this Agreement, or anyactions taken, delayed or omitted to be taken by the Company pursuant to this Agreement or at the request of Parent orMerger Sub ; ( D ) decrease in revenues from the Company ’s generic products related to price reductions or reduced market sharein the ordinary course of business as a result of competition from current or future competitors ; ( E ) any adverse determinationin connection with any litigation under Paragraph IV of the Drug Price Competition and Patent Term Restoration Act of 1984;and ( F ) the FDA OAI Matter ; or ( ii ) the ability of the Company to consummate the Merger . For avoidance of doubt, ( i ) thecontinuation of the Company ’s FDA Official Action Indicated ( OAI ) status relating to its Davie, Florida47 manufacturing facilities shall not constitute, and shall not be considered in determining the existence of, a Material AdverseEffect, and ( ii ) no matter arising out of or resulting from the FDA OAI Matter ( other than solely a matter described in theimmediately succeeding sentence hereof ) shall constitute, or shall be considered in determining the existence of, a MaterialAdverse Effect . With regard to matters arising out of the FDA OAI Matter, only the actual occurrence prior to the Closing Dateof the following shall constitute a Material Adverse Effect : any actual seizure or recall of or reduction in manufacturing ordistribution activities for Cartia XT, Taztia XT, Altoprev or Metformin XT or any fine or criminal or civil penalty, in any ofthe foregoing cases imposed by a Governmental Entity ( or, in the case of a recall or reduction in manufacturing or distributionactivities, voluntarily undertaken by the Company ), which has had, individually or in the aggregate, a material adverse effecton the properties, assets, liabilities, business, results of operations or financial condition of the Company and its Subsidiaries, taken as a whole