definiens: means any event, condition, change, occurrence or development of a state of facts, individually or in the aggregate with all other events, conditions, changes, occurrences or developments of a state of facts, that has had amaterial adverse effect on ( i ) the business, operations, assets, properties, financial condition or results of operations of the Company and theCompany Subsidiaries, taken as a whole, or ( ii ) the ability of the Company to consummate the Transactions on or before the Outside Date;provided that no such event, condition, change, occurrence or development of a state of facts shall be considered in determining whether aCompany Material Adverse Effect has occurred for purposes of clause ( i ) above to the extent that it results from ( 1 ) changes or proposedchanges in any applicable Law or GAAP or interpretation thereof, ( 2 ) changes generally affecting the economy, or financial, credit orsecurities markets or regulatory, legislative or political conditions, in each case in the United States or elsewhere in the world, ( 3 ) generalconditions ( or changes therein ) in the industry in which the Company and the Company Subsidiaries operate, ( 4 ) any Transaction Litigation,(5 ) geopolitical conditions, the outbreak of hostilities, acts of terrorism, acts or threats of war, sabotage, cyber - intrusion, epidemics, naturalor man - made disasters, weather - related event, fire or any national or international calamity, crisis or disaster or 3any escalation or worsening thereof occurring after the date hereof, ( 6 ) any failure, in and of itself, by the Company to meet any internal orpublished industry analyst projections or forecasts or estimates of revenues, earnings or other financial or operating metrics for any periodbefore, or ending on or after the date hereof, or changes in the market price or trading volume of the Company Common Stock ( it beingunderstood and agreed that the facts and circumstances giving rise to such failure may be taken into account in determining whether therehas been a Company Material Adverse Effect ), ( 7 ) the announcement or pendency of the Transactions or the identity of Parent ( includingany loss of or adverse change in the relationship of the Company and the Company Subsidiaries with their respective employees, contractors, customers, partners, suppliers, vendors, service providers, collaboration partners, licensors, licensees or any party havingmaterial business dealings with the Company ), it being understood and agreed that this clause ( 7 ) shall not apply with respect to anyrepresentation or warranty the purpose of which is to expressly address the consequences of the execution and delivery of this Agreement, the consummation of the Transactions or the performance of obligations hereunder, ( 8) the compliance with the express covenants containedin this Agreement ( excluding the requirement that the Company comply with Section 7.1(a ) ), ( 9 ) any action not required by the terms of thisAgreement and taken by the Company at Parent ’s written request or with Parent ’s written consent, ( 10 ) the results of, or data derived from, preclinical or clinical studies of any competitors of the Company or announcements thereof, including with respect to any side effects, adverse events or safety observations, ( 11 ) FDA approval ( or other preclinical or clinical or regulatory developments ), market entry orthreatened market entry of any product competitive with any of the Company ’s products or product candidates or ( 12 ) any recommendations, statements or other pronouncements made, published or proposed by professional medical organizations or private payors, or anyrepresentative thereof, or any panel or advisory body empowered or appointed by any of the foregoing, relating to any of the products orproduct candidates of the Company or of any competitors of the Company ; provided ( A ) in each case with respect to clauses ( 1 ), ( 2 ), ( 3 ) and(5 ), only if the Company and the Company Subsidiaries, taken as a whole, are not disproportionately affected by such changes or eventsrelative to other companies in the biotechnology or pharmaceutical industry, and then only to the extent of such disproportionate impact and(B ) in each case with respect to clause ( 12 ), only to the extent such event, condition, change, occurrence or development of a state of factsdoes not result from any action taken ( or the failure to take any action ) by or at the direction of the Company or any Company Subsidiaryconstituting fraud