definiens: means any change, event, effect or occurrence that ( i ) has amaterial adverse effect on the business, assets, financial condition or results of operations of the Company and theCompany Subsidiaries, taken as a whole, or ( ii ) prevents or materially delays the consummation of Offer, the Mergerand the other Transactions or the ability of the Company to perform its obligations under this Agreement in anymaterial respect ; provided, however, that none of the following shall be deemed either alone or in combination toconstitute, and none of the following shall be taken into account in determining whether there has been a CompanyMaterial Adverse Effect : any change, event, effect or occurrence to the extent resulting from or arising in connectionwith ( A ) general conditions in the industries in which the Company and the Company Subsidiaries operate, ( B ) generaleconomic or regulatory, legislative or political conditions or securities, credit, financial or other capital marketsconditions ( including changes generally in prevailing interest rates, currency exchange rates, credit markets and pricelevels or trading volumes ), in each case in the United States or elsewhere in the world, ( C ) any change or prospectivechange in applicable Law or GAAP ( or interpretation or enforcement thereof ), ( D ) geopolitical conditions, the outbreakor escalation of hostilities, any acts of war, sabotage, cyber - intrusion or terrorism, or any escalation or worsening ofany such acts of war, sabotage, cyber - intrusion or terrorism, ( E ) any hurricane, tornado, flood, volcano, earthquake orother natural or man - made disaster, ( F ) the failure, in and of itself, of the Company to meet any internal or externalprojections, forecasts, estimates or predictions in respect of revenues, earnings or other financial or operating metricsbefore, on or after the date of this Agreement, or changes or prospective changes in the market price or tradingvolume of the Company Common Stock or the credit rating of the Company ( it being understood that the underlyingfacts giving rise or contributing to such failure or change may be taken into account in determining whether there hasbeen a Company Material Adverse Effect if such facts are not otherwise excluded under this definition ), ( G ) theannouncement, pendency or performance of any of the Transactions, including any stockholder ( direct or derivative)Proceeding in respect of this Agreement or any of the Transactions, actions specifically required by the covenantscontained in this Agreement ( excluding the Company operating in the ordinary course of business ) and any loss of orchange in relationship, contractual or otherwise, with any customer, Governmental Entity, supplier, vendor, investor, licensor, licensee or other business partner, or departure of any employee or officer, of the Company or any of theCompany58Subsidiaries to the extent resulting from or arising in connection with such announcement, pendency or performance,(it being understood that this clause ( G ) shall not apply with respect to a representation or warranty contained in thisAgreement to the extent that the purpose of such representation or warranty is to address the consequences resultingfrom the execution and delivery of this Agreement or the consummation of the Transactions or the performance ofobligations under this Agreement ), ( H ) ( 1 ) any action taken by the Company or any of the Company Subsidiaries atParent ’s written request or with Parent ’s written consent or that is expressly required by this Agreement or ( 2 ) thefailure to take any action by the Company or any of the Company Subsidiaries if that action is prohibited by thisAgreement to the extent that Parent unreasonably withholds its consent after receipt of a written request therefor, ( I)the identity of, or any facts or circumstances relating to, Parent, Merger Sub or their respective affiliates, ( J ) anydetermination by, or delay of a determination by, the FDA or any other Governmental Entity, or any panel or advisorybody empowered or appointed thereby, or any indication that any such entity, panel or body will make anydetermination or delay in making any determination, with respect to the approvability, manufacturing, labeling, contents of package insert, prescribing information, risk management profile, chemistry, manufacturing and controls(CMC ) matters or pre - approval inspection matters relating to any Product Candidates or any products or productcandidates of any competitors of the Company, or any requirement relating to the results of any pre - clinical or clinicaltesting being conducted by or on behalf of the Company, any of its competitors or any of their respective collaborationpartners, including any requirement to conduct further clinical trials or any delayed or accelerated launch of anyProduct Candidates or any products or product candidates of any competitors of the Company, ( K ) the results of, orany data derived from, any pre - clinical or clinical testing being conducted by or on behalf of the Company, any of itscompetitors or any of their respective collaboration partners or any announcement thereof, ( L ) increased incidence orseverity of any previously identified side effects, adverse events or safety observations, or reports of new sideeffects, adverse events or safety observations, with respect to any Product Candidates or any products or productcandidates of any competitors of the Company, ( M ) any recommendations, statements or other pronouncementsmade, published or proposed by professional medical organizations or any Governmental Entity or representativethereof, or any panel or advisory body empowered or appointed thereby, relating to any Product Candidates or anyproducts or product candidates of any competitors of the Company, ( N ) any supply chain disruption affecting ProductCandidates or any products or product candidates of any competitors of the Company, ( O ) any determination ordevelopment relating to coverage, reimbursement or payor rules or policies applicable to, or pricing of, any ProductCandidates or any products or product candidates of any competitors of the Company, and ( P ) the expiry, finding ofinvalidity or unenforceability or loss of exclusivity with respect to any patent owned or licensed by the Company andcovering any product candidate of the Company, except ( 1 ) in the case of clause ( A ), ( B ), ( C ), ( D ) or ( E ), to the extentthat the Company and the Company Subsidiaries, taken as a whole, are disproportionately affected thereby ascompared with other participants in the industries in which the Company and the Company Subsidiaries operate ( inwhich case the incremental disproportionate impact or impacts may be taken into account in determining whetherthere has been a Company Material Adverse Effect ) and ( 2 ) in the59case of clause ( J ), ( K ), ( L ), ( M ), ( O ), or ( P ) to the extent that such change, event, effect or occurrence results fromfraud by the Company or the Company Subsidiaries ( in which case such change, event, effect or occurrence, to theextent resulting from fraud by the Company or the Company Subsidiaries, may be taken into account in determiningwhether there has been a Company Material Adverse Effect )