definiens: means any change, event, condition, development, circumstance, state of facts, effect or occurrence that ( i ) has a material adverse effect on the business, assets, f inancial condition or results of operations of the Company and the Com pany Subsidiary, taken as a whole or ( ii ) prevents the ability of the Company to consummate the Transactions on or before the Outside Date ; provided ; however, that f or purposes of clause ( i ), none of the following, and no change, event, condition, development, circumsta nce, state of facts, effect or occurrence that results from or arises in connection with the following, either al one or in combination, shall be deemed to constitute a Compan y Material Adverse Effect and none of the following shall be taken into account in determining whether there has been a Company Material Adverse Effect : any cha nge, event, condition, development, circumstance, state of facts, effect or occurrence to the extent result ing from or arising in connection with ( A ) general conditions ( or changes therein ) in the industries in which the Company and the Company Subsidiary operate, ( B ) general eco nomic or regulatory, legislative or political condi tions ( or changes therein ) or securities, credit, financial o r other capital markets conditions ( including chang es generally in prevailing interest rates, currency exchange rat es, credit markets or equity price levels or tradin g volumes ), in each case in the United States, the European Union or elsewhere in the world, ( C ) any change or prospe ctive change in applicable Law or GAAP ( or the authoritat i ve interpretation or enforcement thereof ), ( D ) geo political conditions, the outbreak or escalation of hostiliti es, any acts or threats of war ( whether or not decl ared ), sabotage, cyber - intrusion, terrorism or any epidemi cs, or any escalation or worsening of any such acts or threat of war ( whether or not declared ), sabotage, cyber - i ntrusion, terrorism or any epidemics, ( E ) any hurri cane, tornado, flood, fire, volcano, earthquake or other natural or man - made disaster or any other national or international calamity, crisis or disaster, ( F ) the failure, in and of itself, of the Company to meet any internal or external projections, forecasts, estimates or predi ctions in respect of revenues, earnings or other fi nancial or operating metrics before, on or after the date of t his Agreement, or changes in the market price or tr ading volume of the Company Common Stock or the credit rating of the Company ( it being understood that the underlyi ng facts giving rise or contributing to such failure o r change may be taken into account in determining w hether there has been a Company Material Adverse Effect if such facts are not otherwise excluded under this definit ion ), ( G ) the announcement, pendency or performance of any of the Transactions, including any stockholder Procee ding ( direct or derivative ) in respect of this Agreement or any of the Transactions and any loss of or chan ge in relationship, contractual or otherwise, with any cu stomer, Governmental Entity, supplier, vendor, serv ice provider, collaboration partner or any other busine ss partner ( including the exercise, or prospective exercise, by any party of any rights that arise upon a change of control ), or departure of any employee or officer, of the Company, ( H ) the compliance with the express covena nts contained in this Agreement 52 ( excluding the requirement that the Company operate in the ordinary course of business ), ( I ) any actio n taken by the Company at Parent ’s written request or with Par ent ’s prior written consent, ( J ) any conditions or events that occur in connection with the Company ’s, the Company Subsidiary ’s, their competitors ’, or potential competitors ’ preclinical or clinical studies ( inclu ding regulatory changes that may affect such studie s and/or the market for any particular product ) or the results o f such studies or announcements thereof or in conne ction therewith, ( K ) the identity of, or any facts or cir cumstances relating to, Parent, Merger Sub or their respective affiliates, ( L ) any Proceeding described in Section 3.14 of the Company Disclosure Letter, ( M ) the det ermination by, or the delay of a determination by, a non - U.S. Governmental Entity in connection with any filing, designation, approval or clearance applied for, pro secuted or sought by any licensee of the Company wi th respect to any Company Products, ( N ) FDA approval ( or other clinical or regulatory developments ), mark et entry or threatened market entry of any product com petitive with or related to any of Company Products or any of the Company ’s product candidates or ( O ) any reco mmendations, statements or other pronouncements mad e, published or proposed by professional medical organ izations or any Governmental Entity or representati ve thereof, or any panel or advisory body empowered or appointed thereby, relating to any Company Product s or any products or product candidates of any competito rs of the Company except ( x ) in the case of clause ( A ), ( B ), ( C ), ( D ) or ( E ), to the extent that the Company and the Company Subsidiary, taken as a whole, are disproportionately affected thereby as compared wit h other participants in the industries in which the Company and the Company Subsidiary operate ( in which case t he incremental disproportionate impact or impacts m ay be taken into account in determining whether there has been a Company Material Adverse Effect ) and ( y ) in the case of clauses ( J ), ( M ) and ( O ) to the extent such condition or event results from fraud by the Compa ny ( in which case such condition or event, to the extent r esulting from ( 1 ) fraud by the Company or ( 2 ) any o rder issued by the FDA to the Company causing it to suspend its ongoing clinical trial relating to the Company Pro ducts may be taken into account in determining whether th ere has been a Company Material Adverse Effect )