definiens: or means any foreign or domestic ( federal, state or local ) law, principle of common law, statute, ordinance, regulation, rule, code, permit, license, injunction, judgment, decree or order ; ( l ) or means any change, effect, event, occurrence, state of facts ordevelopment that individually or in the aggregate is or would reasonably be expected ( x ) to prevent, materially delay ormaterially impede the ability of the Company to consummate the Offer, the Merger or the other Transactions or ( y ) to bematerially adverse to ( 1 ) the business, condition ( financial or otherwise ) or results of operations of Company and theCompany Subsidiaries, taken as a whole or ( 2 ) the ability of the Company to perform its obligations under this Agreement orto consummate the Transactions by the End Date ; provided that in the case of ( y)(1 ) above that none of the following shall betaken into account in determining whether there has been or will be a Material Adverse Change or Material Adverse Effect:(i ) any change, effect, event, occurrence, state of facts or development ( A ) in the financial or securities markets or the economyor political conditions in general or ( B ) in the industries in which the Company or any of the Company Subsidiaries operatesin general, to the extent ( in the case of ( A ) or ( B ) ) that such change, effect, event, occurrence, state of facts or developmentdoes not disproportionately impact the Company or any of the Company Subsidiaries in a material fashion, ( ii ) changes in thetrading price of shares of Company Common Stock between the date hereof and the Effective Time ( it being understood thatany fact or development giving rise to or contributing to such change in the trading price of shares of Company CommonStock may be taken into account in determining whether it has been or will be a Material Adverse Change or Material AdverseEffect ), ( iii)50 changes or developments resulting from or caused by natural disasters, outbreaks of major hostilities in which the UnitedStates is involved or any act of war or terrorism within the United States or directed against its facilities, citizens or interestswherever located, ( iv ) failure by the Company to meet internal or third - party projections, forecasts, budgets or any publishedrevenue or earnings projections for any period ( it being understood that any fact or development giving rise to or contributingto such failure may be taken into account in determining whether it has been or will be a Material Adverse Change or MaterialAdverse Effect ), ( v ) a determination by, or the delay of any determination by, the FDA, or any panel or advisory bodyempowered or appointed by the FDA, with respect to any current or future products of the Company or any CompanySubsidiary or any filing or submission by the Company or any Company Subsidiary, ( vi ) the result of any clinical trial,(vii ) actions required or contemplated to be taken by the Company under this Agreement or taken at the express request ordirection of Parent or Merger Sub or any effect to the extent resulting from entering into this Agreement or the announcementof the Transactions, or ( viii ) changes in Law or GAAP or interpretations or enforcement thereof