definiens: means any Effect that, considered together with all other Effects, has a materialadverse effect on : ( a ) the business, financial condition, operations or results of operations of the [COMPANY] Companiestaken as a whole ; provided, however, that, in no event will any of the following, alone or in combination, be deemed toconstitute, nor will any of the following be taken into account in determining whether there has occurred, an AlbireoMaterial Adverse Effect : Effects resulting from ( i ) conditions generally affecting the industries in which Albireoparticipates or the United States or global economy or capital markets as a whole, to the extent that such conditionsdo not have a disproportionate impact on the [COMPANY] Companies, taken as a whole, relative to other companies in theindustry in which the [COMPANY] Companies operate ; ( ii ) any failure by an [COMPANY] Company to meet any estimates orexpectations of its development programs, internal projections or forecasts or third party revenue or earningspredictions for any period ending ( or for which revenues or earnings are released ) on or after the Original AgreementDate ( it being understood, however, that any Effect causing or contributing to such failures to meet projections orpredictions may constitute an [COMPANY] Material Adverse Effect and may be taken into account in determining whetheran [COMPANY] Material Adverse Effect has occurred ) ; ( iii ) the execution, delivery, announcement or performance of theobligations under this Agreement or the announcement, pendency or anticipated consummation of the Acquisition;(iv ) any natural disaster or any acts of terrorism, sabotage, military action or war or any escalation or worseningthereof ; ( v ) any changes ( after the Original Agreement Date ) in GAAP or applicable Legal Requirements to the extentthat such conditions do not have a disproportionate impact on the [COMPANY] Companies, taken as a whole, relative toother companies in the industry in which the [COMPANY] Companies operate ; ( vi ) any changes in or affecting research anddevelopment, clinical A-66trials or other drug development activities ( including the failure to obtain positive results from clinical trials, development activities or favorable responses from any applicable Governmental Body ) conducted by or on behalf ofan [COMPANY] Company or licensees in respect of [COMPANY] ’s products or product candidates ; or ( vii ) regulatory approval of, or regulatory action or announcement with respect to, any product, or product candidates, of a third party that aresimilar to, or expected to compete against, any of [COMPANY] ’s product candidates ; or ( b ) the ability of [COMPANY] or Sellersto consummate the Acquisition or to perform any of their respective covenants or obligations under this Agreement