definiens: means any event, change, effect, circumstance or development thateither individually or in the aggregate ( a ) is or would reasonably be expected to have a materially adverse effect on thefinancial condition, properties, assets, liabilities, business, operations or results of operations of the Company or(b ) would prevent or materially alter or delay the Company ’s ability to consummate the Merger and the othertransactions contemplated hereby ; provided, however, that in determining whether a Company Material Adverse Effecthas occurred, there shall be excluded any effect on the Company relating to or arising in connection with ( i ) theannouncement or pendency of this Agreement, other than for purposes of Section 3.3(b ), or the identity of Parent, including the impact thereof on relationships with employees, ( ii ) changes affecting the industry in which the Companyoperates generally or the economy of the U.S. generally, ( iii ) any change in applicable Legal Requirements or GAAP, or the interpretation thereof, ( iv ) the failure of the Company to meet internal expectations or projections ; provided thatthe underlying facts and circumstances resulting in such failure may be taken into account in determining whether aCompany Material Adverse Effect has occurred unless otherwise excluded by this definition, ( v ) any breach by Parentor Merger Sub of this Agreement, ( vi ) any adverse data, event or outcome, arising out of or related to the pendingclinical trial of Zorblisa, except for any adverse data, event or outcome with respect to Zorblisa that results or wouldreasonably be expected to result in the termination of development of Zorblisa for the indication of EpidermolysisBullosa in the U.S. or the European Union, or ( vii ) earthquakes, hurricanes, tornadoes, natural disasters or global, national or regional political conditions, including hostilities, military actions, political instability, acts of terrorism orwar or any escalation or material worsening thereof ; provided that in the case of clauses ( ii ), ( iii ) and ( vii ), suchchanges do not have a unique or materially disproportionate impact on the Company relative to other businesses inthe industry in which the Company operates