definiens: means any change, effect, event, occurrence or fact that, individually or in the aggregate, would reasonably beexpected to result in, or has resulted in, a materially adverse change or effect to ( a ) the assets, liabilities or condition of the Purchased Assets, taken as awhole, or ( b ) any Seller ’s ability to consummate the Contemplated Transactions ; provided, however, that, for purposes of clause ( a ), none of the followingshall be deemed, either alone or in combination, to constitute, and none of the following shall be taken into account in determining whether there has beenor will be, a Material Adverse Effect : ( i ) any change, effect, event, occurrence, state of facts or development relating to the economy in general in the UnitedStates or in any other jurisdiction in which any Seller has operations or conducts business, or conditions generally affecting the industries in which theSellers operate the Business, so long as the effects do not have a materially disproportionate effect and adversely impact the Purchased Assets, taken as awhole, ( ii ) any change, effect, event, occurrence, state of facts or development reasonably attributable to conditions affecting the pharmaceutical industry(other than as may arise or result from regulatory action by a Regulatory Authority ), so long as the effects do not have a materially disproportionate effectand adversely impact the Purchased Assets, taken as a whole ( iii ) the announcement, pendency or completion of the Contemplated Transactions, includinglosses or threatened losses of employees, customers, suppliers, distributors or others having relationships with any Seller and the Business, ( iv)earthquakes, hurricanes, tornadoes, natural disasters or global, national or regional political conditions, including hostilities, military actions, politicalinstability, acts of terrorism or war or any escalation or material worsening of any such hostilities, military actions, political instability, acts of terrorism or warexisting or underway as of the date hereof ( other than any of the foregoing6[CONFIDENTIAL TREATMENT REQUESTED BY AVADEL PHARMACEUTICALS PLC]that causes any material damage or destruction to or renders unusable any material Purchased Assets and so long as the effects do not have a materiallydisproportionate effect and adversely impact the Purchased Assets, taken as a whole ), ( v ) any effect that results from any action taken at the express priorwritten request of Buyer or with Buyer ’s prior written consent, ( vi ) any failure by the Business to meet any internal or published projections, forecasts orrevenue or earnings predictions ( provided that the underlying causes of such failures may nevertheless constitute a Material Adverse Effect, subject to theother provisions of this definition ) or ( vii ) changes in Law or GAAP or any interpretation thereof ( so long as the effects do not have a materiallydisproportionate effect and adversely impact the Purchased Assets, taken as a whole and it being understood that this clause ( vii ) shall not apply withrespect to any representation or warranty contained in this Agreement the purpose of which is to address compliance with Law or GAAP or anyinterpretation thereof )