definiens: shall mean any change, condition, effect, event or occurrence that, individually orin the aggregate with other changes, conditions, effects, events or occurrences, has had, or would reasonably beexpected to have, a material adverse effect on the business, financial condition, assets or operations of the Companyand its Subsidiaries, taken as a whole, provided, however, that none of the following changes, conditions, effects, events or occurrences ( or the results thereof ), either individually or in the aggregate, shall be considered indetermining whether a Material Adverse Effect has occurred : ( i ) any change in global, national or regional politicalconditions ( including the outbreak of, or changes in, war, acts of terrorism or other hostilities ) or in general global, national or regional economic, regulatory or market conditions or in financial or capital markets, except, in each case, to the extent such changes disproportionately impact the Company and its Subsidiaries relative to other participantsin the same or similar industries ; ( ii ) any change or prospective change in applicable accounting principles or anyadoption, implementation, change or prospective change in any applicable Law ( including any Law in respect ofTaxes ) or any interpretation thereof by a Relevant Authority ; ( iii ) any change generally affecting similar industries ormarket sectors in the geographic regions in which the Company and its Subsidiaries operate, except, in each case, tothe extent such changes disproportionately impact the Company and its Subsidiaries relative to other participants inthe same or similar industries ; ( iv ) the negotiation, execution, announcement or performance of this MoU orconsummation of the transactions contemplated by this MoU ; ( v ) any change or development to the extent resultingfrom any action by the Company or its Subsidiaries that is expressly required to be taken by this MoU ; ( vi ) theannouncement of Parent as the prospective acquirer of the Company and its Subsidiaries or any announcements orcommunications by or authorized by Parent regarding Parent ’s plans or intentions with respect to the Company and itsSubsidiaries ( including the impact of any such announcements or communications on relationships with customers, suppliers, employees or regulators ) ; ( vii ) any actions taken ( or omitted to be taken ) by the Company or itsSubsidiaries upon the written request or written instruction of Parent ; ( viii ) any failure by the Company and itsSubsidiaries to meet any internal or published budgets, projections, forecasts or predictions of financial performancefor any period ; provided that the underlying facts and circumstances giving rise to such failures, unless 7otherwise excluded by this definition, may be deemed to constitute, and may be taken into account in determiningwhether there has been a Material Adverse Effect ; ( ix ) any change in the price and/or trading volume of the ADSs onNASDAQ or any other market in which such securities are quoted for purchase and sale ; provided that the underlyingfacts and circumstances giving rise to such changes, unless otherwise excluded by this definition, may be deemed toconstitute, and may be taken into account in determining whether there has been a Material Adverse Effect ; ( x ) anyactions or inactions, including any decisions, delays of decisions, recommendations, statements or otherpronouncements, by or proposed by the FDA, any other Relevant Authority or any professional medical organization, or any panel or advisory body empowered or appointed thereby, or any indications that any such Relevant Authority, organization, panel or body may take or not take any actions, with respect to any product or product candidate of theCompany, its Subsidiaries or any of their competitors or collaboration partners ; or ( xi ) any side effects, adverseevents, safety observations, non - compliance, or the results of any pre - clinical or clinical testing with respect to anyproducts or product candidates of the Company, its Subsidiaries or any of its or their competitors or collaborationpartners ( including, for the avoidance of doubt, with respect to any pre - clinical or clinical studies or results orannouncements thereof, any increased incidence or severity of any previously identified side effects, adverse effects, adverse events or safety observations or reports of new side effects, adverse events or safety observations )