definiens: of any person means another person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such first person, where means the possession, directlyor indirectly, of the power to direct or cause the direction of the management policies of a person, whether through theownership of voting securities, by contract, as trustee or executor, or otherwise ; ( b ) or means ( i ) with respect to a corporation, as determined under the lawsof the jurisdiction of organization of such entity, capital stock or such shares of capital stock ; ( ii ) with respect to apartnership, limited liability company, or similar entity, as determined under the laws of the jurisdiction of organization ofsuch entity, units, interests, or other partnership or limited liability company interests ; or ( iii ) any other equity ownership orparticipation ; ( c ) or means any change, effect, event, violation, inaccuracy, circumstance, effect, occurrence, state of facts or development ( any such item, other than such itemsdisclosed in either the Disclosure Schedule or the reports, schedules, forms, statements and other documents filed by theCompany with, or furnished by the Company to, the United States Securities and Exchange Commission ( the ) pursuantto sections 13(a ), 13(c ), 14 or 15(d ) of the Exchange Act from 42January 1, 2003 until the date of this Agreement, an ) which individually or in the aggregate when taken together withall other Effects that have occurred prior to the date of determination of the occurrence of the Company Material AdverseChange or Company Material Adverse Effect, that is or is reasonably likely to be ( i ) materially adverse to the business, assets, properties, results of operations or financial condition, taken as a whole, of the Company or ( ii ) prevent or materially impede, interfere with, hinder or delay the consummation by the Company of the Merger ; provided that none of the following Effectsshall be taken into account in determining whether there has been or will be a Company Material Adverse Effect or CompanyMaterial Adverse Change : ( A ) changes affecting the United States economy or any United States or Italian securities market ingeneral ( which changes or developments, in each case, do not disproportionately affect the Company in any material respect),(B ) changes or developments in the pharmaceutical industries in which the Company participates ( which changes ordevelopments, in each case, do not disproportionately affect the Company in any material respect ), ( C ) changes resulting frompolitical instability, acts of terrorism or war, ( D ) changes resulting from or arising out of the announcement of this Agreementor actions pursuant to ( and required by ) this Agreement, ( E ) any change in Company ’s stock price or trading volume ( it beingunderstood that the facts or occurrences giving rise to or contributing to such change in stock price or trading volume may betaken into account in determining whether there has been or will be, a Company Material Adverse Effect or CompanyMaterial Adverse Change ), ( F ) the determination by, or the delay of a determination by, the FDA or its European equivalent, or any panel or advisory body empowered or appointed thereby, with respect to the approval, non - approval or disapproval ofany of Company ’s products, ( G ) the result of any clinical trial, or ( H ) any failure, in and of itself, by the Company to meet anyinternal or published projections, forecasts or revenue or earnings predictions for any period ending on or after the date ofthis Agreement ( it being understood that the facts or occurrences giving rise to or contributing to such failure may be takeninto account in determining whether there has been or will be, a Company Material Adverse Effect or Company MaterialAdverse Change ) ; ( d ) means any change, effect, event, occurrence, state of facts or developmentwhich individually or in the aggregate would reasonably be expected to result in any change or effect that would reasonablybe expected to prevent or materially impede, interfere with, hinder or delay the consummation by Parent or Sub of thetransactions contemplated hereby ; ( e ) means an individual, corporation, partnership, limited liability company, joint venture, association, trust, unincorporated organization or other entity ; and ( f ) a of any person means another person, an amount of the voting securities, other voting rights orvoting partnership interests of which is sufficient to elect at least a majority of its board of directors or other governing body(or, if there are no such voting interests, 50 % or more of the equity interests of which ) is owned directly or indirectly by suchfirst person