definiens: shall mean any change, event, development or effect ( i ) that is materially adverseto the business or financial condition of the Company and its Subsidiaries, taken as a whole, except for any such change, event, development or effect resulting from or arising out of ( A ) changes or developments in the medical device and specialtypharmaceutical industries generally ( which changes or developments, in each case, do not disproportionately affect theCompany or its Subsidiaries in any material respect ), ( B ) changes or developments in financial or securities markets or theeconomy in general ( which changes or developments, in each case, do not disproportionately affect the Company or itsSubsidiaries in any material respect ), ( C ) any change in the Company ’s stock price or trading volume, in and of itself, ( D ) anyfailure by the Company to meet published revenue or earnings projections, in and of itself, ( E ) any changes resulting from orarising out of the announcement of ( 1 ) the termination of the Medicis Agreement, ( 2 ) the Offer, or ( 3 ) this Agreement or anyactions pursuant to ( and required by ) this Agreement, or ( F ) the determination by, or the delay of a determination by, the FDA, or any panel or advisory body empowered or appointed thereby, with respect to the approval, non - approval or disapproval ofany of the Company ’s or its Subsidiaries ’ products, or ( ii ) that prevents the Company from fulfilling its obligation to facilitatethe Offer or consummate the Merger