definiens: shall mean any change, event, development or effect that ( i ) is materially adverse tothe business or financial condition of Parent 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 Parent orits Subsidiaries in any material respect ), ( B ) changes or developments in financial or securities markets or the economy ingeneral ( which changes or developments, in each case, do not disproportionately affect Parent or its Subsidiaries in anymaterial respect ), ( C ) any change in Parent ’s stock price or trading volume, in and of itself, ( D ) any failure by Parent to meetpublished revenue or earnings projections, in and of itself, ( E ) any changes resulting from or arising out of the announcementof this Agreement or actions pursuant to ( and required by ) this Agreement, or ( F ) the determination by, or the delay of adetermination by, the FDA, or any panel or advisory body empowered or appointed thereby, with respect to the approval, non - approval or disapproval of any of Parent ’s or its Subsidiaries ’ products, or ( ii ) prevents Parent and Merger Sub from fulfillingany obligation to consummate the Offer and the Merger