definiens: means any change, state of facts, effect, occurrence, circumstance or development that(A ) is, or would reasonably be expected to be, individually or in the aggregate, materially adverse to the business, financialcondition, assets, liabilities or results of operations of the Company and its Subsidiaries taken as a whole or ( B ) wouldreasonably be expected to, individually or in the aggregate, prevent, materially delay or materially impede the consummationof the transactions contemplated by this Agreement, in each case other than any change, state of facts, effect, occurrence, circumstance or development to the extent resulting from ( i ) any action taken by the Company, Parent or Acquisition Subrequired by the terms and conditions of this Agreement or the Ancillary Agreements ; ( ii ) changes in Law ( including any Lawrelated to Taxes ) or the interpretation thereof ; ( iii ) changes in GAAP or the interpretation thereof ; ( iv ) changes affecting anyof the industries in which the Company or its Subsidiaries operates generally, the United States or worldwide economygenerally, financial markets, interest or exchange rates, or political conditions generally ; ( v ) any natural disaster or any actsof terrorism, sabotage, military action or war ( whether or not declared ) or any escalation or worsening thereof ; ( vi ) failure tomeet internal forecasts or financial projections ( but not the underlying causes thereof ) ; ( vii ) the announcement or pendency ofthe Merger, ( including loss of any employees, customers, suppliers, partners or distributors ) ; ( viii ) solely for purposes ofSection 6.2(a ) and Section 6.2(h ), any litigation arising from allegations of a breach of fiduciary duty or misrepresentation inany disclosure relating to this Agreement ; ( ix ) the effect of the continued incurrence by the Company of net operating lossesto the extent and of the kind incurred historically by the Company ; and ( x ) any end - of - phase 2 CMC meeting held orscheduled to be held between the Company and the FDA ; provided that, in the case of the immediately preceding clauses(ii ), ( iii ), ( iv ) and ( v ), such changes, states of facts, effects, occurrences, circumstances or developments do not affect theCompany or its Subsidiaries 8 disproportionately relative to other companies operating in the same industry ( or in the case of clause ( v ), relative to otherPersons operating in the geographic area in which the applicable event occurs )