definiens: means any change, event, development, occurrence or effect that ( a ) h as a materially adverse effect on the business, financ ial condition or results of operations of Spinco an d the Spinco Subsidiaries, taken as a whole, or ( b ) has a materi al adverse effect on the ability of Pluto to consum mate the Contribution, the Distribution and the Combination or on any Spinco Party to consummate the Combinatio n, in each case prior to the Outside Date ; provided, howe ver, that, with respect to clause ( a ) only, none of the following 13 shall be deemed in themselves, either alone or in c ombination, to constitute, and none of the followin g shall be taken into account in determining whether there is a Spinco Material Adverse Effect : any change, event, development, occurrence or effect to the extent res ulting from or arising in connection with ( i ) any c hanges resulting from general market, economic, financial, capital markets or political or regulatory conditi ons, ( ii ) any changes or proposed changes to applicable Law or GA AP ( or, in each case, authoritative interpretations thereof ), ( iii ) any changes resulting from weather, natural d isaster or any man - made disaster, any act of terror ism, war, national or international hostilities, or any worse ning thereof, ( iv ) any changes generally affecting the industries in which Spinco and the Spinco Subsidiaries conduct their businesses, ( v ) any changes resulting from t he execution of this Agreement or the other Transactio n Documents, the identity of Utah as a counterparty hereto, or the announcement of this Agreement or the other Transaction Documents, or the transactions contempl ated hereby and thereby, including any loss of employees or customers, any cancellation of or delay in cust omer orders or any disruption in or termination of ( or l oss of or other negative effect or change with resp ect to ) customer, supplier, distributor or similar business relationships or partnerships resulting from the t ransactions contemplated by this Agreement or the other Transac tion Documents ( provided that this clause ( v ) does not apply in the context of any representation or warra nty of Pluto to the extent that the purpose of such representation and warranty is to address the conse quences resulting from the execution and delivery o f this Agreement or the other Transaction Documents, the c onsummation of the Combination or the other transac tions contemplated hereby or the performance of obligatio ns under this Agreement ), ( vi ) changes in Pluto ’s s tock price or the trading volume of Pluto ’s stock or any change in the credit rating of Pluto or Spinco ( bu t not, in each case, the underlying cause of any such changes, unl ess such underlying cause would otherwise be except ed by another clause of this definition ), ( vii ) any chang es or effects resulting from any action required to be taken by the terms of the Transaction Documents ( other than Section 8.2 ), ( viii ) the failure of Pluto or Spinco to meet internal or analysts ’ expectations or projections o f results of operations ( but not, in each case, the underlying cause of any such changes, unless such underlying c ause would otherwise be excepted by another clause of this definition ) or ( ix ) national, provincial or local g overnmental or regulatory drug policy initiatives i mpacting the approval, pricing, procurement or reimbursement of Products in China, including ( A ) the Quality Consis tency Evaluation System, ( B ) the centralized medicines pr ocurement programs implemented by the Joint Procure ment Office and other volume - based government tender pro cesses, or ( C ) the National Reimbursement Drug List or the National Essential Medicines List, except, in t he case of clauses ( i ), ( ii ), ( iii ) and ( iv ), to th e extent such changes have a disproportionate impact on Spinco an d the Spinco Subsidiaries, taken as a whole, as com pared to other participants in the industries in which Spinc o and the Spinco Subsidiaries conduct their busines ses ( in which case the incremental disproportionate impact may be taken into account in determining whether th ere has been a Spinco Material Adverse Effect )