definiens: means any event, change, effect, circumstance, fact, development or occurrence that has a materialadverse effect on the business, operations or financial condition of Parent and its Subsidiaries, taken as a whole ; provided, that no event, change, effect, circumstance, fact, development or occurrence to the extent resulting from, arising out of, or relating to any of the following shall be deemed to constitutea Parent Material Adverse Effect or shall be taken into account in determining whether there has been or would reasonably be expected to be a ParentMaterial Adverse Effect : ( i ) any changes in general United States or global economic conditions or other general business, financial or market conditions,(ii ) any changes in conditions generally affecting the industries in which Parent or any of its Subsidiaries operates, ( iii ) fluctuations in the value of anycurrency, ( iv ) any decline, in and of itself, in the market price or trading volume of the Parent Ordinary Shares ( provided, that any events, changes, effects, circumstances, facts, developments or occurrences giving rise to or contributing to such decline that are not otherwise excluded from thedefinition of Parent Material Adverse Effect may be taken into account in determining whether there has been, or would reasonably be expected to be, aParent Material Adverse Effect ), ( v ) regulatory, legislative or political conditions or conditions in securities, credit, financial, debt or other capital markets, in each case in the United States or any foreign jurisdiction, ( vi ) any failure, in and of itself, by Parent or any of its Subsidiaries to meet any internal orpublished projections, forecasts, estimates or predictions, revenues, earnings or other financial or operating metrics for any period ( provided, that anyevents, changes, effects, circumstances, facts, developments or occurrences giving rise to or contributing to such failure that are not otherwise excludedfrom the definition of Parent Material Adverse Effect may be taken into account in determining whether there has been, or would reasonably be expectedto be, a Parent Material Adverse Effect ), ( vii ) the execution and delivery of this Agreement, the public announcement or the pendency of this Agreementor the pendency or consummation of the transactions contemplated by this Agreement ( including the Mergers ), the taking of any action required orexpressly contemplated by this Agreement ( other than, to the extent not excluded by another clause of this definition, 12 Parent ’s compliance with its obligations pursuant to Section 7.01(a ), except to the extent that the Company has unreasonably withheld a consent underSection 7.01(a ) ) or the identity of, or any facts or circumstances relating to the Company or any of its Subsidiaries, including the impact of any of theforegoing on the relationships, contractual or otherwise, of Parent or any of its Subsidiaries with Governmental Authorities, customers, suppliers, partners, officers, employees or other material business relations ( provided, that the foregoing shall not apply with respect to any representation or warranty that isexpressly intended to address the consequences of the execution, delivery or performance of this Agreement or the consummation of the transactionscontemplated hereby ( including Section 5.04(c ) ) or with respect to the condition to Closing contained in Section 9.03(b ), to the extent it relates to suchrepresentations and warranties ), ( viii ) any adoption, implementation, promulgation, repeal, modification, amendment, authoritative interpretation, changeor proposal of any Applicable Law ( or the interpretation thereof ) of or by any Governmental Authority, ( ix ) any changes or prospective changes in IFRS ( orauthoritative interpretations thereof ), ( x ) geopolitical conditions, the outbreak or escalation of hostilities, civil or political unrest, any acts of war, sabotage, cyberattack or terrorism, or any escalation or worsening of any such acts of war, sabotage, cyberattack or terrorism threatened or underway as of the dateof this Agreement, ( xi ) any reduction in the credit rating of Parent or any of its Subsidiaries ( it being understood and agreed that any events, changes, effects, circumstances, facts, developments or occurrences giving rise to or contributing to such reduction that are not otherwise excluded from thedefinition of Parent Material Adverse Effect may be taken into account in determining whether there has been, or would reasonably be expected to be, aParent Material Adverse Effect ), ( xii ) any epidemic, plague, pandemic or other outbreak of illness or public health event, hurricane, earthquake, flood, calamity or other natural disasters, acts of God or any change resulting from weather conditions ( or any worsening of any of the foregoing ), including theresponse of governmental and non - governmental entities, including any impact on new drug approval processes or drug trials, ( xiii ) any claims, actions, suits or proceedings arising from allegations of a breach of fiduciary duty or violation of Applicable Law relating to this Agreement or the transactionscontemplated hereby ( including the Mergers ) or ( xiv ) any regulatory, preclinical, clinical, pricing or reimbursement, or manufacturing events, changes, effects, developments or occurrences relating to any Parent Product or any product of a competitor of Parent, including ( A ) any suspension, rejection orrefusal of, any request to refile or any delay in obtaining or making any regulatory application or filing, ( B ) any actions, requests, recommendations ordecisions of ( or the failure to take or delay in taking any actions or make any requests, recommendations or decisions by ) any Governmental Authority,(C ) any recommendations, statements or other pronouncements made, published or proposed by professional medical organizations, ( D ) any pre - clinicalor clinical studies, tests or results or announcements thereof, ( E ) any decision or action by any Governmental Authority ( or other payor ) with respect topricing and/or reimbursement, ( F ) any delay, hold or termination of any clinical trial or any delay, hold or termination of any planned application formarketing approval, ( G ) any delay, hold or termination of approval with respect to the manufacture, processing, packing or testing of any Parent Productor with respect to any manufacturing facilities, or ( H ) any increased incidence or severity of any previously identified side effects, adverse effects, adverseevents or safety observations or reports of new side effects, adverse effects, adverse events or safety observations, but excluding in the case of thisclause ( xiv ) side effects, adverse effects, adverse events, safety observations or manufacturing events that result in a broad based product recall of, orwithdrawal from the market of, any Parent Product, except 13 that the matters referred to in clauses ( i ), ( ii ), ( iv ), ( v ), ( viii ), ( ix ), ( x ) or ( xii ), may be taken into account ( to the extent not excluded by another clause of thisdefinition ) to the extent that the impact of any such event, change, effect, circumstance, fact, development or occurrence on Parent and its Subsidiaries, taken as a whole, is disproportionately adverse relative to the adverse impact of such event, change, effect, circumstance, fact, development oroccurrence on the operations in the pharmaceutical industry of other participants in such industry, and then solely to the extent of such disproportionality