definiens: means all statutes, regulations, statutory rules and orders of any Governmental Entity having the force of law, andthe term with respect to such Laws and in the context that refers to any person, means such Laws as areapplicable to such person or its business, undertaking, property or securities and that emanate from a Governmental Entityhaving jurisdiction over the person or its business, undertaking, property or securities in Canada, the United States orSwitzerland ; means any mortgage, hypothec, prior claim, lien, pledge, assignment for security, security interest, lease, option, right of third parties or other charge or encumbrance ;, when used in connection with the Company, means any adverse effect that constitutes or wouldreasonably be expected to constitute a material adverse effect on the business, operations or financial condition of theCompany and the Subsidiaries, taken as a whole ; provided, however, that any adverse effect that is temporary in nature orthat results directly or indirectly from or relates directly or indirectly to any of the following shall not be deemed toconstitute, and shall not be taken into account in determining whether there has been or would be, a Material Adverse Effecton the Company : ( a ) changes or developments in international, Canadian, United States or EU political, economic, financial or marketconditions, or in the economy, political or market conditions or currency exchange rates in Canada, the United Statesor the EU;- 5 - ( b ) changes or developments resulting from any natural disaster, any act of sabotage or terrorism or any outbreak ofhostilities or war, or any escalation of any such natural disaster or acts of sabotage or terrorism or hostilities or war ; ( c ) conditions generally affecting the pharmaceutical or biotechnology sector or companies in that sector ( except to theextent such conditions have a disproportionately large adverse effect on the Company and the Subsidiaries bycomparison to the adverse effect such conditions have generally on the other companies in that sector, it beingunderstood that, in determining whether there has been or would be a Material Adverse Effect on the Company, suchdisproportionately large adverse effect may be taken into account only to the limited extent that it exceeds the adverseeffect such conditions have generally on the other companies in that sector ) ; ( d ) conditions generally affecting companies in the U.S., Canada or the EU involved in the development or marketing ofpharmaceutical products used or useful in the treatment of diseases requiring immuno - suppression ( except to the extentsuch conditions have a disproportionately large adverse effect on the Company and the Subsidiaries by comparison tothe adverse effect such conditions have generally on the other companies involved in the development or marketing ofsuch products, it being understood that, in determining whether there has been or would be a Material Adverse Effecton the Company, such disproportionately large adverse effect may be taken into account only to the limited extent thatit exceeds the adverse effect such conditions have generally on the other companies involved in the development ormarketing of such products ) ; ( e ) the introduction, commercial success, lack of commercial success, side effects or pre - clinical or clinical trial results(including adverse events ) of any product or product candidate ( of a person other than the Company and theSubsidiaries ) similar to or potentially competitive with the Specified Pharmaceutical Product ; ( f ) the payment of any amounts due to, or the provision of any other benefits to, any officers or employees underemployment contracts, non - competition agreements, employee benefit plans, severance arrangements or otherarrangements in existence as of the date of this Agreement and disclosed in the Disclosure Letter ; ( g ) any breach by Parent of this Agreement or the Confidentiality Agreement ; ( h ) the announcement of the execution of this Agreement, the pendency of the transactions contemplated hereby, theperformance of any obligation hereunder or the completion of any of the transactions contemplated hereby, includingany Pre - Acquisition Reorganization ( including any litigation or impact on the relationship of the Company or any ofthe Subsidiaries with employees, customers, suppliers, partners, service providers or creditors ) ; ( i ) any event, occurrence, development or circumstance disclosed in the Disclosure Letter;- 6 - ( j ) the taking of any action, or any failure to act, contemplated or permitted by this Agreement or consented to by Parentor Acquisitionco ; ( k ) changes in GAAP or applicable Laws or interpretations thereof ; ( l ) failure to meet any published or other revenue or earnings estimates or projections of the Company, or a decline in themarket price or volume of trading of the Common Shares on the TSX or Nasdaq ( in and of itself ), provided, however, that notwithstanding the foregoing, any adverse effect on the business, operations or financial condition of theCompany and the Subsidiaries that has resulted in such failure or such decline may be taken into account indetermining whether there has been a Material Adverse Effect on the Company ; or ( m ) any request or requirement by any Governmental Entity that any of Parent, Acquisitionco, the Company or any of theSubsidiaries enter into any agreement or arrangement, or take any action, as a condition or prerequisite to the grantingof any of the Appropriate Regulatory Approvals