“Material Adverse Effect” shall mean any event, occurrence, change or development that has a material adverse effect on the business, results of operations or financial condition of the Acquired Corporations taken as a whole; provided, however, that no event, occurrence, change, or development resulting or arising from or relating to or in connection with any of the following matters shall be deemed, either alone or in combination, to constitute or contribute to, or be taken into account in determining whether there has been, a Material Adverse Effect: (i) any change in the market price or trading volume of the Company’s stock (provided, however, that the underlying causes thereof, to the extent not otherwise excluded by this definition, may be deemed to contribute to a Material Adverse Effect); (ii) the execution, announcement or pendency of this Agreement or the terms hereof (including the identity of Parent or Purchaser) or the announcement, pendency or consummation of the Transactions, including the impact thereof on the relationships, contractual or otherwise, of the Company with employees, labor unions, works councils, financing sources, customers, franchisees, suppliers, partners, Governmental Bodies or other business relationships; (iii) the general conditions or trends in the industries in which the Acquired Corporations operate or in the economy generally or other general business, financial or market conditions, including competition in geographic, product or service areas; (iv) domestic, foreign or global political conditions, economic, regulatory, financial or capital markets conditions (including interest rates, exchange rates, tariffs, trade wars and credit markets); (v) any act of civil unrest, civil disobedience, protests, public demonstrations, insurrection, terrorism, war, cyberterrorism, military activity, sabotage or cybercrime, national or international calamity or any other similar event, including an outbreak or escalation of hostilities involving the United States or any other Governmental Body or the declaration by the United States or any other Governmental Body of a national emergency or war, or any worsening of any such conditions threatened or existing on the date of this Agreement; (vi) any natural or manmade disasters, epidemics, pandemics or disease outbreaks (including COVID-19) or any acts of God; (vii) changes to applicable Legal Requirements (including COVID-19 Measures); (viii) any determination by, or delay of a determination by, the FDA or any other Governmental Body, or any panel or advisory body empowered or appointed thereby, or any indication that any such entity, panel or body will make any determination or delay in making any determination, with respect to the approvability, manufacturing, labeling, contents of package insert, prescribing information, risk management profile, chemistry, manufacturing and controls (CMC) matters or pre-approval inspection matters relating to any product candidates of the Acquired Corporations or any products or product candidates of any competitors of the Acquired Corporations, or any requirement relating to the results of any pre-clinical or clinical testing being conducted by or on behalf of the Acquired Corporations, any of its competitors or any of their respective collaboration partners, including any requirement to conduct further clinical trials or any delayed or accelerated launch of any   A-7


product candidates of the Acquired Corporations or any products or product candidates of any competitors of the Acquired Corporations; (ix) the results of, or any data derived from, any pre-clinical or clinical testing being conducted by or on behalf of the Acquired Corporations, any of its competitors or any of their respective collaboration partners or any announcement thereof; (x) increased incidence or severity of any previously identified side effects (including toxicity), adverse events or safety observations, or reports of new side effects, adverse events or safety observations, with respect to any product candidates of the Acquired Corporations or any products or product candidates of any competitors of the Acquired Corporations; (xi) any recommendations, statements or other pronouncements made, published or proposed by professional medical organizations or any Governmental Body or representative thereof, or any panel or advisory body empowered or appointed thereby, relating to any product candidates of the Acquired Corporations or any products or product candidates of any competitors of the Acquired Corporations; (xii) any supply chain disruption affecting product candidates of the Acquired Corporations or any products or product candidates of any competitors of the Acquired Corporations; (xiii) any determination or development relating to coverage, reimbursement or payor rules or policies applicable to, or pricing of, any product candidates of the Acquired Corporations or any products or product candidates of any competitors of the Acquired Corporations; (xiv) the failure of the Company to meet internal or analysts’ expectations or projections, forecasts, guidance, estimates or budgets (provided, however, that the underlying causes thereof, to the extent not otherwise excluded by this definition, may be deemed to contribute to a Material Adverse Effect; provided, further, that this clause (xiv) shall not be construed as implying that the Company is making any representation or warranty hereunder with respect to any internal or analysts’ expectations or projections, forecasts, guidance, estimates or budgets); (xv) any Legal Proceeding relating to or resulting from this Agreement or the transactions contemplated hereby; (xvi) any action taken by the Company at the written direction of Parent or any action expressly required or permitted to be taken by Parent, Purchaser or the Company pursuant to the terms of this Agreement, or the failure of the Company to take any action that the Company is prohibited by the terms of this Agreement from taking or which the Company did not take on account of withheld consent from Parent; (xvii) any breach by Parent or Purchaser of this Agreement; (xviii) any matter to the extent expressly set forth on the Company Disclosure Schedule or (xix) any change in any Legal Requirement or GAAP or any other applicable accounting principles or standards (or change in interpretations of any Legal Requirement or GAAP or any other applicable accounting principles or standards) after the date of this Agreement; provided, however, that, to the extent such events, circumstances, conditions, changes, developments or effects referred to in clauses (iii), (iv), or (v) has had or reasonably likely to have, individually or in the aggregate, a disproportionate adverse effect on the business, financial condition or results of operations of the Acquired Corporations, taken as a whole, relative to other biopharmaceutical companies with products or product candidates that are, or are reasonably likely to be, competitive with the products of the Acquired Corporations (and, in the case of biopharmaceutical companies with multiple product lines or divisions, relative only to the products or product candidates that are, or are reasonably likely to be, competitive with the products of the Acquired Corporations), in which case only the incremental disproportionate impact shall be taken into account when determining whether a “Material Adverse Effect” has occurred or may, would or could occur.  (Pages 73-74)

Question: FLS (MAE) Standard-Answer
Subquestion: <NONE>
Answer: Other forward-looking standard