“Company Material Adverse Effect” means any change, effect, event, inaccuracy, occurrence, or other matter that (x), would reasonably be expected to have, individually or in the aggregate, a material adverse effect on the business, condition (financial or otherwise), assets, operations, or results of operations of the Company, taken as a whole or (y) prevents the ability of the Company to consummate the Contemplated Transactions on or before the Outside Date; provided, however, that for purposes of clause (x), any changes, effects, events, inaccuracies, occurrences, or other matters resulting from any of the following will not be deemed to constitute a Company Material Adverse Effect and will be disregarded in determining whether a Company Material Adverse Effect has occurred: (a) matters generally affecting the U.S. or foreign economies, financial or securities markets, or political, legislative, or regulatory conditions, or the industry in which the Company operates, except to the extent such matters have a materially disproportionate adverse effect on the Company relative to the impact on other companies in the industry in which the Company operates; (b) the announcement of this Agreement or the Contemplated Transactions; (c) any change in the market price or trading volume of the Shares;   -56-


provided, that this exception will not preclude a determination that a matter underlying such change has resulted in or contributed to a Company Material Adverse Effect unless excluded under another clause; (d) acts of war or terrorism (including cyber attacks and computer hacking), national emergencies, natural disasters, force majeure events, weather or environmental events or health emergencies, including pandemics (including COVID-19) or epidemics (or the escalation of any of the foregoing), except to the extent such matters have a materially disproportionate adverse effect on the Company relative to the impact on other companies in the industry in which the Company operates; (e) changes in Laws or regulations, or the authoritative interpretations thereof, except to the extent such changes have a materially disproportionate adverse effect on the Company, relative to the impact on other companies in the industry in which the Company operates; (f) the performance of this Agreement and the Contemplated Transactions, including compliance with covenants set forth herein (excluding the requirement that the Company operate in the ordinary course of business), or any action taken or omitted to be taken by the Company at the request or with the prior written consent of Parent or Purchaser; (g) any adverse safety event, adverse regulatory development or other adverse development relating to or affecting the Company’s manufacturing process, clinical trials, product candidates or development timelines, except for any such events of developments arising from (i) fraud or (ii) if the FDA issues both (a) one or more orders that impose a clinical hold on the investigation of PR001 and (b) one or more orders that impose a clinical hold on the investigation of PR006, the result of which (both (a) and (b)) would reasonably be likely to result in a termination of, or a delay of 18 months or more in dosing patients in, both the PR001 program and the PR006 program; (h) the initiation or settlement of any legal proceedings commenced by or involving (A) any Governmental Body in connection with this Agreement or the Contemplated Transactions or (B) any holder of Shares (on their own or on behalf of the Company) arising out of or related to this Agreement or the Contemplated Transactions; (i) matters listed on the Company Disclosure Letter or in the Company SEC Documents, to the extent the effects or consequences thereof were known or reasonably foreseeable by Parent; or (j) any failure by the Company to meet any internal or analyst projections or forecasts or estimates of revenues, earnings, or other financial metrics for any period; provided, that, this exception will not preclude a determination that a matter underlying such failure has resulted in or contributed to a Company Material Adverse Effect unless excluded under another clause.  (Pages 62-63)

Question: FLS (MAE) applies to
Subquestion: business and operation of Target
Answer: business and operation of Target