Regulatory Events. The following will constitute a "Regulatory Event" governing the rights and obligations of the Parties under this Agreement:
Regulatory Events. 1.1 Compensation is payable by the State to the Company if, after the date of the Tenth Deed of Variation, during the term of the Casino Licence, and without the Company's prior written consent, the State or the Authority or any State authority or State body takes any action or series of actions which has the effect of:
Regulatory Events. Each Party shall keep the other Party informed, commencing within forty-eight (48) hours after notification (or other time period specified below), of any action by, or notification or other information which it receives (directly or indirectly) from, any Regulatory Authority, Third Party or other Governmental Authority, which:
Regulatory Events. Borrowers shall notify the Agent within three (3) Business Days (or such longer period as Agent shall agree) after (a) any material enforcement action (it being agreed, for the avoidance of doubt, that any remediation required by any Governmental Authority in connection with state contract audits in the ordinary course of business does not constitute a material enforcement action), material inquiry (other than ordinary course information requests), or material investigation instituted or, to Borrower’s or any Subsidiary’s knowledge, threatened, against Borrower or any of its Subsidiaries, servicer of the Borrowers’ portfolios of Contracts, or Borrowers’ or servicers’ respective Affiliates by any Governmental Authority, including without limitation any proceeding or action to be commenced by the filing of a stipulation and consent, (b) receipt by Borrower or any of its Subsidiaries, servicer of the Borrowers’ portfolios of Contracts, or Borrowers’ or servicers’ respective Affiliates of an “Early Warning Notice,” “Notice and Opportunity to Respond and Advise”, “Civil Investigative Demand”, or request for information from the Consumer Financial Protection Bureau or similar notice or request from any other Governmental Authority and (c) without duplication, the occurrence of any Regulatory Event.
Regulatory Events. (i) The FDA shall revoke, withdrawal, cancel or terminate marketing approval of XHANCE in the U.S. and such action remains undischarged or unstayed for \DC - 031561/000013 - 10875187 v5 \DC - 031561/000013 - 10875187 v7 \DC - 031561/000013 - 10875187 v9 more than 60 days; or (ii)(1) any Governmental Authority (including the FDA) shall revoke, withdrawal, cancel, terminate, suspend, materially limit or materially modify any Required Permit relating to XHANCE, (2) the marketing of XHANCE is voluntarily suspended by any Note Party or Subsidiary or (3) any Note Party or any Subsidiary shall initiate any recall of XHANCE or any Safety Notice is issued in connection therewith (each of the foregoing clauses (1), (2) and (3), a “Regulatory Event”), and, the occurrence of the Regulatory Event is (x) reasonably expected to prevent the marketing of XHANCE in the U.S. for more than six months; or (y) reasonably expected to result in the Note Parties failure to comply with the financial covenants in Section 8.16(a) and, solely if such covenants (or subsection thereof) is in effect immediately prior to such Regulatory Event, Section 8.16(b), during the twelve-month period following such Regulatory Event; or
Regulatory Events. Each Party shall keep the other Party informed, as soon as possible, but no later than [***] after notification (or other time period specified in the Pharmacovigilance Agreement), of any action by, or notification or other information that it receives (directly or indirectly) from, any Regulatory Authority, Third Party, or other Governmental Authority that:
Regulatory Events. No Regulatory Event or Purchaser Regulatory Event shall have occurred and be continuing or shall occur as a result of the purchase of the Preferred Stock at the Closing.
Regulatory Events. No Regulatory Event has occurred and is continuing.
Regulatory Events. If at any time a Regulatory Event occurs or is likely to occur which adversely affects or may adversely affect the rights of a party or the ability of a party to perform its obligations under this Agreement:
Regulatory Events. Borrowers shall notify the Agent within three (3) Business Days after (a) any enforcement action, inquiry (other than ordinary course information requests), or investigation instituted or, to Borrower’s or any Subsidiary’s knowledge, threatened, against Borrower or any of its Subsidiaries, servicer of the Borrowers’ portfolios of Contracts, or Borrowers’ or servicers’ respective Affiliates by any Governmental Authority, including without limitation any proceeding or action to be commenced by the filing of a stipulation and consent, (b) receipt by Borrower or any of its Subsidiaries, servicer of the Borrowers’ portfolios of Contracts, or Borrowers’ or servicers’ respective Affiliates of an “Early Warning Notice,” “Notice and Opportunity to Respond and Advise”, “Civil Investigative Demand”, or request for information from the Consumer Financial Protection Bureau or similar notice or request from any other Governmental Authority and (c) without duplication, the occurrence of any Regulatory Event.
