Certain Regulatory Matters Sample Clauses
Certain Regulatory Matters. The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority. The Company has established and administers a compliance program applicable to the Company and its subsidiaries, to assist the Company, its subsidiaries and their directors, officers and employees of the Company and its subsidiaries in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing funct...
Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules:
(a) No member of the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated.
(b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products.
(c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Gover...
Certain Regulatory Matters. Without prejudice to Section 7.5, each of the Parties:
(a) acting reasonably and in good faith shall determine and agree in writing whether any pre-Closing consents, approvals, clearances, confirmations, waivers, licenses, permits, orders, or any other authorizations from Governmental Entities are required to implement the Sale and/or the Merger (such agreed approvals being the “Agreed Regulatory Approvals”);
(b) in the event it is determined any Agreed Regulatory Approval is required, shall, and shall ensure that their respective Representatives shall, use their reasonable best efforts to take all actions necessary, proper or advisable, as determined by each of the Parties in their reasonable discretion, to obtain such Agreed Regulatory Approval as promptly as practicable, including: (i) preparing and making all filings, applications, notifications, or submissions (whether initial or supplementary) required under any applicable Laws in connection therewith as promptly as practicable (and in any event in accordance with any applicable time limits); (ii) promptly furnishing to the other Parties and the applicable Governmental Entities such documents, information, and assistance as they may reasonably request (and in any case in accordance with any applicable time limits); (iii) using reasonable best efforts to promptly and in good faith respond to any reasonable requests for information from the other Parties and the applicable Governmental Entities in connection therewith and taking all steps necessary, proper, or advisable to avoid any declaration of incompleteness, suspension or extension of the respective review period by the applicable Governmental Entity; (iv) obtaining duly issued consents, approvals, clearances, confirmations, waivers, licenses, permits, orders or any other authorizations from the applicable Governmental Entities required in connection therewith as soon as practicable (and in any event in accordance with any applicable time limits); (v) otherwise using reasonable best efforts to cooperate in good faith with the other Parties and the applicable Governmental Entities and taking actions necessary, proper, or advisable in connection therewith;
(c) shall, and shall ensure that their Representatives shall: (i) promptly provide the other Parties with copies of all material written communications (and memoranda setting forth the substance of all material oral communications) between each of them, any of their Affiliates, and their respectiv...
Certain Regulatory Matters. (i) None of the Company, the Sponsor or, to the knowledge of the Company, any director, director nominee, officer, agent, employee, affiliate or other person associated with or acting on behalf of the Company: (i) has used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity: (ii) has made any direct or indirect unlawful contribution or payment to any official of, or candidate for, or any employee of, any federal, state or foreign office from corporate funds; (iii) has made any bribe, unlawful rebate, payoff, influence payment, kickback or other unlawful payment; or (iv) is aware of or has taken any action, directly or indirectly, that would result in a violation by such persons of the OECD Convention on Bribery of Foreign Public Officials in International Business Transactions, the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (collectively, the “FCPA”) or any similar law or regulation to which the Company, any director, director nominee, officer, agent, employee, affiliate or other person associated with or acting on behalf of the Company is subject. The Company, the Sponsor and, to the knowledge of the Company, its directors, director nominees, officers, agents, employees and affiliates have each conducted the business of the Company and their own businesses on behalf of the Company in compliance with the FCPA and any applicable similar law or regulation and have instituted and maintain policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith.
(ii) The operations of the Company are and have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements, including those of the Bank Secrecy Act, as amended by Title III of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act), the Currency and Foreign Transactions Reporting Act of 1970, as amended, the applicable money laundering statutes of jurisdictions where the Company conducts business, the applicable rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency,...
Certain Regulatory Matters. (a) Except as set forth on Schedule 3.21, to the extent required pursuant to applicable Requirements of Law, each Broker-Dealer Subsidiary is a member in good standing of FINRA and each Broker-Dealer Subsidiary is duly registered as a broker-dealer and in good standing with the SEC and/or duly registered as an introducing broker with the CFTC, and in each state where the conduct of a material portion of its business requires such registration.
(b) No Loan Party is an EEA Financial Institution.
(c) No Investment Manager Subsidiary is prohibited by (i) any provision of the Advisers Act or the rules and regulations thereunder or (ii) Section 9(a) or 9(b) of the Investment Company Act from acting as an investment adviser to a registered investment company. Neither the Borrower nor any Subsidiary other than the Investment Manager Subsidiaries is required to be registered, licensed or qualified as an investment adviser under the laws requiring any such registration, licensing or qualification in any state in which it conducts business, except where the failure to be so registered, licensed or qualified would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. Neither the Borrower nor any Subsidiary other than the Broker-Dealer Subsidiaries is required to be registered, licensed or qualified as a broker-dealer under the securities laws of any state where it conducts business or is subject to material liability or disability by reason of the failure to be so registered, licensed or qualified except where the failure to be so registered, licensed or qualified would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.
(d) Each Virtus Fund referred to in clause (1) of the definition thereof is duly registered with the SEC as an investment company under the Investment Company Act and in compliance in all material respects with all applicable laws requiring any such registration. Each Virtus Fund referred to in clause (1) of the definition thereof is in compliance in all material respects with the Investment Company Act. To the Borrower’s knowledge, each Virtus Fund is in compliance with all other applicable laws and regulations except as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.
Certain Regulatory Matters. (i) Except for billing disputes with customers arising in the ordinary course of business that in the aggregate involve immaterial amounts, there are no proceedings or investigations pending or, to the actual knowledge of the executive officers of Excel, threatened, before any Governmental Entity directed specifically at Excel or, in the case of matters of general applicability to the telecommunications industry, in which Excel is identified for possible disparate treatment or whose outcome may have a disparate impact on Excel, in which any of the following matters are being considered which are reasonably likely to have a Material Adverse Effect on Excel, nor has Excel or any of its Subsidiaries received written notice or inquiry from any Governmental Entity, indicating that any of such matters should be considered or may become the object of consideration or investigation specifically regarding Excel which are reasonably likely to have a Material Adverse Effect on Excel or, in the case of matters of general applicability to the telecommunications industry, in which Excel is identified for possible disparate treatment or whose outcome may have a disparate impact on Excel; (u) increases in access charges, universal service contributions or the like; (v) traffic routing restrictions or restrictions on use of facilities; (w) reduction or restriction of rates charged to customers; (x) reduction of earnings; (y) refunds or other forfeitures of amounts previously charged to customers; or (z) failure to meet any expense, infrastructure, service quality or other commitments previously made to or imposed by any Governmental Entity.
(ii) Neither Excel nor any of its Subsidiaries has any outstanding commitments made in the context of a matter or proceeding related specifically to Excel or, in the case of matters of general applicability to the telecommunications industry, in which Excel is identified for possible disparate treatment or whose outcome may have a disparate impact on Excel (and no such obligations have been imposed upon Excel and remain outstanding), regarding; (u) increases in access charges, universal service contributions or the like; (v) traffic routing restrictions or restrictions on use of facilities; (w) reduction or restriction of rates charged to customers; (x) reduction of earnings; (y) refunds or other forfeitures of amounts previously charged to customers; or (z) expenses, infrastructure expenditures, service quality or other regulatory requ...
Certain Regulatory Matters. (a) If Citi shall determine, in its sole judgment, that as a result of (i) the taking effect of any Applicable Law after the date hereof, (ii) any change in Applicable Law or in the administration, interpretation or application thereof by any Governmental Authority, (iii) the making or issuance of any request, guideline or directive (whether or not having the force of law) or any interpretation thereof by any Governmental Authority or the bringing of any action in a court of competent jurisdiction (regardless of whether related to Citi) or (iv) any interpretation of or proposal to implement any of the foregoing by a Governmental Authority (each, a “Regulatory Event”), Citi or any of its Affiliates is or would (A) not be permitted to hold, store, transport, buy, finance, sell or own any or certain of the commodities subject to the transactions contemplated by the Transaction Documents, (B) be required to hold additional capital, or be assessed any additional capital or other charges, on the basis of holding, storing, transporting, buying, financing, selling, or owing any commodities from time to time, including without limitation, any of the commodities subject to the transactions contemplated by this Agreement and the other Transaction Documents, (C) be unable to perform in any material respect its obligations under this Agreement and the other Transaction Documents, or (D) were it to continue to hold, store, transport, buy, finance, sell or own any of the commodities subject to the transactions contemplated by this Agreement and the Transaction Documents or perform any such obligations, and taking into account other commodities and the volumes thereof held by Citi or any of its Affiliates from time to time, be or likely to be required to hold additional capital, or be assessed any additional capital or other charges, or be or likely to be subject to additional or increased burdens or costs (such additional capital or other charges, burdens and costs, collectively, “Additional Costs”), then it shall notify the Delek Entities in writing of such determination (a “Regulatory Event Notice”). Promptly following the sending of a Regulatory Event Notice, Citi shall propose what actions or steps, if any, the Parties could implement to alleviate, minimize and/or mitigate the effect of any such Regulatory Event, and each Delek Entity shall consider any such actions or steps in good faith. If, in Citi’s sole judgment, Citi is able to identify actions or steps that ca...
Certain Regulatory Matters. (a) None of the Company or its Subsidiaries or any of their respective Representatives is (i) a person listed in any Sanctions-related list of designated persons maintained by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”) or the U.S. Department of State, (ii) a person operating, organized or resident in a country or region which is itself the subject or target of any Sanctions (“Sanctioned Country”), or (iii) any person owned or controlled by any person or persons specified in (i) or (ii) above or otherwise the target of Sanctions (together “Sanctioned Persons”). The Company and its Subsidiaries and each of their respective Representatives is in compliance with applicable Sanctions in all material respects and is not engaged in any activity that would reasonably be expected to result in the such Person being designated as a Sanctioned Person. None of the Company, its Subsidiaries or any of their respective Representatives (in such capacity) is engaged directly in any business or transactions with any Sanctioned Person or in any Sanctioned Country, or knowingly engaged in any indirect business or transactions with any Sanctioned Person or in any Sanctioned Country or any in any manner that would result in the violation of Sanctions by any Person.
(b) (i) The Company and its Subsidiaries are in compliance in all material respects with all anti-money laundering laws, rules, regulations and orders of jurisdictions applicable to the Company (collectively, “AML Laws”), including without limitation, the USA PATRIOT Act and (ii) no proceeding involving the Company or any of its Subsidiaries with respect to AML Laws is currently pending or, to the Knowledge of the Company, threatened. Neither the Company nor any of its Subsidiaries is required to be registered with the U.S. Department of the Treasury as a money services business, as such term is defined by federal law or regulation, nor is the Company required to be registered or licensed as a money services business, money transmitter, or equivalent enterprise under the applicable Law of any other jurisdiction.
(c) Since January 31, 2018, none of the Company, any of its Subsidiaries or any director, officer or, to the Knowledge of the Company, employee or agent of the Company or any of its Subsidiaries has: (i) used any funds for unlawful contributions, gifts, entertainment, or other unlawful payments relating to an act by any Governmental Entity; (ii) made any unlawful payment to a...
Certain Regulatory Matters. If ▇▇▇▇ shall determine, in its sole judgment, that as a result of any law or regulation or interpretation thereof (or compliance by it with any request, guideline or directive) it is not permitted to hold or own asphalt or it would, were it to continue to hold or own asphalt, be or likely to be subject to additional or increased burdens or costs, then it shall notify the Company in writing of such determination and specify in such notice a date (the “Asphalt Transfer Date”) upon which the Company shall purchase from ▇▇▇▇ all asphalt then held by ▇▇▇▇ in any of the Product Storage Facilities at a per Barrel purchase price equal to the applicable price listed on Schedule B hereto; provided that if the basis for giving such notice is that ▇▇▇▇ is or likely may be subject to additional or increased burdens or costs, then such Asphalt Transfer Date shall occur no earlier than 6 months after the date such notice is given and to the extent that ▇▇▇▇ incurs any such additional or increased burdens or costs after such notice and prior to such Asphalt Transfer Date, such additional or increased burdens or costs shall constitute Ancillary Costs hereunder; provided, however, that the Company may give notice to ▇▇▇▇ of the acceleration of the Asphalt Transfer Date to an earlier date, with such earlier date occurring no less than three (3) months following the date of the Company’s notice of acceleration. ▇▇▇▇ shall estimate the volume of such asphalt and aggregate purchase price therefor and such aggregate estimated purchase price shall be payable to ▇▇▇▇ as part of the Interim Payment due on such date. Thereafter, ▇▇▇▇ shall promptly determine the volume of such asphalt and the aggregate definitive purchase price therefor (which to the extent applicable will reflect the application of the monthly true up calculations pursuant to Schedule C hereto) and to the extent such aggregate definitive purchase price differs from such aggregate estimated purchase price, the difference shall be included as an adjustment to the first Interim Payment due following the determination of such aggregate definitive purchase price. In addition, from and after the Asphalt Transfer Date, asphalt shall no longer constitute a Product for purposes of this Agreement or any of the other documents related hereto and, to the extent reasonably requested by ▇▇▇▇, the parties shall make such further amendments to this Agreement and such other documents are may be necessary to reflect the removal of ...
Certain Regulatory Matters. (i) As promptly as practicable, and in any event within ten (10) Business Days after the date of this Agreement, the Parties shall each prepare and file any required notifications or filings under any applicable Antitrust Laws or other applicable Legal Requirements in connection with the Transactions, including pursuant to the NSIA. The Parties shall promptly and in good faith respond to all information requested of it by a Governmental Entity in connection with any such notifications and filings and otherwise cooperate in good faith with each other and such Governmental Entities. Each Party will promptly furnish to the other such information and assistance as the other may reasonably request in connection with its preparation of any filing or submission that is necessary and will take all other actions necessary or desirable to cause the expiration or termination of the applicable waiting periods as soon as practicable. Each Party will promptly provide the other with copies of all material written communications (and memoranda setting forth the substance of all oral communications) between each of them, any of their Affiliates and their respective agents, representatives and advisors, on the one hand, and any Governmental Entity, on the other hand, with respect to this Agreement or the Transactions. Without limiting the foregoing, each Party shall: (A) promptly inform the others of any material communication to or from a Governmental Entity regarding the Transactions; (B) permit each other to review in advance any material proposed written communication to any such Governmental Entity and incorporate reasonable comments thereto; (C) give the other prompt written notice of the commencement of any Legal Proceeding with respect to such transactions; (D) not agree to participate in any substantive meeting or discussion with any such Governmental Entity in respect of any filing, investigation or inquiry concerning this Agreement or the Transactions unless, to the extent reasonably practicable, it consults with the other Party in advance and, to the extent permitted by such Governmental Entity, gives the other Party the opportunity to attend; (E) keep the other reasonably informed as to the status of any such Legal Proceeding; and (F) promptly furnish each other with copies of all material correspondence, filings (subject to appropriate redaction, and only to the extent allowed under applicable Legal Requirements) and material written communications between suc...