Regulatory Matters Clause Samples
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Regulatory Matters. The preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) were, or if still pending are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Co...
Regulatory Matters. The parties will negotiate in good faith to resolve regulatory criticisms or concerns expressed by the Office of the Comptroller of the Currency or other U.S. federal or state banking Regulators that can reasonably be addressed through a modification of the Agreement or adoption of mutually agreeable policies or procedures to prevent or resolve a Material Default described by clause (iii) of such definition, subject to applicable legal requirements including restrictions on disclosing confidential supervisory information.
Regulatory Matters. (a) Except as would not be material to the Company Group, taken as a whole: (i) the Company Products are in compliance with all current applicable Device Regulatory Laws; (ii) each member of the Company Group is in compliance with all applicable Device Regulatory Laws relating to the sourcing, procurement, and the import of raw materials for the Company Products and the methods and materials used in, and the facilities and controls used for, the design, manufacture, processing, packaging, labeling, storage, distribution, export, and import, if applicable, of the Company Products; (iii) each member of the Company Group has received confirmation from the Notified Body that a formal application for conformity assessment of the Company Products has been accepted and that the Company Products may continue to be placed on the market of the European Union countries until December 31, 2028; and (iv) since January 1, 2021, all such raw materials and all Company Products have been sourced, procured, processed, manufactured, packaged, labeled, stored, handled, distributed, exported, and imported, if applicable, by the Company Group in compliance with all applicable Device Regulatory Laws.
(b) Except as would not be material to the Company Group, taken as a whole: (i) all preclinical and clinical investigations sponsored by or on behalf of a member of the Company Group with respect to any Company Product are being, and since January 1, 2021, have been, conducted in compliance with applicable Device Regulatory Laws, including Good Clinical Practices and Good Laboratory Practices requirements, and federal and state Laws restricting the use and disclosure of individually identifiable health information; and (ii) each member of the Company Group complies with, and since January 1, 2021, has complied with, all requirements under the Laws relating to monitoring and reporting of adverse events during clinical trials.
(c) No action has been taken by any Governmental Authority or is in the process of being taken that would slow, halt or enjoin the development, manufacturing, or marketing of the Company Products or the operation of the business of the Company Group or subject the development, manufacturing, or marketing of the Company Products or a member of the Company to regulatory enforcement action.
(d) Except as would not be material to the Company Group, taken as a whole, since January 1, 2021, the members of the Company Group have maintained records relating to the devel...
Regulatory Matters. (a) FSIC and CCT shall as promptly as practicable, but in no case later than five (5) Business Days after the date of this Agreement, jointly prepare and file with the SEC the Registration Statement. Each of FSIC and CCT shall use its reasonable best efforts to have the Registration Statement declared effective under the Securities Act as promptly as practicable after such filing and to keep the Registration Statement effective as long as necessary to consummate the Mergers. CCT and FSIC shall use reasonable best efforts to cause the Joint Proxy Statement/Prospectus to be promptly mailed or delivered to their respective stockholders upon such effectiveness. FSIC shall also use its reasonable best efforts to obtain all necessary state securities Law or “blue sky” permits and approvals required to carry out the Transactions, if any, and CCT shall use reasonable best efforts to furnish all information concerning CCT and the holders of CCT Common Stock as may be reasonably requested by FSIC in connection with any such action.
(b) Each of FSIC and CCT shall cooperate with the other in the preparation of the Registration Statement and shall furnish to the other all information reasonably requested as may be reasonably necessary or advisable in connection with the Registration Statement or any other filing or application made by or on behalf of FSIC, CCT or any of their respective Consolidated Subsidiaries to any Governmental Entity in connection with the Mergers and the other Transactions. Prior to the Effective Time, each party hereto shall promptly notify the other party (i) upon becoming aware of any event or circumstance that is required to be described in an amendment to the Registration Statement or in a supplement to the Joint Proxy Statement/Prospectus and (ii) after the receipt by it of any comments of the SEC with respect to the Joint Proxy Statement/Prospectus or the Registration Statement.
(c) Subject to applicable Law, each of FSIC and CCT shall promptly advise the other upon receiving any communication from any Governmental Entity, the consent or approval of which is required for consummation of the Transactions, that causes such party to believe that there is a reasonable likelihood that any Regulatory Approval will not be obtained or that the receipt of any such approval may be materially delayed or conditioned.
Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.
Regulatory Matters. (a) Promptly after the date of this Agreement, ▇▇▇▇▇▇▇ and Sterling shall prepare and file with the SEC the Joint Proxy Statement and ▇▇▇▇▇▇▇ shall prepare and file with the SEC the S-4, in which the Joint Proxy Statement will be included as a prospectus. The parties shall use reasonable best efforts to make such filings within thirty (30) business days of the date of this Agreement. The S-4 shall also, to the extent required under the Securities Act and the regulations promulgated thereunder, register the shares of New ▇▇▇▇▇▇▇ Preferred Stock (or depositary shares in lieu thereof) that will be issued in the transaction. Each of ▇▇▇▇▇▇▇ and Sterling shall use its reasonable best efforts to have the S-4 declared effective under the Securities Act as promptly as practicable after such filings, and ▇▇▇▇▇▇▇ and Sterling shall thereafter mail or deliver the Joint Proxy Statement to their respective stockholders. ▇▇▇▇▇▇▇ shall also use its reasonable best efforts to obtain all necessary state securities law or “Blue Sky” permits and approvals required to carry out the transactions contemplated by this Agreement, and Sterling shall furnish all information concerning Sterling and the holders of Sterling Common Stock and Sterling Series A Preferred Stock as may be reasonably requested in connection with any such action.
(b) The parties hereto shall cooperate with each other and use their reasonable best efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings (and in the case of applications, notices, petitions and filings in respect of the Requisite Regulatory Approvals, use their reasonable best efforts to make such filings within thirty (30) business days of the date of this Agreement), to obtain as promptly as practicable all permits, consents, approvals and authorizations of all third parties and Governmental Entities which are necessary or advisable to consummate the transactions contemplated by this Agreement (including the Merger and the Bank Merger), and to comply with the terms and conditions of all such permits, consents, approvals and authorizations of all such Governmental Entities. ▇▇▇▇▇▇▇ and Sterling shall have the right to review in advance, and, to the extent practicable, each will consult the other on, in each case subject to applicable laws relating to the exchange of information, all the information relating to Sterling or ▇▇▇▇▇▇▇, as the case may be, and any of their respectiv...
Regulatory Matters. (a) Parent and the Company shall promptly prepare and file with the SEC the Joint Proxy Statement and Parent shall promptly prepare and file with the SEC the S-4, in which the Joint Proxy Statement will be included as a prospectus. Each of the Company and Parent shall use all reasonable efforts to have the S-4 declared effective under the Securities Act as promptly as practicable after such filing, and the Company and Parent shall thereafter mail or deliver the Joint Proxy Statement to their respective shareholders. Parent shall also use all reasonable efforts to obtain all necessary state securities law or "Blue Sky" permits and approvals required to carry out the transactions contemplated by this Plan, and the Company shall furnish all information concerning the Company and the holders of the Company Common Stock as may be reasonably requested in connection with any such action.
(b) The parties hereto shall cooperate with each other and use their best efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings, to obtain as promptly as practicable all permits, consents, approvals and authorizations of all third parties and Governmental Entities which are necessary or advisable to consummate the transactions contemplated by this Plan (including, without limitation, the Merger), and to comply with the terms and conditions of all such permits, consents, approvals and authorizations of all such Governmental Entities. The Company and Parent shall have the right to review in advance, and, to the extent practicable, each will consult the other on, in each case subject to applicable laws relating to the exchange of information, all the information relating to Parent or the Company, as the case may be, and any of their respective subsidiaries, which appear in any filing made with, or written
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities,...
Regulatory Matters. (a) Promptly after the date of this Agreement, Purchaser and Company shall cooperate with each other to prepare or cause to be prepared the Proxy Statement and Form S-4 in which the Proxy Statement will be included as a prospectus. Purchaser shall use its commercially reasonable efforts to file the Form S-4 within forty-five (45) days of the date herewith and have the Form S-4 declared effective under the Securities Act as promptly as practicable after such filing. Company and Purchaser shall thereafter mail or deliver the Proxy Statement to their respective shareholders. Purchaser shall also use its commercially reasonable efforts to obtain all necessary state securities Law or “Blue Sky” permits and approvals required to carry out the transactions contemplated by this Agreement, and Company shall furnish all information concerning Company and the holders of Company Common Shares as may be reasonably requested in connection with any such action.
(b) Promptly after the date of this Agreement, the parties shall cooperate with each other and use their respective commercially reasonable efforts to prepare and file all necessary documentation, to effect all applications, notices, petitions and filings, to obtain as promptly as practicable all permits, consents, approvals and authorizations of all third parties and Governmental Entities that are necessary or advisable to consummate the transactions contemplated by this Agreement (including the Merger and the Bank Merger), and to comply with the terms and conditions of all such permits, consents, approvals and authorizations of all such third parties or Governmental Entities. Purchaser will prepare or cause to be prepared and use commercially reasonable efforts to file within forty-five (45) days of the date of this Agreement all applications, requests, or notices with the Federal Reserve and ODFI necessary for the consummation of the Merger. Purchaser Bank will prepare or cause to be prepared and use commercially reasonable efforts to file within forty-five (45) days of the date herewith an Interagency Bank Merger Act Application, or such other application as deemed acceptable or appropriate by the OCC, with the OCC, FDIC and ODFI. Each of Company and Purchaser shall have the right to review in advance, subject to applicable Laws, all of the information relating to Company or Purchaser, as the case may be, and its respective Subsidiaries, that appear in any filing or written response to a filing made with, or w...
Regulatory Matters. (a) Subject to Section 4.4, the Stockholder shall, and shall use their reasonable best efforts to cause their Affiliates to, use their reasonable best efforts, consistent with the time frames set forth in Section 6.4 of the Merger Agreement, to supply and provide information that, to such Stockholder’s knowledge, is complete and accurate in all material respects to any Governmental Authority requesting such information in connection with filings or notifications under, or relating to, applicable laws that are required or advisable as a result of, or pursuant to, the Merger Agreement and the related financings and transactions, including, without limitation, information required or requested to be provided to any antitrust, financial or national security regulatory authorities in connection with any approvals reasonably sought in connection with the consummation of the Merger (collectively, the “Regulatory Filings” and the, “Regulatory Disclosures”, respectively). If any Governmental Authority seeks to prevent the consummation of the transactions contemplated by the Merger Agreement based on the HSR Act or any other Antitrust Laws or based on any other required approval, consent, notice or filing with a Governmental Authority and such actions by the Governmental Authority relate to the activities or investments of such Stockholder or its Affiliates (solely for purposes of this Section 4, an “Affiliate” of the Stockholder shall include any portfolio company in which such Stockholder or any of its Affiliates has made a debt or an equity investment), then if Parent in good faith reasonably determines that such actions by the Governmental Authority will not be resolved sufficiently in advance of the Termination Date, Parent may provide written notice of that determination to the Stockholder, and Parent may elect to terminate the obligations under Section 2 and Section 4.6 of this Agreement (in which case the Stockholder’s obligations under the Equity Commitment Letter shall also automatically terminate) and, in that context, the Stockholder shall be entitled to receive the Per Share Price under the Merger Agreement with respect to its shares of Common Stock; provided, however that Parent shall not terminate the Equity Commitment Letter or the obligations under Section 2 of this Agreement pursuant to this Section 4.3(a) without first obtaining alternative financing arrangements which provide Parent with funds in an amount equal to the Rollover Amount; provided t...