Regulatory Matters Clause Samples
POPULAR SAMPLE Copied 4 times
Regulatory Matters. (a) All existing Registrations held by Reliant as of the date of this Agreement are set forth in Schedule 1.1.102. Reliant is the sole and exclusive owner of the Registrations. Reliant has delivered to the Purchaser true and correct copies of the Registrations and has made available to the Purchaser copies of material written communications between Reliant, on the one hand, and the FDA or any other applicable Medical Product Regulatory Authority, on the other hand, since October 11, 2000 (the “Reliant Acquisition Date”), and any existing written summaries of material discussions between Reliant and the FDA or any other applicable Medical Product Regulatory Authority since the Reliant Acquisition Date, including, without limitation, copies of (i) all warning letters, FD-483s, notices of adverse findings and similar correspondence received by Reliant from the FDA since the Reliant Acquisition Date, (ii) all audit reports relating to audits for compliance with the Act performed since the Reliant Acquisition Date and submitted to the FDA; (iii) any document concerning any significant oral or written communication received from the FDA by Reliant (whether directly or via any third party) since the Reliant Acquisition Date; and (iv) any written notification from the FDA or any other applicable Medical Product Regulatory Authority indicating that the Product is misbranded or adulterated as defined in the Act. Reliant has delivered any of the foregoing materials sent to or received by the third party manufacturer of the Product that are currently in Reliant’s possession.
(b) The promotion, distribution, marketing and sale and, to Reliant’s Knowledge, manufacture of the Product in the Territory has been conducted in compliance with the Registrations and all applicable Laws, including the Act and the PDM Act. The Registrations required for the manufacturing, promotion, marketing, sale and distribution of the Product in the Territory are in full force and effect.
(c) There are no proceedings pending against Reliant or, to Reliant’s Knowledge, threatened which could result in the revocation, cancellation or suspension of any Registrations listed in Schedule 1.1.102.
(d) Reliant is in compliance in all material respects with all Laws applicable to the ownership, operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing of the Product and the Acquired Assets and, to the Knowledge of Reliant, has not ...
Regulatory Matters. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect:
(a) Since January 1, 2023, the Company and all of its Subsidiaries are and have been in compliance with applicable requirements under: (i) the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., and all regulations promulgated by the U.S. Food and Drug Administration (“FDA”) thereunder (collectively, the “FDCA”); (ii) the Federal Trade Commission Act, 15 U.S.C. § 41 et seq., and all regulations promulgated by the U.S. Federal Trade Commission (“FTC”) thereunder (collectively, the “FTC Act”); (iii) the Controlled Substances Act, 21 U.S.C. § 801 et seq., and all regulations promulgated by the Drug Enforcement Administration (“DEA”) thereunder (collectively, the “CSA”); (iv) all Laws, statutes and regulations administered by the United States Department of Agriculture (“USDA”) applicable to activities of the Company; and, (v) all federal, national, state, and local Laws applicable to the activities of the Company and its Subsidiaries with respect to foods, dietary supplements, cosmetics, drugs, medical devices, controlled substances, and other products or practices regulated by FDA, DEA, FTC, and USDA (subsections (i)-(v), collectively, the “Regulatory Laws”).
(b) The Company and all of its Subsidiaries hold all Permits necessary for the Company and its Subsidiaries to own, lease and operate their properties and assets, and to carry on and operate their businesses as currently conducted in material compliance with applicable requirements under Regulatory Laws (collectively, the “Regulatory Permits”).
(c) All Regulatory Permits are valid, in full force and effect, and unencumbered.
(d) Neither the Company nor any of its Subsidiaries have written notice of, and to the Knowledge of the Company, no circumstances exist that would reasonably be expected to result in, the actual or threatened withdrawal, revocation, suspension, encumbrance, or failure to renew any Regulatory Permit.
(e) To the Knowledge of the Company, all applications, notifications, submissions, information, claims, reports, and data submitted to FDA, DEA, USDA, or other Governmental Authorities, were true, complete and correct in all material respects as of the date of submission, except as revised by any necessary or required material updates, changes, corrections or modifications.
(f) Since January 1, 2023, (i) neither the Company nor any of its Subsidiaries have v...
Regulatory Matters. 9.1 In the event that the FERC takes any adverse action with respect to the Tariffs or any tariffs that MPL may file in the future, in each case that negatively affects the rights or obligations of MPC under this Agreement, MPL shall diligently defend the Tariffs, including appealing any such adverse action. If any such adverse action is not stayed pending appeal, each Party’s obligations under this Agreement shall be suspended until a stay is implemented or a final, non-appealable decision is rendered with respect to such adverse action. If a final, non-appealable decision is ultimately issued by the FERC and confirmed by a court having final authority in the matter that requires MPL to amend the Tariffs in a manner that is fundamentally contradictory to the provisions of this Agreement, then the Parties shall negotiate in good faith to amend this Agreement to comply with any such judgment and to retain the protections and structures reflected by its current terms to the maximum extent permissible under such judgment. In the event the Parties are unable to reach agreement with respect to such an amendment within a reasonable period of time (which shall not be less than thirty (30) Days) after the issuance of such final judgment, then either Party may terminate this Agreement upon written notice to the other Party.
9.2 MPC hereby agrees: (a) to take all such actions and do all such things as MPL shall reasonably request in connection with its applications for, and the processing of, any necessary certificates, approvals and authorizations of any applicable Governmental Authorities; (b) at all times to support the Tariffs specified in this Agreement as a rate that MPC has agreed to pay; (c) not directly or indirectly take any action that indicates a lack of support for the Tariffs at the terms agreed to by MPC in this Agreement; and (d) not to file any action, protest, complaint or other action with the FERC with respect to the Tariffs, including any increased rates based on the inflationary index referred to in Section 3.12.
9.3 The Parties acknowledge and agree that MPL operates the Pipeline System as a common carrier, and MPC’s rights as a shipper on the Pipeline System shall be subject to all Applicable Laws related to common carrier pipelines. The terms and provisions of the Tariffs shall apply to the services provided by MPL pursuant to this Agreement.
9.4 In carrying out the terms and provisions of this Agreement, the Parties shall comply with all pr...
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) Schedule 3.14(a) sets forth a list of all Regulatory Approvals held by the Company or the Selling Parties relating to the Company Business. The Company, the Selling Parties and any of their respective Affiliates have conducted the Company Business (including research, storage, development and testing) in compliance in all material respects with all applicable requirements under the FDCA, the PHSA, the CSA, and their applicable implementing regulations, and all comparable applicable state and foreign applicable Laws.
(b) All animal studies or other preclinical tests performed in connection with the Company Business by or on behalf of the Company, any of the Selling Parties or any of their respective Affiliates in connection with the Company Business that have been, or are intended to be, submitted to any Regulatory Authority to support Regulatory Approval of a MDA5 Compound, NLRP1 Compound or any product containing any such compound, either (i) have been conducted in accordance, in all material respects, with applicable Good Laboratory Practice (“GLP”) regulations as described in 21 C.F.R. Part 58 or comparable foreign applicable Laws or (ii) involved experimental research techniques that could not be performed by a registered GLP testing laboratory (with appropriate notice being given to the FDA or applicable Governmental Entity) and have employed the procedures and controls generally used by qualified experts in animal or preclinical study of products comparable to those being developed in connection with the Company Business.
(c) All manufacturing operations conducted by or on behalf of the Company or any of the Selling Parties or any of their respective Affiliates in connection with the Company Business have been and are being conducted in accordance, in all material respects, with current Good Manufacturing Practices, as such term is defined by the FDA.
(d) None of the Selling Parties, the Company or any of their respective Affiliates, nor, to the Selling Parties’ Knowledge, any of their respective managers, directors, officers, or employees has committed any act, made any statement, or failed to make any statement, including with respect to any scientific data or information, that could provide a basis for the FDA to invoke the FDA policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of the Selling Parties, the Comp...
Regulatory Matters. (a) ▇▇▇▇▇ Fargo and Norwest shall promptly prepare and file with the SEC the Joint Proxy Statement and Norwest 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 ▇▇▇▇▇ Fargo and Norwest shall use their reasonable best efforts to have the S-4 declared effective under the Securities Act as promptly as practicable after such filing, and ▇▇▇▇▇ Fargo and Norwest shall thereafter mail or deliver the Joint Proxy Statement to their respective stockholders. Norwest 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 ▇▇▇▇▇ Fargo shall furnish all information concerning ▇▇▇▇▇ Fargo and the holders of ▇▇▇▇▇ Fargo Capital 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, 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, without limitation, the Merger) and the Option Agreements, and to comply with the terms and conditions of all such permits, consents, approvals and authorizations of all such Governmental Entities. ▇▇▇▇▇ Fargo and Norwest 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 Norwest or ▇▇▇▇▇ Fargo, as the case may be, and any of their respective Subsidiaries, which appear in any filing made with, or written materials submitted to, any third party or any Governmental Entity in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto shall act reasonably and as promptly as practicable. The parties hereto agree that they will consult with each other with respect to the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary or advisable to consummate the transactions contemplated by this Agreement and the Option Agreem...
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 shall, and shall cause their respective Affiliates to, cooperate with each other and use their reasonable best efforts to as promptly as practicable after the date hereof prepare and file, or cause to be prepared and filed, all necessary documentation to effect all applications, notices, petitions and filings with, and to obtain as promptly as practicable after the date hereof all permits, consents, approvals, waivers and authorizations of, all third parties and Governmental Entities that are necessary or advisable to timely consummate the transactions contemplated by this Agreement, including under the HSR Act. Subject to the foregoing, the Parties agree to use their reasonable best efforts to satisfy any conditions or requirements imposed by any Governmental Entity in connection with the consummation of the transactions contemplated by this Agreement. Each party hereto (the “Reviewing Party”) will have the right to review in advance, and the other party (the “Filing Party”) will consult with the Reviewing Party on, all the information relating to the Reviewing Party and its Affiliates that appears in any filing or written materials submitted by the Filing Party to any third party or any Governmental Entity in connection with the transactions contemplated by this Agreement. The Parties agree that they will consult with each other with respect to the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary or advisable to consummate the transactions contemplated by this Agreement and that each party will keep the other parties reasonably apprised in a timely manner of the status of matters relating to completion of the transactions contemplated herein. Each of the Parties agrees that none of the information regarding it or any of its Affiliates supplied or to be supplied by it, or to be supplied on its behalf, in writing specifically for inclusion in any documents to be filed with any Governmental Entity in connection with the transactions contemplated hereby will, at the respective times such documents are filed with any Governmental Entity, 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. Each Party shall promptly advise the other Parties upon receiving any communication from any Governmental...
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) As promptly as practicable following the date of this Agreement, Cascade shall promptly prepare and file with the SEC the S-4, in which the Joint Proxy Statement will be included. Each of Cascade and Home shall use its commercially reasonable best efforts to respond as promptly as practicable to any written or oral comments from the SEC or its staff with respect to the S-4 or any related matters. Each of Home and Cascade shall use its commercially reasonable best efforts to have the S-4 declared effective under the Securities Act as promptly as practicable after such filing and to maintain such effectiveness for as long as necessary to consummate the Merger and the other transactions contemplated by this Agreement. Upon the S-4 being declared effective, Home and Cascade shall thereafter mail or deliver the Joint Proxy Statement to their respective shareholders. Cascade shall also use its commercially 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 Home shall furnish all information concerning Home and the holders of Home Common Stock as may be reasonably requested in connection with any such action. If at any time prior to the Effective Time any event occurs or information relating to Home or Cascade, or any of their respective affiliates, directors or officers, should be discovered by Home or Cascade that should be set forth in an amendment or supplement to either the S-4 or the Joint Proxy Statement, so that either such document would not include any misstatement of a material fact or omit to state any material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, the party that discovers such information shall promptly notify the other party hereto and an appropriate amendment or supplement describing such information shall be promptly filed with the SEC and, to the extent required by applicable law, disseminated to Home’s shareholders.
(b) In addition to their obligations pursuant to Section 6.1(a), Cascade shall make all necessary filings with respect to the Merger and the other transactions contemplated by this Agreement under the Securities Act, the Exchange Act and applicable foreign or state securities or “Blue Sky” laws and regulations promulgated thereunder and provide Home with copies of any such filings. Cascade shall advise Home, promptly afte...