Regulatory Controls Sample Clauses

Regulatory Controls. 11.1 The Parties acknowledge and agree that the relevant MNO and the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which the MNO is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency: (i) require the MNO's Equipment to be modified, (ii) temporarily or permanently stop use of the MNO's Equipment, and/or (iii) deactivate any affected part of the Service, in its sole discretion. Where any such modification or deactivation is required:
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Regulatory Controls. 9.1 The Parties acknowledge and agree that the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which Freshwave is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency: (i) require the Equipment to be modified, (ii) temporarily or permanently stop use of the Equipment, and/or
Regulatory Controls. 11.1. The Parties acknowledge and agree that the relevant MNO and the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which the MNO is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency: (i) require the MNO's Equipment to be modified,
Regulatory Controls. Transferee covenants and agrees that it shall take all appropriate action to obtain such 21 consents, exceptions, exemptions or approvals of governmental authorities as may be necessary to permit it to comply fully with all of its covenants, stipulations , obligations and agreements contained in this Agreement. Transferor covenants to cooperate reasonably with Transferee in this regard. SECTION 4. 10 .
Regulatory Controls. Except as disclosed on the DISCLOSURE SCHEDULE, no Loan Party has received any notices concerning, and there are no existing orders of, proceedings pending before or other requirements of any Governmental Authority, expressly including the Bureau of Land Management, Minerals Management Service, or the Federal Energy Regulatory Commission and the comparable Governmental Authority for the States of Alabama, Colorado, Louisiana, Mississippi, Oklahoma, Texas and Utah, other than as may affect the oil and gas industry in general, which (a) could or will materially interfere with such Loan Party's development, production, operation, transportation and/or marketing of the such Loan Party's Oil and Gas Interests or (b) could or will require such Loan Party to refund any portion of the proceeds received or to be received from the sale of Hydrocarbons from such Loan Party's Oil and Gas Interests.
Regulatory Controls. 46 SECTION 5.20. Engineering Report..................................... 46 SECTION 5.21.
Regulatory Controls. 7.1. Filing/Registration Change Control CYTOVANCE and CLIENT QA shall jointly notify one another of any proposed change that might, in reasonable judgment, affect regulatory filing/registrations. These changes may include, but are not limited to, formulation change to Product or components, changes in manufacturing/packaging/testing site, equipment, batch size or process, test methods, etc. Prior approval from CLIENT QA/Regulatory Affairs is required prior to implementation of the changes that may impact the filing/registration. Any changes to CYTOVANCE documents and information contained in CLIENT’S regulatory Filings must be reviewed and approved by CLIENT QA/Regulatory Affairs prior to implementation at CYTOVANCE.
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Regulatory Controls. Transferee covenants and agrees that it shall take all appropriate action to obtain such consents, exceptions, exemptions or approvals of governmental -,-, authorities as may be necessary to permit it to comply fully with -... = -6,-.- all of its covenants, stipulations, obligations and agreements :.•L'A-J. contained in this Agreement. Transferor covenants to cooperate reasonably with Transferee in this regard. • .'''.:' SECTION 4.10. License and Accreditation. Transferee will • ,J-, :o procure and maintain in good standing a license from the State of Georgia to operate the System as a hospital. Transferee will . „ cause the System to have JCAHO accreditation throughout the term of this Agreement, or in the event that such accreditation is . .--0. superseded by comparable and federally recognized standards which -21- . . - -41 _ __ _ • ,7,3::,-, 4V y4?,. X. x- . ,, ',x,x, 1,„ : it1.4 provide for third party payor authorization, Transferee shall cause the System to obtain in a reasonable period of time such •.:m.1 other accreditation; provided, however, that Transferor may waive 4`. this requirement if the Board of Directors of Transferee shall vt,4-1 have determined in good faith, evidenced by a resolution of said --zi Board, that such compliance is not in Transferee's best interest :trlei and that lack of such compliance would not materially impair its W, ability to make the Required Payments hereunder. rf• SECTION 4.11. Medical Staff/Other Practitioners. Transferee dit't will, effective as of the Commencement Date, adopt the bylaws of ,,,, -• .,:, the System's medical staff and will extend privileges to all We: 4-i,f• 1- present members of the System's medical staff, affiliates, non-staff referring physicians and non-physician practitioners who *--., are in good standing, on the same terms as they presently enjoy. 44744: During the term of this Agreement, Transferee (i) will maintain fX: appropriate procedures for review and amendment of the medical Vlig P,-. staff bylaws of the System, and for appointment, reappointment, suspension and termination of medical staff privileges, (ii) shall WI: have the power and authority to grant temporary and emergency medical staff privileges to qualified new applicants, and 'es5--•,-Sk (iii) shall take all other actions which it may deem necessary or ' flt ,ikt, appropriate with respect to medical staff bylaws and privileges, 0 .,... ;M..11t including, without limitation, all final action regarding the ' granting, deni...
Regulatory Controls 

Related to Regulatory Controls

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • Regulatory Compliance a. Monitor compliance with the 1940 Act requirements, including:

  • Regulatory Consents The waiting period applicable to the consummation of the Merger under the HSR Act shall have expired or been earlier terminated.

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiaries: (i) are in compliance in all material respects with all statutes, rules, regulations, ordinances, orders and decrees applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursement, storage, import, export or disposal of any product manufactured or distributed by or for the Company or any of its subsidiaries (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to the knowledge of Company and its subsidiaries, have not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) have not received any Food and Drug Administration (“FDA”) Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) have not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of their respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (vi) have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion from any governmental authority or Institutional Review Board alleging that any of their respective operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (vii) have not received written notice that any governmental authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viii) have, or have had on their behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ix) have not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter or investigator notice relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company or any of its subsidiaries to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus. Neither the Company nor any of its subsidiaries has received any written notices or other correspondence from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or any of its subsidiaries or in which the Company or any of its subsidiaries has participated.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Regulatory Authority If any regulatory authority having jurisdiction (or any successor boards or agencies), a court of competent jurisdiction or other Governmental Authority with the appropriate jurisdiction (collectively, the ''Regulatory Body'') issues a rule, regulation, law or order that has the effect of cancelling, changing or superseding any term or provision of this Agreement (the ''Regulatory Requirement''), then this Agreement will be deemed modified to the extent necessary to comply with the Regulatory Requirement. Notwithstanding the foregoing, if a Regulatory Body materially modifies the terms and conditions of this Agreement and such modification(s) materially affect the benefits flowing to one or both of the Parties, as determined by either of the Parties within twenty (20) business days of the receipt of the Agreement as materially modified, the Parties agree to attempt in good faith to negotiate an amendment or amendments to this Agreement or take other appropriate action(s) so as to put each Party in effectively the same position in which the Parties would have been had such modification not been made. In the event that, within sixty (60) days or some other time period mutually agreed upon by the Parties after such modification has been made, the Parties are unable to reach agreement as to what, if any, amendments are necessary and fail to take other appropriate action to put each Party in effectively the same position in which the Parties would have been had such modification not been made, then either Party shall have the right to unilaterally terminate this Agreement forthwith.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Other Regulatory Approvals Each party hereto shall cooperate and use its reasonable best efforts to promptly prepare and file all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and use all reasonable efforts to obtain (and will cooperate with each other in obtaining) any consent, acquiescence, authorization, order or approval of, or any exemption or nonopposition by, any Governmental Entity required to be obtained or made by Parent or the Company or any of their respective Subsidiaries in connection with the Offer and the Merger or the taking of any other action contemplated by this Agreement.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

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