RoW - Regulatory Inspections Sample Clauses

RoW - Regulatory Inspections. If a Regulatory Authority in RoW desires to conduct an inspection or audit of MEI’s facilities or facilities under contract with MEI with regard to Manufacturing of the Compound or Product, MEI shall cooperate with such Regulatory Authority during such inspection or audit and shall [*CONFIDENTIAL*] details of which shall be discussed under the JP and RoW Quality Agreement. KKC shall reimburse MEI for any costs MEI incurs under this Section 6.1(f) (RoW - Regulatory Inspections) promptly following receipt of an invoice for any such costs. Notwithstanding anything to the contrary herein, and without limiting Section 13.5 (Special Indirect and Other Losses), MEI’s liability toward KKC caused by such a CMO’s failure to perform its obligation under this Section 6.1(f) (RoW - Regulatory Inspections) [*CONFIDENTIAL*]. For the avoidance of any doubt, this limitation of liability in the previous sentence shall not affect MEI’s liability toward KKC under any other Sections of this Agreement.
AutoNDA by SimpleDocs

Related to RoW - Regulatory Inspections

  • Regulatory Inspections Manufacturer will permit Rhythm or its agents to be present and participate in any visit or inspection by any Authority of the Facility (to the extent it relates in any way to any Product) or the Manufacturing Process. Manufacturer will give as much advance notice as reasonably possible to Rhythm of any such visit or inspection. Manufacturer will provide Rhythm with a copy of any report or other written communication * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Development and/or Manufacture of Product) or the Manufacturing Process, within two (2) business days after receipt, and will consult with, and require approval from, Rhythm before responding to each such communication. Manufacturer will provide Rhythm with a copy of its final responses within five (5) business days after submission.

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

  • Regulatory Information (a) All the notaries at De Pinna LLP are regulated through the Faculty Office of the Archbishop of Canterbury. Its address is The Faculty Office, 0 Xxx Xxxxxxxxx, Xxxxxxxxxxx, Xxxxxx XX0X 0XX, its telephone: 000 0000 0000, and it can be reached by email at xxxxxxx.xxxxxx@0xxxxxxxxxxxx.xxx. It also has a website at xxx.xxxxxxxxxxxxx.xxx.xx. (b) We are required to comply with the rules of professional conduct and other regulatory arrangements of the Master of the Faculties, the sole regulator of notarial activities under the Legal Services Act 2007. Information about those rules and regulations may be found at xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/i-am-a-notary/notaries-rules-regulations/. (c) We comply with the Code of Practice published by the Master of the Faculties: xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/code-of-practice.

  • Audits/Inspections Contractor agrees to permit the County’s Auditor-Controller or the Auditor- Controller’s authorized representative (including auditors from a private auditing firm hired by the County) access during normal working hours to all books, accounts, records, reports, files, financial records, supporting documentation, including payroll and accounts payable/receivable records, and other papers or property of Contractor for the purpose of auditing or inspecting any aspect of performance under this Contract. The inspection and/or audit will be confined to those matters connected with the performance of the Contract including, but not limited to, the costs of administering the Contract. The County will provide reasonable notice of such an audit or inspection. The County reserves the right to audit and verify the Contractor’s records before final payment is made. Contractor agrees to maintain such records for possible audit for a minimum of three years after final payment, unless a longer period of records retention is stipulated under this Contract or by law. Contractor agrees to allow interviews of any employees or others who might reasonably have information related to such records. Further, Contractor agrees to include a similar right to the County to audit records and interview staff of any subcontractor related to performance of this Contract. Should the Contractor cease to exist as a legal entity, the Contractor’s records pertaining to this Contract shall be forwarded to the County’s project manager.

  • OIG INSPECTION, AUDIT, AND REVIEW RIGHTS ‌ In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine or request copies of Xxxxxx’x books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Xxxxxx’x locations for the purpose of verifying and evaluating: (a) Xxxxxx’x compliance with the terms of this IA and (b) Xxxxxx’x compliance with the requirements of the Federal health care programs. The documentation described above shall be made available by Xxxxxx to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview Xxxxxx and any of Xxxxxx’x employees or contractors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Xxxxxx shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Xxxxxx’x employees and contractors may elect to be interviewed with or without a representative of Xxxxxx present.

  • Safety Inspection During inspection of County facilities conducted by the State Division of Occupational Safety and Health for the purpose of determining compliance with the California OSHA requirements, an OCEA designated employee shall be allowed to accompany the inspector while the inspector is in the employee's agency/department. The employee so designated shall suffer no loss of pay when this function is performed during the employee's regularly scheduled work hours.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • 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.

  • Investigatory Interview When the employee under investigation is to be interviewed concerning the alleged conduct which could result in discharge or other discipline, the employee and his or her representative shall be notified in writing, at least forty-eight (48) hours prior to the interview. In the event of an emergency, such reasonable notice as the circumstances permit shall be given. The notice shall state that an official investigation is being conducted and shall state the subject matter of the investigatory interview. a. Prior to being interviewed pursuant to this section, the employee shall be afforded a reasonable opportunity and facilities to contact and consult privately with his or her union representative or union attorney. b. Any interview of an employee under this section shall be conducted at a reasonable time, at a suitable location and, when practicable, on the department’s premises when the employee is on duty. The union representative or union attorney may participate in the interview. c. The interview shall be limited to questions that are directly, narrowly, and specifically related to the employee’s job performance as it relates to the allegation(s) or complaints. The employee shall not be subjected to any offensive language nor be threatened with transfer, dismissal or other disciplinary action. Confidentiality of the interview shall be maintained.

  • Voltage Regulators Whenever the Large Generating Facility is operated in parallel with the New York State Transmission System, the automatic voltage regulators shall be in automatic operation at all times. If the Large Generating Facility’s automatic voltage regulators are not capable of such automatic operation, the Developer shall immediately notify NYISO, or its designated representative, and ensure that such Large Generating Facility’s real and reactive power are within the design capability of the Large Generating Facility’s generating unit(s) and steady state stability limits and NYISO system operating (thermal, voltage and transient stability) limits. Developer shall not cause its Large Generating Facility to disconnect automatically or instantaneously from the New York State Transmission System or trip any generating unit comprising the Large Generating Facility for an under or over frequency condition unless the abnormal frequency condition persists for a time period beyond the limits set forth in ANSI/IEEE Standard C37.106, or such other standard as applied to other generators in the New York Control Area on a comparable basis.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!