Government Agency Inspections Sample Clauses

Government Agency Inspections. Communication and Requisitions Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. Patheon will notify Cangene within [**] Business Days of receipt of any notice of inspection from a regulatory authority and within [**] of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. Patheon will notify Cangene within [**] of receipt of any Form 483, warning letter, or the like from any regulatory agency that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. Suitable documentation in a redacted manner, if needed, will be presented. The responses from Patheon related to the Product will be reviewed and approved by Cangene prior to submission to the regulatory agency. Notwithstanding, Patheon reserves the right to respond to the regulatory agency without approval, if, in the reasonable opinion of Patheon’s Legal counsel, it is required to do so. If relevant inspections by Regulatory Authorities will be performed on Cangene’s Product, Cangene reserves the right to be in the Facility during such inspections. Inspections requirements must be communicated in a timely manner to Cangene. Quality QG01-05-T001-01 Agreement
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Related to Government Agency 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.

  • Governmental Review The Buyer understands that no United States federal or state agency or any other government or governmental agency has passed upon or made any recommendation or endorsement of the Securities.

  • System Agency Data A. As between the Parties, all data and information acquired, accessed, or made available to Grantee by, through, or on behalf of System Agency or System Agency contractors, including all electronic data generated, processed, transmitted, or stored by Grantee in the course of providing data processing services in connection with Xxxxxxx’s performance hereunder (the “System Agency Data”), is owned solely by System Agency. B. Grantee has no right or license to use, analyze, aggregate, transmit, create derivatives of, copy, disclose, or process the System Agency Data except as required for Grantee to fulfill its obligations under the Grant Agreement or as authorized in advance in writing by System Agency. C. For the avoidance of doubt, Grantee is expressly prohibited from using, and from permitting any third party to use, System Agency Data for marketing, research, or other non-governmental or commercial purposes, without the prior written consent of System Agency. D. Grantee shall make System Agency Data available to System Agency, including to System Agency’s designated vendors, as directed in writing by System Agency. The foregoing shall be at no cost to System Agency. E. Furthermore, the proprietary nature of Xxxxxxx’s systems that process, store, collect, and/or transmit the System Agency Data shall not excuse Xxxxxxx’s performance of its obligations hereunder.

  • Inspection Reports A "full inspection report" comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A "detailed report" responds to specific queries about a firm by the other Party.

  • Due Diligence Review; Information The Company shall make available, during normal business hours, for inspection and review by the Investors, advisors to and representatives of the Investors (who may or may not be affiliated with the Investors and who are reasonably acceptable to the Company), all financial and other records, all SEC Filings (as defined in the Purchase Agreement) and other filings with the SEC, and all other corporate documents and properties of the Company as may be reasonably necessary for the purpose of such review, and cause the Company’s officers, directors and employees, within a reasonable time period, to supply all such information reasonably requested by the Investors or any such representative, advisor or underwriter in connection with such Registration Statement (including, without limitation, in response to all questions and other inquiries reasonably made or submitted by any of them), prior to and from time to time after the filing and effectiveness of the Registration Statement for the sole purpose of enabling the Investors and such representatives, advisors and underwriters and their respective accountants and attorneys to conduct initial and ongoing due diligence with respect to the Company and the accuracy of such Registration Statement. The Company shall not disclose material nonpublic information to the Investors, or to advisors to or representatives of the Investors, unless prior to disclosure of such information the Company identifies such information as being material nonpublic information and provides the Investors, such advisors and representatives with the opportunity to accept or refuse to accept such material nonpublic information for review and any Investor wishing to obtain such information enters into an appropriate confidentiality agreement with the Company with respect thereto.

  • 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.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Grievance Investigations Where an employee has asked or is obliged to be represented by the Institute in relation to the presentation of a grievance and an employee acting on behalf of the Institute wishes to discuss the grievance with that employee, the employee and the representative of the employee will, where operational requirements permit, be given reasonable leave with pay for this purpose when the discussion takes place in the headquarters area of such employee and leave without pay when it takes place outside the headquarters area of such employee.

  • Investigation and Prevention DST shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to: (A) cooperate with Fund in its efforts to comply with statutory notice or other legal obligations applicable to Fund or its clients arising out of unauthorized access and to seek injunctive or other equitable relief; (B) cooperate with Fund in litigation and investigations against third parties reasonably necessary to protect its proprietary rights; and (C) take reasonable actions necessary to mitigate loss from any such authorized access.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

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