Notice of Audits and Inquiries Sample Clauses

Notice of Audits and Inquiries. (a) Manufacturer agrees to promptly notify Distributor of any audit requested by the FDA, a FDA Counterpart or any other Governmental Entity, of its facilities used for the Manufacture of the Products, or any request for information from the FDA, a FDA Counterpart or any other Governmental Entity, related to the Manufacture of Products, as soon as practicable after Manufacturer receives notice of such audit or request, but in any case no later than (i) two (2) days following the delivery or receipt of such request, if such request is written and (ii) one (1) day following the delivery or receipt of such request, if such request is not written. (b) Manufacturer agrees to provide Distributor with copies of all other correspondence from the FDA, a FDA Counterpart or any other Governmental Entity relating to the Products within one (1) week following the receipt of such correspondence. (c) Manufacturer agrees to (i) provide Distributor with copies of all of its correspondence relating to the Product in advance of any delivery to the FDA, a FDA Counterpart or any other Governmental Entity and a reasonable opportunity to review and comment on any such correspondence and (ii) shall consider in good faith all comments and input made by Distributor with respect thereto.
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Related to Notice of Audits and Inquiries

  • AUDITS AND INVESTIGATIONS 27.1 Each invoice paid by UNDP shall be subject to a post-payment audit by auditors, whether internal or external, of UNDP or by other authorized and qualified agents of UNDP at any time during the term of the Contract and for a period of three (3) years following the expiration or prior termination of the Contract. 27.2 UNDP may conduct investigations relating to any aspect of the Contract or the award thereof, the obligations performed under the Contract, and the operations of the Contractor generally relating to performance of the Contract at any time during the term of the Contract and for a period of three 27.3 The Contractor shall provide its full and timely cooperation with any such inspections, post- payment audits or investigations. Such cooperation shall include, but shall not be limited to, the Contractor’s obligation to make available its personnel and any relevant documentation for such purposes at reasonable times and on reasonable conditions and to grant to UNDP access to the Contractor’s premises at reasonable times and on reasonable conditions in connection with such access to the Contractor’s personnel and relevant documentation. The Contractor shall require its agents, including, but not limited to, the Contractor’s attorneys, accountants or other advisers, to reasonably cooperate with any inspections, post-payment audits or investigations carried out by UNDP hereunder. 27.4 UNDP shall be entitled to a refund from the Contractor for any amounts shown by such audits or investigations to have been paid by UNDP other than in accordance with the terms and conditions of the Contract. The Contractor also agrees that, where applicable, donors to UNDP whose funding is the source of, in whole or in part, the funding for the procurement of Goods and/or Services which are the subject of this Contract, shall have direct recourse to the Contractor for the recovery of any funds determined by UNDP to have been used in violation of or inconsistent with this Contract.

  • Submission of Audits and Financial Statements A. Audits Due the earlier of 30 days after receipt of the independent certified public accountant's report or nine months after the end of the fiscal year, Grantee shall submit electronically one copy of the single audit or program-specific audit to the System Agency via: i. HHS portal at: or, ii. Email to: xxxxxx_xxxxx_xxxxxx@xxxx.xxxxx.xx.xx. B. Financial Statements Due no later than nine months after the Grantee’s fiscal year end, Grantees which are not required to submit an audit, shall submit electronically financial statements via: i. HHS portal at: ii. Email to: xxxxxx_xxxxx_xxxxxx@xxxx.xxxxx.xx.xx.

  • COMPLAINTS AND INVESTIGATIONS 1. This article applies to complaints or allegations made externally and not from normal supervisory activities. 2. A department head shall be responsible for ensuring that all allegations of misconduct or other complaints against an employee on which any action is to be taken or a record is to be made shall be investigated. The investigator shall be allowed to interview the complainant prior to notifying the employee.

  • Audits and Inspections At any time during normal business hours and as often as the City may deem necessary, Service Provider shall make available to the City for the City’s examination all of Service Provider’s records and documents with respect to all matters covered by this Agreement and, furthermore, Service Provider will permit the City to audit, examine and make copies, excerpts or transcripts from such records, and to make audits of all contracts, invoices, materials, payrolls, records of personnel, conditions of employment and other data relating to all matters covered by this Agreement.

  • Certifications and Audits Company shall promptly complete and return to BNYM any certifications which BNYM in its sole discretion may from time to time send to Company, certifying that Company is using the Licensed System in strict compliance with the terms and conditions set forth in this Agreement. BNYM may, at its expense and after giving reasonable advance written notice to Company, enter Company locations during normal business hours and audit Company’s utilization of the Licensed System, the number of copies of the Documentation in Company’s possession, and the scope of use and information pertaining to Company’s compliance with the provisions of this Agreement. The foregoing right may be exercised directly by BNYM or by delegation to an independent auditor acting on its behalf. If BNYM discovers that there is any unauthorized scope of use or that Company is not in compliance with the aforementioned provisions, Company shall reimburse BNYM for the full costs incurred in conducting the audit.

  • Field Audits and Examination Reports; Confidentiality; Disclaimers by Lenders; Other Reports and Information By becoming a party to this Agreement, each Lender: (a) is deemed to have requested that Agent furnish such Lender, promptly after it becomes available, a copy of each field audit or examination report (each a "Report" and collectively, "Reports") prepared by Agent, and Agent shall so furnish each Lender with such Reports, (b) expressly agrees and acknowledges that Agent does not (i) make any representation or warranty as to the accuracy of any Report, and (ii) shall not be liable for any information contained in any Report, (c) expressly agrees and acknowledges that the Reports are not comprehensive audits or examinations, that Agent or other party performing any audit or examination will inspect only specific information regarding Borrowers and will rely significantly upon the Books, as well as on representations of Borrowers' personnel, (d) agrees to keep all Reports and other material, non-public information regarding Borrowers and their Subsidiaries and their operations, assets, and existing and contemplated business plans in a confidential manner; it being understood and agreed by Borrowers that in any event such Lender may make disclosures (a) to counsel for and other advisors, accountants, and auditors to such Lender, (b) reasonably required by any bona fide potential or actual Assignee or Participant in connection with any contemplated or actual assignment or transfer by such Lender of an interest herein or any participation interest in such Lender's rights hereunder, (c) of information that has become public by disclosures made by Persons other than such Lender, its Affiliates, assignees, transferees, or Participants, or (d) as required or requested by any court, governmental or administrative agency, pursuant to any subpoena or other legal process, or by any law, statute, regulation, or court order; provided, however, that, unless prohibited by applicable law, statute, regulation, or court order, such Lender shall notify Administrative Borrower of any request by any court, governmental or administrative agency, or pursuant to any subpoena or other legal process for disclosure of any such non-public material information concurrent with, or where practicable, prior to the disclosure thereof, and (e) without limiting the generality of any other indemnification provision contained in this Agreement, agrees: (i) to hold Agent and any such other Lender preparing a Report harmless from any action the indemnifying Lender may take or conclusion the indemnifying Lender may reach or draw from any Report in connection with any loans or other credit accommodations that the indemnifying Lender has made or may make to Borrowers, or the indemnifying Lender's participation in, or the indemnifying Lender's purchase of, a loan or loans of Borrowers; and (ii) to pay and protect, and indemnify, defend and hold Agent, and any such other Lender preparing a Report harmless from and against, the claims, actions, proceedings, damages, costs, expenses, and other amounts (including, attorneys fees and costs) incurred by Agent and any such other Lender preparing a Report as the direct or indirect result of any third parties who might obtain all or part of any Report through the indemnifying Lender. In addition to the foregoing: (x) any Lender may from time to time request of Agent in writing that Agent provide to such Lender a copy of any report or document provided by Borrowers to Agent that has not been contemporaneously provided by Borrowers to such Lender, and, upon receipt of such request, Agent shall provide a copy of same to such Lender, (y) to the extent that Agent is entitled, under any provision of the Loan Documents, to request additional reports or information from Borrowers, any Lender may, from time to time, reasonably request Agent to exercise such right as specified in such Lender's notice to Agent, whereupon Agent promptly shall request of Administrative Borrower the additional reports or information reasonably specified by such Lender, and, upon receipt thereof from Administrative Borrower, Agent promptly shall provide a copy of same to such Lender, and (z) any time that Agent renders to Administrative Borrower a statement regarding the Loan Account, Agent shall send a copy of such statement to each Lender.

  • AUDITS AND EXAMINATIONS 8.1. Each Party to this Agreement will be responsible for the accuracy and quality of its data as submitted to the other Party involved. Subject to each Party’s reasonable security requirements and except as may be otherwise specifically provided in this Agreement, either Party, at its own expense, may audit the other Party’s books, records and other documents directly related to billing and invoicing once in any twelve (12) month period for the purpose of evaluating the accuracy of the other Party’s billing and invoicing. "Audit" shall mean a comprehensive review of bills for services performed under this Agreement; "Examination" shall mean an inquiry into a specific element of or process related to bills for services performed under this Agreement. Either party (the “Requesting Party”) may perform one (1) Audit per twelve (12) month period commencing with the Effective Date, with the assistance of the other Party, which will not be unreasonably withheld. The Audit period will include no more than the preceding twelve (12) month period as of the date of the Audit request. The Requesting Party may perform Examinations, as it deems necessary, with the assistance of the other Party, which will not be unreasonably withheld.

  • INSPECTIONS AND AUDITS 30 A. ADMINISTRATOR, any authorized representative of COUNTY, any authorized representative 31 of the State of California, the Secretary of the United States Department of Health and Human Services, 32 the Comptroller General of the United States, or any other of their authorized representatives, shall have 33 access to any books, documents, and records, including but not limited to, financial statements, general 34 ledgers, relevant accounting systems, medical and client records, of CONTRACTOR that are directly 35 pertinent to this Agreement, for the purpose of responding to a beneficiary complaint or conducting an 36 audit, review, evaluation, or examination, or making transcripts during the periods of retention set forth 37 in the Records Management and Maintenance Paragraph of this Agreement. Such persons may at all 1 reasonable times inspect or otherwise evaluate the services provided pursuant to this Agreement, and the 2 premises in which they are provided. 3 B. CONTRACTOR shall actively participate and cooperate with any person specified in 4 Subparagraph A. above in any evaluation or monitoring of the services provided pursuant to this 5 Agreement, and shall provide the above–mentioned persons adequate office space to conduct such 6 evaluation or monitoring. 7 C. AUDIT RESPONSE 8 1. Following an audit report, in the event of non–compliance with applicable laws and 9 regulations governing funds provided through this Agreement, COUNTY may terminate this Agreement 10 as provided for in the Termination Paragraph or direct CONTRACTOR to immediately implement 11 appropriate corrective action. A plan of corrective action shall be submitted to ADMINISTRATOR in 12 writing within thirty (30) calendar days after receiving notice from ADMINISTRATOR. 13 2. If the audit reveals that money is payable from one party to the other, that is, reimbursement 14 by CONTRACTOR to COUNTY, or payment of sums due from COUNTY to CONTRACTOR, said 15 funds shall be due and payable from one party to the other within sixty (60) calendar days of receipt of 16 the audit results. If reimbursement is due from CONTRACTOR to COUNTY, and such reimbursement 17 is not received within said sixty (60) calendar days, COUNTY may, in addition to any other remedies 18 provided by law, reduce any amount owed CONTRACTOR by an amount not to exceed the 19 reimbursement due COUNTY. 20 D. CONTRACTOR shall retain a licensed certified public accountant, who will prepare an annual 21 Single Audit as required by 31 USC 7501 – 7507, as well as its implementing regulations under 2 CFR 22 Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal 23 Awards. CONTRACTOR shall forward the Single Audit to ADMINISTRATOR within fourteen (14) 24 calendar days of receipt. 25 E. CONTRACTOR shall forward to ADMINISTRATOR a copy of any audit report within 26 fourteen (14) calendar days of receipt. Such audit shall include, but not be limited to, management, 27 financial, programmatic or any other type of audit of CONTRACTOR’s operations, whether or not the 28 cost of such operation or audit is reimbursed in whole or in part through this Agreement. 29

  • Submitting Loop Makeup Service Inquiries 2.6.2.1 Comcast Phone may obtain LMU information by submitting a mechanized LMU query or a Manual LMUSI. Mechanized LMUs should be submitted through BellSouth's OSS interfaces. After obtaining the Loop information from the mechanized LMU process, if Comcast Phone needs further Loop information in order to determine Loop service capability, Comcast Phone may initiate a separate Manual Service Inquiry for a separate nonrecurring charge as set forth in Exhibit A of this Attachment. 2.6.2.2 Manual LMUSIs shall be submitted according to the guidelines in the LMU CLEC Information Package, incorporated herein by reference, as it may be amended from time to time, which can be found at the following BellSouth website: xxxx://xxxxxxxxxxxxxxx.xxxxxxxxx.xxx/guides/html/unes.html . The service interval for the return of a Manual LMUSI is three (3) business days. Manual LMUSIs are not subject to expedite requests. This service interval is distinct from the interval applied to the subsequent service order.

  • Pending Proceedings and Examinations The Registration Statement is not the subject of a pending proceeding or examination under Section 8(d) or 8(e) of the 1933 Act, and the Company is not the subject of a pending proceeding under Section 8A of the 1933 Act in connection with the offering of the Securities.

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