Client Inspections and Audits Sample Clauses

Client Inspections and Audits. A. During the Term of this Agreement, duly-authorized employees, agents and representatives of Client shall be granted access at a mutually agreed upon time during regular business hours to only the portion of the Facilities where Catalent Processes or Packages Product for the purpose of inspecting and verifying that Catalent is Processing or Packaging Product in accordance with cGMPs, the Specifications and the Product master batch record. For purposes of this Section 9.5, duly-authorized agents and representatives shall be required to sign Catalent’s standard Confidential Disclosure Agreement prior to being allowed access to Catalent’s Facilities. B. With due regard for information and operations which constitute Proprietary Information of Catalent, duly-authorized employees, agents and representatives of Client shall have the right to inspect Catalent Batch records relating to Product and those portions of Catalent’s Facilities used for Processing and Packaging Product. Client’s Quality Assurance Manager will arrange audit visits with Catalent Quality Management.
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Client Inspections and Audits. A. During the term of this Agreement, duly authorized employees, agents and representatives of Client shall be granted access upon at least twenty-four (24) hours’ prior notice and at reasonable times during Catalent’s regular business hours to only the portion of the Facilities where Catalent Processes Product for the purpose of inspecting and verifying that Catalent is Processing Product in accordance with the Specifications and Applicable Laws. For purposes of this Section 9.5, duly-authorized agents and representatives shall be required to sign Catalent’s standard confidential disclosure agreement prior to being allowed access to Catalent’s Facilities. Client shall indemnify and hold Catalent harmless for any action or activity of Client’s duly authorized employees and agents while on Catalent’s premises. B. With due regard to information and operations which constitute Proprietary Information of Catalent, duly-authorized employees, agents and representatives of Client shall have the right to inspect Catalent Batch Records relating to Product and those portions of Catalent’s Facilities used for Processing Product. Client’s Quality Assurance Manager will arrange audit visits with Catalent Quality Management.
Sample 1Sample 2See All (4)
Client Inspections and Audits. A. During the Term, duly-authorized employees, agents and representatives of Client shall be granted access upon at least [*] prior notice and at reasonable times during regular business hours to (i) the portion of the Facility where Catalent performs Processing, (ii) relevant personnel involved in Processing and (iii) Processing records described in Section 9.2, in each case solely for the purpose of inspecting and verifying that Catalent is Processing in accordance with cGMPs, the Specifications and the Product master Batch records. Client shall provide the name and title of each such employee, agent or representative to Catalent. Agents or independent contractors of Client shall be given access to Catalent’s Facility [*]. Client shall indemnify Catalent for any and all acts or omissions of Client’s employees, agents, and representative while on Catalent’s premises. B. Client’s Quality Assurance Manager will arrange audit visits with Catalent Quality Management. Inspections shall be designed to minimize disruption of operations at the Facility. Client may not conduct an inspection under this Section 9.5 more than [*] during any 12-month period; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or its Processing.
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Client Inspections and Audits. (a) During the Term, up to […***…] duly-authorized employees, agents and representatives of Client shall be granted access for a maximum of up to […***…] days (unless otherwise agreed to by PCI in writing) upon reasonable prior written notice and at reasonable times during regular business hours to (i) the portion of the Facility where PCI performs Packaging, (ii) relevant personnel involved in Packaging and (iii) Packaging records described in Section 9.2, in each case solely for the purpose of inspecting and verifying that PCI is Packaging in accordance with cGMPs and the Specifications. (b) Client will arrange audit visits with PCI Quality Management at least […***…] days in advance of such visit. Inspections shall be designed to minimize disruption of operations at the Facility. Client may not conduct an inspection under this Section 9.5 more than […***…] during any […***…] period; provided, that additional inspections may be conducted upon reasonable advance written notice in the event there is a material quality or compliance issue concerning Packaging. PCI will allow such an additional inspection within […***…] of the discovery of any material quality or compliance issue subject to the terms of the Quality Agreement. (c) During the Term, up to […***…] duly-authorized employees, agents and representatives of Client shall be granted access for a maximum of up to […***…] days (unless otherwise agreed to by PCI in writing) upon reasonable prior written notice and at reasonable times during regular business hours solely for the purpose of conducting an audit of Packaged Product, Client-supplied Materials, or other inventory of Client that is required to be audited for the purpose of preparing Client’s financial statements. (d) Employees, agents and representatives of Client performing an audit or inspection shall abide by all PCI safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance and must have the appropriate insurance in place to cover such responsibilities. Client shall indemnify and hold harmless PCI for Losses resulting from any action, omission or other activity of such representatives while on PCI’s premises. PCI reserves the right to require such representatives to enter into separate confidentiality agreements directly with PCI in such persons’ individual capacities on terms substantially similar to those set forth in Article 10.
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Client Inspections and Audits. (a) During the Term, up to [***] ([***]) duly-authorized employees, agents or representatives of Client shall be granted access for a maximum of up to [***] ([***]) [***] (unless otherwise agreed to by PCI in writing) upon reasonable prior written notice and at reasonable times during regular business hours to (i) the portion of a Facility where PCI performs Packaging, (ii) relevant personnel involved in Packaging and (iii) Records described in Section 10.2, in each case solely for the purpose of [***]. (b) Client will arrange audit visits with PCI Quality Management at least [***] ([***]) [***] in advance of such visit. Inspections shall be designed to minimize disruption of operations at such Facility. Client may not conduct an inspection under this Section 10.5 more than [***] during any [***] ([***])- [***] period; provided, that additional US-DOCS\111993788.6 054663-0011 inspections may be conducted upon reasonable advance written notice in the event there is a specific quality problem concerning Packaging. (c) The costs incurred by Client for any [***] audit, examination or inspection under this Section 10 will be borne by Client, except in the case of a “for cause” audit, in which case [***]. In all instances, PCI shall be solely responsible for its own costs, including without limitation any out-of-pocket costs that PCI may incur in connection with any audit, examination or inspection under this Section 10. (d) Employees, agents and representatives of Client performing an audit or inspection shall abide by all PCI safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance and must have the appropriate insurance in place to cover such responsibilities. [***] PCI reserves the right to require such representatives to enter into separate confidentiality agreements directly with PCI in such persons’ individual capacities on terms substantially similar to those set forth in Article 11.
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Client Inspections and Audits. A. During the Term, duly authorized employees, agents and representatives of Client shall be granted access upon at least [**] prior notice and at reasonable times during regular business hours to (i) the Client Space, (ii) relevant personnel involved in Processing and (iii) Processing records described in Section 12.1, in each case solely for the purpose of inspecting and verifying that Catalent is Processing in accordance with cGMPs, the Specifications and the Product master Batch records. For purposes of this Section 12.4, Client’s duly authorized agents and representatives shall be required to sign Catalent’s standard Confidential Disclosure Agreement prior to being allowed access to the Facility. B. Client’s Quality Assurance Manager will arrange audit visits with Catalent Quality Management. Inspections shall be designed to minimize disruption of operations at the Facility. Client may not conduct an inspection under this Section 12.4 more than [**] during any 12 month period; provided, that additional inspections maybe conducted in the event there is a material quality, for cause or compliance issue concerning Product or its Processing.
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Client Inspections and Audits. (a) During the Term, up to two duly-authorized employees, agents and representatives of Client shall be granted access for a maximum of up to [***] (unless otherwise agreed to by PCI in writing) upon reasonable prior written notice and at reasonable times during regular business hours to (i) the portion of the Facility where PCI performs Packaging, (ii) relevant personnel involved in Packaging and (iii) Packaging records described in Section 9.2, in each case solely for the purpose of inspecting and verifying that PCI is Packaging in accordance with cGMPs and the Specifications. (b) Client will arrange audit visits with PCI Quality Management at least 30 days in advance of such visit. Inspections shall be designed to minimize disruption of operations at the Facility. Client may not conduct an inspection under this Section 9.5 more than [***] during any 12-month period; provided, that additional inspections may be conducted upon reasonable advance written notice in the event there is a material quality or compliance issue concerning Packaging. (c) Employees, agents and representatives of Client performing an audit or inspection shall abide by all PCI safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance and must have the appropriate insurance in place to cover such responsibilities. Client shall indemnify and hold harmless PCI for Losses resulting from any action, omission or other activity of such representatives while on PCI’s premises. PCI reserves the right to require such representatives to enter into separate confidentiality agreements directly with PCI in such persons’ individual capacities on terms substantially similar to those set forth in Article 10.
Sample 1
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Client Inspections and Audits. A. During the Term and for *** years thereafter, or as otherwise required by Applicable Law, duly-authorized employees, agents and representatives of Client shall be granted access upon at least *** days prior notice and at reasonable times during regular business hours to (i) the portion of any Facility where Catalent performs Processing, Packaging, Validation Services, or Product Maintenance Services, (ii) relevant personnel involved in Processing, Packaging, Validation Services, or Product Maintenance Services and (iii) Processing, Packaging, Validation Services, or Product Maintenance Services records described in Section 9.2, in each case solely for the purpose of (1) inspecting and verifying that Catalent is Processing, Packaging, Validation Services, and Product Maintenance Services in accordance with cGMPs, this Agreement, the Specifications and the Product master Batch records and environmental, health and safety regulations, (2) performing inventories of the API and Client-supplied Materials, and (3) reviewing correspondence, reports, filings and other documents from or to Regulatory Authorities to the extent related to the Processing or Packaging of Product or the Validation Services or Product Maintenance Services. Client’s Representatives who are not employees of the Client may be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Any information obtained by Client through such inspections shall be treated as Confidential Information in accordance with Article 10 below. Catalent agrees to reasonably assist Client in the performance of any such inspections. B. Client’s Quality Assurance Manager will arrange audit visits with Catalent Quality Management. Inspections shall be designed to minimize disruption of operations at the applicable Facility. Subject to Section 4.6, Client may not conduct an inspection under this
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Related to Client Inspections and Audits

  • 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

  • Records and Audit/Inspections 6.13.1 A-E shall keep an accurate record of time expended by A-E and/or consultants employed by A-E in the performance of this CONTRACT. 6.13.2 Within ten (10) days of COUNTY's written request, A-E shall allow COUNTY or authorized State or Federal agencies or any duly authorized representative to have the right to access, examine, audit, excerpt, copy or transcribe any pertinent transaction, activity, time cards or other records relating to this CONTRACT. 6.13.3 A-E shall keep such material, including all pertinent cost accounting, financial records and proprietary data for a period of three (3) years after termination or completion of the CONTRACT or until resolution of any claim or dispute between the PARTIES, whichever is later. 6.13.4 Should A-E cease to exist as a legal entity, records pertaining to this CONTRACT shall be forwarded within a reasonable period of time not to exceed sixty (60) days to its successor in interest or surviving entity in a merger or acquisition, or, in the event of liquidation, to COUNTY.

  • INSPECTION AND AUDIT The CONTRACTOR shall maintain, and the LEA shall have the right to examine and audit all of the books, records, documents, accounting procedures and practices and other evidence that reflect all costs claimed to have been incurred or fees claimed to have been earned under this Agreement. CONTRACTOR shall provide access to LEA to all records including, but not limited to: student records as defined by California Education Code section 49061(b); registers and roll books of teachers; daily service logs and notes or other documents used to record the provision of related services; Medi-Cal/daily service logs and notes used to record provision of services provided by instructional assistants, behavior intervention aides, bus aides, and supervisors; absence verification records (parent/doctor notes, telephone logs, and related documents); bus rosters; staff lists specifying credentials held, business licenses held, documents evidencing other qualifications, social security numbers, dates of hire, and dates of termination; staff time sheets; non-paid staff and volunteer sign-in sheets; transportation and other related service subcontracts; school calendars; bell/class schedules when applicable; liability and worker’s compensation insurance policies; state NPS/A certifications; by-laws; lists of current board of directors/trustees, if incorporated; other documents evidencing financial expenditures; federal/state payroll quarterly reports Form 941/DE3DP; and bank statements and canceled checks or facsimile thereof. Such access shall include unannounced inspections by XXX. CONTRACTOR shall make available to LEA all budgetary information including operating budgets submitted by CONTRACTOR to LEA for the relevant contract period being audited. CONTRACTOR shall make all records available at the office of LEA or CONTRACTOR’s offices (to be specified by XXX) at all reasonable times and without charge. All records shall be provided to LEA within five (5) working days of a written request from XXX. CONTRACTOR shall, at no cost to LEA, provide assistance for such examination or audit. XXX’s rights under this section shall also include access to CONTRACTOR’s offices for purposes of interviewing CONTRACTOR’s employees. If any document or evidence is stored in an electronic form, a hard copy shall be made available to the LEA, unless the LEA agrees to the use of the electronic format. CONTRACTOR shall obtain from its subcontractors and suppliers written agreements to the requirements of this section and shall provide a copy of such agreements to LEA upon request by XXX. If an inspection, review, or audit by XXX, a state agency, a federal agency, and/or an independent agency/firm determines that CONTRACTOR owes LEA monies as a result of CONTRACTOR’s over billing or failure to perform, in whole or in part, any of its obligations under this Master Contract, LEA shall provide to CONTRACTOR written notice demanding payment from CONTRACTOR and specifying the basis or bases for such demand. Unless CONTRACTOR and XXX otherwise agree in writing, CONTRACTOR shall pay to LEA the full amount owed as result of CONTRACTOR’s over billing and/or failure to perform, in whole or in part, any of its obligations under this Master Contract, as determined by an inspection, review, or audit by XXX, a state agency, a federal agency, and/or an independent agency/firm. CONTRACTOR shall make such payment to LEA within thirty (30) days of receipt of XXX’s written notice demanding payment.

  • Right to Inspect and Audit AHS and the Minister shall have the right (including all access rights required) to inspect or audit the Facility and all of the equipment, Staff and records of the Operator (and to take copies of records where either desires to do so) related to Services performed or to be performed (and goods and services sold or otherwise provided to persons receiving such Services) at all reasonable times and without prior notice in cases of emergency or whenever there is any reasonable apprehension of any ongoing danger to Clients for the purposes of determining compliance with this Agreement, the accuracy of any information provided and compliance with all Applicable Laws.

  • Tests and Inspections § 15.5.1 Tests, inspections and approvals of portions of the Work shall be made as required by the Design-Build Documents and by applicable laws, statutes, ordinances, codes, rules and regulations or lawful orders of public authorities. Unless otherwise provided, the Design-Builder shall make arrangements for such tests, inspections and approvals with an independent testing laboratory or entity acceptable to the Owner, or with the appropriate public authority, and shall bear all related costs of tests, inspections and approvals. The Design-Builder shall give the Owner timely notice of when and where tests and inspections are to be made so that the Owner may be present for such procedures. The Owner shall bear costs of (1) tests, inspections or approvals that do not become requirements until after bids are received or negotiations concluded, and (2) tests, inspections or approvals where building codes or applicable laws or regulations prohibit the Owner from delegating their cost to the Design-Builder. § 15.5.2 If the Owner determines that portions of the Work require additional testing, inspection or approval not included under Section 15.5.1, the Owner will instruct the Design-Builder to make arrangements for such additional testing, inspection or approval by an entity acceptable to the Owner, and the Design-Builder shall give timely notice to the Owner of when and where tests and inspections are to be made so that the Owner may be present for such procedures. Such costs, except as provided in Section 15.5.3, shall be at the Owner’s expense. § 15.5.3 If such procedures for testing, inspection or approval under Sections 15.5.1 and 15.5.2 reveal failure of the portions of the Work to comply with requirements established by the Design-Build Documents, all costs made necessary by such failure shall be at the Design-Builder’s expense. § 15.5.4 Required certificates of testing, inspection or approval shall, unless otherwise required by the Design-Build Documents, be secured by the Design-Builder and promptly delivered to the Owner. § 15.5.5 If the Owner is to observe tests, inspections or approvals required by the Design-Build Documents, the Owner will do so promptly and, where practicable, at the normal place of testing. § 15.5.6 Tests or inspections conducted pursuant to the Design-Build Documents shall be made promptly to avoid unreasonable delay in the Work.

  • 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.

  • Books and Records; Inspection and Audit Rights Each of Holdings and the Borrower will, and will cause each Restricted Subsidiary to, maintain proper books of record and account in which entries that are full, true and correct in all material respects and are in conformity with GAAP consistently applied shall be made of all material financial transactions and matters involving the assets and business of Holdings, the Borrower or its Restricted Subsidiary, as the case may be. Each of Holdings and the Borrower will, and will cause each Restricted Subsidiary to, permit any representatives designated by the Administrative Agent or any Lender, upon reasonable prior notice, to visit and inspect its properties, to examine and make extracts from its books and records, and to discuss its affairs, finances and condition with its officers and independent accountants, all at such reasonable times and as often as reasonably requested; provided that, excluding any such visits and inspections during the continuation of an Event of Default, only the Administrative Agent on behalf of the Lenders may exercise visitation and inspection rights of the Administrative Agent and the Lenders under this Section 5.08 and the Administrative Agent shall not exercise such rights more often than two times during any calendar year absent the existence of an Event of Default and only one such time shall be at the Borrower’s expense; provided further that (a) when an Event of Default exists, the Administrative Agent or any Lender (or any of their respective representatives or independent contractors) may do any of the foregoing at the expense of the Borrower at any time during normal business hours and upon reasonable advance notice and (b) the Administrative Agent and the Lenders shall give Holdings and the Borrower the opportunity to participate in any discussions with Holdings’ or the Borrower’s independent public accountants.

  • 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.

  • Inspection and Audit of Records Any records or documents that Section 9.2 of this Agreement requires Consultant to maintain shall be made available for inspection, audit, and/or copying at any time during regular business hours, upon oral or written request of the City. Under California Government Code Section 8546.7, if the amount of public funds expended under this Agreement exceeds TEN THOUSAND DOLLARS ($10,000.00), the Agreement shall be subject to the examination and audit of the State Auditor, at the request of City or as part of any audit of the City, for a period of three (3) years after final payment under the Agreement.

  • ACCESS AND AUDITS The CONTRACTOR shall establish and maintain a reasonable accounting system, which enables ready identification of CONTRACTOR’S cost of goods and use of funds. Such accounting system shall also include adequate records and documents to justify all prices for all items invoiced as well as all charges, expenses and costs incurred in providing the goods for at least five (5) years after completion of this contract. The COUNTY or its designee shall have access to such books, records, subcontract(s), financial operations, and documents of the CONTRACTOR or its sub- Contractors as required to comply with this section for the purpose of inspection or audit anytime during normal business hours at the CONTRACTOR’S place of business. This right to audit shall include the CONTRACTOR’S sub-Contractors used to procure goods or services under the contract with the COUNTY. CONTRACTOR shall ensure the COUNTY has these same rights with sub-Contractor(s) and suppliers.

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