Company Inspections and Audits Sample Clauses

Company Inspections and Audits. (i) Takeda shall allow an [***] pre-scheduled audit to perform inspections of the authorized facilities and all documents relevant to the Bulk Drug Product(s) and/or service(s) provided under this Agreement, with prior notification of [***] by Company, with up to [***] Company auditors (or a Third Party designee) access to the premises for up to [***], or as many days as appropriate relative to such service(s) or Bulk Drug Product(s). Takeda shall cooperate, and shall use reasonable efforts to cause the contract facility to cooperate, with Company during such inspection. As necessary, Company shall provide a request in advance when additional time is needed to conduct audit activities. As often as necessary, Takeda shall allow ‘for cause’ audits with immediate notice, or for other audits such as for pre-approval inspection readiness with advanced notice from the Company. (ii) During such audits, Takeda shall allow Company the right to observe the service(s) provided under this Agreement and to observe the use of all associated raw materials and packaging components for the Bulk Drug Product(s) to ensure adherence to the agreed upon standards. (iii) Company shall provide to Takeda a detailed audit observation report, listing all observations, if any, as discussed during the on-site audit (the “Audit Report”) within [***]. Takeda shall provide to Company a written response, including corrective actions and preventative actions (“CAPA”) plan for all observations documented in the Audit Report, within [***] of receipt thereof. (iv) Takeda shall ensure timely resolution of all deficiencies identified by Company within the committed timeframe.
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Related to Company 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

  • 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.

  • 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.

  • 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.

  • 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.

  • Records and Audits The Contractor shall maintain accounts and records, including personnel, property, and financial records, adequate to identify and account for all costs pertaining to the Contract and such other records as may be deemed necessary by the City to assure proper accounting for all project funds. These records will be made available for audit purposes to the City or any authorized representative, and will be retained for three years after the expiration of this Contract.

  • 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.

  • Environmental Reports and Audits As soon as practicable following receipt thereof, copies of all environmental audits and reports with respect to environmental matters at any Facility or which relate to any environmental liabilities of Holdings or its Subsidiaries which, in any such case, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect;

  • Records and Audit A. Concessionaire shall maintain complete, accurate, and detailed accounting records of all transactions pertaining to the Concession Operation covered by this Agreement that will enable Concessionaire to prepare financial statements in accordance with generally accepted accounting principles. Concessionaire shall make such records available to any authorized representative of Department upon request, as often as it is deemed necessary by Department, to determine the effectiveness of the financial management system and internal procedures that have been established by Concessionaire, and to ensure compliance with the terms and conditions of this Agreement and that the financial statements and reports present fairly the results of Concessionaire's operations pursuant to this Agreement. Failure to do so shall be a material breach of this Agreement. Said records shall be maintained and made available to Department and the State of New Jersey for a period of seven (7) years after the termination or expiration of this Agreement. B. Concessionaire shall utilize a cash register as part of the Concession Operation. Concessionaire may request Department approval to also or alternatively utilize a Point of Service (POS) device. If approved in writing by Department, Concessionaire may then utilize a POS device as part of the Concession Operation. Any use of a POS device as part of the Concession Operation without the required prior Department-written approval shall be a material breach of this Agreement, subject to Suspension of Operations and/or Termination in accordance with the Terms and Conditions set forth in Paragraphs 9 and 10. C. All sales shall be recorded by means of cash registers or Department-approved POS devices that publicly display the amount of each sale and automatically issue a customer receipt or certify the amount recorded on a sales slip. Said cash registers or Department-approved POS devices shall, in all cases, have locked-in sales totals and transactions counters that constantly accumulate and that cannot, in either case, be reset. In addition, such cash registers must have a tape located within the register upon which transaction numbers and sales details are imprinted. Beginning and ending cash register or Department-approved POS device readings shall be recorded on a daily basis. In the event of technical or electrical failure of the cash register or Department-approved POS device, Concessionaire shall record all transactions by hand and issue a sequentially pre-numbered customer receipt in like manner. Failure to have a working cash register or Department-approved POS device shall be a material breach of this Agreement subject to immediate Suspension of Operations and/or Termination in accordance with the terms and conditions set forth in Paragraphs 9 and 10. Each cash register or Department-approved POS device must have the following: ● Dual Tape/Readable tape/or Electronic Report that records individual sales, total sales, and can generate a receipt (customer must be offered a paper or electronic receipt upon request) ● Customer Display ● Continuous grand total Each cash register must have the following: • Cumulative “Z” counter • Current printed date on detail tape

  • 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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