INSPECTIONS AND CONTROLS Sample Clauses

INSPECTIONS AND CONTROLS. 3.1 Subject to confidentiality obligations contained in Section 7, Sumika agrees to allow inspections of its manufacturing facilities in which the Compound is being manufactured, analyzed or tested, by representatives of BioNumerik or Grelan Pharmaceutical Co., Ltd. ("Grelan"), as well as FDA and other material regulatory authorities of the U.S. or other governments, during normal working hours upon prior written notice to Sumika. Sumika shall grant access to such premises and to the documentation necessary for or appropriate to the manufacturing and quality control of the Compound. BioNumerik shall cause Grelan to comply with the Confidentiality obligations set forth in this Agreement and shall be responsible for any breach of such obligations by Grelan. 3.2 Sumika shall ensure all manufacturing, test and inspection equipment is maintained under a documented calibration program that is ISO9002 and ICH compliant. This includes providing equipment calibration certifications as required. 3.3 Sumika will maintain environmental controls, including particulate and bioburden monitoring, pest controls and housekeeping procedures in accordance with FDA cGMP, ISO9002 and ICH regulations and guidelines. The use of supplies of process water, air and particulate handling, etc., for cGMP manufacture of the Compound, shall be consistent with FDA cGMP specifications and ICH regulations and guidelines. 3.4 Sumika shall maintain a Quality Control department, which is a distinct department separate from manufacturing. Sumika Quality Control/Quality Assurance will perform incoming, in-process and finished product inspections, review records, perform line clearances, maintain batch history records, provide batch history records for review and accuracy and completeness and provide product release services in accordance with cGMP and ICH regulations and guidelines. 3.5 Sumika will promptly notify BioNumerik of any FDA or other material regulatory inspection of Sumika related to the Compound, and will promptly provide BioNumerik with a copy of documentation and Sumika's correspondence and plans to address any deficiencies relating to such inspection.
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INSPECTIONS AND CONTROLS. 3.1 Subject to confidentiality obligations contained in Section 7, RPS agrees, without additional charge to BioNumerik, to allow inspections of its manufacturing facilities in which the Compound is being manufactured, analyzed or tested, by representatives of BioNumerik or its agents (including inspections by regulatory authorities) during normal working hours upon prior written notice to RPS, which notice will occur at least three days in advance of the inspection, unless not possible with respect to an inspection by a regulatory agency. RPS shall grant access to such premises and to the documentation necessary for or appropriate to the manufacturing and quality control of the Compound. During such visits, RPS shall make sure that at least one technical person from each of Quality Assurance, Quality Control, project teams, and, if reasonably possible, business development/coordination is present to answer questions or discuss matters of concern with the BioNumerik personnel conducting such audit or inspection. 3.2 RPS shall ensure all relevant and/or critical manufacturing, test and inspection equipment is maintained under a documented calibration and maintenance program. This includes providing equipment calibration certifications as required. 3.3 RPS will maintain environmental controls, including particulate and bioburden monitoring, pest controls and housekeeping procedures in accordance with FDA cGMP and ICH guidelines. The use of supplies of process water, air and particulate handling, etc., for cGMP manufacture of the Compound, shall be consistent with relevant FDA cGMP specifications and ICH guidelines. 3.4 RPS shall maintain a quality control department, which is a distinct department separate from manufacturing. RPS quality control/quality assurance will perform incoming, in-process and finished product inspections, review records, perform line clearance inspections, maintain batch history records, provide batch history records for review and accuracy and completeness and provide product release services. RPS [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. will promptly inform BioNumerik of any changes in management control related to the work conducted hereunder. 3.5 The conditions to be maintained for the storage of API, raw materials, and intermediates are set forth on Annex 7. 3.6 RPS will promptly notify BioNum...
INSPECTIONS AND CONTROLS. After due notice to the Supplier, the Buyer is authorised to make inspection visits to the latter and/or to sub- suppliers at any time in order to verify the quality standards of the supply and the Order’s progress. To this end, the Supplier agrees to guarantee free access to its premises and those of any third parties, subject to prior notice. The Supplier also agrees to perform the checks, tests and inspections requested by the Buyer, showing the relevant documentation and the results of the tests performed if necessary. If upon completion of the inspections of the Supplier's premises the Buyer finds that the execution of the supply is not proceeding in accordance with the established conditions and/or does not comply with the agreed quality standards, the Buyer shall be entitled to take action directly or through a third party, charging the relevant expenses to the Supplier, or to fully or partially terminate the Contract at its sole discretion.

Related to INSPECTIONS AND CONTROLS

  • Inspection of Property; Books and Records; Discussions Keep proper books of records and account in which full, true and correct entries in conformity with GAAP and all Requirements of Law shall be made of all dealings and transactions in relation to its business and activities; and permit representatives of any Lender (upon reasonable advance notice coordinated through the Administrative Agent) to visit and inspect any of its properties and examine and make abstracts from any of its books and records at any reasonable time and as often as may reasonably be desired and to discuss the business, operations, properties and financial and other condition of the Borrower and its Subsidiaries with officers and employees of the Borrower and its Subsidiaries and with its independent certified public accountants.

  • Books and Records; Inspection and Examination The Borrower will keep accurate books of record and account for itself pertaining to the Collateral and pertaining to the Borrower's business and financial condition and such other matters as the Lender may from time to time request in which true and complete entries will be made in accordance with GAAP and, upon the Lender's request, will permit any officer, employee, attorney or accountant for the Lender to audit, review, make extracts from or copy any and all corporate and financial books and records of the Borrower at all times during ordinary business hours, to send and discuss with account debtors and other obligors requests for verification of amounts owed to the Borrower, and to discuss the Borrower's affairs with any of its directors, officers, employees or agents. The Borrower will permit the Lender, or its employees, accountants, attorneys or agents, to examine and inspect any Collateral, other collateral covered by the Security Documents or any other property of the Borrower at any time during ordinary business hours.

  • 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.

  • 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.

  • Maintaining Records; Access to Properties and Inspections Maintain financial records in accordance with GAAP and, upon reasonable notice, permit any representatives designated by the Administrative Agent or any Lender to visit and inspect the financial records and the properties of the Borrower or any Significant Subsidiary during normal business hours and to discuss the affairs, finances and condition of the Borrower or any Significant Subsidiary with the officers thereof and independent accountants therefor.

  • Inspection of Property, Books and Records The Borrower will keep, and will cause each Subsidiary to keep, proper books of record and account in which full, true and correct entries shall be made of all dealings and transactions in relation to its business and activities; and will permit, and will cause each Subsidiary to permit, representatives of any Bank at such Bank's expense to visit and inspect any of their respective properties, to examine and make abstracts from any of their respective books and records and to discuss their respective affairs, finances and accounts with their respective officers, employees and independent public accountants, all at such reasonable times and as often as may reasonably be desired.

  • Inspection; Compliance Lessor and Lessor's Lender(s) (as defined in Paragraph 8.3(a)) shall have the right to enter the Premises at any time, in the case of an emergency, and otherwise at reasonable times, for the purpose of inspecting the condition of the Premises and for verifying compliance by Lessee with this Lease and all Applicable Laws (as defined in Paragraph 6.3), and to employ experts and/or consultants in connection therewith and/or to advise Lessor with respect to Lessee's activities, including but not limited to the installation, operation, use, monitoring, maintenance, or removal of any Hazardous Substance or storage tank on or from the Premises. The costs and expenses of any such inspections shall be paid by the party requesting same, unless a Default or Breach of this Lease, violation of Applicable Law, or a contamination, caused or materially contributed to by Lessee is found to exist or be imminent, or unless the inspection is requested or ordered by a governmental authority as the result of any such existing or imminent violation or contamination. In any such case, Lessee shall upon request reimburse Lessor or Lessor's Lender, as the case may be, for the costs and expenses of such inspections.

  • Inspections and Tests 26.1 The Supplier shall at its own expense and at no cost to the Procuring Entity carry out all such tests and/or inspections of the Goods and Related Services as are specified in the SCC. 26.2 The inspections and tests may be conducted on the premises of the Supplier or its Subcontractor, at point of delivery, and/or at the Goods' final destination, or in another place in Kenya as specified in the SCC. Subject to GCC Sub-Clause 26.3, if conducted on the premises of the Supplier or its Subcontractor, all reasonable facilities and assistance, including access to drawings and production data, shall be furnished to the inspectors at no charge to the Procuring Entity. 26.3 The Procuring Entity or its designated representative shall be entitled to attend the tests and/or inspections referred to in GCC Sub-Clause 26.2, provided that the Procuring Entity bear all of its own costs and expenses incurred in connection with such attendance including, but not limited to, all travelling and board and lodging expenses. 26.4 Whenever the Supplier is ready to carry out any such test and inspection, it shall give a reasonable advance notice, including the place and time, to the Procuring Entity. The Supplier shall obtain from any relevant third party or manufacturer any necessary permission or consent to enable the Procuring Entity or its designated representative to attend the test and/or inspection. 26.5 The Procuring Entity may require the Supplier to carry out any test and/or inspection not required by the Contract but deemed necessary to verify that the characteristics and performance of the Goods comply with the technical specifications codes and standards under the Contract, provided that the Supplier's reasonable costs and expenses incurred in the carrying out of such test and/or inspection shall be added to the Contract Price. Further, if such test and/or inspection impedes the progress of manufacturing and/or the Supplier's performance of its other obligations under the Contract, due allowance will be made in respect of the Delivery Dates and Completion Dates and the other obligations so affected. 26.6 The Supplier shall provide the Procuring Entity with a report of the results of any such test and/or inspection. 26.7 The Procuring Entity may reject any Goods or any part thereof that fail to pass any test and/or inspection or do not conform to the specifications. The Supplier shall either rectify or replace such rejected Goods or parts thereof or make alterations necessary to meet the specifications at no cost to the Procuring Entity, and shall repeat the test and/or inspection, at no cost to the Procuring Entity, upon giving a notice pursuant to GCC Sub- Clause 26.4. 26.8 The Supplier agrees that neither the execution of a test and/or inspection of the Goods or any part thereof, nor the attendance by the Procuring Entity or its representative, nor the issue of any report pursuant to GCC Sub-Clause 26.6, shall release the Supplier from any warranties or other obligations under the Contract.

  • Books and Records; Inspections Each Credit Party will, and will cause each of its Subsidiaries to, keep proper books of record and accounts in which full, true and correct entries in conformity in all material respects with GAAP shall be made of all dealings and transactions in relation to its business and activities. Each Credit Party will, and will cause each of its Subsidiaries to, permit any authorized representatives designated by the Administrative Agent at the request of the Requisite Lenders (including the right to appoint third party agents), at the Borrower’s expense (subject to the proviso below), to visit and inspect any of the properties of any Credit Party and any of its respective Subsidiaries, to inspect, copy and take extracts from its and their financial and accounting records, and to discuss its and their affairs, finances and accounts with its and their officers and independent public accountants (and an authorized representative of the Borrower shall be allowed to be present during such discussions), all upon reasonable notice and at such reasonable times during normal business hours and as often as may reasonably be requested, in each case, in a manner that does not unduly interfere with the business and operations of the Credit Parties and their Subsidiaries; provided that (i) the Borrower shall only be obligated to reimburse the Administrative Agent and the Requisite Lenders for the expenses of one such inspection per calendar year prior to the occurrence of an Event of Default; and (ii) any authorized representatives designated by any Lender (including the right to appoint third party agents) may accompany the Administrative Agent or its representative in connection with any inspection, in each case at such Lender’s sole expense; provided, further, that, notwithstanding anything to the contrary in this Section 5.6, none of Holdings or any of its Subsidiaries will be required to disclose, permit the inspection, examination or making copies or abstracts of, or discussion of, any document, information or other matter (a) in respect of which disclosure to the Administrative Agent or any Lender (or their respective representatives or contractors) is prohibited by law or any binding confidentiality obligation pursuant to any Contractual Obligation with any Third Party in effect prior to (and not entered into in contemplation of) such Credit Party’s or Subsidiary’s obligations under this Section 5.6 (it being understood and agreed that the Credit Parties shall use their commercially reasonable efforts to provide such information in a manner which would comply with such confidentiality obligation) or (b) that is subject to attorney-client or similar privilege or constitutes attorney work product.

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