Agency Inspection Sample Clauses

Agency Inspection. Cardinal Health hereby agrees to advise Purchaser promptly; but not later than two business days, of any proposed or, scheduled or unannounced inspection of the Product(s), Packaged Products or Packaging process or procedures by any Agency and will, to the extent practicable, permit Purchaser to be present during any such inspection. If Purchaser is not present during such an inspection, Cardinal Health shall promptly provide a report of the results of the inspection to Purchaser.
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Agency Inspection. API shall permit the FDA and other Agencies to conduct inspections of the Facility as they may request, including pre-approval inspections, and shall cooperate with such Agencies with respect to the inspections and any related matters, in each case which is related to the Products, Packaging of the Product, Packaged Products, or this Agreement. API hereby agrees to advise Purchaser promptly (within twenty-four (24) hours if possible) of any proposed or unannounced inspection by any Agency of the Product(s), Packaged Products or Packaging process or procedures and will, to the extent possible, permit a representative of Purchaser to be present at such inspections and assist in the preparation thereof, including actions taken by API to remedy conditions cited in the inspections, and shall provide a report of the results of the inspection issued by the inspectors to Purchaser and a copy of the API response to the inspection report, and all subsequent material correspondences referring to the aforementioned inspection(s) (including, but not limited to, FDA Form 483). API shall keep Purchaser informed about the results and conclusions of each such regulatory inspection, and if API fails such inspection or is required to take actions to be in compliance with the inspector’s requirements, API shall inform Purchaser, in writing, of the steps API is taking and/or response to the inspector if API disagrees with the inspector’s assessment. Similarly, API agrees to promptly notify and provide Purchaser copies of any request, directive or other communication of the FDA or other Agency relating to Products, Packaging, Packaged Products or this Agreement, and to cooperate with Purchaser in responding to such requests, directives and communications.
Agency Inspection. In each case, to the extent permitted under its Upstream Supply Agreements, (a) CytoDyn hereby agrees to immediately notify Vyera in writing in the event that CytoDyn is notified of any proposed visit or inspection by any Governmental Authority, including, any Agency (such as the FDA) or any environmental regulatory authority if such visit or inspection has the potential to impact Product, and (b) CytoDyn shall promptly (and in no event later than one (1) Business Day) furnish Vyera summaries of all reports, documents or correspondence with respect to any Agency requests or inspections of the Facility related to the Manufacture of the Product as well as a copy of each such report, document or correspondence, including but not limited to any Form 483 or Establishment Inspection Report (EIR). To the extent permitted under its Upstream Supply Agreements, CytoDyn shall also provide Vyera any proposed corrective actions, responses and other changes arising out of such review or inspection by such Agency.
Agency Inspection. Bachem shall immediately notify Apellis in writing in the event that Bachem is notified of any proposed visit or inspection by any governmental authority, including, any Agency (such as the FDA or Swissmedic) or any environmental regulatory authority if such visit or inspection is related to Drug Substance. Apellis shall have the right to be onsite during the visit or inspection, but shall not be allowed participate in the inspection unless it is a pre-approval inspection.. Bachem shall promptly (and in no event later than [**]) furnish Apellis with copies of all reports, documents or correspondence with respect to any Agency requests or inspections of the Facility related to the Manufacture of the Drug Substance, including but not limited to any Form 483 or Establishment Inspection Report (EIR) relating to the Manufacture of the Drug Substance. Bachem shall also provide Apellis any proposed corrective actions, responses and other changes arising out of such review or inspection by such Agency that is related to the Drug Substance.
Agency Inspection. PCI hereby agrees to advise the Purchaser promptly ----------------- in writing of any proposed or unannounced inspection of the Product(s), Packaged Products or Packaging process or procedures by any Agency and will, to the extent practicable, permit the Purchaser to be present during any such inspection. If the Purchaser is not present during such an inspection, PCI shall promptly provide a report of the results of the inspection to the Purchaser. PCI shall promptly provide Purchaser with a copy of any report, citation, or the like provided to PCI by such Agency relating to Product(s), Packaged Product(s) or the Package processes.
Agency Inspection. A. The Client Agency’s designated representative reserves the right to inspect all of the Contractor’s work that is performed under the terms and conditions of this Contract. After inspection, all work that is found to be outside the scope of manufacturer’s recommendations, or that has in anyway corrupted or compromised the functional integrity of the temperature control and mechanical systems, shall be promptly corrected at no additional charge to the Client Agency.
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Agency Inspection. Tazza hereby agrees to advise Xxxxxxxx immediately of any proposed or scheduled or unannounced inspection of the Products, Packaged Products or Packaging by any Agency. Tazza will, to the extent permitted by the relevant Agency, permit Aberrant to be present during an Agency inspection. Tazza shall promptly provide a written report to Aberrant of the results of the inspection regardless of whether Aberrant attends the inspection.

Related to Agency Inspection

  • Records; Inspection Payor shall keep, and shall require its Permitted Sellers to keep, complete, true and accurate books of accounts and records for the purpose of determining the basis and accuracy of payments to be made under this Agreement. Such records shall be kept in accordance with GAAP, showing Net Sales on country-by-country and Licensed Product-by-Licensed Product basis, and Payor’s or its Permitted Sellers’ usual internal practices and procedures (which shall be commercially reasonable), consistently applied. Such books and records shall be kept for at least [*] ([*]) years following the end of the Calendar Quarter to which they pertain. Such records will be open for inspection by Payee during such five (5) year period by independent accountants reasonably acceptable to Payor, solely for the purpose of verifying the basis and accuracy of amounts in the payment statements hereunder. Such inspections shall be made no more than [*] each Calendar Year, at reasonable time and on reasonable notice and shall be limited to information related to Licensed Products. Results of any such inspection shall be deemed to be Confidential Information of Payor. If any errors in favor of Payor are discovered in the course of such inspection, then within thirty (30) days of written request by Payee, Payor shall pay Payee those amounts that Payee would have received in the absence of such errors, plus interest pursuant to and in accordance with Section 6.1(c). Inspections conducted under this Section 6.5 shall be at the expense of Payee, unless a variation or error in favor of Payor exceeding [*] percent ([*] %) of the amount due for the period covered by the inspection is established in the course of such inspection, whereupon all reasonable, documented costs relating to the inspection for such period will be paid promptly by Payor. In the event of overpayment to Payee, any amount of such overpayment shall be fully creditable against amounts payable for the immediately succeeding Calendar Quarter.

  • Site Inspection Where a site inspection is required by the Bid Specifications or Project Definition, Bidder shall be required to inspect the site, including environmental or other conditions for pre-existing deficiencies that may affect the installed Product, equipment, or environment or services to be provided and, which may affect Bidder’s ability to properly deliver, install or otherwise provide the required Product. All inquiries regarding such conditions shall be made in writing. Bidder shall be deemed to have knowledge of any deficiencies or conditions which such inspection or inquiry might have disclosed. Bidder must provide a detailed explanation with its Bid if additional work is required under this clause in order to properly complete the delivery and installation of the required Product or provide the requested service.

  • Property Inspection The Servicer is required to inspect each Delinquent Mortgaged Property at such time and in such manner as is in accordance with Prudent Servicing Practices. The Servicer must prepare a Property Inspection Report following each inspection. All Property Inspection Reports must be retained by the Servicer and copies thereof must be forwarded to the Master Servicer promptly upon request. All expenses related to the foregoing shall be recoverable by the Servicer from the Principal or from Liquidation Proceeds, Insurance Proceeds, payments on the related Mortgage Loan or any other source relating to the related Mortgage Loan or the related Mortgaged Property. The foregoing shall not preclude the Servicer from recovering such expenses from the Borrower to the extent permitted by applicable law and the related Mortgage Loan Documents.

  • Final Inspection Contractor shall complete the list of items identified on the pre-final Punchlist prior to requesting a final inspection. Unless otherwise specified, or otherwise agreed in writing by the parties as documented on the Certificate of Substantial Completion, Contractor shall complete and/or correct all Work within thirty (30) days of the Substantial Completion date. Upon completion of the pre-final Punchlist work, Contractor shall give written notice to ODR and A/E that the Work will be ready for final inspection on a specific date. Contractor shall accompany this notice with a copy of the updated pre-final Punchlist indicating resolution of all items. On the date specified or as soon thereafter as is practicable, ODR, A/E and Contractor will inspect the Work. A/E will submit to Contractor a final Punchlist of open items that the inspection team requires corrected or completed before final acceptance of the Work.

  • Property Inspections The Servicer shall conduct property inspections in accordance with the milestones of the repair and rehabilitation plan for such Mortgaged Property and prepare Property Inspection Reports on any Mortgaged Property involving property damage over $15,000. The Servicer shall furnish a copy of the repair and rehabilitation plan for such Mortgaged Property to the Master Servicer upon request.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Environmental Inspection 13 ARTICLE XI....................................................................14 11.1 Modifications...................................................14 ARTICLE XII...................................................................15 12.1

  • 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.

  • Books and Records; Inspection The Parent will keep, and will cause each of its Subsidiaries to keep, proper books of record and account in all material respects, in which materially proper and correct entries shall be made of all financial transactions and the assets, liabilities and business of the Parent and its Subsidiaries in accordance with GAAP. The Parent will, and will cause each of its Subsidiaries to, permit officers and designated representatives of the Facility Agent at the reasonable request of any Lead Arranger to visit and inspect, under guidance of officers of the Parent or such Subsidiary, any of the properties of the Parent or such Subsidiary, and to examine the books of account of the Parent or such Subsidiary and discuss the affairs, finances and accounts of the Parent or such Subsidiary with, and be advised as to the same by, its and their officers and independent accountants, all upon reasonable prior notice and at such reasonable times and intervals and to such reasonable extent as the Facility Agent at the reasonable request of any such Lead Arranger may reasonably request.

  • Environmental Inspections In the event Landlord has a reasonable basis to believe that Tenant is in breach of its obligations under this Article XXXII, Landlord shall have the right, from time to time, during normal business hours, subject to the rights of subtenants and hotel guests at the Leased Property and upon not less than five (5) days written notice to Tenant, except in the case of an emergency in which event no notice shall be required, to conduct an inspection of the Leased Property to determine the existence or presence of Hazardous Substances on or about the Leased Property. Landlord shall have the right to enter and inspect the Leased Property, (upon not less than ten (10) days written notice to Tenant for invasive testing except in the case of emergency when no advance notice shall be required; provided, that Landlord shall provide notice to Tenant within a reasonable period thereafter) conduct any testing, sampling and analyses it deems necessary and shall have the right to inspect Hazardous Substances brought into the Leased Property; provided that, except in the case of emergency or during the occurrence and continuance of an Event of Default, Landlord shall use commercially reasonable efforts to cause any such testing, sampling and analyses to be performed in such a manner so as to reasonably minimize any interference with the operations and occupancy of the Leased Property and to reasonably minimize any disturbance to guests of Tenant. Landlord may, in its discretion, retain such experts to conduct the inspection, perform the tests referred to herein, and to prepare a written report in connection therewith. All reasonable costs and expenses incurred by Landlord under this Section 32.5 shall be paid on demand as Additional Charges by Tenant to Landlord. Failure to conduct an environmental inspection or to detect unfavorable conditions if such inspection is conducted shall in no fashion be intended as a release of any liability for environmental conditions subsequently determined to be associated with or to have occurred during Xxxxxx’s tenancy. To the extent Tenant may be liable pursuant to this Article XXXII, Tenant shall remain liable for any environmental condition related to or having occurred during its tenancy regardless of when such conditions are discovered and regardless of whether or not Landlord conducts an environmental inspection at the termination of this Master Lease.

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