Facility Maintenance; Inspection; Reports Sample Clauses

Facility Maintenance; Inspection; Reports. (a) Each Manufacturer shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Supply Products are manufactured, packaged, tested, stored, warehoused or shipped, and implement such quality control procedures, as is reasonably required so as to be able to perform its obligations hereunder in accordance with all applicable Governmental Rules, including without limitation, the cGMP Requirements. Not more than [****] (or more often for follow‑up audits or inspections directed at significant or critical quality issues observed during the regular audit or brought to the Buyer’s attention through customer complaints or claims or by Governmental Entities), each Manufacturer shall permit, or cause its contractors to permit, quality assurance representatives of the Buyer or designated third parties to inspect such facilities, operations, documents, and records related to the handling, manufacture, testing, inspection, packaging, storage, disposal and transportation of the Supply Products by each Manufacturer or the applicable contractor upon reasonable notice (which shall not be less than [****]), during normal business hours and on a confidential basis. Each Manufacturer shall also permit, and cause its contractors to permit, representatives of the FDA to inspect such facilities as requested by the FDA. Each Manufacturer shall promptly provide, or cause its contractor to provide, the Buyer with a copy of any FDA Form 483s received at the conclusion of an inspection relating to any Supply Product sold by it or any facility where any Supply Product is Manufactured (to the extent the observation affects the Manufacture of the Supply Product). [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions.
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Facility Maintenance; Inspection; Reports. Duramed shall, at all times, maintain and operate all facilities where Shire Products are manufactured, packaged or tested, and implement required quality control procedures to perform its obligations under this Agreement. Not more than once every twelve (12) months (or more often in the case of a deficiency), Duramed shall permit, or cause its contractors to permit, quality assurance representatives of Shire or designated third parties and representatives of the applicable Government Authority to inspect such facilities upon reasonable advance notice, during normal business hours and on a confidential basis. Duramed shall promptly provide, or cause its contractor to provide, Shire with a copy of any notice from the applicable Government Authority received at the conclusion of an inspection relating to any Shire Product.
Facility Maintenance; Inspection; Reports. (a) Quoin shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Product is manufactured, packaged, tested, stored, warehoused or shipped in compliance with cGMP. Not more than once every twelve (12) months, Quoin shall permit, or cause its contractors to permit, quality assurance representatives of the Licensee or designated third parties (subject to appropriate confidentiality obligations) to inspect such facilities, operations, documents, and records directly related to the handling, manufacture, testing, inspection, packaging, storage, disposal and transportation of the Product by Quoin or the applicable contractor upon reasonable notice (which shall not be less than ten (10) days), during normal business hours and on a confidential basis. Quoin shall also permit, and cause its contractors to permit, representatives of the applicable Governmental Authority to inspect such facilities as requested by the such Governmental Authority.
Facility Maintenance; Inspection; Reports. (a) The Licensor shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Products are Manufactured, packaged, tested, stored, warehoused or shipped, and implement such quality control procedures, as is reasonably required so as to be able to perform its obligations hereunder in accordance with all applicable Governmental Rules, including without limitation, the cGMP Requirements. Not more than once every twelve (12) months (or more often for follow-up audits or inspections directed at significant or critical quality issues observed during the regular audit or brought to the Licensee's attention through customer complaints or claims or by Governmental Entities), the Licensor shall permit, or cause its contractors to permit, quality assurance representatives of the Licensee or designated third parties to inspect such facilities, operations, documents, and records related to the handling, manufacture, testing, inspection, packaging, storage, disposal and transportation of the Products by the Licensor or the applicable contractor upon reasonable notice (which shall not be less than ten (10) days), during normal business hours and on a confidential basis. The Licensor shall also permit, and cause its contractors to permit, representatives of the FDA to inspect such facilities as requested by the FDA.
Facility Maintenance; Inspection; Reports. Each party shall maintain and operate its respective facilities and implement such quality control procedures so as to meet the requirements of applicable FDA or any other relevant regulations and so as to be able to perform timely its obligations hereunder. Each party shall (and shall cause its Third Party Manufacturers and packagers, if applicable, to) permit quality assurance representatives of the other party to inspect its facilities, including the Commercial Manufacturing Site, once per calendar year upon reasonable written notice, during normal business hours and on a confidential basis; provided, that, if an inspecting party finds any non-compliance during any such inspection with respect to the Product, the party subject to inspection shall (i) use Commercially Reasonable Efforts to promptly and diligently rectify such non-compliance and implement appropriate procedures with a view to avoiding such non-compliance and (ii) permit such additional inspection(s) by the inspecting party as such inspecting party shall deem reasonably necessary to verify that such non-compliance has been rectified. Each party shall promptly provide the other party with a copy of any correspondences exchanged with any Regulatory Authorities, together with the response and corrective action taken by the party with respect to the Product.
Facility Maintenance; Inspection; Reports. (a) Impax shall permit Leiner to conduct reasonable periodic visits to the Plant upon reasoxxxxx notice during normal business hours (no more than once annually during the Term), subject to confidentiality obligations set forth in Section 13, to discuss manufacturing and supply issues and for general inspection purposes.
Facility Maintenance; Inspection; Reports. (a) Par shall (or shall obtain the agreement of its third-party manufacturer and/or packager, if applicable, to) use commercially reasonable efforts to maintain and operate the manufacturing and packaging facility designated in the ANDAs and implement such quality control procedures required so as to meet the requirements of FDA regulations and so as to be able to perform timely its obligations hereunder. Par shall (and shall obtain the agreement of any third-party manufacturer and/or packager, if applicable, to) permit quality assurance representatives of Xxxxxxx reasonably acceptable to Par to inspect such facilities not more than once per calendar year upon reasonable notice, during normal business hours and on a confidential basis. Xxxxxxx shall cause its quality assurance representatives to provide Par with a written report of the results of any such inspection simultaneously with the provision of such report to Xxxxxxx. If such inspecting party finds any non-compliance during any such inspection with respect to the Generic Product, Par shall (and shall obtain the agreement of any third-party manufacturer and/or packager, if applicable, to) diligently rectify such non-compliance and implement appropriate procedures with a view to avoiding repetition of such non-compliance; provided, that, if Par disagrees with the conclusions of such inspecting party, it shall so notify Xxxxxxx in writing, and the parties shall cooperate in good faith to resolve such dispute and, in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Par’s notice pursuant to this Section 5.3 or such other time period mutually agreeable to the parties, the parties shall submit such dispute to a mutually satisfactory, non-Affiliated third-party consultant. The determination of such consultant shall be final and binding on the parties, and the costs therefor shall be borne by the parties in proportion to the percentage of fault attributed to each party by such consultant.
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Facility Maintenance; Inspection; Reports. (a) Genpharm shall cause the Manufacturer to maintain and operate the Plant and implement such quality control procedures so as to be able to perform its obligations hereunder. Genpharm shall cause the Manufacturer to provide access to quality assurance representatives of Leiner and/or Par, at either party's request, to inspect the Plant at all times upon reasonable notice, during normal business hours and on a confidential basis. Genpharm shall also cause the Manufacturer to permit Leiner and/or Par, at either party's request, to conduct reasonable periodic visits to such Plant to discuss manufacturing and supply issues with management of Genpharm and the Manufacturer.
Facility Maintenance; Inspection; Reports. NovaDel shall (and shall cause its third-party manufacturer, if applicable, to) maintain and operate the manufacturing facility or facilities designated in the NDA and implement such quality control procedures so as to meet the requirements of FDA regulations and so as to be able to perform timely its obligations hereunder. NovaDel shall (and shall cause its third-party manufacturer, if applicable, to) permit quality assurance representatives of Par to inspect such manufacturing facility or facilities at all times upon reasonable notice, during normal business hours and on a confidential basis. Par shall also be permitted reasonable periodic visits to such manufacturing facility to discuss manufacturing and supply issues with management of NovaDel and/or of its third-party manufacturer, if applicable. NovaDel shall (and shall cause its third-party manufacturer, if applicable, to) promptly provide Par with a copy of any FDA Form 483 ("Notice of Observations") received at the conclusion of an inspection relating to the Product and all follow-up correspondence from the FDA, if any. INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

Related to Facility Maintenance; Inspection; Reports

  • Maintenance and Inspection Consultant shall maintain complete and accurate records with respect to all costs and expenses incurred under this Agreement. All such records shall be clearly identifiable. Consultant shall allow a representative of City during normal business hours to examine, audit, and make transcripts or copies of such records and any other documents created pursuant to this Agreement. Consultant shall allow inspection of all work, data, documents, proceedings, and activities related to the Agreement for a period of three (3) years from the date of final payment under this Agreement.

  • Installation, Inspection, and Maintenance The Contractor is responsible for installation and maintenance of the BMPs as a part of its Bid. The Design Professional shall obtain the services of a qualified testing laboratory to inspect the BMPs in accordance with the permits, the costs of such inspections to be borne by the Owner. In the event of Abnormal Weather Conditions or force majeure, the Contractor shall be compensated for re-installation of BMPs at established Unit Prices.

  • Equipment Testing and Inspection 2.1.1 The Interconnection Customer shall test and inspect its Small Generating Facility and Interconnection Facilities prior to interconnection. The Interconnection Customer shall notify the NYISO and the Connecting Transmission Owner of such activities no fewer than five Business Days (or as may be agreed to by the Parties) prior to such testing and inspection. Testing and inspection shall occur on a Business Day. The Connecting Transmission Owner may, at its own expense, send qualified personnel to the Small Generating Facility site to inspect the interconnection and observe the testing. The Interconnection Customer shall provide the NYISO and Connecting Transmission Owner a written test report when such testing and inspection is completed. The Small Generating Facility may not commence parallel operations if the NYISO, in consultation with the Connecting Transmission Owner, finds that the Small Generating Facility has not been installed as agreed upon or may not be operated in a safe and reliable manner.

  • 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.

  • Inspection Reports Copies of the incident inspection reports and related documentation shall be distributed as follows:

  • Maintenance & Repairs 5.1 Lessee shall at all times be responsible for maintaining at its own expense the leased premises in a clean, orderly and safety condition, except as hereinafter provided. Lessee shall be responsible, at its own expense, to clean and maintain all trade fixtures, machinery and equipment furnished by Lessee within the leased premises. Lessee shall be responsible to deposit normal office waste and rubbish at a location at the Central School as designated by Lessor.

  • Maintenance and Inspection of Records The City, or its authorized auditors or representatives, shall have access to and the right to audit and reproduce any of the Contractor's records to the extent the City deems necessary to insure it is receiving all money to which it is entitled under the Contract and/or is paying only the amounts to which Contractor is properly entitled under the Contract or for other purposes relating to the Contract. The Contractor shall maintain and preserve all such records for a period of at least three (3) years after termination of the Contract. The Contractor shall maintain all such records in the City of Xxxxxx. If not, the Contractor shall, upon request, promptly deliver the records to the City of Xxxxxx or reimburse the City for all reasonable and extra costs incurred in conducting the audit at a location other than the City of Xxxxxx, including, but not limited to, such additional (out of the City) expenses for personnel, salaries, private auditors, travel, lodging, meals, and overhead.

  • Construction Reports Each Constructing Entity shall issue reports to each other Construction Party on a monthly basis, and at such other times as reasonably requested, regarding the status of the construction and installation of the Interconnection Facilities. Each Construction Party shall promptly identify, and shall notify each other Construction Party of, any event that the Construction Party reasonably expects may delay completion, or may significantly increase the cost, of the Interconnection Facilities. Should a Construction Party report such an event, Transmission Provider shall, within fifteen days of such notification, convene a technical meeting of the Construction Parties to evaluate schedule alternatives.

  • Maintenance of Books and Records; Inspection The Company shall maintain its books, accounts and records in accordance with generally accepted accounting principles consistently applied, and permit the Secured Party, its officers and employees and any professionals designated by the Secured Party in writing, at any time to visit and inspect any of its properties (including but not limited to the collateral security described in the Transaction Documents and/or the Loan Instruments), corporate books and financial records, and to discuss its accounts, affairs and finances with any employee, officer or director thereof.

  • MAINTENANCE & REPAIR Tenant agrees that if there is any delay in maintenance or repairs for reasons beyond Landlord's control, this shall have no effect on Tenant's obligations under this lease.

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