Facility Maintenance; Inspection; Reports Sample Clauses

Facility Maintenance; Inspection; Reports. (a) The 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), the 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 the Manufacturer or the applicable contractor upon reasonable notice (which shall not be less than [****]), during normal business hours and on a confidential basis. The Manufacturer shall also permit, and cause its contractors to permit, representatives of the FDA to inspect such facilities as requested by the FDA. The 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 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. (b) The Manufacturer shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control testing and release of the Supply Products and all other Manufacturing services provided hereunder in material compliance with the cGMP Requirements and any other relevant Governmental Rules, at all times during the performance of the Manufacturing services and for a period as required by Governmental Rules. (c) The...
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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.
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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. (b) Quoin shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control testing and release of the Product and all other manufacturing services provided hereunder in material compliance with cGMP. (c) Quoin shall notify Licensee as soon as reasonably practicable and in any event within five (5) business days following receipt of notice of any Governmental Authority inspection of the manufacturing facility if such inspection pertains to the Product.
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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.
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Facility Maintenance; Inspection; Reports. (a) Impax shall permit Leiner to conduct reasonable periodic visits to the Plant upon reasxxxxxx 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. (b) Leiner shall provide Impax access to the portions of the Leiner Facxxxxx where Product is packaged or stored upon reasonable xxxxxx, during normal business hours (no more than once annually during the Term) and subject to confidentiality obligations set forth in Section 13. (c) Each party shall promptly provide the other with an unredacted copy (except identifying information regarding entities for whom such party is obligated to protect as confidential) of any FDA Form 483 Establishment Inspection Report, NDA Field Alert Report, Warning Letter, or Notice of Violation Letter relating to the Product and any responses or other correspondence relating thereto. (d) Each party shall notify the other Party of any Out of Specification ("OOS") testing results within three (3) business days.
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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 such Governmental Authority. (b) Quoin shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control testing and release of the Product and all other manufacturing services provided hereunder in compliance with cGMP. (c) Quoin shall notify Licensee as soon as reasonably practicable and in any event within five (5) business days following receipt of notice of any Governmental Authority inspection of the manufacturing facility if such inspection pertains to the Product or impacts on the manufacture of the Product. (d) Quoin shall immediately inform Licensee of any quality or safety issue impacting the sales of the supplied Product, and of any regulatory action taken concerning the sales of the Product.
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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. (b) If Par or any third-party manufacturer and/or packager of the Generic Product receives an FDA Form 483 (“Notice of Observations”) evidencing any non-compliance 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. Par shall prov...
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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.
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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. (b) Leiner shall maintain and operate the Leiner Facility and implement such quality control procedures so as to be able to perform its obligations hereunder. Leiner shall provide access to quality assurance representatives of Genpharm (who may be accompanied by quality assurance representatives of the Manufacturer) and/or Par, at either party's request, to inspect the Leiner Facility at all times upon reasonable notice, during normal business hours and on a confidential basis. (c) Leiner shall promptly provide Genpharm and Par with a copy of any FDA Form 483 received at the conclusion of an inspection relating to the Product. Genpharm shall cause Leiner and Par to be promptly provided with a copy CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH SECURITIES AND EXCHANGE COMMISSION ASTERISKS DENOTE SUCH OMISSION of any FDA Form 483 received by the Manufacturer following the conclusion of an inspection relating to the Product.
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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.

  • 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. 2.1.2 The NYISO and Connecting Transmission Owner shall each provide the Interconnection Customer written acknowledgment that it has received the Interconnection Customer’s written test report. Such written acknowledgment shall not be deemed to be or construed as any representation, assurance, guarantee, or warranty by the NYISO or Connecting Transmission Owner of the safety, durability, suitability, or reliability of the Small Generating Facility or any associated control, protective, and safety devices owned or controlled by the Interconnection Customer or the quality of power produced by the Small Generating Facility.

  • 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 A "full inspection report" comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A "detailed report" responds to specific queries about a firm by the other Party.

  • 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. 5.2 Lessee shall be responsible to perform all repairs the need for which is caused by Xxxxxx's use of the premises except that Lessor shall be responsible to perform major repairs of a structural nature. Lessor shall be responsible to arrange for removal of waste and rubbish from the location designated as the deposit location for lessees. All costs incurred by Lessor pursuant to the obligations of this Paragraph shall be included within "operating costs". 5.3 Lessor shall provide custodian services for the common areas of Central School. Costs incurred by Lessor in providing such custodian services shall be included within "operating costs".

  • Maintenance and Inspection of Records A. The SERVICE PROVIDER at such times and in such forms as the CITY may require, shall furnish to the CITY such statements, records, reports, data, and information as the CITY may request pertaining to matters covered by this Agreement. B. The SERVICE PROVIDER shall maintain books, records and documents, which sufficiently and properly reflect all direct and indirect costs related to the performance of this Agreement and shall maintain such accounting procedures and practices as may be necessary to assure proper accounting of all funds paid pursuant to this Agreement. These records shall be subject at all reasonable times to inspection, review, or audit, by the CITY, its authorized representative, the State Auditor, or other governmental officials authorized by law to monitor this Agreement. C. To ensure the CITY’S compliance with the Public Records Act, RCW 42.56, the SERVICE PROVIDER shall retain all books, records, documents and other material relevant to this agreement, for six (6) years after its expiration. The SERVICE PROVIDER agrees that the CITY or its designee shall have full access and right to examine any of said materials at all reasonable times during said period.

  • 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.

  • Maintenance Repairs and Alterations 7.1 Lessee's Obligations. -------------------- (a) Subject to Lessor's obligations under Paragraphs 6.2(b), 6.3(a), 7.3, 9 and 40, Lessee shall keep in good order, condition and repair the non- structural elements of the Premises and every part thereof, (whether or not the need for such repairs occurs as a result of Lessee's use, any prior use, the elements or the age of such portion of the Premises) including, without limiting the generality of the foregoing, all exposed plumbing, heating and air conditioning, ventilating, electrical, lighting facilities and equipment within the Premises, fixtures, walls (interior and nonstructural elements of exterior), ceilings, floors, windows, doors, plate glass and skylights located within the Premises, and all driveways, parking lots and striping thereon, landscaping, exterior lighting, fences and signs located on the Premises and sidewalks and parkways adjacent to the Premises. If the cost of repairing an element of the Premises is covered by a warranty obtained by Lessor from a third party contractor, subcontractor, consultant or material supplier in connection with construction work performed on the Premises prior to the Effective Date, Lessor shall make available such warranty to Lessee and shall assign to Lessee Lessor's rights thereunder, provided that Lessee shall not take any action which shall invalidate any such warranty or derogate from Lessor's remedies or recourse thereunder. (b) Lessee shall maintain the Premises as provided in Paragraph 7. I (a) and in accordance with the requirements of all Laws and any covenants or restrictions as may from time to time be applicable to Lessee's specific manner of use of the Premises and the conduct and operation of Lessee's business. Lessee, in keeping the Premises in good order, condition and repair, shall exercise and perform good maintenance practices and any damage or deterioration shall not be deemed "ordinary wear and tear" if the same could have been prevented by good maintenance practice. Lessee's obligations shall include restorations, replacements or renewals when determined not to be due to ordinary wear and tear or when made necessary due to failure to perform proper maintenance. (c) If the term of this Lease, as the same may be extended or renewed, exceeds five (5) years, Lessor shall have the right to require Lessee to repaint the exterior of THE improvements. but not more often than once every five (5) years, as reasonably necessary. (d) Lessee's obligations under this Paragraph 7.1 shall not apply to replacement, repair or restoration of items which are Lessor's obligation to replace, repair or restore pursuant to the terms of Paragraph 6.3(a) (relating to Existing Defects) Paragraph 7.3(a) relating to structural repairs and certain replacements) Paragraph 9 (relating to destruction of the Premises) or Paragraph 14 (relating to condemnation of the Premises).

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