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.
Sample 1Sample 2See All (5)
AutoNDA by SimpleDocs
Facility Maintenance; Inspection; Reports. Shire shall, at all times, maintain and operate all facilities where Products are manufactured, packaged or tested, and implement required quality control procedures to perform its obligations under this Agreement. Not more than once every [*] (or more often in the case of a deficiency), Shire shall permit, or cause its contractors to permit, quality assurance representatives of Duramed 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. Shire shall promptly provide, or cause its contractor to provide, Duramed with a copy of any notice from the applicable Government Authority received at the conclusion of an inspection relating to any Product.
Sample 1Sample 2See All (4)
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.
Sample 1Sample 2
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.
Sample 1Sample 2
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.
Sample 1Sample 2
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.
Sample 1
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.
Sample 1
AutoNDA by SimpleDocs
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.
Sample 1
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.
Sample 1

Related to Facility Maintenance; Inspection; Reports

  • MAINTENANCE AND INSPECTION OF COLLATERAL Grantor shall maintain all tangible Collateral in good condition and repair. Grantor will not commit or permit damage to or destruction of the Collateral or any part of the Collateral. Lender and its designated representatives and agents shall have the right at all reasonable times to examine, inspect, and audit the Collateral wherever located. Grantor shall immediately notify Lender of all cases involving the return, rejection, repossession, loss or damage of or to any Collateral; of any request for credit or adjustment or of any other dispute arising with respect to the Collateral; and generally of all happenings and events affecting the Collateral or the value or the amount of the Collateral.

  • Maintaining Records; Access to Properties and Inspections; Maintenance of Ratings (a) Keep proper books of record and account in which full, true and correct entries in conformity with GAAP and all requirements of law are made of all dealings and transactions in relation to its business and activities. Each Loan Party will, and will cause each of its subsidiaries to, permit any representatives designated by the Administrative Agent or any Lender to visit and inspect the financial records and the properties of such Person at reasonable times and as often as reasonably requested and to make extracts from and copies of such financial records, and permit any representatives designated by the Administrative Agent or any Lender to discuss the affairs, finances and condition of such Person with the officers thereof and independent accountants therefor.

  • 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) The Shipowner will at all reasonable times afford the Mortgagee or its authorized representatives full and complete access to the Vessel for the purpose of inspecting the Vessel and her cargo and papers, including without limitation all records pertaining to the Vessel’s maintenance and repair, and, at the request of the Mortgagee, the Shipowner will deliver for inspection copies of any and all contracts and documents relating to the Vessel, whether on board or not.

  • 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.

  • Repairs; Maintenance and Compliance Borrower shall at all times maintain, preserve and protect all franchises and trade names, and Borrower shall cause the Property to be maintained in a good and safe condition and repair and shall not remove, demolish or alter the Improvements or Equipment (except for alterations performed in accordance with Section 5.4.2 below and normal replacement of Equipment with Equipment of equivalent value and functionality). Borrower shall promptly comply with all Legal Requirements and immediately cure properly any violation of a Legal Requirement. Borrower shall notify Lender in writing within two (2) Business Days after Borrower first receives notice of any such non-compliance. Borrower shall promptly repair, replace or rebuild any part of the Property that becomes damaged, worn or dilapidated and shall complete and pay for any Improvements at any time in the process of construction or repair.

  • Site Visits and Inspections; Regulatory Examinations During the term of this Agreement, authorized representatives of the Fund may conduct periodic site visits of the Transfer Agent’s facilities and inspect the Transfer Agent’s records and procedures solely as they pertain to the Transfer Agent’s services for the Fund under or pursuant to this Agreement. Such inspections shall be conducted at the Fund’s expense (which shall include costs related to providing materials, copying, faxing, retrieving stored materials, and similar expenses) and shall occur during the Transfer Agent’s regular business hours and, except as otherwise agreed to by the parties, no more frequently than twice a year. In connection with such site visit and/or inspection, the Fund shall not attempt to access, nor will it review, the records of any other clients of the Transfer Agent and the Fund shall conduct the visit/inspection in a manner that will not interfere with the Transfer Agent’s normal and customary conduct of its business activities, including the provision of services to the Fund and to other clients. The Transfer Agent shall have the right to immediately require the removal of any Fund representatives from its premises in the event that their actions, in the reasonable opinion of the Transfer Agent, jeopardize the information security of its systems and/or other client data or otherwise are disruptive to the business of the Transfer Agent. The Transfer Agent may require any persons seeking access to its facilities to provide reasonable evidence of their authority. The Transfer Agent may also reasonably require any of the Fund’s representatives to execute a confidentiality agreement before granting such individuals access to its facilities. The Transfer Agent will also provide reasonable access to the Fund’s governmental regulators, at the Fund’s expense, solely to (i) the Fund’s records held by the Transfer Agent and (ii) the procedures of the Transfer Agent directly related to its provision of services to the Fund under the Agreement.

  • Audit and Inspection During the Term of this Agreement each Party and its duly authorized representatives, upon reasonable notice and during normal working hours, shall have access to the accounting records and other documents maintained by the other Party, or any of the other Party’s contractors and agents, which relate to this Agreement; provided that, neither this Section nor any other provision hereof shall entitle the Company to have access to any records concerning any xxxxxx or offsetting transactions or other trading positions or pricing information that may have been entered into with other parties or utilized in connection with any transactions contemplated hereby or by any other Transaction Document. The right to inspect or audit such records shall survive termination of this Agreement for a period of two (2) years following the Termination Date. Each Party shall preserve, and shall cause all contractors or agents to preserve, all of the aforesaid documents for a period of at least two (2) years from the Termination Date.

  • Collateral Maintenance The Borrower will not permit the Appraised Value of the Vessel (such value, the “Vessel Value”) to be less than 125% of the aggregate outstanding principal amount of Loans at such time; provided that, so long as any non-compliance in respect of this Section 10.08 is not caused by a voluntary Collateral Disposition, such non-compliance shall not constitute a Default or an Event of Default so long as within 10 Business Days of the occurrence of such default, the Borrower shall either (i) post additional collateral reasonably satisfactory to the Required Lenders in favor of the Collateral Agent (it being understood that cash collateral comprised of Dollars is satisfactory and that it shall be valued at par), pursuant to security documentation reasonably satisfactory in form and substance to the Collateral Agent and the Lead Arrangers, in an aggregate amount sufficient to cure such non-compliance (and shall at all times during such period and prior to satisfactory completion thereof, be diligently carrying out such actions) or (ii) repay Loans in an amount sufficient to cure such non-compliance; provided, further, that, subject to the last sentence in Section 9.01(c), the covenant in this Section 10.08 shall be tested no more than once per calendar year beginning with the first calendar year end to occur after the Delivery Date in the absence of the occurrence of an Event of Default which is continuing.

  • Maintenance Repairs and Alterations 6.01 Tenant's Obligations to Repair ------------------------------ Tenant shall at its sole cost and expense, maintain in clean and safe condition, and make all repairs and replacements to the Premises and every part thereof, structural and non-structural, so as to keep, maintain and preserve the Premises in first class condition and repair, including, without limitation, the roof, the foundation, the heating, ventilation and air conditioning system ("HVAC"), elevators, if any, all plumbing and sewage facilities, fire sprinklers, electrical and lighting facilities, systems, appliances, and equipment within the Premises, fixtures, interior and exterior walls, floors, ceilings, windows, doors, entrances, all interior and exterior glass (including plate glass), and skylights located within the Premises, and all sidewalks, service areas, parking areas and landscaping comprising part of the Premises. All repairs and replacements required to be made by Tenant shall be made promptly with new materials of like kind and quality to those used in the original construction of the Premises. If the repair or replacement work affects the structural parts of the Premises, or if the estimated cost of any item or repair or replacement exceeds $10,000, then Tenant shall first obtain Landlord's written approval of the scope of work, plans therefor, and materials to be used. Any such work shall be performed by Landlord's contractor or by such contractor as Tenant may choose from an approved list to be submitted by Landlord. Landlord shall have the right to make any repairs or replacements which are not promptly made by Tenant and charge Tenant, as Additional Rent, for the cost thereof together with interest thereon at the Agreed Rate from the date of payment thereof by Landlord. Without limiting any of Tenant's obligations hereunder, during the Lease Term Tenant, at its expense, shall obtain and keep in force an HVAC service contract and a roof maintenance program satisfactory to Landlord. Tenant hereby waives the benefit of any statute now or hereafter in effect which would otherwise afford Tenant the right to make repairs at Landlord's expense or to terminate this Lease because of Landlord's failure to keep the Premises in good condition, order and repair. Tenant specifically waives all rights it may have under Sections 1932(1), 1941 and 1942 of the California Civil Code, and any similar or successor statute or law. Notwithstanding anything to the contrary contained herein, Landlord shall exercise its rights under any guaranties or warranties relating to the original construction of the Premises if the need to make repairs arises due to a defect therein; provided, however, Landlord shall not have any liability or be required to expend any funds if such guaranties or warranties are not honored by the makers hereof.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!