Records, Retained Samples and Storage Sample Clauses

Records, Retained Samples and Storage. Innocoll shall, and shall cause its Affiliates and Third Party manufacturers to, retain samples and maintain records from each Batch of Products for a period required by applicable Laws for record keeping, testing and regulatory purposes or specified in the Quality Agreement (“Samples”). When storing Product, Innocoll shall, and shall cause its Affiliates and Third Party manufacturers to, comply with and maintain all storage facilities in compliance with Specifications and in accordance with cGMPs and applicable Laws, and perform ongoing stability testing of Product during such storage.
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Records, Retained Samples and Storage. Strakan shall, and shall cause its Affiliates and Contract Manufacturer(s), to retain samples and maintain records from each Lot of Product for a period required by Law for record keeping, testing and regulatory purposes or specified in the Product Quality Agreement and shall make the same available to Aptalis at Aptalis’ request to address any issues raised by any Regulatory Authority relating to the Manufacture of the Product in the Territory or any other reasonable request of Aptalis. When storing Product, Strakan shall, and shall cause its Affiliates and Contract Manufacturer(s) to, comply with and maintain all storage facilities in compliance with Specifications and in accordance with cGMP and Law.
Records, Retained Samples and Storage. Supplier shall retain samples and maintain records from each batch of BX7, Validation Batches and/or the API Compound for a period required by applicable Laws for record keeping, testing and regulatory purposes or specified in the Quality Agreement. When storing Compound, nonconforming Compound or Wastes, Supplier shall comply with and maintain all storage facilities in compliance with Specifications and in accordance with cGMPs and applicable Laws.
Records, Retained Samples and Storage. CRL shall retain all materials, data and documentation obtained or generated by CRL in the course of performing the Manufacturing Activities, including, without limitation, reference standards, retained samples of Drug Product and key intermediaries, computerized records and files and records from each batch of Drug Product (collectively, the “Records”) in a secure area reasonably protected from fire, theft and destruction for the longer of (a) five (5) years after completion of the applicable Purchase Order under which such Records were generated or (b) two (2) years past the last expiration date of Drug Product supplied under this Agreement, or, in each case, for such longer period as is required by applicable Laws for record keeping, testing and regulatory purposes or specified in the Quality Agreement (the “Retention Period”). At the end of the Retention Period, all Records will, at Client’s option, either be (i) delivered to Client or to its designee in such form as is then currently in the possession of CRL at Client’s cost, (ii) retained by CRL, at Client’s cost, until further disposition instructions are received, or (iii) disposed of, at the direction and written request of Client at Client’s cost. In no event will CRL dispose of any Records without first giving Client at least sixty (60) days’ prior written notice of its intent to do so and an opportunity to have the Records transferred to Client. While in the possession and control of CRL, Records will be available during audits or at other mutually agreed to times for inspection, examination, review or copying by Client and its representatives; provided, however, that CRL may exclude or redact from such Records any confidential or proprietary information of Third Parties. Notwithstanding anything in this Section 3.3.1 to the contrary, CRL may retain copies of any Records as necessary to comply with applicable Law, regulatory requirements or its obligations under this Agreement, subject to the obligations of confidentiality of CRL under this Agreement.
Records, Retained Samples and Storage. Hospira shall retain samples and maintain records from each batch or lot of Product for a period of time required by Applicable [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Laws for record keeping, testing and regulatory purposes or as specified in the Quality Technical Agreement. When storing Bulk, nonconforming Bulk, Waste, or Specially Regulated Waste, Hospira shall comply with and maintain all storage facilities in compliance with Bulk Specifications and in accordance with cGMP and Applicable Laws.
Records, Retained Samples and Storage. PII shall retain samples and maintain records from each batch of Drug Product for a period required by applicable Laws for record keeping, testing and regulatory purposes or specified in the Quality Agreement. When storing Compound, nonconforming Compound or Wastes, PII shall comply with and maintain all storage facilities in compliance with Specifications and in accordance with cGMPs and applicable Laws.
Records, Retained Samples and Storage. Hospira shall retain samples and maintain records from each batch or lot of the Product for a period of time required by Applicable Laws for record keeping, testing and regulatory purposes or as specified in the Technical & Quality Agreement. When storing API, any non-conforming API, Waste, or Specially Regulated Waste, Hospira shall comply with and maintain all storage facilities in compliance with the API Specifications and in accordance with cGMP and Applicable Laws.
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Records, Retained Samples and Storage. ENDOCEUTICS shall retain samples and maintain records from each lot of PRODUCT for any period required by Applicable Law for record keeping, testing and regulatory purposes or specified in the QAA and shall make the same available to AMAG at AMAG’s request to address any issues raised by any Regulatory Authority relating to the Manufacture of the PRODUCT, which issues shall be referred to AMAG and for which AMAG shall have the right to lead any such interactions with such Regulatory Authority, but shall give ENDOCEUTICS reasonable notice of, and an opportunity to be involved in, all such interactions. When storing PRODUCT, ENDOCEUTICS shall comply with and maintain all storage facilities in compliance with Specifications and in accordance with Applicable Law.

Related to Records, Retained Samples and Storage

  • 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.

  • Access to Properties and Records (a) CCE shall, and shall cause TPC to, afford to ETP and ETP’s accountants, counsel and representatives full reasonable access during normal business hours throughout the period prior to the Closing Date (or the earlier termination of this Agreement pursuant to Article VII hereof) to all of the properties, books, contracts, commitments and records (including all environmental studies, reports and other environmental records and all pipeline cost-of-service and rate-related studies, reports and records related to TPC and, during such period, shall furnish to ETP all information concerning the business, properties, Liabilities and personnel related to TPC as ETP may request, provided, however, that no investigation or receipt of information pursuant to this Section 5.2 shall affect any representation or warranty of CCE or the conditions to the obligations of ETP. To the extent not located at the offices or properties of TPC as of the Closing Date, as promptly as practicable thereafter, CCE shall deliver, or cause its appropriate Affiliates to deliver to ETP all of the books of accounts, minute books, record books and other records (including safety, health, environmental, maintenance and engineering records and drawings) pertaining to the business operations of TPC and all financial and accounting records related to TPC. Such delivery shall include all work papers, pleadings, testimony, exhibits, spread sheets, research, drafts, memoranda, correspondence and other documents related to the TPC Rate Case (“TPC Rate Case Work Product”). TPC Rate Case Work Product has been and will be prepared in contemplation of litigation, and the use of TPC Rate Case Work Product has been and will be under the control of TPC’s attorneys. Notwithstanding anything to the contrary contained in this Agreement, CCE shall not be obligated to provide to ETP any documents or records relating to litigation and regulatory matters in which TPC is involved to the extent that CCE reasonably believes such documents or records are subject to the attorney-client or other applicable privilege in circumstances in which TPC is not the sole client unless the parties entitled to such attorney-client or other applicable privilege shall consent thereto and enter into an appropriate joint defense agreement for the purpose of preservation of such attorney-client or other applicable privilege. (b) The information contained herein, in the CCE Disclosure Letter or heretofore or hereafter delivered to ETP or its authorized representatives in connection with the transactions contemplated by this Agreement shall be held in confidence by ETP and its representatives in accordance with the Confidentiality Agreement until the Closing Date with respect to information relating to TPC. Following the Closing Date, CCE shall keep confidential all information related to the business and properties of TPC to the same extent as ETP is obligated to keep such information confidential in accordance with the terms of the Confidentiality Agreement (without regard to the preceding sentence) prior to the Closing Date.

  • Access to Personnel Records Upon written request to the Chief of Police, an employee shall have access to the employee's records during normal office hours of the records custodian. Such access to personnel records shall be within a reasonable time of said request. Such request shall not interfere with the employee's regularly scheduled working hours. Review of the records shall be made in the presence of the Chief or the Chief’s designated representative.

  • Access to Premises and Records Between the date of this Agreement ------------------------------ and the Closing Date, Seller will give Buyer and its counsel, accountants and other representatives full access during normal business hours upon reasonable notice to all the premises and books and records of the Business and to all the Assets and to the System personnel and will furnish to Buyer and such representatives all such documents, financial information, and other information regarding the Business and the Assets as Buyer from time to time reasonably may request; provided that no such investigation will affect or limit the scope of any of Seller's representations, warranties, covenants and indemnities in this Agreement or any Transaction Document or limit liability for any breach of any of the foregoing.

  • Access to Records; Contractor Financial Records Contractor agrees that District and its authorized representatives are entitled to review all Contractor books, documents, papers, plans, and records, electronic or otherwise (“Records”), directly pertinent to this Contract for the purpose of making audit, examination, excerpts, and transcripts.

  • Personnel, Office Space, and Facilities of Manager The Manager at its own expense shall furnish or provide and pay the cost of such office space, office equipment, office personnel, and office services as the Manager requires in the performance of its investment advisory and other obligations under this Agreement.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Additional Requirements for Sleeping Rooms The Contractor shall provide departing Attendees a secured area for storing belongings.

  • Minimum Site Requirements for TIPS Sales (when applicable to TIPS Sale). Cleanup: When performing work on site at a TIPS Member’s property, Vendor shall clean up and remove all debris and rubbish resulting from their work as required or directed by the TIPS Member or as agreed by the parties. Upon completion of work, the premises shall be left in good repair and an orderly, neat, clean and unobstructed condition. Preparation: Vendor shall not begin a project for which a TIPS Member has not prepared the site, unless Vendor does the preparation work at no cost, or until TIPS Member includes the cost of site preparation in the TIPS Sale Site preparation includes, but is not limited to: moving furniture, installing wiring for networks or power, and similar pre‐installation requirements. Registered Sex Offender Restrictions: For work to be performed at schools, Vendor agrees that no employee of Vendor or a subcontractor who has been adjudicated to be a registered sex offender will perform work at any time when students are, or reasonably expected to be, present unless otherwise agreed by the TIPS Member. Vendor agrees that a violation of this condition shall be considered a material breach and may result in the cancellation of the TIPS Sale at the TIPS Member’s discretion. Vendor must identify any additional costs associated with compliance of this term. If no costs are specified, compliance with this term will be provided at no additional charge. Safety Measures: Vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage. Smoking: Persons working under Agreement shall adhere to the TIPS Member’s or local smoking statutes, codes, ordinances, and policies.

  • REMOVAL OF RECORDS FROM PREMISES Where performance of the Contract involves use by the Contractor (or the Contractor’s subsidiaries, affiliates, partners, agents or subcontractors) of Authorized User owned or licensed papers, files, computer disks or other electronic storage devices, data or records at Authorized User facilities or offices, or via remote access, the Contractor (or the Contractor’s subsidiaries, affiliates, partners, agents or subcontractors) shall not remotely access, modify, delete, copy or remove such Records without the prior written approval of the Authorized User. In no case, with or without the written approval of the Authorized User, can the Authorized User data be accessed, moved or sent outside the continental United States.

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