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.
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Records, Retained Samples and Storage. Supplier shall retain samples and maintain records from each batch of 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.
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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.
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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.
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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.
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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 [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 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.
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Related to Records, Retained Samples and Storage

  • Records; Visits The books and records pertaining to the Fund, which are in the possession or under the control of PFPC, shall be the property of the Fund. Such books and records shall be prepared and maintained as required by the 1940 Act and other applicable securities laws, rules and regulations. The Fund and Authorized Persons shall have access to such books and records at all times during PFPC's normal business hours. Upon the reasonable request of the Fund, copies of any such books and records shall be provided by PFPC to the Fund or to an Authorized Person, at the Fund's expense.

  • Maintaining Records; Access to Properties and Inspections Maintain all financial records in accordance with GAAP and permit any persons designated by the Administrative Agent or, upon the occurrence and during the continuance of an Event of Default, any Lender to visit and inspect the financial records and the properties of the Borrower or any of the Subsidiaries at reasonable times, upon reasonable prior notice to the Borrower, and as often as reasonably requested and to make extracts from and copies of such financial records, and permit any persons designated by the Administrative Agent or, upon the occurrence and during the continuance of an Event of Default, any Lender upon reasonable prior notice to the Borrower to discuss the affairs, finances and condition of the Borrower or any of the Subsidiaries with the officers thereof and independent accountants therefor (so long as the Borrower has the opportunity to participate in any such discussions with such accountants), in each case, subject to reasonable requirements of confidentiality, including requirements imposed by law or by contract.

  • 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.

  • 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.

  • Records Retention The Asset Representations Reviewer will maintain copies of Review Materials, Review Reports and internal work papers and correspondence (collectively the “Client Records”) for a period of two years after the termination of this Agreement. At the expiration of the retention period, the Asset Representations Reviewer shall return all Client Records to the Servicer, in electronic format or, to the extent held in tangible form, in that form. Upon the return of the Client Records, the Asset Representations Reviewer shall have no obligation to retain such Client Records or to respond to inquiries concerning any Asset Review.

  • Maintaining Records; Access to Properties and Inspections; Annual Meetings (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 Company will permit any representatives designated by the Administrative Agent or any Lender to visit and inspect the financial records and the property of such Company 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, accounts and condition of any Company with the officers and employees thereof and advisors therefor (including independent accountants).

  • Access to Properties and Records; Confidentiality (a) Raritan and the Bank shall permit United and its agents and representatives, including, without limitation, officers, directors, employees, attorneys, accountants and financial advisors (collectively, "Representatives"), and United and UNB shall permit Raritan and its Representatives, reasonable access to their respective properties, and shall disclose and make available to United and its Representatives or Raritan and its Representatives as the case may be, all books, papers and records relating to their respective assets, stock ownership, properties, operations, obligations and liabilities, including, but not limited to, all books of account (including the general ledger), tax records, minute books of directors' and stockholders' meetings, organizational documents, bylaws, material contracts and agreements, filings with any regulatory authority, independent auditors' work papers (subject to the receipt by such auditors of a standard access representation letter), litigation files, plans affecting employees, and any other business activities or prospects in which United and its Representatives or Raritan and its Representatives may have a reasonable interest. Neither party shall be required to provide access to or to disclose information where such access or disclosure would violate or prejudice the rights of any customer or would contravene any law, rule, regulation, order or judgment or, in the case of a document which is subject to an attorney client privilege, would compromise the right of the disclosing party to claim that privilege. The parties will use all reasonable efforts to obtain waivers of any such restriction (other than the attorney client privilege) and in any event make appropriate substitute disclosure arrangements under circumstances in which the restrictions of the preceding sentence apply. Raritan acknowledges that United may be involved in discussions concerning other potential acquisitions and United shall not be obligated to disclose such information to Raritan except as such information is publicly disclosed by United.

  • Production of Witnesses; Records; Cooperation (a) After the Effective Time, except in the case of a Dispute between Parent and SpinCo, or any members of their respective Groups, each Party shall use its commercially reasonable efforts to make available to the other Party, upon written request, the former, current and future directors, officers, employees, other personnel and agents of the members of its respective Group as witnesses and any books, records or other documents within its control or which it otherwise has the ability to make available without undue burden, to the extent that any such person (giving consideration to business demands of such directors, officers, employees, other personnel and agents) or books, records or other documents may reasonably be required in connection with any Action in which the requesting Party (or member of its Group) may from time to time be involved, regardless of whether such Action is a matter with respect to which indemnification may be sought hereunder. The requesting Party shall bear all costs and expenses in connection therewith.

  • 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.

  • Cooperation and Records Retention Seller and Buyer shall (i) each provide the other with such assistance as may reasonably be requested by any of them in connection with the preparation of any return, audit, or other examination by any taxing authority or judicial or administrative proceedings relating to liability for Taxes, (ii) each retain and provide the other with any records or other information that may be relevant to such return, audit or examination, proceeding or determination, and (iii) each provide the other with any final determination of any such audit or examination, proceeding, or determination that affects any amount required to be shown on any tax return of the other for any period. Without limiting the generality of the foregoing, Buyer and Seller shall each retain, until the applicable statutes of limitations (including any extensions) have expired, copies of all tax returns, supporting work schedules, and other records or information, in a timely manner, as and that may be relevant to such returns for all tax periods or portions thereof ending on or before the Closing Date and shall not destroy or otherwise dispose of any such records without first providing the other party with a reasonable opportunity to review and copy the same.

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