Executed Batch Records Sample Clauses

Executed Batch Records. ELITE shall keep records of the manufacture, testing and shipping of the Product, to comply with the Product Specifications and all manufacturing regulatory requirements and Laws applicable to ELITE, as well as to assist with resolving Product complaints and other similar investigations. Copies of such records and samples shall be retained according to a record retention procedure and for a period of five (5) years following the date of Product(s) expiry or longer if required by applicable Law, after which ELITE may destroy such records.
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Executed Batch Records all Deviations, including proposed CAPA’s where appropriate, associated with the manufactured API
Executed Batch Records. Provide a copy of all documents included in the Master Batch Record as executed for the released batch. This includes; compounding, filtration, filling, inspection, labeling, packaging and analytical data from laboratory tests. This will include deviations, variances and out of specification investigations associated with the released batch.
Executed Batch Records. Summaries of all AGU testing, lot release data and Deviations will be documented in the Batch Record and an electronic copy provided to DYNAVAX for review. X Copy of executed Batch Record and related records as required

Related to Executed Batch Records

  • Executed Documents The Initial Purchasers shall have received fully executed originals of each Document (each of which shall be in full force and effect on terms reasonably satisfactory to the Initial Purchasers), and each opinion, certificate, letter and other document to be delivered in connection with the Offering or any other Transaction.

  • Executed Agreement The Offerors shall have received from the Placement Agents an executed copy of this Agreement.

  • Electronic Records You acknowledge and agree that we may in our discretion store all records electronically; and that we will not retain and have no obligation to retain any original documents for any period of time. This applies to all documentation including but not limited to checks, transaction records, notes, mortgages, deeds of trust and other loan and/or security documentation. We will routinely destroy all original documentation. We may store records electronically via imaging, scanning, filming or other technology used in the financial services industry for the storage of documentation via internal processes or third-party processors that we approve for these services. You agree that such storage shall be secure, and further agree that such records shall for all purposes be recognized and admissible in evidence or otherwise to prove the agreements, rights and obligations of the parties pursuant to any such records.

  • Project Records Borrower shall: Make and keep books, records, and accounts, in such reasonable detail, so as to fully, accurately, and fairly reflect the activities of Borrower. Record the Project’s assets, liabilities, revenues, expenses, receipts and disbursements in separate accounts from any other assets, liabilities, revenues, expenses, receipts and disbursements of Borrower so as to permit the production of a Statement of Financial Position, a Statement of Profit and Loss (Statement of Activities), and a Statement of Cash Flows for Borrower in which the activities of Borrower are separately identifiable from the activities of the Operator, unless Borrower is also Operator. Devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that: Transactions are executed, and access to assets is permitted, only in accordance with Xxxxxxxx’s authorization; Transactions are accurately and timely recorded to permit the preparation of quarterly and annual financial reports in conformity with applicable Program Obligations; Transactions are timely recorded in sufficient detail so as to permit an efficient audit of the Borrower’s books and records in accordance with Generally Accepted Auditing Standards (GAAS), Generally Accepted Government Auditing Standards (GAGAS), and other applicable Program Obligations; and Transactions are timely recorded in sufficient detail so as to maintain accountability of the Borrower’s assets. The recorded accountability for assets shall be compared with the existing assets at reasonable intervals, but not less than annually, and appropriate action shall be taken with respect to any differences. Make the books, records and accounts of Borrower available for inspection by HUD or its authorized representatives, after reasonable prior notice, during normal business hours, at the Project or other mutually agreeable location or, at HUD’s request, shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes a request for such documents. Include as a requirement in any operating or management contract that the books, records, and accounts of any agent of Borrower, as they pertain to the operations of the Project, shall be kept in accordance with the requirements of this Section 19 and be available for examination by HUD or its authorized representatives after reasonable prior notice during customary business hours at the Project or other mutually agreeable location or, at HUD’s request, the Management Agent shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes the request.

  • Electronic Visit Verification ("EVV A. To ensure: 1. the EVV system is used to verify the provision of services governed under 40 TAC, Chapter 68 or its successor; 2. only authorized people access the Contractor's EVV account; 3. all data elements required by HHSC or HHSC's designee are uploaded or entered and maintained in the EVV system completely, accurately, and prior to submitting the claim; 4. that each time services governed by 40 TAC Chapter 68 or its successor are delivered to an individual, the Contractor's staff uses an HHSC-approved EVV system; and 5. service delivery documentation is immediately available for review by HHSC when requested. B. Equipment provided to Contractor by HHSC, HHSC’s designee, or an HHSC-approved EVV vendor, must be returned in good condition when the equipment is no longer needed under this Contract. In the context of this agreement, “good condition” means Contractor must not place any marks or identifying information on the equipment and may not alter information on the equipment including logos and serial numbers. If the equipment is lost, stolen, marked, altered or damaged by Contractor, Contractor may be required to pay the replacement cost for each piece of equipment that is lost, stolen, marked or damaged. Replacement costs for lost, stolen, marked or damaged equipment may be assessed periodically. If Contractor recovers previously lost or stolen equipment for which Contractor paid the replacement cost in the prior 12 months, Contractor may return the equipment and be reimbursed for the replacement costs within 12 months of the date HHSC, HHSC’s designee or an HHSC-approved EVV vendor (as applicable) received payment in full from the Contractor. This is provided the equipment is returned in good condition as specified above. C. HHSC may perform EVV compliance oversight reviews to determine if Contractor has complied with EVV compliance requirements as outlined in 40 TAC Chapter 68 or its successor, EVV Policy posted on the HHSC EVV website or EVV Policy Handbook. D. If the Contractor determines an electronic record in the EVV system needs to be adjusted at any time, the Contractor will make the adjustment in the EVV system using the most appropriate EVV reason code number(s), EVV reason code description(s) and enter any required free text when completing visit maintenance in the EVV system, if applicable. E. Contractor must begin using an HHSC-approved EVV system prior to submitting an EVV relevant claim. F. All claims for services required to use EVV (EVV claims) must match to an accepted EVV visit transaction in the EVV Aggregator (the state’s centralized EVV database) prior to reimbursement of an EVV claim. Without a matching accepted EVV visit transaction, the claim will be denied. G. Contractor must submit all EVV related claims through the Texas Medicaid Claims Administrator, or as otherwise described in the EVV Policy posted on the HHSC EVV website or in the EVV Policy Handbook. H. Contractor must complete all required EVV training as outlined in the EVV Policy posted on the HHSC EVV website or EVV Policy Handbook: • Prior to using either an EVV vendor system or an EVV proprietary system and • Yearly thereafter. I. Contractor and, if applicable, the Contractor’s appointed EVV system administrator, must complete, sign and date the EVV Onboarding Form as outlined in 40 TAC Chapter 68 or its successor, EVV Policy posted on the HHSC website or EVV Policy Handbook.

  • Complete Copies of Materials The Company has delivered or made available true and complete copies of each document (or summaries of same) that has been requested by Parent or its counsel.

  • Receivable Files Complete There exists a Receivable File pertaining to each Receivable. Related documentation concerning the Receivable, including any documentation regarding modifications of the Contract, will be maintained electronically by the Servicer in accordance with customary policies and procedures. With respect to any Receivables that are tangible chattel paper, the complete Receivable File for each Receivable currently is in the possession of the Custodian.

  • Database File The Servicer will provide the Successor Servicer with a magnetic tape (in a format reasonably acceptable to the Indenture Trustee and the Servicer) containing the database file for each Contract (i) as of the Initial Cutoff Date, (ii) the Subsequent Cutoff Date, (iii) thereafter, as of the last day of the preceding Due Period on each Determination Date prior to a Service Transfer and (iv) on and as of the Business Day before the actual commencement of servicing functions by the Successor Servicer following the occurrence of a Service Transfer.

  • Electronic Record Search The Reporting Estonian Financial Institution must review electronically searchable data maintained by the Reporting Estonian Financial Institution for any of the following U.S. indicia: a) Identification of the Account Holder as a U.S. citizen or resident; b) Unambiguous indication of a U.S. place of birth; c) Current U.S. mailing or residence address (including a U.S. post office box); d) Current U.S. telephone number; e) Standing instructions to transfer funds to an account maintained in the United States; f) Currently effective power of attorney or signatory authority granted to a person with a U.S. address; or g) An “in-care-of” or “hold mail” address that is the sole address the Reporting Estonian Financial Institution has on file for the Account Holder. In the case of a Preexisting Individual Account that is a Lower Value Account, an “in-care-of” address outside the United States or “hold mail” address shall not be treated as U.S. indicia.

  • Medical Records Medical records relating to Trial Subjects that are not submitted to Sponsor may include some of the same information as is included in Trial Data; however, Sponsor makes no claim of ownership to those documents or the information they contain.

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