Released Executed Batch Record Sample Clauses

Released Executed Batch Record. Xxxxxx shall test, or cause to be tested by agreed upon third parties, as set forth in the MBR and in accordance with the Specifications or, in the case of clinical Production, the applicable SOW, each Lot of Client Product Produced pursuant to this Agreement before delivery of the Released Executed Batch Record to Client. The parties may agree that parts of such testing be performed by Client or a qualified third party chosen by Client. The Certificate of Analysis and Released Executed Batch Record for each Lot Produced shall comply with the Quality Agreement.
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Related to Released Executed Batch Record

  • Separate Grievance File All documents, communications and records dealing with the processing of a grievance shall be filed in a separate grievance file and shall not be kept in the personnel file of any of the participants.

  • 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.

  • Electronic Execution; Electronic Records; Counterparts This Agreement, any Loan Document and any other Communication, including Communications required to be in writing, may be in the form of an Electronic Record and may be executed using Electronic Signatures. Each of the Loan Parties and each of the Administrative Agent and each Lender Party agrees that any Electronic Signature on or associated with any Communication shall be valid and binding on such Person to the same extent as a manual, original signature, and that any Communication entered into by Electronic Signature, will constitute the legal, valid and binding obligation of such Person enforceable against such Person in accordance with the terms thereof to the same extent as if a manually executed original signature was delivered. Any Communication may be executed in as many counterparts as necessary or convenient, including both paper and electronic counterparts, but all such counterparts are one and the same Communication. For the avoidance of doubt, the authorization under this paragraph may include, without limitation, use or acceptance of a manually signed paper Communication which has been converted into electronic form (such as scanned into PDF format), or an electronically signed Communication converted into another format, for transmission, delivery and/or retention. The Administrative Agent and each of the Lender Parties may, at its option, create one or more copies of any Communication in the form of an imaged Electronic Record (“Electronic Copy”), which shall be deemed created in the ordinary course of such Person’s business, and destroy the original paper document. All Communications in the form of an Electronic Record, including an Electronic Copy, shall be considered an original for all purposes, and shall have the same legal effect, validity and enforceability as a paper record. Notwithstanding anything contained herein to the contrary, neither the Administrative Agent, L/C Issuer nor Swing Line Lender is under any obligation to accept an Electronic Signature in any form or in any format unless expressly agreed to by such Person pursuant to procedures approved by it; provided, further, without limiting the foregoing, (a) to the extent the Administrative Agent, L/C Issuer and/or Swing Line Lender has agreed to accept such Electronic Signature, the Administrative Agent and each of the Lender Parties shall be entitled to rely on any such Electronic Signature purportedly given by or on behalf of any Loan Party and/or any Lender Party without further verification and (b) upon the request of the Administrative Agent or any Lender Party, any Electronic Signature shall be promptly followed by such manually executed counterpart. Neither the Administrative Agent, L/C Issuer nor Swing Line Lender shall be responsible for or have any duty to ascertain or inquire into the sufficiency, validity, enforceability, effectiveness or genuineness of any Loan Document or any other agreement, instrument or document (including, for the avoidance of doubt, in connection with the Administrative Agent’s, L/C Issuer’s or Swing Line Lender’s reliance on any Electronic Signature transmitted by telecopy, emailed .pdf or any other electronic means). The Administrative Agent, L/C Issuer and Swing Line Lender shall be entitled to rely on, and shall incur no liability under or in respect of this Agreement or any other Loan Document by acting upon, any Communication (which writing may be a fax, any electronic message, Internet or intranet website posting or other distribution or signed using an Electronic Signature) or any statement made to it orally or by telephone and believed by it to be genuine and signed or sent or otherwise authenticated (whether or not such Person in fact meets the requirements set forth in the Loan Documents for being the maker thereof). Each of the Loan Parties and each Lender Party hereby waives (i) any argument, defense or right to contest the legal effect, validity or enforceability of this Agreement, any other Loan Document based solely on the lack of paper original copies of this Agreement, such other Loan Document, and (ii) waives any claim against the Administrative Agent, each Lender Party and each Related Party for any liabilities arising solely from the Administrative Agent’s and/or any Lender Party’s reliance on or use of Electronic Signatures, including any liabilities arising as a result of the failure of the Loan Parties to use any available security measures in connection with the execution, delivery or transmission of any Electronic Signature.

  • Electronic Funds Transfer (EFT) The recipient/cooperator shall designate a financial institution or an authorized payment agent through which a federal payment may be made in accordance with US Treasury Regulations, Money and Finance at 00 XXX 000, which requires that federal payments are to be made by EFT to the maximum extent possible. A waiver may be requested and payments received by check by certifying in writing that one of the following situations apply: 1. The payment recipient does not have an account at a financial institution. 2. EFT creates a financial hardship because direct deposit will cost the payment recipient more than receiving a check. 3. The payment recipient has a physical or mental disability, or a geographic, language, or literacy barrier. In order to receive EFT payments the recipient/cooperator shall register in the System for Award Management (XXX). You may register by going to xxx.xxx.gov and following the instructions provided online. For assistance, contact the XXX User Help by contacting the supporting Federal Service Desk at (000)000-0000 or xxx.xxx.xxx .

  • Cancellation of electronic bill notification The electronic Xxxxxx reserves the right to cancel the presentment of electronic bills at any time. You may cancel electronic bill presentment at any time. The timeframe for cancellation of your electronic bill presentment may vary from Xxxxxx to Xxxxxx. It may take up to sixty (60) days, depending on the billing cycle of each Xxxxxx. We will notify your electronic Xxxxxx(s) as to the change in status of your account and it is your sole responsibility to make arrangements for an alternative form of bill delivery. We will not be responsible for presenting any electronic bills that are already in process at the time of cancellation.

  • ELECTRONIC SUBMITTALS Contractor shall obtain a license for the State to utilize Submittal Exchange for the purposes of this project. The State and its representatives will have full control of the use of Submittal Exchange by authorized users of the State.

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • 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.

  • Contractor Certification Regarding Ethics The Contractor certifies that the Contractor is now, and shall remain, in compliance with Chapter 42.52 RCW, Ethics in Public Service, throughout the term of this Contract.

  • Account Verification Whether or not a Default or Event of Default exists, Agent shall have the right at any time, in the name of Agent, any designee of Agent or any Borrower, to verify the validity, amount or any other matter relating to any Accounts of Borrowers by mail, telephone or otherwise. Borrowers shall cooperate fully with Agent in an effort to facilitate and promptly conclude any such verification process.

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