Deviation Report Sample Clauses

Deviation Report. If during the manufacture, processing, storage, distribution, testing, transport, disposal or other handling of PPF by Supplier there arises a result that is classified as either a Type I Incident or a Type II Incident (as defined below), then Supplier shall prepare within seven (7) days following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send to Bayer such Deviation Report prior to Supplier’s delivery of the PPF which is the subject of such report. If Bayer rejects a shipment of PPF based on a Deviation Report, it shall promptly notify Supplier, such PPF shall be considered a Nonconforming Product and the provisions of Section 7.1 shall apply. For purposes of this Agreement, a “Type I Incident” shall be defined as an unexpected result that has potential serious impact on product safety, identity, strength, quality, purity, efficacy or manufacturing/testing process. Examples of Type I Incidents include final product sterility and stability failure, media fill failure, pyrogen specification exceeded for bulk or final container and inadequate viral inactivation process. For purposes of this Agreement, a “Type II Incident” shall be defined as an unexpected result that has the potential to affect product safety, identity, strength, quality, purity, efficacy or manufacturing/testing process. Examples of Type II Incidents include clean steam exceeding action level for LAL and Presterile in-process bioburden exceeding action level.
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Deviation Report. If during the Manufacture, including but not limited to the processing, storage, distribution, testing, transport, disposal or other handling, of Vector Product by SAFC an unexpected result arises that [***].
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Deviation Report. In the event that during the manufacture or ---------------- other handling of a Product by Supplier (i) the process or analytical limits exceed established report ranges, (ii) other events occur which could affect quality or otherwise are unusual or not expected, (iii) there is any reason to doubt full compliance of such Product with the Specifications, or (iv) an unplanned processing event leads to a deviation outside registered or defined processing parameters, then Supplier shall investigate and prepare a written report detailing such factors (a "Deviation Report"). Attached as an exhibit to such Deviation Report shall be copies of all relevant batch records. Any such investigations and reports regarding Primary Products to be used in the manufacture of Secondary/Steriles Products shall be reviewed and approved by GWI prior to incorporation of such Products into any Secondary/Steriles Products.
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Deviation Report. (i) If during the Manufacture of the Contractual Products by Talecris Inc. these arises a result that is classified as either a Type I Incident or a Type II Incident, then Talecris GmbH shall ensure that Talecris Inc. prepares within seven (7) days following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send to Xxxxx such Deviation Report prior to Talecris GmbH’s delivery of the Contractual Products which are the subject of such report. If Xxxxx rejects shipment of the Contractual Products based on a Deviation Report, it shall promptly notify Talecris GmbH, such Contractual Products shall be considered Nonconforming Products and the provisions of Section 12.1 shall apply. For purposes of this Agreement, a “
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Deviation Report. If during the manufacture, processing, storage, distribution, testing, transport, disposal or other handling of Product by SAFC there arises an unexpected result that has an unknown or potential impact on product safety, identity, strength, quality, purity, efficacy or manufacturing/testing process then SAFC shall prepare within ten (10)business days following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send to CLIENT such Deviation Report prior to SAFC’s delivery of the Product which is the subject of such report. If CLIENT rejects a shipment of Product based on a Deviation Report, it shall promptly notify SAFC, such Product shall be considered a Nonconforming Product and the provisions of Section 8.3 shall apply.
Sample 1
Deviation Report. If during the Manufacture, including the processing, storage, distribution, testing, transport, disposal or other handling, of a Deliverable by PROVIDER there arises an unexpected result that has an unknown or potential serious impact on product safety, identity, strength, quality, purity, efficacy or manufacturing/testing process, then PROVIDER shall prepare promptly, as defined in the Quality Agreement and following the discovery of such deviation, a written report detailing such deviation (a “Deviation Report”) and promptly send to CLIENT such Deviation Report prior to any delivery of the Deliverable which is the subject of such report. If CLIENT rejects a Deliverable based on a Deviation Report, it shall promptly notify PROVIDER, such Deliverable shall be considered a Nonconforming Product and the provisions of Section 8.3 shall apply. PROVIDER agrees not to reprocess or rework any Batch of Product, or any intermediate in the Manufacture of Product, without the prior written approval of CLIENT (in its sole discretion) in writing.
Sample 1

Related to Deviation Report

  • Evaluation Report 20.5.4.1 The summary evaluation report shall be prepared by the Faculty Evaluation Committee and administrative evaluator(s) and shall include each evaluator’s individual rating. The summary evaluation report shall take into account the results of each of the evaluation components (Section 20.5.3) in order to arrive at an overall rating. When the committee and the administrative evaluator(s) cannot reach an agreement as to the overall rating, the report must include written explanation.

  • Project Reports; Completion Report 1. The Recipient shall monitor and evaluate the progress of the Project and prepare Project Reports in accordance with the provisions of Section 2.06 of the Standard Conditions and on the basis of indicators agreed with the World Bank. Each Project Report shall cover the period of one (1) calendar semester, and shall be furnished to the World Bank not later than one (1) month after the end of the period covered by such report.

  • Implementation Report Within 120 days after the Effective Date, Xxxxxxxx shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include:

  • Construction Reports Each Constructing Entity shall issue reports to each other Construction Party on a monthly basis, and at such other times as reasonably requested, regarding the status of the construction and installation of the Interconnection Facilities. Each Construction Party shall promptly identify, and shall notify each other Construction Party of, any event that the Construction Party reasonably expects may delay completion, or may significantly increase the cost, of the Interconnection Facilities. Should a Construction Party report such an event, Transmission Provider shall, within fifteen days of such notification, convene a technical meeting of the Construction Parties to evaluate schedule alternatives.

  • Evaluation Reports Where a formal evaluation of an employee's performance is carried out, the employee shall be provided with a copy to read and review. Provision shall be made on the evaluation form for an employee to sign it. The form shall provide for the employee's signature in two (2) places, one indicating that the employee has read and accepts the evaluation, and the other indicating that the employee disagrees with the evaluation. The employee shall sign in one of the places provided within seven (7) calendar days. No employee may initiate a grievance regarding the contents of an evaluation report unless the signature indicates disagreement with the evaluation. The employee shall receive a copy of the evaluation report at the time of signing. An evaluation report shall not be changed after an employee has signed it, without the knowledge of the employee, and any such changes shall be subject to the grievance procedure.

  • Compliance Statement Within 30 days after the last day of each month and together with the statements set forth in Section 5.3(c), a duly completed Compliance Statement, confirming that as of the end of such month, Borrower was in full compliance with all of the terms and conditions of this Agreement, and setting forth calculations showing compliance with the financial covenants set forth in this Agreement and such other information as Bank may reasonably request;

  • Deviation Should Subrecipient wish to deviate from the requirements of this Paragraph F or wish to issue a sub-contract to other than the lowest bidder or competitor, Subrecipient shall submit written justification therefore to Administrator for approval or denial and shall withhold any further action until receipt of written notice of Administrator’s approval of said request. The decision of Administrator shall be final.

  • Monthly Report A. A Monthly Report shall be submitted within ten (10) calendar days of the end of each calendar month of the Period of Operation. Each Monthly Report shall be signed, dated, and certified by Concessionaire, Concessionaire’s Bookkeeper, or Accountant, and contain a Statement of Total Gross Receipts, excluding New Jersey State Sales Tax, derived by Concessionaire from operation of the Concession during the previous month. Each Monthly Report shall be based on the daily “Z” tapes or Point-of-Service (POS) device equivalent for that same month showing each day’s sales activity. Failure on the part of Concessionaire to provide the Monthly Report, when due, shall constitute a material breach of this Agreement subject to Suspension of Operations and/or Termination, in accordance with the terms and conditions set forth in Paragraphs 9 and 10. Concessionaire shall provide Department with any additional written clarification and/or information necessary to confirm the accuracy of any or all of Concessionaire’s Monthly Reports.

  • Inspection Reports Copies of the incident inspection reports and related documentation shall be distributed as follows:

  • Servicer Compliance Statement On or before March 1 of each calendar year, commencing in 2007, the Servicer shall deliver to the Owner and any Depositor a statement of compliance addressed to the Owner and such Depositor and signed by an authorized officer of the Servicer, to the effect that (i) a review of the Servicer’s activities during the immediately preceding calendar year (or applicable portion thereof) and of its performance under this Agreement and any applicable Reconstitution Agreement during such period has been made under such officer’s supervision, and (ii) to the best of such officers’ knowledge, based on such review, the Servicer has fulfilled all of its obligations under this Agreement and any applicable Reconstitution Agreement in all material respects throughout such calendar year (or applicable portion thereof) or, if there has been a failure to fulfill any such obligation in any material respect, specifically identifying each such failure known to such officer and the nature and the status thereof.

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