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.
Sample 1Sample 2Sample 3See All (5)
AutoNDA by SimpleDocs
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 “
Sample 1Sample 2
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 [***].
Sample 1Sample 2
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.
Sample 1Sample 2
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
Deviation Report. NONCONFORMITY 5.1
Sample 1
AutoNDA by SimpleDocs

Related to Deviation Report

  • Termination Report will pay to Stanford all applicable royalties and submit to Stanford a written report within 90 days after the license terminates or expires. ***** will continue to submit earned royalty payments and reports to Stanford after the license terminates or expires, until all Licensed Products made or imported under the license have been sold.

  • 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 A "full inspection report" comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A "detailed report" responds to specific queries about a firm by the other Party.

  • 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.

  • Borrowing Base Report The Agent shall have received from the Borrower the initial Borrowing Base Report dated as of the Closing Date.

  • Property Condition Report A property condition report from a firm of professional engineers or architects selected by Borrower and reasonably acceptable to Agent (the “Inspector”) satisfactory in form and content to the Agent, dated not more than ninety (90) days prior to the inclusion of such Real Estate in the Collateral, addressing such matters as the Agent may reasonably require.

  • Information Reporting (a) The Fund agrees that, during the Current Special Rate Period and so long as BANA or any Affiliate thereof is the beneficial owner of any Outstanding VRDP Shares, it will deliver, or direct the Tender and Paying Agent to deliver, to BANA and any such Affiliate:

  • Progress Report 10.1 If required, you shall submit progress reports in connection with the Service (“Report”) on at least a monthly basis, or as we may require. The Report shall include a summary of the activities and accomplishments during the previous reporting period.

  • Transaction Reports Subadviser shall provide Investment Manager a daily trade file with information relating to all transactions concerning the allocated portion of the Fund’s assets for which Subadviser is responsible and shall provide Investment Manager with such other information regarding the Fund upon Investment Manager’s reasonable request. Subadviser shall affirm or send a trade file of these transactions as instruction to the custodian of the Fund.

  • Borrowing Base Reports Within thirty (30) days after the last day of each month, aged listings of accounts receivable and accounts payable (by invoice date) (the “Borrowing Base Reports”);

Time is Money Join Law Insider Premium to draft better contracts faster.