Certificate of Compliance and Certificate of Analysis Sample Clauses

Certificate of Compliance and Certificate of Analysis. For each batch certified by Patheon, prior to release for shipment to Cangene, Patheon will deliver to Cangene a Certificate of Analysis, CoA (signed by QC Manager) which contains a statement of compliance of batch to Specifications and Certificate of Compliance, CoC (signed by Qualified Person) which will include a statement that the batch has been manufactured in accordance with cGMPs and complies with the Specifications. Both documents will be provided under official Patheon letterhead (containing address) and their format will comply with the templates reported in Appendix F and Appendix G in accordance with approved specifications. Clinical Trial Material (CTM) batches already manufactured in Patheon [**] facility and following Clinical Trials Manufacturing Agreement may be requested by Cangene to be re-designated to commercial destination. In such instances, the batches will be re-examined in the light of requirements of this Quality Agreement, Product Registration and Specification; if such compliance is demonstrated the batches will be re-certified and new CoAs and CoCs will be issued by Patheon. This circumstance shall apply to either batches already released according to CTM requirements and batches still pending release, irrespective if still present in Patheon warehouse or already delivered to Client. Additional reference samples may be collected if necessary. Quality QG01-05-T001-01 Agreement
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Certificate of Compliance and Certificate of Analysis. For each batch certified by Patheon prior to release for shipment to Synageva, Patheon will deliver to Synageva a Certificate of Analysis, CoA (signed by QC Manager) which contains a statement of compliance of batch to Specifications and Certificate of Compliance, CoC (signed by Qualified Person) which will include a statement that the batch has been Manufactured in accordance with cGMPs and complies to the Specifications.

Related to Certificate of Compliance and Certificate of Analysis

  • 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).

  • Certificate of Compliance The Servicer shall deliver to the Note Issuer, the Note Trustee, the Certificate Trustee and the Rating Agencies on or before March 31 of each year, commencing March 31, 2006 to and including the March 31 succeeding the Retirement of the Notes, an Officer’s Certificate substantially in the form of Exhibit A hereto (a “Certificate of Compliance”), stating that: (i) a review of the activities of the Servicer during the twelve months ended the preceding December 31 (or, in the case of the first Certificate of Compliance to be delivered on or before March 31, 2006, the period of time from the date of this Agreement until December 31, 2005) and of its performance under this Agreement has been made under such Responsible Officer’s supervision, and (ii) to the best of such Responsible Officer’s knowledge, based on such review, the Servicer has fulfilled all of its obligations under this Agreement in all material respects throughout such twelve months (or, in the case of the Certificate of Compliance to be delivered on or before March 31, 2006, the period of time from the date of this Agreement until December 31, 2005), or, if there has been a failure to fulfill any such obligation in any material respect, specifying each such failure known to such Responsible Officer and the nature and status thereof.

  • Annual Certificate of Compliance The Issuer will deliver to the Indenture Trustee within 90 days after the end of each year, starting in the year after the Closing Date, an Officer’s Certificate signed by a Responsible Person of the Issuer, stating that (a) a review of the Issuer’s activities and of its performance under this Indenture during the prior year has been made under a Responsible Person’s supervision and (b) to the Responsible Person’s knowledge, based on the review, the Issuer has fulfilled in all material respects its obligations under this Indenture throughout the prior year or, if there has been a failure to fulfill an obligation in any material respect, stating each failure known to the Responsible Person and the nature and status of the failure. A copy of the Officer’s Certificate may be obtained by any Noteholder or Person certifying it is a Note Owner by request to the Indenture Trustee at its Corporate Trust Office. The Issuer’s obligation to deliver an Officer’s Certificate under this Section 3.9 will terminate on the payment in full of the Notes.

  • Certificates of Analysis Illumina shall, once made available for all TG Consumables as part of Illumina’s standard commercial offering for TG Consumables, provide a Certificate of Analysis for each lot of TG Consumables sold to Customer under this Agreement.

  • Form of Compliance Certificate Reference is made to the Amended and Restated Five-Year Credit Agreement dated as of October 25, 2012 (as modified and supplemented and in effect from time to time, the “Credit Agreement”) by and among SOUTH CAROLINA FUEL COMPANY, INC., the Lenders from time to time parties thereto, XXXXX FARGO BANK, NATIONAL ASSOCIATION, as Swingline Lender and administrative agent (in such capacity, the “Agent”), Bank of America, N.A. and Xxxxxx Xxxxxxx Senior Funding, Inc., as Co-Syndication Agents, and JPMorgan Chase Bank, N.A., Mizuho Corporate Bank, LTD. and TD Bank N.A., as Documentation Agents. Capitalized terms used herein shall have the meanings ascribed thereto in the Credit Agreement; all amounts shown herein, unless expressly set forth to the contrary, shall be without duplication. Pursuant to the terms of the Credit Agreement, _________________________, the duly authorized ____________________ of the Borrower, hereby certifies to the Agent and the Lenders that, as of and for the Fiscal Quarter/Fiscal Year ended ___________, (i) no Default or Event of Default is in existence on and as of the date hereof, and [(ii) the quarterly financial statements for the fiscal period cited, which accompany this certificate or have been delivered to Agent by electronic transmission pursuant to the terms of Section 7.01 of the Credit Agreement, fairly present in all material respects the financial condition of the Borrower and have been prepared in accordance with GAAP (subject to changes resulting from normal year-end audit adjustments except that a cash flow statement is not provided and such statements contain fewer footnotes than the annual financial statements) consistently applied (other than changes in accounting principles recorded in accordance with GAAP);]. SOUTH CAROLINA FUEL COMPANY, INC. By: Name: Title: E-#PageNum# LEGAL02/33561677v8 EXHIBIT F FORM OF NOTICE OF SWINGLINE BORROWER [Date] This Notice of Swingline Borrowing is given under and pursuant to Section 2.04(b) of the Amended and Restated Five-Year Credit Agreement (as amended from time to time, the “Credit Agreement”) dated as of October 25, 2012 among SOUTH CAROLINA FUEL COMPANY, INC., the Lenders identified therein, XXXXX FARGO BANK, NATIONAL ASSOCIATION, as Swingline Lender and administrative agent (in such capacity, the “Agent”), Bank of America, N.A. and Xxxxxx Xxxxxxx Senior Funding, Inc., as Co-Syndication Agents, and JPMorgan Chase Bank, N.A., Mizuho Corporate Bank, LTD. and TD Bank N.A., as Documentation Agents. Capitalized terms used and not defined herein shall have the meanings assigned to them in the Credit Agreement.

  • Annual Statement of Compliance The Officer’s Certificate required to be delivered by the Issuing Entity, pursuant to Section 3.9 of the Indenture or the Officer’s Certificate required to be delivered by the Servicer pursuant to Section 4.01(a) of the Servicing Agreement, as applicable.

  • Report on Assessment of Compliance and Attestation (a) On or before March 1 of each calendar year, commencing in 2007, the Servicer shall:

  • Certificate of Financial Officer — Compliance Concurrently with any delivery of financial statements under Section 8.01(a) or Section 8.01(b), a certificate of a Financial Officer in substantially the form of Exhibit D hereto (i) certifying as to whether a Default has occurred and, if a Default has occurred, specifying the details thereof and any action taken or proposed to be taken with respect thereto, (ii) setting forth reasonably detailed calculations demonstrating compliance with Section 8.13(b) and Section 9.01 and (iii) stating whether any change in GAAP or in the application thereof has occurred since the date of the audited financial statements referred to in Section 7.04 and, if any such change has occurred, specifying the effect of such change on the financial statements accompanying such certificate.

  • Provision and contents of Compliance Certificate (a) The Company shall supply a Compliance Certificate to the Agent with each set of its audited consolidated Annual Financial Statements and each set of its consolidated Quarterly Financial Statements.

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