Certificates of Analysis and Compliance Sample Clauses

Certificates of Analysis and Compliance. Eagle shall, or shall cause the Third Party Manufacturer, to provide MDCO with a copy of the certificate of analysis, the materials safety data sheet and a certificate of compliance (together, the “Certificates”), with, or at the same time of, each delivery of Finished Product supplied hereunder. In the event MDCO requires additional documentation due to a change in Applicable Laws or Regulatory Approvals, without which the release into commerce and selling of Product in the Field in the Territory under any Regulatory Approval would be impossible or impracticable (hereinafter “Additional Documentation”), Eagle shall, or shall use Commercially Reasonable Efforts to cause its Third Party Manufacturer to, supply such documentation with each delivery of Product. Subject to any variations agreed to in the Quality Agreement, such Certificates shall certify, with respect to each shipment and Batch (identified by Batch number): (i) the quantity of the shipment, (ii) that the Product delivered conforms to, and was handled in compliance with, the Product Specifications, (iii) that the Product was Manufactured in accordance with cGMP and all other Applicable Laws and any applicable Regulatory Approvals, as well as any further information required by the relevant regulatory authorities that MDCO may have previously notified Eagle is necessary, (iv) confirmation that all quality controls tests on the active pharmaceutical ingredients, excipients and other Product and Finished Product components, Labeling and Packaging were conducted in accordance with all Applicable Laws and applicable Regulatory Approvals, and the results thereof, and (v) confirmation that each such Batch has been released for commercial sale by the Third Party Manufacturer in accordance with all Applicable Laws and applicable Regulatory Approvals, and (vi) such information as pharmaceutical manufacturers generally include in certifications similar to the Certificates, including the release tests performed by Eagle or the Third Party Manufacturer and the results of those tests.
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Certificates of Analysis and Compliance. Lonza shall deliver to Customer the Certificate of Analysis, Certificate of Compliance and such other documentation as is reasonably required and/or requested by Customer to meet all applicable regulatory requirements of the Governmental Authorities not later than the date of Release of such cGMP Batches; provided that Lonza may, upon notice to Customer, supply certain trade secret information, such as Lonza’s media and feed formulation, directly to the relevant Governmental Authority instead of supplying it to Customer.
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Certificates of Analysis and Compliance. Alfacell shall provide Par with a copy of the certificate of analysis and a certificate of compliance (together, the “Certificates”), with, or at the same time of, each delivery of Product supplied hereunder. In the event Par requires additional documentation due to a change in the law or a Regulatory Approval without which the release into commerce and selling of Product in the Field in the Territory under any Regulatory Approval would be impossible or impracticable, Alfacell will use Commercially Reasonable Efforts to supply (unless such documentation is required from all manufacturers of pharmaceutical products, in which case Alfacell shall supply or cause its Third Party Manufacturer to supply) such documentation with each delivery of Product. Subject to variations agreed to in the Quality Agreement, such Certificates shall certify, with respect to each shipment and batch (identified by batch number): (i) the quantity of the shipment, (ii) that the Product delivered conforms to, and was handled in compliance with, the Product Specifications and (iii) that the Product was Manufactured in accordance with cGMP and any applicable Regulatory Approval, as well as any further information required by the relevant regulatory authorities that Par may have previously notified Alfacell is necessary. Par shall be under no obligation to accept any shipment of Product without the accompanying Certificates.
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Certificates of Analysis and Compliance. NovaDel shall provide appropriate certification that the Licensed Product supplied meets specifications, and other applicable quality standards, as determined by the parties in the Quality Agreement, to BioAlliance with each shipment of Licensed Product supplied hereunder. In the event BioAlliance requires additional documentation from a Manufacturer (whether due to a change in the applicable laws, rules or regulations or in a Regulatory Approval for Licensed Product) to Exploit Licensed Product in the Territory under any Regulatory Approval, NovaDel will use Commercially Reasonable Efforts to supply such documentation with each shipment of Licensed Product. Such certificates shall certify with respect to each shipment and batch (identified by batch number) (i) the quantity of the shipment, (ii) that the Licensed Product delivered conforms to the Specifications and (iii) that the Licensed Product was Manufactured in accordance with *** Portion for which confidential treatment requested.
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Certificates of Analysis and Compliance. XXX shall deliver to Pharmion, together with each delivery of each batch of Product, the corresponding Certificate of Compliance and the Certificate of Analysis relating to such batch. The Certificate of Analysis shall give full analytical results with respect to regulatory Specifications for each batch. The Certificate of Compliance will confirm that the Product has been made and tested in accordance with the master batch record, the Specifications and the test methods specified in the NDA. XXX shall promptly inform Pharmion of significant events and/or results including, but not limited to, quality incidents and batch deviations which may have occurred during the Manufacturing and/or Packing and which might affect the quality of the Product.
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Certificates of Analysis and Compliance. 11 CONTACTS..................................................................... 11
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Certificates of Analysis and Compliance. 4.1 Schering requires a Certificate of Analysis (COA) from Millennium to accompany each lot of delivered Product. The COA must list the Product's Specifications, test results obtained for the particular lot, test method reference, and the signature of the person authorized to release the lot to Schering. In addition, the location where the Product was manufactured and tested, if different from that on the letter head, must be identified. A Certificate of Compliance (COC) that states the lot was Manufactured under cGMP conditions must accompany the lot or the declaration may appear on the COA. 4.2 Schering may request copies of batch documentation including the executed batch record and associated deviations and investigations. 4.3 Millennium shall have a program in place to qualify and assess periodically the performance of its Authorized Contractors, regardless of whether Millennium receives a COA/COC for each delivery of material. 4.4 All raw materials must comply with TSE (transmissible spongiform encephalopathy)/ BSE (bovine spongiform encephalography) guideline EMEA /410/01 Rev. 1) and Residual Solvent guideline (ICH Topic QC3, Impurities: Residual Solvents). In addition, raw materials should be traceable to the original supplier.
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Certificates of Analysis and Compliance. Schering shall deliver to Pharmion, together with each delivery of each batch of Product, the corresponding Certificate of Compliance and the Certificate of Analysis relating to such batch. The Certificate of Analysis shall give full analytical results with respect to regulatory Specifications for each batch. The Qualified Person working for the Manufacturer shall sign a Certificate of Compliance confirming that the Product has been made and tested in accordance with the master batch record, the Specifications and the test methods specified in the approved registration dossier. Schering shall promptly inform Pharmion of significant events and/or results including, but not limited to, quality incidents and batch deviations which may have occurred during the Manufacturing and/or Packing and which might affect the quality of the Product.
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Related to Certificates of Analysis and Compliance

  • Certificates of Compliance The Company shall provide, from time to time upon request of the Dealer Manager, certificates of its chief executive officer and chief financial officer of compliance by the Company of the requirements of this Agreement.

  • Contractor Compliance Contractor represents and warrants to pay, at its sole expense, for all applicable permits, licenses, tariffs, tolls and fees to give all notices and comply with all laws, ordinances, rules and regulations of any governmental entity in conjunction with the performance of obligations under the Contract. Prior to award and during the Contract term and any renewals thereof, Contractor must establish to the satisfaction of the Commissioner that it meets or exceeds all requirements of the Bid/Contract and any applicable laws, including but not limited to, permits, insurance coverage, licensing, proof of coverage for worker’s compensation, and shall provide such proof as required by the Commissioner. Failure to do so may constitute grounds for the Commissioner to cancel or suspend this Contract, in whole or in part, or to take any other action deemed necessary by the Commissioner.

  • Documentation and compliance (a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses. (b) The Parties shall be able to demonstrate compliance with these Clauses. In particular, the data importer shall keep appropriate documentation on the processing activities carried out on behalf of the data exporter. (c) The data importer shall make available to the data exporter all information necessary to demonstrate compliance with the obligations set out in these Clauses and at the data exporter’s request, allow for and contribute to audits of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. In deciding on a review or audit, the data exporter may take into account relevant certifications held by the data importer.

  • Standards Compliance Registry Operator shall comply with relevant existing RFCs and those published in the future by the Internet Engineering Task Force (IETF), including all successor standards, modifications or additions thereto relating to the DNS and name server operations including without limitation RFCs 1034, 1035, 1123, 1982, 2181, 2182, 2671, 3226, 3596, 3597, 4343, and 5966. DNS labels may only include hyphens in the third and fourth position if they represent valid IDNs (as specified above) in their ASCII encoding (e.g., “xn--ndk061n”).

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

  • ETHICS COMPLIANCE All Bidders/Contractors and their employees must comply with the requirements of Sections 73 and 74 of the Public Officers Law, other State codes, rules, regulations and executive orders establishing ethical standards for the conduct of business with New York State. In signing the Bid, Bidder certifies full compliance with those provisions for any present or future dealings, transactions, sales, contracts, services, offers, relationships, etc., involving New York State and/or its employees. Failure to comply with those provisions may result in disqualification from the Bidding process, termination of contract, and/or other civil or criminal proceedings as required by law.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • FUND COMPLIANCE 3.1 The Fund and the Adviser acknowledge that any failure (whether intentional or in good faith or otherwise) to comply with the requirements of Subchapter M of the Code or the diversification requirements of Section 817(h) of the Code may result in the Contracts not being treated as variable contracts for federal income tax purposes, which would have adverse tax consequences for Contract owners and could also adversely affect the Company's corporate tax liability. The Fund and the Adviser further acknowledge that any such failure may result in costs and expenses being incurred by the Company in obtaining whatever regulatory authorizations are required to substitute shares of another investment company for those of the failed Fund or as well as fees and expenses of legal counsel and other advisors to the Company and any federal income taxes, interest or tax penalties incurred by the Company in connection with any such failure. 3.2 The Fund represents and warrants that it is currently qualified as a Regulated Investment Company under Subchapter M of the Code, and that it will maintain such qualification (under Subchapter M or any successor or similar provision) and that it will notify the Company immediately upon having a reasonable basis for believing that it has ceased to so qualify or that it might not so qualify in the future. 3.3 The Fund represents that it will at all times invest money from the Contracts in such a manner as to ensure that the Contracts will be treated as variable contracts under the Code and the regulations issued thereunder; including, but not limited to, that the Fund will at all times comply with Section 817(h) of the Code and Treasury Regulation 1.817-5, as amended from time to time, relating to the diversification requirements for variable annuity, endowment, or life insurance contracts, and with Section 817(d) of the Code, relating to the definition of a variable contract, and any amendments or other modifications to such Section or Regulation. The Fund will notify the Company immediately upon having a reasonable basis for believing that the Fund or a Portfolio thereunder has ceased to comply with the diversification requirements or that the Fund or Portfolio might not comply with the diversification requirements in the future. In the event of a breach of this representation by the Fund, it will take all reasonable steps to adequately diversify the Fund so as to achieve compliance within the grace period afforded by Treasury Regulation 1.817-5. 3.4 The Adviser agrees to provide the Company with a certificate or statement indicating compliance by each Portfolio of the Fund with Section 817(h) of the Code, such certificate or statement to be sent to the Company no later than thirty (30) days following the end of each calendar quarter.

  • GAAP Compliance Contractor maintains an adequate system of accounting and internal controls that meets Generally Accepted Accounting Principles.

  • CEQA Compliance The District has complied with all assessment requirements imposed upon it by the California Environmental Quality Act (Public Resource Code Section 21000 et seq. (“CEQA”) in connection with the Project, and no further environmental review of the Project is necessary pursuant to CEQA before the construction of the Project may commence.

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