Certificates of Analysis and Compliance Sample Clauses

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. 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 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. 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. 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. 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. 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. 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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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.
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Related to Certificates of Analysis and Compliance

  • Y2K Compliance PFPC further represents and warrants that any and all electronic data processing systems and programs that it uses or retains in connection with the provision of services hereunder on or before January 1, 1999 will be year 2000 compliant.

  • 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).

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus 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 and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; 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, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits 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”) for the operation of the Company’s business as currently conducted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; 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, the Time of Sale Prospectus 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 and regulations of the Regulatory Agencies except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • 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.

  • Assessments of Compliance and Attestation Reports SECTION 3.22 Access to Certain Documentation.

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • SAFE Compliance The Company shall comply with the SAFE Rules and Regulations, and shall use commercially reasonable efforts to cause its shareholders and option holders that are, or that are directly or indirectly owned or controlled by, PRC residents or PRC citizens, to comply with the SAFE Rules and Regulations applicable to them in connection with the Company, including without limitation, requesting each shareholder and option holder, that is, or is directly or indirectly owned or controlled by, a PRC resident or PRC citizen to complete any registration and other procedures required under applicable SAFE Rules and Regulations.

  • ADA Compliance If necessary, as of the Closing Date, Borrower shall be in compliance with the Americans with Disabilities Act of 1990 ("ADA"), or, if any renovations of Borrower's facilities or modifications of Borrower's employment practices shall be required to bring them into compliance with the ADA, review and approval by FINOVA of Borrower's proposed plan to come into such compliance. Borrower shall deliver representations and warranties to FINOVA concerning Borrower's compliance with the ADA, and no evidence shall have come to the attention of FINOVA indicating that Borrower is not in compliance with the ADA (except to the extent that FINOVA has reviewed and approved Borrower's plan to come into compliance).

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall:

  • Regulatory Compliance a. Monitor compliance with the 1940 Act requirements, including:

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