GMP Compliance Sample Clauses

GMP Compliance. 4.8.1 All Products will be Manufactured in accordance with GMP and in compliance with all other applicable statutes, regulations, laws, quality control standards, and Marketing Authorizations, as well as in compliance with the Quality Assurance Agreement between LTS CORP and CYGNUS to be executed within ninety (90) calendar days after the Effective Date of this Agreement, as may be amended by the written agreement of the Parties from time to time and annexed hereto as soon as appropriate. LTS CORP will notify CYGNUS of any change in a supplier of Raw Materials or a change in the manufacturing process (but not the specific details if such details are proprietary) so that the Parties can discuss the regulatory impact, if any, of such change.
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GMP Compliance. Lilly shall ensure that the Manufacturing Facility (including equipment, systems, record keeping and utilities) complies with Applicable Law and is operated in accordance with GMPs and the conditions set forth in Regulatory Approvals. Lilly shall store all components and raw materials (including the Compound) and the Product until shipment in accordance with the Specifications and Applicable Laws. Lilly shall manufacture the Product in compliance with Applicable Law and the Specifications. Lilly shall perform quality control testing and quality oversight on the Product to be delivered hereunder in accordance with Applicable Law, Specifications, cGMPs, the MRD, and the Quality Agreement. Lilly shall ship the Product in compliance with Applicable Law and the Specifications.
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GMP Compliance. Any costs and expenses which need to be incurred by Praecis or its contract manufacturers and suppliers to ensure compliance with GMP and other Regulatory Requirements applicable in the Territory shall be borne solely by Praecis and its respective contract manufacturers and suppliers. Following any inspections by Schering, as described in Section 10.9, Schering may prepare a report detailing any deficiencies identified in Praecis’ or its contract manufacturers’ progress towards achieving, or maintaining, GMP standards. Praecis will discuss with Schering any recommendations made by Schering and will implement those with which it agrees. For the avoidance of doubt, any official advice received from a relevant Health Regulatory Authority regarding the requirements of GMP will be conclusive, unless Praecis can reasonably demonstrate that such advice is erroneous, and, unless Praecis so demonstrates, Praecis will implement any such requirements. However, and for the further avoidance of doubt, Praecis shall not be obligated to implement official advice which is in the form of suggestions that are not necessary for compliance with GMP. The Parties agree that Praecis shall ensure that Sterigenics shall comply with the Regulatory Requirements in the Territory, including but not limited to monitoring and storage conditions. Nothing contained in this Section 10.10 is intended to limit or otherwise affect the provisions of Article VI, and, to the extent such provisions are applicable in accordance with their terms, such provisions, and not this Section 10.10, shall control.
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GMP Compliance. All Bulk rh[*] supplied by GTC shall meet the GMP guidelines required by the applicable Regulatory Authorities and shall meet the Specifications, on a country-by country basis, and such other specifications as are mutually agreed upon by GTC and X.
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Related to GMP 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.

  • FCPA Compliance The Company has not and, to the best of the Company’s knowledge, none of its employees or agents at any time during the last five years have (i) made any unlawful contribution to any candidate for foreign office, or failed to disclose fully any contribution in violation of law, or (ii) made any payment to any federal or state governmental officer or official, or other person charged with similar public or quasi-public duties, other than payments required or permitted by the laws of the United States or any jurisdiction thereof.

  • 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).

  • SOX Compliance The Company has taken all actions it deems reasonably necessary or advisable to take on or prior to the date of this Agreement to assure that, upon and at all times after the Effective Date, it will be in compliance in all material respects with all applicable provisions of the Sxxxxxxx-Xxxxx Act of 2002 and all rules and regulations promulgated thereunder or implementing the provisions thereof. (the “Sxxxxxxx-Xxxxx Act”) that are then in effect and will take all action it deems reasonably necessary or advisable to assure that it will be in compliance in all material respects with other applicable provisions of the Sxxxxxxx-Xxxxx Act not currently in effect upon it and at all times after the effectiveness of such provisions.

  • CRA Compliance Neither Buyer nor any Buyer Subsidiary has received any notice of non-compliance with the applicable provisions of the CRA and the regulations promulgated thereunder. As of the date hereof, Buyer’s and each Buyer Subsidiary’s most recent examination rating under the CRA was “satisfactory” or better. Buyer knows of no fact or circumstance or set of facts or circumstances which would be reasonably likely to cause Buyer or any Buyer Subsidiary to receive any notice of non-compliance with such provisions of the CRA or cause the CRA rating of Buyer or any Buyer Subsidiary to decrease below the “satisfactory” level.

  • ISRA Compliance (a) Tenant shall, at Tenant’s own expense, comply with the Industrial Site Recovery Act, N.J.

  • HIPAA Compliance To the extent that and for so long as a Loan Party is a “covered entity” within the meaning of HIPAA, such Loan Party (i) has undertaken or will promptly undertake all applicable surveys, audits, inventories, reviews, analyses and/or assessments (including any required risk assessments) of all areas of its business and operations required by HIPAA; (ii) has developed or will promptly develop a detailed plan and time line for becoming HIPAA Compliant (a “HIPAA Compliance Plan”); and (iii) has implemented or will implement those provisions of such HIPAA Compliance Plan in all material respects necessary to ensure that such Loan Party is or becomes HIPAA Compliant.

  • 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).

  • HSR Compliance The applicable waiting period under the HSR Act shall have expired or been terminated.

  • 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.

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