Dispute Concerning Certificate of Analysis Sample Clauses

Dispute Concerning Certificate of Analysis. 2.6.1. In the event of a dispute concerning whether a Certificate of Analysis should have been issued for a Product Batch pursuant to Article 7 of the Master Quality Agreement, the quality assurance managers of Lifecore and Semnur, or their authorized quality assurance consultants, will diligently and in good faith attempt to resolve such dispute. If they fail to reach agreement within thirty (30) days of initiating dispute procedures, such dispute will be submitted to the appointed officers of the parties. If ​ ​ the appointed officers fail to reach agreement within thirty (30) days, such dispute will be submitted to an independent, qualified third-party expert that is mutually acceptable and selected by Lifecore and Semnur promptly, and in good faith. Such expert will determine whether the requirements for the Certificate of Analysis had been met, and such expert’s determinations will be final and determinative for purposes of this Agreement. The party against whom the expert rules will bear all costs of the expert’s activities. Any dispute relating to such expert’s determination may be resolved as set forth in Section 19 (Disputes). For the avoidance of doubt, both parties will be responsible for their own costs that are not the costs of the expert’s activities. 2.6.2. If it is determined by agreement of the parties or through a final determination under Section 2.6.1 that the Certificate of Analysis for a Batch should not have been issued, and that the nonconformity of the Batch was not due in any part to Lifecore’s failure to comply with the Batch records, Product Specifications, Lifecore Procedures or Applicable Law, Semnur will be required […***…]. 2.6.3. If it is determined by agreement of the parties or through a final determination under Section 2.6.1 above that the Manufacture of a Batch of Product did not conform to the Batch records, Product Specifications, Lifecore Procedures or Applicable Law, and this nonconformity is due to Lifecore’s failure to comply with the Batch records, Product Specifications, Lifecore Procedures or Applicable Law (“Lifecore Non-Conformity”), Semnur will, in its sole discretion, elect one of the following actions which, if successful, will be deemed to cure any breach that otherwise may have been deemed as a result of a Lifecore Non-Conformity: […***…]. In each case, Lifecore and Semnur will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with the Batch records, Product...
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Related to Dispute Concerning 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).

  • RECYCLING CERTIFICATION The Contractor shall certify in writing under penalty of perjury, the minimum, if not exact, percentage of post consumer material as defined in the Public Contract Code Section 12200, in products, materials, goods, or supplies offered or sold to the State regardless of whether the product meets the requirements of Public Contract Code Section 12209. With respect to printer or duplication cartridges that comply with the requirements of Section 12156(e), the certification required by this subdivision shall specify that the cartridges so comply (Pub. Contract Code §12205).

  • Regulatory Good Standing Certification Does Vendor certify that its entity is in good standing will all government entities and agencies, whether local, state, or federal, that regulate any aspect of Vendor's field of work or business operations? If Vendor selects "No", Vendor must provide explanation on the following attribute question. Yes

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Company hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace at the Project Location. The Company will give written notice to the IEDC within ten (10) days after receiving actual notice that the Company, or an employee of the Company in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of payments under the Agreement, termination of the Agreement and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in the Agreement is in excess of $25,000.00, the Company agrees that it will provide a drug-free workplace by: A. Publishing and providing to all of its employees a statement notifying them that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Company’s workplace, and specifying the actions that will be taken against employees for violations of such prohibition;

  • Conformity Assessment Procedures 1. Each Party shall give positive consideration to accepting the results of conformity assessment procedures of other Parties, even where those procedures differ from its own, provided it is satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to its own procedures. 2. Each Party shall seek to enhance the acceptance of the results of conformity assessment procedures conducted in the territories of other Parties with a view to increasing efficiency, avoiding duplication and ensuring cost effectiveness of the conformity assessments. In this regard, each Party may choose, depending on the situation of the Party and the specific sectors involved, a broad range of approaches. These may include but are not limited to: (a) recognition by a Party of the results of conformity assessments performed in the territory of another Party; (b) recognition of co-operative arrangements between accreditation bodies in the territories of the Parties; (c) mutual recognition of conformity assessment procedures conducted by bodies located in the territory of each Party; (d) accreditation of conformity assessment bodies in the territory of another Party; (e) use of existing regional and international multilateral recognition agreements and arrangements; (f) designating conformity assessment bodies located in the territory of another Party to perform conformity assessment; and (g) suppliers’ declaration of conformity. 3. Each Party shall exchange information with other Parties on its experience in the development and application of the approaches in Paragraph 2(a) to (g) and other appropriate approaches with a view to facilitating the acceptance of the results of conformity assessment procedures. 4. A Party shall, upon request of another Party, explain its reasons for not accepting the results of any conformity assessment procedure performed in the territory of that other Party.

  • Invoice Certification When and if requested by DXC, as a condition precedent to payment thereof, Supplier shall separately certify each invoice as follows: “We certify that contract deliverables listed hereon were produced in compliance with all applicable requirements of Sections 6, 7, and 12 of the Fair Labor Standards Act, as amended, and of regulations and orders of the U.S. Department of Labor issued under Section 14 thereof. We further certify that any and all additional contract deliverables will be produced in compliance with same.”

  • Regulatory Good Standing Certification - Explanation - Continued If Vendor responded to the prior attribute that "No", Vendor is not in good standing, Vendor must provide an explanation of that lack of good standing here for TIPS consideration.

  • Escrow Format Specification Deposit’s Format. Registry objects, such as domains, contacts, name servers, registrars, etc. will be compiled into a file constructed as described in draft-xxxxx-xxxxxxx-registry-data-escrow, see Part A, Section 9, reference 1 of this Specification and draft-xxxxx-xxxxxxx-dnrd-objects-mapping, see Part A, Section 9, reference 2 of this Specification (collectively, the “DNDE Specification”). The DNDE Specification describes some elements as optional; Registry Operator will include those elements in the Deposits if they are available. If not already an RFC, Registry Operator will use the most recent draft version of the DNDE Specification available at the Effective Date. Registry Operator may at its election use newer versions of the DNDE Specification after the Effective Date. Once the DNDE Specification is published as an RFC, Registry Operator will implement that version of the DNDE Specification, no later than one hundred eighty (180) calendar days after. UTF-8 character encoding will be used.

  • Escrow Analysis If applicable, with respect to each Mortgage Loan, the Seller has within the last twelve months (unless such Mortgage was originated within such twelve month period) analyzed the required Escrow Payments for each Mortgage and adjusted the amount of such payments so that, assuming all required payments are timely made, any deficiency will be eliminated on or before the first anniversary of such analysis, or any overage will be refunded to the Mortgagor, in accordance with RESPA and any other applicable law;

  • Lobbying Certification This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S.C. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

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