Testing of API Sample Clauses

Testing of API. Prior to release of the API, Chemport shall test the API in accordance with the Validation testing procedures described in the (a) applicable Drug Applications, (b) API Specifications, (c) cGMPs, (d) Legal Requirements, (e) Quality Agreement and (f) those procedures and in-plant quality control checks applicable to any products packaged by Chemport. Chemport shall provide Amarin with a copy of the records pertaining to such testing if reasonably requested, subject to redaction of any Chemport Confidential Information. Additionally, Chemport shall provide Amarin with a Certificate of Analysis and/or any other certificate required by any applicable Governmental Body for release of API (collectively, the “Certificates”) for each batch of API. Amarin shall be under no obligation to accept any shipment of API without the accompanying Certificates. For the avoidance of doubt, all information provided to Amarin under this Section 6.2 is Chemport Confidential Information and nothing in this Section 6.2 shall be construed as giving Amarin any right to use or disclose (A) any Chemport Intellectual Property (except as may be permitted by any express license from Chemport), or (B) any Chemport Confidential Information (except as may be permitted under Article XIII hereof).
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Testing of API. API shall be tested by Nycomed or its appointee and Patheon as provided for in the Quality Agreement and each delivery of API by Nycomed shall be accompanied by the documentation as set forth in the Quality Agreement. At any time so detected by Patheon, whether by testing the API or otherwise, that API supplied by Nycomed does not conform to its Specification or is otherwise defective, Patheon shall promptly and in writing notify Nycomed about such non-compliance or defect.
Testing of API. Prior to release of the API, Novasep shall test the API in accordance with the testing procedures described in the (i) applicable Drug Applications, (ii) API Specifications, (iii) cGMPs, (iv) Legal Requirements, (v) those procedures and in-plant quality control checks applicable to any products manufactured or packaged by Novasep, and (vi) such other methods and procedures as agreed upon by the Parties from time to time. Novasep shall provide Inspire with a copy of the records pertaining to such testing, including the applicable master batch record and a copy of the applicable deviation or other investigatory report, if any, and any other information as requested by Inspire. Additionally, Novasep shall provide Inspire with a Certificate of Analysis and/or any other certificate required by any applicable Governmental Body for release of API (collectively, the “Certificates”) for each batch of API. Inspire shall be under no obligation to accept any shipment of API without the accompanying Certificates.
Testing of API. Prior to release of the API, Equateq shall test the API in accordance with the testing procedures described in the (i) applicable Drug Applications, (ii) API Specifications, (iii) cGMPs, (iv) Legal Requirements, (v) those procedures and in-plant quality control checks applicable to any products manufactured by Equateq, and (vi) such other methods and procedures as Amarin shall reasonably determine from time to time. Equateq shall provide Amarin with a copy of the records pertaining to such testing if requested subject to the overriding condition that nothing in this Agreement shall oblige Equateq to disclose its batch records in whole or in part to Amarin; provided, however, that redacted batch records may be reviewed by Amarin as part of any audit subject to and in accordance with Section 9.2. Additionally, Equateq shall provide Amarin with a Certificate of Analysis and/or any other certificate required by any applicable Governmental Body for release of API (collectively, the “Certificates”) for each batch of API. Amarin shall be under no obligation to accept any shipment of API without the accompanying Certificates.

Related to Testing of API

  • Reporting of Sales to TIPS by Vendor The Participation Fee that was published as part of the Solicitation and the fee published is the legally effective fee, along with any fee conditions stated in the Solicitation. Collection of the fees by TIPS is required under Texas Government Code §791.011 Et seq. Fees are due on all TIPS purchases reported by either Vendor or Member. Fees are due to TIPS upon payment by the Member to the Vendor, Reseller or Vendor Assigned Dealer. Vendor, Reseller or Vendor Assigned Dealer agrees that the participation fee is due to TIPS for all Agreement sales immediately upon receipt of payment including partial payment, from the Member Entity and must be paid to TIPS at least on a monthly basis, specifically within 31 calendar days of receipt of payment, if not more frequently, or as otherwise agreed by TIPS in writing and signed by an authorized signatory of TIPS. Thus, when an awarded Vendor, Reseller or Vendor Assigned Dealer receives any amount of payment, even partial payment, for a TIPS sale, the legally effective fee for that amount is immediately due to TIPS from the Vendor and fees due to TIPS should be paid at least on a monthly basis, specifically within 31 calendar days of receipt of payment, if not more frequently. Reporting of Sales to TIPS by Vendor Vendor is required to report all sales under the TIPS contract to TIPS. When a public entity initiates a purchase with a TIPS Awarded Vendor, if the Member inquires verbally or in writing whether the Vendor holds a TIPS Contract, it is the duty of the Vendor to verify whether or not the Member is seeking a TIPS purchase. Once verified, the Vendor must include the TIPS Contract number on any communications and related sales documents exchanged with the TIPS Member entity. To report sales, the Vendor must login to the TIPS Vendor Portal online at xxxxx://xxx.xxxx-xxx.xxx/vendors_form.cfm and click on the PO’s and Payments tab. Pages 3-7 of the Vendor Portal User Guide will walk you through the process of reporting sales to TIPS. Please refer to the TIPS Accounting FAQ’s for more information about reporting sales and if you have further questions, contact the Accounting Team at xxxxxxxxxx@xxxx-xxx.xxx. The Vendor or vendor assigned dealers are responsible for keeping record of all sales that go through the TIPS Agreement and submitting same to TIPS. Failure to render the participation fee to TIPS shall constitute a breach of this agreement with our parent governmental entity, Texas Education Service Center Region 8, as established by the Texas legislature and shall be grounds for termination of this agreement and any other agreement held with TIPS and possible legal action. Any overpayment of participation fees to TIPS by a Vendor will be refunded to the Vendor within ninety (90) days of receipt of notification if TIPS receives written notification of the overpayment not later than the expiration of six (6) months from the date of overpayment and TIPS determines that the amount was not legally due to TIPS pursuant to this agreement and applicable law. It is the Vendor’s responsibility to identify which sales are TIPS Agreement sales and pay the correct participation fee due for TIPS Agreement sales. Any notification of overpayment received by TIPS after the expiration of six (6) months from the date of overpayment will be non-refundable. Region 8 ESC and TIPS reserve the right to extend the six (6) month deadline to notify if approved by the Region 8 ESC Board of Directors. TIPS reserves all rights under the law to collect the fees due. Please contact TIPS at xxxx@xxxx-xxx.xxx or call (000) 000-0000 if you have questions about paying fees.

  • Testing of Metering Equipment Connecting Transmission Owner shall inspect and test all of its Metering Equipment upon installation and at least once every two (2) years thereafter. If requested to do so by NYISO or Developer, Connecting Transmission Owner shall, at Developer’s expense, inspect or test Metering Equipment more frequently than every two (2) years. Connecting Transmission Owner shall give reasonable notice of the time when any inspection or test shall take place, and Developer and NYISO may have representatives present at the test or inspection. If at any time Metering Equipment is found to be inaccurate or defective, it shall be adjusted, repaired or replaced at Developer’s expense, in order to provide accurate metering, unless the inaccuracy or defect is due to Connecting Transmission Owner’s failure to maintain, then Connecting Transmission Owner shall pay. If Metering Equipment fails to register, or if the measurement made by Metering Equipment during a test varies by more than two percent from the measurement made by the standard meter used in the test, Connecting Transmission Owner shall adjust the measurements by correcting all measurements for the period during which Metering Equipment was in error by using Developer’s check meters, if installed. If no such check meters are installed or if the period cannot be reasonably ascertained, the adjustment shall be for the period immediately preceding the test of the Metering Equipment equal to one-half the time from the date of the last previous test of the Metering Equipment. The NYISO shall reserve the right to review all associated metering equipment installation on the Developer’s or Connecting Transmission Owner’s property at any time.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Public Posting of Approved Users’ Research Use Statement The PI agrees that information about themselves and the approved research use will be posted publicly on the dbGaP website. The information includes the PI’s name and Requester, project name, Research Use Statement, and a Non-Technical Summary of the Research Use Statement. In addition, and if applicable, this information may include the Cloud Computing Use Statement and name of the CSP or PCS. Citations of publications resulting from the use of controlled-access datasets obtained through this DAR may also be posted on the dbGaP website.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Rescheduling of Tests If the Independent Engineer certifies to the Authority and the Concessionaire that it is unable to issue the Completion Certificate or Provisional Certificate, as the case may be, because of events or circumstances on account of which the Tests could not be held or had to be suspended, the Concessionaire shall be entitled to re-schedule the Tests and hold the same as soon as reasonably practicable.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Random Testing Notwithstanding any provisions of the Collective Agreement or any special agreements appended thereto, section 4.6 of the Canadian Model will not be applied by agreement. If applied to a worker dispatched by the Union, it will be applied or deemed to be applied unilaterally by the Employer. The Union retains the right to grieve the legality of any imposition of random testing in accordance with the Grievance Procedure set out in this Collective Agreement.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.

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