Non-Conforming Drug Product Sample Clauses

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to CLIENT’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).
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Non-Conforming Drug Product. Within [+] calendar days from the release of the executed Batch Record to CLIENT, CLIENT shall determine whether the Drug Product conforms to the Drug Product Specifications, Master Batch Record, XXXX'x current SOPs, and the Project Plan (collectively the "Product Requirements"). If any batch of Drug Product conforms to the Product Requirements, CLIENT must accept the Drug Product. If CLIENT fails to notify XXXX within the [+] calendar day period that the Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. If CLIENT believes any batch of Drug Product does not conform to the Product Requirements, it shall notify XXXX by telephone including a detailed explanation of the alleged non-conformity and shall confirm such notice in writing via overnight delivery. Upon receipt of such notice, XXXX will investigate such alleged non-conformity, and (i) if XXXX agrees such Drug Product is non-conforming as a result of the negligence of XXXX, deliver to CLIENT a corrective action plan within [+] calendar days after receipt of CLIENT's notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or XXXX, or (ii) if XXXX disagrees with CLIENT's determination that the Drug Product is non-conforming as a result of the negligence of XXXX, XXXX shall so notify CLIENT by telephone within the [+] calendar day period and confirm such notice in writing by overnight delivery. If the parties dispute whether the Drug Product is conforming or non-conforming or whether the non-conformity was caused by XXXX or CLIENT, samples of the Drug Product will be submitted to a mutually acceptable third party for resolution, whose determination of conformity or non-conformity and the party responsible therefore shall be binding upon the parties. The incorrect party shall hear the costs of such third party. In the event XXXX agrees that the Drug Product is non-conforming as a result of the negligence of XXXX or the third party determines that the Drug Product is non-conforming solely as a result of the negligence of XXXX, then XXXX, at its expense, but subject to CLIENT, at its expense, supplying the replacement Bulk Drug Substance, and upon payment for the non-conforming Drug Product by CLIENT, shall replace such non-conforming Drug Product within [+] calendar days from receipt of replacement Bulk...
Sample 1
Non-Conforming Drug Product. Within *** after the date of Production of any Batch pursuant to the Project Plan, BPS shall promptly forward to NTI, or to NTI’s designee, reasonable quantities of samples of such Batch as specified in the MBR. Within *** days after receipt by NTI (or by NTI’s designee) of the samples, or within *** days after receipt by NTI (or by NTI’s designee) of the Released Executed Batch Record, whichever is later, NTI shall determine whether such Batch of Drug Product conforms to the Master Batch Record, BPS SOPs, Specifications and the Project Plan (collectively the “Product Requirements”).
Sample 1
Non-Conforming Drug Product. Within 30 calendar days after receipt by Altus of a particular Batch, or 15 calendar days after receipt by Altus of the Released Executed Batch Record for a delivered Batch, whichever is later, Altus shall use reasonable efforts to determine whether Drug Product in the Batch conforms to the Specifications, the Master Batch Record, the Process, and the Project Plan (collectively the "Product Requirements").
Sample 1
Non-Conforming Drug Product. In the event Aclaris and/or its agent(s) believes that the Drug Product are defective or do not conform to the Specifications set forth herein (“Non-Conforming Drug Product”), Aclaris shall send to Xxxxx Xxxxxxxxx via overnight delivery service or certified mail, return receipt requested, within five (5) Business Days of discovery of the defect, a notice of rejection along with samples of the rejected Drug Product. If Xxxxx Xxxxxxxxx agrees that the Drug Product are Non-Conforming Drug Product, Xxxxx Xxxxxxxxx, at Aclaris’ option, will either Manufacture new Drug Product, at Xxxxx Xxxxxxxxx’x expense, and ship them to Aclaris within a commercially reasonable timeframe subject to Xxxxx Xxxxxxxxx’x capacity, or shall issue a full refund for that particular lot to Aclaris within thirty (30) calendar days from the date of Aclaris’ request for same. If Xxxxx Xxxxxxxxx does not agree with Aclaris’ determination that the Drug Product fail to meet the Specifications, then after reasonable efforts to resolve the disagreement, either Party may pursue available remedies under this Agreement; provided, however, Xxxxx Xxxxxxxxx must inform Aclaris within ten (10) Business Days if Xxxxx Xxxxxxxxx determines that the Drug Product rejected by Aclaris met the Specifications.
Sample 1

Related to Non-Conforming Drug Product

  • Non-Conforming Product If Reliant notifies Cardinal Health during the Review Period that the Manufacturing Sample does not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees with Client’s determination, Client shall not be responsible to pay for such batch (the “Defective Product”), and Cardinal Health shall, at Reliant’s option, either (A) replace any Batch of non-conforming Product, or (B) credit any payments made by Reliant for such Batch. If Cardinal Health does not agree with Reliant’s determination that such Product fails to meet the warranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, the Parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on the Manufacturing Sample. The results of the independent review shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Party. THE OBLIGATION OF CARDINAL HEALTH TO (A) REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY RELIANT FOR DEFECTIVE PRODUCT AND (B) REIMBURSE RELIANT FOR API LOST IN THE DEFECTIVE BATCH, SUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, SHALL BE RELIANT’S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY INDEMNIFICATION OBLIGATIONS UNDER SECTION 14.1 OR THE OBLIGATIONS OF SECTION 10.6 (RECALL)) UNDER THIS ARTICLE FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Defective Product Seller must guarantee a return for all defective products. a) Goods rejected by Buyer for whatever reason shall be held, transported and/or stored at Seller’s sole expense. Seller shall promptly reimburse Buyer for any such expenses. B) Defective product purchase COD will be returned COD to Seller or COD check will be cancelled, at Buyer’s discretion. c) Seller is responsible for all costs associated RoHS noncompliance returns and will accept a full return for all parts not meeting RoHS compliance criteria if necessary. d) Seller is 100% responsible for all monetary and/or rework costs associated with product failures in addition to any further cost whatsoever associated with product failures. e) If suspect parts/counterfeit parts are furnished under this agreement such parts shall be impounded by Buyer. Buyer may provide a sample batch Supplier for verification and authentication. In addition, Buyer reserves the right to send such items to the appropriate manufacturer and appropriate authorities for investigation. f) Seller shall be liable for all costs relating to impound, investigation, removal, or replacement of suspect/counterfeit parts.

  • Product Warranty Seller provides general warranties of fitness and general warranties that the goods are free from defects, for 1 year from acceptance of the goods, except as may otherwise be set forth in the Description/Proposal, or other attached warranty.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Term SOFR Conforming Changes In connection with the use or administration of Term SOFR, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document. The Administrative Agent will promptly notify the Borrower and the Lenders of the effectiveness of any Conforming Changes in connection with the use or administration of Term SOFR.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

  • Non-Conforming Communications Agent and Lenders may rely upon any notices purportedly given by or on behalf of any Borrower even if such notices were not made in a manner specified herein, were incomplete or were not confirmed, or if the terms thereof, as understood by the recipient, varied from a later confirmation. Each Borrower shall indemnify and hold harmless each Indemnitee from any liabilities, losses, costs and expenses arising from any telephonic communication purportedly given by or on behalf of a Borrower.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

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