Non-Conforming Batch Sample Clauses

Non-Conforming Batch. The following provisions shall apply if it is ascertained by either Party that a Drug Substance Batch is a Non-Conforming Batch:
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Non-Conforming Batch. A Batch which; after review of the Disposition Package, is deemed by both Dyax’s and Fujifilm’s quality assurance groups to not meet the requirements of a Conforming Batch. Process The process for the manufacture of Bulk Drug Substance in accordance with cGMP as defined in the approved; Process Specification, Issued Batch Manufacturing Records, SOPs, analytical procedures. Process Specification The document which defines the Process, including any critical processing parameters, as validated previously by Fujifilm or as subsequently agreed by Dyax and Fujifilm in writing. Process-Specific Consumable A Consumable which is required to operate the Process and which is specific to the Process or a Consumable which is required in such large volumes as would not be possible for Fujifilm to consume during other manufactures within the shelf life of the Consumable. Process-Specific Equipment An item of equipment (including the cost of installation and qualification thereof) which is required to operate the Process and which is specific to the Process. Quality Agreement The document agreed between the parties setting out:
Sample 1
Non-Conforming Batch. The following provisions shall apply in the event that (i) during Disposition of a Batch, it is ascertained that such Batch is a Non-Conforming Batch or (ii) Dyax submits a complaint under the Quality Agreement in respect of a Batch within the period(s) set out in Clause 3.4 above and Fujifilm accepts that such Batch is a Non-Conforming Batch or (iii) an independent expert appointed under the Quality Agreement determines that a Batch is a Non-Conforming Batch:
Sample 1
Non-Conforming Batch. (es). If CLIENT asserts that the Product does not comply as described in the prior sentence with the Product Warranties set forth in Section 5.1 above, CLIENT will deliver to LWI, in accordance with the notice provisions set forth in Section 17.3 hereof, written notice of disapproval (the “Disapproval Notice”) of such Product, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LWI during the Acceptance Period, then LWI and CLIENT will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to both the production of the Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Acceptance Period, the Product will be deemed accepted and ready for shipment and the Product shall be delivered to CLIENT. CLIENT shall accept delivery thereof within [ * ] days after such acceptance. Risk of loss to such Product shall pass to CLIENT at the time of delivery to the common carrier pursuant to Section 4.3.
Sample 1
Non-Conforming Batch. A cGMP Batch which: (i) has not been produced in accordance with cGMP; and/or (ii) does not meet the Product Specification. Non-Manufacturing Activity All Stages of a Programme identified in the applicable Scope of Work, other than the Manufacturing Activities. Process A process for manufacture of a Product. Process Specification The document which defines the Process, including any critical processing parameters. Process Demonstration Stage A Stage of a Programme identified in the applicable Scope of Work during which a proving run or scale-up or large-scale demonstration of the Process is intended to take place. Process-Specific Consumable A Consumable which is required to operate the Process and which is specific to the Process or a Consumable which is required in such large volumes as would not be possible for Fujifilm to consume during other manufactures and/or within the shelf life of such Consumable. Process-Specific Equipment An item of equipment which is required to operate the Process and which is specific to the Process. Product The compound or molecule which is the subject of a Programme as identified in the applicable Scope of Work. Product Specification The specification for Product to be manufactured during a Manufacturing Stage set out in the QC Document. Programme A programme of work to be carried out by Fujifilm under this Agreement as set out in the applicable Scope(s) of Work together with any additional work which the Parties agree to add using a Change Order. QC Document The document which sets out the Product Specification, the schedule for the taking of samples for quality control purposes, details of any subcontract laboratories to be utilised and the final Product label. Quality Agreement The document agreed by the Parties prior to commencement of any cGMP activities {including preparation for Cell Bank manufacture) which sets out: (i) the mutually agreed quality standards applicable for the manufacture of Cell Banks, any Intermediate and Product in accordance with cGMP; and (ii) the roles and responsibilities of each Party’s personnel in relation to quality matters. Regulatory Authority(ies) The U.S. Food and Drug Administration, the European Medicines Agency, or any equivalent governmental regulatory body which the Parties agree in writing, or any successor entity thereto. Scope of Work or SoW The document setting out in detail the work to be undertaken during a Programme. Shelf Life The most recent shelf life of any Product as ...
Sample 1
Non-Conforming Batch. A Batch which does not conform to the Drug Substance Requirements. Prime Contract A contract between PharmAthene and a national government or agency thereof for supply of services in relation to Drug Substance or Drug Product, including, at the date of this Agreement, the contracts set out below:
Sample 1
Non-Conforming Batch a) Upon completion of a cGMP Batch and the determination by Fujifilm that such Batch conforms to cGMP, Product specifications, and specifications for the testing performed by Fujifilm and listed in the Batch Packet. Fujifilm shall provide Sponsor’s quality assurance department with a Batch Packet and a recommendation for such Batch to be released. Within [***] after Sponsor’s receipt of such documentation and recommendation, Sponsor shall review the Batch Packet to CONFIDENTIAL [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Sample 1
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Non-Conforming Batch. If Supplier supplies a delivery which does not meet the Minimum Quality Specifications, Refiner shall be entitled either to reject such volumes (in which case Supplier shall be responsible for the costs associated with the redelivery to Supplier of such volumes) or to accept such volumes. In either case, the Parties agree to execute a price adjustment for volumes delivered in the non-conforming delivery, including a full refund of the purchase price and associated costs (e.g., transportation costs) incurred by Refiner for volumes that are rejected.
Sample 1

Related to Non-Conforming Batch

  • 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.

  • 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.

  • 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.

  • Warranty Period Except as may be otherwise specified or agreed, Contractor shall repair all defects in materials, equipment, or workmanship appearing within one year from the date of Substantial Completion of the Work. If Substantial Completion occurs by phase, then the warranty period for that the Work performed for each phase begins on the date of Substantial Completion of that phase, or as otherwise stipulated on the Certificate of Substantial Completion for the particular phase.

  • Benchmark Replacement Conforming Changes In connection with the use, administration, adoption or implementation of a Benchmark Replacement, 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.

  • 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.

  • Purchase Order A Customer may use purchase orders to buy commodities or contractual services pursuant to the Contract and, if applicable, the Contractor must provide commodities or contractual services pursuant to purchase orders. Purchase orders issued pursuant to the Contract must be received by the Contractor no later than the close of business on the last day of the Contract’s term. The Contractor is required to accept timely purchase orders specifying delivery schedules that extend beyond the Contract term even when such extended delivery will occur after expiration of the Contract. Purchase orders shall be valid through their specified term and performance by the Contractor, and all terms and conditions of the Contract shall survive the termination or expiration of the Contract and apply to the Contractor’s performance. The duration of purchase orders for recurring deliverables shall not exceed the expiration of the Contract by more than twelve months. Any purchase order terms and conditions conflicting with these Special Contract Conditions shall not become a part of the Contract.

  • 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.

  • 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.

  • 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.

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