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: I. If Fujifilm is the first to discover the non-conformity, Fujifilm shall provide written notice of same, including an explanation of the non-conformity, to Sponsor within the period specified in the Quality Agreement, If Sponsor is the first to discover the non-conformity, Sponsor shall provide written notice, including an explanation of the non-conformity, within the period specified in the Quality Agreement. If Sponsor does not provide notice of non-conformity in the time frame set forth above, Sponsor shall be deemed to have accepted such Drug Substance Batch. II. The Non-Conforming Batch shall not be delivered to Sponsor if it is still located at the GMP Facility on the date of Fujifilm’s issuance or receipt (as applicable) of the notice of non-conformity. III. If Sponsor has provided the notice of a Non-Conforming Batch to Fujifilm within the period specified in Quality Agreement, Fujifilm shall investigate the non-conformity in accordance with the Quality Agreement and notify Sponsor in writing as to whether Fujifilm agrees or disagrees in good faith with Sponsor’s determination of the existence or cause of the non-conformity and the reasons therefor. IV. If Fujifilm has provided the notice of a Non-Conforming Batch to Sponsor within the period specified in the Quality Agreement, Sponsor shall notify Fujifilm whether Sponsor agrees or disagrees in good faith with Fujifilm’s determination of the existence or cause of the non-conformity and the reasons therefore. If Sponsor does not provide a written notice within such period, Sponsor shall be deemed to have accepted the existence and cause of non-conformity as stated by Fujifilm.
Sample 1Sample 2
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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
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. (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 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: (a) The Non-Conforming Batch shall not be delivered to Dyax, unless Dyax requests it. If Dyax requests delivery of the Non-Conforming Batch, Fujifilm shall deliver such Non-Conforming Batch in accordance with Clause 2.5. (b) If Dyax does not wish to take delivery of the Non-Conforming Batch, Fujifilm shall manufacture a further Batch as soon as reasonably practicable but in any case no later than six (6) months after Dyax's notice that it does not wish to take delivery of the Non-Conforming Batch. (c) If the Non-Conforming Batch arose other than as a result of a Fujifilm Factor, Dyax shall be obliged to make all payments associated with the manufacture and Disposition of such Batch. (d) The following provisions shall apply if the Non-Conforming Batch arose as a result of a Fujifilm Factor: (i) If Dyax wishes to take delivery of the Non-Conforming Batch under Clause 3.5(a), the parties shall agree in writing a reduction in the consideration payable in respect of such Batch; or (ii) If Dyax does not wish to take delivery of the Non-Conforming Batch under Clause 3.5(a), manufacture of a further Batch under Clause 3.5(b) shall be undertaken at Fujifilm's cost and expense and as soon as reasonably practicable but in any case no later than six (6) months after Dyax's notice that it does not wish to take delivery of the Non-Conforming Batch. (e) Subsequent to Disposition as a Conforming Batch in the event that Dyax claims that any Batch was a Non-Conforming Batch, subsequent to Disposition and such non-conformance could not have been reasonably discovered by Dyax during the Disposition period described in Clause 3.4, then Dyax shall notify Fujifilm in writing promptly after discovery of such latent defect and the parties shall meet to discuss such matter. If the parties are unable to agree, after consultation with senior management of both parties, then the matter shall be referred to an independent expert in accordance with Appendix 2 of the Quality Agreement.
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
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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 [***] 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

Related to Non-Conforming Batch

  • Non-Conforming Product (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

  • Non-Conforming Measures 1. Articles 2, 3 and 6 shall not apply to: (a) any existing non-conforming measure that is Maintained by the following, as set out in the Schedule of each Contracting Party in Annex I: (i) the central government of a Contracting Party; or (ii) a prefecture of Japan or a province or a Municipality of the Republic of Mozambique; (b) any existing non-conforming measure that is maintained by a local government other than a prefecture and a province and a municipality referred to in subparagraph (a)(ii); (c) the continuation or prompt renewal of any nonconforming measure referred to in subparagraphs (a) and (b); or (d) an amendment or modification to any nonconforming measure referred to in subparagraphs (a) and (b), provided that the amendment or modification does not decrease the conformity of the measure as it existed immediately before the amendment or modification with Articles 2, 3 and 6. 2. Articles 2, 3 and 6 shall not apply to any measure that a Contracting Party adopts or maintains with respect to sectors, sub-sectors or activities set out in its Schedule in Annex II. 3. Neither Contracting Party shall, under any measure adopted after the date of entry into force of this Agreement and covered by its Schedule in Annex II, require an investor of the other Contracting Party, by reason of its nationality, to sell or otherwise dispose of an investment that exists at the time when the measure becomes effective. 4. In cases where a Contracting Party makes an amendment or a modification to any existing non-conforming measure set out in its Schedule in Annex I or where a Contracting Party adopts any new or more restrictive measure with respect to sectors, sub-sectors, or activities set out in its Schedule in Annex II after the date of entry into force of this Agreement, the Contracting Party shall, prior to the implementation of the amendment or modification or the new or more restrictive measure, or in exceptional circumstances, as soon as possible thereafter: (a) notify the other Contracting Party of detailed information on such amendment or modification, or such measure; and (b) hold, upon request by the other Contracting Party, consultations in good faith with the other Contracting Party with a view to achieving mutual satisfaction. 5. Each Contracting Party shall endeavour, where appropriate, to reduce or eliminate the non-conforming measures specified in its Schedules in Annexes I and II respectively. 6. Articles 2, 3 and 6 shall not apply to any measure covered by the exceptions to, or derogations from, obligations under Articles 3 and 4 of the TRIPS Agreement, as specifically provided in Articles 3 through 5 of the TRIPS Agreement. 7. Articles 2, 3 and 6 shall not apply to any measure that a Contracting Party adopts or maintains with respect to government procurement.

  • ACCEPTANCE OF DEFECTIVE OR NON-CONFORMING WORK 13.3.1 The State may accept defective or nonconforming Work pursuant to Paragraph 13.2.1

  • Inspection and Rejection of Nonconforming Goods The Buyer has the right to inspect the Goods on or after the Delivery Date. Buyer, at its sole option, may inspect all or a sample of the Goods, and may reject all or any portion of the Goods if it determines the Goods are nonconforming or defective. If Buyer rejects any portion of the Goods, Buyer has the right, effective upon written notice to Seller, to: (a) rescind the Order in its entirety; (b) accept the Goods at a reasonably reduced price; or (c) reject the Goods and require replacement of the rejected Goods. If Buyer requires replacement of the Goods, Seller shall, at its expense, promptly replace the nonconforming Goods and pay for all related expenses, including, but not limited to, transportation charges for the return of the defective goods and the delivery of replacement Goods. If Seller fails to timely deliver replacement Goods, Buyer may replace them with goods from a third party and charge Seller the cost thereof and terminate this Order for cause pursuant to Section 19. Any inspection or other action by Buyer under this Section shall not reduce or otherwise affect Seller's obligations under the Order, and Buyer shall have the right to conduct further inspections after Seller has carried out its remedial actions.

  • Nonconforming Work 5.6.1 Rejection, Removal and Replacement of Nonconforming Work

  • ACCEPTANCE OF INCOMPLETE OR NON-CONFORMING DELIVERABLES If, instead of requiring immediate correction or removal and replacement of defective or non- conforming deliverables, the City prefers to accept it, the City may do so. The Contractor shall pay all claims, costs, losses and damages attributable to the City’s evaluation of and determination to accept such defective or non-conforming deliverables. If any such acceptance occurs prior to final payment, the City may deduct such amounts as are necessary to compensate the City for the diminished value of the defective or non-conforming deliverables. If the acceptance occurs after final payment, such amount will be refunded to the City by the Contractor.

  • ACCEPTANCE OF NONCONFORMING WORK If the Owner prefers to accept Work that is not in accordance with the requirements of the Contract Documents, the Owner may do so instead of requiring its removal and correction, in which case the Contract Sum will be reduced as appropriate and equitable. Such adjustment shall be effected whether or not final payment has been made.

  • 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.

  • Rejection of Work Using the Notice of Non-Conforming Work procedures outlined in the General Conditions, the Design Professional shall reject work that does not comply with the requirements of the Contract Documents or that does not comply with the applicable laws and codes. The Design Professional shall have authority to order testing of the Work, as is provided in the Contract Documents or as otherwise required in its judgment, whether such work is fabricated, installed, or completed.

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