Non-Conforming Batches Sample Clauses

The Non-Conforming Batches clause defines the procedures and responsibilities when goods or products delivered do not meet the agreed-upon specifications or quality standards. Typically, this clause outlines the steps for inspection, notification of defects, and the remedies available, such as rejection, replacement, or repair of the non-conforming items. Its core function is to ensure that only products meeting contractual requirements are accepted, thereby protecting the buyer from receiving substandard goods and providing a clear process for addressing quality issues.
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Non-Conforming Batches. If a Batch of Product, whether an individual Batch or part of a sequence of Batches in the case of process validation Batches fails to conform to the Specifications or was not manufactured in compliance with Applicable Laws, the Process, or the Quality Agreement, then Lonza will, at Kolltan’s sole option: (a) refund [**] the Price and expenses paid by Kolltan for such Batch, and the [**] used in the manufacture of such Batch(es); or (b) at [**], including the [**] and used in the manufacture of such Batch(es), produce a new Batch of Product as soon as reasonably possible, that conforms to the Specifications and is manufactured in compliance with the Applicable Laws, Process and Quality Agreement; or (c) Reprocess the Product, [**], so that the Batch can be deemed to have been manufactured in compliance with the Applicable Laws, Process and Quality Agreement, and to conform to Specifications; or (d) If the Batch was part of a sequence of Batches as in the case of validation Batches, determine jointly with Kolltan the root cause for such non-conformance. If the non-conformance results in one or more of the Batches in a sequence being unusable for commercial sale, clinical use or other development use, and if the root cause was due to Lonza’s Fault, Lonza will either (i) [**] for the unusable portion sequence of Batch(es), including the [**] used in the manufacture of such Batch(es); or (ii) at [**], including the [**], and used in the manufacture of such Batch(es), replace the unusable sequence of Batch(es) of Product as soon as reasonably possible. For the avoidance of doubt, if any of the Batch(es) in the sequence are usable for commercial sale, clinical use or other development use, then Lonza would only be liable of the non-usable Batch(es).
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Non-Conforming Batches a) Fujifilm shall [**] ensure that it will only deliver Batches to Sponsor that (i) are Manufactured in accordance with, and meet the requirements of, this Agreement, the Quality Agreement (including the Specifications) and Applicable Laws (including cGMPs) [**]. b) The following provisions shall apply if it is ascertained by either Party that a Batch is a Non-Conforming Batch during disposition of a Batch or as a result of Sponsor’s review of the applicable Batch Packet [**]: 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 [**] from discovery, but not to exceed [**] from discovery. If Sponsor is the first to discover the non-conformity, Sponsor shall [**] provide written notice, including an explanation of the non-conformity, to Fujifilm within [**] from discovery, but not to exceed [**] from Sponsor’s receipt of Batch, or in the case of [**] from Sponsor’s receipt of the Batch. ii. The Non-Conforming Batch shall not be delivered to Sponsor if it is still located at the GMP Facility as of 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 [**] of receiving such notice, Fujifilm shall investigate the presence and source of defect following the Fujifilm complaint procedure 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. [**].
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Non-Conforming Batches. Purchaser will have the right to inspect and determine whether each Batch conforms to the applicable Product Requirements. During the [***] period after delivery of each Batch or after Release of Batch, whichever occurs later, Purchaser may reject any Batch that does not conform to the applicable Product Requirements by providing written notice thereof to Supplier; provided, however, that with respect to any Batch that includes a Latent Defect, such [***] period shall not commence until Purchaser discovers or otherwise becomes aware of such Latent Defect but provided, further, that such notice must be given before the expiration of the initial shelf-life of the any such Batch prior to any re-testing period. Any claim by Purchaser that the Batch does not meet the applicable Product Requirements must be made in writing to Supplier within such applicable [***] (the “Non-Conformance Claim”). Upon Purchaser’s timely notification to Supplier of Purchaser’s rejection of a Batch, [***] shall reasonably cooperate with each other to [***] investigate, confirm and analyze whether or not the rejected Batch meets the applicable Product Requirements and the root cause of non-conforming Batch in accordance with the applicable Quality Agreement within [***] of Supplier’s receipt of the Non-Conformance Claim (the “Investigation Period”). Upon Supplier’s written request, if applicable, Purchaser shall deliver to Supplier samples of the rejected Batch for Supplier’s evaluation. If, subject to Section 6.8 (Non-Conformance Disputes), the Parties agree that the rejected Batch is in non-conformance and [***] (“Supplier Responsibility”), [***] will be entitled to [***] with respect to such Batch.
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Related to Non-Conforming Batches

  • Non-Conforming Product (a) Within [*****] of Chiesi’s receipt of an order for the Product, Chiesi may reject any such order or portion thereof that (i) does not conform to the warranty under Section 8.1 above, including to the Specifications, or (ii) is based on any claimed shortage in quantity, provided that such non-conformity in (i) above is not due to any failure by Chiesi, its Affiliates, agents or representatives to ship, handle, maintain, or store the Product as required under the Specifications. Kamada shall reasonably assist Chiesi in performing any such testing by providing to Chiesi any necessary technical information to accomplish such testing by Chiesi. Chiesi shall notify Kamada in writing within such [*****] period of its rejection of any order or portion thereof of the Product delivered by Kamada, which notice of rejection must contain the reason for such rejection; provided, however, that this limitation shall not apply to hidden defects in the Product. In the case of hidden defects, Chiesi shall have [*****] days from the date it becomes aware or reasonably should have become aware of any hidden defect to reject any order of the Product in accordance with applicable terms and conditions hereof. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) In the event of the rejection of the Product under this Section 8.2, or any other nonconformity or defect which the Parties mutually agree is a proper basis for rejection, and if such rejection is appropriately made by Chiesi, Kamada shall use its Best Reasonable Efforts to replace the rejected Product or make up the shortage at its expense within [*****] of the notice of such rejection or shortage, and in any case as soon as reasonably possible after receiving such notice, at no additional cost to Chiesi (including shipping and transportation costs), and Kamada shall make arrangements with Chiesi for the return or disposal of any rejected Product, such return shipping or disposal charges to be paid by Kamada. (c) In the event of a conflict regarding whether or not the Product conforms to the warranty under Section 8.1 above, including to the Specifications at the time of delivery, and Chiesi and Kamada are unable to resolve such conflict after a good faith attempt by both Parties to resolve such matter in a period of [*****] days after the conflict arises, a sample of the Product shall be submitted by Chiesi to an independent laboratory reasonably acceptable to both Parties for testing against the Specifications or other defect and the test results obtained by such laboratory shall be final and controlling for purposes of this Agreement. If the Parties are unable to agree upon such independent laboratory in a period of [*****] days after the conflict arises, such independent laboratory shall be selected by the President of the ICC. The fees and expenses of such laboratory testing shall be borne entirely by the Party against whom such laboratory’s findings are made. In the event the independent laboratory test results indicate that the Product in question did not meet the Specifications or is otherwise defective, Kamada shall use its Best Reasonable Efforts to replace the rejected Product at no additional cost to Chiesi within [*****] days after receipt of such results if replacement Product stock is available, and in any case as soon as reasonably possible after receipt of such independent laboratory test. In the event the independent laboratory test results indicate that the rejected Product in question meets the Specifications, then Chiesi shall pay all additional shipping and transportation costs, incurred by Kamada as a result of the conflict as well as the cost of the Products to the extent that such Products have not been previously paid for by Chiesi, and shall accept and pay for the previously rejected Product in accordance with all applicable provisions hereunder. (d) Without derogating from Section 4.2(e) and from any obligations that Kamada may have under this Agreement with respect to Third Party Claims, the foregoing shall be Chiesi’s sole and exclusive remedy with respect to non-conforming Products or shortages, and all other remedies at law or in equity shall not be available to Chiesi. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.

  • Non-Conforming Measures 1. Paragraph 1 of Article 2, paragraph 1 of Article 3, Article 5 and Article 10 shall not apply to: (a) any existing non-conforming measure that is maintained by the central government of a Contracting Party, as set out in its Schedule in Annex I; (b) any existing non-conforming measure that is maintained by a local government of a Contracting Party; (c) the continuation or prompt renewal of any non- conforming measure mentioned in subparagraphs (a) and (b); or (d) an amendment or modification to any non- conforming measure referred to in subparagraphs (a) and (b) to the extent that the amendment or modification does not decrease the conformity of the measure as it existed immediately before the amendment or modification, with paragraph 1 of Article 2, paragraph 1 of Article 3, Article 5 and Article 10. 2. Paragraph 1 of Article 2, paragraph 1 of Article 3, Article 5 and Article 10 shall not apply to any measures that a Contracting Party adopts or maintains, with respect to sectors, sub sectors or activities, as 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 with respect to sectors, sub-sectors or activities as set out in its Schedule in Annex II, require an investor of the other Contracting Party, by reason of its nationality, to sell or otherwise dispose of investments existing at the time 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 after the date of entry into force of this Agreement, the Contracting Party shall, to the extent possible, notify the other Contracting Party of such amendment or modification. 5. In the case where a Contracting Party adopts any measure after the date of entry into force of this Agreement, with respect to sectors, sub-sectors or activities as set out in its Schedule in Annex II, the Contracting Party shall, to the extent possible, notify the other Contracting Party of such measure. 6. Each Contracting Party recognizes the importance of reviewing from time to time the reservations specified in its Schedules in Annexes I and II with a view to the reduction or elimination of those reservations. 7. Paragraph 1 of Article 2, paragraph 1 of Article 3 and Article 5 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. 8. Paragraph 1 of Article 2, paragraph 1 of Article 3 and Article 5 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