Common use of ACCEPTANCE AND REJECTION Clause in Contracts

ACCEPTANCE AND REJECTION. Leiner shall give written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratory. The determination by such laboratory shall be final and binding and the costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expense.

ACCEPTANCE AND REJECTION. Leiner Purchaser shall give have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware rejection. If Supplier agrees with Purchaser's determination that a shipment of such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Efforts to replace the terms and conditionx xxxxof nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be accompanied submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate Parties promptly in good faith to rexxxxx any disputxx xxxsing therefrom faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impaxlaboratory's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratory. The determination by such laboratory shall be final and binding determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the costs therefor shall supply problem will be borne resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by the non-prevailing party. Leiner shall not dispose Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of any Product claimed to be non-compliant xxxxx final resolution such shipment of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expenseComponents.

ACCEPTANCE AND REJECTION. Leiner Jubilant shall give written notice be entitled to Impax reject any shipment of any non-compliance Products that fails to conform to the Product Specifications or Packaging Specifications at the time of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware delivery to Jubilant. Jubilant shall notify Cadista of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice rejection within thirty (30) days after knowledge delivery of such Products shipment to Jubilant, and shall set forth in such notification the basis under this Agreement for such rejection, including any testing or inspection results, provided, however, that in the event any such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does conformity is latent or was not comply with the terms obvious and conditionx xxxxof shall could not be accompanied by readily discovered from a true and correct copy physical inspection of the results Products shipment, Jubilant may give written notice to Cadista of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve its rejection of such dispute shipment within thirty (30) calendar days from the date of Impaxafter Jubilant's receipt of Leiner's notice discovery of such non-complianceconformance. Failure to so notify Cadista, or failure to identify the basis under this Agreement for rejection of any Product, shall constitute acceptance of such Product, except to the extent the Product fails to conform to the Product Specifications or Packaging Specifications as the case may be. After such failure to notify, Jubilant shall be obligated to make payment for such Product in accordance with pricing provisions of this Agreement. If the parties disagree as to whether any Product meets the Product Specifications or Packaging Specifications and the parties are unable to negotiate a commercially reasonable resolution, then samples and/or batch records, as appropriate, from the disputed shipment shall submit sucx xxxxxxe promptly be submitted for testing and evaluation to a mutually agreed-upon an independent laboratoryThird Party as shall be agreed to in writing by both parties. The determination by of such laboratory Third Party as to whether the disputed Product shipment meets the Product Specifications or Packaging Specifications shall be final and binding binding. The cost of the testing and evaluation by the costs therefor independent third party shall be borne by the party whose position is found to be erroneous. If, pursuant to this Section 3.2, any Products are found not to conform to the Product Specifications or Packaging Specifications, as a result of a cause occurring prior to placement thereof with the carrier (and not arising as a result of the Materials being defective or failing to meet their respective specifications), at Cadista’s option, Jubilant shall either (i) deliver such non-prevailing partyconforming Products to Cadista or (ii) destroy such non-conforming Products in accordance with applicable laws, rules and regulations. Leiner Cadista shall not dispose reimburse Jubilant for all reasonable costs and expenses in connection such delivery or destruction, and, at Cadista’s option and as Jubilant’s exclusive remedy, Cadista shall either: (i) credit Jubilant for the amount paid or payable by Jubilant to Cadista for such rejected Product shipment (and reimburse Jubilant for the Material of such rejected batch at Jubilant’s cost for such Materials), or (ii) replace such rejected Product shipment (with Cadista paying Jubilant for all Materials or such replacement shipment in an amount equal to Jubilant’s cost), at no additional cost to Jubilant, as promptly as reasonably practicable, but in no event later than forty-five (45) days from receipt of notice of non-conformity of such shipment from Jubilant. Jubilant shall notify Cadista in writing of any claim relating to quantitative deficiencies in any shipment of Product claimed that Jubilant considers to be non-compliant xxxxx final resolution have been caused prior to shipment hereunder within thirty (30) days following receipt of any dispute such shipment. Any claim for a quantitative deficiency which is not made within such thirty (30) days shall be deemed to have been waived by Jubilant and Jubilant shall be obligated to make payment for such Product in accordance with respect thereto or Impax's written consentSection 5 of this Agreement. In the event Leiner requests Impax's consent Jubilant determines there is a quantitative deficiency from the applicable shipping documentation, the parties shall investigate such deficiency and, if the parties agree that such deficiency occurred prior to destroy a reasonable percentage ox xxxxuted Product shipment, Cadista shall, at Jubilant’s option and Impax declinesas Jubilant’s exclusive remedy for such quantitative deficiency, Impax will pay one hundred percent (100%a) credit Jubilant for the amount paid by Jubilant to Cadista in excess of the storage costs allocated aggregate price for actual quantities shipped; or (b) subject to Cadista having Product on hand at the time of request by Jubilant, rectify any such deficiency by promptly shipping the appropriate quantities of any relevant Product if Leiner is to Jubilant, but in no event later than fifteen (15) calendar days following the prevailing party occurrence of such a deficiency, in the dispute. If Leiner is not the xxxxxxling party, Leiner which case Jubilant shall be obligated to pay one hundred perxxxx (100%) for any such quantities pursuant to Section 5 of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expensethis Agreement.

ACCEPTANCE AND REJECTION. Leiner (a) Cardiome shall inspect all shipments of Supplied Items promptly upon receipt and may reject any shipment of Supplied Items or portion thereof that fails to conform to the Product Warranty (“Defective Product”). In order to reject any shipment of Supplied Items or portion thereof, Cardiome must give written notice of rejection to Impax SteadyMed within [*] after receipt of such Supplied Item at Cardiome’s or its designee’s address for delivery specified in the applicable purchase order (or, in the case of any Latent Defect, within [*] after discovery by Cardiome of the Latent Defect, but [*]). Should Cardiome fail to give written notice of rejection to SteadyMed within [*] after such receipt or [*] after discovery of a Latent Defect, as applicable, then the Supplied Item will be deemed to have been accepted by Cardiome on the [*] after such receipt or the [*] after discovery of the Latent Defect, as applicable. (b) Promptly after timely delivery to SteadyMed of any notice of rejection, Cardiome shall cooperate with SteadyMed in determining whether such rejection is necessary or justified. SteadyMed will evaluate process issues and other reasons for any non-compliance conformity. SteadyMed shall notify Cardiome as promptly as reasonably possible whether it accepts Cardiome’s basis for any rejection. Whether or not SteadyMed accepts Cardiome’s assertion that certain Supplied Item is Defective Product, SteadyMed shall use Commercially Reasonable Efforts to replace such allegedly Defective Product with Supplied Item that conforms to the Product Warranty as promptly as practicable. If SteadyMed disagrees with Cardiome’s assertion that certain Supplied Item is Defective Product, a sample of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof rejected Supplied Item shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe submitted to a mutually agreed-upon acceptable independent Third Party laboratory, which shall determine whether such Supplied Item is Defective Product. The Parties agree that such laboratory’s determination by such laboratory shall be final and binding and upon the Parties. The Party against whom the Third Party laboratory rules shall bear the reasonable costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the disputetesting. If Leiner the Third Party laboratory rules that the Supplied Item is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Defective Product, with compliant ProductCardiome shall purchase such Supplied Item at the agreed-upon price, at Impax's sole cost and expenseirrespective of whether SteadyMed has already replaced it.

ACCEPTANCE AND REJECTION. Leiner (a) SGI may reject any quality control sample or batch delivery which does not conform with the Product Specifications or applicable documentation and process requirements. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) In order to reject a quality control sample, SGI must give written notice to Impax Supplier of SGI’s rejection of any non-compliance delivery within [***] after receipt of txx Xxxduct with the terms applicable quality control sample or [***] after receipt of this Agreementthe associated documentation, promptly whichever is later (the “Acceptance Period”). If no such notice of rejection is received, SGI shall be deemed to have accepted such quality control sample upon the earlier expiration of (i) its becoming aware the Acceptance Period, and Supplier shall be authorized to make delivery of the full batch of such non-compliance Product. (c) In order to reject delivery of a full batch of Product, SGI must give written notice to Supplier of SGI’s rejection of any delivery within [***] after receipt of such delivery. If no such notice of rejection is received, SGI shall be deemed to have accepted such delivery of Product within [***] of delivery of the batch. Once SGI accepts a batch of Product, SGI [***], except as provided in Section 6 below. (d) After notice of rejection is given, SGI’s head of Quality Assurance and Supplier’s head of Quality, or (ii) the date it should have become aware of their delegated representatives, shall cooperate in determining whether rejection is necessary or justified. Supplier will evaluate process issues and other reasons for such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance Supplier shall constitute acceptance thereofnotify SGI as promptly as reasonably possible whether it accepts SGI’s basis for any rejection. Any notice by Leiner If Supplier disagrees with SGI’s determination that any certain Product does not comply with meet the terms and conditionx xxxxof Product Specifications, such Product shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe submitted to a mutually agreed-upon independent acceptable third party laboratory. The Such third party laboratory shall determine whether such Product meets the Product Specifications and the parties agree that such laboratory’s determination by such laboratory shall be final and binding determinative. The party against whom the third party laboratory rules shall bear all costs of the third party testing. Whether or not Supplier accepts SGI’s basis for rejection, promptly on receipt of a notice of rejection of a full batch of such Product, Supplier shall use reasonable efforts at SGI’s request to replace such rejected Product. If the third party laboratory rules that the samples submitted to it meet Product Specifications, [***]. (e) SGI may not destroy any batch of rejected Product until it receives written notification from Supplier that Supplier does not dispute that the batch fails to meet specifications and that Supplier does not request return of the costs therefor Product. Upon authorization from Supplier to do so, SGI shall be borne by the non-prevailing party. Leiner shall not dispose of destroy any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party received in the disputerejected delivery promptly at [***] and provide Supplier with certification of such destruction. If Leiner is not the xxxxxxling partySGI shall, Leiner shall pay one hundred perxxxx (100%) upon receipt of the storage costs. Imxxx xxall Supplier’s request for return, promptly replace any non-compliant Product, with compliant Productreturn said Product or quality control sample to Supplier, at Impax's sole cost and expense[***].

ACCEPTANCE AND REJECTION. Leiner VIACELL shall give have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the Specifications for the Cell Separation Kit to confirm that such shipment meets the applicable Specifications. If VIACELL rejects in whole or in part any nonconforming shipment of Cell Separation Kits, VIACELL shall provide MILTENYI written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware rejection no later than [**] days after receipt of such non-complianceshipment of Cell Separation Kits. Failure If VIACELL fails to provide MILTENYI with such notice of rejection within thirty (30) days after knowledge such [**] day inspection period, VIACELL shall be deemed to have accepted the applicable shipment of such non-compliance shall constitute acceptance thereof. Any notice by Leiner Cell Separation Kits. 3.7.1 If MILTENYI agrees with VIACELL's determination that any Product a shipment of Cell Separation Kits does not comply with applicable Specifications, then MILTENY shall, [**]. 3.7.2 If MILTENYI disagrees with VIACELL's determination that the terms and conditionx xxxxof rejected shipment did not meet the applicable Specifications, a sample of the rejected shipment shall be accompanied provided by a true VIACELL to MILTENYI. [**]. (a) If the shipment of Cell Separation Kits failed to meet the applicable Specifications, then MILTENY shall, [**] use reasonable efforts to replace the nonconforming Cell Separation Kits with Cell Separation Kits meeting the applicable Specifications at no additional cost to VIACELL and correct copy MILTENYL shall bear all costs of the testing pursuant to Section 3.7.2. (b) If the [**] the Cell Separation Kit does not meet the applicable specifications, and [**]. At such time, the Parties will discuss in good faith potential solutions to the supply problem. (c) If [**] the rejected shipment of Cell Separation Kits met the applicable specifications, then VIACELL shall accept such shipment (including all costs of shipping and insurance) and VIACELL shall bear all costs of the testing pursuant to Section 3.7.2. 3.7.3 Shipments of Cell Separation Kits not meeting the applicable specifications may, at MILTENYI's option and expense, be returned to MILTENYI or destroyed by VIACELL. If MILTENYI has acknowledged in writing that it is unable to produce conforming Cell Separation Kits, any sums actually paid therefore will be refunded. 3.7.4 The remedy of replacement or refund is available only if such nonconformance was not caused by VIACELL's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Cell Separation Kits, including, but not limited to, any nonconformance due to or the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratory. The determination by such laboratory shall be final and binding and the costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) shipping of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expenseCell Separation Kits.

ACCEPTANCE AND REJECTION. Leiner 5.3.1 UCB shall give deliver to Buyer, concurrently with the delivery of each shipment, a certificate of analysis and other documents and materials set forth in the Quality Agreement. Within ten (10) days after receipt of any shipment of Finished Product, Buyer shall assess the quantity and visually inspect the quality of the Finished Product. Within thirty (30) days after delivery of Finished Product to Buyer in accordance with Section 7, Buyer shall examine the Finished Product to determine whether the Finished Product conforms to the Specifications. No claim for defective quality or shortage in quantity of any individual shipment of Finished Product shall be valid unless made by written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice given within thirty (30) days after knowledge from the date of such delivery, except in the case of latent (or other non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof obvious) defects, in which case such claims shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate made in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute writing within thirty (30) calendar days from the date such defect became discoverable (but in no event later than the date upon which the Finished Product has expired according to its expiry date). Any such notice shall describe in reasonable detail the defect or non-conformity, and shall include samples of Impax's receipt the Finished Product being rejected, if appropriate, and copies of Leiner's written reports relating to tests, studies or investigations performed by or on behalf of Buyer on the Finished Product being rejected. Failure to deliver a notice of such non-complianceconformance in the manner contemplated in this Section 5.3.1 shall constitute an acceptance of the applicable Finished Product by Buyer. 5.3.2 If there is any dispute as to whether any shipment fails, in whole or in part, to meet the parties Specifications, such dispute shall submit sucx xxxxxxe to a mutually agreed-upon be resolved by an independent laboratorytesting organization of recognized repute within the pharmaceutical industry in the Territory appointed by both UCB and Buyer. The determination by expense of hiring such laboratory shall be final and binding and the costs therefor organization shall be borne by the non-prevailing party. Leiner Party against whom the decision is rendered. 5.3.3 UCB shall not dispose of make up any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly shortfall and/or replace any non-compliant conforming Finished Product or rework the rejected Finished Product, with compliant if applicable, as promptly as practicable and at no additional cost to Buyer; provided that UCB shall have no liability or obligation to Buyer under this Section 5.3 if it is determined that any such defect or non-conformance is attributable to the failure by any Person (including Buyer) to store, transport or care for such Finished Product in a proper manner after such Finished Product left UCB's possession. Upon UCB's instructions, Buyer shall destroy or return, in either case at UCB's cost, the non-conforming Finished Product; provided that if it is determined that any such defect or non-conformance is attributable to the failure by any Person (including Buyer) to store, transport or care for such Finished Product in a proper manner after such Finished Product left UCB's possession, such destruction or return shall be at ImpaxBuyer's cost. It is acknowledged and agreed that notwithstanding any other provision of this Agreement, Buyer's sole cost and expenseexclusive remedy in the event of UCB's delivery of defective or non-conforming Finished Product shall be replacement of the rejected Finished Product in accordance with this Section 5.3.3, and that Buyer shall not be entitled to remedies, whether under any other provision of this Agreement (including without limitation Section 6.4) or otherwise.

ACCEPTANCE AND REJECTION. Leiner (a) Purchaser may reject any batch delivery which does not conform with the Materials Specifications or with applicable documentation and process requirements. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. (b) Reserved. (c) In order to reject delivery of a full batch of Materials, Purchaser must give written notice to Impax Supplier of Purchaser’s rejection of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware delivery within [******] after receipt of such non-compliance delivery. If no such notice of rejection is timely received, Purchaser shall be deemed to have accepted such delivery of Materials within [******]of delivery of the batch. Once Purchaser accepts a batch of Materials, Purchaser shall have no recourse against Supplier if the product is subsequently deemed unsuitable for use for any reason, except for Latent Defects or as provided in Article 10 below. (iid) the date it should have become aware After notice of rejection is given, Purchaser shall cooperate with Supplier in determining whether rejection is necessary or justified. Supplier will evaluate process issues and other reasons for such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance Supplier shall constitute acceptance thereofnotify Purchaser as promptly as reasonably possible whether it accepts Purchaser’s basis for any rejection. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate If Supplier in good faith to rexxxxx any disputxx xxxsing therefrom and in disagrees with Purchaser’s determination that certain Materials does not meet the event that the parties Materials Specifications, such Materials shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe submitted to a mutually agreed-upon independent acceptable Third Party laboratory. The Such Third Party laboratory shall determine whether such Materials meets the Materials Specifications and the parties agree that such laboratory’s determination by such laboratory shall be final and binding and determinative. The party against whom the Third Party tester rules shall bear all costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated Third Party testing. Whether or not Supplier accepts Purchaser’s basis for rejection, promptly on receipt of a notice of rejection of a full batch of Materials, Supplier shall use reasonable efforts at Purchaser’s request to replace such Product if Leiner is rejected Materials. If the prevailing party Third Party tester rules that the batch meets Materials Specifications, Purchaser shall purchase that batch and any replacement batch at the agreed-upon price, irrespective of whether Supplier has already replaced it. (e) Purchaser may not destroy any batch of Materials until it receives written notification from Supplier that Supplier does not dispute that the batch fails to meet Materials Specifications and that Supplier does not request return of the Materials. Upon authorization from Supplier to do so, Purchaser shall destroy the Materials received in the disputerejected delivery promptly at Supplier’s cost and provide Supplier with certification of such destruction. If Leiner is not the xxxxxxling partyPurchaser shall, Leiner shall pay one hundred perxxxx (100%) upon receipt of the storage costs. Imxxx xxall Supplier’s request for return, promptly replace any non-compliant Product, with compliant Productreturn said Materials or quality control sample to Supplier, at Impax's sole cost and expenseSupplier’s cost.

ACCEPTANCE AND REJECTION. Leiner (a) If a shipment of Jubilant Products or any portion thereof fails to conform to the Jubilant Product specifications, then Trigen may reject such nonconforming shipment or the non­conforming portion thereof, as the case may be. Trigen shall give written notice to Impax Jubilant of any its rejection hereunder within fourteen (14) days from date of receipt of Jubilant Product by Trigen, specifying in detail the grounds for such rejection. The non-compliance conforming shipment of txx Xxxduct with Jubilant Products, or the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance conforming portion thereof, shall be held for Jubilant’s disposition, or (ii) shall be returned to Jubilant, in each case at Jubilant’s expense, as directed by Jubilant. Jubilant shall use commercially reasonable efforts to replace the date it should have become aware of such non-compliance. Failure to provide such conforming shipment of Jubilant Products, or the non-conforming portion thereof, with conforming Jubilant Products as soon as reasonably practicable after receipt of notice of rejection thereof, and in any event will ship conforming Jubilant Products within thirty (30) days after knowledge receipt of notice of rejection thereof at no cost to Trigen. Jubilant shall make arrangements with Trigen for the return or destruction, at Jubilant’s option and cost, of any rejected Jubilant Products. All such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof return shipping charges or costs of destruction shall be accompanied paid by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in Jubilant. (b) In the event that Trigen has paid for rejected Jubilant Products, and such Jubilant Products have not been satisfactorily replaced, Jubilant shall promptly refund or, at Trigen’s option, extend a credit to Trigen for the parties full amount paid by Trigen for such Jubilant Products or dispute such claim and, if necessary, initiate dispute resolution in accordance with Section 3.2(c). (c) In the event of a conflict regarding any nonconforming Jubilant Products which Jubilant and Trigen are unable to resolve, a sample of such Jubilant Products, together with mutually agreed upon questions, shall be unable submitted by Trigen to resolve such dispute within thirty (30) calendar days from an independent laboratory reasonably acceptable to both parties for testing against the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratoryJubilant Product specifications. The determination test results obtained by such laboratory shall will be final and binding upon the parties. The fees and expenses of such laboratory testing, and all additional shipping and transportation costs incurred as a result of the costs therefor dispute, shall be borne entirely by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consentparty against whom such laboratory’s findings are made. In the event Leiner requests Impax's consent the test results obtained by such laboratory indicate that the Jubilant Products in question do not conform to destroy a reasonable percentage ox xxxxuted the Jubilant Product and Impax declinesspecifications, Impax will pay one hundred percent (100%) of the storage costs allocated to Jubilant shall replace such Product if Leiner is the prevailing party Jubilant Products with conforming Jubilant Products in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, accordance with compliant Product, at Impax's sole cost and expensethis Section 3.2.

ACCEPTANCE AND REJECTION. Leiner Purchaser shall give have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall provide Supplier written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice within rejection no later than thirty (30) days after knowledge receipt of such non-compliance shipment of Components. If Purchaser fails to provide Supplier with such notice of rejection within such thirty (30) day inspection period, Purchaser shall constitute acceptance thereofbe deemed to have accepted the applicable shipment of Components. Any notice by Leiner If Supplier agrees with Purchaser's determination that any Product a shipment of Components does not comply with applicable specifications, [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Supplier shall use Reasonable Efforts to replace the terms and conditionx xxxxof nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be accompanied submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate Parties promptly in good faith to rexxxxx any disputxx xxxsing therefrom faith. Such laboratory shall determine whether the rejected Components meet the applicable specifications, and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impaxlaboratory's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratory. The determination by such laboratory shall be final and binding and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs therefor of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, then at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be borne by reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the non-prevailing party. Leiner applicable specifications shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the disputeshipped. If Leiner the laboratory rules that the Components do not meet the applicable specifications, and if Supplier is unable to produce conforming Components, any sums actually paid therefore shall be refunded to Purchaser with interest. At such time, the Parties will discuss in good faith potential solutions to the supply problem. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Productapplicable specifications may, at ImpaxSupplier's sole cost option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components.

ACCEPTANCE AND REJECTION. Leiner shall give (a) Within [***] days after delivery of Finished Products or Kits to MMCO in accordance with Section 3.8, if for any reason MMCO becomes aware that such products did not conform to the Specifications, master batch record or relevant SOPs at the time of delivery, then MMCO will have the right to reject such defective shipment of the products by giving written notice of rejection to Impax Spectrum and specify the grounds for such rejection within such [***] calendar day period. If MMCO provides such notice within such period and Spectrum does not dispute in good faith such rejection or such dispute is resolved in MMCO's favor pursuant to Section 12.1, then at Spectrum's option, the defective shipment of any non-compliance the products will be disposed of txx Xxxduct by MMCO or will be returned to Spectrum, in each case at Spectrum's expense, MMCO will not be obligated to pay the invoice therefor in accordance with the terms of this AgreementSection 5.2 and MMCO may, promptly upon the earlier of at its option, (i) require Spectrum to use its becoming aware commercially reasonable efforts to promptly replace the shipment of such non-compliance the defective products with conforming products as soon as reasonably practicable or (ii) inform Spectrum that it does not wish to receive replacement therefor, in which case the date it should have become aware of such non-compliancerelevant Firm Order will be deemed cancelled. Failure to If MMCO does not provide such notice within thirty (30) days after knowledge such [***] calendar day period then such products shall be considered accepted and MMCO shall not have a right to reject it except with respect to a latent defect which existed at the time of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does delivery and was not comply reasonably discoverable at the time of delivery and for which Spectrum still has the right, under its agreement with the terms and conditionx xxxxof shall be accompanied by a true and correct copy relevant Third Party manufacturer, to reject such products. (b) If Spectrum disputes MMCO's grounds for rejecting all or part of any shipment of the results of any tests conducted by Leiner thereon. Leiner products as set forth above, and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute is not resolved by mutual agreement of the Parties within thirty (30) [***] calendar days from the date of Impax's receipt of LeinerMMCO's notice of rejection, such non-compliance, dispute will be resolved by the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratoryTesting Laboratory. The final written determination by such laboratory shall of the Testing Laboratory with respect to all or part of any shipment will be final and binding upon each Party, but only as to reasons given by MMCO in rejecting the shipment or portion thereof and will have no effect on any matter for which the costs therefor shall be borne Testing Laboratory did not render a determination. The Testing Laboratory will render such determination within [***] days of its appointment by the non-prevailing partyParties. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product The fees and Impax declines, Impax will pay one hundred percent (100%) expenses of the storage costs allocated to such Product if Leiner Testing Laboratory will be paid by the Party against which the determination is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expensemade.

ACCEPTANCE AND REJECTION. Leiner shall give written notice to Impax Within [***] days following receipt of any non-compliance each delivery of txx Xxxduct with Device supplied under the terms of this Supply Agreement, promptly upon TRANSCEPT or its designee may conduct an inspection of the earlier Device and may reject such quantities of the Device on the grounds that such quantities (i) fail to conform with the applicable shipping requirements as specified under the applicable purchase order placed by TRANSCEPT or its becoming aware of such non-compliance designee in accordance with the Supply Agreement or (ii) fail to conform to any product warranty for the date it should have become aware Device provided under the Supply Agreement (“Non-Conforming Devices”). TRANSCEPT shall notify SNBL in writing of any Non-Conforming Devices within such [***] day period following receipt of each delivery of Device supplied under the Supply Agreement or, if such nonconformity is not evident upon reasonable physical inspection, within [***] days after discovery of such nonconformity. To the extent such Devices constitute Non-Conforming Devices, SNBL shall promptly replace, at its expense, each such Non-Conforming Device with a Device conforming to the product warranties for the Device provided under the Supply Agreement. Upon request from SNBL, TRANSCEPT shall return any Non-Conforming Device in accordance with SNBL’s instructions at SNBL’s expense. If the Parties disagree as to whether any quantities of Devices are Non-Conforming Devices, TRANSCEPT shall submit a sample of the relevant shipment of Non-Conforming Devices to an independent testing laboratory of recognized repute selected by TRANSCEPT and approved by SNBL, such approval not to be unreasonably withheld, delayed or conditioned, for analysis of whether such Device constitutes a Non-Conforming Device. The costs associated with such analysis by such independent testing laboratory will be paid by the Party whose assessment of whether the Device constituted a non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratoryConforming Device was mistaken. The determination by such laboratory shall the independent testing laboratory, unless clearly erroneous, will be final and binding binding. Recalls: TRANSCEPT shall have the sole responsibility for, and sole control over, initiating and managing any recall or withdrawal of any Product, provided that TRANSCEPT shall consult with SNBL and adopt its reasonable comments and suggestions with respect to any recall or withdrawal of Product to the costs therefor extent resulting from the Device component of Product. At TRANSCEPT’s request, SNBL shall cooperate and provide assistance in connection with any such recall or withdrawal. Any such recall or withdrawal, including any assistance provided by SNBL, shall be borne by at TRANSCEPT sole expense, except to the non-prevailing party. Leiner shall not dispose extent that any such recall or withdrawal is a result of any breach of Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto warranties for Device or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expenseSNBL’s negligence or intentional misconduct.

ACCEPTANCE AND REJECTION. Leiner Purchaser shall give have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall provide Supplier written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice within rejection no later than thirty (30) days after knowledge receipt of such non-compliance shipment of Components. If Purchaser fails to provide Supplier with such notice of 12. rejection within such thirty (30) day inspection period, Purchaser shall constitute acceptance thereofbe deemed to have accepted the applicable shipment of Components. Any notice by Leiner If Supplier agrees with Purchaser's determination that any Product a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable Efforts to replace the terms and conditionx xxxxof nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be accompanied submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate Parties promptly in good faith to rexxxxx any disputxx xxxsing therefrom faith. Such laboratory shall determine whether the rejected Components meet the applicable specifications, and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impaxlaboratory's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratory. The determination by such laboratory shall be final and binding and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs therefor of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, then at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be borne by reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the non-prevailing party. Leiner applicable specifications shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the disputeshipped. If Leiner the laboratory rules that the Components do not meet the applicable specifications, and if Supplier is unable to produce conforming Components, any sums actually paid therefore shall be refunded to Purchaser with interest. At such time, the Parties will discuss in good faith potential solutions to the supply problem. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Productapplicable specifications may, at ImpaxSupplier's sole cost option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components.

ACCEPTANCE AND REJECTION. Leiner shall give written notice GWM may reject Product delivered by PharmaChem for failure to Impax of any non-compliance of txx Xxxduct comply with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of warranties in Section 13 by giving PharmaChem written notice. Any rejection for noncompliance with such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice warranties that is based on shall be made within thirty (30) days after knowledge of GWM’s receipt of the Quality Documentation, as such non-compliance shall constitute acceptance thereofperiod may be reasonably extended by notice from GWM in the event of investigation of a potential deviation by GWM. Any GWM will be deemed to have accepted any shipment of Product that it does not reject consistent with the preceding timeframe. In case of notice of rejection by Leiner that GWM, the Parties will cooperate to determine whether rejection was necessary or justified. PharmaChem will notify GWM promptly as to whether it accepts GWM’s basis for any rejection. If the Parties disagree whether the Product does batch did not comply with the terms and conditionx xxxxof shall be accompanied by warranties, they will submit a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice sample of such non-compliance, the parties shall submit sucx xxxxxxe Product batch and applicable documentation to a mutually agreed-upon acceptable independent third party laboratory. The Such third party laboratory will determine whether such Product batch conforms with the warranties, and such determination by such laboratory shall be final and final, binding and determinative as to whether rejection of such Product batch was justified. The Party against whom the third party tester rules will bear all costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing third party in the disputetesting. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) GWM has given notice of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Productrejection, at Impax's sole cost GWM’s request PharmaChem will use best efforts to replace such rejected Product. If the third party tester rules that a rejected batch meets the warranties, GWM will purchase such batch, irrespective of whether PharmaChem has already replaced it. If PharmaChem accepts GWM’s basis for rejection or the third party tester rules that a rejected batch did not meet the warranties, PharmaChem will not charge GWM for such batch or for shipping, insurance or freight costs therefor, or will promptly refund any such amounts already paid by GWM. At its election, [ * ], until and expenseunless it is finally determined that the batch complied with the warranties in Section 13.

ACCEPTANCE AND REJECTION. Leiner (a) Purchaser may reject any batch delivery which does not conform with the Materials Specifications or to applicable documentation and process requirements. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. (b) In order to reject delivery of a full batch of Current Materials or Commercial Materials, Purchaser must give written notice to Impax Supplier of Purchaser’s rejection of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware delivery within [*****] after receipt of such non-compliance delivery. If no such notice of rejection is timely received, Purchaser shall be deemed to have accepted such delivery of Current Materials or Commercial Materials within [*****] of delivery of the batch. Once Purchaser accepts a batch of Current Materials or Commercial Materials, Purchaser shall have no recourse against Supplier if the product is subsequently deemed unsuitable for use for any reason except for Latent Defects. (iic) the date it should have become aware After notice of rejection is given, Purchaser shall cooperate with Supplier in determining whether rejection is necessary or justified. Supplier will evaluate process issues and other reasons for such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance Supplier shall constitute acceptance thereofnotify Purchaser as promptly as reasonably possible whether it accepts Purchaser’s basis for any rejection. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate If Supplier in good faith to rexxxxx any disputxx xxxsing therefrom and in disagrees with Purchaser’s determination that certain Current Materials or Commercial Materials do not meet the event that the parties Materials Specifications, such Current Materials or Commercial Materials shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe submitted to a mutually agreed-upon independent acceptable Third Party laboratory. The Such Third Party laboratory shall determine whether such Current Materials or Commercial Materials meets the Materials Specifications and the parties agree that such laboratory’s determination by such laboratory shall be final and binding and determinative. The party against whom the Third Party tester rules shall bear all costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated Third Party testing. Whether or not Supplier accepts Purchaser’s basis for rejection, promptly on receipt of a notice of rejection of a full batch of Current Materials or Commercial DexCom Confidential Materials, Supplier shall use reasonable efforts at Purchaser’s request to replace such Product if Leiner is rejected Current Materials or Commercial Materials. If the prevailing party Third Party tester rules that the batch meets Materials Specifications, Purchaser shall purchase that batch and any replacement batch at the agreed-upon price, irrespective of whether Supplier has already replaced it. (d) Purchaser may not destroy any batch of Current Materials or Commercial Materials until it receives written notification from Supplier that Supplier does not dispute that the batch fails to meet Materials Specifications and that Supplier does not request return of the Current Materials or Commercial Materials. Upon authorization from Supplier to do so, Purchaser shall destroy the Current Materials or Commercial Materials received in the disputerejected delivery promptly at Supplier’s cost and provide Supplier with certification of such destruction. If Leiner is not the xxxxxxling partyPurchaser shall, Leiner shall pay one hundred perxxxx (100%) upon receipt of the storage costs. Imxxx xxall Supplier’s request for return, promptly replace any non-compliant Product, with compliant Productreturn said Current Materials or Commercial Materials or quality control sample to Supplier, at Impax's sole cost and expenseSupplier’s cost.

ACCEPTANCE AND REJECTION. Leiner Purchaser shall give have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware rejection. If Supplier agrees with Purchaser's determination that a shipment of such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product Components does not comply with applicable specifications, Supplier shall use Reasonable Efforts to replace the terms and conditionx xxxxof nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be accompanied submitted to an independent, 62. qualified Third Party laboratory that is mutually acceptable and selected by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate Parties promptly in good faith to rexxxxx any disputxx xxxsing therefrom faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impaxlaboratory's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratory. The determination by such laboratory shall be final and binding determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the costs therefor shall supply problem will be borne resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by the non-prevailing party. Leiner shall not dispose Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of any Product claimed to be non-compliant xxxxx final resolution such shipment of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expenseComponents.

ACCEPTANCE AND REJECTION. Leiner shall Buyer may reject any Product that does not conform to the Specifications or to the Product Warranties. To reject a Product, Buyer must give written notice of rejection to Impax Supplier within sixty (60) days after receipt of any non-compliance such Product or, in the case of txx Xxxduct with the terms of this Agreementa Latent Defect, promptly upon the earlier of within sixty (i60) its becoming days after Buyer becomes aware of such non-compliance or Latent Defect, which notice shall specify Buyer’s reason for rejection. If no such notice of rejection is received within sixty (ii60) days after receipt of the date it should have become Product or, in the case of a Latent Defect, within sixty (60) days after Buyer becomes aware of such non-complianceLatent Defect, Buyer shall be deemed to have accepted such shipment of Products, provided that, notwithstanding any acceptance or deemed acceptance of Products, the Product Warranties shall continue to cover the Supplier Product. Failure Any Product rejected by Buyer will be returned to provide Supplier at Supplier’s request and expense within sixty (60) days after receipt of such notice Product or, in the case of a Latent Defect, within sixty (60) days after Buyer becomes aware of such Latent Defect. Whether or not Supplier accepts Buyer’s basis for rejection, Supplier will supply replacement Product within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereofnotice of rejection at no additional cost. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within Within thirty (30) calendar days from the date of Impax's receipt of Leiner's after receiving any notice of such non-compliancerejection from Buyer, Supplier will respond stating whether (a) it accepts the rejection or (b) it disputes the rejection, in which case the parties shall submit sucx xxxxxxe will refer such dispute to a mutually agreedacceptable independent third party with the appropriate expertise to assess the conformity or non-upon conformity of the rejected Product to the Product Warranties. Such independent laboratorythird party shall examine or test the applicable Products and shall determine whether such Products conformed or did not conform to the Product Warranties. The parties agree that such third party’s determination by such laboratory shall be final and binding upon the parties. The party against whom the independent third party rules shall bear the costs of testing by such independent third party, and if such third party determines that Buyer’s rejection of the Products was incorrect, Buyer will purchase and pay for both the initially rejected Products and the costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expensereplacement Products.

ACCEPTANCE AND REJECTION. Leiner shall give written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (ia) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that Customer may reject any Product delivered under this Agreement that does not comply with the terms and conditionx xxxxof warranties set forth in Section 6.3 (a “Defective Product”) by giving written notice of such Defective Product to Supplier within forty-five (45) days after receipt thereof. Customer shall be accompanied entitled to reject all or a portion of an entire lot or shipment of a Product if a tested sample of that lot or shipment contains any Defective Products. Acceptance of Products by Customer shall not limit Customer’s rights under Section 7.1. (b) If, after Customer’s initial acceptance, Customer discovers that such Product is a true Defective Product and correct copy that the nature of such defect likely could not have been discovered through the results exercise of any tests conducted reasonable diligence within forty-five (45) days of Customer’s receipt of such product, Customer may revoke its acceptance of such Defective Product by Leiner thereonproviding written notice to Supplier of such revocation. (c) Customer shall return Defective Products to Supplier at Supplier’s expense. Leiner With respect to Defective Products that have been properly rejected pursuant to Section 3.6(a) or 3.6(b), Customer shall not be required to pay for such Defective Products under Section 5.1. Supplier shall replace such Defective Products as quickly as possible, and Impax Customer shall cooperate pay Supplier for such replacement Product in good faith to rexxxxx any disputxx xxxsing therefrom and accordance with Section 5.1, or in the event that Customer has already paid for the parties Defective Products, Supplier shall be replace such Defective Products at its own expense. (d) If, after Customer rejects any Defective Product, Supplier fails to promptly replace such Defective Product, then Customer shall have the right, upon notice to Supplier, to cancel the applicable purchase order relative to the rejected Products without penalty and require refund of any payments made relative to the rejected Products. (e) If Supplier disagrees with Customer’s determination that certain units of Product are Defective Product, the Parties will first use good faith efforts to settle such dispute within forty-five (45) days of Customer’s notice of such alleged defects. If the Parties are unable to resolve such dispute within thirty this forty-five (3045) calendar days from the date of Impax's receipt of Leiner's notice of day period, such non-compliance, the parties Product shall submit sucx xxxxxxe be submitted to a mutually agreed-upon independent laboratoryacceptable Third Party testing service. The Such Third Party testing service shall determine whether such Product meets the Specifications, and the Parties agree that such testing service’s determination by such laboratory shall be final and binding and on the Parties. The Party against whom the Third Party laboratory rules shall bear all costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expenseThird Party testing.

ACCEPTANCE AND REJECTION. Leiner XTENT shall give written notice to Impax inspect all shipments of BESA Items promptly upon receipt thereof. In the event of any non-compliance shortage, damage or discrepancy in or to a shipment of txx Xxxduct Products, XTENT shall, within fifteen (15) business days after delivery to XTENT (the “Rejection Period”), promptly report the same to BESA and furnish such written evidence or other documentation as BESA may deem appropriate. BESA shall not be liable for any such shortage, damage or discrepancy unless BESA has received notice and substantiating evidence thereof from XTENT within the Rejection Period unless it is determined that such shortage, damage or discrepancy occurred prior to the delivery of the shipment to the carrier. Any Product not properly rejected within the Rejection Period shall be deemed accepted. If any portion of a BESA Item is shipped by XTENT or at XTENT’s request to a third party or used by XTENT prior to expiration of the Rejection Period, in each case for purposes other than acceptance testing or qualification of such portion, then that portion shall be deemed accepted upon shipment or usage by XTENT. If the substantiating evidence delivered by XTENT shall demonstrate to BESA’s satisfaction that BESA is responsible for such shortage, damage or discrepancy, BESA shall promptly deliver additional or substitute BESA Items to XTENT in accordance with the terms delivery procedures set forth herein, but in no event shall BESA or its Affiliates be liable for any additional costs, expenses or damages incurred by XTENT, directly or indirectly, as a result of such shortage, damage or discrepancy in or to a shipment. As soon as practicable after the execution of this Restated Agreement, promptly the Parties shall agree upon the earlier of (i) its becoming aware of such non-compliance or (ii) acceptance criteria and acceptance test protocols to be used for the date it should have become aware of such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof BESA Items, which shall be accompanied set forth in a separate written document executed by a true both Parties. The acceptance criteria and correct copy test protocols applicable to each purchase order shall be the same as those of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a previous purchase order unless changes are mutually agreed-upon in writing in advance of such purchase order. If acceptance testing by XTENT according to the agreed-upon protocol indicates that any shipment fails to meet the agreed-upon acceptance criteria, and XTENT delivers the results of such testing to BESA within the Rejection Period, it shall be presumed that such shipment has been properly rejected and the burden to prove otherwise shall shift to BESA. Within fifteen (15) business days of receiving XTENT’s rejection, BESA shall communicate any disagreement with such rejection to XTENT in writing and its reasons therefor, or the shipment shall be deemed rejected. XTENT may respond with additional information to BESA within a reasonable time thereafter, even if the Rejection Period has passed. If after good faith efforts the Parties are unable to resolve any disagreement regarding the rejection of a shipment within sixty (60) days of rejection, the rejected product shall be submitted for analysis to an independent laboratorylaboratory mutually agreed to by the parties. The determination by costs of such laboratory shall be final and binding and the costs therefor analysis shall be borne by the non-prevailing party. Leiner Party against whom the discrepancy is resolved.. Fulfilment of any purchase orders issued by XTENT shall not dispose of be delayed due to a disagreement or testing in connection with any Product claimed other shipment, unless independent third party testing indicates that XTENT’s handling, storage, testing methods or acceptance criteria do not conform with the agreed-upon specifications, in which case shipments shall resume promptly upon XTENT’s written notification to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent BESA that it has revised its testing methods and/or acceptance criteria to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated conform to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expensespecifications.

ACCEPTANCE AND REJECTION. Leiner shall give (a) Purchaser may reject any Supply Deliverable delivered under this Agreement that does not comply with the warranties set forth in Section 6.2 (a “Defective Product”) by giving written notice of such Defective Products to Impax Supplier within ninety (90) days after receipt thereof. If Purchaser fails to so notify Supplier of any non-compliance Defective Product within such ninety (90) day period, Purchaser will be deemed to have accepted the Product, subject to Section 3.3(b) and without otherwise limiting Purchaser’s remedies at law or equity. (b) If, after ninety (90) days after Purchaser’s receipt of txx Xxxduct with the terms of this AgreementSupply Deliverables, promptly upon Purchaser discovers that an accepted Supply Deliverable is a Defective Product and that the earlier of (i) its becoming aware nature of such non-compliance defect was not visible or (ii) the date it should have become aware easily discoverable upon reasonable physical inspection of such non-compliance. Failure to provide such notice product within the time period set forth in Section 3.3(a), there shall be an additional period of thirty (30) days after knowledge in which Purchaser may revoke its acceptance of such non-compliance shall constitute acceptance thereofDefective Product by providing written notice to Supplier of such revocation. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof shall be accompanied by a true and correct copy of the results If Purchaser fails to so notify Supplier of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve Defective Product within such dispute within thirty (30) calendar day period, Purchaser will be deemed to have irrevocably accepted the Product, without limiting Purchaser’s remedies (i) under Section 4.5 or Article 7 or (ii) otherwise available for Supplier’s breach of the warranty set forth in Section 6.2. (c) In notifying Supplier of Defective Product, Purchaser shall identify in reasonable detail the nature of the defect and Purchaser’s determination as to the cause of the defect. Supplier shall have a reasonable opportunity, not to exceed forty-five (45) days from the date of Impax's receipt of Leiner's notice notification, to review any materials provided by Purchaser to substantiate the existence of a Defective Product and to inspect its own stocks (if any) of Supply Deliverables. Supplier shall thereafter provide Purchaser with detailed written instructions to return or dispose of such Defective Product, subject to Section 3.4 of this Agreement. If Supplier requests that Purchaser return allegedly Defective Product, Supplier shall immediately provide a Returned Material Authorization (“RMA”) number to Purchaser. Within thirty (30) business days of its receipt of the RMA number, Purchaser shall return to Supplier the allegedly Defective Product, freight prepaid, in a shipping carton with the RMA number displayed on the outside of the carton. Supplier reserves the right to refuse to accept any allegedly Defective Products that do not bear an RMA number on the outside of the carton. Purchaser shall have no obligation to pay for any Supply Deliverable that is subject to a claim of non-compliancecompliance or defect made pursuant to this Section. Subject to Section 3.4, Supplier shall, at the parties shall submit sucx xxxxxxe option of the Purchaser, either: (1) within eight (8) weeks, and at Supplier’s own expense, replace such defective or nonconforming Supply Deliverable, or (2) credit Purchaser with the transfer price paid by Purchaser in connection with such Supply Deliverable and reimburse Purchaser for its costs incurred in connection with the shipment and return of the Defective Product, or (3) refund any sums paid to a mutually agreed-upon independent laboratorySupplier attributable to the defective or nonconforming Supply Deliverable, and reimburse Purchaser for its costs incurred in connection with the shipment and return of the Defective Product. The determination by such laboratory shall be final and binding and the costs therefor shall be borne by the non-prevailing party. Leiner Purchaser shall not dispose have the right to return any quantity of any Product claimed Supply Deliverables except for Defective Products subject to be non-compliant xxxxx final resolution of any dispute and in accordance with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expensethis Section 3.3(c).

ACCEPTANCE AND REJECTION. Leiner (a) Client may reject any Product supplied hereunder that does not conform with the Specifications or with cGMPs. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. (b) Client shall have [***] from the date of receipt of the Product and all associated quality control samples and documentation (inclusive of the Certificate of Analysis) to inspect such Product, review the Certificate of Analysis and other documents {M1463853.1 } and/or perform or have performed any or all of the quality control procedures outlined in the relevant Specifications or the Quality Agreement to determine if the Product conforms to the Specifications. In order to reject Product, Client must give written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware CoreRx of such non-compliance rejection within [***] after receipt of such Product and the associated quality control samples and documentation, and if no such notice of rejection is received, Client shall be deemed to have accepted such delivery of Product within [***] of delivery thereof; provided, however, that in the event a Latent Defect is discovered by Client after such [***] inspection period, Client shall promptly, and in no event more than [***] after discovery of such Latent Defect, provide written notice to CoreRx rejecting such Product as a result of such discovered Latent Defect. (c) After notice of rejection is given, Client shall cooperate with CoreRx in determining whether rejection is necessary or (ii) the date it should have become aware of justified. CoreRx will evaluate process issues and other reasons for such non-compliance. Failure to provide such notice within thirty (30) days after knowledge of such non-compliance CoreRx shall constitute acceptance thereofnotify Client as promptly as reasonably possible whether it accepts Client’s basis for any rejection. Any notice by Leiner If CoreRx in good faith disagrees with Client’s determination that any certain Product does not comply with meet the terms and conditionx xxxxof Specifications, such Product shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impax's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe submitted to a mutually agreed-upon independent acceptable third party laboratory. The Such third party laboratory shall determine whether such Product meets the Specifications, and the parties agree that such laboratory’s determination by such laboratory shall be final and binding and determinative. The party against whom the third party tester rules shall bear all costs therefor shall be borne by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing third party in the disputetesting. If Leiner is Whether or not the xxxxxxling partyCoreRx accepts Client’s basis for rejection, Leiner shall pay one hundred perxxxx (100%) promptly on receipt of the storage costs. Imxxx xxall promptly replace any non-compliant a notice of rejection of Product, with compliant CoreRx shall replace such rejected Product, at Impax's sole its cost, within [***], subject to Section 6.3(e) of this Agreement. If the third party tester rules that such Product meets Specifications, Client shall purchase that batch at the agreed-upon price, irrespective of whether CoreRx has already replaced it. (d) Client may not destroy any rejected Product until it receives written notification from CoreRx that CoreRx does not dispute that such Product fails to meet Specifications and that CoreRx does not request return of such Product. Upon authorization from CoreRx to do so, Client shall destroy such rejected Product promptly at CoreRx’s cost and expenseprovide CoreRx with certification of such destruction. Client shall, upon receipt of CoreRx’s request for return of rejected Product, promptly return such Product to CoreRx, at CoreRx’s cost. (e) Client acknowledges that, where CoreRx is required to manufacture and deliver a Product for use in clinical trials where the manufacturing process has not been validated yet, failing to meet the manufacturing Specifications shall not constitute a failure to deliver, provided that CoreRx has complied with the processes and procedures established in the batch record for the manufacture of the Product at the date of manufacture.

ACCEPTANCE AND REJECTION. Leiner (a) If a shipment of the Products or any portion thereof fails to conform to the Product Specifications, then INB shall give written notice have the right to Impax reject such nonconforming shipment of any non-compliance of txx Xxxduct with the terms of this AgreementProducts or the its rejection hereunder, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice within thirty (30) days after knowledge INB's receipt of such non-compliance shall constitute acceptance thereof. Any notice by Leiner shipment, specifying the grounds for such rejection; provided, however, that any Product does not comply with the terms and conditionx xxxxof shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that such defect is latent or was not obvious and could not be readily discovered from a physical inspection of the parties shall be unable Products' shipment, INB may give written notice to resolve Aloe of its rejection of such dispute shipment within thirty (30) calendar days from the date of Impaxafter INB's receipt of Leiner's notice discovery of such non-complianceconformance, specifying the parties grounds for such rejection. The non-conforming shipment of Products, or the non-conforming portion thereof, shall submit sucx xxxxxxe be held for Aloe's disposition, or shall be returned to Aloe, in each case at Aloe's expense, as directed by Aloe. Aloe shall use its commercially reasonable efforts to replace the non-conforming shipment of Products, or the non-conforming portion thereof, with conforming Products as soon as reasonably practicable after receipt of notice of rejection thereof, and in any event will do so within forty-five (45) days after receipt of notice of rejection thereof at no cost to INB. (b) In the event of a conflict regarding any nonconforming Product which Aloe and INB are unable to resolve, a sample of such Product, together with mutually agreed upon questions, shall be submitted by INB to a mutually agreed-upon qualified independent laboratory. The determination laboratory reasonably acceptable to both parties for testing against the Product Specifications and the test results ("Test Results") obtained by such laboratory shall be final and binding upon the parties hereto. The fees and expenses of such aboratory testing, and all additional shipping and transportation costs incurred as a result of the costs therefor dispute, shall be borne entirely by the non-prevailing party. Leiner shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impaxparty against whom such laboratory's written consentfindings are made. In the event Leiner requests Impax's consent the Test Results indicate that the Product in question does not conform to destroy a reasonable percentage ox xxxxuted the Product and Impax declinesSpecifications, Impax will pay one hundred percent (100%) of the storage costs allocated to Aloe shall replace such Product if Leiner is the prevailing party with conforming Product in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly replace any non-compliant Product, accordance with compliant Product, at Impax's sole cost and expensethis Section 3.2.

ACCEPTANCE AND REJECTION. Leiner 5.3.1 UCB shall give deliver to Buyer, concurrently with the delivery of each shipment, a certificate of analysis and other documents and materials set forth in the Quality Agreement. Within ten (10) days after receipt of any shipment of Resin, Buyer shall assess the quantity and visually inspect the quality of the Resin. Within thirty (30) days after delivery of Resin to Buyer in accordance with Section 7, Buyer shall examine the Resin to determine whether the Resin conforms to the Specifications. No claim for defective quality or shortage in quantity of any individual shipment of Resin shall be valid unless made by written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice given within thirty (30) days after knowledge from the date of such delivery, except in the case of latent (or other non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof obvious) defects, in which case such claims shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate made in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute writing within thirty (30) calendar days from the date such defect became discoverable (but in no event later than the date upon which the Resin has expired according to its expiry date). Any such notice shall describe in reasonable detail the defect or non-conformity, and shall include samples of Impax's receipt the Resin being rejected, if appropriate, and copies of Leiner's written reports relating to tests, studies or investigations performed by or on behalf of Buyer on the Resin being rejected. Failure to deliver a notice of such non-complianceconformance in the manner contemplated in this Section 5.3.1 shall constitute an acceptance of the applicable Resin by Buyer. 5.3.2 If there is any dispute as to whether any shipment fails, in whole or in part, to meet the parties Specifications, such dispute shall submit sucx xxxxxxe to a mutually agreed-upon be resolved by an independent laboratorytesting organization of recognized repute within the pharmaceutical industry in the Territory appointed by both UCB and Buyer. The determination by expense of hiring such laboratory shall be final and binding and the costs therefor organization shall be borne by the non-prevailing party. Leiner Party against whom the decision is rendered. 5.3.3 UCB shall not dispose of make up any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly shortfall and/or replace any non-compliant Productconforming Resin or rework the rejected Resin, with compliant Productif applicable, as promptly as practicable and at Impaxno additional cost to Buyer; provided that UCB shall have no liability or obligation to Buyer under this Section 5.3 if it is determined that any such defect or non-conformance is attributable to the failure by any Person (including Buyer) to store, transport or care for such Resin in a proper manner after such Resin left UCB's possession. Upon UCB's instructions, Buyer shall destroy or return, in either case at UCB's cost, the non-conforming Resin; provided that if it is determined that any such defect or non-conformance is attributable to the failure by any Person (including Buyer) to store, transport or care for such Resin in a proper manner after such Resin left UCB's possession, such destruction or return shall be at Buyer's cost. It is acknowledged and agreed that notwithstanding any other provision of this Agreement, Buyer's sole cost and expenseexclusive remedy in the event of UCB's delivery of defective or non-conforming Resin shall be replacement of the rejected Resin in accordance with this Section 5.3.3, and that Buyer shall not be entitled to remedies, whether under any other provision of this Agreement (including without limitation Section 6.4) or otherwise.

ACCEPTANCE AND REJECTION. Leiner a) MonoSol shall give deliver to Buyer, concurrently with the delivery of each shipment, a certificate of analysis and other documents and materials set forth in the Quality Agreement. Within ten (10) days after receipt of any shipment of Finished Product, Buyer shall assess the quantity and visually inspect the quality of the Finished Product. Within thirty (30) days after delivery of Finished Product to Buyer in accordance with Section 7, Buyer shall examine the Finished Product to determine whether the Finished Product conforms to the Specifications. No claim for defective quality or shortage in quantity of any individual shipment of Finished Product shall be valid unless made by written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice given within thirty (30) days after knowledge from the date of such delivery, except in the case of latent (or other non-compliance shall constitute acceptance thereof. Any notice by Leiner that any Product does not comply with the terms and conditionx xxxxof obvious) defects, in which case such claims shall be accompanied by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate made in good faith to rexxxxx any disputxx xxxsing therefrom and in the event that the parties shall be unable to resolve such dispute writing within thirty (30) calendar days from the date such defect was discovered by Buyer (but in no event later than the date upon which the Finished Product has expired according to its expiry date). Any such notice shall describe in reasonable detail the defect or non-conformity, and shall include samples of Impax's receipt the Finished Product being rejected, if appropriate, and copies of Leiner's written reports, if any, relating to tests, studies or investigations performed by or on behalf of Buyer on the Finished Product being rejected. Failure to deliver a notice of such non-complianceconformance in the manner contemplated in this Section 5.3(a) shall constitute an acceptance of the applicable Finished Product by Buyer. b) If there is any dispute as to whether any shipment fails, in whole or in part, to meet the parties Specifications, such dispute shall submit sucx xxxxxxe to a mutually agreed-upon be resolved by an independent laboratorytesting organization of recognized repute within the pharmaceutical industry in the Territory appointed by both MonoSol and Buyer. The determination by expense of hiring such laboratory shall be final and binding and the costs therefor organization shall be borne by the non-prevailing party. Leiner Party against whom the decision is rendered. c) MonoSol shall not dispose of make up any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the dispute. If Leiner is not the xxxxxxling party, Leiner shall pay one hundred perxxxx (100%) of the storage costs. Imxxx xxall promptly shortfall and/or replace any non-compliant conforming Finished Product or rework the rejected Finished Product, if applicable, as promptly as practicable and at no additional cost to Buyer. Upon MonoSol’s instructions, Buyer shall destroy or return, in either case at MonoSol’s cost, the non-conforming Finished Product. Buyer shall not knowingly distribute any Finished Product with compliant Product, at Impax's sole cost and expensea defect or non-conformity.

ACCEPTANCE AND REJECTION. Leiner Purchaser shall give have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall provide Supplier written notice to Impax of any non-compliance of txx Xxxduct with the terms of this Agreement, promptly upon the earlier of (i) its becoming aware of such non-compliance or (ii) the date it should have become aware of such non-compliance. Failure to provide such notice within rejection no later than thirty (30) days after knowledge receipt of such non-compliance shipment of Components. If Purchaser fails to provide Supplier with such notice of rejection within such thirty (30) day inspection period, Purchaser shall constitute acceptance thereofbe deemed to have accepted the applicable shipment of Components. Any notice by Leiner If Supplier agrees with Purchaser's determination that any Product a shipment of Components does not comply with applicable specifications, [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Supplier shall use Reasonable Efforts to replace the terms and conditionx xxxxof nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be accompanied submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by a true and correct copy of the results of any tests conducted by Leiner thereon. Leiner and Impax shall cooperate Parties promptly in good faith to rexxxxx any disputxx xxxsing therefrom faith. Such laboratory shall determine whether the rejected Components meet the applicable specifications, and in the event that the parties shall be unable to resolve such dispute within thirty (30) calendar days from the date of Impaxlaboratory's receipt of Leiner's notice of such non-compliance, the parties shall submit sucx xxxxxxe to a mutually agreed-upon independent laboratory. The determination by such laboratory shall be final and binding and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs therefor of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, then at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be borne by reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the non-prevailing party. Leiner applicable specifications shall not dispose of any Product claimed to be non-compliant xxxxx final resolution of any dispute with respect thereto or Impax's written consent. In the event Leiner requests Impax's consent to destroy a reasonable percentage ox xxxxuted Product and Impax declines, Impax will pay one hundred percent (100%) of the storage costs allocated to such Product if Leiner is the prevailing party in the disputeshipped. If Leiner the laboratory rules that the Components do not meet the applicable specifications, and if Supplier is not unable to produce conforming Components, any sums actually paid therefore shall be refunded to Purchaser with interest. At such time, the xxxxxxling partyParties will discuss in good faith potential solutions to the supply problem. If the laboratory rules the rejected shipment of Components met the applicable specifications, Leiner then Purchaser shall pay one hundred perxxxx accept such shipment (100%) including all costs of the storage costs. Imxxx xxall promptly replace any non-compliant Product, with compliant Product, at Impax's sole cost and expense.shipping and