Remedies for Non-Conforming Product. 7.4.1 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.3, that a Batch of Product or a portion thereof materially fails to conform to the Product Warranties due to the failure of: (a) CBSW personnel properly to execute the Master Production Record, (b) CBSW personnel to comply with cGMP, (c) CBSW or its personnel otherwise, or (d) the Facility utilities, then CBSW will produce for Client sufficient quantities of Product to replace the non-conforming Batch of Product or portion thereof (the "Production Rerun"), in accordance with the provisions of this Agreement without charging Client monthly fees or portion thereof for the time needed for such Production Rerun, (ii) for Hourly Fees (as set forth on Schedule 11.1), (iii) for Materials needed for the Production Rerun and (iv) other expenses incurred in The Production Rerun (collectively the "Production Rerun Expenses"). In addition, [***] .
7.4.2 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.3, that a Batch of Product or portion thereof materially fails to conform to the Product Warranties for any reason other than as set forth in Section 7.4.1, then CBSW will perform a Production Rerun at Client's expense and Client will bear the expenses of any resulting required Product recall.
7.4.3 Client acknowledges and agrees that its sole remedy with respect to the failure of Product to conform with any of the Product Warranties is as set forth in this Section 7.4, and in furtherance thereof, Client hereby waives all other remedies at law or in equity regarding the foregoing claims.
7.4.4 Nothing in this Section 7.4 or elsewhere in this Agreement shall preclude Client from making a claim against CBSW [***] .
Remedies for Non-Conforming Product. 5.4.1 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, a Batch of Product materially fails to conform to the Product Warranties due to the failure of: (a) LWI to properly execute the Master Production Record in respect of the manufacture of the Product, (b) LWI to comply with cGMP, (c) LWI’s negligence or willful misconduct, or (d) LWI facilities or utilities then, at CLIENT’s request, LWI will promptly produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT. If the CLIENT has not yet paid for the failed Batch of Product, then CLIENT will be billed when it receives the replacement.
5.4.2 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties for any reason other than as set forth in Section 5.4.1, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense.
5.4.3 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties and such failure is (a) not the result of an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any cell lines originally provided by CLIENT, or (b) not the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, LWI will produce for CLIENT as soon as practicable a Production Rerun, in accordance with the provisions of this Agreement and at no additional cost to CLIENT.
5.4.4 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to...
Remedies for Non-Conforming Product. THE OBLIGATION OF CARDINAL HEALTH TO PROVIDE A REFUND FOR OR REPLACE NON-CONFORMING PRODUCT IN ACCORDANCE WITH THIS ARTICLE 4 SHALL BE XENCOR’S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR PRODUCT THAT DOES NOT CONFORM TO SPECIFICATIONS AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.
Remedies for Non-Conforming Product. In the event that a Panther Instrument fails to conform to the warranty set forth in Section 5.3 above and Gen-Probe receives written notice from Roka of such non-conformity within the Warranty Period, Gen-Probe shall:
5.5.1. Promptly investigate such non-conformity, and deliver to Roka a corrective action plan within thirty (30) days after receipt of Roka’s written notice of non-conformity, or such additional time as is approved by Roka if such investigation or plan requires data from sources other than Roka or Gen-Probe.
5.5.2. At Gen-Probe’s expense, repair or replace such non-conforming Part(s) as soon as reasonably practicable with Part(s) that conform to the Specifications and refund any freight charges (and related taxes and duties) incurred by Roka related to such non-conforming Part(s). The labor for the replacement of such Part(s) shall be provided by Roka.
5.5.3. In the event Roka is unable to repair or replace such non-conforming Part(s), Gen-Probe at its discretion shall either repair or replace such non-conforming Panther Instrument(s) as soon as reasonably practicable with Panther Instrument(s) that conform to the Specifications and refund any freight charges (and related taxes and duties) incurred by Roka related to such non-conforming Panther Instrument(s).
Remedies for Non-Conforming Product. In the event that Hospira agrees that a shipment of Product is non-conforming, or if the outside testing laboratory or consultant determines that such Product is non-conforming, then, at Omeros’ election, Hospira shall [†]. Upon Hospira’s instructions, Omeros shall destroy or return, at Hospira’s cost, the non-conforming Product.
Remedies for Non-Conforming Product. If Novavax accepts Customer’s rejection of Product as set forth in Section 3.2, accepts Customer’s warranty claim in Section 4.1 or if the Independent Expert determines that any Product is non-Conforming Product as set forth in Section 4.3, then Novavax shall, at Customer’s option and at no additional charge to Customer, either (a) replace the non-Conforming Product [***] or (b) credit or refund the pro-rated amount paid of the Total Price of such non-Conforming Product. If Novavax so requests, Customer shall, [***], return any non-Conforming Product to Novavax; otherwise, Customer shall dispose of Product in compliance with applicable laws and regulations.
Remedies for Non-Conforming Product. 5.4.1 In the event that the Parties agree, or an independent testing laboratory determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties due to the failure of: (a) LWI personnel properly to execute the Master Production Record, (b) LWI personnel to comply with cGMP, or (c) the Facility utilities, then, at CLIENT’s request, LWI will produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT.
5.4.2 In the event that the Parties agree, or an independent testing laboratory determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties for any reason other than as set forth in Section 5.4.1 , then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT a Production Rerun at CLIENT’s expense.
5.4.3 CLIENT acknowledges and agrees that its sole remedy with respect to the failure of Product to conform with any of the Product Warranties is as set forth in this Section 5.4, and in furtherance thereof, Client hereby waives all other remedies at law or in equity regarding the foregoing claims.
Remedies for Non-Conforming Product. 7.2.1 BAXTER shall replace such non-conforming Product within *** (***) calendar days from the date of determination by the third party of non-conformity or agreement by BAXTER of such non-conformity assuming sufficient Active will be provided by PONIARD ***, except as set forth below, in due time to carry out the manufacturing. The non-conforming Product shall be returned to BAXTER for disposal. In the event of any destruction of the non-conforming Product, the party directing the destruction shall deliver to the other an appropriate certificate of destruction. If the non-conformity was due solely to XXXXXX’x negligence or willful misconduct or solely to XXXXXX’x breach of its representations or warranties under this Agreement, as may be agreed to by BAXTER or determined by the laboratory or consultant named in Section 7.1.3, BAXTER shall be responsible for the costs of disposal of the non-conforming Product, XXXXXX’x costs associated with Product replacement, and BAXTER shall reimburse PONIARD for the API for the non-conforming Batch, which API reimbursement shall amount to *** (***) Euros per *** of API but in no event shall such API reimbursement amount exceed the value of the Firm Purchase Order.
7.2.2 However, BAXTER is not responsible for defects that are caused by Components supplied by PONIARD or upon specific manufacturing instructions of PONIARD as set forth in the Product Master Plan.
7.2.3 Deviations which occur during the Production of Product and testing and that cause the Production to be non-compliant with cGMPs or registration requirements as agreed upon by BAXTER and PONIARD shall be deemed to cause such Product to be non-conforming. Likewise, deviations which occur during Production and testing of Product, which do not cause the Product to be non-compliant with cGMPs or registration requirements, shall not be deemed to cause such Product to be non-conforming.
Remedies for Non-Conforming Product. 4.4.1 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 4.3, that a Batch of Product fails to conform to the Product Warranties due to the failure of: (a) CBSW personnel properly to execute the Master Production Record, (b) CBSW personnel to comply with cGMP, (c) the Facility utilities, then CBSW will initiate and produce, within three (3) months of a final determination by either the Parties, the laboratory or the arbitrator as to that Batch of Products’ failure to conform to the Product Warranties, for Clients sufficient quantities of Product to replace the non-conforming portion of such Batch of Product (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to Clients, or (d) CBSW to otherwise comply with its the obligations under this Agreement.
4.4.2 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 4.3, that a Batch of Product fails to conform to the Product Warranties for any reason other than as set forth in Section 4.4.1, then CBSW will produce for Clients a Production Rerun at Clients’ expense.
4.4.3 The Parties acknowledge and agree that after the first *** consecutive attempts at replacement, Clients shall be entitled to request that CBSW continue to perform Production Reruns until Product is produced that conforms with the Product Warranties or Clients may terminate the Agreement by providing written notice executed by each of them to CBSW. Clients acknowledge and agree that the remedies with respect to the failure of Product to conform with any of the Product Warranties are the remedies as set forth in this Section 4.4, and in furtherance thereof, Clients hereby waive all other remedies at law or in equity regarding the foregoing claims.
Remedies for Non-Conforming Product. If any API delivered to Company fails to conform to API Requirements, SAFC, [***] within a commercially reasonable period not to exceed [***] from the date that Company notifies SAFC of such nonconformity. In addition, if the API is determined not to have met the API Requirements, SAFC shall [***]. Pursuant to written directions from SAFC, Company shall either return the nonconforming API to SAFC or destroy it, in each case, at SAFC’s expense. If Company is directed to destroy nonconforming API, then Company shall provide SAFC a certificate certifying such destruction. Except for SAFC’s indemnification obligations in respect of third party claims under Section 6.8 below, the remedy under this Section 4.3 shall be Company’s exclusive remedy and SAFC’s sole liability for any claim that API fails to conform to the API Requirements.
