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. 7.2.1 In the event XXXXXX agrees that a Batch is non-conforming or the laboratory determines that a Batch is non-conforming, XXXXXX shall provide replacement Product for such non-conforming Batch which shall be Released by XXXXXX within the latter of (a) [***] ([***]) calendar days from receipt of replacement Exenatide Drug Substance from AMYLIN or (b) [***] ([***]) calendar days from the date of determination by the third party of non-conformity or agreement by XXXXXX of such non-conformity.
7.2.2 AMYLIN shall pay for all Product, including replacement Product and the cost of Exenatide Drug Substance therefore, except as specifically set forth in Section 7.2.3.
7.2.3 In the event XXXXXX agrees, or the laboratory or consultant determines, that a Batch is non-conforming, solely as a result of the negligence or willful misconduct of XXXXXX, AMYLIN shall not be required to pay for such Batch, XXXXXX shall provide replacement Product as specified in Section 7.2.1., shall reimburse AMYLIN for its actual cost of the Exenatide Drug Substance for the non-conforming Batch, which cost shall not exceed [***] percent ([***]%) of the Purchase Price for Units comprising the non-conforming Batch of Product, and shall bear the costs of such laboratory or consultant and any storage fees incurred by AMYLIN for the non-conforming Batch. The foregoing shall be AMYLIN’s sole and exclusive remedy and XXXXXX’x sole liability for replacement of conforming Product.
Remedies for Non-Conforming Product. 5.4.1 In the event that the Parties agree, or an independent testing laboratory or arbitrator, as applicable, determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties (for clarity, CLIENT’s inability to use such Batch caused by non-conformance with the Product Warranties as determined by an independent testing laboratory or an arbitrator, as applicable, of Product shall be deemed, inter alia, a material failure) 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 or provide another Batch of Product in accordance with CLIENT’s reasonable request (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT; provided, however, CLIENT shall have first paid for the original Batch of Product.
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 (except to the extent such failure is caused due to LWI’s gross negligence or willful misconduct) are (i) as set forth in this Section 5.4, and (ii) when [*] Production Reruns are produced (pursuant to Section 5.4.1), and the [*] Production Rerun materially fails to conform to the Product Warranties due to: (a) LWI personnel to properly execute the Master Production Record, (b) LWI personnel to comply with cGMP, or (c) the Facility utilities, then CLIENT may terminate this Agreement [*], and in furtherance thereof, CLIENT hereby waives all other remedies at law or in equity regarding the foregoing claims. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.8...
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, L WI will produce for CLIENT sufficient quantities of Product to replace the nonconforming 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 L WI 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. In the event AXXXXX agrees that the Batch of Company Plasmid DNA is non-conforming in whole or in part as a result of the negligence of AXXXXX or the laboratory determines that the shipment of Company Plasmid DNA is non-conforming in whole or in part as a result of the negligence of AXXXXX, then CLIENT, at its option, shall either (i) allow AXXXXX at its expense to replace such non-conforming Company Plasmid DNA within forty-five (45) calendar days from the date product is determined to be non-conforming, or (ii) be granted a full refund of the total Purchase Price of Company Plasmid DNA as stated in the Project Plan which includes all services provided by AXXXXX directly or indirectly in Production of Company Plasmid DNA. In addition, the due date for the final invoice issued at completion of production of Company Plasmid DNA will be extended until the date at which replacement Company Plasmid DNA is released and determined to be conforming by AXXXXX and CLIENT.
Remedies for Non-Conforming Product. In the event XXXXXX agrees that the Batch of Drug Product is non-conforming as a result of the negligence, willful misconduct, or breach of this agreement by XXXXXX or the laboratory determines that the shipment of Drug Product is non-conforming as a result of the negligence, willful misconduct, or breach of this Agreement by XXXXXX, then XXXXXX, at CLIENT’S option, and at ALTHEA’S sole cost and expense shall either (i) replace such non-conforming Drug Product within sixty (60) calendar days from receipt of replacement Bulk Drug Substance from CLIENT and reimburse CLIENT for reasonable costs of replacing Bulk Drug Substance, or (ii) refund the Purchase Price of the non-conforming Drug Product and reimburse CLIENT for the reasonable costs of replacing Bulk Drug Substance. XXXXXX will obtain specific insurance coverage in order to reimburse the client for replacing Bulk Drug Substance during the period of performance and the cost of this supplemental insurance shall be at the CLIENT’S expense. In no event will ALTHEA’S liability for the replacement costs of Bulk Drug Substance exceed $[******].
