Common use of Remedies for Non-Conforming Product Clause in Contracts

Remedies for Non-Conforming Product. 7.2.1 In the event ▇▇▇▇▇▇ agrees that a Batch is non-conforming or the laboratory determines that a Batch is non-conforming, ▇▇▇▇▇▇ shall provide replacement Product for such non-conforming Batch which shall be Released by ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ agrees, or the laboratory or consultant determines, that a Batch is non-conforming, solely as a result of the negligence or willful misconduct of ▇▇▇▇▇▇, AMYLIN shall not be required to pay for such Batch, ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇’▇ sole liability for replacement of conforming Product.

Remedies for Non-Conforming Product. 7.2.1 In the event ▇▇▇▇▇▇ agrees that a Batch is non-conforming or the laboratory determines that a Batch is non-conforming, ▇▇▇▇▇▇ BAXTER shall provide replacement Product for replace such non-conforming Batch which shall be Released by ▇▇▇▇▇▇ Product 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 ▇▇▇▇▇▇ BAXTER of such non-conformity. 7.2.2 AMYLIN shall pay for all Product, including replacement Product and the cost of Exenatide Drug Substance thereforeconformity assuming sufficient Active will be provided by PONIARD ***, except as specifically set forth below, in Section 7.2.3. 7.2.3 due time to carry out the manufacturing. The non-conforming Product shall be returned to BAXTER for disposal. In the event ▇▇▇▇▇▇ agrees, or of any destruction of the laboratory or consultant determines, that a Batch is non-conformingconforming Product, the party directing the destruction shall deliver to the other an appropriate certificate of destruction. If the non-conformity was due solely as a result of the negligence or willful misconduct of to ▇▇▇▇▇▇’▇ negligence or willful misconduct or solely to ▇▇▇▇▇▇’▇ breach of its representations or warranties under this Agreement, AMYLIN as may be agreed to by BAXTER or determined by the laboratory or consultant named in Section 7.1.3, BAXTER shall not be required to pay responsible for such Batchthe costs of disposal of the non-conforming Product, ▇▇▇▇▇▇’▇ shall provide replacement costs associated with Product as specified in Section 7.2.1.replacement, and BAXTER shall reimburse AMYLIN PONIARD for its actual cost of the Exenatide Drug Substance API for the non-conforming Batch, which cost API reimbursement shall not exceed [amount to *** (***] percent ([) Euros per ***]%) * of API but in no event shall such API reimbursement amount exceed the value of the Firm Purchase Price Order. 7.2.2 However, BAXTER is not responsible for Units comprising 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-conforming Batch 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, and shall bear which do not cause the costs of such laboratory or consultant and any storage fees incurred by AMYLIN for the Product to be non-conforming Batch. The foregoing compliant with cGMPs or registration requirements, shall not be AMYLIN’s sole and exclusive remedy and ▇▇▇▇▇▇’▇ sole liability for replacement of conforming Productdeemed to cause such Product to be non-conforming.

Remedies for Non-Conforming Product. 7.2.1 In the event ▇▇▇▇▇▇ agrees that a Batch is non-conforming or the laboratory determines that a Batch is non-conforming, ▇▇▇▇▇▇ shall provide replacement Product for such non-conforming Batch which shall be Released by ▇▇▇▇▇▇ within the latter of (a) [***] ([***]) calendar days from receipt of replacement Exenatide Pramlintide Drug Substance from AMYLIN or (b) [***] ([***]) calendar days from the date of determination by the third party of non-conformity or agreement by ▇▇▇▇▇▇ of such non-conformity. 7.2.2 AMYLIN shall pay for all Product, including replacement Product and the cost of Exenatide Pramlintide Drug Substance therefore, except as specifically set forth in Section 7.2.3. 7.2.3 In the event ▇▇▇▇▇▇ agrees, or the laboratory or consultant determines, that a Batch is non-conforming, solely as a result of the negligence or willful misconduct of ▇▇▇▇▇▇, AMYLIN shall not be required to pay for such Batch, ▇▇▇▇▇▇ shall provide replacement Product as specified in Section 7.2.1., shall reimburse AMYLIN for its actual cost of the Exenatide Pramlintide 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 ▇▇▇▇▇▇’▇ sole liability for replacement of conforming Product.

Remedies for Non-Conforming Product. 7.2.1 In If the event ▇▇▇▇▇▇ agrees that a Batch is non-conforming or the laboratory determines that a Batch is non-conforming, ▇▇▇▇▇▇ shall provide replacement Product for such non-conforming Batch which shall be Released by ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ agrees, or the laboratory or consultant determines, that a Batch is non-conforming, solely as a result quality of the negligence or willful misconduct Product Delivered by Seller to the Companies fails to conform to the Specifications as provided in Article IV (Quality), the Companies may, in their sole discretion, issue a Specification waiver if the Companies determine that their use of ▇▇▇▇▇▇, AMYLIN shall not be required to pay for such Batch, ▇▇▇▇▇▇ 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 BatchProduct will not adversely affect the Companies. If the Companies elect not to issue a Specification waiver, which cost Seller shall not exceed [***] percent ([***]%) of the Purchase Price for Units comprising correct the non-conforming Batch Product by Delivering to the Companies additional Product of Producta quality that, and shall bear the costs of such laboratory or consultant and any storage fees incurred by AMYLIN for when blended with the non-conforming BatchProduct, will result in conformance with the Specifications. The foregoing Seller shall be AMYLIN’s sole and exclusive remedy and ▇▇▇▇▇▇’▇ sole liability for replacement Deliver such additional Product to the Companies’ storage tank(s) at a Receiving Facility as directed by the Companies. If such efforts fail to resolve the failure of the Product to conform to the Specifications, the Companies may return the non-conforming Product to Seller, in which case Seller shall replace the non-conforming Product by Delivering an equal volume of conforming Product, quality verified by the Companies, to the Companies’ designated Receiving Facilities in a timely manner. Notwithstanding the preceding, the Companies shall always have the right to refuse Delivery of any Product if the Companies have a good faith basis to believe that the Product does not meet the Specifications. In such an event, either (i) Seller shall replace the non-conforming Product in the manner described above at Seller’s sole cost and expense; or (ii) the Companies may obtain the Product from another vendor if, in the Companies’ reasonable discretion, the Seller’s replacement of non-conforming Product may not be performed in time to prevent a possible interruption of the Companies’ operations. Any remedy of non-conforming Product accepted by the Companies under this Section 6.5(B)(4) (Remedies for Non-Conforming Product) shall not operate or be construed to remedy any similar non-conforming Product or to change the Specification of the Product acceptable to the Companies under the terms of this Agreement.