Nonconforming Work 5.6.1 Rejection, Removal and Replacement of Nonconforming Work
Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.
Product Warranty Seller provides general warranties of fitness and general warranties that the goods are free from defects, for 1 year from acceptance of the goods, except as may otherwise be set forth in the Description/Proposal, or other attached warranty.
Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, ▇▇▇▇▇ may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.
(b) To the extent a recall is required by applicable Law, or due to a potential safety hazard, non-compliance or Serial Defect, which is caused by Supplier, Supplier shall indemnify and hold Buyer harmless from all reasonable costs and expenses incurred in connection with any recall, repair, replacement or refund program, including all costs related to: (i) investigating and/or inspecting the affected goods; (ii) notifying Buyer’s customers; (iii) repairing, or where repair of the goods is impracticable or impossible, repurchasing or replacing the recalled goods; (iv) packing and shipping the recalled goods; and (v) media notification. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall, potential safety hazard, non- compliance or Serial Defect, except where such consultation would prevent timely notification required by Law.
Non-Conforming Product (a) Within [*****] of Chiesi’s receipt of an order for the Product, Chiesi may reject any such order or portion thereof that (i) does not conform to the warranty under Section 8.1 above, including to the Specifications, or (ii) is based on any claimed shortage in quantity, provided that such non-conformity in (i) above is not due to any failure by Chiesi, its Affiliates, agents or representatives to ship, handle, maintain, or store the Product as required under the Specifications. Kamada shall reasonably assist Chiesi in performing any such testing by providing to Chiesi any necessary technical information to accomplish such testing by Chiesi. Chiesi shall notify Kamada in writing within such [*****] period of its rejection of any order or portion thereof of the Product delivered by Kamada, which notice of rejection must contain the reason for such rejection; provided, however, that this limitation shall not apply to hidden defects in the Product. In the case of hidden defects, Chiesi shall have [*****] days from the date it becomes aware or reasonably should have become aware of any hidden defect to reject any order of the Product in accordance with applicable terms and conditions hereof. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.
(b) In the event of the rejection of the Product under this Section 8.2, or any other nonconformity or defect which the Parties mutually agree is a proper basis for rejection, and if such rejection is appropriately made by Chiesi, Kamada shall use its Best Reasonable Efforts to replace the rejected Product or make up the shortage at its expense within [*****] of the notice of such rejection or shortage, and in any case as soon as reasonably possible after receiving such notice, at no additional cost to Chiesi (including shipping and transportation costs), and Kamada shall make arrangements with Chiesi for the return or disposal of any rejected Product, such return shipping or disposal charges to be paid by Kamada.
(c) In the event of a conflict regarding whether or not the Product conforms to the warranty under Section 8.1 above, including to the Specifications at the time of delivery, and Chiesi and Kamada are unable to resolve such conflict after a good faith attempt by both Parties to resolve such matter in a period of [*****] days after the conflict arises, a sample of the Product shall be submitted by Chiesi to an independent laboratory reasonably acceptable to both Parties for testing against the Specifications or other defect and the test results obtained by such laboratory shall be final and controlling for purposes of this Agreement. If the Parties are unable to agree upon such independent laboratory in a period of [*****] days after the conflict arises, such independent laboratory shall be selected by the President of the ICC. The fees and expenses of such laboratory testing shall be borne entirely by the Party against whom such laboratory’s findings are made. In the event the independent laboratory test results indicate that the Product in question did not meet the Specifications or is otherwise defective, Kamada shall use its Best Reasonable Efforts to replace the rejected Product at no additional cost to Chiesi within [*****] days after receipt of such results if replacement Product stock is available, and in any case as soon as reasonably possible after receipt of such independent laboratory test. In the event the independent laboratory test results indicate that the rejected Product in question meets the Specifications, then Chiesi shall pay all additional shipping and transportation costs, incurred by Kamada as a result of the conflict as well as the cost of the Products to the extent that such Products have not been previously paid for by Chiesi, and shall accept and pay for the previously rejected Product in accordance with all applicable provisions hereunder.
(d) Without derogating from Section 4.2(e) and from any obligations that Kamada may have under this Agreement with respect to Third Party Claims, the foregoing shall be Chiesi’s sole and exclusive remedy with respect to non-conforming Products or shortages, and all other remedies at law or in equity shall not be available to Chiesi. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.