Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon, if Patheon manufactures Product in accordance with the agreed upon process specifications, the batch production record, and Patheon’s standard operating procedures for manufacturing, and a batch or portion of batch of Product does not meet a finished Product specification, Client will pay Patheon the applicable fee per unit for the non-conforming Product. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a).
Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and mutually agreed upon, to the extent the same differ from the Specifications. If Patheon manufactures Product in accordance with the agreed upon process specifications, the Specifications, cGMPs, Applicable Laws and the terms and conditions of this Agreement, and a batch or portion of batch of Product does not meet the Finished Product Specifications, Client will not reject the non-conforming Product solely on account of such failure to meet the Finished Product Specifications.
Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and mutually agreed upon. If Patheon manufactures Product in accordance with the agreed upon process specifications and a batch or portion of batch of Product does not meet a Finished Product Specification, […***…]. If Client previously paid for the non-conforming Product, Patheon will promptly, at Clients election, either: (i) refund the labor and overhead costs associated with such non-conforming Product; or (ii) offset such costs against other amounts due to Patheon hereunder.
Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon. If a Batch or portion of a Batch of Product does not meet a finished Product Specification despite Patheon’s assertion that it manufactured the Product in accordance with the agreed upon process specifications, the Batch production record, and Patheon’s standard operating procedures for manufacturing, the Parties agree that they will mutually select an independent laboratory or expert to evaluate if such laboratory or expert can determine why the Products do not meet a finished Product Specification. The evaluation will be binding on the Parties. If the independent laboratory or expert determines that the Product is Non-Conforming due to an act or omission by Patheon or does not otherwise comply with the Terms of the Agreement, Client may reject those Products in the manner contemplated by Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the independent laboratory determines that the Patheon complied with the agreed upon process specifications, the Batch production record, and Patheon’s standard operating procedures and that the Product does not meet a finished Product specification, Client will be responsible for the cost of the evaluation and will pay Patheon the applicable fee per unit for the Non-Conforming Product. In which case, the API in the Non-Conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a).
Product Rejection for Finished Product Specification Failure. If a batch or a portion of a batch is rejected (outside of typical batch yield variations) and the deviation does not determine that Patheon has failed to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws (“Rejected Properly Manufactured Product”), Client will pay Patheon the applicable fee per unit for the Rejected Properly Manufactured Product. For greater certainty, Client will pay Patheon the applicable fee per unit for the Rejected Properly Manufactured Product under the circumstances described in Section 6.3(c). The API in the Rejected Properly Manufactured Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a).
Product Rejection for Finished Product Specification Failure. If the parties agree, after a full quality investigation by the parties in accordance with cGMP requirements, Applicable Laws, and the applicable Quality Agreement, that Patheon manufactured Product in accordance with the Specifications, the batch production record, Patheon’s standard operating procedures for manufacturing, cGMPs, Applicable Laws, and the other terms and conditions of this Agreement, and the batch or partial batch of Product does not meet a Specification, Client will pay Patheon [***]% of the Component cost and [***]% of the manufacturing labor cost directly incurred from manufacturing the non-conforming Product. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a).
Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon. If after a full investigation as set forth in Section 6.1(b), it is determined that Patheon manufactured Product in accordance with the agreed upon in-process specifications, cGMP, the batch production record, Patheon’s standard operating procedures for manufacturing and the other requirements of the Agreement and the applicable Product Agreement, and a batch or portion of batch of Product does not meet a finished Product Specification, Client will pay Patheon [***] for the non-conforming Product. Patheon will be responsible for the materials and Client will be responsible for the API. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a). If it is determined that the Product failure is due to error on Patheon’s part, Patheon will pay for product disposal, provide a certificate of destruction to the Client, and the API in the non-conforming Product will be excluded from the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a).
Product Rejection for Finished Product Specification Failure. If Patheon manufactures Product in accordance with the agreed upon Specifications and the Manufacturing Requirements and a batch or portion of a batch of Product does not meet the Specifications for Bulk Tablet Packaging, Client will pay Patheon the applicable Price per unit for the non-conforming Product. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a).
Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon and set out in Schedule A of a Product Agreement. If after a full investigation as set forth in Section 6.1(b), it is determined that Patheon manufactured Product in accordance with (i) the agreed upon process specifications, (ii) the batch production record, (iii) Patheon’s standard operating procedures for manufacturing (including requirements relating to maintenance and operation of equipment), (iv) cGMPs and (v) Applicable Laws, and, despite the manufacturing being *** Confidential Treatment Requested performed by Patheon in accordance with all of the foregoing, a batch or portion of batch of Product does not meet a finished Product specification, and no root cause is determined for the out of specification result following the full investigation a set forth in Section 6.1(b), Client will pay Patheon the applicable fee per unit for the non-conforming Product if it has not been released for shipment by Patheon. Patheon shall not release for shipment any Product that does not meet a finished Product specification and Client shall not be obliged to pay for any such released Product. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.3(a).
Product Rejection for Finished Product Specification Failure. If Patheon manufactures Product in accordance with the Specifications, except that a batch or portion of batch of Product does not meet a finished Product specification (as provided in (e) of the definition of “Specifications” above), Client will [*].
