Common use of Non-Conforming Client Product Clause in Contracts

Non-Conforming Client Product. Within [***] from the date of completion of testing and Althea’s release of Batch of Client Product, Xxxxxx shall promptly forward to Client, or Client’s designee, copies of the Released Executed Batch Record and samples of such Batch. Within [***] after receipt by Client of such samples together with the documentation, Client shall perform any testing it deems appropriate and review the documentation in order to determine, subject to Client’s rights below, whether Client Product is Conforming. (a) If (i) such Batch of Client Product is Conforming, or (ii) Client does not notify Xxxxxx within the applicable [***] time period that such Batch of Client Product is non-Conforming, then Client shall be deemed to have accepted the Client Product and waived its right to revoke acceptance; provided however that Client shall have the right to revoke acceptance for any Batch which is non-Conforming under all of the following conditions: [***]. Alternatively, rather than initially issuing a notice of rejection, Client may given written notice to Xxxxxx within the time period specified in this Section 5.1(a) of a Client decision to investigate whether a potentially non-Conforming Batch should be rejected, which investigation shall, unless otherwise agreed by Client and Xxxxxx, be completed within the time period set forth in this Section 5.1(a). (b) If Client believes any Batch of Client Product is non-Conforming, it shall notify Xxxxxx [***], including a detailed explanation of the non-conformity, and shall [***]. Upon receipt of such notice, Xxxxxx will investigate such alleged non-conformity, and (i) if Xxxxxx agrees such Client Product is non-Conforming, deliver to Client a corrective action plan within [***] after receipt of Client’s [***] notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than Client or Xxxxxx, or (ii) if Xxxxxx disagrees with Client’s determination that the Batch of Client Product is non-Conforming, Xxxxxx shall so notify Client [***] within the [***] period [***]. (c) If the parties dispute whether Client Product is Conforming, samples of the Batch of Client Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of Conformity, and the cause thereof if non-Conforming, shall be binding upon the parties. The fees of the laboratory or consultant shall be paid by [***], with each party initially paying directly to the laboratory or consultant one-half of the fees[***]. XXXXXX & XXXXX CONFIDENTIAL 12 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (d) For clarity, the parties agree that deviations and investigations may or may not result in non-Conforming Client Product, and that the occurrence of a deviation or investigation does not, in and of itself, deem Client Product to be non-Conforming. The provisions set forth in the Quality Agreement shall control whether manufacturing deviations and investigations result in non-Conforming Client Product.

Non-Conforming Client Product. Within [***] from the date of completion of testing and Althea’s release of Batch of Client Product, Xxxxxx shall promptly forward to Client, or Client’s designee, copies of the Released Executed Batch Record and samples of such Batch. Within [***] after receipt by Client of such samples together with the documentation, Client shall perform any testing it deems appropriate and review the documentation in order to determine, subject to Client’s rights below, whether Client Product is Conforming. (a) If (i) such Batch of Client Product is Conforming, or (ii) Client does not notify Xxxxxx within the applicable [***] time period that such thirty (30) days of receipt of delivery of a Batch of Client Product is non-Conformingthat such Batch does not conform to the Specifications and cGMP, then Client shall be deemed to have accepted the Client Product Batch and waived its right to revoke acceptance; , provided however that Client shall have may revoke such acceptance in the right to revoke acceptance for any event that all release testing of such Batch which is was performed by Xxxxxx, or its designee as permitted under the Quality Agreement, and Client Product contains a defect or non-Conforming conformity that (i) existed at the time of shipment by Xxxxxx under all Section 2.7 (ii) was not discoverable by Client upon its review of the following conditions: [***]. AlternativelyBatch production records and release documentation, rather than initially issuing a (iii) was caused by Althea’s negligence or willful misconduct and (iv) Client gives notice of rejection, Client may given written notice to Xxxxxx within thirty (30) days of the time period specified in this Section 5.1(a) identification of a Client decision to investigate whether a potentially such non-Conforming conformity or defect, and prior to expiration date of such Batch, but in no event later than eighteen (18) months from the date of shipment by Xxxxxx (a “Limited Latent Defect”). Notwithstanding the above, a defect or non-conformity which could not have been discovered by Xxxxxx in connection with Althea’s release testing of such Batch should be rejectedin accordance with the testing Specifications, which investigation shallSpecifications shall be determined by the Client, unless otherwise agreed by Client and Xxxxxx, shall not be completed within the time period set forth in this Section 5.1(a)deemed a Limited Latent Defect. (b) If Client believes any such Batch of Client Product is non-Conformingdoes not conform to the Specifications and cGMP, it shall notify Xxxxxx [***], including by telephone and provide a detailed explanation of the non-conformity, and shall [***]confirm such notice in writing via overnight delivery to Xxxxxx. Upon receipt of such notice, Xxxxxx will investigate such alleged non-conformity, and (i) if Xxxxxx agrees such Client Product Batch is non-Conformingconforming, shall deliver to Client a corrective action plan within [***] thirty (30) days after receipt of Client’s [***] written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than Client or Xxxxxx, or . (iic) if If Xxxxxx disagrees with Client’s determination that the such Batch of Client Product is non-Conformingconforming, Xxxxxx shall so notify Client [***] by telephone within the [***] thirty (30) day period [***]. (c) If the parties dispute whether Client Product is Conformingand confirm such notice in writing by overnight delivery. In connection with such a disagreement, samples of the such Batch of Client Product will be submitted to a mutually acceptable laboratory or independent consultant for resolution, whose determination of Conformityconformity or non-conformity, and the cause thereof if non-Conformingconforming, shall be binding upon the partiesParties. The fees of the laboratory or consultant All expenses related to such third party investigation shall be paid shared equally by [***]the Parties, with each party initially paying directly unless and until the non-conformity shall have been found to have been caused by the laboratory or consultant one-half negligence of the fees[***]. XXXXXX & XXXXX CONFIDENTIAL 12 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTXxxxxx, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDEDin which case Xxxxxx shall reimburse Client for its portion of such expenses previously paid. (d) For clarity, the parties agree that Manufacturing deviations and investigations may or may not result in non-Conforming Client Product, and that the occurrence which occur during Production of a deviation or investigation does not, in Batch and of itself, deem Client Product which do not cause the Production to be non-Conforming. The provisions set forth in compliant with cGMP, shall not be deemed to cause the Quality Agreement shall control whether manufacturing deviations and investigations result in Batch to be non-Conforming Client Productconforming.

Non-Conforming Client Product. Within [***] from the date of completion of testing and Althea’s release of Batch of Client Product, Xxxxxx shall promptly forward to Client, or Client’s designee, copies of the Released Executed Batch Record and samples of such Batch. Within [***] after receipt by Client of such samples together with the documentation, Client shall perform any testing it deems appropriate and review the documentation in order to determine, subject to Client’s rights below, whether Client Product is Conforming. (a) If (i) such Batch of Client Product is Conforming, or (ii) Client does not notify Xxxxxx within the applicable [***] time period that such Batch of Client Product is non-Conforming, then Client shall be deemed to have accepted the Client Product and waived its right to revoke acceptance; provided however that Client shall have the right to revoke acceptance for any Batch which is non-Conforming under all of the following conditions: [***]. Alternatively, rather than initially issuing a notice of rejection, Client may given written notice to Xxxxxx within the time period specified in this Section 5.1(a) of a Client decision to investigate whether a potentially non-Conforming Batch should be rejected, which investigation shall, unless otherwise agreed by Client and Xxxxxx, be completed within the time period set forth in this Section 5.1(a). (b) If Client believes any Batch of Client Product is non-Conforming, it shall notify Xxxxxx [***], including a detailed explanation of the non-conformity, and shall [***]. Upon receipt of such notice, Xxxxxx will investigate such alleged non-conformity, and (i) if Xxxxxx agrees such Client Product is non-Conforming, deliver to Client a corrective action plan within [***] after receipt of Client’s [***] notice of non-conformity, or such additional time as is reasonably required if such investigation or XXXXXX & ALDER CONFIDENTIAL 11 FINAL [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. plan requires data from sources other than Client or Xxxxxx, or (ii) if Xxxxxx disagrees with Client’s determination that the Batch of Client Product is non-Conforming, Xxxxxx shall so notify Client [***] within the [***] period [***]. (c) If the parties dispute whether Client Product is Conforming, samples of the Batch of Client Product will be submitted to a mutually acceptable laboratory or consultant [***] for resolution, whose determination of Conformity, and the cause thereof if non-Conforming, shall be binding upon the parties[***]. The fees of the laboratory or consultant shall be paid by [***], with each party initially paying directly to the laboratory or consultant one-half of the fees[***]. XXXXXX & XXXXX CONFIDENTIAL 12 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (d) For clarity, the parties agree that deviations and investigations may or may not result in non-Conforming Client Product, and that the occurrence of a deviation or investigation does not, in and of itself, deem Client Product to be non-Conforming. The provisions set forth in the Quality Agreement shall control whether manufacturing deviations and investigations result in non-Conforming Client Product.