Exclusive Remedies for Non Conforming Product. In the event Xxxxxx agrees, or the independent laboratory determines, that the Batch of Rejected Product is non-conforming as a result of the negligence of Xxxxxx, then Xxxxxx, at Client’s option, shall either (a) at Althea’s expense, and subject to Client, at Client’s expense supplying the replacement Bulk Compound and any other Client-Supplied Components (subject to section 5.3), replace such non-conforming Client Product within [***] from receipt of replacement Bulk Compound from Client, or (b) (i) cancel the invoice and refund or credit any prepayment amounts for Rejected Product or (ii) for Limited Latent Defects, refund or credit (at Client’s option) all amounts paid by Client with respect to such non-conforming Client Product and comply with Section 5.3 below and (c) for Rejected Product count the non-conforming Batches towards Client’s obligations under the applicable Firm Commitment. In such event Xxxxxx shall also reimburse Client for any independent laboratory fees paid by Client under section 5.1(c). In the event such Client Product is determined by the independent laboratory to be conforming, or to be non-conforming other than due to the negligence of or breach of this Agreement by Xxxxxx, then Client shall reimburse Xxxxxx for Althea’s portion of such laboratory’s fees. For clarity and by way of example, if Client Product is non-conforming due to non-conforming Bulk Compound or other Client-Supplied Components or other matters within the responsibilities of Client, then Client will not be entitled to the foregoing remedies to the extent attributable thereto. In the case of replacement Client Product, the due date for the final invoice issued at completion of Production of said non-conforming Batch of Client Product will be extended until the date at which replacement Client Product is released and determined to be conforming by Xxxxxx and Client and all such replacement Client Product shall be subject to all rights and remedies of Client hereunder the same as of such Client Product was being submitted to Client for the first time.
Appears in 3 contracts
Samples: Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc)
Exclusive Remedies for Non Conforming Product. In the event Xxxxxx agrees, or the independent laboratory third party referenced in Section 5.1(c) determines, that the Batch of Rejected Client Product is non-conforming as Conforming and the non-Conformity was caused by Althea’s negligence or more culpable act or omission or Althea’s breach of this Agreement, the Quality Agreement or the related PWA, and Client rejects the Batch, (or, in the event of a result [***], Client revokes acceptance of the negligence of XxxxxxBatch in accordance with Section 5.1(a)), then Xxxxxx, at Client’s option, shall either either:
(ai) at Althea’s expense, and subject to Client, at Client’s expense supplying supply of the replacement Bulk Compound and any other Client-Client Supplied Components (subject to section 5.3[***]), and [***], replace such non-Conforming Bulk Drug, Drug Product or Finished Product, as the case may be, with conforming Client Bulk Drug, Drug Product or Finished Product, as applicable, within the following timeframes: (a) for Production of replacement Bulk Drug, within [***] from receipt of replacement Bulk Compound Client Supplied Components from Client, or and (b) for Production of replacement Drug Product or Finished Product where Xxxxxx Produced the Bulk Drug or Drug Product for the non-Conforming Batch, within [***] from Client’s election of remedies under this Section 5.2, or
(ii) upon demand, refund the Purchase Price of the non-Conforming Client Product [***]. In addition, in either (i) cancel the invoice and refund or credit any prepayment amounts for Rejected Product or (ii) for Limited Latent Defects), refund or credit (Xxxxxx shall, if applicable, reimburse Client upon demand at Client’s option) all amounts cost for the value of the related resins or other Components which were supplied or paid for by Client with respect Client, to the extent the life span of such non-conforming Client Product and comply with Section 5.3 below and resins or other Components has been shortened or such resins or other Components have been rendered unusable (c) for Rejected Product count the non-conforming Batches towards Client’s obligations under the applicable Firm Commitment. In such event Xxxxxx shall also reimburse Client for any independent laboratory fees paid by Client under section 5.1(ccontamination, etc.). In If the event such Client Product is determined by the independent laboratory to be conforming, or to be non-conforming other than due to the negligence of or breach of this Agreement by Xxxxxx, then Client shall reimburse Xxxxxx for Althea’s portion of such laboratory’s fees. For clarity and by way of example, if parties agree [***] that Client Product is non-conforming Conforming due in whole or in part to (a) non-conforming Bulk Compound or other Client-Client Supplied Components or for which Client has testing and release responsibilities, (b) other matters within which are the responsibilities responsibility of Client, or (c) non-conforming Client Supplied Components for which Xxxxxx has testing and release responsibilities, where the non-conformity was a latent defect that was not discoverable, at time of delivery, by reasonable testing of the Components and review of related documentation, then: (1) if the non-Conformity is due in whole to such matters, then Client will not be entitled to the foregoing remedies remedies, and (2) if the non-Conformity is due in part to such matters, then Althea’s financial responsibility under this Section 5.2 will be proportionately reduced based on the extent to which such matters contributed to the extent attributable theretonon-Conformity. In addition, if Client elects the case of replacement Client Productremedy under Section 5.2(i) above, the due date for the final invoice to be issued at completion of Production of said non-conforming Conforming Batch of Client Product will not be extended issued and the amounts due thereunder will not be payable until the date at which replacement Client Product is released and determined to be conforming Conforming by Xxxxxx and Client and all such replacement Client Product shall be subject to all rights and remedies of Client hereunder the same as of such Client Product was being submitted to Client for the first timeClient. XXXXXX & XXXXX CONFIDENTIAL 13 [***] = 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.
Appears in 2 contracts
Samples: Master Product Development and Clinical Supply Agreement, Master Product Development and Clinical Supply Agreement (Alder Biopharmaceuticals Inc)
Exclusive Remedies for Non Conforming Product. In the event Xxxxxx agrees, or the independent laboratory determines[***], that the Batch of Rejected Client Product is non-conforming as Conforming and the non-Conformity was caused by Althea’s negligence or more culpable act or omission or Althea’s breach of this Agreement, the Quality Agreement or the related PWA, and Client rejects the Batch, (or, in the event of a result [***], Client revokes acceptance of the negligence of XxxxxxBatch in accordance with Section 5.1(a)), then Xxxxxx, at Client’s option, shall either either:
(ai) at Althea’s expense, and subject to Client, at Client’s expense supplying supply of the replacement Bulk Compound and any other Client-Client Supplied Components (subject to section 5.3[***]), and [***], replace such non-Conforming Bulk Drug, Drug Product or Finished Product, as the case may be, with conforming Client Bulk Drug, Drug Product or Finished Product, as applicable, within the following timeframes: (a) for Production of replacement Bulk Drug, within [***] from receipt of replacement Bulk Compound Client Supplied Components from Client, or and (b) for Production of replacement Drug Product or Finished Product where Xxxxxx Produced the Bulk Drug or Drug Product for the non-Conforming Batch, within [***] from Client’s election of remedies under this Section 5.2, or
(ii) upon demand, refund the Purchase Price of the non-Conforming Client Product [***]. In addition, in either (i) cancel the invoice and refund or credit any prepayment amounts for Rejected Product or (ii) for Limited Latent Defects), refund or credit (Xxxxxx shall, if applicable, reimburse Client upon demand at Client’s option) all amounts cost for the value of the related resins or other Components which were supplied or paid for by Client with respect Client, to the extent the life span of such non-conforming Client Product and comply with Section 5.3 below and resins or other Components has been shortened or such resins or other Components have been rendered unusable (c) for Rejected Product count the non-conforming Batches towards Client’s obligations under the applicable Firm Commitment. In such event Xxxxxx shall also reimburse Client for any independent laboratory fees paid by Client under section 5.1(ccontamination, etc.). In If the event such Client Product is determined by the independent laboratory to be conforming, or to be non-conforming other than due to the negligence of or breach of this Agreement by Xxxxxx, then Client shall reimburse Xxxxxx for Althea’s portion of such laboratory’s fees. For clarity and by way of example, if parties agree [***] that Client Product is non-conforming Conforming due in whole or in part to (a) non-conforming Bulk Compound or other Client-Client Supplied Components or for which Client has testing and release responsibilities, (b) other matters within which are the responsibilities responsibility of Client, or (c) non-conforming Client Supplied Components for which Xxxxxx has testing and release responsibilities, where the non-conformity was a latent defect that was not discoverable, at time of delivery, by reasonable testing of the Components and review of related documentation, then: (1) if the non-Conformity is due in whole to such matters, then Client will not be entitled to the foregoing remedies remedies, and (2) if the non-Conformity is due in part to such matters, then Althea’s financial responsibility under this Section 5.2 will be proportionately reduced based on the extent to which such matters contributed to the extent attributable theretonon-Conformity. In addition, if Client elects the case of replacement Client Productremedy under Section 5.2(i) above, the due date for the final invoice to be issued at completion of Production of said non-conforming Conforming Batch of Client Product will not be extended issued and the amounts due thereunder will not be payable until the date at which replacement Client Product is released and determined to be conforming Conforming by Xxxxxx and Client and all such replacement Client Product shall be subject to all rights and remedies of Client hereunder the same as of such Client Product was being submitted to Client for the first timeClient. XXXXXX & XXXXX CONFIDENTIAL 12 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.
Appears in 1 contract
Samples: Master Product Development and Clinical Supply Agreement (Alder Biopharmaceuticals Inc)