Consequences of Defective Product. Where the Defect is, as between NOVASEP and CUSTOMER, substantially due to NOVASEP (or its Affiliates’ or contractors’) acts, omissions or breach of its obligations under this Agreement, (including where such acts and omissions or breaches could be, but are not limited, to operator mistakes equipment failure, power shortages and building environmental control failures) or where the Specification of a Batch is not met when the Parties have agreed that such Specification should be bidding with regards to a particular Batch, NOVASEP shall (i) use all Reasonable Endeavours to replace at its own cost and as soon as reasonably practicable (and in any event within one hundred and ninety (190) business days of the Defect notice) an equal quantity of Product free of defects as that which was Defective; and (ii) pay all expenses, fees and charges associated with the manufacture and return of the defective Product, and (iii) reimburse CUSTOMER (subject to Sections 12.3 and 12.4 of this Agreement) for any reasonably Incurred or foreseeable costs incurred by CUSTOMER (and which could not be refunded to CUSTOMER), as a result of the Products being defective. The Parties agree and acknowledge that any samples held by NOVASEP from the manufacturing run pursuant to the terms of this Agreement including the Product that is Defective shall be made available for testing purposes in the event any Product is Defective. Any disputes regarding a Defect or calculating the appropriate refund of monies shall be referred to an Independent expert, reasonably acceptable to and appointed by both Parties and subject to confidentiality provisions comparable to those set out in this Agreement, The independent expert shall undertake the relevant analysts to assess whether the Product was defective and whether NOVASEP was responsible in any way. Both Parties agree to cooperate with the independent expert’s reasonable requests for assistance in connection with its analysis hereunder. The independent expert shall act as an expert and not arbitrator. The decision of the independent expert shall be written and given in English and be considered final and binding on the Parties unless there has been a manifest error on the face or the decision whereupon the Parties shall revert to the dispute resolution procedure in this Agreement. The fees and expenses of such expert shall be borne in full by the Party against whom the Indendent expert decides.
Consequences of Defective Product. 6.10.1 If Customer demonstrates that the Defect is due to CMC’s fault and not as a result of any third party or Customer action or inaction and CMC accepts that finding, then CMC will use Commercially Reasonable Efforts to either replace or rework the Defective Product at CMC’s election and at no additional cost to Customer. CMC will undertake those efforts as soon as reasonably practicable taking into account CMC’s other obligations and commercial commitments to third parties.
6.10.2 If there is a dispute regarding a Defect (“Disputed Product”), then (a) analysts from both parties must directly communicate to determine that the parties’ respective methods of analysis are the same and are being executed in the same manner and to attempt to determine whether any non-compliance may have been caused during the shipment of the sample from CMC’s Facility, and (b) carefully controlled and split samples as agreed must be sent from one site to the other for testing. This process may involve Customer sending a representative and a sample of the Disputed Product to CMC, and the parties conducting jointly agreed on tests on the samples. The parties must use good faith efforts for a period of 30 days after completing those tests to resolve whether the Disputed Product is Defective due to CMC’s failure to manufacture in accordance with this agreement.
6.10.3 If the parties cannot resolve their dispute in the manner described above as to whether a Disputed Product meets the Specification, the parties must require an independent agreed-on laboratory to test the Disputed Product. The costs of the independent laboratory will be shared by the parties equally; provided, however, that the party that is determined to be incorrect as to whether the Disputed Product meets the Specification will be responsible for those reasonable costs and must reimburse the correct party for its share of the reasonable costs incurred. The decision of the independent laboratory must be in writing. The decision will be binding on the parties as to whether the Disputed Product meets the Specification unless there has been a manifest error, in which case, the parties will revert to the dispute resolution procedure in Section 15.
Consequences of Defective Product. Upon receipt of the Defect Notice CMC shall promptly investigate whether or not the Defect is due to CMC’s negligence or failure to comply with its obligations hereunder and shall report to Customer within fifteen (15) Business Days of receipt of the Defect Notice whether it accepts responsibility for the Defect in full, in part or not.
Consequences of Defective Product. 6.10.1 If Customer reasonably demonstrates that the Defect is due to CMC’s Fault (including, for clarity, that the Product did not meet Specifications when delivered by CMC with a Certificate of Analysis) and not as a result of any third party or Customer action or inaction, [* * *]. CMC will undertake those efforts [* * *].
6.10.2 If there is a dispute regarding the existence or cause of a Defect (“Disputed Product”), [* * *]. This process may involve Customer sending a representative and a sample of the Disputed Product to CMC, and the parties conducting[* * *]. The parties must [* * *] after completing those tests to resolve whether the Disputed Product is Defective due to CMC’s Fault.
6.10.3 If the parties cannot resolve their dispute in the manner described above as to whether a Disputed Product meets the Specification or as to the cause of a Defective Product, [* * *]
Consequences of Defective Product. 6.10.1 If Customer demonstrates that the Defect is due to CMC’s fault and not as a result of [***], then CMC will [***]. CMC will undertake those efforts [***].
6.10.2 If there is a dispute regarding a Defect (“Disputed Product”), then [***]. This process may involve Customer sending a representative and a sample of the Disputed Product to CMC, and the parties conducting [***] on the samples. The parties must use [***] after [***] to resolve whether the Disputed Product is Defective [***].
6.10.3 If the parties cannot resolve their dispute in the manner described above as to whether a Disputed Product meets the Specification, the parties must require an independent agreed-on laboratory to test the Disputed Product. The [***]; provided, however, that [***]. The decision of the independent laboratory must be in writing. The decision will be binding on the parties as to whether the Disputed Product meets the Specification unless there has been a manifest error, in which case, the parties will revert to the dispute resolution procedure in Section 15.
Consequences of Defective Product. 6.8.1 If Customer and CMC agree that the Product is Defective Product, then CMC will either replace or rework the Defective Product at Customer’s election and at no additional charge to Customer. CMC will undertake those efforts as soon as reasonably practicable and shall not delay such efforts on account of CMC’s other obligations and commercial commitments to third parties.
6.8.2 If there is a dispute regarding whether a Product is a Defective Product (“Disputed Product”), then analysts from both parties must directly communicate to determine that the parties’ respective methods of analysis are the same and are being executed in the same manner. The parties must use good faith efforts for a period of [***] days to resolve whether the Disputed Product is Defective Product.
6.8.3 If the parties cannot resolve their dispute in the manner described above as to whether a Disputed Product is a Defective Product, the parties must require an independent agreed-on laboratory to test the Disputed Product. The costs of the independent laboratory will be [***]. The decision of the independent laboratory must be in writing. The decision will be binding on the parties as to whether the Disputed Product is a Defective Product unless there has been a manifest error, in which case, the parties will revert to the dispute resolution procedure in Section 15.
Consequences of Defective Product. Upon receipt of the Defect Notice CMC shall promptly investigate whether or not the Defect is due to CMC’s negligence or failure to comply with its obligations hereunder and shall report to Customer [***]. Commercial Supply Agreement 244238347 v3
Consequences of Defective Product. If Customer can demonstrate or if the independent laboratory pursuant to Clause 6.15 determines that the Defect is not the result of any wrongful action or inaction by Customer or a Customer-Provided Materials (or, if attributable to the Customer-Provided Materials, is the result of any failure to comply with cGMP by AGC) or any Third Party (other than a contractor or agent of AGC performing Services), then AGC shall replace the Defective Deliverables. AGC shall use its [***] to commence the manufacture of such Defective Deliverables within [***] days after AGC accepts fault or is determined to be at fault pursuant to Clause 6.15, [***]. In the event AGC cannot commence the manufacture of a replacement single Batch within such [***] days period or within [***] days after the end of a campaign if the Defective Batch was part of a campaign, [***]. Any amounts paid by Customer hereunder for such Defective Deliverables shall be credited to future amounts due to AGC hereunder, and any residual amounts existing at the time of termination of this Agreement shall be subject to Clause 14.4.
Consequences of Defective Product. If CMC accepts or, subject to Clause 6.17, it is reasonably proven that the Defect was caused by CMC’s breach of its obligations hereunder and not as a consequence of third party or Customer action or inaction and Customer has notified the Defect to CMC in accordance with Clause 6 then (i) Customer shall, at CMC’s election, either return such Product to CMC or destroy or dispose of such Product in the least expensive and most environmentally sound manner; and (ii) at Customer’s option, (a) CMC shall be relieved of any obligation to deliver any replacement Batch with respect to the Defective Product and will refund Customer the full Price of those Batch(es) that were the subject of the Defect Notice, or (b) CMC shall, at no additional cost to Customer beyond the Price for the Defective Product, use its Standard to promptly replace the Defective Product with non-Defective Product or, to the extent permitted under Regulatory Obligations, rework the affected Deliverables to overcome the Defect. If Customer elects to receive a refund in accordance with subsection (a) above, the Defective Batches at issue shall not be considered for purposes of determining whether a Supply Failure has occurred. In the situation described in subsection (ii)(b) of this Clause 6.16, CMC shall be responsible for Commercial Supply Agreement – JUNE 2011 31 the costs of Raw Materials that may be incurred by it in replacing the Defective Product with non-Defective Product or reworking the affected Deliverables to overcome the Defect, as applicable.
