Common use of Product and Process Failure Clause in Contracts

Product and Process Failure. 3.9.1. Product shall be Manufactured in accordance with cGMP and the Manufacturing Process approved mutually by Customer and BVL in accordance with this Agreement. Each Batch of Product will be sampled and tested by BVL against the Specification in accordance with the Master Production Record. BVL will provide to Customer a Certificate of Analysis showing the results of the testing performed under the preceding sentence. The quality assurance department of BVL will review the Certificate of Analysis and the other Records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP and other Applicable Law and the Manufacturing Process. 3.9.2. If, based upon such tests, a Batch of Product conforms to the Specification and was Manufactured according to cGMP and the Manufacturing Process, then a Certificate of Compliance will be generated and approved by the quality assurance department of BVL and delivered to Customer. This Certificate of Compliance, a Certificate of Analysis, and a complete and accurate copy of the executed Batch records (collectively, the “Batch Records”) for each Batch of Product (including, but not limited to, all the Batch documentation described in Attachment “D” to this Agreement) will be delivered to Customer by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt requested to verify delivery date. Unless the Batch is shipped under Quarantine (as defined in Section 6.3 below), in the event that Customer has not received all such Batch Records at the time of receipt of BVL’s invoice for such Batch, Customer will notify BVL in writing. In the event that Customer requires additional copies of the Batch Records, these will be provided by BVL to Customer at mutually agreed upon fees. 3.9.3. Customer will review the Batch Records for each Batch of Product and may test samples of the Batch of Product against the Specification. Customer will notify BVL in writing of its acceptance or rejection of such Batch within 30 calendar days of receipt of the complete Batch Records and test samples relating to such Batch. If no acceptance or rejection in writing is received by BVL within such 30 days, the Batch will be deemed accepted for purposes of Section 6.3. 1. During this review period, the Parties agree to respond punctually, but in any event within ten (10) calendar days, to any reasonable inquiry by the other Party with respect to the Batch Records. Customer has no obligation to accept a Batch if such Batch (i) does not comply with the Specification, (ii) was not Manufactured in compliance with cGMP and/or the Manufacturing Process or (iii) is otherwise contaminated, adulterated or misbranded other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer or its agents. 3.9.4. In case of any disagreement between the Parties as to whether Product conforms to the applicable Specification, a representative sample of such Product shall be submitted to an independent testing laboratory mutually agreed upon by the Parties for tests and final determination of whether such Product conforms to such Specification. The laboratory must meet cGMP requirements and be of recognized standing in the industry. Consent to the appointment of such laboratory shall not be unreasonably withheld or delayed by either Party. Such laboratory shall use the validated test methods contained in the applicable Specification. The determination of conformance by such laboratory with respect to all or part of such Product shall be final and binding on the Parties with respect to the determination as to whether the Specifications were met. The fees and expenses of the laboratory incurred in making such determination shall be paid by the Party against whom the determination is made. 3.9.5. Subject to Section 6.4 and 8.5, if a Batch of Product (i) does not conform to the Specification, (ii) was not Manufactured in compliance with cGMP , other Applicable Laws, the Manufacturing Process or the requirements of this Agreement, or (iii) is otherwise contaminated, adulterated or misbranded, other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer’s agents, then BVL shall, after consultation with and written agreement from Customer: 3.9.5.1. refund [*] paid by Customer on a pro rata basis over the usable portion for such Batch; or 3.9.5.2. [*] produce a new Batch of Product as soon as reasonably possible. 3.9.6. BVL may postpone all scheduled Manufacture of the Product until such time as final disposition of a rejected Batch has been determined and complete investigations have been finalized with root cause analysis and corrective actions determined to prevent further Batch rejections which will be agreed to in writing by the Parties. BVL will perform such investigations, root cause analysis and corrective actions diligently and expeditiously. Under circumstances where BVL has postponed scheduled Manufacture of Product under the preceding sentence, Customer may request in writing that BVL resume Manufacture prior to completion of an investigation root cause analysis and corrective actions, and BVL will comply with such request, provided, Customer agrees to [*] during such period for reasons substantially similar to the issue that is the subject of the investigation. 3.9.7. The Parties shall meet to discuss, evaluate and analyze the reasons for and implications of any failure to meet the Specification or comply with the cGMP or other Applicable Law and/or the Manufacturing Process.

Product and Process Failure. 3.9.1. Product shall be Manufactured in accordance with cGMP and the Manufacturing Process approved mutually by Customer and BVL. Customer acknowledges that it is aware that in May 2011 and November 2011, BVL’s manufacturing facility was inspected by the United States Food and Drug Administration and by the European Medicines Agency in March 2011 and November 2011. Customer further acknowledges that each of these inspections resulted in observations from the regulatory authority citing deviations from current Good Manufacturing Practices. Customer acknowledges The European Medicines Agency and the Therapeutic Goods Administration have issued BVL short-dated, restricted GMP licenses. Customer further acknowledges that it is aware BVL voluntarily suspended manufacturing at its site as of November 2011. Customer has reviewed the records of inspection from the above mentioned regulatory authorities as well as BVL’s corrective action responses to the regulatory agencies and is satisfied that the corrective actions set forth in accordance with this AgreementBVL’s corrective action plan should rectify the cGMP issues at the manufacturing facility that directly or indirectly affect Customer’s Product. Each Batch of Product will be sampled and tested by BVL against the Specification in accordance with the Master Production Record. BVL will provide to Customer a Certificate of Analysis showing the results of the testing performed under the preceding sentenceSpecification. The quality assurance department Quality Assurance Department of BVL will review the Certificate of Analysis and the other Records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP and other Applicable Law and the Manufacturing Process. 3.9.2. If, based upon such teststests and/or review, a Batch of Product conforms to the Specification and was Manufactured according to cGMP and the Manufacturing Process, then a Certificate of Compliance will be generated and approved by the quality assurance department Quality Assurance Department of BVL and delivered to CustomerBVL. This Certificate of Compliance, a Certificate of Analysis, if required, and a complete and accurate copy of the executed Batch records (collectively, the “Batch Records”) for each Batch of Product (including, but not limited to, including all the Batch documentation described in Attachment “D” to this Agreement) will be delivered to Customer in advance of Product shipment by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt requested to verify delivery date. As Customer is aware, the European Medicines Agency and Therapeutic Goods Administration have issued BVL restricted, short-dated GMP licenses. In addition, BVL’s GMP license in Canada has been restricted to medically necessary products. Based on these restricted GMP licenses, BVL has modified its Certificate of Compliance, a copy of which is included in Attachment “H”). Unless the Batch is shipped under Quarantine (as defined in Section 6.3 below)quarantine, in the event that Customer has not received all such Batch Records at the time of receipt of BVL’s invoice for such Batch, Customer will notify BVL in writing, and unless the Batch (or a partial Batch) is shipped under quarantine, Customer shall be entitled to withhold payment until Customer receives the Batch Record. In the event that Customer requires additional copies of the Batch Records, these will be provided by BVL to Customer at mutually agreed upon fees. 3.9.3. Customer will review the Batch Records for each Batch of Product and may test samples of the Batch of Product against the Specification. Customer will notify BVL in writing of its acceptance or rejection lot disposition of such Batch within 30 **** (****) calendar days of receipt of the complete Batch Records and test samples relating to such Batch. If no acceptance or rejection in writing is received by BVL within such 30 **** (****) days, the Batch will be conclusively deemed accepted for purposes of Section 6.3. 1. During this review period, the Parties agree to respond punctually, but and shall endeavor in any event good faith to comply in the typical circumstance within ten five (105) calendar days, to any reasonable inquiry by the other Party with respect to the such Batch Records. Customer has no obligation to accept a Batch if to the extent such Batch (i) does not comply with the Specification, Applicable Law (ii) for purposes solely due to BVL or BVL’s Manufacturing or services hereunder), and/or was not Manufactured in compliance with cGMP and/or and the Manufacturing Process or (iii) is otherwise contaminated, adulterated or misbranded other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer or its agentsProcess. 3.9.4. In case of any disagreement between the Parties as to whether Product conforms to the applicable Specification, a representative sample of such Product shall be submitted to an independent testing laboratory mutually agreed upon by the Parties for tests and final determination of whether such Product conforms to such Specification. The laboratory must meet cGMP requirements and requirements, be of recognized standing in the pharmaceutical industry. Consent , and consent to the appointment of such laboratory shall not be unreasonably withheld or delayed by either Party. Such laboratory shall use the validated test methods contained in the applicable Specification. The determination of conformance or not by such laboratory with respect to all or part of such Product shall be final and binding on the Parties with respect to the determination as to whether the Specifications were metParties. The fees and expenses of the laboratory incurred in making such determination shall be paid by the Party against whom the determination is made. 3.9.5. Subject to Section 6.4 and 8.5Article 8, if a BVL does not manufacture any Batch of Product (i) does not conform Products according to the Specification, (ii) was not Manufactured in compliance with cGMP , other Applicable Laws, GMP or the Manufacturing Process or and the Product does not meet the requirements of this Agreement, or (iii) is otherwise contaminated, adulterated or misbranded, other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer’s agents, Agreement then BVL shall, after consultation with and written agreement from Customer: 3.9.5.1. refund [*] any Manufacturing fees and expenses paid by Customer to BVL on a pro rata basis over the usable portion for such Batch; or 3.9.5.2. [*] at BVL’s cost and expense produce a new Batch of Product as soon as reasonably possible. 3.9.6. BVL may postpone all scheduled Manufacture of the Product until such time as final disposition of a rejected Batch has been determined and complete investigations have been finalized with root cause analysis and corrective actions determined to prevent further Batch rejections which will be agreed to in writing by the Parties. BVL will perform such investigations, root cause analysis and corrective actions diligently and expeditiously. Under circumstances where BVL has postponed scheduled Manufacture of Product under the preceding sentence, Customer may request in writing that BVL resume Manufacture prior to completion of an investigation root cause analysis and corrective actions, and BVL will comply with such request, provided, Customer agrees to [*] during such period for reasons substantially similar to the issue that is the subject of the investigation. 3.9.7. The Parties shall meet to discuss, evaluate and analyze the reasons for and implications of any failure to meet the Specification or comply with the cGMP or other Applicable Law and/or the Manufacturing Process.; and

Product and Process Failure. 3.9.1. Product shall be Manufactured in accordance with cGMP and the Manufacturing Process approved mutually by Customer and BVL. Customer acknowledges that it is aware that in May 2011 and November 2011, BVL’s manufacturing facility was inspected by the United States Food and Drug Administration and by the European Medicines Agency in March 2011 and November 2011. Customer further acknowledges that each of these inspections resulted in observations from the regulatory authority citing deviations from current Good Manufacturing Practices. Customer acknowledges The European Medicines Agency and the Therapeutic Goods Administration have issued BVL short-dated, restricted GMP licenses. Customer further acknowledges that it is aware BVL voluntarily suspended manufacturing at its site as of November 2011. Customer has reviewed the records of inspection from the above mentioned regulatory authorities as well as BVL’s corrective action responses to the regulatory agencies and is satisfied that the corrective actions set forth in accordance with this AgreementBVL’s corrective action plan should rectify the cGMP issues at the manufacturing facility that directly or indirectly affect Customer’s Products. Each Batch of Product will be sampled and tested by BVL against the Specification in accordance with the Master Production Record. BVL will provide to Customer a Certificate of Analysis showing the results of the testing performed under the preceding sentenceSpecification. The quality assurance department Quality Assurance Department of BVL will review the Certificate of Analysis and the other Records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP and other Applicable Law and the Manufacturing Process. 3.9.2. If, based upon such teststests and/or review, a Batch of Product conforms to the Specification and was Manufactured according to cGMP and the Manufacturing Process, then a Certificate of Compliance will be generated and approved by the quality assurance department Quality Assurance Department of BVL and delivered to CustomerBVL. This Certificate of Compliance, a Certificate of Analysis, if required, and a complete and accurate copy of the executed Batch records (collectively, the “Batch Records”) for each Batch of Product (including, but not limited to, including all the Batch documentation described in Attachment “D” to this Agreement) will be delivered to Customer in advance of Product shipment by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt requested to verify delivery date. As Customer is aware, the European Medicines Agency and Therapeutic Goods Administration have issued BVL restricted, short-dated GMP licenses. In addition, BVL’s GMP license in Canada has been restricted to medically necessary products. Based on these restricted GMP licenses, BVL has modified its Certificate of Compliance, a copy of which is included in Attachment “H”. Unless the Batch is shipped under Quarantine (as defined in Section 6.3 below), in the event that Customer has not received all such Batch Records at the time of receipt of BVL’s invoice for such Batch, Customer will notify BVL in writing, and unless the Batch (or a partial Batch) is shipped under Quarantine, Customer shall be entitled to withhold payment until Customer receives the Batch Record. In the event that Customer requires additional copies of the Batch Records, these will be provided by BVL to Customer at mutually agreed upon fees. 3.9.3. Customer will review the Batch Records for each Batch of Product and may test samples of the Batch of Product against the Specification. Customer will notify BVL in writing of its acceptance or rejection lot disposition of such Batch within 30 **** (****) calendar days of receipt of the complete Batch Records and test samples relating to such Batch. If no acceptance or rejection in writing is received by BVL within such 30 **** (****) days, the Batch will be conclusively deemed accepted for purposes of Section 6.3. 1accepted. During this review period, the Parties agree to respond punctually, but and shall endeavor in any event good faith to comply in the typical circumstance within ten five (105) calendar days, to any reasonable inquiry by the other Party with respect to the such Batch Records. Customer has no obligation to accept a Batch if to the extent such Batch (i) does not comply with the Specification, Applicable Law (ii) for purposes solely due to BVL or BVL’s Manufacturing or services hereunder), and/or was not Manufactured in compliance with cGMP and/or and the Manufacturing Process or (iii) is otherwise contaminated, adulterated or misbranded other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer or its agentsProcess. 3.9.4. In case of any disagreement between the Parties as to whether Product conforms to the applicable Specification, a representative sample of such Product shall be submitted to an independent testing laboratory mutually agreed upon by the Parties for tests and final determination of whether such Product conforms to such Specification. The laboratory must meet cGMP requirements and requirements, be of recognized standing in the pharmaceutical industry. Consent , and consent to the appointment of such laboratory shall not be unreasonably withheld or delayed by either Party. Such laboratory shall use the validated test methods contained in the applicable Specification. The determination of conformance or not by such laboratory with respect to all or part of such Product shall be final and binding on the Parties with respect to the determination as to whether the Specifications were metParties. The fees and expenses of the laboratory incurred in making such determination shall be paid by the Party against whom the determination is made. 3.9.5. Subject to Section 6.4 and 8.5Article 8, if a BVL does not manufacture any Batch of Product (i) does not conform Products according to the Specification, (ii) was not Manufactured in compliance with cGMP , other Applicable Laws, or the Manufacturing Process or and the Product does not meet the requirements of this Agreement, or (iii) is otherwise contaminated, adulterated or misbranded, other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer’s agents, Agreement then BVL shall, after consultation with and written agreement from Customer: 3.9.5.1. refund [*] any Manufacturing fees and expenses paid by Customer to BVL on a pro rata basis over the usable portion for such Batch; or 3.9.5.2. [*] at BVL’s cost and expense produce a new Batch of Product as soon as reasonably possible. 3.9.6. BVL may postpone all scheduled Manufacture of the Product until such time as final disposition of a rejected Batch has been determined and complete investigations have been finalized with root cause analysis and corrective actions determined to prevent further Batch rejections which will be agreed to in writing by the Parties. BVL will perform such investigations, root cause analysis and corrective actions diligently and expeditiously. Under circumstances where BVL has postponed scheduled Manufacture of Product under the preceding sentence, Customer may request in writing that BVL resume Manufacture prior to completion of an investigation root cause analysis and corrective actions, and BVL will comply with such request, provided, Customer agrees to [*] during such period for reasons substantially similar to the issue that is the subject of the investigation. 3.9.7. The Parties shall meet to discuss, evaluate and analyze the reasons for and implications of any failure to meet the Specification or comply with the cGMP or other Applicable Law and/or the Manufacturing Process.; and

Product and Process Failure. 3.9.1. Product shall be Manufactured in accordance with cGMP and the Manufacturing Process approved mutually by Customer and BVL in accordance with this AgreementBVL. Each Batch of Product will be sampled and tested by BVL against the Specification in accordance with the Master Production Record. BVL will provide to Customer a Certificate of Analysis showing the results of the testing performed under the preceding sentenceSpecification. The quality assurance department of BVL will review the Certificate of Analysis and the other Records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP and other Applicable Law and the Manufacturing Process. 3.9.2. If, based upon such tests, a Batch of Product conforms to the Specification and was Manufactured according to cGMP and the Manufacturing Process, then a Certificate of Compliance will be generated and approved by the quality assurance department of BVL and delivered to CustomerBVL. This Certificate of Compliance, a Certificate of Analysis, and a complete and accurate copy of the executed Batch records (collectively, the “Batch Records”) for each Batch of Product (including, but not limited to, including all the Batch documentation described in Attachment “D” to this Agreement) will be delivered to Customer by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt requested to verify delivery date. Unless the Batch is shipped under Quarantine (as defined in Section 6.3 below), in the event that Customer has not received all such Batch Records at the time of receipt of BVL’s invoice for such Batch, Customer will notify BVL in writingwriting and BVL shall provide Customer a copy at no additional cost. In the event that Customer requires additional copies of the Batch Records, these will be provided by BVL to Customer at mutually agreed upon fees. 3.9.3. Customer will review the Batch Records for each Batch of Product and may test samples of the Batch of Product against the Specification. Customer will notify BVL in writing of its acceptance or rejection of such Batch within 30 calendar days of receipt of the complete Batch Records and test samples BVL batch release documents (Attachment D) relating to such Batch. If no acceptance or rejection in writing is received by BVL within such 30 [*]days, the Batch will be conclusively deemed accepted for purposes of Section 6.3. 1accepted. During this review period, the Parties agree to respond punctually, but in any event within ten (10) [*] calendar days, to any reasonable inquiry by the other Party with respect to the such Batch Records. Customer has no obligation to accept a Batch if such Batch (i) does not ______________ [*] Confidential Treatment Requested Manufacturing and Service Agreement (BVL and Vion Pharmaceuticals, Inc.) comply with the Specification, (ii) Specification and/or was not Manufactured in compliance with cGMP and/or and the Manufacturing Process or (iii) is otherwise contaminated, adulterated or misbranded other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer or its agentsProcess. 3.9.4. In case of any disagreement between the Parties as to whether Product conforms to the applicable Specification, a representative sample of such Product shall be submitted to an independent testing laboratory mutually agreed upon by the Parties for tests and final determination of whether such Product conforms to such Specification. The laboratory must meet cGMP requirements and requirements, be of recognized standing in the industry. Consent , and consent to the appointment of such laboratory shall not be unreasonably withheld or delayed by either Party. Such laboratory shall use the validated test methods contained in the applicable Specification. The determination of conformance by such laboratory with respect to all or part of such Product shall be final and binding on the Parties with respect to the determination as to whether the Specifications were metParties. The fees and expenses of the laboratory incurred in making such determination shall be paid by the Party against whom the determination is made. 3.9.5. Subject to Section 6.4 and 8.5, if a the Batch of Product (i) does not conform to the Specification, (ii) or was not Manufactured in compliance with cGMP , other Applicable Laws, and the Manufacturing Process or the requirements of this Agreement, or (iii) is otherwise contaminated, adulterated or misbranded, other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer’s agentsProcess, then BVL shall, after consultation with and written agreement from Customer: 3.9.5.1. refund [*] any fees and expenses paid by Customer on a pro rata basis over the usable portion for such Batch; or 3.9.5.2. [*] at BVL’s cost and expense produce a new Batch of Product as soon as reasonably possible. 3.9.6. BVL or Customer may postpone all scheduled Manufacture of the Product until such time as final disposition of a rejected Batch Batch(s) has been determined and complete investigations have been finalized with root cause analysis and corrective actions determined to prevent further Batch rejections which will be agreed to in writing by the Parties. BVL will perform such investigations, root cause analysis and corrective actions diligently and expeditiously. Under circumstances where BVL has postponed scheduled Manufacture of Product under the preceding sentence, Customer may request Manufacture in writing that BVL resume Manufacture prior to completion with Customer’s assumption of an investigation root cause analysis and corrective actions, and BVL will comply with such request, provided, Customer agrees to [*] during such period financial responsibility in the event of further batch rejection for reasons substantially similar to the issue that is the subject of the investigationreasons. 3.9.7. The Moreover, the Parties shall meet to discuss, evaluate and analyze the reasons for and implications of any the failure to meet the Specification or comply with the cGMP or other Applicable Law and/or the Manufacturing Process.

Product and Process Failure. 3.9.1. Product shall be Manufactured in accordance with cGMP and the Manufacturing Process approved mutually by Customer and BVL in accordance with this AgreementBVL. Each Batch of Product will be sampled and tested by BVL against the Specification in accordance with the Master Production Record. BVL will provide to Customer a Certificate of Analysis showing the results of the testing performed under the preceding sentenceSpecification. The quality assurance department Quality Assurance Department of BVL will review the Certificate of Analysis and the other Records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP and other Applicable Law and the Manufacturing Process. 3.9.2. If, based upon such teststests and/or review, a Batch of Product conforms to the Specification and was Manufactured according to cGMP and the Manufacturing Process, then a Certificate of Compliance will be generated and approved by the quality assurance department Quality Assurance Department of BVL and delivered to CustomerBVL. This Certificate of Compliance, a Certificate of Analysis, if required, and a complete and accurate copy of the executed Batch records (collectively, the “Batch Records”) for each Batch of Product (including, but not limited to, including all the Batch documentation described in Attachment “D” to this Agreement) will be delivered to Customer in advance of Product shipment by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt requested to verify delivery date. Unless the Batch is shipped under Quarantine (as defined in Section 6.3 below), in the event that Customer has not received all such Batch Records at the time of receipt of BVL’s invoice for such Batch, Customer will notify BVL in writing, and unless the Batch (or a partial Batch) is shipped under Quarantine, Customer shall be entitled to withhold payment until Customer receives the Batch Record. In the event that Customer requires additional copies of the this Batch Records, these will be provided by BVL to Customer at mutually agreed upon fees. 3.9.3. Customer will review the Batch Records for each Batch of Product and may test samples of the Batch of Product against the Specification. Customer will notify BVL in writing of its acceptance or rejection lot disposition of such Batch within 30 **** calendar days of receipt of the complete Batch Records and test samples relating to such Batch. If no acceptance or rejection in writing is received by BVL within such 30 **** days, the Batch will be conclusively deemed accepted for purposes of Section 6.3. 1accepted. During this review period, the Parties agree to respond punctually, but and shall endeavor in any event good faith to comply in the typical circumstance within ten five (105) calendar days, to any reasonable inquiry by the other Party with respect to the such Batch Records. Customer has no obligation to accept a Batch if to the extent such Batch (i) does not comply with the Specification. Applicable Law (for purposes solely due to BVL or BVL’s Manufacturing or services hereunder), (ii) and/or was not Manufactured in compliance with cGMP and/or and the Manufacturing Process or (iii) is otherwise contaminated, adulterated or misbranded other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer or its agentsProcess. 3.9.4. In case of any disagreement between the Parties as to whether Product conforms to the applicable Specification, a representative sample of such Product shall be submitted to an independent testing laboratory mutually agreed upon by the Parties for tests and final determination of whether such Product conforms to such Specification. The laboratory must meet cGMP requirements and requirements, be of recognized standing in the pharmaceutical industry. Consent , and consent to the appointment of such laboratory shall not be unreasonably withheld or delayed by either Party. Such laboratory shall use the validated test methods contained in the applicable Specification. The determination of conformance or not by such laboratory with respect to all or part of such Product shall be final and binding on the Parties with respect to the determination as to whether the Specifications were metParties. The fees and expenses of the laboratory incurred in making such determination shall be paid by the Party against whom the determination is made. 3.9.5. Subject to Section 6.4 and 8.5Article 8, if a BVL does not manufacture any Batch of Product (i) does not conform according to the Specification, (ii) was not Manufactured in compliance with cGMP , other Applicable Laws, or the Manufacturing Process or and the Product does not meet the requirements of this Agreement, or (iii) is otherwise contaminated, adulterated or misbranded, other than as a result of defective, adulterated or misbranded API or contamination, adulteration or misbranding caused by Customer’s agents, agreement then BVL shall, after consultation with and written agreement from Customer:Customers. 3.9.5.1. refund [*] and Manufacturing fees and expenses paid by Customer to BVL on a pro rata basis over the usable portion for such Batch; or 3.9.5.2. [*] at BVL’s cost and expense produce a new Batch of Product as soon as reasonably possible; and 3.9.5.3. reimburse Customer for any loss of API or Customer-supplied Composition pursuant to the terms set forth in Section 8.5 to the extent the reimbursement is not provided in Section 3.9.5.1. or Section 3.9.5.2. 3.9.6. BVL or Customer may postpone all scheduled Manufacture of the affected Product until such time as final disposition of a rejected Batch Batch(s) has been determined and complete investigations have been finalized with root cause analysis and corrective actions determined to prevent further Batch rejections rejections. BVL shall without any undue delay perform all investigations (including for such rejected Batches) diligently and expeditiously. The Parties will use good faith efforts to investigate and perform corrective actions to address Batches for which will be any Batch Record indicates an out-of profile condition as defined by generally accepted practice and mutually agreed to in writing upon by the Parties. BVL will perform such investigations, root cause analysis and corrective actions diligently and expeditiously. Under circumstances where BVL has postponed scheduled Manufacture of Product under the preceding sentence, Customer may request request, in writing writing, that BVL resume continue to Manufacture Product pending its investigation, and in the event that BVL elects to Manufacture Customer’s Product prior to the conclusion of an investigation, then Customer shall assume financial responsibility in the event of further Batch rejection for similar reasons. If Customer requests postponement until completion of an investigation root cause analysis and corrective actionsthe Investigation, and BVL will comply with such request, provided, Customer agrees to [*] during such period for reasons substantially similar to the issue that is the subject of the investigationpostponement fees in Section 6.5 do not apply. 3.9.7. The Moreover, the Parties shall meet to discuss, evaluate and analyze the reasons for and implications of any the failure to meet the Specification or comply with the cGMP or other Applicable Law and/or the Manufacturing Process.