Common use of Batch Failure during Manufacture Clause in Contracts

Batch Failure during Manufacture. 5.8.1 If, during Manufacture of a Batch and prior to SBL’s Batch release, the Core Team determines that a Batch is Non-Conforming Product (a “Batch Failure”), SBL shall take Commercially Reasonable Efforts to promptly Manufacture (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client a replacement Batch on a date to be mutually agreed by the Parties, which Batch shall be invoiced and paid for as if it were the failed Batch (i.e., Client shall only be invoiced for the Batch conforming to the Specifications and Manufactured in compliance with cGMP, and actually delivered). Client shall be responsible for the costs and fees of the Raw Materials and Client Materials for the replacement Batch as if it were the failed Batch (i.e., Client shall only be invoiced the applicable cost of the Raw Materials and Client Materials actually used to Manufacture the conforming, cGMP compliant replacement Batch). Client shall use Commercially Reasonable Efforts to ensure that SBL has adequate Client Materials to Manufacture such Batches and Client’s failure to provide such Client Materials shall relieve SBL of its obligations to provide a remedy pursuant to this Section 5.8. The remedies contained in Section 5.8 of this MSA shall be the sole and exclusive remedies of Client regarding a Batch Failure and a Batch Failure shall not constitute a material breach of this MSA or a PSA unless SBL fails to provide the remedies contained in this Section 5.8. 5.8.2 The Parties shall conduct a root cause analysis (including an analysis of whether the Batch Failure was the fault of SBL, Client, neither or both) of the Batch Failure, which shall be done through SBL’s deviation process and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, and the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer review of such root cause analysis to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be borne by the Party responsible for the Batch Failure, as determined by the independent laboratory, whose written decision shall be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. 5.8.3 The PSA applicable to such Product Batch Failure shall set forth responsibility among the Parties for the following costs in the event of a Batch Failure: (1) the SBL Service Fee to Manufacture the failed Batch; (2) SBL’s costs to procure the Raw Materials used in the failed Batch plus applicable SBL handling fees associated with such Raw Materials; (3) SBL handling fees associated with the applicable Client Materials used in the failed Batch; and (4) Client’s cost to procure the Client Materials (which shall not include Cell Line) used in the failed Batch which amount is to be calculated based on the actual replacement value (as opposed to the market value) of such materials as supported by reasonable documentary evidence by Client. 5.8.4 In the event that any of the foregoing procedures results in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee in effect in the Year in which such re-Manufactured Batch is actually delivered by SBL unless the root cause analysis determined the Batch Failure resulted from SBL Assignable Error, in which case, the Service Fee in effect at the time of the Purchase Order for the failed Batch shall apply.

Batch Failure during Manufacture. 5.8.1 If, during Manufacture of a Batch and prior to SBL’s Batch batch release, the Core Team determines that a Batch is Non-Conforming Product (a “Batch Failure”), SBL shall take Commercially Reasonable Efforts to promptly Manufacture [***] (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client a replacement Batch [***] on a date to be mutually agreed by the Parties, but no later than [***] (as defined in the applicable PSA) for such Product pursuant to the applicable PSA. which Batch shall be invoiced and paid for as if it were the failed Batch (i.e., Client shall only be invoiced for the Batch conforming to the Specifications and Manufactured in compliance with cGMP, and actually delivered). Client shall be responsible for the costs and fees of the Raw Materials and Client Materials for the replacement Batch as if it were the failed Batch (i.e., Client shall only be invoiced the applicable cost of the Raw Materials and Client Materials actually used to Manufacture the conforming, cGMP compliant replacement Batch). Client shall use Commercially Reasonable Efforts to ensure that SBL has adequate Client Materials to Manufacture such Batches and Client’s failure to provide such Client Materials shall relieve SBL of its obligations to provide a remedy pursuant to this Section 5.8Batches. The remedies contained in Section 5.8 of this MSA shall be the sole and exclusive remedies of Client regarding a Batch Failure and a Batch Failure shall not constitute a material breach of this MSA or a PSA unless SBL fails to provide the remedies contained in this Section 5.85.8 or deliver such replacement Batch within the time period set forth in the applicable PSA. 5.8.2 The Parties shall conduct a root cause analysis (including an analysis of whether the Batch Failure was the fault of SBL, Client, neither or both) of the Batch Failure, which shall be done through SBL’s deviation process and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, and or the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer review of such root cause analysis to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be borne shared by the Parties equally; provided, however, that to the extent either Party responsible for is determined to be incorrect as to the root cause of the Batch Failure, as determined by such Party will be responsible for the reasonable costs of the independent laboratory and must reimburse the other Party for such Party’s share of the reasonable costs incurred with respect to the independent laboratory, whose written ’s analysis. The decision shall of the independent laboratory must be in writing and will be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. 5.8.3 The PSA applicable to such Product Batch Failure shall set forth responsibility among the Parties for of the following costs in the event of a Batch Failure: (1) the SBL Service Fee to Manufacture the failed Batch; (2) SBL’s costs to procure the Raw Materials used in the failed Batch plus applicable SBL handling fees associated with such Raw Materials; (3) SBL handling fees associated with the applicable Client Materials used in the failed Batch; and (4) Client’s cost to procure the Client Materials (which shall not include Cell Line) used in the failed Batch which amount is to be calculated based on the actual replacement value (as opposed to the market value) costs of such materials as supported by reasonable documentary evidence (as opposed to the market value thereof) incurred by Client. Notwithstanding anything to the contrary, SBL shall not be responsible in the event of Batch Failure to the extent: (a) Drug Substance that is Client Material pursuant to a Drug Product PSA and (b) Cell Line that is Client Material pursuant to a Drug Substance PSA. 5.8.4 In the event that any of the foregoing procedures results in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee in effect set forth in the Year in which applicable PSA for such re-Manufactured Batch is actually delivered by SBL unless the root cause analysis determined the Batch Failure resulted from SBL Assignable Error, in which case, the Service Fee in effect at the time of the Purchase Order for the failed Batch shall applyBatch.

Batch Failure during Manufacture. 5.8.1 If, during Manufacture of a Batch and prior to SBL’s Batch batch release, the Core Team determines that all of a Batch is Non-Conforming Product (a “Batch Failure”), SBL shall take use Commercially Reasonable Efforts to promptly re-Manufacture (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client a replacement Batch on a date to be mutually agreed by the Parties, which Batch Service Fees and associated costs/fees (as set forth in Section 9.1 below) shall be invoiced and paid for as if it were by the failed Batch (i.e., Client shall only be invoiced for the Batch conforming to the Specifications and Manufactured in compliance with cGMP, and actually delivered)Client. Client shall be responsible for the costs and fees of the Raw Materials and Client Materials for the replacement Batch as if it were the failed Batch (i.e., Client shall only be invoiced the applicable cost of the Raw Materials and Client Materials actually used to Manufacture the conforming, cGMP compliant replacement Batch). Client shall use Commercially Reasonable Efforts to ensure that SBL has adequate Client Materials to Manufacture such Batches and Client’s failure to provide such Client Materials shall relieve SBL of its obligations to provide a remedy pursuant to this Section 5.8Batches. The remedies contained in Section 5.8 of this MSA shall be the sole and exclusive remedies of Client regarding a Batch Failure and a Batch Failure shall not constitute a material breach of this MSA or a PSA unless SBL fails to provide the remedies contained in this Section 5.8. 5.8.2 The Parties shall conduct a root cause analysis (including an analysis of whether the Batch Failure was the fault of SBL, Client, neither or both) of the Batch Failure, which shall be done through SBL’s deviation process and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, and or the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer review of such root cause analysis to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be borne shared by the Parties equally; provided, however, that the Party that is determined to be incorrect as to the Batch Failure will be responsible for those reasonable costs and must reimburse the Batch Failure, as determined by correct Party for its share of the reasonable costs incurred. The decision of the independent laboratory, whose written decision shall laboratory must be in writing and will be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. 5.8.3 The PSA applicable to such Product Batch Failure shall set forth responsibility among the Parties for of the following costs in the event of a Batch Failure: (1) : [***]. Notwithstanding anything to the contrary, SBL Service Fee to Manufacture the failed Batch; (2) SBL’s costs to procure the Raw Materials used shall not be responsible in the failed event of Batch plus applicable SBL handling fees associated with such Raw Materials; (3) SBL handling fees associated with the applicable Client Materials used in the failed Batch; and (4) Client’s cost to procure the Client Materials (which shall not include Cell Line) used in the failed Batch which amount is to be calculated based on the actual replacement value (as opposed to the market value) of such materials as supported by reasonable documentary evidence by ClientFailure for: [***]. 5.8.4 In the event that any of the foregoing procedures results in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee in effect in the Year in which such re-Manufactured Batch is actually delivered by SBL unless the root cause analysis determined the Batch Failure resulted from SBL Assignable Error, in which case, the Service Fee in effect at the time of the Purchase Order for the failed Batch shall applySBL.

Batch Failure during Manufacture. 5.8.1 4.11.1 If, during Manufacture of a Batch and prior to SBL’s Batch batch release, the Core Team determines that all of a Batch is Non-Conforming Product (a “Batch Failure”), SBL shall take Commercially Reasonable Efforts to promptly re-Manufacture (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client a replacement Batch on a date to be mutually agreed by the Parties, which Batch Service Fees and associated costs/fees (as set forth in Section 8.1 below) shall be invoiced and paid for as if it were by the failed Batch (i.e., Client shall only be invoiced for the Batch conforming to the Specifications and Manufactured in compliance with cGMP, and actually delivered)Client. Client shall be responsible for the costs and fees of the Raw Materials and Client Materials for the replacement Batch as if it were the failed Batch (i.e., Client shall only be invoiced the applicable cost of the Raw Materials and Client Materials actually used to Manufacture the conforming, cGMP compliant replacement Batch). Client shall use Commercially Reasonable Efforts to ensure that SBL has adequate Client Materials to Manufacture such Batches and Client’s failure to provide such Client Materials shall relieve SBL of its obligations to provide a remedy pursuant to this Section 5.8Batches. The remedies contained in Section 5.8 4.11 of this MSA shall be the sole and exclusive remedies of Client regarding a Batch Failure and a Batch Failure shall not constitute a material breach of this MSA or a PSA unless SBL fails to provide the remedies contained in this Section 5.84.11. 5.8.2 4.11.2 The Parties shall conduct a root cause analysis (including an analysis of whether the Batch Failure was the fault of SBL, Client, neither or both) of the Batch Failure, which shall be done through SBL’s deviation process and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, and or the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer review of such root cause analysis to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be borne shared by the Parties equally; provided, however, that the Party that is determined to be incorrect as to the Batch Failure will be responsible for those reasonable costs and must reimburse the Batch Failure, as determined by correct Party for its share of the reasonable costs incurred. The decision of the independent laboratory, whose written decision shall laboratory must be in writing and will be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. 5.8.3 The PSA applicable to such Product 4.11.3 In the event of Batch Failure due solely to SBL Assignable Error (other than due to gross negligence, fraud, or willful misconduct of SBL), SBL shall set forth responsibility among the Parties be responsible for the following costs: [***] [***]. In the case of Batch Failure due solely to SBL Assignable Error due to gross negligence, fraud, or willful misconduct of SBL, in addition to the costs described in (1) – (4) above, SBL shall additionally be responsible for [***]. In the event of Batch Failure due to a Batch Failure: reason not solely SBL Assignable Error, Client shall be responsible for the full costs described in (1) the SBL Service Fee to Manufacture the failed Batch; (2) SBL’s costs to procure the Raw Materials used in the failed Batch plus applicable SBL handling fees associated with such Raw Materials; (3) SBL handling fees associated with the applicable Client Materials used in the failed Batch; and – (4) in the preceding sentence. Any such cost responsibility shall be refunded to Client or, at Client’s cost to procure the Client Materials (which shall not include Cell Line) used in the failed Batch which amount is to be calculated based on the actual replacement value (option, issued as opposed to the market value) of such materials as supported a credit against future invoices by reasonable documentary evidence by ClientSBL. 5.8.4 4.11.4 In the event that any of the foregoing procedures results result in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee in effect set forth in the Year in which such re-Manufactured Batch is actually delivered by SBL unless the root cause analysis determined the Batch Failure resulted from SBL Assignable Error, in which case, the Service Fee in effect at the time of the Purchase Order for the failed Batch shall applyPSA.

Batch Failure during Manufacture. 5.8.1 4.11.1 If, during Manufacture of a Batch and prior to SBL’s Batch release, Client and/or the Core Team determines that a Batch is Non-Conforming Product (a “Batch Failure”), SBL shall take Commercially Reasonable Efforts to promptly re-Manufacture (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client a replacement Batch on a date to be mutually agreed by the Parties, which Batch Service Fees and associated costs/fees (as set forth in Section 8.1 below) shall be invoiced and paid for as if it were by the failed Batch (i.e., Client shall only be invoiced for the Batch conforming to the Specifications and Manufactured in compliance with cGMP, and actually delivered). Client shall be responsible for the costs and fees of the Raw Materials and Client Materials for the replacement Batch as if it were the failed Batch (i.e., Client shall only be invoiced the applicable cost of the Raw Materials and Client Materials actually used to Manufacture the conforming, cGMP compliant replacement Batch). Client shall use Commercially Reasonable Efforts to ensure that SBL has adequate Client Materials to Manufacture such Batches and Client’s failure to provide such Client Materials shall relieve SBL of its obligations to provide a remedy pursuant to this Section 5.8. The remedies contained in Section 5.8 4.11 of this MSA shall be the sole and exclusive remedies of Client regarding a Batch Failure [* * *] and a Batch Failure shall not constitute a material breach of this MSA or a PSA unless SBL fails to provide the remedies contained in this Section 5.84.11. 5.8.2 4.11.2 The Parties shall conduct a root cause analysis (including an analysis of whether the Batch Failure was the fault of SBL, Client, neither or both) of the Batch Failure, which shall be done through SBL’s the deviation process under the requirements of the QAG and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, and or the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer review of such root cause analysis to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be borne shared by the Parties equally; provided, however, that the Party that is determined to be incorrect as to the Batch Failure will be responsible for those reasonable costs and must reimburse the Batch Failure, as determined by correct Party for its share of the reasonable costs incurred. The decision of the independent laboratory, whose written decision shall laboratory must be in writing and will be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. 5.8.3 4.11.3 The PSA applicable to such Product Batch Failure shall set forth responsibility among the Parties for of the following costs in the event of a Batch Failure: (1) the SBL Service Fee to Manufacture the failed Batch; (2) SBL’s costs to procure the Raw Materials used in the failed Batch [* * *] plus applicable SBL handling fees associated with such Raw Materials[* * *]; (3) SBL handling fees associated with the applicable Client Materials used in the failed Batch[* * *]; and (4) Client’s cost to procure the Client Materials (which shall not include Cell Line) used in the failed Batch [* * *] which amount is to be calculated based on the actual replacement value (as opposed to the market value) costs of such materials as supported by reasonable documentary evidence (as opposed to the market value thereof)[* * *]. To the extent the Batch Failure is caused [* * *], SBL shall be responsible for (1) – (4) above, and in all other Batch Failure cases Client shall be responsible for (1) – (4) above. Any such cost responsibility shall be issued as a credit against future invoices by ClientSBL or a refund to Client if the credit exceeds the value of future invoices. Notwithstanding anything to the contrary, SBL shall not be responsible in the event of Batch Failure for: (a) [* * *] and (b) [* * *]. 5.8.4 4.11.4 In the event that any of the foregoing procedures results result in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee in effect in the Year year in which such re-Manufactured Batch is actually delivered by SBL unless the root cause analysis determined the Batch Failure resulted from SBL Assignable Error, in which case, the Service Fee in effect at the time of the Purchase Order for the failed Batch shall applySBL.

Batch Failure during Manufacture. 5.8.1 If, during Manufacture of a Batch and prior to SBL*’s Batch release, the Core Team determines that a Batch is Non-Conforming Product (a “Batch Failure”), SBL * shall take Commercially Reasonable Efforts to promptly Manufacture (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client a replacement Batch on a date to be mutually agreed by the Parties, which Batch shall be invoiced and paid for as if it were the failed Batch (i.e., Client shall only be invoiced for the Batch conforming to the Specifications and Manufactured in compliance with cGMP, and actually delivered). Client shall be responsible for the costs and fees of the Raw Materials and Client Materials for the replacement Batch as if it were the failed Batch (i.e., Client shall only be invoiced the applicable cost of the Raw Materials and Client Materials actually used to Manufacture the conforming, cGMP compliant replacement Batch). Client shall use Commercially Reasonable Efforts to ensure that SBL * has adequate Client Materials to Manufacture such Batches and Client’s failure to provide such Client Materials shall relieve SBL * of its obligations to provide a remedy pursuant to this Section 5.8. The remedies contained in Section 5.8 of this MSA shall be the sole and exclusive remedies of Client regarding a Batch Failure and a Batch Failure shall not constitute a material breach of this MSA or a PSA unless SBL * fails to provide the remedies contained in this Section 5.8. 5.8.2 The Parties shall conduct a root cause analysis (including an analysis of whether the Batch Failure was the fault of SBL*, Client, neither or both) of the Batch Failure, which shall be done through SBL*’s deviation process and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, and the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer review of such root cause analysis to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be borne by the Party responsible for the Batch Failure, as determined by the independent laboratory, whose written decision shall be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. 5.8.3 The PSA applicable to such Product Batch Failure shall set forth responsibility among the Parties for the following costs in the event of a Batch Failure: (1) the SBL * Service Fee to Manufacture the failed Batch; (2) SBL*’s costs to procure the Raw Materials used in the failed Batch plus applicable SBL * handling fees associated with such Raw Materials; (3) SBL * handling fees associated with the applicable Client Materials used in the failed Batch; and (4) Client’s cost to procure the Client Materials (which shall not include Cell Line) used in the failed Batch which amount is to be calculated based on the actual replacement value (as opposed to the market value) of such materials as supported by reasonable documentary evidence by Client. 5.8.4 In the event that any of the foregoing procedures results in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee in effect in the Year in * Confidential material redacted and filed separately with the Commission. which such re-Manufactured Batch is actually delivered by SBL * unless the root cause analysis determined the Batch Failure resulted from SBL * Assignable Error, in which case, the Service Fee in effect at the time of the Purchase Order for the failed Batch shall apply.

Batch Failure during Manufacture. 5.8.1 4.11.1 If, during Manufacture of a Batch and prior to SBL’s Batch batch release, the Core Team determines that all of a Batch is Non-Conforming Product (a “Batch Failure”), SBL shall take Commercially Reasonable Efforts to promptly re-Manufacture (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client a replacement Batch on a date to be mutually agreed by the Parties, which Batch Service Fees and associated costs/fees (as set forth in Section 8.1 below) shall be invoiced and paid for as if it were by the failed Batch (i.e., Client shall only be invoiced for the Batch conforming to the Specifications and Manufactured in compliance with cGMP, and actually delivered)Client. Client shall be responsible for the costs and fees of the Raw Materials and Client Materials for the replacement Batch as if it were the failed Batch (i.e., Client shall only be invoiced the applicable cost of the Raw Materials and Client Materials actually used to Manufacture the conforming, cGMP compliant replacement Batch). Client shall use Commercially Reasonable Efforts to ensure that SBL has adequate Client Materials to Manufacture such Batches and Client’s failure to provide such Client Materials shall relieve SBL of its obligations to provide a remedy pursuant to this Section 5.8Batches. The remedies contained in Section 5.8 4.11 of this MSA MDSA shall be the sole and exclusive remedies of Client regarding a Batch Failure [***] and a Batch Failure shall not constitute a material breach of this MSA MDSA or a PSA unless SBL fails to provide the remedies contained in this Section 5.84.11. 5.8.2 4.11.2 The Parties shall conduct a root cause analysis (including an analysis of whether the Batch Failure was the fault of SBL, Client, neither or both) of the Batch Failure, which shall be done through SBL’s deviation process and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, and or the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer review of such root cause analysis to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be borne shared by the Parties equally; provided, however, that the Party that is determined to be incorrect as to the Batch Failure will be responsible for those reasonable costs and must reimburse the Batch Failure, as determined by correct Party for its share of the reasonable costs incurred. The decision of the independent laboratory, whose written decision shall laboratory must be in writing and will be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. 5.8.3 The PSA applicable to such Product 4.11.3 In the event of Batch Failure Failure, SBL or Client shall set forth responsibility among the Parties be responsible for the following costs as set forth in the event of a Batch Failure: this Section 4.11.3: (1) the SBL Service Fee to Manufacture the failed Batch; (2) SBL’s costs to procure the Raw Materials used in the failed Batch [***] plus applicable SBL handling fees associated with such Raw Materials[***]; (3) SBL handling fees associated with the applicable Client Materials used in the failed Batch[***]; and (4) Client’s cost to procure the Client Materials (which shall not include Cell Line) used in the failed Batch [***] which amount is to be calculated based on the actual replacement value (as opposed to the market value) costs of such materials as supported by reasonable documentary evidence (as opposed to the market value thereof) incurred by Client. 5.8.4 In . To the event that any of the foregoing procedures results in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee in effect in the Year in which such re-Manufactured Batch is actually delivered by SBL unless the root cause analysis determined extent the Batch Failure resulted from is caused [***], SBL Assignable Errorshall be responsible for (1)-(4) above, and in which caseall other Batch Failure cases Client shall be responsible for (1)-(4) above. Any such cost responsibility shall be [***]. Notwithstanding anything to the contrary, the Service Fee in effect at the time of the Purchase Order for the failed Batch SBL shall applynot be responsible [***].