Common use of Specific Limitation of Liability for Process-Related (i.e., during Manufacturing) Losses Clause in Contracts

Specific Limitation of Liability for Process-Related (i.e., during Manufacturing) Losses. 8.5.1. Notwithstanding anything to the contrary set forth herein or in any collateral documents hereunder (invoices, purchase orders, etc.), the Parties acknowledge and agree that BVL’s sole liability to Customer for in-process Manufacturing losses (i.e. loss of API, or Customer-supplied Composition) is set forth exclusively in this section 8.5. Except for Batches of Definity (where the maximum liability shall be $****), BVL agrees to reimburse Customer up to a maximum of $**** per Batch pro-rated over the usable portion of the Batch, if applicable, for any loss of API or Customer-supplied Composition for each Batch that does not meet Specification or was not Manufactured in accordance with the Manufacturing Process or cGMP and therefore can not be released; provided that the loss of such materials can be shown after Investigation to be caused solely and directly by: (a) the failure of BVL to follow its SOP’s; or (b) BVL’s negligence, willful misconduct or breach of this Agreement; or (c) BVL’s willful misconduct, where, solely for purposes of this Section 8.5.1, such “willful misconduct” shall have the meaning set forth under Delaware law. In the absence of a showing of (a), (b) or (c), above, then BVL shall have no liability to Customer for such Batch of Product. In addition to this payment, BVL will be responsible for all Manufacturing fees incurred during the Manufacture of the failed Batch, pro-rated over the usable portion of the Batch, if applicable. Notwithstanding the foregoing, or any declared value of API costs in excess of $**** or $****, as applicable, or the insurance levels identified in Section 8.4 or elsewhere, in no event shall BVL’s liability to Customer for in-process loss of API or Customer-supplied Composition be in excess of $**** or $****, as applicable, per Batch.

Specific Limitation of Liability for Process-Related (i.e., during Manufacturing) Losses. 8.5.1. Notwithstanding anything to the contrary set forth herein or in any collateral documents hereunder (invoices, purchase orders, etc.), the Parties acknowledge and agree that BVL’s sole liability to Customer for in-process Manufacturing losses (i.e. loss of API, or Customer-supplied Composition) is set forth exclusively in this section 8.5. Except for Batches of Definity (where the maximum liability shall be $****), BVL agrees to reimburse Customer up to a maximum of $**** per Batch pro-rated over the usable portion of the Batch, if applicable, for any loss of API or Customer-supplied Composition for each Batch that does not meet meet. Specification or was not Manufactured in accordance with the Manufacturing Process or cGMP and therefore can not be released; provided that the loss of such materials can be shown after Investigation investigation to be caused solely and directly by: (a) the failure of BVL to follow its SOP’s; or (b) BVL’s negligence, willful misconduct or breach of this Agreement; or (c) BVL’s willful misconduct, where, solely for purposes of this Section 8.5.1, such “willful misconduct” shall have the meaning set forth under Delaware law. In the absence of a showing of (a), (b) or (c), above, then BVL shall have no liability to Customer for such Batch of Product. In addition to this payment, BVL will be responsible for all Manufacturing fees incurred during the Manufacture of the failed Batch, pro-rated over the usable portion of the Batch, if applicable. The maximum amounts set forth in Section 8.5.1 shall increase annually by the percentage increase of the actual cost of the API and Customer-supplied Composition or as in the case of Definity the percentage increase as applied to the $**** maximum as described above as shown by Customer’s written records. The monetary values of all Customer-supplied Composition and API must be disclosed by Customer to BVL in writing prior to production in the questionnaire provided by BVL to Customer. The Customer is responsible for notifying BVL in writing of any changes in the value of the Customer-supplied Composition and API supplied to BVL, and BVL shall not be liable for any increase in the cost of the foregoing if Customer fails to provided the abovementioned notice or timely updates thereto. Notwithstanding the foregoing, or any declared value of API costs in excess of $**** or $****, * as applicable, or the insurance levels identified in Section 8.4 or elsewhere, in no event shall BVL’s liability to Customer for in-process loss of API or Customer-supplied Composition be in excess of $**** or $****, as applicable, per BatchBatch except to the extent permitted by Applicable Law.