Common use of Responsibility for Recalled Product Clause in Contracts

Responsibility for Recalled Product. For a Commercial Product, either Party shall notify the other Party as soon as practicably possible if any Commercial Product is the subject of a threatened or actual recall by a Regulatory Authority, (a “Recall”) which may be attributable to any Service or Manufacture by or on behalf of SBL hereunder. Client shall be responsible for conducting all Recalls and shall make all decisions regarding, and in all events shall have sole authority for, conducting any recalls, market withdrawals or corrections with respect to the Product and SBL shall at all times exercise Commercially Reasonable Efforts to provide its assistance and cooperation to Client in conducting such Recalls to the extent the Recall arises out of SBL’s Manufacture of Product. Details regarding the roles and responsibilities of the Parties in regard to Recalls are set forth in the applicable QAG. If such Recall results solely from SBL Assignable Error, SBL shall be responsible for direct and documented out-of-pocket costs associated with such Recall subject to the limitation of liability sections of the PSA applicable to such Recalled Product and, subject to written instructions of Client to the contrary, will use its Commercially Reasonable Efforts to replace the Recalled Products with new Products, contingent upon the receipt from Client free-of-charge of all Client Materials required for the Manufacture of the replacement Product. If SBL is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the Client Materials), then SBL shall credit to Client the price that Client paid to SBL for Manufacturing and Services for the affected Products. In all other circumstances, Recalls will be made at Client’s cost and expense. The provisions of this Section 8.2 shall not apply to any Clinical Product and shall be Client’s sole and exclusive remedy with respect to a Recall due to the delivery of Non-Conforming Product. For the purpose of this Section, Recall expenses shall not include the value of the Product that is the subject of such Recall or any loss of reputation or good will, or lost profits or any other costs or expenses not associated with the Product that is the subject of the Recall. If SBL and Client cannot agree which Party is at fault or whether a Recall was reasonably beyond the control of the Parties, then an independent third party technical expert of international repute, acceptable to both Parties, shall be designated to make such determination. The designated technical expert shall not be an employee, consultant, officer, director or shareholder of, or otherwise associated with, or have been retained during the prior five (5) years by, or be retained during the ensuing five (5) years, by SBL, Client or their respective Affiliates. The technical expert’s determination will be, in the absence of fraud or manifest error, binding and conclusive upon the Parties. The cost of designating such technical expert shall be borne by the Party determined at fault, and if neither Party is determined to be at fault, then the cost of such technical expert shall be borne by both Parties in equal proportion.

Responsibility for Recalled Product. For a Commercial Product, either Party shall notify the other Party as soon as practicably possible if any Commercial Product is the subject of a threatened or actual recall by a Regulatory Authority, Authority (a “Recall”) which may be attributable to any Service or Manufacture by or on behalf of SBL hereunder. Client shall be responsible for conducting all Recalls and shall make all decisions regarding, and in all events shall have sole authority for, conducting any recalls, market withdrawals or corrections with respect to the Product and SBL shall at all times exercise Commercially Reasonable Efforts to provide its reasonable assistance and cooperation to Client in conducting such Recalls to the extent the Recall arises out of SBL’s Manufacture of the Product. Details regarding the roles and responsibilities of the Parties in regard to Recalls are set forth in the applicable QAG. If such Recall results solely from SBL Assignable Error, SBL shall be responsible for direct and documented out-of-pocket costs associated with such Recall subject to Section 14 of this Agreement and the section on limitation of liability sections of in the PSA applicable to such Recalled Product andPSA, subject to written instructions of Client to the contrary, and will use its Commercially Reasonable Efforts to replace the Recalled Products with new Products, contingent upon the receipt from Client free-of-charge of all Client Materials required for the Manufacture of the replacement Product. If SBL is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the Client Materials), then SBL shall credit to Client the price that Client paid to SBL for Manufacturing and Services for the affected Products[***]. In all other circumstances, Recalls will be made at Client’s cost and expense. The provisions of this Section 8.2 8.3 shall not apply to any Clinical Product and shall be Client’s sole and exclusive remedy with respect to a Recall due to the delivery of Non-Conforming ProductRecall. For the purpose of this Section, Recall expenses shall not include the value of the Product that is the subject of such Recall [***] or any loss of reputation or good will, or lost profits or any other costs or expenses not associated with the Product [***] that is the subject of the Recall. If SBL and Client cannot agree which Party is at fault or whether a Recall was reasonably beyond the control of the Parties, then an independent third party technical expert of international repute, acceptable to both Parties, shall be designated to make such determination. The designated technical expert shall not be an employee, consultant, officer, director or shareholder of, or otherwise associated with, or have been retained during the prior five (5) years by, or be retained during the ensuing five (5) years, by SBL, Client or their respective Affiliates. The technical expert’s determination will be, in the absence of fraud or manifest error, be binding and conclusive upon the Parties. The cost of designating such technical expert shall be borne by the Party determined at fault, and if neither Party is determined to be at fault, then the cost of such technical expert shall be borne by both Parties in equal proportion.

Responsibility for Recalled Product. For a Commercial Product, either Party shall notify the other Party as soon as practicably possible if any Commercial Product is the subject of a threatened or actual recall by a Regulatory Authority, (a “Recall”) which may be attributable to any Service or Manufacture by or on behalf of SBL hereunder. Client shall be responsible for conducting all Recalls and shall make all decisions regarding, and in all events shall have sole authority for, conducting any recalls, market withdrawals or corrections with respect to the Product and SBL shall at all times exercise Commercially Reasonable Efforts to provide its assistance and cooperation to Client in conducting such Recalls to the extent the Recall arises out of SBL’s Manufacture of Product. Details regarding the roles and responsibilities of the Parties in regard to Recalls are set forth in the applicable QAG. If such Recall results solely from SBL Assignable Error, SBL shall be responsible for direct and documented out-of-of- pocket costs associated with such Recall subject to the limitation of liability sections of the PSA applicable to such Recalled Product and, subject to written instructions of Client to the contrary, will use ​ ​ ​ its Commercially Reasonable Efforts to replace the Recalled Products with new Products, contingent upon the receipt from Client free-of-charge of all Client Materials required for the Manufacture of the replacement Product. If SBL is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the Client Materials), then SBL shall credit to Client the price that Client paid to SBL for Manufacturing and Services for the affected Products[*]. In all other circumstances, Recalls will be made at Client’s cost and expense. The provisions of this Section 8.2 shall not apply to any Clinical Product and shall be Client’s sole and exclusive remedy with respect to a Recall due to the delivery of Non-Conforming Product. ​ For the purpose of this Section, Recall expenses shall not include the value of the Product that is the subject of such Recall [*] or any loss of reputation or good will, or lost profits or any other costs or expenses not associated with the Product [*] that is the subject of the Recall. If SBL and Client cannot agree which Party is at fault or whether a Recall was reasonably beyond the control of the Parties, then an independent third third-party technical expert of international repute, acceptable to both Parties, shall be designated to make such determination. The designated technical expert shall not be an employee, consultant, officer, director or shareholder of, or otherwise associated with, or have been retained during the prior five (5) years by, or be retained during the ensuing five (5) years, by SBL, Client or their respective Affiliates. The technical expert’s determination will be, in the absence of fraud or manifest error, binding and conclusive upon the Parties. The cost of designating such technical expert shall be borne by the Party determined at fault, and if neither Party is determined to be at fault, then the cost of such technical expert shall be borne by both Parties in equal proportion.. ​

Responsibility for Recalled Product. For a Commercial Product, either Party shall notify the other Party as soon as practicably possible if any Commercial Product is the subject of a threatened or actual recall by a Regulatory Authority, (a “Recall”) which may be attributable to any Service or Manufacture by or on behalf of SBL * hereunder. Client shall be responsible for conducting all Recalls and shall make all decisions regarding, and in all events shall have sole authority for, conducting any recalls, market withdrawals or corrections with respect to the Product and SBL * shall at all times exercise Commercially Reasonable Efforts to provide its assistance and cooperation to Client in conducting such Recalls to the extent the Recall arises out of SBL*’s Manufacture of Product. Details regarding the roles and responsibilities of the Parties in regard to Recalls are set forth in the applicable QAG. If such Recall results solely from SBL * Assignable Error, SBL * shall be responsible for direct and documented out-of-pocket costs associated with such Recall subject to the limitation of liability sections of the PSA applicable to such Recalled Product and, subject to written instructions of Client to the contrary, will use its Commercially Reasonable Efforts to replace the Recalled Products with new Products, contingent upon the receipt from Client free-of-charge of all Client Materials required for the Manufacture of the replacement Product. If SBL * is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the Client Materials), then SBL * shall credit to Client the price that Client paid to SBL * for Manufacturing and Services for the affected Products. In all other circumstances, Recalls will be made at Client’s cost and expense. The provisions of this Section 8.2 shall not apply to any Clinical Product and shall be Client’s sole and exclusive remedy with respect to a Recall due to the delivery of Non-Conforming Product. * Confidential material redacted and filed separately with the Commission. For the purpose of this Section, Recall expenses shall not include the value of the Product that is the subject of such Recall or any loss of reputation or good will, or lost profits or any other costs or expenses not associated with the Product that is the subject of the Recall. If SBL * and Client cannot agree which Party is at fault or whether a Recall was reasonably beyond the control of the Parties, then an independent third party technical expert of international repute, acceptable to both Parties, shall be designated to make such determination. The designated technical expert shall not be an employee, consultant, officer, director or shareholder of, or otherwise associated with, or have been retained during the prior five (5) years by, or be retained during the ensuing five (5) years, by SBL*, Client or their respective Affiliates. The technical expert’s determination will be, in the absence of fraud or manifest error, binding and conclusive upon the Parties. The cost of designating such technical expert shall be borne by the Party determined at fault, and if neither Party is determined to be at fault, then the cost of such technical expert shall be borne by both Parties in equal proportion.