Common use of Product Recall Clause in Contracts

Product Recall. (a) Distributor will maintain or cause to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the Product, including inventory withdrawal in connection with any of the foregoing (each a “Recall”). (b) Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing of any information which indicates a Recall of any Product may be necessary, any safety or regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring a Recall. (c) To the extent permitted by circumstances, the Parties will confer before initiating any Recall. If the Parties do not agree on the need for or the extent of such a Recall, either Party may authorize the Recall. (d) Each Party will cooperate fully with the other Party in connection with any Recall efforts. (e) Distributor shall be responsible for the carrying out of any and all Recalls in accordance with applicable Laws. (f) If any Recall is required (I) due to the failure of the Product to conform to the Specifications at the time title is transferred to Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratory, or (II) due to the fact that Product samples (both retention and stability) stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples), Cipher will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Price of any Product subject to the Recall and, if the Parties are unable to agree, then Cipher shall supply to Distributor replacement Product that conforms to the Specifications and Distributor will distribute the replacement Product. (g) If any Recall is required in circumstances other than provided for in Section 5.3(f) and (h), Distributor will be responsible for the direct costs of such Recall and will reimburse Cipher and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. (h) If any Recall is required due to Active Ingredient side effects referred to in Section 10.4, the Parties shall be equally responsible for any direct out-of-pocket costs of such Recall that either Party or its Affiliates incur and will reimburse the other Party and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail.

Product Recall. (a) Distributor CytoDyn shall be responsible, at its sole expense, for serialization of the Product. American Regent, at its sole expense, will maintain or cause to be maintained such traceability records of its sales of the Product, as are necessary to permit a recall, market withdrawal or field correction of the Product, a Product including any inventory withdrawal in connection with any of the foregoing (each a “Recall”). (b) Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing of any information which indicates a Recall of any Product may be necessary, any safety or regulatory concerns, or any order, request or directive of a court or other Regulatory Authority the FDA requesting or requiring a Recall. (c) To the extent permitted by circumstances, the Parties will confer before initiating any Recall. If the Parties do not agree on the need for or the extent of such a Recall, either Party may authorize the Recall. (d) Each With respect to Recalls agreed on by both Parties, American Regent shall manage, in accordance with CytoDyn’s oversight and direction, the carrying out of such Recalls of Product sold by it in accordance with Applicable Laws. In the event CytoDyn materially impedes American Regent’s efforts to Recall the Product, American Regent shall have the right to terminate this Agreement with [***] written notice to CytoDyn. (e) If any Recall is required primarily and substantially because of failure of a Product to conform to the Specifications already existing at the time title is transferred to American Regent or as a result of a material breach of CytoDyn’s obligations, as confirmed by a mutually acceptable Third Party laboratory, including a Latent Defect that is shown to have existed at the time of such title transfer, CytoDyn will be responsible for only the direct costs of such Recall (including reimbursement to American Regent and its Affiliates for their direct, out-of-pocket costs and expenses incurred during such Recall). In such event, CytoDyn shall supply to American Regent free of cost and expense replacement Product for any removed Product. (f) If any Recall is required primarily or substantially because of failure of a Product to conform to the Specifications after title is transferred to American Regent or in circumstances caused by the negligence, mistake, fault, error or omission of American Regent, its Affiliates or subcontractors, including any breach by American Regent of a representation, warranty or covenant hereunder, American Regent will be responsible for the direct costs of such Recall (including reimbursement to CytoDyn and its Affiliates for all of their direct out-of-pocket costs and expenses incurred during such Recall) and the Transfer Price of all Products removed from American Regent’s inventory. (g) If any Recall is required under circumstances not covered in Section 5.2(e) or (f) above, the Parties will equally share the direct costs of such Recall, including direct out-of-pocket costs and expenses related to such Recall. (h) Without limiting the foregoing, each Party will cooperate fully with the other Party in connection with any Recall efforts. (e) Distributor shall be responsible for the carrying out of any and all Recalls in accordance with applicable Laws. (f) If any Recall is required (I) due to the failure of the Product to conform to the Specifications at the time title is transferred to Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratory, or (II) due to the fact that Product samples (both retention and stability) stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples), Cipher will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Price of any Product subject to the Recall and, if the Parties are unable to agree, then Cipher shall supply to Distributor replacement Product that conforms to the Specifications and Distributor will distribute the replacement Product. (g) If any Recall is required in circumstances other than provided for in Section 5.3(f) and (h), Distributor will be responsible for the direct costs of such Recall and will reimburse Cipher and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. (h) If any Recall is required due to Active Ingredient side effects referred to in Section 10.4, the Parties shall be equally responsible for any direct out-of-pocket costs of such Recall that either Party or its Affiliates incur and will reimburse the other Party and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail.

Product Recall. (a) Sub-Distributor will maintain or cause to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the ProductProduct in the Market, including inventory withdrawal in connection with any of the foregoing (each a “Recall”). (b) Each Party shall promptly (but in any case, not later than twenty-four within two (242) hours business days of receipt) notify the other Party in writing of any information which indicates a Recall of any Product may be necessary, any safety or regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring a Recall. (c) To the extent permitted by circumstances, the Parties will Sub-Distributor shall confer with Vertical and Cipher before initiating any Recall. If the Parties do not agree on the need for or the extent of such a Recall, either Party may authorize the Recall. (d) Each Party will cooperate fully with the other Party and with Cipher in connection with any Recall efforts. (ed) Sub-Distributor shall be responsible for the carrying out of any and all Recalls in accordance with applicable Applicable Laws. (fe) If any Recall is required (I) due to the failure of the Product to conform to the Specifications at the time title is transferred to Sub-Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratory, or (II) due to the fact that Product samples (both retention and stability) stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples), Cipher will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any ’s Minimum Net Sales Purchase Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ Sub-Distributor’s ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Transfer Price of any Product subject to the Recall and, if the Parties are unable or to agree, then Cipher shall supply to Distributor replacement replace recalled Product with Product that conforms to the Specifications and Distributor will distribute the replacement ProductSpecifications. (gf) If any a Recall is required due to (i) any act or omission of Sub-Distributor in circumstances other than provided for in Section 5.3(fthe storage, handling, marketing, sale or distribution of Product or (ii) and (h)any breach by Sub-Distributor of its duties under this Agreement, Sub-Distributor will be responsible for the direct costs of such Recall and will reimburse Cipher Vertical and its Affiliates within ten (10) Business Days business days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. (hg) If any a Recall is required due to Active Ingredient side effects referred to in circumstances other than provided for in Section 10.45.9(f), the Parties shall as between Vertical and Sub-Distributor, Vertical will be equally responsible for any the direct out-of-pocket costs of such Recall that either Party or its Affiliates incur and will reimburse the other Party Sub-Distributor and its Affiliates within ten (10) Business Days business days after receipt of an invoice with supporting detaildetail for all of their direct out-of-pocket costs and direct expenses related to such Recall.

Product Recall. (a) Distributor will maintain or cause to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the Product, Supplied Product including inventory withdrawal in connection with any of the foregoing (each a “Recall”). (b) Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing of any information which indicates a Recall of any Supplied Product may be necessary, any safety or regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring a Recall. (c) To the extent permitted by circumstances, the Parties will confer before initiating any Recall. If the Parties do not agree on the need for or the extent of such a Recall, either Party may authorize the Recall. (d) Each Party will cooperate fully with the other Party in connection with any Recall efforts. (e) Distributor shall be responsible for the carrying out of any and all Recalls with respect to the Supplied Product in accordance with applicable Laws. (fe) If any Recall is required primarily and substantially because of (Ii) due to the breach of Can-Xxxx of a representation, warranty or covenant hereunder, or (ii) failure of the Supplied Product to conform to the Specifications at the time title is transferred to the Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratoryLaboratory, or (II) due including a Latent Defect that is shown to the fact that Product samples (both retention and stability) stored under controlled conditions have existed at the time of such title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples)transfer, Cipher Can-Xxxx will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Transfer Price of any Supplied Product subject to the any Recall and, if the Parties are unable to agree, then Cipher Can-Xxxx shall supply to Distributor free of cost and expense replacement Supplied Product that conforms to the Specifications and Distributor will distribute the replacement Supplied Product. (gf) If any Recall is required primarily or substantially in circumstances other than provided for in Section 5.3(f) and (h)caused by the negligence, mistake, fault, error or omission of Distributor, its Affiliates or subcontractors, including any breach by Distributor of a representation, warranty or covenant hereunder, Distributor will be responsible for the direct costs of such Recall and will reimburse Cipher Can-Xxxx and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. (hg) If any Recall is required due to Active Ingredient side effects referred to under circumstances not covered in Section 10.4Clauses (e) or (f) above, the Parties shall be parties will equally responsible for any share the direct costs of such Recall, including direct out-of-pocket costs of and expenses related to such Recall that either Party or its Affiliates incur and will reimburse the other Party and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detailRecall.

Product Recall. 13.1 Subject to Clause 13.3.1, the costs and obligations with respect to any Recall of Product and handling enquiries and contacts from any Regulatory Authority relating to any Recall of Product shall be the responsibility of Customer. Customer shall notify all Regulatory Authorities having jurisdiction over Product (awhether or not the issue arose in the jurisdiction controlled by the Regulatory Authority) Distributor will maintain or cause of any Recall, and shall be responsible for coordinating all necessary activities regarding the action taken. CMC shall, at Customer’s expense, provide all reasonable assistance to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the Product, including inventory withdrawal Customer in connection with any of the foregoing (Recall. The Parties agree to keep each a “Recall”). (b) Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing advised of any information which indicates a Recall Recall, the progress of undertaking any Product Recall, and to exchange copies of such documentation as may be necessaryreasonably required, any safety or to assure regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring compliance with a Recall. 13.2 If either Party has reason to believe that any Product (cwhether the Product itself or particular Batch(es)) To should be Recalled, such Party shall promptly inform the extent permitted other in writing, to also include the reasons and explanations for the Recall, prior to taking any such action. In addition, Customer shall give CMC prompt written notice of any Recalls that Customer believes were caused by circumstancesor may have been caused by CMC’s failure to comply with its obligations under this Agreement. 13.3 If any Product is Recalled for safety reasons or due to a mandatory notification from a Regulatory Authority dictating the Recall and, in either case, such reasons are solely as a result of CMC’s failure to manufacture Product in accordance with the terms of this Agreement or cGMP (“CMC Failure”), then CMC shall, subject to Clause 12, reimburse Customer for all reasonable expenses incurred by Customer in undertaking the Recall of those specific Products which are the subject of a CMC Failure. Such payment shall be made within forty-five (45) days after Customer providing CMC with an invoice for such costs. If CMC disputes that the Recall is: 13.3.1 due to safety reasons or mandatory notification from a Regulatory Authority dictating the Recall then the Parties will confer before initiating shall mutually select a regulatory expert to evaluate whether the Recall was appropriate to address the safety reason or comply with the Regulatory Authority’s notice (as applicable); and/or 13.3.2 due to CMC’s CMC Failure, then the Parties shall mutually select an independent laboratory to evaluate whether the Product is defective due to CMC’s CMC Failure; and COMMERCIAL SUPPLY Agreement the evaluation(s) by the regulatory expert and/or independent laboratory shall be binding on the Parties (other than where such decision is a manifest error). If such evaluation substantially supports CMC’s basis(es) for the dispute, then CMC shall not be responsible for any costs of the Recall. If Subject to Clauses 9 and 12, any payment by CMC under this Clause 13.3 shall be Customer’s sole remedy for the Parties do not agree on the need for or the extent costs of such a Recall, either Party may authorize the Recall. (d) Each Party will cooperate fully with the 13.4 In all circumstances other Party in connection with any Recall efforts. (e) Distributor than those explicitly identified under Clause 13.3, Customer shall be responsible for the carrying out of any and all Recalls in accordance with applicable Laws. (f) If any Recall is required (I) due to the failure of the Product to conform to the Specifications at the time title is transferred to Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratory, or (II) due to the fact that Product samples (both retention and stability) stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples), Cipher will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Price of undertaking any Product subject to the Recall and, if the Parties are unable to agree, then Cipher shall supply to Distributor replacement Product that conforms to the Specifications and Distributor will distribute the replacement Product. (g) If any Recall is required in circumstances other than provided for in Section 5.3(f) and (h), Distributor will be responsible for the direct costs of such Recall and will reimburse Cipher and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. (h) If any Recall is required due to Active Ingredient side effects referred to in Section 10.4, the Parties shall be equally responsible for any direct out-of-pocket costs of such Recall that either Party or its Affiliates incur and will reimburse the other Party and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail.

Product Recall. 13.1 Subject to Clause 13.3.1, the costs and obligations with respect to any Recall of Product and handling enquiries and contacts from any Regulatory Authority relating to any Recall of Product shall be the responsibility of Customer. Customer shall notify all Regulatory Authorities having jurisdiction over Product (awhether or not the issue arose in the jurisdiction controlled by the Regulatory Authority) Distributor will maintain or cause of any Recall, and shall be responsible for coordinating all necessary activities regarding the action taken. AGC shall, at Customer’s expense, provide all reasonable assistance to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the Product, including inventory withdrawal Customer in connection with any of the foregoing (Recall. The Parties agree to keep each a “Recall”). (b) Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing advised of any information which indicates a Recall Recall, the progress of undertaking any Product Recall, and to exchange copies of such documentation as may be necessaryreasonably required, any safety or to assure regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring compliance with a Recall. 13.2 If either Party has reason to believe that any Product (cwhether the Product itself or particular Batch(es)) To should be Recalled, such Party shall promptly inform the extent permitted by circumstancesother in writing, to also include the Parties will confer before initiating any Recall. If reasons and explanations for the Parties do not agree on the need for or the extent of such a Recall, either Party prior to taking any such action. In addition, Customer shall give AGC prompt written notice of any Recalls that Customer believes were caused by or may authorize the Recallhave been caused by AGC’s failure to comply with its obligations under this Agreement. (d) Each Party will cooperate fully with the other Party in connection with any Recall efforts. (e) Distributor shall be responsible for the carrying out of any and all Recalls in accordance with applicable Laws. (f) 13.3 If any Recall Product is required (I) Recalled for safety reasons or due to the failure of the Product to conform to the Specifications at the time title is transferred to Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratory, or (II) due to the fact that Product samples (both retention and stability) stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or mandatory notification from a mutually acceptable Third Party laboratory (for retention samples), Cipher will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Price of any Product subject to Regulatory Authority dictating the Recall and, if in either case, such reasons are directly a result of AGC’s failure to manufacture Product in accordance with the Parties are unable to agreeterms of this Agreement or the Commercial Quality Agreement or [***] (“Manufacturing Failure”), then Cipher AGC shall, subject to Clause 12, reimburse Customer for all reasonable expenses actually and properly incurred by Customer in undertaking the Recall of those [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED COMMERCIAL SUPPLY AGREEMENT specific Products which are the subject of a Manufacturing Failure. Such payment shall supply to Distributor replacement Product that conforms to the Specifications and Distributor be made within [***] days of Customer providing AGC will distribute the replacement Product. (g) If any Recall is required in circumstances other than provided for in Section 5.3(f) and (h), Distributor will be responsible for the direct costs a detailed breakdown of such Recall and will reimburse Cipher and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related responses to such Recall.all requests for clarification by AGC with respect thereto. If AGC disputes that the Recall is: (h) If any Recall is required 13.3.1 due to Active Ingredient side effects referred to in Section 10.4, safety reasons or mandatory notification from a Regulatory Authority dictating the Recall then the Parties shall mutually select a regulatory expert to evaluate whether the Recall was appropriate to address the safety reason or comply with the Regulatory Authority’s notice (as applicable); and/or 13.3.2 due to AGC’s Manufacturing Failure, then the Parties shall mutually select an independent laboratory to evaluate whether the Product is Defective due to AGC’s Manufacturing Failure; and the evaluation(s) by the regulatory expert and/or independent laboratory shall be equally responsible for binding on the Parties (other than where such decision is a manifest error). If such evaluation upholds any direct out-of-pocket part of AGC’s dispute then the Parties shall share the costs of such the Recall that either Party or its Affiliates incur pro rata. Subject to Clauses 9 and will reimburse 12, any payment by AGC under this Clause 13.3 shall be Customer’s sole remedy for the other Party and its Affiliates within ten (10) Business Days after receipt costs of an invoice with supporting detailthe Recall.

Product Recall. (a) Distributor CKD will maintain or cause to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the Product, Product including inventory withdrawal in connection with any of the foregoing (each a “Recall”). (b) Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing of any information which indicates a Recall of any Product may be necessary, any safety or regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring a Recall. (c) To the extent permitted by circumstances, the Parties will confer before initiating any Recall. If the Parties do not agree on the need for or the extent of such a Recall, either Party may authorize the Recall. (d) Each Party will cooperate fully with the other Party in connection with any Recall efforts. (e) Distributor CKD shall be responsible for the carrying out of any and all Recalls with respect to the Product in the Territory in the Field in accordance with applicable Laws. (fe) If any Recall is required primarily and substantially because of (Ii) due to the breach of Can-Xxxx of a representation, warranty or covenant hereunder, or (ii) failure of the Product to conform to the Specifications at the time title is transferred to Distributorthe CKD, as subsequently confirmed by a mutually acceptable Third Party laboratoryLaboratory, or (II) due to the fact that Product samples (both retention and stability) stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples), Cipher Can-Xxxx will be responsible for the direct costs of such Recall, will reimburse DistributorCKD, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail Sublicensees for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Transfer Price of any Product subject to the any Recall and, if the Parties are unable to agree, then Cipher Can-Xxxx shall supply to Distributor CKD free of cost and expense replacement Product that conforms to the Specifications and Distributor CKD will distribute the replacement Product. (gf) If any Recall is required primarily or substantially in circumstances other than provided for in Section 5.3(f) and (h)caused by the negligence, Distributor mistake, fault, error or omission of CKD, its Affiliates or Sublicensees, including any breach by CKD of a representation, warranty or covenant hereunder, CKD will be responsible for the direct costs of such Recall and will reimburse Cipher Can-Xxxx and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. (g) If any regulatory authority in any territory other than the Territory (the “Other Territory”) orders or requires the recall of any of the Products in the Other Territory, or in Can-Xxxx’x opinion a recall is recommended, Can-Xxxx will promptly notify CKD regarding such recall order or requirement and provide such information regarding such recall order or requirement as may be reasonably requested by CKD. If at any time Can-Xxxx believes that a recall of any of the Products is required pursuant to the laws and regulations of the Other Territory, Can-Xxxx will promptly notify CKD of such requirement and provide such information regarding such laws, regulations and requirements as may be reasonably requested by CKD in connection with initiating such recall. Following such notification, Can-Xxxx shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a regulatory authority, in which case it shall be required) or to take other corrective action in the Other Territory and the manner in which any such recall, market withdrawal or corrective action shall be conducted. All expenses and costs resulting from and related to the recall of the Product in the Territory as a result of a recall in a Other Territory shall be borne by the Can-Xxxx and Can-Xxxx shall promptly reimburse CKD for all out-of-pocket direct costs incurred by CKD to carry out such recall. In such case, Can-Xxxx shall replace the Product that has been recalled, including expedited shipping costs and costs and expenses associated with hiring or contracting with personnel to conduct the recall. (h) If any Recall is required due to Active Ingredient side effects referred to under circumstances not covered in Section 10.4Clauses ‎(e), ‎(f) or (g) above, the Parties shall be parties will equally responsible for any share the direct costs of such Recall, including direct out-of-pocket costs of and expenses related to such Recall that either Party or its Affiliates incur and will reimburse the other Party and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detailRecall.