Common use of Recalls Clause in Contracts

Recalls. Vendor agrees to promptly notify Division after becoming aware of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.

Recalls. Vendor agrees The Parties agree that the procedure for a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate a recall. In the event of a product recall, Mylan shall provide all necessary lists; Insys shall be responsible for all FDA contacts. In the event that the FDA or other governmental body orders a recall with respect to promptly notify Division after becoming any Product supplied hereunder or a recall is voluntarily initiated by Mylan, and the cause of such recall is due to (a) a breach by Insys of any of its representations, warranties, obligations, covenants or other agreements contained herein or in other written agreements between the Parties, then Insys shall be liable, and shall reimburse Mylan for the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating to or arising out of such recall, or (b) a breach by Mylan of any of its representations, warranties, obligations, covenants or other agreements contained herein, then Mylan shall be liable and shall reimburse Insys for its reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating to or arising out of such recall; provided that if both parties share responsibility with respect to such recall, the costs shall be shared in the ratio of the Parties’ contributory responsibility. Insys and Mylan agree to abide by all Healthcare Distribution Management Association published guidelines for product recall reimbursement. The Parties shall each maintain traceability records as are sufficient and as may be necessary to permit a recall. The Parties agree that if either Party shall discover or become aware of any patient safety issue involving the Products fact, condition, circumstance or Services. If any Product event (whether actual or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, potential) concerning or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall related to the FDAProduct which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. Notices In the event (a) the FDA or other governmental body requests that the Product be recalled or (b) a court of competent jurisdiction orders such a recall, the Parties shall take all appropriate remedial actions with respect to Division such recall. The obligations under this Section shall survive the complete or partial termination of this Agreement. Each Party shall make every reasonable effort to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated reimbursed by the FDA, if applicable, other Party pursuant to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated ProductsSection.

Recalls. Vendor agrees In the event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform to promptly notify Division after becoming aware the Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of any patient safety issue involving the Products or Servicesrecall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. If any Product or any Adams shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its components is subject warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to recall each party's percentage of fault as that term is defined under 21 C.F.R. Part 7determined jointly by the parties, or a voluntary recall by VendorPROVIDED, or is subject to HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated court action for removing or correcting violative, distributed nationwide recall where the scope of the recall is directed at all products or components (containing any of the foregoing being referred active ingredients in the Drug Product and where the purpose of such recall is not attributable to as a “Recall”)the fault of either Adams or Cardinal, Vendor Adams shall notify Purchasers be responsible for all Adams and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice Cardixxx xxpenses of the Recall to xxxxll, PROVIDED, HOWEVER, THAT NEXXXXX PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. For the FDA. Notices to Division purposes of this Agreement, the expenses of recall shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by include, without limitation, the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor expenses of notification or Distributor (if purchased from a Distributor) any Products where the Products destruction or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected recalled Drug Product and shall reimburse each Purchaser Adams' or Cardinal's total, unrecoverable, actual, internal costs for Purchaser’s original costs, including freight, in acquiring each affected Product. To xxxxfacturing and shipping the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related Drug Product that was later subject to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productsrecall.

Recalls. Vendor agrees to promptly notify Division after becoming aware of any patient safety issue involving In the Products or Services. If event: (a) Purchaser reasonably determines that any Product should be recalled due to its non-conformance with the terms of this Agreement; (b) any Applicable Regulatory Agency issues a request, directive or order that any Product be recalled; or (c) a court of its components is subject to competent jurisdiction orders such a recall as that term is defined under 21 C.F.R. Part 7(either (b) or (c) together, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “RecallOrder”), Vendor each Party shall notify Purchasers and Division within twenty-four (24) hours after becoming aware take all appropriate corrective actions reasonably requested by the other Party or any Applicable Regulatory Agency. Only Purchaser is authorized to conduct a recall of a Product. Supplier shall cooperate fully with Purchaser in the event of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, recall and provide such assistance in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each connection therewith as Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Productmay reasonably request. To the extent such Recall precludes Vendor from supplying recall solely results from: (i) Supplier’s failure to properly and completely perform any Products covenant, agreement or Services undertaking on the part of Supplier contained in this Agreement, including supply of Product that conforms to Specifications; (ii) the negligence or willful misconduct of Supplier or its directors, officers, employees, agents, contractors, successors and assigns; or (iii) Supplier’s failure to follow Applicable Laws to the extent required under this Agreement, then Supplier shall be responsible for: (x) its own out-of-pocket costs for such recall; (y) Purchaser’s reasonable and documented out-of-pocket costs for such recall; and (z) replacing as soon as commercially practicable, at no cost or expense to Purchaser, Product that conforms to the Specifications. If and to the extent the recall results from any other reason, Purchaser compliance requirements shall be responsible for its costs of such recall and Supplier’s reasonable and documented out-of-pocket costs for such recall. For purposes of this Agreement, out-of-pocket costs of such recall shall be all direct expenses incurred by either Party relative to notification, shipping, disposal and return of the recalled or purchase requirements under withdrawn Product, which shall include making Purchaser whole, subject to Section 16.3 (Limitation of Liability) on consumer returns of the Product at retail. The Parties have the right to audit such recall costs. Purchaser shall be responsible for coordinating any and all such recall activities with the Regulatory Agencies, its customers or otherwise. Purchaser and Supplier shall agree on all public statements regarding any recall, and neither Party shall make any public statements regarding this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Productswithout the Party’s prior, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productswritten approval.

Recalls. Vendor agrees to will promptly notify Division after HealthTrust upon becoming aware of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division HealthTrust within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division HealthTrust shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. If a Recall notice suggests or requires that a Product or any component of a Product be returned or otherwise removed from use, Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any such Products where the Products or any components therein are subject to a Recallat Vendor’s expense, regardless of whether actual including return of the Products or components to Vendor or any Distributor is requiredshipping, recommended, or suggested by the Recall, in which case and Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s its original costs, including freight, in acquiring each affected such Product. For any other Recall, which provides Purchaser the option of Vendor repair or replacement of the Product, if Vendor is unable to do so to Purchaser’s satisfaction, Purchaser shall have the right to return the Product for reimbursement and refund at Vendor’s expense as provided in the preceding sentence. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products Purchaser-Specific Agreement shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, and a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable Vendor’s inability to provide said designated Productssupply.

Recalls. Vendor agrees to promptly notify Division HPG after becoming aware of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division HPG within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division HPG shall be sent by e-mail to: * Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission. xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.

Recalls. Vendor agrees XANODYNE, with data and assistance provided by DSM, is responsible for filing Field Alerts and initiating product recalls due to promptly notify Division after becoming aware any defect considered sufficiently serious. XANODYNE will provide DSM with a copy of any patient safety issue involving regulatory correspondence related to field alerts or recalls, in the event that DSM has reason to believe that any Products should be recalled or Serviceswithdrawn from distribution, DSM shall promptly inform XANODYNE in writing prior to taking any such action. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor XANODYNE shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, DEA, and any foreign regulatory agencies of any recall, and shall be responsible for coordinating all necessary activities regarding the action taken. XANODYNE acknowledges and understands that DSM, as manufacturer of the Product, has significant regulatory obligations if applicablethere are any indications that recall or withdrawal would be necessary. Accordingly, DSM and XANODYNE agree to cooperate fully regarding any proposed recall, product withdrawal, or field correction; and the Parties agree to keep each other advised, and to exchange copies of such documentation as may be required, to address such Recall with each Purchaserassure regulatory compliance. Purchasers shall have With prior notification to the right other party, either party may, in exigent circumstances, make a unilateral, final decision to return to Vendor or Distributor (if purchased from notify appropriate regulatory agencies, 27 DISPUTE RESOLUTION In the event that a Distributor) any Products where dispute arises between DSM and XANODYNE regarding the Products or any components therein are subject to nonconformity of a Recall, regardless of whether actual return batch of the Products or components regarding other matters, the senior management of the quality departments from both companies shall in good faith promptly attempt to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Productsresolve disputed issues. If any the parties cannot reach agreement, the matter shall be resolved in accordance with dispute resolution provisions of the Supply Agreement. XANODYNE may only dispute a batch of Product, which has been dispositioned by DSM for release. Xanodyne Corporate Quality Assurance retains at all times the right to determine Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements release status for designated Productscommercial distribution. Financial liability shall be determined according to the Supply Agreement. APPENDIX I: OUTLINE OF RESPONSIBILITIES FUNCTION DSM XANODYNE -------- ---- -------- MANUFACTURING [**] [**] In-Process TESTING (Physical, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.Chemical Microbial) [**] [**] FP TESTING - Physical, Chemical [**] [**] FP TESTING - Sterility [**] [**] FP RELEASE [**] [**] DISTRIBUTION [**] [**] FP RETAINS [**] [**] FP STABILITY [**] [**] C OF A [**] [**] BATCH RECORD REVIEW/SIGNOFF [**] [**] INVESTIGATIONS INTO DEVIATIONS AND NON-CONFORMANCES [**] [**] COMPLAINT RECEIPTS [**] [**] COMPLAINT INVESTIGATIONS [**] [**] ADVERSE EVENT REPORTS [**] [**] FIELD ALERT REPORTS [**] [**] RECALLS [**] [**] CUSTOMER RETURNS [**] [**] RAW MATERIAL (Active) ORDERS [**] [**] RAW MATERIAL (Active) TESTING AND Release [**] [**] RAW MATERIAL (Inactives/Printed Packaging Materials) ORDERS [**] [**] RAW MATERIALS (Inactives/Printed Packaging Materials) TESTS [**] [**] RAW MATERIAL (Inactives/Printed Packaging Materials) RELEASE [**] [**] SUPPLIER AUDITS (Active) [**] [**] SUPPLIER AUDITS (Inactives/Printed Packaging Materials) [**] [**] MAINTENANCE OF VENDOR LISTS [**] [**] NOTICE OF PROPOSED CHANGES [**] [**] DOCUMENT CHANGE CONTROL [**] [**] ANNUAL Product REVIEW [**] [**] APPENDIX II: CONTACT INFORMATION XANODYNE KEY CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- --------- ---------------------- -------------- G. Xxxxx Xxxxx Director, 859-547- 859-814- General Quality xxxxxx@xxxxxxxx.xxx Quality 0000 0000 (cell) Assurance Xxxxxx X. Xxxxx Manager, 859-547- 859-992- General Quality xxxxxx@xxxxxxxx.xxx Quality 00000 0000 (cell) Assurance OSM Key CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- ----------------- ------------------------ -------------- Xxxxxx XX, Quality Ph: 000-000-0000 General Quality Norton Assurance xxxxxx.xxxxxx@xxx.xxx Xxx Xxxxx Director, Quality Ph: 000-000-0000 rob. Manufacturing Assurance xxxxx@dsm. com Oversight Xxxxx Xxxxxxxxxx Director, Quality Ph: 000-000-0000 Lab Oversight Assurance xxxxx.xxxxxxxxxx@xxx.xxx Will Mitten Director, Lab Ph: 000-000-0000 Lab Services Services xxxx.xxxxxx@xxx.xxx Xxxx Xxxxxxxx Manager, Ph: 000-000-0000 xxxx. Stability Stability xxxxxxxx @dsm. com Xxxx Manager, Quality Ph: 000-000-0000 APRs, Complaints, Xxxxxxx Assurance xxxx.xxxxxxx@xxx.xxx Audits, APPENDIX III: PRODUCTS DARVOCETN-100 QUALITY AGREEMENT HISTORY OF CHANGES VERSION DATE NAME REVISIONS/COMMENTS ------- ---- ---- ------------------ EXHIBIT D: CONFIDENTIALITY AGREEMENT

Recalls. Vendor agrees to promptly notify Division after becoming aware of In the event (i) any patient safety issue involving the Products Regulatory Authority issues a request, directive or Services. If any order that Licensed Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7be recalled, or (ii) a voluntary recall by Vendorcourt of competent jurisdiction orders such a recall, or is subject (iii) Pacira reasonably determines after consultation with Aratana that the Licensed Product should be recalled because the Licensed Product does not conform to an FDA-initiated court action the applicable Specification at the time of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. shipment by Pacira, the Parties will take all appropriate corrective actions reasonably requested by the other Party hereto or by any Regulatory Authority. In the event that such recall (a) results from the breach of Pacira’s warranties under Section 7.2 of this Agreement, Pacira will be responsible for removing or correcting violative, distributed products or components (any all of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers costs and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice expenses of the Recall to recall or (b) results from the FDA. Notices to Division shall breach of Aratana’s warranties or covenants under this Agreement, Aratana will be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return responsible for all of the Products or components to Vendor or any Distributor is required, recommended, or suggested by costs and expenses of the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Productrecall. To the extent that such Recall precludes Vendor from supplying any Products recall is not covered by either clause (a) or Services under (b) of the immediately preceding sentence, then Pacira and Aratana shall share equally the costs and expenses of the recall. For the purposes of this Agreement, the expenses of the recall will be the expenses of notification and destruction or return of the recalled Licensed Product, as well as any Purchaser compliance requirements reasonable out-of-pocket costs incurred by Pacira and/or Aratana in connection with any corrective action taken by Pacira and Aratana. Notwithstanding anything to the contrary, to the extent that a recall of the Licensed Product is caused by a Party’s gross negligence or purchase requirements under this Agreement willful misconduct, all costs and expenses of the recall (regardless of the Party incurring such cost or any facility agreement between any Purchaser expense) shall be borne by the responsible Party (and Vendor related to the responsible Party shall promptly reimburse the other Party for such Products shall not be effective for as long as Vendor is unable to supply Recall Expenses incurred in connection with such Products. If any Product pricing is dependent recall upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productsreceipt of an invoice therefor).

Recalls. Vendor agrees to promptly notify Division after becoming aware of In the event (i) any patient safety issue involving the Products Regulatory Authority issues a request, directive or Services. If any order that Licensed Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7be recalled, or (ii) a voluntary recall by Vendorcourt of competent jurisdiction orders such a recall, or is subject (iii) Pacira reasonably determines after consultation with Aratana that the Licensed Product should be recalled because the Licensed Product does not conform to an FDA-initiated court action the applicable Specification at the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. time of shipment by Pacira, the Parties will take all appropriate corrective actions reasonably requested by the other Party hereto or by any Regulatory Authority. In the event that such recall (a) results from the breach of Pacira’s warranties under Section 7.2 of this Agreement, Pacira will be responsible for removing or correcting violative, distributed products or components (any all of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers costs and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice expenses of the Recall to recall or (b) results from the FDA. Notices to Division shall breach of Aratana’s warranties or covenants under this Agreement, Aratana will be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return responsible for all of the Products or components to Vendor or any Distributor is required, recommended, or suggested by costs and expenses of the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Productrecall. To the extent that such Recall precludes Vendor from supplying any Products recall is not covered by either clause (a) or Services under (b) of the immediately preceding sentence, then Pacira and Aratana shall share equally the costs and expenses of the recall. For the purposes of this Agreement, the expenses of the recall will be the expenses of notification and destruction or return of the recalled Licensed Product, as well as any Purchaser compliance requirements reasonable out-of-pocket costs incurred by Pacira and/or Aratana in connection with any corrective action taken by Pacira and Aratana. Notwithstanding anything to the contrary, to the extent that a recall of the Licensed Product is caused by a Party’s gross negligence or purchase requirements under this Agreement willful misconduct, all costs and expenses of the recall (regardless of the Party incurring such cost or any facility agreement between any Purchaser expense) shall be borne by the responsible Party (and Vendor related to the responsible Party shall promptly reimburse the other Party for such Products shall not be effective for as long as Vendor is unable to supply Recall Expenses incurred in connection with such Products. If any Product pricing is dependent recall upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productsreceipt of an invoice therefor).

Recalls. Vendor agrees to promptly notify Division after becoming aware of any patient safety issue involving Principal may cease selling the Products in any Country/Region in the Territory at any time during the Term and recall the Products within any Country/Region in the Territory as necessary if any of the below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Country/Region in the Territory: unforeseen effects of the relative type of the Products lead to, in Principal's sole opinion, unacceptable safety risks; Principal ceases the sale of the Products worldwide for any reason; a Governmental Authority requests the cessation of the sale of Products in any Country/Region in the Territory; Principal may cease the sale of the Products in any Country/Region in the Territory for safety concerns; Principal may transfer or Servicescease all or part of the business related to the Products; or other circumstances of recalls as required under the Applicable Law. If The Distributor undertakes with respect to any Product product recall that: (i) it will implement and complete the recall of the Products within the Territory by the statutory deadline or a shorter period as reasonably requested by Principal in all aspects in strict compliance with the Applicable Law; and (ii) it shall provide full cooperation to Principal, including timely transmitting and providing feedbacks of drug recall information, controlling and recovering drugs with potential safety hazards. The Distributor may not recall any of the Products from any of the Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following the decision to implement a Recall, Principal and Distributor shall mutually agree on a prepared statement for use in response to any inquiries regarding such Recall. Distributor shall use such prepared statement to respond to any inquiries received with regard to such Recall and shall not make any other statement regarding such Recall; provided, that if Principal fails to agree with Distributor on a prepared statement prior to the launch of such Recall, Distributor shall prepare and issue the statement as proposed by Principal regarding such Recall. To the extent the Products are recalled due to causes other than Distributor’s non-compliance with relevant obligations under this Agreement, Principal shall (a) indemnify the Distributor for the costs and expenses reasonably incurred by the Distributor for recalling the Products and for any subsequent disposal or destruction of the same; and (b) repurchase the Products that are subject to the Recall at the purchase price paid by the Distributor and in addition pay Distributor a handling charge equal to 10% of the purchase price. In the event that the Products are recalled due to Distributor or its Permitted Sub-distributors’ or any of its components Representatives’ negligence or wilful misconduct or its breach of this Agreement, the Distributor shall (a) indemnify the Principal for the costs and expenses reasonably incurred by the Principal for recalling the Products and for any subsequent disposal or destruction of the same; and (b) indemnify the Principal for its loss or damages caused by such Recall. Principal shall in connection with any Recall be entitled, upon reasonable prior notification and during Business Hours, to inspect and audit the conduct of such Recall, including Distributor's recall procedures, Distributor's records relating to the distribution and sales of the Recalled Products, Distributor's records relating to such Recall and the costs incurred by Distributor in connection with implementing such Recall. In the event of a Recall, the obligations of Distributor to sell the Recalled Products in the Territory and of Principal to supply such Recalled Products to Distributor pursuant to this Agreement shall be suspended with immediate effect and such obligations shall only become enforceable again if and when the circumstances that caused the Recall have been resolved. If the Recalled Products are thereafter totally withdrawn from the Territory for the remainder of the Term, then Principal may by written notice to Distributor terminate the Recalled Products from the Territory. The Distributor shall inform Principal immediately upon being informed about any defective products returned to the Distributor or detected in the Distributor's inventory. The Distributor shall inform Principal immediately about any complaint received. The Distributor shall be responsible for the collection and investigation of End Ccustomers' complaints (whether these customers complain to the Distributor directly or forwarded by Principal and/or its Affiliates), and retain accurate records of such collections and investigations and maintain appropriate records during the Term. AUDIT RIGHTS AND REPORTING During the Term, Principal shall be entitled, through itself or an independent audit firm appointed by Principal (the "Independent Auditor"), to inspect and audit (i) such books, documents, papers and records which relate to sales of the Products or any costs and expenses invoiced or charged by Distributor to Principal in connection with this Agreement, (ii) Distributor's compliance with Clause 1817, and (iii) all facilities of Distributor in which Distributor performs its obligations under this Agreement and maintains inventory of the Products (an "Audit"). If an Audit reveals matters that Principal determines should be corrected by Distributor, Principal shall provide a list of such matters and may propose corrective action to be taken by Distributor. Distributor shall respond within 15 days of receipt of such notification indicating the corrective action to be taken and an estimated completion date. The Audit of any books, documents, papers or records that relate to or contain any information regarding any business dealings with or the affairs of any other client or principal of Distributor may only be conducted by the Independent Auditor. Such Independent Auditor shall (i) provide a copy of the audit report to Distributor no later than thirty (30) Business Days after such report is subject provided to recall as Principal and (ii) disclose to Principal relevant necessary information to enable Principal to determine whether Distributor is in compliance with this Agreement or not, and in any event shall never disclose to Principal any information regarding any business dealings with or the affairs of any other client or principal of Distributor that term such Independent Auditor may come across in the course of performing its audit under this provision, unless it is defined under 21 C.F.R. Part 7required by Applicable Law. Principal shall not request an Audit more than once each Calendar Year, unless required more frequently by any regulatory authorities which have regulatory oversight over Principal or the Products, or a voluntary recall unless breaches of Distributor's obligations under this Agreement have been identified in the course of an Audit or in the inspection by Vendorany competent authorities and subsequent Audits are required to confirm that Distributor has remedied such breaches. All Audits, including the cost of the Independent Auditor, shall be solely at Principal's expense unless the results of audit demonstrate that Distributor had failed to make due payment to Principal of an amount exceeding 5%, or is subject Distributor had breached a material obligation under this Agreement. All Audits shall take place only during Business Hours and only upon at least seven Business Days prior written notice to an FDA-initiated court action for removing Distributor. During any audits, inspections or correcting violativeexaminations conducted by Principal or any authorised agent under this Agreement, distributed products including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or components (any of the foregoing being referred to as a “Recall”)Clause 19.6, Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor Principal agrees that it and its duly authorised agents, including any Independent Auditor: will comply abide by all internal regulations and policies of Distributor enforced at such time; will not interfere with the business or operation of Distributor; and without prejudice to any process mandated confidentiality limitations in this Agreement, shall at the request of Distributor enter into a separate non-disclosure agreement prepared by Distributor, prior to being granted access to any of Distributor's premises, books, documents, papers or records. In the FDAevent that the result of Audit demonstrates that Distributor fails to make due payment to Principal, or Distributor had breached any of its obligation under this Agreement, Distributor shall cure such breach within 30 days (in the case of a failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if applicableDistributor fails to do so, to address such Recall with each Purchaser. Purchasers Principal shall have the right to return terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties shall in good faith agree on a Safety Data Exchange Agreement (as set forth in Exhibit G) that sets out the responsibilities of each Party with respect to Vendor or Distributor (if purchased from a Distributor) any Products where the pharmacovigilance matters relating to the Products or any components therein are subject as soon as practicable after the execution of this Agreement. The Parties shall in good faith agree on the Quality Agreement that sets out the responsibilities and processes for quality activities with respect to a Recallsupply, regardless distribution and quality management relating to the Products as soon as practicable after the execution of whether actual return this Agreement. INTELLECTUAL PROPERTY Principal warrants to Distributor that throughout the Term: it has and will continue to have full legal rights to use the Licensed Marks and to grant the use of the Licensed Marks to Distributor; it has and will continue to have full legal rights to use the patents, formulae and all other intellectual property rights employed in the development and production of the Products; and to the best knowledge of Principal, the exercise by Distributor of the rights and licences granted to Distributor under this Agreement (including the use of the Licensed Marks) and the distribution, offer for sale and sale of the Products by Distributor would not infringe any right (including intellectual property rights) of any person or components give rise to Vendor any liability to pay royalty or any other compensation. The warranties in this Clause 21.1 are separate and independent and shall not be limited by anything in this Agreement. Principal hereby authorises Distributor is required, recommended, or suggested by to use the Recall, Licensed Marks in which case Vendor shall pay all freight costs incurred the Territory in relation to the Products for the return purpose only of each affected Product exercising its rights and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services performing its obligations under this Agreement. Principal agrees that no payment shall be due from Distributor to Principal in connection with such use. Distributor shall promptly inform Principal of any actual, threatened or suspected infringement in the Territory of the Licensed Marks or other intellectual property rights of Principal relating to the Products which comes to the notice of Distributor, and of any Purchaser compliance requirements claim by any person coming to its notice that the sale or purchase requirements under distribution of the Products in the Territory infringes any rights of any other person. Distributor shall provide such information and assistance to Principal as Principal may reasonably require in taking or resisting any proceedings in relation to any such infringement or claim. Distributor shall not: alter, remove or tamper with any of the Licensed Marks, numbers, or other means of identification used on or in relation to the Products; or use any of the Licensed Marks in any way which might prejudice their distinctiveness or validity or the goodwill of Principal therein; Distributor hereby acknowledges that, except as expressly provided in this Agreement or any facility agreement between any Purchaser and Vendor related to such Products Agreement, Distributor shall not be effective for as long as Vendor is unable acquire any other rights in respect of the Licensed Marks from the distribution and sales of the Products and the use of the Licensed Marks pursuant to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productsthis Agreement.

Recalls. Vendor agrees to will promptly notify Division after upon becoming aware of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx xxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. If a Recall notice suggests or requires that a Product or any component of a Product be returned or otherwise removed from use, Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any such Products where the Products or any components therein are subject to a Recallat Vendor’s expense, regardless of whether actual including return of the Products or components to Vendor or any Distributor is requiredshipping, recommended, or suggested by the Recall, in which case and Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s its original costs, including freight, in acquiring each affected such Product. For any other Recall which provides Purchaser the option of Vendor repair or replacement of the Product, if Vendor is unable to do so to Purchaser’s satisfaction, Purchaser shall have the right to return the Product for reimbursement and refund at Vendor’s expense as provided in the preceding sentence. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products Purchaser-Specific Agreement shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, and a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable Vendor’s inability to provide said designated Productssupply.

Recalls. Vendor agrees In the event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Xxxxx reasonably determines after consultations with Cardinal that a Drug Product should be recalled because the Drug Product does not conform to promptly notify Division after becoming aware the Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Xxxxx' expenses of any patient safety issue involving the Products or Servicesrecall to the extent such recall results from the breach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. If any Product or any Xxxxx shall be responsible for all Xxxxx' and Cardinal's expenses of the recall to the extent that such recall results from a cause other than Cardinal's breach of its components is subject warranties under this Agreement, PROVIDED, HOWEVER, XXXXX SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Xxxxx and Cardinal, each party shall be responsible for the expenses of recall in direct proportion to recall each party's percentage of fault as that term is defined under 21 C.F.R. Part 7determined jointly by the parties, or a voluntary recall by VendorPROVIDED, or is subject to HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated court action for removing or correcting violative, distributed nationwide recall where the scope of the recall is directed at all products or components (containing any of the foregoing being referred active ingredients in the Drug Product and where the purpose of such recall is not attributable to as a “Recall”)the fault of either Xxxxx or Cardinal, Vendor Xxxxx shall notify Purchasers be responsible for all Xxxxx and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice Cardinal expenses of the Recall to recall, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. For the FDA. Notices to Division purposes of this Agreement, the expenses of recall shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by include, without limitation, the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor expenses of notification or Distributor (if purchased from a Distributor) any Products where the Products destruction or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected recalled Drug Product and shall reimburse each Purchaser Xxxxx' or Cardinal's total, unrecoverable, actual, internal costs for Purchaser’s original costs, including freight, in acquiring each affected Product. To manufacturing and shipping the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related Drug Product that was later subject to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productsrecall.

Recalls. Vendor agrees to promptly notify Division HPG after becoming aware of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division HPG within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division HPG shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase volume requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.

Recalls. In the event Purchaser believes a Recall may be necessary with respect to a Product, Purchaser shall immediately notify Vendor agrees in writing within [**]. Vendor may at its sole discretion require Purchaser to promptly notify Division after becoming aware take part in a recall, withdrawal, customer notification or correction action with respect to the products sold to Purchaser. In the event a Recall is requested by Vendor required by the directive or order of any patient safety issue involving governmental authority or court of competent jurisdiction, Purchaser shall strictly follow Vendor’s directions or the recalling authority’s instructions for conducting the Recall and for returning or destroying and certifying destruction of the recalled Products or Servicesafter completion of the Recall and will provide reasonable cooperation and assistance to Vendor in taking all other appropriate actions. If any Product or any of its components is subject Purchaser declines to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “conduct such Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours have the authority to conduct a Recall at Purchaser’s expense beginning immediately after becoming aware of providing notice to Purchaser. Purchaser shall inform Vendor in writing before initiating or conducting any Recall or after of a Product. In the event of a Recall, Purchaser shall, upon Vendor’s request, contact the Purchaser’s customers of the affected Product, assist in arranging for return shipment of the Product to Vendor, and distribute any required notifications. Vendor’s sole liability relating to a Recall is to replace Product that is recalled with conforming Product and will be responsible for all reasonable expenses incurred by the Purchaser in the Territory that are related to the Recall. Vendor provides notice shall be responsible for the expenses of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address unless such Recall with each actions result from Purchaser. Purchasers shall have the right to return to Vendor ’s negligence or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recallwillful misconduct, in which case Vendor the Purchaser shall pay all freight costs incurred be responsible for the return those expenses. For purposes of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, the expenses of the Recall will be the reasonable direct expenses of notification and return or destruction of the recalled Products, Vendor’s cost to replace or refund the price of the recalled Product and any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such costs directly associated with distribution of replacement Products. If any Product pricing In all cases, the Purchaser shall conduct the Recall in a manner which is dependent upon a appropriate and reasonable under the circumstances and in conformity with accepted trade practices and applicable law. Purchaser meeting compliance shall deliver copies of all Recall-related records to Vendor within [**] of Purchaser receiving or purchase requirements for designated Productspreparing them. Certain confidential information contained in this document, a Purchaser’s pricing will marked by [**], has been omitted because SOPHiA GENETICS SA (SOPHiA) has determined that the information (i) is not change for failure to meet material and (ii) is the compliance type that SOPHiA customarily and actually treats as private or purchase requirements during the time period when Vendor is unable to provide said designated Productsconfidential.

Recalls. Vendor From time to time throughout the Term, AASTROM mxx xn its discretion determine that it is necessary or advisable to recall Cell Cassettes manufactured by MOLL. In such event, if AASTROM reasonably determines that the numbex xx reported incidence of defective Cell Cassettes is high in relation to AASTROM's historical incidence rate for defective Cell Cassettes and/or general medical product industry standards and AASTROM recalls one or more Shipment Lots due to a failure of such units to meet Specifications during the Warranty Period, AASTROM shall so notify MOLL of the recall and the Parties shall jointly exchange relevant ixxxxmation and consult on causation of the defective units prior to implementing the recall. In the event it is determined by the Parties that the Cell Cassettes were defective due to a failure of such units to meet Specifications during the Warranty Period, MOLL agrees to reimburse AASTROM for the reasonable direct costs incxxxxd by AASTROM in conjunction with the recall including the cost of replacing, shipping and testing the units of the Shipment Lot(s) recalled, whether or not all such units are ultimately determined to have been defective, by way of a reduction in MOLL's applicable mark-up rates (as set forth on Appendix III) to 15% xxxxl the cost ox xxe recall has been recovered by AASTROM. Any disputes regarding causation of defective units involved in a recall that cannot be resolved by the Parties will be resolved through arbitration in accordance with Section 24(b). Furthermore, in the event this Agreement is terminated for any reason prior to AASTROM recovering the full amount of its recall costs from MOLL, MOLL shall promptly notify Division after becoming aware pay to AASTROM the amount of any patient safety issue involving un-reimbuxxxx cxxxx. For the Products purpose of clarification, it is agreed that AASTROM shall be solely responsible for determining whether any product recall, correction or Services. If any Product or any of its components withdrawal is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action required and for removing or correcting violative, distributed products or components (any complying with all of the foregoing being referred medical device reporting requirements pursuant to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products21 CFR Part 803.

Recalls. Vendor agrees to promptly notify Division after becoming aware Vericel, in consultation with Xxxxxx, will prepare and maintain a written Standard Operating Procedure (“SOP”) in compliance with FDA requirements that sets forth the Parties’ respective responsibilities in handling any recalls of any patient safety issue involving Product in the Products Territory. In the event that (i) any governmental agency or Servicesauthority issues a request or directive or orders that the Product be recalled or retrieved, (ii) a court of competent jurisdiction orders that the Product be recalled or retrieved, or (iii) Vericel reasonably determines that the Product should be recalled, retrieved or a “dear doctor” letter is required relating to restrictions on use of Product, Xxxxxx will provide Vericel with any reasonable CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. If any Product or A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. assistance requested by Vericel, and the Parties will take all appropriate corrective actions and will execute the steps detailed in the SOP. Vericel will be responsible for all of the expenses of such activities, except to the extent the event causing the recall results from a breach of any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements Xxxxxx’x obligations under this Agreement or Xxxxxx’x negligence or willful misconduct. For purposes of this Agreement, the expenses may include, but are not limited to, the expenses of notification and return or destruction (if authorized by Vericel) of the Product, the cost of replacement of the Product, and any facility agreement between costs directly associated with the distribution of replacement Product. Xxxxxx and Vericel will cooperate fully with one another in conducting any Purchaser and Vendor related activity contemplated by this provision. Xxxxxx will arrange for the destruction of Product lawfully recalled only upon Vericel’s (or any regulatory authority’s) written instruction to arrange for the destruction of such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated ProductsProduct.

Recalls. Vendor agrees to promptly notify Division after becoming Nuwellis represents and warrants that Nuwellis is not aware of any patient safety issue involving facts which are reasonably likely to cause (i) a Recall of the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, Products; (ii) a change in the marketing classification or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of material change in the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return labeling of the Products or components (iii) termination or suspension of the marketing of the Products. In the event a Product is the subject of a Recall, Nuwellis shall notify DaVita within two (2) business days of being made aware of any such Recall. Nuwellis shall work in conjunction with DaVita to Vendor make all contacts with DaVita Facilities and the FDA. Nuwellis shall be responsible for coordinating all activities in connection with any such Recall and shall make all statements to the media, including press releases and interviews for publication or broadcast, provided, however, that in no event may Nuwellis reference DaVita in any such statements. DaVita reserves the right, in its sole and reasonable discretion, to take any actions necessary to comply with all applicable Laws and general guidance issued by the FDA or any Distributor is requiredapplicable Governmental Authority. DaVita may independently terminate or otherwise restrict use of any affected Products used within DaVita or DaVita Facilities (e.g., recommendedquarantine or withdraw Products or communicate with DaVita clinicians and patients) without Nuwellis’s consent. Nuwellis shall reimburse DaVita for direct and actually incurred costs related to (a) the aggregate price for all units of Products that are defective pursuant to the Recall; (b) reasonable and out-of-pocket expenses relating to such Recall, or suggested by which could include expenses associated with implementation of a strategy for the Recall, costs of cover, retrieval, transportation, examination, analysis, decontamination, destruction, correction, repair, replacement, modification, relabeling, storage, returns, recovery, cancellation charges, notifications, advertising, warnings, Recall instructions, follow-up and effectiveness checks and reconditioning); and (c) any losses incurred by DaVita or its affiliates in which case Vendor shall pay all freight costs incurred defending a third-party Claim arising out of a Recall. Any Products affected by a Recall may be returned to Nuwellis for a full refund of the return of each affected Product Purchase Price or pro ratable Rental Price, as applicable, paid by DaVita, at Nuwellis’s sole cost and shall reimburse each Purchaser for Purchaser’s original costsexpense, including freightF.O.B. Origin, in acquiring each affected ProductFreight Collect. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Supply and Collaboration Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.DaVita Confidential & Proprietary

Recalls. Vendor agrees to promptly notify Division after becoming aware of In the event that any patient safety issue involving the Products governmental agency or Services. If authority requests a recall, a field corrective action, Product withdrawal or takes similar action in connection with any Product or any of its components is subject in the event NxStage determines an event, incident or circumstance with respect to a Product has occurred that results in the need for a recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as each a “Product Recall”), Vendor NxStage shall promptly notify Purchasers and Division Customer within twenty-four (24) hours after becoming aware [**] of such governmental agency or authority request or action or of NxStage’s decision to voluntarily institute a Product Recall. In the event of a Product Recall of any Product, NxStage shall (a) reimburse Customer and the Authorized Customer Locations for reasonable handling expenses incurred in returning units of such Product to NxStage or otherwise implementing the Product Recall; and (b) use all commercially reasonable efforts to promptly repair or replace the Product subject to a Product Recall with another NxStage Product performing the same function in good working order. NxStage shall allocate replacement Products to Customer and the Authorized Customer Locations on a first-priority basis consistent with Customer’s and the Authorized Customer Locations’ then-current share of NxStage’s Product base that has been purchased, and consistent with the then-affected prescription items included in Customer’s and the Authorized Customer Locations’ Monthly Dialysis Supplies orders. In addition to the foregoing, if NxStage is unable to repair or after Vendor provides notice replace a recalled Cycler or PureFlow SL purchased by Customer or any Authorized Customer Location, such that such purchased Cycler or PureFlow SL is therefore rendered unusable and continues to be unusable for a period of [**] consecutive months (for purposes hereof, a purchased Cycler or PureFlow SL shall not be unusable if it can be used with other non-NxStage products, consistent with then-current product labeling), NxStage shall be obligated to pay Customer and the Authorized Customer Locations actual damages within [**] days of the Recall expiration of such [**] month period (with the amount of such damages to be mutually agreed upon by the parties in good faith, up to the FDAamount of Customer’s and the Authorized Customer Locations’ then-current [**] for the purchased Cyclers and/or Pure Flow SLs which Customer and the Authorized Customer Locations have been prevented from using for [**] consecutive months (measured as of the date of such Product Recall); provided that such [**] is calculated in good faith and in accordance with generally accepted accounting standards). Notices NxStage’s obligation to Division make any payment pursuant to this Section 3 of Schedule C may be accelerated to the date of filing of a voluntary or involuntary bankruptcy proceeding with respect to NxStage or the date NxStage refunds, all or any significant portion of, the purchase price of any Cyclers and/or PureFlow SLs that have been the subject of a Product Recall (and where such refund is specifically provided solely in connection with, and due to, such Product Recall) to any other customer or group of customers that has purchased such Cyclers and/or PureFlow SLs for the treatment of chronic home hemodialysis patients (it being understood that Customer’s and the Authorized Customer Locations’ right to damages hereunder shall not be so accelerated if such refund involves no more than [**] Cyclers and/or PureFlow SLs in the aggregate across all other NxStage chronic customers). No other remedy shall be sent provided to Customer or any Authorized Customer Location in connection with a Product Recall, except as set forth in Section 22 of the Agreement. In the event NxStage elects to obtain recall insurance covering a Product Recall of any purchased Cyclers and/or PureFlow SLs, Customer and NxStage agree that the parties shall share the cost of such insurance coverage, up to a maximum amount of $200,000 per party per annum; provided that Customer shall consider in good faith requests made by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor NxStage to share insurance costs in excess of $200,000. Any recall insurance obtained by NxStage, shall name Customer and the Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such policy shall offset any damages determined to be owed to Customer or any Authorized Customer Location hereunder pursuant to the foregoing terms, with NxStage obligated to pay any remainder pursuant to the terms hereof. If, during the Term, NxStage contractually agrees with one or more other customers purchasing any of NxStage’s home hemodialysis products in the continental United States to provide [**] provisions to such customer(s) that are more favorable to such customer(s) than are set forth in Section [**] of the Agreement and Sections [**] of this Schedule C, NxStage agrees that it will comply shall promptly offer such [**] provisions to Customer, on a prospective basis; provided that such terms shall be offered to Customer to cover only [**] purchased by Customer and the Authorized Customer Locations which corresponds with any process mandated the [**] purchased by the FDA[**] and provided further that such terms, if applicableaccepted by Customer, shall in no way alter the other provisions hereof. Attachment C-1 to address such Recall with each Purchaser. Purchasers shall have the right Schedule C System Ones Subject to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless Expiration of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Service Term Schedule D Preferred Relationship Schedule D Chronic Outpatient Therapy Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.Preferred Relationship

Recalls. Vendor agrees As used herein, "Initiated Recall" shall mean a recall (a) initiated at the direction of the Federal Food and Drug Administration or other regulatory authority, arising out of, based on, or caused by defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to meet the Specifications; or (b) initiated voluntarily by either Party where evidence indicates that defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to meet the Specifications warrants such a recall. Each Party shall promptly notify Division after becoming aware the other Party of any patient safety issue involving situation which may lead to an Initiated Recall of the Products or Services. If any Product or any of its components is subject Products, however, YYY and XYZ shall have joint authority as to recall as that term is defined under 21 C.F.R. Part 7, or whether to institute a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor recall. YYY shall notify Purchasers XYZ, in writing, if it is required to implement a total or <PAGE> partial Initiated Recall. Both Parties agree to work together to properly manage an Initiated Recall, foremost in terms of urgency and Division within twenty-four (24) hours after becoming aware safety for the end customer, and secondly for the efficient utilization of resources to accomplish such Initiated Recall. The costs of any total or partial Initiated Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recallallocated as follows, regardless of whether actual return it was recalled by XYZ, YYY, or a governmental or regulatory authority: (a) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of XYZ, XYZ shall bear the out-of-pocket costs and expenses associated with the Initiated Recall; (b) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of YYY, YYY shall bear the out-of-pocket costs and expenses associated with the Initiated Recall; (c) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably deemed to be the direct result of negligent or willful acts or omissions by both Parties, each Party will bear a portion of the Products or components to Vendor or any Distributor is required, recommended, or suggested by out-of-pocket costs and expenses roughly commensurate with its proportional responsibility for the Initiated Recall, in and (d) if it cannot reasonably be determined which case Vendor shall pay all freight costs incurred party was responsible for the return of each affected Product defects or problems giving rise to the reason for the Initiated Recall, then the Parties shall equally share the out-of-pocket costs and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To expenses associated with the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated ProductsInitiated Recall.

Recalls. Vendor agrees to promptly notify Division after becoming aware of In the event Perrigo or Cumberland shall be required or requested by any patient safety issue involving the Products governmental authority (or Services. If any Product or any of its components is subject shall voluntarily decide) to recall as that term is defined under 21 C.F.R. Part 7any Products because such Products may violate any Laws or for any other reason, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor Parties shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply cooperate fully with one another in connection with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Productrecall. To the extent such Recall precludes Vendor from supplying any Products a recall is due to Cumberland’s gross negligence, willful misconduct or Services under material breach of this Agreement, Cumberland shall reimburse Perrigo for all of the reasonable costs and expenses actually incurred by Perrigo in connection with the recall including, but not limited to, costs of retrieving Products already delivered to customers, costs and expenses Perrigo is required to pay for notification, shipping and handling charges, and such other costs as may be reasonably related to the recall. To the extent a recall is due to Xxxxxxx’x gross negligence, willful misconduct or material breach of this Agreement, Perrigo shall remain responsible for the Supply Price for such recalled Products and shall reimburse Cumberland for all the reasonable costs and expenses described above in the immediately preceding sentence actually incurred by Cumberland in connection with such recall, including without limitation administration of the recall and such other actual costs as may be reasonably related to the recall. To the extent a recall results from a cause other than the gross negligence, willful misconduct or material breach of this Agreement of or by Perrigo or Cumberland, the Parties shall share equally in the costs of the recall. Prior to any Purchaser compliance requirements or purchase requirements reimbursements pursuant to this Section, the Party claiming any reimbursement shall provide the other Party with reasonably acceptable documentation of all reimbursable costs and expenses. Notwithstanding anything herein to the contrary, neither Party will be liable to the other under this Agreement Section 7.2 for consequential damages or lost profits of any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productskind.

Recalls. Vendor agrees Spectrum and Xxxxxxx shall both have the authority to make decisions with respect to any recall, market withdrawal or any other corrective action related to a Product. Spectrum shall promptly notify Division after becoming aware Xxxxxxx of any patient safety issue involving mandatory recall, market withdrawal, any corrective action that it may take or any other corrective action required by the Products or ServicesFDA regarding a Product in the Territory. If any Product a corrective action is due to Shantha's negligence, recklessness, willful misconduct or any breach of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements defect in design of a Product, or purchase requirements under any failure of a Product to meet its specifications, Xxxxxxx shall reimburse Spectrum for the amount paid by Spectrum for any orders of the Product subject to such recall and all of the reasonable costs and expenses actually incurred by Spectrum in connection with such corrective action, including, but not limited to, administration of the recall and costs for notification and for retrieving Product already delivered to customers. If a corrective action is due to Spectrum's negligence, recklessness, willful misconduct or breach of this Agreement, or the promotion or marketing of the Product in the Territory, Spectrum shall reimburse Xxxxxxx for all the reasonable costs and expenses actually incurred by Xxxxxxx in connection with such corrective action, including but not limited to, costs for notification and for retrieving Product already delivered to customers. If a corrective action results from a cause other than the negligence, recklessness, willful misconduct or breach of this Agreement of or by Spectrum or Xxxxxxx, the parties hereto shall share equally, all of the costs of the corrective action, including the amount paid by Spectrum for any facility agreement between any Purchaser and Vendor related orders of the Product subject to such Products corrective action. Prior to any reimbursements pursuant to this Section, the party claiming any reimbursement shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet provide the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productsother party with reasonably acceptable documentation of all reimbursable costs and expenses.

Recalls. Vendor From time to time throughout the Term, AASTROM may in its ------- discretion determine that it is necessary or advisable to recall Cell Cassettes manufactured by MSP. In such event, if AASTROM reasonably determines that the number of reported incidence of defective Cell Cassettes is high in relation to AASTROM's historical incidence rate for defective Cell Cassettes and/or general medical product industry standards and AASTROM recalls one or more Shipment Lots due to a failure of such units to meet Specifications during the Warranty Period, AASTROM shall so notify MSP of the recall and the Parties shall jointly exchange relevant information and consult on causation of the defective units prior to implementing the recall. In the event it is determined by the Parties that the Cell Cassettes were defective due to a failure of such units to meet Specifications during the Warranty Period, MSP agrees to reimburse AASTROM for the reasonable direct costs incurred by AASTROM in conjunction with the recall including the cost of replacing, shipping and testing the units of the Shipment Lot(s) recalled, whether or not all such units are ultimately determined to have been defective, by way of a reduction in MSP's applicable xxxx-up rates (as set forth on Appendix III) to 15% until the cost of the recall has been recovered by AASTROM. Any disputes regarding causation of defective units involved in a recall that cannot be resolved by the Parties will be resolved through arbitration in accordance with Section 24(b). Furthermore, in the event this Agreement is terminated for any reason prior to AASTROM recovering the full amount of its recall costs from MSP, MSP shall promptly notify Division after becoming aware pay to AASTROM the amount of any patient safety issue involving unreimbursed costs. For the Products purpose of clarification, it is agreed that AASTROM shall be solely responsible for determining whether any product recall, correction or Services. If any Product or any of its components withdrawal is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action required and for removing or correcting violative, distributed products or components (any complying with all of the foregoing being referred medical device reporting requirements pursuant to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products21 CFR Part 803.

Recalls. Vendor agrees to promptly notify Division after becoming aware of any patient safety issue involving Principal may cease selling the Products in any Country/Region in the Territory at any time during the Term and recall the Products within any Country/Region in the Territory as necessary if any of the below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Country/Region in the Territory: unforeseen effects of the relative type of the Products lead to, in Principal's sole opinion, unacceptable safety risks; Principal ceases the sale of the Products worldwide for any reason; a Governmental Authority requests the cessation of the sale of Products in any Country/Region in the Territory; Principal may cease the sale of the Products in any Country/Region in the Territory for safety concerns; Principal may transfer or Servicescease all or part of the business related to the Products; or other circumstances of recalls as required under the Applicable Law. If The Distributor undertakes with respect to any Product product recall that: (i) it will implement and complete the recall of the Products within the Territory by the statutory deadline or a shorter period as reasonably requested by Principal in all aspects in strict compliance with the Applicable Law; and (ii) it shall provide full cooperation to Principal, including timely transmitting and providing feedbacks of drug recall information, controlling and recovering drugs with potential safety hazards. The Distributor may not recall any of the Products from any of the Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following the decision to implement a Recall, Principal and Distributor shall mutually agree on a prepared statement for use in response to any inquiries regarding such Recall. Distributor shall use such prepared statement to respond to any inquiries received with regard to such Recall and shall not make any other statement regarding such Recall; provided, that if Principal fails to agree with Distributor on a prepared statement prior to the launch of such Recall, Distributor shall prepare and issue the statement as proposed by Principal regarding such Recall. To the extent the Products are recalled due to causes other than Distributor’s non-compliance with relevant obligations under this Agreement, Principal shall (a) indemnify the Distributor for the costs and expenses reasonably incurred by the Distributor for recalling the Products and for any subsequent disposal or destruction of the same; and (b) repurchase the Products that are subject to the Recall at the purchase price paid by the Distributor and in addition pay Distributor a handling charge equal to 10% of the purchase price. In the event that the Products are recalled due to Distributor or its Permitted Sub-distributors’ or any of its components Representatives’ negligence or wilful misconduct or its breach of this Agreement, the Distributor shall (a) indemnify the Principal for the costs and expenses reasonably incurred by the Principal for recalling the Products and for any subsequent disposal or destruction of the same; and (b) indemnify the Principal for its loss or damages caused by such Recall. Principal shall in connection with any Recall be entitled, upon reasonable prior notification and during Business Hours, to inspect and audit the conduct of such Recall, including Distributor's recall procedures, Distributor's records relating to the distribution and sales of the Recalled Products, Distributor's records relating to such Recall and the costs incurred by Distributor in connection with implementing such Recall. In the event of a Recall, the obligations of Distributor to sell the Recalled Products in the Territory and of Principal to supply such Recalled Products to Distributor pursuant to this Agreement shall be suspended with immediate effect and such obligations shall only become enforceable again if and when the circumstances that caused the Recall have been resolved. If the Recalled Products are thereafter totally withdrawn from the Territory for the remainder of the Term, then Principal may by written notice to Distributor terminate the Recalled Products from the Territory. The Distributor shall inform Principal immediately upon being informed about any defective products returned to the Distributor or detected in the Distributor's inventory. The Distributor shall inform Principal immediately about any complaint received. The Distributor shall be responsible for the collection and investigation of customers' complaints (whether the customers complain to the Distributor directly or forwarded by Principal and/or its Affiliates), and retain accurate records of such collections and investigations and maintain appropriate records during the Term. AUDIT RIGHTS AND REPORTING During the Term, Principal shall be entitled, through itself or an independent audit firm appointed by Principal (the "Independent Auditor"), to inspect and audit (i) such books, documents, papers and records which relate to sales of the Products or any costs and expenses invoiced or charged by Distributor to Principal in connection with this Agreement, (ii) Distributor's compliance with Clause 1817, and (iii) all facilities of Distributor in which Distributor performs its obligations under this Agreement and maintains inventory of the Products (an "Audit"). If an Audit reveals matters that Principal determines should be corrected by Distributor, Principal shall provide a list of such matters and may propose corrective action to be taken by Distributor. Distributor shall respond within 15 days of receipt of such notification indicating the corrective action to be taken and an estimated completion date. The Audit of any books, documents, papers or records that relate to or contain any information regarding any business dealings with or the affairs of any other client or principal of Distributor may only be conducted by the Independent Auditor. Such Independent Auditor shall (i) provide a copy of the audit report to Distributor no later than thirty (30) Business Days after such report is subject provided to recall as Principal and (ii) disclose to Principal relevant necessary information to enable Principal to determine whether Distributor is in compliance with this Agreement or not, and in any event shall never disclose to Principal any information regarding any business dealings with or the affairs of any other client or principal of Distributor that term such Independent Auditor may come across in the course of performing its audit under this provision, unless it is defined under 21 C.F.R. Part 7required by Applicable Law. Principal shall not request an Audit more than once each Calendar Year, unless required more frequently by any regulatory authorities which have regulatory oversight over Principal or the Products, or a voluntary recall unless breaches of Distributor's obligations under this Agreement have been identified in the course of an Audit or in the inspection by Vendorany competent authorities and subsequent Audits are required to confirm that Distributor has remedied such breaches. All Audits, including the cost of the Independent Auditor, shall be solely at Principal's expense unless the results of audit demonstrate that Distributor had failed to make due payment to Principal of an amount exceeding 5%, or is subject Distributor had breached a material obligation under this Agreement. All Audits shall take place only during Business Hours and only upon at least seven Business Days prior written notice to an FDA-initiated court action for removing Distributor. During any audits, inspections or correcting violativeexaminations conducted by Principal or any authorised agent under this Agreement, distributed products including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or components (any of the foregoing being referred to as a “Recall”)Clause 19.6, Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor Principal agrees that it and its duly authorised agents, including any Independent Auditor: will comply abide by all internal regulations and policies of Distributor enforced at such time; will not interfere with the business or operation of Distributor; and without prejudice to any process mandated confidentiality limitations in this Agreement, shall at the request of Distributor enter into a separate non-disclosure agreement prepared by Distributor, prior to being granted access to any of Distributor's premises, books, documents, papers or records. In the FDAevent that the result of Audit demonstrates that Distributor fails to make due payment to Principal, or Distributor had breached any of its obligation under this Agreement, Distributor shall cure such breach within 30 days (in the case of a failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if applicableDistributor fails to do so, to address such Recall with each Purchaser. Purchasers Principal shall have the right to return terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties shall in good faith agree on a Safety Data Exchange Agreement (as set forth in Exhibit G) that sets out the responsibilities of each Party with respect to Vendor or Distributor (if purchased from a Distributor) any Products where the pharmacovigilance matters relating to the Products or any components therein are subject as soon as practicable after the execution of this Agreement. The Parties shall in good faith agree on the Quality Agreement that sets out the responsibilities and processes for quality activities with respect to a Recallsupply, regardless distribution and quality management relating to the Products as soon as practicable after the execution of whether actual return this Agreement. INTELLECTUAL PROPERTY Principal warrants to Distributor that throughout the Term: it has and will continue to have full legal rights to use the Licensed Marks and to grant the use of the Licensed Marks to Distributor; it has and will continue to have full legal rights to use the patents, formulae and all other intellectual property rights employed in the development and production of the Products; and to the best knowledge of Principal, the exercise by Distributor of the rights and licences granted to Distributor under this Agreement (including the use of the Licensed Marks) and the distribution, offer for sale and sale of the Products by Distributor would not infringe any right (including intellectual property rights) of any person or components give rise to Vendor any liability to pay royalty or any other compensation. The warranties in this Clause 21.1 are separate and independent and shall not be limited by anything in this Agreement. Principal hereby authorises Distributor is required, recommended, or suggested by to use the Recall, Licensed Marks in which case Vendor shall pay all freight costs incurred the Territory in relation to the Products for the return purpose only of each affected Product exercising its rights and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services performing its obligations under this Agreement. Principal agrees that no payment shall be due from Distributor to Principal in connection with such use. Distributor shall promptly inform Principal of any actual, threatened or suspected infringement in the Territory of the Licensed Marks or other intellectual property rights of Principal relating to the Products which comes to the notice of Distributor, and of any Purchaser compliance requirements claim by any person coming to its notice that the sale or purchase requirements under distribution of the Products in the Territory infringes any rights of any other person. Distributor shall provide such information and assistance to Principal as Principal may reasonably require in taking or resisting any proceedings in relation to any such infringement or claim. Distributor shall not: alter, remove or tamper with any of the Licensed Marks, numbers, or other means of identification used on or in relation to the Products; or use any of the Licensed Marks in any way which might prejudice their distinctiveness or validity or the goodwill of Principal therein; Distributor hereby acknowledges that, except as expressly provided in this Agreement or any facility agreement between any Purchaser and Vendor related to such Products Agreement, Distributor shall not be effective for as long as Vendor is unable acquire any other rights in respect of the Licensed Marks from the distribution and sales of the Products and the use of the Licensed Marks pursuant to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productsthis Agreement.

Recalls. Vendor agrees to promptly notify Division after becoming OMP and Rohto agree that, if either Party discovers or becomes aware of any patient safety issue involving the Products fact, condition, circumstance or Services. If event (whether actual or potential) concerning or related to any Product in the Territory that may reasonably require a report, a recall or any market withdrawal of its components is subject such Product in the Territory, such Party shall promptly communicate such fact, condition, circumstance or event to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division other Party within twenty-four (24) hours after becoming aware hours. In the event (i) any governmental entity or regulatory body requests that a Product be recalled or withdrawn, (ii) a court of competent jurisdiction orders a Product recall or withdrawal, or (iii) Rohto (in consultation with OMP) determines that a Product should be recalled or withdrawn from the market, Rohto shall take all appropriate remedial actions with respect to such recall or withdrawal of Product (“Remedial Action”). Rohto shall be responsible for all reporting, pharmacovigilance reporting and recalls associated with Product in the Channel in the Territory, and Rohto shall be the primary contact person/ entity for any communications to any governmental entity, regulatory body, the media and customers in the Territory concerning the Remedial Action, with OMP’s reasonable cooperation. If such recalls are necessary because of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division event that listed in Section 9 (b), Rohto shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDAsolely responsible for, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costsOMP for, including freightall costs reasonably incurred as a result of, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement Remedial Action or any facility agreement between Product recalls or market withdrawals, and shall reimburse OMP for all costs reasonably incurred by OMP in connection with OMP’s reasonable cooperation, and OMP shall be solely responsible for, and shall reimburse Rohto for, all costs reasonably incurred as a result of, such Remedial Action if such recalls are necessary because of any Purchaser event listed in Section 9 (a). OMP and Vendor Rohto shall discuss and determine how to share the costs incurred as a result of such Remedial Action if such recalls are necessary because of any event other than that listed in Section 9 (a) or (b). Rohto shall notify OMP within forty-eight (48) hours of undertaking a Remedial Action, and the reasons therefor. The Parties shall cooperate fully with one another to obtain, but Rohto shall be solely responsible for preparing and submitting, all information reasonably required by regulatory or governmental authorities related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any the affected Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet in the compliance or purchase requirements during the time period when Vendor is unable to provide said designated ProductsTerritory.

Recalls. Vendor agrees SMBI and NuVim shall notify the other promptly if any batch of Product purchased by NuVim pursuant to promptly notify Division after becoming aware this Agreement is subject to recall, seizure, market withdrawal or correction or if any end user notifies NuVim of an adverse reaction as a result of the use of any patient safety issue involving Product, and the parties agree to cooperate in the handling and disposition of such recall, seizure, market withdrawal or correction or notification of adverse reaction; provided, however, in the event of a disagreement as to any matters related to such recall, seizure, market withdrawal or correction or adverse reaction, SMBI shall have final authority with respect to such matters. SMBI shall bear the costs of all recalls, seizures, market withdrawals or corrections of Products purchased by NuVim pursuant to this Agreement if such recall, seizure, market withdrawal or Services. If any Product or correction is due to a breach by SMBI of any of its components obligations hereunder; NuVim shall bear the costs of all recalls, seizures, market withdrawals or corrections of Products purchased by NuVim pursuant to this Agreement if such recall, seizure, market withdrawal or correction is subject due to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall breach by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (NuVim of any of the foregoing being referred its obligations hereunder; and to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying recall, seizure, market withdrawal or correction is not a result of a breach by either NuVim or SMBI of any of their respective obligations hereunder, the costs of any recall, seizure, market withdrawal or correction shall be borne by NuVim. In the event of any recall, seizure, market withdrawal or correction, SMBI shall, to the extent it is required to bear the costs of such recall, seizure, market withdrawal or correction as provided above, in addition to bearing the cost of such recall, seizure, market withdrawal or correction, (i) replace the amount of Products recalled, seized or Services under this Agreementwithdrawn and (ii) reimburse NuVim for all verifiable out-of-pocket costs incurred by NuVim in respect of such recalled, any Purchaser compliance requirements seized or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such withdrawn Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated ProductsNuVim shall maintain records of all sales of Products in accordance with its standard operating procedure.

Recalls. Vendor agrees to promptly notify Division after becoming aware In the case of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to a recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred Product, Emergent and Rovi CM shall inform each other promptly so as to provide as much advance notice as possible. X X Have a “Recall”), Vendor written recall procedure. X X The parties shall notify Purchasers and Division within twenty-four (24) hours after becoming aware cooperate in the exchange of any Recall information required to effectively conduct a recall or after Vendor provides notice of the Recall to the FDArecall investigation. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have X X Auditing Emergent has the right to return audit Rovi’s facilities, systems and documentation, as they relate to Vendor the manufacturing, storing, distributing, packaging, labeling, testing, releasing and handling of Product(s), at mutually agreed upon times, not more than one compliance audit every [**] years. An audit deemed “For cause” by -Emergent, will be allowed at any time as mutually agreed upon and will not count against the biennial audit. All “For Cause” audits must be linked to the triggering event. The scope of the “For Cause” audit shall be focused on the events associated with the Deviation or Distributor (if purchased Complaint. X Allow Emergent to audit facilities, systems and documentation, as they relate to the manufacture of Product(s), at mutually agreed upon times. X If required, a confidentiality agreement will be executed within a reasonable period of time prior to the audit or other exchange of information. X X Rovi Contract Manufacturing S.L. – SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY RESPONSIBILITIES Rovi Emergent Not Applicable Emergent shall issue a confidential written audit report to Rovi, which will include audit observations, within [**] calendar days from the audit date. X Rovi shall issue responses within [**] calendar days to all observations in writing to Emergent Quality Assurance designee. Where Rovi commits to a Distributorcorrective action, a description and timeframe for completion will be included in the written response. X Where applicable, agree upon requirements for auditing third parties used in association with Product(s) any Products where production, processing, warehousing, or testing. X X Training Rovi shall have a written training program to ensure that each person engaged in the Products manufacture, processing, storing, packaging, labeling, distributing, testing, releasing or holding of a product used for injection shall have education, training and experience, or any components therein combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee’s functions. Training shall be conducted by qualified individuals on a regular basis and with sufficient frequency to assure that employees remain familiar with internal processes and CGMP requirements. X Lot Disposition Prior to release of any batch of product/material, Rovi shall ensure all required testing is complete and results are subject within specifications and that any associated non-conformances have been closed. X Stability Program Rovi shall perform On-going stability testing to a Recallestablish to comply with GMP ([**] per year and additional if any critical manufacturing problem arise) X Rovi Contract Manufacturing S.L. – SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY RESPONSIBILITIES Rovi Emergent Not Applicable Raw Materials and Packaging Materials Prepare specifications X Approve specifications X Vendor selection, regardless qualification, and approval X Provide prior notification to Emergent of whether actual return changes to source material vendors X Procurement of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product starting materials from qualified and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Productapproved vendors. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.X

Recalls. Vendor agrees In the event that any governmental agency or authority requests a recall, a field corrective action, Product withdrawal or takes similar action in connection with any Product (each a "Product recall"), or in the event NxStage determines an event, incident or circumstance has occurred that results in the need for a Product recall, NxStage shall promptly notify Customer within [**] of such governmental agency or authority request or action or of NxStage's decision to voluntarily institute a Product recall. In the event of a Product recall of any Product, NxStage shall (a) reimburse Customer for reasonable handling expenses incurred in returning units of the Product to NxStage or otherwise implementing the Product recall; and (b) use all commercially reasonable efforts to promptly notify Division after becoming aware of any patient safety issue involving repair or replace the Products or Servicesrecalled Product with another NxStage Product performing the same function in good working order. If any a Product or any of its components is subject recall materially and negatively impacts Customer's ability to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services perform under this Agreement, any Purchaser compliance the Volume Commitment amounts and dates and other requirements for maintaining Exclusivity that are set forth in Schedule E shall be adjusted as mutually agreed by NxStage and Customer so as to reflect the impact of such Product recall on Customer's patient volumes, and NxStage shall allocate replacement Products to Customer on a first-priority basis consistent with Customer's then-current share of NxStage's equipment field base that has either been purchased or is under extended (e.g. two years or more) lease arrangements, and consistent with the then-effected prescription items included in Customer's Monthly Dialysis Supplies orders; provided that Customer's purchase orders for System One equipment shall be allocated to Customer on a first priority basis, so long as such purchase orders are consistent with the other requirements under this Agreement set forth herein, including without limitation those set forth in Schedule E, Paragraph 7. In addition to the foregoing, if NxStage is unable to repair or any facility agreement between any Purchaser replace recalled System One Cyclers or PureFlow SLs purchased by Customer, such that such purchased Cyclers or PureFlow SLs are therefore rendered unusable and Vendor related continue to such Products be unusable for a period of [**] consecutive months (for purposes hereof, purchased Cyclers and PureFlow SLs shall not be effective unusable if they can be used with other non-NxStage products, consistent with then-current product labeling), NxStage shall be obligated to pay Customer actual damages within [**] days of the expiration of such [**] month period (with the amount Chronic Outpatient Therapy Purchase and Rental Agreement DaVita, Inc. of such damages to be mutually agreed upon by the parties in good faith, up to the amount of Customer's then-current net book value for the purchased Cyclers or PureFlow SLs which Customer has been prevented from using for [**] consecutive months (measured as long of the date of such recall); provided such net book value is calculated in good faith and in accordance with generally accepted accounting standards); provided that NxStage's obligation to make such a payment may be accelerated to the date of filing of a voluntary or involuntary bankruptcy proceeding for NxStage or the date NxStage refunds, all or any significant portion of, the purchase price of any Cyclers or PureFlow SLs that have been the subject of such a recall (and where such refund is specifically provided solely in connection with, and due to, such recall) to any other customer or group of customers that has purchased such Cyclers or PureFlow SLs for the treatment of chronic home hemodialysis patients (it being understood that Customer's right to damages hereunder shall not be so accelerated if such refund involves no more than [**] Cyclers or PureFlow SLs, in aggregate across all other NxStage chronic customers). No other remedy shall be provided to Customer in connection with Product recalls, except as Vendor is unable set forth in Section 21 of Schedule A. In the event NxStage elects to supply obtain recall insurance covering the recall of purchased System One Cyclers and/or PureFlow SLs, Customer and NxStage agree that the parties shall share the cost of such Productsinsurance coverage, up to a maximum amount of $200,000 per party per annum; provided that Customer shall consider in good faith requests made by NxStage to share insurance costs in excess of these amounts. If Recall insurance, if obtained by NxStage, shall name Customer (but no other customer of NxStage) as an additional insured. Any insurance payment to Customer under such policy shall offset any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Productsdamages determined to be owed to Customer hereunder pursuant to the foregoing terms, a Purchaser’s pricing will not change for failure with NxStage obligated to meet pay any remainder pursuant to the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.terms hereof. Chronic Outpatient Therapy Purchase and Rental Agreement DaVita, Inc. SCHEDULE D CHRONIC OUTPATIENT THERAPY AUTHORIZED CUSTOMER LOCATIONS (IF MORE THAN ONE LOCATION IS COVERED BY THIS AGREEMENT) List name of location, address, provider number, and phone number. [**] SCHEDULE E PREFERRED RELATIONSHIP

Recalls. Vendor agrees to promptly notify Division after becoming aware of In the event that any patient safety issue involving the Products governmental agency or Services. If authority requests a recall, a field corrective action, Product withdrawal or takes similar action in connection with any Product or any of its components is subject in the event NxStage determines an event, incident or circumstance with respect to a Product has occurred that results in the need for a recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as each a “Product Recall”), Vendor NxStage shall promptly notify Purchasers and Division Customer within twenty-four (24) hours after becoming aware [**] of such governmental agency or authority request or action or of NxStage’s decision to voluntarily institute a Product Recall. In the event of a Product Recall of any Product, NxStage shall (a) reimburse Customer and the Authorized Customer Locations for reasonable handling expenses incurred in returning units of such Product to NxStage or otherwise implementing the Product Recall; and (b) use all commercially reasonable efforts to promptly repair or replace the Product subject to a Product Recall with another NxStage Product performing the same function in good working order. NxStage shall allocate replacement Products to Customer and the Authorized Customer Locations on a first-priority basis consistent with Customer’s and the Authorized Customer Locations’ then-current share of NxStage’s Product base that has been purchased, and consistent with the then-affected prescription items included in Customer’s and the Authorized Customer Locations’ Monthly Dialysis Supplies orders. In addition to the foregoing, if NxStage is unable to repair or after Vendor provides notice replace a recalled Cycler or PureFlow SL purchased by Customer or any Authorized Customer Location, such that such purchased Cycler or PureFlow SL is therefore rendered unusable and continues to be unusable for a period of [**] consecutive months (for purposes hereof, a purchased Cycler or PureFlow SL shall not be unusable if it can be used with other non-NxStage products, consistent with then-current product labeling), NxStage shall be obligated to pay Customer and the Authorized Customer Locations actual damages within [**] days of the Recall expiration of such [**] month period (with the amount of such damages to be mutually agreed upon by the parties in good faith, up to the FDAamount of Customer’s and the Authorized Customer Locations’ then-current [**] for the purchased Cyclers and/or Pure Flow SLs which Customer and the Authorized Customer Locations have been prevented from using for [**] consecutive months (measured as of the date of such Product Recall); provided that such [**] is calculated in good faith and in accordance with generally accepted accounting standards). Notices NxStage’s obligation to Division make any payment pursuant to this Section 3 of Schedule C may be accelerated to the date of filing of a voluntary or involuntary bankruptcy proceeding with respect to NxStage or the date NxStage refunds, all or any significant portion of, the purchase price of any Cyclers and/or PureFlow SLs that have been the subject of a Product Recall (and where such refund is specifically provided solely in connection with, and due to, such Product Recall) to any other customer or group of customers that has purchased such Cyclers and/or PureFlow SLs for the treatment of chronic home hemodialysis patients (it being understood that Customer’s and the Authorized Customer Locations’ right to damages hereunder shall not be so accelerated if such refund involves no more than [**] Cyclers and/or PureFlow SLs in the aggregate across all other NxStage chronic customers). No other remedy shall be sent provided to Customer or any Authorized Customer Location in connection with a Product Recall, except as set forth in Section 22 of the Agreement. In the event NxStage elects to obtain recall insurance covering a Product Recall of any purchased Cyclers and/or PureFlow SLs, Customer and NxStage agree that the parties shall share the cost of such insurance coverage, up to a maximum amount of $200,000 per party per annum; provided that Customer shall consider in good faith requests made by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor NxStage to share insurance costs in excess of $200,000. Any recall insurance obtained by NxStage, shall name Customer and the Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such policy shall offset any damages determined to be owed to Customer or any Authorized Customer Location hereunder pursuant to the foregoing terms, with NxStage obligated to pay any remainder pursuant to the terms hereof. If, during the Term, NxStage contractually agrees with one or more other customers purchasing any of NxStage’s home hemodialysis products in the continental United States to provide [**] provisions to such customer(s) that are more favorable to such customer(s) than are set forth in Section [**] of the Agreement and Sections [**] of this Schedule C, NxStage agrees that it shall promptly offer such [**] provisions to Customer, on a prospective basis; provided that such terms shall be offered to Customer to cover only [**] purchased by Customer and the Authorized Customer Locations which corresponds with the [**] purchased by [**]; and provided further that such terms, if accepted by Customer, shall in no way alter the other provisions hereof. Attachment C-1 to Schedule C System Ones Subject to Expiration of Service Term Schedule D Other Customer represents and warrants to NxStage that it has not entered into any agreement which conflicts with the terms and conditions of the Agreement and that it will comply not do so during the Term. NxStage understands and acknowledges that neither Customer nor any of the Authorized Customer Locations have promised or committed to [**]. NxStage represents and warrants to Customer that: (a) it has not entered into any agreement which conflicts with the terms and conditions of the Agreement and that it will not do so during the Term, and (b) it shall not enter into any distributorship agreement or other similar agreement with any process mandated by third party covering the FDAsale, if applicablerental, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor licensing, leasing or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return distribution of the Products or components to Vendor or System One for chronic home hemodialysis in the Continental United States and Hawaii, except where any Distributor is required, recommended, or suggested by such agreements are consistent with the Recall, in which case Vendor shall pay all freight costs incurred for terms and conditions of the return of each affected Product and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected ProductAgreement. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Products.Schedule E Hawaii Schedule E

Recalls. Vendor agrees to will promptly notify Division after HealthTrust upon becoming aware of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division HealthTrust within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division HealthTrust shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser, and each Purchase and HealthTrust shall provide reasonable cooperation to Vendor to facilitate Vendor’s compliance with such process. If a Recall notice suggests or requires that a Product or any component of a Product be returned or otherwise removed from use, Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any such Products where the Products or any components therein are subject to a Recallat Vendor’s expense, regardless of whether actual including return of the Products or components to Vendor or any Distributor is requiredshipping, recommended, or suggested by the Recall, in which case and Vendor shall pay all freight costs incurred for the return of each affected Product and shall reimburse each Purchaser for Purchaser’s its original costs, including freight, in acquiring each affected such Product. For any other Recall which provides Purchaser the option of Vendor repair or replacement of the Product, if Vendor is unable to do so to Purchaser’s satisfaction, Purchaser shall have the right to return the Product for reimbursement and refund at Vendor’s expense as provided in the preceding sentence. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products Purchaser-Specific Agreement shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, and a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable Vendor’s inability to provide said designated Productssupply.

Recalls. Vendor agrees As used herein, "Initiated Recall" shall mean a recall (a) initiated at the direction of the Federal Food and Drug Administration or other regulatory authority, arising out of, based on, or caused by defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to meet the Specifications; or (b) initiated voluntarily by either Party where evidence indicates that defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to meet the Specifications warrants such a recall. Each Party shall promptly notify Division after becoming aware the other Party of any patient safety issue involving situation which may lead to an Initiated Recall of the Products or Services. If any Product or any of its components is subject Products, however, Roche and ACLARA shall have joint authority as to recall as that term is defined under 21 C.F.R. Part 7, or whether to institute a voluntary recall by Vendor, or is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor recall. Roche shall notify Purchasers ACLARA, in writing, if it is required to implement a total or partial Initiated Recall. Both Parties agree to work together to properly manage an Initiated Recall, foremost in terms of urgency and Division within twenty-four (24) hours after becoming aware safety for the end customer, and secondly for the efficient utilization of resources to accomplish such Initiated Recall. The costs of any total or partial Initiated Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recallallocated as follows, regardless of whether actual return it was recalled by ACLARA, Roche, or a governmental or regulatory authority: (a) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of ACLARA, ACLARA shall bear the out-of-pocket costs and expenses associated with the Initiated Recall; (b) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of Roche, Roche shall bear the out-of-pocket costs and expenses associated with the Initiated Recall; (c) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably deemed to be the direct result of negligent or willful acts or omissions by both Parties, each Party will bear a portion of the Products or components to Vendor or any Distributor is required, recommended, or suggested by out-of-pocket costs and expenses roughly commensurate with its proportional responsibility for the Initiated Recall, in and (d) if it cannot reasonably be determined which case Vendor shall pay all freight costs incurred party was responsible for the return of each affected Product defects or problems giving rise to the reason for the Initiated Recall, then the Parties shall equally share the out-of-pocket costs and shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To expenses associated with the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor related to such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated ProductsInitiated Recall.

Recalls. Vendor agrees Genentech shall notify Lonza promptly (and in any event within three (3) business days of receipt of written notice) if any batch of Bulk Drug or resulting Finished Product is the subject of a recall, market withdrawal or correction. Genentech shall (i) bear the cost of and be responsible for conducting all recalls, market withdrawals or corrections of Bulk Drug or Finished Product, (ii) remain obligated to promptly notify Division after becoming aware pay Lonza the Purchase Price for the Bulk Drug recalled or used to make such recalled Finished Product (as long as it is not Non-Conforming Bulk Drug), and (iii) reimburse Lonza for its direct out-of-pocket expenses related to the recall, if any. Notwithstanding the foregoing, to the extent such recall, market withdrawal or correction was caused by Lonza’s breach of any patient safety issue involving the Products or Services. If any Product or any of its components is subject to recall as that term is defined under 21 C.F.R. Part 7warranties set forth in Article 7 hereof, or a voluntary recall by Vendor, or is subject to an FDA-initiated court action Lonza shall credit Genentech for removing or correcting violative, distributed products or components (any all of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by the FDA, if applicable, to address such Recall with each Purchaser. Purchasers shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred Purchase Price for the return of each affected Bulk Drug recalled or used to make such recalled Finished Product and shall reimburse each Purchaser Genentech for Purchaserall of Genentech’s original costs, including freight, in acquiring each affected Product. To the extent such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and Vendor reasonable out-of-pocket expenses directly related to the recall, if any. For the avoidance of doubt such Products expenses shall not be effective for not, except Table of Contents as long as Vendor is unable provided in Section 17.4, include any Consequential Damages. As between the Parties, Genentech or its agent shall make all decisions regarding, and in all events shall have sole authority for, conducting any recalls, market withdrawals or corrections with respect to supply such Products. If any the Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet in the compliance or purchase requirements during the time period when Vendor is unable to provide said designated ProductsTerritory.

Recalls. Vendor agrees 5.2.1 BioMarin may, in its sole discretion, determine whether or when to promptly notify Division after becoming aware initiate any recalls of Aldurazyme in the United States and Genzyme may, in its sole discretion, determine whether or when to initiate any recalls of Aldurazyme anywhere else in the world. As of the Effective Date and throughout the term of this Agreement, BioMarin and Genzyme shall prepare and maintain a written SOP, to handle any recalls of Aldurazyme. Such SOP shall include, without limitation, prior notice to and consultation with the other Party of any patient safety issue involving recall; provided, however, that in no event shall such consultation be deemed to limit or supersede the Products Parties’ ability to make recall decisions in their sole discretion pursuant to the first sentence hereof. Genzyme shall transmit recall decision information to BioMarin to Vice President, -23- Regulatory Affairs, by phone at (000) 000-0000 or Servicesfacsimile at (000) 000-0000. If BioMarin shall transmit recall decision information to Genzyme to Regulatory Affairs/QA, attention: Vice President, Regulatory Affairs and Corporate Quality Compliance, by phone at (000) 000-0000 or facsimile at (000) 000-0000. In the event that (i) any Product regulatory authority or any other governmental agency or authority issues a request or directive or orders that Aldurazyme be recalled or retrieved, (ii) a court of its components is subject to recall as competent jurisdiction orders that term is defined under 21 C.F.R. Part 7Aldurazyme be recalled or retrieved or (iii) a Party determines that Aldurazyme should be recalled, retrieved or a voluntary recall by Vendor“Dear Doctor” letter is required relating to restrictions on use of Aldurazyme in a country for which it is responsible, or is subject to an FDA-initiated court action the Party responsible for removing or correcting violative, distributed products or components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Recall relevant country pursuant to the FDA. Notices to Division first sentence hereof shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor agrees that it will comply with any process mandated by conduct such activity and the FDA, if applicable, to address such Recall with each Purchaser. Purchasers Parties shall have the right to return to Vendor or Distributor (if purchased from a Distributor) any Products where the Products or any components therein are subject to a Recall, regardless of whether actual return of the Products or components to Vendor or any Distributor is required, recommended, or suggested by the Recall, in which case Vendor shall pay take all freight costs incurred for the return of each affected Product appropriate corrective actions and shall reimburse each Purchaser for Purchaser’s original costs, including freight, execute the steps detailed in acquiring each affected Productthe SOP. To the extent practicable, the Parties shall coordinate the notices of any such Recall precludes Vendor from supplying any Products or Services under this Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement recall to be delivered to regulatory authorities (including the timing thereof). Genzyme and BioMarin shall cooperate fully with one another in conducting such action. Genzyme shall destroy units of Aldurazyme lawfully recalled only upon BioMarin’s (or any facility agreement between regulatory authority’s) written instruction to destroy such units of Aldurazyme, and only then in accordance with BioMarin’s procedures and instructions. Otherwise, Genzyme may return the recalled units of Aldurazyme to BioMarin in accordance with BioMarin’s instructions within thirty (30) days after completion of the action. In the event that either BioMarin or Genzyme becomes aware of circumstances that may necessitate a recall of Aldurazyme in any Purchaser and Vendor related country for which it is not responsible pursuant to this Section 5.2, it will promptly notify the other Party of such Products shall not be effective for as long as Vendor is unable to supply such Products. If any Product pricing is dependent upon a Purchaser meeting compliance or purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is unable to provide said designated Productscircumstances.