Common use of Recalls Clause in Contracts

Recalls. 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 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party pursuant to this Section.

Recalls. The Parties agree that Vendor agrees to promptly notify Division after becoming aware of any patient safety issue involving the procedure for a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan Products or from activities performed by InsysServices. 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 If 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 representationscomponents is subject to recall as that term is defined under 21 C.F.R. Part 7, warrantiesor a voluntary recall by Vendor, obligationsor is subject to an FDA-initiated court action for removing or correcting violative, covenants distributed products or other agreements contained herein 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 in other written agreements between after Vendor provides notice of the Parties, then Insys Recall to the FDA. Notices to Division shall be liablesent 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 Mylan each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the reasonable Lossesextent such Recall precludes Vendor from supplying any Products or Services under this Agreement, Legal Expenses any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser 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 Vendor related to such recallProducts 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 costs shall be shared in compliance or purchase requirements during the ratio of the Parties’ contributory responsibility. Insys and Mylan agree time period when Vendor is unable 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party pursuant to this Sectionprovide said designated Products.

Recalls. 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 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. In the event (a) the FDA any government authority issues a request, directive or other governmental body requests order that the any Drug Product be recalled 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 Parties Drug Product does not conform to the Specifications, the parties shall take all appropriate remedial actions with respect corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent such recall. The obligations recall results from xxx xreach of Cardinal's warranties under this Section 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. Adams shall survive be responsible for all Adams' and Cardinal's expenses of xxx xecall to the complete extent that such xxxxxl results from a cause other than Cardinal's breach of its 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 each party's percentage of fault as determined jointly by the parties, 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. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose of such recall is not attributable to the fault of either Adams or partial termination Cardinal, Adams shall be responsible for all Adams and Cardixxx xxpenses of the 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 purposes of this Agreement. Each Party , the expenses of recall shall make every reasonable effort include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this Sectionrecall.

Recalls. Decisions with respect to recalls, withdrawals or corrections of Licensed Product related to manufacturing or product quality issues shall be handled in accordance with the Clinical Supply Agreement and the Commercial Supply Agreement. The Parties agree that JSC shall have decision-making authority with respect to issuing all other recall, market withdrawal or correction of any Licensed Product in the procedure Territory. The members of the JSC for each Party shall delegate their authority under this Section to the appropriate executive officers in their respective regulatory departments who shall develop appropriate standard operating procedures with respect to recalls. To the extent regulatory timeframes or public safety considerations require immediate action, a telephone conference of the JSC's designees under this Section shall be called within the required timeframe to consider the action and make a decision. Each Party shall notify the other Party promptly (and in any event within twenty-four (24) hours of receipt of CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS (*) DENOTE SUCH OMISSIONS. written notice) if any Licensed Product recall and FDA notifications shall depend on whether is alleged or proven to be the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate subject of a recall, market withdrawal or correction in any country in the Territory. In Once a recall or withdrawal decision has been made under this Section, the event Distributing Party, under the direction of a product recallthe JCT and the designees of the JSC, Mylan shall provide all necessary lists; Insys shall be responsible for handling and implementing such recalls and market withdrawals of any Licensed Product in the Territory, provided that such activities be performed in accordance with standard operating procedures approved by the JCT and the JSC. The other Party will make available to the Distributing Party, upon request, all FDA contacts. In of the event other Party's pertinent records that the FDA Distributing Party may reasonably request to assist it in effecting any recall or other governmental body orders a recall with respect to 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 reimbursementmarket withdrawals. The Parties shall each maintain traceability records as are sufficient share equally all costs of a recall or marketing withdrawal in the Territory in accordance with a budget for such activities to be agreed upon by the JCT and as may be necessary to permit a recallapproved by the JSC. The Parties agree that if either A Party shall discover have no obligation to reimburse or become aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by otherwise compensate the other Party pursuant to this Sectionfor any lost profits or income that may arise in connection with any such recall or market withdrawal. Any investigation conducted in connection with a Licensed Product recall shall be undertaken jointly by the Parties under the direction of the JSC.

Recalls. The Parties agree that Vendor will promptly notify HealthTrust upon becoming aware of any patient safety issue involving the procedure for a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan Products or from activities performed by InsysServices. 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 If 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 components is subject to or arising out of such recallrecall 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 (b) a breach by Mylan of any of its representationsthe foregoing being referred to as a “Recall”), warranties, obligations, covenants or other agreements contained herein, then Mylan Vendor shall be liable notify Purchasers and shall reimburse Insys for its reasonable Losses, Legal Expenses and other outHealthTrust within twenty-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 four (24) hours after becoming aware of any fact, condition, circumstance Recall or event (whether actual or potential) concerning or related after Vendor provides notice of the Recall to the FDA. Notices to HealthTrust shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor 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 at Vendor’s expense, including return shipping, and Vendor shall reimburse Purchaser for its original costs, including freight, in acquiring such Product. For any other Recall, which may reasonably require a recallprovides Purchaser the option of Vendor repair or replacement of the Product, such Party if Vendor is unable to do so to Purchaser’s satisfaction, Purchaser shall promptly communicate such fact, condition, circumstance or event have the right to the other Party. In the event (a) the FDA or other governmental body requests that return the Product be recalled 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 (b) a court of competent jurisdiction orders such a recall, the Parties shall take all appropriate remedial actions with respect to such recall. The obligations Services under this Section Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any Purchaser-Specific Agreement shall survive not be effective for as long as Vendor is unable to supply such Products, and a Purchaser’s pricing will not change for failure to meet the complete compliance or partial termination of this Agreement. Each Party shall make every reasonable effort purchase requirements during the Vendor’s inability to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this Sectionsupply.

Recalls. 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 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. In the event (ai) the FDA any Regulatory Authority issues a request, directive or other governmental body requests order that the Licensed Product be recalled recalled, or (bii) a court of competent jurisdiction orders such a recall, or (iii) Pacira reasonably determines after consultation with Aratana that the Licensed Product should be recalled because the Licensed Product does not conform to 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 shall will take all appropriate remedial corrective actions with respect to reasonably requested by the other Party hereto or by any Regulatory Authority. In the event that such recall. The obligations recall (a) results from the breach of Pacira’s warranties under this Section shall survive the complete or partial termination 7.2 of this Agreement, Pacira will be responsible for all of the costs and expenses of the recall or (b) results from the breach of Aratana’s warranties or covenants under this Agreement, Aratana will be responsible for all of the costs and expenses of the recall. Each Party To the extent that such recall is not covered by either clause (a) or (b) of the immediately preceding sentence, then Pacira and Aratana shall make every 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 reasonable effort to mitigate any Losses, Legal Expenses and other 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 willful misconduct, all costs and expenses to of the recall (regardless of the Party incurring such cost or expense) shall be reimbursed borne by the responsible Party (and the responsible Party shall promptly reimburse the other Party pursuant to this Sectionfor such Recall Expenses incurred in connection with such recall upon receipt of an invoice therefor).

Recalls. 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 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. In the event (ai) the FDA any Regulatory Authority issues a request, directive or other governmental body requests order that the Licensed Product be recalled recalled, or (bii) a court of competent jurisdiction orders such a recall, or (iii) Pacira reasonably determines after consultation with Aratana that the Licensed Product should be recalled because the Licensed Product does not conform to 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 shall will take all appropriate remedial corrective actions with respect to reasonably requested by the other Party hereto or by any Regulatory Authority. In the event that such recall. The obligations recall (a) results from the breach of Pacira’s warranties under this Section shall survive the complete or partial termination 7.2 of this Agreement, Pacira will be responsible for all of the costs and expenses of the recall or (b) results from the breach of Aratana’s warranties or covenants under this Agreement, Aratana will be responsible for all of the costs and expenses of the recall. Each Party To the extent that such recall is not covered by either clause (a) or (b) of the immediately preceding sentence, then Pacira and Aratana shall make every 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 reasonable effort to mitigate any Losses, Legal Expenses and other 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 willful misconduct, all costs and expenses to of the recall (regardless of the Party incurring such cost or expense) shall be reimbursed borne by the responsible Party (and the responsible Party shall promptly reimburse the other Party pursuant to this Sectionfor such Recall Expenses incurred in connection with such recall upon receipt of an invoice therefor).

Recalls. The Parties agree that If the procedure for FDA or any other regulatory authority under Applicable Law seizes any Product, requests a Product recall of the Product, or otherwise notifies NeuroPace or Greatbatch of any violation or potential violation of any Applicable Law, the first notified party must promptly notify the other party and FDA notifications shall depend on whether the issue arose from activities performed by Mylan provide it with a copy of any applicable recall letter or from activities performed by Insysequivalent written notification. Only Mylan can initiate a recall. In NeuroPace and Greatbatch will reasonably cooperate with each other in the event of any recall of any Product. NeuroPace and Greatbatch will each provide information reasonably requested by the other to investigate the cause and extent of the problem. To the extent the recall is in a product recallcountry where the Product is sold under NeuroPace’s approval or marketing clearance, Mylan shall provide all necessary lists; Insys shall be responsible for all FDA contactsNeuroPace will have the final authority to determine the course of action, after consultation with Greatbatch. In the event that the FDA or other governmental body orders Greatbatch independently believes that a recall with respect to for any Product supplied hereunder of the Products may be necessary or a recall is voluntarily initiated by Mylanappropriate, Greatbatch will notify NeuroPace. The parties will fully discuss, in good faith, and cooperate with each other concerning the cause necessity and nature of such recall is due to (a) a breach action; however, the coordination thereof will be handled by Insys NeuroPace, whether or not such action was initially requested by Greatbatch. Recalls will be the responsibility 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 liableNeuroPace, and shall reimburse Mylan NeuroPace will bear all expenses connected therewith. For the purposes of this Agreement, the expenses of the recall will include, but not be limited to, all expenses for notification of customers and the destruction or return of the recalled Product, as well as all reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating to or arising out of such recall, or (b) a breach incurred by Mylan of any of its representations, warranties, obligations, covenants or other agreements contained herein, then Mylan shall be liable NeuroPace 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other PartyGreatbatch. In the event any recall is attributable to a breach of any of the warranties provided in Section 3.3, Greatbatch will credit NeuroPace’s account for the Products recovered and returned to NeuroPace or Greatbatch (aor destroyed at NeuroPace’s request). [ *** ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) the FDA or other governmental body requests that the Product not material and (ii) would be recalled or (b) a court of competent jurisdiction orders such a recall, the Parties shall take all appropriate remedial actions with respect to 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 reimbursed by the other Party pursuant to this Sectioncompetitively harmful if publicly disclosed.

Recalls. 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 cease all or part of the business related to the Products; or other circumstances of recalls as required under the Applicable Law. The Parties Distributor undertakes with respect to any 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 procedure Products are recalled due to Distributor or its Permitted Sub-distributors’ or any of its Representatives’ negligence or wilful misconduct or its breach of this Agreement, the Distributor shall (a) indemnify the Principal for a Product 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 FDA notifications shall depend on whether sales of the issue arose from activities performed Recalled Products, Distributor's records relating to such Recall and the costs incurred by Mylan or from activities performed by Insys. Only Mylan can initiate a recallDistributor in connection with implementing such Recall. In the event of a product recallRecall, Mylan 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 provide all necessary lists; Insys 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 FDA contactsfacilities 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 provided to 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 such Independent Auditor may come across in the course of performing its audit under this provision, unless it is required 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 unless breaches of Distributor's obligations under this Agreement have been identified in the course of an Audit or in the inspection by any 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 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 Distributor. During any audits, inspections or examinations conducted by Principal or any authorised agent under this Agreement, including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or Clause 19.6, Principal agrees that it and its duly authorised agents, including any Independent Auditor: will 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 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 event that the FDA result of Audit demonstrates that Distributor fails to make due payment to Principal, or other governmental body orders Distributor had breached any of its obligation under this Agreement, Distributor shall cure such breach within 30 days (in the case of a recall failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if Distributor fails to do so, Principal shall have the right to 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 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 pharmacovigilance matters relating to or arising out the Products as soon as practicable after the execution 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 reimbursementthis Agreement. The Parties shall each maintain traceability records as are sufficient in good faith agree on the Quality Agreement that sets out the responsibilities and as may be necessary to permit a recall. The Parties agree that if either Party shall discover or become aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 processes for quality activities with respect to such recall. The obligations under this Section shall survive supply, distribution and quality management relating to the complete or partial termination Products as soon as practicable after the execution of this Agreement. Each Party 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 give rise to any liability to pay royalty or other compensation. The warranties in this Clause 21.1 are separate and independent and shall make every reasonable effort not be limited by anything in this Agreement. Principal hereby authorises Distributor to mitigate use the Licensed Marks in the Territory in relation to the Products for the purpose only of exercising its rights and 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 Lossesactual, Legal Expenses 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 claim by any person coming to its notice that the sale or distribution of the Products in the Territory infringes any rights of any other out-of-pocket costs person. Distributor shall provide such information and expenses assistance to be reimbursed by 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 Party 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, Distributor shall not 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 this SectionAgreement.

Recalls. 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 case of a recall of the Product, Emergent and Rovi CM shall inform each other promptly so as to provide as much advance notice as possible. X X Have a written recall procedure. X X The parties shall cooperate in the exchange of information required to effectively conduct a recall or recall investigation. X X Auditing Emergent has the right to audit Rovi’s facilities, systems and documentation, as they relate to 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 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 corrective 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) production, processing, warehousing, or testing. X X Training Rovi shall have a written training program to ensure that each person engaged in the manufacture, processing, storing, packaging, labeling, distributing, testing, releasing or holding of a product recallused for injection shall have education, Mylan shall provide all necessary lists; Insys training and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be responsible for all FDA contacts. In in the event particular operations that the FDA or other governmental body orders 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 recall regular basis and with respect sufficient frequency to assure that employees remain familiar with internal processes and CGMP requirements. X Lot Disposition Prior to release of any Product supplied hereunder or a recall batch of product/material, Rovi shall ensure all required testing is voluntarily initiated by Mylancomplete and results are within specifications and that any associated non-conformances have been closed. X Stability Program Rovi shall perform On-going stability testing to establish 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, qualification, and the cause approval X Provide prior notification to Emergent of such recall is due changes to (a) a breach by Insys source material vendors X Procurement 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, starting materials from qualified 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 responsibilityapproved vendors. 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party pursuant to this Section.X

Recalls. The Parties agree 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 procedure 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 Product failure of such units to meet Specifications during the Warranty Period, AASTROM shall so notify MOLL of the recall and FDA notifications the Parties shall depend jointly exchange relevant ixxxxmation and consult on whether causation of the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate a 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 pay to AASTROM the amount of any un-reimbuxxxx cxxxx. For the purpose of clarification, it is agreed that AASTROM shall be solely responsible for determining whether any product recall, Mylan shall provide correction or withdrawal is required and for complying with 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 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party medical device reporting requirements pursuant to this Section21 CFR Part 803.

Recalls. The Parties agree that Vendor agrees to promptly notify HPG after becoming aware of any patient safety issue involving the procedure for a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan Products or from activities performed by InsysServices. 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 If 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 representationscomponents is subject to recall as that term is defined under 21 C.F.R. Part 7, warrantiesor a voluntary recall by Vendor, obligationsor is subject to an FDA-initiated court action for removing or correcting violative, covenants distributed products or other agreements contained herein components (any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and HPG within twenty-four (24) hours after becoming aware of any Recall or in other written agreements between after Vendor provides notice of the Parties, then Insys Recall to the FDA. Notices to HPG shall be liablesent 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 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 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 Mylan each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the reasonable Lossesextent such Recall precludes Vendor from supplying any Products or Services under this Agreement, Legal Expenses any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser 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 Vendor related to such recallProducts 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 costs shall be shared in compliance or purchase requirements during the ratio of the Parties’ contributory responsibility. Insys and Mylan agree time period when Vendor is unable 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party pursuant to this Sectionprovide said designated Products.

Recalls. The Parties agree Nuwellis represents and warrants that Nuwellis is not aware of any facts which are reasonably likely to cause (i) a Recall of the procedure for Products; (ii) a Product recall and FDA notifications shall depend on whether change in the issue arose from activities performed by Mylan marketing classification or from activities performed by Insys. Only Mylan can initiate a recallmaterial change in the labeling of the Products or (iii) termination or suspension of the marketing of the Products. In the event a Product is the subject of a product recallRecall, Mylan Nuwellis shall provide notify DaVita within two (2) business days of being made aware of any such Recall. Nuwellis shall work in conjunction with DaVita to make all necessary lists; Insys contacts with DaVita Facilities and the FDA. Nuwellis shall be responsible for coordinating all FDA contactsactivities 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. In DaVita reserves the event that 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 other governmental body orders a recall any applicable Governmental Authority. DaVita may independently terminate or otherwise restrict use of any affected Products used within DaVita or DaVita Facilities (e.g., quarantine or withdraw Products or communicate with respect to any Product supplied hereunder or a recall is voluntarily initiated by Mylan, DaVita clinicians and the cause of such recall is due patients) without Nuwellis’s consent. Nuwellis shall reimburse DaVita for direct and actually incurred costs related to (a) a breach by Insys the aggregate price for all units of any of its representations, warranties, obligations, covenants or other agreements contained herein or in other written agreements between Products that are defective pursuant to the Parties, then Insys shall be liable, Recall; (b) reasonable and shall reimburse Mylan for the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating to such Recall, 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 defending a third-party Claim arising out of such recall, or (b) a breach Recall. Any Products affected by Mylan of any of its representations, warranties, obligations, covenants or other agreements contained herein, then Mylan shall a Recall may be liable and shall reimburse Insys returned to Nuwellis 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 a full refund of the Parties’ contributory responsibilityPurchase Price or pro ratable Rental Price, as applicable, paid by DaVita, at Nuwellis’s sole cost and expense, F.O.B. Origin, Freight Collect. Insys Supply 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party pursuant to this Section.Collaboration Agreement DaVita Confidential & Proprietary

Recalls. The Parties agree that Spectrum and Xxxxxxx shall both have 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 authority to make decisions with respect to any recall, market withdrawal or any other corrective action related to a Product. Spectrum shall promptly notify Xxxxxxx of any mandatory recall, market withdrawal, any corrective action that it may take or any other corrective action required by the FDA regarding a Product supplied hereunder or in the Territory. If a recall is voluntarily initiated by Mylan, and the cause of such recall corrective action is due to (a) Shantha's negligence, recklessness, willful misconduct or breach of this Agreement, any defect in design of a breach by Insys Product, or any failure of any of a Product to meet its representationsspecifications, warranties, obligations, covenants or other agreements contained herein or in other written agreements between the Parties, then Insys shall be liable, and Xxxxxxx shall reimburse Mylan Spectrum for the amount paid by Spectrum for any orders of the Product subject to such recall and all of the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating 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 arising out breach of such recallthis Agreement, or (b) a breach by Mylan the promotion or marketing of any of its representationsthe Product in the Territory, warranties, obligations, covenants or other agreements contained herein, then Mylan shall be liable and Spectrum shall reimburse Insys Xxxxxxx for its all the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating 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 arising out breach of such recall; provided that if both this Agreement of or by Spectrum or Xxxxxxx, the parties hereto shall share responsibility with respect equally, all of the costs of the corrective action, including the amount paid by Spectrum for any orders of the Product subject to such recall, the costs shall be shared in the ratio of the Parties’ contributory responsibilitycorrective action. Insys and Mylan agree Prior 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party 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.

Recalls. 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 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. In the event (a) the FDA any government authority issues a request, directive or other governmental body requests order that the any Drug Product be recalled 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 Parties Drug Product does not conform to the Specifications, the parties shall take all appropriate remedial actions with respect corrective actions. Cardinal shall be responsible for Cardinal's and Xxxxx' expenses of the recall to the extent such recall. The obligations recall results from the breach of Cardinal's warranties under this Section 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. Xxxxx shall survive be responsible for all Xxxxx' and Cardinal's expenses of the complete recall to the extent that such recall results from a cause other than Cardinal's breach of its 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 each party's percentage of fault as determined jointly by the parties, 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. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose of such recall is not attributable to the fault of either Xxxxx or partial termination Cardinal, Xxxxx shall be responsible for all Xxxxx and Cardinal expenses of the 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 purposes of this Agreement. Each Party , the expenses of recall shall make every reasonable effort include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Xxxxx' or Cardinal's total, unrecoverable, actual, internal costs for manufacturing and shipping the Drug Product that was later subject to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this Sectionrecall.

Recalls. The Parties agree that In the procedure for event Purchaser believes a Product recall and FDA notifications Recall may be necessary with respect to a Product, Purchaser shall depend on whether the issue arose from activities performed by Mylan or from activities performed by Insysimmediately notify Vendor in writing within [**]. Only Mylan can initiate Vendor may at its sole discretion require Purchaser to 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 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 after completion of the Recall and will provide reasonable cooperation and assistance to Vendor in taking all other appropriate actions. If Purchaser declines to conduct such Recall, Vendor shall have the authority to conduct a Recall at Purchaser’s expense beginning immediately after providing notice to Purchaser. Purchaser shall inform Vendor in writing before initiating or conducting any Recall of a Product. In the event of a product recallRecall, Mylan shall provide 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 necessary lists; Insys reasonable expenses incurred by the Purchaser in the Territory that are related to the Recall. Vendor shall be responsible for all FDA contacts. In the event that expenses of the FDA Recall unless such actions result from Purchaser’s negligence or other governmental body orders a recall with respect to any Product supplied hereunder or a recall is voluntarily initiated by Mylanwillful misconduct, and in which case 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 Purchaser shall be liable, and shall reimburse Mylan responsible 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 responsibilitythose expenses. 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 such recall. The obligations under this Section shall survive the complete or partial termination For purposes of 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 costs directly associated with distribution of replacement Products. Each Party In all cases, the Purchaser shall make every conduct the Recall in a manner which is appropriate and reasonable effort under the circumstances and in conformity with accepted trade practices and applicable law. Purchaser shall deliver copies of all Recall-related records to mitigate any LossesVendor within [**] of Purchaser receiving or preparing them. Certain confidential information contained in this document, Legal Expenses marked by [**], has been omitted because SOPHiA GENETICS SA (SOPHiA) has determined that the information (i) is not material and other out-of-pocket costs (ii) is the type that SOPHiA customarily and expenses to be reimbursed by the other Party pursuant to this Sectionactually treats as private or confidential.

Recalls. The Parties agree Vericel, in consultation with Xxxxxx, will prepare and maintain a written Standard Operating Procedure (“SOP”) in compliance with FDA requirements that sets forth the procedure for a Parties’ respective responsibilities in handling any recalls of any Product recall and FDA notifications shall depend on whether in 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 contactsTerritory. In the event that the FDA (i) any governmental agency or other governmental body authority issues a request or directive or orders a recall with respect to 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. In the event (a) the FDA or other governmental body requests that the Product be recalled or retrieved, (bii) a court of competent jurisdiction orders such that the Product be recalled or retrieved, or (iii) Vericel reasonably determines that the Product should be recalled, retrieved or a recall“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 “[***]”. 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 shall will take all appropriate remedial corrective actions with respect and will execute the steps detailed in the SOP. Vericel will be responsible for all of the expenses of such activities, except to such recall. The the extent the event causing the recall results from a breach of any of Xxxxxx’x obligations under this Section shall survive the complete Agreement or partial termination 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 costs directly associated with the distribution of replacement Product. Each Party shall make every reasonable effort Xxxxxx and Vericel will cooperate fully with one another in conducting any 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 mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by arrange for the other Party pursuant to this Sectiondestruction of such Product.

Recalls. The Parties agree 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 procedure event NxStage determines an event, incident or circumstance has occurred that results in the need for a Product recall and FDA notifications recall, NxStage shall depend on whether the issue arose from activities performed by Mylan promptly notify Customer within [**] of such governmental agency or from activities performed by Insys. Only Mylan can initiate authority request or action or of NxStage's decision to voluntarily institute a Product recall. In the event of a product 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 repair or replace the recalled Product with another NxStage Product performing the same function in good working order. If a Product recall materially and negatively impacts Customer's ability to perform under this Agreement, Mylan shall provide all necessary lists; Insys the Volume Commitment amounts and dates and other requirements for maintaining Exclusivity that are set forth in Schedule E shall be responsible 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 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 replace recalled System One Cyclers or PureFlow SLs purchased by Customer, such that such purchased Cyclers or PureFlow SLs are therefore rendered unusable and continue to be unusable for a period of [**] consecutive months (for purposes hereof, purchased Cyclers and PureFlow SLs shall not be 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 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 FDA contactsor 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 set forth in Section 21 of Schedule A. In the event NxStage elects to obtain recall insurance covering the recall of purchased System One Cyclers and/or PureFlow SLs, Customer and NxStage agree that the FDA or other governmental body orders a recall with respect to any Product supplied hereunder or a recall is voluntarily initiated by Mylan, and parties shall share the cause cost of such recall is due insurance coverage, up to (a) a breach by Insys maximum amount 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$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. Recall insurance, if both parties share responsibility with respect obtained by NxStage, shall name Customer (but no other customer of NxStage) as an additional insured. Any insurance payment to Customer under such recall, the costs policy shall offset any damages determined to be shared in the ratio of the Parties’ contributory responsibility. Insys and Mylan agree owed 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 fact, condition, circumstance or event (whether actual or potential) concerning or related Customer hereunder pursuant to the Product which may reasonably require a recallforegoing terms, such Party shall promptly communicate such fact, condition, circumstance or event with NxStage obligated to pay any remainder pursuant to the other Partyterms hereof. In the event Chronic Outpatient Therapy Purchase and Rental Agreement DaVita, Inc. SCHEDULE D CHRONIC OUTPATIENT THERAPY AUTHORIZED CUSTOMER LOCATIONS (aIF MORE THAN ONE LOCATION IS COVERED BY THIS AGREEMENT) the FDA or other governmental body requests that the Product be recalled or (b) a court List name of competent jurisdiction orders such a recalllocation, the Parties shall take all appropriate remedial actions with respect to such recalladdress, provider number, and phone number. 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 reimbursed by the other Party pursuant to this Section.[**] SCHEDULE E PREFERRED RELATIONSHIP

Recalls. The Parties agree 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 or in the procedure event NxStage determines an event, incident or circumstance with respect to a Product has occurred that results in the need for a recall (each a “Product recall and FDA notifications Recall”), NxStage shall depend on whether the issue arose from activities performed by Mylan promptly notify Customer within [**] of such governmental agency or from activities performed by Insys. Only Mylan can initiate authority request or action or of NxStage’s decision to voluntarily institute a recallProduct 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 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 recalllabeling), Mylan shall provide all necessary lists; Insys NxStage shall be responsible obligated to pay Customer and the Authorized Customer Locations actual damages within [**] days of the 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 amount 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). NxStage’s obligation to 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 FDA contactsor 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 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 FDA or other governmental body orders 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 NxStage to share insurance costs in excess of $200,000. Any recall with respect to any Product supplied hereunder or a recall is voluntarily initiated insurance obtained by MylanNxStage, shall name Customer and the cause Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such recall is due 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 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) a breach by Insys it has not entered into any agreement which conflicts with the terms and conditions 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 liableAgreement and that it will not do so during the Term, 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 it shall not enter into any of its representations, warranties, obligations, covenants distributorship agreement or other agreements contained hereinsimilar agreement with any third party covering the sale, then Mylan shall be liable and shall reimburse Insys rental, licensing, leasing or distribution of the System One 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 chronic home hemodialysis in the ratio Continental United States and Hawaii, except where any such agreements are consistent with the terms and conditions 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party pursuant to this Section.Schedule E Hawaii Schedule E

Recalls. 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 Perrigo or Cumberland shall be responsible required or requested by any governmental authority (or shall voluntarily decide) to recall any Products because such Products may violate any Laws or for all FDA contactsany other reason, the Parties shall cooperate fully with one another in connection with any recall. In To the event that the FDA or other governmental body orders extent a recall with respect to any Product supplied hereunder or a recall is voluntarily initiated by Mylan, and the cause of such recall is due to (a) Cumberland’s gross negligence, willful misconduct or 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 by Insys of any of its representationsthis Agreement, warranties, obligations, covenants or other agreements contained herein or in other written agreements between Perrigo shall remain responsible for the Parties, then Insys shall be liable, Supply Price for such recalled Products and shall reimburse Mylan Cumberland for all the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating to or arising out of described above in the immediately preceding sentence actually incurred by Cumberland in connection with 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 including without limitation administration of the Parties’ contributory responsibility. Insys recall 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 such other actual costs as may be necessary to permit a recall. The Parties agree that if either Party shall discover or become aware of any fact, condition, circumstance or event (whether actual or potential) concerning or reasonably related to the Product which may reasonably require recall. To the extent a recallrecall results from a cause other than the gross negligence, such Party shall promptly communicate such fact, condition, circumstance willful misconduct or event to the other Party. In the event (a) the FDA material breach of this Agreement of or other governmental body requests that the Product be recalled by Perrigo or (b) a court of competent jurisdiction orders such a recallCumberland, the Parties shall take all appropriate remedial actions with respect to such share equally in the costs of the recall. The obligations under this Section shall survive the complete or partial termination of this Agreement. Each Party shall make every reasonable effort Prior to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party 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 Section 7.2 for consequential damages or lost profits of any kind.

Recalls. The Parties agree Vendor agrees to promptly notify 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 procedure for foregoing being referred to as a Product recall “Recall”), Vendor shall notify Purchasers and FDA notifications shall depend on whether HPG within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the issue arose from activities performed by Mylan or from activities performed by InsysRecall to the FDA. Only Mylan can initiate a recall. In the event of a product recall, Mylan shall provide all necessary lists; Insys Notices to HPG shall be responsible for all FDA contacts. In the event that the FDA or other governmental body orders a recall 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 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 each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the reasonable Lossesextent such Recall precludes Vendor from supplying any Products or Services under this Agreement, Legal Expenses any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser 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 Vendor related to such recallProducts 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 costs shall be shared in compliance or purchase requirements during the ratio of the Parties’ contributory responsibility. Insys and Mylan agree time period when Vendor is unable 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party pursuant to this Sectionprovide said designated Products.

Recalls. The Parties agree 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 procedure 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 Product failure of such units to meet Specifications during the Warranty Period, AASTROM shall so notify MSP of the recall and FDA notifications the Parties shall depend jointly exchange relevant information and consult on whether causation of the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate a 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 pay to AASTROM the amount of any unreimbursed costs. For the purpose of clarification, it is agreed that AASTROM shall be solely responsible for determining whether any product recall, Mylan shall provide correction or withdrawal is required and for complying with 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 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 reimbursed by the other Party medical device reporting requirements pursuant to this Section21 CFR Part 803.

Recalls. The Parties OMP and Rohto 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 recallthat, 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 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 discovers or become becomes aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to any Product in the Product which Territory that may reasonably require a recallreport, a recall or market withdrawal of such Product in the Territory, such Party shall promptly communicate such fact, condition, circumstance or event to the other PartyParty within twenty-four (24) hours. In the event (ai) the FDA any governmental entity or other governmental regulatory body requests that the a Product be recalled or withdrawn, (bii) a court of competent jurisdiction orders such a recallProduct recall or withdrawal, or (iii) Rohto (in consultation with OMP) determines that a Product should be recalled or withdrawn from the Parties market, Rohto shall take all appropriate remedial actions with respect to such recallrecall 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 event that listed in Section 9 (b), Rohto shall be solely responsible for, and shall reimburse OMP for, all costs reasonably incurred as a result of, such Remedial Action or any 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 event listed in Section 9 (a). OMP and 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 obligations under this Section Parties shall survive 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 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 reimbursed by affected Product in the other Party pursuant to this SectionTerritory.

Recalls. The Parties agree that the procedure XANODYNE, with data and assistance provided by DSM, is responsible for filing Field Alerts and initiating product recalls due to any defect considered sufficiently serious. XANODYNE will provide DSM with a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan copy of any regulatory correspondence related to field alerts or from activities performed by Insys. Only Mylan can initiate a recall. In recalls, in the event that DSM has reason to believe that any Products should be recalled or withdrawn from distribution, DSM shall promptly inform XANODYNE in writing prior to taking any such action. XANODYNE shall notify the FDA, DEA, and any foreign regulatory agencies of a product any recall, Mylan shall provide all necessary lists; Insys and shall be responsible for coordinating all FDA contactsnecessary activities regarding the action taken. XANODYNE acknowledges and understands that DSM, as manufacturer of the Product, has significant regulatory obligations if there 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 assure regulatory compliance. With prior notification to the other party, either party may, in exigent circumstances, make a unilateral, final decision to notify appropriate regulatory agencies, 27 DISPUTE RESOLUTION In the event that a dispute arises between DSM and XANODYNE regarding the FDA nonconformity of a batch of the Products or regarding other governmental body orders a recall with respect matters, the senior management of the quality departments from both companies shall in good faith promptly attempt to any Product supplied hereunder or a recall is voluntarily initiated by Mylanresolve disputed issues. If the parties cannot reach agreement, 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 matter shall be liableresolved in accordance with dispute resolution provisions of the Supply Agreement. XANODYNE may only dispute a batch of Product, and shall reimburse Mylan which has been dispositioned by DSM for release. Xanodyne Corporate Quality Assurance retains at all times the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating right 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 determine Product release status for commercial distribution. Financial liability 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 fact, condition, circumstance or event (whether actual or potential) concerning or related determined according to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 such recall. The obligations under this Section shall survive the complete or partial termination of this Supply Agreement. Each Party shall make every reasonable effort to mitigate any LossesAPPENDIX I: OUTLINE OF RESPONSIBILITIES FUNCTION DSM XANODYNE -------- ---- -------- MANUFACTURING [**] [**] In-Process TESTING (Physical, Legal Expenses and other outChemical 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-ofCONFORMANCES [**] [**] 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-pocket costs and expenses to be reimbursed by the other Party pursuant to this Section.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. 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 any Product supplied hereunder or a recall is voluntarily initiated by Mylan, and the cause of such recall is due to event: (a) a breach by Insys Purchaser reasonably determines that any Product should be recalled due to its non-conformance with the terms 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 this Agreement; (b) any Applicable Regulatory Agency issues a breach by Mylan of request, directive or order that 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. In the event (a) the FDA or other governmental body requests that the Product be recalled recalled; or (bc) a court of competent jurisdiction orders such a recallrecall (either (b) or (c) together, the Parties an “Order”), each Party shall take all appropriate remedial 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 respect Purchaser in the event of any such recall and provide such assistance in connection therewith as Purchaser may reasonably request. To the extent such recall solely results from: (i) Supplier’s failure to such recall. The obligations properly and completely perform any covenant, agreement or 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 Section Agreement, then Supplier 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 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 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 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 reimbursed by responsible for coordinating any and all such recall activities with the other Regulatory Agencies, its customers or otherwise. Purchaser and Supplier shall agree on all public statements regarding any recall, and neither Party pursuant to shall make any public statements regarding this SectionAgreement without the Party’s prior, written approval.

Recalls. The Parties agree that Vendor will promptly notify HealthTrust upon becoming aware of any patient safety issue involving the procedure for a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan Products or from activities performed by InsysServices. 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 If 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 components is subject to or arising out of such recallrecall 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 (b) a breach by Mylan of any of its representationsthe foregoing being referred to as a “Recall”), warranties, obligations, covenants or other agreements contained herein, then Mylan Vendor shall be liable notify Purchasers and shall reimburse Insys for its reasonable Losses, Legal Expenses and other outHealthTrust within twenty-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 four (24) hours after becoming aware of any fact, condition, circumstance Recall or event (whether actual or potential) concerning or related after Vendor provides notice of the Recall to the FDA. Notices to HealthTrust shall be sent by e-mail to: xxxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor 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 at Vendor’s expense, including return shipping, and Vendor shall reimburse Purchaser for its original costs, including freight, in acquiring such Product. For any other Recall which may reasonably require a recallprovides Purchaser the option of Vendor repair or replacement of the Product, such Party if Vendor is unable to do so to Purchaser’s satisfaction, Purchaser shall promptly communicate such fact, condition, circumstance or event have the right to the other Party. In the event (a) the FDA or other governmental body requests that return the Product be recalled 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 (b) a court of competent jurisdiction orders such a recall, the Parties shall take all appropriate remedial actions with respect to such recall. The obligations Services under this Section Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any Purchaser-Specific Agreement shall survive not be effective for as long as Vendor is unable to supply such Products, and a Purchaser’s pricing will not change for failure to meet the complete compliance or partial termination of this Agreement. Each Party shall make every reasonable effort purchase requirements during the Vendor’s inability to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this Sectionsupply.

Recalls. The Parties agree 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 procedure for a Product recall and FDA notifications shall depend on whether Products, or failure of the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate Products to meet the Specifications warrants such a recall. In Each Party shall promptly notify the event other Party of any situation which may lead to an Initiated Recall of the Products, however, Roche and ACLARA shall have joint authority as to whether to institute a product voluntary recall. Roche shall notify ACLARA, Mylan shall provide all necessary lists; Insys 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 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 shall be responsible for all FDA contacts. In the event that the FDA or other governmental body orders a recall with respect to any Product supplied hereunder allocated as follows, regardless of whether it was recalled by ACLARA, Roche, or a recall is voluntarily initiated by Mylan, and the cause of such recall is due to governmental or regulatory authority: (a) a breach by Insys of any of its representations, warranties, obligations, covenants if the defects or other agreements contained herein or in other written agreements between problems giving rise to the Parties, then Insys shall be liable, and shall reimburse Mylan reason for the reasonable LossesInitiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of ACLARA, Legal Expenses and other ACLARA shall bear the out-of-pocket costs and expenses relating to or arising out of such recall, or associated with the Initiated Recall; (b) a breach by Mylan if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of any negligent or willful acts or omissions on the part of its representationsRoche, warranties, obligations, covenants or other agreements contained herein, then Mylan Roche shall be liable and shall reimburse Insys for its reasonable Losses, Legal Expenses and other bear the out-of-pocket costs and expenses relating 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 arising out of such recall; provided that if willful acts or omissions by both parties share responsibility with respect to such recallParties, the costs shall be shared in the ratio each Party will bear a portion 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 fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 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 roughly commensurate with its proportional responsibility for the Initiated Recall, and (d) if it cannot reasonably be determined which party was responsible for the defects or problems giving rise to be reimbursed by the other Party pursuant to this Sectionreason for the Initiated Recall, then the Parties shall equally share the out-of-pocket costs and expenses associated with the Initiated Recall.

Recalls. The Parties agree that Vendor will promptly notify Division upon becoming aware of any patient safety issue involving the procedure for a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan Products or from activities performed by InsysServices. 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 If 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 components is subject to or arising out of such recallrecall 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 (b) a breach by Mylan of any of its representationsthe foregoing being referred to as a “Recall”), warranties, obligations, covenants or other agreements contained herein, then Mylan Vendor shall be liable notify Purchasers and shall reimburse Insys for its reasonable Losses, Legal Expenses and other outDivision within twenty-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 four (24) hours after becoming aware of any fact, condition, circumstance Recall or event (whether actual or potential) concerning or related after Vendor provides notice of the Recall to the FDA. Notices to Division shall be sent by e-mail to: xxxxxxxxxxx@xxxxxxxxxxxxx.xxx Vendor 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 at Vendor’s expense, including return shipping, and Vendor shall reimburse Purchaser for its original costs, including freight, in acquiring such Product. For any other Recall which may reasonably require a recallprovides Purchaser the option of Vendor repair or replacement of the Product, such Party if Vendor is unable to do so to Purchaser’s satisfaction, Purchaser shall promptly communicate such fact, condition, circumstance or event have the right to the other Party. In the event (a) the FDA or other governmental body requests that return the Product be recalled 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 (b) a court of competent jurisdiction orders such a recall, the Parties shall take all appropriate remedial actions with respect to such recall. The obligations Services under this Section Agreement, any Purchaser compliance requirements or purchase requirements under this Agreement or any Purchaser-Specific Agreement shall survive not be effective for as long as Vendor is unable to supply such Products, and a Purchaser’s pricing will not change for failure to meet the complete compliance or partial termination of this Agreement. Each Party shall make every reasonable effort purchase requirements during the Vendor’s inability to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this Sectionsupply.

Recalls. 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 cease all or part of the business related to the Products; or other circumstances of recalls as required under the Applicable Law. The Parties Distributor undertakes with respect to any 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 procedure Products are recalled due to Distributor or its Permitted Sub-distributors’ or any of its Representatives’ negligence or wilful misconduct or its breach of this Agreement, the Distributor shall (a) indemnify the Principal for a Product 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 FDA notifications shall depend on whether sales of the issue arose from activities performed Recalled Products, Distributor's records relating to such Recall and the costs incurred by Mylan or from activities performed by Insys. Only Mylan can initiate a recallDistributor in connection with implementing such Recall. In the event of a product recallRecall, Mylan 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 provide all necessary lists; Insys 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 FDA contactsfacilities 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 provided to 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 such Independent Auditor may come across in the course of performing its audit under this provision, unless it is required 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 unless breaches of Distributor's obligations under this Agreement have been identified in the course of an Audit or in the inspection by any 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 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 Distributor. During any audits, inspections or examinations conducted by Principal or any authorised agent under this Agreement, including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or Clause 19.6, Principal agrees that it and its duly authorised agents, including any Independent Auditor: will 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 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 event that the FDA result of Audit demonstrates that Distributor fails to make due payment to Principal, or other governmental body orders Distributor had breached any of its obligation under this Agreement, Distributor shall cure such breach within 30 days (in the case of a recall failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if Distributor fails to do so, Principal shall have the right to 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 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 pharmacovigilance matters relating to or arising out the Products as soon as practicable after the execution 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 reimbursementthis Agreement. The Parties shall each maintain traceability records as are sufficient in good faith agree on the Quality Agreement that sets out the responsibilities and as may be necessary to permit a recall. The Parties agree that if either Party shall discover or become aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party. 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 processes for quality activities with respect to such recall. The obligations under this Section shall survive supply, distribution and quality management relating to the complete or partial termination Products as soon as practicable after the execution of this Agreement. Each Party 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 give rise to any liability to pay royalty or other compensation. The warranties in this Clause 21.1 are separate and independent and shall make every reasonable effort not be limited by anything in this Agreement. Principal hereby authorises Distributor to mitigate use the Licensed Marks in the Territory in relation to the Products for the purpose only of exercising its rights and 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 Lossesactual, Legal Expenses 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 claim by any person coming to its notice that the sale or distribution of the Products in the Territory infringes any rights of any other out-of-pocket costs person. Distributor shall provide such information and expenses assistance to be reimbursed by 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 Party 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, Distributor shall not 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 this SectionAgreement.