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 8.1 Each Party shall promptly notify the other if such Party believes 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, withdrawal or field correction (each, a “Recall”) of the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA shall be responsible for the Recall decision, notification of Regulatory Authorities, the Recall strategy and generation of the final Recall letter. During the period in which the Warehouse Services Agreement is in effect, if any, GENERICO will be responsible for executing the Recall, reconciling Product, preparing and submitting Recall status reports and termination requests to applicable Regulatory Authorities with respect to Recall of the Product and any Pipeline Product. Following termination of the Warehouse Services Agreement, NEW ALPHA will be responsible for all Recall activities with respect to Recall of the Product and any Pipeline Product that was not previously shipped from the Premises (as defined in the Warehouse Services Agreement) by GENERICO. In either case, NEW ALPHA shall (subject to Section 8.3) bear all expenses incurred by GENERICO (with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA in connection with such Recall. Each of the Parties will reasonably cooperate with the other Party in connection with any Recall. Each Party will maintain complete and accurate Recall records relating to the Product or any Pipeline Product for any periods that are required by any Legal Requirements. Note: Redacted portions have been marked with (***). The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission. 8.3 In the event that it is determined that any Product or Pipeline Product is recalled as a result of GENERICO’s gross negligence, bad faith, intentional misconduct or intentional breach of this Agreement, then GENERICO shall bear all of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, customer credits for recalled stock, the cost of notifying customers and costs associated with shipment of recalled Product or Pipeline Product from customers and shipment of an equal amount of replacement Product or Pipeline Product to those customers, subject to Sections 12.2 and 12.8. In the event that any Product or Pipeline Product is recalled other than as a result of a product recallGENERICO’s gross negligence, Mylan bad faith, intentional misconduct or intentional breach of this Agreement (or for which the liability would exceed the limitations set forth in Section 12.9), then NEW ALPHA shall provide bear all necessary lists; Insys shall be responsible for of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all FDA contactsrequired Regulatory Authorities, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product or Pipeline Product from customers and shipment of an equal amount of replacement Product to those customers. In the event that the FDA or other governmental body orders a recall with respect to reason for any Recall of Product supplied hereunder or a recall is voluntarily initiated by Mylanin part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, and then 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 expenses shall be allocated in other written agreements an equitable manner between the Parties. 8.4 If the Parties are unable to mutually agree on the source cause of the Recall within 5 days of the event causing the Recall, then Insys shall such dispute will be liable, and shall reimburse Mylan for resolved in the reasonable Losses, Legal Expenses and other out-of-pocket costs same manner as set forth in Section 6.2. The fees and expenses relating to or arising out of such recall, or (b) a breach the testing entity making the determination will be paid by Mylan the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition 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 SectionRecalled Product.

Recalls. The Parties agree AbbVie shall make every reasonable effort to notify Galapagos promptly following its determination that any event, incident, or circumstance has occurred that may result in the procedure need for a recall, market suspension, or market withdrawal of a Product recall in the AbbVie Territory, and FDA notifications shall depend on include in such notice the reasoning behind such determination, and any supporting facts. AbbVie (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate a recallAbbVie Territory. In the event that either Party believes that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a product Product in the Galapagos Territory (including any requirement or recommendation by a Regulatory Authority with respect to a recall, Mylan market suspension, or market withdrawal), such Party shall provide all necessary lists; Insys immediately so notify the other Party and shall be responsible for all FDA contactsinclude in such notice the reasoning behind such belief and any supporting facts, and the Parties shall discuss and attempt in good faith to reach agreement as to whether such recall, market suspension or market withdrawal is necessary. In the event that the FDA Parties cannot reach prompt agreement with respect to the need for a recall, market suspension or market withdrawal of a Product in the Galapagos Territory, then such recall, market suspension or market withdrawal shall be implemented. If a recall, market suspension, or market withdrawal of any Product is determined to be required in accordance with this Section 3.12.3, (a) Galapagos (or its Sublicensee) shall implement any such recall, market suspension or market withdrawal in the Galapagos Territory, and (b) AbbVie (or its Sublicensee) shall implement any such recall, market suspension, or market withdrawal in any other governmental body orders country in the Territory, in each case, in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.12.3, the Party responsible for the recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to Article 11, (1) if and to the extent that a recall recall, market suspension, or market withdrawal resulted from a Party’s or its Affiliate’s breach of its obligations hereunder, or from such Party’s or its Affiliate’s negligence or willful misconduct, such Party shall bear the expense of such recall, market suspension, or market withdrawal, (2) with respect to any recall, market suspension, or market withdrawal of a Co-Promotion Product supplied hereunder or in the Co-Promotion Territory other than as described in clause (1) above, the expenses incurred by the Parties as 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 result of such recall, market suspension, or (b) a breach by Mylan of any of its representations, warranties, obligations, covenants or other agreements contained herein, then Mylan market withdrawal shall be liable included in Allowable Expenses hereunder and shared by the Parties pursuant to Section 6.7, (3) with respect to any recall, market suspension, or market withdrawal of a Product in the Galapagos Territory other than as described in clause (1) above, Galapagos shall reimburse Insys be responsible for its reasonable Losses, Legal Expenses and other out-of-pocket all costs and expenses relating to or arising out of such recall; provided that if both parties share responsibility , market suspension, or market withdrawal, and (4) with respect to any recall, market suspension, or market withdrawal not covered by clause (1), (2) or (3), AbbVie shall be responsible for all costs of such recall, market suspension, or market withdrawal, and 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 refunds with respect to such recall. The obligations under this Section recalled Product 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 deducted from Net Sales pursuant to this SectionArticle 6.

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. 11.3.1 In the event of any recall or seizure of any Product, other than a product recallPurchaser Recall (as defined below) Seller shall, Mylan shall provide all necessary lists; Insys shall be responsible for all FDA contacts. In at 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 Mylanwritten election of Purchaser and at Seller’s sole cost, and the cause of such recall is due to either: (a) a breach undertake Commercially Reasonable Efforts to replace the amount of Product recalled or seized; or (b) give credit to Purchaser against outstanding receivables due from Purchaser in an amount equal to the amount paid 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 Purchaser for the Product (including any Gross Profit Split paid to Seller on such Product) so recalled or seized or otherwise owing by Purchaser hereunder; plus reimburse (or, at the written election of Purchaser, credit) Purchaser for the aggregate and reasonable Lossestransportation costs, Legal Expenses taxes, freight insurance, handling and other reasonable and verifiable out-of-pocket costs and expenses relating to or arising out incurred by Purchaser in respect of such recalled or seized Product. 11.3.2 In the event of any recall or seizure of any Product occurring primarily as a result of any breach of this Agreement by, or negligent acts of omissions or intentional misconduct of, Purchaser or its Affiliates (a “Purchaser Recall”), (i) if such Purchaser Recall is classified by FDA as a Class I recall, Seller shall be responsible (as between Purchaser and Seller) for such recalled or seized Product and shall bear all costs of such recall or seizure, (bii) if such Purchaser Recall is classified by FDA as a breach Class II recall, Seller shall be responsible (as between Purchaser and Seller) for such recalled or seized Product and the parties shall share equally all costs of such recall or seizure and (iii) if such Purchaser Recall is classified by Mylan FDA as a Class III recall, Purchaser shall be responsible (as between Purchaser and Seller) for such recalled or seized Product and shall bear all costs of such recall or seizure, including reimbursement of Seller of any of its representations, warranties, obligations, covenants or other agreements contained herein, then Mylan shall be liable reasonable and shall reimburse Insys for its reasonable Losses, Legal Expenses and other verifiable out-of-pocket costs and expenses relating incurred by Seller related to the recall or arising out seizure of such recall; provided that if both parties share responsibility Product. Purchaser’s costs with respect to such any Purchaser Recall as set forth above shall not be deducted in connection with the calculation of Purchaser’s Net Sales or Gross Profit hereunder. 11.3.3 For purposes of this Section 11.3, “recall” shall mean (i) any action by Seller, the costs shall be shared Purchaser, any Affiliate of either to recover title to or possession of any Product sold or shipped and/or (ii) any decision by Purchaser not to sell or ship Product to third parties which would have been subject to recall or seizure if it had been sold or shipped, in each case taken in the ratio good faith belief that such action was appropriate or required under the circumstances. For purposes of the Parties’ contributory responsibilitythis Section 11.3, “seizure” shall mean any action by any government agency to detain or destroy any Product. 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 Notwithstanding anything to the Product which may reasonably require a recallcontrary in this Section 11.3, such Party Seller 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 have final authority with respect to any recall of the Product and neither Purchaser nor its Affiliates shall initiate any recall of the Product without Seller’s prior written approval (such recallapproval not to be unreasonably conditioned, withheld or delayed). 11.3.4 Seller and Purchaser shall keep the other fully informed of any notification or other information, whether received directly or indirectly, that might affect the marketability, safety or effectiveness of the Product, or which might result in liability issues or otherwise necessitate action on the part of either party, or which might result in recall or seizure of any Product. The obligations under this Section Purchaser shall survive maintain records of all sales of Product and customers reasonably sufficient to adequately administer a recall or seizure for the complete longer of three years after termination or partial termination expiration of this AgreementAgreement or the period required by Applicable Law. Each Party Seller will be responsible for assuring that such recall is closed-out with the FDA, unless the FDA 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 Sectionotherwise require.

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: 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. (A) The Parties agree that shall exchange their internal standard operating procedures, if any, as to product recalls ("SOPs") reasonably promptly after the procedure Effective Date and thereafter reasonably promptly after such SOPs are approved or modified. If either Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Product recall Recall in any country in the Territory, it shall promptly so notify the other Party and FDA notifications shall depend on whether the issue arose from activities performed by Mylan Party having the right to control such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes or from activities performed by Insys. Only Mylan can initiate a recallpublic safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent of the event of a product recall, Mylan shall provide all necessary lists; Insys JSC and shall be responsible for made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make available to the Party having the first right to control such Recall all FDA contactspertinent records which the Party having the first right to control such Recall may reasonably request to assist in effecting any Recall. (B) With respect to any clinical studies conducted by ViaCell under this Agreement, ViaCell shall have the exclusive right to control a Recall of any Cell Therapy Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. In the event that the FDA or other governmental body orders a recall Other than with respect to any Product supplied hereunder or a recall is voluntarily initiated clinical studies conducted by MylanViaCell under this Agreement, and Amgen shall have the cause exclusive right to control any Recall 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 the Collaboration Products in other written agreements between the Parties, then Insys shall be liableTerritory, and shall reimburse Mylan for the reasonable Losses, Legal Expenses conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell 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 Amgen shall each maintain traceability complete and accurate records as are sufficient and of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be necessary to permit a recall. The Parties agree that if either Party shall discover or become aware of required by legal requirements, but in 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 Sectionfor no less than [**].

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 Authority issues a request, directive or other governmental body requests order that the Product be recalled recalled, or (bii) a court of competent jurisdiction orders such a recall, or (iii) DEPOMED reasonably determines that the Product should be recalled, the Parties shall take all appropriate remedial actions corrective actions. 8.1.1 In the event that such Recall results from the manufacture, packaging, storage, testing and handling of the Product by MOVA and such recall or event is due to MOVA’s failure to provide the manufacturing services hereunder in accordance with respect to such recall. The obligations under this Section the Specifications, and Applicable Law, as determined by the Laboratory, MOVA shall survive be responsible for the complete or partial termination of this Agreement. Each Party shall make every reasonable effort to mitigate any Losses, Legal Expenses and other documented out-of-pocket expenses of such Recall or return and shall use its commercially reasonable efforts to replace the recalled or returned Products with new Products contingent upon the receipt from Depomed of all API required for the manufacture of such replacement Product. For greater certainty, MOVA’s responsibility for any loss of API in connection with the recalled Product shall be subject to the limitation set forth in Section 7.6.1. In the event that MOVA is unable to replace the recalled or returned Products, then DEPOMED may request MOVA to reimburse DEPOMED for the Production Fees paid to MOVA with respect to the recalled Products. In all other circumstances, Recalls, returns or other corrective actions shall be made at DEPOMED’s cost and expense. For the purposes of this Agreement, the expenses of Recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Product, and DEPOMED’s costs for the Product recalled. Marketing and advertising expenses associated with the goodwill of the Product subject to the recall shall not be reimbursed included as an expense of recall and shall, in all instances, be borne by DEPOMED. The remedies set forth above shall constitute the other sole remedy of each Party under this Section 8.1. 8.1.2 MOVA shall have no obligation pursuant to Section 8.1 above to the extent such claim (i) is caused by deficiencies with respect to the setting of the Specifications, the inherent safety, efficacy or marketability of the Products or any distribution thereof, (ii) results from a defect in Materials that is not reasonably discoverable by MOVA using the test methods set forth in the Specifications, (iii) results from a defect in the API or Materials supplied by DEPOMED that is not reasonably discoverable by MOVA using the test methods set forth in the Specifications, (iv) is caused by actions of third parties occurring after such Product is shipped by MOVA pursuant to Section 3.1; (v) is due to packaging or labeling defects or omissions for which MOVA has no responsibility, or (vi) is due to any other breach by DEPOMED of its obligations under 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 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 the procedure for a 9.1 Product recall recalls 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 contacts relating to recall of a product recall, Mylan shall provide all necessary lists; Insys Product shall be responsible for all FDA contactsthe responsibility of, and under the control of, Barrier. In However, 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 has reason to believe that any Products should be recalled 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 recallwithdrawn from distribution, such Party shall promptly communicate inform the other in writing prior to taking any such factaction. Barrier shall notify the FDA, conditionDEA, circumstance or event and any foreign regulatory agencies of any recall, and shall be responsible for coordinating all necessary activities regarding the action taken. DSM and Barrier acknowledge that each Party has significant regulatory obligations; and accordingly agree that each Party shall fully cooperate with the other to complete the recall, and shall thereafter resolve any allocation of liability as may be appropriate in accordance with the terms of this Agreement. 9.2 If any Product is recalled as a result of the supply by DSM of Product that does not conform to the other Party. In the event (a) the FDA Specifications or other governmental body requests that Product requirements of this Agreement, then subject to Section 5.4, DSM shall reimburse Barrier for its reasonable expenses actually incurred as a result of such recall. If Barrier elects to utilize a Third Party to conduct a recall, Barrier shall so notify DSM and shall await DSM’s consent, which consent shall not unreasonably be withheld. 9.3 If each Party contributes to the Product be recalled or (b) a court of competent jurisdiction orders such cause for a recall, the Parties expenses actually incurred as a result of such recall will be shared in proportion to each Party’s responsibility. All other recalls of Product shall take be at Barrier’s sole expense. Barrier shall give DSM prompt written notice of any Product recalls that Barrier believes were caused or may have been caused by DSM’ failure to comply with this Agreement or the Specifications. 9.4 Barrier shall maintain records of all appropriate remedial actions with respect sales of Commercial Product and customers sufficient to such adequately administer a recall. The obligations under this Section shall survive the complete , market withdrawal or partial correction for a period of five (5) years after termination or expiration of this Agreement. Each Party Subject to Section 9.1, Barrier shall make every reasonable effort in all events be responsible for conducting any recalls, market withdrawals or corrections with respect to mitigate any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this SectionProduct.

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 (a) Notwithstanding anything in this Agreement to the procedure for contrary, JV shall have the right to manage any recall of a Product within the Territory, provided that JV shall consult with and receive the Approval of Medifocus with respect to the manner, process and timing of the actions to be taken in connection with such recall, and the obligations of the parties in Sections 4.04(b) and (c) are subject to such right. (b) If, in the judgment of Medifocus or JV, any Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Product, Medifocus may undertake such recall or issue such advisory letter after consultation with JV and FDA notifications JV may undertake such recall or issue such advisory letter after consultation with Medifocus and receipt of Medifocus’ Approval with the respect to the manner, process and timing thereof. The parties shall depend on whether also endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the issue arose manner, text and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement shall not be a precondition to implementing any action necessary to protect users of the Products or to comply with any applicable governmental orders or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. JV shall be solely responsible for the costs of effecting such recall or issuing such advisory letter, including costs related to return of recalled Products, provided, that if such recall or advisory letter result from activities performed by Mylan a design defect in the Product, Medifocus shall be responsible for the costs of effecting such recall or from activities performed by Insys. Only Mylan can initiate a recall. advisory letter. (c) In the event of a product recallrecall of any Product, Mylan JV shall provide all necessary lists; Insys shall be responsible for all FDA contacts. In correct or cause its manufacturers, as applicable, to correct any deficiency relating to the event that the FDA manufacturing, packaging, testing, labeling, storing or other governmental body orders a recall with respect to any Product supplied hereunder or a recall is voluntarily initiated by Mylanhandling of such Product, if applicable, and the cause of shall, upon agreement with Medifocus, either, at JV’s cost (and seek reimbursement from Medifocus if such recall is due to a design defect of the Product), replace each unit of the Product recalled (aincluding units held in inventory by JV or its customers) with a breach by Insys corrected Product within a reasonable period 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 recalltime, 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, refund 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 Sectionpurchase price therefor.

Recalls. The Parties agree that a. If (i) any government agency recommends or requires 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 Products or packaging; or (ii) either Supplier or Distributor reasonably determines that any Products or packaging should be recalled or should be withdrawn from distribution and sale; based upon a determination that such Products or packaging are not fit for human consumption, are contaminated, constitute a health hazard, are of its representations, warranties, obligations, covenants substandard quality or other agreements contained herein or are otherwise not in other written agreements between the Partiesa saleable condition, then Insys Supplier and Distributor shall be liablecoordinate the immediate cessation of sale and distribution and/or the recall or withdrawal as necessary of all such Products or packaging from the Territory. If necessary or advisable, Distributor and Supplier shall reimburse Mylan for cooperate to recall and/or reacquire the reasonable Lossesapplicable Products or packaging from any purchaser thereof. b. If the problem at issue was not caused by Distributor, Legal Expenses and other out-of-pocket then Supplier shall pay the costs and expenses relating to or arising out of associated with any such recall, and Supplier shall indemnify Distributor for (i) its laid-in cost of all unsold recalled Products and packaging and the cost of returning such Products and packaging to Supplier or destroying them, as Supplier may elect; and (bii) a breach by Mylan of any of its representationsreasonable costs and expenses associated with such recall, warrantieswhich costs may include but are not limited to credits, obligationsrefunds, covenants or other agreements contained hereinpayments by Distributor to its customers in connection therewith. For purposes of this Agreement, “laid-in cost” shall include the invoice cost, insurance and freight for packaging and Products purchased in finished form by Distributor. c. If the problem at issue was caused by Distributor, then Mylan Distributor shall be liable pay the costs and expenses associated with any such recall, and Distributor shall reimburse Insys indemnify Supplier 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 associated 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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. Each Party shall make every reasonable effort to mitigate any LossesEACH SUCH PORTION, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this SectionWHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

Recalls. The Parties agree From time to time throughout the Term, AASTROM m▇▇ ▇n 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 numbe▇ ▇▇ 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 i▇▇▇▇mation 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 inc▇▇▇▇d 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% ▇▇▇▇l the cost o▇ ▇▇e 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-reimbu▇▇▇▇ c▇▇▇▇. 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 (a) From the Effective Date until the date on which Scynexis assigns to GSK all right, title and interest in and to all NDAs granted by any Regulatory Authority in the GSK Territory that are existing as of the procedure for a date hereof, that are held in the name of, or otherwise Controlled by, Scynexis or any of its Affiliates and that are necessary or useful to Commercialize any Compound or any Product recall in the GSK Territory in accordance with Section ‎5.2 and FDA notifications the Commercialization Transition Plan and subject to the terms and conditions herein, Scynexis shall depend on have the sole right to determine whether the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate and how to implement a recall. In , suspension, removal or other market withdrawal of any commercial Product in the event of GSK Territory; provided that Scynexis shall consult with GSK on any such decision to implement a product recall, Mylan shall provide all necessary lists; Insys shall be responsible for all FDA contacts. In the event that the FDA suspension, removal or other governmental body orders a recall with market withdrawal and shall consider any recommendation of GSK in good faith. With respect to any Product supplied hereunder sold by Scynexis under a NDA in accordance with the Commercialization Transition Plan following the Effective Date, GSK shall reimburse Scynexis for all costs and expenses related to any recall, suspension, removal or a recall is voluntarily initiated other market withdrawal. On and after the date on which Scynexis assigns to GSK all right, title and interest in and to all NDAs granted by Mylanany Regulatory Authority in the GSK Territory that are existing as of the date hereof, and that are held in the cause of such recall is due to (a) a breach by Insys of name of, or otherwise Controlled by, Scynexis or any of its representationsAffiliates and that are necessary or useful to Commercialize any Compound or any Product in the GSK Territory in accordance with Section ‎5.2 and the Commercialization Transition Plan and subject to the terms and conditions herein, warrantiesGSK shall have the sole right to determine whether and how to implement a recall, obligationssuspension, covenants removal or other agreements contained herein market withdrawal of any commercial Product in the GSK Territory. (b) From the Effective Date until the date on which Scynexis assigns to GSK all right, title and interest in and to all relevant INDs granted by any Regulatory Authority in the GSK Territory that are existing as of the date hereof, that are held in the name of, or otherwise Controlled by, Scynexis or any of its Affiliates and that are necessary or useful to Develop any Compound or any Product in the GSK Territory in accordance with Section ‎5.2 and the Technology Transfer Plan and subject to the terms and conditions herein, Scynexis shall have the sole right to determine whether and how to implement a recall, suspension, removal or other written agreements between market withdrawal of any clinical Product in the PartiesGSK Territory; provided that Scynexis shall consult with GSK on any such decision to implement a recall, then Insys shall be liablesuspension, removal or other market withdrawal and shall consider any recommendation of GSK in good faith. With respect to any clinical Product utilized by Scynexis under an IND in accordance with the Development Plan on behalf of GSK following the Effective Date, GSK shall reimburse Mylan Scynexis for the reasonable Losses, Legal Expenses and other out-of-pocket all costs and expenses relating related to or arising out of such a recall, suspension, removal or (b) a breach other market withdrawal. On and after the date on which Scynexis assigns to GSK all right, title and interest in and to all INDs granted by Mylan any Regulatory Authority in the GSK Territory that are existing as of the date hereof, that are held in the name of, or otherwise Controlled by, Scynexis or any of its representations, warranties, obligations, covenants Affiliates and that are necessary or other agreements contained useful to Develop any Compound or any Product in the GSK Territory in accordance with Section ‎5.2 and the Technology Transfer Plan and subject to the terms and conditions herein, then Mylan GSK shall be liable have the sole right to determine whether and shall reimburse Insys for its reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating how 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 implement a recall, such Party suspension, removal or other market withdrawal of any clinical Product in the GSK Territory. (c) Each Party, to the extent possible, (i) shall promptly communicate such fact, condition, circumstance or event provide notice to the other Party. In , as promptly as possible after such Party becomes aware thereof (and in advance to the extent permitted under the circumstances and under Law), in the event (a) that any Regulatory Authority issues or requests a recall or takes a similar action in connection with any Product in its respective Territory, or in the FDA event such Party determines that an event, incident or other governmental body requests circumstance has occurred that may result in the Product be recalled or (b) a court of competent jurisdiction orders such need for a recall, suspension, removal or other market withdrawal of a Product in its respective Territory, and (ii) to the extent permitted under Law, shall, and shall cause its Affiliates, licensees and sublicensees to, cooperate in good faith with such other Party and disclose to such other Party a high-level summary of any material, non-privileged information relating to any such recall, suspension, removal or other market withdrawal. (d) Except as may otherwise be agreed to by the Parties in writing, each Party shall take all appropriate remedial actions with respect to bear the expense of any such recall. The obligations under this Section shall survive the complete , suspension, removal 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 Sectionmarket withdrawal in its own Territory.

Recalls. The Parties agree Each Party shall notify the other by telephone within [***] after receiving any information, request or directive giving rise to a good faith belief that a recall of any Product manufactured pursuant to this Agreement is or may be required under Applicable Law or is or may be otherwise necessary to avoid risk of injury or liability. Notwithstanding anything in this Agreement or the procedure for Quality Agreement to the contrary, Cadence shall have sole discretion over whether and under what circumstances to require the recall of the Product in the Territory, unless a Product Drug Regulatory Authority in the Territory issues or requests a 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 contactstakes similar action in connection with such Product. In the event that the FDA or other governmental body orders a recall with respect to any Product supplied hereunder or LL, in good faith, believes that a recall is voluntarily initiated required under Applicable Law or is otherwise necessary to avoid risk of injury, it shall inform Cadence by Mylanproviding written notice thereof to Cadence specifying, in reasonable detail, the nature and all relevant circumstances giving rise to LL’s belief that a recall is warranted, and information regarding the cause affected Product. Within [***] following Cadence’s receipt of such recall is due written notification (or sooner if exigent circumstances exist or otherwise are required in order to (a) a breach by Insys of any of its representationscomply with Applicable Law), warranties, obligations, covenants or other agreements contained herein or in other written agreements between the Parties, then Insys Parties shall be liable, discuss the circumstances giving rise to such notification and shall reimburse Mylan for the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating to or arising out content of such recallnotification, or (b) a breach by Mylan and, if so required, the timing and breadth 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 the recall, the costs strategies and notifications to be used by Cadence to effect the recall, and other related issues. In the event that LL recommends to Cadence, in good faith, that a recall of a particular batch or batches of the Product should be conducted, and Cadence declines to recall such Product, LL shall be shared in the ratio entitled to indemnification pursuant to Section 6.2 of the Parties’ contributory responsibilitythis Agreement. Insys LL and Mylan agree to abide by all Healthcare Distribution Management Association published guidelines for product recall reimbursement. The Parties Cadence each shall each maintain such traceability records as are sufficient and as may be necessary to permit a recall, product withdrawal or field correction of any Product. The Parties agree that if either Each 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 provide full cooperation and assistance to the other Party in connection with any recall as may be reasonably requested by the other Party. In the event . (a) If a Product recall results from: (i) the FDA failure of any Product, packaging or other governmental body requests that labeling supplied hereunder to conform to the Specifications; (ii) the failure of any Product, packaging or labeling supplied hereunder to comply with Applicable Laws or the terms of this Agreement, including the Quality Agreement, at the time the Product be was delivered by LL to *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Cadence’s carrier; (iii) any negligent, grossly negligent or willful act or omission by LL or its Affiliates, including without limitation the negligent or grossly negligent manufacture of the Product, LL shall: (x) credit to Cadence an amount equal to the total purchase price paid by Cadence to LL for the Product so recalled, plus Cadence’s actual cost for direct material and direct labor furnished by Cadence or its contracting parties in connection with the manufacture of the recalled Product, (y) reimburse Cadence for all expenses associated with the conduct of the recall action (e.g. advertising, mailing, administration, travel, etc.), and (z) indemnify and hold Cadence harmless from and against any and all damages, costs or charges, lawsuits or expenses associated with or resulting from any such recall, including reasonable legal fees and disbursements. (b) If a court Product recall results from: (i) improper handling, shipping or storage of competent jurisdiction orders such a recallthe Product after delivery by LL to Cadence’s designated carrier, (ii) the Parties inadequate or misleading nature of any text appearing on the packaging or labeling of the Product in compliance with the Specifications; (iii) any negligent, grossly negligent or willful act or omission by Cadence, or (iv) due to circumstances other than those described in Section 3.10(a), above, then LL shall take all appropriate remedial actions have no liability with respect to the recall and Cadence shall indemnify, defend and hold LL and each other LL Indemnitee from any and all Losses suffered by such LL Indemnitee arising or related to such recall. The obligations rights and remedies available to each Party under this Section 3.10 are not exclusive and shall survive the complete or partial termination of this Agreement. Each be in addition to all other right and remedies available to such Party shall make every reasonable effort to mitigate any Losses, Legal Expenses at law and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this Sectionin equity.

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 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) any Agency issues a directive, order or, following the FDA issuance of a safety warning or other governmental body requests alert with respect to a product, a written request that the any Product be recalled or recalled, (bii) a court of competent jurisdiction orders such a recall, or (iii) Cornerstone determines that any Product should be recalled or that a “dear doctor” letter is required relating [***] Confidential portions of the Parties exhibit have been omitted and filed separately with the Securities and Exchange Commissions. to the restrictions on the use of the Product, Chiesi will co-operate with those activities relating to the Product as reasonably required by Cornerstone, having regard to all Applicable Laws. In the event of a recall of the Product, Cornerstone will notify Chiesi in accordance with the Pharmacovigilance Agreement, and Chiesi will cooperate with those recall activities relating to the Product as reasonably required by Cornerstone. 5.16.1 Cornerstone or its designated agent shall take all appropriate remedial actions have the responsibility for handling customer returns of the Product. Chiesi shall provide Cornerstone or its designated agent with respect such assistance as Cornerstone may reasonably require to handle such Product returns. 5.16.2 To the extent that a recall or return results from, or arises out of, a failure by Chiesi (or its contract manufacturer) to manufacture and supply the Product in accordance with the Specifications, Applicable Laws and/or cGMP, at Cornerstone’s option, Chiesi shall be responsible for the documented out-of-pocket expenses of such recall or return and shall either (i) reimburse Cornerstone for the price that Cornerstone paid to Chiesi for manufacturing the Product which are the subject of the recall. The obligations under this Section shall survive , including the complete actual costs incurred in shipping, applicable transit charges, insurance premiums, duties, taxes paid or partial termination of this Agreement. Each Party shall make every reasonable effort to mitigate any Losses, Legal Expenses and other out-of-pocket charges incurred in connection with delivery of such Product to Cornerstone or its designee, or (ii) use its commercially reasonable efforts to replace the recalled or returned Product with new Products at no charge to Cornerstone. Additionally, Chiesi shall reimburse or credit Cornerstone for any out-of-pocket costs paid by Cornerstone to Third Parties for transportation and destruction of the affected Product, and pay or provide a credit to Cornerstone for the actual administrative expenses to be reimbursed and all other reasonable costs incurred by Cornerstone outside of the other Party pursuant to ordinary course of business in connection with the disposition of a Product under this SectionSection 5.16.

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 ▇▇▇▇▇▇▇’▇ 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 that the procedure for a 9.1. Product recall recalls and FDA notifications contacts relating to recall of Product shall depend on whether be the issue arose from activities performed by Mylan or from activities performed by Insysresponsibility of, and under the control of, OMEROS. Only Mylan can initiate a recall. In However, in the event that either Party has reason to believe that any Products should be recalled or withdrawn from distribution, such Party shall promptly inform the other in writing prior to taking any such action. OMEROS shall notify the FDA and other Governmental Authorities, as appropriate, 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. In DSM and OMEROS acknowledge that each Party has significant regulatory obligations; and accordingly, each Party shall fully cooperate with the event other to complete the recall, and shall thereafter resolve any allocation of liability as may be appropriate in accordance with the terms of this Agreement. 9.2. OMEROS shall give DSM prompt written notice of any Product recalls that OMEROS believes were caused or may have been caused by DSM’s failure to comply with this Agreement or the FDA Specifications. If any Product is recalled as a result of the supply by DSM of Product that does not conform to the Specifications or other governmental body orders Product requirements of this Agreement, then subject to Sections 4.2.6 and 5.5, DSM shall promptly reimburse OMEROS for its reasonable expenses incurred as a result of such recall, and, at OMEROS’ election, either refund OMEROS for any amounts paid and cancel any amounts payable pursuant to outstanding Purchase Orders under this Agreement relating to the recalled Product or replace the recalled Product with conforming Product at no cost to OMEROS. If OMEROS elects to utilize a Third Party to conduct a recall, OMEROS shall so notify DSM. Upon the occurrence of a Product recall with respect event, OMEROS shall have the right to any suspend Monthly Forecasts for the Product supplied hereunder or a that is the subject of the recall is voluntarily initiated by Mylan, and neither Party shall be subject to Firm Purchase Commitments related to the recalled Product until the cause of such recall has been identified and a corrective action plan mutually agreed upon by OMEROS and DSM has been implemented. 9.3. The Party responsible for causing a recall of Product shall bear the expenses of the recall. If each Party is due partially responsible for causing the recall, the Parties will share the expenses of the recall in proportion to their respective responsibility. 9.4. OMEROS or its designated Third Party contractor shall maintain records of all sales of Commercial Product and customers sufficient to adequately administer a recall for the longer of (a) a breach by Insys period 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 period of [†] and (c) such other period as required by Mylan Applicable Law. Subject to Sections 9.1, 9.2 and 9.3, OMEROS shall in all events be responsible for conducting any recalls 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 responsibilityProduct. 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.† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

Recalls. (a) Notwithstanding anything in this Agreement to the contrary, BSC shall have the right to manage any recall within the Territory and the obligations of the parties in Sections 4.04(b) and (c) are subject to such right. (b) If, in the judgment of Celsion or BSC, any Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Product, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The Parties parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement shall not be a precondition to any action that either party deems necessary to protect users of the Products or to comply with any applicable governmental orders or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. Celsion shall promptly pay or reimburse BSC for the reasonable costs of effecting such recall or issuing such advisory letter, including costs related to return of recalled Products and refunding to BSC the purchase price paid by BSC for recalled Products, including Products in BSC's inventory; provided, however, that to the procedure extent such recall or the issuance of such advisory letter results from an act or omission of BSC, BSC shall be responsible for a Product the costs of effecting such recall and FDA notifications shall depend on whether or issuing such advisory letter, including costs related to return of recalled Products, to the issue arose extent such recall or the issuance of such advisory letter results from activities performed by Mylan the act or from activities performed by Insys. Only Mylan can initiate a recall. omission of BSC. (c) In the event of a product recallrecall of any Product, Mylan Celsion shall provide all necessary lists; Insys correct any deficiency relating to its manufacturing, packaging, testing, labeling, storing or handling of such Product, if applicable, and shall, at BSC's option, either, at its cost replace each unit of the Product recalled (including units held in inventory by BSC or its customers) with a corrected Product within a reasonable period of time, or refund the purchase price therefor. Celsion shall be responsible reimburse BSC 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(including shipping, or (bquality control testing, notification and restocking costs) incurred by BSC as a breach by Mylan result 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. Each Party shall promptly report in writing to the other Party any failure of the Product, change in the statistically demonstrated reliability of the Product, concerns regarding safety of the Product, other material information relevant to the reliability of the Product or any liability claims related to the Product or any other event that might reasonably be expected to have a material adverse effect on the Manufacture, marketing or sale of the Product of which either Party becomes aware (collectively, “Product Concerns”). The Party that Manufactured the applicable quantity of the Product shall be responsible for evaluating all Product Concerns, and shall use Commercially Reasonable Efforts to take such actions or make such changes in the Product or the Manufacturing thereof as may be necessary or desirable in light of such Product Concerns. The other Party shall reasonably cooperate with the manufacturing Party in any such evaluation and actions or changes. If either Party reasonably believes that a recall of the Product, in whole or in part, or the issuance of an advisory letter regarding reliability of or defects in the Product is advisable or necessary, it will, prior to making a final determination concerning any such recall or issuance of an advisory letter, promptly notify the other Party and the Parties will promptly and in good faith discuss such proposed recall or advisory letter; provided, however, that either Party may, in good faith, initiate a recall or issue an advisory letter. In making a determination to initiate a recall or issue an advisory letter, the applicable Party shall follow the same processes and procedures that it customarily follows with respect to determinations concerning recalls or advisory letters involving product that is manufactured and sold by such Party. In the event the Parties do not agree that regarding the procedure advisability or necessity of any such recall or advisory letter and ▇▇▇▇▇▇’▇ Quality Assurance policies or procedures would, in ▇▇▇▇▇▇’▇ reasonable judgment, prohibit ▇▇▇▇▇▇ from placing further orders with Surmodics for a the 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 recallshipping the Product to customers, ▇▇▇▇▇▇ shall notify Surmodics, and the Parties shall then proceed as provided in Section 13.3.1(i). In the event of a product recallrecall or advisory letter, Mylan shall provide all necessary liststhe Party whose act or omission gave rise to such recall or advisory letter: (A) shall, at its own expense, use its reasonable efforts to promptly correct the problems that caused the recall or advisory letter; Insys and (B) 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 the other Party for all the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating of the recall or advisory letter, including costs of goods, payments to customers, notification, and shipping and handling. In all other cases, each Party shall bear its own costs for the recall or arising out advisory letter. Notwithstanding the foregoing, nothing in this Section 5.7 shall be construed to limit or prevent a Party from complying with the requirements of such recallany law, regulation, or (b) order of 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 responsibilityRegulatory Authority. Insys and Mylan agree to abide by all Healthcare Distribution Management Association published guidelines for product recall reimbursementCERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. 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 SectionCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

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 for a Product recall Fisiopharma 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 Zavante will each maintain traceability records as are sufficient and as may be necessary to permit a recallvoluntary and involuntary recalls or other related actions of Finished Drug Product delivered by Zavante to its customers (collectively, “Recalls”). The Parties agree that if either Each Party shall discover or become aware will promptly notify the other by telephone (to be confirmed in writing) of any factinformation which might affect the marketability, conditionsafety or effectiveness of the Finished Drug Product or which might result in the Recall or seizure of the Finished Drug Product. Upon receiving this notice or upon this discovery, circumstance Fisiopharma will stop making any further shipments of any Bulk Drug Vials in its possession or event (control until a decision has been made whether actual a Recall or potential) concerning or related to some other corrective action is necessary. Zavante will have the Product which responsibility for handling customer returns of the Finished Drug Product, and Fisiopharma will give Zavante any assistance that Zavante may reasonably require to handle any such returns. 10.2.1 The decision to initiate a recallRecall or to take some other corrective action, such Party shall promptly communicate such factif any, conditionwill be made and implemented by Zavante. As used herein, circumstance the term, “Recall” will include any action (i) by Zavante to recover title to or event possession of quantities of the Finished Drug Product sold or shipped to third parties (including, without limitation, the other Party. In voluntary withdrawal of Finished Drug Product from the event (a) the FDA or other governmental body requests that the Product be recalled market); or (bii) by any regulatory authorities to detain or destroy any of the Finished Drug Product. Recall will also include any action by either Party to refrain from selling or shipping quantities of the Finished Drug Product to third parties which would have been subject to a Recall if sold or shipped. 10.2.2 lf (i) any Regulatory Agency issues a directive, order or, following the issuance of a safety warning or alert about the Finished Drug Product, a written request that any Finished Drug Product should be Recalled, (ii) a court of competent jurisdiction orders such a recallRecall, or (iii) Zavante determines that any Finished Drug Product should be Recalled or that a “Dear Doctor” letter is required relating the Parties shall take restrictions on the use of any Finished Drug Product, Fisiopharma will co-operate as reasonably required by Zavante, having regard to 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 SectionApplicable Laws.

Recalls. The Parties agree that (a) Paladin shall administer all recalls or market withdrawals of the procedure for a Licensed Product recall in the Territory (“Recall”) in accordance with applicable Laws and FDA notifications Paladin’s standard operating procedures used in connection with any recalls or withdrawals of Paladin products in the Territory. Paladin 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 promptly consult with Somaxon with respect to any Product supplied hereunder or a recall is voluntarily initiated Recall proposed to be taken by Mylan, Paladin (and in all events reasonably in advance of the cause taking of such recall is due Recall), including all Recalls that are reasonably likely to (a) result in a breach by Insys material adverse effect on the marketability of any of its representationsthe Licensed Product in or outside the Territory. At Paladin’s request, warranties, obligations, covenants or other agreements contained herein or Somaxon shall provide reasonable assistance to Paladin 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 conducting such recall, or Recall. (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 Each Party shall promptly communicate notify the other in writing of any order, request or directive of a court or other Governmental Body to Recall the Licensed Product of which such factParty has notice of or is otherwise aware (but in any case, condition, circumstance not later than 24 hours following such event (or event earlier if required under applicable Law)). (c) Somaxon shall bear the full and reasonable expenses of both Parties incurred in any Recall to the extent resulting from a failure of Somaxon (or its Subcontractors) to Manufacture Bulk Product in accordance with the warranties set forth in Section 2.2(a) (the “Somaxon Manufacturing Responsibilities”), and in all other Partycircumstances Paladin shall bear the full and reasonable expenses of both Parties incurred in any Recall. In If any Recall results in part from the event failure of Somaxon (aor its Subcontractor(s)) to Manufacture Bulk Product in accordance with Somaxon Manufacturing Responsibilities, Somaxon shall bear a pro rata portion of the FDA full and reasonably expenses of both Parties incurred in any Recall based on its contribution to the particular facts of the Recall. Such expenses of Recall shall include the expenses of notification and destruction or other governmental body requests that return of the recalled Licensed Product, distribution of replacement Licensed Product be and all sums paid by Third Parties for the recalled or (b) a court of competent jurisdiction orders such a recallLicensed Product. Without limiting the foregoing, to 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 extent any Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed Recall is caused by the other Party pursuant failure of Somaxon (or Subcontractor) to this SectionManufacture Bulk Product in accordance with the Somaxon Manufacturing Responsibilities, Somaxon shall further reimburse Paladin for any and all transportation and storage charges incurred by Paladin in connection with such recalled Licensed Product.

Recalls. The Parties agree that IDEC shall notify Nordion promptly if the procedure for a Product recall and FDA notifications shall depend on whether Labelled Drug is 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 and IDEC [CONFIDENTIAL TREATMENT REQUESTED] shall have sole responsibility for the handling and disposition of such recall. In IDEC [CONFIDENTIAL TREATMENT REQUESTED] shall bear the event costs of a product recallany recall of Labeled Drug unless and to the extent such recall shall have been the result of Nordion's employees or agents, Mylan acts or omissions or any defects in Isotope to meet Specification, in which case Nordion shall provide all necessary lists; Insys shall be responsible for all FDA contacts[CONFIDENTIAL TREATMENT REQUESTED]: (i) [CONFIDENTIAL TREATMENT REQUESTED], (ii) [CONFIDENTIAL TREATMENT REQUESTED], and (iii) [CONFIDENTIAL TREATMENT REQUESTED]. In the event that Nordion disputes IDEC's determination that the FDA fault is due to Nordion and/or its agent, the parties will select a mutually agreeable outside consulting firm which will be instructed to review the applicable information and data and to confirm or other governmental body orders a recall dissent from IDEC's determination. If the consulting firm confirms IDEC's determination, Nordion will pay the fees of such consulting firm. If the consulting firm dissents from IDEC's determination, Nordion will not have the obligations set forth herein with respect to any Product supplied hereunder or a the recall is voluntarily initiated by Mylan, and IDEC will pay the fees of such consulting firm. The decision of the consulting firm shall be final and the cause provisions of such recall is due Sections 27.3 shall not apply. For the period of time as required by applicable regulation, Nordion shall maintain records of all sales and shipments of Isotope and IDEC [CONFIDENTIAL TREATMENT REQUESTED] shall maintain records of all sales, shipping records of Labelled Drug and customers, sufficient 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 adequately administer 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 Nordion and Navidea shall fully comply with the procedure for a Product terms of the Quality Agreement regarding their respective obligations and responsibilities with respect to any recall and FDA notifications of or corrective action related to the Precursor, Reference Standards or [123I]NAV5001. Navidea shall depend on whether notify Nordion promptly if [123I]NAV5001 is the issue arose from activities performed by Mylan or from activities performed by Insys. Only Mylan can initiate a recall. In the event subject of a recall or correction (a “Recall”), and Navidea and/or its designee shall have sole responsibility for the handling and disposition of such Recall. Navidea and/or its designee shall bear the costs of any Recall of [123I]NAV5001 unless and to the extent such Recall shall have been the result of Nordion’s or its agents or employees negligent acts or omissions or any product recall, Mylan defects for which Nordion is responsible in which case Nordion shall provide all necessary lists; Insys shall to such extent 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 Navidea’s reasonable Losses, Legal Expenses and other out-of-pocket costs incurred for: (i) notification of recall to Nordion and expenses relating to third parties; (ii) return shipment or arising out of such recall, or (b) a breach by Mylan destruction of any defective [123I]NAV5001 to Nordion; and (iii) replacement 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[123I]NAV5001 . In the event (a) the FDA or other governmental body requests that Nordion disputes Navidea’s determination that the Product be recalled fault is due to Nordion and/or to its employees or (b) a court of competent jurisdiction orders such a recallagents, the Parties shall take all appropriate remedial actions parties will select a mutually agreeable outside consulting firm which will be instructed to review the applicable information and data and to confirm or dissent from Navidea’s determination. If the consulting firm confirms Navidea’s determination, Nordion will pay the fees of such consulting firm. If the consulting firm dissents from Navidea’s determination Nordion will not have the obligations set forth herein with respect to the Recall and Navidea will pay the fees of such recallconsulting firm. The obligations under this Section Navidea and/or its designee shall survive maintain records of all sales, shipping records of [123I]NAV5001 and customers in sufficient detail to adequately administer a Recall for the complete or partial termination period of this Agreementtime as required by applicable regulation. Each Party shall make every reasonable effort to mitigate any Losses, Legal Expenses Confidential Treatment – Asterisked material has been omitted and other out-of-pocket costs filed separately with the Securities and expenses to be reimbursed by the other Party Exchange Commission pursuant to this Sectiona request for confidential treatment.

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 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 if both parties Customer shall consider in good faith requests made by NxStage to share responsibility insurance costs in excess of $200,000. Any recall insurance obtained by NxStage, shall name Customer and the Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such policy shall offset any damages determined to be owed to Customer or any Authorized Customer Location hereunder pursuant to the foregoing terms, with respect 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 recallcustomer(s) that are more favorable to such customer(s) than are set forth in Section [**] of the Agreement and Sections [**] of this Schedule C, the costs NxStage agrees that it shall promptly offer such [**] provisions to Customer, on a prospective basis; provided that such terms shall be shared 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 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 no way alter 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 Sectionprovisions hereof.

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 notify the other Party promptly (but in no event later than [Redacted] following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal of a Licensed Product in the AbbVie Territory or the I-Mab Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, (a) AbbVie shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the AbbVie Territory, and (b) I-Mab shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the I-Mab Territory (except that I-Mab shall implement any recall, market suspension or market withdrawal that AbbVie requests based on a Manufacturing issue with respect to any Licensed Product supplied by AbbVie); provided that prior to any implementation of such a recall, market suspension or market withdrawal, the recalling Party shall consult with the other Party and shall consider the other Party’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the AbbVie Territory, with respect to AbbVie, or the I-Mab Territory, with respect to I-Mab, such Party shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this SectionSection 8.7, the Party responsible for the recall, market suspension or market withdrawal shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to Article 14, unless otherwise provided in the AbbVie Supply Agreement or I-Mab Supply Agreement, as applicable, each recalling Party shall be responsible for all of its costs incurred in connection with the conduct of such recall, market suspension or market withdrawal.

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) any Agency issues a directive, order or, following the FDA issuance of a safety warning or other governmental body requests alert with respect to a product, a written request that the any Product be recalled or recalled, (bii) a court of competent jurisdiction orders such a recall, or (iii) Cornerstone determines that any Product should be recalled or that a “dear doctor” letter is required relating to the Parties restrictions on the use of the Product, Chiesi will co-operate with those activities relating to the Product as reasonably required by Cornerstone, having regard to all Applicable Laws. In the event of a recall of the Product, Cornerstone will notify Chiesi in accordance with the Pharmacovigilance Agreement, and Chiesi will cooperate with those recall activities relating to the Product as reasonably required by Cornerstone. 5.16.1 Cornerstone or its designated agent shall take all appropriate remedial actions have the responsibility for handling customer returns of the Product. Chiesi shall provide Cornerstone or its designated agent with respect such assistance as Cornerstone may reasonably require to handle such Product returns. 5.16.2 To the extent that a recall or return results from, or arises out of, a failure by Chiesi (or its contract manufacturer) to manufacture and supply the Product in accordance with the Specifications, Applicable Laws and/or cGMP, at Cornerstone’s option, Chiesi shall be responsible for the documented out-of-pocket expenses of such recall or return and shall either (i) reimburse Cornerstone for the price that Cornerstone paid to Chiesi for manufacturing the Product which are the subject of the recall. The obligations under this Section shall survive , including the complete actual costs incurred in shipping, applicable transit charges, insurance premiums, duties, taxes paid or partial termination of this Agreement. Each Party shall make every reasonable effort to mitigate any Losses, Legal Expenses and other out-of-pocket charges incurred in connection with delivery of such Product to Cornerstone or its designee, or (ii) use its commercially reasonable efforts to replace the recalled or returned Product with new Products at no charge to Cornerstone. Additionally, Chiesi shall reimburse or credit Cornerstone for any out-of-pocket costs paid by Cornerstone to Third Parties for transportation and expenses to be reimbursed by [***] Confidential portions of the other Party pursuant to this Sectionexhibit have been omitted and filed separately with the Securities and Exchange Commissions.

Recalls. The Parties SMBI and NuVim shall notify the other promptly if any batch of Product purchased by NuVim pursuant to this Agreement is subject to recall, seizure, market withdrawal or correction or if any end user notifies NuVim of an adverse reaction as a result of the use of any Product, and the parties agree that to cooperate in the procedure for handling and disposition of such recall, seizure, market withdrawal or correction or notification of adverse reaction; provided, however, in the event of a Product recall disagreement as to any matters related to such recall, seizure, market withdrawal or correction or adverse reaction, SMBI shall have final authority with respect to such matters. SMBI shall bear the costs of all recalls, seizures, market withdrawals or corrections of Products purchased by NuVim pursuant to this Agreement if such recall, seizure, market withdrawal or correction is due to a breach by SMBI of any of its obligations hereunder; NuVim shall bear the costs of all recalls, seizures, market withdrawals or corrections of Products purchased by NuVim pursuant to this Agreement if such recall, seizure, market withdrawal or correction is due to a breach by NuVim of any of its obligations hereunder; and FDA notifications to the extent such recall, seizure, market withdrawal or correction is not a result of a breach by either NuVim or SMBI of any of their respective obligations hereunder, the costs of any recall, seizure, market withdrawal or correction shall depend on whether the issue arose from activities performed be borne by Mylan or from activities performed by Insys. Only Mylan can initiate a recallNuVim. In the event of a product any recall, Mylan shall provide all necessary lists; Insys shall be responsible seizure, market withdrawal or correction, SMBI shall, to the extent it is required to bear the costs of such recall, seizure, market withdrawal or correction as provided above, in addition to bearing the cost of such recall, seizure, market withdrawal or correction, (i) replace the amount of Products recalled, seized or withdrawn and (ii) reimburse NuVim 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 verifiable out-of-pocket costs and expenses relating to or arising out incurred by NuVim in respect of such recallrecalled, seized or (b) a breach by Mylan withdrawn Products. NuVim shall maintain records of any all sales of Products in accordance with 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 Sectionstandard operating procedure.

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 either Party determines that an event, incident or circumstance has occurred which may result in the FDA need for a “recall” or “market withdrawal” (as such terms are defined in U.S. regulations in 21 CFR 7.3 or other governmental body orders similar national, state or local law or regulation) (hereinafter referred to as a recall with respect to “Recall”), of Collaboration Product or any Product supplied hereunder or a recall is voluntarily initiated by Mylan, and the cause of such recall is due to (alot(s) 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 recallthereof, such Party shall promptly communicate such fact, condition, circumstance or event to notify the other Party. In Party in writing whether or not to conduct such Recall and shall follow the event (procedures set forth below: a) Pharmacia shall have the FDA or other governmental body requests that sole discretion to determine whether and upon what terms and conditions the Collaboration Product shall be recalled or otherwise withdrawn from sale to Third Parties within any country in the Territory (a “Recall”). Prior to making any Recall decision, however, Pharmacia shall consult with Celltech. Pharmacia shall be responsible for discussions with regulatory officials within the applicable country regarding all aspects of the Recall decision and the execution thereof. Upon the request of Pharmacia, Celltech shall cooperate completely in all Recall efforts. b) a court Any costs or expenses of competent jurisdiction orders such a recallany Recall shall be shared by the Parties as follows: i) If the Recall is solely applicable to Collaboration Products sold for the RA Indication or the IBD Indication in the Major Territories, 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 of such Recall shall be deemed to be reimbursed an Other Expense; ii) If the Recall is solely applicable to Collaboration Products sold for the RA Indication or the IBD Indication in the Other Territories or to the Other Indications in any country in the Territory, the costs and expenses of such Recall shall be borne by Pharmacia; iii) If the other Recall is solely applicable to Collaboration Products sold for a Celltech Other Indication, the costs and expenses, net of any insurance proceeds recovered by Pharmacia from a Third Party, of such Recall shall be borne solely by Celltech; iv) If the Recall is applicable to Collaboration Products sold for both (i) the RA Indication or the IBD Indication and (ii) any Other Indication, an equitable portion of the costs and expenses of such Recall shall be included in Other Expense. Notwithstanding the foregoing, if such Recall is due in whole or in part to the gross negligence or intentional misconduct on the part of only one Party, such Party pursuant to this Sectionshall fully bear all of the cost and expense for the Recall, net of any insurance proceeds recovered from a Third Party.

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: ▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ 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 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 ▇▇▇▇-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 agree (a) Prior to the applicable YUTIQ IND and NDA Transfer Effective Date, the following terms and conditions shall apply: (i) if either Party [***] has determined 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 , withdrawal or other form of market action is advisable or necessary with respect to YUTIQ in the event of a product U.S., then EyePoint shall initiate such recall, Mylan withdrawal or other form of market action, and shall provide communicate with the FDA with respect thereto (as approved by Alimera); provided, that prior to initiating a voluntary recall, withdrawal or any other form of market action with respect to YUTIQ in the U.S., the Parties shall [***] as to whether to initiate any such recall, withdrawal or other form of market action, and (ii) Alimera shall have the final decision-making authority to determine if a recall, withdrawal or other form of market action is advisable or necessary with respect to YUTIQ in the Field in the Ex-U.S. Licensed Territory and the sole right to communicate with applicable Regulatory Authorities with respect thereto. Alimera shall be responsible for taking all actions necessary lists; Insys to effect any recall, withdrawal or market action concerning YUTIQ in the Field in the Licensed Territory that occurs during the Term, and shall be responsible for all FDA contactscosts incurred in connection therewith except as provided under the Commercial Supply Agreement. In At Alimera’s request, without limitation of any obligations of the event that Parties under the FDA Commercial Supply Agreement, EyePoint will cooperate with A▇▇▇▇▇▇ at A▇▇▇▇▇▇’s cost regarding A▇▇▇▇▇▇’s handling of any recalls, withdrawals or similar market actions. (b) From and following the applicable YUTIQ IND and NDA Transfer Effective Date, the following terms and conditions shall apply: As between the Parties, Alimera shall have the final decision-making authority to determine if a recall, withdrawal or other governmental body orders form of market action is advisable or necessary with respect to YUTIQ in the Field in the Licensed Territory, and the sole right to communicate with Regulatory Authorities with respect thereto. As between the Parties, A▇▇▇▇▇▇ shall be responsible for taking all actions necessary to effect any recall, withdrawal or market action concerning YUTIQ in the Field in the Licensed Territory that occurs during the Term, and shall be responsible for all costs incurred in connection therewith except as provided under the Commercial Supply Agreement. At Alimera’s request, without limitation of any obligations of the Parties under the Commercial Supply Agreement, EyePoint will cooperate with A▇▇▇▇▇▇ at A▇▇▇▇▇▇’s cost regarding A▇▇▇▇▇▇’s handling of any recalls, withdrawals or similar market actions. (c) As between the Parties, A▇▇▇▇▇▇ shall have final decision-making authority to determine if a recall recall, withdrawal or other form of market action is advisable or necessary with respect to any Product supplied hereunder or a recall is voluntarily initiated by Mylanin the Field in the Licensed Territory other than YUTIQ, and the cause of such recall is due sole right 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 communicate with Regulatory Authorities with respect thereto. Alimera shall be liableresponsible for taking all actions necessary to effect any recall, withdrawal or market action concerning such Products that occurs during the Term, and shall reimburse Mylan be responsible for the reasonable Losses, Legal Expenses and other out-of-pocket all 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 incurred 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 Sectionconnection therewith.

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 Losses, Legal Expenses and other out-of-pocket costs and expenses to be reimbursed by the other Party pursuant to this SectionVendor within [**] of Purchaser receiving or preparing them.

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 nonconformity of a batch of the Products or regarding other matters, the senior management of the quality departments from both companies shall in good faith promptly attempt to resolve disputed issues. If the parties cannot reach agreement, the matter shall be resolved in accordance with dispute resolution provisions of the Supply Agreement. XANODYNE may only dispute a batch of Product, which has been dispositioned by DSM for release. Xanodyne Corporate Quality Assurance retains at all times the right to determine Product release status for commercial distribution. Financial liability shall be determined according to the Supply Agreement. APPENDIX I: OUTLINE OF RESPONSIBILITIES FUNCTION DSM XANODYNE -------- ---- -------- MANUFACTURING [**] [**] In-Process TESTING (Physical, Chemical Microbial) [**] [**] FP TESTING - Physical, Chemical [**] [**] FP TESTING - Sterility [**] [**] FP RELEASE [**] [**] DISTRIBUTION [**] [**] FP RETAINS [**] [**] FP STABILITY [**] [**] C OF A [**] [**] BATCH RECORD REVIEW/SIGNOFF [**] [**] INVESTIGATIONS INTO DEVIATIONS AND NON-CONFORMANCES [**] [**] COMPLAINT RECEIPTS [**] [**] COMPLAINT INVESTIGATIONS [**] [**] ADVERSE EVENT REPORTS [**] [**] FIELD ALERT REPORTS [**] [**] RECALLS [**] [**] CUSTOMER RETURNS [**] [**] RAW MATERIAL (Active) ORDERS [**] [**] RAW MATERIAL (Active) TESTING AND Release [**] [**] RAW MATERIAL (Inactives/Printed Packaging Materials) ORDERS [**] [**] RAW MATERIALS (Inactives/Printed Packaging Materials) TESTS [**] [**] RAW MATERIAL (Inactives/Printed Packaging Materials) RELEASE [**] [**] SUPPLIER AUDITS (Active) [**] [**] SUPPLIER AUDITS (Inactives/Printed Packaging Materials) [**] [**] MAINTENANCE OF VENDOR LISTS [**] [**] NOTICE OF PROPOSED CHANGES [**] [**] DOCUMENT CHANGE CONTROL [**] [**] ANNUAL Product REVIEW [**] [**] APPENDIX II: CONTACT INFORMATION XANODYNE KEY CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- --------- ---------------------- -------------- G. ▇▇▇▇▇ ▇▇▇▇▇ Director, 859-547- 859-814- General Quality ▇▇▇▇▇▇@▇▇▇▇▇▇▇▇.▇▇▇ Quality ▇▇▇▇ ▇▇▇▇ (cell) Assurance ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Manager, 859-547- 859-992- General Quality ▇▇▇▇▇▇@▇▇▇▇▇▇▇▇.▇▇▇ Quality ▇▇▇▇▇ ▇▇▇▇ (cell) Assurance OSM Key CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- ----------------- ------------------------ -------------- ▇▇▇▇▇▇ ▇▇, Quality Ph: ▇▇▇-▇▇▇-▇▇▇▇ General Quality Norton Assurance ▇▇▇▇▇▇.▇▇▇▇▇▇@▇▇▇.▇▇▇ ▇▇▇ ▇▇▇▇▇ Director, Quality Ph: ▇▇▇-▇▇▇-▇▇▇▇ rob. Manufacturing Assurance ▇▇▇▇▇@dsm. com Oversight ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ Director, Quality Ph: ▇▇▇-▇▇▇-▇▇▇▇ Lab Oversight Assurance ▇▇▇▇▇.▇▇▇▇▇▇▇▇▇▇@▇▇▇.▇▇▇ Will Mitten Director, Lab Ph: ▇▇▇-▇▇▇-▇▇▇▇ Lab Services Services ▇▇▇▇.▇▇▇▇▇▇@▇▇▇.▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ Manager, Ph: ▇▇▇-▇▇▇-▇▇▇▇ ▇▇▇▇. Stability Stability ▇▇▇▇▇▇▇▇ @dsm. com ▇▇▇▇ Manager, Quality Ph: ▇▇▇-▇▇▇-▇▇▇▇ APRs, Complaints, ▇▇▇▇▇▇▇ Assurance ▇▇▇▇.▇▇▇▇▇▇▇@▇▇▇.▇▇▇ Audits, APPENDIX III: PRODUCTS DARVOCETN-100 QUALITY AGREEMENT HISTORY OF CHANGES VERSION DATE NAME REVISIONS/COMMENTS ------- ---- ---- ------------------ EXHIBIT D: CONFIDENTIALITY AGREEMENT 1. During the term of this Agreement, the undersigned Parties may disclose certain confidential and proprietary information and data to each other relating to their respective products, including active pharmaceutical ingredients and the finished dosage forms of such active pharmaceutical ingredients (collectively "Products") and businesses, including, but not limited to, financial and other business information, Product samples, formulas, manufacturing processes, specifications, drawings, schematics and other technical, customer and Product development plans, forecasts, strategies and other data. Except as otherwise specifically provided herein, all information disclosed by one Party (in such capacity, the "Disclosing Party") to the other Party (in such capacity, the "Receiving Party") relating to the Disclosing Party's Products and/or its business operations and the results, reports, etc., of testing and evaluation of any such information shall constitute "Proprietary Information." 2. The Disclosing Party shall disclose and supply its Proprietary Information to the Receiving Party solely to assist the Receiving Party in performing its obligations under this Agreement, any related API Schedules, and AAI purchase orders. 3. In consideration of the Disclosing Party's disclosure and supply of Proprietary Information, each Party, as a potential Receiving Party, agrees that, for a period of seven (7) years from the date of such disclosure, it: (a) shall use The Disclosing Party's Proprietary Information exclusively for the limited purposes set forth in the first numbered paragraph hereof; and (b) shall not disclose, without the express written consent of the Disclosing Party, any Proprietary Information, including this Agreement or the interest of the Disclosing Party in exploring the possibility of entering into a business relationship with the Receiving Party, to any person other than to those employees of the Receiving Party ("Representatives") who will be directly involved in fulfilling the Receiving Party's obligations hereunder, provided that such Representatives have assumed like obligations of confidentiality to the Disclosing Party. 4. Each Party, as a potential Receiving Party, agrees to advise those of its Representatives who receive Proprietary Information that such information (a) is proprietary and confidential to the Disclosing Party and (b) shall not be disclosed to anyone except as authorized herein. Each Party further agrees to take the precautions it normally takes with its own confidential and proprietary information to prevent unauthorized disclose or use of such Proprietary Information, but no less than reasonable precautions. 5. In the event that the FDA or other governmental body orders a recall Receiving Party becomes compelled to disclose any Proprietary Information, it will provide the Disclosing Party with respect prompt advance notice in writing so that the Disclosing Party may, at its discretion, intervene prior to disclosure. The Receiving Party will exercise its commercially reasonable best efforts to obtain reliable assurance that confidential treatment will be accorded such Proprietary Information. 6. Notwithstanding any Product supplied hereunder or a recall is voluntarily initiated by Mylanof the foregoing, the term "Proprietary Information" and the cause obligation of such recall is due confidentiality associated therewith shall not apply to the following information: (a) a information which, at the time of the Disclosing Party's disclosure to the Receiving Party, is in the public domain; (b) information which, after the Disclosing Party's disclosure to the Receiving Party, enters the public domain, except where such entry is the result of the Receiving Party's breach of this Agreement or otherwise is the result of any unauthorized disclosure by Insys of any of its representationsemployees; (c) information which, warrantiesprior to the Disclosing Party's disclosure to the Receiving Party, obligationswas already in the Receiving Party's possession; (d) information which, covenants or other agreements contained herein or subsequent to the Disclosing Party's disclosure to the Receiving Party, is obtained by the Receiving Party from a third Party which is Lawfully 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 possession of such recall, information and not subject to a contractual or fiduciary relationship to the Disclosing Party with respect thereto or (be) information which is developed independently by the Receiving Party without reference to the Proprietary Information. 7. Upon the termination of this Agreement and upon receipt of a breach written request from the Disclosing Party, the Receiving Party shall promptly return to the Disclosing Party the originals and all copies of any Proprietary Information then in the Receiving Party's possession. Notwithstanding the foregoing, Receiving Party may retain one copy of such Proprietary Information for archival purposes. 8. Each Party understands and acknowledges that, due to the unique nature of each Party's Proprietary Information, any unauthorized disclosure of any portion of Proprietary Information may cause irreparable injury to the Disclosing Party and that no adequate or complete remedy may be available to the Disclosing Party to compensate for such injury. Accordingly, each Party hereby acknowledges that the Disclosing Party may be entitled to injunctive relief in the event of such unauthorized disclosure by Mylan of the Receiving Party or any of its representationsemployees in addition to whatever remedies it might have at Law. In addition, warrantiesthe Receiving Party shall indemnify the Disclosing Party from any loss or harm, obligationsincluding, covenants without limitation, reasonable attorney's fees, resulting from any breach or enforcement of the Receiving Party's obligations hereunder or the unauthorized use or release of any such Proprietary Information. The Receiving Party will notify the Disclosing Party in writing promptly upon the occurrence of any such unauthorized release or other agreements contained hereinbreach of which it becomes aware. MANUFACTURING AND SUPPLY AGREEMENT PRODUCT SCHEDULE PRODUCT SCHEDULE TO MANUFACTURING AND SUPPLY AGREEMENT (the "Supply Agreement") DATED JANUARY 26, then Mylan 2004 AND ORIGINALLY EXECUTED BY DSM PHARMACEUTICALS ("Manufacturer") AND AAIPHARMA LLC ("AAI") This Product Schedule, effective as of January 26, 2004, supplements the Supply Agreement by, among other things, identifying a particular Product, the purchase and sale of which 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, governed by the costs shall be shared in the ratio terms 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 Supply Agreement as are sufficient and well 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 SectionSchedule.

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 (a) Licensee shall administer all recalls or market withdrawals of the procedure for a Licensed Product recall in the Territory (“Recall”) in accordance with applicable Laws and FDA notifications Licensee’s standard operating procedures used in connection with any recalls or withdrawals of Licensee products in the Territory. Licensee 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 promptly consult with Somaxon with respect to any Product supplied hereunder or a recall is voluntarily initiated Recall proposed to be taken by Mylan, Licensee (and in all events reasonably in advance of the cause taking of such recall is due Recall), including all Recalls that are reasonably likely to (a) result in a breach by Insys material adverse effect on the marketability of any of its representations, warranties, obligations, covenants the Licensed Product in or other agreements contained herein or in other written agreements between outside 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 Territory. (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 Each Party shall promptly communicate notify the other in writing of any order, request or directive of a court or other Governmental Body to Recall the Licensed Product of which such factParty has notice of or is otherwise aware (but in any case, condition, circumstance not later than 24 hours following such event (or event earlier if required under applicable Law)). (c) Somaxon shall bear the full and reasonable expenses of both Parties incurred in any Recall to the extent resulting from a failure of Somaxon (or its Subcontractors) to Manufacture Bulk Product in accordance with the warranties set forth in Section 2.2(a) (the “Somaxon Manufacturing Responsibilities”), and in all other Partycircumstances Licensee shall bear the full and reasonable expenses of both Parties incurred in any Recall. In If any Recall results in part from the event failure of Somaxon (aor its Subcontractor(s)) to Manufacture Bulk Product in accordance with Somaxon Manufacturing Responsibilities, Somaxon shall bear a pro rata portion of the FDA full and reasonable expenses of both Parties incurred in any Recall based on its contribution to the particular facts of the Recall. Such expenses of Recall shall include the expenses of notification and destruction or other governmental body requests that return of the recalled Licensed Product, distribution of replacement Licensed Product be and all sums paid by Third Parties for the 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 SectionLicensed Product.

Recalls. The Parties agree that Spectrum and ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ for its all the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating actually incurred by ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇, 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 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 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: 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 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. ▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ 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 that (a) Subject to this Section 3.1.4, a Recall in the procedure for a Product recall Co-Promotion Territory shall be the responsibility, and FDA notifications shall depend on whether under the issue arose from activities performed by Mylan or from activities performed by Insyscontrol, of ZGEN. Only Mylan can initiate a recall. In the event of a product recall, Mylan Bayer shall provide all necessary lists; Insys shall be responsible for all FDA contactspertinent records and such other assistance to ZGEN as ZGEN reasonably may request to assist in effecting any Recall in the Co-Promotion Territory. In addition, Bayer will maintain all records relating to 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 Recall for the reasonable Lossesperiod required by legal requirements, Legal Expenses and other outbut for no less than three (3) years. ZGEN shall bear the costs of the Recall in the Co-of-pocket costs and expenses relating Promotion Territory except to the extent that a Recall results from the negligence or arising out willful misconduct of such recall, or Bayer. (b) If either Party becomes aware of information about quantities of Initial Licensed Product that may not conform to the specifications for the Initial Licensed Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Initial Licensed Product itself is alleged or proven to be the subject of a breach by Mylan of Recall in 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 country 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 factworld, condition, circumstance or event (whether actual or potential) concerning or related to the Product which may reasonably require a recall, such Party shall it will promptly communicate such fact, condition, circumstance or event to so notify the other Party. In The Parties will meet (in person, by telephone or otherwise) to discuss the event (a) circumstances of a Recall in the FDA or other governmental body requests that the Product be recalled or (b) a court Co-Promotion Territory and to consider appropriate courses of competent jurisdiction orders such a recall, the Parties shall take all appropriate remedial actions action with respect such Recall; provided that ZGEN may take immediate action when regulatory time frames or public safety considerations so require. (c) If ZGEN fails to conduct a Recall in the Co-Promotion Territory after Bayer gives written notice that, in the good faith opinion of Bayer, a Recall should be undertaken to address specific issues of Initial Licensed Product safety (“Safety Issues”), which written notice identifies the specific Safety Issues, then (i) Bayer shall have no obligation to defend or indemnify ZGEN under Article 8 for any Losses arising in connection with the Safety Issues for Initial Licensed Product that was sold, promoted or distributed in the Co-Promotion Territory after receiving such recall. The written notice from Bayer, (ii) ZGEN will defend and indemnify Bayer under Article 8 for any such Losses, and (iii) Bayer will have no further obligations under this Section shall survive Agreement to Detail or otherwise promote the complete or partial termination relevant Initial Licensed Product unless and until the Safety Issues are resolved in the good faith opinion 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 SectionBayer.

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.

Recalls. The Parties agree that (1) If, for any reason, it shall become necessary to trace back or recall any particular batch of the procedure for a Product recall and FDA notifications Product, or to identify the customer or customers to whom any unit from such batch has been delivered, the Distributor 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. co-operate with DRAXIMAGE in doing so. (2) In the event that either Party has reason to believe that one or more lots of the FDA Product should be recalled or withdrawn from distribution in the Territory, such Party shall immediately notify the other governmental body orders Party in writing or by telephone if the notice is to be given on a day other than a Business Day. To the extent permitted by the circumstances, the Parties shall confer together before initiating any recall in order to exchange any relevant information, but the decision as to whether or not to initiate a recall with respect of the Product in the Territory shall be taken by DRAXIMAGE. In this respect, DRAXIMAGE shall have the right, at any time, to recall any of the Product supplied hereunder promptly by giving notice to the Distributor by telephone (to be immediately confirmed in writing, by facsimile or courier) and the Distributor shall upon receipt of such notice, immediately cease and desist from further selling and for distributing the Product to be returned to the Distributor and shipped back to DRAXIMAGE pursuant to DRAXIMAGE’s instructions. If the Distributor deems there is a situation that necessitates a recall is voluntarily initiated and advises DRAXIMAGE of same and DRAXIMAGE does not respond to Distributor’s inquiry regarding same within twenty-four (24) hours notice of the receipt of the written notice by MylanDistributor, then the Distributor shall be entitled to initiate a recall of the Product. In such event, Distributor shall advise DRAXIMAGE of all procedures taken and all related information. However both parties agree to work together in good faith to reach a mutually agreed upon decision in each case where a recall may be necessary. If the cause of such recall is due to (a) required because of a breach by Insys modification or withdrawal of any an approval from a Regulatory Authority or of its representationsa negligent act or omission of DRAXIMAGE, warranties, obligations, covenants or other agreements contained herein or in other written agreements between DRAXIMAGE shall promptly reimburse the Parties, then Insys shall be liable, and shall reimburse Mylan Distributor for the reasonable Losses, Legal Expenses cost and other out-of-pocket costs and expenses relating to or arising out expense of such recall, and, at DRAXIMAGE’s option, DRAXIMAGE shall replace the recalled Product or refund the purchase price (bas referenced in Schedule 7 hereto) of such recalled Product. If the recall is required because of a breach by Mylan negligent act or omission of any the Distributor in connection with the handling, refrigeration, storage or distribution of its representations, warranties, obligations, covenants or other agreements contained hereinthe Product, then Mylan such recall shall be liable conducted by the Distributor at its sole cost and expense and the Distributor shall reimburse Insys for its reasonable Lossesnot be entitled to any such replacements or refunds from DRAXIMAGE. If such recall is required because of a joint act or omission of the Parties, Legal Expenses the Distributor shall conduct the recall and other out-of-pocket costs the Parties shall negotiate in good faith an appropriate allocation of the cost and expenses relating to or arising out expense 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 (a) In the procedure for a Product recall and FDA notifications shall depend on whether the issue arose from activities performed by Mylan event ViroPharma should be required or from activities performed by Insys. Only Mylan can should voluntarily decide to initiate a recall. In , withdrawal, or field correction of any ViroPharma pharmaceutical containing the event Product, Alpharma shall reasonably cooperate with ViroPharma concerning the necessity and nature of a product recall, Mylan shall provide all necessary lists; Insys shall be responsible for all FDA contacts. such action if it is associated with the Product. (b) In the event that Alpharma independently believes that a recall, withdrawal, or field correction of the FDA ViroPharma pharmaceutical containing the Product may be necessary or appropriate due to reasons associated with the Product, Alpharma shall notify ViroPharma and the parties shall fully cooperate with each other governmental body orders concerning the necessity and nature of such action. [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. (c) In the event that any ViroPharma pharmaceutical containing the Product is recalled as a recall with respect to any result of (1) the Product supplied hereunder by Alpharma not conforming to the warranties set forth in this Agreement, or a recall is voluntarily initiated by Mylan, and (2) the cause negligent or intentionally wrongful act of such recall is due to (a) a breach by Insys of any of Alpharma or its representations, warranties, obligations, covenants or other agreements contained herein or in other written agreements between the Partiesrepresentatives, then Insys Alpharma shall be liable, and shall reimburse Mylan for bear all of the reasonable Losses, Legal Expenses and other out-of-pocket costs and expenses relating directly related to or arising out such recall including, without limitation, expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled ViroPharma pharmaceuticals containing the Product from customers and shipment of an equal amount of replacement pharmaceuticals to those customers. In the event that any ViroPharma pharmaceutical containing the Product is recalled for any other reason, then ViroPharma shall bear all of the costs and expenses of such recall, including without limitation expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled ViroPharma pharmaceuticals from customers and shipment of an equal amount of replacement ViroPharma pharmaceuticals to those customers. In the event that the reason for any recall of ViroPharma pharmaceutical containing the Product hereunder is in part the responsibility of Alpharma and in part the responsibility of ViroPharma, then the expenses shall be allocated [***]. In the event either party decides to proceed with a voluntary recall under subsections (a) or (b) a breach by Mylan of any of its representations, warranties, obligations, covenants or above and the 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 party disagrees with the propriety of such recall; provided that if both parties share responsibility with respect to such voluntary recall, the costs cost sharing provisions of this subsection (c) 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 only apply 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 holds that 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 recall was 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 Sectionproper.

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. 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.

Recalls. (a) The ultimate determination as to whether a recall, withdrawal or corrective action (collectively, the “Recall”) of any Licensed Product is required shall be made in PuriCore’s sole discretion; provided, however, if Misonix believes a Recall is required or appropriate, Misonix will promptly notify PuriCore and if PuriCore subsequently determines such Recall is appropriate or required, the Parties will jointly develop a plan for implementing such Recall. (b) If there shall be a Recall, the expense of such Recall shall be borne as follows: (i) If (i) it is established that the Licensed Product was nonconforming pursuant to Section 5.2 upon delivery by PuriCore to Misonix, or (ii) such Recall arises from any breach by PuriCore of the provisions of this Agreement or Applicable Law, then PuriCore shall hold Misonix harmless and shall bear all expenses related to the Recall, including the replacement of the recalled or withdrawn Licensed Product, which shall be replaced as soon as reasonably practicable. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. (ii) If such Recall arises as a result of actions or omissions on the part of Misonix, or from any breach by Misonix of the provisions of this Agreement, then Misonix shall hold PuriCore harmless and shall bear all costs and expenses in connection with such Recall. (c) The Parties agree shall reasonably cooperate in good faith to effect a Recall. Misonix shall have sufficient quality control policies and procedures in place that it can track its shipments of Licensed Product so that Licensed Product sold by Misonix can be Recalled or customers notified of 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. Recall. (d) In the event that the FDA or other governmental body orders a recall with respect to any Recall is triggered because of nonconforming Licensed 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 recallas determined under Section 5.2), the costs shall be shared in the ratio provisions 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 Section 4.9, if either Party shall discover or become aware of any facttriggered, 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 Sectionwill control.