Common use of Recalls Clause in Contracts

Recalls. 8.1 Each Party shall promptly notify the other if such Party believes that 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 GENERICO’s gross negligence, 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 bear all of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required 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 reason for any Recall of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in 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, such dispute will be resolved in the same manner as set forth in Section 6.2. The fees and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Product.

Recalls. 8.1 Each Party The Parties agree that the procedure for a Product recall and FDA notifications shall promptly notify depend on whether the other if such Party believes that 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, withdrawal or field correction (each, a “Recall”) of the Product or any Pipeline Product may be Mylan shall provide all necessary or advisable. 8.2 NEW ALPHA lists; Insys 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 GENERICO’s gross negligence, 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 bear all of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required 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 customersFDA contacts. In the event that the reason 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 Recall of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described its representations, warranties, obligations, covenants or other agreements contained herein, then the expenses Mylan shall be allocated 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 an equitable manner between the ratio of the Parties. 8.4 If ’ 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 are unable shall take all appropriate remedial actions with respect to mutually agree on the source cause of the Recall within 5 days of the event causing the Recall, such dispute will be resolved in the same manner as set forth in Section 6.2recall. The fees 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 the testing entity making the determination will to be paid reimbursed by the other Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Productpursuant to this Section.

Recalls. 8.1 Each Party shall promptly notify In the other if event (i) any Authority issues a request, directive or order that the Product be recalled, or (ii) a court of competent jurisdiction orders such Party believes that a recall, withdrawal or field correction (eachiii) DEPOMED reasonably determines that the Product should be recalled, a “Recall”) the Parties shall take all appropriate 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 any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA event is due to MOVA’s failure to provide the manufacturing services hereunder in accordance with the Specifications, and Applicable Law, as determined by the Laboratory, MOVA shall be responsible for the documented out-of-pocket expenses of such Recall decision, notification 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 Regulatory Authorities, all API required for the Recall strategy and generation manufacture 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 such replacement Product. Following termination For greater certainty, MOVA’s responsibility for any loss 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 API 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 recalled Product shall be subject 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 12.8set forth in Section 7.6.1. In the event that any Product MOVA is unable to replace the recalled or Pipeline Product is 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 than as a result of GENERICOcircumstances, Recalls, returns or other corrective actions shall be made at DEPOMED’s gross negligence, bad faith, intentional misconduct or intentional breach cost and expense. For the purposes of this Agreement 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 included as an expense of recall and shall, in all instances, be borne by DEPOMED. The remedies set forth above shall constitute the 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 for which marketability of the liability would exceed Products or any distribution thereof, (ii) results from a defect in Materials that is not reasonably discoverable by MOVA using the limitations test methods set forth in Section 12.9)the Specifications, then NEW ALPHA 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, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product or Pipeline Product (iii) results from customers and shipment of an equal amount of replacement Product to those customers. In the event that the reason for any Recall of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in 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, such dispute will be resolved a defect in the same manner as 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 6.2. The fees and expenses 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 the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Productits obligations under this Agreement.

Recalls. 8.1 Each Party AbbVie shall make every reasonable effort to notify Galapagos promptly notify following its determination that any event, incident, or circumstance has occurred that may result in the other if such Party believes that need for a recall, market suspension, or market withdrawal of a Product in the AbbVie Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. AbbVie (or field correction (each, a “Recall”its Sublicensee) of shall have 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 right to make the final Recall letter. During the period in which the Warehouse Services Agreement is in effectdetermination whether to voluntarily implement any such recall, if anymarket suspension, 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 or market withdrawal 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 12.8AbbVie 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 in the Galapagos Territory (including any requirement or Pipeline Product is recalled other than as recommendation by a result of GENERICO’s gross negligenceRegulatory Authority with respect to a recall, bad faithmarket suspension, intentional misconduct or intentional breach of this Agreement (or for which the liability would exceed the limitations set forth in Section 12.9market withdrawal), then NEW ALPHA such Party shall bear all of immediately so notify the costs other Party and expenses of shall include in such Recallnotice the reasoning behind such belief and any supporting facts, including without limitation expenses related and the Parties shall discuss and attempt in good faith to communications and meetings with all required Regulatory Authoritiesreach agreement as to whether such recall, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product market suspension or Pipeline Product from customers and shipment of an equal amount of replacement Product to those customersmarket withdrawal is necessary. In the event that the reason 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 Recall 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 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, 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 hereunder is in part the responsibility of GENERICO Co-Promotion Territory other than as described herein in clause (1) above, the expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal shall be 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 part the responsibility of NEW ALPHA Galapagos Territory other than as described hereinin clause (1) above, then the expenses Galapagos shall be allocated in an equitable manner between responsible for all costs of such recall, 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 Partiescosts of refunds with respect to recalled Product shall be deducted from Net Sales pursuant to Article 6. 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, such dispute will be resolved in the same manner as set forth in Section 6.2. The fees and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Product.

Recalls. 8.1 Each Party shall Vendor agrees to promptly notify Division after becoming aware of any patient safety issue involving the other if such Party believes 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 recallvoluntary recall by Vendor, withdrawal or field correction is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (each, any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and Division within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Product Recall to the FDA. Notices to Division shall be sent 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 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 components therein are subject to a request 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 confidential treatment that has been filed with the Securities return of each affected Product and Exchange Commission. 8.3 In shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the event that it is determined that extent such Recall precludes Vendor from supplying any Product Products or Pipeline Product is recalled as a result of GENERICO’s gross negligence, bad faith, intentional misconduct or intentional breach of Services under this Agreement, then GENERICO shall bear all of the costs any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and expenses of such Recall, including without limitation expenses Vendor related to communications and meetings with all required Regulatory Authorities, customer credits such Products shall not be effective 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 as long as Vendor is unable to those customers, subject to Sections 12.2 and 12.8supply such Products. In the event that If any Product pricing is dependent upon a Purchaser meeting compliance or Pipeline Product purchase requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is recalled other than as a result of GENERICO’s gross negligence, 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 bear all of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required 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 reason for any Recall of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in 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, such dispute will be resolved in the same manner as set forth in Section 6.2. The fees and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Productprovide said designated Products.

Recalls. 8.1 Each Party shall Product recalls will be the responsibility of, and under the control of, Client. In the event that Hovione has reason to believe that any Product should be recalled or withdrawn from distribution, it will promptly inform Client in writing of such belief. Client will notify the other if such Party believes that a appropriate Regulatory Authorities of any recall, withdrawal or field correction (eachif required under Applicable Law, 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 coordinating all necessary activities regarding the Recallaction taken. Hovione and Client will fully cooperate to complete the recall, reconciling Product, preparing and submitting Recall status reports will thereafter resolve any allocation of liability as may be appropriate in accordance with the terms of this Agreement. The costs and termination requests to applicable Regulatory Authorities with respect to Recall expenses of the Product and conducting any Pipeline Product. Following termination of the Warehouse Services Agreement, NEW ALPHA recall will be responsible for all Recall activities with respect to Recall of the Product and treated as follows: (a) If 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 GENERICOHovione’s gross negligence, bad faith, intentional negligence or willful misconduct or intentional breach of this Agreement, then GENERICO shall bear all in Manufacture 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 failure to Manufacture Product in accordance with the Manufacturing Standards then, except to the extent the recall resulted from customers and shipment any failure of an equal amount Client-Supplied Materials unless Hovione knew of, or should have known of replacement Product or Pipeline Product a failure of the Client Supplied Materials to those customersconform to the applicable Material Specifications, subject to Sections 12.2 and 12.8. In the event that any Product or Pipeline Product is recalled other than as a result the testing of GENERICOClient-Supplied Materials the parties had mutually agreed in writing would be performed by Hovione as part of Services, *. In addition, in such event, Hovione, *, will promptly replace such rejected and recalled amounts with Product that conforms to the Product Specifications and is Manufactured in accordance with the Manufacturing Standards and shall reimburse Client for Material Loss in accordance with Section 6.6. Hovione’s gross negligencetotal liability to Client under this Section 8.11 for each particular recall, bad faithmarket withdrawal or correction shall not exceed the aggregate Manufacturing Fees, intentional misconduct if any, paid by Client to Hovione for the total amount of Product that is contained in the drug product that is recalled, withdrawn from the market or intentional breach of this Agreement (or for which the liability would exceed corrected. In addition, the limitations set forth in Section 12.9), then NEW ALPHA 14.4 hereof shall bear all also apply to any liability of Hovione under this Section 8.11. (b) If each Party contributes to the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, expenses of replacement stockcause for a recall, 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 reason for any Recall amounts contemplated under paragraph (a) will be *; and (c) All recalls of Product hereunder is supplied to Client under this Agreement other than those described in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in 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, such dispute clauses (a) or (b) will be resolved in the same manner as set forth in Section 6.2at * sole expense. The fees and expenses of the testing entity making the determination Client will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition give Hovione prompt written notice of any Recalled ProductProduct recalls for which Client believes Hovione has responsibility under Section 8.11(a) or (b).

Recalls. 8.1 Each Party shall If the FDA or any other regulatory authority under Applicable Law seizes any Product, requests a recall of the Product, or otherwise notifies NeuroPace or Greatbatch of any violation or potential violation of any Applicable Law, the first notified party must promptly notify the other if such Party believes that party and provide it with a recall, withdrawal copy of any applicable recall letter 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 equivalent written notification. NeuroPace 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 Greatbatch will reasonably cooperate with each other in the event of any recall of any Product. NeuroPace and Greatbatch will each provide information reasonably requested by the other Party to investigate the cause and extent of the problem. To the extent the recall is in connection with any Recall. Each Party will maintain complete and accurate Recall records relating to a country where the Product is sold under NeuroPace’s approval or any Pipeline Product for any periods that are required by any Legal Requirements. Note: Redacted portions marketing clearance, NeuroPace will have been marked the final authority to determine the course of action, after consultation 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 12.8Greatbatch. In the event that Greatbatch independently believes that a recall for any Product of the Products may be necessary or Pipeline Product is recalled other than as a result of GENERICO’s gross negligenceappropriate, bad Greatbatch will notify NeuroPace. The parties will fully discuss, in good faith, intentional misconduct and cooperate with each other concerning the necessity and nature of such action; however, the coordination thereof will be handled by NeuroPace, whether or intentional breach not such action was initially requested by Greatbatch. Recalls will be the responsibility of NeuroPace, and NeuroPace will bear all expenses connected therewith. For the purposes of this Agreement (or for which Agreement, the liability would exceed the limitations set forth in Section 12.9), then NEW ALPHA shall bear all expenses of the recall will include, but not be limited to, all expenses for notification of customers and the destruction or return of the recalled Product, as well as all reasonable out-of-pocket costs and expenses of such Recall, including without limitation expenses related to communications incurred by NeuroPace and meetings with all required 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 customersGreatbatch. In the event that the reason for any Recall recall is attributable to a breach of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in an equitable manner between the Parties. 8.4 If the Parties are unable to mutually agree on the source cause any of the Recall within 5 days of the event causing the Recall, such dispute will be resolved in the same manner as set forth warranties provided in Section 6.2. The fees 3.3, Greatbatch will credit NeuroPace’s account for the Products recovered and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Productreturned to NeuroPace or Greatbatch (or destroyed at NeuroPace’s request).

Recalls. 8.1 Each 9.1 Product recalls and FDA contacts relating to recall of Product shall be the responsibility of, and under the control of, Discovery Labs. 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. Discovery Labs shall notify the other if such Party believes that a FDA, DEA, or any foreign regulatory agencies of any recall, withdrawal or field correction (each, a “Recall”) of the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA and shall be responsible for coordinating all necessary activities regarding the Recall decisionaction taken, notification of Regulatory Authoritiesto the extent required by law or deemed advisable by Discovery Labs. DSM and Discovery Labs acknowledge that each Party has significant regulatory obligations; and accordingly, 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 each Party 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 fully cooperate with the other Party to complete the recall, and shall thereafter resolve any allocation of liability as may be appropriate 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 accordance with the Securities and Exchange Commissionterms of this Agreement. 8.3 In the event that it is determined that 9.2 If any Product or Pipeline Product is recalled as a result of GENERICO’s gross negligence, bad faith, intentional misconduct the supply by DSM of Product that does not conform to the Specifications or intentional breach other Product requirements 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 4.2.7 and 12.8. In the event that any Product or Pipeline Product is recalled other than 5.3, DSM shall reimburse Discovery Labs for its reasonable expenses actually incurred as a result of GENERICOsuch recall. If Discovery Labs elects to utilize a Third Party to conduct a recall, Discovery Labs shall so notify DSM of such Third Party utilized as soon as reasonably practical. 9.3 If each Party contributes to the cause for a recall, the expenses actually incurred as a result of such recall will be shared in proportion to each Party’s gross negligenceresponsibility. All other recalls of Product shall be at Discovery Labs sole expense. Discovery Labs shall give DSM prompt written notice of any Product recalls that Discovery Labs believes were caused or may have been caused by DSM’s failure to comply with this Agreement or the Specifications. 9.4 Discovery Labs shall maintain records of all sales of Commercial Product and customers sufficient to adequately administer a recall, bad faith, intentional misconduct market withdrawal or intentional breach correction for a period of five (5) years after termination or expiration of this Agreement (Agreement. Subject to Section 9.1, Discovery Labs shall in all events be responsible for conducting any recalls, market withdrawals or for which corrections with respect to the liability would exceed the limitations set forth in Section 12.9), then NEW ALPHA 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, 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 reason for any Recall of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in 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, such dispute will be resolved in the same manner as set forth in Section 6.2. The fees and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Product.

Recalls. 8.1 Each Party shall Vendor agrees to promptly notify HPG after becoming aware of any patient safety issue involving the other if such Party believes 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 recallvoluntary recall by Vendor, withdrawal or field correction is subject to an FDA-initiated court action for removing or correcting violative, distributed products or components (each, any of the foregoing being referred to as a “Recall”), Vendor shall notify Purchasers and HPG within twenty-four (24) hours after becoming aware of any Recall or after Vendor provides notice of the Product Recall to the FDA. Notices to HPG shall be sent 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 any Products where the Products 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 components therein are subject to a request Recall, regardless of whether actual return of the Products or components to Vendor is required, recommended, or suggested by the Recall, in which case Vendor shall pay all freight costs incurred for confidential treatment that has been filed with the Securities return of each affected Product and Exchange Commission. 8.3 In shall reimburse each Purchaser for Purchaser’s original costs, including freight, in acquiring each affected Product. To the event that it is determined that extent such Recall precludes Vendor from supplying any Product Products or Pipeline Product is recalled as a result of GENERICO’s gross negligence, bad faith, intentional misconduct or intentional breach of Services under this Agreement, then GENERICO shall bear all of the costs any Purchaser compliance requirements or purchase requirements under this Agreement or any facility agreement between any Purchaser and expenses of such Recall, including without limitation expenses Vendor related to communications and meetings with all required Regulatory Authorities, customer credits such Products shall not be effective 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 as long as Vendor is unable to those customers, subject to Sections 12.2 and 12.8supply such Products. In the event that If any Product pricing is dependent upon a Purchaser meeting compliance or Pipeline Product purchase volume requirements for designated Products, a Purchaser’s pricing will not change for failure to meet the compliance or purchase requirements during the time period when Vendor is recalled other than as a result of GENERICO’s gross negligence, 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 bear all of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required 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 reason for any Recall of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in 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, such dispute will be resolved in the same manner as set forth in Section 6.2. The fees and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Productprovide said designated Products.

Recalls. 8.1 Each Party shall promptly notify the other if such Party believes that 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 governmental agency or authority requests a recall, a field corrective action, Product withdrawal or Pipeline takes similar action in connection with any Product is (each a "Product recall"), or in the event NxStage determines an event, incident or circumstance has occurred that results in the need for a Product recall, NxStage shall promptly notify Customer within [**] of such governmental agency or authority request or action or of NxStage's decision to voluntarily institute a Product recall. In the event of a Product recall of any Product, NxStage shall (a) reimburse Customer for reasonable handling expenses incurred in returning units of the Product to NxStage or otherwise implementing the Product recall; and (b) use all commercially reasonable efforts to promptly 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, the Volume Commitment amounts and dates and other than as a result of GENERICO’s gross negligence, bad faith, intentional misconduct or intentional breach of this Agreement (or requirements for which the liability would exceed the limitations maintaining Exclusivity that are set forth in Section 12.9), then NEW ALPHA Schedule E shall bear all of be adjusted as mutually agreed by NxStage and Customer so as to reflect the costs and expenses impact of such RecallProduct 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 expenses related to communications and meetings with all required Regulatory Authoritiesthose set forth in Schedule E, 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 customersParagraph 7. In addition to the event foregoing, if NxStage is unable to repair or replace recalled System One Cyclers or PureFlow SLs purchased by Customer, such that the reason such purchased Cyclers or PureFlow SLs are therefore rendered unusable and continue to be unusable for any Recall a period of Product hereunder is in part the responsibility of GENERICO as described herein [**] consecutive months (for purposes hereof, purchased Cyclers and in part the responsibility of NEW ALPHA as described hereinPureFlow SLs shall not be unusable if they can be used with other non-NxStage products, then the expenses consistent with then-current product labeling), NxStage shall be allocated in an equitable manner between the Parties. 8.4 If the Parties are unable obligated to mutually agree on the source cause of the Recall pay Customer actual damages within 5 [**] days of the event causing expiration of such [**] month period (with the Recallamount 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 or any significant portion of, the purchase price of any Cyclers or PureFlow SLs that have been the subject of such a recall (and where such refund is specifically provided solely in connection with, and due to, such dispute will 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 resolved so accelerated if such refund involves no more than [**] Cyclers or PureFlow SLs, in the same manner 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 6.221 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 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 these amounts. The fees Recall insurance, if obtained by NxStage, shall name Customer (but no other customer of NxStage) as an additional insured. Any insurance payment to Customer under such policy shall offset any damages determined to be owed to Customer hereunder pursuant to the foregoing terms, with NxStage obligated to pay any remainder pursuant to the terms hereof. Chronic Outpatient Therapy Purchase and expenses Rental Agreement DaVita, Inc. SCHEDULE D CHRONIC OUTPATIENT THERAPY AUTHORIZED CUSTOMER LOCATIONS (IF MORE THAN ONE LOCATION IS COVERED BY THIS AGREEMENT) List name of the testing entity making the determination will be paid by the Party against which the determination is madelocation, address, provider number, and phone number. NEW ALPHA shall have the final determination over the disposition of any Recalled Product.[**] SCHEDULE E PREFERRED RELATIONSHIP

Recalls. 8.1 Each Party (a) In the event ViroPharma should be required or should voluntarily decide to initiate a recall, withdrawal, or field correction of any ViroPharma pharmaceutical containing the Product, Alpharma shall promptly notify reasonably cooperate with ViroPharma concerning the other necessity and nature of such action if such Party it is associated with the Product. (b) In the event that Alpharma independently believes that a recall, withdrawal withdrawal, or field correction (each, a “Recall”) of the Product or any Pipeline ViroPharma pharmaceutical containing the Product may be necessary or advisable. 8.2 NEW ALPHA shall be responsible for appropriate due to reasons associated with 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 Alpharma shall notify ViroPharma 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 parties 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 fully cooperate with each other concerning the other Party in connection with any Recallnecessity and nature of such action. 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 ] Indicates material that has been omitted and for which confidential treatment that has been requested. All such omitted material has been filed with the Securities and Exchange CommissionCommission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. 8.3 (c) In the event that it is determined that any Product or Pipeline ViroPharma pharmaceutical containing the Product is recalled as a result of GENERICO’s gross negligence, bad faith, intentional misconduct or intentional breach of (1) the Product supplied by Alpharma not conforming to the warranties set forth in this Agreement, or (2) the negligent or intentionally wrongful act of Alpharma or its representatives, then GENERICO Alpharma shall bear all of the out-of-pocket costs and expenses of directly related to such Recallrecall including, including without limitation 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 GENERICO’s gross negligence, 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 bear all of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authoritiesregulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product or Pipeline 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 recall of ViroPharma pharmaceutical containing the Product hereunder is in part the responsibility of GENERICO as described herein Alpharma and in part the responsibility of NEW ALPHA as described hereinViroPharma, then the expenses shall be allocated in 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 [***]. In the event causing either party decides to proceed with a voluntary recall under subsections (a) or (b) above and the Recallother party disagrees with the propriety of such voluntary recall, the cost sharing provisions of this subsection (c) shall only apply if a court of competent jurisdiction holds that such dispute will be resolved in the same manner as set forth in Section 6.2. The fees recall was reasonable and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Productproper.

Recalls. 8.1 Each Party Nordion and Navidea shall fully comply with the terms of the Quality Agreement regarding their respective obligations and responsibilities with respect to any recall of or corrective action related to the Precursor, Reference Standards or [123I]NAV5001. Navidea shall notify Nordion promptly notify if [123I]NAV5001 is the other if such Party believes that subject of a recall, withdrawal recall or field correction (each, 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 Product 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 Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA shall be product defects for which Nordion is 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 case Nordion shall 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 such extent be responsible for all Recall activities of Navidea’s reasonable out-of-pocket costs incurred for: (i) notification of recall to Nordion and third parties; (ii) return shipment or destruction of any defective [123I]NAV5001 to Nordion; and (iii) replacement of [123I]NAV5001 . In the event that Nordion disputes Navidea’s determination that the fault is due to Nordion and/or to its employees or agents, 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 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 consulting firm. Navidea and/or its designee shall maintain records of all sales, shipping records of [123I]NAV5001 and customers in sufficient detail to adequately administer a Recall for the Product period of time as required by applicable regulation. Confidential Treatment – Asterisked material has been omitted 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 (filed separately with the consent of NEW ALPHA not to be unreasonably withheld) Securities 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 Exchange Commission pursuant to a request for confidential treatment that has been filed with the Securities and Exchange Commissiontreatment. 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 GENERICO’s gross negligence, 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 bear all of the costs and expenses of such Recall, including without limitation expenses related to communications and meetings with all required 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 reason for any Recall of Product hereunder is in part the responsibility of GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein, then the expenses shall be allocated in 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, such dispute will be resolved in the same manner as set forth in Section 6.2. The fees and expenses of the testing entity making the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled Product.