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 (A) The Parties 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 effectexchange their internal standard operating procedures, if any, GENERICO will be responsible as to product recalls ("SOPs") reasonably promptly after the 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 executing the Recall, reconciling such Collaboration Product, preparing 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 Recall in any country in the Territory, it shall promptly so notify the other Party and submitting the Party having the right to control such a Recall status reports pursuant to Section 5.10(b) may take [**] when the regulatory timeframes or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent of the JSC and termination requests shall be made by the Party having the first right to applicable Regulatory Authorities 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 pertinent 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. Other than with respect to any clinical studies conducted by ViaCell under this Agreement, Amgen shall have the exclusive right to control any 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 Collaboration Products in the Warehouse Services Agreement) by GENERICOTerritory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. In either case, NEW ALPHA ViaCell and Amgen 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 each maintain complete and accurate records of any Recall records relating it has the right to the Product or any Pipeline Product control pursuant to this Section 5.10 for any such periods that are as may be required by legal requirements, but in any Legal Requirements. Note: Redacted portions have been marked with (event for no less than [***). 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 shall promptly notify In the other if event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such Party believes that a recall, withdrawal or field correction (eachc) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform to the Specifications, a “Recall”) the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the Product or any Pipeline Product may recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall be necessary or advisable. 8.2 NEW ALPHA responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the Recall decisionexpenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, notification PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of Regulatory Authorities, an FDA-initiated nationwide recall where the Recall strategy and generation scope of the final Recall letter. During the period in which the Warehouse Services Agreement recall 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 directed at all products containing any of the active ingredients in the Drug Product and any Pipeline Product. Following termination where the purpose of such recall is not attributable to the Warehouse Services Agreementfault of either Adams or Cardinal, NEW ALPHA will Adams shall be responsible for all Recall activities with respect to Recall Adams and Cardixxx xxpenses of the Product and any Pipeline Product that was not previously shipped from xxxxll, PROVIDED, HOWEVER, THAT NEXXXXX PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. For the 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 purposes of this Agreement, then GENERICO the expenses of recall shall bear all include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and expenses of such Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, customer credits for recalled stock, shipping the cost of notifying customers and costs associated with shipment of recalled Drug Product or Pipeline Product from customers and shipment of an equal amount of replacement Product or Pipeline Product to those customers, that was later 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 Partiesrecall. 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 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 promptly notify 11.3.1 In the event of any recall or seizure of any Product, other than a Purchaser Recall (as defined below) Seller shall, at the written election of Purchaser and at Seller’s sole cost, either: (a) 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 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 transportation costs, taxes, freight insurance, handling and reasonable and verifiable out-of-pocket costs 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 Party believes that Purchaser Recall is classified by FDA as a Class I recall, withdrawal Seller shall be responsible (as between Purchaser and Seller) for such recalled or field correction seized Product and shall bear all costs of such recall or seizure, (eachii) if such Purchaser Recall is classified by FDA as a 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 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 reasonable and verifiable out-of-pocket costs incurred by Seller related to the recall or seizure of such Product. Purchaser’s costs with respect to 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”recall” shall mean (i) any action by Seller, 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 good faith belief that such action was appropriate or required under the circumstances. For purposes of this Section 11.3, “seizure” shall mean any action by any government agency to detain or destroy any Product. Notwithstanding anything to the contrary in this Section 11.3, Seller shall 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 approval not to be unreasonably conditioned, withheld or any Pipeline Product may be necessary or advisabledelayed). 8.2 NEW ALPHA 11.3.4 Seller and Purchaser shall be responsible 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. Purchaser shall maintain records of all sales of Product and customers reasonably sufficient to adequately administer a recall or seizure for the Recall decision, notification longer of Regulatory Authorities, the Recall strategy and generation three years after termination or expiration of the final Recall letter. During this Agreement or the period in which the Warehouse Services Agreement is in effect, if any, GENERICO required by Applicable Law. Seller 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 assuring 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 (such recall is closed-out with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA in connection with such Recall. Each of FDA, unless 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 CommissionFDA shall otherwise require. 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 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 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 shall promptly notify In the other if such Party event Xxxxx believes that a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product Processed and supplied under this Agreement, Curia shall immediately notify Indivior in writing. Curia will not act to initiate a recall, field alert, Product withdrawal or field correction without the express prior written approval of Indivior, unless otherwise required by Applicable Laws. In the event Indivior believes a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product Processed and supplied under this Agreement, Indivior shall immediately notify Curia in writing and Curia shall provide all reasonable cooperation and assistance to Indivior, at Indivior's expense. Indivior shall be financially responsible for the cost of, or expenses incurred in connection with, any recall, field alert, Product withdrawal or field correction, unless a recall, field alert, Product withdrawal or field correction is a result of Curia's gross negligence or willful misconduct. In the event a recall, field alert, Product withdrawal or field correction is caused by Curia's gross negligence or willful misconduct, Curia shall bear the reasonable, actual and documented administrative costs incurred by Indivior for such recall, field ale1t, Product withdrawal or field correction (eache.g., 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 Authoritiesregulatory authorities, customer credits for recalled stock, the cost of notifying customers and costs customers, reasonable professional fees). Further, in the event of any recall, each xxxxx shall use Commercially Reasonable Efforts to determine the cause of such recall and, in the event Curia is determined to have contributed to any necessary recall, the parties will negotiate in good faith how to address such recall, taking into account the extent to which such recall is reasonably associated with shipment Curia's Processing failures under this Agreement. For the avoidance of recalled Product or Pipeline Product from customers and shipment of an equal amount of replacement Product or Pipeline Product to those customersdoubt, subject to Sections 12.2 and 12.8. In in the event that any Indivior's use of Non-conforming Product results in a recall, field alert, Product withdrawal or Pipeline Product is recalled other than as a result of GENERICO’s gross negligencefield correction, bad faith, intentional misconduct or intentional breach of Indivior shall be entitled to both the remedy set forth in this Agreement (or for which Section 9.7 with respect to the liability would exceed recall and the limitations remedy set forth in Section 12.9), then NEW ALPHA shall bear all of 6.1 with respect 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 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 Non-conforming Product.

Recalls. 8.1 Each Party a. If (i) any government agency recommends or requires the recall 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 substandard quality or are otherwise not in a saleable condition, then Supplier and Distributor shall promptly notify coordinate the other if immediate cessation of sale and distribution and/or the recall or withdrawal as necessary of all such Party believes that a recall, withdrawal Products or field correction (each, a “Recall”) of packaging from the Product or any Pipeline Product may be Territory. If necessary or advisable, Distributor and Supplier shall cooperate to recall and/or reacquire the applicable Products or packaging from any purchaser thereof. 8.2 NEW ALPHA shall be responsible for b. If 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 problem at issue was not previously shipped from caused by Distributor, then Supplier shall pay the Premises costs and expenses 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 defined in the Warehouse Services AgreementSupplier may elect; and (ii) its reasonable costs and expenses associated with such recall, which costs may include but are not limited to credits, refunds, or other payments by GENERICO. In either case, NEW ALPHA shall (subject Distributor to Section 8.3) bear all expenses incurred by GENERICO (with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA its customers in connection with such Recalltherewith. 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 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 GENERICO Distributor shall bear all of pay 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 any such recall, 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 Distributor shall indemnify Supplier for which the liability would exceed the limitations set forth in Section 12.9), then NEW ALPHA shall bear all of the its reasonable 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 customerssuch recall. 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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, then the expenses shall be allocated in an equitable manner between the PartiesWHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 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 (a) Notwithstanding anything in this Agreement to the contrary, JV shall promptly notify have the other 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 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 also 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 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 Party believes that recall or advisory letter result from a recalldesign defect in the Product, withdrawal or field correction (each, a “Recall”) of the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA Medifocus shall be responsible for the Recall decisioncosts of effecting such recall or advisory letter. (c) In the event of a recall of any Product, notification JV shall correct or cause its manufacturers, as applicable, to correct any deficiency relating to the manufacturing, packaging, testing, labeling, storing or handling of Regulatory Authoritiessuch Product, the Recall strategy if applicable, and generation 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 final Recall letter. During the period in which the Warehouse Services Agreement is in effectProduct), 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 replace each unit of the Product and any Pipeline Product. Following termination recalled (including units held in inventory by JV or its customers) with a corrected Product within a reasonable period of time, or refund 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 Commissionpurchase price therefor. 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 In the event: (a) Purchaser reasonably determines that any Product should be recalled due to its non-conformance with the terms of this Agreement; (b) any Applicable Regulatory Agency issues a request, directive or order that any Product be recalled; or (c) a court of competent jurisdiction orders such a recall (either (b) or (c) together, an “Order”), each Party shall promptly notify take all appropriate corrective actions reasonably requested by the other if such Party believes that a recall, withdrawal or field correction (each, a “Recall”) of the Product or any Pipeline Applicable Regulatory Agency. Only Purchaser is authorized to conduct a recall of a Product. Supplier shall cooperate fully with Purchaser in the event of any 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 properly and completely perform any covenant, agreement or undertaking on the part of Supplier contained in this Agreement, including supply of Product may that conforms to Specifications; (ii) the negligence or willful misconduct of Supplier or its directors, officers, employees, agents, contractors, successors and assigns; or (iii) Supplier’s failure to follow Applicable Laws to the extent required under this Agreement, then Supplier shall be necessary 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 advisable. 8.2 NEW ALPHA 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 the Recall decision, notification its costs of Regulatory Authorities, the Recall strategy such recall and generation of the final Recall letterSupplier’s reasonable and documented out-of-pocket costs for such recall. 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 For purposes of this Agreement, then GENERICO out-of-pocket costs of such recall shall bear be all direct expenses incurred by either Party relative to notification, shipping, disposal and return of the costs and expenses of such Recallrecalled or withdrawn Product, 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 customerswhich shall include making Purchaser whole, subject to Sections 12.2 Section 16.3 (Limitation of Liability) on consumer returns of the Product at retail. The Parties have the right to audit such recall costs. Purchaser shall be responsible for coordinating any and 12.8all such recall activities with the Regulatory Agencies, its customers or otherwise. In the event that Purchaser and Supplier shall agree on all public statements regarding any Product or Pipeline Product is recalled other than as a result of GENERICO’s gross negligencerecall, bad faith, intentional misconduct or intentional breach of and neither Party shall make any public statements regarding this Agreement (or for which without the liability would exceed the limitations set forth in Section 12.9)Party’s prior, 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 Partieswritten approval. 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 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 JSC shall have decision-making authority with respect to issuing all other recall, market withdrawal or correction of any Licensed Product in the 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 promptly 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 such Party believes that any Licensed Product is alleged or proven to be the subject of a recall, market withdrawal or field correction (eachin any country in the Territory. Once a recall or withdrawal decision has been made under this Section, a “Recall”) the Distributing Party, under the direction of the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA JCT and the designees of the JSC, shall be responsible for handling and implementing such recalls and market withdrawals of any Licensed Product in the Recall decisionTerritory, notification of Regulatory Authoritiesprovided 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, the Recall strategy and generation upon request, all of the final Recall letterother Party's pertinent records that the Distributing Party may reasonably request to assist it in effecting any recall or market withdrawals. 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 The Parties shall share equally all costs 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 a recall or marketing 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 (Territory in accordance with the consent of NEW ALPHA not a budget for such activities to be unreasonably withheld) agreed upon by the JCT and NEW ALPHA in connection with such Recallapproved by the JSC. Each of the Parties will reasonably cooperate with A Party shall have no obligation to reimburse or otherwise compensate the other Party for any lost profits or income that may arise in connection with any Recallsuch recall or market withdrawal. Each Party will maintain complete and accurate Recall records relating to Any investigation conducted in connection with a Licensed Product recall shall be undertaken jointly by 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 Parties under 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 direction 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 PartiesJSC. 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 SMBI and NuVim shall promptly notify the other promptly if such Party believes that a any batch of Product purchased by NuVim pursuant to this Agreement is subject to recall, seizure, market withdrawal or field correction (each, a “Recall”) or if any end user notifies NuVim 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 an adverse reaction as a result of GENERICO’s gross negligencethe use of any Product, bad faithand the parties agree to cooperate in the handling and disposition of such recall, intentional misconduct seizure, market withdrawal or intentional breach correction or notification of this Agreementadverse reaction; provided, then GENERICO however, in the event of a disagreement as to any matters related to such recall, seizure, market withdrawal or correction or adverse reaction, SMBI shall have final authority with respect to such matters. SMBI shall bear all of 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 expenses to the extent such recall, seizure, market withdrawal or correction is not a result of such Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, customer credits for recalled stocka breach by either NuVim or SMBI of any of their respective obligations hereunder, the cost costs of notifying customers and costs associated with shipment of recalled Product any recall, seizure, market withdrawal 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 12.8correction shall be borne by NuVim. In the event that of any Product recall, seizure, market withdrawal or Pipeline Product correction, SMBI shall, to the extent it 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 required to bear all of the costs and expenses of such Recallrecall, including without limitation expenses related seizure, market withdrawal or correction as provided above, in addition to communications and meetings with all required Regulatory Authorities, expenses of replacement stock, bearing the cost of notifying customers and costs associated with shipment of recalled Product such recall, seizure, market withdrawal or Pipeline Product from customers and shipment of an equal correction, (i) replace the amount of replacement Product to those customersProducts recalled, seized or withdrawn and (ii) reimburse NuVim for all verifiable out-of-pocket costs incurred by NuVim in respect of such recalled, seized or withdrawn Products. In the event that the reason for any Recall NuVim shall maintain records of Product hereunder is all sales of Products 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 Partiesaccordance with its standard operating procedure. 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 9.1 Product recalls and FDA contacts relating to recall of Product shall be the responsibility of, and under the control of, AMAG. 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. AMAG shall notify the other if such Party believes that a FDA, DEA, and 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. DSM and AMAG acknowledge that each Party has significant regulatory obligations; and accordingly, 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 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 applicable provisions of this Agreement, including non-conformity due to the negligence or willful misconduct of DSM, 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 5.5, DSM shall reimburse AMAG for its reasonable expenses actually incurred as a result of GENERICOsuch recall. If AMAG elects to utilize a Third Party to conduct a recall, AMAG shall so notify DSM and shall await DSM’s gross negligenceconsent, bad faithwhich consent shall not unreasonably be withheld. 9.3 If each Party contributes to the cause for a recall, intentional misconduct or intentional breach the expenses actually incurred as a result of such recall will be shared in proportion to each Party’s responsibility. All other recall costs for the Product shall be at AMAG’s sole expense subject to the other terms of this Agreement. AMAG shall give DSM prompt written notice of any Product recalls that AMAG believes were caused or may have been caused by DSM’s failure to comply with this Agreement or the Specifications. [***] 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 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 9.4 AMAG shall maintain records of all sales of Commercial Product and customers sufficient to adequately administer a recall, market withdrawal or correction for a period of two (2) years (or for which a shorter period as may be permitted by applicable law) after termination or expiration of this Agreement. Subject to Section 9.1, AMAG shall in all events be responsible for conducting any recalls, market withdrawals or 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 promptly notify In the other if such Party believes event that it becomes necessary to conduct a recall, market withdrawal or field correction (each, a “Recall”hereafter collectively referred to as "recall") of any Licensed Product manufactured by SANO and sold by Par or its Affiliates the Product or any Pipeline Product may be necessary or advisable.following provisions shall govern such a recall: 8.2 NEW ALPHA (a) After consulting with SANO, and on terms and conditions reasonably satisfactory to SANO, Par shall be responsible for conduct (and shall cause its Affiliate to conduct) the Recall decision, notification of Regulatory Authorities, the Recall strategy recall 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 shall have primary responsibility therefore and submitting Recall status reports SANO 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 Par 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 each cooperate with the other Party in connection with recalling any Recallaffected Licensed Product(s). Each Party will Par covenants and agrees to maintain complete and accurate Recall to cause its Affiliates to maintain such records relating to of all sales of the Product Licensed Products made by Par or any Pipeline Product for any periods that its Affiliates as are required by any Legal Requirements. Note: Redacted portions have been marked with (***). The redacted portions the FDA or as are subject reasonably appropriate for a distributor of pharmaceutical products to maintain so as to enable a request for confidential treatment that has been filed with the Securities and Exchange Commissionrecall to be properly completed. 8.3 In (b) Irrespective of whether the event that recall is initiated by Par or by SANO: (i) If it is determined later demonstrated that any Product the reason for the recall was due primarily to acts or Pipeline Product is recalled as a result omissions of GENERICO’s gross negligence, bad faith, intentional misconduct SANO (or intentional breach of this Agreement, then GENERICO shall bear all the safety or efficacy 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 Licensed 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 acts or intentional breach omissions of this Agreement (Par or for which the liability would exceed the limitations set forth in Section 12.9its Affiliates), then NEW ALPHA SANO shall bear pay or reimburse, as the case may be, all reasonable direct out-of-pocket expenses, including but not limited to reasonable attorney's fees and expenses and credits and recall expenses claimed by and paid to customers, incurred by Par or SANO in connection with performing any such recall, provided that expenses incurred by Par shall be in accordance with the terms and conditions of the recall approved by SANO; or (ii) If it is later determined that the reason for the recall was due primarily to the acts or omissions of Par or its Affiliates, then Par shall pay or reimburse, as the case may be, all direct out-of-pocket expenses, including but not limited to reasonable attorney's fees and expenses and credits and recall expenses claimed by and paid to customers, incurred by Par or SANO in connection with performing any such recall; or (iii) If the parties are unable to agree that the cause of the recall was due primarily to the act or omission of one of the parties (or its Affiliates, as the case may be) within sixty days of the initiation of the recall and have not commenced arbitration proceedings to resolve such dispute within such sixty day period then all direct out-of-pocket costs incurred by Par and SANO, including but not limited to reasonable attorney's fees and expenses and credits and recall expenses claimed by and paid to customers, shall be shared by the parties in proportion to their sharing of Gross Profits in respect of the Licensed Products recalled. Each of the parties shall use its reasonable best efforts to minimize the expenses of recall which it incurs. It is understood and agreed that the direct out-of-pocket costs and expenses of such Recallthe recall contemplated in Paragraphs (i), including without limitation expenses (ii) and (iii) above shall not include the invoice price charged by PRI or its Affiliates to the customers for the Products recalled, which amount shall be dealt with in accordance with the provisions of Section 9 hereof and shall also not include any excess re-procurement costs (within the meaning of Paragraph 14.3 hereof) and related penalties and assessments, which costs, penalties and assessments shall be an expense of Par except to communications and meetings with all required Regulatory Authorities, expenses the extent that it is an expense of replacement stockSANO pursuant to Section 14.3 hereof (provided that where the provisions of Paragraph (iii) above apply, the cost excess reprocurement costs and related penalties and assessments incurred pursuant to Approved Contracts [as that term is defined in Section 14.3 hereof] shall be shared by the parties in the proportion in which Gross Profits are shared in respect of notifying the recalled Products sold pursuant to such Approved Contracts). (c) All Licensed Products recalled pursuant to this Section 14.1 shall be treated as Licensed Products returned to Par by its customers and costs associated with shipment the provisions of recalled Product Section 9 shall apply thereto. (d) The party initiating the recall shall inform FDA of the proposed recall; however, nothing contained herein shall preclude either party from informing FDA of any proposed or Pipeline Product from customers and shipment actual recall by either party should the recalling party fail to inform FDA of an equal amount that recall within ten (10) days of replacement Product a written request by the non-recalling party to those customers. In so inform FDA. (e) For greater certainty, in the event that of a recall, neither party or its Affiliates shall profit from any out-of-pocket expenses incurred by it in connection with the reason recall and for which it is reimbursed by the other party and, except where the recall relates directly to an intentional breach of a representation or warranty contained in this Agreement or arises directly out of a willful material breach by a party of any of its duties or obligations hereunder (in each case, as contemplated in Section 10.1 hereof), neither party shall have a claim against the other party for any Recall of Product hereunder is damages, losses or expenses which it suffers or incurs as a result thereof except to the extent permitted or contemplated 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 Partiesthis Section 14. 8.4 If (f) Each party shall provide reasonable evidence to the Parties are unable to mutually agree on the source cause other of the Recall within 5 days out-of-pocket expenses being claimed by it and the rights of SANO pursuant to Section 11.4 and the event causing the Recall, such dispute will be resolved in the same manner as set forth in rights of Par pursuant to 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 11.8 shall have the final determination over the disposition of any Recalled Productapply thereto.

Recalls. 8.1 Each Party shall promptly make every reasonable effort to notify the other if such Party believes 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 field correction the I-Mab Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, (eacha) 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 “Recall”) 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 Product 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 any Pipeline Product may 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 Section 8.7, the Party responsible for the recall, market suspension or market withdrawal shall be necessary 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 advisable. 8.2 NEW ALPHA I-Mab Supply Agreement, as applicable, each recalling Party shall be responsible for the Recall decision, notification all 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 its costs 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 conduct of such Recallrecall, 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 market suspension 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 Partiesmarket withdrawal. 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 (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 party shall promptly notify the other if party in a timely manner prior to making any recall or issuing any advisory letter. The 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 Party believes matters in time to comply with any applicable legal or regulatory requirements, but such agreement shall not be a precondition to any action that a recall, withdrawal or field correction (each, a “Recall”) either party deems necessary to protect users of the Product Products or to comply with any Pipeline Product may be necessary applicable governmental orders or advisable. 8.2 NEW ALPHA 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 extent such recall or the issuance of such advisory letter results from an act or omission of BSC, BSC shall be responsible for the Recall decisioncosts of effecting such recall or issuing such advisory letter, notification including costs related to return of Regulatory Authoritiesrecalled Products, to the Recall strategy and generation extent such recall or the issuance of such advisory letter results from the final Recall letter. During act or omission of BSC. (c) In the period in which the Warehouse Services Agreement is in effectevent of a recall of any Product, Celsion shall correct any deficiency relating to its manufacturing, packaging, testing, labeling, storing or handling of such Product, if anyapplicable, GENERICO will be responsible for executing the Recalland shall, reconciling Productat BSC's option, preparing and submitting Recall status reports and termination requests to applicable Regulatory Authorities with respect to Recall either, at its cost replace each unit of the Product and any Pipeline Productrecalled (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. Following termination of the Warehouse Services Agreement, NEW ALPHA will be responsible Celsion shall reimburse BSC for all Recall activities with respect to Recall of the Product costs and any Pipeline Product that was not previously shipped from the Premises expenses (as defined in the Warehouse Services Agreementincluding shipping, quality control testing, notification and restocking costs) 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 BSC 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 Partiesrecall. 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 promptly notify the other if such Party believes Nuwellis represents and warrants that Nuwellis is not aware of any facts which are reasonably likely to cause (i) a recall, withdrawal or field correction (each, a “Recall”) Recall of the Products; (ii) a change in the marketing classification or a material change in the labeling of the Products or (iii) termination or suspension of the marketing of the Products. In the event a Product or is the subject of a Recall, Nuwellis shall notify DaVita within two (2) business days of being made aware of any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA such Recall. Nuwellis shall work in conjunction with DaVita to make all contacts with DaVita Facilities and the FDA. Nuwellis 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 coordinating 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 such Recall and shall make all statements to the media, including press releases and interviews for publication or broadcast, provided, however, that in no event may Nuwellis reference DaVita in any such statements. DaVita reserves the right, in its sole and reasonable discretion, to take any actions necessary to comply with all applicable Laws and general guidance issued by the FDA or any 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 DaVita clinicians and patients) without Nuwellis’s consent. Nuwellis shall reimburse DaVita for direct and actually incurred costs related to (a) the aggregate price for all units of Products that are defective pursuant to the Recall. Each Party will maintain complete ; (b) reasonable and accurate Recall records out-of-pocket expenses 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 which could include 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 implementation 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 strategy 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 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 a Recall. Any Products affected by a Recall may be resolved in the same manner as set forth in Section 6.2. The fees and expenses returned to Nuwellis for a full refund of the testing entity making the determination will be Purchase Price or pro ratable Rental Price, as applicable, paid by the Party against which the determination is madeDaVita, at Nuwellis’s sole cost and expense, F.O.B. Origin, Freight Collect. NEW ALPHA shall have the final determination over the disposition of any Recalled Product.Supply and Collaboration Agreement DaVita Confidential & Proprietary

Recalls. 8.1 Each Party shall promptly notify the other if such Party believes that (a) The ultimate determination as to whether a recall, withdrawal or field correction corrective action (eachcollectively, a 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 Product or any Pipeline Product may be necessary or advisableParties will jointly develop a plan for implementing such Recall. 8.2 NEW ALPHA (b) If there shall be responsible for the Recall decision, notification of Regulatory Authoritiesa Recall, the expense of such Recall strategy and generation 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 final Recall letter. During the period in which the Warehouse Services provisions of this Agreement is in effector Applicable Law, if any, GENERICO will be responsible for executing then PuriCore shall hold Misonix harmless and shall bear all expenses related to the Recall, reconciling including the replacement of the recalled or withdrawn Licensed Product, preparing and submitting 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 status reports and termination requests to applicable Regulatory Authorities with respect to Recall arises as a result of actions or omissions on the part of Misonix, or from any breach by Misonix of the Product and any Pipeline Product. Following termination provisions of the Warehouse Services this Agreement, NEW ALPHA will be responsible for all Recall activities with respect to Recall of the Product then Misonix shall hold PuriCore harmless 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 costs and expenses incurred by GENERICO (with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA in connection with such Recall. (c) The Parties shall reasonably cooperate in good faith to effect a Recall. Each 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 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 (d) In the event that it a Recall is triggered because of nonconforming Licensed Product (as 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 stockunder Section 5.2), the cost provisions 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 customersSection 4.9, 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 negligenceif triggered, 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 Partieswill control. 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 In the event that either Party determines that an event, incident or circumstance has occurred which may result in the need for a “recall” or “market withdrawal” (as such terms are defined in U.S. regulations in 21 CFR 7.3 or other similar national, state or local law or regulation) (hereinafter referred to as a “Recall”), of Collaboration Product or any lot(s) thereof, such Party shall promptly notify the other if Party in writing whether or not to conduct such Party believes that a recall, withdrawal Recall and shall follow the procedures set forth below: a) Pharmacia shall have the sole discretion to determine whether and upon what terms and conditions the Collaboration Product shall be recalled or field correction otherwise withdrawn from sale to Third Parties within any country in the Territory (each, a “Recall”) of the Product or ). Prior to making any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA 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 decisiondecision and the execution thereof. Upon the request of Pharmacia, notification Celltech shall cooperate completely in all Recall efforts. b) Any costs or expenses of Regulatory Authoritiesany 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 costs and expenses of such Recall strategy and generation of shall be deemed to be an Other Expense; ii) If the final Recall letter. During is solely applicable to Collaboration Products sold for the period in which RA Indication or 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 IBD Indication 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 Other Territories or to the Product Other Indications in any country in the Territory, the costs and expenses of such Recall shall be borne by Pharmacia; iii) If the 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 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 negligenceOther Indication, bad faith, intentional misconduct or intentional breach of this Agreement, then GENERICO shall bear all an equitable portion of the costs and expenses of such RecallRecall shall be included in Other Expense. Notwithstanding the foregoing, including without limitation expenses related if such Recall is due in whole or in part 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 gross negligence 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 on the part of this Agreement (or for which the liability would exceed the limitations set forth in Section 12.9)only one Party, then NEW ALPHA such Party shall fully bear all of the costs cost 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 expense 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 net of any Recalled Productinsurance proceeds recovered from a Third Party.

Recalls. 8.1 Each OMP and Rohto agree that, if either Party discovers or becomes aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to any Product in the Territory that may reasonably require a report, a recall or market withdrawal of such Product in the Territory, such Party shall promptly notify communicate such fact, condition, circumstance or event to the other if such Party believes within twenty-four (24) hours. In the event (i) any governmental entity or regulatory body requests that a recallProduct be recalled or withdrawn, (ii) a court of competent jurisdiction orders a Product recall or withdrawal, or (iii) Rohto (in consultation with OMP) determines that a Product should be recalled or withdrawn from the market, Rohto shall take all appropriate remedial actions with respect to such recall or withdrawal or field correction of Product (each, a “RecallRemedial Action”) of the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA ). Rohto shall be responsible for all reporting, pharmacovigilance reporting and recalls associated with Product in the Recall decisionChannel in the Territory, notification of Regulatory Authoritiesand Rohto shall be the primary contact person/ entity for any communications to any governmental entity, regulatory body, the Recall strategy media and generation customers in the Territory concerning the Remedial Action, with OMP’s reasonable cooperation. If such recalls are necessary because of the final Recall letter. During the period any event that listed in which the Warehouse Services Agreement is in effectSection 9 (b), if anyRohto shall be solely responsible for, GENERICO will be responsible for executing the Recalland shall reimburse OMP for, reconciling Productall costs reasonably incurred as a result of, preparing such Remedial Action or any Product recalls or market withdrawals, 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 shall reimburse OMP 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 costs reasonably incurred by GENERICO (with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA 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 Recall. Each Remedial Action if such recalls are necessary because of the Parties will reasonably cooperate with the other Party any event listed 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 Section 9 (***a). The redacted portions are subject OMP and Rohto shall discuss and determine how to a request for confidential treatment that has been filed with share the Securities and Exchange Commission. 8.3 In the event that it is determined that any Product or Pipeline Product is recalled costs incurred as a result of GENERICO’s gross negligencesuch 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, bad faithand the reasons therefor. The Parties shall cooperate fully with one another to obtain, intentional misconduct but Rohto shall be solely responsible for preparing and submitting, all information reasonably required by regulatory or intentional breach of this Agreement, then GENERICO shall bear all of the costs and expenses of such Recall, including without limitation expenses governmental authorities 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 affected 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 ProductTerritory.

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.

Recalls. 8.1 Each (1) If, for any reason, it shall become necessary to trace back or recall any particular batch of the Product, or to identify the customer or customers to whom any unit from such batch has been delivered, the Distributor shall co-operate with DRAXIMAGE in doing so. (2) In the event that either Party shall promptly notify the other if such Party believes has reason to believe that a recall, withdrawal one or field correction (each, a “Recall”) more lots of the Product should be recalled 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 withdrawn from the Premises (as defined distribution in the Warehouse Services Agreement) by GENERICO. In either caseTerritory, NEW ALPHA such 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 cooperate with immediately notify the other Party in connection with 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 Recallrecall in order to exchange any relevant information, but the decision as to whether or not to initiate a recall of the Product in the Territory shall be taken by DRAXIMAGE. Each Party will maintain complete and accurate Recall records relating In this respect, DRAXIMAGE shall have the right, at any time, to recall any of the Product 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 or any Pipeline Product for any periods 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 are required necessitates a recall 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 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 AgreementDistributor, then GENERICO the Distributor shall bear all be entitled to initiate a recall of the costs Product. In such event, Distributor shall advise DRAXIMAGE of all procedures taken and expenses 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 recall is required because of a modification or withdrawal of an approval from a Regulatory Authority or of a negligent act or omission of DRAXIMAGE, DRAXIMAGE shall promptly reimburse the Distributor for the cost and expense of such Recallrecall, including without limitation expenses related to communications and meetings with all required Regulatory Authoritiesand, customer credits for recalled stockat DRAXIMAGE’s option, DRAXIMAGE shall replace the cost of notifying customers and costs associated with shipment of recalled Product or Pipeline Product from customers and shipment refund the purchase price (as referenced in Schedule 7 hereto) of an equal amount such recalled Product. If the recall is required because of replacement Product a negligent act or Pipeline Product to those customersomission of the Distributor in connection with the handling, subject to Sections 12.2 and 12.8. In refrigeration, storage or distribution of 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)Product, then NEW ALPHA such recall shall bear all be conducted by the Distributor at its sole cost and expense and the Distributor shall not be entitled to any such replacements or refunds from DRAXIMAGE. If such recall is required because of a joint act or omission of the costs Parties, the Distributor shall conduct the recall and expenses the Parties shall negotiate in good faith an appropriate allocation of the cost and expense 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 Partiesrecall. 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 promptly notify In the other if event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such Party believes that a recall, withdrawal or field correction (eachc) Xxxxx reasonably determines after consultations with Cardinal that a Drug Product should be recalled because the Drug Product does not conform to the Specifications, a “Recall”) the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Xxxxx' expenses of the Product or any Pipeline Product may recall to the extent such recall results from the breach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Xxxxx shall be necessary or advisable. 8.2 NEW ALPHA responsible for all Xxxxx' and Cardinal's expenses of the recall to the extent that such recall results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, XXXXX SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Xxxxx and Cardinal, each party shall be responsible for the Recall decisionexpenses of recall in direct proportion to each party's percentage of fault as determined jointly by the parties, notification PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of Regulatory Authorities, an FDA-initiated nationwide recall where the Recall strategy and generation scope of the final Recall letter. During the period in which the Warehouse Services Agreement recall 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 directed at all products containing any of the active ingredients in the Drug Product and any Pipeline Product. Following termination where the purpose of such recall is not attributable to the Warehouse Services Agreementfault of either Xxxxx or Cardinal, NEW ALPHA will Xxxxx shall be responsible for all Recall activities with respect to Recall Xxxxx and Cardinal expenses of the Product and any Pipeline Product that was not previously shipped from recall, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. For the 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 purposes of this Agreement, then GENERICO the expenses of recall shall bear all include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Xxxxx' or Cardinal's total, unrecoverable, actual, internal costs for manufacturing and expenses of such Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, customer credits for recalled stock, shipping the cost of notifying customers and costs associated with shipment of recalled Drug Product or Pipeline Product from customers and shipment of an equal amount of replacement Product or Pipeline Product to those customers, that was later 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 Partiesrecall. 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 promptly notify Principal may cease selling the other 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 such Party believes that a recall, withdrawal or field correction (each, a “Recall”) any of the Product or below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA shall be responsible for Country/Region in the Recall decision, notification of Regulatory Authorities, the Recall strategy and generation Territory: unforeseen effects of the final Recall letterrelative 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. 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 The Distributor undertakes with respect to Recall any product recall that: (i) it will implement and complete the recall of the Product 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 Pipeline Productof the Products from any of the Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following termination of the Warehouse Services Agreementdecision to implement a Recall, NEW ALPHA will be responsible Principal and Distributor shall mutually agree on a prepared statement for all Recall activities with respect use in response 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 inquiries regarding such Recall. Each 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 Parties will reasonably cooperate with the other Party in connection with any statement as proposed by Principal regarding such Recall. Each Party will maintain complete and accurate Recall records relating To the extent the Products are recalled due to the Product or any Pipeline Product for any periods that are required by any Legal Requirements. Note: Redacted portions have been marked causes other than Distributor’s non-compliance 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 relevant obligations under this Agreement, then GENERICO Principal shall bear all of (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 such Recall, including without limitation expenses related to communications the same; and meetings with all required Regulatory Authorities, customer credits for recalled stock, (b) repurchase 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, Products that are subject to Sections 12.2 the Recall at the purchase price paid by the Distributor and 12.8. In the event that any Product or Pipeline Product is recalled other than as in addition pay Distributor 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 handling charge equal to 10% 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 customerspurchase price. In the event that the reason 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 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 Product hereunder such Recall, including Distributor's recall procedures, Distributor's records relating to the distribution and sales of the Recalled Products, Distributor's records relating to such Recall and the costs incurred by Distributor in connection with implementing such Recall. In the event of a Recall, the obligations of Distributor to sell the Recalled Products in the Territory and of Principal to supply such Recalled Products to Distributor pursuant to this Agreement shall be suspended with immediate effect and such obligations shall only become enforceable again if and when the circumstances that caused the Recall have been resolved. If the Recalled Products are thereafter totally withdrawn from the Territory for the remainder of the Term, then Principal may by written notice to Distributor terminate the Recalled Products from the Territory. The Distributor shall inform Principal immediately upon being informed about any defective products returned to the Distributor or detected in the Distributor's inventory. The Distributor shall inform Principal immediately about any complaint received. The Distributor shall be responsible for the collection and investigation of End Ccustomers' complaints (whether these customers complain to the Distributor directly or forwarded by Principal and/or its Affiliates), and retain accurate records of such collections and investigations and maintain appropriate records during the Term. AUDIT RIGHTS AND REPORTING During the Term, Principal shall be entitled, through itself or an independent audit firm appointed by Principal (the "Independent Auditor"), to inspect and audit (i) such books, documents, papers and records which relate to sales of the Products or any costs and expenses invoiced or charged by Distributor to Principal in connection with this Agreement, (ii) Distributor's compliance with Clause 1817, and (iii) all facilities of Distributor in which Distributor performs its obligations under this Agreement and maintains inventory of the Products (an "Audit"). If an Audit reveals matters that Principal determines should be corrected by Distributor, Principal shall provide a list of such matters and may propose corrective action to be taken by Distributor. Distributor shall respond within 15 days of receipt of such notification indicating the corrective action to be taken and an estimated completion date. The Audit of any books, documents, papers or records that relate to or contain any information regarding any business dealings with or the affairs of any other client or principal of Distributor may only be conducted by the Independent Auditor. Such Independent Auditor shall (i) provide a copy of the audit report to Distributor no later than thirty (30) Business Days after such report is provided to Principal and (ii) disclose to Principal relevant necessary information to enable Principal to determine whether Distributor is in part the responsibility of GENERICO as described herein compliance with this Agreement or not, and in part any event shall never disclose to Principal any information regarding any business dealings with or the responsibility affairs of NEW ALPHA as described hereinany other client or principal of Distributor that such Independent Auditor may come across in the course of performing its audit under this provision, then 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 expenses 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 allocated 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 an equitable manner between this Agreement, shall at the Parties. 8.4 If 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 result of Audit demonstrates that Distributor fails to make due payment to Principal, or Distributor had breached any of its obligation under this Agreement, Distributor shall cure such breach within 30 days (in the case of a failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if Distributor fails to do so, Principal shall have the right to terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties are unable to mutually shall in good faith 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 a Safety Data Exchange Agreement (as set forth in Section 6.2Exhibit G) that sets out the responsibilities of each Party with respect to the pharmacovigilance matters relating to the Products as soon as practicable after the execution of this Agreement. The fees Parties shall in good faith agree on the Quality Agreement that sets out the responsibilities and expenses processes for quality activities with respect to supply, distribution and quality management relating to the Products as soon as practicable after the execution of this Agreement. INTELLECTUAL PROPERTY Principal warrants to Distributor that throughout the Term: it has and will continue to have full legal rights to use the Licensed Marks and to grant the use of the testing entity making Licensed Marks to Distributor; it has and will continue to have full legal rights to use the determination will be paid 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 Party against which rights and licences granted to Distributor under this Agreement (including the determination is made. NEW ALPHA shall have use of the final determination over Licensed Marks) and the disposition distribution, offer for sale and sale of the Products by Distributor would not infringe any right (including intellectual property rights) of any Recalled Productperson 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 not be limited by anything in this Agreement. Principal hereby authorises Distributor to 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 actual, threatened or suspected infringement in the Territory of the Licensed Marks or other intellectual property rights of Principal relating to the Products which comes to the notice of Distributor, and of any 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 person. Distributor shall provide such information and assistance to Principal as Principal may reasonably require in taking or resisting any proceedings in relation to any such infringement or claim. Distributor shall not: alter, remove or tamper with any of the Licensed Marks, numbers, or other means of identification used on or in relation to the Products; or use any of the Licensed Marks in any way which might prejudice their distinctiveness or validity or the goodwill of Principal therein; Distributor hereby acknowledges that, except as expressly provided in this Agreement, 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 Agreement.

Recalls. 8.1 (a) Licensee shall administer all recalls or market withdrawals of the Licensed Product in the Territory (“Recall”) in accordance with applicable Laws and Licensee’s standard operating procedures used in connection with any recalls or withdrawals of Licensee products in the Territory. Licensee shall promptly consult with Somaxon with respect to any Recall proposed to be taken by Licensee (and in all events reasonably in advance of the taking of such Recall), including all Recalls that are reasonably likely to result in a material adverse effect on the marketability of the Licensed Product in or outside the Territory. (b) Each Party shall promptly notify the other if in writing of any order, request or directive of a court or other Governmental Body to Recall the Licensed Product of which such Party believes that a recallhas notice of or is otherwise aware (but in any case, withdrawal not later than 24 hours following such event (or field correction (each, a “Recall”) of the Product or any Pipeline Product may be necessary or advisableearlier if required under applicable Law)). 8.2 NEW ALPHA (c) Somaxon shall be responsible for bear the full and reasonable expenses of both Parties incurred in any Recall decision, notification to the extent resulting from a failure of Regulatory Authorities, the Recall strategy and generation of the final Recall letter. During the period Somaxon (or its Subcontractors) to Manufacture Bulk Product 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 (accordance 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 warranties set forth in Section 12.92.2(a) (the “Somaxon Manufacturing Responsibilities”), then NEW ALPHA and in all other circumstances Licensee shall bear all the full and reasonable expenses of both Parties incurred in any Recall. If any Recall results in part from the failure of Somaxon (or its Subcontractor(s)) to Manufacture Bulk Product in accordance with Somaxon Manufacturing Responsibilities, Somaxon shall bear a pro rata portion of the costs full and reasonable expenses of such both Parties incurred in any Recall based on its contribution to the particular facts of the Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, . Such expenses of replacement stockRecall shall include the expenses of notification and destruction or return of the recalled Licensed Product, the cost of notifying customers and costs associated with shipment of recalled Product or Pipeline Product from customers and shipment of an equal amount distribution of replacement Licensed 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 all sums paid by Third Parties for the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition of any Recalled recalled Licensed Product.

Recalls. 8.1 Each Party shall promptly notify the other if such Party believes that a recall, withdrawal or field correction (eacha) Subject to this Section 3.1.4, a “Recall”) of Recall in the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA Co-Promotion Territory shall be responsible for the responsibility, and under the control, of ZGEN. Bayer shall provide all pertinent records and such other assistance to ZGEN as ZGEN reasonably may request to assist in effecting any 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 GENERICOCo-Promotion Territory. In either caseaddition, 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 Bayer will maintain complete and accurate Recall all records relating to the Product or any Pipeline Product Recall for any periods that are the period required by any Legal Requirementslegal requirements, but for no less than three (3) years. Note: Redacted portions have been marked with (***). The redacted portions are subject ZGEN shall bear the costs of the Recall in the Co-Promotion Territory except to the extent that a request for confidential treatment that has been filed with Recall results from the Securities and Exchange Commissionnegligence or willful misconduct of Bayer. 8.3 In (b) If either Party becomes aware of information about quantities of Initial Licensed Product that may not conform to the event that it is determined that any Product specifications for the Initial Licensed Product, or Pipeline Product is recalled as a result of GENERICO’s gross negligencefor which there are potential adulteration, bad faithmisbranding and/or other issues regarding safety or effectiveness, 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 Initial Licensed Product itself is alleged or proven to be the limitations set forth subject of a Recall in Section 12.9any country in the world, it will promptly so notify the other Party. The Parties will meet (in person, by telephone or otherwise) to discuss the circumstances of a Recall in the Co-Promotion Territory and to consider appropriate courses of 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 NEW ALPHA (i) Bayer shall bear all of the costs and expenses of such Recall, including without limitation expenses related have no obligation 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 defend or Pipeline Product from customers and shipment of an equal amount of replacement Product to those customers. In the event that the reason indemnify ZGEN under Article 8 for any Recall of Losses arising in connection with the Safety Issues for Initial Licensed Product hereunder is that was sold, promoted or distributed in part the responsibility of GENERICO as described herein Co-Promotion Territory after receiving such written notice from Bayer, (ii) ZGEN will defend and in part indemnify Bayer under Article 8 for any such Losses, and (iii) Bayer will have no further obligations under this Agreement to Detail or otherwise promote the responsibility of NEW ALPHA as described herein, then relevant Initial Licensed Product unless and until the expenses shall be allocated in an equitable manner between the Parties. 8.4 If the Parties Safety Issues 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 good faith opinion 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 ProductBayer.

Recalls. 8.1 Each Party shall promptly notify In the other if event (i) any Agency issues a directive, order or, following the issuance of a safety warning or alert with respect to a product, a written request that any Product be recalled, (ii) a court of competent jurisdiction orders such Party believes that a recall, withdrawal or field correction (eachiii) Cornerstone determines that any Product should be recalled or that a “dear doctor” letter is required relating [***] Confidential portions of the 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 have the responsibility for handling customer returns of the Product. Chiesi shall provide Cornerstone or its designated agent with 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 “Recall”failure by Chiesi (or its contract manufacturer) of to manufacture and supply the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA in accordance with the Specifications, Applicable Laws and/or cGMP, at Cornerstone’s option, Chiesi shall be responsible for the Recall decision, notification documented out-of-pocket expenses of Regulatory Authorities, such recall or return and shall either (i) reimburse Cornerstone for the Recall strategy and generation price that Cornerstone paid to Chiesi for manufacturing the Product which are the subject of the final Recall letter. During recall, including the period actual costs incurred in which the Warehouse Services Agreement is in effectshipping, if anyapplicable transit charges, GENERICO will be responsible for executing the Recallinsurance premiums, reconciling Productduties, preparing and submitting Recall status reports and termination requests to applicable Regulatory Authorities with respect to Recall of the Product and taxes paid or 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 other out-of-pocket charges incurred by GENERICO (with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA in connection with delivery of such RecallProduct 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. Each 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 Parties will reasonably cooperate with affected Product, and pay or provide a credit to Cornerstone for the actual administrative expenses and all other Party reasonable costs incurred by Cornerstone outside of the ordinary course of business 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 Producta Product under this Section 5.16.

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 takes similar action in connection with any Product or Pipeline in the event NxStage determines an event, incident or circumstance with respect to a Product is recalled other than as has occurred that results in the need for a result of GENERICO’s gross negligence, bad faith, intentional misconduct or intentional breach of this Agreement recall (or for which the liability would exceed the limitations set forth in Section 12.9each a “Product Recall”), then NEW ALPHA NxStage shall bear all of the costs and expenses promptly notify Customer within [**] of such governmental agency or authority request or action or of NxStage’s decision to voluntarily institute a Product 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 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 hereunder 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 in part the responsibility 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 GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein[**] consecutive months (for purposes hereof, then the expenses a purchased Cycler or PureFlow SL shall not be unusable if it can be used with other non-NxStage products, consistent with then-current product labeling), NxStage shall be allocated in an equitable manner between obligated to pay Customer and the Parties. 8.4 If the Parties are unable to mutually agree on the source cause of the Recall Authorized Customer Locations actual damages within 5 [**] days of the event causing 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 or any significant portion of, the purchase price of any Cyclers and/or PureFlow SLs that have been the subject of a Product Recall (and where such refund is specifically provided solely in connection with, and due to, such Product Recall) to any other customer or group of customers that has purchased such Cyclers and/or PureFlow SLs for the treatment of chronic home hemodialysis patients (it being understood that Customer’s and the Authorized Customer Locations’ right to damages hereunder shall not be so accelerated if such refund involves no more than [**] Cyclers and/or PureFlow SLs in the aggregate across all other NxStage chronic customers). No other remedy shall be provided to Customer or any Authorized Customer Location in connection with a Product Recall, such dispute will be resolved in the same manner except as set forth in Section 6.2. The fees and expenses 22 of the testing entity making Agreement. In the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition event NxStage elects to obtain recall insurance covering a Product Recall of any Recalled Productpurchased 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 $200,000. Any recall insurance obtained by NxStage, shall name Customer and the Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such policy shall offset any damages determined to be owed to Customer or any Authorized Customer Location hereunder pursuant to the foregoing terms, with NxStage obligated to pay any remainder pursuant to the terms hereof. If, during the Term, NxStage contractually agrees with one or more other customers purchasing any of NxStage’s home hemodialysis products in the continental United States to provide [**] provisions to such customer(s) that are more favorable to such customer(s) than are set forth in Section [**] of the Agreement and Sections [**] of this Schedule C, NxStage agrees that it shall promptly offer such [**] provisions to Customer, on a prospective basis; provided that such terms shall be offered to Customer to cover only [**] purchased by Customer and the Authorized Customer Locations which corresponds with the [**] purchased by [**] and provided further that such terms, if accepted by Customer, shall in no way alter the other provisions hereof.

Recalls. 8.1 Each Party shall promptly notify In the other if event (i) any Agency issues a directive, order or, following the issuance of a safety warning or alert with respect to a product, a written request that any Product be recalled, (ii) a court of competent jurisdiction orders such Party believes that a recall, withdrawal or field correction (eachiii) Cornerstone determines that any Product should be recalled or that a “dear doctor” letter is required relating 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 have the responsibility for handling customer returns of the Product. Chiesi shall provide Cornerstone or its designated agent with 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 “Recall”failure by Chiesi (or its contract manufacturer) of to manufacture and supply the Product or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA in accordance with the Specifications, Applicable Laws and/or cGMP, at Cornerstone’s option, Chiesi shall be responsible for the Recall decision, notification documented out-of-pocket expenses of Regulatory Authorities, such recall or return and shall either (i) reimburse Cornerstone for the Recall strategy and generation price that Cornerstone paid to Chiesi for manufacturing the Product which are the subject of the final Recall letter. During recall, including the period actual costs incurred in which the Warehouse Services Agreement is in effectshipping, if anyapplicable transit charges, GENERICO will be responsible for executing the Recallinsurance premiums, reconciling Productduties, preparing and submitting Recall status reports and termination requests to applicable Regulatory Authorities with respect to Recall of the Product and taxes paid or 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 other out-of-pocket charges incurred by GENERICO (with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA in connection with delivery of such RecallProduct 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. 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 Additionally, Chiesi shall reimburse or any Pipeline Product credit Cornerstone for any periods that are required out-of-pocket costs paid by any Legal Requirements. Note: Redacted portions have been marked with (Cornerstone to Third Parties for transportation and [***). The redacted ] Confidential portions are subject to a request for confidential treatment that has of the exhibit have been omitted and filed separately with the Securities and Exchange CommissionCommissions. 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 IDEC shall notify Nordion promptly notify if the other if such Party believes that Labelled Drug is the subject of a recall, market withdrawal or field correction (eachand IDEC [CONFIDENTIAL TREATMENT REQUESTED] shall have sole responsibility for the handling and disposition of such recall. IDEC [CONFIDENTIAL TREATMENT REQUESTED] shall bear the costs of any recall of Labeled Drug unless and to the extent such recall shall have been the result of Nordion's employees or agents, a “Recall”) of the Product acts or omissions or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA shall be responsible for the Recall decisiondefects in Isotope to meet Specification, 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 effectcase Nordion shall [CONFIDENTIAL TREATMENT REQUESTED]: (i) [CONFIDENTIAL TREATMENT REQUESTED], (ii) [CONFIDENTIAL TREATMENT REQUESTED], 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 and (as defined in the Warehouse Services Agreementiii) 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[CONFIDENTIAL TREATMENT REQUESTED]. In the event that any Product Nordion disputes IDEC's determination that the 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 Pipeline Product is recalled other than as a result dissent from IDEC's determination. If the consulting firm confirms IDEC's determination, Nordion will pay the fees of GENERICO’s gross negligencesuch consulting firm. If the consulting firm dissents from IDEC's determination, bad faith, intentional misconduct or intentional breach of this Agreement (or for which Nordion will not have the liability would exceed the limitations obligations set forth in Section 12.9), then NEW ALPHA shall bear all herein with respect to the recall and IDEC will pay the fees of such consulting firm. The decision 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 consulting firm shall be allocated in an equitable manner between final and the Partiesprovisions of 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 adequately administer a recall. 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 promptly will notify the other if such Party believes promptly following the first Party’s determination that any event, incident, or circumstance has occurred that may result in the need for a recall, withdrawal or field correction (eachincluding the dissemination of relevant information) of the Product. To the extent possible, such Party will include in such notice the reasoning behind such determination, and any supporting facts. The Parties shall cooperate to gather information required to assess and discuss the situation. If a recall, withdrawal or correction (including the dissemination of relevant information) of any Product in a Party’s Territory is mandated by a Regulatory Authority, or if a Regulatory Authority requires or advises a Party or its Affiliates or licensees or Sublicensees (as applicable) to disseminate a “Dear Healthcare Provider” letter or its equivalent regarding use of any Product in such Party’s Territory (any such recall, withdrawal, correction, or dissemination of information shall be referred to herein as a “Mandatory Recall”) or if a recall, withdrawal or correction of a Product in a Party’s Territory is deemed advisable by either Party (“Voluntary Recall”), such Party shall so notify the Product other Party immediately and promptly confirm such notice in writing. Otsuka will initiate, control and manage any Mandatory Recall in the Otsuka Territory, as mandated by the applicable Regulatory Authority, and any Voluntary Recall in the Otsuka Territory that Otsuka deems advisable in its sole discretion, in each case in compliance with Applicable Law. If Aurinia notifies Otsuka that Aurinia deems it advisable to implement a Voluntary Recall in the Otsuka Territory, then promptly after Aurinia provides such notice, each Party’s quality, safety, compliance, or regulatory affairs personnel with authority to make product recall decisions on behalf of such Party (the “Recall Decision-Makers”) will discuss and attempt to agree on whether or not to implement such Voluntary Recall in the Otsuka Territory, and if the Parties’ Recall Decision-Makers fail to agree within a reasonably appropriate time period (depending upon the circumstances), Otsuka will have the right to decide whether or not to implement such Voluntary Recall in the Otsuka Territory; provided that if Aurinia’s Recall Decision-Makers determine, and provide information to Otsuka’s Recall Decision-Makers supporting such determination, that a Voluntary Recall should be carried out in the Otsuka Territory for health or safety reasons or other “for cause” reasons (such as the commencement or requirement to commence a Mandatory Recall in the Aurinia Territory) and if Otsuka nonetheless decides not to implement such Voluntary Recall in the Otsuka Territory, Otsuka shall indemnify and hold harmless Aurinia from and against any Losses that may result thereafter from Otsuka’s failure to implement such Voluntary Recall despite Aurinia’s determination that such Voluntary Recall should be carried out in the Otsuka Territory. In connection with any Mandatory Recall in the Otsuka Territory or any Pipeline Product Voluntary Recall that Otsuka’s undertakes in the Otsuka Territory, Aurinia shall provide Otsuka with such assistance as may be necessary reasonably requested by Otsuka and in any Voluntary Recall 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 Mandatory Recall, reconciling Product, preparing each Party shall conduct such activities in coordination 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 collaboration with the other Party Party, in connection with any Recall. Each Party will maintain complete and accurate Recall records relating a manner that enables both Parties 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 comply with all required Applicable Laws and requests and mandates from any Regulatory Authorities, customer credits as expeditiously as possible. [Terms 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 Partiescost-sharing redacted. 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 Fisiopharma and Zavante will each maintain records necessary to permit voluntary and involuntary recalls or other related actions of Finished Drug Product delivered by Zavante to its customers (collectively, “Recalls”). Each Party shall will promptly notify the other if such Party believes that a recall, withdrawal or field correction by telephone (each, a “Recall”to be confirmed in writing) of any information which might affect the marketability, safety 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, Fisiopharma will stop making any Pipeline Product further shipments of any Bulk Drug Vials in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. Zavante will have the responsibility for handling customer returns of the Finished Drug Product, and Fisiopharma will give Zavante any assistance that Zavante may be necessary or advisablereasonably require to handle any such returns. 8.2 NEW ALPHA shall be responsible for the 10.2.1 The decision to initiate a 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 effector to take some other corrective action, if any, GENERICO will be responsible for executing made and implemented by Zavante. As used herein, the term, “Recall, reconciling Product, preparing and submitting Recall status reports and termination requests ” will include any action (i) by Zavante to applicable Regulatory Authorities with respect recover title to Recall or possession of quantities of the Finished Drug Product and sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Finished Drug Product from the market); or (ii) by any Pipeline regulatory authorities to detain or destroy any of the Finished Drug Product. Following termination Recall will also include any action by either Party to refrain from selling or shipping quantities of the Warehouse Services Agreement, NEW ALPHA will be responsible for all Recall activities with respect Finished Drug Product 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 third parties which would have been marked with (***). The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange CommissionRecall if sold or shipped. 8.3 In 10.2.2 lf (i) any Regulatory Agency issues a directive, order or, following the event that it is determined issuance of a safety warning or alert about the Finished Drug Product, a written request that any Finished Drug Product or Pipeline Product is recalled as should be Recalled, (ii) a result court 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 competent jurisdiction orders a 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 (iii) Zavante determines that any Finished Drug Product should be Recalled or Pipeline Product that a “Dear Doctor” letter 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 required relating 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 restrictions 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 use of any Recalled Finished Drug Product, Fisiopharma will co-operate as reasonably required by Zavante, having regard to all Applicable Laws.

Recalls. 8.1 Each (a) Prior to the applicable YUTIQ IND and NDA Transfer Effective Date, the following terms and conditions shall apply: (i) if either Party shall promptly notify the other if such Party believes [***] has determined that a recall, withdrawal or field correction other form of market action is advisable or necessary with respect to YUTIQ in the U.S., then EyePoint shall initiate such recall, withdrawal or other form of market action, and shall communicate with the FDA with respect thereto (eachas approved by Alimera); provided, that prior to initiating a “Recall”) of the Product voluntary recall, withdrawal or any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA shall be responsible for other form of market action with respect to YUTIQ in the Recall decision, notification of Regulatory AuthoritiesU.S., the Recall strategy Parties shall [***] as to whether to initiate any such recall, withdrawal or other form of market action, and generation of (ii) Alimera shall have the final Recall letter. During 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 period Field in which the Warehouse Services Agreement is in effect, if any, GENERICO will be responsible for executing Ex-U.S. Licensed Territory and the Recall, reconciling Product, preparing and submitting Recall status reports and termination requests sole right to communicate with applicable Regulatory Authorities with respect thereto. Alimera shall be responsible for taking all actions necessary to Recall of effect any recall, withdrawal or market action concerning YUTIQ in the Product Field in the Licensed Territory that occurs during the Term, and any Pipeline Product. Following termination of the Warehouse Services Agreement, NEW ALPHA will shall 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 costs incurred by GENERICO (with the consent of NEW ALPHA not to be unreasonably withheld) and NEW ALPHA in connection with such Recalltherewith except as provided under the Commercial Supply Agreement. Each At Alimera’s request, without limitation of any obligations of the Parties under the Commercial Supply Agreement, EyePoint will reasonably cooperate with the other Party in connection with Axxxxxx at Axxxxxx’s cost regarding Axxxxxx’s handling of any Recall. Each Party will maintain complete and accurate Recall records relating to the Product recalls, withdrawals 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 Commissionsimilar market actions. 8.3 In (b) From and following 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 applicable YUTIQ IND and expenses of such Recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, customer credits for recalled stockNDA Transfer Effective Date, the cost of notifying customers following terms 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 conditions 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 apply: As 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 Alimera shall have the final determination over 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 disposition Field in the Licensed Territory, and the sole right to communicate with Regulatory Authorities with respect thereto. As between the Parties, Axxxxxx 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 Recalled Productobligations of the Parties under the Commercial Supply Agreement, EyePoint will cooperate with Axxxxxx at Axxxxxx’s cost regarding Axxxxxx’s handling of any recalls, withdrawals or similar market actions. (c) As between the Parties, Axxxxxx shall have final decision-making authority to determine if a recall, withdrawal or other form of market action is advisable or necessary with respect to any Product in the Field in the Licensed Territory other than YUTIQ, and the sole right to communicate with Regulatory Authorities with respect thereto. Alimera shall be responsible for taking all actions necessary to effect any recall, withdrawal or market action concerning such Products that occurs during the Term, and shall be responsible for all costs incurred in connection therewith.

Recalls. 8.1 Each Party shall promptly notify From time to time throughout the other if such Party believes that a recallTerm, 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 AASTROM mxx xn its discretion determine that it is determined necessary or advisable to recall Cell Cassettes manufactured by MOLL. In such event, if AASTROM reasonably determines that any Product the numbex xx reported incidence of defective Cell Cassettes is high in relation to AASTROM's historical incidence rate for defective Cell Cassettes and/or general medical product industry standards and AASTROM recalls one or Pipeline Product is recalled as more Shipment Lots due to a result failure of GENERICO’s gross negligencesuch units to meet Specifications during the Warranty Period, bad faith, intentional misconduct or intentional breach of this Agreement, then GENERICO AASTROM shall bear all so notify MOLL of the costs recall and expenses the Parties shall jointly exchange relevant ixxxxmation and consult on causation of such Recall, including without limitation expenses related the defective units prior to communications and meetings with all required Regulatory Authorities, customer credits for recalled stock, implementing 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 12.8recall. In the event it is determined by the Parties that any Product the Cell Cassettes were defective due to a failure of such units to meet Specifications during the Warranty Period, MOLL agrees to reimburse AASTROM for the reasonable direct costs incxxxxd by AASTROM in conjunction with the recall including the cost of replacing, shipping and testing the units of the Shipment Lot(s) recalled, whether or Pipeline Product is recalled other than not all such units are ultimately determined to have been defective, by way of a reduction in MOLL's applicable mark-up rates (as set forth on Appendix III) to 15% xxxxl the cost ox xxe recall has been recovered by AASTROM. Any disputes regarding causation of defective units involved in a result of GENERICO’s gross negligencerecall that cannot be resolved by the Parties will be resolved through arbitration in accordance with Section 24(b). Furthermore, bad faith, intentional misconduct or intentional breach of in the event this Agreement (is terminated for any reason prior to AASTROM recovering the full amount of its recall costs from MOLL, MOLL shall promptly pay to AASTROM the amount of any un-reimbuxxxx cxxxx. For the purpose of clarification, it is agreed that AASTROM shall be solely responsible for determining whether any product recall, correction or withdrawal is required and for which the liability would exceed the limitations set forth in Section 12.9), then NEW ALPHA shall bear complying with all of the costs and expenses of such Recall, including without limitation expenses related medical device reporting requirements pursuant 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 Parties21 CFR Part 803. 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 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 takes similar action in connection with any Product or Pipeline in the event NxStage determines an event, incident or circumstance with respect to a Product is recalled other than as has occurred that results in the need for a result of GENERICO’s gross negligence, bad faith, intentional misconduct or intentional breach of this Agreement recall (or for which the liability would exceed the limitations set forth in Section 12.9each a “Product Recall”), then NEW ALPHA NxStage shall bear all of the costs and expenses promptly notify Customer within [**] of such governmental agency or authority request or action or of NxStage’s decision to voluntarily institute a Product 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 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 hereunder 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 in part the responsibility 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 GENERICO as described herein and in part the responsibility of NEW ALPHA as described herein[**] consecutive months (for purposes hereof, then the expenses a purchased Cycler or PureFlow SL shall not be unusable if it can be used with other non-NxStage products, consistent with then-current product labeling), NxStage shall be allocated in an equitable manner between obligated to pay Customer and the Parties. 8.4 If the Parties are unable to mutually agree on the source cause of the Recall Authorized Customer Locations actual damages within 5 [**] days of the event causing 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 or any significant portion of, the purchase price of any Cyclers and/or PureFlow SLs that have been the subject of a Product Recall (and where such refund is specifically provided solely in connection with, and due to, such Product Recall) to any other customer or group of customers that has purchased such Cyclers and/or PureFlow SLs for the treatment of chronic home hemodialysis patients (it being understood that Customer’s and the Authorized Customer Locations’ right to damages hereunder shall not be so accelerated if such refund involves no more than [**] Cyclers and/or PureFlow SLs in the aggregate across all other NxStage chronic customers). No other remedy shall be provided to Customer or any Authorized Customer Location in connection with a Product Recall, such dispute will be resolved in the same manner except as set forth in Section 6.2. The fees and expenses 22 of the testing entity making Agreement. In the determination will be paid by the Party against which the determination is made. NEW ALPHA shall have the final determination over the disposition event NxStage elects to obtain recall insurance covering a Product Recall of any Recalled Productpurchased 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 $200,000. Any recall insurance obtained by NxStage, shall name Customer and the Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such policy shall offset any damages determined to be owed to Customer or any Authorized Customer Location hereunder pursuant to the foregoing terms, with NxStage obligated to pay any remainder pursuant to the terms hereof. If, during the Term, NxStage contractually agrees with one or more other customers purchasing any of NxStage’s home hemodialysis products in the continental United States to provide [**] provisions to such customer(s) that are more favorable to such customer(s) than are set forth in Section [**] of the Agreement and Sections [**] of this Schedule C, NxStage agrees that it shall promptly offer such [**] provisions to Customer, on a prospective basis; provided that such terms shall be offered to Customer to cover only [**] purchased by Customer and the Authorized Customer Locations which corresponds with the [**] purchased by [**]; and provided further that such terms, if accepted by Customer, shall in no way alter the other provisions hereof. 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) it has not entered into any agreement which conflicts with the terms and conditions of the Agreement and that it will not do so during the Term, and (b) it shall not enter into any distributorship agreement or other similar agreement with any third party covering the sale, rental, licensing, leasing or distribution of the System One for chronic home hemodialysis in the Continental United States and Hawaii, except where any such agreements are consistent with the terms and conditions of the Agreement.

Recalls. 8.1 Each Party shall promptly notify From time to time throughout the other if such Party believes that a recallTerm, withdrawal or field correction (each, a “Recall”) of the Product or any Pipeline Product AASTROM 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 its ------- discretion determine that it is determined necessary or advisable to recall Cell Cassettes manufactured by MSP. In such event, if AASTROM reasonably determines that any Product the number of reported incidence of defective Cell Cassettes is high in relation to AASTROM's historical incidence rate for defective Cell Cassettes and/or general medical product industry standards and AASTROM recalls one or Pipeline Product is recalled as more Shipment Lots due to a result failure of GENERICO’s gross negligencesuch units to meet Specifications during the Warranty Period, bad faith, intentional misconduct or intentional breach of this Agreement, then GENERICO AASTROM shall bear all so notify MSP of the costs recall and expenses the Parties shall jointly exchange relevant information and consult on causation of such Recall, including without limitation expenses related the defective units prior to communications and meetings with all required Regulatory Authorities, customer credits for recalled stock, implementing 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 12.8recall. In the event it is determined by the Parties that any Product 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 Pipeline Product is recalled other than not all such units are ultimately determined to have been defective, by way of a reduction in MSP's applicable xxxx-up rates (as set forth on Appendix III) to 15% until the cost of the recall has been recovered by AASTROM. Any disputes regarding causation of defective units involved in a result of GENERICO’s gross negligencerecall that cannot be resolved by the Parties will be resolved through arbitration in accordance with Section 24(b). Furthermore, bad faith, intentional misconduct or intentional breach of 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, correction or withdrawal is required and for which the liability would exceed the limitations set forth in Section 12.9), then NEW ALPHA shall bear complying with all of the costs and expenses of such Recall, including without limitation expenses related medical device reporting requirements pursuant 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 Parties21 CFR Part 803. 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 In the event Purchaser believes a Recall may be necessary with respect to a Product, Purchaser shall promptly immediately notify the other if such Party believes that Vendor in writing within [**]. Vendor may at its sole discretion require Purchaser to take part in a recall, withdrawal withdrawal, customer notification or field correction (eachaction 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 Recall”) , Purchaser shall, upon Vendor’s request, contact the Purchaser’s customers of the affected Product, assist in arranging for return shipment of the Product or to Vendor, and distribute any Pipeline required notifications. Vendor’s sole liability relating to a Recall is to replace Product may that is recalled with conforming Product and will be necessary or advisable. 8.2 NEW ALPHA responsible for all reasonable expenses incurred by the Purchaser in the Territory that are related to the Recall. Vendor shall be responsible for the Recall decision, notification expenses of Regulatory Authorities, the Recall strategy and generation of the final Recall letter. During the period unless such actions result from Purchaser’s negligence or willful misconduct, in which case the Warehouse Services Agreement is in effect, if any, GENERICO will Purchaser shall 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 Productthose expenses. 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 For purposes 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 will be the reasonable direct expenses of notification and return or destruction of the event causing recalled Products, Vendor’s cost to replace or refund the Recall, such dispute will be resolved in the same manner as set forth in Section 6.2. The fees and expenses price of the testing entity making recalled Product and any costs directly associated with distribution of replacement Products. In all cases, the determination will be paid by Purchaser shall conduct the Party against Recall in a manner which is appropriate and reasonable under the determination is madecircumstances and in conformity with accepted trade practices and applicable law. NEW ALPHA Purchaser shall have the final determination over the disposition deliver copies of any Recalled Productall Recall-related records to Vendor within [**] of Purchaser receiving or preparing them.

Recalls. 8.1 Each Party 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 copy of any regulatory correspondence related to field alerts or 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 other if such Party believes that a FDA, DEA, and 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. XANODYNE acknowledges and understands that DSM, notification of Regulatory Authorities, the Recall strategy and generation as manufacturer 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 has significant regulatory obligations if there are any indications that recall or withdrawal would be necessary. Accordingly, DSM and submitting Recall status reports XANODYNE agree to cooperate fully regarding any proposed recall, product withdrawal, or field correction; 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 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 party, either party may, in connection with any Recall. Each Party will maintain complete and accurate Recall records relating exigent circumstances, make a unilateral, final decision 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 notify appropriate regulatory agencies, 27 DISPUTE RESOLUTION In the event that it is 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 that any 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 or Pipeline Product is recalled as a result of GENERICO’s gross negligenceREVIEW [**] [**] APPENDIX II: CONTACT INFORMATION XANODYNE KEY CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- --------- ---------------------- -------------- G. Xxxxx Xxxxx Director, bad faith859-547- 859-814- General Quality xxxxxx@xxxxxxxx.xxx Quality 0000 0000 (cell) Assurance Xxxxxx X. Xxxxx Manager, intentional misconduct or intentional breach 859-547- 859-992- General Quality xxxxxx@xxxxxxxx.xxx Quality 00000 0000 (cell) Assurance OSM Key CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- ----------------- ------------------------ -------------- Xxxxxx XX, Quality Ph: 000-000-0000 General Quality Norton Assurance xxxxxx.xxxxxx@xxx.xxx Xxx Xxxxx Director, Quality Ph: 000-000-0000 rob. Manufacturing Assurance xxxxx@dsm. com Oversight Xxxxx Xxxxxxxxxx Director, Quality Ph: 000-000-0000 Lab Oversight Assurance xxxxx.xxxxxxxxxx@xxx.xxx Will Mitten Director, Lab Ph: 000-000-0000 Lab Services Services xxxx.xxxxxx@xxx.xxx Xxxx Xxxxxxxx Manager, Ph: 000-000-0000 xxxx. Stability Stability xxxxxxxx @dsm. com Xxxx Manager, Quality Ph: 000-000-0000 APRs, Complaints, Xxxxxxx Assurance xxxx.xxxxxxx@xxx.xxx Audits, APPENDIX III: PRODUCTS DARVOCETN-100 QUALITY AGREEMENT HISTORY OF CHANGES VERSION DATE NAME REVISIONS/COMMENTS ------- ---- ---- ------------------ EXHIBIT D: CONFIDENTIALITY AGREEMENT 1. During the term of this Agreement, then GENERICO 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 bear all 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 costs Disclosing Party's disclosure and expenses 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 Recalldisclosure, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, customer credits it: (a) shall use The Disclosing Party's Proprietary Information exclusively 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 limited purposes set forth in Section 12.9)the first numbered paragraph hereof; and (b) shall not disclose, then NEW ALPHA shall bear all without the express written consent of the costs 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 expenses 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 RecallProprietary Information, 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 customersbut no less than reasonable precautions. 5. In the event that the reason for Receiving Party becomes compelled to disclose any Recall Proprietary Information, it will provide the Disclosing Party with 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 of Product hereunder the foregoing, the term "Proprietary Information" and the obligation of confidentiality associated therewith shall not apply to the following information: (a) information which, at the time of the Disclosing Party's disclosure to the Receiving Party, is in part the responsibility 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 GENERICO the Receiving Party's breach of this Agreement or otherwise is the result of any unauthorized disclosure by any of its employees; (c) information which, prior to the Disclosing Party's disclosure to the Receiving Party, was already in the Receiving Party's possession; (d) information which, 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 possession of such information and not subject to a contractual or fiduciary relationship to the Disclosing Party with respect thereto or (e) 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 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 the Receiving Party or any of its employees in addition to whatever remedies it might have at Law. In addition, the Receiving Party shall indemnify the Disclosing Party from any loss or harm, including, 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 breach of which it becomes aware. MANUFACTURING AND SUPPLY AGREEMENT PRODUCT SCHEDULE PRODUCT SCHEDULE TO MANUFACTURING AND SUPPLY AGREEMENT (the "Supply Agreement") DATED JANUARY 26, 2004 AND ORIGINALLY EXECUTED BY DSM PHARMACEUTICALS ("Manufacturer") AND AAIPHARMA LLC ("AAI") This Product Schedule, effective as described herein of January 26, 2004, supplements the Supply Agreement by, among other things, identifying a particular Product, the purchase and in part the responsibility sale of NEW ALPHA as described herein, then the expenses which shall be allocated in an equitable manner between governed by the Parties. 8.4 If the Parties are unable to mutually agree on the source cause terms of the Recall within 5 days of the event causing the Recall, such dispute will be resolved in the same manner Supply Agreement 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 Productwell as this Schedule.

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 9.1. Product recalls and FDA contacts relating to recall of Product shall be the responsibility of, and under the control of, OMEROS. 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 if such Party believes that a Governmental Authorities, as appropriate, 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. DSM and OMEROS acknowledge that each Party has significant regulatory obligations; and accordingly, 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 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 accordance with the terms of this Agreement. 9.2. OMEROS shall give DSM prompt written notice of any Recall. Each Party will maintain complete and accurate Recall records relating to the Product recalls that OMEROS believes were caused or any Pipeline Product for any periods that are required by any Legal Requirements. Note: Redacted portions may have been marked caused by DSM’s failure to comply with (***)this Agreement or the Specifications. 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 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 4.2.6 and 12.8. In the event that any Product or Pipeline Product is recalled other than 5.5, DSM shall promptly reimburse OMEROS for its reasonable expenses incurred as a result of GENERICO’s gross negligencesuch recall, bad faithand, intentional misconduct or intentional breach of at OMEROS’ election, either refund OMEROS for any amounts paid and cancel any amounts payable pursuant to outstanding Purchase Orders under this Agreement (or for which relating 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 replace the recalled Product from customers 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 event, OMEROS shall have the right to suspend Monthly Forecasts for the Product that is the subject of the recall and shipment neither Party shall be subject to Firm Purchase Commitments related to the recalled Product until the cause of an equal amount of replacement Product to those customerssuch recall has been identified and a corrective action plan mutually agreed upon by OMEROS and DSM has been implemented. 9.3. In the event that the reason The Party responsible for any Recall causing a recall of Product hereunder is in part shall bear 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 recall. If each Party is partially responsible for causing the determination 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 period of [†], (b) a period of [†] and (c) such other period as required by Applicable Law. Subject to Sections 9.1, 9.2 and 9.3, OMEROS shall in all events be paid by the Party against which the determination is maderesponsible for conducting any recalls of Product. NEW ALPHA shall have the final determination over the disposition of any Recalled Product.† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

Recalls. 8.1 Each Party (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 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 in the GSK Territory in accordance with Section ‎5.2 and the Commercialization Transition Plan and subject to the terms and conditions herein, Scynexis shall promptly notify have the other if such Party believes that sole right to determine whether and how to implement a recall, suspension, removal or other market withdrawal of any commercial Product in the GSK Territory; provided that Scynexis shall consult with GSK on any such decision to implement a recall, suspension, removal or field correction (eachother market withdrawal and shall consider any recommendation of GSK in good faith. With respect to any Product sold by Scynexis under a NDA in accordance with the Commercialization Transition Plan following the Effective Date, a “Recall”) GSK shall reimburse Scynexis for all costs and expenses related to any recall, suspension, removal or 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 any Regulatory Authority in the GSK Territory that are existing as of the Product date hereof, that are held in the name of, or otherwise Controlled by, Scynexis or any Pipeline Product may be of its Affiliates and that are necessary or advisableuseful 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, GSK shall have the sole right to determine whether and how to implement a recall, suspension, removal or other market withdrawal of any commercial Product in the GSK Territory. 8.2 NEW ALPHA shall be responsible for (b) From the Recall decisionEffective Date until the date on which Scynexis assigns to GSK all right, notification of title and interest in and to all relevant INDs granted by any Regulatory Authorities, Authority in the Recall strategy and generation GSK Territory that are existing as of the final Recall letterdate 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 market withdrawal of any clinical Product in the GSK Territory; provided that Scynexis shall consult with GSK on any such decision to implement a recall, suspension, removal or other market withdrawal and shall consider any recommendation of GSK in good faith. 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 With respect to Recall 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 Scynexis for all costs and expenses related to a recall, suspension, removal or 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 any Regulatory Authority in the GSK Territory that are existing as of the Product and any Pipeline Product. Following termination of the Warehouse Services Agreementdate hereof, 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 are held in the Warehouse Services Agreement) by GENERICO. In either casename of, NEW ALPHA shall (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 Section 8.3the terms and conditions herein, GSK shall have the sole right to determine whether and how to implement a recall, suspension, removal or other market withdrawal of any clinical Product in the GSK Territory. (c) bear all expenses incurred by GENERICO Each Party, to the extent possible, (with the consent of NEW ALPHA not i) shall provide notice to be unreasonably withheld) and NEW ALPHA in connection with such Recall. Each of the Parties will reasonably cooperate with the other Party, 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 that any Regulatory Authority issues or requests a recall or takes a similar action in connection with any Recall. Each Product in its respective Territory, or in the event such Party will maintain complete determines that an event, incident or circumstance has occurred that may result in the need for a recall, suspension, removal or other market withdrawal of a Product in its respective Territory, and accurate Recall records (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 the Product any such recall, suspension, removal 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 Commissionother market withdrawal. 8.3 In (d) Except as may otherwise be agreed to by the event that it is determined that any Product or Pipeline Product is recalled as a result of GENERICO’s gross negligenceParties in writing, bad faith, intentional misconduct or intentional breach of this Agreement, then GENERICO each Party 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 expense of any Recalled Productsuch recall, suspension, removal or other market withdrawal in its own Territory.

Recalls. 8.1 Each Party BII or its Affiliates shall use reasonable efforts to notify Epizyme promptly notify following its determination that any event, incident, or circumstance has occurred that may result in the other if need for a recall, market suspension, or market withdrawal of a Joint Product in the Territory and shall include in such Party believes notice the reasoning behind such determination, and any supporting facts. BII (or its Affiliates or Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Territory. If a recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, then BII (or its Affiliates or its Sublicensee) 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 Section 5.4 (Recalls), BII (or its Affiliates or Sublicensee) responsible for the recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof and Epizyme shall reasonably cooperate in all such recall efforts. Subject to ARTICLE 12 (Indemnity), (a) in the event that a recall, market suspension or market withdrawal resulted from a Party’s or field correction 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, (eachb) with respect to any other recall, a “Recall”) market suspension or market withdrawal of the Joint Product in the U.S., 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 resolved pursuant to Section 5.2.2(a)(iv) (Allocation) and (c) with respect to any Pipeline Product may be necessary recall, market suspension or advisable. 8.2 NEW ALPHA market withdrawal not covered by clause (a) or (b), BII 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 Recallrecall, 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 market suspension 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 Partiesmarket withdrawal. 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 promptly notify Principal may cease selling the other 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 such Party believes that a recall, withdrawal or field correction (each, a “Recall”) any of the Product or below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Pipeline Product may be necessary or advisable. 8.2 NEW ALPHA shall be responsible for Country/Region in the Recall decision, notification of Regulatory Authorities, the Recall strategy and generation Territory: unforeseen effects of the final Recall letterrelative 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. 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 The Distributor undertakes with respect to Recall any product recall that: (i) it will implement and complete the recall of the Product 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 Pipeline Productof the Products from any of the Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following termination of the Warehouse Services Agreementdecision to implement a Recall, NEW ALPHA will be responsible Principal and Distributor shall mutually agree on a prepared statement for all Recall activities with respect use in response 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 inquiries regarding such Recall. Each 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 Parties will reasonably cooperate with the other Party in connection with any statement as proposed by Principal regarding such Recall. Each Party will maintain complete and accurate Recall records relating To the extent the Products are recalled due to the Product or any Pipeline Product for any periods that are required by any Legal Requirements. Note: Redacted portions have been marked causes other than Distributor’s non-compliance 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 relevant obligations under this Agreement, then GENERICO Principal shall bear all of (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 such Recall, including without limitation expenses related to communications the same; and meetings with all required Regulatory Authorities, customer credits for recalled stock, (b) repurchase 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, Products that are subject to Sections 12.2 the Recall at the purchase price paid by the Distributor and 12.8. In the event that any Product or Pipeline Product is recalled other than as in addition pay Distributor 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 handling charge equal to 10% 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 customerspurchase price. In the event that the reason 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 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 Product hereunder such Recall, including Distributor's recall procedures, Distributor's records relating to the distribution and sales of the Recalled Products, Distributor's records relating to such Recall and the costs incurred by Distributor in connection with implementing such Recall. In the event of a Recall, the obligations of Distributor to sell the Recalled Products in the Territory and of Principal to supply such Recalled Products to Distributor pursuant to this Agreement shall be suspended with immediate effect and such obligations shall only become enforceable again if and when the circumstances that caused the Recall have been resolved. If the Recalled Products are thereafter totally withdrawn from the Territory for the remainder of the Term, then Principal may by written notice to Distributor terminate the Recalled Products from the Territory. The Distributor shall inform Principal immediately upon being informed about any defective products returned to the Distributor or detected in the Distributor's inventory. The Distributor shall inform Principal immediately about any complaint received. The Distributor shall be responsible for the collection and investigation of customers' complaints (whether the customers complain to the Distributor directly or forwarded by Principal and/or its Affiliates), and retain accurate records of such collections and investigations and maintain appropriate records during the Term. AUDIT RIGHTS AND REPORTING During the Term, Principal shall be entitled, through itself or an independent audit firm appointed by Principal (the "Independent Auditor"), to inspect and audit (i) such books, documents, papers and records which relate to sales of the Products or any costs and expenses invoiced or charged by Distributor to Principal in connection with this Agreement, (ii) Distributor's compliance with Clause 1817, and (iii) all facilities of Distributor in which Distributor performs its obligations under this Agreement and maintains inventory of the Products (an "Audit"). If an Audit reveals matters that Principal determines should be corrected by Distributor, Principal shall provide a list of such matters and may propose corrective action to be taken by Distributor. Distributor shall respond within 15 days of receipt of such notification indicating the corrective action to be taken and an estimated completion date. The Audit of any books, documents, papers or records that relate to or contain any information regarding any business dealings with or the affairs of any other client or principal of Distributor may only be conducted by the Independent Auditor. Such Independent Auditor shall (i) provide a copy of the audit report to Distributor no later than thirty (30) Business Days after such report is provided to Principal and (ii) disclose to Principal relevant necessary information to enable Principal to determine whether Distributor is in part the responsibility of GENERICO as described herein compliance with this Agreement or not, and in part any event shall never disclose to Principal any information regarding any business dealings with or the responsibility affairs of NEW ALPHA as described hereinany other client or principal of Distributor that such Independent Auditor may come across in the course of performing its audit under this provision, then 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 expenses 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 allocated 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 an equitable manner between this Agreement, shall at the Parties. 8.4 If 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 result of Audit demonstrates that Distributor fails to make due payment to Principal, or Distributor had breached any of its obligation under this Agreement, Distributor shall cure such breach within 30 days (in the case of a failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if Distributor fails to do so, Principal shall have the right to terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties are unable to mutually shall in good faith 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 a Safety Data Exchange Agreement (as set forth in Section 6.2Exhibit G) that sets out the responsibilities of each Party with respect to the pharmacovigilance matters relating to the Products as soon as practicable after the execution of this Agreement. The fees Parties shall in good faith agree on the Quality Agreement that sets out the responsibilities and expenses processes for quality activities with respect to supply, distribution and quality management relating to the Products as soon as practicable after the execution of this Agreement. INTELLECTUAL PROPERTY Principal warrants to Distributor that throughout the Term: it has and will continue to have full legal rights to use the Licensed Marks and to grant the use of the testing entity making Licensed Marks to Distributor; it has and will continue to have full legal rights to use the determination will be paid 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 Party against which rights and licences granted to Distributor under this Agreement (including the determination is made. NEW ALPHA shall have use of the final determination over Licensed Marks) and the disposition distribution, offer for sale and sale of the Products by Distributor would not infringe any right (including intellectual property rights) of any Recalled Productperson 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 not be limited by anything in this Agreement. Principal hereby authorises Distributor to 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 actual, threatened or suspected infringement in the Territory of the Licensed Marks or other intellectual property rights of Principal relating to the Products which comes to the notice of Distributor, and of any 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 person. Distributor shall provide such information and assistance to Principal as Principal may reasonably require in taking or resisting any proceedings in relation to any such infringement or claim. Distributor shall not: alter, remove or tamper with any of the Licensed Marks, numbers, or other means of identification used on or in relation to the Products; or use any of the Licensed Marks in any way which might prejudice their distinctiveness or validity or the goodwill of Principal therein; Distributor hereby acknowledges that, except as expressly provided in this Agreement, 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 Agreement.