Common use of Recalls Clause in Contracts

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, 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 such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make available to the Party having the first right to control such Recall all 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. In the event (Aa) The Parties shall exchange their internal standard operating proceduresany government authority issues a request, if anydirective or order that any Drug Product be recalled, as to product recalls or ("SOPs"b) a court of competent jurisdiction orders such a recall, or (c) Adams reasonably promptly determines after consultations with Cardinal that a Xxxx Product should be recalled because 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 Drug Product supplied from ViaCell to Amgen, which may does not conform to the specifications Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party Cardinal's and the Party having the right to control such a Recall 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 Adams' expenses of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make available recall to the Party having the first right to control extent 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 recall results from xxx xreach of Cardinal's warranties under this Agreement, ViaCell 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 have be responsible for all Adams' and Cardinal's expenses of xxx xecall to the exclusive right to control extent that such xxxxxl results from a Recall cause other than Cardinal's breach 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 its warranties under this Agreement, Amgen 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 have be responsible for the exclusive right expenses xx xxcall in direct proportion to control any Recall each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the Collaboration Products recall is directed at all products containing any of the active ingredients in the TerritoryDrug Product and where the purpose of such recall is not attributable to the fault of either Adams or Cardinal, Adams shall be responsible for all Adams and Cardixxx xxpenses of the xxxxll, PROVIDED, HOWEVER, THAT NEXXXXX PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. For the purposes of this Agreement, the expenses of recall shall conduct such a Recall at any time at which regulatory timeframes include, without limitation, the expenses of notification or public safety considerations so require. ViaCell destruction or return of the recalled Drug Product and Amgen shall each maintain complete Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and accurate records of any Recall it has shipping the right Drug Product that was later subject to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]recall.

Recalls. In the event: (Aa) The Parties 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 exchange their internal standard operating procedures, if any, as to product recalls ("SOPs") take all appropriate corrective actions 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 such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify requested by the other Party or any Applicable Regulatory Agency. Only Purchaser is authorized to conduct a recall of a Product. Supplier shall cooperate fully with Purchaser in the event of any such recall and provide such assistance in connection therewith as Purchaser may reasonably request. To the Party having extent such recall solely results from: (i) Supplier’s failure to properly and completely perform any covenant, agreement or undertaking on the right part of Supplier contained in this Agreement, including supply of Product that conforms to control such a Recall pursuant 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 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make available follow Applicable Laws 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 extent required under this Agreement, ViaCell then Supplier shall have be responsible for: (x) its own out-of-pocket costs for such recall; (y) Purchaser’s reasonable and documented out-of-pocket costs for such recall; and (z) replacing as soon as commercially practicable, at no cost or expense to Purchaser, Product that conforms to the exclusive right Specifications. If and to control a Recall the extent the recall results from any other reason, Purchaser shall be responsible for its costs of any Cell Therapy Products in the Territory, such recall and shall conduct Supplier’s reasonable and documented out-of-pocket costs for such a Recall at any time at which regulatory timeframes or public safety considerations so requirerecall. Other than with respect to any clinical studies conducted by ViaCell under For purposes of this Agreement, Amgen out-of-pocket costs of such recall shall have the exclusive right be all direct expenses incurred by either Party relative to control any Recall notification, shipping, disposal and return of the Collaboration Products in recalled or withdrawn Product, which shall include making Purchaser whole, subject to Section 16.3 (Limitation of Liability) on consumer returns of the Territory, and shall conduct such a Recall Product at any time at which regulatory timeframes or public safety considerations so requireretail. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has The Parties have the right to control pursuant to audit such recall costs. Purchaser shall be responsible for coordinating any and all such recall activities with the Regulatory Agencies, its customers or otherwise. Purchaser and Supplier shall agree on all public statements regarding any recall, and neither Party shall make any public statements regarding this Section 5.10 for such periods as may be required by legal requirementsAgreement without the Party’s prior, but in any event for no less than [**]written approval.

Recalls. (Aa) The Parties shall exchange their internal standard operating procedures, if any, procedures as to product recalls ("“SOPs"”) reasonably promptly after the Effective Date first filing of a Drug Approval Application for an Antibody Product and thereafter reasonably promptly after such SOPs are approved or modifiedmodified thereafter. If either Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to AmgenIn the event that, in a country, the Territorial Commercial Lead for such country determines that an event, incident or circumstance has occurred which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country result in the Territoryneed for a “recall” or “market withdrawal” or “stock recovery” (as such terms are defined in U.S. regulations in 21 CFR 7.3 or another similar national, it state or local law or regulation), hereinafter collectively referred to as a “Recall”, of Antibody Product or any lot(s) thereof, such Party shall promptly so notify the other Party and the Party having in writing. (b) The Territorial Commercial Lead shall have the right to control such determine whether and upon what terms and conditions to Recall the Antibody Product within its Lead Territory; provided however, if the Territorial Commercial Lead shall elect not to conduct a Recall pursuant of the Antibody Product, and solely if the other Party is responsible for the manufacture of Antibody Raw Material or Antibody Product in Finished Form, and the manufacture of Antibody Raw Material or Antibody Product in Finished Form is the basis of such proposed Recall, the other Party shall have the right to Section 5.10(b) may take [**] when the conduct such Recall if, in its good faith opinion, regulatory timeframes requirements or public safety considerations so require. In Prior to making any Recall decision in any part of its Territory, each Party shall consult with the other Party. The Territorial Commercial Lead shall be responsible for discussions with Regulatory Authorities within the applicable country regarding all other circumstances, Recalls can only be made by [**] consent aspects of the JSC Recall decision and the execution thereof. Any costs or expenses of any Recall in any part of the Territory shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b)Commercialisation Expense. 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell Celltech and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 Article 4.8 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. (Aa) The Parties shall exchange their internal standard operating procedures, if any, 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 Notwithstanding anything in this Agreement to the specifications for such Collaboration Productcontrary, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which JV shall have the Collaboration Product itself is alleged or proven right to be the subject manage any recall of a Recall in any country in Product within the Territory, it provided that JV shall promptly so notify consult with and receive the other Party and the Party having the right to control such a Recall 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 Approval of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action Medifocus with respect to a Recall shall be consistent with the internal SOP manner, process and timing of the Party having the first right actions to control be taken in connection with such Recall pursuant to Section 5.10(b)recall, and the other Party shall make available obligations of the parties in Sections 4.04(b) and (c) are subject 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 Recallright. (Bb) With 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 clinical studies conducted by ViaCell under this Agreementrecall or issuing any advisory letter regarding the manner, ViaCell shall have the exclusive right to control a Recall text and timing of any Cell Therapy Products publicity to be given such matters in the Territory, and shall conduct such a Recall at time to comply with any time at which applicable legal or 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but such agreement shall not be a precondition to implementing any action necessary to protect users of the Products or to comply with any applicable governmental orders or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. JV shall be solely responsible for the costs of effecting such recall or issuing such advisory letter, including costs related to return of recalled Products, provided, that if such recall or advisory letter result from a design defect in the Product, Medifocus shall be responsible for the costs of effecting such recall or advisory letter. (c) In the event for no less than [**]of a recall of any Product, JV shall correct or cause its manufacturers, as applicable, to correct any deficiency relating to the manufacturing, packaging, testing, labeling, storing or handling of such Product, if applicable, and shall, upon agreement with Medifocus, either, at JV’s cost (and seek reimbursement from Medifocus if such recall is due to a design defect of the Product), replace each unit of the Product recalled (including units held in inventory by JV or its customers) with a corrected Product within a reasonable period of time, or refund the purchase price therefor.

Recalls. Product recalls will be the responsibility of, and under the control of, Client. In the event that Hovione has reason to believe that any Product should be recalled or withdrawn from distribution, it will promptly inform Client in writing of such belief. Client will notify the appropriate Regulatory Authorities of any recall, if required under Applicable Law, and will be responsible for coordinating all necessary activities regarding the action taken. Hovione and Client will fully cooperate to complete the recall, and will thereafter resolve any allocation of liability as may be appropriate in accordance with the terms of this Agreement. The costs and expenses of conducting any recall will be treated as follows: (Aa) The Parties If any Product is recalled as a result of Hovione’s negligence or willful misconduct in Manufacture of the Product or failure to Manufacture Product in accordance with the Manufacturing Standards then, except to the extent the recall resulted from any failure of Client-Supplied Materials unless Hovione knew of, or should have known of a failure of the Client Supplied Materials to conform to the applicable Material Specifications, as a result the testing of Client-Supplied Materials the parties had mutually agreed in writing would be performed by Hovione as part of Services, *. In addition, in such event, Hovione, *, will promptly replace such rejected and recalled amounts with Product that conforms to the Product Specifications and is Manufactured in accordance with the Manufacturing Standards and shall exchange their internal standard operating proceduresreimburse Client for Material Loss in accordance with Section 6.6. Hovione’s total liability to Client under this Section 8.11 for each particular recall, market withdrawal or correction shall not exceed the aggregate Manufacturing Fees, if any, as paid by Client to product recalls ("SOPs") reasonably promptly after Hovione for the Effective Date and thereafter reasonably promptly after such SOPs are approved or modified. If either Party becomes aware total amount of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself that is alleged or proven to be the subject of a Recall in any country contained in the Territorydrug product that is recalled, it shall promptly so notify withdrawn from the other Party and the Party having the right to control such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes market or public safety considerations so requirecorrected. In all other circumstancesaddition, Recalls can only be made by [**] consent the limitations set forth in Section 14.4 hereof shall also apply to any liability of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Hovione under this 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 Recall8.11. (Bb) With respect If each Party contributes to any clinical studies conducted by ViaCell the cause for a recall, the amounts contemplated under paragraph (a) will be *; and (c) All recalls of Product supplied to Client under this Agreement, ViaCell shall have the exclusive right to control a Recall Agreement other than those described in clauses (a) or (b) will be at * sole expense. Client will give Hovione prompt written notice of any Cell Therapy Products in the Territory, and shall conduct such a Recall at any time at Product recalls for which regulatory timeframes Client believes Hovione has responsibility under Section 8.11(a) 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**](b).

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, as Any decision to product recalls ("SOPs") reasonably promptly after the Effective Date and thereafter reasonably promptly after such SOPs are approved initiate a recall or modified. If either Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject withdrawal of a Recall in any country Product or MDX-1379 in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall 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 Royalty Territory shall be made by the applicable Lead Regulatory Party, in consultation with the JEC, provided that if, as a result of patient safety concerns, there is not sufficient time for the JEC to meet, and in any event before the applicable Lead Regulatory Party having initiates a recall or withdrawal, the first Parties shall promptly and in good faith discuss the reasons therefor and the strategy for implementing any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and the non-Lead Regulatory Party shall have no right to control object to a Recall recall or withdrawal requested by the Lead Regulatory Party for failure of a Product to meet the Specifications, for material safety concerns, for the manufacture of such Product in a manner that does not comply with the Act or as requested by Regulatory Authorities. In the event of any recall or withdrawal, the Lead Regulatory Party shall take any and all necessary action to implement such recall or withdrawal in accordance with Applicable Law, with assistance from the non-lead Party as reasonably requested by the Lead Regulatory Party. The costs of any such recall or withdrawal in the Royalty Territory shall be borne solely by BMS, except to the extent that the recall or withdrawal is attributable to (x) the negligence of Medarex, in which event Medarex shall bear such costs or (y) the negligence of both Parties, in which event each Party shall bear such costs to the extent of its respective responsibility, and in either case ((x) or (y)), such costs shall be excluded from Development Costs and Allowable Expenses. Except with respect to the negligence of Medarex as provided in the preceding sentence, BMS shall reimburse Medarex pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances 6.8 on an FTE cost 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 direct out-of-pocket cost basis for any Recall. (B) With respect to any clinical studies conducted by ViaCell assistance Medarex provides 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]3.5.5.

Recalls. (Aa) The Parties In the event that Genpharm or a Manufacturer shall exchange their internal standard operating proceduresbe required (or shall voluntarily decide) to initiate a recall, if anyproduct withdrawal or field correction of any Product (a "RECALL"), as to product recalls whether or not such Recall has been requested or ordered by the FDA ("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 Amgenany other governmental body, which may not conform to the specifications for such Collaboration Product, agency 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 official having jurisdiction in the Territory) or by a court, it Genpharm shall, or shall promptly so cause the applicable Manufacturer to, notify PRI and PRI shall fully co-operate and shall cause its Affiliates to fully co-operate with Genpharm (and such Manufacturer) in notifying their customers to return all such Product and shall follow any other instructions provided by Genpharm (or such Manufacturer). (b) In the other Party event that PRI believes that a Recall may be necessary and/or appropriate, prior to taking any action PRI shall immediately notify Genpharm and the Party having applicable Manufacturer and Genpharm and PRI shall co-operate and cause their respective Affiliates to co-operate with each other (and the right to control such a Recall pursuant to Section 5.10(bother's Affiliate) may take [**] when in determining the regulatory timeframes or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent necessity and nature of the JSC action to be taken. (c) With respect to any Recall, Genpharm or the Manufacturer shall make all contacts with the FDA and shall be made responsible for co-ordinating all of the necessary activities in connection with such Recall and PRI (and its Affiliates) and Genpharm (and its Affiliate) shall each co-operate with the other (and with the other's Affiliate) in recalling the affected Product. (d) In the event that it is determined by agreement of the Party having parties or by arbitration as herein contemplated that a Recall results solely from any cause or event arising from the first manufacture, labelling, storage, handling, or packaging of the Product by Genpharm or a Manufacturer or other cause or event attributable to Genpharm or a Manufacturer, Genpharm shall be responsible for all expenses of such Recall. In the event that it is determined by agreement of the parties or by arbitration as herein contemplated that a Recall results solely from any cause or event arising from the transportation, manufacturing (if applicable), repackaging, labelling, storage, handling, marketing or distribution of the Product by PRI or any of its Affiliates or other cause or event attributable to PRI or any of its Affiliates, PRI shall be responsible for all expenses of such Recall. If: (i) within 60 days of the initiation of a Recall, the parties are unable to agree that the cause of such Recall was solely the responsibility of PRI or its Affiliates or Genpharm or a Manufacturer as hereinbefore contemplated; or (ii) an arbitrator pursuant to an arbitration initiated by one of the parties in respect of such Recall within the 60 day period contemplated in (i) above, determines that the cause of such Recall was not solely the responsibility of PRI or its Affiliates or of Genpharm or a Manufacturer as hereinbefore contemplated; then PRI shall initially pay or reimburse Genpharm and its Affiliates, as the case may be, for the expenses of the Recall but shall be entitled to recover from Genpharm *** % of the expenses so incurred through deductions to and sharing of Gross Profits. (e) For purposes of this agreement, Recall expenses shall include, but not be limited to, the expenses of notification and destruction or return of the recalled Product, as the case may be, and PRI's (and its Affiliates') and Genpharm's and its Affiliates' reasonable out-of-pocket costs in connection with such Recall including but not limited to reasonable attorney's fees and expenses and credits and recall expenses claimed and paid to customers (the "RECALL EXPENSES"). Each of the parties shall use, and shall cause its Affiliates to use, its reasonable best efforts to minimize the Recall Expenses which it incurs and shall provide to the other, upon request, reasonable evidence of the out-of-pocket expenses being claimed by it. The direct out-of-pocket costs and expenses of the Recall contemplated above shall not include the gross amount invoiced by PRI or its Affiliates to the customers on the sale of the Product recalled, which amount shall be dealt with in accordance with the provisions of Section F.2 of Schedule "F" hereto and shall also not include any Excess Reprocurement Costs (within the meaning of Section F.3 of Schedule "F" hereto), which costs shall be paid by PRI (subject to its right to control a Recall partially recover same through deduction from Gross Profits). (f) All Product recalled pursuant to this Section 5.10(b). The JSC will meet I.7 shall be treated as Product returned to PRI by its customers and the provisions of Section F.2 of Schedule "F" hereto shall apply thereto. (in person, by telephone or otherwiseg) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect All communications relating 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), held in confidence and the other Party shall make available be subject 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 terms 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 requireSchedule "J" hereof. 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH SECURITIES AND EXCHANGE COMMISSION ASTERISKS DENOTE SUCH OMISSION SCHEDULE "J"

Recalls. (Aa) The Parties shall exchange their internal standard operating procedures, if any, 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 by the Manufacturing Lead to Amgen, the other Party which may not conform to the specifications for such Collaboration ProductProduct then in effect pursuant to the Program Plan, 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 the Party having the right to control such a Recall pursuant to Section 5.10(b4.9(b) below may take [***] with notice to the Steering Committee when the regulatory timeframes or public safety considerations so require. In all other circumstances, circumstances Recalls can only be made by [***] consent of the JSC Steering Committee and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b4.9(b), below. The JSC Steering Committee 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)4.9(b) below, 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. (Bb) With respect to any clinical studies conducted by ViaCell Hyseq under this Agreement, ViaCell Hyseq shall have the exclusive first right to control a Recall of any Cell Therapy Products the Collaboration Product in the Territory, and . If Hyseq shall elect not to conduct such a Recall at any time at which of the Collaboration Product in the Territory when, in the good faith opinion of Amgen, regulatory timeframes or public safety considerations so require, Amgen shall have the right to conduct such Recall. Other than with respect to any clinical studies conducted by ViaCell Hyseq under this Agreement, Amgen the Commercial Lead shall have the exclusive first right to control any Recall of the Collaboration Products Product in the Territory, and . If the Commercial Lead shall elect not to conduct such a Recall at any time at which of the Collaboration Product in the Territory when, in the good faith opinion of the other Party, regulatory timeframes or public safety considerations so require, the other Party shall have the right to conduct such Recall. ViaCell Hyseq and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 4.9 for such periods as may be required by legal requirements, but in any event for no less than [***].

Recalls. (Aa) The Parties shall exchange their internal standard operating procedures, if any, 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 such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes or public safety considerations so require*]. In all other circumstances, circumstances Recalls can only be made by [**] consent *]of the JSC Steering Committee and shall be made by the Party having the first right to control [***]a Recall pursuant to Section 5.10(b4.9(b), below. The JSC Steering Committee 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)4.9(b) below, 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. (Bb) With respect to any clinical studies conducted by ViaCell Hyseq under this Agreement, ViaCell Hyseq shall have the exclusive right to control [***]a Recall of any Cell Therapy Products the Collaboration Product in the Territory, and . If Hyseq shall elect not to conduct such a Recall at any time at which of the Collaboration Product in the Territory when, in the good faith opinion of Amgen, regulatory timeframes or public safety considerations so require, Amgen shall have the right to conduct such Recall. Other than with respect to any clinical studies conducted by ViaCell Hyseq under this Agreement, Amgen the Commercial Lead shall have the exclusive right to control [***]any Recall of the Collaboration Products Product in the Territory. [***], and the other Party shall have the right to conduct such a Recall at any time at which regulatory timeframes or public safety considerations so requireRecall. ViaCell Hyseq and Amgen shall each maintain complete and accurate records of any Recall it has the right to control [***] pursuant to this Section 5.10 4.9 for such periods as may be required by legal requirements, but in any event for no less than [***].

Recalls. (Aa) The Parties shall exchange their internal standard operating procedures, if any, procedures as to product recalls ("“SOPs"”) reasonably promptly after the Effective Date first filing of a Drug Approval Application for an Antibody Product and thereafter reasonably promptly after such SOPs are approved or modifiedmodified thereafter. If either Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to AmgenIn the event that, in a country, the Territorial Commercial Lead for such country determines that an event, incident or circumstance has occurred which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country result in the Territoryneed for a “recall” or “market withdrawal” or “stock recovery” (as such terms are defined in U.S. regulations in 21 CFR 7.3 or another similar national, it state or local law or regulation), hereinafter collectively referred to as a “Recall”, of Antibody Product or any lot(s) thereof, such Party shall promptly so notify the other Party and the Party having in writing. (b) The Territorial Commercial Lead shall have the right to control such determine whether and upon what terms and conditions to Recall the Antibody Product within its Lead Territory; provided however, if the Territorial Commercial Lead shall elect not to conduct a Recall pursuant of the Antibody Product, and solely if the other Party is responsible for the manufacture of Antibody Raw Material or Antibody Product in Finished Form, and the manufacture of Antibody Raw Material or Antibody Product in Finished Form is the basis of such proposed Recall, the other Party 47 shall have the right to Section 5.10(b) may take [**] when the conduct such Recall if, in its good faith opinion, regulatory timeframes requirements or public safety considerations so require. In Prior to making any Recall decision in any part of its Territory, each Party shall consult with the other Party. The Territorial Commercial Lead shall be responsible for discussions with Regulatory Authorities within the applicable country regarding all other circumstances, Recalls can only be made by [**] consent aspects of the JSC Recall decision and the execution thereof. Any costs or expenses of any Recall in any part of the Territory shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b)Commercialisation Expense. 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell Celltech and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 Article 4.8 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. (Aa) The Parties Each party shall exchange their internal standard operating procedurespromptly notify the other party in writing if it determines that any event, if anyincident or circumstance has occurred which may result in the need for a “recall” or “market withdrawal,” as such terms are defined in 21 C.F.R. Part 7.3, of the Co-Promotion Collaboration Product in the United States (“Permanent Recall”) or a “recall” or “market withdrawal”, as such terms are defined in 21 C.F.R. Part 7.3, of the Co-Promotion Collaboration Product in the United States that is limited in territory or as to product recalls any lot(s) or batches of the Co-Promotion Collaboration Product ("SOPs"“Limited Recall” and collectively with Permanent Recall, a “Recall”). (b) 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 Amgenparty gives a notice described in Section 7.4(a), which may not conform to and [ * ], the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues Executive Committee will immediately meet and confer regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject advisability of a Recall in any country (which conference may be in the Territoryform of a telephone conference or video conference). If [ * ], it the Executive Committee may provide its recommendation to [ * ] on the course of action preferred by that Committee. Notwithstanding the foregoing, nothing contained herein shall promptly so notify be construed to imply any right of [ * ], to consent to any decision by [ * ] to discontinue, temporarily or permanently or on a limited basis, the distribution and sale of the Co-Promotion Collaboration Product. [ * ] will have sole responsibility for and will make all decisions with respect to any recall, market withdrawal, or any other Party corrective action of similar nature related to the Co-Promotion Collaboration Product. [ * ] shall be solely responsible for interactions with the FDA or other Governmental and the Party having the right Regulatory Authorities with regard to control any such a Recall pursuant to Section 5.10(b) corrective action, except that [ * ] may take [**] when the regulatory timeframes or public safety considerations so requiresuch actions as may be required of it by Applicable Laws. In all other matters subject to this Section 7.4(b): (i) [ * ] shall notify and consult with [ * ] as promptly as reasonably practicable taking into account all relevant circumstances, Recalls can only be made by [**and (ii) if [ * ] consent of the JSC and shall be made by the Party having the first right to control decides that a Recall pursuant to Section 5.10(b). The JSC is necessary, it will meet (in person, notify the [ * ] by telephone or otherwise) to discuss in writing in advance of initiating or publicly announcing 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. (Bc) With respect If [ * ] makes a determination that a Limited Recall of the Co-Promotion Collaboration Product is necessary but [ * ] disagrees with such determination, [ * ] may initiate a joint discussion by the parties of such issue with [ * ] within [ * ] days of such determination, and such [ * ] shall make its decision within a reasonable period of time not to any clinical studies conducted by ViaCell under this Agreementexceed [ * ] days of the [ * ] receipt of notice of the determination. If such [ * ] advises the parties that [ * ] believes there should be a Limited Recall, ViaCell the parties shall voluntarily implement a Limited Recall of the Co-Promotion Collaboration Product. (d) If [ * ] makes a determination that a Permanent Recall of the Co-Promotion Collaboration Product is necessary but [ * ] disagrees with such determination, [ * ] 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 Agreementthe Co-Promotion Collaboration Product and to [ * ] with respect to the Co-Promotion Collaboration Product. In such case, Amgen [ * ] in the [ * ]. [ * ] shall thereafter have exclusive authority and control over the exclusive right to control any Recall commercialization of Co-Promotion Collaboration Product in the [ * ]. [ * ] shall thereafter receive [ * ] realized from the sale of Co-Promotion Collaboration Product [ * ]. Such [ * ] arrangement shall continue until [ * ], and the provisions of Sections 16.7 through 16.13 of the Collaboration Products Agreement shall apply to such payments. (e) Any documented, direct, out-of-pocket costs paid or accrued by a party with respect to participating in such Recall, market withdrawal, or other corrective action will be an [ * ]; provided, however that if such recall, market withdrawal or other corrective action was caused by (i) a party’s negligence, malfeasance, or willful misconduct occurring while the TerritoryCo-Promotion Collaboration Product was under such party’s control, and shall conduct or (ii) a Material Breach, such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has party will reimburse the right to control pursuant to this Section 5.10 other for such periods as may costs and they will not be required by legal requirements, but in any event for no less than [**deemed [ * ].

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, procedures as to product recalls ("“SOPs"”) reasonably promptly after the Effective Date [*] and thereafter thereafter, reasonably promptly after such SOPs are approved or modified. If either Party becomes aware of information about quantities of Collaboration a Licensed Product supplied from ViaCell by Amgen to Amgen, Licensee which may not conform to the specifications for such Collaboration Producta Licensed Product then in effect, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration a Licensed Product itself is alleged or proven is likely to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall pursuant to Section 5.10(b4.14.1 (Licensee Right) may or 4.14.2 (Amgen Right) shall have the right to take [**] immediate action with notice to the other Party 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC Parties will meet (in person, by telephone or otherwise) to discuss such other the circumstances of any potential Recall 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(b4.14.1 (Licensee Right) or 4.14.2 (Amgen Right), 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. Recall (B) With respect to any clinical studies conducted by ViaCell under this Agreementprovided, 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 Agreementhowever, Amgen shall have be obligated to provide manufacturing information to Licensee only to the exclusive right extent necessary for Licensee to control any Recall of the Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell Recall, and Amgen shall each maintain complete and accurate records also have the right to instead provide any such manufacturing information directly to the relevant Governmental Authority (including by provision of any Recall it has a drug master file) as appropriate (in order to better protect the confidentiality of such information). In the event of an order of a Governmental Authority having jurisdiction in the Territory mandating a Recall, the Party having the right to control such a Recall pursuant to this Section 5.10 for subsection 4.14.1 (Licensee Right) or 4.14.2 (Amgen Right) shall promptly comply with such periods as may be required by legal requirements, but in any event for no less than [**]order with written notice to the other Party.

Recalls. As used herein, "Initiated Recall" shall mean a recall (Aa) The Parties shall exchange their internal standard operating proceduresinitiated at the direction of the Federal Food and Drug Administration or other regulatory authority, if anyarising out of, as based on, or caused by defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to product recalls meet the Specifications; or ("SOPs"b) reasonably promptly after the Effective Date and thereafter reasonably promptly after such SOPs are approved or modified. If initiated voluntarily by either Party becomes aware where evidence indicates that defects in materials or workmanship, improper manufacture of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration ProductProducts, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which failure of the Collaboration Product itself is alleged or proven Products to be meet the subject of Specifications warrants such a Recall in any country in the Territory, it recall. Each Party shall promptly so notify the other Party and the Party having the right of any situation which may lead to control such a an Initiated Recall 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 Products, however, YYY and XYZ shall be made by have joint authority as to whether to institute a voluntary recall. YYY shall notify XYZ, in writing, if it is required to implement a total or <PAGE> partial Initiated Recall. Both Parties agree to work together to properly manage an Initiated Recall, foremost in terms of urgency and safety for the Party having end customer, and secondly for the first right efficient utilization of resources to control a Recall pursuant to Section 5.10(b)accomplish such Initiated Recall. The JSC will meet (in person, by telephone costs of any total or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a partial Initiated Recall shall be consistent allocated as follows, regardless of whether it was recalled by XYZ, YYY, or a governmental or regulatory authority: (a) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of XYZ, XYZ shall bear the out-of-pocket costs and expenses associated with the internal SOP Initiated Recall; (b) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of YYY, YYY shall bear the out-of-pocket costs and expenses associated with the Initiated Recall; (c) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably deemed to be the direct result of negligent or willful acts or omissions by both Parties, each Party will bear a portion of the Party having out-of-pocket costs and expenses roughly commensurate with its proportional responsibility for the first right to control such Recall pursuant to Section 5.10(b)Initiated Recall, and (d) if it cannot reasonably be determined which party was responsible for the other Party shall make available defects or problems giving rise to the Party having reason for the first right to control such Recall all pertinent records which Initiated Recall, then the Party having Parties shall equally share the first right to control such Recall may reasonably request to assist in effecting any out-of-pocket costs and expenses associated with the Initiated 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, procedures 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 Dmab supplied from ViaCell by Amgen to Amgen, Collaborator which may not conform to the specifications for such Collaboration ProductDmab then in effect, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product Dmab 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 the Party having the right to control such a Recall pursuant to Section 5.10(bsubsection 4.16.1 (Collaborator Right) may or 4.16.2 (Amgen Right) shall have the right to take [**] immediate action with notice to the other Party 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC Parties will meet (in person, by telephone or otherwise) to discuss such other the circumstances of any potential Recall 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(bsubsection 4.16.1 (Collaborator Right) or 4.16.2 (Amgen Right), 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. Recall (B) With respect to any clinical studies conducted by ViaCell under this Agreementprovided, 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 Agreementhowever, Amgen shall have be obligated to provide manufacturing information to Collaborator only to the exclusive right extent necessary for Collaborator to control any Recall of the Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell Recall, and Amgen shall each maintain complete and accurate records also have the right to instead provide any such manufacturing information directly to the relevant Governmental Authority (including by provision of any Recall it has a drug master file) if such provision will satisfy such requirement (in order to better protect the confidentiality of such information). In the event of an order of a Governmental Authority having jurisdiction in the Territory mandating a Recall, the Party having the right to control such a Recall pursuant to this Section 5.10 for subsection 4.16.1 (Collaborator Right) or 4.16.2 (Amgen Right) shall promptly comply with such periods as may be required by legal requirements, but in any event for no less than [**]order with written notice to the other Party.

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, as to product recalls ("SOPs") reasonably promptly after Principal may cease selling 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 such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall Products in any country Country/Region in the Territory at any time during the Term and recall the Products within any Country/Region in the Territory as necessary if any of the below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Country/Region in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall 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 : unforeseen effects of the JSC and shall be made by relative type of the Party having Products lead to, in Principal's sole opinion, unacceptable safety risks; Principal ceases the first right 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 control a Recall pursuant to Section 5.10(b)the Products; or other circumstances of recalls as required under the Applicable Law. 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 Distributor undertakes with respect to any product recall that: (i) it will implement and complete the recall of the Products within the Territory by the statutory deadline or a Recall shall be consistent shorter period as reasonably requested by Principal in all aspects in strict compliance with the internal SOP Applicable Law; and (ii) it shall provide full cooperation to Principal, including timely transmitting and providing feedbacks of drug recall information, controlling and recovering drugs with potential safety hazards. The Distributor may not recall any of the Party having Products from any of the first right Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following the decision to control implement a Recall, Principal and Distributor shall mutually agree on a prepared statement for use in response to any inquiries regarding such Recall. Distributor shall use such prepared statement to respond to any inquiries received with regard to such Recall pursuant and shall not make any other statement regarding such Recall; provided, that if Principal fails to Section 5.10(b), and the other Party shall make available agree with Distributor on a prepared statement prior to the Party having launch of such Recall, Distributor shall prepare and issue the first right statement as proposed by Principal regarding such Recall. To the extent the Products are recalled due 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 causes other than Distributor’s non-compliance with relevant obligations under this Agreement, ViaCell Principal shall have (a) indemnify the exclusive right Distributor for the costs and expenses reasonably incurred by the Distributor for recalling the Products and for any subsequent disposal or destruction of the same; and (b) repurchase the Products that are subject to control the Recall at the purchase price paid by the Distributor and in addition pay Distributor a handling charge equal to 10% of the purchase price. In the event that the Products are recalled due to Distributor or its Permitted Sub-distributors’ or any of its 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 any Cell Therapy 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 conduct 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 Recall at 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 time at which regulatory timeframes books, documents, papers or public safety considerations so require. Other than records that relate to or contain any information regarding any business dealings with respect to or the affairs of any clinical studies other client or principal of Distributor may only be conducted by ViaCell the Independent Auditor. Such Independent Auditor shall (i) provide a copy of the audit report to Distributor no later than thirty (30) Business Days after such report is provided to Principal and (ii) disclose to Principal relevant necessary information to enable Principal to determine whether Distributor is in compliance with this Agreement or not, and in any event shall never disclose to Principal any information regarding any business dealings with or the affairs of any other client or principal of Distributor that such Independent Auditor may come across in the course of performing its audit under this provision, unless it is required by Applicable Law. Principal shall not request an Audit more than once each Calendar Year, unless required more frequently by any regulatory authorities which have regulatory oversight over Principal or the Products, or unless breaches of Distributor's obligations under this Agreement have been identified in the course of an Audit or in the inspection by any competent authorities and subsequent Audits are required to confirm that Distributor has remedied such breaches. All Audits, including the cost of the Independent Auditor, shall be solely at Principal's expense unless the results of audit demonstrate that Distributor had failed to make due payment to Principal of an amount exceeding 5%, or Distributor had breached a material obligation under this Agreement. All Audits shall take place only during Business Hours and only upon at least seven Business Days prior written notice to Distributor. During any audits, inspections or examinations conducted by Principal or any authorised agent under this Agreement, Amgen including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or Clause 19.6, Principal agrees that it and its duly authorised agents, including any Independent Auditor: will abide by all internal regulations and policies of Distributor enforced at such time; will not interfere with the business or operation of Distributor; and without prejudice to any confidentiality limitations in this Agreement, shall at the request of Distributor enter into a separate non-disclosure agreement prepared by Distributor, prior to being granted access to any of Distributor's premises, books, documents, papers or records. In the event that the 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 exclusive right to control any Recall terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties shall in good faith agree on a Safety Data Exchange Agreement (as set forth in Exhibit G) that sets out the responsibilities of each Party with respect to the pharmacovigilance matters relating to the Products as soon as practicable after the execution of this Agreement. The Parties shall in good faith agree on the Quality Agreement that sets out the responsibilities and processes for quality activities with respect to 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 Collaboration Licensed Marks to Distributor; it has and will continue to have full legal rights to use the patents, formulae and all other intellectual property rights employed in the development and production of the Products; and to the best knowledge of Principal, the exercise by Distributor of the rights and licences granted to Distributor under this Agreement (including the use of the Licensed Marks) and the distribution, offer for sale and sale of the Products by Distributor would not infringe any right (including intellectual property rights) of any person or give rise to any liability to pay royalty or other compensation. The warranties in this Clause 21.1 are separate and independent and shall 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, and shall conduct such a Recall at Territory infringes any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records rights of any Recall it has 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 right Licensed Marks, numbers, or other means of identification used on or in relation to control 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 Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]Agreement.

Recalls. (A) The Parties shall exchange their internal standard operating procedures5.2.1 BioMarin may, if anyin its sole discretion, as determine whether or when to product initiate any recalls ("SOPs") reasonably promptly after of Aldurazyme in the United States and Genzyme may, in its sole discretion, determine whether or when to initiate any recalls of Aldurazyme anywhere else in the world. As of the Effective Date and thereafter reasonably promptly throughout the term of this Agreement, BioMarin and Genzyme shall prepare and maintain a written SOP, to handle any recalls of Aldurazyme. Such SOP shall include, without limitation, prior notice to and consultation with the other Party of any recall; provided, however, that in no event shall such consultation be deemed to limit or supersede the Parties’ ability to make recall decisions in their sole discretion pursuant to the first sentence hereof. Genzyme shall transmit recall decision information to BioMarin to Vice President, Regulatory Affairs, by phone at (000) 000-0000 or facsimile at (000) 000-0000. BioMarin shall transmit recall decision information to Genzyme to Regulatory Affairs/QA, attention: Vice President, Regulatory Affairs and Corporate Quality Compliance, by phone at (000) 000-0000 or facsimile at (000) 000-0000. In the event that (i) any regulatory authority or other governmental agency or authority issues a request or directive or orders that Aldurazyme be recalled or retrieved, (ii) a court of competent jurisdiction orders that Aldurazyme be recalled or retrieved or (iii) a Party determines that Aldurazyme should be recalled, retrieved or a “Dear Doctor” letter is required relating to restrictions on use of Aldurazyme in a country for which it is responsible, the Party responsible for the relevant country pursuant to the first sentence hereof shall conduct such activity and the Parties shall take all appropriate corrective actions and shall execute the steps detailed in the SOP. To the extent practicable, the Parties shall coordinate the notices of any such recall to be delivered to regulatory authorities (including the timing thereof). Genzyme and BioMarin shall cooperate fully with one another in conducting such action. Genzyme shall destroy units of Aldurazyme lawfully recalled only upon BioMarin’s (or any regulatory authority’s) written instruction to destroy such units of Aldurazyme, and only then in accordance with BioMarin’s procedures and instructions. Otherwise, Genzyme may return the recalled units of Aldurazyme to BioMarin in accordance with BioMarin’s instructions within thirty (30) days after such SOPs are approved completion of the action. In the event that either BioMarin or modified. If either Party Genzyme becomes aware of information about quantities circumstances that may necessitate a recall of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall Aldurazyme in any country in the Territoryfor which it is not responsible pursuant to this Section 5.2, it shall will promptly so notify the other Party of such circumstances. 5.2.2 In the event a recall results from the manufacture of Aldurazyme (including without limitation changes made pursuant Sections 3.11 and 3.12 hereof) or BioMarin’s negligence or willful misconduct, BioMarin shall be responsible for the Party having the right to control such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes or public safety considerations so requireexpenses thereof. In all other circumstancesthe event a recall results from Genzyme’s filling, Recalls can only packaging, labeling or storage of Aldurazyme, or Genzyme’s negligence or willful misconduct (including without limitation any negligence or willful misconduct resulting in adulteration of Aldurazyme), Genzyme shall be made by [**] consent responsible for the expenses thereof. Otherwise, the Parties shall share equally the expenses of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b)action. The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses For purposes 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 the expenses of the action shall have be the exclusive right to control a Recall expenses of any Cell Therapy Products in notification and return or destruction (if such destruction is authorized by BioMarin or the Territoryapplicable regulatory authority) of units of the recalled Aldurazyme, the cost of replacement of the recalled Aldurazyme, and any costs directly associated with the distribution of replacement Aldurazyme. For the avoidance of doubt, amounts payable under Article 6 hereof shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. Other than with respect only be payable on Aldurazyme used to any clinical studies conducted by ViaCell under this Agreement, Amgen shall have replace the exclusive right to control any Recall of recalled Aldurazyme (not on the Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]returned Aldurazyme itself).

Recalls. (Aa) EyePoint and Xxxxxxx will each maintain records necessary to permit a Recall of the Product delivered to Alimera or customers of Alimera. Each Party will [***] notify the other Party of any information that it becomes aware of in relation to the Manufacture of Product which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product. Upon receipt of such information, each Party will stop making any further shipments of the Product in its possession or control until a decision has been made by the owner of the YUTIQ NDA as to whether a Recall or some other corrective action is necessary. The Parties shall exchange their internal standard operating proceduresdecision to initiate a Recall or to take some other corrective action, if any, 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 with respect to the specifications Product in the U.S. market will be made by the owner of the YUTIQ NDA and implemented in accordance with Section 4.6 of the Product Rights Agreement. (b) If (i) any Regulatory Authority issues a directive, order or written request that the Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Alimera determines that the Product should be Recalled or that a “Dear Doctor” letter is required for such Collaboration the Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it each Party shall promptly so notify provide all assistance reasonably requested by the other Party and the Party having the right to control such with respect thereto. (c) If a Recall pursuant of the Product for the U.S. market results from, or arises out of, a failure by EyePoint to Section 5.10(b) may take Manufacture the Product in accordance with the Product Requirements, then EyePoint shall be responsible for Xxxxxxx’s reasonable and documented expenses of the Recall and EyePoint shall [***] when either (i) [***] [***] replace the regulatory timeframes Nonconforming Product with Product that meets the Product Requirements as soon as possible, at EyePoint’s cost, or public safety considerations so require(ii) refund Alimera for the invoice price of any amounts paid in respect of the Nonconforming Product within [***] of the Recall date. EyePoint shall [***] prevent future Nonconformities. Additionally, EyePoint shall bear the cost of disposition for any Recalled Product for which it bears responsibility under this Section 4.5(c). Alimera will give EyePoint prompt written notice of any Recalls for which Xxxxxxx believes EyePoint has responsibility under this Section 4.5(c). In all other circumstancescircumstances where the Recall for the Product does not result from, Recalls can only or arise out of, a failure by EyePoint to Manufacture the Product in accordance with the Product Requirements, recalls or other corrective actions for the Product in the U.S. market will be made at Alimera’s cost and expense, including any costs incurred by [**] consent of the JSC and shall be made EyePoint to provide assistance reasonably requested by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (Xxxxxxx 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 Recallconnection therewith. (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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, as Any decision to product recalls ("SOPs") reasonably promptly after the Effective Date and thereafter reasonably promptly after such SOPs are approved initiate a recall or modified. If either Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject withdrawal of a Recall in any country Product or MDX-1379 in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall 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 United States shall be made by the applicable Lead Regulatory Party, after consultation with the JEC, provided that if, as a result of patient safety concerns, there is not sufficient time for the JEC to meet, and in any event before the applicable Lead Regulatory Party having initiates a recall or withdrawal, the first right to control a Recall pursuant to Section 5.10(b)Parties shall promptly and in good faith discuss the reasons therefor and the strategy for implementing any such recall or withdrawal. The JSC will meet costs of any such recall or withdrawal relating to (in person, by telephone a) the Development of a Product or otherwiseMDX-1379 for an Indication prior to the Initial Regulatory Approval (or Compendia Listing) to discuss for such Indication (other circumstances and to consider appropriate courses of action, which courses of action than with respect to a Recall recall related to a Partially Co-Funded Indication) or the Commercialization of a Co-Promotion Product, each shall be consistent Regulatory Expenses, and (b) the Development of a Product or MDX-1379 for a Partially Co-Funded Indication or the Commercialization of a Non-Co-Promoted Product, each shall be borne solely by BMS and shall be excluded from Development Costs and Allowable Expenses, except, in each case ((a) and (b)), to the extent that any such recall or withdrawal is attributable to (x) the negligence of a Party, in which event such Party shall bear such costs or (y) the negligence of both Parties, in which event each Party shall bear such costs to the extent of its respective responsibility; and in either case ((x) or (y)), such costs shall be excluded from Development Costs and Allowable Expenses. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and with the internal SOP of the respect to Co-Promotion Products, neither Party having the first shall have any right to control such Recall pursuant object to Section 5.10(b), and a recall or withdrawal requested by the other Party shall make available for failure of a Product to meet the Party having Specifications, for material safety concerns, for the first right to control manufacture of such Recall all pertinent records which Product in a manner that does not comply with the Party having Act or as requested by Regulatory Authorities. In 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 event of any Cell Therapy Products recall or withdrawal, the Lead Regulatory Party shall take any and all necessary action to implement such recall or withdrawal in accordance with Applicable Law, with assistance from 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods other Party as may be required by legal requirements, but in any event for no less than [**]reasonably requested.

Recalls. (Aa) EyePoint and Xxxxxxx will each maintain records necessary to permit a Recall of the Product delivered to Alimera or customers of Alimera. Each Party will [***] notify the other Party of any information that it becomes aware of in relation to the Manufacture of Product which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product. Upon receipt of such information, each Party will stop making any further shipments of the Product in its possession or control until a decision has been made by the owner of the YUTIQ NDA as to whether a Recall or some other corrective action is necessary. The Parties shall exchange their internal standard operating proceduresdecision to initiate a Recall or to take some other corrective action, if any, 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 with respect to the specifications Product in the U.S. market will be made by the owner of the YUTIQ NDA and implemented in accordance with Section 4.6 of the Product Rights Agreement. (b) If (i) any Regulatory Authority issues a directive, order or written request that the Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Alimera determines that the Product should be Recalled or that a “Dear Doctor” letter is required for such Collaboration the Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it each Party shall promptly so notify provide all assistance reasonably requested by the other Party and the Party having the right to control such with respect thereto. (c) If a Recall pursuant of the Product for the U.S. market results from, or arises out of, a failure by EyePoint to Section 5.10(b) may take Manufacture the Product in accordance with the Product Requirements, then EyePoint shall be responsible for Xxxxxxx’s reasonable and documented expenses of the Recall and EyePoint shall [***] when either (i) [***] [***] replace the regulatory timeframes Nonconforming Product with Product that meets the Product Requirements as soon as possible, at EyePoint’s cost, or public safety considerations so require(ii) refund Alimera for the invoice price of any amounts paid in respect of the Nonconforming Product within [***] of the Recall date. EyePoint shall [***] prevent future Nonconformities. Additionally, EyePoint shall bear the cost of disposition for any Recalled Product for which it bears responsibility under this Section 4.5(c). Alimera will give EyePoint prompt written notice of any Recalls for which Xxxxxxx believes EyePoint has responsibility under this Section 4.5(c). In all other circumstancescircumstances where the Recall for the Product does not result from, Recalls can only or arise out of, a failure by EyePoint to Manufacture the Product in accordance with the Product Requirements, recalls or other corrective 9 actions for the Product in the U.S. market will be made at Alimera’s cost and expense, including any costs incurred by [**] consent of the JSC and shall be made EyePoint to provide assistance reasonably requested by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (Xxxxxxx 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 Recallconnection therewith. (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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. (A) The Parties shall exchange their internal standard operating proceduresimmediately inform each other in writing of all information related to (a) any incident relating to a PRODUCT and/or any lot of a PRODUCT that is the subject of recall, if anymarket withdrawal or correction, as to or (b) any PRODUCT that may require, whether based on manufacturing defect, tampering, or otherwise, a recall, field alert, product recalls ("SOPs") reasonably promptly after the Effective Date and thereafter reasonably promptly after withdrawal or field correction arising from any defect in any such SOPs are approved or modifiedPRODUCT provided under this Agreement. If either Party becomes aware believes that a recall of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY is desirable 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 Territoryrequired by law, it shall will promptly so notify the other Party Party. The Parties will then discuss reasonably and in good faith whether such recall is appropriate or required and the manner in which any recall shall be handled; provided, however, in the event either Party having determines that a recall is necessary, such recall shall be implemented. Coulxxx xxxll be solely responsible for the right to control handling and disposition of such a Recall recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in TERRITORY A, pursuant to Section 5.10(b) may take [**] when procedures set forth on EXHIBIT J. SB shall cooperate with Coulxxx xx allowing such recall in TERRITORY A to occur pursuant to the regulatory timeframes or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent of the JSC and procedures set forth on EXHIBIT J. SB shall be made by solely responsible for the Party having handling and disposition of such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in the first right to control a Recall NON-USA TERRITORY, pursuant to Section 5.10(b). The JSC will meet (procedures set forth on EXHIBIT J. Cxxxxxx xxxll cooperate with SB in person, by telephone or otherwise) allowing such recall in the NON-USA TERRITORY 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 occur 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 procedures set forth on EXHIBIT J. EXHIBIT J 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 be modified at any time at which regulatory timeframes or public safety considerations so require. Other than with respect by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM subject to any clinical studies conducted by ViaCell under this Agreement, Amgen shall have the exclusive right to control any Recall approval of the Collaboration Products in the Territory, JDC and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]JCC.

Recalls. (Aa) The Parties shall exchange their internal standard operating procedures, if any, 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 Notwithstanding anything in this Agreement to the specifications for 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 Collaboration 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 for which there are potential adulteration, misbranding and/or issue such advisory letter after consultation with the 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 party. Each party shall promptly so notify the other Party 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 the Party having the right timing of any publicity to control be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement shall not be a Recall pursuant precondition 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 any action that either party deems necessary to protect users of the JSC Products or to comply with any applicable governmental orders or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. Celsion shall promptly pay or reimburse BSC for the reasonable costs of effecting such recall or issuing such advisory letter, including costs related to return of recalled Products and refunding to BSC the purchase price paid by BSC for recalled Products, including Products in BSC's inventory; provided, however, that to the extent such recall or the issuance of such advisory letter results from an act or omission of BSC, BSC shall be made by responsible for the Party having the first right costs of effecting such recall or issuing such advisory letter, including costs related to control a Recall pursuant to Section 5.10(b). The JSC will meet (in personreturn of recalled Products, 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 extent such recall or the first right to control issuance of such Recall all pertinent records which advisory letter results from the Party having the first right to control such Recall may reasonably request to assist in effecting any Recallact or omission of BSC. (Bc) With respect to any clinical studies conducted by ViaCell under this Agreement, ViaCell shall have In the exclusive right to control event of a Recall recall of any Cell Therapy Products in the TerritoryProduct, Celsion shall correct any deficiency relating to its manufacturing, packaging, testing, labeling, storing or handling of such Product, if applicable, and shall conduct such a Recall shall, at any time BSC's option, either, 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 its cost replace each unit of the Collaboration Products Product recalled (including units held in inventory by BSC or its customers) with a corrected Product within a reasonable period of time, or refund the Territorypurchase price therefor. Celsion shall reimburse BSC for all costs and expenses (including shipping, quality control testing, notification and shall conduct such restocking costs) incurred by BSC as a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records result of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]recall.

Recalls. To the extent (Aa) The Parties shall exchange their internal standard operating proceduresany governmental or regulatory authority issues a request, if any, as to product recalls ("SOPs") reasonably promptly after directive or order that the Effective Date and thereafter reasonably promptly after such SOPs are approved Product be recalled or modified. If either Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country withdrawn in the Territory, it shall promptly so notify (b) a court of competent jurisdiction orders a recall or withdrawal of the Product in the Territory or (c) either Party determines, after consultation with the other Party and Party, that the Party having the right to control such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes Product should be recalled or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make available to the Party having the first right to control such Recall all 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 withdrawn in the Territory, the Parties shall recall or withdraw the Product as set forth in this Section 8.2. As between the Parties, Astellas shall control and shall conduct coordinate, including making all contacts with regulatory authorities, all activities it deems necessary in connection with such a Recall at recall or withdrawal in the Territory. All out-of-pocket expenses related to the execution of any time at which regulatory timeframes recall 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 withdrawal of the Collaboration Product (“Recall Costs”) shall be shared equally between the Parties, provided that in the case of (c) above, if the Parties do not mutually agree on having the Product recalled or withdrawn, then the Party requesting the recall or withdrawal shall bear initially the entire expense of such recall or withdrawal; but in each case subject to the final allocation between the Parties as follows. In the event that it is finally determined, or agreed between the Parties, that such recall or withdrawal is caused by: (a) breach of the representations and warranties of XenoPort set forth in Section 13.2 below, or the gross negligence or willful misconduct of XenoPort, or the failure by XenoPort to comply with applicable laws and regulations (collectively, the “Fault of XenoPort”) XenoPort shall be responsible for Recall Costs to extent of such Fault of XenoPort, (b) the failure of Astellas to properly perform the manufacturing, formulation or packaging of the Compound and/or Products, or the gross negligence or willful misconduct of Astellas, or the failure by Astellas to comply with applicable laws and regulations, including its failure to properly file for Marketing Approval of the Products in the TerritoryTerritory (collectively, the “Fault of Astellas”), Astellas shall be responsible for Recall Costs to the extent of such Fault of Astellas and (c) in all other cases, the Recall Costs shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell be shared by the Parties as follows: [… * …] shall be borne by Astellas and Amgen [… * …] shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required borne by legal requirements, but in any event for no less than [**]XenoPort.

Recalls. 10.3.1 [*] (Adirectly or through its designated Affiliates or Sublicensees) shall have responsibility and control over any recalls, withdrawals, or field corrections of Agreement Product or its, its Affiliates’, or any GENUPRO Sublicensee’s Related Product (collectively, “Recalls”) in a country that occurs on or after the [*]. However, if such a Recall involves one or more lots of Agreement Product that were distributed and sold both (i) by ALZA or its Affiliates in one or more countries and (ii) by or on behalf of GENUPRO or its Affiliates and/or Sublicensees in one or more countries in the Territory (each, a “Split Lot”), then the Parties shall notify each other immediately upon becoming aware of any possible Recall (or any circumstances reasonably justifying a Recall) that may affect such Split Lot. The Parties shall, to the extent reasonably possible, meet prior to instituting any such Recall with respect to Agreement Product in an attempt to come to a mutually acceptable decision regarding such Recall; provided, however, that [*] in a country at the time of Recall (the “Responsible Party”) shall exchange their internal standard operating procedures, if any, [*] in such case as to product recalls whether to institute a Recall ("SOPs"regardless of whether such Recall is mandated by a Regulatory Authority or voluntarily instituted by the Responsible Party) reasonably promptly after in such country. [*] shall have the Effective Date and thereafter reasonably promptly after right, solely [*], to contact any Regulatory Authority with respect to Agreement Product if [*] has a reasonable good faith belief that such SOPs are approved or modified. If either Party becomes aware of information about quantities of Collaboration Agreement Product supplied from ViaCell to Amgen, which may not conform meet the representations and warranties set forth with respect thereto in this Agreement or any of the Manufacturing Agreements in a manner that may reasonably justify a Recall. Except as may otherwise be provided for in this Agreement or any of the Manufacturing Agreements, [*] shall, subject to Sections 12.3 and 12.4, indemnify [*] and its Affiliates against all reasonable, documented costs and expenses incurred in connection with any Recall of Agreement Product that is distributed and/or sold on or after [*] or otherwise by [*] or any of its Affiliates or Sublicensees. 10.3.2 [*] shall have responsibility and control over any Recalls of Agreement Product in a country that occur following [*] and prior to the specifications [*] for such Collaboration Productcountry, or for which there are potential adulterationprovided that (i) [*] shall, misbranding and/or other issues regarding safety or effectivenessto the extent reasonably practicable, or for which provide written notice of any such proposed Recall as promptly as reasonably possible, with such notice to include detailed information concerning the Collaboration amount of Agreement Product itself is alleged or proven to be Recalled, the subject circumstances justifying or supporting such Recall, and copies of any correspondence with Regulatory Authorities or other government agencies concerning such Recall, and [*] shall provide [*] a reasonable opportunity to comment on the proposed scope of such Recall or the manner in which such Recall shall be conducted. Further, in the event of any such Recall in any country that may have a material adverse impact on the development, marketing, sale, or distribution of Agreement Product in the Territorysuch country, it shall promptly so notify the other Party and the Party having the right to control such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes or public safety considerations so require. In all other circumstancesshall, Recalls can only be made if and as requested by [**] consent of the JSC in writing and shall be made by the Party having the first right in addition to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make available to the Party having the first right to control such Recall all pertinent records which the Party having the first right to control such Recall may reasonably request to assist in effecting any Recall, immediately suspend all further distribution of Agreement Product in such country under any Sales Services Agreement. (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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. (A) The Parties 9.1. Product recalls and FDA contacts relating to recall of Product shall exchange their internal standard operating proceduresbe the responsibility of, if anyand 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 Governmental Authorities, as appropriate, of any recall, and shall be responsible for coordinating all necessary activities regarding the action taken. DSM and OMEROS acknowledge that each Party has significant regulatory obligations; and accordingly, each Party shall fully cooperate with the other to product complete the recall, and shall thereafter resolve any allocation of liability as may be appropriate in accordance with the terms of this Agreement. 9.2. OMEROS shall give DSM prompt written notice of any Product recalls ("SOPs") reasonably promptly after that OMEROS believes were caused or may have been caused by DSM’s failure to comply with this Agreement or the Effective Date and thereafter reasonably promptly after such SOPs are approved or modifiedSpecifications. If either Party becomes aware any Product is recalled as a result of information about quantities the supply by DSM of Collaboration Product supplied from ViaCell to Amgen, which may that does not conform to the specifications Specifications or other Product requirements of this Agreement, then subject to Sections 4.2.6 and 5.5, DSM shall promptly reimburse OMEROS for its reasonable expenses incurred as a result of such Collaboration Productrecall, and, at OMEROS’ election, either refund OMEROS for any amounts paid and cancel any amounts payable pursuant to outstanding Purchase Orders under this Agreement relating to the recalled Product or replace the recalled Product with conforming Product at no cost to OMEROS. If OMEROS elects to utilize a Third Party to conduct a recall, OMEROS shall so notify DSM. Upon the occurrence of a Product recall event, OMEROS shall have the right to suspend Monthly Forecasts for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself that is alleged or proven to be the subject of the recall and neither Party shall be subject to Firm Purchase Commitments related to the recalled Product until the cause of such recall has been identified and a Recall in any country in corrective action plan mutually agreed upon by OMEROS and DSM has been implemented. 9.3. The Party responsible for causing a recall of Product shall bear the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall 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 expenses of the JSC recall. If each Party is partially responsible for causing the recall, the Parties will share the expenses of the recall in proportion to their respective responsibility. 9.4. OMEROS or its designated Third Party contractor shall maintain records of all sales of Commercial Product and shall be made by customers sufficient to adequately administer a recall for the Party having the first right to control longer of (a) a Recall pursuant to Section 5.10(b). The JSC will meet period of [†], (in person, by telephone or otherwiseb) to discuss a period of [†] and (c) 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods period as may be required by legal requirementsApplicable Law. Subject to Sections 9.1, but 9.2 and 9.3, OMEROS shall in all events be responsible for conducting any event for no less than [**].recalls of Product. † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, as to product recalls ("SOPs") reasonably promptly after the Effective Date and thereafter reasonably promptly after such SOPs are approved or modified. If either Each Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and in writing if it determines that any event, incident or circumstance has occurred which may result in the Party having need for a permanent "recall" or "market withdrawal", as such terms are defined in 21 C.F.R. Part 7.3, of a Product in the right to control Territory ("PERMANENT RECALL") or a limited "recall" or "market withdrawal," as such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes or public safety considerations so require. In all other circumstancesterms are defined in 21 C.F.R. Part 7.3, Recalls can only be made by [**] consent of the JSC and shall be made by Product in the Party having the first right Territory that is limited in territory or as to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone any lot(s) 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 batches of the Party having the first right to control such Recall pursuant to Section 5.10(bProduct ("LIMITED RECALL" and collectively with Permanent Recall, a "RECALL"), 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 BPI shall determine whether to voluntarily implement any Permanent Recall and upon what terms and conditions the Product shall be subject to a Permanent Recall; provided, however that prior to any implementation of a Permanent Recall, BPI shall consult with Kos and consider in good faith any comments Kos may have with respect to such implementation. BPI shall be primarily responsible for discussions with the FDA regarding all aspects of a Permanent Recall. BPI shall provide Kos reasonable prior notice of any clinical studies conducted by ViaCell under this Agreement, ViaCell meetings and conferences scheduled with the FDA with respect to a Product in the Territory. At all such meetings and conferences Kos shall have the exclusive right to control attend as an observer to the extent permitted by the FDA. (C) BPI shall determine whether to voluntarily implement a Limited Recall and upon what terms and conditions the Product shall be subject to a Limited Recall or otherwise temporarily or on a limited basis withdrawn from sale to Third Parties in the Territory; provided, however that prior to any implementation of a Limited Recall, BPI shall consult with Kos and consider in good faith any comments Kos may have with respect to such implementation. BPI shall be primarily responsible for discussions with the FDA regarding all aspects of Limited Recalls. BPI shall provide Kos reasonable prior notice of any meetings and conferences scheduled with the FDA with respect to the Product in the Territory. At all such meetings and conferences Kos shall have the right to attend as an observer to the extent permitted by the FDA. (D) If Kos reasonably believes that a Limited Recall or Permanent Recall of the Product is necessary, Kos shall consult with BPI and BPI shall consider in good faith any comments Kos may have with respect thereto. In the event that, after such consultation, Kos continues to reasonably believe that a Limited Recall or Permanent Recall of the Product is necessary, but BPI disagrees with such determination, then, upon written notice from Kos confirming Kos's determination to implement a Limited Recall or Permanent Recall, BPI shall promptly authorize such Limited Recall or Permanent Recall hereunder. Notwithstanding the foregoing, such dispute shall be subject to resolution pursuant to Section 14.1, and in the event it is ultimately determined that such Limited Recall or Permanent Recall was unwarranted, Kos shall not be relieved of paying the full amount of the Cardizem LA Threshold Purchases amounts resulting therefrom (to the extent Kos's obligation was relieved or reduced pursuant to Section 2.19.2). (E) In the event it is determined that a Permanent Recall or Limited Recall is implemented, Kos shall, in consultation with BPI, conduct and carry out such Recall. Kos shall utilize a batch tracing and recall system which will enable Kos to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers. (F) All costs and expenses associated with implementing a Recall of any Cell Therapy Products a Product in the TerritoryTerritory shall be allocated between BPI and Kos as follows: (I) In the event, and to the extent, that the Recall arises out of (i) the negligence or willful misconduct of Kos, (ii) a material breach of this Agreement by Kos, or (iii) the manufacturing, handling, shipping or storage of any Product by Kos, Kos shall conduct bear the costs and expenses for the Recall (including any out-of-pocket expenses reasonably incurred by BPI in conducting 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 Recall). (II) In the exclusive right to control any Recall of the Collaboration Products in the Territoryevent, and to the extent, that the Recall arises out of (i) the negligence or willful misconduct of BPI, (ii) a material breach of this Agreement by BPI, or (iii) the handling, shipping or storage of a Product by BPI, BPI shall conduct bear the costs and expenses for the Recall (including any out-of-pocket expenses reasonably incurred by Kos in conducting such a Recall). (III) In the event, and to the extent, that the Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records arises out of any Recall it has the right to control pursuant to this Section 5.10 for event other than those set forth in Sections 3.13.8(f)(i) or 3.13.8(f)(ii), such periods as may costs and expenses shall be required by legal requirements, but in any event for no less than [borne **]**.

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, procedures 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 a Licensed Product supplied from ViaCell by Amgen to Amgen, Licensee which may not conform to the specifications for such Collaboration ProductLicensed Product then in effect, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration a Licensed Product itself is alleged or proven is likely to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall pursuant to Section 5.10(b4.13.1 (Licensee Right) may or 4.13.2 (Amgen Right) shall have the right to take [**] immediate action with notice to the other Party 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC Parties will meet (in person, by telephone or otherwise) to discuss such other the circumstances of any potential Recall 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(b4.13.1 (Licensee Right) or 4.13.2 (Amgen Right), 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. Recall (B) With respect to any clinical studies conducted by ViaCell under this Agreementprovided, 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 Agreementhowever, Amgen shall have be obligated to provide manufacturing information to Licensee only to the exclusive right extent necessary for Licensee to control any Recall of the Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell Recall, and Amgen shall each maintain complete and accurate records also have the right to instead provide any such manufacturing information directly to the relevant Governmental Authority (including by provision of any Recall it has a drug master file) as appropriate (in order to better protect the confidentiality of such information). In the event of an order of a Governmental Authority having jurisdiction in the Territory mandating a Recall, the Party having the right to control such a Recall pursuant to this Section 5.10 for subsection 4.13.1 (Licensee Right) or 4.13.2 (Amgen Right) shall promptly comply with such periods as may be required by legal requirements, but in any event for no less than [**]order with written notice to the other Party.

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, as Each Party will promptly provide notice 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 such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall pursuant to Section 5.10(b(a) may take [**] when the regulatory timeframes if it is considering withdrawing or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone recalling or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of taking similar action with respect to a Recall shall be consistent with the internal SOP Licensed Product (or Licensed Diagnostic Product) (a “Recall”) or (b) of the Party having the first right any newly identified safety issue or safety signal related to control a Licensed Product (or Licensed Diagnostic Product) or any circumstance arising in such Recall pursuant to Section 5.10(bParty’s studies of a Licensed Product (or Licensed Diagnostic Product), and the other Party shall make available to the Party having the first right to control such Recall all pertinent records in each case, for which the Party having reasonably believes that an action warranting a Recall may be required to protect public health. Such notice will be given by telephone and e-mail (which notice will be provided [...***...], unless such recall involves an SAE, in which case, such notice will be provided [...***...]) and confirmed in writing promptly thereafter. The Parties will promptly meet (either in person or by teleconference or videoconference, or by other means as agreed to by the first Parties) and discuss in good faith the reason the notifying Party is considering a Recall (including any safety issues or signals), the scope thereof and the process for undertaking such Recall (provided that such discussions do not delay any action to protect public health) and work in good faith to jointly implement a strategy and any actions that may be required to protect public health, including Recalling Licensed Product (or Licensed Diagnostic Product) in one or more countries. Notwithstanding the foregoing, as between the Parties, (i) Celgene will have the sole right to control such determine whether to implement, and will be solely responsible for implementing a Recall may reasonably request with respect to assist Licensed Product (or Licensed Diagnostic Product) in effecting any Recall. the Celgene Territory in the Field, and (ii) BeiGene will have the sole right to determine whether to implement, and will be solely responsible for implementing a Recall with respect to Licensed Product (or Licensed Diagnostic Product) (A) in the Celgene Territory solely in the Heme Field, and (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 BeiGene Territory, and shall conduct such a Recall at any time at which regulatory timeframes . The Parties will reasonably cooperate in connection with Recalls of Licensed Product (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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]Licensed Diagnostic Product).

Recalls. (A) The Parties Each Party shall exchange their internal standard operating proceduresnotify the other by telephone within [***] hours after receiving any information, if any, as request or directive giving rise to product recalls ("SOPs") reasonably promptly after a good faith belief that a recall of any Product manufactured pursuant to this Agreement is or may be required under Applicable Law or is or may be otherwise necessary to avoid risk of injury or liability. Notwithstanding anything in this Agreement or the 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 Quality Agreement to the specifications for such Collaboration Productcontrary, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which Cadence shall have sole discretion over whether and under what circumstances to require the Collaboration recall of the Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, unless a Drug Regulatory Authority in the Territory issues or requests a recall or takes similar action in connection with such Product. In the event that LL, in good faith, believes that a recall is required under Applicable Law or is otherwise necessary to avoid risk of injury, it shall promptly inform Cadence by providing written notice thereof to Cadence specifying, in reasonable detail, the nature and all relevant circumstances giving rise to LL’s belief that a recall is warranted, and information regarding the affected Product. Within [***] following Cadence’s receipt of such written notification (or sooner if exigent circumstances exist or otherwise are required in order to comply with Applicable Law), the Parties shall discuss the circumstances giving rise to such notification and *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. the content of such notification, and, if so notify required, the timing and breadth of the recall, the strategies and notifications to be used by Cadence to effect the recall, and other related issues. In the event that LL recommends to Cadence, in good faith, that a recall of a particular batch or batches of the Product should be conducted, and Cadence declines to recall such Product, LL shall be entitled to indemnification pursuant to Section 6.2 of this Agreement. LL and Cadence each shall maintain such traceability records as are sufficient and as may be necessary to permit a recall, product withdrawal or field correction of any Product. Each Party shall provide full cooperation and assistance to the other Party and in connection with any recall as may be reasonably requested by the Party having other Party. (a) If a Product recall results from: (i) the right failure of any Product, packaging or labeling supplied hereunder to control such a Recall pursuant conform to Section 5.10(bthe Specifications; (ii) may take [**] when the regulatory timeframes failure of any Product, packaging or public safety considerations so require. In all other circumstanceslabeling supplied hereunder to comply with Applicable Laws or the terms of this Agreement, Recalls can only be made including the Quality Agreement, at the time the Product was delivered by [**] consent LL to Cadence’s carrier; (iii) any negligent, grossly negligent or willful act or omission by LL or its Affiliates, including without limitation the negligent or grossly negligent manufacture of the JSC Product, LL shall: (x) credit to Cadence an amount equal to the total purchase price paid by Cadence to LL for the Product so recalled, plus Cadence’s actual cost for direct material and direct labor furnished by Cadence or its contracting parties in connection with the manufacture of the recalled Product, (y) reimburse Cadence for all expenses associated with the conduct of the recall action (e.g. advertising, mailing, administration, travel, etc.), and (z) indemnify and hold Cadence harmless from and against any and all damages, costs or charges, lawsuits or expenses associated with or resulting from any such recall, including reasonable legal fees and disbursements. (b) If a Product recall results from: (i) improper handling, shipping or storage of the Product after delivery by LL to Cadence’s designated carrier, (ii) the inadequate or misleading nature of any text appearing on the packaging or labeling of the Product in compliance with the Specifications; (iii) any negligent, grossly negligent or willful act or omission by Cadence, or (iv) due to circumstances other than those described in Section 3.10(a), above, then LL shall have no liability with respect to the recall and Cadence shall indemnify, defend and hold LL and each other LL Indemnitee from any and all Losses suffered by such LL Indemnitee arising or related to such recall. The rights and remedies available to each Party under this Section 3.10 are not exclusive and shall be made by the Party having the first in addition to all other right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make remedies available to the such 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 at law and in effecting any Recallequity. (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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. (A) The Parties shall exchange their internal standard operating procedures, if any, as to product recalls ("SOPs") reasonably promptly after Principal may cease selling 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 such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall Products in any country Country/Region in the Territory at any time during the Term and recall the Products within any Country/Region in the Territory as necessary if any of the below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Country/Region in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall 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 : unforeseen effects of the JSC and shall be made by relative type of the Party having Products lead to, in Principal's sole opinion, unacceptable safety risks; Principal ceases the first right 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 control a Recall pursuant to Section 5.10(b)the Products; or other circumstances of recalls as required under the Applicable Law. 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 Distributor undertakes with respect to any product recall that: (i) it will implement and complete the recall of the Products within the Territory by the statutory deadline or a Recall shall be consistent shorter period as reasonably requested by Principal in all aspects in strict compliance with the internal SOP Applicable Law; and (ii) it shall provide full cooperation to Principal, including timely transmitting and providing feedbacks of drug recall information, controlling and recovering drugs with potential safety hazards. The Distributor may not recall any of the Party having Products from any of the first right Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following the decision to control implement a Recall, Principal and Distributor shall mutually agree on a prepared statement for use in response to any inquiries regarding such Recall. Distributor shall use such prepared statement to respond to any inquiries received with regard to such Recall pursuant and shall not make any other statement regarding such Recall; provided, that if Principal fails to Section 5.10(b), and the other Party shall make available agree with Distributor on a prepared statement prior to the Party having launch of such Recall, Distributor shall prepare and issue the first right statement as proposed by Principal regarding such Recall. To the extent the Products are recalled due 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 causes other than Distributor’s non-compliance with relevant obligations under this Agreement, ViaCell Principal shall have (a) indemnify the exclusive right Distributor for the costs and expenses reasonably incurred by the Distributor for recalling the Products and for any subsequent disposal or destruction of the same; and (b) repurchase the Products that are subject to control the Recall at the purchase price paid by the Distributor and in addition pay Distributor a handling charge equal to 10% of the purchase price. In the event that the Products are recalled due to Distributor or its Permitted Sub-distributors’ or any of its 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 any Cell Therapy 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 conduct 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 Recall at 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 time at which regulatory timeframes books, documents, papers or public safety considerations so require. Other than records that relate to or contain any information regarding any business dealings with respect to or the affairs of any clinical studies other client or principal of Distributor may only be conducted by ViaCell the Independent Auditor. Such Independent Auditor shall (i) provide a copy of the audit report to Distributor no later than thirty (30) Business Days after such report is provided to Principal and (ii) disclose to Principal relevant necessary information to enable Principal to determine whether Distributor is in compliance with this Agreement or not, and in any event shall never disclose to Principal any information regarding any business dealings with or the affairs of any other client or principal of Distributor that such Independent Auditor may come across in the course of performing its audit under this provision, unless it is required by Applicable Law. Principal shall not request an Audit more than once each Calendar Year, unless required more frequently by any regulatory authorities which have regulatory oversight over Principal or the Products, or unless breaches of Distributor's obligations under this Agreement have been identified in the course of an Audit or in the inspection by any competent authorities and subsequent Audits are required to confirm that Distributor has remedied such breaches. All Audits, including the cost of the Independent Auditor, shall be solely at Principal's expense unless the results of audit demonstrate that Distributor had failed to make due payment to Principal of an amount exceeding 5%, or Distributor had breached a material obligation under this Agreement. All Audits shall take place only during Business Hours and only upon at least seven Business Days prior written notice to Distributor. During any audits, inspections or examinations conducted by Principal or any authorised agent under this Agreement, Amgen including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or Clause 19.6, Principal agrees that it and its duly authorised agents, including any Independent Auditor: will abide by all internal regulations and policies of Distributor enforced at such time; will not interfere with the business or operation of Distributor; and without prejudice to any confidentiality limitations in this Agreement, shall at the request of Distributor enter into a separate non-disclosure agreement prepared by Distributor, prior to being granted access to any of Distributor's premises, books, documents, papers or records. In the event that the 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 exclusive right to control any Recall terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties shall in good faith agree on a Safety Data Exchange Agreement (as set forth in Exhibit G) that sets out the responsibilities of each Party with respect to the pharmacovigilance matters relating to the Products as soon as practicable after the execution of this Agreement. The Parties shall in good faith agree on the Quality Agreement that sets out the responsibilities and processes for quality activities with respect to 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 Collaboration Licensed Marks to Distributor; it has and will continue to have full legal rights to use the patents, formulae and all other intellectual property rights employed in the development and production of the Products; and to the best knowledge of Principal, the exercise by Distributor of the rights and licences granted to Distributor under this Agreement (including the use of the Licensed Marks) and the distribution, offer for sale and sale of the Products by Distributor would not infringe any right (including intellectual property rights) of any person or give rise to any liability to pay royalty or other compensation. The warranties in this Clause 21.1 are separate and independent and shall 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, and shall conduct such a Recall at Territory infringes any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records rights of any Recall it has 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 right Licensed Marks, numbers, or other means of identification used on or in relation to control 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 Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]Agreement.

Recalls. (A) The Parties shall exchange their internal standard operating procedures5.2.1 BioMarin may, if anyin its sole discretion, as determine whether or when to product initiate any recalls ("SOPs") reasonably promptly after of Aldurazyme in the United States and Genzyme may, in its sole discretion, determine whether or when to initiate any recalls of Aldurazyme anywhere else in the world. As of the Effective Date and thereafter reasonably promptly throughout the term of this Agreement, BioMarin and Genzyme shall prepare and maintain a written SOP, to handle any recalls of Aldurazyme. Such SOP shall include, without limitation, prior notice to and consultation with the other Party of any recall; provided, however, that in no event shall such consultation be deemed to limit or supersede the Parties’ ability to make recall decisions in their sole discretion pursuant to the first sentence hereof. Genzyme shall transmit recall decision information to BioMarin to Vice President, -23- Regulatory Affairs, by phone at (000) 000-0000 or facsimile at (000) 000-0000. BioMarin shall transmit recall decision information to Genzyme to Regulatory Affairs/QA, attention: Vice President, Regulatory Affairs and Corporate Quality Compliance, by phone at (000) 000-0000 or facsimile at (000) 000-0000. In the event that (i) any regulatory authority or other governmental agency or authority issues a request or directive or orders that Aldurazyme be recalled or retrieved, (ii) a court of competent jurisdiction orders that Aldurazyme be recalled or retrieved or (iii) a Party determines that Aldurazyme should be recalled, retrieved or a “Dear Doctor” letter is required relating to restrictions on use of Aldurazyme in a country for which it is responsible, the Party responsible for the relevant country pursuant to the first sentence hereof shall conduct such activity and the Parties shall take all appropriate corrective actions and shall execute the steps detailed in the SOP. To the extent practicable, the Parties shall coordinate the notices of any such recall to be delivered to regulatory authorities (including the timing thereof). Genzyme and BioMarin shall cooperate fully with one another in conducting such action. Genzyme shall destroy units of Aldurazyme lawfully recalled only upon BioMarin’s (or any regulatory authority’s) written instruction to destroy such units of Aldurazyme, and only then in accordance with BioMarin’s procedures and instructions. Otherwise, Genzyme may return the recalled units of Aldurazyme to BioMarin in accordance with BioMarin’s instructions within thirty (30) days after such SOPs are approved completion of the action. In the event that either BioMarin or modified. If either Party Genzyme becomes aware of information about quantities circumstances that may necessitate a recall of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall Aldurazyme in any country in the Territoryfor which it is not responsible pursuant to this Section 5.2, it shall will promptly so notify the other Party of such circumstances. 5.2.2 In the event a recall results from the manufacture of Aldurazyme (including without limitation changes made pursuant Sections 3.11 and 3.12 hereof) or BioMarin’s negligence or willful misconduct, BioMarin shall be responsible for the Party having the right to control such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory timeframes or public safety considerations so requireexpenses thereof. In all other circumstancesthe event a recall results from Genzyme’s filling, Recalls can only packaging, labeling or storage of Aldurazyme, or Genzyme’s negligence or willful misconduct (including without limitation any negligence or willful misconduct resulting in adulteration of Aldurazyme), Genzyme shall be made by [**] consent responsible for the expenses thereof. Otherwise, the Parties shall share equally the expenses of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b)action. The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses For purposes 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 the expenses of the action shall have be the exclusive right to control a Recall expenses of any Cell Therapy Products in notification and return or destruction (if such destruction is authorized by BioMarin or the Territoryapplicable regulatory authority) of units of the recalled Aldurazyme, the cost of replacement of the recalled Aldurazyme, and any costs directly associated with the distribution of replacement Aldurazyme. For the avoidance of doubt, amounts payable under Article 6 hereof shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. Other than with respect only be payable on Aldurazyme used to any clinical studies conducted by ViaCell under this Agreement, Amgen shall have replace the exclusive right to control any Recall of recalled Aldurazyme (not on the Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]returned Aldurazyme itself).

Recalls. (Aa) The Parties Subject to this Section 3.1.4, a Recall in the Co-Promotion Territory shall exchange their internal standard operating proceduresbe the responsibility, if anyand under the control, of ZGEN. Bayer shall provide all pertinent records and such other assistance to ZGEN as ZGEN reasonably may request to product recalls assist in effecting any Recall in the Co-Promotion Territory. In addition, Bayer will maintain all records relating to the Recall for the period required by legal requirements, but for no less than three ("SOPs"3) reasonably promptly after years. ZGEN shall bear the Effective Date and thereafter reasonably promptly after such SOPs are approved costs of the Recall in the Co-Promotion Territory except to the extent that a Recall results from the negligence or modified. willful misconduct of Bayer. (b) If either Party becomes aware of information about quantities of Collaboration Initial Licensed Product supplied from ViaCell to Amgen, which that may not conform to the specifications for such Collaboration the Initial Licensed Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Initial Licensed Product itself is alleged or proven to be the subject of a Recall in any country in the Territoryworld, it shall will promptly so notify the other Party and the Party having the right to control such a Recall 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b)Party. The JSC Parties will meet (in person, by telephone or otherwise) to discuss such other the circumstances of a Recall in the Co-Promotion Territory 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 Recall; provided that ZGEN 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 take immediate action when regulatory time at which regulatory timeframes frames or public safety considerations so require. Other than . (c) If ZGEN fails to conduct a Recall in the Co-Promotion Territory after Bayer gives written notice that, in the good faith opinion of Bayer, a Recall should be undertaken to address specific issues of Initial Licensed Product safety (“Safety Issues”), which written notice identifies the specific Safety Issues, then (i) Bayer shall have no obligation to defend or indemnify ZGEN under Article 8 for any Losses arising in connection with respect to the Safety Issues for Initial Licensed Product that was sold, promoted or distributed in the Co-Promotion Territory after receiving such written notice from Bayer, (ii) ZGEN will defend and indemnify Bayer under Article 8 for any clinical studies conducted by ViaCell such Losses, and (iii) Bayer will have no further obligations under this Agreement, Amgen shall have Agreement to Detail or otherwise promote the exclusive right to control any Recall of relevant Initial Licensed Product unless and until the Collaboration Products Safety Issues are resolved in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records good faith opinion of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]Bayer.

Recalls. (A) The Parties 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 exchange their internal standard operating procedurespromptly inform XANODYNE in writing prior to taking any such action. XANODYNE shall notify the FDA, if anyDEA, and any foreign regulatory agencies of any recall, and shall be responsible for coordinating all necessary activities regarding the action taken. XANODYNE acknowledges and understands that DSM, as manufacturer of the Product, has significant regulatory obligations if there are any indications that recall or withdrawal would be necessary. Accordingly, DSM and XANODYNE agree to cooperate fully regarding any proposed recall, product recalls ("SOPs") reasonably withdrawal, or field correction; and the Parties agree to keep each other advised, and to exchange copies of such documentation as may be required, to assure regulatory compliance. With prior notification to the other party, either party may, in exigent circumstances, make a unilateral, final decision to notify appropriate regulatory agencies, 27 DISPUTE RESOLUTION In the event that a dispute arises between DSM and XANODYNE regarding the nonconformity of a batch of the Products or regarding other matters, the senior management of the quality departments from both companies shall in good faith promptly after the Effective Date and thereafter reasonably promptly after such SOPs are approved or modifiedattempt to resolve disputed issues. If either Party becomes aware the parties cannot reach agreement, the matter shall be resolved in accordance with dispute resolution provisions of information about quantities the Supply Agreement. XANODYNE may only dispute a batch of Collaboration Product supplied from ViaCell to AmgenProduct, which may not conform to the specifications has been dispositioned by DSM for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having release. Xanodyne Corporate Quality Assurance retains at all times the right to control such a Recall pursuant determine Product release status for commercial distribution. Financial liability shall be determined according to Section 5.10(b) may take the Supply Agreement. APPENDIX I: OUTLINE OF RESPONSIBILITIES FUNCTION DSM XANODYNE -------- ---- -------- MANUFACTURING [**] when the regulatory timeframes or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent In-Process TESTING (Physical, Chemical Microbial) [**] [**] FP TESTING - Physical, Chemical [**] [**] FP TESTING - Sterility [**] [**] FP RELEASE [**] [**] DISTRIBUTION [**] [**] FP RETAINS [**] [**] FP STABILITY [**] [**] C OF A [**] [**] BATCH RECORD REVIEW/SIGNOFF [**] [**] INVESTIGATIONS INTO DEVIATIONS AND NON-CONFORMANCES [**] [**] COMPLAINT RECEIPTS [**] [**] COMPLAINT INVESTIGATIONS [**] [**] ADVERSE EVENT REPORTS [**] [**] FIELD ALERT REPORTS [**] [**] RECALLS [**] [**] CUSTOMER RETURNS [**] [**] RAW MATERIAL (Active) ORDERS [**] [**] RAW MATERIAL (Active) TESTING AND Release [**] [**] RAW MATERIAL (Inactives/Printed Packaging Materials) ORDERS [**] [**] RAW MATERIALS (Inactives/Printed Packaging Materials) TESTS [**] [**] RAW MATERIAL (Inactives/Printed Packaging Materials) RELEASE [**] [**] SUPPLIER AUDITS (Active) [**] [**] SUPPLIER AUDITS (Inactives/Printed Packaging Materials) [**] [**] MAINTENANCE OF VENDOR LISTS [**] [**] NOTICE OF PROPOSED CHANGES [**] [**] DOCUMENT CHANGE CONTROL [**] [**] ANNUAL Product REVIEW [**] [**] APPENDIX II: CONTACT INFORMATION XANODYNE KEY CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- --------- ---------------------- -------------- G. Xxxxx Xxxxx Director, 859-547- 859-814- General Quality xxxxxx@xxxxxxxx.xxx Quality 0000 0000 (cell) Assurance Xxxxxx X. Xxxxx Manager, 859-547- 859-992- General Quality xxxxxx@xxxxxxxx.xxx Quality 00000 0000 (cell) Assurance OSM Key CONTACTS PRODUCT NAME TITLE CONTACT NUMBERS RESPONSIBILITY ---- ----------------- ------------------------ -------------- Xxxxxx XX, Quality Ph: 000-000-0000 General Quality Norton Assurance xxxxxx.xxxxxx@xxx.xxx Xxx Xxxxx Director, Quality Ph: 000-000-0000 rob. Manufacturing Assurance xxxxx@dsm. com Oversight Xxxxx Xxxxxxxxxx Director, Quality Ph: 000-000-0000 Lab Oversight Assurance xxxxx.xxxxxxxxxx@xxx.xxx Will Mitten Director, Lab Ph: 000-000-0000 Lab Services Services xxxx.xxxxxx@xxx.xxx Xxxx Xxxxxxxx Manager, Ph: 000-000-0000 xxxx. Stability Stability xxxxxxxx @dsm. com Xxxx Manager, Quality Ph: 000-000-0000 APRs, Complaints, Xxxxxxx Assurance xxxx.xxxxxxx@xxx.xxx Audits, APPENDIX III: PRODUCTS DARVOCETN-100 QUALITY AGREEMENT HISTORY OF CHANGES VERSION DATE NAME REVISIONS/COMMENTS ------- ---- ---- ------------------ EXHIBIT D: CONFIDENTIALITY AGREEMENT 1. During the term of this Agreement, the JSC undersigned Parties may disclose certain confidential and shall be made 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 the one Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in personsuch capacity, by telephone or otherwisethe "Disclosing Party") 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 (in such capacity, the "Receiving Party") relating to the Disclosing Party's Products and/or its business operations and the results, reports, etc., of testing and evaluation of any such information shall constitute "Proprietary Information." 2. The Disclosing Party having shall disclose and supply its Proprietary Information to the first right to control such Recall all pertinent records which the Receiving Party having the first right to control such Recall may reasonably request solely to assist the Receiving Party in effecting any Recall. (B) With respect to any clinical studies conducted by ViaCell performing its obligations under this Agreement, ViaCell any related API Schedules, and AAI purchase orders. 3. In consideration of the Disclosing Party's disclosure and supply of Proprietary Information, each Party, as a potential Receiving Party, agrees that, for a period of seven (7) years from the date of such disclosure, it: (a) shall have use The Disclosing Party's Proprietary Information exclusively for the exclusive right to control a Recall of any Cell Therapy Products limited purposes set forth in the Territoryfirst numbered paragraph hereof; and (b) shall not disclose, and shall conduct such without the express written consent of the Disclosing Party, any Proprietary Information, including this Agreement or the interest of the Disclosing Party in exploring the possibility of entering into a Recall at any time at which regulatory timeframes or public safety considerations so require. Other than business relationship with respect the Receiving Party, to any clinical studies conducted by ViaCell under this Agreement, Amgen shall have the exclusive right person other than to control any Recall those employees of the Collaboration Products Receiving Party ("Representatives") who will be directly involved in fulfilling the TerritoryReceiving Party's obligations hereunder, provided that such Representatives have assumed like obligations of confidentiality to the Disclosing Party. 4. Each Party, as a potential Receiving Party, agrees to advise those of its Representatives who receive Proprietary Information that such information (a) is proprietary and confidential to the Disclosing Party and (b) shall conduct 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 a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirementsProprietary Information, but in any event for no less than [**]reasonable precautions. 5. In the event that the Receiving Party becomes compelled to disclose any 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 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 the public domain; (b) information which, after the Disclosing Party's disclosure to the Receiving Party, enters the public domain, except where such entry is the result of the Receiving Party's breach of this Agreement or otherwise is the result of any unauthorized disclosure by 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 of January 26, 2004, supplements the Supply Agreement by, among other things, identifying a particular Product, the purchase and sale of which shall be governed by the terms of the Supply Agreement as well as this Schedule.

Recalls. (Aa) The Parties shall will exchange their internal standard operating proceduresSOPs, if any, as to product recalls ("SOPs") reasonably promptly Recalls within [ * ] after the Effective Date and thereafter reasonably promptly within [ * ] after such SOPs are approved or modifiedmodified and become effective. If either Party becomes aware of information about quantities of Collaboration Licensed Product supplied from ViaCell to Amgen, which that may not conform to the specifications for such Collaboration the Licensed Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Licensed Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall will promptly so notify the other Party. Either Party and may take immediate action, with notice to the Party having the right other Party, with respect to control such a Recall pursuant to Section 5.10(b) may take [**] in such Party’s portion of the Territory when the regulatory timeframes time frames or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent of the JSC and shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC Parties will meet (in person, by telephone or otherwise) to discuss such other circumstances of a Recall in the Territory and to consider appropriate courses of actionaction with respect to such Recall, which courses of action with respect to a Recall shall will be consistent with the internal SOP SOPs of the Bayer or ZGEN, as applicable. Each Party having the first right shall provide all pertinent records and such other assistance to control such Recall pursuant to Section 5.10(b), and the other Party shall make available to the as such other Party having the first right to control such Recall all pertinent records which the Party having the first right to control such Recall reasonably may reasonably request to assist in effecting any Recall. (B) With respect . In addition, each Party will maintain all records relating 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 for 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be period required by legal requirements, but in any event for no less than [**[ * ]. (b) The Parties shall bear the costs of a Recall as follows: (i) To the extent that the Recall results from the acts or omissions of a Third Party manufacturer of Bulk Drug Substance or Licensed Product, including a Recall that results from the failure of Bulk Drug Substance or Licensed Product to meet the manufacturing specifications set forth in the contract with such Third Party manufacturer, each Party’s responsibility for the costs relating to the Recall shall be as set forth in the Manufacturing Agreements (consistent with the terms set forth in Exhibit I) or in any other supply or manufacturing agreements entered into by the Parties, as applicable. (ii) To the extent that the Recall results from the negligence or willful misconduct of a Party (the “First Party”), the First Party shall bear the out-of-pocket costs of the other Party relating to the Recall; provided that if the other Party fails to conduct a Recall in its portion of the Territory after the First Party gives written notice that, in the good faith opinion of the First Party, a Recall should be undertaken to address specific issues of Licensed Product safety (“Safety Issues”), which written notice identifies the specific Safety Issues, then the First Party shall have no obligation to defend or indemnify the other Party under Article 16 for any Losses arising in connection with the Safety Issues for Licensed Product that was sold or distributed by the other Party after receiving such written notice from the First Party, and the other Party will defend and indemnify the First Party under Article 16 for any such Losses. (iii) To the extent that a Recall does not fall within Section 7.10(b)(i) or (ii), each Party shall bear the costs of the Recall in its own portion of the Territory.

Recalls. (Aa) The In the event that either Party obtains information that a Licensed Product or any portion thereof has been alleged or proven not to meet the Specifications, labeling, or Approved ANDA for such Licensed Product or to be otherwise defective, such Party shall notify the other Party immediately and, to the extent that such Licensed Product has been supplied to Kos hereunder, both Parties shall exchange their internal standard operating procedurescooperate fully regarding the investigation and disposition of any such matter, including with respect to any Licensed Product recall, Licensed Product withdrawal or field correction, as appropriate (collectively, a "Recall"). Xxxx and Kos shall each maintain such traceability records as are sufficient and as may be necessary to permit a Recall or field correction of any Licensed Products. In the event (i) any applicable Governmental Authority should issue a request, directive or order that a Licensed Product be Recalled or (ii) either Party determines that any Licensed Product already in interstate commerce presents a risk of injury or gross deception or is otherwise defective and that a Recall of such Licensed Product is appropriate, each Party shall give telephonic notice (to be confirmed in writing) to the other within 24 hours of the occurrence of such event. (b) For so long as Kos is the only Person commercializing a Licensed Product, Kos shall consult with Xxxx, but Kos shall have sole responsibility, in its reasonable discretion (but subject to the superseding rights of Xxxx as the ANDA holder to have the final say pursuant to Section 4.1) for determining all corrective action to be taken (including a Recall) with respect to any Licensed Product sold by Kos, its Affiliates or sublicensees and for carrying out the Recall, if any, as which shall be conducted in Kos' name. Xxxx will provide reasonable cooperation and assistance to product recalls Kos upon request in connection therewith. Kos shall be responsible for all costs and expenses of any such Recall ("SOPs"including any reasonable out-of-pocket costs incurred by Xxxx in connection with such cooperation) 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 except to the specifications for extent such Collaboration Recall is attributable to Xxxx'x (or its designees', subcontractors' or Affiliates') breach of their respective obligations or representations or warranties under this Agreement. Commencing on the date, if any, that Kos is not the only Person commercializing a Licensed Product, or the Parties agree to cooperate in good faith to reach agreement on a joint decision 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 determining all corrective action to be the subject of taken (including a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall pursuant to Section 5.10(bRecall) 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to that Licensed Product and for carrying out the Recall, if any. Notwithstanding the foregoing, should Xxxx determine that it is necessary to initiate a Recall Recall, and Kos does not so agree despite the Parties good faith efforts to reach agreement, Xxxx'x determination on this matter shall be consistent with the internal SOP binding on both Parties. Xxxx shall be responsible for all costs and expenses of the Party having the first right to control any such Recall pursuant to Section 5.10(b), and the other Party shall make available (including any reasonable out-of-pocket costs incurred by Xxxx in connection with such cooperation) to the Party having the first right to control extent such Recall all pertinent records which the Party having the first right is attributable to control such Recall may reasonably request to assist in effecting any RecallXxxx'x (or its designees', subcontractors' or Affiliates') breach of their respective obligations or representations or warranties under this Agreement. (Bc) With respect to any clinical studies conducted by ViaCell under this Agreement, ViaCell Xxxx shall have the exclusive right sole responsibility, in its reasonable discretion, for determining all corrective action to control be taken (including 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 Recall) with respect to any clinical studies Licensed Product not sold by Kos, its Affiliates or sublicensees and for carrying out the Recall, if any, which shall be conducted by ViaCell under this Agreement, Amgen in its own name. Kos will provide reasonable cooperation and assistance to Xxxx upon request in connection therewith. Xxxx shall have the exclusive right to control any Recall of the Collaboration Products in the Territory, be responsible for all costs and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records expenses of any such Recall it has the right to control pursuant to this Section 5.10 for (including any reasonable out-of-pocket costs incurred by Kos in connection with such periods as may be required by legal requirements, but in any event for no less than [**]cooperation).

Recalls. (A) The Parties Each Party shall exchange their internal standard operating proceduresnotify the other by telephone within [***] after receiving any information, if any, as request or directive giving rise to product recalls ("SOPs") reasonably promptly after a good faith belief that a recall of any Product manufactured pursuant to this Agreement is or may be required under Applicable Law or is or may be otherwise necessary to avoid risk of injury or liability. Notwithstanding anything in this Agreement or the 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 Quality Agreement to the specifications for such Collaboration Productcontrary, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which Cadence shall have sole discretion over whether and under what circumstances to require the Collaboration recall of the Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, unless a Drug Regulatory Authority in the Territory issues or requests a recall or takes similar action in connection with such Product. In the event that LL, in good faith, believes that a recall is required under Applicable Law or is otherwise necessary to avoid risk of injury, it shall promptly inform Cadence by providing written notice thereof to Cadence specifying, in reasonable detail, the nature and all relevant circumstances giving rise to LL’s belief that a recall is warranted, and information regarding the affected Product. Within [***] following Cadence’s receipt of such written notification (or sooner if exigent circumstances exist or otherwise are required in order to comply with Applicable Law), the Parties shall discuss the circumstances giving rise to such notification and the content of such notification, and, if so notify required, the timing and breadth of the recall, the strategies and notifications to be used by Cadence to effect the recall, and other related issues. In the event that LL recommends to Cadence, in good faith, that a recall of a particular batch or batches of the Product should be conducted, and Cadence declines to recall such Product, LL shall be entitled to indemnification pursuant to Section 6.2 of this Agreement. LL and Cadence each shall maintain such traceability records as are sufficient and as may be necessary to permit a recall, product withdrawal or field correction of any Product. Each Party shall provide full cooperation and assistance to the other Party and in connection with any recall as may be reasonably requested by the Party having other Party. (a) If a Product recall results from: (i) the right failure of any Product, packaging or labeling supplied hereunder to control such a Recall pursuant conform to Section 5.10(bthe Specifications; (ii) may take [the failure of any Product, packaging or labeling supplied hereunder to comply with Applicable Laws or the terms of this Agreement, including the Quality Agreement, at the time the Product was delivered by LL to **] when * Certain information on this page has been omitted and filed separately with the regulatory timeframes Commission. Confidential treatment has been requested with respect to the omitted portions. Cadence’s carrier; (iii) any negligent, grossly negligent or public safety considerations so require. In all other circumstanceswillful act or omission by LL or its Affiliates, Recalls can only be made by [**] consent including without limitation the negligent or grossly negligent manufacture of the JSC Product, LL shall: (x) credit to Cadence an amount equal to the total purchase price paid by Cadence to LL for the Product so recalled, plus Cadence’s actual cost for direct material and direct labor furnished by Cadence or its contracting parties in connection with the manufacture of the recalled Product, (y) reimburse Cadence for all expenses associated with the conduct of the recall action (e.g. advertising, mailing, administration, travel, etc.), and (z) indemnify and hold Cadence harmless from and against any and all damages, costs or charges, lawsuits or expenses associated with or resulting from any such recall, including reasonable legal fees and disbursements. (b) If a Product recall results from: (i) improper handling, shipping or storage of the Product after delivery by LL to Cadence’s designated carrier, (ii) the inadequate or misleading nature of any text appearing on the packaging or labeling of the Product in compliance with the Specifications; (iii) any negligent, grossly negligent or willful act or omission by Cadence, or (iv) due to circumstances other than those described in Section 3.10(a), above, then LL shall have no liability with respect to the recall and Cadence shall indemnify, defend and hold LL and each other LL Indemnitee from any and all Losses suffered by such LL Indemnitee arising or related to such recall. The rights and remedies available to each Party under this Section 3.10 are not exclusive and shall be made by the Party having the first in addition to all other right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action with respect to a Recall shall be consistent with the internal SOP of the Party having the first right to control such Recall pursuant to Section 5.10(b), and the other Party shall make remedies available to the such 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 at law and in effecting any Recallequity. (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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].

Recalls. In the event that it becomes necessary to conduct a recall, market withdrawal or field correction (Ahereafter collectively referred to as "recall") The Parties of any Licensed Product manufactured by SANO and sold by Par or its Affiliates the following provisions shall exchange their internal standard operating proceduresgovern such a recall: (a) After consulting with SANO, if anyand on terms and conditions reasonably satisfactory to SANO, Par shall conduct (and shall cause its Affiliate to conduct) the recall and shall have primary responsibility therefore and SANO and Par shall each cooperate with the other in recalling any affected Licensed Product(s). Par covenants and agrees to maintain and to cause its Affiliates to maintain such records of all sales of the Licensed Products made by Par or its Affiliates as are required by the FDA or as are reasonably appropriate for a distributor of pharmaceutical products to maintain so as to enable a recall to be properly completed. (b) Irrespective of whether the recall is initiated by Par or by SANO: (i) If it is later demonstrated that the reason for the recall was due primarily to acts or omissions of SANO (or the safety or efficacy of the Licensed Product other than as a result of acts or omissions of Par or its Affiliates), then SANO shall pay or reimburse, as the case may be, all reasonable direct out-of-pocket expenses, including but not limited to product recalls 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 ("SOPs"ii) reasonably promptly after If it is later determined that the Effective Date 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 thereafter reasonably promptly after expenses and credits and recall expenses claimed by and paid to customers, incurred by Par or SANO in connection with performing any such SOPs recall; or (iii) If the parties are approved unable to agree that the cause of the recall was due primarily to the act or modifiedomission 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. If either Party becomes aware Each of information about quantities the parties shall use its reasonable best efforts to minimize the expenses of Collaboration Product supplied from ViaCell recall which it incurs. It is understood and agreed that the direct out-of-pocket costs and expenses of the recall contemplated in Paragraphs (i), (ii) and (iii) above shall not include the invoice price charged by PRI or its Affiliates to Amgenthe customers for the Products recalled, which may amount shall be dealt with in accordance with the provisions of Section 9 hereof and shall also not conform 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 the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself extent that it is alleged or proven to be the subject an expense of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall SANO pursuant to Section 5.10(b14.3 hereof (provided that where the provisions of Paragraph (iii) may take above apply, the excess reprocurement costs and related penalties and assessments incurred pursuant to Approved Contracts [**as that term is defined in Section 14.3 hereof] when shall be shared by the regulatory timeframes or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent parties in the proportion in which Gross Profits are shared in respect of the JSC and shall be made by the Party having the first right to control a Recall recalled Products sold pursuant to Section 5.10(bsuch Approved Contracts). 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. (Bc) 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 All Licensed 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control recalled pursuant to this Section 5.10 14.1 shall be treated as Licensed Products returned to Par by its customers and the provisions of 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 actual recall by either party should the recalling party fail to inform FDA of that recall within ten (10) days of a written request by the non-recalling party to so inform FDA. (e) For greater certainty, in the event of a recall, neither party or its Affiliates shall profit from any out-of-pocket expenses incurred by it in connection with the recall and for such periods 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 may be required contemplated in Section 10.1 hereof), neither party shall have a claim against the other party for any damages, losses or expenses which it suffers or incurs as a result thereof except to the extent permitted or contemplated in this Section 14. (f) Each party shall provide reasonable evidence to the other of the out-of-pocket expenses being claimed by legal requirements, but in any event for no less than [**]it and the rights of SANO pursuant to Section 11.4 and the rights of Par pursuant to Section 11.8 shall apply thereto.

Recalls. (A) The Parties shall exchange their internal standard operating proceduresIn the event Manufacturer is required to initiate a recall, if any, as to product recalls ("SOPs") reasonably promptly after the Effective Date and thereafter reasonably promptly after such SOPs are approved withdrawal or modified. If either Party becomes aware of information about quantities of Collaboration Product supplied from ViaCell to Amgen, which may not conform to the specifications for such Collaboration Product, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, or for which the Collaboration Product itself is alleged or proven to be the subject of a Recall in any country in the Territory, it shall promptly so notify the other Party and the Party having the right to control such a Recall 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 shall be made by the Party having the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss such other circumstances and to consider appropriate courses of action, which courses of action field correction 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 Finished US Goods provided under this Agreement, ViaCell Manufacturer shall have immediately notify Buyer in writing. In the exclusive right to control event that Buyer believes that a Recall of any Cell Therapy Products in the Territoryrecall, and shall conduct such a Recall at any time at which regulatory timeframes withdrawal or public safety considerations so require. Other than field correction is necessary with respect to any clinical studies conducted by ViaCell Finished US Goods provided under this Agreement, Amgen Buyer shall so notify Manufacturer and both parties shall cooperate to determine the appropriate action to take. In the event any Governmental Entity issues a request, directive or order requiring that any Finished US Goods provided under this Agreement be recalled, or detains or destroys or prevents the release of any Finished US Goods provided under this Agreement, each party shall give the other party telephonic notice (to be confirmed in writing) within twenty-four (24) hours of the occurrence of such event. In the event of such a recall, withdrawal or field correction, Buyer shall have the exclusive right sole responsibility to control any Recall implement the recall or other corrective action, but shall keep Manufacturer informed on a regular basis of its progress in planning and implementing the Collaboration Products recall or other corrective action. Manufacturer shall cooperate with Buyer in the Territoryconnection with, and the provisions of Section 7.6(c) shall conduct be applicable to, any such action. Without limiting the provisions of Section 5.8, if there is a Recall at disagreement between the parties as to whether a recall, withdrawal or field correction is required or advisable, the parties shall in good faith cooperate and consider each other’s view to reach agreement as promptly as possible on a mutually acceptable course of action in accordance with relevant Governmental Rules. If relevant, either party may refer the matter for analysis to a specialized laboratory of national reputation acceptable to both parties, and any time at which regulatory timeframes or public safety considerations so require. ViaCell determination by such laboratory shall be final and Amgen shall each maintain complete and accurate records of any Recall it has binding upon the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**]parties.

Recalls. (A) The Parties shall exchange their internal standard operating proceduresIf a recall, if any, 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 such Collaboration Productwithdrawal, or for which there are potential adulteration, misbranding and/or other issues regarding safety or effectivenesscorrection (including the dissemination of relevant information) of any Product in a Party’s Territory (a “Recall”) is required by a Regulatory Authority of competent jurisdiction, or for which the Collaboration Product itself is alleged or proven to be the subject if a Recall of a Recall Product in any country its respective Territory is deemed advisable by such Party in the Territoryits sole discretion, it then such Party shall promptly so notify the other Party no later than the earlier of (a) twenty-four (24) hours after receipt by the applicable Party of such requirement from a Regulatory Authority and (b) one (1) Business Day in advance of the earlier of (i) initiation of a Recall, or (ii) the submission of plans for such an action to a Regulatory Authority. Promptly after being notified of a Recall, each Party having shall provide the right to control other Party with such assistance in connection with such Recall as may be reasonably requested by such other Party. All costs and expenses in connection with a Recall pursuant in a Party’s Territory, including the costs and expenses related to Section 5.10(bthe dissemination of relevant information, shall be borne by such Party unless such Party proves that such Recall is required due to (x) may take [**] when the regulatory timeframes or public safety considerations so require. In all other circumstances, Recalls can only be made by [**] consent Party’s breach of the JSC and shall be made representations, warranties, covenants or obligations under this Agreement (or the Supply Agreement or Quality Agreement) or violation of Applicable Laws, (y) the intentional misconduct or negligent acts by the other Party having or (z) defects in the first right to control a Recall pursuant to Section 5.10(b). The JSC will meet (in personProduct caused by the other Party; provided that, 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 of Product and Related Substance that is supplied by or on behalf of ADCT pursuant to a Supply Agreement entered into between the internal SOP of the Party having the first right to control such Recall Parties pursuant to Section 5.10(b8.2 (Supply Agreement), any applicable provisions of the applicable supply agreement shall solely apply. Sobi shall determine and the other Party shall make available communicate with applicable Regulatory Authority regarding whether 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 initiate any Recall. (B) With respect , of any Product in the Sobi Territory and ADCT shall determine and communicate with the applicable Regulatory Authorities regarding whether to initiate any clinical studies conducted by ViaCell under this Agreement, ViaCell shall have the exclusive right to control a Recall of any Cell Therapy Products Product in the ADCT 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 Collaboration Products in the Territory, and shall conduct such a Recall at any time at which regulatory timeframes or public safety considerations so require. ViaCell and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Section 5.10 for such periods as may be required by legal requirements, but in any event for no less than [**].