Common use of Recalls Clause in Contracts

Recalls. In the event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform to the Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose of such recall is not attributable to the fault of either Adams or 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recall.

Recalls. In “Layoffs” shall be defined as a necessary reduction in the event work force or hours beyond normal attrition. Bargaining Unit Members will receive thirty (a30) any government authority issues calendar days notice of layoff. If a request, directive or order that any Drug Product be recalled, or (b) Health Aide position is eliminated due to a court of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because student’s dropped enrollment from the Drug Product does not conform to the Specificationsdistrict, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLHealth Aide will receive five (5) school days notice. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients a necessary reduction in the Drug Product work force or hours, the District shall first layoff probationary Bargaining Unit Members in the affected classification, then the least-senior Bargaining Unit Member in that classification. In no case shall a new Bargaining Unit Member be employed by the District while there are laid- off Bargaining Unit Members who are qualified for a vacant or newly-created position. A laid-off Bargaining Unit Member, at his/her option, be granted priority status on the substitute list according to his/her seniority. If it is apparent a layoff is imminent, the Association and where the District shall work in a timely manner to identify a mutually-acceptable solution. If no such solution can be developed, the provisions of this contract shall apply. Bargaining Unit Members whose positions have been eliminated due to reduction in work force or who have been affected by layoff shall have the right to assume a position for which they are qualified, according to the job description, which is held by the least-senior full time/part-time member. Part-time members whose positions have been affected by a layoff shall have the right to assume a position for which they are qualified which is held by the least-senior-part-time member. In the event of a layoff, a full-time Bargaining Unit Member may claim seniority over another Bargaining Unit Member for the purpose of such recall is not attributable maintaining his/her normal work schedule, provided he/she has greater seniority than the Bargaining Unit Member he/she seeks to replace. A part- time Bargaining Unit Member may claim seniority over another part-time Bargaining Unit Member for the fault purpose of either Adams or Cardinalmaintaining his/her normal work schedule, Adams shall be responsible for all Adams and Cardixxx xxpenses of provided he/she has greater seniority than 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject part-time Bargaining Unit Member he/she seeks to recallreplace.

Recalls. In Decisions with respect to recalls, withdrawals or corrections of Licensed Product related to manufacturing or product quality issues shall be handled in accordance with the Clinical Supply Agreement and the Commercial Supply Agreement. The JSC shall have decision-making authority with respect to issuing all other recall, market withdrawal or correction of any Licensed Product in the Territory. The members of the JSC for each Party shall delegate their authority under this Section to the appropriate executive officers in their respective regulatory departments who shall develop appropriate standard operating procedures with respect to recalls. To the extent regulatory timeframes or public safety considerations require immediate action, a telephone conference of the JSC's designees under this Section shall be called within the required timeframe to consider the action and make a decision. Each Party shall notify the other Party promptly (and in any event within twenty-four (a24) hours of receipt of CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS (*) DENOTE SUCH OMISSIONS. written notice) if any government authority issues a request, directive Licensed Product is alleged or order that any Drug Product proven to be recalled, or (b) a court the subject of competent jurisdiction orders such a recall, market withdrawal or (c) Adams reasonably determines after consultations with Cardinal that correction in any country in the Territory. Once a Xxxx Product should be recalled because the Drug Product does not conform to the Specificationsrecall or withdrawal decision has been made under this Section, the parties shall take all appropriate corrective actions. Cardinal Distributing Party, under the direction of the JCT and the designees of the JSC, shall be responsible for Cardinal's handling and Adams' expenses implementing such recalls and market withdrawals of any Licensed Product in the Territory, provided that such activities be performed in accordance with standard operating procedures approved by the JCT and the JSC. The other Party will make available to the Distributing Party, upon request, all of the other Party's pertinent records that the Distributing Party may reasonably request to assist it in effecting any recall or market withdrawals. The Parties shall share equally all costs of a recall or marketing withdrawal in the Territory in accordance with a budget for such activities to be agreed upon by the extent JCT and approved by the JSC. A Party shall have no obligation to reimburse or otherwise compensate the other Party for any lost profits or income that may arise in connection with any such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLor market withdrawal. Adams Any investigation conducted in connection with a Licensed Product recall shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined undertaken 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 Parties under the event of an FDA-initiated nationwide recall where the scope direction of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose of such recall is not attributable to the fault of either Adams or 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recallJSC.

Recalls. AbbVie shall make every reasonable effort to notify Galapagos promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the AbbVie Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. AbbVie (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the AbbVie Territory. In the event that either Party believes that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Galapagos Territory (including any ***Confidential Treatment Requested*** requirement or recommendation by a Regulatory Authority with respect to a recall, market suspension, or market withdrawal), such Party shall immediately so notify the other Party and shall include in such notice the reasoning behind such belief and any supporting facts, and the Parties shall discuss and attempt in good faith to reach agreement as to whether such recall, market suspension or market withdrawal is necessary. In the event that the Parties cannot reach prompt agreement with respect to the need for a recall, market suspension or market withdrawal of a Product in the Galapagos Territory, then such recall, market suspension or market withdrawal shall be implemented. If a recall, market suspension, or market withdrawal of any Product is determined to be required in accordance with this Section 3.12.3, (a) Galapagos (or its Sublicensee) shall implement any government authority issues a requestsuch recall, directive market suspension or order that any Drug Product be recalledmarket withdrawal in the Galapagos Territory, or and (b) a court of competent jurisdiction orders AbbVie (or its Sublicensee) shall implement any such recall, market suspension, or market withdrawal in any other country in the Territory, in each case, in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.12.3, the Party responsible for the recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to Article 11, (1) if and to the extent that a recall, market suspension, or market withdrawal resulted from a Party’s or its Affiliate’s breach of its obligations hereunder, or from such Party’s or its Affiliate’s negligence or willful misconduct, such Party shall bear the expense of such recall, market suspension, or market withdrawal, (c2) Adams reasonably determines after consultations with Cardinal that respect to any recall, market suspension, or market withdrawal of a Xxxx Co-Promotion Product should be recalled because in the Drug Product does not conform to the SpecificationsCo-Promotion Territory other than as described in clause (1) above, the parties shall take all appropriate corrective actions. Cardinal expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal shall be responsible for Cardinal's included in Allowable Expenses hereunder and Adams' expenses shared by the Parties pursuant to Section 6.7, (3) with respect to any recall, market suspension, or market withdrawal of a Product in the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this AgreementGalapagos Territory other than as described in clause (1) above, 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 Galapagos shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose costs of such recall is recall, market suspension, or market withdrawal, and (4) with respect to any recall, market suspension, or market withdrawal not attributable to the fault of either Adams covered by clause (1), (2) or Cardinal(3), Adams AbbVie shall be responsible for all Adams costs of such recall, market suspension, or market withdrawal, and Cardixxx xxpenses the costs 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 refunds with respect to recalled Product shall include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject be deducted from Net Sales pursuant to recallArticle 6.

Recalls. In the event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform to the Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that any governmental agency or authority requests a recall, a field corrective action, Product withdrawal or takes similar action in connection with any Product or in the event NxStage determines an event, incident or circumstance with respect to a Product has occurred that results in the need for a recall (each a “Product Recall”), NxStage shall promptly notify Customer within [**] of such recall results from the joint negligence governmental agency or authority request or action or of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion NxStage’s decision to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLvoluntarily institute a Product Recall. In the event of an FDAa Product Recall of any Product, NxStage shall (a) reimburse Customer and the Authorized Customer Locations for reasonable handling expenses incurred in returning units of such Product to NxStage or otherwise implementing the Product Recall; and (b) use all commercially reasonable efforts to promptly repair or replace the Product subject to a Product Recall with another NxStage Product performing the same function in good working order. NxStage shall allocate replacement Products to Customer and the Authorized Customer Locations on a first-initiated nationwide recall where priority basis consistent with Customer’s and the scope Authorized Customer Locations’ then-current share of NxStage’s Product base that has been purchased, and consistent with the then-affected prescription items included in Customer’s and the Authorized Customer Locations’ Monthly Dialysis Supplies orders. In addition to the foregoing, if NxStage is unable to repair or replace a recalled Cycler or PureFlow SL purchased by Customer or any Authorized Customer Location, such that such purchased Cycler or PureFlow SL is therefore rendered unusable and continues to be unusable for a period of [**] consecutive months (for purposes hereof, a purchased Cycler or PureFlow SL shall not be unusable if it can be used with other non-NxStage products, consistent with then-current product labeling), NxStage shall be obligated to pay Customer and the Authorized Customer Locations actual damages within [**] days of the expiration of such [**] month period (with the amount of such damages to be mutually agreed upon by the parties in good faith, up to the amount of Customer’s and the Authorized Customer Locations’ then-current [**] for the purchased Cyclers and/or Pure Flow SLs which Customer and the Authorized Customer Locations have been prevented from using for [**] consecutive months (measured as of the date of such Product Recall); provided that such [**] is calculated in good faith and in accordance with generally accepted accounting standards). NxStage’s obligation to make any payment pursuant to this Section 3 of Schedule C may be accelerated to the date of filing of a voluntary or involuntary bankruptcy proceeding with respect to NxStage or the date NxStage refunds, all or any significant portion of, the purchase price of any Cyclers and/or PureFlow SLs that have been the subject of a Product Recall (and where such refund is specifically provided solely in connection with, and due to, such Product Recall) to any other customer or group of customers that has purchased such Cyclers and/or PureFlow SLs for the treatment of chronic home hemodialysis patients (it being understood that Customer’s and the Authorized Customer Locations’ right to damages hereunder shall not be so accelerated if such refund involves no more than [**] Cyclers and/or PureFlow SLs in the aggregate across all other NxStage chronic customers). No other remedy shall be provided to Customer or any Authorized Customer Location in connection with a Product Recall, except as set forth in Section 22 of the Agreement. In the event NxStage elects to obtain recall is directed at all insurance covering a Product Recall of any purchased Cyclers and/or PureFlow SLs, Customer and NxStage agree that the parties shall share the cost of such insurance coverage, up to a maximum amount of $200,000 per party per annum; provided that Customer shall consider in good faith requests made by NxStage to share insurance costs in excess of $200,000. Any recall insurance obtained by NxStage, shall name Customer and the Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such policy shall offset any damages determined to be owed to Customer or any Authorized Customer Location hereunder pursuant to the foregoing terms, with NxStage obligated to pay any remainder pursuant to the terms hereof. If, during the Term, NxStage contractually agrees with one or more other customers purchasing any of NxStage’s home hemodialysis products containing in the continental United States to provide [**] provisions to such customer(s) that are more favorable to such customer(s) than are set forth in Section [**] of the Agreement and Sections [**] of this Schedule C, NxStage agrees that it shall promptly offer such [**] provisions to Customer, on a prospective basis; provided that such terms shall be offered to Customer to cover only [**] purchased by Customer and the Authorized Customer Locations which corresponds with the [**] purchased by [**]; and provided further that such terms, if accepted by Customer, shall in no way alter the other provisions hereof. Attachment C-1 to Schedule C System Ones Subject to Expiration of Service Term Schedule D Other Customer represents and warrants to NxStage that it has not entered into any agreement which conflicts with the terms and conditions of the Agreement and that it will not do so during the Term. NxStage understands and acknowledges that neither Customer nor any of the active ingredients Authorized Customer Locations have promised or committed to [**]. NxStage represents and warrants to Customer that: (a) it has not entered into any agreement which conflicts with the terms and conditions of the Agreement and that it will not do so during the Term, and (b) it shall not enter into any distributorship agreement or other similar agreement with any third party covering the sale, rental, licensing, leasing or distribution of the System One for chronic home hemodialysis in the Drug Product Continental United States and Hawaii, except where any such agreements are consistent with the purpose of such recall is not attributable to the fault of either Adams or Cardinal, Adams shall be responsible for all Adams terms and Cardixxx xxpenses conditions 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 RECALLAgreement. For the purposes of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recall.Schedule E Hawaii Schedule E

Recalls. AbbVie shall make every reasonable effort to notify Galapagos promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the AbbVie Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. AbbVie (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the AbbVie Territory. In the event that either Party believes that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Galapagos Territory (including any requirement or recommendation by a Regulatory Authority with respect to a recall, market suspension, or market withdrawal), such Party shall immediately so notify the other Party and shall include in such notice the reasoning behind such belief and any supporting facts, and the Parties shall discuss and attempt in good faith to reach agreement as to whether such recall, market suspension or market withdrawal is necessary. In the event that the Parties cannot reach prompt agreement with respect to the need for a recall, market suspension or market withdrawal of a Product in the Galapagos Territory, then such recall, market suspension or market withdrawal shall be implemented. If a recall, market suspension, or market withdrawal of any Product is determined to be required in accordance with this Section 3.12.3, (a) Galapagos (or its Sublicensee) shall implement any government authority issues a requestsuch recall, directive market suspension or order that any Drug Product be recalledmarket withdrawal in the Galapagos Territory, or and (b) a court of competent jurisdiction orders AbbVie (or its Sublicensee) shall implement any such recall, market suspension, or market withdrawal in any other country in the Territory, in each case, in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.12.3, the Party responsible for the recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to Article 11, (1) if and to the extent that a recall, market suspension, or market withdrawal resulted from a Party’s or its Affiliate’s breach of its obligations hereunder, or from such Party’s or its Affiliate’s negligence or willful misconduct, such Party shall bear the expense of such recall, market suspension, or market withdrawal, (c2) Adams reasonably determines after consultations with Cardinal that respect to any recall, market suspension, or market withdrawal of a Xxxx Co-Promotion Product should be recalled because in the Drug Product does not conform to the SpecificationsCo-Promotion Territory other than as described in clause (1) above, the parties shall take all appropriate corrective actions. Cardinal expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal shall be responsible for Cardinal's included in Allowable Expenses hereunder and Adams' expenses shared by the Parties pursuant to Section 6.7, (3) with respect to any recall, market suspension, or market withdrawal of a Product in the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this AgreementGalapagos Territory other than as described in clause (1) above, 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 Galapagos shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose costs of such recall is recall, market suspension, or market withdrawal, and (4) with respect to any recall, market suspension, or market withdrawal not attributable to the fault of either Adams covered by clause (1), (2) or Cardinal(3), Adams AbbVie shall be responsible for all Adams costs of such recall, market suspension, or market withdrawal, and Cardixxx xxpenses the costs 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 refunds with respect to recalled Product shall include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject be deducted from Net Sales pursuant to recallArticle 6.

Recalls. In the event As used herein, "Initiated Recall" shall mean a recall (a) any government authority issues a requestinitiated at the direction of the Federal Food and Drug Administration or other regulatory authority, directive arising out of, based on, or order that any Drug Product be recalledcaused by defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to meet the Specifications; or (b) a court initiated voluntarily by either Party where evidence indicates that defects in materials or workmanship, improper manufacture of competent jurisdiction orders the Products, or failure of the Products to meet the Specifications warrants such a recall. Each Party shall promptly notify the other Party of any situation which may lead to an Initiated Recall of the Products, however, Roche and ACLARA shall have joint authority as to whether to institute a voluntary recall. Roche shall notify ACLARA, in writing, if it is required to implement a total or partial Initiated Recall. Both Parties agree to work together to properly manage an Initiated Recall, foremost in terms of urgency and safety for the end customer, and secondly for the efficient utilization of resources to accomplish such Initiated Recall. The costs of any total or partial Initiated Recall shall be allocated as follows, regardless of whether it was recalled by ACLARA, Roche, 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 ACLARA, ACLARA shall bear the out-of-pocket costs and expenses associated with the 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 Roche, Roche shall bear the out-of-pocket costs and expenses associated with the Initiated Recall; (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because if the Drug Product does not conform defects or problems giving rise to the Specificationsreason for the Initiated Recall can reasonably deemed to be the direct result of negligent or willful acts or omissions by both Parties, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses each Party will bear a portion of the recall to out-of-pocket costs and expenses roughly commensurate with its proportional responsibility for the extent such recall results from xxx xreach of Cardinal's warranties under this AgreementInitiated Recall, 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 and (d) if it cannot reasonably be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each determined which party shall be was responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose of such recall is not attributable defects or problems giving rise to the fault of either Adams or Cardinalreason for the Initiated Recall, Adams then the Parties shall be responsible for all Adams equally share the out-of-pocket costs and Cardixxx xxpenses of expenses associated with 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recallInitiated Recall.

Recalls. In the event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform to the Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that any governmental agency or authority requests a recall, a field corrective action, Product withdrawal or takes similar action in connection with any Product or in the event NxStage determines an event, incident or circumstance with respect to a Product has occurred that results in the need for a recall (each a “Product Recall”), NxStage shall promptly notify Customer within [**] of such recall results from the joint negligence governmental agency or authority request or action or of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion NxStage’s decision to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLvoluntarily institute a Product Recall. In the event of an FDAa Product Recall of any Product, NxStage shall (a) reimburse Customer and the Authorized Customer Locations for reasonable handling expenses incurred in returning units of such Product to NxStage or otherwise implementing the Product Recall; and (b) use all commercially reasonable efforts to promptly repair or replace the Product subject to a Product Recall with another NxStage Product performing the same function in good working order. NxStage shall allocate replacement Products to Customer and the Authorized Customer Locations on a first-initiated nationwide recall where priority basis consistent with Customer’s and the scope Authorized Customer Locations’ then-current share of NxStage’s Product base that has been purchased, and consistent with the then-affected prescription items included in Customer’s and the Authorized Customer Locations’ Monthly Dialysis Supplies orders. In addition to the foregoing, if NxStage is unable to repair or replace a recalled Cycler or PureFlow SL purchased by Customer or any Authorized Customer Location, such that such purchased Cycler or PureFlow SL is therefore rendered unusable and continues to be unusable for a period of [**] consecutive months (for purposes hereof, a purchased Cycler or PureFlow SL shall not be unusable if it can be used with other non-NxStage products, consistent with then-current product labeling), NxStage shall be obligated to pay Customer and the Authorized Customer Locations actual damages within [**] days of the expiration of such [**] month period (with the amount of such damages to be mutually agreed upon by the parties in good faith, up to the amount of Customer’s and the Authorized Customer Locations’ then-current [**] for the purchased Cyclers and/or Pure Flow SLs which Customer and the Authorized Customer Locations have been prevented from using for [**] consecutive months (measured as of the date of such Product Recall); provided that such [**] is calculated in good faith and in accordance with generally accepted accounting standards). NxStage’s obligation to make any payment pursuant to this Section 3 of Schedule C may be accelerated to the date of filing of a voluntary or involuntary bankruptcy proceeding with respect to NxStage or the date NxStage refunds, all or any significant portion of, the purchase price of any Cyclers and/or PureFlow SLs that have been the subject of a Product Recall (and where such refund is specifically provided solely in connection with, and due to, such Product Recall) to any other customer or group of customers that has purchased such Cyclers and/or PureFlow SLs for the treatment of chronic home hemodialysis patients (it being understood that Customer’s and the Authorized Customer Locations’ right to damages hereunder shall not be so accelerated if such refund involves no more than [**] Cyclers and/or PureFlow SLs in the aggregate across all other NxStage chronic customers). No other remedy shall be provided to Customer or any Authorized Customer Location in connection with a Product Recall, except as set forth in Section 22 of the Agreement. In the event NxStage elects to obtain recall is directed at all products containing insurance covering a Product Recall of any purchased Cyclers and/or PureFlow SLs, Customer and NxStage agree that the parties shall share the cost of such insurance coverage, up to a maximum amount of $200,000 per party per annum; provided that Customer shall consider in good faith requests made by NxStage to share insurance costs in excess of $200,000. Any recall insurance obtained by NxStage, shall name Customer and the Authorized Customer Locations (but no other customer of NxStage) as additional insureds. Any insurance payment to Customer or any Authorized Customer Location under such policy shall offset any damages determined to be owed to Customer or any Authorized Customer Location hereunder pursuant to the foregoing terms, with NxStage obligated to pay any remainder pursuant to the terms hereof. If, during the Term, NxStage contractually agrees with one or more other customers purchasing any of the active ingredients NxStage’s home hemodialysis products in the Drug Product continental United States to provide [**] provisions to such customer(s) that are more favorable to such customer(s) than are set forth in Section [**] of the Agreement and where the purpose Sections [**] of this Schedule C, NxStage agrees that it shall promptly offer such recall is not attributable [**] provisions to the fault of either Adams or CardinalCustomer, Adams on a prospective basis; provided that such terms shall be responsible for all Adams offered to Customer to cover only [**] purchased by Customer and Cardixxx xxpenses the Authorized Customer Locations which corresponds with the [**] purchased by [**] and provided further that such terms, if accepted by Customer, shall in no way alter the other provisions hereof. Attachment C-1 to Schedule C System Ones Subject to Expiration of 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recall.Service Term Schedule D Preferred Relationship Schedule D Chronic Outpatient Therapy Agreement Preferred Relationship

Recalls. In the event The Parties shall immediately inform each other in writing of all information related to (a) any government authority issues incident relating to a requestPRODUCT and/or any lot of a PRODUCT that is the subject of recall, directive market withdrawal or order that any Drug Product be recalledcorrection, or (b) a court of competent jurisdiction orders such any PRODUCT that may require, whether based on manufacturing defect, tampering, or otherwise, a recall, field alert, product withdrawal or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform to the Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent field correction arising from any defect in any such recall results from xxx xreach of Cardinal's warranties PRODUCT provided under this Agreement. If either Party believes that a recall of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY is desirable or required by law, 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 RECALLit will promptly notify the other Party. Adams 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 responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreementhandled; provided, PROVIDEDhowever, 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 in the event either Party determines that a recall is necessary, such recall results from the joint negligence of Adams and Cardinal, each party shall be implemented. Coulxxx xxxll be solely responsible for the expenses handling and disposition of such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in TERRITORY A, pursuant to procedures set forth on EXHIBIT J. SB shall cooperate with Coulxxx xx xxcall allowing such recall in direct proportion TERRITORY A to each party's percentage occur pursuant to the procedures set forth on EXHIBIT J. SB shall be solely responsible for the handling and disposition of fault as determined jointly such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in the NON-USA TERRITORY, pursuant to procedures set forth on EXHIBIT J. Cxxxxxx xxxll cooperate with SB in allowing such recall in the NON-USA TERRITORY to occur pursuant to the procedures set forth on EXHIBIT J. EXHIBIT J may be modified at any time 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 MANUFACTURE AND SUPPLY CHAIN SUBTEAM subject to the event of an FDA-initiated nationwide recall where the scope approval of the recall is directed at all products containing any of the active ingredients in the Drug Product JDC 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recallJCC.

Recalls. In the event (a) any government authority issues a request, directive BII or order its Affiliates shall use reasonable efforts to notify Epizyme promptly following its determination that any Drug Product be recalledevent, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Joint Product in the Territory and shall include in such notice the reasoning behind such determination, and any supporting facts. BII (bor its Affiliates or Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Territory. If a court of competent jurisdiction orders recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, then BII (or its Affiliates or its Sublicensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 5.4 (Recalls), BII (or its Affiliates or Sublicensee) responsible for the recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof and Epizyme shall reasonably cooperate in all such recall efforts. Subject to ARTICLE 12 (Indemnity), (a) in the event that a recall, market suspension or market withdrawal resulted from a Party’s or its Affiliate’s breach of its obligations hereunder, or from such Party’s or its Affiliate’s negligence or willful misconduct, such Party shall bear the expense of such recall, market suspension or market withdrawal, (b) with respect to any other recall, market suspension or market withdrawal of the Joint Product in the U.S., the expenses incurred by the Parties as a result of such recall, market suspension or market withdrawal shall be included in Allowable Expenses hereunder and resolved pursuant to Section 5.2.2(a)(iv) (Allocation) and (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does respect to any recall, market suspension or market withdrawal not conform to the Specificationscovered by clause (a) or (b), the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams BII shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose costs of such recall is not attributable to the fault of either Adams recall, market suspension 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recallmarket withdrawal.

Recalls. In Principal may cease selling the event (a) Products in any government authority issues Country/Region in the Territory at any time during the Term and recall the Products within any Country/Region in the Territory as necessary if any of the below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Country/Region in the Territory: unforeseen effects of the relative type of the Products lead to, in Principal's sole opinion, unacceptable safety risks; Principal ceases the sale of the Products worldwide for any reason; a request, directive 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 order that any Drug Product be recalled, cease all or (b) a court part of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform business related to the Specifications, Products; or other circumstances of recalls as required under the parties shall take all appropriate corrective actionsApplicable Law. Cardinal shall be responsible for Cardinal's The Distributor undertakes with respect to any product recall that: (i) it will implement and Adams' expenses complete the recall of the Products within the Territory by the statutory deadline or a shorter period as reasonably requested by Principal in all aspects in strict compliance with the Applicable Law; and (ii) it shall provide full cooperation to Principal, including timely transmitting and providing feedbacks of drug recall information, controlling and recovering drugs with potential safety hazards. The Distributor may not recall any of the Products from any of the Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following the decision to implement a Recall, Principal and Distributor shall mutually agree on a prepared statement for use in response to any inquiries regarding such Recall. Distributor shall use such prepared statement to respond to any inquiries received with regard to such Recall and shall not make any other statement regarding such Recall; provided, that if Principal fails to agree with Distributor on a prepared statement prior to the launch of such Recall, Distributor shall prepare and issue the statement as proposed by Principal regarding such Recall. To the extent such recall results from xxx xreach of Cardinal's warranties the Products are recalled due to causes other than Distributor’s non-compliance with relevant obligations under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams Principal shall be responsible (a) indemnify the Distributor for all Adams' the costs and Cardinal's expenses reasonably incurred by the Distributor for recalling the Products and for any subsequent disposal or destruction of xxx xecall the same; and (b) repurchase the Products that are subject to the extent that such xxxxxl results from Recall at the purchase price paid by the Distributor and in addition pay Distributor a cause other than Cardinal's breach handling charge equal to 10% of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLthe 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 such Recall, including Distributor's recall results 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 joint negligence Territory for the remainder of Adams and Cardinalthe Term, each party then Principal may by written notice to Distributor terminate the Recalled Products from the Territory. The Distributor shall inform Principal immediately upon being informed about any defective products returned to the Distributor or detected in the Distributor's inventory. The Distributor shall inform Principal immediately about any complaint received. The Distributor shall be responsible for the collection and investigation of customers' complaints (whether the customers complain to the Distributor directly or forwarded by Principal and/or its Affiliates), and retain accurate records of such collections and investigations and maintain appropriate records during the Term. AUDIT RIGHTS AND REPORTING During the Term, Principal shall be entitled, through itself or an independent audit firm appointed by Principal (the "Independent Auditor"), to inspect and audit (i) such books, documents, papers and records which relate to sales of the Products or any costs and expenses xx xxcall invoiced or charged by Distributor to Principal in direct proportion connection with this Agreement, (ii) Distributor's compliance with Clause 1817, and (iii) all facilities of Distributor in which Distributor performs its obligations under this Agreement and maintains inventory of the Products (an "Audit"). If an Audit reveals matters that Principal determines should be corrected by Distributor, Principal shall provide a list of such matters and may propose corrective action to each party's percentage be taken by Distributor. Distributor shall respond within 15 days of fault as determined jointly receipt of such notification indicating the corrective action to be taken and an estimated completion date. The Audit of any books, documents, papers or records that relate to or contain any information regarding any business dealings with or the affairs of any other client or principal of Distributor may only be conducted by the partiesIndependent 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, PROVIDEDand 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, HOWEVERunless it is required by Applicable Law. Principal shall not request an Audit more than once each Calendar Year, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIALunless required more frequently by any regulatory authorities which have regulatory oversight over Principal or the Products, INDIRECTor 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, INCIDENTAL OR CONSEQUENTIAL DAMAGESincluding the cost of the Independent Auditor, INCLUDINGshall 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%, WITHOUT LIMITATIONor 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, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLinspections or examinations conducted by Principal or any authorised agent under this Agreement, including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or Clause 19.6, Principal agrees that it and its duly authorised agents, including any Independent Auditor: will abide by all internal regulations and policies of Distributor enforced at such time; will not interfere with the business or operation of Distributor; and without prejudice to any confidentiality limitations in this Agreement, shall at the request of Distributor enter into a separate non-disclosure agreement prepared by Distributor, prior to being granted access to any of Distributor's premises, books, documents, papers or records. In the event that the result of an FDA-initiated nationwide recall where 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 scope case of a failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if Distributor fails to do so, Principal shall have the right to terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties 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 recall is directed at Licensed Marks to Distributor; it has and will continue to have full legal rights to use the patents, formulae and all products containing 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 infringes any rights of any other person. Distributor shall provide such information and assistance to Principal as Principal may reasonably require in taking or resisting any proceedings in relation to any such infringement or claim. Distributor shall not: alter, remove or tamper with any of the active ingredients Licensed Marks, numbers, or other means of identification used on or in the Drug Product and where the purpose of such recall is not attributable relation to the fault of either Adams Products; or Cardinal, Adams shall be responsible for all Adams and Cardixxx xxpenses use any of the xxxxllLicensed Marks in any way which might prejudice their distinctiveness or validity or the goodwill of Principal therein; Distributor hereby acknowledges that, 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 except as expressly provided in this Agreement, the expenses of recall Distributor shall include, without limitation, the expenses of notification or destruction or return not acquire any other rights in respect of the recalled Drug Product Licensed Marks from the distribution and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing sales of the Products and shipping the Drug Product that was later subject use of the Licensed Marks pursuant to recallthis Agreement.

Recalls. In the event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform Each Party shall promptly report in writing to the Specificationsother Party any failure of the Product, change in the parties shall take all appropriate corrective actionsstatistically demonstrated reliability of the Product, concerns regarding safety of the Product, other material information relevant to the reliability of the Product or any liability claims related to the Product or any other event that might reasonably be expected to have a material adverse effect on the Manufacture, marketing or sale of the Product of which either Party becomes aware (collectively, “Product Concerns”). Cardinal The Party that Manufactured the applicable quantity of the Product shall be responsible for Cardinal's evaluating all Product Concerns, and Adams' expenses shall use Commercially Reasonable Efforts to take such actions or make such changes in the Product or the Manufacturing thereof as may be necessary or desirable in light of such Product Concerns. The other Party shall reasonably cooperate with the manufacturing Party in any such evaluation and actions or changes. If either Party reasonably believes that a recall of the recall Product, in whole or in part, or the issuance of an advisory letter regarding reliability of or defects in the Product is advisable or necessary, it will, prior to the extent making a final determination concerning any such recall results from xxx xreach or issuance of Cardinal's warranties under this Agreementan advisory letter, PROVIDEDpromptly notify the other Party and the Parties will promptly and in good faith discuss such proposed recall or advisory letter; provided, HOWEVERhowever, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIALthat either Party may, INDIRECTin good faith, INCIDENTAL OR CONSEQUENTIAL DAMAGESinitiate a recall or issue an advisory letter. In making a determination to initiate a recall or issue an advisory letter, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams the applicable Party shall be responsible for all Adams' follow the same processes and Cardinal's expenses of xxx xecall procedures that it customarily follows with respect to the extent determinations concerning recalls or advisory letters involving product that is manufactured and sold by such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLParty. In the event that the Parties do not agree regarding the advisability or necessity of any such recall results or advisory letter and Xxxxxx’x Quality Assurance policies or procedures would, in Xxxxxx’x reasonable judgment, prohibit Xxxxxx from the joint negligence of Adams and Cardinal, each party shall be responsible placing further orders with Surmodics for the expenses xx xxcall Product or from shipping the Product to customers, Xxxxxx shall notify Surmodics, and the Parties shall then proceed as provided in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLSection 13.3.1(i). In the event of an FDA-initiated nationwide a recall where or advisory letter, the scope of Party whose act or omission gave rise to such recall or advisory letter: (A) shall, at its own expense, use its reasonable efforts to promptly correct the problems that caused the recall is directed at all products containing any of the active ingredients in the Drug Product or advisory letter; and where the purpose of such recall is not attributable to the fault of either Adams or Cardinal, Adams (B) shall be responsible for and shall reimburse the other Party for all Adams the reasonable out-of-pocket costs and Cardixxx xxpenses expenses of the xxxxllrecall or advisory letter, PROVIDEDincluding costs of goods, HOWEVERpayments to customers, THAT NEXXXXX PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIALnotification, INDIRECTand shipping and handling. In all other cases, 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 each Party shall include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal bear its own costs for xxxxfacturing and shipping the Drug Product that was later subject recall or advisory letter. Notwithstanding the foregoing, nothing in this Section 5.7 shall be construed to recalllimit or prevent a Party from complying with the requirements of any law, regulation, or order of a Regulatory Authority. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Recalls. In Each Party shall make every reasonable effort to notify the other Party promptly (but in no event later than [Redacted] following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal of a Licensed Product in the AbbVie Territory or the I-Mab Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, (a) AbbVie shall have the right to make the final determination whether to voluntarily implement any government authority issues a requestsuch recall, directive market suspension or order that any Drug Product be recalledmarket withdrawal in the AbbVie Territory, or and (b) I-Mab shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the I-Mab Territory (except that I-Mab shall implement any recall, market suspension or market withdrawal that AbbVie requests based on a court Manufacturing issue with respect to any Licensed Product supplied by AbbVie); provided that prior to any implementation of competent jurisdiction orders such a recall, market suspension or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform to the Specificationsmarket withdrawal, the parties recalling Party shall take consult with the other Party and shall consider the other Party’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the AbbVie Territory, with respect to AbbVie, or the I-Mab Territory, with respect to I-Mab, such Party shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all appropriate corrective actions. Cardinal recalls, market suspensions or market withdrawals undertaken pursuant to this Section 8.7, the Party responsible for the recall, market suspension or market withdrawal shall be solely responsible for Cardinal's the execution thereof, and Adams' expenses of the recall to the extent other Party shall reasonably cooperate in all such recall results from xxx xreach of Cardinal's warranties under this efforts. Subject to Article 14, unless otherwise provided in the AbbVie Supply Agreement or I-Mab Supply Agreement, PROVIDEDas applicable, 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 each recalling Party shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In costs incurred in connection with the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose conduct of such recall is not attributable to the fault of either Adams recall, market suspension 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recallmarket withdrawal.

Recalls. Vericel, in consultation with Xxxxxx, will prepare and maintain a written Standard Operating Procedure (“SOP”) in compliance with FDA requirements that sets forth the Parties’ respective responsibilities in handling any recalls of any Product in the Territory. In the event that (ai) any government governmental agency or authority issues a request, request or directive or order orders that any Drug the Product be recalledrecalled or retrieved, or (bii) a court of competent jurisdiction orders such a recallthat the Product be recalled or retrieved, or (ciii) Adams Vericel reasonably determines after consultations with Cardinal that a Xxxx the Product should be recalled because recalled, retrieved or a “dear doctor” letter is required relating to restrictions on use of Product, Xxxxxx will provide Vericel with any reasonable CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. assistance requested by Vericel, and the Drug Product does not conform to the Specifications, the parties shall Parties will take all appropriate corrective actionsactions and will execute the steps detailed in the SOP. Cardinal shall be responsible for Cardinal's and Adams' expenses of the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall Vericel will be responsible for all Adams' and Cardinal's of the expenses of xxx xecall such activities, except to the extent that such xxxxxl the event causing the recall results from a cause other than Cardinal's breach of its warranties any of Xxxxxx’x obligations under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint Agreement or Xxxxxx’x negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose of such recall is not attributable to the fault of either Adams or 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 RECALLwillful misconduct. For the purposes of this Agreement, the expenses of recall shall may include, without limitationbut are not limited to, the expenses of notification and return or destruction or return (if authorized by Vericel) of the Product, the cost of replacement of the Product, and any costs directly associated with the distribution of replacement Product. Xxxxxx and Vericel will cooperate fully with one another in conducting any activity contemplated by this provision. Xxxxxx will arrange for the destruction of Product lawfully recalled Drug Product and Adams' only upon Vericel’s (or Cardinal's total, unrecoverable, actual, internal costs any regulatory authority’s) written instruction to arrange for xxxxfacturing and shipping the Drug Product that was later subject to recalldestruction of such Product.

Recalls. In Principal may cease selling the event (a) Products in any government authority issues Country/Region in the Territory at any time during the Term and recall the Products within any Country/Region in the Territory as necessary if any of the below circumstances occurs, and the Distributor shall, at Principal's expense, actively cooperate with Principal to timely recall the affected Products in any Country/Region in the Territory: unforeseen effects of the relative type of the Products lead to, in Principal's sole opinion, unacceptable safety risks; Principal ceases the sale of the Products worldwide for any reason; a request, directive 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 order that any Drug Product be recalled, cease all or (b) a court part of competent jurisdiction orders such a recall, or (c) Adams reasonably determines after consultations with Cardinal that a Xxxx Product should be recalled because the Drug Product does not conform business related to the Specifications, Products; or other circumstances of recalls as required under the parties shall take all appropriate corrective actionsApplicable Law. Cardinal shall be responsible for Cardinal's The Distributor undertakes with respect to any product recall that: (i) it will implement and Adams' expenses complete the recall of the Products within the Territory by the statutory deadline or a shorter period as reasonably requested by Principal in all aspects in strict compliance with the Applicable Law; and (ii) it shall provide full cooperation to Principal, including timely transmitting and providing feedbacks of drug recall information, controlling and recovering drugs with potential safety hazards. The Distributor may not recall any of the Products from any of the Countries/Regions without Principal's prior written consent, unless such recall is mandated under the Applicable Law. Following the decision to implement a Recall, Principal and Distributor shall mutually agree on a prepared statement for use in response to any inquiries regarding such Recall. Distributor shall use such prepared statement to respond to any inquiries received with regard to such Recall and shall not make any other statement regarding such Recall; provided, that if Principal fails to agree with Distributor on a prepared statement prior to the launch of such Recall, Distributor shall prepare and issue the statement as proposed by Principal regarding such Recall. To the extent such recall results from xxx xreach of Cardinal's warranties the Products are recalled due to causes other than Distributor’s non-compliance with relevant obligations under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams Principal shall be responsible (a) indemnify the Distributor for all Adams' the costs and Cardinal's expenses reasonably incurred by the Distributor for recalling the Products and for any subsequent disposal or destruction of xxx xecall the same; and (b) repurchase the Products that are subject to the extent that such xxxxxl results from Recall at the purchase price paid by the Distributor and in addition pay Distributor a cause other than Cardinal's breach handling charge equal to 10% of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLthe 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 such Recall, including Distributor's recall results 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 joint negligence Territory for the remainder of Adams and Cardinalthe Term, each party then Principal may by written notice to Distributor terminate the Recalled Products from the Territory. The Distributor shall inform Principal immediately upon being informed about any defective products returned to the Distributor or detected in the Distributor's inventory. The Distributor shall inform Principal immediately about any complaint received. The Distributor shall be responsible for the collection and investigation of End Ccustomers' complaints (whether these customers complain to the Distributor directly or forwarded by Principal and/or its Affiliates), and retain accurate records of such collections and investigations and maintain appropriate records during the Term. AUDIT RIGHTS AND REPORTING During the Term, Principal shall be entitled, through itself or an independent audit firm appointed by Principal (the "Independent Auditor"), to inspect and audit (i) such books, documents, papers and records which relate to sales of the Products or any costs and expenses xx xxcall invoiced or charged by Distributor to Principal in direct proportion connection with this Agreement, (ii) Distributor's compliance with Clause 1817, and (iii) all facilities of Distributor in which Distributor performs its obligations under this Agreement and maintains inventory of the Products (an "Audit"). If an Audit reveals matters that Principal determines should be corrected by Distributor, Principal shall provide a list of such matters and may propose corrective action to each party's percentage be taken by Distributor. Distributor shall respond within 15 days of fault as determined jointly receipt of such notification indicating the corrective action to be taken and an estimated completion date. The Audit of any books, documents, papers or records that relate to or contain any information regarding any business dealings with or the affairs of any other client or principal of Distributor may only be conducted by the partiesIndependent 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, PROVIDEDand 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, HOWEVERunless it is required by Applicable Law. Principal shall not request an Audit more than once each Calendar Year, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIALunless required more frequently by any regulatory authorities which have regulatory oversight over Principal or the Products, INDIRECTor 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, INCIDENTAL OR CONSEQUENTIAL DAMAGESincluding the cost of the Independent Auditor, INCLUDINGshall 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%, WITHOUT LIMITATIONor 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, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLinspections or examinations conducted by Principal or any authorised agent under this Agreement, including without limitation under this Clause 20, Clause 5.5, Clause 6.4 or Clause 19.6, Principal agrees that it and its duly authorised agents, including any Independent Auditor: will abide by all internal regulations and policies of Distributor enforced at such time; will not interfere with the business or operation of Distributor; and without prejudice to any confidentiality limitations in this Agreement, shall at the request of Distributor enter into a separate non-disclosure agreement prepared by Distributor, prior to being granted access to any of Distributor's premises, books, documents, papers or records. In the event that the result of an FDA-initiated nationwide recall where 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 scope case of a failure to pay) or 60 days (in the case of a material breach) after receiving the written notice from Principal, if Distributor fails to do so, Principal shall have the right to terminate this Agreement immediately. PHARMACOVIGILANCE AND QUALITY The Parties 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 recall is directed at Licensed Marks to Distributor; it has and will continue to have full legal rights to use the patents, formulae and all products containing 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 infringes any rights of any other person. Distributor shall provide such information and assistance to Principal as Principal may reasonably require in taking or resisting any proceedings in relation to any such infringement or claim. Distributor shall not: alter, remove or tamper with any of the active ingredients Licensed Marks, numbers, or other means of identification used on or in the Drug Product and where the purpose of such recall is not attributable relation to the fault of either Adams Products; or Cardinal, Adams shall be responsible for all Adams and Cardixxx xxpenses use any of the xxxxllLicensed Marks in any way which might prejudice their distinctiveness or validity or the goodwill of Principal therein; Distributor hereby acknowledges that, 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 except as expressly provided in this Agreement, the expenses of recall Distributor shall include, without limitation, the expenses of notification or destruction or return not acquire any other rights in respect of the recalled Drug Product Licensed Marks from the distribution and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing sales of the Products and shipping the Drug Product that was later subject use of the Licensed Marks pursuant to recallthis Agreement.

Recalls. 5.2.1 BioMarin may, in its sole discretion, determine whether or when to initiate any recalls 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 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 (ai) any government regulatory authority or other governmental agency or authority issues a request, request or directive or order orders that any Drug Product Aldurazyme be recalledrecalled or retrieved, or (bii) a court of competent jurisdiction orders such a recall, that Aldurazyme be recalled or retrieved or (ciii) Adams reasonably a Party determines after consultations with Cardinal that a Xxxx Product Aldurazyme should be recalled because 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 Drug Product does not conform Party responsible for the relevant country pursuant to the Specifications, first sentence hereof shall conduct such activity and the parties Parties shall take all appropriate corrective actionsactions and shall execute the steps detailed in the SOP. Cardinal To the extent practicable, the Parties shall coordinate the notices of any such recall to be responsible for Cardinal's delivered to regulatory authorities (including the timing thereof). Genzyme and Adams' expenses 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 completion of the recall to the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLaction. In the event that such either BioMarin or Genzyme becomes aware of circumstances that may necessitate a recall results from of Aldurazyme in any country for which it is not responsible pursuant to this Section 5.2, it will promptly notify the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose other Party 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recallcircumstances.

Recalls. From time to time throughout the Term, AASTROM mxx xn its discretion determine that it is necessary or advisable to recall Cell Cassettes manufactured by MOLL. In the event (a) any government authority issues a requestsuch event, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Adams if AASTROM reasonably determines after consultations with Cardinal that the numbex xx reported incidence of defective Cell Cassettes is high in relation to AASTROM's historical incidence rate for defective Cell Cassettes and/or general medical product industry standards and AASTROM recalls one or more Shipment Lots due to a Xxxx Product should be recalled because failure of such units to meet Specifications during the Drug Product does not conform to the SpecificationsWarranty Period, the parties AASTROM shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and Adams' expenses so notify MOLL of the recall and the Parties shall jointly exchange relevant ixxxxmation and consult on causation of the defective units prior to implementing the extent such recall results from xxx xreach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALLrecall. In the event it is determined by the Parties that the Cell Cassettes were defective due to a failure of such recall results from units to meet Specifications during the joint negligence of Adams and CardinalWarranty Period, each party shall be responsible MOLL agrees to reimburse AASTROM for the expenses xx xxcall reasonable direct costs incxxxxd by AASTROM in direct proportion conjunction with the recall including the cost of replacing, shipping and testing the units of the Shipment Lot(s) recalled, whether or not all such units are ultimately determined to each partyhave been defective, by way of a reduction in MOLL's percentage applicable mark-up rates (as set forth on Appendix III) to 15% xxxxl the cost ox xxe recall has been recovered by AASTROM. Any disputes regarding causation of fault as determined jointly defective units involved in a recall that cannot be resolved by the partiesParties will be resolved through arbitration in accordance with Section 24(b). Furthermore, 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 in the event this Agreement is terminated for any reason prior to AASTROM recovering the full amount of an FDAits recall costs from MOLL, MOLL shall promptly pay to AASTROM the amount of any un-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where reimbuxxxx cxxxx. For the purpose of such recall clarification, it is not attributable to the fault of either Adams or Cardinal, Adams agreed that AASTROM shall be solely responsible for determining whether any product recall, correction or withdrawal is required and for complying with 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 include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject medical device reporting requirements pursuant to recall21 CFR Part 803.

Recalls. In SMBI and NuVim shall notify the other promptly if any batch of Product purchased by NuVim pursuant to this Agreement is subject to recall, seizure, market withdrawal or correction or if any end user notifies NuVim of an adverse reaction as a result of the use of any Product, and the parties agree to cooperate in the handling and disposition of such recall, seizure, market withdrawal or correction or notification of adverse reaction; provided, however, in the event (a) of a disagreement as to any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders matters related to such a recall, seizure, market withdrawal or (c) Adams reasonably determines after consultations correction or adverse reaction, SMBI shall have final authority with Cardinal that respect to such matters. SMBI shall bear the costs of all recalls, seizures, market withdrawals or corrections of Products purchased by NuVim pursuant to this Agreement if such recall, seizure, market withdrawal or correction is due to a Xxxx Product should be recalled because breach by SMBI of any of its obligations hereunder; NuVim shall bear the Drug Product does not conform costs of all recalls, seizures, market withdrawals or corrections of Products purchased by NuVim pursuant to the Specificationsthis Agreement if such recall, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's seizure, market withdrawal or correction is due to a breach by NuVim of any of its obligations hereunder; and Adams' expenses of the recall to the extent such recall results from xxx xreach recall, seizure, market withdrawal or correction is not a result of Cardinal's warranties under this Agreementa breach by either NuVim or SMBI of any of their respective obligations hereunder, PROVIDEDthe costs of any recall, HOWEVERseizure, 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 market withdrawal or correction shall be responsible for all Adams' and Cardinal's expenses of xxx xecall to the extent that such xxxxxl results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams and Cardinal, each party shall be responsible for the expenses xx xxcall in direct proportion to each party's percentage of fault as determined jointly borne 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 RECALLNuVim. In the event of an FDA-initiated nationwide recall where any recall, seizure, market withdrawal or correction, SMBI shall, to the scope of extent it is required to bear the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose costs of such recall is not attributable recall, seizure, market withdrawal or correction as provided above, in addition to bearing the fault cost of either Adams such recall, seizure, market withdrawal or Cardinalcorrection, Adams shall be responsible (i) replace the amount of Products recalled, seized or withdrawn and (ii) reimburse NuVim for all Adams and Cardixxx xxpenses verifiable out-of-pocket costs incurred by NuVim in respect of the xxxxllsuch recalled, 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 RECALLseized or withdrawn Products. For the purposes NuVim shall maintain records of this Agreement, the expenses all sales of recall shall include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and Adams' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing and shipping the Drug Product that was later subject to recallProducts in accordance with its standard operating procedure.

Recalls. In the event (a) any government authority issues a request, directive or order that any Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Adams Xxxxx reasonably determines after consultations with Cardinal that a Xxxx Drug Product should be recalled because the Drug Product does not conform to the Specifications, the parties shall take all appropriate corrective actions. Cardinal shall be responsible for Cardinal's and AdamsXxxxx' expenses of the recall to the extent such recall results from xxx xreach the breach of Cardinal's warranties under this Agreement, PROVIDED, HOWEVER, CARDINAL SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. Adams Xxxxx shall be responsible for all AdamsXxxxx' and Cardinal's expenses of xxx xecall the recall to the extent that such xxxxxl recall results from a cause other than Cardinal's breach of its warranties under this Agreement, PROVIDED, HOWEVER, ADAMS XXXXX SHALL NOT BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENXXX XR INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event that such recall results from the joint negligence of Adams Xxxxx and Cardinal, each party shall be responsible for the expenses xx xxcall of recall in direct proportion to each party's percentage of fault as determined jointly by the parties, PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. In the event of an FDA-initiated nationwide recall where the scope of the recall is directed at all products containing any of the active ingredients in the Drug Product and where the purpose of such recall is not attributable to the fault of either Adams Xxxxx or Cardinal, Adams Xxxxx shall be responsible for all Adams Xxxxx and Cardixxx xxpenses Cardinal expenses of the xxxxllrecall, PROVIDED, HOWEVER, THAT NEXXXXX NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. For the purposes of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification or destruction or return of the recalled Drug Product and AdamsXxxxx' or Cardinal's total, unrecoverable, actual, internal costs for xxxxfacturing manufacturing and shipping the Drug Product that was later subject to recall.