Common use of Product Withdrawals and Recalls Clause in Contracts

Product Withdrawals and Recalls. If (a) any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediately, and in any event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of the event or makes such determination. Astellas shall, to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall or withdraw the Product in the applicable country(ies); provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by the negligence, breach or intentional misconduct of a particular Party or any of its Affiliates or subcontractors, such Party shall bear the costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibility.

Product Withdrawals and Recalls. If (a) any Regulatory Authority (i) threatens, initiates or advises any action to remove any the Licensed Product from the market in any country of the Territory world, or (ii) requires or advises Ambiteither Party or such Party’s Affiliates, Astellas, licensees or any of their respective Affiliates or Sublicensees sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such the Licensed Product in any country of the world, then Licensor (if such action is outside the Territory or in the Territory but outside the Field) or Licensee (if such action is in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediately, and in any event within three (3) Business Days (or sooner if required by lawLaws and Regulations) after such Party becomes aware of the event action, threat, advice or makes such determinationrequirement (as applicable). Astellas shall, The JSC will discuss and attempt to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall or withdraw the Product in the applicable country(ies)Licensed Product; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing or if the exigencies of matter involves a safety issue that, in order to protect patient safety, does not allow for sufficient time for a discussion at the situation)JSC level, then Astellas Licensor shall decide whether to recall or withdraw the Licensed Product outside the Territory and shall undertake any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under outside the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expensesat its own cost and expense, and (iii) with respect Licensee shall decide whether to any Products outside recall or withdraw the U.S. or Products other than Co-Promoted Products Licensed Product in the U.S., unless otherwise agreed in an applicable form of supply agreement, Territory and shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the undertake any such recall or withdrawal is caused in the Territory at its own cost and expense. Notwithstanding the foregoing, if any recall or withdrawal that was threatened, initiated or advised by a Regulatory Authority results from (a) the negligence, breach negligence or intentional willful misconduct of a particular Party or any of its Affiliates or subcontractors, and such Party is not the Party responsible for the costs of such recall or withdrawal under the immediately preceding two sentences, then such Party that acted negligently or with willful misconduct shall bear be responsible for the costs of such recall or withdrawal to the extent that such negligence or willful misconduct directly caused such recall or withdrawal; or (b) any Nanoparticles manufactured or quality controlled by or on behalf of its Licensor which did not conform with the specifications with which such Nanoparticles were required to comply under the terms of the applicable supply agreement between Licensor and Licensee, then Licensor shall be responsible for the costs of such recall or its Affiliate’s withdrawal to the extent that the non-conformity with the agreed specifications caused such recall or subcontractor’s responsibilitywithdrawal.

Product Withdrawals and Recalls. If With respect to each Optioned Program, if (aA) any Regulatory Authority threatens, initiates or advises any action to remove any applicable Optioned Product from the market in the Territory or requires or advises AmbitGalapagos, AstellasGilead, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of any such Optioned Product in any country in the Territory, Territory or (bB) either Party determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then then, in each case ((aA) or (bB)) Ambit ), Galapagos or AstellasGilead, as applicable, shall shall, to the extent practicable, notify the other Party of such event or determination immediately, and in any event within three (3) Business Days […***…] (or sooner if required by lawApplicable Law) after such Party becomes aware of the event or makes such determination. Astellas Each Party shall, to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, and agree with Ambit upon the other Party whether to recall or withdraw the such Optioned Product in the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas each Party shall decide whether to recall or withdraw such Optioned Product in its Respective Territory. Each Party shall be responsible, at its sole cost and expense, for conducting any recalls or withdrawals or taking such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested necessary remedial action (i) actions with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Optioned Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expenseits Respective Territory, except that (1) in the case of subsections (i) and (ii) aboveeach Party’s respective Territory, to the extent that the recall or withdrawal is caused by attributable to the negligence, breach or intentional misconduct of a particular the other Party or any of its Affiliates or subcontractors, in which event such other Party shall bear the such costs of such recall or withdrawal and expenses to the extent of its or its Affiliate’s or subcontractor’s responsibilityresponsibility or (2) in each Party’s respective Territory, solely to the extent set forth in any applicable supply agreement, if any, between such Party (or any of its Affiliates) and the other Party (or any of its Affiliates) with respect to an applicable Optioned Product.

Product Withdrawals and Recalls. If (a) any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises AmbitUnum, AstellasSGI, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit Unum or AstellasSGI, as applicable, shall will, to the extent practicable, notify the other Party of such event or determination immediately, and in any event within three twenty-four (324) Business Days hours (or sooner if required by law) after such Party becomes aware of the event or makes such determination. Astellas shallEach Party will, to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, and agree with Ambit the other Party upon whether to recall or withdraw the Product in the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas shall (i) Unum will decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) Shared Territory; and (ii) aboveSGI will decide whether to recall or withdraw such Product in the Licensed Territory. The Parties will be jointly responsible for conducting any recalls or taking such other necessary remedial action with respect to Products in the Shared Territory, except to the extent that the recall or withdrawal is caused by attributable to the negligence, breach or intentional misconduct of a particular the other Party or any of its Affiliates or subcontractors, in which event the other Party will bear such Party shall bear costs to the costs extent of its or its Affiliate’s or subcontractor’s responsibility. SGI will be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action with respect to Products in the Licensed Territory, except to the extent that the recall or withdrawal is attributable to the negligence, breach or intentional misconduct of Unum or any of its Affiliates or subcontractors, in which event Unum will bear such costs to the extent of its or its Affiliate’s or subcontractor’s responsibility.

Product Withdrawals and Recalls. If any Regulatory Authority (a) any Regulatory Authority threatens, initiates or advises any action to remove any Licensed Product from the market in the Lexicon Territory or Licensed Territory, or (b) requires or advises Ambit, Astellas, either Party or any of their respective such Party’s Affiliates or Sublicensees sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Licensed Product in any country in the Territory, Lexicon Territory or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Licensed Territory, then in each case ((a) Lexicon or (b)) Ambit or AstellasIpsen, as applicable, shall notify the other Party of such event or determination immediately, and in any event within three (3) Business Days as soon as practicable but not later than [**] (or sooner if required by lawapplicable Laws) after such Party becomes aware of the event action, threat, advice or makes such determinationrequirement (as applicable). Astellas shall, The JSC or any senior representatives of the Parties will discuss and attempt to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall or withdraw the a Licensed Product in the applicable country(ies)Licensed Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period or if the matter involves a safety issue that, in order to protect patient safety, does not allow for sufficient time for a discussion at the JSC level (recognizing in which event Ipsen, as the exigencies holder of the situationMAA in the Licensed Territory for the Licensed Product at issue, shall nonetheless provide advance notice and consultation with Lexicon to the maximum practical extent prior to making a decision), then Astellas Ipsen shall decide whether to recall or withdraw any such Licensed Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, Licensed Territory and shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by the negligence, breach or intentional misconduct of a particular Party or undertake any of its Affiliates or subcontractors, such Party shall bear the costs of such recall or withdrawal at its own cost and expense. If requested by Ipsen, Lexicon shall reasonably cooperate with Ipsen in such efforts to recall or withdraw such Licensed Product in the extent of Licensed Territory. For clarity, Lexicon shall decide in its sole discretion whether to recall or withdraw a Licensed Product in the Lexicon Territory and shall undertake any such recall or withdrawal at its Affiliate’s or subcontractor’s responsibilityown cost and expense.

Product Withdrawals and Recalls. If In the event that (a) any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident incident, or circumstance has occurred that which may result in the need for a recall or other removal of the Licensed Product or any lot or lots thereof from the market withdrawal in the Licensed Field in the Territory; (b) any country Regulatory Authority in the Territory threatens or initiates any action to remove the Licensed Product from the market in the Licensed Field in the Territory; or (c) any Regulatory Authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent, regarding use of the Licensed Product in the Licensed Field in the Territory, then TGTX shall promptly advise Precision in each case writing with respect thereto, and shall provide to Precision copies of all relevant correspondence, notices, and any other related documents. In the event that (x) an event, incident, or circumstance has occurred which may result in the need for a recall or other removal of any Licensed Product or any lot or lots thereof from the market outside the Licensed Field in the Territory; (ay) any Regulatory Authority in the Territory threatens or initiates any action to remove any Licensed Product from the market outside the Licensed Field in the Territory; or (bz) any Regulatory Authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent, regarding use of the Licensed Product outside the Licensed Field in the Territory, Precision shall promptly (after it becomes aware of any of the events in (x) – (z)) Ambit advise TGTX, and shall require its licensees to promptly advise Precision, in writing with respect thereto, and shall provide to TGTX, and shall require its licensees to provide to Precision, copies of all relevant correspondence, notices, and any other related documents in its, or Astellasits licensee’s, as applicable, possession. Unless otherwise agreed by the Parties, TGTX shall notify be responsible for conducting a recall of the Licensed Product in the Licensed Field. TGTX will have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal of the Licensed Product in the Licensed Field in the Territory. Each Party will cooperate with the other Party of such event or determination immediately, and in any event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of the event or makes such determination. Astellas shall, to the extent practicable, endeavor to discuss and, in the case performance of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall or withdraw the Product in the applicable country(ies); provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by the negligence, breach or intentional misconduct of a particular Party or any of its Affiliates or subcontractors, such Party shall bear the costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibilitywithdrawal.

Product Withdrawals and Recalls. If With respect to each Optioned Product, if (aA) any Regulatory Authority threatens, initiates or advises any action to remove any such Optioned Product from the market in the Gilead Territory or the Third Party Territory or requires or advises AmbitArcus, AstellasGilead, 49 or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of any such Optioned Product in any country in the Territory, or (bB) either Party determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Gilead Territory or the Third Party Territory, then then, in each case ((aA) or (bB)) Ambit ), Arcus or AstellasGilead, as applicable, shall shall, to the extent practicable, notify the other Party of such event or determination immediately, and in any event within three (3) Business Days [***] (or sooner if required by lawApplicable Law) after such Party becomes aware of the event or makes such determination. Astellas Each Party shall, to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, and agree with Ambit upon the other Party whether to recall or withdraw the Product in the applicable country(ies)such Optioned Product; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas Gilead shall decide whether to recall or withdraw such Optioned Product in the Gilead Territory. Gilead shall be responsible for conducting any recalls or withdrawals or taking such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested necessary remedial action (i) actions with respect to any Clinical Trial supplies of Product used or intended to be used Optioned Products in carrying out activities under the Development Program Gilead Territory. Except as otherwise provided in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) an applicable supply agreement with respect to Co-Promoted Products within such Optioned Product between Gilead (or any of its Affiliates) and Arcus (or any of its Affiliates), the U.S. shall be included in Allowed Expenses, costs and (iii) expenses with respect to any Products outside the U.S. or Products other than Co-Promoted Products product withdrawals and recalls in the U.S., unless otherwise agreed Gilead Territory as provided in an applicable form of supply agreement, shall this Section 5.2(g)(iii) will be at Astellas’s sole expense, except deemed Research and Development Costs (if occurring prior to first commercial sale) or Allowable Expenses (thereafter); provided further that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by attributable to the negligence, breach or intentional misconduct of a particular either Party or any of its Affiliates Affiliates, Sublicensees or subcontractors, such Party shall bear the such costs of such recall or withdrawal and expenses to the extent of its or its Affiliate’s, Sublicensee’s or subcontractor’s responsibilitynegligence, breach or intentional misconduct.

Product Withdrawals and Recalls. If The Parties shall exchange their internal standard operating procedures (a“SOPs”) any Regulatory Authority threatens, initiates or advises any action to remove any for conducting product recalls reasonably in advance of Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediatelyLaunch, and in shall discuss and resolve any event within three (3) Business Days (or sooner if required by law) conflicts between such SOPs and issues relating thereto promptly after such exchange. In the event of any disagreement as to how to resolve any such conflicts, Vivus’ SOP shall control. If either Party becomes aware of information relating to the event Product that indicates that a unit or makes such determinationbatch of the Product in the Sanofi Territory may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of the Product in the Sanofi Territory, it shall promptly so notify the other Party. Astellas shall, to To the extent practicable, endeavor to the Parties shall discuss and, in the case circumstances of any Co-Promoted potential product recall, field correction, or withdrawal of any Product in the U.S. during the applicable Co-Promotion TermSanofi Territory and possible appropriate courses of action. If Sanofi decides to initiate a recall, agree with Ambit upon whether to recall field correction, or withdraw the withdrawal of Product in the applicable country(iesSanofi Territory, Sanofi shall have the right and responsibility, at its expense, to control such recall, field correction, or withdrawal in a manner consistent with its internal SOPs (as revised pursuant to the first sentence of this Section 5.4(c), if applicable); provided, however, that if such discussion is not practicable or if Sanofi shall consider in good faith the Parties fail views of Vivus as to so agree within an appropriate time period (recognizing the exigencies of the situation)whether a recall, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall field correction, or withdrawal expenses is necessary or expenses for taking other related ***Confidential Treatment Requested remedial action appropriate. If (i) with respect to any Clinical Trial supplies a Regulatory Authority or other Applicable Law requires a recall, field correction, or withdrawal of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S.Sanofi Territory, unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) aboveSanofi fails to initiate such recall, field correction, or withdrawal within *** of being notified of such requirement, Vivus shall have the right (but not the obligation), at its expense, to control such recall, field correction, or withdrawal in a manner consistent with its internal SOPs (as revised pursuant to the extent that first sentence of this Section 5.4(c), if applicable); provided, however, Vivus shall consider in good faith the recall views of Sanofi as to whether a recall, field correction, or withdrawal is caused by necessary or appropriate. For clarity, as between the negligenceParties, breach or intentional misconduct Vivus shall have the right (but not the obligations), at its expense, to control all recalls, field corrections, and withdrawals of a particular Party or any of its Affiliates or subcontractors, such Product in the Vivus Territory. Each Party shall bear the costs maintain complete and accurate records of such recall any recall, field correction, or withdrawal to the extent of in its or its Affiliate’s or subcontractor’s responsibilityterritory for such periods as may be required by Applicable Laws, but in no event for less than ***.

Product Withdrawals and Recalls. If (a) any Regulatory Authority threatens, initiates or advises any action to remove any Licensed Product from the market in the Territory or requires or advises AmbitGalapagos, AstellasGilead, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Licensed Product in any country in the Territory, or (b) either Party Gilead determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit Galapagos or AstellasGilead, as applicable, shall shall, to the extent practicable, notify the other Party of such event or determination immediately, and in any event within three (3) Business Days […***…] (or sooner if required by law) after such Party becomes aware of the event or makes such determination. Astellas Gilead shall, to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, and agree with Ambit Galapagos upon whether to recall or withdraw the Licensed Product in the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas Gilead shall decide whether to recall or withdraw such Licensed Product in the Territory. Subject to Section 5.5(b), Gilead shall be responsible, at its sole expense, for conducting any recalls or taking such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested necessary remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Licensed Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expenseTerritory, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by attributable to the negligence, breach or intentional misconduct of a particular Party Galapagos or any of its Affiliates or subcontractors, such Party in which event Galapagos shall bear the such costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibility.

Product Withdrawals and Recalls. If Each Party shall make every reasonable effort to notify the other Party promptly (abut in no event later than [***] hours) following its determination that any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall recall, market suspension or market withdrawal in any country in the Territory, then in each case of a Product ((a) whether a Joint Product or (ba Unilateral Product)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediately, and shall include in any event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of notice the event or makes reasoning behind such determination, and any supporting facts. Astellas shall, The Parties will discuss in good faith and attempt to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall recall, suspend or withdraw the Product in throughout the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation)period, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of a Joint Product used or intended to be used in carrying out activities under its Profit Share Region (if any), the Development Program in or Party that is the Lead Commercialization Party for the benefit of applicable Commercialization Territory within the Profit Share Region shall decide whether to recall, suspend or withdraw such Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development CostsProduct therein; and (ii) with respect to Co-Promoted a Unilateral Product in its Royalty Region (if any), the Party that is the Participating Party therefor shall decide whether to recall, suspend or withdraw such Unilateral Product therein. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in a country in the Territory, the Lead Commercialization Party shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. The Party that is not the Lead Commercialization Part shall reasonably cooperate in all recall, market suspension or market withdrawal efforts. Any expenses in connection with a recall, market withdrawal or market suspension with respect to Joint Products within the U.S. Profit Share Region shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, treated as Commercialization Costs except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by attributable to (A) the negligencenegligence or willful misconduct of, or breach of this Agreement by, a Party, or intentional (B) a Manufacturing defect in the Joint Product, in which events ((A) or (B)): (1) the Party that was negligent or committed willful misconduct or breach, or the Party responsible for Manufacture of the Joint Product, as applicable, shall bear that portion of the recall expenses attributable thereto; and (2) such costs shall not be included in Commercialization Costs. Any expenses in connection with a particular recall, market withdrawal or market suspension with respect to Unilateral Products within the Royalty Region shall be the Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. sole responsibility of the Participating Party except to the extent that the recall or any withdrawal is attributable to the negligence or willful misconduct of, or breach of its Affiliates or subcontractorsthis Agreement by, such the Non-Participating Party, in which event the Non-Participating Party shall bear that portion of the costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibilityexpenses attributable thereto.

Product Withdrawals and Recalls. If The Parties shall exchange their internal standard operating procedures (a“SOPs”) any Regulatory Authority threatens, initiates or advises any action to remove any for conducting product recalls reasonably in advance of Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediatelyLaunch, and in shall discuss and resolve any event within three (3) Business Days (or sooner if required by law) conflicts between such SOPs and issues relating thereto promptly after such exchange. In the event of any disagreement as to how to resolve any such conflicts, VIVUS’s SOP shall control unless and until VIVUS transfers ownership of the Product Marketing Authorization to Menarini, and Menarini’s SOP shall control thereafter. If either Party becomes aware of information relating to any Product that indicates that a unit or batch of such Product may not conform to the event specifications therefor, or makes such determinationthat potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Products, it shall promptly so notify the other Party. Astellas shall, to To the extent practicable, endeavor to the Parties shall discuss and, in the case circumstances of any Co-Promoted potential product recall, field correction, or withdrawal of any Product and possible appropriate courses of action. If Menarini decides to initiate a recall, field correction, or withdrawal of Product in the U.S. during Menarini Territory, Menarini shall have the applicable Co-Promotion Termright and responsibility, agree at its expense, to control such recall, field correction, or withdrawal in a manner consistent with Ambit upon whether its internal SOPs (as revised pursuant to recall or withdraw the Product in the applicable country(iesfirst sentence of this Section 5.5(c), if applicable); provided, however, that if such discussion is not practicable or if Menarini shall consider in good faith the Parties fail views of VIVUS as to so agree within an appropriate time period (recognizing the exigencies of the situation)whether a recall, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall field correction, or withdrawal expenses is necessary or expenses for taking other related ***Confidential Treatment Requested remedial action appropriate. If (i) with respect to any Clinical Trial supplies a Regulatory Authority or other Applicable Law requires a recall, field correction, or withdrawal of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S.Menarini Territory, unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) aboveMenarini fails to initiate such recall, field correction, or withdrawal within the deadline imposed by the Regulatory Authority, VIVUS shall have the right, at its expense, to control such recall, field correction, or withdrawal in a manner consistent with its internal SOPs (as revised pursuant to the extent that first sentence of this Section 5.5(c), if applicable); provided, however, VIVUS shall consider in good faith the recall views of Menarini as to whether a recall, field correction, or withdrawal is caused by necessary or appropriate. For clarity, as between the negligenceParties, breach or intentional misconduct VIVUS shall have the right, at its expense, to control all recalls, field corrections, and withdrawals of a particular Party or any of its Affiliates or subcontractors, such Product in the VIVUS Territory. Each Party shall bear the costs maintain complete and accurate records of such recall any recall, field correction, or withdrawal to the extent of in its or its Affiliate’s or subcontractor’s responsibilityterritory for such periods as may be required by Applicable Laws, but in no event for less than five (5) years.

Product Withdrawals and Recalls. If (a) If any Regulatory Authority (i) threatens, initiates or advises any action to remove any the Product from the market in the Territory Territory, or (ii) requires or advises AmbitAnacor, Astellas, Sandoz or any of their respective Affiliates or Sublicensees to distribute a “Dear DoctorHealth Care Provider” letter or its equivalent regarding use of such the Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) Anacor or (b)) Ambit or AstellasSandoz, as applicable, shall notify the other Party of such event or determination immediately, and in any event within three (3) Business Days (or sooner if required by lawApplicable Laws) after such Party becomes aware of the event action, threat, advice or makes such determinationrequirement (as applicable). Astellas shallThe JSC, via the Parties’ respective heads of Quality or other designees, will discuss and attempt to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall or withdraw the Product in the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing period, Anacor shall have the exigencies of the situation), then Astellas shall right to decide whether to recall or withdraw any such the Product (including any Co-Promoted Product) in such country(ies)the Territory. Any recall or withdrawal expenses or expenses for taking other related with respect to the Product in the Territory will be [***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense**], except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused attributable to the negligence or willful misconduct of [*****], in which event [*****] shall bear such costs for which it is responsible. Subject to the preceding sentence, (x) within [*****] after the end of a Calendar Quarter in which [*****] incurs recall expenses, [*****] shall submit a statement of such expenses to [*****] and (y) Sandoz shall adjust its next payment to Anacor under Section 8.4 and make any additional payment to Anacor that is not otherwise covered by the negligence, breach or intentional misconduct adjustment to the applicable payment to Anacor under Section 8.4 for the Calendar Quarter so that [*****] of a particular Party or any of its Affiliates or subcontractors, such Party shall bear the costs total of such recall or withdrawal expenses in the applicable Calendar Quarter that are to be [*****] pursuant to the extent of its or its Affiliate’s or subcontractor’s responsibility.preceding sentence. CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 240.24b-2. [*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. EXECUTION COPY

Product Withdrawals and Recalls. If Each Party shall make every reasonable effort to notify the other Party promptly (abut in no event later than [***] hours) following its determination that any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall recall, market suspension or market withdrawal in any country in the Territory, then in each case of a Product ((a) whether a Joint Product or (ba Unilateral Product)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediately, and shall include in any event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of notice the event or makes reasoning behind such determination, and any supporting facts. Astellas shall, The Parties will discuss in good faith and attempt to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall recall, suspend or withdraw the Product in throughout the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation)period, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of a Joint Product used or intended to be used in carrying out activities under its Profit Share Region (if any), the Development Program in or Party that is the Lead Commercialization Party for the benefit of applicable Commercialization Territory within the Profit Share Region shall decide whether to recall, suspend or withdraw such Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development CostsProduct therein; and (ii) with respect to Co-Promoted a Unilateral Product in its Royalty Region (if any), the Party that is the Participating Party therefor shall decide whether to recall, suspend or withdraw such Unilateral Product therein. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in a country in the Territory, the Lead Commercialization Party shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. The Party that is not the Lead Commercialization Part shall reasonably cooperate in all recall, market suspension or market withdrawal efforts. Any expenses in connection with a recall, market withdrawal or market suspension with respect to Joint Products within the U.S. Profit Share Region shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, treated as Commercialization Costs except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by attributable to (A) the negligencenegligence or willful misconduct of, or breach of this Agreement by, a Party, or intentional (B) a Manufacturing defect in the Joint Product, in which events ((A) or (B)): (1) the Party that was negligent or committed willful misconduct or breach, or the Party responsible for Manufacture of the Joint Product, as applicable, shall bear that portion of the recall expenses attributable thereto; and (2) such costs shall not be included in Commercialization Costs. Any expenses in connection with a particular recall, market withdrawal or market suspension with respect to Unilateral Products within the Royalty Region shall be the sole responsibility of the Participating Party Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. except to the extent that the recall or any withdrawal is attributable to the negligence or willful misconduct of, or breach of its Affiliates or subcontractorsthis Agreement by, such the Non-Participating Party, in which event the Non-Participating Party shall bear that portion of the costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibilityexpenses attributable thereto.

Product Withdrawals and Recalls. If (a) any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediately, and in any event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of the event or makes such determination. Astellas shall, to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall or withdraw the Product in the applicable country(ies); provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested CONFIDENTIAL remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by the negligence, breach or intentional misconduct of a particular Party or any of its Affiliates or subcontractors, such Party shall bear the costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibility.

Product Withdrawals and Recalls. If The Parties shall exchange their internal standard operating procedures (a“SOPs”) any Regulatory Authority threatens, initiates or advises any action to remove any for conducting product recalls reasonably in advance of Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediatelyLaunch, and in shall discuss and resolve any event within three (3) Business Days (or sooner if required by law) conflicts between such SOPs and issues relating thereto promptly after such exchange. In the event of any disagreement as to how to resolve any such conflicts with respect to the Product, VIVUS ‘s SOP shall control unless and until VIVUS transfers ownership of the Product Marketing Authorization to Licensee, and Licensee’s SOP shall control thereafter. If either Party becomes aware of information relating to the event Product that indicates that a unit or makes batch of such determinationProduct may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Products, it shall promptly so notify the other Party. Astellas shall, to To the extent practicable, endeavor to the Parties shall discuss and, in the case circumstances of any Co-Promoted potential product recall, field correction, or withdrawal of any Product and possible appropriate courses of action. If Licensee decides to initiate a recall, field correction, or withdrawal of Product in the U.S. during Licensee Territory, Licensee shall have the applicable Co-Promotion Termright and responsibility, agree at its expense but without limiting any claims Licensee may have against VIVUS or any other Person, to control such recall, field correction, or withdrawal in a manner consistent with Ambit upon whether its internal SOPs (as revised pursuant to recall or withdraw the Product in the applicable country(iesfirst sentence of this Section 5.5(c), if applicable); provided, however, that if such discussion is not practicable or if Licensee shall consider in good faith the Parties fail views of VIVUS as to so agree within an appropriate time period (recognizing the exigencies of the situation)whether a recall, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expensesfield correction, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by necessary or appropriate. For clarity, as between the negligenceParties, breach or intentional misconduct VIVUS shall have the right, at its expense, to control all recalls, field corrections, and withdrawals of a particular Party or any of its Affiliates or subcontractors, such Product in the VIVUS Territory. Each Party shall bear maintain complete and accurate records of any recall, field correction, or withdrawal in its territory for such periods as may be required by Applicable Laws, but in no event for less than five (5) years. For purposes of clarity, for Product supplied by VIVUS under the Commercial Supply Agreement, the Parties’ respective responsibilities for the costs of such recall any Product recall, field correction, or withdrawal to of such Product shall be as set forth in the extent of its or its Affiliate’s or subcontractor’s responsibilityCommercial Supply Agreement.

Product Withdrawals and Recalls. If The Parties shall exchange their internal standard operating procedures (a“SOPs”) any Regulatory Authority threatens, initiates or advises any action to remove any for conducting product recalls reasonably in advance of Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediatelyLaunch, and in shall discuss and resolve any event within three (3) Business Days (or sooner if required by law) conflicts between such SOPs and issues relating thereto promptly after such exchange. In the event of any disagreement as to how to resolve any such conflicts with respect to the Product, VIVUS’s SOP shall control unless and until VIVUS transfers ownership of the Product Marketing Authorization to Auxilium, and Auxilium’s SOP shall control thereafter. If either Party becomes aware of information relating to the event Product that indicates that a unit or makes batch of such determinationProduct may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Products, it shall promptly so notify the other Party. Astellas shall, to To the extent practicable, endeavor to the Parties shall discuss and, in the case circumstances of any Co-Promoted potential product recall, field correction, or withdrawal of any Product and possible appropriate courses of action. If Auxilium decides to initiate a recall, field correction, or withdrawal of Product in the U.S. during Auxilium Territory, Auxilium shall have the applicable Co-Promotion Termright and responsibility, agree at its expense but without limiting any claims Auxilium may have against VIVUS or any other Person, to control such recall, field correction, or withdrawal in a manner consistent with Ambit upon whether its internal SOPs (as revised pursuant to recall or withdraw the Product in the applicable country(iesfirst sentence of this Section 5.6(c), if applicable); provided, however, that if such discussion is not practicable or if Auxilium shall consider in good faith the Parties fail views of VIVUS as to so agree within an appropriate time period (recognizing the exigencies of the situation)whether a recall, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall field correction, or withdrawal expenses is necessary or expenses appropriate. For clarity, as between the Parties, VIVUS shall have the right, at its expense, to control all recalls, field corrections, and withdrawals of any Product in the VIVUS Territory. Each Party shall maintain complete and accurate records of any recall, field correction, or withdrawal in its territory for taking other related such periods as may be required by Applicable Laws, but in no event for less than ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies . For purposes of clarity, for Product used or intended to be used in carrying out activities supplied by VIVUS under the Development Program in or Commercial Supply Agreement, the Parties’ respective responsibilities for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by the negligence, breach or intentional misconduct of a particular Party or any of its Affiliates or subcontractors, such Party shall bear the costs of such recall any Product recall, field correction, or withdrawal to of such Product shall be as set forth in the extent of its or its Affiliate’s or subcontractor’s responsibilityCommercial Supply Agreement.

Product Withdrawals and Recalls. If The Parties shall exchange their internal standard operating procedures (a“SOPs”) any Regulatory Authority threatens, initiates or advises any action to remove any for conducting product recalls reasonably in advance of Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediatelyLaunch, and in shall discuss and resolve any event within three (3) Business Days (or sooner if required by law) conflicts between such SOPs and issues relating thereto promptly after such exchange. In the event of any disagreement as to how to resolve any such conflicts with respect to the Product, VIVUS’s SOP shall control unless and until VIVUS transfers ownership of the Product Marketing Authorization to Auxilium, and Auxilium’s SOP shall control thereafter. If either Party becomes aware of information relating to the event Product that indicates that a unit or makes batch of such determinationProduct may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Products, it shall promptly so notify the other Party. Astellas shall, to To the extent practicable, endeavor to the Parties shall discuss and, in the case circumstances of any Co-Promoted potential product recall, field correction, or withdrawal of any Product and possible appropriate courses of action. If Auxilium decides to initiate a recall, field correction, or withdrawal of Product in the U.S. during Auxilium Territory, Auxilium shall have the applicable Co-Promotion Termright and responsibility, agree at its expense but without limiting any claims Auxilium may have against VIVUS or any other Person, to control such recall, field correction, or withdrawal in a manner consistent with Ambit upon whether its internal SOPs (as revised pursuant to recall or withdraw the Product in the applicable country(iesfirst sentence of this Section 5.6(c), if applicable); provided, however, that if such discussion is not practicable or if Auxilium shall consider in good faith the Parties fail views of VIVUS as to so agree within an appropriate time period (recognizing the exigencies of the situation)whether a recall, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expensesfield correction, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by necessary or appropriate. For clarity, as between the negligenceParties, breach or intentional misconduct VIVUS shall have the right, at its expense, to control all recalls, field corrections, and withdrawals of a particular Party or any of its Affiliates or subcontractors, such Product in the VIVUS Territory. Each Party shall bear maintain complete and accurate records of any recall, field correction, or withdrawal in its territory for such periods as may be required by Applicable Laws, but in no event for less than [**]. For purposes of clarity, for Product supplied by VIVUS under the Commercial Supply Agreement, the Parties’ respective responsibilities for the costs of such recall any Product recall, field correction, or withdrawal to of such Product shall be as set forth in the extent of its or its Affiliate’s or subcontractor’s responsibilityCommercial Supply Agreement.

Product Withdrawals and Recalls. If (a) any Regulatory Authority threatens, initiates or advises any action to remove any Licensed Product from the market in the Territory or requires or advises AmbitGalapagos, AstellasGilead, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Licensed Product in any country in the Territory, or (b) either Party Gilead determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall or market withdrawal in any country in the Territory, then in each case ((a) or (b)) Ambit Galapagos or AstellasGilead, as applicable, shall shall, to the extent practicable, notify the other Party of such event or determination immediately, and in any event within three (3) Business Days […***…] (or sooner if required by law) after such Party becomes aware of the event or makes such determination. Astellas Gilead shall, to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, and agree with Ambit Galapagos upon whether to recall or withdraw the Licensed Product in the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then Astellas Gilead shall decide whether to recall or withdraw such Licensed Product in the Territory. Subject to Section 5.5(a), Gilead shall be responsible, at its sole expense, for conducting any recalls or taking such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested necessary remedial action (i) with respect to any Clinical Trial supplies of Product used or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Licensed Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expenseTerritory, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by attributable to the negligence, breach or intentional misconduct of a particular Party Galapagos or any of its Affiliates or subcontractors, such Party in which event Galapagos shall bear the such costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibility.

Product Withdrawals and Recalls. If Each Party shall make every reasonable effort to notify the other Party promptly (abut in no event later than [***] hours) following its determination that any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in any country in the Territory, or (b) either Party determines that an event, incident incident, or circumstance has occurred that may result in the need for a recall recall, market suspension or market withdrawal in any country in the Territory, then in each case of a Product ((a) whether a Joint Product or (ba Unilateral Product)) Ambit or Astellas, as applicable, shall notify the other Party of such event or determination immediately, and shall include in any event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of notice the event or makes reasoning behind such determination, and any supporting facts. Astellas shall, The Parties will discuss in good faith and attempt to the extent practicable, endeavor to discuss and, in the case of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Term, agree with Ambit upon whether to recall recall, suspend or withdraw the Product in throughout the applicable country(ies)Territory; provided, however, that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation)period, then Astellas shall decide whether to recall or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) with respect to any Clinical Trial supplies of a Joint Product used or intended to be used in carrying out activities under its Profit Share Region (if any), the Development Program in or Party that is the Lead Commercialization Party for the benefit of applicable Commercialization Territory within the Profit Share Region shall decide whether to recall, suspend or withdraw such Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development CostsProduct therein; and (ii) with respect to Co-Promoted a Unilateral Product in its Royalty Region (if any), the Party that is the Participating Party therefor shall decide whether to recall, suspend or withdraw such Unilateral Product therein. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in a country in the Territory, the Lead Commercialization Party shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. The Party that is not the Lead Commercialization Part shall reasonably cooperate in all recall, market suspension or market withdrawal efforts. Any expenses in connection with a recall, market withdrawal or market suspension with respect to Joint Products within the U.S. Profit Share Region shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at Astellas’s sole expense, treated as Commercialization Costs except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by attributable to (A) the negligencenegligence or willful misconduct of, or breach of this Agreement by, a Party, or intentional (B) a Manufacturing defect in the Joint Product, in which events ((A) or (B)): (1) the Party that was negligent or committed willful misconduct or breach, or the Party responsible for Manufacture of the Joint Product, as applicable, shall bear that portion of the recall expenses attributable thereto; and (2) such costs shall not be included in Commercialization Costs. Any expenses in connection with a particular recall, market withdrawal or market suspension with respect to Unilateral Products within the Royalty Region shall be the Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. sole responsibility of the Participating Party except to the extent that the recall or any withdrawal is attributable to the negligence or willful misconduct of, or breach of its Affiliates or subcontractorsthis Agreement by, such the Non-Participating Party, in which event the Non-Participating Party shall bear that portion of the costs of such recall or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibilityexpenses attributable thereto.

Product Withdrawals and Recalls. If In the event that either Party (a) becomes aware of an event, incident or circumstance that has occurred which may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (b) becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Product from the market; (c) is required by any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Ambit, Astellas, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent equivalent, regarding use of such Product in any country in the Territory, Product; or (bd) either Party determines that an event, incident or circumstance has occurred that may result in the need places a clinical trial for a recall or market withdrawal in any country in the TerritoryProduct on hold for clinical safety reasons, then in each case ((a) or (b)) Ambit or Astellas, as applicable, such Party shall notify promptly advise the other Party of such event or determination immediatelyin writing with respect thereto, and shall provide to such other Party copies of all relevant correspondence, notices, and the like. The holder of the Marketing Authorization (if any) for the Product shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the jurisdiction covered by that Marketing Authorization and shall be responsible for conducting any recalls or taking such other remedial action, and each Party agrees, upon reasonable request by the Marketing Authorisation holder and at the expense of the Marketing Authorization holder, to assist with respect to such recalls or remedial actions. STOCOSIL shall have final authority to make all decisions relating to any recall, withdrawal or other corrective action with respect to the Product in use in a Clinical Trial, and DAEWOONG agrees, upon reasonable request and notice by STOCOSIL and at the expense of STOCOSIL, to assist with respect to such recall, withdrawal or other corrective action. 12.1.6 In the event within three that (3i) Business Days any recall, market withdrawal or other corrective action is (or sooner if may be) required in relation to the Product Manufactured and supplied by lawDAEWOONG to STOCOSIL pursuant to the Manufacturing and Supply Agreement and (ii) after such Party becomes aware there is any conflict or inconsistency between the provisions of that Manufacturing and Supply Agreement and the provisions of Clause 12.1.6, the provisions of the event or makes such determination. Astellas Manufacturing and Supply Agreement shall, to the extent practicableof such inconsistency or conflict, endeavor prevail. 13. MEDICAL GOVERNANCE 13.1 It is agreed that where in a clinical study relating to discuss andthe Product: (a) the route of administration is to be changed; (b) patient exposure is designed to be significantly increased beyond that of the originator molecules; and/or (c) there is a high risk of drug on drug interactions (as assessed by STOCOSIL), no clinical studies shall be undertaken, prior to commencement, such study shall be submitted to STOCOSIL’s Global Safety Board for review and comment. 13.2 In the event that the Parties do not agree with the comments of STOCOSIL’s Global Safety Board made following a referral to it under Clause 13.1, the decision as to whether the Clinical Trial in question shall proceed and on what terms shall be made in accordance with the provisions set out in Clause 4.2. 13.3 The Parties agree at all times to comply with the Global Scientific Principles and Standards and that in particular any publicity and marketing relating to the Products shall comply with such principles and standards. -34- 14. CLINICAL TRIALS 14.1 Conduct of Clinical Trials 14.1.1 STOCOSIL shall be responsible for conducting and funding, in its sole direction, all Phase III Clinical Trials for the case of any Co-Promoted Product and/or Optional Product in the U.S. during Territory. 14.1.2 Unless otherwise agreed by the applicable Co-Promotion TermParties or required by Applicable Law, agree with Ambit upon whether STOCOSIL shall own all data and reports related to recall or withdraw Clinical Studies in the Territory. All data, database information and safety reports from such Clinical Trials in the Territory for the Product and/or Optional Product shall be centralised and held by STOCOSIL with copies of such data, information or reports provided to DAEWOONG to the extent required as contemplated in this Agreement or the applicable country(ies); provided, however, that if such discussion is not practicable or if the Parties fail Development Plan to so agree within an appropriate time period (recognizing the exigencies support application for Marketing Authorization outside of the situation)Territory. 14.2 Clinical Trial Registry 14.2.1 To the extent required by Applicable Laws, then Astellas STOCOSIL shall decide whether have the right at any time during and after the term of this Agreement to recall publish the results or withdraw any such Product (including any Co-Promoted Product) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related ***Confidential Treatment Requested remedial action (i) summaries of results of all clinical trials conducted with respect to the Product and/or Optional Product in any Clinical Trial supplies clinical trial register maintained by STOCOSIL or its Affiliate and the protocols of clinical trials relating to such Product used and/or Optional Product on xxx.XxxxxxxxXxxxxx.xxx and/or in each case publish the results, summaries and/or protocols of clinical trials on such other websites and/or repositories and in a peer-reviewed journal within such timescales as required by law or intended to be used in carrying out activities under the Development Program in or for the benefit of the Joint Development Territory (except to the extent covered by clause (ii)) shall be included in Development Costs; (ii) with respect to Co-Promoted Products within the U.S. shall be included in Allowed Expenses, and (iii) with respect to any Products outside the U.S. or Products other than Co-Promoted Products in the U.S., unless otherwise agreed in an applicable form of supply agreement, shall be at AstellasSTOCOSIL’s sole expense, except that in the case of subsections (i) and (ii) above, to the extent that the recall or withdrawal is caused by the negligence, breach or intentional misconduct of a particular Party or any of its Affiliates or subcontractors, such Party shall bear the costs of such recall or withdrawal to the extent of its or its Affiliate’s standard operating procedures, irrespective of the outcome of such clinical trials. Each such publication made in accordance with this Clause 14 shall not be a breach of the applicable confidentiality obligations set out in the Agreement and STOCOSIL shall be entitled to maintain such publication even following any termination of STOCOSIL’s rights in respect of the relevant Product and/or Optional Product. 14.2.2 DAEWOONG shall have the right to publish the results or subcontractor’s responsibilitysummaries of results of all Clinical Trials conducted with respect to the Product and/or Optional Product outside of the Territory as allowed by Applicable Laws. Prior to public disclosure or submission for publication of a proposed publication describing the results of any scientific or clinical activity relating to the Product and Optional Product outside of the Territory, DAEWOONG shall send STOCOSIL by expedited delivery a copy of the proposed publication to be submitted and shall allow STOCOSIL a reasonable time period (but no more than sixty (60) days from the date of confirmed receipt) in which to determine whether the proposed publication contains subject matter for which patent protection should be sought (prior to publication of such proposed publication) for the purpose of protecting an invention, or whether the proposed publication contains Confidential Information of STOCOSIL. Following the expiration of applicable time period for review, DAEWOONG shall be free to submit such proposed publication for publication and publish or otherwise disclose to the public such scientific or clinical results. 15.