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 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 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 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 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 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 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 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 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 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 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 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 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) 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 remedial action (i) with respect to any Clinical Trial supplies of the 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 Territory will 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 preceding sentence. (b) If and when Anacor recovers any recall expenses from [*****], subject to [*****], Anacor shall promptly pay to Sandoz [*****] of its or its Affiliate’s or subcontractor’s responsibilitysuch recovered amounts received (net of any applicable Taxes).

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 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 (a) If any Regulatory Authority (a) threatens, initiates or advises any action regarding clinical holds of trials or any validated safety signals or to remove any Product from the market in the Territory or (b) requires or advises Ambit, Astellas, a Party or any of their respective its Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such any 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, such Party 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 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 a 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)period, then Astellas Arcturus shall decide whether to recall or withdraw any such OTC Product (including or Co-Developed Arcturus Product in the Territory, and CureVac shall decide whether to recall or withdraw any Co-Promoted ProductDeveloped CureVac Product in the Territory. CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT between CUREVAC and ARCTURUS Confidential (b) in such country(ies). Any recall or withdrawal expenses or expenses for taking other related 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)) Products shall be included in treated as Clinical Development Costs or Joint Commercialization 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 expenseas applicable, 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 gross negligence or intentional willful misconduct of a particular Party or any of its Affiliates or subcontractors, in which event (i) such Party shall bear the such costs of for which it is responsible and (ii) such recall costs shall not be included in Clinical Development Costs or withdrawal to the extent of its or its Affiliate’s or subcontractor’s responsibilityJoint Commercialization Costs.

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 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 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, 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 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 (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 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 threatens, initiates or advises any action to remove any Product from In 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 event that (ba) 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 Product or any lot or lots thereof from the market withdrawal in any country in the Territory, then Field; (b) any Regulatory Authority in each case ((a) the Territory threatens or initiates any action to remove the Product from the market in the Field; or (b)c) 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, Regulatory Authority in the case Territory requires distribution of any Co-Promoted Product in the U.S. during the applicable Co-Promotion Terma “Dear Doctor” letter or its equivalent, agree with Ambit upon whether to recall or withdraw regarding use of the Product in the applicable country(ies); providedField, howeverthe Party having knowledge of such event shall promptly advise the other Party in writing with respect thereto, that if such discussion is not practicable or if and shall provide the Parties fail to so agree within an appropriate time period (recognizing other Party copies of all relevant correspondence, notices, and any other related documents. Unless otherwise agreed by the exigencies Parties, UTC shall be responsible for conducting the recall. Pluristem shall, upon reasonable request by UTC assist UTC in the conduct 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 in the Territory. Each Party will cooperate with the other Party in the performance of any recall or expenses for taking other related remedial action withdrawal. (b) To the extent any recall of the Product is implemented as a result of the occurrence of an activity identified in Sections ‎12.2(a) through ‎12.2(e) inclusive by the Pluristem Indemnitees, Pluristem shall (i) bear all of Pluristem’s costs and all Reasonable Costs incurred by UTC in connection 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) such recall and (ii) aboveeither, at UTC’s option, replace or credit UTC for the cost of the relevant lots of the Product subject to the recall. (c) To the extent that any recall of the recall or withdrawal Product is caused implemented as a result of the occurrence of an activity identified in Sections ‎12.1(a) through ‎12.1(f) inclusive by the negligenceUTC Indemnitees, breach or intentional misconduct UTC shall (i) bear all of a particular Party or any of its Affiliates or subcontractors, such Party shall bear the UTC’s costs of and all Reasonable Costs incurred by Pluristem in connection with such recall or withdrawal and (ii) if not already paid for by UTC, pay Pluristem for the cost of the relevant lots of the Product subject to the extent recall. (d) Section ‎12.3 shall apply to the allocation of its or its Affiliate’s or subcontractor’s responsibilityresponsibility set out in this Section, mutatis mutandis.