Common use of Product Withdrawal Clause in Contracts

Product Withdrawal. With respect to a Product Withdrawal within the Territory, immediately after receipt of such notification, the JSC (or its co-chairpersons) shall discuss and, unless the Product Withdrawal is mandated by a Regulatory Authority, shall attempt to agree on whether to voluntarily implement the Product Withdrawal within the Territory. If a Regulatory Authority mandates that the Product Withdrawal within the Territory be implemented then ARIAD SWISSCO, in consultation with ARIAD US, shall initiate the Product Withdrawal within the Territory as and to the extent mandated by the Regulatory Authority and in compliance with Applicable Laws. In the case of a Product Withdrawal that is not mandated by Regulatory Authority, if the JSC (or its co-chairpersons) fail(s) to agree within a reasonably appropriate time period (depending upon the circumstances) whether to voluntarily implement or undertake a Product Withdrawal within the Territory, then ARIAD SWISSCO and/or the MAH shall have the right to make the determination whether or not to voluntarily implement such Product Withdrawal within the Territory; provided that, to the extent practicable prior to deciding to initiate a Product Withdrawal within the Territory, ARIAD SWISSCO shall or shall procure that the relevant MAH shall consider ARIAD US’s reasonable comments in good faith. ARIAD SWISSCO or its Sublicensees shall carry out such Product Withdrawal activities in consultation with ARIAD US, in a manner which enables the Parties to meet their respective Regulatory Requirements as expeditiously as possible, and in compliance with all Applicable Laws. In the event of a mandated or voluntary Product Withdrawal in the Territory, the Parties will consider whether such action is necessary also in the Reserved Territory. If either Party or the relevant MAH does not choose to undertake a voluntary Product Withdrawal in its respective territory, despite the other Party’s written recommendation that such Product Withdrawal should be undertaken, then, notwithstanding anything to the contrary herein, such Party shall indemnify and hold harmless the other Party from and against any Losses that may arise or result thereafter from such Party’s failure to undertake such Product Withdrawal following such written recommendation from the other Party pursuant to the procedures set forth in Section 22.3.

Product Withdrawal. With respect If either Otsuka or Acucela discovers or becomes aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to a Collaboration Product that may reasonably require Product Withdrawal within or a “Dear Doctor” letter related to Collaboration Product in any country in the Territory, immediately after receipt of such notificationParty shall communicate such fact, the JSC (condition, circumstance or its co-chairpersons) shall discuss and, unless the Product Withdrawal is mandated by a Regulatory Authority, shall attempt to agree on whether to voluntarily implement the Product Withdrawal within the Territory. If a Regulatory Authority mandates that the Product Withdrawal within the Territory be implemented then ARIAD SWISSCO, in consultation with ARIAD US, shall initiate the Product Withdrawal within the Territory as and event promptly to the extent mandated by the Regulatory Authority and in compliance with Applicable Laws. In the case of a Product Withdrawal that is not mandated by Regulatory Authority, if the JSC (or its co-chairpersons) fail(s) to agree within a reasonably appropriate time period (depending upon the circumstances) whether to voluntarily implement or undertake a Product Withdrawal within the Territory, then ARIAD SWISSCO and/or the MAH shall have the right to make the determination whether or not to voluntarily implement such Product Withdrawal within the Territory; provided that, to the extent practicable prior to deciding to initiate a Product Withdrawal within the Territory, ARIAD SWISSCO shall or shall procure that the relevant MAH shall consider ARIAD US’s reasonable comments in good faith. ARIAD SWISSCO or its Sublicensees shall carry out such Product Withdrawal activities in consultation with ARIAD US, in a manner which enables the Parties to meet their respective Regulatory Requirements as expeditiously as possible, and in compliance with all Applicable Lawsother Party. In the event (i) any Regulatory Authority issues a request, directive or order that Collaboration Product be withdrawn from the market; (ii) a court of competent jurisdiction orders that Collaboration Product be recalled or withdrawn from the market; or (iii) the JDC (in the Shared Territory), Otsuka (in the Otsuka Territory) or Acucela (in the Acucela Territory) reasonably determines, after mutual consultation with each other, that Collaboration Product should be withdrawn from the market in a mandated given country or voluntary countries or that a “Dear Doctor” letter should be sent relating to use of Collaboration Product, each Party shall take all appropriate remedial actions with respect thereto, provided, however, that Otsuka in the Otsuka Territory and Acucela in the Acucela Territory shall, in its sole discretion, finally determine any Product Withdrawal matters. To the extent that it is necessary or appropriate to communicate with any Person, including to any Regulatory Authority, the media or any customer, concerning any such fact, condition, circumstance or event, Otsuka with respect to the Shared Territory, Otsuka with respect to the Otsuka Territory and Acucela with respect to the Acucela Territory, shall be the primary contact concerning the remedial actions. All costs associated with any such remedial actions (“Product Withdrawal Expenses”) shall be borne by the Party at fault for giving rise to the fact, condition, circumstance or event resulting in Product Withdrawal as determined by a mutually acceptable testing laboratory or a regulatory consultant that is familiar with the circumstances of the Product Withdrawal. Notwithstanding the foregoing, if a Product Withdrawal in the TerritoryShared Territory becomes necessary not due to the fault of either Party but due to an intrinsic problem or defect in the efficacy or safety of Collaboration Compound contained in the Collaboration Product (the “Intrinsic Defect”), all Product Withdrawal Expenses shall be allocated as follows; (i) all Product Withdrawal Expenses with respect to the Shared Territory shall be equally shared between the Parties will consider whether such action is necessary also in the Reserved Territory. If either Party or the relevant MAH does not choose to undertake (and shall constitute a voluntary part of Allowable Expenses, if applicable); (ii) * of Product Withdrawal in its respective territory, despite Expenses with respect to the other Party’s written recommendation that such Otsuka Territory shall be borne by Otsuka; and (iii) * of Product Withdrawal should be undertaken, then, notwithstanding anything Expenses with respect to the contrary herein, such Party Acucela Territory shall indemnify and hold harmless the other Party from and against any Losses that may arise or result thereafter from such Party’s failure to undertake such Product Withdrawal following such written recommendation from the other Party pursuant to the procedures set forth in Section 22.3be borne by Acucela.

Product Withdrawal. With respect to a Product Withdrawal within the Territory, immediately after receipt of such notification, the JSC Steering Committee (or its co-chairpersons) shall discuss and, unless the Product Withdrawal is mandated by a Regulatory Authority, shall attempt to agree on whether to voluntarily implement the Product Withdrawal within the Territory. If a Regulatory Authority mandates that the Product Withdrawal within the Territory be implemented then ARIAD SWISSCOVinbiocare, in consultation and coordination with ARIAD USArcturus, shall initiate the Product Withdrawal within the Territory as and to the extent mandated by the Regulatory Authority and in compliance with Applicable Laws. In the case of a Product Withdrawal that is not mandated by a Regulatory Authority, if the JSC Steering Committee (or its co-chairpersons) fail(s) to agree within a reasonably appropriate time period (depending upon the circumstances) whether to voluntarily implement or undertake a Product Withdrawal within the Territory, then ARIAD SWISSCO and/or the MAH Arcturus shall have the right to make the determination whether or not to voluntarily implement such Product Withdrawal within the Territory; provided that, to the extent practicable prior to deciding to initiate a Product Withdrawal within the Territory, ARIAD SWISSCO Arcturus shall or shall procure that the relevant MAH consult with Vinbiocare’s Steering Committee representative, and shall consider ARIAD USVinbiocare’s reasonable comments in good faith. ARIAD SWISSCO Notwithstanding that Arcturus shall have the right to decide whether or its Sublicensees not to initiate a voluntary Product Withdrawal, if Vinbiocare, as the distributor of Vaccine in the Territory, is responsible for carrying out and physically recovering the withdrawn Vaccine in the Territory, Vinbiocare shall carry out such Product Withdrawal activities in coordination and consultation with ARIAD USArcturus, in a manner which enables the Parties Arcturus to meet their respective Regulatory Requirements its regulatory requirements as expeditiously as possible, and in compliance with all Applicable Laws. In the event of a mandated or voluntary Product Withdrawal in the Territory, the Parties will consider whether such action is necessary also in the Reserved Territory. If either Party or the relevant MAH does not choose to undertake a voluntary Product Withdrawal in its respective territory, despite the other Party’s written recommendation that such Product Withdrawal should be undertaken, then, notwithstanding anything to the contrary herein, such Party shall indemnify and hold harmless the other Party from and against any Losses that may arise or result thereafter from such Party’s failure to undertake such Product Withdrawal following such written recommendation from the other Party pursuant to the procedures set forth in Section 22.3.

Product Withdrawal. With respect If either Otsuka or Acucela discovers or becomes aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to a Collaboration Product that may reasonably require Product Withdrawal within or a “Dear Doctor” letter related to Collaboration Product in any country in the Territory, immediately after receipt of such notificationParty shall communicate such fact, the JSC (condition, circumstance or its co-chairpersons) shall discuss and, unless the Product Withdrawal is mandated by a Regulatory Authority, shall attempt to agree on whether to voluntarily implement the Product Withdrawal within the Territory. If a Regulatory Authority mandates that the Product Withdrawal within the Territory be implemented then ARIAD SWISSCO, in consultation with ARIAD US, shall initiate the Product Withdrawal within the Territory as and event promptly to the extent mandated by the Regulatory Authority and in compliance with Applicable Laws. In the case of a Product Withdrawal that is not mandated by Regulatory Authority, if the JSC (or its co-chairpersons) fail(s) to agree within a reasonably appropriate time period (depending upon the circumstances) whether to voluntarily implement or undertake a Product Withdrawal within the Territory, then ARIAD SWISSCO and/or the MAH shall have the right to make the determination whether or not to voluntarily implement such Product Withdrawal within the Territory; provided that, to the extent practicable prior to deciding to initiate a Product Withdrawal within the Territory, ARIAD SWISSCO shall or shall procure that the relevant MAH shall consider ARIAD US’s reasonable comments in good faith. ARIAD SWISSCO or its Sublicensees shall carry out such Product Withdrawal activities in consultation with ARIAD US, in a manner which enables the Parties to meet their respective Regulatory Requirements as expeditiously as possible, and in compliance with all Applicable Lawsother Party. In the event (i) any Regulatory Authority issues a request, directive or order that Collaboration Product be withdrawn from the market; (ii) a court of competent jurisdiction orders that Collaboration Product be recalled or withdrawn from the market; or (iii) the JDC (in the Shared Territory), Otsuka (in the Otsuka Territory) or Acucela (in the Acucela Territory) reasonably determines, after mutual consultation with each other, that Collaboration Product should be withdrawn from the market in a mandated given country or voluntary countries or that a “Dear Doctor” letter should be sent relating to use of Collaboration Product, each Party shall take all appropriate remedial actions with respect thereto, provided, however, that Otsuka in the Otsuka Territory and Acucela in the Acucela Territory shall, in its sole discretion, finally determine any Product Withdrawal matters. To the extent that it is necessary or appropriate to communicate with any Person, including to any Regulatory Authority, the media or any customer, concerning any such fact, condition, circumstance or event, Otsuka with respect to the Shared Territory, Otsuka with respect to the Otsuka Territory and Acucela with respect to the Acucela Territory, shall be the primary contact concerning the remedial actions. All costs associated with Execution Copy any such remedial actions (“Product Withdrawal Expenses”) shall be borne by the Party at fault for giving rise to the fact, condition, circumstance or event resulting in Product Withdrawal as determined by a mutually acceptable testing laboratory or a regulatory consultant that is familiar with the circumstances of the Product Withdrawal. Notwithstanding the foregoing, if a Product Withdrawal in the TerritoryShared Territory becomes necessary not due to the fault of either Party but due to an intrinsic problem or defect in the efficacy or safety of Collaboration Compound contained in the Collaboration Product (the “Intrinsic Defect”), all Product Withdrawal Expenses shall be allocated as follows; (i) all Product Withdrawal Expenses with respect to the Shared Territory shall be equally shared between the Parties will consider whether such action is necessary also in the Reserved Territory. If either Party or the relevant MAH does not choose to undertake (and shall constitute a voluntary part of Allowable Expenses, if applicable); (ii) * of Product Withdrawal in its respective territory, despite Expenses with respect to the other Party’s written recommendation that such Otsuka Territory shall be borne by Otsuka; and (iii) * of Product Withdrawal should be undertaken, then, notwithstanding anything Expenses with respect to the contrary herein, such Party Acucela Territory shall indemnify and hold harmless the other Party from and against any Losses that may arise or result thereafter from such Party’s failure to undertake such Product Withdrawal following such written recommendation from the other Party pursuant to the procedures set forth in Section 22.3be borne by Acucela.

Product Withdrawal. With respect to a Product Withdrawal within the Territory, immediately after receipt of such notification, the JSC JDCC (or its co-chairpersons) shall discuss and, unless the Product Withdrawal is mandated by a Regulatory Authority, shall attempt to agree on whether to voluntarily implement the Product Withdrawal within the Territory. If a Regulatory Authority mandates that the Product Withdrawal within the Territory be implemented then ARIAD SWISSCOOtsuka, in consultation and coordination with ARIAD USARIAD, shall initiate the Product Withdrawal within the Territory as and to the extent mandated by the Regulatory Authority and in compliance with Applicable Laws. In the case of a Product Withdrawal that is not mandated by Regulatory Authority, if the JSC JDCC (or its co-chairpersons) fail(s) to agree within a reasonably appropriate time period (depending upon the circumstances) whether to voluntarily implement or undertake a Product Withdrawal within the Territory, then ARIAD SWISSCO and/or the MAH shall have the right to make the determination whether or not to voluntarily implement such Product Withdrawal within the Territory; provided that, to the extent practicable prior to deciding to initiate a Product Withdrawal within the Territory, ARIAD SWISSCO shall consult with Otsuka’s JDCC co-chairperson or shall procure that the relevant MAH Senior Officer, and shall consider ARIAD USOtsuka’s reasonable comments in good faith. Notwithstanding that ARIAD SWISSCO shall have the right to decide whether or its Sublicensees not to initiate a voluntary Product Withdrawal, if Otsuka, as the distributor of Product in the Territory, is responsible for carrying out and physically recovering the withdrawn Product in the Territory, Otsuka shall carry out such Product Withdrawal activities in coordination and consultation with ARIAD USARIAD, in a manner which enables the Parties ARIAD to meet their respective Regulatory Requirements its regulatory requirements as expeditiously as possible, and in compliance with all Applicable Laws. In the event of a mandated or voluntary Product Withdrawal in the Territory, the Parties will consider whether such action is necessary also in the Reserved Territory. If either Party or the relevant MAH ARIAD does not choose to undertake a voluntary Product Withdrawal in its respective territorythe Territory, despite the other PartyOtsuka’s written recommendation notice to ARIAD that such Product Withdrawal should be undertaken, then, notwithstanding anything to the contrary herein, such Party ARIAD shall indemnify and hold harmless the other Party Otsuka from and against any Losses that may arise or result thereafter from such PartyARIAD’s failure to undertake such Product Withdrawal following such written recommendation notice from Otsuka. Portions of this Exhibit, indicated by the other Party xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the procedures set forth in Section 22.3Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.