Common use of Product Withdrawals and Recalls Clause in Contracts

Product Withdrawals and Recalls. If any Regulatory Authority (a) threatens, initiates or advises any action to remove any Licensed Product from the market in any country of the world, or (b) requires or advises either Party or such Party’s Affiliates or sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of any Licensed Product in any country of the world, then Servier (if such action is in the Servier Territory) or MacroGenics (if such action is in the MacroGenics Territory), as applicable, shall notify the other Party of such event within *** (or sooner if required by applicable Law) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JRDC will discuss and attempt to agree upon whether to recall or withdraw such Licensed Product; provided, however, that if the Parties fail to 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 JRDC level, Servier shall decide whether to recall or withdraw such Licensed Product in the Servier Territory and shall undertake any such recall or withdrawal in the Servier Territory at its own cost and expense, and MacroGenics shall decide whether to recall or withdraw such Licensed Product in the MacroGenics Territory and shall undertake any such recall or withdrawal in the MacroGenics Territory at its own cost and expense.

Product Withdrawals and Recalls. If any Regulatory Authority (a) threatens, initiates or advises any action to remove any the Licensed Product from the market in any country of the world, or (b) requires or advises either Party or such Party’s Affiliates or sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of any the Licensed Product in any country of the world, then Servier MERRIMACK (if such action is outside the PEI Territory) or PEI (if such action is in the Servier Territory) or MacroGenics (if such action is in the MacroGenics PEI Territory), as applicable, shall notify the other Party of such event within [*** ] Business Days (or sooner if required by applicable Law) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JRDC JSC will discuss and attempt to agree upon whether to recall or withdraw such the Licensed Product; provided, however, that if the Parties fail to 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 JRDC JSC level, Servier MERRIMACK shall decide whether to recall or withdraw the Licensed Product outside the PEI Territory and shall undertake any such recall or withdrawal outside the PEI Territory at its own cost and expense, and PEI shall decide whether to recall or withdraw the Licensed Product in the Servier PEI Territory and shall undertake any such recall or withdrawal in the Servier Territory at its own cost and expense, and MacroGenics shall decide whether to recall or withdraw such Licensed Product in the MacroGenics Territory and shall undertake any such recall or withdrawal in the MacroGenics PEI Territory at its own cost and expense.

Product Withdrawals and Recalls. If any Regulatory Authority (a) threatens, initiates or advises any action to remove any Licensed Product from the market in any country of the world, or (b) requires or advises either Party or such Party’s Affiliates or sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of any Licensed Product in any country of the world, then Servier (if such action is in the Servier Territory) or MacroGenics (if such action is in the MacroGenics Territory), as applicable, shall notify the other Party of such event within *** (or sooner if required by applicable Law) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JRDC will discuss and attempt to agree upon whether to recall or withdraw such Licensed Product; provided, however, that if the Parties fail to 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 JRDC level, Servier shall decide whether to recall or withdraw such Licensed Product in the Servier Territory and shall undertake any such recall or withdrawal in the Servier Territory at its own cost and expense, and MacroGenics shall decide whether to recall or withdraw such Licensed Product in the MacroGenics Territory and shall undertake any such recall or withdrawal in the MacroGenics Territory at its own cost and expense. *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission.