Common use of Product Withdrawals and Recalls Clause in Contracts

Product Withdrawals and Recalls. If any Regulatory Authority in or outside the Territory (a) threatens, initiates or advises any action to remove any Product from the market or (b) requires or advises FibroGen, AstraZeneca, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product, then FibroGen or AstraZeneca, as applicable, shall notify the other Party of such event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall or

Product Withdrawals and Recalls. If any Regulatory Authority in or outside the Territory (a) threatens, initiates or advises any action to remove any Product from the market or (b) requires or advises FibroGen, AstraZeneca, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product, then FibroGen or AstraZeneca, as applicable, shall notify the other Party of such event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall oror withdraw a Product; provided, however, that if the Parties fail to agree within an appropriate time period, the Party who is the then-holder of the NDA for the Product at issue shall decide whether to

Product Withdrawals and Recalls. If any Regulatory Authority in or outside the Territory (a) threatens, initiates or advises any action to remove any Product from the market or (b) requires or advises FibroGenFibroGen China, AstraZeneca, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product, then FibroGen China or AstraZeneca, as applicable, shall notify the other Party of such event within three (3) Business Days (or sooner if required by law) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall oror withdraw a Product in the Territory; provided, however, that if