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. In the event that (a) 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 in the Field in the Territory; (b) any Regulatory Authority in the Territory threatens or initiates any action to remove the Licensed Product from the market in the 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 Field in the Territory, Santarus shall promptly advise Shore in writing with respect thereto. Unless otherwise agreed by the Parties and subject to the Impax Sublicense Agreement, Santarus shall be responsible for conducting the recall or other removal from the market and neither CHRP nor Shore shall consent to the conduct of a recall or other removal of any Licensed Product from the market in the Territory without obtaining the prior written consent of Santarus, not to be unreasonably withheld, conditioned or delayed. Shore (and CHRP to the extent required by Applicable Law) shall, upon reasonable request by Santarus, assist Santarus in the conduct of any such recall or removal from the market in the Territory, which recall or removal shall be controlled by Santarus in Santarus’ sole discretion. Subject to any obligations under ARTICLE 11, to the extent any recall or removal of a Licensed Product is implemented as a result of lots Manufactured prior to the Effective Date, Shore shall bear all reasonable costs incurred in connection with such recall or removal to the extent it is responsible for such lots under Section 6.2 with respect to Licensed Product returns (including all of Santarus’ reasonable out-of-pocket costs); otherwise (subject to the Impax Sublicense Agreement), Santarus shall bear all of Santarus’ costs, all of Shore’s reasonable out-of-pocket costs, and all other reasonable costs incurred in connection with such recall.
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. In the event that either Party (a) determines that an event, incident, or circumstance 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 in the Field in the Territory; (b) becomes aware that a Governmental Authority in the Territory is threatening or has initiated an action to remove the Product from the market; or (c) is required by any Governmental Authority in the Territory to distribute a “Dear Doctor” letter or its equivalent, regarding use of the Product, such Party shall promptly advise the other Party in writing with respect thereto, and shall provide to such other Party copies of all relevant correspondence, notices, and the like. Solvay shall be responsible for conducting any recall of the Product in the Field, whether voluntary or involuntary, or taking such other remedial action required by Applicable Laws or agreed to by the Parties. At Solvay’s request, Depomed shall assist Solvay with respect to any such recall or remedial action, and will provide Solvay with all information that Solvay may request in connection with its dealings with a Governmental Authority in connection with such recall or remedial action. If any recall of the Product is implemented as a result of Depomed’s material breach of its obligations under this Agreement or its negligence, Depomed shall bear that portion of all direct expenses incurred by Solvay in connection with such recall attributable to such material breach or negligence. For any and all recalls of Product in the Field in the Territory required due to any other reason, Solvay shall bear all expenses incurred in connection with such recall.
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 or 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 recall or withdraw such Product. AstraZeneca shall be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action in the Territory, except that FibroGen will be responsible for such expenses to the extent (i) resulting from the failure of any Product supplied by FibroGen to conform to the applicable specifications; or (ii) such recall results from an event outside the Territory and outside the territory licensed under the China Agreement.
Product Withdrawals and Recalls. In the event that (i) Roche determines that an event, incident, or circumstance 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 in the Territory; (ii) any Regulatory Authority in the Territory threatens or initiates any action to remove a Product from the market in the Field; or (iii) any Regulatory Authority in the Territory requires distribution of a "Dear Doctor" letter or its equivalent, regarding use of Product in the Field, Roche shall promptly advise Aspreva in writing with respect thereto, and shall provide to Aspreva copies of all relevant correspondence, notices, and the like. Aspreva further agrees, upon reasonable request by Roche and at Roche's cost and expense, to assist Roche in the conduct of any such Product recall or withdrawal in the Territory.
Product Withdrawals and Recalls. Any decision to initiate a recall or withdrawal of a Product will be made by Sanofi, including with respect to any recall or withdrawal during the Early Development Program. In the event of any recall or withdrawal, Sanofi will take any and all necessary action to implement such recall or withdrawal in accordance with Applicable Law, with assistance from Principia as reasonably requested by Sanofi. Any such recall or withdrawal will be at Sanofi Cost (except in the case of a recall or withdrawal in the context of Development using materials used by Principia or its Affiliates or transferred to Sanofi by Principia that were non-conforming, in which case and to such extent such costs will be borne by Principia). [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. EXECUTION VERSION
Product Withdrawals and Recalls. If any Regulatory Authority (a) threatens, initiates or advises any action against a Party or such Party’s Affiliates or Licensee Partners to remove any Licensed Product(s) from the market in the Territory, or (b) requires or advises a Party or such Party’s Affiliates or Licensee Partners to distribute a “Dear Doctor” letter or its equivalent regarding use of such Licensed Product(s) in the Territory, then such Party 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 Party that is responsible for booking sales in the U.S. shall decide whether to recall or withdraw such Licensed Product(s) in the U.S., and the Commercializing Party shall decide whether to recall or withdraw such Licensed Product(s) in any other territory, at such Party’s own cost and expense; provided, however, that the Parties will discuss in good faith whether to recall or withdraw such Licensed Product(s), or to place a recalled or withdrawn Licensed Product(s) back on the market, in the relevant Territory. The deciding Party shall keep the other Party reasonably apprised of the efforts undertaken by such Party to recall or withdraw such Licensed Product(s), or to place such Licensed Product(s) back on the market, in the relevant Territory, and the other Party shall reasonably cooperate in such efforts.
Product Withdrawals and Recalls. Any decision to initiate a recall or withdrawal of a Licensed Product shall be made by Jazz or its applicable Affiliate. In the event of any such recall or withdrawal, Jazz shall take any and all necessary action to implement such recall or withdrawal in accordance with Applicable Laws, with assistance from Codiak and its Affiliates as reasonably requested by Jazz. The costs of any such recall or withdrawal shall be borne solely by Jazz, except where Codiak has exercised a Development and Commercialization Option, in which case any recall expenses with respect to the applicable Licensed Product within the Shared Territory shall be treated as Development Costs prior to First Commercial Sale of the applicable Licensed Product and thereafter as Allowable Expenses. Notwithstanding the foregoing, to the extent there is any conflict between this Section 5.3 and any supply agreement (or associated quality agreement or SDEA) entered into by the Parties regarding the Licensed Products, such supply agreement (or associated quality agreement or SDEA) will control regarding the conduct and costs of any recalls or withdrawals of a Licensed Product.
