Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of Product in the Territory, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any released Product that indicates that a unit or batch of Product may not conform to the specifications thereof, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released Product, it shall promptly so notify the other Party. To the extent Daewoong requires such information to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the Territory to the extent such event of recall, field correction, or withdrawal is due to the material breach by Ampio of this Agreement or the Supply Agreement. Daewoong shall be responsible for all other costs incurred for any recall, field correction, or withdrawal of any released Product for the Territory. The procedures and consequences of such recalls shall be defined in the Supply Agreement. The Party having the right to control such recall pursuant to this Section 9.8 may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal SOPs of such Party; provided, however, that such controlling Party shall promptly notify the other Party of any recall action being considered and where practicable, consider the views of the non-controlling Party prior to taking any recall action. Daewoong shall maintain complete and accurate records of any recall according to its then current SOPs in the Territory for such periods as may be required by applicable Laws, but in no event for less than three (3) years.
Recalls and Voluntary Withdrawals. 5.5.1 For each country in the Territory, Kyowa Kirin and Reata will, through the JSC, confer and coordinate regarding their respective internal standard operating procedures (and any changes thereto) regarding product recalls and the treatment of and response to product complaints and inquiries as to safety, quality or efficacy that would be relevant to the Licensed Products.
5.5.2 If either Party becomes aware of information about a Licensed Product indicating that it may not conform to the Specifications or that there are potential adulterations, misbranding and/or other material adverse issues regarding safety of a Licensed Product (or otherwise that a recall or withdrawal of a Licensed Product is potentially at issue), it will as soon as practical (but in any event within such period as the Parties may mutually establish to ensure their respective compliance with Applicable Law) so notify the other Party. With respect to the Territory, the Parties will promptly meet to discuss such circumstances and to consider appropriate courses of action, including Licensed Product recalls. Unless agreed by the Parties in writing, Kyowa Kirin will make any decisions regarding, and implement and be responsible, at its sole expense (except as provided below), for all recalls of Licensed Product in the Territory, and will maintain complete and accurate records of any Licensed Product recall for such periods as may be required by legal requirements. Notwithstanding the foregoing, Reata shall reimburse Kyowa Kirin for the reasonable and necessary out-of-pocket expenses incurred by Kyowa Kirin for any recalls of Licensed Products (or API) manufactured or supplied by or for Reata to Kyowa Kirin hereunder to the extent attributable to the failure of such Licensed Product or API to conform to the Specifications or to be manufactured in compliance with Applicable Laws, which failure was due to negligence or was known to Reata (or its suppliers) or could reasonably have been discovered by Reata (or its suppliers) with the application of reasonable and customary quality assurance and quality control practices or the application of GMPs, and such failure could not have been identified or detected by Kyowa Kirin (or if applicable its Permitted Sublicensees) through its application of reasonable and customary quality assurance and quality control practices, or other inspections or activities required under Applicable Law with respect to such Licensed Products, prior to distributio...
Recalls and Voluntary Withdrawals. Each Party shall notify the other Party promptly but in no event later than [***] following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product under any MAA or Regulatory Approval for the Product held by such Party and filed with Regulatory Authorities in the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Such Party shall have the sole right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, the such Party shall, to the extent practical, consult with the other Party and shall consider the other Party’s comments in good faith. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 9.11, such Party shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to ARTICLE 17, such Party shall be responsible for all costs of any such recall, market suspension, or market withdrawal; provided that, the other Party shall be responsible for the costs of any recall, market suspension, or market withdrawal with respect to a Product in the Territory to the extent such recall, market suspension, or market withdrawal is attributable to the other Party’s breach of its obligations hereunder or its negligence, recklessness or willful misconduct.
Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any Licensed Product in the Territory, and shall discuss and resolve in writing any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any Licensed Product that indicates that a unit or batch of such Licensed Product 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 Licensed Products, it shall promptly so notify the other Party. The Party having the right to control such recall pursuant to this Section 5.7(b) may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal SOP of such Party; provided however that such controlling Party shall promptly notify the other Party of any recall action being considered, and where practicable, consider the views of the non-controlling Party prior to taking any recall action. MPI shall have the right, [***] to control any recalls, field corrections, field alerts or withdrawals of any Licensed Product in the Licensed Territory. SGI shall have the right, [***], to control all recalls, field corrections, field alerts and withdrawals of any Licensed Product in the SGI Territory. MPI and SGI shall maintain complete and accurate records of any recall of Licensed Product according to its then current SOPs for such periods as may be required by applicable Laws, but in no event for less than [***].
Recalls and Voluntary Withdrawals. If either Party becomes aware of information about distributed Product containing Bulk Product indicating that it may be Non-Conforming with respect to the Bulk Product or that there is potential adulteration, misbranding and/or any potential issues regarding safety or effectiveness with respect to the Bulk Product, it shall promptly serve Notice to that effect on the other Party. Savient will initiate an investigation and assessment of such circumstances and shall promptly notify BTG of its findings and any proposed course of action. The Parties shall meet to discuss such circumstances and to consider appropriate courses of action. Savient shall bear all costs associated with a recall of the Product unless such recall is caused by a Hidden Defect with respect to the Bulk Product, in which case BTG shall pay all costs associated with the recall, up to the maximum value of the Product Price paid by Savient to BTG for the Bulk Product containing such Hidden Defect.
Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures ("SOPs") as to product recalls reasonably in advance of Commercial Launch of any Licensed Product in the Gilead Territory. If either Party becomes aware of information about any Licensed Product indicating that it may not conform to the specifications for Licensed Product then in effect pursuant to the Supply Agreement, or that there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, it shall promptly so notify the other Party. The Steering Committee shall meet to discuss such circumstances and to consider appropriate courses of action, which courses of action with respect to each recall shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 4.8. Gilead shall have the right to control, [*], a recall of the Licensed Product in the Gilead Territory, unless such recall is caused by a Manufacturing Defect (as defined by the Supply Agreement), in which case [*] shall [*] associated with the recall. Cubist shall control, [*], all recalls of Licensed Product outside the Gilead Territory. Gilead shall maintain complete and accurate records of any recall for such periods as may be required by legal requirements, but in any event for no less than [* ].
Recalls and Voluntary Withdrawals. 18.1 COMPANY shall have the sole right to control a Recall of the Product in the Field in the Territory; provided that COMPANY shall not take any action with respect to any Recall in the Field in the Territory without first notifying AMGEN and meeting (in person, by telephone or otherwise, as mutually agreed) with AMGEN (and, if so requested by AMGEN, Japan Licensee) to discuss the circumstances of such potential Recall and to consider appropriate courses of action provided that the foregoing shall not limit COMPANY’s obligations in relation to Recalls under any applicable Law and COMPANY shall be entitled to take action in relation to a Recall without first notifying AMGEN where it considers such action is reasonably necessary to be taken in a time-frame that does not reasonably permit such notification (in which case it shall provide such notification promptly thereafter). COMPANY shall maintain complete and accurate records of any such Recall for such periods as may be required by Law, but in any event for no less than fifteen (15) years. AMGEN (and its licensees) shall have the sole right to control the handling of any Recall in Japan.
Recalls and Voluntary Withdrawals. 18.1 COMPANY shall have the sole right to control a Recall of the Product in the Field in the Territory; provided that COMPANY shall not take any action with respect to any Recall in the Field in the Territory without first notifying AMGEN and meeting (in person, by telephone or otherwise, as mutually agreed) with [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Recalls and Voluntary Withdrawals. 5.5.1 For each country in the Territory, UGNX and KHK shall, through the JSC, confer and coordinate regarding their respective internal standard operating procedures (and any changes thereto) regarding product recalls and the treatment of and response to product complaints and inquiries as to safety, quality or efficacy that may be relevant to the Licensed Products.
5.5.2 If either Party becomes aware of information about a Licensed Product indicating that it may not conform to the applicable Specifications or that there are potential adulterations, misbranding and/or other material adverse issues regarding safety of a Licensed Product (or otherwise that a recall or withdrawal of a Licensed Product is potentially at issue), such Party shall notify the other Party as soon as practical (but in any event within such period as the Parties may mutually establish in order to ensure their respective compliance with Applicable Laws). With respect to in the Territory, the Parties shall promptly meet to discuss such circumstances and to consider appropriate courses of action, including Licensed Product recalls.
Recalls and Voluntary Withdrawals. Company shall use reasonable efforts to notify MacroGenics promptly, but in no event later than [***], following its determination that any event, incident, or circumstance related to safety issues or regulatory concerns has occurred that is reasonably likely to result in the need for a recall, market suspension or market withdrawal of a Product in the Territory, and shall include in such notice the reasoning behind such determination and any supporting facts. Company shall have the sole right to make the final determination of whether to voluntarily implement any such recall, market suspension or market withdrawal in the Territory, provided that, prior to the implementation of such a recall, market suspension or market withdrawal, Company shall, to the extent practical, consult with MacroGenics and shall consider MacroGenics’ comments in good faith. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 5.4, Company shall be solely responsible for the execution thereof and MacroGenics shall reasonably cooperate in all such recall efforts. Subject to ARTICLE 15, Company shall be responsible for all costs of conducting any such recall, market suspension, or market withdrawal. For the sake of clarity, during the Co-Funding Term certain [***] associated with recalls and market withdrawals [***] in accordance with Section 9.9.
