Common use of Notification and Determination Clause in Contracts

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business day, after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Product Approval in the Territory) shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory, and Auxilium, as holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer or Auxilium (as the case may be), as the distributor of the Product, shall determine the necessary actions to be taken, and, shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by Pfizer, but Pfizer, acting as the holder of the Product Approval in the Territory, shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiated. Pfizer shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.1.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Finished Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business day, after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer Sobi (acting as the holder of the Product Approval in the Territory) shall determine whether to initiate any recall, withdrawal or market notification of the Finished Product in the Field in the Territory, and Auxilium, as as, between the Parties, holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Finished Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer Sobi or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer Sobi or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer Sobi or Auxilium (as the case may be), as the distributor of the Finished Product, shall determine the necessary actions to be taken, and, shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall have the right to propose that a Finished Product recall, withdrawal or market notification should be initiated by PfizerSobi, but PfizerSobi, acting as the holder of the Product Approval in the Territory, shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiated. Pfizer Sobi shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Finished Product of any particular batch, and to recall such Finished Product from such customers as set forth in this Section 5.7.1.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Finished Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business day, after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer Actelion (acting as the holder of the Product Approval in the Territory) shall determine whether to initiate any recall, withdrawal or market notification of the Finished Product in the Field in the Territory, and Auxilium, as as, between the Parties, holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Finished Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer Actelion or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer Actelion or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer Actelion or Auxilium (as the case may be), as the distributor of the Finished Product, shall determine the necessary actions to be taken, and, shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall have the right to propose that a Finished Product recall, withdrawal or market notification should be initiated by PfizerActelion, but PfizerActelion, acting as the holder of the Product Approval in the Territory, shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiated. Pfizer Actelion shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Finished Product of any particular batch, and to recall such Finished Product from such customers as set forth in this Section 5.7.1.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business dayBusiness Day, after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting Licensee, as the holder intended beneficiary under this Agreement of the Product Approval privileges of ownership of the Regulatory Approvals in the Field in the Territory) , shall determine (and notify VBL with respect to such determination) whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory, and AuxiliumVBL, acting as the holder of the Product Approval outside Regulatory Approval, shall act on behalf of Licensee in any recall, withdrawal and market notification of the Territory Product. VBL shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Field in the Territory, or outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall, or “dear doctor” letter) or market notification; provided, however that however, that, before Pfizer Licensee or Auxilium VBL (as the case may be) initiates a recall, withdrawal or market notificationnotification in the Territory, the Parties shall promptly meet and discuss in good faith the reasons therefor; provided, provided that such discussions discussion shall not delay any action that Pfizer or Auxilium (as the case may be) reasonably believes has is required to be taken under Applicable Laws in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notificationnotification in the Territory, Pfizer or Auxilium (as the case may be), as the distributor of the Product, Licensee shall determine the necessary actions to be taken, and, and shall implement such action, with the other Party VBL providing reasonable input (which the first Party Licensee shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium in the event of a recall, withdrawal or market notification outside the Territory, VBL shall have the right to propose that cause Licensee to initiate a Product recall, withdrawal or market notification should be initiated by Pfizer, but Pfizer, acting as the holder of the Product Approval in the Territory; provided, shall make the final decision as however, that, before VBL can cause Licensee to whether or not the initiate a recall, withdrawal or market notification will be initiatedin the Territory, the Parties shall promptly meet and discuss in good faith the reasons therefor. Pfizer Licensee shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.15.8.1. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in for the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business dayBusiness Day, after receipt thereof. Notwithstanding Before Licensee or Amarin (as the foregoingcase may be) initiates a recall, withdrawal or market notification for the Product in the Territory, the Parties shall promptly meet and discuss in good faith the reasons therefor; provided, that such discussion shall not delay any action that is required to be taken under Applicable Laws in relation to any recall, withdrawal or market notification for the Product. In all cases Pfizer (acting Licensee, as the holder intended beneficiary under this Agreement of the privileges of ownership of the Product Approval Approvals for the Product in the Territory) Territory for the Field (and any other New Indication for which Licensee is a current licensee pursuant to Section 2.4), shall determine (and notify Amarin with respect to such determination) whether to initiate any recall, withdrawal or market notification of the Product in the Field in Territory for the TerritoryField, and AuxiliumAmarin, acting as the holder of the Product Approval for the Product outside the Territory or outside the Field (and any New Indications for which Licensee is a current licensee pursuant to Section 2.4), shall act on behalf of Licensee in any recall, withdrawal and market notification of the Product outside the Territory or outside the Field (and outside of any New Indications for which Licensee is a current licensee pursuant to Section 2.4). Amarin shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Field (and any New Indications for which Licensee is a current licensee pursuant to Section 2.4) in the Territory, or outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall, or “dear doctor” letter) or market notification; provided, however that before Pfizer or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notificationnotification for the Product in the Territory, Pfizer Licensee or Auxilium Amarin (as the case may be), as the distributor of the Product, ) shall determine the necessary actions to be taken, and, and shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by Pfizer, but Pfizer, acting as the holder of the Product Approval in the Territory, shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiated. Pfizer [***] Licensee shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.15.8.1.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1)) business day, after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer Asahi (acting as the holder of the Product Approval in the Territory) shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory, and Auxilium, as as, between the Parties, holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however however, that before Pfizer Asahi or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer Asahi or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer Asahi or Auxilium (as the case may be), as the distributor of the Product, shall determine the necessary actions to be taken, and, shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by PfizerAsahi, but PfizerAsahi, acting as the holder of the Product Approval in the Territory, shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiated. Pfizer Asahi shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.15.8.1.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field whether inside in the Territory, or one Party otherwise determines that a recall, withdrawal or market notification in the Field in the Territory or outside the Territory (in whole or in part)is necessary, the Party receiving notice thereof thereof, or such determining Party, shall notify the other Party of such communication communication, or such determination, thereof immediately, but in no event later than one [**] (1[**]) business day[**], after receipt thereof or such determination thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Product Approval in the Territory) shall Parties will together determine whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory, and Auxilium, as holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall notification by way of promptly meet and discuss discussing in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer or Auxilium (as the case may be)Ono, as the distributor of Product in the ProductTerritory, shall determine the necessary actions to be taken, and, and shall implement such actionactions to conduct such recall, withdrawal or market notification, with the other Party Onyx providing reasonable input (which the first Party Ono shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium Onyx shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by PfizerOno, but PfizerOno, acting as the holder of the Product Approval in the Territory, shall make the final decision as to whether or not the such a recall, withdrawal or market notification in the Field in the Territory proposed by Onyx will be initiated. Pfizer Ono shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.15.8.1. In the event that any Governmental Authority threatens or initiates any action to remove Product from the market in the Field outside the Territory, or Onyx otherwise determines that such recall or withdrawal is necessary or determines to recall or withdraw the Product outside of the Territory, Onyx shall notify Ono of such communication or such determination thereof by Onyx immediately, but in no event later than [**] ([**]) [**], after receipt thereof or such determination thereof by Onyx, and the Parties shall promptly discuss whether to initiate any recall, withdrawal or market notification of Product in the Field in the Territory (which would be conducted in accordance with this Section 5.8.1).

Notification and Determination. In the event that If any Governmental Authority threatens in writing or initiates any action to remove the a Licensed Product or Sarepta Diagnostic Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part)) in the Roche Territory, then the Party receiving notice thereof shall will notify the other Party of such communication immediately, but in no event later than one (1) business day, two Business Days after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Regulatory Responsible Party for a Licensed Product Approval in the Territory) shall a given jurisdiction will determine whether to initiate any recall, withdrawal withdrawal, or market notification field alert of the such Licensed Product or applicable Sarepta Diagnostic Product in the Field in the Territory, and Auxilium, as holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territoryjurisdiction, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer or Auxilium (as field alert. Before the case may be) Regulatory Responsible Party for a Licensed Product in a certain jurisdiction in the Roche Territory initiates a recall, withdrawal withdrawal, or market notificationfield alert for such Licensed Product or Sarepta Diagnostic Product in such jurisdiction, the Parties shall will use reasonable efforts to promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall will not delay any action that Pfizer or Auxilium (as the case may be) such Regulatory Responsible Party reasonably believes has to should be taken in relation to any actual or potential recall, withdrawal withdrawal, or market notificationfield alert. In the event of any such recall, withdrawal withdrawal, or market notificationfield alert in the Roche Territory, Pfizer or Auxilium (as the case may be), as Regulatory Responsible Party for the distributor of applicable Licensed Product and the Product, shall applicable jurisdiction will determine the necessary actions to be taken, and, shall taken and will implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall either Party will have the right to propose that a Product recall, withdrawal withdrawal, or market notification field alert for a Licensed Product or Sarepta Diagnostic Product should be initiated by Pfizersuch Party, but Pfizer, acting as the holder of Regulatory Responsible Party for the applicable Licensed Product Approval in the Territory, shall applicable jurisdiction in the Roche Territory will have the right to make the final decision as to whether or not to initiate the recall, withdrawal withdrawal, or market notification will be initiatedfield alert. Pfizer shall at all times utilize a batch tracing system which will enable Notwithstanding any provision to the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as contrary set forth in this Section 5.7.1Agreement, if Sarepta notifies Roche of a Manufacturing issue related to a Licensed Product that Sarepta reasonably believes could give rise to a recall, withdrawal, or field alert, then Roche, if it is the Regulatory Responsible Party for the applicable Licensed Product in the applicable jurisdiction in the Roche Territory, will assess such notification from Sarepta and initiate such recall, withdrawal, or field alert as appropriate. In all cases, Sarepta will determine whether to initiate any recall, withdrawal, or field alert of any Option Product, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert and will have sole control over and decision-making authority with respect thereto.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business day[***], after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting Licensee, as the holder intended beneficiary under this Agreement of the privileges of ownership of the Product Approval Approvals in the Field in the Territory) , shall determine (and notify Amarin with respect to such determination) whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory, and AuxiliumAmarin, acting as the holder of the Product Approval outside Approval, shall act on behalf of Licensee in any recall, withdrawal and market notification of the Territory Product. Amarin shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Field in the Territory, or outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall, or “dear doctor” letter) or market notification; provided, however that however, that, before Pfizer Licensee or Auxilium Amarin (as the case may be) initiates a recall, withdrawal or market notificationnotification in the Territory, the Parties shall promptly meet and discuss in good faith the reasons therefor; provided, provided that such discussions discussion shall not delay any action that Pfizer or Auxilium (as the case may be) reasonably believes has is required to be taken under Applicable Laws in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notificationnotification in the Territory, Pfizer Licensee or Auxilium Amarin (as the case may be), as the distributor of the Product, ) shall determine the necessary actions to be taken, and, and shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium Amarin shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by Pfizer, but Pfizer, acting as the holder of the Product Approval Licensee in the Territory, and the Parties shall jointly make the final decision as to whether or not the CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. recall, withdrawal or market notification will be initiated; provided, however, that, in the event Licensee does not agree to initiate such recall, withdrawal or market notification, then Licensee shall indemnify Amarin under Section 11.2 with respect thereto. Pfizer Licensee shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.15.8.1.

Notification and Determination. In the event that any Governmental Authority threatens in writing or initiates any action to remove the a DT Co-Co Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part)) in the Territory, the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business day, two Business Days after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Regulatory Responsible Party for a DT Co-Co Product Approval in the Territory) a Region shall determine whether to initiate any recall, withdrawal withdrawal, or market notification field alert of the such DT Co-Co Product in the Field in the Territory, and Auxilium, as holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territoryapplicable Region, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer or Auxilium (as field alert. Before the case may be) Regulatory Responsible Party initiates a recall, withdrawal withdrawal, or market notificationfield alert for a DT Co-Co Product in a Region, as applicable, the Parties shall use reasonable efforts to promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer or Auxilium (as the case may be) such Regulatory Responsible Party reasonably believes has to should be taken in relation to any actual or potential recall, withdrawal withdrawal, or market notificationfield alert. In the event of any such recall, withdrawal withdrawal, or market notificationfield alert, Pfizer or Auxilium (as the case may be), as Regulatory Responsible Party for the distributor of the Product, applicable Region shall determine the necessary actions to be taken, and, taken and shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium either Party shall have the right to propose that a Product recall, withdrawal withdrawal, or market notification field alert for a DT Co-Co Product should be initiated by Pfizersuch Party, but Pfizer, acting as the holder of Regulatory Responsible Party for the Product Approval in applicable Region shall have the Territory, shall right to make the final decision as to whether or not to initiate the recall, withdrawal withdrawal, or market notification will be initiatedfield alert. Pfizer Notwithstanding the foregoing, if a recall, withdrawal, or field alert is reasonably necessary due to a Manufacturing issue related to a DT Co-Co Product, Moderna shall at all times utilize a batch tracing system which will enable promptly notify Metagenomi of such issue and provide relevant information on such Manufacturing issue. Upon written request by Moderna for such recall, withdrawal, or field alert, such request to include the Parties to identifyscope of the recall or withdrawal, on a prompt basisas applicable, customers within Metagenomi (if Metagenomi is the Territory who have been supplied Regulatory Responsible Party for the applicable Region), shall initiate such recall, withdrawal, or field alert in accordance with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.1Moderna’s request.

Notification and Determination. In the event that If any Governmental Authority threatens in writing or initiates any action to remove the a Licensed Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), or if a Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, withdrawal or field alert of a Licensed Product, then the Party initiating or receiving notice thereof shall of such recall, withdrawal or field alert will notify the other Party of such communication immediately, but in no event later than one (1) business day, [***] after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Product Approval Regulatory Responsible Party for in the Territory) shall a given jurisdiction will determine whether to initiate any recall, withdrawal withdrawal, or market notification field alert of the Product Licensed Products in the Field in the Territory, and Auxilium, as holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territoryjurisdiction, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer or Auxilium (as field alert. Before the case may be) Regulatory Responsible Party in a certain jurisdiction initiates a recall, withdrawal withdrawal, or market notificationfield alert for such Licensed Product in such jurisdiction, the Parties shall will use reasonable efforts to promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall will not delay any action that Pfizer or Auxilium (as the case may be) such Regulatory Responsible Party reasonably believes has to should be taken in relation to any actual or potential recall, withdrawal withdrawal, or market notificationfield alert. In the event of any such recall, withdrawal withdrawal, or market notificationfield alert, Pfizer or Auxilium (as the case may be), as Regulatory Responsible Party in the distributor of the Product, shall applicable jurisdiction will determine the necessary actions to be taken, and, shall taken and will implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall either Party will have the right to propose that a Product recall, withdrawal withdrawal, or market notification field alert for a Licensed Product should be initiated by Pfizersuch Party, but Pfizer, acting as the holder of the Product Approval Regulatory Responsible Party in the Territory, shall applicable jurisdiction will have the right to make the final decision as to whether or not to initiate the recall, withdrawal withdrawal, or market notification will be initiatedfield alert. Pfizer shall at all times utilize a batch tracing system which will enable Notwithstanding any provision to the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as contrary set forth in this Agreement, if Fulcrum notifies Sanofi of a Manufacturing issue related to a Licensed Product prior to the Sanofi Territory Manufacturing Handover Date that Fulcrum reasonably believes could give rise to a recall, withdrawal, or field alert, then Sanofi, if it is the Regulatory Responsible Party for the applicable Licensed Product in the applicable jurisdiction, will initiate such recall, withdrawal, or field alert in accordance with Fulcrum’s request. The Parties’ rights and obligations under this Section 5.7.16.11 (Recalls, Withdrawal or Field Alerts) shall be subject to the terms of any applicable Pharmacovigilance Agreement entered into between the Parties. In the event of a conflict between the provisions of any Pharmacovigilance Agreement, and this Section 6.11 (Recalls, Withdrawal or Field Alerts), the provisions of such Pharmacovigilance Agreement shall govern with respect to the subject matter in this Section 6.11 (Recalls, Withdrawal or Field Alerts).

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product Licensed Products from the market whether in the Field whether inside the Incyte Territory or outside in the Hengrui Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediatelypromptly, but in no event later than one (1) business day[**], after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Product Approval in the Territory) Incyte shall determine whether to initiate any recall, withdrawal or market notification of the Product Licensed Products in the Field in the Incyte Territory, and Auxilium, as holder of the Product Approval outside the Territory Hengrui shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside Licensed Products in the Hengrui Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however however, that before Pfizer Incyte or Auxilium Hengrui (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor; provided, provided further, that such discussions shall not delay any action that Pfizer Incyte or Auxilium Hengrui (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer Incyte or Auxilium Hengrui (as the case may be), as the distributor of the Product, ) shall determine the necessary actions to be taken, and, and shall implement such action, with the other Party providing reasonable input (which the first [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium each Party shall have the right to propose that a Licensed Product recall, withdrawal or market notification should be initiated by Pfizerthe other Party, but Pfizer, acting as the holder of the Product Approval in the Territory, such other Party shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiatedinitiated in its Territory. Pfizer Each Party shall at all times utilize a batch tracing system which will enable the Parties each to identify, on a prompt basis, customers within the its Territory who have been supplied with Product of any particular batch, and to recall such Licensed Product from such customers as set forth in this Section 5.7.15.6.

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field whether inside in the Territory, or one Party otherwise determines that a recall, withdrawal or market notification in the Field in the Territory or outside the Territory (in whole or in part)is necessary, the Party receiving notice thereof thereof, or such determining Party, shall notify the other Party of such communication communication, or such determination, thereof immediately, but in no event later than one [*] (1[*]) business day[*], after receipt thereof or such determination thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Product Approval in the Territory) shall Parties will together determine whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory, and Auxilium, as holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall notification by way of promptly meet and discuss discussing in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer or Auxilium (as the case may be)Ono, as the Manufacturer of Ono-Requested Configurations (and [*] Configurations or Additional Onyx Configurations, if applicable) and distributor of Product in the ProductTerritory, shall determine the necessary actions to be taken, and, and shall implement such actionactions to conduct such recall, withdrawal or market notification, with the other Party Onyx providing reasonable input (which the first Party Ono shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium Onyx shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by PfizerOno, but PfizerOno, acting as the holder of the Product Approval in the Field in the Territory, shall make the final decision as to whether or not the such a recall, withdrawal or market notification in the Field in the Territory proposed by Onyx will be initiated. Pfizer Ono shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.15.8.1. In the event that any Governmental Authority threatens or initiates any action to remove Product from the market in the Field outside the Territory, or Onyx otherwise determines that such recall or withdrawal is necessary or determines to recall or withdraw the Product outside of the Territory, Onyx shall notify Ono of such communication or such determination thereof by Onyx immediately, but in no event later than [*] ([*]) [*], after receipt thereof or such determination thereof by Onyx, and the Parties shall promptly discuss whether to initiate any recall, withdrawal or market notification of Product in the Field in the Territory (which would be conducted in accordance with this Section 5.8.1).