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 any 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 [***], after receipt thereof, and the Parties shall discuss in good faith the appropriate response to such notice. Notwithstanding the foregoing, in all cases AKP, as the intended beneficiary under this Agreement of the privileges of ownership of the Product Approvals in the Field in the Territory, shall determine (and notify VectivBio with respect to such determination) whether to initiate any recall, withdrawal (e.g., a full or partial recall, temporary or permanent recall, or “dear doctor” letter) or market notification of the Product in the Field in the Territory; provided, however, that if VectivBio determines to initiate a recall for a certain batch of the Product, or withdrawal or market notification outside the Territory, the JSC, rather than AKP, will determine whether a corresponding recall for the same batch of the Product, or withdrawal or market notification will be initiated within the Territory unless required by Applicable Law. VectivBio shall determine whether to initiate any such recall, withdrawal or market notification of any Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, temporary or permanent recall, or “dear doctor” letter) or market notification of the Product in the Field outside the Territory. In the event of any such recall, withdrawal or market notification in the Territory, the AKP shall determine the necessary actions to be taken, and shall implement such action.

Notification and Determination. In the event that any Governmental Authority threatens threatens, initiates or initiates recommends any voluntary or involuntary action to remove any 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. In all cases, and Prestwick shall make the Parties shall discuss in good faith the appropriate response to such notice. Notwithstanding the foregoing, in all cases AKP, as the intended beneficiary under this Agreement of the privileges of ownership of the Product Approvals in the Field in the Territory, shall determine (and notify VectivBio with respect to such determination) final determination regarding whether or not to initiate any recall, recall or withdrawal (e.g., a full or partial recall, temporary or permanent recall, or “dear doctor” letter) or market notification of the Product in the Field in the Territory; provided, however, that if VectivBio determines to initiate a recall for a certain batch of the Product, or withdrawal or market notification outside the Territory, the JSC, rather than AKP, will determine whether a corresponding recall for the same batch of the Product, or withdrawal or market notification will be initiated within the Territory unless required by Applicable Law. VectivBio shall determine whether to initiate any such recall, withdrawal or market notification of any 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); provided, however, that before Prestwick determines whether or “dear doctor” letter) not to initiate a recall or market notification of withdrawal, the Product Parties shall promptly meet and discuss in good faith the Field outside the Territoryreasons therefor, provided further that such discussions shall not delay any action that Prestwick reasonably believes has to be taken in relation to any recall. In the event of any such recallrecall or withdrawal, withdrawal whether voluntary or market notification in involuntary, Distributor shall implement any necessary action, with assistance from Prestwick as reasonably requested by Distributor, to conduct such recall or withdrawal. Distributor shall utilize a batch tracing and recall system which will enable Distributor to identify, on a prompt basis, customers within the Territory, the AKP shall determine the necessary actions to be takenTerritory who have been supplied with Product of any particular batch, and shall implement to recall such actionProduct from such customers in accordance with Prestwick’s instructions.

Notification and Determination. In the event that any Governmental Authority Agency threatens or initiates any action to remove any recall or withdraw a Licensed Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part)Territory, the Party receiving notice thereof shall promptly notify the other Party of such communication communication, but in no event later than […***], …] after receipt thereof, and the Parties shall discuss in good faith the appropriate response to such notice. Notwithstanding the foregoing, in all cases AKPNBIX, as the intended beneficiary under this Agreement of Approval holder for the privileges of ownership of the Product Approvals in the Field Licensed Products in the Territory, shall determine (and notify VectivBio with respect to such determination) whether to initiate any recall, recall or withdrawal (e.g., a full or partial recall, temporary or permanent recall, or “dear doctor” letter) or market notification of the such Licensed Product in the Field in the Territory; provided, however, that if VectivBio determines to initiate a recall for a certain batch of the Product, or withdrawal or market notification outside the Territory, the JSC, rather than AKP, will determine whether a corresponding recall for the same batch of the Product, or withdrawal or market notification will be initiated within the Territory unless required by Applicable Law. VectivBio shall determine whether to initiate any such recall, withdrawal or market notification of any Product outside the Territory, including the scope of such recall or withdrawal (e.g.( e.g. , a full or partial recall, or a temporary or permanent recall); provided, however that to the extent practicable and appropriate based on the reasons for the recall or “dear doctor” letter) withdrawal, before NBIX initiates a recall or market notification of withdrawal, the Product Parties shall promptly discuss in good faith the Field outside the Territoryreasons therefor, provided that such discussions shall not delay any action that any Party reasonably believes has to be taken in relation to any recall. In the event of any such recallrecall or withdrawal, NBIX shall implement any necessary action to conduct such recall or withdrawal. As the manufacturer of Licensed Products, BIAL shall use a batch tracing system which will allow NBIX to identify, on a prompt basis, customers within the Territory or patients enrolled in Development Studies in the Territory who have been supplied with Licensed Product of any particular batch(es), and to recall such batches from such customers or patients, as the case may be. For clarity, all matters relating to a withdrawal or market notification in recall of a Licensed Product outside the TerritoryTerritory will be determined, the AKP shall determine the necessary actions to be taken, coordinated and shall implement such actioncontrolled by BIAL.

Notification and Determination. In the event that any Governmental Authority Agency threatens or initiates any action to remove any recall or withdraw a Licensed Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part)Territory, the Party receiving notice thereof shall promptly notify the other Party of such communication communication, but in no event later than […***], …] after receipt thereof, and the Parties shall discuss in good faith the appropriate response to such notice. Notwithstanding the foregoing, in all cases AKPNBIX, as the intended beneficiary under this Agreement of Approval holder for the privileges of ownership of the Product Approvals in the Field Licensed Products in the Territory, shall determine (and notify VectivBio with respect to such determination) whether to initiate any recall, recall or withdrawal (e.g., a full or partial recall, temporary or permanent recall, or “dear doctor” letter) or market notification of the such Licensed Product in the Field in the Territory; provided, however, that if VectivBio determines to initiate a recall for a certain batch of the Product, or withdrawal or market notification outside the Territory, the JSC, rather than AKP, will determine whether a corresponding recall for the same batch of the Product, or withdrawal or market notification will be initiated within the Territory unless required by Applicable Law. VectivBio shall determine whether to initiate any such recall, withdrawal or market notification of any 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); provided, however that to the extent practicable and appropriate based on the reasons for the recall or “dear doctor” letter) withdrawal, before NBIX initiates a recall or market notification of withdrawal, the Product Parties shall promptly discuss in good faith the Field outside the Territoryreasons therefor, provided that such discussions shall not delay any action that any Party reasonably believes has to be taken in relation to any recall. In the event of any such recallrecall or withdrawal, NBIX shall implement any necessary action to conduct such recall or withdrawal. As the manufacturer of Licensed Products, BIAL shall use a batch tracing system which will allow NBIX to identify, on a prompt basis, customers within the Territory or patients enrolled in *** Confidential Treatment Requested Development Studies in the Territory who have been supplied with Licensed Product of any particular batch(es), and to recall such batches from such customers or patients, as the case may be. For clarity, all matters relating to a withdrawal or market notification in recall of a Licensed Product outside the TerritoryTerritory will be determined, the AKP shall determine the necessary actions to be taken, coordinated and shall implement such actioncontrolled by BIAL.