Common use of Notification and Determination Clause in Contracts

Notification and Determination. In the event that any Governmental Authority threatens, initiates or recommends any voluntary or involuntary action to remove Product from the market in 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, Prestwick shall make the final determination regarding whether or not to initiate any recall or withdrawal of Product in 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 not to initiate a recall or withdrawal, the Parties shall promptly meet and discuss in good faith the reasons 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 recall or withdrawal, whether voluntary or 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 who have been supplied with Product of any particular batch, and to recall such Product from such customers in accordance with Prestwick’s instructions.

Notification and Determination. In the event that any Governmental Authority threatens, Agency threatens or initiates or recommends any voluntary or involuntary action to remove recall or withdraw a Licensed Product from the market in or outside the Territory (in whole or in part)Territory, the Party receiving notice thereof shall promptly notify the other Party of such communication immediatelycommunication, but in no event later than one (1) Business Day, […***…] after receipt thereof. In all casesNBIX, Prestwick as the Approval holder for the Licensed Products in the Territory, shall make the final determination regarding determine whether or not to initiate any recall or withdrawal of such Licensed Product in 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, howeverhowever that to the extent practicable and appropriate based on the reasons for the recall or withdrawal, that before Prestwick determines whether or not to initiate NBIX initiates a recall or withdrawal, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided further that such discussions shall not delay any action that Prestwick any Party reasonably believes has to be taken in relation to any recall. In the event of any such recall or withdrawal, whether voluntary or involuntary, Distributor NBIX shall implement any necessary action, with assistance from Prestwick as reasonably requested by Distributor, action to conduct such recall or withdrawal. Distributor As the manufacturer of Licensed Products, BIAL shall utilize use a batch tracing and recall system which will enable Distributor 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 batchbatch(es), and to recall such Product batches from such customers in accordance with Prestwick’s instructionsor patients, as the case may be. For clarity, all matters relating to a withdrawal or recall of a Licensed Product outside the Territory will be determined, coordinated and controlled by BIAL.

Notification and Determination. In the event that any Governmental Authority threatens, Agency threatens or initiates or recommends any voluntary or involuntary action to remove recall or withdraw a Licensed Product from the market in or outside the Territory (in whole or in part)Territory, the Party receiving notice thereof shall promptly notify the other Party of such communication immediatelycommunication, but in no event later than one (1) Business Day, […***…] after receipt thereof. In all casesNBIX, Prestwick as the Approval holder for the Licensed Products in the Territory, shall make the final determination regarding determine whether or not to initiate any recall or withdrawal of such Licensed Product in the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall); provided, howeverhowever that to the extent practicable and appropriate based on the reasons for the recall or withdrawal, that before Prestwick determines whether or not to initiate NBIX initiates a recall or withdrawal, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided further that such discussions shall not delay any action that Prestwick any Party reasonably believes has to be taken in relation to any recall. In the event of any such recall or withdrawal, whether voluntary or involuntary, Distributor NBIX shall implement any necessary action, with assistance from Prestwick as reasonably requested by Distributor, action to conduct such recall or withdrawal. Distributor As the manufacturer of Licensed Products, BIAL shall utilize use a batch tracing and recall system which will enable Distributor 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 batchbatch(es), and to recall such Product batches from such customers in accordance with Prestwick’s instructionsor patients, as the case may be. For clarity, all matters relating to a withdrawal or recall of a Licensed Product outside the Territory will be determined, coordinated and controlled by BIAL.

Notification and Determination. In the event that any Governmental Authority threatens, threatens or initiates or 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, and the Parties shall discuss in good faith the appropriate response to such notice. In Notwithstanding the foregoing, in all casescases AKP, Prestwick as the intended beneficiary under this Agreement of the privileges of ownership of the Product Approvals in the Field in the Territory, shall make the final determination regarding determine (and notify VectivBio with respect to such determination) whether or not 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 in 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 not to initiate a recall “dear doctor” letter) or withdrawal, market notification of the Parties shall promptly meet and discuss Product in good faith the reasons therefor, provided further that such discussions shall not delay any action that Prestwick reasonably believes has to be taken in relation to any recallField outside the Territory. In the event of any such recall recall, withdrawal or withdrawalmarket notification in the Territory, whether voluntary or involuntarythe AKP shall determine the necessary actions to be taken, Distributor and shall implement any necessary such 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 who have been supplied with Product of any particular batch, and to recall such Product from such customers in accordance with Prestwick’s instructions.