Common use of Notification and Determination Clause in Contracts

Notification and Determination. In the event that any Agency threatens or initiates any action to recall or withdraw a Licensed Product from the market in or outside the Territory, the Party receiving notice thereof shall promptly notify the other Party of such communication, but in no event later than […***…] after receipt thereof. NBIX, as the Approval holder for the Licensed Products in the Territory, shall determine whether 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, however that to the extent practicable and appropriate based on the reasons for the recall or withdrawal, before NBIX initiates a recall or withdrawal, the Parties shall promptly discuss in good faith the reasons 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 recall 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 recall of a Licensed Product outside the Territory will be determined, coordinated and controlled by BIAL.

Notification and Determination. In the event that any Agency threatens or initiates any action to recall or withdraw a Licensed Product from the market in or outside the Territory, the Party receiving notice thereof shall promptly notify the other Party of such communication, but in no event later than […***…] after receipt thereof. NBIX, as the Approval holder for the Licensed Products in the Territory, shall determine whether 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, however that to the extent practicable and appropriate based on the reasons for the recall or withdrawal, before NBIX initiates a recall or withdrawal, the Parties shall promptly discuss in good faith the reasons 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 recall 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 recall of a Licensed Product outside the Territory will be determined, coordinated and controlled by BIAL.

Notification and Determination. In the event that any Agency threatens Governmental Authority threatens, initiates or initiates recommends any voluntary or involuntary action to recall or withdraw a Licensed remove Product from the market in the Territory (in whole or outside the Territoryin part), the Party receiving notice thereof shall promptly notify the other Party of such communicationcommunication immediately, but in no event later than […***…] one (1) Business Day, after receipt thereof. NBIXIn all cases, as Prestwick shall make the Approval holder for the Licensed Products in the Territory, shall determine final determination regarding 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, however however, that before Prestwick determines whether or not to the extent practicable and appropriate based on the reasons for the recall or withdrawal, before NBIX initiates 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 any Party Prestwick reasonably believes has to be taken in relation to any recall. In the event of any such recall or withdrawal, NBIX whether voluntary or involuntary, Distributor shall implement any necessary action action, with assistance from Prestwick as reasonably requested by Distributor, to conduct such recall or withdrawal. As the manufacturer of Licensed Products, BIAL Distributor shall use utilize a batch tracing and recall system which will allow NBIX enable Distributor 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)batch, and to recall such batches Product from such customers or 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 BIALin accordance with Prestwick’s instructions.