Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone. Celgene shall, after reasonable consultation with Vividion, decide whether to conduct a recall, market withdrawal or similar action in such country or portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
(b) The costs and expenses incurred before the Vividion Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of...
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, notify the other Party’s Alliance Manager and JCC representatives thereof by telephone or e-mail. Each Party, in consultation with the other Party, will decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the Parties, [***] Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in its Territory. The Parties’ rights and obligations under this Section 6.2.7 will be subject to the terms of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements and this Section 6.2.7, the provisions of such supply agreement, SDEA or quality related agreements will govern.
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a T1 Licensed Product, Novartis will have the sole right to decide whether to conduct a recall and the manner in which any such recall will be conducted. [***]
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in its own Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within [**] hours advise the other Party thereof by telephone, or by email or facsimile together with telephone confirmation. Each Party, in consultation with the other Party, shall decide whether to conduct a recall in its own Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but shall notify the other Party as soon as possible). [**]. Each Party will make available all of its pertinent records that may be reasonably requested in order to effecting a recall in the other Party’s Territory.
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Licensed Products in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or stock recovery in its own Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within twenty-four (24) hours and in all cases prior to the execution of such recall, market withdrawal or stock recovery advise the other Party thereof by telephone, facsimile or e-mail (except in the case of a government mandated recall, when such Party may not provide such advance notice but shall notify the other Party as soon as possible). Each Party, in consultation with the other Party, shall decide whether to conduct a recall in its own Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when such Party may act without such advance consultation but shall notify the other Party as soon as possible). Each Party shall be responsible for the execution of any such recall in its own Territory, and in each such case the other Party shall take such actions as reasonably requested by the executing Party in connection therewith and otherwise reasonably cooperate in all such efforts. Except as otherwise provided in a Supply Agreement, each Party shall bear the expense of any such recall in its own Territory, provided that Summit shall reimburse Sarepta for the expense of any such recall in the Sarepta Territory to the extent such recall is the result of a Manufacturing defect in Licensed Product supplied by (or on behalf of) Summit to Sarepta. In addition, each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order to effect a recall in the other Party’s Territory.
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Licensed Product in the Territory, or in the event MedCo determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, MedCo shall, within [***] hours after it receives such information from such Regulatory Authority or makes such determination, advise Alnylam thereof by telephone, facsimile or e-mail.
Recalls, Market Withdrawals or Corrective Actions. If any Regulatory Authority issues or requests a recall or takes a similar action in connection with Licensed Product, or if either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party notified of such recall or similar action, or the Party that desires such recall, withdrawal or similar action, shall within twenty-four (24) hours, advise the other Party thereof by telephone or facsimile. Biogen Idec, in consultation with AVEO (except in the case of a government mandated recall, when Biogen Idec may, if there is not sufficient time, act without such consultation, but shall notify AVEO as soon as possible), shall decide whether to conduct a recall or product withdrawal of Licensed Product in the Licensed Territory and the manner in which any such recall or withdrawal shall be conducted. AVEO, in consultation with Biogen Idec (except in the case of a government mandated recall, when AVEO may, if there is not sufficient time, act without such advance consultation, but shall notify Biogen Idec as soon as possible) shall decide whether to conduct a recall or product withdrawal of Licensed Product in the AVEO Territory and the manner in which any such recall or withdrawal shall be conducted. Each Party shall make available to the other Party, upon request, all pertinent records in its control that may reasonably be needed by the requesting Party in effecting a recall or withdrawal of Licensed Product.
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or market withdrawal or takes a similar action in connection with a Product in the Territory, or in the event either Party or any of its Affiliates, licensees, Distributors or Sublicensees determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of the Product, the Party notified of such recall or similar action, or the Party that desires, or whose Affiliate, licensee, Distributor or Sublicensee desires, such recall or similar action, shall, within twenty-four (24) hours, advise the other Party thereof by telephone or facsimile. Eagle (itself or via its Affiliates, Distributors, licensees or Sublicensees) shall, in consultation with MDCO, determine whether to conduct a recall of the Product in the Field in the Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when Eagle (or its Affiliates, licensees or Sublicensees) may act without such advance notice but shall notify MDCO as soon as possible); provided, however, that MDCO may conduct a recall of the Product in the Field in the Territory if reasonably determined by MDCO to be necessary or appropriate to comply with Applicable Laws, or to protect the safety of individuals or MDCO’s reputation. Each Party (or its Affiliates, licensees or Sublicensees (other than the other Party or its Affiliates or Sublicensees)) shall bear the expense of all recalls conducted by it or on its behalf; provided that this will not limit any remedy that each Party may have against the other Party in connection with such recall. Each Party will make available all of its pertinent records that may be reasonably requested in order to effect a recall conducted by or on behalf of the other Party.
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Global AT3 Licensed Product, Genzyme shall have the sole right to decide whether to conduct a recall and the manner in which any such recall shall be conducted. Genzyme shall bear the expense of any such recall.
Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Licensed Product in the Field in the Territory, Sanofi will, as between the Parties, have the sole right to decide whether to conduct a recall and the manner in which any such recall will be conducted. Without limiting any indemnification obligation Kymera may have under this Agreement, (a) during the applicable Opt-In Period, [***], (b) during any time other than the applicable Opt-In Period, [***], and (c) [***].
