Common use of Recalls, Market Withdrawals or Corrective Actions Clause in Contracts

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 If any Regulatory Authority issues or requests a recall or market withdrawal or takes a similar action in connection with a Product anywhere in the Territoryworld, or in the event if 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, desires such recall or similar action, shall, within twenty-four (24) hours, [*****] advise the other Party thereof by telephone e-mail, overnight courier or facsimile. Eagle (itself or via its Affiliates, Distributors, licensees or Sublicensees) Defiante shall, in consultation with MDCODyax, determine whether to conduct a recall of the Product in the Field in the Defiante 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) Defiante may act without such advance notice but shall notify MDCO Dyax as soon as possible); provided. Similarly, howeverDyax shall, that MDCO may in consultation with Defiante, determine whether to conduct a recall of the Product in the Field in the Territory if reasonably determined by MDCO to Dyax Territory, and shall determine the manner in which such recall shall be necessary or appropriate to comply with Applicable Lawsconducted (except in the case of a government mandated recall, 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 Sublicenseeswhen Dyax may act without such advance notice but shall notify Defiante as soon as possible)) 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 affect a recall conducted by or on behalf of the other Party. Costs and expenses for the recall shall be borne by the Party whose action or omission caused the recall.