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. (a) In the event that any Regulatory Authority issues or requests a recall or recall, market withdrawal or takes a similar action in connection with a Co-Co Product in any portion of 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 recall, market withdrawal or similar action in any portion of the ProductTerritory, the Party notified of such recall recall, market withdrawal or similar action, or the Party that desiresdesires such recall, or whose Affiliate, licensee, Distributor or Sublicensee desires, such recall market withdrawal or similar action, shall, shall within twenty-four (24) hours, hours advise the other Party thereof by telephone or facsimile. Eagle (itself or via its Affiliates, Distributors, licensees or Sublicensees) The Lead Party shall, in after reasonable consultation with MDCOthe other Party, determine decide whether to conduct a recall recall, market withdrawal or similar action in its applicable portion of the Product in the Field in the Territory and the manner in which any such recall recall, market withdrawal or similar action 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 recallconducted. 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 be reasonably requested request to assist such other Party in order to effect a recall conducted by effecting any recall, market withdrawal or on behalf of the other Partysimilar action. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

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.