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 takes a similar action in connection with an Optioned Product, 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 each case, in any jurisdiction or region, 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 orally or in writing Unless Denali has exercised the Denali Worldwide Royalty Option, the Commercial Lead, in consultation with the Non-Commercial Lead, shall decide whether to conduct a recall in such jurisdiction or region (except in the case of a government mandated recall, when the Commercial Lead may act without such advance notice or consultation but, shall notify the Non-Commercial Lead as soon as possible) and the manner in which any such recall shall be conducted. Each Party shall make available to the other Party, upon request, all of such Party’s pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall. The costs and expenses of any recall in the Territory shall be included in calculating Allowable Expenses, unless Denali has exercised the Denali Worldwide Royalty Option for the relevant Collaboration Program.

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 an Optioned Productthe 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 recall, market withdrawal or market withdrawal, stock recovery in each case, in any jurisdiction or regionits own Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within [***] hourstwenty-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 orally telephone, facsimile or in writing Unless Denali has exercised the Denali Worldwide Royalty Option, the Commercial Lead, in consultation with the None-Commercial Lead, shall decide whether to conduct a recall in such jurisdiction or region mail (except in the case of a government mandated recall, when the Commercial Lead such Party may act without not provide such advance notice or consultation but, [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. but shall notify the Non-Commercial Lead 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 conductedconducted (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, upon request, all of such Party’s pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall. The costs and expenses of any recall in the Territory shall be included in calculating Allowable Expenses, unless Denali has exercised the Denali Worldwide Royalty Option for the relevant Collaboration ProgramTerritory.

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 an Optioned Productthe 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 recall, market withdrawal or market withdrawal, stock recovery in each case, in any jurisdiction or regionits own Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within [***] hourstwenty-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 orally telephone, facsimile or in writing Unless Denali has exercised the Denali Worldwide Royalty Option, the Commercial Lead, in consultation with the None-Commercial Lead, shall decide whether to conduct a recall in such jurisdiction or region mail (except in the case of a government mandated recall, when the Commercial Lead such Party may act without not provide such advance notice or consultation but, but shall notify the Non-Commercial Lead 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 conductedconducted (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, upon request, all of such Party’s pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall. The costs and expenses of any recall in the Territory shall be included in calculating Allowable Expenses, unless Denali has exercised the Denali Worldwide Royalty Option for the relevant Collaboration ProgramTerritory.

Recalls, Market Withdrawals or Corrective Actions. In the event that any If a Regulatory Authority issues or requests a recall or takes a similar action in connection with an Optioned Productany of the Licensed Products in the Territory, or in the event if either Party determines (acting reasonably and in good faith) that an event, incident or circumstance has occurred which results in reasonable grounds for believing that there may result in the need for be an actual or suspected defect with a Licensed Product such that a recall or market withdrawal, withdrawal in each case, in any jurisdiction or regionthe Territory may be required, the Party notified of such recall or similar action, or the Party that desires believes such recall or similar actionaction is required, shall within [***] hours], advise the other Party thereof by orally telephone or email. The Parties shall discuss and agree (acting reasonably and in writing Unless Denali has exercised the Denali Worldwide Royalty Option, the Commercial Lead, in consultation with the Non-Commercial Lead, shall decide good faith) whether to conduct a recall in such jurisdiction one (1) or region more countries in Territory A or Territory B (except in the case of a government mandated recall, when the Commercial Lead may act without such advance notice or consultation but, shall notify the Non-Commercial Lead as soon as possibleapplicable) and the manner in which any such recall shall be conducted, provided, however, in the event of a ​ ​ [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. ​ ​ Regulatory Authority-mandated recall, Genmab (in respect of [*]) and Licensee (in respect of [*]) may act without such advance notice but in any event shall notify the other Party as soon as reasonably possible. In either case, if the Parties cannot agree as to whether a recall is required in the Territory, [*] shall have final decision-making authority with respect to such matter (which shall not be subject to challenge, review or arbitration). Each Party shall will make available to the other Party, upon request, all of such Party’s (and its Affiliates’ and Subcontractors’ and sublicensees’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall. The costs and expenses of any such recall in the Territory shall be included taken into account in calculating Allowable Expensesdetermining Pre-Tax Profit or Loss as, unless Denali has exercised and to the Denali Worldwide Royalty Option for the relevant Collaboration Programextent, provided in Schedule 10.

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 an Optioned Producta Product anywhere in the world, or in the event either Party reasonably determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, in each case, in any jurisdiction or region*Confidential Treatment Requested. Omitted portions filed with the Commission. withdrawal of the Product, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall shall, within [***] hours, twenty-four (24) hours advise the other Party thereof by orally telephone or in writing Unless Denali has exercised the Denali Worldwide Royalty Option, the Commercial Leadfacsimile. Cubist shall, in consultation with the Non-Commercial LeadDyax, shall decide determine whether to conduct a recall of the Product in the Field in the Cubist Territory and the manner in which any such jurisdiction or region recall shall be conducted (except in the case of a government mandated recall, when the Commercial Lead Cubist may act without such advance notice or consultation but, but shall notify the Non-Commercial Lead Dyax as soon as possible) ). Similarly, Dyax shall, in consultation with Cubist, determine whether to conduct a recall of Product in the Field in the Dyax Territory, or outside the Field, and shall determine the manner in which any such recall shall be conductedconducted (except in the case of a government mandated recall, when Dyax may act without such advance notice but shall notify Cubist as soon as possible). []*, in which case such other Party shall be responsible for the expenses; provided that this will not limit any remedy that either Party may have against the other Party in connection with such recall. Each Party shall will make available all of its pertinent records that may be reasonably requested in order to affect a recall conducted by the other Party, upon request, all of such Party’s pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall. The costs and expenses of any recall in the Territory shall be included in calculating Allowable Expenses, unless Denali has exercised the Denali Worldwide Royalty Option for the relevant Collaboration Program.