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 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 Products in a Territoryan 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 recallrecall or market withdrawal, market withdrawal in each case, in any jurisdiction or stock recovery in its own Territoryregion, 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[***] hours, market withdrawal or stock recovery advise the other Party thereof by telephoneorally or in writing Unless Denali has exercised the Denali Worldwide Royalty Option, facsimile the Commercial Lead, in consultation with the Non-Commercial Lead, shall decide whether to conduct a recall in such jurisdiction or e-mail region (except in the case of a government mandated recall, when such Party the Commercial Lead may not provide act without such advance notice but or consultation but, shall notify the other Party Non-Commercial Lead 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)conducted. Each Party shall be responsible for make available to the execution 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 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 shall be included in calculating Allowable Expenses, unless Denali has exercised the extent such recall is Denali Worldwide Royalty Option for 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 Territoryrelevant 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 a Licensed Product in the Licensed Products United States or in a the OUS 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 or market withdrawal in the United States or stock recovery in its own the OUS 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[***] hours, market withdrawal or stock recovery advise the other Party thereof by telephonetelephone or email. GSK, facsimile or e-mail in consultation with Alector, shall decide whether to conduct a recall of a Cost Profit Sharing Product in the United States (except in the case of a government mandated recall, when such Party GSK may not provide act without such advance notice but but, shall notify the other Party Alector 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 and in the case event of any disagreement regarding a recall in the United States, the approach that is more conservative shall control). GSK shall decide, in its sole discretion, whether to conduct a recall in any country in the OUS Territory of a government mandated recallLicensed Product, when or in the United States of an Opt Out Product, and shall have sole discretion to determine the manner in which any such Party may act without such advance consultation but recall shall notify the other Party as soon as possible)be conducted. Each Party shall be responsible for the execution of any such recall in its own Territory, and in each such case will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party shall take may reasonably request to assist such actions as reasonably requested by the executing other Party in connection therewith effecting any recall. The costs 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 expenses of any such recall in the Sarepta Territory United States for a Cost Profit Sharing Product shall be taken into account in determining Pre-Tax Profit or Loss as, and 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 additionextent, 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 provided in the other Party’s TerritoryFinancial Exhibit.

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 Product anywhere in the Licensed Products in a Territoryworld, 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, recall or market *Confidential Treatment Requested. Omitted portions filed with the Commission. withdrawal or stock recovery in its own Territoryof the Product, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall 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 telephone 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)facsimile. Each PartyCubist shall, in consultation with the other PartyDyax, shall decide determine whether to conduct a recall of the Product in its own the Field in the Cubist Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when such Party Cubist may act without such advance consultation notice but shall notify the other Party Dyax as soon as possible). Each 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 such recall shall be conducted (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 execution of expenses; provided that this will not limit any such recall in its own Territory, and in each such case remedy that either Party may have against the other Party shall take such actions as reasonably requested by the executing Party in connection therewith and otherwise reasonably cooperate in all with such effortsrecall. 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 Each Party will make available all of its pertinent records that may be reasonably requested in order to affect a recall conducted by the other Party in order to effect a recall in the other Party’s Territory.