Recalls and Market Withdrawals. As between the Parties, [[Unknown Identifier]] shall have the sole right to determine whether to implement, and to implement, a recall, field alert, withdrawal or other corrective action related to the Product. [[Unknown Identifier]] shall bear the cost and expense of any such recall, field alert, withdrawal or other corrective action. Each Party shall promptly (but in any case, not later than ​ after) notify the other Party in writing of any order, request or directive of a court or other Governmental Authority to recall or withdraw the Product. BI shall reasonably cooperate with [[Unknown Identifier]] with any recall, field alert, withdrawal or other corrective action related to the Product by requiring that Oncology Personnel inform # prescribers of any such recall, field alert, withdrawal or corrective action, and # [[Unknown Identifier]] of any relevant information related thereto following such prescriber discussions.

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 sold in the Territory during the Term, or in the event a Betta Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, Betta will advise [[Agenus:Organization]] thereof by telephone, facsimile or e-mail as promptly as practicable, but at least ​ prior to public disclosure of such recall, market withdrawal or corrective action conducted, except where such advisement would reasonably be expected to result in Betta’s non-compliance with Applicable Law, in which case, Betta will advise [[Agenus:Organization]] thereof as soon as reasonably practicable. Except where it would reasonably be expected to result in Betta’s non-compliance with Applicable Law, Betta, in consultation with [[Agenus:Organization]], will decide whether to conduct a recall, market withdrawal or similar action in the Territory and the manner in which any such recall will be conducted. If the Licensed Product that is subject to such recall, market withdrawal or corrective action was supplied by [[Agenus:Organization]], [[Agenus:Organization]] will make available all of its pertinent records that may be ​ by Betta in order to effect a recall in the Territory. Betta will bear all costs and expenses that may be incurred in connection with any Licensed Product recall or withdrawal in the Territory; provided, however, that to the extent any such recall or withdrawal is due to the failure of the Licensed Products supplied by [[Agenus:Organization]] to comply with the specifications of the Licensed Product in accordance with the terms and conditions of the Supply Agreement, [[Agenus:Organization]] will bear all reasonable costs and expenses incurred in connection with such recall or withdrawal.

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 sold during the Term, or in the event [[Organization A:Organization]] or any of its Affiliates or 36165924.6

credits or allowances actually given or made for rejection of or return of previously sold Product (whether as a result of Recalls, market withdrawals, other corrective actions, damaged, defective goods or otherwise), for retroactive price reductions and billing errors, or other allowances specifically identifiable as relating to the Products; and

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 a Territory, or in the event that 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 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 JSC representatives thereof by telephone or e-mail, and will discuss with the other Party the reasons for the recall, market withdrawal or similar action. Each Party will decide whether to conduct a recall of a 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, 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 and subject to Section 11, each Party will bear the expense of any such recall in its own Territory. 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 Licensed Product in its Territory. The Parties’ rights and obligations under this Section 4.7 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 4.7, the provisions of such supply agreement, SDEA or quality related agreements will govern.

overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development 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 a Licensed Product in the Field in the Territory, Licensee will, as between the Parties, have the sole right to decide whether to conduct a recall, market withdrawal, or corrective action and the manner in which any such recall, market withdrawal, or corrective action will be conducted. Without limiting any indemnification obligation Relay may have under this Agreement, # if such recall, market withdrawal or corrective action occurs during the Opt-In Term, all such costs and expenses in the Profit Share Territory will be treated as Allowable Expenses (as applicable), # if such recall, market withdrawal or corrective action occurs outside the Opt-In Term, Licensee will bear the costs and expenses of any such recall, market withdrawal or corrective action in the former Profit Share Territory, and # Licensee will bear the costs and expenses of any such recall, market withdrawal or corrective action in the Royalty Territory.

Recalls and Market Withdrawals. As between the Parties, TYME shall have the sole right to determine whether to implement, and to implement, a recall, field alert, withdrawal or other corrective action related to the Product. TYME shall bear the cost and expense of any such recall, field alert, withdrawal or other corrective action. Each Party shall promptly (but in any case, not later than one (1) day after) notify the other Party in writing of any order, request or directive of a court or other Governmental Authority to recall or withdraw the Product.

amounts allowed or credited by reason of rejections, return of goods (including as a result of recalls, market withdrawals and other corrective actions), and retroactive price reductions or allowances specifically identifiable as relating to a Licensed Product including allowances and credits related to inventory management or similar agreements with wholesalers;

Recalls, Market Withdrawals or Corrective Actions. Subject to the applicable Quality Agreement, in the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Product in 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 or market withdrawal in the Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within ​, advise the other Party thereof by telephone or facsimile. Nektar, in consultation with BMS, through the JDC, JCC or JMC, as applicable, shall decide whether to conduct a recall in any market in the Territory (except in the case of a government mandated recall, when Nektar may act without such advance notice but, shall notify BMS as soon as possible) and the manner in which any such recall shall be conducted (and in the event of any disagreement regarding a recall in the Territory, the approach that is more conservative shall control). 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. The costs and expenses of any such recall shall be taken into account in determining Net Profits and calculated in accordance with Section 9.5.