Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo shall notify AstraZeneca following its determination that any event, incident or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal of a Product in the Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Field in the Territory. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Mereo shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 6.2, as between the Parties, Mereo shall be solely responsible for the execution thereof. For clarity, on or after the exercise of the Option pursuant to Section 2.1.3, Mereo shall have the sole right and obligation to determine whether to implement any recall, market suspension or market withdrawal in the Field in the Territory and Mereo shall be solely responsible for the execution thereof and shall be under no obligation to notify AstraZeneca thereof. Mereo shall be responsible for all costs of any recall, market suspension or market withdrawal, except in the event and to the extent that a recall, market suspension or market withdrawal resulted from AstraZeneca’s or its Affiliate’s breach of its obligations hereunder or from such AstraZeneca’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca shall bear the expense of such recall, market suspension or market withdrawal.
Recalls, Suspensions or Withdrawals. As between the Parties, subject to the applicable recall provisions of any supply agreement entered into by the Parties pursuant to Section 5.6, GBT shall be solely responsible for handling any recall, market suspension or market withdrawal in the Field in the Territory at its sole cost and expense. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, GBT shall initiate such a recall, market suspension or market withdrawal in compliance with applicable Law.
Recalls, Suspensions or Withdrawals. Insmed shall notify AstraZeneca promptly (but in no event later than [***]) following its determination that any event, incident or circumstance has occurred that is reasonably likely to result in the need for a recall, market suspension or market withdrawal of a Licensed Product in the Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Insmed shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. withdrawal in the Field in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Insmed shall consult with AstraZeneca and shall consider AstraZeneca’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Insmed shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 4.2.3, as between the Parties, Insmed shall be solely responsible for the execution thereof. Subject to Article 11, Insmed shall be responsible for all costs of any such recall, market suspension or market withdrawal.
Recalls, Suspensions or Withdrawals. From and after the Option Exercise Date, as between the Parties, AstraZeneca shall have the right to make the final determination whether to voluntarily implement any recall, market suspension, or market withdrawal of the applicable Licensed Product in the Territory. If any such recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, then, from and after the Option Exercise Date, as between the Parties, AstraZeneca shall be solely responsible for initiating such recall, market suspension, or market withdrawal. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 6.5 (Recalls, Suspensions, or Withdrawals), as between the Parties, AstraZeneca shall be solely responsible for the execution thereof and Cellectis shall reasonably cooperate in all such efforts at AstraZeneca’s reasonable cost. Subject to Article 13 (Indemnification; Limitation of Liability; Insurance), to the extent that a recall, market suspension, or market withdrawal resulted from a Party’s or its Affiliate’s breach of its obligations hereunder or from such Party’s or its Affiliates’ fraud, negligence, or willful misconduct, such Party shall bear the expense of such recall, market suspension, or market withdrawal.
Recalls, Suspensions or Withdrawals. Licensee shall notify Nabriva promptly following its determination that any event, incident or circumstance has occurred that would reasonably be expected to result in the need for a recall, market suspension or market withdrawal of a Licensed Product in the Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Licensee shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal of a Licensed Product in the Field in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Licensee shall consult with Nabriva and shall consider Nabriva’s comments in good faith. If a recall, market suspension or market withdrawal of a Licensed Product in the Field in the Territory is mandated by a Regulatory Authority in the Territory, as between the Parties, Licensee shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Clause 3.2(c) (Recalls, Suspensions or Withdrawals), as between the Parties, Licensee shall be solely responsible for the execution thereof. Subject to Clause 9 (INDEMNITY), Licensee shall be responsible for all costs of any such recall, market suspension or market withdrawal.
Recalls, Suspensions or Withdrawals. (a) Each Party shall notify the other Party promptly (but in no event later than [***]) following its determination that any event, incident or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal (each, a “Recall”) of the applicable product controlled by such Party in the Territory (in the case of Innate, any CD39 Option Product, and in the case of MedImmune, any MedImmune Product), and shall include in such notice the reasoning behind such determination and any supporting facts.
(b) As between the Parties, each Party shall have the sole responsibility and right to (i) determine if any Recall is necessary with respect to any such Party’s proprietary product in the Territory (in the case of MedImmune, including any MedImmune Product), and (ii) initiate, undertake, execute and implement such Recall; provided that prior to any final determination or implementation of such a Recall, MedImmune or Innate, as applicable, shall, to the extent practicable under the circumstances, consult with the other Party and shall consider its comments in good faith.
(c) As between the Parties, the Party undertaking any Recall pursuant to this Section 9.4 shall be solely responsible for the execution and implementation thereof, shall bear all costs and expenses associated therewith. The other Party shall reasonably cooperate with the Party responsible for any Recall.
Recalls, Suspensions or Withdrawals. The Parties, shall consult with each other, with Newsoara having the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Field in the Territory. If a recall, market suspension, or market withdrawal of a Licensed Product in the Field in the Territory is mandated by a Regulatory Authority in the Territory, then, as between the Parties, Newsoara shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 7.2.3 (Recalls, Suspensions or Withdrawals), as between the Parties, Newsoara shall be solely responsible for the execution thereof. Newsoara shall be responsible for all costs of any such recall, market suspension, or market withdrawal in the Field in the Territory. AUM shall inform and consult with Newsoara with respect to any recall, market suspension, or market withdrawal of the Licensed Product in the Field outside the Territory, provided that AUM has the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Field outside the Territory.
Recalls, Suspensions or Withdrawals. As between the Parties, Licensee shall be solely responsible for handling any recall, market suspension or market withdrawal in the Field in the Territory at its sole cost and expense; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Licensee shall consult with MedImmune to the extent such consultation may be made in a timely manner and consistent with Applicable Law, and shall consider MedImmune’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Licensee shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law.
Recalls, Suspensions or Withdrawals. In the event that any government agency or authority issues or requests a recall or takes similar action in connection with the Collaboration Compounds or the Collaboration Products, or in the event Sanofi determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party notified of or desiring such recall or market withdrawal shall as promptly as reasonably practical under the circumstances advise the other Party thereof. As between the Parties, Sanofi shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Territory. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Sanofi shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 5.5.2, as between the Parties, Sanofi shall be solely responsible for the execution and DiCE shall reasonably cooperate in all such efforts. Sanofi shall be responsible for all costs of any such recall, market suspension or market withdrawal.
Recalls, Suspensions or Withdrawals. Licensee shall immediately notify Licensor and the Joint Steering Committee (the “JSC”) in writing following its determination that any event, incident, or circumstance has occurred that would reasonably be expected to result in the need for a recall, market suspension, or market withdrawal of a Licensed Product in the Field in the Territory, and the JSC shall convene a telephonic meeting to discuss such recall, market suspension, or market withdrawal within twenty-four (24) hours after such notification. Licensee shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Field in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Licensee shall consider the JSC’s comments in good faith. If a recall, market suspension, or market withdrawal is requested by a Regulatory Authority in the Territory, Licensee shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Laws. Licensee shall be responsible for all costs and expenses of any such recall, market suspension, or market withdrawal.
