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. Xxxxx shall make reasonable efforts to notify ACI in writing promptly 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 Licensed Product in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Xxxxx 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, Lilly 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 3.3.3, as between the Parties, Xxxxx shall be solely responsible for the execution and ACI shall reasonably cooperate in all such efforts. Subject to Article 11, Xxxxx shall be solely responsible for all costs of any such recall, market suspension or market withdrawal, except in the event and to the extent that a recall, market suspension or market withdrawal resulted from ACI’s or its Affiliate’s breach of its obligations hereunder or from ACI’s or its Affiliate’s fraud, negligence or willful misconduct, in which case, ACI 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. (a) Licensee shall notify AstraZeneca promptly (but in no event later than [***]) following its determination that an event, incident or circumstance has occurred which may 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 in the Field in the Territory, provided that prior to the implementation of any such recall, market suspension or market withdrawal due to an event, incident or circumstance (i) related to the Licensed Compound, or (ii) which, in AstraZeneca’s reasonable judgment, may otherwise affect a Licensed Product outside the Field, Licensee shall consult with AstraZeneca and shall consider AstraZeneca’s comments in good faith.
Recalls, Suspensions or Withdrawals. 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 of a Licensed Product for use in the Licensed Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, PARTNER shall have the right to make the final determination of whether to voluntarily implement any such recall, market suspension or market withdrawal in the Licensed Field in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal in the United States, PARTNER shall consult with REGENX and shall consider REGENX’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, PARTNER shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. Any costs and expenses incurred by the Parties in the event of any recall, market suspension or market withdrawal of a Licensed Product for use in the Licensed Field will be borne by the Parties as follows:
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. Everest shall notify NPLH 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 Licensed Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Everest shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Licensed Field in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Everest shall consult with NPLH and shall consider NPLH’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, Everest shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Laws. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 5.5 (Recalls, Suspensions or Withdrawals), as between the Parties, Everest shall be solely responsible for the execution thereof. Subject to ARTICLE 13 (Indemnification; Liability), Everest shall be responsible for all costs and expenses 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 CD39 OPTION MedImmune Product), and shall include in such notice the reasoning behind such determination and any supporting facts.
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. (a) Each Party shall notify the other Party reasonably promptly 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 Licensed Product or RTGel Component in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
