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. Everest shall notify Sxxxx 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 Sxxxx and shall consider Sxxxx’x comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 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 6.5 (Recalls, Suspensions or Withdrawals), as between the Parties, Everest shall be solely responsible for the execution thereof. Subject to ARTICLE 14 (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) 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. 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. 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. Each Party shall notify the other Party 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 Field in the first Party’s Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, the first Party 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 its Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, the first Party shall consult with the other Party and shall consider the other Party’s reasonable comments in good faith. If a recall, market suspension, or market withdrawal of a Licensed Product in the Field in a Party’s Territory is mandated by a Regulatory Authority in such Territory, then, as between the Parties, such Party 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 3.2.7, each Party shall, as between the Parties, be solely responsible for the execution and costs thereof in its own Territory.
Recalls, Suspensions or Withdrawals. Midatech shall notify Novartis 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 in the Field in any country in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts; provided that such notice shall be required whether such recall or withdrawal is related to either commercial or clinical use of a Licensed Product. As between the Parties, Midatech 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 any country in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Midatech shall consult with Novartis and shall consider Novartis’ comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the applicable country in the Territory, as between the Parties, Midatech 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 3.2.3, as between the Parties, Midatech shall be solely responsible for the execution thereof. Subject to Article 8, Midatech shall be responsible for all costs of any such recall, market suspension or market withdrawal.
Recalls, Suspensions or Withdrawals. As between the Parties, from and after the Continuation Date, Gilead shall have the sole right to make all determinations with respect to and to implement any recall, market suspension, market withdrawal or other corrective action with respect to an IL-12 Molecule or IL-12 Product in the Territory. Xilio shall, and shall cause its Affiliates to, cooperate in any recalls, market suspensions, market withdrawals or other corrective actions undertaken pursuant to this Section 7.2.2 with respect to any IL-12 Molecules or IL-12 Products Manufactured by Xxxxx. Subject to Article 12, Gilead shall be responsible for all costs of any such recall, market suspension, market withdrawal or other corrective action in the Territory, except in the event and to the extent that a recall, market suspension, market withdrawal or other corrective action resulted from (a) any inventory of IL-12 Molecules and IL-12 Products (including intermediates and components thereof and material therefor) transferred or supplied by Xilio to Gilead pursuant to Section 4.3.5, Section 6.1 or Section 6.2, except to the extent resulting from an action or inaction of Gilead or its Affiliates or Sublicensees after transfer or supply thereof to Gilead or its designee, or (b) Xxxxx’s or its Affiliate’s breach of its obligations hereunder or from Xxxxx’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case ((a) and (b)), Xilio shall bear the expense of such recall, market suspension or market withdrawal.
Recalls, Suspensions or Withdrawals. (a) With respect to the United States, (i) the MA Holder for the United States shall use [****] efforts to notify the Non-MA Holder Party for the United States 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 in the United States, and shall include in such notice the reasoning behind such determination, and any supporting facts; and (ii) the MA Holder for the United States shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in United States; provided that prior to any implementation of such recall, market suspension or market withdrawal, the MA Holder for the United States shall, to the extent practicable, consult with the Non-MA Holder Party for the United States and shall consider the Non-MA Holder Party’s comments [****]. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the United States, the MA Holder 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 5.1.4(a), the MA Holder shall be solely responsible for the execution thereof, and the Non-MA Holder Party shall [****] cooperate in all such efforts. Without limiting Article 10, (x) if and to the extent that a recall, market suspension or market withdrawal resulted from a Party’s or any of its Affiliate’s material breach of its obligations hereunder, or from such Party’s or any of its Affiliate’s gross negligence or willful misconduct, such Party shall be responsible for the costs and expenses of such recall, market suspension or market withdrawal incurred by or on behalf of either Party and (y) except as set forth in the foregoing clause (x), [****].
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. [REDACTED] EXECUTION COPY
