Common use of Recalls, Suspensions or Withdrawals Clause in Contracts

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. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Licensee shall notify AstraZeneca MedImmune promptly (but in no event later than [***] in the case of commercially distributed Licensed Product) following its determination that any event, incident or circumstance has occurred that may result in the need for a recall, market suspension 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, Mereo Licensee shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension suspension, or market withdrawal in the Field in the Territory; provided that, to the extent practicable under the circumstances, prior to any implementation of such a recall of a commercially distributed Licensed Product (including samples), or market suspension or market withdrawal of a Licensed Product, Licensee shall consult with MedImmune and shall consider MedImmune’s comments in good faith. If a recall, market suspension 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, Mereo Licensee shall initiate such a recall, market suspension suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions suspensions, or market withdrawals undertaken pursuant to this Section 6.23.4.3, as between the Parties, Mereo Licensee shall be solely responsible for the execution thereof. For claritySubject to Article 8, 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 Licensee 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 suspension, or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of In the Option pursuant to Section 2.1.3event that the Territory is not worldwide, Mereo each Party shall notify AstraZeneca the other Party promptly (but in no event later than [***]) following its determination that any event, incident or circumstance has occurred that such Party has determined may result in the need for a recall, market suspension or market withdrawal of a Licensed Product in the Field in the Territory its respective territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo Licensee shall have the right to make the final determination be solely responsible for determining whether to voluntarily implement any such recall, market suspension or market withdrawal in the Field in the Territory, and AstraZeneca shall be solely responsible for determining whether to voluntarily implement any recall, market suspension or market withdrawal in the Field in the Terminated Territory; provided that, prior to any implementation of such a recall, market suspension or market withdrawal, the Party instituting such action shall consult with the other Party and shall consider the other Party’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, Mereo Licensee shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Terminated Territory, as between the Parties, AstraZeneca 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 6.23.4.2, 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 Licensee shall be solely responsible for the execution thereof in the Territory, and AstraZeneca shall be under no obligation solely responsible for the execution thereof in the Terminated Territory. Subject to notify AstraZeneca thereof. Mereo Article 8 (INDEMNITY), each Party shall be responsible for all costs of any such recall, market suspension or market withdrawalwithdrawal for which it is responsible, except in the event and to the extent that a recall, market suspension or market withdrawal resulted from AstraZenecathe other Party’s or its Affiliate’s breach of its obligations hereunder or from such AstraZenecathe other Party’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca the other Party shall bear the expense of such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Licensee shall notify AstraZeneca 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 the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo 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 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, Mereo 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 Section 6.23.4.2, as between the Parties, Mereo Licensee shall be solely responsible for the execution thereof. For claritySubject to Article 8, 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 Licensee shall be 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 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 wilful misconduct, in which case, AstraZeneca shall bear the expense of such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Licensee shall notify AstraZeneca 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 the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo 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 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, Mereo 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 Section 6.23.4.2, as between the Parties, Mereo Licensee shall be solely responsible for the execution thereof. For claritySubject to Article 8, 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 Licensee shall be 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 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. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Each Party shall notify AstraZeneca the other Party promptly following its determination that any event, incident or circumstance has occurred that may 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, Mereo EverInsight 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, EverInsight shall consult with VistaGen and shall consider VistaGen’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, Mereo EverInsight shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable LawLaws. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 6.25.5 (Recalls, Suspensions or Withdrawals), as between the Parties, Mereo EverInsight shall be solely responsible for the execution thereof. For claritySubject to ARTICLE 13 (Indemnification; Liability), on EverInsight shall be responsible for all costs and expenses of any such recall, market suspension or after market withdrawal. Notwithstanding the exercise of the Option pursuant to Section 2.1.3foregoing, Mereo shall have the sole right and obligation to determine whether to implement any recall, market suspension or market withdrawal in that relates to the Field in the Territory Manufacture and Mereo supply of a Compound or Licensed Product by VistaGen to EverInsight shall be solely responsible for governed by the execution thereof terms and shall be under no obligation to notify AstraZeneca thereof. Mereo shall be responsible for all costs conditions 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 withdrawalInitial Supply Agreement.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo (a) Licensee shall notify AstraZeneca promptly (but in no event later than [***]) following its determination that any an event, incident or circumstance has occurred that 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, Mereo 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. (b) AstraZeneca shall notify Licensee 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 outside the Field and which, in AstraZeneca’s reasonable judgment, affects a Licensed Product in the Field in the Territory. Such notice shall include the reasoning behind such determination and any supporting facts. Licensee, after consultation with AstraZeneca and if reasonably requested by AstraZeneca, shall initiate a recall, market suspension or market withdrawal of the Licensed Product in the Field in the Territory. (c) If a recall, market suspension or market withdrawal of a Licensed Product in the Field is mandated by a Regulatory Authority in the Territory, as between the Parties, Mereo Licensee shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. . (d) For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 6.23.3.2, as between the Parties, Mereo Licensee shall be solely responsible for the execution thereof. For claritySubject to Article 8, 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 Licensee 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. Prior to exercise of In the Option pursuant to Section 2.1.3, Mereo shall notify AstraZeneca following its determination event that any government agency or authority issues or requests a recall or takes similar action in connection with the Licensed Compounds or the Licensed Products, 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 suspension the Party notified of or desiring such recall or market withdrawal of a Product in shall as promptly as reasonably practical under the Field in circumstances advise the Territory and shall include in such notice the reasoning behind such determination and any supporting factsother Party thereof. As between the Parties, Mereo Sanofi 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 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 6.23.2.3, as between the Parties, Mereo Sanofi shall be solely responsible for the execution thereofand Lexicon shall reasonably cooperate in all such efforts. For claritySubject to ARTICLE 11, 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 Sanofi shall be 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 AstraZenecaLexicon’s or its Affiliate’s breach of its obligations hereunder or under any Ancillary Agreement or from such AstraZenecaLexicon’s or its Affiliate’s fraud, gross or subcontractor’s breach of this Agreement or its negligence or willful misconduct, in which case, AstraZeneca Lexicon shall bear the expense of such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo (a) Each Party shall notify AstraZeneca 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 in the Field 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. (b) As between the Parties, Mereo Allergan 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 TerritoryTerritory with respect to a Licensed Product. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Mereo Allergan 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 6.23.2.2, as between the Parties, Mereo Allergan shall be solely responsible for the execution thereofand UroGen shall reasonably cooperate in all such efforts. For clarity, on or after the exercise of the Option pursuant Subject to Section 2.1.310.1.2, 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 Allergan shall be 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 AstraZenecaUroGen’s or its Affiliate’s breach of its representations, warranties, covenants or obligations hereunder or from such AstraZenecaUroGen’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca UroGen shall bear reimburse Allergan the expense of such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior Xxxxx shall make reasonable efforts to exercise of the Option pursuant to Section 2.1.3, Mereo shall notify AstraZeneca 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 Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo Xxxxx 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 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 6.2‎3.3.3, as between the Parties, Mereo Xxxxx shall be solely responsible for the execution thereofand ACI shall reasonably cooperate in all such efforts. For claritySubject to Article 11, 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 Xxxxx 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 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 AstraZenecaACI’s or its Affiliate’s breach of its obligations hereunder or from such AstraZenecaACI’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca ACI shall bear the expense of such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Each Party shall notify AstraZeneca the other Party promptly (but in no event later than forty-eight (48) hours) 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 Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo 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 Territory and RVL shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal outside the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, the Party making such determination shall, when circumstances permit, make an attempt to consult with the other Party, and the other Party shall respond on an expedited basis to such request for consultation, and if requested, the other Party shall provide reasonable cooperation and assistance to the determining Party in the TerritoryParty’s initiation or implementation of such a recall, market suspension or market withdrawal. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the TerritoryAuthority, as between the Parties, Mereo Licensee shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable LawLaw in the Territory and RVL shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law outside the Territory. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 6.23.2.4, as between the Parties, Mereo Licensee shall be solely responsible for the execution thereof. For clarityand all costs thereof in the Territory, on or after and RVL shall be solely responsible for the exercise of execution and all costs thereof outside the Option pursuant to Section 2.1.3Territory, Mereo shall have the sole right and obligation to determine whether to implement any except where such recall, market suspension or market withdrawal arises from (i) the failure to comply with RVL’s obligation under Section 3.2.1(i) to provide Licensee true and complete copies of the Regulatory Documentation submitted by RVL to Regulatory Authorities, (ii) RVL’s breach of its representation and warranty set forth in Section 8.2.10, (iii) defects in the Field products, materials, or components supplied by the non-initiating Party (in the Territory and Mereo which cases such costs shall be borne solely responsible for by the execution thereof and shall be under no obligation non-initiating Party) or (iv) where the Parties have a separate agreement covering the situation leading 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 such 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 case such separate agreement shall bear the expense of such recall, market suspension or market withdrawalbe followed).

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Everest shall notify AstraZeneca NPLH promptly following its determination that any event, incident or circumstance has occurred that may 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, Mereo 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, Mereo Everest shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable LawLaws. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 6.25.5 (Recalls, Suspensions or Withdrawals), as between the Parties, Mereo Everest shall be solely responsible for the execution thereof. For claritySubject to ARTICLE 13 (Indemnification; Liability), 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 Everest shall be responsible for all costs and expenses 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. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Each Party shall notify AstraZeneca the other Party promptly following its determination that any event, incident or circumstance has occurred that may 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 such Party’s Respective Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo each Party 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 such Party’s Respective Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, the TerritoryParties shall consult with each other and shall consider comments of the other in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Pfizer Territory, as between the Parties, Mereo Pfizer shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable LawLaws. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Excluded Territory, as between the Parties, Sxxxx 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 6.25.5 (Recalls, Suspensions or Withdrawals), as between the Parties, Mereo each Party shall be solely responsible for the execution thereofthereof in such Party’s Respective Territory. For claritySubject to ARTICLE 13 (Indemnification; Liability), on or after the exercise each Party shall be responsible for all costs and expenses of the Option pursuant to Section 2.1.3, Mereo shall have the sole right and obligation to determine whether to implement any such 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 AstraZenecasuch Party’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 withdrawalRespective Territory.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Licensee shall notify AstraZeneca ArQule promptly following its determination that any event, incident or circumstance has occurred that may 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, Mereo 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 consult with ArQule and shall consider ArQule'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, Mereo 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 Section 6.2Clause 3.2(c) (Recalls, Suspensions or Withdrawals), as between the Parties, Mereo Licensee shall be solely responsible for the execution thereof. For claritySubject to Clause 9 (INDEMNITY; INSURANCE), 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 Licensee shall be responsible for all costs and expenses 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. Prior (a) REGENXBIO will notify Clearside as soon as reasonably practical following its determination that any event, incident or circumstance relating to exercise the Clearside Device has occurred that may result in the need for a recall, market suspension or market withdrawal of Covered Product Exploited by REGENXBIO, its Affiliates or Sublicensees in the Option Territory and will include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, REGENXBIO will 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 of Covered Product Exploited by REGENXBIO, its Affiliates or Sublicensees is mandated by a Regulatory Authority in the Territory, as between the Parties, REGENXBIO will initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market Certain information has been excluded from this agreement (indicated by “[***]”) because such information (i) is not material and (ii) would be competitively harmful if publicly disclosed. 16 suspensions or market withdrawals undertaken pursuant to this Section 2.1.34.2.2(a), Mereo shall as between the Parties, REGENXBIO will be solely responsible for the execution and Clearside will reasonably cooperate in all such efforts. REGENXBIO will be responsible for all costs of any recall, market suspension or market withdrawal of Covered Product in the Territory, except in the event and to the extent that a recall, market suspension or market withdrawal resulted from Clearside’s or its Affiliate’s material breach of its obligations hereunder or from Clearside’s or its Affiliate’s fraud, negligence or willful misconduct, in which case, Clearside will bear the expense of such recall, market suspension or market withdrawal. In the event of a recall, market suspension or market withdrawal undertaken pursuant to this Section 4.2.2(a), REGENXBIO will keep Clearside reasonably informed with respect to such recall, market suspension or market withdrawal. (b) Clearside will notify AstraZeneca REGENXBIO 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 Clearside Devices in the Territory and shall will include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo shall Clearside will have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Field of Clearside Devices in the Territory. If a recall, market suspension or market withdrawal of Clearside Devices in the Territory is mandated by a Regulatory Authority in the Territory, as between the Parties, Mereo shall Clearside will 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 6.24.2.2(b), as between the Parties, Mereo shall Clearside will be solely responsible for the execution thereofand REGENXBIO will reasonably cooperate in all such efforts. 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 Clearside will be responsible for all costs of any recall, market suspension or market withdrawalwithdrawal of Clearside Devices, except in the event and to the extent that a recall, market suspension or market withdrawal resulted from AstraZenecaREGENXBIO’s or its Affiliate’s material breach of its obligations hereunder or from such AstraZenecaREGENXBIO’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca shall REGENXBIO will bear the expense of such recall, market suspension or market withdrawal. In the event of a recall, market suspension or market withdrawal undertaken pursuant to this Section 4.2.2(b), Clearside will keep REGENXBIO reasonably informed with respect to such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo (a) Each Party shall notify AstraZeneca 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 in the Field or RTGel Component in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. . (b) As between the Parties, Mereo Allergan 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 TerritoryTerritory with respect to a Licensed Product. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Mereo Allergan 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 6.23.2.2, as between the Parties, Mereo Allergan shall be solely responsible for the execution thereofand UroGen shall reasonably cooperate in all such efforts. For clarity, on or after the exercise of the Option pursuant Subject to Section 2.1.310.1.2, 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 Allergan shall be 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 AstraZenecaUroGen’s or its Affiliate’s breach of its representations, warranties, covenants or obligations hereunder or from such AstraZenecaUroGen’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca UroGen shall bear reimburse Allergan the expense of such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Licensee shall notify AstraZeneca Licensor promptly (but in no event later than twenty-four (24) hours in the case of commercially distributed Licensed Product) following its determination that any event, incident or circumstance has occurred that may result in the need for a recall, market suspension 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, Mereo Licensee shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension suspension, or market withdrawal in the Field in the Territory; provided that, to the extent practicable under the circumstances, prior to any implementation of such a recall of a commercially distributed Licensed Product (including samples), or market suspension or market withdrawal of a Licensed Product, Licensee shall consult with Licensor and shall consider Licensor’s comments in good faith, such comments to be provided within forty-eight (48) hours of Licensee’s consultation with Licensor. If a recall, market suspension 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, Mereo Licensee shall initiate such a recall, market suspension suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions suspensions, or market withdrawals undertaken pursuant to this Section 6.24.3.4, as between the Parties, Mereo Licensee 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 reasonable costs of any incurred in connection with a recall, market suspension suspension, or market withdrawal, except in unless the event and to the extent that a recall, market suspension suspension, or market withdrawal resulted from AstraZeneca’s is due to or its Affiliate’s breach of its obligations hereunder or from such AstraZeneca’s or its Affiliate’s fraud, gross negligence or willful misconductcaused by [***], in which case, AstraZeneca shall bear the expense of such recall, market suspension or market withdrawalcase [***].

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo Each Party shall notify AstraZeneca 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, Mereo 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, Mereo PARTNER 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 Any costs and expenses incurred by the Parties, Mereo shall be solely responsible for Parties in the execution thereof. For clarity, on or after the exercise event 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 of a Licensed Product for use in the Licensed Field in will be borne by 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 Parties as follows: 3.7.1 in the event and to the extent that a recall, market suspension suspension, or market withdrawal resulted from AstraZenecaa Party’s or its Affiliate’s breach of its obligations hereunder hereunder, under the Clinical Supply Agreement, the Commercial Supply Agreement, the Clinical Quality Agreement or the Commercial Quality Agreement or from such AstraZenecaParty’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca such Party shall bear the expense of such recall, market suspension suspension, or market withdrawal; 3.7.2 subject to clause (a) above, in the event that a recall, market suspension, or market withdrawal occurs in a country prior to Marketing Authorization in such 3.7.3 subject to clauses (a) and (b) above, with respect to any recall, market suspension, or market withdrawal of a Licensed Product in the United States, the expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal in the United States shall be included in Allowable US Expenses hereunder; and 3.7.4 subject to clause (a) above, with respect to any recall, market suspension, or market withdrawal of a Licensed Product that occurs in a country other than the United States after Marketing Authorization in such country from the applicable Regulatory Authority, PARTNER shall be responsible for any expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior to exercise of the Option pursuant to Section 2.1.3, Mereo shall (i) BioCryst will notify AstraZeneca Clearside within [***] ([***]) Business Days following its determination that any event, incident or circumstance relating to the Covered Product has occurred that may result in the need for a recall, market suspension or market withdrawal of a the Covered Product in the Field Exploited by BioCryst, its Affiliates, Distributors or Sublicensees in the Territory and shall will include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Mereo shall BioCryst will 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 of the Covered Product Exploited by BioCryst, its Affiliates, Distributors, or Sublicensees is mandated by a Regulatory Authority in the Territory, as between the Parties, Mereo shall BioCryst will 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 6.23.2(b)(i), as between the Parties, Mereo shall BioCryst will 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 recallsuch recalls, market suspension suspensions or market withdrawal withdrawals and Clearside will reasonably cooperate 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 thereofall such efforts. Mereo shall BioCryst will be responsible for all costs of any recall, market suspension or market withdrawal of the Covered Product in the Territory, except in the event and to the extent that such recall, market suspension or market withdrawal resulted from (A) Clearside’s or its Affiliate’s material breach of its obligations hereunder or from Clearside’s or its Affiliate’s fraud, negligence or willful misconduct, or (B) any event, incident or circumstance relating to a Clearside Device pursuant to Section 3.2(b)(ii), in which case of ((A) and (B)), Clearside will bear the expense of such recall, market suspension or market withdrawal. In the event of a recall, market suspension or market withdrawal undertaken pursuant to this Section 3.2(b)(i), BioCryst will keep Clearside reasonably informed with respect to such recall, market suspension or market withdrawal. (ii) Clearside will notify BioCryst within [***] ([***]) Business Days 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 Clearside Device in the Territory and will include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Clearside will have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal of a Clearside Device in the Territory. If a recall, market suspension or market withdrawal of a Clearside Device in the Territory is mandated by a Regulatory Authority in the Territory, as between the Parties, Clearside will 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(b)(ii), as between the Parties, Clearside will be solely responsible for the execution of such recalls, market suspensions or market withdrawals and BioCryst will reasonably cooperate in all such efforts. Clearside will be responsible for all costs of any recall, market suspension or market withdrawal of a Clearside Device, except in the event and to the extent that a recall, market suspension or market withdrawal resulted from AstraZenecaBioCryst’s or its Affiliate’s material breach of its obligations hereunder or from such AstraZenecaBioCryst’s or its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca shall BioCryst will bear the expense of such recall, market suspension or market withdrawal. In the event of a recall, market suspension or market withdrawal undertaken pursuant to this Section 3.2(b)(ii), Clearside will keep BioCryst reasonably informed with respect to such recall, market suspension or market withdrawal.

Recalls, Suspensions or Withdrawals. Prior (a) With respect to exercise of the Option pursuant United States, (i) the MA Holder for the United States shall use [****] efforts to Section 2.1.3, Mereo shall notify AstraZeneca 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 Field in the Territory United States, and shall include in such notice the reasoning behind such determination determination, and any supporting facts. As between ; and (ii) the Parties, Mereo 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 Field in MA Holder for the TerritoryUnited 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 TerritoryUnited States, as between the Parties, Mereo 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 6.25.1.4(a), as between the Parties, Mereo MA Holder shall be solely responsible for the execution thereof, and the Non-MA Holder Party shall [****] cooperate in all such efforts. For clarityWithout limiting Article 10, 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 (x) if and to the extent that a recall, market suspension or market withdrawal resulted from AstraZenecaa Party’s or any of its Affiliate’s material breach of its obligations hereunder hereunder, or from such AstraZenecaParty’s or any of its Affiliate’s fraud, gross negligence or willful misconduct, in which case, AstraZeneca such Party shall bear be responsible for the expense costs and expenses of such recall, market suspension or market withdrawalwithdrawal incurred by or on behalf of either Party and (y) except as set forth in the foregoing clause (x), [****]. (b) With respect to each country in the OUS Territory, the MA Holder for such country shall have the right to make the final determination whether to voluntarily implement any recall, market suspension or market withdrawal of a Licensed Product in such country. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 5.1.4(b), 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, (i) 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 (ii) except as set forth in the foregoing clause (i), [****].