Common use of Remedial Actions Clause in Contracts

Remedial Actions. Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the Territory.

Remedial Actions. Each Party shall party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product of the Products may be subject to any recall, field corrective action or other regulatory action (other than a corrective and preventive action ("CAPA") under the Act) with respect to a Product taken either by any Governmental Authority virtue of applicable federal, state, foreign or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) other law or regulation or good business judgment (a “"Remedial Action”"). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ATS shall have sole responsibility for collecting information from its customers, including customer complaints. ATS will determine whether to commence any Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxProduct. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, will maintain adequate records to permit the Parties to trace the manufacture of the Product and the distribution and use of the Product. In the event ATS determines that any Remedial Action with respect to the Product should be commenced or Remedial Action is required by any governmental authority having jurisdiction over the matter, ATS will control and coordinate all efforts necessary to conduct such Remedial Action. If ATS conducts any Remedial Action related to the Product and GBI is determined to be (either by mutual agreement or by arbitration pursuant to the terms of this Agreement) responsible for the problem requiring the Remedial Action (i.e., a problem arises from faulty manufacture), GBI, at ATS' option, will either issue a credit to ATS or reimburse ATS for the sales price of all ATS devices recalled in such Remedial Action and the Territoryother reasonable costs of conducting such Remedial Action. GBI shall have sole responsibility for handling any CAPA's. ATS shall cooperate with GBI to the extent reasonably requested by GBI in handling any CAPA.

Remedial Actions. Each Party shall, and shall ensure that its Affiliates shall, notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any the Product may be subject to any recall, corrective action recall or other regulatory action withdrawal with respect to a Product taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to virtue of applicable Law in the extent it would reasonably be expected to affect the Territory) Licensed Territory (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action, provided that SIIL shall have sole and final decision-making authority as to the initiation and scope of any Remedial Action in the Licensed Territory. To the extent required by applicable Law, SIIL shall, and shall ensure that its Affiliates shall, maintain or have maintained adequate records to permit the Parties to trace the Manufacture of the Product and the distribution and, to the extent feasible, the use of the Product. If SIIL determines that any Remedial Action with respect to the TerritoryProduct in the Field in the Licensed Territory should be commenced or Remedial Action is required by any Regulatory Authority having jurisdiction over the matter, SIIL shall control and coordinate all efforts necessary to conduct such Remedial Action. Zai For clarity, as between the Parties, Visterra shall have sole discretion with respect to any matters relating to any Remedial Action in the Visterra Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses expense of any a Remedial Action arising from the Development, Manufacture or Commercialization of the Product in the Field in the Licensed Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent SIIL. Except as may be provided in a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such both Parties in respect of a Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shallarising from the Development, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use Manufacture or Commercialization of the Product in the TerritoryVisterra Territory shall be borne solely by Visterra.

Remedial Actions. (a) Each Party shall will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any an A1PI IV Product may be subject to any recall, corrective action or other regulatory action (other than a corrective and preventive action (“CAPA”) under the Act,) worldwide, taken either by any Governmental Authority virtue of applicable federal, state, foreign or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) other law or regulation or good business judgment (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that Xxxxxx shall have sole responsibility for collecting information from its customers, including customer complaints. The BLA Party shall determine whether to commence any Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxA1PI IV Product. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, will maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the distribution and use of such product. In the event the BLA Party determines that any Remedial Action with respect to the A1PI IV Product should be commenced, or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially Reasonable Efforts to conduct such Remedial Action. The other Party shall use Commercially Reasonable Efforts to cooperate with such Party in implementing any such Remedial Action to the extent such cooperation is necessary to effect the Remedial Action. The BLA Party shall have sole responsibility for handling any CAPAs in a reasonable manner; provided that Xxxxxx shall be responsible for handling and shall bear all costs and expenses related to field corrections to the extent caused by the acts or omissions of Xxxxxx. The other Party shall cooperate with the BLA Party to the extent reasonably requested by the BLA Party in handling any CAPA. Any costs and expenses incurred by either Party in connection with a Remedial Action shall be borne by the Party whose acts or omissions caused or resulted in the Territorynecessity for such Remedial Action, and such Party shall reimburse or credit the other Party for any such costs or expenses within [*****] of receiving written notice from the other Party that the cost or expense has been incurred.

Remedial Actions. Hxxxxx will monitor regulatory matters with respect to Hxxxxx Products and will take all commercially reasonable actions necessary to maintain Hxxxxx Product availability in conformity with applicable legal requirements. Similarly, St. Jude will monitor regulatory matters with respect to the Fully Integrated EnSite System and will take all commercially reasonable actions necessary to maintain availability of the Fully Integrated EnSite System in conformity with applicable legal requirements. The parties will notify each other within two Business Days of learning of any material regulatory development with respect to Hxxxxx Products or the Fully Integrated EnSite System. Each Party shall party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product of the Hxxxxx Products or the Fully Integrated EnSite System may be subject to any Remedial Action. “Remedial Action” shall mean any recall, field corrective action action, safety alert, notification or other regulatory action with respect to one or more of the Hxxxxx Products or the Fully Integrated EnSite System taken either by any Governmental Authority virtue of applicable federal, state, foreign or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) (a “Remedial Action”)other law or regulation or good business judgment. The Parties shall parties will assist each other in gathering and evaluating such information as is reasonably necessary to allow the party controlling the pertinent product to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, party will maintain adequate records to permit the Parties other party to trace the manufacture of the Hxxxxx Products and the Fully Integrated EnSite System and the distribution and use of the Product Hxxxxx Products and the Fully Integrated EnSite System. In the event that the party in control of a product (i.e., Hxxxxx controls the TerritoryHxxxxx Products and St. Jude controls the Fully Integrated EnSite System) determines that any Remedial Action with respect to a product must be commenced or Remedial Action is required by any governmental authority having jurisdiction over the matter, the party in control of such product will control and coordinate all efforts necessary to conduct such Remedial Action. Without limiting the foregoing, such responsibility shall apply to any recall, whether required or recommended by any government or other authority or organization, or otherwise deemed appropriate by the party in control of such product. Hxxxxx shall monitor on-going manufacturing quality trends and promptly notify St. Jude in writing of any known safety-related defects which are known to directly impact present St. Jude inventory or previously distributed Products. Similarly, St. Jude shall monitor on-going manufacturing quality trends and promptly notify Hxxxxx in writing of any known safety-related defects which are known to directly impact present Hxxxxx inventory or previously distributed Fully Integrated EnSite System. Notification shall include description of issue, product/batch scope, and scope mitigation recommendation. The notifying party shall follow-up within three days of notification with a Risk Analysis/Health Hazard Evaluation associated with the issue outlining investigative elements associated with issues severity, occurrence, and detection.

Remedial Actions. Each Party shall will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TPTX Territory and LaNova Territory, as applicable. Zai shall have TPTX has sole discretion with respect to any matters relating to any Remedial Action in the TPTX Territory, including the decision to commence such Remedial Action and the control over such Remedial Action and LaNova has sole discretion with respect to any matter relating to any Remedial Action in the LaNova Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the TPTX Territory shall or the LaNova Territory will be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the TPTX Territory results primarily from the failure of the Product supplied by Xxxxxxxx LaNova to comply with the Product Specifications, applicable specifications or product warranties (as set forth in the Clinical Supply AgreementAgreement (as defined below)) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall LaNova will reimburse Zai TPTX for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxLaNova. Each Party shallwill, and shall will ensure that its Affiliates Affiliates, licensees and sublicensees shallwill, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the TPTX Territory and the LaNova Territory.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any the Product may be subject to any recall, corrective action or other regulatory action taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the manufacture, distribution and use of the Product. In the event Mundipharma determines that any Remedial Action with respect to the Product in the TerritoryField in the Licensed Territory should be commenced or is required by the applicable Regulatory Authority, Mundipharma shall have the right to control and coordinate all efforts necessary to conduct such Remedial Action; provided that, with respect to any such Remedial Action that is not imposed upon Mundipharma by applicable Law or a Regulatory Authority, such Remedial Action shall have been reviewed and approved by the JSC. In the event Allos determines that any Remedial Action with respect to the Product in the Field in the Allos Territory should be commenced or is required by the applicable Regulatory Authority, Allos shall have the right, at its expense, to control and coordinate all efforts necessary to conduct such Remedial Action; provided that, with respect to any such Remedial Action that is not imposed upon Allos by applicable Law or a Regulatory Authority, such Remedial Action shall have been reviewed and approved by the JSC. If the JSC fails to approve a Remedial Action that is not imposed upon a Party by applicable Law or Regulatory Authority within [ * ] after such Remedial Action is presented to the JSC for review and approval, then the Parties’ Executive Officers shall, within [ * ] thereafter, review and approve such Remedial Action or, in the event that the Executive Officers fail to approve such Remedial Action within such time period, the Party that has the right to control and coordinate the efforts necessary to conduct such Remedial Action as provided above shall have the final decision-making authority regarding such Remedial Action notwithstanding Section 13.1 or 13.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any a Product may be subject to any recall, withdrawal, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only with respect to the extent it would reasonably be expected to affect the Territory) Product taken by virtue of Applicable Laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TerritoryAction. Zai KHK shall have the sole discretion with respect to any matters relating to any Remedial Action with respect to any Product in the Field in the Territory, including the decision to commence such Remedial Action and the control over the conduct of such Remedial Action; , provided that Xxxxxxxx KHK shall notify MEI prior to making any public disclosure of Remedial Action and shall keep MEI regularly informed regarding any such Remedial Action. KHK shall be solely responsible for the cost and expense of any such Remedial Action in the Field in the Territory. MEI shall have the sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related with respect to any Global Study. The cost and expenses of any Product outside the Territory, including the decision to commence such Remedial Action in and the Territory control over the conduct of such Remedial Action, provided that MEI shall notify KHK prior to making any public disclosure of Remedial Action and shall keep KHK regularly informed regarding any such Remedial Action. MEI shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai responsible for the reasonable cost and expense of any such Remedial Action if outside the Territory. Notwithstanding anything to the contrary in this is required and after consultation with Xxxxxxxx. Each Party shallSection 5.7 (Remedial Actions), and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties acknowledge and agree that supply and/or quality agreements between the Parties may vary and/or augment the rights and responsibilities of the Parties with respect to trace Remedial Actions. Without prejudice to other rights and remedies set forth in this Agreement, or any other agreement executed pursuant to this Agreement, including the distribution Clinical Supply Agreement, the Commercial Supply Agreement, the Pharmacovigilance Agreement and use of the Quality Agreements, all internal and external costs (excluding any costs or damages arising from a Claims by a Third Party to which a Party is entitled to indemnification under Article 13 (Indemnification; Liability)) incurred by the Parties in connection with implementing a recall or withdrawal (a “Recall”) with respect to the Product in the TerritoryField in the Territory (“Recall Costs”) shall be allocated between MEI and KHK as follows: . (a) [*CONFIDENTIAL*] (b) [*CONFIDENTIAL*] (c) [*CONFIDENTIAL*]

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action Action. Luoxin shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the packaging, labeling, distribution, sale and use (to the extent possible) of the Licensed Product in the Luoxin Territory. [*] 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 Territoryomitted portion. Zai Luoxin shall have sole discretion with respect to any matters relating to any Remedial Action in the Luoxin Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The its territory, at its cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretionexpense; provided, however, that if Synergy believes that any Remedial Action with respect to any Licensed Product in the extent Luoxin Territory should be commenced or is required by applicable Laws or Regulatory Authority, Synergy shall discuss such Remedial Action with Luoxin and Luoxin shall reasonably take Synergy’s advice into consideration; provided, further, however, that if Luoxin elects not to follow Synergy’s advice, then Synergy will have no obligation to indemnify Luoxin under Section 11.1 for any Losses in that portion attributable to Luoxin’s election not to follow Synergy’s advice. Each Party shall provide the other Party, at the other Party’s expense, with such assistance in connection with a Remedial Action in as may be reasonably requested by such other Party. Notwithstanding the Territory results primarily from foregoing, any Remedial Action that relates to the failure manufacture and supply of Licensed Products by Synergy to Luoxin shall be governed by the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in terms and conditions of the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the Territory.

Remedial Actions. Each Party shall notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to a Licensed Product taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Laws (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TerritoryAction. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party Derma shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the distribution and use of the Product Licensed Products. BIOD shall have the right to decide whether any Remedial Action with respect to Licensed Products should be commenced and BIOD shall control and coordinate all efforts necessary to conduct such Remedial Action, provided that before taking action, BIOD shall consult with Derma as to the course of Remedial Action to be taken. If Derma disagrees with BIOD as to whether Remedial Action should be taken or what Remedial Action is appropriate, then the Executive Officers of the parties shall convene within 24 hours in an attempt to resolve the Territorydisagreement. If the disagreement cannot be resolved by them, then the dispute shall be decided by expedited arbitration pursuant to Article 12, provided that the arbitrator appointed shall have FDA regulatory experience. Notwithstanding the above, the parties shall comply with all orders of the FDA on a timely basis. The cost of any Remedial Action shall be borne by Derma, except that BIOD shall bear the cost of any Remedial Action to the extent the Remedial Action is made necessary by a manufacturing problem or defect affecting a Licensed Product.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any the Product may be subject to any recall, corrective action or other regulatory action taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Laws (a “"Remedial Action”"). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the manufacture, distribution and use of the Product. In the event Mundipharma determines that any Remedial Action with respect to the Product in the TerritoryField in the Licensed Territory should be commenced or is required by the applicable Regulatory Authority, Mundipharma shall have the right to control and coordinate all efforts necessary to conduct such Remedial Action; provided that, with respect to any such Remedial Action that is not imposed upon Mundipharma by applicable Law or a Regulatory Authority, such Remedial Action shall have been reviewed and approved by the JSC. In the event Allos determines that any Remedial Action with respect to the Product in the Field in the Allos Territory should be commenced or is required by the applicable Regulatory Authority, Allos shall have the right, at its expense, to control and coordinate all efforts necessary to conduct such Remedial Action; provided that, with respect to any such Remedial Action that is not imposed upon Allos by applicable Law or a Regulatory Authority, such Remedial Action shall have been reviewed and approved by the JSC. If the JSC fails to approve a Remedial Action that is not imposed upon a Party by applicable Law or Regulatory Authority within [*] after such Remedial Action is presented to the JSC for review and approval, then the Parties' Executive Officers shall, within [*] thereafter, review and approve such Remedial Action or, in the event that the Executive Officers fail to approve such Remedial Action within such time period, the Party that has the right to control and coordinate the efforts necessary to conduct such Remedial Action as provided above shall have the final decision-making authority regarding such Remedial Action notwithstanding Section 13.1 or 13.

Remedial Actions. Each Party shall notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product in the SymBio Territory may be subject to any a recall, corrective action or other regulatory action taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Laws (a “Remedial Action”). The Parties shall assist each ) and upon receipt of notice from the other in gathering and evaluating such information as is necessary to determine the necessity of conducting Party that a Remedial Action with respect to is or may be needed, the Territory. Zai Parties shall have sole discretion with respect to any matters relating to any Remedial Action in collaborate through the Territory, including the decision to commence such Remedial Action JSC and the control over such Remedial Action; provided adopt a comprehensive written remedial action plan that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost set forth timelines and expenses details of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a (“Remedial Action Plan”). SymBio shall, at its cost and expense, use Commercially Reasonable Efforts to carry out the Remedial Action Plan (or, if no Remedial Action Plan is agreed, use Commercially Reasonable Efforts to complete Remedial Actions) and Eagle shall provide SymBio, at SymBio’s expense, with such assistance in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply connection with the Product Specifications, product warranties (Remedial Action Plan or other Remedial Actions as may be reasonably requested by SymBio. If SymBio fails to achieve the goals set forth in the Supply Agreement) or any Applicable LawRemedial Action Plan within the timelines set forth therein, including cGMP requirements, then Xxxxxxxx the Parties shall reimburse Zai further collaborate through the JSC to consider the reasons for the reasonable failure and to adopt a revised Remedial Action Plan and SymBio shall carry out such revised Remedial Action Plan at its cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxxexpense. Each Party SymBio shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace to the distribution extent required by applicable Law the packaging, labeling, distribution, sale and use (to the extent possible) of the each Licensed Product in the SymBio Territory. Any Remedial Action Plan that relates to the Manufacture and supply of Licensed Product by Eagle to SymBio shall be governed by the terms and conditions of the Supply Agreement.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that a Product or any Product other pharmaceutical product (other than a Product) including the Licensed Compound may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only with respect to the extent it would reasonably be expected to affect the Territory) Product taken by virtue of applicable laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect Action. Dermavant shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit Dermavant to trace the Territorymanufacture, distribution and use of the Products. Zai Dermavant shall have the sole discretion with respect to any matters relating to any Remedial Action with respect to any Product in the Licensed Field in the Territory, including the decision to commence such Remedial Action and the control over the conduct of such Remedial Action; , provided that Xxxxxxxx Dermavant shall notify Portola prior to making any public disclosure of a Remedial Action and shall keep Portola regularly informed regarding any such Remedial Action. [***]. Portola shall have the sole discretion with respect to any matters relating to any Remedial Action with respect to any Licensed Compound or pharmaceutical product (other than Products) including the Licensed Compound in the Territory Retained Field in the Territory, including the decision to the extent related to any Global Study. The cost and expenses of any commence such Remedial Action in and the Territory control over the conduct of such Remedial Action, provided that Portola shall be borne solely by the Party with sole discretion; provided, however, that notify Dermavant prior to the extent making any public disclosure of a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or and shall keep Dermavant regularly informed regarding any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxAction. Each Party shall[***]. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, and shall ensure that its Affiliates and sublicensees shallMARKED BY BRACKETS, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the TerritoryIS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Remedial Actions. Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x Deciphera’s notification obligation, only to the extent it would reasonably be expected to affect the Territory) ) (a ““ Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx Deciphera shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, provided however that to the extent a Remedial Action in the Territory results primarily from the failure of the Licensed Product supplied by Xxxxxxxx Deciphera to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any and Applicable LawLaws, including cGMP requirements, then Xxxxxxxx Deciphera shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxDeciphera. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Licensed Product in the Territory.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of Applicable Law (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect Action. Apollomics shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the packaging, labeling, distribution, sale and use (to the extent possible) of the Licensed Product in the Apollomics Territory. Zai Apollomics shall have sole discretion with respect to any matters relating to any Remedial Action in the Apollomics Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The its territory, at its cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretionexpense; provided, however, if GlycoMimetics determines in good faith that any Remedial Action with respect to any Licensed Product in the Apollomics Territory should be commenced or is required by Applicable Law or Regulatory Authority, (a) GlycoMimetics shall discuss such Remedial Action with Apollomics and (b) Apollomics shall carry out such Remedial Action upon GlycoMimetics’ request. Notwithstanding anything to the extent contrary in clause (b) above, if Apollomics in good faith disagrees that such Remedial Action should be commenced or is required by Applicable Law or Regulatory Authority, such Remedial Action shall be conducted at GlycoMimetics’ cost; provided that, if a Regulatory Authority later determines that such Remedial Action is required, Apollomics shall reimburse GlycoMimetics such costs. Each Party shall provide the other Party, at the other Party’s expense, with such assistance in connection with a Remedial Action in the Territory results primarily from the failure of the Product supplied as may be reasonably requested by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the Territoryother Party.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any a Product may be subject to any recall, corrective action or other regulatory action taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of Laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the manufacture, distribution and use of the such Product. If Licensee determines that any Remedial Action with respect to such Product in the TerritoryField in the Licensed Territory should be commenced or is required by Law or the applicable Regulatory Authority, Licensee may, at its expense (except to the extent that such Remedial Action is due to Licensor’s default or inaction), control and coordinate all efforts necessary to conduct such Remedial Action; provided that, with respect to any such Remedial Action that is not required by Laws or the applicable Regulatory Authority, the JSC will review and approve such Remedial Action. If the JSC fails to approve a Remedial Action that is not imposed upon Licensee by Laws or a Regulatory Authority within [***] after such Remedial Action is presented to the JSC for review and approval, then the Parties’ Executive Officers shall, within [***] thereafter, review and approve such Remedial Action or, if the Executive Officers fail to approve such Remedial Action within such time period, Licensee shall make the final decision regarding such Remedial Action notwithstanding Sections 13.1 and 13.2, provided that, so long as Licensor is the Product License Holder for a Product, Licensor shall make the final decision regarding such Remedial Action involving such Product notwithstanding Sections 13.1 and 13.2. Notwithstanding the foregoing, the terms and conditions of any agreements entered into by and between the Parties regarding manufacture and supply of a Product shall govern any Remedial Action that relates to the manufacture and supply of such Product.

Remedial Actions. (a) Each Party shall will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any an A1PI IV Product may be subject to any recall, corrective action or other regulatory action (other than a corrective and preventive action (“CAPA”) under the Act,) worldwide, taken either by any Governmental Authority virtue of applicable federal, state, foreign or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) other law or regulation or good business judgment (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that Bxxxxx shall have sole responsibility for collecting information from its customers, including customer complaints. The BLA Party shall determine whether to commence any Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxA1PI IV Product. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, will maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the distribution and use of the such product. In the event the BLA Party determines that any Remedial Action with respect to the A1PI IV Product should be commenced, or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially Reasonable Efforts to conduct such Remedial Action. The other Party shall use Commercially Reasonable Efforts to cooperate with such Party in implementing any such Remedial Action to the extent such cooperation is necessary to effect the Remedial Action. The BLA Party shall have sole responsibility for handling any CAPAs in a reasonable manner; provided that Bxxxxx shall be responsible for handling and shall bear all costs and expenses related to field corrections to the extent caused by the acts or omissions of Bxxxxx. The other Party shall cooperate with the BLA Party to the extent reasonably requested by the BLA Party in handling any CAPA. Any costs and expenses incurred by either Party in connection with a Remedial Action shall be borne by the Party whose acts or omissions caused or resulted in the Territorynecessity for such Remedial Action, and such Party shall reimburse or credit the other Party for any such costs or expenses within [*****] of receiving written notice from the other Party that the costs or expense has been incurred.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that a Product or any Product other pharmaceutical product (other than a Product) including the Licensed Compound may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only with respect to the extent it would reasonably be expected to affect the Territory) Product taken by virtue of applicable laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect Action. Dermavant shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit Dermavant to trace the Territorymanufacture, distribution and use of the Products. Zai Dermavant shall have the sole discretion with respect to any matters relating to any Remedial Action with respect to any Product in the Licensed Field in the Territory, including the decision to commence such Remedial Action and the control over the conduct of such Remedial Action; , provided that Xxxxxxxx Dermavant shall notify Portola prior to making any public disclosure of a Remedial Action and shall keep Portola regularly informed regarding any such Remedial Action. [***]. Portola shall have the sole discretion with respect to any matters relating to any Remedial Action with respect to any Licensed Compound or pharmaceutical product (other than Products) including the Licensed Compound in the Territory Retained Field in the Territory, including the decision to the extent related to any Global Study. The cost and expenses of any commence such Remedial Action in and the Territory control over the conduct of such Remedial Action, provided that Portola shall be borne solely by the Party with sole discretion; provided, however, that notify Dermavant prior to the extent making any public disclosure of a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or and shall keep Dermavant regularly informed regarding any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxAction. Each Party shall[***]. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, and shall ensure that its Affiliates and sublicensees shallMARKED BY [***], maintain adequate records to permit the Parties to trace the distribution and use of the Product in the TerritoryHAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product Licensed Product(s) may be subject to any recall, corrective action or other regulatory action with respect to such product taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of Applicable Law (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect Action. Each Party will, and will ensure that its Affiliates and Sublicensees will, maintain adequate records to permit the Parties to trace the manufacture, distribution and use (to the Territoryextent possible) of the Licensed Product(s). As between the Parties, Zai shall Lab will have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product(s) in the Territory, including the decision to commence such Remedial Action Zai Lab Territory and the control over such Remedial Action; provided that Xxxxxxxx shall INCY will have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product(s) in the Territory to INCY Territory. In the extent related to any Global Study. The cost and expenses of event that a Party determines that any Remedial Action with respect to the Licensed Product(s) in its Territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the Territory shall matter in its Territory, such Party will control and coordinate all efforts necessary to conduct such Remedial Action and will be borne solely by the Party with sole discretionresponsible for [***] of such Remedial Action in its territory; provided, however, that to the extent a (a) if such Remedial Action in the Zai Lab Territory results primarily from the failure is attributable to any inaction or action of the Product supplied by Xxxxxxxx to comply with the Product SpecificationsINCY, product warranties (as set forth in the Supply Agreement) any of its Affiliates, or a Third Party on behalf of INCY or any Applicable Law, including cGMP requirementsof its Affiliates, then Xxxxxxxx shall reimburse Zai INCY will be responsible for the reasonable all cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shallin the Zai Lab Territory, and shall ensure that (b) if such Remedial Action in the INCY Territory is attributable to any inaction or action of Zai Lab, any of its Affiliates, any sublicensee or any Third Party on behalf of Zai Lab or any of its Affiliates or sublicensees, then Zai Lab will be responsible for all cost and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use expense of the Product such Remedial Action in the INCY Territory.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Law (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TerritoryAction. Zai Simcere shall have sole discretion with respect to any matters relating to any Remedial Action for the Product in the Field in the Territory. In the event that Simcere determines that any Remedial Action with respect to the Product should be commenced in the Field in the Territory, including the decision to commence such or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in the Territory, Simcere will control and the control over coordinate all efforts necessary to conduct such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action Field in the Territory and shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai responsible for the reasonable all cost and expense of such Remedial Action if this (unless the Remedial Action is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records due to permit the Parties to trace the distribution and use of the Product Manufacturing defect in the TerritoryCompound or Product supplied by Xxxxx, in which case Xxxxx shall reimburse Simcere for the cost and expense of such Remedial Action). Notwithstanding the foregoing, to the extent possible, Simcere will consult with Xxxxx regarding any such Remedial Action plan and provide to Xxxxx a copy of any communication from, or which Simcere proposes to provide to, a Regulatory Authority relating to a Remedial Action. Xxxxx may review and provide comments on any proposed communications to a Regulatory Authority by Simcere, in which case Simcere must consider such comments in good faith and acting reasonably.

Remedial Actions. Each The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of Product in the Territories, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any released Product that indicates that a unit or batch of Product may not conform to the specifications hereof, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released Product, it shall promptly so notify the other immediatelyParty. To the extent Circassia requires such information to comply with applicable Laws or to determine whether to conduct a recall, and AIT Therapeutics shall promptly confirm disclose to Circassia any Information related to such notice in writingnonconformance, if it obtains information indicating that adulteration, misbranding or other related issue. Circassia shall have the right, at its expense (except as provided herein), to control any Product may recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territories. AIT Therapeutics shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territories. AIT Therapeutics shall be subject to responsible for all costs incurred for any recall, corrective action field correction, or other regulatory action by withdrawal of any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only released Product for the Territories to the extent it would reasonably such event of recall, field correction, or withdrawal is due to the material breach by AIT Therapeutics of this Agreement or the Supply Agreement. Circassia shall be expected to affect responsible for all other costs incurred for any recall, field correction, or withdrawal of any released Product for the Territory) (a “Remedial Action”)Territories. The Parties procedures and consequences of such recalls shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action be defined in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global StudySupply Agreement. The cost and expenses Party having the right to control such recall pursuant to this Section 6.5 may, at its sole discretion, take appropriate courses of any Remedial Action in the Territory action, which shall be borne solely by consistent with the Party with sole discretioninternal SOPs of such Party; provided, however, that to such controlling Party shall promptly notify the extent a Remedial Action in other Party of any recall action being considered and where practicable, consider the Territory results primarily from the failure views of the Product supplied by Xxxxxxxx non-controlling Party prior to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or taking any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxxrecall action. Each Party shall, shall maintain complete and shall ensure that accurate records of any recall according to its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Product then current SOPs in the TerritoryTerritories for such periods as may be required by applicable Laws, but in no event for less than three (3) years.

Remedial Actions. Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action action, or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TerritoryAction. Zai shall have Cutia has sole discretion with respect to any matters relating to any Remedial Action in the Cutia Territory, including the decision to commence such Remedial Action and the control over such Remedial ActionAction in the Cutia Territory; provided provided, however, if Foamix determines in good faith that Xxxxxxxx shall have sole discretion any Remedial Action with respect to any matters relating to any Licensed Product in the Cutia Territory should be commenced or is required by Law or Regulatory Authority, (a) Foamix shall discuss such Remedial Action with Cutia and (b) Cutia shall consider in the Territory to the extent related to any Global Studygood faith such Remedial Action upon Foamix’s request. The cost and expenses of any Remedial Action in the Cutia Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxCutia. Each Party Cutia shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the distribution distribution, sale and use of the Product Licensed Products in the Cutia Territory. Each Party shall provide the other Party, at the other Party’s expense, with such assistance in connection with a Remedial Action as may be reasonably requested by such other Party. Notwithstanding the foregoing, any Remedial Action that relates to the manufacture and supply of Licensed Products by Foamix to Cutia shall be governed by the terms and conditions of the applicable Supply Agreement.

Remedial Actions. Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x Deciphera’s notification obligation, only to the extent it would reasonably be expected to affect the Territory) (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx Deciphera shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, provided however that to the extent a Remedial Action in the Territory results primarily from the failure of the Licensed Product supplied by Xxxxxxxx Deciphera to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any and Applicable LawLaws, including cGMP requirements, then Xxxxxxxx Deciphera shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxDeciphera. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Licensed Product in the Territory.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any a Product may be subject to any recall, corrective action or other regulatory action taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of Laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the manufacture, distribution and use of the such Product. If Licensee determines that any Remedial Action with respect to such Product in the TerritoryField in the Licensed Territory should be commenced or is required by Law or the applicable Regulatory Authority, Licensee may, at its expense (except to the extent that such Remedial Action is due to Licensor’s default or inaction), control and coordinate all efforts necessary to conduct such Remedial Action; provided that, with respect to any such Remedial Action that is not required by Laws or the applicable Regulatory Authority, the JSC will review and approve such Remedial Action. If the JSC fails to approve a Remedial Action that is not imposed upon Licensee by Laws or a Regulatory Authority within [***] after such Remedial Action is presented to the JSC for review and approval, then the Parties’ Executive Officers shall, within [***] thereafter, review and approve such Remedial Action or, if the Executive Officers fail to approve such Remedial Action within such time period, Licensee shall make the final decision regarding such Remedial Action notwithstanding Sections 13.1 and 13.2, provided that, so long as Licensor is the Product License Holder for a Product, Licensor shall make the final decision regarding such Remedial Action involving such Product notwithstanding Sections 13.1 and 13.2.

Remedial Actions. Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action action, or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TerritoryAction. Zai shall have Verrica has sole discretion with respect to any matters relating to any Remedial Action in the Territorywith respect to Product that Verrica, its Affiliates, or its Sublicensees distributed, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have . Lytix has sole discretion with respect to any matters relating to any Remedial Action in with respect to Product that Lytix, its Affiliates, or their licensees (excluding Verrica, its Affiliates, or its Sublicensees) distributed, including the Territory decision to commence such Remedial Action and the extent related to any Global Studycontrol over such Remedial Action. The cost Each Party shall bear all costs and expenses of any Remedial Action in the Territory shall be borne solely conducted by the Party with sole discretion; provided, however, that it pursuant to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxSection 0. Each Party shall, and shall ensure that its Affiliates and sublicensees shallSublicensees or licensees, as applicable, will, maintain adequate records to permit the Parties to trace the distribution distribution, sale and use of the Product Products in the Territory. Each Party shall provide the other Party, at the other Party’s expense, with such assistance in connection with a Remedial Action as may be reasonably requested by such other Party. Notwithstanding the foregoing, any Remedial Action that relates to the Manufacture and supply of Products by Lytix to Verrica is governed by the terms and conditions of the applicable Supply Agreement.

Remedial Actions. Each Party shall notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to a Licensed Product taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Laws (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TerritoryAction. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party CCT shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the distribution and use of the Licensed Products. CCT shall have the right to decide whether any Remedial Action with respect to any Licensed Product should be commenced and CCT shall, at its expense, control and coordinate all efforts necessary to conduct such Remedial Action. Upon CCT’s reasonable request, Alliqua shall reasonably cooperate with, and provide reasonable assistance to, CCT in connection with any activities undertaken by CCT pursuant to the Territoryimmediately preceding sentence, at [****] sole cost and expense. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.

Remedial Actions. Each Party shall notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to a Licensed Product taken by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) virtue of applicable Laws (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action Action, provided that before taking action, Celularity shall consult with respect Sanuwave as to the Territory. Zai shall have sole discretion with respect to any matters relating to any course of the Remedial Action in the Territory, including the decision to commence such be taken. If Sanuwave disagrees with Celularity as to whether Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any should be taken or what Remedial Action is appropriate, then the Executive Officers of both parties shall convene within twenty-four (24) hours in an attempt to resolve the Territory disagreement. If the disagreement cannot be resolve by them, then then the matter shall be decided by the Executive Officer, or his or her designee, of Celularity in good faith, giving appropriate consideration to the extent related to reasonable business concerns of Sanuwave and without limiting Sanuwave’s rights and licenses under this Agreement. Notwithstanding the above, the Parties shall comply with all orders of the FDA or any Global Studyother applicable authority on a timely basis. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxCelularity. Each Party Celularity shall, and shall ensure that its Affiliates and sublicensees shallwill, maintain adequate records to permit the Parties to trace the distribution and use of the Licensed Products. Celularity shall have the right to decide whether any Remedial Action with respect to any Licensed Product should be commenced and Celularity shall, at its expense, control and coordinate all efforts necessary to conduct such Remedial Action. Upon Celularity’s reasonable request, Sanuwave shall reasonably cooperate with, and provide reasonable assistance to, Celularity in connection with any activities undertaken by Celularity pursuant to the Territoryimmediately preceding sentence, at Celularity’s sole cost and expense.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains receives information indicating that any Product may be subject to any recall, corrective action or other regulatory action taken by any virtue of Applicable Laws or request of relevant Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect Action. Each Party shall, and shall ensure that its Affiliates, Sublicensees and Subcontractors will, maintain adequate records to permit the Parties to trace the packing, labeling, distribution, sale and use (to the extent possible) of the Products in the Field in the SciClone Territory. Zai SciClone shall have sole discretion with respect to any matters relating to any Remedial Action in the SciClone Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretionits territory; provided, however, if Y-mAbs determines in good faith that any Remedial Action with respect to any Product in the SciClone Territory should be commenced or is required by Applicable Laws or Regulatory Authority, (i) Y-mAbs shall discuss such Remedial Action with SciClone and (ii) SciClone shall carry out such Remedial Action upon Y-mAbs’ reasonable request. Notwithstanding anything to the extent contrary in clause (ii) above, if SciClone in good faith disagrees that such Remedial Action should be commenced or is required by Applicable Laws or Regulatory Authority, such Remedial Action shall be conducted by SciClone at Y-mAbs’ cost; provided that, if a Regulatory Authority in the SciClone Territory later determines that such Remedial Action is required, SciClone shall reimburse Y-mAbs such costs. Subject to the above in this Section ‎3.2‎(d), each Party shall (a) provide the other Party, at the other Party’s cost and expense, with such assistance in connection with a Remedial Action in such other Party’s territory as may be reasonably requested by such other Party and (b) be responsible for all costs and expenses with respect to such Remedial Action conducted in its own territory and reimburse the Territory results primarily from other Party for all such costs and expenses incurred by the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (other Party as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense a result of such Remedial Action; provided that, to the extent such Remedial Action if was conducted as a result of the other Party’s or any of the other Party’s Affiliates’, Sublicensees’ or Subcontractors’ fraud, negligence, willful misconduct or breach of their respective representations, warranties, covenants or obligations under this is required Agreement, such other Party shall be responsible for such costs and after consultation with Xxxxxxxx. Each Party shall, expenses and shall ensure that its Affiliates reimburse the first Party for such costs and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the Territoryexpenses.

Remedial Actions. Each Party shall will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any a Licensed Product may be subject to any recall, withdrawal, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only with respect to the extent it would reasonably be expected to affect the Territory) Licensed Product taken by virtue of Applicable Laws (a “Remedial Action”). The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TerritoryAction. Zai Sinovant shall have the sole discretion with respect to any matters relating to any Remedial Action with respect to any Licensed Product in the Licensed Field in the Territory, including the decision to commence such Remedial Action and the control over the conduct of such Remedial Action; , provided that Xxxxxxxx Sinovant shall notify Angion prior to making any public disclosure of Remedial Action and shall keep Angion regularly informed regarding any such Remedial Action. Sinovant shall be solely responsible for the cost and expense of any such Remedial Action in the Licensed Field. Angion shall have the sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related with respect to any Global StudyLicensed Product outside the Territory, including the decision to commence such Remedial Action and the control over the conduct of such Remedial Action, provided that Angion shall notify Sinovant prior to making any public disclosure of Remedial Action and shall keep Sinovant regularly informed regarding any such Remedial Action. The Angion shall be solely responsible for the cost and expenses expense of any such Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that Angion Field. Notwithstanding anything to the extent a contrary in this Section 5.7 (Remedial Action in Actions), the Territory results primarily from Parties acknowledge and agree that supply and/or quality agreements between the failure Parties may vary and/or augment the rights and responsibilities of the Product supplied by Xxxxxxxx Parties with respect to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with Xxxxxxxx. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the TerritoryActions.

Remedial Actions. (a) Each Party shall will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any an A1PI IV Product may be subject to any recall, corrective action or other regulatory action (other than a corrective and preventive action (“CAPA”) under the Act,) worldwide, taken either by any Governmental Authority virtue of applicable federal, state, foreign or Regulatory Authority (as to Xxxxxxxx’x notification obligation, only to the extent it would reasonably be expected to affect the Territory) other law or regulation or good business judgment (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties shall will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that Xxxxxx shall have sole responsibility for collecting information from its customers, including customer complaints. The BLA Party shall determine whether to commence any Remedial Action with respect to the Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided that Xxxxxxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study. The cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the Territory results primarily from the failure of the Product supplied by Xxxxxxxx to comply with the Product Specifications, product warranties (as set forth in the Supply Agreement) or any Applicable Law, including cGMP requirements, then Xxxxxxxx shall reimburse Zai for the reasonable cost and expense of such Remedial Action if this is required and after consultation with XxxxxxxxA1PI IV Product. Each Party shall, and shall ensure that its Affiliates and sublicensees shall, will maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the distribution and use of the such product. In the event the BLA Party determines that any Remedial Action with respect to the A1PI IV Product should be commenced, or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially Reasonable Efforts to conduct such Remedial Action. The other Party shall use Commercially Reasonable Efforts to cooperate with such Party in implementing any such Remedial Action to the extent such cooperation is necessary to effect the Remedial Action. The BLA Party shall have sole responsibility for handling any CAPAs in a reasonable manner; provided that Xxxxxx shall be responsible for handling and shall bear all costs and expenses related to field corrections to the extent caused by the acts or omissions of Xxxxxx. The other Party shall cooperate with the BLA Party to the extent reasonably requested by the BLA Party in handling any CAPA. Any costs and expenses incurred by either Party in connection with a Remedial Action shall be borne by the Party whose acts or omissions caused or resulted in the Territorynecessity for such Remedial Action, and such Party shall reimburse or credit the other Party for any such costs or expenses within [*****] of receiving written notice from the other Party that the costs or expense has been incurred.