Common use of Remedial Actions Clause in Contracts

Remedial Actions. (a) Each Party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that 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 virtue of applicable federal, state, foreign or 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 will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. 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 necessity 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. (a) Each Party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that 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 virtue of applicable federal, state, foreign or 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 will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. 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 necessity 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 costs or expense has been incurred.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV the 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 virtue of applicable federal, state, foreign or other law or regulation or good business judgment Laws (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party will shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the manufacture, distribution and use of such productthe Product. In the event the BLA Party Mundipharma determines that any Remedial Action with respect to the A1PI IV Product in the Field in the Licensed Territory should be commenced, commenced or Remedial Action is required by any governmental authority having jurisdiction over the matterapplicable Regulatory Authority, Mundipharma shall have the BLA Party shall use Commercially Reasonable Efforts right to control and coordinate all efforts necessary to conduct such Remedial Action. The other Party shall use Commercially Reasonable Efforts ; provided that, with respect to cooperate with such Party in implementing 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 extent such cooperation 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 effect the conduct such Remedial Action. The BLA Party ; 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 sole responsibility for handling any CAPAs in a reasonable manner; provided that ▇▇▇▇▇▇ shall be responsible for handling been reviewed and shall bear all costs and expenses related to field corrections to the extent caused approved by the acts or omissions of ▇▇▇▇▇▇JSC. The other Party shall cooperate with If the BLA Party JSC fails to the extent reasonably requested by the BLA Party in handling any CAPA. Any costs and expenses incurred by either Party in connection with approve a Remedial Action shall be borne 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 whose acts or omissions caused or resulted in that has the necessity for right to control and coordinate the efforts necessary to conduct such Remedial Action, and Action as provided above shall have the final decision-making authority regarding such Party shall reimburse Remedial Action notwithstanding Section 13.1 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 incurred13.

Remedial Actions. (a) Each Party party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV the 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 virtue of applicable federal, state, foreign or 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 parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting Remedial Action; provided that ▇▇▇▇▇▇ BIOMET shall have sole responsibility for collecting information from its customers, including customer complaints. The BLA Party INNOCOLL shall determine whether to commence any Remedial Action with respect to the A1PI IV Product. Each Party party will maintain adequate records to permit the Parties parties to trace the manufacture of the applicable A1PI IV Product and the distribution and use of such productthe Product. In the event the BLA Party INNOCOLL 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 BIOMET shall use Commercially Reasonable Efforts to conduct such Remedial Action. The other Party INNOCOLL shall use Commercially Reasonable Efforts to cooperate with such Party BIOMET in implementing any such Remedial Action to the extent such cooperation is necessary to effect the Remedial Action. The BLA Party INNOCOLL shall have sole responsibility for handling any CAPAs in a reasonable manner; provided that ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. The other Party BIOMET shall cooperate with the BLA Party INNOCOLL to the extent reasonably requested by the BLA Party INNOCOLL in handling any CAPA. Any costs and expenses incurred by either Party party in connection with a Remedial Action shall be borne by the Party party whose acts or omissions caused or resulted in the necessity for such Remedial Action, and such Party party shall reimburse or credit the other Party party for any such costs or expenses within [*****] of receiving written notice from the other Party that the cost or expense has been incurredexpenses.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV a 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 virtue of applicable federal, state, foreign or other law or regulation or good business judgment Laws (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party will shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the manufacture, distribution and use of such productProduct. In the event the BLA Party If Licensee determines that any Remedial Action with respect to such Product in the A1PI IV Product Field in the Licensed Territory should be commencedcommenced or is required by Law or the applicable Regulatory Authority, or Licensee may, at its expense (except to the extent that such Remedial Action is required by any governmental authority having jurisdiction over the matterdue to Licensor’s default or inaction), the BLA Party shall use Commercially Reasonable Efforts control and coordinate all efforts necessary to conduct such Remedial Action. The other Party shall use Commercially Reasonable Efforts ; provided that, with respect to cooperate with such Party in implementing any such Remedial Action to that is not required by Laws or the extent applicable Regulatory Authority, the JSC will review and approve 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 ▇▇▇▇▇▇ shall be responsible for handling and shall bear all costs and expenses related If the JSC fails to field corrections to the extent caused by the acts or omissions of ▇▇▇▇▇▇. 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 approve a Remedial Action shall be borne that is not imposed upon Licensee by the Party whose acts Laws or omissions caused or resulted in the necessity for such Remedial Action, and such Party shall reimburse or credit the other Party for any such costs or expenses 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 receiving written notice from any agreements entered into by and between the other Party Parties regarding manufacture and supply of a Product shall govern any Remedial Action that relates to the cost or expense has been incurredmanufacture and supply of such Product.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV any 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, with respect to such product taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment Law (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ▇▇▇▇▇▇ . Simcere shall have sole responsibility for collecting information from its customers, including customer complaints. The BLA Party shall determine whether discretion with respect to commence any matters relating to any Remedial Action with respect to for the A1PI IV Product. Each Party will maintain adequate records to permit Product in the Parties to trace Field in the manufacture of the applicable A1PI IV Product and the distribution and use of such productTerritory. In the event the BLA Party that Simcere determines that any Remedial Action with respect to the A1PI IV Product should be commencedcommenced in the Field in the Territory, or if Remedial Action is required by any governmental authority Regulatory Authority having jurisdiction over the mattermatter in the Territory, the BLA Party shall use Commercially Reasonable Efforts Simcere will control and coordinate all efforts necessary to conduct such Remedial Action. The other Party Action in the Field in the Territory and shall use Commercially Reasonable Efforts to cooperate with such Party in implementing any be responsible for all cost and expense of such Remedial Action to the extent such cooperation is necessary to effect (unless the Remedial Action. The BLA Party shall have sole responsibility for handling any CAPAs Action is due to Manufacturing defect in a reasonable manner; provided that the Compound or Product supplied by ▇▇▇▇▇, in which case ▇▇▇▇▇ shall be responsible reimburse Simcere for handling the cost and shall bear all costs and expenses related to field corrections expense of such Remedial Action). Notwithstanding the foregoing, to the extent caused by the acts or omissions of possible, Simcere will consult with ▇▇▇▇▇ regarding any such Remedial Action plan and provide to ▇▇. The other Party shall cooperate with the BLA Party ▇▇▇ a copy of any communication from, or which Simcere proposes to the extent reasonably requested by the BLA Party in handling any CAPA. Any costs and expenses incurred by either Party in connection with provide to, a Regulatory Authority relating to a Remedial Action shall be borne Action. ▇▇▇▇▇ may review and provide comments on any proposed communications to a Regulatory Authority by the Party whose acts or omissions caused or resulted Simcere, in the necessity for which case Simcere must consider such Remedial Action, comments in good faith 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 incurredacting reasonably.

Remedial Actions. (a) H▇▇▇▇▇ will monitor regulatory matters with respect to H▇▇▇▇▇ Products and will take all commercially reasonable actions necessary to maintain H▇▇▇▇▇ 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 H▇▇▇▇▇ Products or the Fully Integrated EnSite System. Each Party party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV Product any of the H▇▇▇▇▇ 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 (other than a corrective and preventive action (“CAPA”) under with respect to one or more of the Act,) worldwide, H▇▇▇▇▇ Products or the Fully Integrated EnSite System taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment (a “Remedial Action”)judgment. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties 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 any Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party party will maintain adequate records to permit the Parties other party to trace the manufacture of the applicable A1PI IV Product H▇▇▇▇▇ Products and the Fully Integrated EnSite System and the distribution and use of such productthe H▇▇▇▇▇ Products and the Fully Integrated EnSite System. In the event that the BLA Party party in control of a product (i.e., H▇▇▇▇▇ controls the H▇▇▇▇▇ Products and St. Jude controls the Fully Integrated EnSite System) determines that any Remedial Action with respect to the A1PI IV Product should a product must be commenced, commenced or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially Reasonable Efforts party in control of such product will control and coordinate all efforts necessary to conduct such Remedial Action. The Without limiting the foregoing, such responsibility shall apply to any recall, whether required or recommended by any government or other Party shall use Commercially Reasonable Efforts to cooperate with authority or organization, or otherwise deemed appropriate by the party in control of such Party in implementing any such Remedial Action to the extent such cooperation is necessary to effect the Remedial Actionproduct. The BLA Party shall have sole responsibility for handling any CAPAs in a reasonable manner; provided that ▇H▇▇▇▇▇ shall be responsible for handling 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 bear all costs monitor on-going manufacturing quality trends and expenses related to field corrections to the extent caused by the acts or omissions of promptly notify H▇▇▇▇▇ in writing of any known safety-related defects which are known to directly impact present H▇▇▇▇▇ inventory or previously distributed Fully Integrated EnSite System. Notification shall include description of issue, product/batch scope, and scope mitigation recommendation. The other Party notifying party shall cooperate follow-up within three days of notification with a Risk Analysis/Health Hazard Evaluation associated 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 issue outlining investigative elements associated with a Remedial Action shall be borne by the Party whose acts or omissions caused or resulted in the necessity for such Remedial Actionissues severity, occurrence, 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 incurreddetection.

Remedial Actions. (a) Each Party will shall notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV any Licensed Product may be subject to any recall, corrective action or other regulatory action (other than with respect to a corrective and preventive action (“CAPA”) under the Act,) worldwide, Licensed Product taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment Laws (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided . Derma shall, and shall ensure that ▇▇▇▇▇▇ shall have sole responsibility for collecting information from its customersAffiliates will, including customer complaints. The BLA Party shall determine whether to commence any Remedial Action with respect to the A1PI IV Product. Each Party 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 productthe Licensed Products. In BIOD shall have the event the BLA Party determines that right to decide whether any Remedial Action with respect to the A1PI IV Product Licensed Products should be commenced, or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party commenced and BIOD shall use Commercially Reasonable Efforts control and coordinate all efforts necessary to conduct such Remedial Action. The other Party , provided that before taking action, BIOD shall use Commercially Reasonable Efforts consult with Derma as to cooperate with such Party in implementing any such 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 extent such cooperation is necessary Executive Officers of the parties shall convene within 24 hours in an attempt to effect resolve the Remedial Actiondisagreement. 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 BLA Party shall have sole responsibility for handling cost of any CAPAs in a reasonable manner; provided that ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. 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 necessity for such Remedial ActionDerma, and such Party except that BIOD shall reimburse or credit the other Party for any such costs or expenses within [*****] of receiving written notice from the other Party that bear the cost of any Remedial Action to the extent the Remedial Action is made necessary by a manufacturing problem or expense has been incurreddefect affecting a Licensed Product.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV the 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 virtue of applicable federal, state, foreign or other law or regulation or good business judgment Laws (a “"Remedial Action”"). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party will shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the manufacture, distribution and use of such productthe Product. In the event the BLA Party Mundipharma determines that any Remedial Action with respect to the A1PI IV Product in the Field in the Licensed Territory should be commenced, commenced or Remedial Action is required by any governmental authority having jurisdiction over the matterapplicable Regulatory Authority, Mundipharma shall have the BLA Party shall use Commercially Reasonable Efforts right to control and coordinate all efforts necessary to conduct such Remedial Action. The other Party shall use Commercially Reasonable Efforts ; provided that, with respect to cooperate with such Party in implementing 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 extent such cooperation 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 effect the conduct such Remedial Action. The BLA Party ; 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 sole responsibility for handling any CAPAs in a reasonable manner; provided that ▇▇▇▇▇▇ shall be responsible for handling been reviewed and shall bear all costs and expenses related to field corrections to the extent caused approved by the acts or omissions of ▇▇▇▇▇▇JSC. The other Party shall cooperate with If the BLA Party JSC fails to the extent reasonably requested by the BLA Party in handling any CAPA. Any costs and expenses incurred by either Party in connection with approve a Remedial Action shall be borne that is not imposed upon a Party by the Party whose acts applicable Law or omissions caused or resulted in the necessity for such Remedial Action, and such Party shall reimburse or credit the other Party for any such costs or expenses Regulatory Authority within [****] after such Remedial Action is presented to the JSC for review and approval, then the Parties' Executive Officers shall, within [*] of receiving written notice from thereafter, review and approve such Remedial Action or, in the other event that the Executive Officers fail to approve such Remedial Action within such time period, the Party that has the cost 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 expense has been incurred13.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV any Licensed 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 virtue of applicable federal, state, foreign or other law or regulation or good business judgment Laws (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided . Luoxin shall, and shall ensure that ▇▇▇▇▇▇ shall have sole responsibility for collecting information from its customersAffiliates and sublicensees will, including customer complaints. The BLA Party shall determine whether to commence any Remedial Action with respect to the A1PI IV Product. Each Party will maintain adequate records to permit the Parties to trace the manufacture packaging, labeling, distribution, sale and use (to the extent possible) of the applicable A1PI IV 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 omitted portion. 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 distribution control over such Remedial Action in its territory, at its cost and use of such product. In the event the BLA Party determines expense; provided, however, that if Synergy believes that any Remedial Action with respect to any Licensed Product in the A1PI IV Product Luoxin Territory should be commenced, commenced or Remedial Action is required by any governmental authority having jurisdiction over the matterapplicable Laws or Regulatory Authority, the BLA Party Synergy 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 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 the extent such cooperation is necessary follow Synergy’s advice, then Synergy will have no obligation to effect the Remedial Actionindemnify Luoxin under Section 11.1 for any Losses in that portion attributable to Luoxin’s election not to follow Synergy’s advice. The BLA Each Party shall have sole responsibility for handling any CAPAs in a reasonable manner; provided that ▇▇▇▇▇▇ shall be responsible for handling and shall bear all costs and expenses related to field corrections to provide the extent caused by other Party, at the acts or omissions of ▇▇▇▇▇▇. The other Party shall cooperate Party’s expense, 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 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 Synergy to Luoxin shall be borne governed by the Party whose acts or omissions caused or resulted in terms and conditions of the necessity 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 incurredSupply Agreement.

Remedial Actions. (a) Each Party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that 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 virtue of applicable federal, state, foreign or 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 will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting Remedial Action; provided that ▇B▇▇▇▇▇ 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 A1PI IV Product. Each Party 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 ▇B▇▇▇▇▇ 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 ▇B▇▇▇▇▇. 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 necessity 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 costs or expense has been incurred.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains receives information indicating that an A1PI IV any 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 virtue of applicable federal, state, foreign Applicable Laws or other law or regulation or good business judgment request of relevant Governmental Authority (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party will shall, and shall ensure that its Affiliates, Sublicensees and Subcontractors will, maintain adequate records to permit the Parties to trace the manufacture packing, labeling, distribution, sale and use (to the extent possible) of the applicable A1PI IV Product Products in the Field in the SciClone Territory. 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 distribution and use of control over such product. In the event the BLA Party Remedial Action in its territory; provided, however, if Y-mAbs determines in good faith that any Remedial Action with respect to any Product in the A1PI IV Product SciClone Territory should be commencedcommenced 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 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 by any governmental authority having jurisdiction over required, SciClone shall reimburse Y-mAbs such costs. Subject to the matterabove in this Section ‎3.2‎(d), the BLA each Party shall use Commercially Reasonable Efforts to conduct such Remedial Action. The (a) provide the other Party shall use Commercially Reasonable Efforts to cooperate Party, at the other Party’s cost and expense, 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. 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 assistance in connection with a Remedial Action shall in such other Party’s territory as may be borne reasonably requested by the such other Party whose acts or omissions caused or resulted in the necessity and (b) be responsible for all costs and expenses with respect to such Remedial Action, Action conducted in its own territory and such Party shall reimburse or credit the other Party for any all such costs or and expenses within [*****] of receiving written notice from incurred by the other Party that as a result of such Remedial Action; provided that, to the cost extent such Remedial Action was conducted as a result of the other Party’s or expense has been incurredany 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 Agreement, such other Party shall be responsible for such costs and expenses and shall reimburse the first Party for such costs and expenses.

Remedial Actions. (a) Each Party will shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV any Product may be subject to any recall, corrective action action, or other regulatory action (other than a corrective and preventive action (“CAPA”) under the Act,) worldwide, taken either by virtue of applicable federal, state, foreign any Governmental Authority or other law or regulation or good business judgment Regulatory Authority (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ▇▇▇▇▇▇ shall have . Oncoheroes has sole responsibility for collecting information from its customers, including customer complaints. The BLA Party shall determine whether discretion with respect to commence any matters relating to any Remedial Action with respect to Product that Oncoheroes, its Affiliates, or its Sublicensees distributed, including the A1PI IV Productdecision to commence such Remedial Action and the control over such Remedial Action. Allarity has sole discretion with respect to any matters relating to any Remedial Action with respect to Product that Allarity, its Affiliates, or their licensees (excluding Oncoheroes, its Affiliates, or its Sublicensees) distributed, including the decision to commence such Remedial Action and the control over such Remedial Action. Each Party will shall bear all costs and expenses of any Remedial Action conducted by it pursuant to this Section 5.6. Each Party shall, and shall ensure that its Affiliates and Sublicensees or licensees, as applicable, will, maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the distribution distribution, sale and use of such productProducts in the Territory. 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 Each Party shall use Commercially Reasonable Efforts to conduct such Remedial Action. The provide the other Party shall use Commercially Reasonable Efforts to cooperate Party, at the other Party’s expense, 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. 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 assistance in connection with a Remedial Action shall as may be borne reasonably requested by such other Party. Notwithstanding the foregoing, any Remedial Action that relates to the Manufacture and supply of Products by Allarity to Oncoheroes is governed by the Party whose acts or omissions caused or resulted in terms and conditions of the necessity for such Remedial Action, applicable Supply Agreement 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 incurredNovartis Head License Agreement.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV any Licensed 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 virtue of applicable federal, state, foreign or other law or regulation or good business judgment Applicable Law (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided . Apollomics shall, and shall ensure that ▇▇▇▇▇▇ shall have sole responsibility for collecting information from its customersAffiliates and sublicensees will, including customer complaints. The BLA Party shall determine whether to commence any Remedial Action with respect to the A1PI IV Product. Each Party will maintain adequate records to permit the Parties to trace the manufacture packaging, labeling, distribution, sale and use (to the extent possible) of the applicable A1PI IV Licensed Product in the Apollomics Territory. 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 distribution control over such Remedial Action in its territory, at its cost and use of such product. In the event the BLA Party expense; provided, however, if GlycoMimetics determines in good faith that any Remedial Action with respect to any Licensed Product in the A1PI IV Product Apollomics Territory should be commencedcommenced 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 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 by any governmental authority having jurisdiction over the matterrequired, the BLA Apollomics shall reimburse GlycoMimetics such costs. Each Party shall use Commercially Reasonable Efforts to conduct such Remedial Action. The provide the other Party shall use Commercially Reasonable Efforts to cooperate Party, at the other Party’s expense, 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. 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 assistance in connection with a Remedial Action shall as may be borne reasonably requested by the Party whose acts or omissions caused or resulted in the necessity 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 incurredParty.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV Product any Licensed Product(s) may be subject to any recall, corrective action or other regulatory action (other than a corrective and preventive action (“CAPA”) under the Act,) worldwide, with respect to such product taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment Applicable Law (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided that ▇▇▇▇▇▇ 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 A1PI IV Product. Each Party will, and will ensure that its Affiliates and Sublicensees will, maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the manufacture, distribution and use (to the extent possible) of such productthe Licensed Product(s). As between the Parties, Zai Lab will have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product(s) in the Zai Lab Territory and INCY will have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product(s) in the INCY Territory. In the event the BLA that a Party determines that any Remedial Action with respect to the A1PI IV Product Licensed Product(s) in its Territory should be commenced, or if Remedial Action is required by any governmental authority Regulatory Authority having jurisdiction over the mattermatter in its Territory, the BLA such Party shall use Commercially Reasonable Efforts will control and coordinate all efforts necessary 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 ▇▇▇▇▇▇ shall and will 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 ▇▇▇▇▇▇. 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 necessity 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 such Remedial Action in its territory; provided, however, that (a) if such Remedial Action in the other Zai Lab Territory is attributable to any inaction or action of INCY, any of its Affiliates, or a Third Party that on behalf of INCY or any of its Affiliates, then INCY will be responsible for all cost and expense of such Remedial Action in the Zai Lab Territory, and (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 or and expense has been incurredof such Remedial Action in the INCY Territory.

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV any Licensed Product may be subject to any a recall, corrective action action, or other regulatory action (other than a corrective and preventive action (“CAPA”) under the Act,) worldwide, taken either by virtue of applicable federal, state, foreign any governmental authority or other law or regulation or good business judgment Regulatory Authority (a “Remedial Action”) (as to Verastem’s notification obligation, only to the extent it would reasonably be expected to affect the Retained Territory). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting Remedial Action; provided that ▇▇▇▇▇▇ shall have sole responsibility for collecting information from its customers, including customer complaints. The BLA Party shall determine whether to commence any a Remedial Action with respect to the A1PI IV Productapplicable territory, and otherwise reasonably cooperate with each other with respect to such Remedial Action or potential Remedial Action. Each Party Verastem will maintain adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product have sole discretion and the distribution final decision- making authority with respect to, and use of such product. In the event the BLA Party determines that control over, any Remedial Action with respect in the Territory, including any decision to the A1PI IV Product should be commenced, or commence such Remedial Action is required by any governmental authority having jurisdiction over in the matterTerritory, the BLA Party shall use Commercially Reasonable Efforts to conduct and will bear all costs of such Remedial Action. The other Party shall use Commercially Reasonable Efforts GenFleet will have sole discretion and final decision-making authority with respect to, and control over, any Remedial Action in the Retained Territory, including any decision to cooperate with such Party in implementing any commence such Remedial Action to in the extent Retained Territory, and will bear all costs of such cooperation is necessary to effect the Remedial Action. The BLA Party shall have sole responsibility Notwithstanding the foregoing, if the need for handling a Remedial Action arises as a result of any CAPAs in gross negligence or breach of a reasonable manner; provided that ▇▇▇▇▇▇ shall be responsible for handling and shall bear Supply Agreement by or on behalf of GenFleet or its Affiliates, then all costs and expenses related to field corrections to the extent caused by the acts or omissions of ▇▇▇▇▇▇. 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 such Remedial Action shall be borne by (including costs of notification, destruction, and return of the Party whose acts or omissions caused or resulted in the necessity affected Licensed Product and any refund to customers of amounts paid for such Remedial ActionLicensed Product) will be the sole responsibility of GenFleet. The Parties’ rights and obligations under the Pharmacovigilance Agreement, Supply Agreements, 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 incurredquality agreements will be consistent with this Section 6.8 (Remedial Actions).

Remedial Actions. (a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV any Licensed 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 virtue of applicable federal, state, foreign or other law or regulation or good business judgment Laws (a “Remedial Action”). [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action; provided . Launxp International shall, and shall ensure that ▇▇▇▇▇▇ shall have sole responsibility for collecting information from its customersAffiliates and permitted Sublicensees will, including customer complaints. The BLA Party shall determine whether to commence any Remedial Action with respect to the A1PI IV Product. Each Party will maintain adequate records to permit the Parties to trace the manufacture packaging, labeling, distribution, sale and use (to the extent possible) of the applicable A1PI IV Licensed Product in the Launxp Territory. Apollomics shall, and shall ensure that its Affiliates 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. Launxp International shall have sole discretion with respect to any matters relating to any Remedial Action in the Launxp Territory, including the decision to commence such Remedial Action and the distribution control over such Remedial Action in its territory, at its cost and use of such product. In the event the BLA Party expense; provided, however, if Apollomics determines in good faith that any Remedial Action with respect to any Licensed Product in the A1PI IV Product Launxp Territory should be commencedcommenced or is required by applicable Laws or Regulatory Authority, (a) Apollomics shall discuss such Remedial Action with Launxp International and (b) Launxp International shall carry out such Remedial Action upon Apollomics’s request. Notwithstanding anything to the contrary in clause (b) above, if Launxp International 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 at Apollomics’s cost; provided that, if a Regulatory Authority later determines that such Remedial Action is required by any governmental authority having jurisdiction over the matterrequired, the BLA Launxp International shall reimburse Apollomics such costs. Each Party shall use Commercially Reasonable Efforts to conduct such Remedial Action. The provide the other Party shall use Commercially Reasonable Efforts to cooperate Party, at the other Party’s expense, 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇. 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 assistance in connection with a Remedial Action shall as may be borne reasonably requested by the Party whose acts or omissions caused or resulted in the necessity 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 incurredParty.