Common use of Adverse Events Reporting Clause in Contracts

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] thereafter, Zai and Entasis shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, or Sublicensees to comply with its legal obligations. The Safety Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates and Sublicensees to comply with such obligations. (b) Zai shall maintain an Adverse Event database for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply with all Applicable Laws governing Adverse Events in its respective territory, and shall notify the other Party on a timely basis of any Adverse Events occurring in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] ninety (90) days thereafter, Zai and Entasis ▇▇▇▇▇▇▇▇ shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.9, Section 6.10, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territorythe Territory for all Clinical Trials performed by Zai, including the Local Studies and Joint Global Studies, and ▇▇▇▇▇▇▇▇ shall notify be responsible for complying with all Applicable Laws covering Adverse Events (i) in the other Party on a timely basis Territory for all Clinical Trials performed by ▇▇▇▇▇▇▇▇ for the Global Studies that Zai does not participate in and (ii) outside the Territory for all Clinical Trials. (c) ▇▇▇▇▇▇▇▇ shall hold and control the global safety database for all Products and for the exchange by the Parties in English of any Adverse Events occurring in its respective territory. Each information which a Party shall submit copies becomes aware of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in concerning any event within twenty-four (24) hours of receiving any serious Adverse Event reports experienced by a subject or patient being administered any Product, including any such information received by either Party from Clinical Trials any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees shall have the right to disclose such information if such disclosure is monitoring, notice from a reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] 60 days thereafter, Zai and Entasis shall Paratek will develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement shall will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Agreement shall will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.4, Section 6.5, or any related definitions and the Safety Agreement, the Safety Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall will maintain an Adverse Event database for the Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report and will be responsible for reporting quality complaints, Adverse Events and safety data related to the Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in the Territory. Zai shall will provide to Entasis Paratek access to to, and the information contained in, Zai’s Adverse Event database for the Territory. Entasis shall , and Paratek will maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply Zai will be responsible for complying with all Applicable Laws Law governing Adverse Events in its respective territory, and shall the Territory that occur after the Effective Date. Zai will notify the other Party Paratek on a timely basis of any Adverse Events occurring in its respective territoryat or reported by any Clinical Trial location at which Zai is responsible for performing Clinical Trials. Each Party shall Zai will submit copies of reports of Adverse Events to the other Party Paratek simultaneously with submission to the applicable Regulatory Authorities. Each Party shall will notify the other in a timely manner and in any event within twenty-four (24) 24 hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial clinical trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed ProductsProduct. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] one hundred eighty (180) days thereafter, Zai Licensee and Entasis Licensor shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirementsApplicable Law. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. (b) Zai Licensee shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territorythe Licensee Territory, and Licensor shall notify be responsible for complying with all Applicable Laws covering Adverse Events in the other Party on a timely basis Licensor Territory. (c) Licensor shall hold and control the global safety database for all Products and for the exchange by the Parties in English of any information which a Party becomes aware of concerning any Adverse Events occurring in its respective territoryEvent experienced by a subject or patient being administered any Product, including any such information received by either Party from any Third Party (subject to receipt of any required consents from such Third Party). Each Party and its Affiliates, licensees and sublicensees shall submit copies have the right to disclose such information if such disclosure is reasonably necessary to comply with Applicable Laws or requirements of reports of Adverse Events to the other Party simultaneously with submission to the any applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] one hundred eighty (180) days thereafter, Zai Licensee and Entasis Licensor shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees, or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirementsApplicable Law. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. (b) Zai Licensee shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territorythe Licensee Territory, and Licensor shall notify be responsible for complying with all Applicable Laws covering Adverse Events in the other Party on a timely basis Licensor Territory. (c) Licensor shall hold and control the global safety database for all Products and for the exchange by the Parties in English of any information which a Party becomes aware of concerning any Adverse Events occurring in its respective territoryEvent experienced by a subject or patient being administered any Product, including any such information received by either Party from any Third Party (subject to receipt of any required consents from such Third Party). Each Party and its Affiliates, licensees and sublicensees shall submit copies have the right to disclose such information if such disclosure is reasonably necessary to comply with Applicable Laws or requirements of reports of Adverse Events to the other Party simultaneously with submission to the any applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. TenX, on behalf of itself and any permitted sublicensees, shall advise Genmab within three (a3) Promptly following Business Days after TenX or its sublicensees become aware of any serious or unexpected side effects, injury, toxicity or sensitivity reaction, or any unexpected incidence, and the Effective Dateseverity thereof, but in no event later than [*] thereafter, Zai associated with the Development and Entasis shall develop and agree Commercialization of a Product that relates to the worldwide safety Retained Field or could likely relate to the Retained Field (collectively, “TenX Adverse Events”). Genmab shall advise TenX within three (3) Business Days after Genmab becomes aware of any serious or unexpected side effects, injury, toxicity or sensitivity reaction, or any unexpected incidence, and pharmacovigilance procedures for the Parties severity thereof, associated with its Development and Commercialization of any product that relates to or could likely relate to the Licensed Technology (collectively, “Genmab Adverse Events;” and together with TenX Adverse Events, “Adverse Events”). The Party reporting an Adverse Event shall provide the other Party with a written report delivered by overnight mail in regards to an Adverse Event, stating the full facts known to the Party reporting an Adverse Event, including investigator name, site details, customer name, address, telephone number, batch, lot and serial numbers (each, as applicable) and any other information required by Law. In the event that the non-reporting Party requires information regarding Adverse Events with respect to Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring reports required to be filed by it in a written agreement (the “Safety Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, or Sublicensees order to comply with its legal obligations. The Safety Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates and Sublicensees to comply with such obligations. (b) Zai shall maintain an Adverse Event database for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable applicable Laws, shall including obligations to report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply with all Applicable Laws governing Adverse Events in its respective territory, and shall notify the other Party on a timely basis of any Adverse Events occurring in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Regulatory Authorities, subject to applicable Law, the Party simultaneously with submission reporting an Adverse Event agrees to use good faith efforts to promptly provide such information to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twentynon-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Productsreporting Party.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [***] days thereafter, Zai and Entasis TPTX shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.9, Section 6.10, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territorythe Territory for all Clinical Trials performed by Zai, including the Local Studies and Joint Global Studies, and TPTX shall notify be responsible for complying with all Applicable Laws covering Adverse Events (i) in the other Party on a timely basis Territory for all Clinical Trials performed by TPTX for the Global Studies that Zai does not participate in and (ii) outside the Territory for all Clinical Trials. (c) TPTX shall hold and control the global safety database for all Products and for the exchange by the Parties in English of any Adverse Events occurring in its respective territory. Each information which a Party shall submit copies becomes aware of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in concerning 92975109_3 243114426 v7 any event within twenty-four (24) hours of receiving any serious Adverse Event reports experienced by a subject or patient being administered any Product, including any such information received by either Party from Clinical Trials any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees shall have the right to disclose such information if such disclosure is monitoring, notice from a reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] 60 days thereafter, Zai and Entasis shall Paratek will develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement shall will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Agreement shall will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.4, Section 6.5, or any related definitions and the Safety Agreement, the Safety Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall will maintain an Adverse Event database for the Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report and will be responsible for reporting quality complaints, Adverse Events and safety data related to the Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in the Territory. Zai shall will provide to Entasis Paratek access to to, and the information contained in, Zai’s Adverse Event database for the Territory. Entasis shall , and Paratek will maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply Zai will be responsible for complying with all Applicable Laws Law governing Adverse Events in its respective territory, and shall the Territory that occur after the Effective Date. Zai will notify the other Party Paratek on a timely basis of any Adverse Events occurring in its respective territoryat or reported by any Clinical Trial location at which Zai is responsible for performing Clinical Trials. Each Party shall Zai will submit copies of reports of Adverse Events to the other Party Paratek simultaneously with submission to the applicable Regulatory Authorities. Each Party shall will notify the other in a timely manner and in any event within twenty-four (24) 24 hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial clinical trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed ProductsProduct.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than the earlier of (i) [***] thereafterfollowing the Effective Date and (ii) [***], Zai Licensee and Entasis G1 shall develop and agree to the worldwide upon written safety and pharmacovigilance procedures for the Parties with respect to Licensed ProductsProducts worldwide, such as safety data sharing and exchange, Adverse Events adverse events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement Pharmacovigilance Agreement shall describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting, reporting and exchange of information between the Parties concerning Adverse Events adverse events or any other safety problem issue of any significance, significance and product quality and product complaints involving Adverse Eventsadverse events, in each case with respect to Licensed Products and sufficient to permit each Party, Party and its Affiliates, or Third Party Licensees and Sublicensees to comply with its legal obligationsobligations with respect thereto and shall otherwise be on customary and reasonable terms for agreements of its type and consistent with the terms of this Agreement. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirementsApplicable Laws. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, Third Party Licensees and Sublicensees to comply with such obligations. (b) Zai Licensee shall maintain an Adverse Event the global adverse event database for the Licensed Compound and Licensed Products in the TerritoryField, at its sole cost and expense, and, [***]. Licensee shall be responsible for reporting to the extent required by Applicable Laws, shall report applicable Regulatory Authorities all quality complaints, Adverse Events adverse events and safety data related to Licensed Products to in the applicable Regulatory Authorities Field in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for Field in the Territory. Entasis ; provided that G1 shall maintain a global Adverse Event database at (or shall cause its sole cost Affiliates and expense, and shall provide Zai Third Party Licensee(s) to) [***] cooperate with information contained Licensee in performing such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetingsreporting obligations. (c) Each Party shall comply with all Applicable Laws governing Adverse Events in its respective territory, and shall notify the other Party on a timely basis of any Adverse Events occurring in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] thirty (30) days thereafter, Zai and Entasis Deciphera shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.4, Section 6.5, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territory, the Territory for all Clinical Trials performed by Zai and Deciphera shall notify the other Party on a timely basis of any be responsible for complying with all Applicable Laws covering Adverse Events occurring (i) in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Territory for all Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar performed by Deciphera ([***]) and (ii) outside the Territory for all Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed ProductsTrials.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] thereaftersixty (60) days before the commencement of a clinical study with respect to Development of any Licensed Product by Cutia in the Cutia Territory, Zai Cutia and Entasis Foamix shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement Safety Agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, or Sublicensees sublicensees to comply with its legal obligations. The Parties shall promptly update the Safety Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to shall comply with its respective obligations under the Safety Agreement and to cause its Affiliates and Sublicensees sublicensees to comply with such obligations. (b) Zai Cutia shall maintain an Adverse Event database for Licensed Products in the Cutia Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Cutia Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Cutia Territory. Zai Cutia shall provide to Entasis Foamix access to ZaiCutia’s Adverse Event database for the Cutia Territory. Entasis Foamix shall maintain a global Adverse Event database at its sole cost and expense, and and, except as prohibited by applicable Law, shall provide Zai Cutia with information contained in such global 222330578 v11 Adverse Event database at JDC meetings, provided, that Entasis Foamix shall promptly provide Zai Cutia with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply with all Applicable Laws governing Adverse Events in its respective territory, and shall notify the other Party on a timely basis of any Adverse Events occurring in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than […***…] days thereafter, Zai and Entasis TPTX shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.9, Section 6.10, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territorythe Territory for all Clinical Trials performed by Zai, including the Local Studies and Joint Global Studies, and TPTX shall notify be responsible for complying with all Applicable Laws covering Adverse Events (i) in the other Party on a timely basis Territory for all Clinical Trials performed by TPTX for the Global Studies that Zai does not participate in and (ii) outside the Territory for all Clinical Trials. (c) TPTX shall hold and control the global safety database for all Products and for the exchange by the Parties in English of any Adverse Events occurring in its respective territory. Each information which a Party shall submit copies becomes aware of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in concerning any event within twenty-four (24) hours of receiving any serious Adverse Event reports experienced by a subject or patient being administered any Product, including any such information received by either Party from Clinical Trials any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees shall have the right to disclose such information if such disclosure is monitoring, notice from a reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.. 231245765 v3

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] thirty (30) days thereafter, Zai and Entasis Deciphera shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.4, Section 6.5, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territory, the Territory for all Clinical Trials performed by Zai and Deciphera shall notify the other Party on a timely basis of any be responsible for complying with all Applicable Laws covering Adverse Events occurring (i) in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Territory for all Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar performed by Deciphera [***] and (ii) outside the Territory for all Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed ProductsTrials.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [*] thereafter, Zai TPTX and Entasis shall develop LaNova will generate and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Productsthe Product, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. (b) Zai shall maintain an Adverse Event database for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply will be responsible for complying with all Applicable Laws governing Adverse Events in its respective territoryfor all Clinical Trials performed by such Party, including the Local Studies, Global Studies, and shall notify [***]. (c) [***] will hold and control the other Party on a timely basis global safety database for the Product and for the exchange by the Parties, in English, of any Adverse Events occurring in its respective territory. Each information which a Party shall submit copies becomes aware of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in concerning any event within twenty-four (24) hours of receiving any serious Adverse Event reports experienced by a subject or patient being administered the Product, including any such information received by either Party from Clinical Trials any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees has the right to disclose such information if disclosure is monitoring, notice from a reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products. [***].

Adverse Events Reporting. (a) Promptly following the Effective DateLicensee, but in no event later than [*] thereafterits Affiliates and Permitted Sublicensees shall be solely responsible for collecting, Zai and Entasis shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement shall describe the coordination of collection, investigation, reportinginvestigating, and exchange of information concerning Adverse Events reporting any adverse events or any other safety problem issue of any significance, significance and product quality and product complaints involving Adverse Eventsadverse events, sufficient in each case with respect to permit each Party, its Affiliates, or Sublicensees to comply with its legal obligations. The Safety Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement Licensed Compound and to cause its Affiliates and Sublicensees to comply with such obligations. (b) Zai shall maintain an Adverse Event database for any Licensed Products Product in the Territory. Licensor or its Affiliates or their licensees shall be solely responsible for collecting, at its sole cost investigating, and expensereporting any adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, andin each case with respect to the Licensed Compound and any Licensed Product outside the Territory. At a Party’s request, the other Party shall promptly provide any of the above information to such other Party in writing and reasonably assist such other Party in completing any reporting obligations with respect to the Licensed Compound and Licensed Product pursuant to the Applicable Laws in the other Party’s Applicable Territory. Following the Effective Date, the Parties shall negotiate in good faith and enter into a separate pharmacovigilance agreement to further define the Parties’ responsibilities in data exchange, adverse event reporting and other pharmacovigilance matters in connection with the Licensed Compound and Licensed Product. The Party primarily responsible for causing such adverse event, other safety issue, product quality, or product complaints, to the extent required by Applicable Lawsassessable, shall report quality complaints, Adverse Events and safety data related to Licensed Products to bear the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expenseexpenses of the investigation, reporting, or other handling of the Licensed Compound or Licensed Product and if the causation of such adverse event, other safety issue, product quality, or product complaints cannot be reasonably assessed, each Party shall provide Zai with information contained be responsible for costs and expenses in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetingseach Party’s Applicable Territory. (c) Each Party shall comply with all Applicable Laws governing Adverse Events in its respective territory, and shall notify the other Party on a timely basis of any Adverse Events occurring in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than [***] days thereafter, Zai and Entasis TPTX shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.9, Section 6.10, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territorythe Territory for all Clinical Trials performed by Zai, including the Local Studies and Joint Global Studies, and TPTX shall notify be responsible for complying with all Applicable Laws covering Adverse Events (i) in the other Party on a timely basis Territory for all Clinical Trials performed by TPTX for the Global Studies that Zai does not participate in and (ii) outside the Territory for all Clinical Trials. (c) TPTX shall hold and control the global safety database for all Products and for the exchange by the Parties in English of any Adverse Events occurring in its respective territory. Each information which a Party shall submit copies becomes aware of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in concerning any event within twenty-four (24) hours of receiving any serious Adverse Event reports experienced by a subject or patient being administered any Product, including any such information received by either Party from Clinical Trials any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees shall have the right to disclose such information if such disclosure is monitoring, notice from a reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.

Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than […***…] days thereafter, Zai and Entasis TPTX shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Pharmacovigilance Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.9, Section 6.10, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (b) Zai shall maintain an Adverse Event database be responsible for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply complying with all Applicable Laws governing Adverse Events in its respective territorythe Territory for all Clinical Trials performed by Zai, including the Local Studies and Joint Global Studies, and TPTX shall notify be responsible for complying with all Applicable Laws covering Adverse Events (i) in the other Party on a timely basis Territory for all Clinical Trials performed by TPTX for the Global Studies that Zai does not participate in and (ii) outside the Territory for all Clinical Trials. (c) TPTX shall hold and control the global safety database for all Products and for the exchange by the Parties in English of any Adverse Events occurring in its respective territory. Each information which a Party shall submit copies becomes aware of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in concerning any event within twenty-four (24) hours of receiving any serious Adverse Event reports experienced by a subject or patient being administered any Product, including any such information received by either Party from Clinical Trials any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees shall have the right to disclose such information if such disclosure is monitoring, notice from a reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products.. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

Adverse Events Reporting. (ai) Promptly following Following the Effective Date, but in no event later less than [*] thereafterninety (90) days prior to the initiation of a Phase II Clinical Trial by either Newsoara or vTv, Zai Newsoara and Entasis shall vTv will develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement shall will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or Sublicensees sublicensees to comply with its legal obligations. The Safety Agreement shall will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates Affiliates, licensees and Sublicensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 5.2 or any related definitions and the Safety Agreement, the Safety Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters. (bii) Zai shall Each Party (and their respective sublicensees, to the extent applicable) will maintain an Adverse Event database for Licensed the Products in the TerritoryTerritory (in the case of Newsoara) or outside the Territory (in the case of vTv), at its such party’s sole cost and expense, and, to the extent required by Applicable Laws, shall report and will be responsible for reporting quality complaints, Adverse Events and safety data related to Licensed the Products to the applicable Regulatory Authorities in the TerritoryTerritory (in the case of Newsoara) or outside the Territory (in the case of vTv), as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed the Products in the TerritoryTerritory (in the case of Newsoara) or outside the Territory (in the case of vTv). Zai shall Each Party will provide to Entasis the other with access to Zaito, and the information contained in, such Party’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetingsdatabase. (ciii) Each Party shall comply will be responsible for complying with all Applicable applicable Laws governing Adverse Events in its respective territory, the Territory (in the case of Newsoara) and shall outside the Territory (in the case of vTv) that occur after the Effective Date. Each Party will notify the other Party on a timely basis of any Adverse Events occurring in its respective territoryat or reported by any clinical trial location at which such Party is responsible for performing clinical trials. Each The reporting Party shall will submit copies of reports of Adverse Events to the other non-reporting Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall will notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials clinical trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial clinical trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Productsany Product.