Common use of Adverse Event Reporting and Safety Data Exchange Clause in Contracts

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA in the U.S. to AstraZeneca, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) that the Parties shall employ with respect to Products to protect patient safety and promote the appropriate treatment of safety information of Products in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen shall maintain a global safety database for the Products, the expenses for which will be included in Development Costs and reimbursed by AstraZeneca, to the extent not borne or reimbursed by Astellas. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of (i) the commencement of any Clinical Trial or any other activities that would generate safety data required to be reported to Regulatory Authorities that are conducted by AstraZeneca or (ii) the transfer of the first NDA in the U.S. to AstraZeneca, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreedAgreements) that the Parties shall employ with respect to Products and to Probe Compounds independently Developed and Commercialized by FibroGen China to protect patient safety and promote the appropriate treatment of safety information of Products such products in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Productsuch product in the Territory. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen China shall maintain a global safety database for the ProductsProducts in the Territory, the expenses for which will be included in Development Costs Costs. FibroGen China shall be responsible for reporting quality complaints, adverse events and reimbursed by AstraZenecasafety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the extent not borne or reimbursed by AstellasTerritory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees Sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer Following ITI’s exercise of the first NDA in the U.S. Co-Promotion Option pursuant to AstraZenecaSection 6.4, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) that the Parties shall employ with respect to Products to protect patient safety and promote the appropriate treatment of safety information of Products the Co-Promotion Product in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Co-Promotion Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen Takeda shall maintain a global safety an adverse event database for the Products in the Territory, at Takeda’s expense. With respect to all Products that are not Co-Promotion Products, the expenses Parties will discuss and finalize the methods and procedure to exchange safety information (AE and SAE) for which will be included in Development Costs and reimbursed by AstraZenecasuch Products at reasonable timing after the Effective Date, to satisfy ITI’s reasonable needs for such safety information. Takeda shall be responsible for reporting quality complaints, adverse events and safety data related to Products to applicable Regulatory Authorities in the extent not borne or reimbursed by AstellasTerritory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Territory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At No later than [***] before the Initiation of a time determined by the JSC, but in any event prior Clinical Trial with respect to the first to occur of (i) the commencement Development of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA Licensed Product in the U.S. to AstraZenecaKaken Territory, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products such Licensed Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”)) for the Development of the Licensed Product globally. For clarityFurther, no later than [***] before the anticipated launch date of any Licensed Product in the Kaken Territory, the Parties shall enter into a separate Pharmacovigilance Agreement shall include all relevant safety data regarding for the Commercialization of the Licensed Product, irrespective . Each of territory or indication. These responsibilities the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordationrecording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any the Licensed Product, and other routine pharmacovigilance reporting requirements. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain provide for an adverse event database for the Licensed Products in the Field in the Kaken Territory to be maintained by Kaken at Kaken’s expense, and a global safety database for the ProductsLicensed Products to be maintained by Spruce at Spruce’s expense. As between the Parties, Kaken shall be responsible for preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the expenses Field in the Kaken Territory, and Kaken shall be responsible for which will filing such reports and responses with Regulatory Authorities in the Kaken Territory. As between the Parties, Kaken shall also be included responsible for reporting any quality complaints, adverse events and safety data related to Licensed Products in Development Costs and reimbursed by AstraZeneca, the Field in the Kaken Territory to Spruce for inclusion in the extent not borne or reimbursed by Astellasglobal safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees Sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of No later than * (i*) days before the commencement of an additional clinical study with respect to Development of any Clinical Trial to be conducted Licensed Product by AstraZeneca or (ii) the transfer of the first NDA Luoxin in the U.S. to AstraZenecaLuoxin Territory, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products such Licensed Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”)) for the Development of the Licensed Product. For clarityFurther, no later than * (*) days before the anticipated launch date of any Licensed Product in the Luoxin Territory, the Parties shall enter into a separate Pharmacovigilance Agreement shall include all relevant safety data regarding for the Commercialization of the Licensed Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any the Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain provide for an adverse event database for the Licensed Products in the Luoxin Territory to be maintained by Luoxin at Luoxin’s expense, and a global safety database for the Licensed Products, to be maintained by Synergy at Synergy’s expense. As between the expenses Parties, each Party shall be responsible for which will preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in their respective territories, and shall be included responsible for filing such reports and responses with Regulatory Authorities in Development Costs their respective territories. As between the Parties, Luoxin shall also be responsible for reporting any quality complaints, adverse events and reimbursed by AstraZeneca, safety data related to Licensed Products to Synergy for inclusion in the extent not borne or reimbursed by Astellasglobal safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a time determined by (a) Within ninety (90) days after the JSC, but in any event prior to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA in the U.S. to AstraZenecaEffective Date, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products a Licensed Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. FibroGen GSK shall maintain be responsible for reporting quality complaints, adverse events and safety data related to a global Licensed Product to applicable Regulatory Authorities in the Licensed Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to a Licensed Product in the Licensed Territory. The Pharmacovigilance Agreement shall also provide for a worldwide safety database to be maintained by GSK at its cost. GSK shall provide Impax with information from the safety database in a manner that is sufficient for the ProductsImpax to comply with applicable Laws, the expenses for which will be included in Development Costs and reimbursed by AstraZeneca, including Impax’s obligation to the extent not borne report to Regulatory Authorities or reimbursed by Astellasto respond to regulatory requests. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At No later than ninety (90) days before the Initiation of a time determined by the JSC, but in any event prior Clinical Trial with respect to the first to occur of (i) the commencement Development of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA Product in the U.S. to AstraZenecaAdvaccine Territory, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products such Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”)) for the Development of the Product globally. For clarityFurther, no later than one hundred and eighty (180) days before the anticipated launch date of any Product in the Advaccine Territory, the Parties shall enter into a separate Pharmacovigilance Agreement shall include all relevant safety data regarding for the Commercialization of the Product, irrespective . Each of territory or indication. These responsibilities the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordationrecording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any the Product, and other routine pharmacovigilance reporting requirements. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain provide for an adverse event database for the Products in the Field in the Advaccine Territory to be maintained by Advaccine at Advaccine’s expense, and a global safety database for the ProductsProducts to be maintained by Inovio at Inovio’s expense. As between the Parties, the expenses Advaccine shall be responsible for which will be included in Development Costs preparing all adverse event reports and reimbursed by AstraZeneca, responses to safety issues and requests of Regulatory Authorities relating to the extent not borne or reimbursed by AstellasProducts in the Field in the Advaccine Territory, and Advaccine shall be responsible for filing such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED reports and responses with Regulatory Authorities in the Advaccine Territory. As between the Parties, Advaccine shall also be responsible for reporting any quality complaints, adverse events and safety data related to the Products in the Field in the Advaccine Territory to Inovio for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees Sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At Before the Initiation of a time determined by the JSC, but in any event prior Clinical Trial with respect to the first to occur of (i) the commencement Development of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA Product in the U.S. to AstraZenecaAdvaccine Territory by or on behalf of Advaccine, the Parties shall enter into or amend the then current pharmacovigilance agreement to define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products such Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”)) for the Development of the Product globally. For clarityFurther, unless otherwise agreed by the JSC, no later than sixty (60) days before the anticipated launch date of any Product in the Advaccine Territory, the Parties shall enter into a separate Pharmacovigilance Agreement shall include all relevant safety data regarding for the Commercialization of the Product, irrespective . Each of territory or indication. These responsibilities the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordationrecording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any the Product, and other routine pharmacovigilance reporting requirements. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain provide for an adverse event database for the Products in the Field in the Advaccine Territory to be maintained by Advaccine at Advaccine’s expense, and a global safety database for the ProductsProducts to be maintained by Inovio at Inovio’s expense. As between the Parties, the expenses Advaccine shall be responsible for which will be included in Development Costs preparing all adverse event reports and reimbursed by AstraZeneca, responses to safety issues and requests of Regulatory Authorities relating to the extent not borne or reimbursed by AstellasProducts in the Field in the Advaccine Territory, and Advaccine shall be responsible for filing such reports and responses with Regulatory Authorities in the Advaccine Territory. As between the Parties, Advaccine shall also be responsible for reporting any quality complaints, adverse events and safety data related to the Products in the Field in the Advaccine Territory to Inovio for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees Sublicensees to comply with such obligations. If and Notwithstanding the foregoing to the extent necessarycontrary, Inovio shall be responsible for the pharmacovigilance activities in the Advaccine Territory (other than Greater China) in connection with the Global Phase 3 Study, provided however that, a copy of any pharmacovigilance-related filings or reporting for the Global Phase 3 Study shall be provided to Advaccine for review and comment pursuant to the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a ProductAgreement.

Adverse Event Reporting and Safety Data Exchange. At a time determined by (a) Under the JSCImportation Paradigm, but the Licensor shall be the responsible party for the applicable post marketing surveillance and vigilance obligation of the Imported Products in any event prior the Territory, in all cases with assistance from Licensee, and to the first extent permitted by and subject to occur the Applicable Law, Licensee shall act as Licensor’s authorized Person (i.e. the domestic agent of (iLicensor) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA in the U.S. to AstraZeneca, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) that the Parties shall employ implement specific vigilance obligations with respect to Products to protect patient safety and promote the appropriate treatment of safety information of Imported Products in a written pharmacovigilance agreement (the “Pharmacovigilance Territory in accordance with the Applicable Law and this Agreement”). For claritythe avoidance of doubt, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product. Such guidelines and procedures Licensor shall be in accordance withresponsible for Products’ post marketing surveillance and vigilance activities, including maintaining the global and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen shall maintain a global safety database for the Products, at Licensor’s expense, and Licensee shall be responsible for Imported Products vigilance activities as reasonably requested by Licensor, subject to Applicable Law and this Agreement, in the Territory at Licensor’s expense. Each Party shall bear its own Personnel expenses in the manner provided for which will in the last paragraph of Article 4.6. Licensor shall be included in Development Costs responsible to, upon Licensee’s request, for the purpose of compliance with Applicable Law, promptly provide relevant information on Imported Product vigilance, vigilance training and reimbursed by AstraZenecarisk analysis reporting, and relevant post approval development or regulatory data with respect to the Imported Product, in each case in a timely manner in accordance with the Applicable Law and requirements of Regulatory Authorities. Furthermore, Licensor will bear all costs of post-marketing surveillance for the Imported Products required by Applicable Laws in the Territory. To the extent not borne required under and in accordance with this Agreement and Applicable Law, Licensee shall also be responsible for reporting adverse events and safety data related to the Imported Products to Licensor for inclusion in the global safety database and Licensor shall be responsible for reporting adverse events and safety data related to the Imported Products out of the Territory to Licensee for Licensee’s information upon the occurrence of such adverse events. Licensor shall be responsible for global vigilance risk management with respect to the Imported Product, and shall promptly notify Licensee in writing of any change in Imported Product safety risk characteristics, or reimbursed by AstellasImported Product recall due to safety reasons, etc., and perform its due diligence as the holder of Regulatory Approval of the Imported Products. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance this Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If CONFIDENTIAL License and to Distribution Agreement between Axxxxxx and Zylox For those costs arising out of adverse events and recall which are caused by or arise out of the extent necessaryquality of the Imported Products as supplied by Licensor, the Pharmacovigilance Agreement Licensor shall be amended bear such costs incurred. For those costs arising out of adverse events and recall which are caused by the Partiesacts or omissions of Licensee, or Licensee shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Productbear such costs incurred.

Adverse Event Reporting and Safety Data Exchange. At a time determined No later than thirty (30) days after the delivery by the JSC, but in any event prior Aradigm to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer Grifols of the first NDA in the U.S. to AstraZenecaPhase III Report, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) that the Parties shall employ with respect to Products to protect patient safety and promote the appropriate treatment of safety information of Products in enter into a written commercially reasonable pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the The Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable customary guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Aradigm Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelinesguidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain a global safety provide for an adverse event database for Aradigm Products in the ProductsTerritory to be maintained by Grifols at Grifols’ expense. Grifols shall be responsible for reporting quality complaints, adverse events and safety data related to Aradigm Products to applicable Regulatory Authorities in the expenses for which will be included Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Aradigm Products in Development Costs the Territory. Aradigm shall provide Grifols with all reasonable assistance and reimbursed by AstraZenecacooperation, to at Grifols’ request and expense, in connection with the extent not borne or reimbursed by Astellasmaintenance of the adverse events database and all of the foregoing reporting and response requirements. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of (i) No later than [***] before the commencement of any a Clinical Trial to be conducted of any Licensed Product by AstraZeneca or (ii) the transfer of the first NDA Hansoh in the U.S. to AstraZenecaHansoh Territory, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products such Licensed Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”)) for the Development of the Licensed Product. For clarityFurther, no later than [***] before the anticipated launch date of any Licensed Product in the Hansoh Territory, the Parties shall enter into a separate Pharmacovigilance Agreement shall include all relevant safety data regarding for the Commercialization of such Licensed Product, irrespective of territory or indication. These responsibilities shall include the applicable terms of this Section 5.8 and other mutually acceptable guidelines and procedures for the receipt, investigation, recordationrecording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any the Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national fulfill all regulatory reporting obligations under applicable laws and regulationsApplicable Law. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain require each Party to report any serious related and unexpected adverse event to the other Party or its designee within [***] of becoming aware of such event and shall provide for an adverse event database for the Licensed Products in the Hansoh Territory to be maintained [***], and a global safety database for the Licensed Products, [***]. As between the expenses Parties, Hansoh shall be responsible for which will preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the Hansoh Territory, and Keros shall be included responsible for filing such reports and responses with Regulatory Authorities in Development Costs the Keros Territory. As between the Parties, Hansoh shall also be responsible for reporting any quality complaints, adverse events and reimbursed by AstraZeneca, safety data related to Licensed Products to Keros for inclusion in the extent not borne or reimbursed by Astellasglobal safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a time determined by No later than [*] days before the JSC, but in any event prior to the first to occur of (i) the commencement anticipated launch date of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA Licensed Product in the U.S. to AstraZenecaCollaboration Territory, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) that the Parties shall employ with respect to Products to protect patient safety and promote the appropriate treatment of safety information of Products in enter into a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, ) for the Pharmacovigilance Agreement shall include all relevant safety data regarding Commercialization of the Licensed Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (exchange, as between the Parties) , of adverse event reports, pregnancy reports, and any other information concerning the safety of any the Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain provide for an adverse event database for the Licensed Products in the Collaboration Territory to be maintained by KVK at KVK’s expense, and also a global safety database for the ProductsLicensed Products to be maintained by KemPharm at KemPharm’s expense. As between the Parties, KVK shall be responsible for preparing and filing with Regulatory Authorities in the expenses Collaboration Territory all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the Collaboration Territory. As between the Parties, KVK shall also be responsible for which will be included reporting quality complaints, adverse events and safety data related to Licensed Products to KemPharm for inclusion in Development Costs and reimbursed by AstraZeneca, to the extent not borne or reimbursed by Astellasglobal safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At Within [***] the anticipated launch of a time determined by the JSC, but in any event prior to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA Product in the U.S. to AstraZenecaLicensed Territory, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products such Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any such Product’s safety. Such guidelines and procedures shall will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulationsLaws. Furthermore, such agreed procedure shall will be consistent with GCP and relevant ICH guidelinesGuidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen Licensee shall report quality complaints, adverse events and safety data related to such Product in the Field to applicable Regulatory Authorities in the Licensed Territory, and shall respond to safety issues and to all requests of Regulatory Authorities relating to such Product in the Field in the Licensed Territory. Licensor shall maintain a global worldwide safety database for the Products, the expenses for which will be included in Development Costs and reimbursed by AstraZeneca, pursuant to the extent not borne or reimbursed by Astellasterms of the Pharmacovigilance Agreement. Each Party hereby agrees to shall comply with its respective obligations under such the Pharmacovigilance Agreement and to shall cause its Affiliates and permitted sublicensees Sublicensees to comply with such obligations. If Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 under the extent necessaryExchange Act of 1934, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.as amended. Confidential Portions are marked: [***]

Adverse Event Reporting and Safety Data Exchange. At a time determined The Parties agree that each Party will be responsible for the monitoring of all clinical experiences for any clinical trial it conducts. AMAG will be responsible for maintaining the global safety database and filing all required reports for the Product to Regulatory Authorities outside the Licensed Territory throughout the Development of the Product. Takeda will be responsible for filing all required reports for the Product to the Regulatory Authorities in the Licensed Territory throughout the Development of the Product, and if AMAG is the Regulatory Lead, AMAG shall cooperate with Takeda as necessary for Takeda to comply with applicable regulatory requirements. Each Party shall have the right to review all such information and reports prepared or maintained by the JSCother Party at reasonable times, but upon prior written request. The Parties shall cooperate to develop methods and/or procedures for sharing safety information relating to such clinical experiences in any event prior to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer accordance with safety reporting requirements of the first NDA in the U.S. respective Regulatory Authorities and as necessary for a Party to AstraZenecacomply with applicable Laws. In connection with such discussions, the Parties shall define may convene any joint working groups in the subject matter to provide recommendations to the Parties. Specific details regarding the sharing and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) that the Parties shall employ with respect to Products to protect patient safety and promote the appropriate treatment management of safety information of Products adverse events related to the Development and the Commercialization of the Product both within and outside the Licensed Territory will be delineated in a written separate pharmacovigilance and safety data exchange agreement (the “Pharmacovigilance Agreement”)) that shall be agreed to by the Parties by the earlier of three (3) months after the Effective Date or one (1) month from the IND. For clarityUntil the Pharmacovigilance Agreement is signed, AMAG shall provide Takeda with AMAG’s quarterly summary, when prepared by AMAG, of AMAG’s monitoring of all clinical experiences for trials of the Products, and such additional related details as reasonably requested by Takeda to evaluate the information contained in the summary. The Parties agree that the Pharmacovigilance Agreement shall include all relevant set forth the procedures by which each Party shall report and maintain safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communicationprescription events monitoring, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, contain customary terms for such agreed procedure shall be consistent with GCP and relevant an agreement no less stringent than those required by ICH guidelines, except where such guidelines may conflict with existing applicable Laws and applicable local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen shall maintain a global safety database for the Products, the expenses for which will be included in Development Costs and reimbursed by AstraZeneca, to the extent not borne or reimbursed by Astellas. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA in the U.S. to AstraZeneca, the The Parties shall define have defined and finalize finalized the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreedAgreements) that the Parties shall employ with respect to Products and to Probe Compounds independently Developed, Manufactured, and Commercialized by FibroGen China to protect patient safety and promote the appropriate treatment of safety information of Products such products in a written pharmacovigilance agreement agreement, effective July 8, 2014, between AstraZeneca on the one hand and FibroGen WFOE and FibroGen, Inc. on the other hand (such agreement, as amended to date, the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Productsuch product in the Territory. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen China shall maintain a global safety database for the ProductsProducts in the Territory, the expenses for which will be included in Development Costs Costs. FibroGen China shall be responsible for reporting quality complaints, adverse events and reimbursed by AstraZenecasafety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the extent not borne or reimbursed by AstellasTerritory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees Sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.

Adverse Event Reporting and Safety Data Exchange. At a Within such time determined period as may be agreed upon by the JSCParties, but in any event prior to the first to occur of (i) the commencement Licensee’s performance of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer clinical study of the first NDA in the U.S. to AstraZenecaProduct, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to the Products to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For claritythe avoidance of doubt, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product. Such guidelines and procedures Licensor shall be in accordance withresponsible for global pharmacovigilance activities, and enable including maintaining the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen shall maintain a global safety database for the Products, at Licensor’s expense, and Licensee shall be responsible for local pharmacovigilance activities in the expenses Territory at Licensee’s expense. Furthermore, Licensee will bear all costs of post-marketing surveillance for which will the Products required by Applicable Laws in the Territory. To the extent required under and in accordance with the Pharmacovigilance Agreement, Licensee shall also be included in Development Costs responsible for reporting adverse events and reimbursed by AstraZeneca, safety data related to the extent not borne or reimbursed by AstellasProducts to Licensor for inclusion in the global safety database and Licensor shall be responsible for reporting adverse events and safety data related to the Products to Licensee for Licensee’s information. Each Party hereby agrees to comply with its respective obligations under such the Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If L icensor’s assistance. As required by the applicable regulatory authority in the Territory, Licensor shall (i) provide reference and retention samples as required by Licensee free of charge; (ii) provide CMS with all necessary assistance for the purpose of regulatory activities with respect to the extent necessaryproducts for and in the Territory, including designated specially-assigned person to discuss and make recommendations to the Pharmacovigilance Agreement shall be amended by regulatory strategies and plans with respect to the Products. COMMERCIALIZATION Overview . Subject to the terms and conditions of this Agreement, Licensee will have the right to Commercialize the Products in the Territory in its own or Designated Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance ’ name with full control and discretion over all aspects of the first NDA approval for Commercialization of Products in the Field in the Territory in compliance with the Applicable Laws, including with respect to each Product: (a) developing and executing a Productcommercial launch, (b) negotiating with applicable Governmental Authorities regarding product pricing and reimbursement status of the Products; (c) marketing, advertising, promotion, tendering, bidding and hospital listing; (d) booking sales, distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) determining pricing and terms of sale of Products; (g) providing customer support, including handling medical queries, and performing other related functions; and (h) conforming its practices and procedures to Applicable Laws relating to the marketing, detailing and promotion of the Products in the Field in the Territory. Licensee shall bear all of the costs and expenses incurred in connection with such Commercialization activities.

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of (i) No later than [***] before the commencement of a clinical study with respect to Development of any Clinical Trial to be conducted Licensed Product by AstraZeneca or (ii) the transfer of the first NDA Apollomics in the U.S. to AstraZenecaApollomics Territory, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) actions that the Parties shall employ with respect to Products such Licensed Product to protect patient safety patients and promote the appropriate treatment of safety information of Products their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”)) for the Development of the Licensed Product. For clarityFurther, no later than [***] before the anticipated launch date of any Licensed Product in the Apollomics Territory, the Parties shall enter into a separate Pharmacovigilance Agreement shall include all relevant safety data regarding for the Commercialization of the Licensed Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordationrecording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any the Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national fulfill all regulatory reporting obligations under applicable laws and regulationsApplicable Law. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. FibroGen The Pharmacovigilance Agreement shall maintain provide for an adverse event database for the Licensed Products in the Apollomics Territory to be maintained by Apollomics at Apollomics’ expense, and a global safety database for the Licensed Products, to be maintained by GlycoMimetics at GlycoMimetics’ expense. As between the expenses Parties, Apollomics shall be responsible for which will preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the Apollomics Territory, and Apollomics shall be included responsible for filing such reports and responses with Regulatory Authorities in Development Costs the Apollomics Territory. As between the Parties, Apollomics shall also be responsible for reporting any quality complaints, adverse events and reimbursed by AstraZeneca, safety data related to Licensed Products to GlycoMimetics for inclusion in the extent not borne or reimbursed by Astellasglobal safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.