Common use of Adverse Events Reporting Clause in Contracts

Adverse Events Reporting. Prior to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Products, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party shall be responsible for reporting quality complaints, adverse events and safety data related to the Products to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Products in its territory, in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global safety database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 [***] Option is not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligations.

Adverse Events Reporting. Prior Within [***] after the Closing Date, but in no event later than any Regulatory Submission to be made by or on behalf of Jazz in the execution Territory to conduct a Clinical Trial or for Regulatory Approval of the Pharmacovigilance Agreement as described below for the applicable Licensed Product, MyoKardia Jazz and Zymeworks shall be responsible for handling product complaints for such Product develop and MyoKardia shall be solely responsible for all adverse event reporting with respect agree in a written agreement to the Compounds worldwide safety and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance SDEA Agreement”). Such procedures SDEA Agreement shall be in accordance with(a) describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local and national regulatory reporting licensees or sublicensees to comply with Applicable Laws and, with respect to Zymeworks, its obligations under to the Ex-Territory Partner; (b) be promptly updated if required by changes in Applicable Law. Each Party ; (c) provide that (i) Jazz shall maintain a safety database for Clinical Trials conducted in the Territory, other than those conducted under the Zymeworks Development Plan, at its sole cost and expense; (ii) Jazz shall be responsible for (A) reporting quality complaintsto the applicable Regulatory Authorities in the Territory, all required adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products Territory, other than those conducted under the Zymeworks Development Plan for which Zymeworks is required to the applicable Regulatory Authorities in its territory, as well as make such reports under Applicable Laws and (B) responding to safety issues and to all requests of Regulatory Authorities related to such safety issues with respect to the Licensed Products in its territorythe Field in the Territory, in each case at its own cost. The Pharmacovigilance Agreement ((A) and (B)), other than the Zymeworks Ongoing Studies, with respect to which Zymeworks will retain such responsibilities and will keep Jazz reasonably informed through the JSC and (C) making final decisions with respect to any safety governance issues with respect to the Licensed Products in the Territory after transfer of the First BLA by Zymeworks to Jazz (or, in the event Jazz initiates a Clinical Trial prior to the transfer of the First BLA by Zymeworks to Jazz, after such initiation); (iii) Jazz shall also provide to Zymeworks access to Jazz’s safety database for a the Licensed Product in the Territory; (iv) Zymeworks shall maintain the global safety database for the Licensed Products, including with respect to be established Clinical Trials conducted under the Zymeworks Development Plan; and maintained by Sanofi, and for MyoKardia to (v) Zymeworks will provide to Sanofi all Jazz with safety information obtained by MyoKardia for regarding the Licensed Products prior in accordance with the SDEA Agreement; and (d) use the definitions relating to Sanofi“adverse events” and “adverse drug experiences” as set forth in 21 C.F.R. 312.32 and 21 C.F.R. 314.80. Upon the earlier of completion of the Zymeworks Ongoing Studies and Zymeworks Korean Studies or Jazz’s establishment written request, the Parties will cooperate in good faith to transfer of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect for the Licensed Products to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 [***] Option is not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by Jazz[***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligations.[***]

Adverse Events Reporting. Prior (a) Promptly following the Effective Date, but in no event later than [***] thereafter, ▇▇▇ and ▇▇▇▇▇▇ shall develop and agree to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the ProductsLicensed Product, such as safety data sharingsharing and exchange, adverse events Adverse Events reporting and prescription events monitoring in a written agreement (the “Pharmacovigilance Agreement”). Such procedures 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 to comply with its legal obligations. The Pharmacovigilance Agreement shall be promptly updated if required by changes in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party shall be responsible for reporting quality complaints, adverse events and safety data related to the Products to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Products in its territory, in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global safety database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 [***] Option is not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and (Sub)licensees sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 5.8, Section 5.9, 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 be responsible for complying with all Applicable Laws governing Adverse Events in the Licensed Territory for all Clinical Trials performed by or on behalf of Zai, its Affiliates, Subcontractors and Sublicensees, including the Local Studies and Joint Global Studies, and ▇▇▇▇▇▇ shall be responsible for complying with all Applicable Laws covering Adverse Events (i) in the Licensed Territory for all Clinical Trials performed by or on behalf of Karuna, its Affiliates, Subcontractors and licensees for the Global Studies that ▇▇▇ does not participate in, and (ii) outside the Licensed Territory for all Clinical Trials. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED (c) Karuna shall hold and control the global safety database for all Licensed Product and for the exchange by the Parties in English of any information which a Party becomes aware of concerning any Adverse Event experienced by a subject or patient being administered the Licensed Product, including any such information received by either Party from 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 reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority.

Adverse Events Reporting. Prior Promptly following the Effective Date, but in no event later than […***…] thereafter, BeiGene and Zymeworks shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting 55 Competitive Information – Commercially Sensitive Terms. 56 Competitive Information – Commercially Sensitive Terms. 57 Competitive Information – Commercially Sensitive Terms. and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures Pharmacovigilance Agreement shall be in accordance with(a) describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local and national regulatory reporting licensees or sublicensees to comply with its legal obligations under with respect thereto; (b) be promptly updated if required by changes in Applicable Law. Each Party ; (c) provide that (i) BeiGene shall maintain an adverse event database for Clinical Trials conducted in the Territory under the Territory Development Plan and the Global Development Plan […***…]; (ii) BeiGene shall be responsible for (A) reporting to the applicable Regulatory Authorities in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the Global Development Plan, as well as responding (B) responding, to safety issues and to all requests of Regulatory Authorities related to the Products in its territory, in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global such safety database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) issues with respect to any HCM1 the Licensed Products in the Field in the Territory […***…]; (iii) BeiGene shall provide to Zymeworks access to BeiGene’s adverse event database for the Licensed Product and/or HCM2 Productin the Territory; (iv) Zymeworks shall maintain a global adverse event database for the Licensed Products, be shared equally by MyoKardia and Sanofi, except that such costs including with respect to Clinical Trials conducted under the Global Development Plan, at Zymeworks’ cost and expense, except for any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordinglycosts allocated to BeiGene pursuant to Section 5.4; and (bv) Zymeworks will provide BeiGene with respect to DCM1 Productsadverse event information regarding the Licensed Products in accordance with the PV Agreement; and (d) include the following definition of “adverse event”: any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment; an adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), if symptom, or disease temporally associated with the DCM1 [***] Option is use of a medicinal product, whether or not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, related to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligations.medicinal product.58

Adverse Events Reporting. Prior At least [*] prior to the execution of the Pharmacovigilance Agreement [*] Development [*] Development or as described below for the applicable Product, MyoKardia shall otherwise may be responsible for handling product complaints for such Product and MyoKardia shall be solely responsible for all adverse event reporting with respect required to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Partysatisfy regulatory requirements, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Collaboration Products, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Lawapplicable Laws. Each A Party responsible for the first Pivotal Registration Study for a Collaboration Product in any Collaboration Indication shall establish, prior to the Initiation of the first Pivotal Registration Study for the applicable Collaboration Product, the global safety database for the Collaboration Products, and shall maintain such global safety database for so long as such Collaboration Product is under Development and/or Commercialization hereunder. The [*] to the extent [*] such Collaboration Product for use in a Collaboration Indication. Until the First Commercial Sale of a Collaboration Product, such responsible Party shall be responsible hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Collaboration Products to such database and to the applicable Regulatory Authorities in its territoryAuthorities, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Products in its territoryCollaboration Products, in each case at its own cost[*] and to the extent required by the applicable Law. The Pharmacovigilance Agreement If each of the Parties is separately conducting Pivotal Registration Studies for the same Collaboration Product for the same Collaboration Indication, then Astellas shall also provide hold the primary responsibility for a establishing and maintaining the global safety database to be established for such Collaboration Product and maintained by Sanofireporting quality complaints, adverse events and safety data; provided however, that the [*]. After the First Commercial Sale of a Collaboration Product, Astellas shall hold primary responsibility for MyoKardia to provide to Sanofi all reporting quality complaints, adverse events and safety information obtained by MyoKardia data, except during the Cytokinetics Commercialization Period, in which case Cytokinetics shall hold primary responsibility for such activities [*], unless the Products prior to Sanofi’s establishment of Parties agree otherwise in writing. After the Cytokinetics Commercialization Period, Cytokinetics will transfer the global safety database. The costs data in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect Collaboration Product to DCM1 Products, if the DCM1 [***] Option is not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory requestAstellas. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and (Sub)licensees sublicensees to comply with such obligations.

Adverse Events Reporting. Prior (a) Promptly following the Effective Date, but in no event later than [***] days thereafter, Zai and NVCR shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Safety Agreement”). Such procedures Safety Agreement shall be in accordance withdescribe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local licensees or sublicensees to comply with its legal obligations with respect thereto, including, for clarity, NVCR’s obligations as the owner or holder of Regulatory Approvals and national regulatory reporting obligations Regulatory Submissions for the Licensed Product in the Territory, as applicable. (b) Zai shall maintain an adverse event database for Clinical Trials conducted in the Territory under Applicable Lawthe Territory Development Plan [***]. Each Party Zai shall be responsible for reporting to the applicable Regulatory Authorities in the Territory, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the Global Development Plan, as well as responding responding, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, the Field and in each case at its own costthe Territory. The Pharmacovigilance Agreement Zai shall also provide to NVCR access to Zai’s adverse event database for the Territory. NVCR shall maintain a global safety adverse event database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for Clinical Trials conducted under the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 Global Development Plan at [***] Option is not exercised, be at Sanofi’s cost and expense, and if the DCM1 except for any costs allocated to [***] Option is exercised, be deemed, pursuant to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligationsSection 5.5.

Adverse Events Reporting. Prior (a) Promptly following the Effective Date, but in no event later than [***] days thereafter, Zai and NVCR shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Safety Agreement”). Such procedures Safety Agreement shall be in accordance withdescribe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local licensees or sublicensees to comply with its legal obligations with respect thereto, including, for clarity, NVCR’s obligations as the owner or holder of Regulatory Approvals and national regulatory reporting obligations Regulatory Submissions for the Licensed Product in the Territory, as applicable. (b) Zai shall maintain an adverse event database for Clinical Trials conducted in the Territory under Applicable Lawthe Territory Development Plan [***]. Each Party Zai shall be responsible for CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. reporting to the applicable Regulatory Authorities in the Territory, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the Global Development Plan, as well as responding responding, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, the Field and in each case at its own costthe Territory. The Pharmacovigilance Agreement Zai shall also provide to NVCR access to Zai’s adverse event database for the Territory. NVCR shall maintain a global safety adverse event database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for Clinical Trials conducted under the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 Global Development Plan at [***] Option is not exercised, be at Sanofi’s cost and expense, and if the DCM1 except for any costs allocated to [***] Option is exercised, be deemed, pursuant to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligationsSection 5.5.

Adverse Events Reporting. Prior to No later than the execution of the Pharmacovigilance Agreement as described below first IND filing for the applicable a Licensed Product, MyoKardia Skye and Tautomer shall be responsible for handling product complaints for such Product develop and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance written agreement for safety and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Compounds and Licensed Products, such as safety data sharing, sharing and exchange and adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures Pharmacovigilance Agreement shall be in accordance with(a) describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Compounds and Licensed Products and sufficient to permit each Party and its Affiliates, local licensees or (sub)licensees to comply with its legal obligations with respect thereto; (b) be promptly updated if required by changes in applicable Laws; and national regulatory reporting obligations under Applicable Law. Each Party (c) provide that (i) Tautomer shall maintain an adverse event database for clinical trials conducted in the Territory; (ii) Tautomer shall be responsible for (A) reporting to the applicable Regulatory Authorities in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all clinical trials conducted in the Products to the applicable Regulatory Authorities in its territoryTerritory, as well as responding (B) responding, to safety issues and to all requests of Regulatory Authorities related to the Products in its territory, in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global such safety database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) issues with respect to Licensed Products in the Field in the Territory; (iii) Tautomer shall provide to Skye access to Tautomer’s adverse event database for Licensed Products in the Territory; (iv) Tautomer shall promptly consult with Skye regarding all adverse event reports originating in the Territory and reasonably consider any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect input from Skye prior to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, finalizing adverse event reports for such Expanded Use Product, and shared by the Parties accordinglyevents and/or making any submission to a Regulatory Authority regarding such events; (v) Skye shall maintain a global adverse event database for Licensed Compound; and (bvi) Skye will provide Tautomer with respect access to DCM1 Products, if the DCM1 [***] Option is not exercised, be at SanofiSkye’s expense, global adverse event database regarding Licensed Compound and if the DCM1 [***] Option is exercised, be deemed, to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall promptly provide MyoKardia Tautomer with any adverse event information from the safety database regarding Licensed Compound in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately accordance with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligationsAgreement.

Adverse Events Reporting. Prior (a) Promptly following the Effective Date, but in no event later than [***] thereafter, Zai and Five Prime shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Safety Agreement”). Such procedures Safety Agreement shall describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to Licensed Products and sufficient to permit each Party and its Affiliates, licensees or sublicensees to comply with its legal obligations with respect thereto, including, for clarity, Five Prime’s obligations as the owner or holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, as applicable. The Safety Agreement shall be promptly updated if required by changes in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Lawlegal requirements. Each Party agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. CONFIDENTIAL EXECUTION (b) Zai shall maintain an adverse event database for Clinical Trials conducted in the Territory under the Territory Development Plan, at its sole cost and expense. Zai shall be responsible for reporting to the applicable Regulatory Authorities in the Territory, on Five Prime’s behalf during such time that Five Prime is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the Global Development Plan, as well as responding responding, on Five Prime’s behalf during such time that Five Prime is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, in each case at its own costthe Territory. The Pharmacovigilance Agreement Zai shall also provide to Five Prime access to Zai’s adverse event database for the Territory. Five Prime shall maintain a global safety adverse event database to be established for Clinical Trials conducted under the Global Development Plan at Five Prime’s cost and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofiexpense, except that such for any costs with respect allocated to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option Zai pursuant to Section 5.4. (c) Zai shall be deemed Registration Program Costs responsible for complying with all Applicable Laws governing adverse events in the Territory. Zai shall notify Five Prime on a timely basis of any adverse events occurring in the Territory. Zai shall submit copies of reports of adverse events to Five Prime simultaneously with submission to the applicable Regulatory Authorities in the Territory. Each Party shall notify the other in a timely manner and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 in any event within [***] Option of receiving any serious adverse event reports from Clinical Trials that the applicable Party is not exercisedmonitoring, be at Sanofi’s expensenotice from a Regulatory Authority, and if the DCM1 [***] Option is exercisedindependent review committee, be deemed, 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 extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligationsefficacy of Licensed Products.

Adverse Events Reporting. Prior Promptly following BeiGene’s receipt of (x) the Trial Completion Notice or (y) the Dose Identification Notice, whichever occurs first, but in no event later than […***…] thereafter, BeiGene and Zymeworks shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures Pharmacovigilance Agreement shall be in accordance with(a) describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local and national regulatory reporting licensees or 7 Competitive Information – Commercially Sensitive Terms. 8 Competitive Information – Commercially Sensitive Terms. 9 Competitive Information – Commercially Sensitive Terms. sublicensees to comply with its legal obligations under with respect thereto; (b) be promptly updated if required by changes in Applicable Law. Each Party ; (c) provide that (i) BeiGene shall maintain an adverse event database for Clinical Trials conducted in the Territory under the Territory Development Plan and the Global Development Plan, […***…]; (ii) BeiGene shall be responsible for (A) reporting to the applicable Regulatory Authorities in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the Global Development Plan, as well as responding (B) responding, to safety issues and to all requests of Regulatory Authorities related to such safety issues with respect to the Licensed Products in its territorythe Field in the Territory, in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global safety database to be established ((i) and maintained by Sanofi(ii)), and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for other than the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) Zymeworks Territory Studies, with respect to any HCM1 which Zymeworks will retain such responsibilities and will keep BeiGene reasonably informed until such time as the Regulatory Submissions for the Zymeworks Territory Studies are assigned to BeiGene pursuant to Section 6.1, at which time BeiGene will assume such responsibilities; (iii) BeiGene shall provide to Zymeworks access to BeiGene’s adverse event database for the Licensed Product and/or HCM2 Productin the Territory; (iv) Zymeworks shall maintain a global adverse event database for the Licensed Products, be shared equally by MyoKardia and Sanofi, except that such costs including with respect to Clinical Trials conducted under the Global Development Plan, at Zymeworks’ cost and expense, except for any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordinglycosts allocated to BeiGene pursuant to Section 5.4; and (bv) Zymeworks will provide BeiGene with respect to DCM1 Productsadverse event information regarding the Licensed Products in accordance with the PV Agreement; and (d) include the following definition of “adverse event”: any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment; an adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), if symptom, or disease temporally associated with the DCM1 [***] Option is use of a medicinal product, whether or not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, related to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligations.medicinal product.10”

Adverse Events Reporting. Prior to the execution Promptly following BeiGene’s receipt of the Pharmacovigilance Agreement as described below for the applicable ProductTrial Completion Notice, MyoKardia but in no event later than […***…] thereafter, BeiGene and Zymeworks shall be responsible for handling product complaints for such Product develop and MyoKardia shall be solely responsible for all adverse event reporting with respect agree in a written agreement to the Compounds worldwide safety and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures Pharmacovigilance Agreement shall be in accordance with(a) describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local and national regulatory reporting licensees or sublicensees to comply with its legal obligations under with respect thereto; (b) be promptly updated if required by changes in Applicable Law. Each Party ; (c) provide that (i) BeiGene shall maintain an adverse event database for Clinical Trials conducted in the Territory under the Territory Development Plan and the Global Development Plan […***…]; (ii) BeiGene shall be responsible for (A) reporting to the applicable Regulatory Authorities in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the Global Development Plan, as well as responding (B) responding, to safety issues and to all requests of Regulatory Authorities related to the Products in its territory, in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global such safety database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) issues with respect to any HCM1 the Licensed Products in the Field in the Territory; (iii) BeiGene shall provide to Zymeworks access to BeiGene’s adverse event database for the Licensed Product and/or HCM2 Productin the Territory; (iv) Zymeworks shall maintain a global adverse event database for the Licensed Products, be shared equally by MyoKardia and Sanofi, except that such costs including with respect to Clinical Trials conducted under the Global Development Plan, at Zymeworks’ cost and expense, except for any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordinglycosts allocated to BeiGene pursuant to Section 5.4; and (bv) Zymeworks will provide BeiGene with respect to DCM1 Productsadverse event information regarding the Licensed Products in accordance with the PV Agreement; and (d) include the following definition of “adverse event”: any untoward medical occurrence in a patient or clinical 57 Competitive Information – Commercially Sensitive Terms. investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment; an adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), if symptom, or disease temporally associated with the DCM1 [***] Option is use of a medicinal product, whether or not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, related to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordinglymedicinal product. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligations.58

Adverse Events Reporting. Prior (a) Promptly following the Effective Date, but in no event later than [***] thereafter, Zai and Five Prime shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Safety Agreement”). Such procedures Safety Agreement shall be in accordance withdescribe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party shall be responsible for reporting quality complaints, concerning adverse events or any other safety issue of any significance and safety data related to the Products to the applicable Regulatory Authorities in its territory, as well as responding to safety issues product quality and to all requests of Regulatory Authorities related to the Products in its territoryproduct complaints involving adverse events, in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global safety database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 ProductLicensed Products and sufficient to permit each Party and its Affiliates, be shared equally by MyoKardia and Sanofi, except that such costs licensees or sublicensees to comply with its legal obligations with respect to any Expanded Use thereto, including, for clarity, Five Prime’s obligations as the owner or holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product after Sanofi’s exercise of in the Expanded Use Option shall be deemed Registration Program Costs and Allowable ExpensesTerritory, as applicable, for such Expanded Use Product, and shared . The Safety Agreement shall be promptly updated if required by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 [***] Option is not exercised, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database changes in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory requestlegal requirements. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Safety Agreement and to cause its Affiliates, licensees and (Sub)licensees sublicensees to comply with such obligations. (b) Zai shall maintain an adverse event database for Clinical Trials conducted in the Territory under the Territory Development Plan, at its sole cost and expense. Zai shall be responsible for reporting to the applicable Regulatory Authorities in the Territory, on Five Prime’s behalf during such time that Five Prime is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Territory under the Territory Development Plan or the Global Development Plan, as well as responding, on Five Prime’s behalf during such time that Five Prime is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, to safety issues (c) Zai shall be responsible for complying with all Applicable Laws governing adverse events in the Territory. Zai shall notify Five Prime on a timely basis of any adverse events occurring in the Territory. Zai shall submit copies of reports of adverse events to Five Prime simultaneously with submission to the applicable Regulatory Authorities in the Territory. Each Party shall notify the other in a timely manner and in any event within [***] of receiving any serious adverse event reports from Clinical Trials that the applicable 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. Prior (a) Promptly following the Effective Date, but in no event later than [***] days thereafter, Zai and NVCR shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Safety Agreement”). Such procedures Safety Agreement shall be in accordance withdescribe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local licensees or sublicensees to comply with its legal obligations with respect thereto, including, for clarity, NVCR’s obligations as the owner or holder of Regulatory Approvals and national regulatory reporting obligations Regulatory Submissions for the Licensed Product in the Territory, as applicable. (b) Zai shall maintain an adverse event database for Clinical Trials conducted in the Territory under Applicable Lawthe Territory Development Plan [***]. Each Party Zai shall be responsible for reporting to the applicable Regulatory Authorities in the Territory, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the [***] Plan, as well as responding responding, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, the Field and in each case at its own costthe Territory. The Pharmacovigilance Agreement Zai shall also provide to NVCR access to Zai’s adverse event database for the Territory. NVCR shall maintain a global safety adverse event database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for Clinical Trials conducted under the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 [***] Option is not exercised, be Plan at Sanofi’s expense, and if the DCM1 [***] Option is exercisedcost and expense, be deemed, except for any costs allocated to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or ] pursuant to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligationsSection 5.5.

Adverse Events Reporting. Prior (a) Promptly following the Effective Date, but in no event later than [***] days thereafter, Zai and NVCR shall develop and agree in a written agreement to the execution of the Pharmacovigilance Agreement as described below for the applicable Product, MyoKardia shall be responsible for handling product complaints for such Product worldwide safety and MyoKardia shall be solely responsible for all adverse event reporting with respect to the Compounds and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Safety Agreement”). Such procedures Safety Agreement shall be in accordance withdescribe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and enable exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to fulfillLicensed Products and sufficient to permit each Party and its Affiliates, local licensees or sublicensees to comply with its legal obligations with respect thereto, including, for clarity, NVCR’s obligations as the owner or holder of Regulatory Approvals and national regulatory reporting obligations Regulatory Submissions for the Licensed Product in the Territory, as applicable. (b) Zai shall maintain an adverse event database for Clinical Trials conducted in the Territory under Applicable Lawthe Territory Development Plan [***]. Each Party Zai shall be responsible for THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 23 reporting to the applicable Regulatory Authorities in the Territory, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, all quality complaints, adverse events and safety data related to Licensed Products for all Clinical Trials conducted in the Products to Territory under the applicable Regulatory Authorities in its territoryTerritory Development Plan or the Global Development Plan, as well as responding responding, on NVCR’s behalf during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, the Field and in each case at its own costthe Territory. The Pharmacovigilance Agreement Zai shall also provide to NVCR access to Zai’s adverse event database for the Territory. NVCR shall maintain a global safety adverse event database to be established and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for Clinical Trials conducted under the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (a) with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs with respect to any Expanded Use Product after Sanofi’s exercise of the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Product, and shared by the Parties accordingly; and (b) with respect to DCM1 Products, if the DCM1 Global Development Plan at [***] Option is not exercised, be at Sanofi’s cost and expense, and if the DCM1 except for any costs allocated to [***] Option is exercised, be deemed, pursuant to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from the safety database in a manner sufficient for MyoKardia to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Regulatory Authorities or to respond to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligationsSection 5.5.

Adverse Events Reporting. Prior Within [***] after the Amendment Effective Date, unless entered into prior to the execution of the Pharmacovigilance Agreement as described below for the applicable ProductAmendment Effective Date, MyoKardia Jazz and Zymeworks shall be responsible for handling product complaints for such Product develop and MyoKardia shall be solely responsible for all adverse event reporting with respect agree in a written agreement to the Compounds worldwide safety and the Products. Prior to the Initiation of the first clinical trial within a Registration Program for a Product or earlier upon the written request of either Party, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharingsharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance SDEA Agreement”). Such procedures SDEA Agreement shall (a) describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and exchange of information between the Parties concerning adverse events or any other safety issue of any significance, in each case with respect to Licensed Products and sufficient to permit each Party and its Affiliates, licensees or sublicensees to comply with Applicable Laws and, with respect to Zymeworks, its obligations to the Ex-Territory Partner as of the Amendment Effective Date; (b) be promptly updated if required by changes in Applicable Law; (c) provide that, following transfer of relevant activities to Jazz in accordance withwith the Transition Services Agreement (i) Jazz shall maintain the global safety database for the Licensed Products, including for Clinical Trials conducted in the Territory at its sole cost and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party expense; (ii) Jazz shall be responsible for (A) reporting quality complaintsto the applicable Regulatory Authorities in the Territory, all required adverse events and safety data related to Licensed Products, including for all Clinical Trials (including the Products to Zymeworks Ongoing Studies) conducted in the applicable Regulatory Authorities in its territoryTerritory and the Zymeworks Korean Studies, as well as and (B) responding to safety issues and to all requests of Regulatory Authorities related to such safety issues with respect to the Licensed Products in its territory, the Field in each case at its own cost. The Pharmacovigilance Agreement shall also provide for a global safety database to be established the Territory and maintained by Sanofi, and for MyoKardia to provide to Sanofi all safety information obtained by MyoKardia for the Products prior to Sanofi’s establishment of the global safety database. The costs in connection with establishment and maintenance of such global safety database shall (aC) making final decisions with respect to any HCM1 Product and/or HCM2 Product, be shared equally by MyoKardia and Sanofi, except that such costs safety governance issues with respect to any Expanded Use Product after Sanofithe Licensed Products in the Territory; (iii) to the extent required to comply with Applicable Laws, Jazz shall provide to Zymeworks access to safety data from Jazz’s exercise of safety database for the Expanded Use Option shall be deemed Registration Program Costs and Allowable Expenses, as applicable, for such Expanded Use Licensed Product, and shared by the Parties accordingly; and (biv) Zymeworks will provide Jazz with respect safety information regarding the Licensed Products in accordance with the SDEA Agreement; and (d) use the definitions relating to DCM1 Products“adverse events” and “adverse drug experiences” as set forth in 21 C.F.R. 312.32 and 21 C.F.R. 314.80. In accordance with the timeline set forth in the Transition Services Agreement and, if the DCM1 in any event, no later than [***] Option is not exercisedafter the Amendment Effective Date, be at Sanofi’s expense, and if the DCM1 [***] Option is exercised, be deemed, to the extent reasonably apportioned to the United States, Registration Program Costs and Allowable Expenses, as applicable, for such DCM1 Product and shared by the Parties accordingly. Sanofi shall provide MyoKardia with information from will cooperate in good faith to transfer the global safety database in a manner sufficient for MyoKardia the Licensed Products to comply with Applicable Law, including MyoKardia’s obligation to report to * Confidential Information, indicated by Jazz. [***], has been omitted from this filing and filed separately with . [***]. The date on which the Securities and Exchange Commission Regulatory Authorities or first IND is transferred to respond Jazz pursuant to regulatory request. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Purchase Agreement and to cause its Affiliates, and (Sub)licensees to comply with such obligations[***].