Adverse Event Reporting; Global Safety Database. EPIZYME, at its sole cost, shall be solely responsible for reporting to applicable Regulatory Authorities in the EPIZYME Territory all adverse drug experiences associated with Licensed Compounds and Licensed Products in the Field. EISAI, at its sole cost, shall be solely responsible for reporting to applicable Regulatory Authorities in the EISAI Territory all adverse drug experiences associated with Licensed Compounds and Licensed Products in the Field. The Parties shall negotiate and agree to, within ninety (90) days following the Restatement Date, a detailed safety data exchange agreement (the “SDEA”) setting forth reasonable and customary procedures governing the collection, investigation, reporting and exchange of information to enable collaboration on all matters of safety of use of the Licensed Compounds and Licensed Products worldwide, including the exchange of adverse drug experience information and similar matters sufficient to permit each Party to comply with its reporting obligations under this Section 2.5.4. EPIZYME, at its sole cost, shall establish, hold and maintain the global pharmacovigilance database for the Licensed Compounds and Licensed Products, and EISAI shall transfer all safety data in its possession as of the Restatement Date to EPIZYME in accordance with Section 2.6.
Adverse Event Reporting; Global Safety Database. CELGENE shall be solely responsible for reporting all adverse drug experiences associated with Licensed Compounds and Licensed Products in the Field in the CELGENE Territory. EPIZYME shall be solely responsible for reporting all adverse drug experiences associated with Licensed Compounds and Licensed Products in the Field in the EPIZYME Territory, and for establishing, holding and maintaining the global safety database for Licensed Compounds and Licensed Products in the Field. Each Party shall provide the other Party with all Licensed Compound, Licensed Product and Diagnostic Product complaints, adverse event information and safety data from clinical studies, in its possession and control, necessary or desirable for the other Party to comply with all applicable Law with respect to the Licensed Compound, Licensed Product and Diagnostic Product. Further, the Parties shall commence good faith discussion with respect to entering into a separate pharmacovigilance agreement, as and when required by the JDC.
Adverse Event Reporting; Global Safety Database. GSK shall be solely responsible for reporting all adverse drug experiences associated with Licensed Compounds, Licensed Products and Diagnostic Products in the Field in the Territory, and for establishing, holding and maintaining the global safety database for Licensed Compounds, Licensed Products and Diagnostic Products in the Field in the Territory.
Adverse Event Reporting; Global Safety Database. Unless otherwise set forth in the applicable Joint Development and Commercialization Agreement, EISAI shall be solely responsible for reporting to applicable Regulatory Authorities all adverse drug experiences associated with Licensed Compounds and Licensed Products in the Field in the Territory, and for establishing, holding and maintaining the global safety database for Licensed Compounds and Licensed Products in the Field in the Territory.
Adverse Event Reporting; Global Safety Database. 3.9.1 PTC shall be responsible for reporting all adverse drug experiences associated with the Products in the PTC Territory to applicable Regulatory Authorities. Akcea shall be responsible for reporting all adverse drug experiences associated with the Products in the Akcea Territory to applicable Regulatory Authorities. Akcea shall also be responsible for establishing, holding and maintaining the global safety database for the Compounds and the Products in the Territory.
3.9.2 Within [***] after the Effective Date, the Parties shall enter into a mutually-agreed safety data exchange agreement (the “SDEA”), which agreement shall provide for the exchange by the Parties of any information of which a Party becomes aware concerning any adverse event experienced by a subject or patient being administered any Product, whether or not such adverse event is determined to be attributable to any Compound or 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 and licensees or sublicensees shall have the right to disclose such information if such disclosure is reasonably necessary to comply with applicable Laws as well as requirements of any applicable Regulatory Authority. ActiveUS 169009360v.1
Adverse Event Reporting; Global Safety Database. 2.11.1 Following the transfer of the IND for the Product to Pfizer under Section 2.8.2(a), Pfizer will be responsible for all reportable events associated with the Product to the applicable Regulatory Authorities and will also be responsible for holding and maintaining the global safety database for the Product in the Territory.
2.11.2 The Parties will enter into a mutually-agreed safety data exchange agreement (the “SDEA”), which agreement will provide for the exchange by the Parties of any information of which a Party becomes aware concerning safety information related to the 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 and licensees or sublicensees will have the right to disclose such information if such disclosure is reasonably necessary to comply with applicable Laws as well as requirements of any applicable Regulatory Authority. The SDEA will remain in effect for so long as the exchange of safety information is required by Law.
Adverse Event Reporting; Global Safety Database. During the CD123 Development Term, MacroGenics shall establish and maintain a drug safety database for MGD024 and the MGD024 Product, and shall be responsible for monitoring of all related clinical experiences, safety monitoring, pharmacovigilance surveillance and compliance and filing of all required safety reports to all Regulatory Authorities in connection therewith (collectively, “Safety/AE Matters”). MacroGenics will use reasonable efforts to complete the transfer to Gilead of such drug safety database for MGD024 and the MGD024 Product promptly following the CD123 Option Effective Date and, following such transfer, Gilead will have the sole right and responsibility for holding and maintaining such drug safety database. On a Research Program-by-Research Program basis, Gilead shall have the sole right and sole control over, at its sole cost and expense, all Safety/AE Matters in connection with the Research Molecules or Research Products for a given Research Program from and after the Research Program Opt-In Effective Date for such Research Program.
Adverse Event Reporting; Global Safety Database. CELGENE shall be solely responsible for reporting all adverse drug experiences associated with Licensed Products in the Field in the CELGENE Territory, and for establishing, holding and maintaining the global safety database for Licensed Products in the Field; provided that the Parties’ costs and expenses of maintaining the global safety database shall be borne [*] percent ([*]%) by CELGENE and [*] percent ([*]%) by SUTRO. SUTRO shall be solely responsible for reporting all adverse drug experiences associated with Licensed Products comprising or containing Non-[*] DCs in the Field in the SUTRO Territory. Each Party shall provide the other Party with all Licensed Product and Diagnostic Product complaints, adverse event information and safety data from clinical studies, in 38 *Confidential Treatment Requested. its possession and control, necessary or desirable for the other Party to comply with all applicable Laws with respect to Licensed Products and Diagnostic Products. Further, the Parties shall commence good faith discussions with respect to entering into a separate pharmacovigilance agreement, as and when required by the JSC.
Adverse Event Reporting; Global Safety Database. CELGENE shall be solely responsible for reporting all adverse drug experiences associated with Licensed Compounds and Licensed Products in the Field in the CELGENE Territory, and for establishing, holding and maintaining the global safety database for Licensed Compounds and Licensed Products in the Field for which the CELGENE Territory is worldwide. EPIZYME shall be solely responsible for reporting all adverse drug experiences associated with Licensed Compounds and Licensed Products in the Field in the EPIZYME Territory, and for establishing, holding and maintaining the global safety database for Licensed Compounds and Licensed Products in the Field for which the CELGENE Territory is not worldwide. Each Party shall provide the other Party with all Licensed Compound, Licensed Product and Diagnostic Product complaints, adverse event information and safety data from clinical studies, in its possession and control, necessary or desirable for the other Party to comply with all applicable Law with respect to the Licensed Compound, Licensed Product and Diagnostic Product. Further, the Parties shall commence good faith discussion with respect to entering into a separate pharmacovigilance agreement, as and when required by the JDC.
Adverse Event Reporting; Global Safety Database. In the event that Felicitex exercises its Option for the Research Program, the applicable provisions regarding “Adverse Event Reporting; Global Safety Database” of the Commercialization and Development Agreement shall apply. With view to the Development, Manufacturing or Commercialization of Program Compounds other than Optioned Compounds, Selvita shall be solely responsible for reporting to applicable Regulatory Authorities all adverse drug experiences associated with such Program Compounds and pharmaceutical products comprising or based upon such Program Compounds in the Territory, and for establishing, holding and maintaining the global safety database for such Program Compounds and respective products in the Territory.
