Pharmacovigilance Agreement; Global Safety Database. The Parties shall enter into a pharmacovigilance agreement at least [*****] days prior to the Initiation of any Clinical Trial of Licensed Product(s) by EverInsight in the Territory providing for the terms pursuant to which (i) VistaGen shall establish, hold and maintain (at VistaGen’s sole cost and expense) the global safety database for Licensed Product and (ii) the Parties will establish a mutually agreed procedure for safety data sharing, adverse event reporting and prescription events monitoring related to the Licensed Product(s), which procedure shall be in accordance with, and enable the Parties to fulfill, their respective regulatory reporting obligations under, all applicable laws. Each Party shall be responsible for reporting safety data, adverse events, quality complaints related to the Products to the global safety database and to the applicable Regulatory Authorities in its Respective Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Product in its Respective Territory, in each case at its own cost. VistaGen shall provide EverInsight with access to the global safety database to allow EverInsight to comply with its regulatory reporting obligations under applicable laws in the Territory.
Pharmacovigilance Agreement; Global Safety Database. The Parties shall enter into a pharmacovigilance agreement at least [***] days prior to the initiation of Phase 1 Clinical Trial by Everest in the Territory providing for the terms pursuant to which (i) Sxxxx shall establish, hold and maintain (at Sxxxx’x sole cost and expense) the global safety database for Licensed Products and (ii) Everest shall timely provide Sxxxx with information in the possession and Control of Everest as necessary for Sxxxx to comply with its pharmacovigilance responsibilities outside the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Laws outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product, in each case, in English, in the form reasonably requested by Sxxxx and at Everest’s sole cost and expense.
Pharmacovigilance Agreement; Global Safety Database. At least [***] days prior to the earlier of (a) Initiation of a clinical trial by Pfizer involving the Compound or a Licensed Product or (b) the Commercialization by Pfizer of a Licensed Product in any country in the Pfizer Territory, the Parties shall enter into a pharmacovigilance agreement providing for the terms pursuant to which (i) the Parties shall establish, hold and maintain the global safety database for Licensed Products and (ii) each Party shall timely provide the other Party with information in the possession and Control of such Party as necessary for such other Party to comply with its pharmacovigilance responsibilities in such Party’s Respective Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Laws outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product. The costs of establishing and maintaining such global database shall be borne by the Party holding and maintaining such global safety database. The costs of a Party supplying such information to such other Party shall be the sole cost and expense of the Party supplying such information.
Pharmacovigilance Agreement; Global Safety Database. Within [***] after the Closing, the Parties shall enter into a separate written pharmacovigilance agreement providing details related to safety and reporting practices and procedures in compliance with all applicable Laws in relation to the Product. Each Party shall, at its sole cost, establish, hold and maintain the safety database for Product in its respective territory. Each Party shall provide the other Party with information in the possession and control of such Party as necessary for the other Party to comply with its pharmacovigilance responsibilities in respect of the Product, in each case, in the form reasonably requested by the other Party. In the event of any inconsistency between the provisions of the pharmacovigilance agreement and the provisions of this Agreement, the wording of the pharmacovigilance agreement shall govern any and all patient safety matters, and this Agreement shall govern all other matters.
Pharmacovigilance Agreement; Global Safety Database. No later than the earlier of (a) the date that is [***] ([***]) months before the date Licensee files an IND for a clinical study with respect to any Licensed Product and (b) the date that Eisai files the BLA for the Existing Licensed Product for the CTCL Indication in the United States, the Parties shall enter into a separate written pharmacovigilance agreement providing details related to managing and reporting adverse events in respect of the Licensed Compound or any Licensed Product that occur during clinical studies and other safety and reporting practices and procedures in compliance with all Applicable Laws. Each Party shall, at its sole cost, establish, hold and maintain the safety database for Licensed Products in its respective Territory. Each Party shall provide the other Party with information in the possession and Control of the first Party as necessary for the other Party to comply with its pharmacovigilance responsibilities in respect of the Licensed Compound and the Licensed Products in its Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. section 312.32 or 600.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States) from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies, and commercial experiences with a Licensed Product, in each case, in the form reasonably requested by the other Party.
Pharmacovigilance Agreement; Global Safety Database. Within [Redacted] after the Effective Date, the Parties shall enter into a separate written pharmacovigilance agreement providing details related to managing and reporting adverse events and product complaints in respect of the Licensed Products in the AbbVie Territory and the I-Mab Territory (including those that occur during clinical studies) and other safety and reporting practices and procedures as well as required post-marketing studies, risk evaluation and mitigation, plans and re-evaluation obligations, in each case, in compliance with all Applicable Laws. Notwithstanding the foregoing, if any adverse event safety data is received or otherwise generated by a Party prior to the execution of such pharmacovigilance agreement, such Party shall, within [Redacted] of receiving or otherwise generating such data, provide such data to the other Party by email to: (a) if to AbbVie, at XXXXxxxxxxXxxxxxxxXxxxxx@xxxxxx.xxx; or (b) if to I-Mab, at xxxxxxxxxx@x-xxxxxxxxxxxx.xxx. AbbVie shall have the right to establish, hold and maintain the global safety database for the Licensed Products. Each Party shall provide the other Party with information in the possession and Control of such Party as necessary for such other Party to comply with its pharmacovigilance responsibilities in respect of the Licensed Products, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to FDA under 21 C.F.R. sections 312.32, 314.80 or 600.80, or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States) and product complaints from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies, and commercial experiences with the Licensed Products, in each case, in the form reasonably requested by such other Party.
Pharmacovigilance Agreement; Global Safety Database. The Parties shall enter into a pharmacovigilance agreement promptly following the Effective Date providing for the terms pursuant to which (i) Nabriva shall establish, hold and maintain (at Nabriva’s sole cost and expense) the global safety database for Licensed Products; (ii) Licensee shall timely, and shall ensure that its Affiliates and Sublicensees, provide Nabriva with information in the Control of Licensee, its Affiliates or Sublicensees as necessary for Nabriva to comply with its pharmacovigilance responsibilities outside the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. Sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States) with respect to any Licensed Product, including from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product, in each case, in the form reasonably requested by Nabriva; (iii) Nabriva shall provide Licensee with access to data in such global safety database as necessary for Licensee to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product.
Pharmacovigilance Agreement; Global Safety Database. 5.4.1. Pharmacovigilance Agreement. No later than [***] prior to the date on which Biogen reasonably anticipates that it will exercise the Option with respect to a Collaboration Program, the Parties shall enter into a written pharmacovigilance agreement governing each Party’s respective obligations with respect to safety-related matters, including matters relating to the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with Products that are the subject of such Collaboration Program, on terms substantially the same as the terms of the safety data exchange agreements entered into by the Parties with respect to the ALS Collaboration Programs and Biogen Conducted Non-ALS Collaboration Programs (each as defined in the Neurology II Agreement).
Pharmacovigilance Agreement; Global Safety Database. The Parties shall enter into a pharmacovigilance agreement promptly following the Effective Date providing for the terms pursuant to which (i) ArQule (and/or any current or future license of ArQule of the Licensed Compound and/or any Licensed Products) shall establish, hold and maintain (at ArQule's sole cost and expense) the global safety database for Licensed Products, (ii) Licensee shall timely provide ArQule with information in the possession and Control of Licensee or its Affiliates and its or their (sub)licensees as necessary for ArQule (and/or any current or future license of ArQule of the Licensed Compound and/or any Licensed Products) to comply with its pharmacovigilance responsibilities outside the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product, in each case, in English, in the form reasonably requested by ArQule and at Licensee’s sole cost and expense, and (iii) ArQule (and/or any current or future license of ArQule of the Licensed Compound and/or any Licensed Products) shall provide Licensee with access to data in such global safety database as necessary for Licensee to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product.
Pharmacovigilance Agreement; Global Safety Database
