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...
Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than ninety (90) days thereafter, Zai and Xxxxxxxx shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.9, Section 6.10, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters.
Adverse Events Reporting. Promptly following the Effective Date, but in no event later than [***] thereafter, Alexion and Eidos shall develop and agree in a written agreement to worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such Pharmacovigilance 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, Third Party Licensees and Sublicensees to comply with its legal obligations with respect thereto. The Pharmacovigilance Agreement shall be promptly updated if required by changes in Applicable Law. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, Third Party Licensees and Sublicensees to comply with such obligations. Without limiting the foregoing, Eidos will be responsible for maintaining a global adverse event database for all Clinical Trials conducted in the Territory and the ROW Territory, [***].
Adverse Events Reporting. Promptly after the filing of the first IND with respect to a Product (including if Intrexon files for IND in the context of Section 4.5), ARES TRADING and Intrexon shall discuss in good faith whether their respective activities would require them to enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for ARES TRADING and Intrexon with respect to the Product, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). If ARES TRADING and Intrexon agree that a Pharmacovigilance Agreement is necessary or otherwise advisable, such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. In any event, ARES TRADING shall maintain an adverse event database for the Products in the Territory at its cost and shall be responsible for reporting in accordance with applicable Laws related to the Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Products in the Territory. Each Party hereby agrees to comply with its respective obligations under a Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.
Adverse Events Reporting. (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 worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, adverse events reporting and prescription events monitoring (the “Safety Agreement”). Such 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, NVCR’s obligations as the owner or holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory, as applicable.
Adverse Events Reporting. On an on-going basis during the Term and for at least ten (10) years after the expiration or termination of this Agreement, each Party agrees to provide the other Party with any written information in its possession which indicates adverse effects in humans associated with KLH or any products using KLH.
Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than 60 days thereafter, Zai and Paratek will develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Safety Agreement will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.4, Section 6.5, or any related definitions and the Safety Agreement, the Safety Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters.
Adverse Events Reporting. Under the Supply Agreement, the Parties shall establish a procedure for monitoring and reporting adverse drug experiences, consistent with Article 15 of the License Agreement.
Adverse Events Reporting. GSK shall be responsible for reporting all safety related events from studies of QS-21 Vaccines to the appropriate Regulatory Authorities and agencies according to the applicable local regulations, including without limitation, the regulations outlined in 21 CFR 312.32 (and other applicable international regulations). GSK and Antigenics MA shall keep each other informed of any serious adverse reactions, or other significant, unusual or unexpected safety findings related to QS-21 as provided for in Section 5.8 of the License Agreement.
Adverse Events Reporting. 4.9.1. The Parties agree to adhere to the terms and conditions of the Pharmacovigilance Agreement.
