Adverse Events Reporting Clause Samples

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. (a) Promptly following the Effective Date, but in no event later than [*] thereafter, Zai and Entasis shall develop and agree to the 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 in a written agreement (the “Safety 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, or Sublicensees to comply with its legal obligations. The Safety Agreement shall 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 and Sublicensees to comply with such obligations. (b) Zai shall maintain an Adverse Event database for Licensed Products in the Territory, at its sole cost and expense, and, to the extent required by Applicable Laws, shall report quality complaints, Adverse Events and safety data related to Licensed 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 Licensed Products in the Territory. Zai shall provide to Entasis access to Zai’s Adverse Event database for the Territory. Entasis shall maintain a global Adverse Event database at its sole cost and expense, and shall provide Zai with information contained in such global Adverse Event database at JDC meetings, provided, that Entasis shall promptly provide Zai with any material Adverse Event information that arises between any such JDC meetings. (c) Each Party shall comply with all Applicable Laws governing Adverse Events in its respective territory, and shall notify the other Party on a timely basis of any Adverse Events occurring in its respective territory. Each Party shall submit copies of reports of Adverse Events to the other Party simultaneously with submission to the applicable Regulatory Authorities. Each Party shall notify the other in a timely manner and in any event within twenty-four (24) hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent revie...

Adverse Events Reporting. [Include Shire standard clause I standard form on adverse events reporting, if applicable.]

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. 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) Within [ * ] of the Effective Date, Seagen and RemeGen shall develop and enter into a written agreement setting forth worldwide safety and pharmacovigilance procedures for the Parties with respect to the RC48 Licensed Product and Opt-In 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 sufficient to permit each Party and its Affiliates, licensees or 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 shall promptly notify the other Party in writing of any such changes in Applicable Law in its Territory upon becoming aware of them. (b) Seagen shall maintain a global adverse event database for the RC48 Licensed Product and Opt-In Products by or on behalf of the Parties, its Affiliates or sublicensees (“Global Safety Database”). RemeGen shall maintain an adverse event database for Clinical Trials conducted on the RC48 Licensed Product and Opt-In Products by or on behalf of RemeGen, its Affiliates or sublicensees, and will provide an initial transfer of safety information from its safety database to the Global Safety Database and thereafter exchange individual safety reports in [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. accordance with the Pharmacovigilance Agreement. Each Party shall be responsible for: (i) reporting to the applicable Regulatory Authorities in its respective Territory all quality complaints, adverse events and safety data related to Royalty Products (in the case of Seagen) and the RC48 Licensed Product and Opt-In Products (in the case of RemeGen) for such Clinical Trials conducted by such Party, its Affiliates or sublicensees; and (ii) responding to safety issues and to all requests of Regulatory Authorities related to such safety issues with respect to such products in the Field in such Territ...

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. 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. Promptly following the Effective Date and, in any event, as otherwise may be required to satisfy 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 Product, 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 Laws. Cytokinetics shall establish the global safety database for the Product, and shall maintain such global safety database for so long as such Product is under Development and/or Commercialization hereunder. The [*] shall be [*]. Each Party shall hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Product in its territory to such database and to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory related to the Product, in each case [*] and to the extent required by the applicable Law. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.