Adverse Events Reporting. 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 Territory to conduct a Clinical Trial or for Regulatory Approval of the Licensed Product, Jazz and Zymeworks 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 “SDEA Agreement”). Such 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; (b) be promptly updated if required by changes in Applicable Law; (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 to 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 Territory, other than those conducted under the Zymeworks Development Plan for which Zymeworks is required to 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 the Field in the Territory, in each case ((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 provide to Zymeworks access to Jazz’s safety database for the Licensed Product in the Territory; (iv) Zymeworks shall maintain the g...
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. 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. 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. 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. The Parties agree to adhere to the terms and conditions of the Pharmacovigilance Agreement.
Adverse Events Reporting. [Include Shire standard clause I standard form on adverse events reporting, if applicable.]
Adverse Events Reporting. 3.5.1 For purposes of this Section 3.5: (a) the definition “drug safety reports” shall comply with the requirements set forth by the FDA in the Code of Federal Regulations, Title 21 CFR 312.32 (“IND Safety Reports”); and (b) all information provided to Xcel pursuant to this Section 3.5 will be provided in a complete and accurate manner.
3.5.2 During such time as Xcel holds the POZEN NDA and POZEN holds the IND for the Initial Licensed Product or is performing work under an IND for any Licensed Product or Foreign Licensed Product, POZEN will submit to Xcel all drug safety reports for Licensed Products or Foreign Licensed Products brought to the attention of POZEN (whether inside or outside the Territory) as well as any material events and matters concerning or affecting the safety of Licensed Products or Foreign Licensed Products. POZEN will forward copies of all such drug safety reports to Xcel within seven days of receipt thereof by POZEN.
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 the Adjuvant or any products using the Adjuvant (including but not limited to Licensed Products).
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.
