Adverse Events Reporting. (a) Promptly following the Effective Date, but in no event later than thirty (30) days thereafter, Zai and Deciphera shall 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 “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 6.4, Section 6.5, 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. 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. 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. (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 13 hereof
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.
Adverse Events Reporting. [Include Shire standard clause I standard form on adverse events reporting, if applicable.] Place: Place: Date: Date: for and on behalf of [Shire Group Company] for and on behalf of Centogene AG Name: Name: Title: Title: Place: Place: Date: Date: for and on behalf of [[additional participants, if any] for and on behalf of [[additional participants, if any] Name: Name: Title: Title: Content of Reports The Patient-blinded Reports to be provided by Centogene shall contain the following information, per month and cumulative for the year to date, on a country-by-country basis and, where permitted by local regulation and requested by the relevant Shire Group Company. on a ZIP-code basis: [*****]
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).
