Example ContractsClausesAdverse Event Reporting and Safety Data Exchange
Adverse Event Reporting and Safety Data Exchange
Adverse Event Reporting and Safety Data Exchange contract clause examples

Adverse Event Reporting and Safety Data Exchange. No later than ​ before the Initiation of a Clinical Trial with respect to the Development of any Licensed Product in the [[3D Medicines:Organization]] Territory, the Parties shall define and finalize the actions that the Parties shall employ with respect to such Licensed Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) for the Development of the Licensed Product globally. Further, no later than ​ before the anticipated launch date of any Licensed Product in the [[3D Medicines:Organization]] Territory, the Parties shall enter into a separate Pharmacovigilance Agreement for the Commercialization of the Licensed Product. Each of the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of the Licensed Product, and other routine pharmacovigilance reporting requirements. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for the Licensed Products in the Field in the [[3D Medicines:Organization]] Territory to be maintained by [[3D Medicines:Organization]] at [[3D Medicines:Organization]]’ expense, and a global safety database for the Licensed Products to be maintained by [[Aravive:Organization]] at [[Aravive:Organization]]’s expense. As between the Parties, [[3D Medicines:Organization]] shall be responsible for preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the Field in the [[3D Medicines:Organization]] Territory, and [[3D Medicines:Organization]] shall be responsible for filing such reports and responses with Regulatory Authorities in the [[3D Medicines:Organization]] Territory. As between the Parties, [[3D Medicines:Organization]] shall also be responsible for reporting any quality complaints, adverse events and safety data related to Licensed Products in the Field in the [[3D Medicines:Organization]] Territory to [[Aravive:Organization]] for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted Sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the commencement of any Clinical Trial or any other activities that would generate safety data required to be reported to Regulatory Authorities that are conducted by AstraZeneca, the Parties shall define and finalize the methods and procedures (based on and consistent with those methods and procedures used by Astellas and FibroGen under the Astellas Agreements) that the Parties shall employ with respect to Products and to Probe Compounds independently Developed and Commercialized by FibroGen China to protect patient safety and promote the appropriate treatment of safety information of such products in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any such product in the Territory. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen China shall maintain a safety database for the Products in the Territory, the expenses for which will be included in Development Costs. FibroGen China shall be responsible for reporting quality complaints, adverse events and safety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Territory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted Sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. No later than [* * *] after the filing of the first NDA for the Product, Catalyst or Catalyst’s sublicensee(s) (if applicable) and ISU shall enter into a commercially reasonable pharmacovigilance agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall include customary guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for Products in the Territory to be maintained by Catalyst at its expense. Catalyst shall be responsible for reporting quality complaints, adverse events and safety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Territory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. No later than ​ before the commencement of a clinical study with respect to Development of any Licensed Product by Apollomics in the Apollomics Territory, the Parties shall define and finalize the actions that the Parties shall employ with respect to such Licensed Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) for the Development of the Licensed Product. Further, no later than ​ before the anticipated launch date of any Licensed Product in the Apollomics Territory, the Parties shall enter into a separate Pharmacovigilance Agreement for the Commercialization of the Licensed Product. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of the Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill all regulatory reporting obligations under Applicable Law. Furthermore, such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting safety reporting requirement, in which case local reporting requirement shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for the Licensed Products in the Apollomics Territory to be maintained by Apollomics at Apollomics’ expense, and a global safety database for the Licensed Products, to be maintained by [[GlycoMimetics:Organization]] at [[GlycoMimetics:Organization]]’ expense. As between the Parties, Apollomics shall be responsible for preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the Apollomics Territory, and Apollomics shall be responsible for filing such reports and responses with Regulatory Authorities in the Apollomics Territory. As between the Parties, Apollomics shall also be responsible for reporting any quality complaints, adverse events and safety data related to Licensed Products to [[GlycoMimetics:Organization]] for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. No later than [* * *] after the filing of the first NDA for the Product, Catalyst or Catalyst’s sublicensee(s) (if applicable) and ISU shall enter into a commercially reasonable pharmacovigilance agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall include customary guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions

Safety and Adverse Event Reporting. At least 90 days prior to submission of the initial IND for the first Product, the Parties will meet to discuss and determine the desirability of entering into a separate, related safety data exchange agreement (the “Safety Data Exchange Agreement”) providing details related to managing adverse events that occur during Clinical Studies, safety issues arising from pre-clinical research and other safety and reporting practices and procedures in compliance with all applicable Laws. If the Parties determine that a separate, written Safety Data Exchange Agreement is desirable, then the Parties will negotiate the terms of such agreement in good faith. Any breach of the Safety Data Exchange Agreement by either Party shall not, in and of itself, be deemed to be a breach of this Agreement.

Safety Reporting Safety Data Exchange Agreement. Within three (3) months of the Effective Date, or as soon as practicable thereafter, and in any event prior to Initiation of the first Combined Therapy Trial, the Parties (under the guidance of their respective safety departments, or equivalents thereof) shall define and finalize their respective responsibilities to protect patients and promote their well-being in connection with the use of the Nektar Compound and the BioXcel Compound in the framework of this Agreement, and to execute a “Safety Data Exchange Agreement.” Such Safety Data Exchange Agreement shall include mutually acceptable procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of the Nektar Compound, the BioXcel Compound and the CPI Compound. Such procedures shall be in accordance with, and enable the Parties and their Affiliates, to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements or Applicable Law, in which case local reporting requirements or

Safety Data Exchange. The Parties will negotiate in good faith promptly following the Effective Date a safety data exchange agreement regarding Product, which will set forth standard operating procedures governing the collection, investigation, reporting and exchange of information concerning adverse drug reactions/experiences sufficient to permit each Party to comply with its regulatory and other legal obligations within the applicable timeframes (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement will # identify which Party will be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product complaints and safety data relating to Product to the appropriate Regulatory Authorities in both the Relief Territory and the Acer Territory in accordance with all Applicable Laws and # allow each Party to comply with all regulatory and legal requirements regarding the management of safety data by providing for the exchange of relevant information in the appropriate format within applicable timeframes.

Safety Data Exchange. Within ​ of the Effective Date, but in any event prior to commencement of any Clinical Trials with respect to the Product in the Territory, the Parties will in good faith negotiate and execute a separate safety data exchange agreement (the “Pharmacovigilance Agreement”), the terms of which shall set forth the obligations, procedures and timelines for MTPC to report information (such as the occurrence of Adverse Events and serious Adverse Events) observed in connection with the Product in order to enable Viela to comply with its safety reporting obligations to Regulatory Authorities in and outside the Territory. Prior to the execution of the Pharmacovigilance Agreement, MTPC shall promptly notify Viela of any information observed in connection with the Product that MTPC reasonably determines to be necessary to enable Viela to comply with its safety reporting obligations to Regulatory Authorities in and outside the Territory. Any serious Adverse Events shall be reported to Viela within ​ after MTPC becomes aware of their occurrence. Viela shall maintain the global safety database for the Product, which shall include Adverse Events and other information relating to the safety of the Product. Upon reasonable advanced request by MTPC, Viela shall make the data maintained in the global safety database accessible and available to MTPC in the form in which such data is then-currently maintained by Viela.

Safety Data Exchange Agreement” has the meaning set forth in Section 4.2 (Safety and Adverse Event Reporting).

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