Pharmacovigilance and Adverse Event Reporting. Within [***] days of the Closing Date and in any event prior to the commencement of any Clinical Study of Licensed Product by or on behalf of Xxxxxxx or its Affiliates or sublicensees, the Parties shall enter into a mutually acceptable pharmacovigilance agreement, setting forth guidelines and procedures for the receipt, investigation, recording, review, communication, and exchange (as between the Parties) of adverse event reports, technical complaints and any other information concerning the safety of Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfil, local and international reporting obligations to Regulatory Authorities. Furthermore, such guidelines and procedures shall be consistent with relevant International Committee on Harmonization (ICH) guidelines, except where said guidelines may conflict with reporting requirements of local Regulatory Authorities, in which case local reporting requirements shall prevail. The Parties shall mutually agree within [***] Business Days (or such shorter period as may be required to comply with applicable Law) on the actions necessary to address any safety concerns with respect to Licensed Product about which one Party provides notice to the other Party; provided, however, that if the Parties cannot reach agreement within such period, then [***] Notwithstanding the foregoing provision, such [***] day period shall be shortened if either Party provides notice to the other Party that more urgent action is required. Genmab’s costs incurred in connection with [***] adverse events and other reportable information as provided in such pharmacovigilance agreement shall be treated as Development Costs in accordance with Clause 4.5. Xxxxxxx shall establish and maintain the global safety database for the Licensed Products, including [***] (the “Global Safety Database”) for the Licensed Products. Genmab shall transfer all adverse events information in its possession or Control to Xxxxxxx for entry into the Global Safety Database within a mutually agreed period of time that provides Xxxxxxx with sufficient time to enter all of the data and to obtain validation of the Global Safety Database. [***] Xxxxxxx shall be obligated to provide all reasonable assistance upon request from Genmab for safety information relevant to the Licensed Product to comply with applicable Laws.
Pharmacovigilance and Adverse Event Reporting. Prior to or concurrent with the Closing Date, the Parties will enter into the Pharmacovigilance Agreement, setting forth guidelines and procedures for the receipt, investigation, recording, review, communication, and exchange (as between the Parties) of adverse event reports, technical complaints and any other information concerning the safety of the Product.
Pharmacovigilance and Adverse Event Reporting. The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Compounds and Licensed Products in accordance with Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. The Regulatory Responsible Party for the Licensed Products will be responsible for all processing of information related to any adverse events for such Licensed Product in the applicable jurisdiction, including any information regarding such adverse events that is received from a Third Party. Each Party will provide to the other Party in a timely manner the relevant safety information it receives (either directly or indirectly) related to the Licensed Compounds and Licensed Products. As soon as practicable after the Effective Date, the Parties will negotiate in good faith and enter into a Pharmacovigilance Agreement related to the Licensed Products, which will define the pharmacovigilance responsibilities of the Parties and include (a) safety data exchange procedures governing the exchange of information affecting the Licensed Products (e.g., Serious Adverse Events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to such Licensed Product and (b) the terms of transfer of the global safety database from Fulcrum to Sanofi pursuant to Section 6.10 (Global Safety Database).
Pharmacovigilance and Adverse Event Reporting. The Parties will cooperate with each other with regard to the reporting and handling of safety information involving the LRRK2 Licensed Products in accordance with applicable law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. Within [***] following the Effective Date or as otherwise agreed by the Parties, the Parties will negotiate in good faith and enter into a pharmacovigilance agreement related to the LRRK2 Licensed Products, which will define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the class and products to enable each Party to comply with all of its legal and regulatory obligations related to such LRRK2 Licensed Products (the “Pharmacovigilance Agreement”). Following the execution of the Pharmacovigilance Agreement, Biogen will own and maintain the global safety database for all LRRK2 Licensed Products that is created by and held by Biogen, and following the execution of the Pharmacovigilance Agreement, Denali shall transfer the contents and ownership of the global safety database for all LRRK2 Licensed Products created by Denali pursuant to a mutually agreed plan in an electronic format agreed upon by the Parties.
Pharmacovigilance and Adverse Event Reporting. The Parties shall execute, within [***], a separate pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to specify details of the Parties’ obligations with respect to reporting any adverse events associated with any Product, exchanging adverse event and other safety information relating to the Products, and any other pharmacovigilance obligations.
Pharmacovigilance and Adverse Event Reporting. The Parties shall cooperate with regard to the reporting and handling of safety information involving the DT Co-Co Products in accordance with the Applicable Laws, regulatory requirements, and regulations on pharmacovigilance and clinical safety. The Regulatory Responsible Party for a DT Co-Co Product in a given Region shall be responsible for all processing of information related to any adverse events for such DT Co-Co Product for the Region. Each Party shall provide to the other Party the relevant safety information it receives (either directly or indirectly) related to a DT Co-Co Product within such time to ensure that all regulatory requirements and timelines are met in the respective territories. The Parties shall negotiate in good faith and enter into a Pharmacovigilance Agreement, which shall define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the DT Co-Co Products (e.g., Serious Adverse Events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to such DT Co-Co Products (the “Pharmacovigilance Agreement”). Moderna shall own and maintain the global safety database for all DT Co-Co Products provided that the Pharmacovigilance Agreement shall provide Metagenomi access to such database and real time notifications and reporting of adverse events, as needed for pharmacovigilance obligations.
Pharmacovigilance and Adverse Event Reporting. The Parties will cooperate with each other with regard to the reporting and handling of safety information involving the Licensed Products and Sarepta Diagnostic Products in accordance with Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. Prior to the commencement of any activities conducted by or on behalf of Roche or any of its Affiliates in furtherance of any Clinical Trial for any Licensed Product, the Parties will negotiate in good faith and enter into a Pharmacovigilance Agreement related to the Licensed Products and a quality agreement, or such other agreement as the Parties may agree, related to the Sarepta Diagnostic Products, which will define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the class and products (e.g., Serious Adverse Events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to such Licensed Products and Sarepta Diagnostic Products. Sarepta will own and maintain the global safety database for all Sarepta Products and Sarepta Diagnostic Products. 79445843_10
Pharmacovigilance and Adverse Event Reporting. 7.1 Kamada shall be responsible for establishing a pharmacovigilance monitoring system, with the reasonable assistance of the Distributor. Such monitoring system will include (i) provision of minimum pharmacovigilance information regarding a reporter who is identifiable by name, initials and/or address; (ii) an identifiable patient/subject (i.e., identifiable by patient number, date of birth, age, or gender); (iii) at least one suspected substance/medicinal product; and (iv) at least one suspected adverse drug event.
7.2 The Distributor shall provide all necessary assistance to Kamada in the establishment and maintaining the pharmacovigilance monitoring system as the distributor of the Products in the Territory at its expense; such assistance shall include field corrections, product withdrawals, adverse event reporting and complaint reporting to Kamada or any other relevant report or action required under any applicable law.
7.3 Without derogating from the above, the parties shall abide by the following reporting requirements:
Pharmacovigilance and Adverse Event Reporting. The Parties shall cooperate with regard to the reporting and handling of safety information involving the Cost Share Products in accordance with Applicable Laws, regulatory requirements, and regulations on pharmacovigilance and clinical safety. At such time as the Parties deem appropriate and to comply with Applicable Law, the Parties shall agree upon pharmacovigilance activities to be conducted by each Party in connection with the Cost Share Products.
Pharmacovigilance and Adverse Event Reporting
