Common use of Pharmacovigilance and Adverse Event Reporting Clause in Contracts

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. Within [***] days of the Closing Date and in any event prior The Parties will cooperate with regard to the commencement reporting and handling of safety information relating to the Licensed Compound or any Clinical Study of Licensed Product in accordance with Applicable Law, including applicable regulatory requirements and regulations on pharmacovigilance and clinical safety. Xxxxxxx will be responsible for all processing of information related to any adverse events for any Licensed Product until such time as the safety database is transferred to GSK on a timeline agreed to by the Parties, taking into account factors such as the allocation between the Parties of Shared Global Development Activities and transfers of Regulatory Filings. Each Party will provide to the other Party the relevant safety information it receives (either directly or on behalf indirectly) related to a Licensed Product in accordance with the pharmacovigilance agreement entered into by the Parties in accordance with this Section 5.2.7 (Pharmacovigilance and Adverse Event Reporting). The drug safety departments from each of Xxxxxxx or its Affiliates or sublicensees, the Parties shall enter into meet and agree upon a mutually acceptable written pharmacovigilance agreement, setting forth guidelines and procedures agreement for the receipt, investigation, recording, review, communication, and exchange (as between the Parties) of exchanging adverse event reports, technical complaints and any other safety 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 timelines within [***] Business Days following the License Effective Date, which pharmacovigilance agreement will provide for the transfer of Xxxxxxx’s then-current safety database for Licensed Products to GSK, including the timing for such transfer (which shall not be earlier than the transfer of the IND to GSK in accordance with Section 6.2.3 (Assignment of Regulatory Filings)). Such written pharmacovigilance agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its Sublicensees or such shorter period as may be required designees) to comply with applicable Lawall Applicable Laws and, without limiting the foregoing, shall include provisions permitting Mersana to receive (a) on the actions necessary to address any all safety concerns information that Mersana requires for its reporting obligations with respect to Licensed Product about which one Party provides notice Clinical Trials sponsored by Xxxxxxx and (b) all safety information that may relate 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 LawsMersana Platform.

Pharmacovigilance and Adverse Event Reporting. Within The Parties shall cooperate with regard to the reporting and handling of safety information involving the SYNGAP1 Co-Co Products in accordance with the Applicable Laws, regulatory requirements, and regulations on pharmacovigilance and clinical safety. The Lead Regulatory Party for a SYNGAP1 Co-Co Product in a given country shall be responsible for all processing of information related to any adverse events for such SYNGAP1 Co-Co Product for such country. Each Party shall provide to the other Party the relevant safety information it receives (either directly or indirectly) related to a SYNGAP1 Co-Co Product within such time to ensure that all regulatory requirements and timelines are met in the respective Territories. No later than [***] days of the Closing Date and in any event prior to the commencement of any Clinical Study of Licensed Product first IND submission, unless mutually agreed in writing by or on behalf of Xxxxxxx or its Affiliates or sublicenseesthe Parties, the Parties shall negotiate in good faith and enter into a mutually acceptable pharmacovigilance agreement, setting forth guidelines and procedures one or more (as appropriate) written Pharmacovigilance Agreements for the receiptSYNGAP1 Co-Co Products, investigation, recording, review, communication, and exchange (as between which agreements shall define the Parties) pharmacovigilance responsibilities 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 include safety data exchange procedures governing the exchange of information affecting the SYNGAP1 Co-Co Products (e.g., serious adverse events, emerging safety issues) to fulfilenable each Party to comply with all of its legal and regulatory obligations related to such SYNGAP1 Co-Co Products (each a “Pharmacovigilance Agreement”). Between the execution of this Agreement and the execution of the Pharmacovigilance Agreement, local and international reporting obligations each Party shall provide 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 the other Party within [***] Business Days (or such shorter period as ], any and all known information that may be required to comply with applicable Law) on the actions necessary to address any impact human safety concerns with respect to Licensed Product about which one Party provides notice to the other Party; providedSYNGAP1 Research Program and SYNGAP1 Co-Co Products. Acadia shall own and maintain, howeverand be responsible for, 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 each SYNGAP1 Co-Co Product. In the Licensed Productsevent of any inconsistency between the terms of this Agreement and the Pharmacovigilance Agreement, including [***] (the “Global Safety Database”) for terms of this Agreement shall prevail and govern, except to the Licensed Products. Genmab shall transfer all adverse events information in its possession or Control extent such conflicting terms relating directly 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 pharmacovigilance responsibilities of the data and to obtain validation Parties (including the exchange of safety data), in which case the terms of the Global Safety Database. [***] Xxxxxxx Pharmacovigilance Agreement shall be obligated to provide all reasonable assistance upon request from Genmab for safety information relevant to the Licensed Product to comply with applicable Lawsprevail and govern.