Example ContractsClausesAdverse Event Reporting
Adverse Event Reporting
Adverse Event Reporting contract clause examples

Adverse Event Reporting. As between the Parties: # Licensee is responsible for the timely reporting of adverse drug reactions/experiences, product quality complaints and safety data relating to Product to the appropriate Regulatory Authorities in the Territory; and # Verrica is responsible for reporting adverse drug reactions/experiences, product quality complaints and product safety data relating to Product to the appropriate Regulatory Authorities in the Verrica Territory; in each case ((i) and (ii)) in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Each Party shall use Commercially Reasonable Efforts to ensure that its Affiliates, licensees and sublicensees comply with such reporting obligations, including the Safety Data Exchange Agreement.

Each Party shall be responsible for the monitoring and reporting of safety information, if any, generated in the conduct of its Research Activities and will promptly report such information to the other Party.

. Lilly shall establish, hold, and maintain the global safety database for Collaboration Compounds, Monospecific Compounds, Modified Compounds and Products with respect to information on adverse events concerning the Collaboration Compounds, Monospecific Compounds, Modified Compounds and Products, as and to the extent required by Applicable Law.

Adverse Event Reporting. The Parties shall use diligent efforts to define and finalize the processes the Parties shall employ to protect patients and promote their well-being in connection with the use of each Combined Therapy, and to execute a written Pharmacovigilance Agreement (“PVA”) within ​ after the Effective Date of this Agreement or sooner as practicable and agreed to by the Parties, and prior to the first dosing of the first study patient in any new clinical trial subject to this Agreement. Such PVA shall # provide that Recipient shall hold and be responsible for the maintenance of the Global Safety Database for the Recipient Study Drug and that BMS shall hold and be responsible for the maintenance of the Global Safety Database for the BMS Study Drug, # provide that Recipient shall be responsible for the safety reporting for the Combined Therapy and shall lead all pharmacovigilance activities for the Combined Therapy, # permit Recipient to disclose or otherwise make available ​ information in the Global Safety Database applicable to the Recipient Study Drug, and # 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 the Combined Therapy. Such guidelines and 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 Applicable Law shall prevail. In the event of a conflict between the terms this Agreement and the terms of the PVA, the PVA shall supersede to the extent related to pharmacovigilance matters associated with the Combined Therapy Clinical Trial and the terms of this Agreement control with respect to any other matters. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled.

Adverse Event Reporting. Subject to the terms of this Agreement, within ​, or as soon as practicable after [[Nektar:Organization]], as agreed to by the Parties and prior to dosing the first study patient in any new Clinical Trial subject to this Agreement, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall use diligent efforts to define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Nektar Assets and BMS Assets in the framework of this Agreement, and to execute one or more written pharmacovigilance agreements (each, a “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement 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 the Nektar Assets and BMS Assets. Such guidelines and 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 Applicable Law shall prevail. Until such guidelines and procedures are set forth in the Pharmacovigilance Agreement, the Party responsible for pharmacovigilance prior to [[Nektar:Organization]] shall have sole pharmacovigilance responsibility for the Party’s Single Agent Compound subject to all applicable regulations and guidelines. To the extent any provision set forth in the Pharmacovigilance Agreement conflicts with any provision in this Agreement, the provision set forth in the Pharmacovigilance Agreement shall control as related to the exchange and reporting of safety information associated with use of the Nektar Asset and BMS Assets pursuant to this Agreement as well as product safety surveillance. The Pharmacovigilance Agreement can be amended from time to time. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled.

Pharmacovigilance and Adverse Event Reporting. The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Products in accordance with the Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. For each Licensed Product, GSK will be responsible for all processing of information related to any adverse events for such Licensed Product. Each Party will provide to the other Party the relevant safety information it receives (either directly or indirectly) related to a Licensed Product in a timely manner. The drug safety departments from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information and timelines within ​ days of the Effective Date, which pharmacovigilance agreement will provide for the transfer of ITEOS’s then-current safety database for Licensed Products to GSK, including the timing for such transfer. 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 designees) to comply with all Applicable Laws. GSK will own and maintain the global safety database for all Licensed Products.

Product Information/Adverse Event Reporting. To the extent any Services performed by Consultant pursuant to this Agreement result in Consultant’s collection, receipt or other form of knowledge of any information about Company’s medicinal or biological product(s) (“Product(s)”), from any source, in any form, relating to a Medication Error, Product Adverse Events, Product Quality Complaints, and/or Pregnancy Information (“Reportable Information”), Consultant represents and warrants that it shall cooperate with Company as set forth in this

Product Information/Adverse Event Reporting. To the extent any Services performed by Consultant pursuant to this Agreement result in Consultant’s collection, receipt or other form of knowledge of any information about Company’s medicinal or biological product(s) (“Product(s)”), from any source, in any form, relating to a Medication Error, Product Adverse Events, Product Quality Complaints, and/or Pregnancy Information (“Reportable Information”), Consultant represents and warrants that it shall cooperate with Company as set

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 [[Unknown Identifier]] Co-Co Products in accordance with the Applicable Laws, regulatory requirements, and regulations on pharmacovigilance and clinical safety. The Lead Regulatory Party for a [[Unknown Identifier]] Co-Co Product in a given country shall be responsible for all processing of information related to any adverse events for such [[Unknown Identifier]] 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 [[Unknown Identifier]] Co-Co Product within such time to ensure that all regulatory requirements and timelines are met in the respective Territories. No later than ​ prior to the first IND submission, unless mutually agreed in writing by the Parties, the Parties shall negotiate in good faith and enter into one or more (as appropriate) written Pharmacovigilance Agreements for the [[Unknown Identifier]] Co-Co Products, which agreements shall define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the [[Unknown Identifier]] 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 [[Unknown Identifier]] Co-Co Products (each a “Pharmacovigilance Agreement”). Between the execution of this Agreement and the execution of the Pharmacovigilance Agreement, each Party shall provide to the other Party within ​, any and all known information that may impact human safety with respect to the [[Unknown Identifier]] Research Program and [[Unknown Identifier]] Co-Co Products. Acadia shall own and maintain, and be responsible for, the global safety database for each [[Unknown Identifier]] Co-Co Product. In the event of any inconsistency between the terms of this Agreement and the Pharmacovigilance Agreement, the terms of this Agreement shall prevail and govern, except to the extent such conflicting terms relating directly to the pharmacovigilance responsibilities of the Parties (including the exchange of safety data), in which case the terms of the Pharmacovigilance Agreement shall prevail and govern.

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