Example ContractsClausesAdverse Event Reports
Adverse Event Reports
Adverse Event Reports contract clause examples

Adverse Event Reports. Within ninety (90) days after the date of this Agreement, the Parties shall enter into an agreement to initiate a process for the exchange of adverse event safety data in a mutually agreed format, including, but not limited to, post-marketing spontaneous reports received by the Party or its Affiliates in order to monitor the safety of the Product and to meet reporting requirements with any applicable Regulatory Authority.

Adverse Event Reports. Poseida shall be responsible for investigating adverse events and other required safety information associated with the use of any Therapeutic Product for such Therapeutic Program. Poseida shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events in accordance with applicable law and Regulatory Authority. Poseida shall promptly notify Roche of any serious

Adverse Event Reports. Roche shall be responsible for investigating adverse events and other required safety information associated with the use of any Therapeutic Product for such Therapeutic Program. Roche shall be responsible for the collection, review, assessment, tracking and filing of information related to such adverse events in accordance with applicable law.

Adverse Event”. Adverse Event means any unwanted or harmful medical occurrence in a patient or subject who is administered a Product, whether or not considered related to such Product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Product.

Adverse Event”. Adverse Event means any unwanted or harmful medical occurrence in a patient or subject who is administered a Product, whether or not considered related to such Product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Product.

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.

92 Article 11 INTELLECTUAL PROPERTY

Next results

Draft better contracts
faster with AllDrafts

AllDrafts is a cloud-based editor designed specifically for contracts. With automatic formatting, a massive clause library, smart redaction, and insanely easy templates, it’s a welcome change from Word.

And AllDrafts generates clean Word and PDF files from any draft.