Common use of Adverse Event Reporting Requirement Clause in Contracts

Adverse Event Reporting Requirement. (a) Consistent with the responsibilities outlined in Section 2.2, above, and after transfer of the existing IND(s) into PPD’s name, Xxxxxxx will use Diligent Efforts to supply PPD with copies of any product safety related information that is necessary for PPD’s Development of Licensed Products in a reasonable time period, as reasonably requested by PPD from time to time. (b) During the period that the Existing IND(s) and/or CTA(s) are in the name of PPD, PPD shall be responsible for the clinical trial safety database, safety monitoring, evaluation, and regulatory reporting obligations. The clinical activities conducted by PPD, including but not limited to the collection, evaluation and reporting of Adverse Events, shall be in accordance with ICH guidance, meeting GCP standards and in compliance with applicable laws and regulations. (c) Should Xxxxxxx exercise the Xxxxxxx Option, (i) PPD shall transfer the accumulated safety data relating to the Licensed Product to Xxxxxxx within a mutually-agreed reasonable time period. The accumulated safety data to be transferred includes single case Adverse Event reports, pregnancy exposure reports, copies of aggregated safety reports (for example IND reports, annual safety reports and other safety reports submitted to the FDA or equivalent health authority), the sequential versions of the investigator’s brochure, all clinical research reports, and any other information concerning the safety of the Licensed Product. (ii) Serious Adverse Event information from the PPD safety database will be transferred from PPD to Xxxxxxx in reasonably-acceptable format and within a mutually-agreed reasonable time period, which shall provide reasonably sufficient time for Xxxxxxx to enter all the data and to obtain validation of the database before the first transfer of regulatory responsibility from PPD to Xxxxxxx occurs. (d) If Xxxxxxx declines to exercise the Xxxxxxx Option, PPD shall remain responsible for the clinical trial safety database and associated responsibilities. (e) Each Party agree to report any updated information coming into its possession concerning any studies performed by or on behalf of such Party to the other Party responsible for the clinical trial safety database.