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.
Adverse Event Reporting Requirement. The Parties recognize that PRI as the holder of all Drug Approval Applications and Regulatory Approval may be required to submit information and file reports to various governmental agencies on THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Collaboration Products under clinical investigation, Collaboration Products proposed for marketing, or marketed Collaboration Products. The information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new Collaboration Product. In addition, supplemental information must be provided on Collaboration Products at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. Consequently, to the extent ACT obtains the following and appropriate persons within ACT are aware thereof, ACT agrees to:
(A) provide to PRI for initial and/or periodic submission to government agencies significant information on the Collaboration Product and components thereof from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Collaboration Product or components thereof;
(B) in connection with investigational drugs, report to PRI within three (3) days of the initial receipt of a report of any serious adverse experiences with the Collaboration Product or components thereof, or sooner if required, for PRI to comply with regulatory requirements; and THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(C) in connection with marketed Collaboration Products, report to PRI including, but not limited to, by telephone and telefax within three (3) business days of the initial receipt of a report of any adverse experience with the Collaboration Product that is serious or sooner if required for PRI to comply with regulatory requirements. For the purposes of this Agreement, serious adverse experiences mean any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpat...
