Extract to table

This approach provides Veridian with full compensation for the coordination services it is required to provide during the wind-down while avoiding overpayment for periods after the wind-down concludes

Invoices for such work must be submitted in accordance with the standard payment procedures set forth in the MCTA and are subject to the same Net 45 payment terms

Veridian and its participating sites must continue to submit invoices in the format and through the channels specified in the MCTA during the wind-down period

This gap was identified as a critical open item in the June 10, 2023 memorandum because the treatment of subjects who may be deriving clinical benefit from penterafenib raises significant ethical, regulatory, and practical concerns that must be addressed in the governing agreement

During the extended access period, the site investigator must actively pursue transition of the subject to commercially available therapy (including approved alternative therapies for advanced HCC) or enrollment in another clinical trial, and must document these efforts in the subject's medical record

Site investigators must report any SAEs to Penterra within twenty-four (24) hours of the site's becoming aware of the event, consistent with 21 C