Extract to table
Pull the structured facts out of a document: parties, dates, amounts, obligations.
Extract to table / preliminary-issues-memo.docx
preliminary-issues-memo.docx
Parties
Harkness LLP
Agreement Between Penterra Pharmaceuticals Corp
Penterra Pharmaceuticals Corp
Callahan LLP
Client Profile Penterra Pharmaceuticals Corp
Delaware General Corp
Hargrove LLP
Dates
March 27, 2023
April 7, 2023
January 15, 2023
April 1, 2023
March 31, 2024
August 14, 2023
Amounts
$80,000,000
$4.2
$1.87
$612
$890
$1.4
$52,000
$4,200,000
$500,000
$15,000,000
Obligations
Third-Party Service Providers (Referenced in MCTA) The CLARION trial will involve several third-party service providers whose roles and contractual relationships must be addressed in or cross-referenced by the MCTA
The Meridian MSA is a separate agreement and is not within the scope of the MCTA negotiation; however, certain provisions of the MCTA — particularly those relating to monitoring visits, safety reporting timelines, and data management protocols — must be coordinated with and cross-referenced to the Meridian MSA to avoid operational conflicts or gaps in coverage
Pinnacle's platform must comply with 21 C
We note that this fee must be supportable under a fair market value analysis for Anti-Kickback Statute compliance purposes (discussed in Section III, Issue 7, below)
The investigator must document the safety rationale for the deviation contemporaneously and must report the deviation to Penterra and Meridian CRO within twenty-four (24) hours
(v) No settlement of any indemnified claim shall be made without the prior written consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned, or delayed