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Extract to table / supplemental-mae-analysis-fda-hold.docx
supplemental-mae-analysis-fda-hold.docx
Parties
HARKNESS LLP
Penterra Pharmaceuticals Corp
Cole LLP
Broadleaf Scientific Consulting LLC
In AB Stable VIII LLC
Resorts One LLC
Dates
September 2, 2024
August 25, 2024
August 14, 2024
August 22, 2024
June 10, 2024
December 31, 2023
March 31, 2024
December 10, 2024
August 16, 2024
August 19, 2024
Amounts
$900,000,000
$87.3
$112.4
$420
$630
$900
$340
$68
$19.3
$79.6
Obligations
This "double-MAE" construct—a bring-down to a Material Adverse Effect-qualified standard—means that the representations need not be perfectly accurate; rather, the inaccuracies, in the aggregate, must rise to the level of a Material Adverse Effect
2(b) provides a standalone condition that "no Material Adverse Effect shall have occurred since the date of this Agreement that is continuing as of the Closing Date
The halt in enrollment creates a gap in the trial timeline that cannot be made up simply by resuming enrollment at a later date; rather, the statistical analysis plan and the trial's powering assumptions must be revisited in light of the interruption
The realistic regulatory timeline for resolution of the clinical hold and resumption of meaningful clinical development can be summarized as follows: (i) Veridian must submit a complete response to the FDA's safety concerns (Protocol v4
Here, because Veridian is a pre-revenue company, the adverse impact must be assessed primarily through the forward-looking "would reasonably be expected to have" prong