Friday, April 19, 2024 7:37:06 PM
+First (1st) FDA approval of a BLA
relating to Lenzilumab for CMML in
the United States, provided such
approval is granted within five (5)
years following the Closing Date.
The next three (3) FDA approvals of
a BLA relating to Lenzilumab for any
follow-on indication to CMML in the
United States provided such
approval(s) is granted within seven
(7) years following the Closing Date.
First (1st) Regulatory Approval of
any HGEN Product for a particular
Therapeutic Indication for
Lenzilumab in the United Kingdom,
Germany, France, Italy, Spain or
Australia (each, an “Approved
Country”), provided such approval is
granted within five (5) years
following the Closing Date."
There are a few other Milestone Events related to various net sales totals.
The Milestone Events can be seen on pages 55 and 56/95, linked here.
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1061258&projectCode=HUM&docketNumber=155&source=DM
What would it take to monetize these Milestone Events? It would take receiving a BLA from the FDA for CMML, and related indications in the US. I think Sanofi, with their deep pipeline of oncology products and processes, would be an excellent partner for us in oncology, once they complete the spin-off of their healthcare division in the coming months.
In other parts of the world, Regulatory approval of lenz from any Approved Country would qualify as a Milestone Event. I think SAMHRI will be of invaluable assistance to us in Australia.
How likely is it that Humanigen will get Regulatory authorization or approval to qualify for these Milestone Events?
The Creditors' Committee must think that not only is this likely, Humanigen may even accomplish more than currently indicated.
"The settlement amended the APA to, among other things, significantly expand the events that will trigger the contingent “Milestone Payments” and increase the amount of those payments under the APA."
page 4/5
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
Any news of regulatory authorization or approval, or news regarding our restructuring, will signal Humanigen to recall their loaned shares.
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