Item 1.01 Entry into a Material Definitive Agreement.
On February 17, 2023, Cryo-Cell International, Inc. ("Company") entered into a
Second Amendment to the License Agreement (the "Second Amendment") with Duke, as
previously disclosed in the Company's Form 10-K filed on February 28, 2023. The
Second Amendment changes the license fee due to Duke. The final payment that was
due on February 23, 2023 was removed and the license fee is paid in full. The
Second Amendment added a new milestone payment upon FDA approval of the first
licensed product comprising cord tissue derived MSC ("ctMSC") for autism
spectrum disorder. The Second Amendment also added a new ctMSC milestone that
the Company will open a manufacturing facility for the licensed product prior to
the initiation of a Phase III clinical trial using ctMSC's. As part of the
Second Amendment, on March 3, 2023, the Company entered into the Clinical Study
and Research Agreement (the "Research Agreement") with Duke to provide funding
to complete the Duke IMPACT Study. In consideration for the work to be performed
under the Research Agreement, the Company will be obligated to make 14 equal
monthly payments commencing in April 2023 and a final payment upon the
submission of a draft proposed publication for peer review and delivered to the
Company of the completed IMPACT Study. Duke agrees this will be no later than
September 30, 2024. The Data Safety Monitoring Board for the IMPACT Study
recently has determined that the trial's targeted accrual has been reached and
consists of 137 patients.
Item 9.01. Financial Statements and Exhibits.
Financial Statements of Businesses Acquired. Not Applicable.
Pro Forma Financial Information Not Applicable.
Shell Company Transactions Not Applicable.
Exhibits.
Exhibit No. Description
104 Cover Page Interactive Data File
(the cover page iXBRL tags are
embedded within the Inline XBRL
document)
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