Item 8.01 Other Events - Letter to Shareholders and Interested Parties.
Dear Shareholders and all Interested Parties,
This letter is in response to the social media outpouring - much of it vitriolic
and malicious - centered around ownership of certain important patent rights and
a phase 3 IND. Therapeutic Solutions International, Inc. ("TSOI") and its Board
of Directors ("Board") aim, herein, to set the record straight. To wit:
On September 29, 2021, an Inter Parties Review (IPR) was filed with the U.S.
Patent and Trial Board between Restem LLC, and Jadi Cell LLC. On September 27,
2022 Dr. Amit Patel was deposed in this matter (see Exhibit Link # 99.1) and on
August 26, Dr. Camillo Ricordi had his deposition taken. (see Exhibit Link #
99.12).
The Board has reviewed the transcripts of these two depositions as well as the
rest of the filings and the following are the many discrepancies, inaccuracies,
and potential perjurious items found therein. Included will be documents and
references to prior TSOI SEC filings that directly contradict the deposition
testimonies of these gentlemen, but also fly in the face of the libelous vitriol
stated by certain anonymous (of course) social media disseminators:
Facts
In Nov-Dec 2020, Jadi Cell LLC ("JADI"), through their sole member, Dr. Amit
Patel ("Patel"), approached TSOI through their director, Dr. Thomas Ichim
("Ichim"), about licensing JADI's JadiCell mesenchymal stem cell ("Jadi Cell")
in the area of COVID-19 lung damage (US Patent 9,803,176 B2 (the "Patent"), and
the drug master file (the Drug Master File), and master cell bank one (the
"Master Cell Bank") for all lung indications, including complications from
COVID-19. This is a similar licensing arrangement that is for use of the same
stem cell for CTE/TBI.
On February 9, 2021, Jadi Cell LLC accepted a $15,000,000 convertible promissory
note ("CPN") (see attached Exhibit # 99.13) for exclusive world-wide patent
rights to US Patent 9,803,176 B2 (the "Patent"), and the drug master file (the
Drug Master File), and master cell bank one (the "Master Cell Bank One") for all
lung indications, including complications from COVID-19.
During negotiations, Patel stated to Timothy Dixon ("Dixon"), CEO of TSOI, that
part of what was being licensed included the Phase 2 Investigational New Drug
Application (the "IND;" IND# 19757) that had been applied for as a Phase 3 study
by University Miami ("UM"). It was presumed at this time that the IND lead
investigator with UM, Dr. Camillo Ricordi ("Ricordi"), was being fully apprised
of the status of TSOI and the License that had been granted in February 2021 and
the promised IND transfer to TSOI, as well as unfettered access to the Master
Cell Bank.
On or about August 18, 2021, a long-time requested meeting occurred involving
Ricordi, Patel, Dixon, Ichim and others via Zoom conference call wherein Ricordi
expressed surprise and "claimed" this was the first time he was hearing about
TSOI and their exclusive world-wide patent license agreement (EPLA) with JADI.
Unsurprisingly, Ricordi's reactions to TSOI's presence was unnerving for Dixon
and Ichim given how long the EPLA was in existence and the parties' established
relationships. Why Dr. Patel and JADI kept TSOI's existence, if true, from the
IND filer and basis of the CPN-Lung and EPLA is a mystery that continues today,
but assuredly contributes to Mr. Dixon and TSOI's unrest and mistrust, as well
as mindset for the character of the CPN at issue and all future dealings to
date. One such result was Ricordi continually making threats through emails and
tweets on multi-media about TSOI's lack of rights and other caustic slander that
further eroded TSOI's confidence that the deal and consideration had truly been
consummated.
After several months of request (initiated by 3rd parties with strong interest
in seeing Phase 3 trials succeed), JADI finally agreed to putting the terms of
the License granted in the CPN of Feb 2021, and a formal License Agreement was
entered into on September 15, 2021, the stated intent being to definitively
memorialize the Parties understanding under the License granted by the CPN. At
this time, Dr. Ricordi became even more disruptive, if that's possible. However,
UM administrators took charge and SLOWLY kept negotiations for the IND advancing
- up until the time JADI elected to demand $15,000,000 cash and denied promising
to convert to shares of TSOI stock (on 2/9/2022, the first time JADI ever said
they were not going to convert the shares), thus fulfilling Mr. Dixon, TSOI, and
its counsel's anticipation of shenanigans.
The reason the facts above are critical are that, until the IND was transferred
to TSOI on 3/24/2022 via an IND Asset Transfer Agreement, as acknowledged by the
FDA (see Exhibit 99.17), there is a question whether the 2/9/21 CPN was in full
force and effect due to the failure of consideration to be exchanged (although
the terms had been agreed to and consistently confirmed by the Parties for
nearly the entirety of 2021 and as reflected in TSOI-JADI Settlement and Release
Agreement dated 2/23/2022 (the "Settlement Agreement"). Indeed, the terms under
the Settlement Agreement suggest the terms continue in force and effect; this
ambiguity is the shared opinion of the CEO, the board, and counsel during all
relevant times and went into the decision as to what needed to be reported in
the financials. While it is true that TSOI moved forward in good faith reliance
that JADI would be converting the shares similar to the prior CPN transaction
related to CTE/TBI/Brain, it was not foreseen that JADI would not do so and
would make a demand for $15,000,000.00 in cash less than ONE WEEK after UM
executed an LOI with TSOI agreeing to finally transfer the IND and provide a
certain number of expanded cGMP clinical grade JadiCells - this after 4 months
of acrimonious negotiation - on 2/4/2022.
Of interest is the fact that on December 1, 2021, legal counsel for JADI sent
the following email to UM included as attached exhibit (see attached Exhibit #
99) to purportedly assist in completing the negotiations for the IND transfer:
"Jadi Cell LLC (Jadi) would like to clarify and confirm the following:
Jadi hereby confirms that TSOI has the exclusive right to utilize the patent to
commercialize products and services in the treatment of lung disease and to
conduct research relating thereto. UofM is not permitted to proceed with phase 3
trials using its existing IND using the Jadi Cell in the absence of TSOI's
approval. The MTA originally granted to UofM does not contemplate a specific
field of use, but obviously the MTA does not authorize UofM to proceed with the
Phase 3 IND, use Jadi's master cell bank or commercialize the cell in the lung
disease treatment field outside of TSOI's approval. Pursuant to UofM's MTA with
Jadi, UofM is required to provide Jadi with notice prior to publishing any
information relating to the Jadi cell and must obtain Jadi's consent to use of
the Jadi cell in any clinical use, and we ask that such notifications be
provided in the future. Jadi will provide all notices and requests received from
UofM (for publication or clinical use of the Jadi cell) relating to the lung
disease field of use to TSOI for its consideration.
Jadi's strong preference is that UofM and TSOI reach an agreement regarding the
phase 3 trial under UofM's IND, and we expect both parties to be reasonable in
their requests."
Despite the above, once JADI sent notice of default to UM, all negotiations
toward an IND transfer and assignment ended with UM stating they could not enter
into any agreement with TSOI "without JADI's permission."
Needless to say, this led to correspondence from TSOI counsel that resulted in
the Settlement Agreement of 2/23/2022 wherein JADI agreed to convert shares per
license agreement that would be modeled upon the 2/9/2021 CPN (not retired since
no longer considered applicable other than the terms and definitions of the
patent license granted for lung indications) and EPLA of 9/15/2021 defining and
describing terms of License pursuant to the CPN-Lung. In TSOI's counsel's
opinion, the soonest effective date would be the execution of the Settlement
Agreement and board resolution for share issuance of 2/23/2022 for purposes of
booking the transaction in the financials for TSOI.
After the Settlement Agreement with JADI was completed and conveyed to UM, an IP
Transfer Agreement (the IND) was executed between UM and TSOI on 3/24/2022.
The above is intended for the reviewer, shareholders, and demagogues to grasp
the chaotic nature of these transactions, as well as the seeming dissonance with
the actions and statements of Ricordi and Patel.
Testimony of Amit N. Patel
On September 27, 2022, Dr. Amit Patel was deposed in the matter of Restem LLC
vs. Jadi Cell LLC. On Pg. 77 of his transcript, Dr. Patel states he was offered
$15 million dollars for JadiCells approximately 2 years ago which would have
been approximately August/September of 2020. In Nov-Dec 2020, Jadi, through
their sole member, Dr. Amit Patel, approached TSOI through their director, Dr.
Thomas Ichim, about licensing JADI's JadiCell mesenchymal stem cell ("JadiCell")
in the area of COVID-19 lung damage (US Patent 9,803,176 B2 (the "Patent"), and
the drug master file (the Drug Master File), and master cell bank one (the
"Master Cell Bank One") for all lung indications, including complications from
COVID-19. This is a similar licensing arrangement that is for use of the same
stem cell for CTE/TBI.
On pages 78 and 79 the discussion continues with Dr. Patel stating that the
offer that preceded TSOIs was "left up in the air due to the IPR. That's what
was stated by the lawyers." This is not possible as the IPR was not filed by
Restem until September 29, 2021. By February 9, 2021, JadiCell LLC accepted a
$15,000,000 convertible note (see attached Exhibit # 99.13) for exclusive
world-wide patent rights to US Patent 9,803,176 B2 (the "Patent"), and the drug
master file (the Drug Master File), and master cell bank one (the "Master Cell
Bank One") for all lung indications, including complications from COVID-19.
Furthermore, in the Declaration given by Patel on Page 8 he states "For example,
even before it issued, one company that learned of the patent application (that
matured into the '176 Patent), and the associated technology, offered to
purchase Jadi Cell, LLC ("Jadi Cell") for 15 million dollars. At that time, the
only patent or patent application Jadi Cell owned was the aforementioned
application that matured into the '176 Patent." (see Exhibit Link # 99.14) It
would appear the prior fifteen million dollar offer was more like 5 years ago at
minimum since the patent did not issue until 10-31-2017. There is no possible
way that the filing of the IPR interfered in us issuing a convertible note for
JadiCells as it did not exist at the time and would not exist for another seven
months.
Later in same deposition Dr. Patel is asked on page 80 of his transcript how
much TSOI paid for Jadi Cells, and Dr. Patel responded, "hundreds of thousands".
This too is incorrect as the convertible note clearly states JadiCell LLC
received $15,000,000 worth of TSOI stock at a fixed price of $0.1004 which they
have since cleared the stock which was underway at the exact time this
deposition was taken.
Testimony of Camillo Ricordi
On August 26, 2022, Dr. Camillo Ricordi was also deposed and beginning on page
13 of his transcript he is asked if he has had any communication with Jadi Cell
about his deposition and states the following "No, I didn't. I didn't
communicate about this procedure or the deposition. I've been communicating in
the past because this trial has been halted and we had all kind of difficulties
moving forward to identify standing sources because when everyone - we had a
Phase III trial approval FDA like a year ago or around a year ago and still we
have been unable to move forward because when people come close and they see
that there is a legal proceeding, they run in the opposite direction. I guess
they don't want to get involved. So practically we had very good results from
the - spectacular results from the Phase I/IIA trial and then we obtained
permission to move for a Phase III trial multisite and we were stuck and unable
to save life and just witness the - COVID-19 to continue to unfold, but we were
unable to help patients."
On March 24, 2022, Office of Technology Transfer, University of Miami, and
Therapeutic Solutions International, Inc. entered into an Asset Transfer and
License Agreement. The material information relevant to public disclosure is the
following: Within ten (10) days of the Effective Date, 1) TSOI shall make an
initial payment of two hundred thousand dollars ($200,000) to UM; 2) Within six
(6) months of the Effective Date, TSOI shall make a second payment of one
million eight hundred thousand dollars ($1,800,000) (at the completion of the
primary endpoint of the phase 2b/3 clinical trial specified in the IND or (ii)
one (1) year from the Effective Date), and 3) TSOI shall make a final payment of
two million dollars ($2,000,000). In turn, upon FDA approval of TSOI as Sponsor,
TSOI will replace UM as Sponsor, receive all trial doses, and intends to appoint
James Veltmeyer, MD, Chief Medical Officer as Principal Investigator (see
Exhibit Link # 99.15).
Then on March 28, 2022, Dr. Ricordi sent a letter to FDA (see attached Exhibit #
99.16) stating that the IND has been transferred to TSOI and that TSOI is the
new owner of IND 19757. On March 28, 2022, Dr. Thomas Ichim also sent a letter
to US FDA notifying them of the IND transfer as well (see attached Exhibit #
99.17). On April 1, 2022, TSOI received notice from FDA that the IND had
officially been transferred (see attached Exhibit # 99.18).
Despite all the above, Dr. Ricordi states that right up to August, 2022, "we
have been unable to move forward because when people come close and they see
that there is a legal proceeding, they run in the opposite direction." At no
time has this IPR interfered with TSOI moving forward.
On page 15 of his transcript he is asked about affiliations, advisory boards,
institutions etc. that he is involved in and he provides a list of people and
entities but fails to disclose his own relationship with Restem which includes
using Restem's mesenchymal stem cell in at least 3 patients (see Exhibit Link #
99.19) as well as an article published on Restem's website (see Exhibit Link #
99.2) and scientific papers (see Exhibit Link # 99.21) he has co-authored with
scientists from Restem. Oddly the lawyer representing Restem doesn't seem to
. . .
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