Date: Fri, 9 Jan 1998 16:25:55 EST
From: Chris Jenks <infinity@sj.bigger.net>
To: Multiple recipients of list <ibogaine@ibogaine.org>
Subject: NDA vs. UM (1/3)
SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF NEW YORK
NDA INTERNATIONAL, INC.,
Plaintiff,
-against-
THE UNIVERSITY OF MIAMI,
Defendant.
NEW YORK COUNTY CLERK'S OFFICE
AUG 15 1997
NOT COMPARED WITH COPY FILED
Index No. 604211/97
Date Filed: 8/13/97
VERIFIED COMPLAINT
PLAINTIFF REQUESTS A TRIAL BY JURY
1. THE UNIVERSITY OF MIAMI (hereinafter referred to as the defendant) is
a Florida corporation, authorized to do and transacting business in the
State of New York.
2. On June 12, 1992, the defendant entered into a written agreement which
by its terms was made in the State of New York (said agreement is attached
hereto as Exhibit A and hereinafter referred to as the June, 1992
Agreement) with NDA INTERNATIONAL, INC. (hereinafter referred to as NDA or
the plaintiff).
3. The June, 1992 Agreement specifically states that it is to be
interpreted according to New York laws.
4. This action arises out of the June 12, 1992 Agreement.
5. As far back as 1980, Mr. Howard Lotsof, the president and founder of
NDA, first began his intensive work regarding dependency and treatment
through Ibogaine, an indole alkaloid (extracted from the African
Tabernanthe iboga plant) of chemical addiction, and more particularly,
methodologies and the development of medications for the relief therefrom.
6. Since that time the plaintiff has undertaken ongoing research and
development, and dedicated in excess of one million dollars and other
valuable resources, to discover and promote a drug and a procedure that
would break the physiological and/or psychological characteristics of
chemical addiction and dependency so as to enable the addict, without
encountering "withdrawal", to recover and lead a productive life.
7. Mr. Lotsof has devoted the past seventeen years of his life to the
development of Ibogaine in its use for relieving addictions to drugs and
alcohol.
8. Along these lines, Mr. Lotsof, on behalf of NDA, has secured six (6)
patents for the treatment of chemical dependence, to wit:
a. Rapid Method for Interrupting the Narcotic Addiction Syndrome, U. S.
Patent Number 4,499,096 filed November 18, 1983 and granted on February
12th, 1985;
b. Rapid Method for Interrupting the Cocaine and Amphetamine Abuse
Syndrome, U. S. Patent Number 4,587,243 filed July 15th, 1985 and granted
on May 6th, 1986;
c. Rapid Method for Attenuating the Alcohol Dependency Syndrome, U. S.
Patent Number 4,857,523 Filed July 18th, 1988, and granted August 15th, 1989;
d. Rapid Method for Interrupting the Nicotine/Tobacco Dependency
Syndrome, U. S. Patent Number 5,026,697 filed May 30th, 1990 and granted on
October 6th, 1992;
e. Rapid Method for Interrupting or Attenuating Poly-Drug Dependency, U.
S. Patent Number 5,152,994 filed May 31st, 1990 and granted on October 6th,
1992; and
f. Method of Treating Chemical Dependency using Beta-Carboline Alkaloids,
Derivatives and Salts Thereof, U. S. Patent Number 5,591,738 filed October
14th, 1994 and awarded January 7th, 1997.
9. NDA is a corporation whose primary objective was and is to develop and
market Ibogaine and its alkaloids and derivatives for the treatment of
chemical dependency.
10. In the 1980's NDA secured agreements with foreign entities from
Europe and Africa to supply the rare and difficult to obtain Tabernanthe
iboga plant, for ongoing research and development of Ibogaine. In fact, the
ability to supply pharmaceutical grade Ibogaine involved many years of
development and substantial monetary outlay.
11. With these components finally in place, as part of NDA's continued
pursuit of Ibogaine use to interrupt chemical dependence, NDA has attempted
to gain FDA approval of Ibogaine for use in connection with treatment of
chemical dependency.
12. To accomplish this mission, NDA was required to follow and fulfill
various FDA requirements, including, but not limited to, conducting trials
to demonstrate pharmacological evidence that Ibogaine is safe and useful in
treating animals; testing the drug on humans; and showing that the drug has
a medical use.
13. Once these requirements had been met, and upon the proper
presentation to the FDA of reliable data, the FDA would be in a position to
approve a new drug application in favor of NDA.
14. In or about 1991 NDA began negotiations with the defendant's medical
department for said defendant to conduct studies on behalf of NDA pursuant
to an NDA protocol to achieve an FDA investigative new drug application
(IND). NDA would then have been able to advance to the next phase of
gaining FDA approval.
15. As evidenced by the extensive and exhaustive provisions within the
June, 1992 Agreement between NDA and defendant, of utmost importance to NDA
was the maintaining of all rights, interests, ownership, title in and
confidentiality over all research performed on behalf of NDA, including but
not limited to inventions, products, drugs, or derivatives discovered
and/or administered, and/or improved upon by the defendant as a result of
such research.
16. Pursuant to the June, 1992 Agreement, NDA was to use and give to
defendant a limited "license" to conduct the "Phase I" study. In exchange,
defendant was to have access to the study results and had permission to
publish articles about the study in scientific journals.
17. In 1994 the parties entered into a supplement to the June, 1992
Agreement (attached as Exhibit B and hereinafter referred to as the 1994
Agreement), pursuant to which the defendant was to receive a percentage of
money derived by plaintiff from the commercialization of Noribogaine, a
metabolite of Ibogaine, which pursuant to the agreement, was owned by the
plaintiff. In exchange, the defendant agreed, among other things, to have
its employee, Dr. Deborah Mash, participate in meetings upon NDA's request
with potential investors regarding plaintiff's Ibogaine development.
18. As a consequence of the defendant's knowledge and resources in this
area, as well its place as the bridge to gaining FDA approval, NDA placed
great trust and confidence in the defendant. The defendant held a special
and unique position and relationship with NDA, much different than those
who normally contract with one another. This relationship created fiduciary
obligations and standards of care.
19. As part of the June, 1992 Agreement, the defendant agreed among other
things that all discoveries, inventions and improvements in any way
relating to NDA's technology or resulting from defendant's services under
the agreement would be the property of NDA and accorded the defendant, its
agents, servants and employees no rights to use or profit from such
discoveries, inventions and improvements.
20. Pursuant to the June, 1992 Agreement, NDA retained the defendant to
conduct a Phase I Clinical Study (hereinafter referred to as the "STUDY")
using NDA's patented Ibogaine process for the treatment of chemical
dependency.
21. Under the STUDY, amongst other things, defendant was to use the
patented Ibogaine process on humans at defendant's facilities, in
accordance with FDA regulations, and record the findings and prepare the
requisite documentation pursuant to FDA protocol.
22. This was to be accomplished with the objective of NDA securing an FDA
new drug application.
23. The June, 1992 Agreement required the defendant to provide NDA with
the following:
(a). A written report with respect to each treatment episode summarizing
each episode and such other supporting documentation which NDA may
reasonably require to confirm the results of such episode; all such
documents to be submitted to NDA within 30 days after the relevant
treatment episode;
(b). A final report on the results of the STUDY within 60 days of the
completion of the STUDY.
(c). Copies of all communications between the defendant and relevant
government agencies including but not limited to the FDA and National
Institute on Drug Abuse (NIDA).
24. Paragraph 9 of the June, 1992 Agreement explicitly states, in
relevant part as follows:
"UM acknowledges that the Procedure is proprietary to NDA and that NDA
retains all rights to and ownership of the Procedure. The only rights
granted to UM with respect to the Procedure are those expressly set forth
in this agreement. Furthermore, UM hereby agrees that any and all
proprietary information, discoveries, inventions, or improvements (whether
patentable or otherwise) in any way relating to the Procedure which are
made, discovered, invented or improved by UM or which results from the
STUDY or any work which UM may do hereunder shall be owned from inception
by NDA.... UM shall assist NDA in every way, including the execution of all
documents and the doing of all acts and things as may be necessary or
desirable ... to enable NDA to confirm, protect or enforce its rights to
such ownership, including assisting NDA in connection with applications for
letters patent, or New Drug Applications in any and all countries...."
25. Paragraph 16. of the June, 1992 Agreement further states in pertinent
part as follows:
"Any services performed by UM in connection with the Procedure, the
STUDY, or any related matter, even though in addition to those expressly
described herein, shall be deemed to be rendered under and subject to this
agreement unless another agreement is stated to apply pursuant to a writing
signed by both parties."
26. To this end, paragraph 19 of the contract goes on to read:
"...No waiver of any of the provisions of this agreement shall be
effective unless in writing and signed by the party charged with such
waiver and such waiver shall be strictly limited to the terms of such
writing...."
27. In addition to the foregoing, NDA retained the defendant in March of
1992 under an agreement where NDA supplied defendant with Ibogaine which
was to be used in a pharmacokinetics study in primates. (Said agreement is
attached as Exhibit C and referred to hereinafter as the March, 1992
Agreement.)
28. This study was to be conducted in the St. Kitts, W. I. Like the June
Agreement referred to hereinabove, the contract expressly stated that the
Ibogaine Procedure (as well as all information, inventions, improvements,
discoveries, and the like resulting therefrom) was to remain proprietary
and protected for the benefit of NDA.
29. In violating the June, 1992 Agreement the defendant has failed to
complete the Phase I Clinical Study. The significance of this shortcoming
is that NDA has been unable to obtain FDA approval for Ibogaine or any of
its derivative products for chemical dependence treatment and thus has been
unable to market or promote its technology for such purposes. The use of
Ibogaine and its derivative products for such treatment has been delayed
for years due to the failure of the defendant to perform as required in the
June, 1992 Agreement. This has caused the loss of significant time and
money which had been invested by NDA in promoting its technology.
30. The defendant has further violated the June, 1992 Agreement by,
despite repeated demands, failing to disclose patient reports, clinical
research findings and other data required by the June, 1992 Agreement.
31. The defendant has further violated the June, 1992 Agreement by
failing to provide NDA with the FDA approved Protocol for the Study as
required by the June, 1992 Agreement.
32. The defendant has further violated the June, 1992 Agreement by
failing to deliver to NDA the findings of its research pursuant to and as
required by the June, 1992 Agreement.
33. The defendant has further violated the June, 1992 Agreement through
its agents, servants and employees who are using NDA's proprietary
procedure for commercial benefit in a drug treatment facility operated by
at least one of its key employees in St. Kitts in direct violation of its
limited license to use said procedure and in competition with NDA's own
facility.
34. The defendant has further violated the June, 1992 Agreement by
creating and claiming ownership of inventions, improvements, and
discoveries derived from defendant's work on behalf of NDA which, pursuant
to the June, 1992 Agreement, is owned by plaintiff.
35. One example of this outrageous behavior is a patent filed for and
obtained by one of the defendant's employees, Deborah C. Mash and a
colleague from the University of Minnesota. On April 1, 1997, Dr. Mash was
awarded a patent entitled "Bioactive Tricyclic Ibogaine, Analogs", which
patent was assigned to the defendant. Neither Dr. Mash not the defendant
had requested permission to file for such a patent, which was derived from
the work performed under the June, 1992 Agreement and therefore owned by
NDA pursuant to the terms of the June, 1992 Agreement.
36. In addition, in violation of the 1994 Agreement, defendant's key
employee, Dr. Mash, has refused on numerous occasions to participate in
meetings with potential NDA investors regarding Ibogaine development as
required by that Agreement.
37. The effect of the foregoing violations has been to deprive NDA of its
ability to commercialize its Ibogaine procedure and to obtain additional
investment support for its activities.
38. Upon information and belief, the motivation for defendant's wrongful
conduct can be traced to its desire to wrongfully appropriate NDA technology.
39. All conditions precedent to the initiation of litigation, if any,
have been performed or have been waived.
40. NDA has been required to retain and pay for the legal services of the
undersigned law form to enforce its rights under the aforementioned contract.
41. NDA is entitled to the recovery of these fees, as well as costs
incurred in bringing this action, pursuant to paragraph 17 of the contract.