Date: Fri, 9 Jan 1998 16:26:39 EST
From: Chris Jenks <email@example.com>
To: Multiple recipients of list <firstname.lastname@example.org>
Subject: NDA vs. UM (2/3)
CAUSES OF ACTION
COUNT I. BREACH OF CONTRACT
42. Plaintiff repeats and realleges as if fully set forth herein, those
allegations set forth under paragraphs 1 through 41 hereinabove.
43. NDA and the defendant entered into those written contracts attached
hereto as Exhibits A, B, and C.
44. NDA met its obligations under said contracts and otherwise performed
45. The defendant breached said contracts as stated in paragraphs 29
through 36 above.
46. As a direct and proximate cause of the defendant's failures under the
contract, the plaintiff has suffered damages in an amount which exceeds the
jurisdictional level of this court.
COUNT II. FRAUD
47. Defendant, its agents, servants and employees committed fraud on the
plaintiff by inducing plaintiff to enter into contracts with defendant and
to disclose to defendant its technology by representing that defendant's
actions as a consequence of such contracts and such disclosure would be for
the benefit of plaintiff when in fact defendant intended otherwise.
48. As the result of the foregoing plaintiff suffered damages in an
amount which exceeds the jurisdictional level of this court.
COUNT III. CONVERSION
49. Defendant, its agents, servants and/or employees and/or affiliates
have converted the technology owned by plaintiff for its own benefit and
additionally have converted income which the plaintiff would have realized
but for the actions of the defendant, thereby causing the plaintiff to
suffer damages in an amount which exceeds the jurisdictional level of this
COUNT IV. BREACH OF FIDUCIARY DUTY
50. Defendant, its agents, servants, employees and/or affiliates have
breached fiduciary duties and duties of good faith and trust by the actions
set forth above, thereby causing the plaintiff to suffer damages in an
amount which exceeds the jurisdictional level of this court.
COUNT V. TORTIOUS INTERFERENCE WITH CONTRACTS
51. Defendant knowingly prevented plaintiff from satisfying its
contractual obligations with others and knowingly caused others to refrain
from doing business with plaintiff by defendant's intentional failure to
fulfill and abide by the terms of its obligations to plaintiff and by
converting plaintiff's property in each case with the intent and effect of
depriving plaintiff of needed resources to be derived from investors and
from the commercialization of plaintiff's technology, which resources were
necessary for the satisfaction of such contractual obligations and the
entering into agreements with other parties, thereby causing the plaintiff
to suffer damages in an amount which exceeds the jurisdictional level of
COUNT VI. ACCOUNTING
52. Plaintiff demands that the defendant provide an accounting of all
income derived by it or its agents, servants, employees or affiliates from
the treatment with Ibogaine or its derivatives at the St. Kitts facility or
any other income derived from treatment with Ibogaine or its derivatives
anywhere else throughout the world.
COUNT VII. CONSTRUCTIVE TRUST
53. Plaintiff respectfully requests that all income derived by the
defendant, its agents, servants, employees or affiliates from the use or
promotion of Ibogaine or its derivatives, be placed into a constructive
trust for the benefit of the plaintiff and order that all income along with
interest be paid over to the plaintiff.
COUNT VIII. ATTORNEY'S FEES
54. Under paragraph 17 of the June, 1992 Agreement, the Plaintiff is
entitled to recover attorney's fees and costs incurred in bringing this
action. Plaintiff has expended and will continue to expend money in
protecting its legal rights which have been violated by the defendant,
thereby causing the plaintiff to suffer damages in an amount which exceeds
the jurisdictional level of this court.
WHEREFORE, premised upon the foregoing, the plaintiff requests that this
honorable Court enter Final Judgment against the defendant on the FIRST,
SECOND, THIRD, FOURTH, FIFTH, SIXTH, SEVENTH AND EIGHTH causes of action in
amounts which exceed the jurisdictional level of this court to compensate
the plaintiff for those losses as described herein, those damages that are
a natural consequence of the defendant's failure to meet its obligations
and interest, costs and attorney's fees and such other relief that this
honorable Court deems just and proper. NDA also seeks punitive and
exemplary damages as a consequence of the outrageous and egregious nature
of the defendant's conduct.
Dated: New York, New York
August 12, 1997
RONEMUS & VILENSKY
Attorneys for Plaintiff
112 Madison Ave.
New York, NY 10017
NDA International, Inc.
46 Oxford Place
Staten Island, New York 10301
Dr. Juan Sanchez-Ramos
(hereinafter called the "Principle Investigator")
Dr. Deborah C. Mash
Dr. Alan Jacobson
University of Miami
Plumer Building, Suite 10
P. O. Box 248052
Coral Gables, Florida 33124-2425
Dear Drs. Sanchez-Ramos, Mash and Jacobson:
NDA International, Inc. (hereinafter called "NDA") wishes the University
of Miami (hereinafter called "UM") to conduct a Phase I clinical study
(hereinafter called the "Study") under a physician initiated IND using
NDA's patented Ibogaine process for the treatment of chemical dependency
called the ENDABUSE(TM) Procedure (hereinafter called the "Procedure"). The
Study will be conducted by Drs. Sanchez-Ramos, Mash and Jacobson. Pursuant
to the Study, the Procedure will be administered to ten person's dependent
on cocaine and four non-cocaine dependent controls.
This letter sets forth the entire agreement between NDA and UM regarding
the Study as follows:
1. UM has informed NDA that the IRB (Institutional Review Board) and the
CRC (Community Research Center) Jackson Memorial Hospital have approved a
protocol proposed by UM for the Study. Said protocol shall be promptly
submitted to NDA for NDA's approval (such protocol as approved by NDA is
hereinafter called the "Protocol").
2. Subject to the compliance by UM with all of its obligations under this
agreement, NDA hereby gives to UM a limited license to use the Procedure
solely for the purpose of the Study at no cost to UM.
3. NDA shall furnish to UM solely for the purposes of the Study the
A. The supplies of Ibogaine needed for the Study;
B. Availability of appropriate personnel to respond to questions
concerning the Procedure or the Study;
C. Copies of available animal and human data to assist UM in the
accomplishment of the Study;
D. A demonstration of the Procedure in Europe to the Principal
Investigator which shall be observed by the Principal Investigator or
another member of the UM treatment team designated by the Principal
E. A Drug Master File to be provided at NDA's instruction by OMNICHEM.
4. UM shall serve as sponsor for the Study and in that capacity furnish
or cause to be furnished in accordance with the Protocol at no charge to
NDA all facilities and services reasonably required for the Study,
including the following:
A. Ten qualified volunteer cocaine dependent subjects and four volunteer
non-cocaine dependent control subjects (collectively hereinafter called the
"Subjects") who meet the needs of the Study;
B. A clinical environment suitable for the treatment episodes consisting
of a private room for each Subject capable of being darkened; and
C. A treatment team consisting of the appropriate category of personnel
as stipulated in the Protocol for the administration of the Procedure.
5. UM shall also use its best efforts to effect follow-up tracking of
each Subject for a period of six months following the treatment of such
Subject to include testing, adjunct therapy or counseling to the Subject as
will be defined in the Protocol.
6. UM shall furnish to NDA in connection with the Study the following:
A. Copies of the IND submission to the FDA by UM for the Study;
B. Copies of all tests and reports relating to Subject intake treatment
and post treatment evaluation. All reports by UM shall keep confidential
the identity of the Subjects;
C. Copies of all communications between UM and relevant government
agencies including the FDA;
D. A written report with respect to each treatment episode summarizing
such 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; and
E. A final report on the results of the Study within 60 days of the
completion of the Study.
7. UM shall promptly inform NDA of any medical emergency resulting from
or relating to the treatment episodes and any medical intervention to
terminate any treatment episode.
8. Pursuant to this agreement, NDA shall furnish to UM information
regarding NDA and the Procedure (including the Drug Master File) of a
confidential or proprietary nature, all of which is hereinafter called
"Confidential Information." UM shall maintain in strict confidence and not
disclose to any other person or entity or use any such Confidential
Information except as such disclosure or use is reasonably required in
order to enable UM to perform its services hereinunder or is otherwise
expressly authorized in writing by NDA. UM shall not disclose Confidential
Information unless the recipient of such Information agrees in writing to
comply with the confidentiality restrictions of this paragraph. At the
request of NDA at any time, UM shall promptly return to NDA any documents
and written information containing and Confidential Information and any and
all copies thereof; however, UM shall have the right to keep an archival
copy of all such documents and written information. Nothing in the
foregoing shall be construed to prevent UM from disclosing or using any
information which was in UM's possession or control prior to the date of
disclosure as evidenced in writing, or was in the public domain or enters
into the public domain through no improper act on the part of UM or any of
its employees or contractors.
9. 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. It is understood that grant applications and scientific
publications shall not be considered proprietary information for this
purpose. 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 at NDA's expense (including compensation for physician/scientist
time at the then standard fees for such physicians or scientists) to enable
NDA to confirm, protect or enforce its rights to such ownership, including
assisting NDA in connection with applications for letters patent, IND's or
New Drug Applications in any and all countries. It is understood, however,
that UM shall not charge NDA for any costs, including physician/scientist
time, incurred by UM in connection with the development and delivery of the
documents referenced in Article 6 above.
10. UM shall have publication privileges in reference to the Study. All
such publications shall keep confidential the identity of the Subjects. NDA
shall have the right to review and approve each such publication with
respect to disclosure of confidential material prior to submission for
publication. It is understood that data resulting from the Study shall not
be considered confidential material for this purpose. Such approval will
not be unreasonably withheld and will be provided within 30 calendar days
from the date of submission to NDA. In the event NDA does not respond to
the submission within such time, approval will be deemed to have been given.
11. Any and all reports or publications by UM relating to the Study shall
acknowledge that the Study was performed under Licensing Agreement with NDA
and any reference to the Procedure in such reports or publications shall
preserve NDA's trademark notice.
12. In the event this agreement shall expire or terminate for any reason,
the provisions of Paragraphs 9 and 10 under this agreement shall survive
any such expiration or termination.
13. Neither party may assign or subcontract this agreement or any of its
rights or obligations under it without the prior written consent of the
14. Each party agrees to execute, acknowledge and deliver or procure the
execution, acknowledgment or delivery of any and all further documents and
to undertake such additional action which the other may reasonably require
in order to confirm, protect or assist in the utilization of such other's
rights hereunder or to effectuate the purposes or intent of this agreement
or any provision hereof. The costs of any such action shall be at the
expense of the requesting party.
15. UM hereby represents and warrants that the performance of its
services under this agreement shall be in full compliance with all
applicable law and that it has all legal right to perform such services and
grant the rights granted to NDA hereunder without in any way infringing on
any rights of any other entity.
16. 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.
17. In the event of a breach of any provision of this agreement by either
party, the other party, in addition to any other remedy it may have, shall
be entitled to recover reasonable attorneys fees and expenses incurred as a
result of such breach.
18. All notices permitted or required under this agreement shall be in
writing and shall be delivered by overnight courier service or sent by
certified mail, return receipt requested, to the respective addresses of
the parties set forth above or to such other address as the party to
receive the notice designates by notice to the other party. Any such notice
shall be deemed effective on delivery or five days after mailing, whichever
19. This letter constitutes the entire agreement and supersedes and
terminates all prior agreements between the parties with respect to its
subject matter, may not be changed or terminated except by a writing signed
by both parties and shall by construed in accordance with the laws of the
State of New York, in which state it is deemed to have been made. 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. This agreement
shall be binding upon and shall inure to the benefit of the successors and
permitted assigns of each party. No representations or warranties other
than as expressly set forth in this agreement have been made to induce
either party to enter into this agreement.
If the foregoing meets with your approval, please sign the enclosed copy
of this letter under the words "ACCEPTED AND AGREED" and return it to us.
Very truly yours,
NDA INTERNATIONAL, INC.
By Howard S. Lotsof
ACCEPTED AND AGREED:
UNIVERSITY OF MIAMI
By Robert W. Rubin
V. P. Research