SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
CURRENT REPORT ON FORM 8-K
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report: April 16, 1997
(Date of Earliest event reported)
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MEDIZONE INTERNATIONAL, INC.
(Exact name of Registrant as specified in its charter)
Nevada 2-93277-D 87-0412648
State of Commission IRS Taxpayer
Incorporation Registration No. I.D. Number
123 East 54th Street, Suite 7B, New York, New York 10022
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Address of Principal executive offices
Registrant's telephone number: (212) 421-0303
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Item 5. Other Events
1. Relationship with JRH Biosciences, Inc.
By letter dated April 16, 1997, Medizone International, Inc. (the
"Company") and JRH Biosciences, Inc. ("JRH"), located in Lenexa, Kansas, entered
into an agreement whose objective is to investigate the commercial applicability
of the Company's viral inactivation technology (the "Process") to treat bovine
serum manufactured by JRH and its affiliate, Filtron Pty Ltd., of Melbourne,
Australia, with a view to licensing the Process to JRH.
Pursuant to this letter, during the initial stage, JRH will investigate the
application of the Process at the lab bench level at its Lenexa, Kansas facility
and evaluate the Process' ability to maintain the bio-performance of bovine
serum subsequent to treatment with ozone, while exhibiting a sufficient degree
of viral inactivation. The Company is to provide the hardware (i.e. the ozone
generator-monitor-dosimeter) to be utilized in connection with the
investigation. The period for this investigation is projected to be twelve
months (the "Stage I Period"), during this period, the Company may not enter
into any arrangements with any other party in connection with the commercial
applicability of the Process with respect to the treatment of bovine serum. If
JRH is satisfied with the results of this initial stage, it may enter into a
subsequent agreements, pursuant to which it is envisioned that the parties would
(i) collaborate on developing a commercially viable device for the application
of the Process to bovine serum and (ii) enter into agreements to license the
Company's technology to JRH for the inactivation of viral contaminants in bovine
serum on mutually agreed to terms.
JRH may discontinue its participation in this arrangement during the Stage
I Period at any time, without penalty. In the event JRH does discontinue its
participation during the Stage I Period, the Company may enter into other
relationships for the purpose of treating bovine serum, provided, however, that
JRH will be provided with notice of such new relationships and, under certain
circumstances, will be permitted to reinstate its research and exclude such
other new relationship on the part of the Company on one occasion during the
initial twelve month period.
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2. Appointment of Chief Executive Officer - Corporate
On April 30, 1997, the Company appointed Arthur P. Bergeron to the position
of Chief Executive Officer - Corporate. Mr. Bergeron, who will remain Vice
President and Chief Financial Officer of the Company, will report directly to
the Company's Board of Directors and will be in charge of the administrative
aspects of the Company's operations, including the day-to-day general management
of the Company and its corporate finance aspects.
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the Registrant
has duly caused this Current Report to be signed on its behalf by the
undersigned, one of its officers thereunto duly authorized.
Dated: New York, NY
May 5, 1997
MEDIZONE INTERNATIONAL, INC.
By: s/Joseph S. Latino
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Joseph S. Latino
President
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EXHIBIT 10TT
Agreement between Medizone International,
Inc. and JRH Biosciences, Inc., dated April
16, 1997.
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April 16, 1997
Dr. Karen Etchberger
JRH Biosciences
13804 W. 107th Street
Lenexa, KS 66215
Fax # (913) 469-5584
Dear Karen,
Based upon our latest conversation of April 1, 1997 and the correspondence to
date, I am pleased to confirm that you wish to proceed with the project. The
following outlines the framework of the strategic partnership between JRH
Biosciences and Medizone International, Inc. Execution of this agreement by both
JRH Biosciences and Medizone International, Inc. shall constitute approval of
the contents herein. The agreement has been subdivided into three separate
Stages (I, II and III) each requiring separate documentation but focuses
primarily on Stage I (Ia and Ib) as defined below. However, the general purpose
and descriptions for Stages II and III as defined herein are prefaced with the
proviso that prior stage success and JRH Biosciences' explicit decision to go
forward to the next stage are requisite (see Go/no go option).
Objective: To license Medizone International, Inc.'s ("MII") viral inactivation
technology ("process") to JRH for the specific application of treating bovine
serum manufactured at JRH BioSciences ("JRH"), Lenexa, Kansas and Filtron Pty
Ltd., Melbourne, Australia.
Plan: Three major stages are envisioned towards licensing this process. Stage I
is broken into two sections; the first (Ia) being the biological performance of
post-treated serum, and the second (Ib) being the viral inactivation kinetics
with model viruses at conditions established in the bio-performance section.
Stage II represents a "scale-up" analysis to determine the most effective device
to be designed that will accommodate JRH's production volume (i.e. 1200
liters/day) and the manufacture of said device. Stage III is the actual
licensing process that will be based on a number of factors, including but not
limited to: market share, degree of subsidization of "scale-up" and development
costs, etc. Successful completion of each Stage, or subdivision, is necessary to
move on to the next level of investigation.
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In addition, MII will not enter into any arrangement(s) for commercial
applicability of the process with any other parties with respect to treatment of
bovine serum prior to JRH completing Stage I as proposed herein or for a period
of twelve (12) months, whichever is shorter. This period of twelve (12) months
permits for an initial three (3) month period of acclimation to the process by
JRH personnel, with the nine (9) month balance being the time period projected
to complete both Stages Ia and Ib. JRH reserves the right to discontinue the
project at any period within Stage I (Go/no go option). In the event that JRH
decides not to proceed at any stage, MII would retain sole ownership of the data
generated to the point of discontinuance of the project. Upon discontinuance,
MII would be permitted to enter into discussions with any entity for the express
purpose of treating bovine serum. Prior to entering into a formal relationship
with any entity for the purpose of treating bovine serum, MII would provide JRH
notice of its intent and offer three (3) business days for JRH to re-institute
the research from the point of discontinuance. In the event that JRH does not
chose to reinstitute the research, all data generated between JRH and MII from
commencement of the partnership to the point of discontinuance would be
delivered to MII for its use at the discretion of MII. This scenario of
restarting the program after discontinuance by JRH is for one time only, after
which any discontinuance renders all data the sole property of MII.
MII agrees that after the twelve (12) month period has elapsed, it would not
enter into any commercial arrangement with other parties that would effectively
exclude a commercial agreement with JRH unless the proposed three stage research
program was stopped short of completion by either party.
Despite the foregoing, MII is not prevented from entering into any other
relationships, research or otherwise, with any party in this field insofar as
the treatment material is not bovine serum.
During the period that JRH evaluating MII's process, any new technological
developments or advances by MII would be afforded to JRH it solely applies to
the treatment of bovine serum. Any new technological developments that are
developed in the scope of the JRH evaluation and outside the scope of MII's
present patent coverage would be owned solely by MII but would be afforded to
JRH for their use in the treatment of bovine serum only.
Stage I Objective: To investigate the application of MII's process at the lab
bench level in JRH's facility in Lenexa, Kansas and to evaluate the process'
ability to maintain bioperformance subsequent to treatment (Stage Ia) while
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exhibiting a sufficient degree of viral inactivation (Stage Ib). Upon entering
into this partnership, MII will provide hardware (ozone
generator-monitor-dosimeter), disposables, and technical expertise necessary for
JRH to perform and complete these investigations.
Ia Studies as listed below will be performed by JRH to determine the level of
bio-performance exhibited by serum treated with MII's process as compared
to untreated serum. Biological performance: Multiple passage (three)
passage growth assay on six different cell lines, plating efficiency on two
cell lines with multiple serum concentrations, cloning efficiency of one
cell line, MTT growth assay on three cell lines with multiple serum
concentrations, IgG production and biochemical profile; Satisfactory
results will be defined as expressing > 75% of control values (non- -
treated serum from the same lot as the treated material).
as Electrophoretic profile: Satisfactory results are defined as the expression
of no additional or missing bands by the treated serum as compared to
control, non-treated serum
Ib Studies as listed below will be performed by JRH on serum artificially
spiked with a number of model pathogens to determine the degree of viral
inactivation exhibited by MII's process under treatment conditions
previously defined in Stage Ia.
- Bacteria, yeast and mycoplasma: detectable absence
satisfactory
- Viruses and phage 6 log reduction is satisfactory
Pathogens:
E. coli Bovine viral diarrhea
B. pumilus Parainfluenza type 3
C. albicans Infectious bovine rhinotracheitis
Acholeplasma laidlawii Porcine parvovirus
JH Strauss Minute virus of mice
Based upon continued success, it is mutually expected that this relationship
between MII and JRH will result in either a licensing or joint venture
agreement; the terms and conditions of which are to be mutually agreed to by JRH
and MII. Regardless of format or structure, the terms and conditions of such
licensing are to be finalized prior to the inception of Stage IIb.
Upon successful completion of Stage I and with consideration to the proviso set
forth in the Go/no go option, initiation of Stage II (terms and conditions to be
memorialized formally as a
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separate agreement at the successful conclusion of Stage I), will commence. In
general, Stage II and III are envisioned as described below. Details may change
as determined and agreed to by both parties.
Stage II:
IIa A task force of personnel from JRH, MII, etc. will be appointed to analyze
and agree upon the most effective type of device necessary to "scale-up"
which will deliver MII's process.
Any commercial agreements that are acknowledged will need to take account
of marketability of the end product and this will be built into the Stage
II agreement.
IIb The development and implementation of this prototypical device or
assemblage of devices will be directed towards replicating the lab bench
inactivation model on a scale that will accommodate present daily volume
production (i.e. 1200 liters).
Upon successful completion of Stage II, licensing of MII's process as previously
discussed will be implemented.
Stage III: Licensing of MII's technology to JRH for the inactivation of viral
contaminants in bovine serum as manufactured in both JRH's and Filtron's
production facilities following terms and conditions to be mutually agreed to by
both parties.
It is understood that any release of information by MII (press, scientific,
etc.) would be provided to JRH prior to release for approval of factual content.
It is further understood that reciprocally, the same prior approval will be
afforded to MII prior to JRH making any informational release.
Medizone International, Inc. JRH Biosciences, Inc.
By:_________________________
By:_______________________
Name:_______________________
Name:_____________________
Title:______________________
Title:____________________
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