(EXHIBIT 10U)
Medical Device Alliance Inc.
September 12, 1995
Via: Federal Express
--- ---------------
Xxxxxx Xxxxxxxx, Ph.D.
President and CEO
Misonix Incorporated
0000 Xxx Xxxxxxx
Xxxxxxxxxxx, Xxx Xxxx 00000
Re: Letter of Agreement between Medical Device Alliance, Inc. and Misonix
Incorporated
Dear Xxx:
Enclosed please find an executed fax by Medical Device Alliance, Inc., in regard
to the above referenced agreement. Also enclosed is an executed acknowledgment
of the Side Letter. A further enclosure is a cashiers check in the amount of
twenty-five thousand dollars to initiate the Exclusive Option Period.
We have faxed copies of the above to you as well as to Xxxxxx X. Xxxxxxxxx,
Xxxxxxx & Xxxxxx LLP. The originals and the check will be sent to your attention
today by Federal Express - Priority Overnight
I will contact you Wednesday, September 13 to discuss any further details.
Yours truly,
MEDICAL DEVICE ALLIANCE, INC.
Xxxxxx X. XxXxxx Chairman
DKM/md
enclosures
cc: Xxxxxx X. Wishelman Xxxxxxx & Xxxxxx LLP
0000 X. XXXXXXX XXXX, XXXX X000. XXX Xxxxx, XXXXXX 00000
PHONE (000) 000-0000 FAX (000) 000-0000
ORIGINAL
MISONIX INCORPORATED
0000 Xxx Xxxxxxx
Xxxxxxxxxxx, Xxx Xxxx 00000
September 11, 1995
Medical Device Alliance, Inc.
000 Xxxx Xxxxxxx Xxxx
Xxxxx X-000
Xxx Xxxxx, Xxxxxx 00000
Gentlemen:
Reference is made to the Letter of Agreement (hereinafter referred to as the
"Agreement"), of even date herewith between Medical Device Alliance (hereinafter
referred to as "MDA"), and Misonix Incorporated (hereinafter referred to as
"Misonix"). All definitions in the Agreement are hereby incorporated by
reference. This shall supplement the Agreement as follows:
1. Misonix has received a check drawn to its order by MDA in the amount of
twenty-five thousand dollars ($25,000.00), representing payment for the
exclusive option period under Section , paragraph C of the Agreement. However,
MDA has been advised and agrees that the effectiveness of the Agreement, and the
binding nature of the same is subject to the approval of the Board of Directors
of Misonix at a meeting to be held September 18, 1995. In order to assist the
Misonix Board in its review and evaluation, you shall supply us with a balance
sheet of MDA at least two days prior to the Board meeting showing that MDA has a
net worth of at least eight hundred thousand dollars ($800,000.00), at the date
hereof. In the event that the Misonix Board approves the Agreement, we shall
deposit your check in our account, and the Agreement shall be immediately
effective. If the Misonix Board fails to approve the Agreement, the Agreement
shall be void, the parties shall have no rights or obligations hereunder (except
for the Confidentiality Disclosure Agreement) and the check shall be forthwith
returned to you.
2. Misonix has informed MDA that two of the co-inventors of the patent,
who have assigned all interest therein to Misonix (Drs. Liang and Narayanan),
are now challenging the validity of the assignment, and asserting that Misonix
does not have exclusive rights to the patent. Misonix has contested this
assertion, and is vigorously challenging the contentions of these two persons.
However, should Misonix not be successful in this regard, MDA understands that
the patent will not be available for licensing to MDA on an exclusive basis (but
only on a non-exclusive basis), and, in such event Misonix and MDA would revise
the terms of the Licensing Agreement between them to
Page 1 of 2
reflect the fact that, while Misonix is licensing all of its rights to MDA on an
exclusive basis, other persons may obtain rights to the technology covered by
such patent from Xx. Xxxxx and Xxxxxxxxx on a non-exclusive basis. Albeit,
without the exclusive rights to U.S. Patent Number 5419761, the value of the
License Agreement may be considered to be reduced thus, MDA and Misonix will
enter good faith negotiations concerning the License payment and/or Royalty
payments provided, however, that notwithstanding the foregoing, the Agreement
shall he regarded as being on an exclusive basis with MDA, and the existing
terms prevail, unless and until a third party has produced and marketed a
medical device based upon a non-exclusive right to the aforesaid U.S. Patent No.
5419761 derived from Xx. Xxxxx and/or Narayanan.
3. The Licensing Agreement shall provide for purchase by MDA from Misonix
the following minimum number of units during the following years.
Number per year Calendar Year
--------------- -------------
75 1996
150 1997
200 1998
4. MDA shall grant Misonix, at the time of entering into the Licensing
agreement, the right and election,* at the option of Misonix for Misonix to
subscribe to purchase two hundred thousand (200,000) shares of a new class of
Series A Preferred shares of MDA, convertible one for one into common Stock of
MDA (there being approximatel y two million (2,000,000) common shares of MDA
outstanding at this time), pursuant to a proposed private placement at preferred
stock by MDA at a price of one dollar ($1.00) per share. Until MDA is publicly
traded, Misonix shall have the right to participate in any and all private
placements of equity securities on the same basis as such shares of securities
are offered to others. In addition, the price per share of the Series A
Preferred shares shall be fully protected against sales of securities of any of
MDA at a lower price. Misonix will execute an Investment Letter consistent with
the attached draft.
5. Upon the exercise of the option described in Paragraph 4 above, Misonix
will have the election to designate one (1) member to the Board of Directors of
MDA until such time as MDA makes its initial public offering. At which time the
share holders will elect the members of the Board of Directors on an annual
basis.
Sincerely, Acknowledged and Accepted:
MISONIX INCORPORATED MEDICAL DEVICE ALLIANCE, INC.
By:
------------------------------ ---------------------------------
Xxxxxx Xxxxxxxx, President Xxxxxx X. XxXxxx, Chairman
* For a period of 4 months
CONFIDENTIAL
MEDICAL DEVICE ALLIANCE INC.
As of September 15, 1995
(Unaudited)
Assets
------
Current Assets:
Cash in Bank 50,000
Securites and other cash equivalents 800,000
Notes Receivable 100,000
Total Current Assets: $950,000
Equipment & Leasehold Improvements:
Furniture & Fixtures 15,000
Equipment 40,000
Net Equipment & Leasehold lmprovements. 55,000
Other Assets:
Option on License 25,000
----------
Total Assets $1,030,000
==========
Liabilities & Shareholders' Equity
----------------------------------
Current Liabilities:
Accounts Payable 15,000
Total Current Liabilities: 15,000
Long Term Liabilities:
Loans from founders 250,000
Total Long Term Liabilities: 250,000
----------
Total Liabilities 265,000
Shareholders' Equity:
Series A Preferred Stock: Liquidating 20,000,000 shares authorized
750,000 shares outstanding
Common Stock:
50,000,000 shares authorized
2,000,000 shares outstanding 350,000
Accumulated Deficit (85,000)
Total Equity 765,000
----------
Total Liabilities and Shareholders' Equity $1,030,000
==========
LETTER OF AGREEMENT
THIS LETTER AGREEMENT is made and entered into as of the 11th day
of September, 1995 by and between MISONIX, INC., a New York Corporation with
its principal offices at 0000 Xxx Xxxxxxx, Xxxxxxxxxxx, Xxx Xxxx 00000
(hereinafter referred to as "MISONIX") and MEDICAL DEVICE ALLIANCE, INC.,
("MDA") a Nevada Corporation having its principal offices at 0000 Xxxx Xxxxxxx
Xxxx, Xxxxx X-000, Xxx Xxxxx, Xxxxxx 00000 (hereinafter referred to as "MDA").
W I T N E S S E T H:
--------------------
WHEREAS, MISONIX has a business which is, in part, based on the
research, development, and manufacturing of ultrasonic equipment for scientific
and industrial purposes; and
WHEREAS, MDA has a business that has been organized to market and
sell, on a worldwide basis, medical devices specifically designed to improve the
treatment of patients desiring a surgical procedure commonly referred to as
"Liposuction" or "Liposculpturing" (hereinafter referred to as the "Procedure");
and
WHEREAS, MISONIX has already utilized its engineering experience,
ultrasonic technology, and prototype manufacturing capabilities to design and
assemble one or more ultrasonic systems (hereinafter referred to as the
"System") specifically for use in performing the Procedure; and
WHEREAS, MDA has experience in identifying various needs in
marketing and selling to the medical fields on a worldwide basis, especially the
specialties of Plastic and Reconstructive Surgery, Cosmetic Surgery and Surgical
Dermatology; and
WHEREAS, MISONIX desires to continue further technical and
application engineering directed to advanced designs of the System utilizing its
patented technology and, in addition, manufacture the finished product; and
WHEREAS, MDA desires to use its market and selling skills to market
the System on an exclusive worldwide basis.
NOW THEREFORE, in consideration of the premises and promises,
warranties and representations herein contained, the parties hereto agree as
follows:
I. Exclusive Option Period: MISONIX will provide MDA an exclusive
option period to evaluate the System under the following conditions:
A. Length of exclusive option period to be ninety (90) calendar days,
commencing on September 11, 1995.
B. MISONIX shall deliver to MDA a functional prototype System, of the
latest design, as soon as possible, but in no case, later than
September 24, 1995.
C. MDA will pay MISONIX twenty-five thousand dollars ($25,000.00) upon
executing this Letter Agreement for the Exclusive Option Period.
D. Development funding for the autoclavability (i.e. sterilization) of
the converter and umbilical cable and the manufacturability of the
System will be provided by MDA. It is estimated at a maximum of
thirty thousand ($30,000.00) per month until the start of
production. A fifteen thousand dollar ($15,000) advance will be made
by MDA to MISONIX against future xxxxxxxx (the "Advance") for the
purpose of assuring that MISONIX will implement the start of the
subject development work as soon as possible: MISONIX will invoice
MDA following the end of each month for the actual amount expended,
which is to be paid by MDA within ten (10) working days of
invoicing by MISONIX. In this manner, the Advance will continue to
remain with MISONIX, on a month-to-month basis, as a credit balance
in favor of MDA, until the start of production, when the credit
provisions of the License Agreement (II.D) come into effect.
Estimated time frame will be six months, subject to suggestions of,
and modifications by, technicians for both parties.
E. MDA will pay MISONIX an additional twenty-five thousand dollars
($25,000.00) on November 11, 1995, for the last thirty (30) days of
the Exclusive Option Period unless:
1. MDA notifies MISONIX that it is terminating this Letter of
Agreement and thus forgoing any further rights to market and sell
the System; or
2. MISONIX and MDA have mutually agreed to the final terms and
conditions of the License Agreement that forgoes the remainder of
the Option Agreement, and is effective when an executed original of
the License Agreement, is delivered to both parties.
II. License Agreement: The License Agreement between MISONIX and MDA
shall be executed prior to the conclusion of the ninety (90) day option period
and no later than December 11, 1995, and will be good for a period of ten (10)
years ending on December 31, 2005. The basic terms and conditions of the License
Agreement shall be:
A. MDA To Receive:
1. Exclusive worldwide marketing and sales rights to the System
utilizing MISONIX Ultrasonic Liposuction technology (including
Patent No. 5,419,761; and all improvement patents and foreign
patents now or hereafter held by MISONIX). MISONIX retains the
rights to ultrasonic technologies for non-medical applications.
-2-
2. Exclusive rights to utilize MISONIX letter, dated October 15,
1993, from the U.S. Food and Drug Administration, which provides
for marketing the System under Section 510(K), based on
substantial equivalence to devices marketed prior to enactment
of the Medical Device Act of 1976.
3. Access to MISONIX technical support and the design history of
the System.
4. Right to modify specifications to meet clinical/market needs at
MDA's cost.
5. Right of name and logo selection by MDA.
6. Commitment by MISONIX to designate and supply a dedicated
product development team to work with MDA market development
team and support staffs for successful project development.
7. First right of license for existing technology improvements or
future medical technology developed by MISONIX (except for
angioplasty) while the License Agreement is in force.
B. MISONIX to Receive:
1. A License Fee payment of three hundred thousand dollars
($300,000.00) upon execution of the License Agreement.
2. MDA will provide market and application development, and a
clinical and marketing plan (milestones) to MISONIX. MDA to be
responsible for planning and funding suitable or necessary
clinical tests of the System.
3. Upon delivery of five (5) prototype units, MDA will pay the cost
of the Systems which is four thousand dollars ($4,000.00) per
unit, plus an additional License Fee of one hundred thousand
dollars ($100,000.00).
4. At the start of regular production, or one year from the date of
the License Agreement, the additional License Fee of one hundred
thousand dollars ($100,000.00) will be paid by MDA for a total
license fee payment of five hundred thousand dollars
($500,000.00).
5. Furthermore a Royalty Fee of five percent (5%) will be paid on
net sales of the System and accessories sold.
6. MDA to grant MISONIX a security interest in this License
Agreement to secure performance by MDA of its obligations
thereunder.
-3-
C. Both to Agree:
1. Mutual non-competition clause in Ultrasonic Assisted
Liposuction for the life of this Agreement.
D. Quantity and Price. MISONIX agrees to sell to MDA and MDA
agrees to buy from MISONIX one hundred percent (100%) of MDA's
requirement of the aforesaid Ultrasonic Assemblies in
accordance with the specifications set forth in Schedule A.
Technological changes and variations from the prototype
specifications shall increase the cost appropriately. The prices
can be increased by MISONIX only under one of the following
circumstances: MISONIX may, with written notification to MDA,
increase the price in accordance with the rise in the Official
Consumer Price Index (CPI). Such increase in the price in
accordance with the CPI, can be made once each year during the
term of the Agreement, except during the first year, and
whenever the cost of labor and/or raw material to MISONIX
changes substantially, MISONIX may change the price of the
Ultrasonic Units, with a ninety (90) day advance written notice
to MDA, to reflect such substantially changing and/or raw
material costs. All Ultrasonic Units for MDA will be
manufactured in accordance with the specifications set forth in
Schedule B.
All shipments will be F.O.B. point of origin. MDA will remit
payment within thirty (30) days from the date each invoice is
received by MDA with respect to shipments of Ultrasonic Units.
Credit terms: (a) open account for up to 20 Units at any time
(b) balance by Letter of Credit or fifty percent (50%) cash
payment at time of order. MDA has no obligation to pay for any
shipment of Ultrasonic Units that does not meet the
specifications as set forth in Schedule B and have been returned
to, and accepted by, MISONIX for credit.
E. Delivery. MDA shall submit purchase orders setting forth the
quantities, delivery date and shipping instructions with respect
to each shipment such purchase order to be received by MISONIX
at least ninety (90) days prior to the stipulated delivery date.
MISONIX shall ship each order to MDA or MDA's designee to the
location specified, as instructed by MDA.
F. Quality. It is understood and agreed that all Ultrasonic Units
sold to MDA hereunder will meet the established specifications,
as described in the attached Schedule B, which Schedule may be
revised from time to time by agreement of the parties
hereunder. Furthermore, MISONIX shall be responsible to adhere
to current good manufacturing practice (GMP) and to all
applicable U.S. governmental laws and regulations, as may be
amended from time to time relating to the manufacture, sale and
shipment of Ultrasonic Units sold hereunder. Cost of future
filings and modifications of units necessitated thereby to be
borne by MDA, which shall receive prior notice of proposed
actions and expenditures and shall participate in the decision
making process.
-4-
G. Quality Assurance. MISONIX will provide MDA with the test
results of all Ultrasonic Units to be shipped to MDA.
Furthermore, MISONIX shall advise MDA of any changes in the
manufacturing process or in materials which have an impact on
the quality or performance of, or regulatory issues relating to,
the Ultrasonic Units purchase hereunder.
All Ultrasonic Units delivered to MDA shall be subject to
acceptance by MDA's quality assurance staff acting reasonable.
Unless MDA gives MISONIX notice to the contrary within ten (10)
working days after receipt of a shipment of a Product, such
shipment shall be deemed to be accepted by MDA. MDA or MDA's
designee shall have the right to reject any shipment made to it
hereunder which does not meet such quality assurance
specifications when such products are received. In the event
that any such shipment is not approved by MDA because it does
not meet said specification, MDA shall advise MISONIX in writing
and MISONIX agrees to replace such shipment at its expense
including charges incurred by MDA for freight and customs
clearance if application, and resubmit to MDA within forty-five
(45) days. At MISONIX'S option, MDA shall return any such
rejected shipment to MISONIX at MISONIX'S expense.
H. Taxes. Any and all taxes imposed upon or with respect to or
measured by the sale or delivery by MISONIX to MDA of Ultrasonic
Units in accordance with MDA's instructions shall be for MDA's
account.
I. Force Majeure. MISONIX'S obligations and any delays in
deliveries hereunder or portion thereof, and MDA's obligations
to take delivery hereunder when due, shall be excused by
strikes, riots, war, invasion, acts of God, fire, explosion,
floods, delay of carrier, shortages or failures in the supply of
materials, acts of government agencies or instrumentality's,
judicial action, delay in constructing manufacturing facilities,
and other contingencies beyond the reasonable control of the
party to be excused. In such event(s), MISONIX will make
reasonable efforts to fulfill MDA's requirements for and MDA
will make reasonable efforts to take delivery of Ultrasonic
Units as defined herein, If for any of the reasons set forth
above, MISONIX shall be unable to delivery any of the agreed
upon quantities of MISONIX Ultrasonic Units when due, MISONIX
shall immediately notify MDA of such inability and of the period
for which such inability is expected to continue. In the event
MDA elects to manufacture or have Ultrasonic Units manufactured
by a third party, MDA may use or release to said third party
MISONIX'S confidential technical information and know-how
relating to Ultrasonic Units under a confidentiality agreement
acceptable to MISONIX, which shall not be unreasonably withheld,
to enable MDA or said third party to manufacture Ultrasonic
Unit for MDA's account.
J. Term. This Agreement shall be effective when signed by both
parties, and shall continue in effect for a period of ten (10)
years. MDA shall have the option to renew this Agreement for
five (5) successive one (1) year periods on the same terms and
conditions, and the price of Ultrasonic Units to be purchased
during
-5-
each one (1) year period shall also be determined pursuant to
the terms and conditions of this Agreement. MDA must notify
MISONIX that it intends to exercise the option at least sixty
(60) days prior to the expiration of the ten (10) year term of
the present Agreement, and thereafter in each successive year
at least sixty (60) days prior to the expiration of the year in
which the option is being exercised.
K. Termination for Cause. If either party shall at any time fail
to abide by any of the provisions of the Agreement, the other
party shall have the right to terminate this Agreement on sixty
(60) days prior written notice to the defaulting party
specifying the default complained of, provided, however, if said
defaulting party cures the default complained of within the said
sixty (60) day period, or if a non-monetary default which
reasonably would take more than 60 days to cure and the
defaulting party is actively taking steps to cure the same, the
Agreement shall continue in full force and effect as if no
default has occurred. The right of either party to terminate
this Agreement, as hereinabove provided, shall not be affected
in any way by its waiver of, or its failure to take action with
respect to, any previous default. This Agreement may also be
terminated by the other party in the event that a petition of
bankruptcy is filed by or against a party and not dismissed
within 30 days, or a receiver or trustee is appointed for all or
a part of the property of a party or a party makes an assignment
for the benefit of creditors.
L. Rights of Termination. Any termination of this Agreement as
provided herein shall not relieve either party of any
obligation arising hereunder prior to such termination.
M. Inability To Supply Full Requirements. In the event that MISONIX
cannot supply one hundred percent (100%) of MDA's requirement of
Ultrasonic Units, after reasonable prior notice and time to gear
up for this, MDA may either itself manufacture or have a third
party manufacture the amount not supplied by MISONIX during the
period that MISONIX cannot supply the same. MDA may release to
said third party MISONIX'S confidential information and know-how
relating to Ultrasonic Units under a confidentiality agreement
acceptable to MISONIX which shall not be unreasonably withheld,
to enable the third party to manufacture the amount of
Ultrasonic Units not supplied by MISONIX for MDA.
N. Purchase Orders. The provisions of this Agreement shall prevail
over any inconsistent statements of provisions contained in any
document related to this Agreement previously passing between
companies. This Agreement shall supersede and prevail over any
other agreement applicable to the subject matter of this
Agreement between the parties which may be in effect at the time
this Agreement is executed.
-6-
O. Limited Warranty and Liability
1. MISONIX warrants that the materials described herein shall
meet the specifications as set forth in Schedule B, but DOES
NOT WARRANT THE SUITABILITY OR USES WHICH MAY BE MADE OF THE
SAME OR THE UNITS TO BE PRODUCED HEREUNDER.
2. Except as provided in Paragraph (3) hereafter, MISONIX shall
not be liable for, and MDA assumes responsibility for, and
hereby agrees to indemnify and hold harmless MISONIX for and
against all costs, expenses and damages (including
reasonable attorney's fees arising from any claim for
personal injury and property damage resulting from the
handling of the Ultrasonic Units, following MDA's acceptance
of the Ultrasonic Units after it has completed its testing
as provided in Quality Assurance.
3. Except as provided in paragraph (5) hereof, MDA shall not
be liable for, and MISONIX assumes responsibility for and
agrees to indemnify and save harmless, MDA, for all personal
injury and property damages which occur during MISONIX'S
manufacturing process of Ultrasonic Units or which
Ultrasonic Units are being delivered to MDA or its designees
or for claims based on violations of Federal, State or local
laws or regulations applicable to employee or environmental
protection in such manufacture or delivery by MISONIX; e.g.,
a claim based on MISONIX'S violations of environmental
standards, standards dealing with providing a safe place to
work, or the transportation of hazardous materials.
4. Either party, upon learning of the claim or lawsuit, under
Paragraphs (2) or (3) of this Article, shall notify the
other, but MDA's attorneys shall handle and control such
claims or suits which fall under Paragraph on Limited
Warranty and Liability (2) and MISONIX'S attorneys shall
handle and control such claims or suits which fall under
Paragraph on Limited Warranty and Liability (3).
5. Notwithstanding the foregoing provisions hereof, MDA
shall secure product liability insurance coverage covering
personal injury and property damage for the products
produced hereunder, at the full cost and expense of MDA, in
an amount of not less than five million dollars ($5,000,000)
with a deductible of approximately two hundred thousand
dollars ($200,000), covering both MISONIX and MDA for any
and all liability. At the time of commercial sales of the
Units, the face amount of such insurance coverage shall be
increased to not less than $10,000,000.
P. Arbitration. All disputes between the parties arising hereunder
shall be finally settled by arbitration in the City of New York,
by the American Arbitration Association, by a board of three
arbitrators one of whom is selected by each party
-7-
and the third selected by the two arbitrators, or if they cannot
agree, from the lists of the American Arbitration Association.
Q. Notices. Any notice or request required or permitted to be given
under or in connection with this Agreement shall be deemed to
have been sufficiently given if in writing and delivered to an
officer of such party or sent by registered airmail, telex or
telegram, prepaid, to the party for which such notice is
intended, at the address set forth for such party below:
In the case of MDA:
President
Medical Device Alliance, Inc.\
0000 Xxxx Xxxxxxx Xxxx
Xxxxx X-000 Xxx Xxxxx, Xxxxxx 00000
In the case of MISONIX:
President
Misonix, Incorporated
0000 Xxx Xxxxxxx
Xxxxxxxxxxx, XX 00000
or to such other address for such party as it shall have
therefore furnished in writing to the other party. If sent by
mail, telex or telegram, the date of mailing or transmission
shall be deemed to be the date on which such notice or request
has been given.
R. Assignment. MDA or MISONIX may assign rights under this
Agreement in whole or in part to any of their respective
affiliates or subsidiaries. Upon the other party's request, the
assigning party shall enter into a separate counterpart
agreement with any such affiliate or subsidiary, it being
expressly agreed that assignor shall remain bound by the
obligations hereof. Such counterpart agreement shall be in the
same form as this Agreement, except for necessary changes to
reflect the extent of the assignment, the substitution of the
affiliate's or subsidiary's name, the effective date of the
assignment and the inclusion of a new provision enabling the
non-assigning party to terminate such separate counterpart
agreement in the event that the assignee ceases to be an
affiliate or subsidiary of the assigning party. This Agreement
shall not otherwise be assignable by either party without the
prior written consent of the other party.
S. Entire Agreement. This Agreement sets forth the entire Agreement
and understanding between the parties as to the subject matter
hereof and merges all prior discussions and negotiations between
them, and neither of the parties shall be bound by any
conditions, definitions, warranties, understandings or
representations with respect to such subject matter other than
as expressly provided herein or as duly set for the on or
subsequent to the date hereof in
-8-
writing and signed by a proper and duly authorized officer or
representative of the party to be bound thereby.
T. Governing Law. This Agreement shall be construed in accordance
with the laws of the Sate of New York.
U. Confidentiality. After execution of the License Agreement,
MISONIX shall disclose to MDA all technical information
reasonably necessary to use Ultrasonic Units or their
equivalents, and MDA shall hold such information except as
provided in Paragraphs dealing with Force Majeure and Inability
To Supply Full Requirement of this Agreement. MISONIX shall also
release to MDA all technical information and know-how which are
reasonably necessary to manufacture Ultrasonic Units, and MDA
may use such information the manner set forth in the
aforementioned Paragraphs of this License Agreement to
manufacture Ultrasonic Units or to have such devices
manufactured by a third party only as permitted in this License
Agreement. In addition to and not in lieu hereof, the parties
re-affirm the provisions of the confidential Disclosure
Agreement dated 8/11/95 which remains in effect and is annexed
as Schedule C hereto.
Information which is necessary for obtaining or maintaining approval of
Ultrasonic Units or its equivalents by any regulatory agency of any foreign
country shall be an exception to the above confidentiality obligations, but only
to the extent necessary and provided said confidentiality is maintained to the
fullest extent possible by MDA.
IN WITNESS WHEREOF, this Letter Agreement has been entered into as of
the day and year first above written.
Very truly yours,
ACCEPTED AND AGREED:
MISONIX, INCORPORATED MEDICAL DEVICE ALLIANCE, INC.
By: By:
------------------------------- ------------------------
Xxxxxx Xxxxxxxx Xxxxxx X. XxXxxx
Its: President and CEO Its: Chairman
-9-
Schedule A
Breakdown of estimated pricing of System components
Item Price
---- --------------------------------------------------
For Minimum of 200 100 or more Units
or more Units -----------------
------------------
Generator $2,330 $2,950
Convertor 1,400 2,050
RF Cable 700 700
Tools 50 50
Manuals 20 20
------- -------
Total System Cost $4,500* $5,770*
* Estimate as of 8/10/95
Tips and Sheaths
5MM Probe 000 000
0XX Sheath 000 000
0XX Probe 500 750
7MM Sheath 100 150
(A) Costs based upon initial commitment of 200 units
(A) All prices based upon designs and costs developed as of 9/94
(A) Costs subject to change as design is finalized
-10-
SCHEDULE B
Specifications of Ultrasonic system
Generator Model xxxx
Controls and Displays Timer: elapse time with US on resettable
Output power +/- 3%
Power Setting
On/Off switch with pilot light
Fault indicator/shut down (possible audible)
Time Totalizer (rear)
================================================================================
Output Control Adjusts amplitude of power output 0 to 100%
Rear Connector foot switch control
================================================================================
Horn Frequency 20Khz+/-__ Khz and Output power ultrasonic __ Xxxxx
================================================================================
Line Voltage Line Selectable Models for World Wide Distribution
100/120/220/240 VAC 48-60 Hz _____VA UL approval
================================================================================
Mechanical Weight __lbs _____in. L x ___ in. W x ___ in. H
================================================================================
Temperature Operating 10 degrees C to 40 degrees C
================================================================================
Tuning Factor Set with Matched converter & probe
================================================================================
Converter Weight ___ ozs. __ in. max dia. w/o cable Autoclavable*
---------
================================================================================
Probe style Type 7mm-25cm length Weight ___ ozs. Autoclavable*
----- -----
Titanium Type 5mm-25cm length Weight ___ ozs. Autoclavable*
XXX alloy Type 7mm-16cm length Weight ___ ozs. Autoclavable*
Type 5mm-16cm length Weight ___ ozs. Autoclavable*
================================================================================
Sheath style Type 7mm-25cm__ ozs. 16cm ___ ozs. Autoclavable*
------ ----- Type 5mm-25cm__ ozs. 16cm ___ ozs. Autoclavable*
================================================================================
Umbilical cable Weight ___ lbs Length 12 Ft. Autoclavable*
--------- -----
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* Autoclavable 200 cycles (500 cycle goal) by Flash sterilizer for 3 minutes at
270 degrees and 30 PSI or Normal cycle sterilizer for 30 minutes at
250 degrees F and 15 PSI
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