EXHIBIT 10.3
AMENDMENT NUMBER ONE TO
LICENSE AGREEMENT
This Amendment Number One ("Amendment") to the License
Agreement ("Agreement") dated December 13, 1996 by and between Vista Medical
Technologies, Inc., a Delaware corporation ("Vista"), and Imagyn Medical
Technologies, Inc., formerly Urohealth Systems, Inc., a Delaware corporation
("Imagyn") is made as of this 2nd day of October, 1998. Capitalized terms used
herein which are not defined herein shall have the definition ascribed to them
in the Agreement.
RECITALS
WHEREAS, Imagyn did not meet the performance standards set
forth on Exhibit C of the Agreement.
WHEREAS, the parties desire to modify Exhibit C of the
Agreement in order to allow Imagyn an additional opportunity to perform in
accordance with the performance standards.
WHEREAS, in order to induce Vista to modify Exhibit C of the
Agreement, Imagyn agrees to further amend the Agreement in the manner set forth
herein below.
In consideration, of the foregoing, and the promises and
covenants contained herein and other good and valuable consideration the receipt
of which is hereby acknowledged, the parties hereto agree as follows:
1. NAME CHANGE. All references to the term Urohealth set
forth in the Agreement shall be deemed to be references to Imagyn.
2. TERMINATION FOR BREACH. Section 5.2 of the Agreement is
hereby amended and restated in its entirety as follows:
"5.2 TERMINATION FOR BREACH. In the event of a
material breach of this Agreement, the nonbreaching party shall be entitled
to terminate this Agreement immediately upon written notice to the breaching
party specifying the breach. The parties agree that if: (i) *** consecutive
royalty payments are not paid when due under Section 4.4, and Imagyn fails to
pay such royalties within thirty (30) days after written notification from
Vista, (ii) Imagyn fails to pay all prosecution, maintenance and infringement
costs associated with the Patent Rights within thirty (30) days after written
notification from Vista, (iii) Imagyn fails to comply with the additional
qualifications set forth in Article 9 of this Agreement within thirty (30)
days after written notification from Vista or (iv) Imagyn fails to meet any
of the performance standards set forth on attached EXHIBIT C within the time
frame contemplated therein, including without limitation the establishment of
a direct sales force and a marketing plan and budget for the United States
and the rest of the world, each shall be deemed to be a material breach by
Imagyn permitting Vista to terminate this Agreement immediately."
3. EFFECT OF TERMINATION. Subsection 5.4(a) of the Agreement
is hereby amended and restated in its entirety as follows:
"(a) If Vista terminates this Agreement pursuant
to Sections 5.2 or 5.3 hereof, (a) the licenses granted to Imagyn under Article
2 of this Agreement shall terminate, (b) all rights to the Patent Rights,
*** Portions of this page have been omitted pursuant to
request for Confidential Treatment and filed separately with
the Commission.
Related Technical Information and Improvements shall revert to Vista, (c) all
rights to develop, make, have made, use, sell and import all Licensed Products
shall revert to Vista. In furtherance of the foregoing, within thirty (30) days
following the termination of this Agreement pursuant to Sections 5.2 or 5.3,
Imagyn shall (a) cause all physical embodiments of the Patent Rights, Related
Technical Information and Improvements to be returned to Vista and shall in
addition, provide to Vista copies of all regulatory clearances or approvals,
designs, drawings, specifications, documentation, computer files, tooling and
moulds relating to the Licensed Product and (b) execute all documents necessary
to vest title in Vista to any Improvements and to transfer to Vista any
regulatory approvals or applications relating to the Licensed Product."
4. IMAGYN PERFORMANCE STANDARDS. Exhibit C of the Agreement
is hereby amended and restated in its entirety as follows:
"EXHIBIT C
IMAGYN PERFORMANCE STANDARDS
A. Imagyn will staff a direct (company employee) sales force
in the United States. This sales force will be adequate in number to call on
gynecologists in the Operating Room setting, and in no event will be less than
*** representatives. Imagyn will seek a strategic partner to distribute the OAC
(Aspiroscope) directly to physicians in their office. Such a partnership,
subject to Vista's written approval, which will not be unreasonably withheld,
will be executed no later than ***.
B. Imagyn will complete the development of the OAC
(Aspiroscope) and begin manufacturing and distribution in the United States
by ***. Imagyn shall launch the OAC (Aspiroscope) by no later than ***. For
purposes of this paragraph "launch" shall mean, (i) have the sales force
contemplated in paragraph 1 above in place, (ii) have demonstration inventory
in the hands of each member of the sales force within 30 days of launch,
(iii) have production inventory available within 80 days of launch and (iv)
have completed final design and (v) have submitted the OAC (Aspiroscope) to
final review by the scientific advisory board for the product, which advisory
board shall include a representative designated by Vista.
C. Imagyn will complete development of other Licensed
Products, including the Female Cysto-Urethroscope, within a time frame
comparable to that for similar medical devices. Imagyn will dedicate a
reasonable allocation of development resources to the Licensed Products,
consistent with the market results of the OAC (Aspiroscope).
D. Imagyn will develop and implement marketing plans and
budgets for the introduction and continued promotion of the OAC
(Aspiroscope), and other Licensed Products as they are distributed in the
United States and worldwide, employing Imagyn's international distribution
network. Such marketing budgets will be at levels appropriate for reasonably
similar products marketed by medical device companies.
E. Imagyn will seek advice regarding clinical applications
of the OAC (Aspiroscope) and other Licensed Products, including relevant
advocacy from appropriate physician scientific advisors with the objective of
creating awareness of product line benefits in the medical community.
F. Imagyn will exhibit the OAC (Aspiroscope), and other
Licensed Products as they are introduced, at key national and international
gynecology, urology and other appropriate surgical trade shows and
conventions.
*** Portions of this page have been omitted pursuant to
request for Confidential Treatment and filed separately with
the Commission.
G. Imagyn will develop and implement training programs for
its domestic sales force and international distributors to provide adequate
levels of knowledge of clinical applications and sales methods for the OAC
(Aspiroscope) and other Licensed Products.
H. Imagyn will maintain active sales and marketing programs
for the OAC (Aspiroscope) and other Licensed Products.
I. Imagyn will pay to Vista all amount due as of the
date of this Amendment *** by no later than October 16, 1998."
5. EFFECT OF AMENDMENT.
Except as amended hereby, the Agreement shall continue in full
force and effect.
6. COUNTERPARTS.
This Amendment may be executed in any number of counterparts,
each which will be deemed an original, and all of which together shall
constitute one instrument.
7. SEVERABILITY.
If one or more provisions of this Amendment are held to be
unenforceable under applicable law, such provision shall be excluded from this
Amendment and the balance of the Amendment shall be interpreted as if such
provision were so excluded and shall be enforceable in accordance with its
terms.
8. ENTIRE AGREEMENT.
This Amendment, together with the Agreement, constitutes the
full and entire understanding and agreement between the parties with regard to
the subjects hereof and thereof.
9. GOVERNING LAW.
This Amendment shall be governed by and construed under the
laws of the State of California, without regard to principles of conflict of
laws.
*** Portions of this page have been omitted pursuant to
request for Confidential Treatment and filed separately with
the Commission.
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This Amendment is hereby executed as of the date first above written.
VISTA MEDICAL TECHNOLOGIES, INC. IMAGYN MEDICAL TECHNOLOGIES, INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇ By: /s/ ▇.▇. ▇▇▇▇
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(Signature) (Signature)
Name: ▇▇▇▇ ▇. ▇▇▇▇ Name: M. ▇▇▇▇▇▇▇▇▇ ▇▇▇▇
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(Print - Block Letters) (Print - Block Letters)
Title: Chief Executive Officer Title: Division President
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(Print - Block Letters)
[SIGNATURE PAGE TO AMENDMENT NUMBER ONE TO
LICENSE AGREEMENT]