EXHIBIT 10.13
Agreement in Principle for Collaboration
Between Galil Medical Ltd. and Influence Medical Technologies Ltd.
Prepared and Signed on 25 March 1998
Background.
Galil Medical Ltd. is involved in the development of technology and systems used
in the performance of cryosurgery treatments in different clinical areas.
Influence Medical Technologies Ltd. is involved in the development of medical
products in the fields of urology and ear-nose-throat, and in the performance of
clinical trials on animal and human subjects.
Influence and Galil Medical are interested in collaborating in the development
and sale of equipment and a method for the treatment of the BPH problem, and for
the treatment of OSA and of enlarged tonsils, by means of cryosurgery and of
"cryo" both alternated and not alternated with heating (hyperthermia).
Subject of Collaboration.
Treatment of patients suffering from the above-mentioned pathologies by
cryogenic and hyperthermic means. The collaboration will include the areas of
the development of the technology and the products, clinical trials and the
obtaining of approvals for sale, development of production ability, production,
marketing and sales.
Non-Competition.
The companies will not compete in the areas in which they will collaborate.
Organization - Stage One.
During this stage, clinical trials will be performed on animal and human
subjects. A probe will be developed which is light and flexible along its entire
length except for the end that is inserted into the body. This end will be of a
small diameter and it will be possible by means of it to cool and heat rapidly.
In addition, a probe will be developed which is short and inflexible for ENT
use. The companies will carry out all the activities necessary in order to
obtain CE Xxxx for the product.
The companies will examine the possible methods of operation to bring about the
joint venture between them at this stage, such as: the establishment of a
company, a joint venture, etc. Accounting and tax considerations, among others,
will be taken into account.
Investments.
Influence:
Lead and perform clinical trials on animal and human subjects until CE Xxxx
approval is obtained, not including obtaining FDA approval.
Galil Medical:
Provision of the equipment necessary for the performance of clinical trials.
Development of a probe which is suitable for the procedure (a probe which is
light and flexible along its full length except for the end that is inserted
into the body. This end will be of a small diameter and it will be possible by
means of it to cool and heat rapidly. In addition, a probe of a small diameter
will be developed which is short and inflexible for ENT use. The probe will
include a device for heating in order to mold the ball and for heating in order
to prevent damage to mucous membrane.).
Authorizations of safety and electromagnetic suitability required in order to
obtain CE Xxxx.
Other operational costs will be divided equally between the companies. The
companies will divide between themselves the cost of registering and maintaining
the joint patents.
Organization - Stage Two.
During this stage, clinical trials and any additional activity necessary for
obtaining of FDA approval will be performed. A marketing and distribution system
will be established and the possibility will be examined of additional
developments including additional systems of applications, etc.
The form of organization, the required investment costs, the location of
operation, etc., will be agreed upon between the parties at a later time.
Location of Operation.
If and when a company or another framework is set up for production activity,
its location will be connected to Galil Medical, on the condition that the cost
of establishment will be competitive.
Production of Materials.
Production of materials will be performed at Galil Medical at a cost competitive
with market prices.
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Marketing.
To be agreed upon between the parties at a later time.
Ownership.
The above-mentioned projects will be owned jointly and in equal portions by
Influence and Galil Medical.
Signed:
Influence Medical Technologies Ltd. Galil Medical Ltd.
/s/ Xxxxx Xxxxx /s/ Shaike Shatzberger
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Xx. Xxxxx Xxxxx, Vice Chairman Shaike Shatzberger, General Manager
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