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Exhibit 10.33
DISTRIBUTION AGREEMENT
This Agreement is made on the 12th day of November 2007 by and
between Paradigm
Medical Industries, Inc., 2355 South 1070 West, Salt Lake City,
Utah 84119, USA,
977-8970
(hereinafter referred to as Paradigm), and LACE Elettronica srl,
Via Zoe Fontana,
220 B1, Rome
00131, Italy, 064-129-4591 (hereinafter,
together with its subsidiaries and representative offices referred
to as LACE).
The effective date of this Agreement shall be 1 January 2008, or the
date when
the product is fully completed, with all accessories and
consumables, to be sold
into the North American markets, whichever comes first. The
effective date for
Canada shall be
effective once CSA
regulatory
approval is obtained
from the
Canadian governmental regulatory body.
Paradigm and LACE wish
to enter into a
Distribution trade
agreement for the
purpose of supplying
product(s) modified or
unmodified,
in accordance with
Appendix 1, to Paradigm for the purpose of resale
under tl the
Paradignibrand
and through the Paradigm distribution channels in the USA and any other
agreed
countries. The LACE
Glaid brand, in
addition to the
Paradigm brand name
will
appear on the product.
Product branding and
brand positioning will
need to be
determined prior to product being brought into field.
1
Definitions
1.1 LACE
products shall mean the products as defined
in Appendix 1,
which will be supplied by LACE to Paradigm and by Paradigm to
its
customers/distributors
in the agreed countries under thec0-brand
of LACE Glaid brand and labeled as a Paradigm with an equal size
font in the following format: PARADIGM - GLAID by LACE.
1.2 Other
products and territories can be included and/or added under
the terms of this
agreement by means of
appending to the
items
listed in Appendix 1.
2
Liaison
2.1 Paradigm and
LACE will each appoint a primary representative who
shall be responsible
for co-coordinating
the activities of
the
parties.
2.2 The initial
primary representatives shall be:
LACE - Mr. Gualtiero Regini Paradigm - Mr. Raymond Cannefax
3
Responsibilities of
the parties
3.1 In the
interests of promoting
LACE products as part
of Paradigm
product range, the
parties agree to: a. Participate in regularly
scheduled periodic
meetings to monitor the results of this
agreement; b.
To jointly develop and collaborate in the
improvement and enhancement of the current product; c. To
develop
enhanced versions
of the current product, or to develop new
products.
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3.2 This
agreement may not be modified except by agreement of both
parties in a written document signed by both parties and
appended
to this agreement and shall not be unreasonably denied.
3.3 FDA 510(k)
approval has been
filed and obtained by
LACE. If so
determined as
necessary and
beneficial,
LACE will arrange
for
Paradigm to also be named on FDA documents.
3.4 Copies of
all FDA and CE
regulatory documents
will be provided
the Paradigm.
Regulatory
document updates will be provided to
Paradigm as soon as such are available and presented to LACE.
3.5 LACE will
maintain patent integrity on the product(s) throughout
the life of this agreement.
3.6 Paradigm
agrees to maintain
individual
product repair/history
files and notify LACE per FDA requirement of any adverse events
and report such to the
appropriate
regulatory
body within the
required time frames.
4
Maintenance and installation
4.1 Warranty:
LACE will provide
twelve (12) months warranty from the
date of delivery
to end user (purchaser) for all the LACE
products supplied to
Paradigm. If faults
cannot be corrected at
Paradigm's facilities
or at the facilities
of trained
Paradigm
repair centers,
the product then must be returned to LACE
for
repair with freight
costs being the burden of LACE.
LACE will
carry out such
repairs as required and return the goods to
Paradigm or to their designated agent or distributor within ten
(10) working days from the date of receiving such goods, at no
cost to Paradigm and will pay return freight costs.
4.2 LACE will
provide technical and product maintenance training to
Paradigm in order for
Paradigm to be able to repair products at
Paradigm's U.S.A.
facility down to the individual component
level.
4.3 LACE will
provide an extended
cost of warranty
for a second or
subsequent years to Paradigm at the initiation of this
agreement.
5
Performance
5.1 The
performance
specification
for the products as
described in
Product Manuals and
promotional
printed material shall be the
only performance
guarantee offered by
Paradigm and shall be the
same performance specifications provided by LACE.
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5.2 If
the performance specifications change, it will be the
responsibility of LACE
to notify Paradigm of the change to
specification to
any product, providing specific details
regarding the change
and the impact this change will have on the
product as well as the impact this change will have on the
users
of the products and their patients and in compliance with FDA
regulations and insure
the product is
approved by the FDA prior
to releasing the product for sale.
5.3 Paradigm,
having
global
distribution,
shall
be given
consideration
for product
placement
into countries where
Paradigm's current
distribution channels
express an interest in
the product. Paradigm
shall have the first
right of refusal for
distribution to any
other country
where Lace is not
currently
selling or marketing
the LACE Glaid
product. Distribution
for
additional (new)
territories
will be subject to
reasonable new
minimum quotas.
Paradigm, when granted
extended distribution,
shall be allowed
exclusive product distribution to Paradigm
ophthalmic and
optometric
product distributors in order to
provide for product
consistency of
Paradigm products sold by
these distributors.
The Authorized
Territories are indicated on
Appendix I.
5.4 LACE will
provide necessary product to the regulatory agencies of
countries that require
product testing by their own
regulatory
bodies, at no cost to
Paradigm. Such
countries include China,
North Korea,
Japan and others
that are not
specified in this
agreement.
6 Scope of Supply, Delivery, Pricing and Packaging
6.1 The standard
conditions of purchase
of LACE products shall apply
to all sales of all LACE products to Paradigm.
6.2 LACE will
make every effort to deliver products within the
delivery times stated in Appendix 3 of this agreement. LACE will
make Paradigm
aware of any problem
that may cause late delivery
of the products
as soon as
possible and as far in advance as
possible. Paradigm
will make LACE aware in advance of any
significant expected
increase or decrease in product order
demand. Paradigm
will notify LACE as far as possible of any
fluctuation of the estimated product delivery requirement and
LACE will use all reasonable endeavors to accommodate such
requirements. Paradigm
will provide to LACE on a monthly basis a
30-day rolling forecast.
6.3 Paradigm
agrees to purchase the
products from LACE at
the price
as specified in Appendix 2.
6.4 LACE will
acknowledge
all purchase orders
from Paradigi i three
(3) working days from receipt of the order.
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6.5 LACE will be
entitled to invoice on
shipping of the products,
which will be paid by Paradigm prior to shipping. Payment to
LACE
by Paradigm shall be as follows: An initial payment of fifty
(50)
percent will be paid to LACE at time of delivery of product
(COD)
with the fifty (50) percent balance due to LACE thirty (30)
days
when product
is received at Paradigm or at the designated
shipping location with proper acceptance of receipt.
6.6 Prices set
out in Appendix 2 will be valid for twelve months from
the effective
date. LACE will notify Paradigm six months in
advance of any price increase and will supply a new price-list
at
this
time. The product prices set out in Appendix 2 are in US
Dollars and are based on an established global banking exchange
in effect on January I, 2008. Pricing adjustments that may need
to be made in case of
a change in competitive elements or a
change in COG are defined in Appendix 2.
6.7 Installation
of the product(s)
will be arranged by
Paradigm its
nominated subsidiary, distributor, representative or agent, at
no
cost to LACE. LACE may be contacted during product installation
to answer any questions that are unique and have not been
previously addressed. A specific contact for this purpose will
be
provided by LACE.
6.8 LACE will
provide the product to
Paradigm as defined in Appendix
1, fully tested and fit for purpose and immediate use, wrapped
in
a sealed plastic bag,
supported inside a
sealed cardboard
box,
with the English operator's manual approved by Paradigm,
suitable
for airfreight and include all parts, components and accessories
that comprise each product.
6.9 LACE
will ship product directly to Paradigm international
customers when
requested in order to
improve delivery time
and
aid cost control as well as deal with regulatory issues.
Paradigm
may provide LACE with
special shipping material to be used in
such shipments such as Paradigm branded packing tape and
possibly
Paradigm branded
boxing. If agreed to, Paradigm will provide
Paradigm brand
specific labeling to
be applied to LACE products
shipped directly to Paradigm customers or distributors.
Paradigm
will provide instruction regarding the placement of the
Paradigm
specific product labels.
6.10 LACE and Paradigm
will absorb the cost of demonstration devices
that both parties agree are necessary for the proper marketing
and sales efforts of
the LACE Glaid device.
LACE will provide
special discounts for demonstration units at fifty (50%) percent
of regular price,
$6,000, with special
net-90 payment terms. It
is agreed that demo
units are not to be sold for a period of one
year after receipt of the demo unit unless otherwise negotiated
and a written modification to this Agreement is provided.
6.11 Consumables - to
be defined further as
development is completed.
The consumables are anticipated to consist of electrodes,
and/or
electrodes with wiring
harness, and/or a
wiring harness.
Also
included in this consum
