EXHIBIT
10.1
MARKETING, SALES and DISTRIBUTION AGREEMENT
Between
LABORATORIES DOLIAGE and CORONADO
INDUSTRIES
THIS AGREEMENT
made and entered into this 21st day of April 2006 (hereinafter
referred to as “Effective Date”), by and between,
Coronado Industries, Inc. having its headquarters at 16857 E.
Saguaro Blvd., Fountain Hills, Arizona 85268, its subsidiaries,
affiliates and partners (hereinafter Coronado Industries referred
to as “CI”), and Laboratoires DOLIAGE having a place of
business located at 81 rue de Verdun, 92150 Suresnes, France,
(hereinafter referred to as “DOLIAGE”).
WITNESSETH
WHEREAS , CI is engaged in the distribution and sale of
a patented Pneumatic Trabeculoplasty (PNT) device as described on
Schedule A (hereinafter called the
“Products”).
WHEREAS DOLIAGE is engaged in the business of marketing,
selling and distributing ophthalmic products within France
(hereinafter referred to as “TERRITORY”).
WHEREAS DOLIAGE has expressed an interest in marketing,
selling and distributing CI’s Pneumatic Trabeculoplasty
device (hereinafter referred to as “PNT”) which is
composed of CI’s proprietary PNT vacuum controller and
CI’s patented PNT fixation ring (hereinafter referred to as
“PRODUCTS”)
NOW
THEREFORE in
consideration of the mutual covenants herein contained, and other
good and valuable consideration, it is mutually agreed as
follows:
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1.
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APPOINTMENT AND ACCEPTANCE
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1.1.
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CI hereby
appoints DOLIAGE as CI’s exclusive partner in the Territory.
Exclusive partner in this Section 1.1 shall mean (i) that CI grants
DOLIAGE the exclusive right to promote, market, sell and distribute
the Products in the Territory under CI’s Brand name(s) and
Trademark(s) and that (ii) that CI shall not appoint any other
party than DOLIAGE to promote, market, sell and distribute the
Products in the Territory
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1.2.
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CI hereby
grants DOLIAGE rights, without the right to sublicense, to use
CI’s patents, listed in Schedule A within the Territory for
the sole purposes of carrying out DOLIAGE's obligations under this
AGREEMENT. DOLIAGE agrees to exercise these rights only as are
necessary to meet its obligations to promote, market, sell or
distribute the Products in the Territory under this Agreement.
DOLIAGE agrees not use these rights to promote, market, sell or
distribute competitive product(s) within the Territory. CI agrees
not to grant rights under the patents listed in Schedule A which
would allow a competitor to promote, market, sell or distribute a
competing medical device for the treatment of primary open angle
glaucoma or ocular hypertension within the Territory. Passive sales
by other distributors within the Territory and sales on part of the
customers of CI shall not be restricted by this
provision
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Confidential treatment has been requested with
respect to certain portions of this exhibit. Omitted portions
have been filed separately with the Securities and Exchange
Commission. This exhibit omits the information subject to the
confidentiality request. Omissions are designated as [ *
].
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1.3.
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DOLIAGE accepts
such appointment and agrees to use its commercially reasonable
efforts to promote, develop and increase sales of the Products
within the Territory. Without limiting the generality of the
foregoing, DOLIAGE shall:
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1.3.1.
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develop and
distribute to the best advantage of the Products such literature
and other advertising material as may be agreed to by CI and will
not use or release any advertising or promotional materials
(including, without limitation, labels, packages, circulars, and
advertisements) without the prior approval of CI. The consent of CI
shall not be unreasonably withheld.
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1.3.2.
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solicit
prospective purchasers who may specify or utilize the
Products;
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1.3.3.
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shall not
promote or sell any other product or other product lines which are
a medical device indicated in the non-surgical treatment of primary
open angle glaucoma or ocular hypertension.
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1.3.4.
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take no action
which might impair the goodwill or reputation of CI or any of its
affiliated companies or of the Products;
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1.3.5.
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refrain from
making quotations or writing letters under the name of CI or any of
its affiliates. The name of CI or its subsidiaries shall not appear
on stationery used by DOLIAGE, except as a marginal note showing
for example “Distributor for Coronado
Industries”;
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1.3.6.
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interface with
customers and potential customers on behalf of CI for inquiries
with respect to the Products and use of the Products;
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1.3.7.
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not make claims
with respect to indications for the Products that are not approved
by the appropriate Health Authority or other appropriate regulatory
body;
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1.3.8.
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purchase
sufficient quantities of the Products from CI so as to be able to
maintain an adequate supply for resale of the Products;
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1.3.9.
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comply with all
applicable European and French laws and regulations with regard to
the promotion, marketing, sale and distribution of the Products,
including any reporting requirements in regards to complaints or
incidents;
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1.4.
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promptly report
to CI, or its European representative which is currently
Donowa Consulting
Srl
Piazza Albania 10
00153 Rome, Italy
all complaints,
incidents or problems it receives relating to the
Products;
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1.5.
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follow all CI
marketing and promotion policies.
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1.6.
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handle and
store all Products in accordance with French and European laws and
the labeling and instructions for the Products.
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1.7.
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CI agrees to
support DOLIAGE in the promotion, marketing, sale, distribution
and/or application for reimbursement of the Products in the
Territory and the technical training for the employees of DOLIAGE.
CI may decide, at its sole discretion, whether such support is
possible for and available within CI.
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2.1.
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The Supply
Price of the Products to DOLIAGE shall be as outlined
below;
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2.1.1.
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PNT controllers
at [ * ] per controller for the first two years of
the AGREEMENT. For years three (3) and four (4) the price will be
[ * ] per controller. For year five (5) until the
end of the original AGREEMENT the costs will be [ *
] per controller.
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2.1.2.
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[ *
] per box of 100
rings. Each ring is individually packaged in a sterile sachet with
current labeling.
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2.2.
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CI will arrange
for shipment of the Products from CI’s manufacturing facility
to DOLIAGE’ warehouse in France. The cost of shipping the
Products from CI’s distribution facility to DOLIAGE’s
central receiving facility in France will be the responsibility of
CI.
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2.3.
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Payment under
Clause 2.11 and 2.22 shall be Net 45 days upon delivery of goods to
DOLIAGES’ facility.
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2.4.
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The above
Supply Prices reflect the current PNT controller and PNT ring
design and manufacturing processes. In the event the United States
Food and Drug Administration (USFDA) or any other competent
governmental health authority (HA) requires modifications to the
PNT controller and/or the PNT ring in order to allow continuing
sale within the Territory which would lead to an increase in the
manufacturing costs to CI of more than [ * ] ,
then CI would supply proper documentation supporting this increase,
and the Parties agree to negotiate a new Supply Price. If DOLIAGE
was to challenge the price increase under this clause, DOLIAGE
could have an auditor give an independent confirmation. If the
auditor found the increase was greater than or equal to [ *
] then DOLIAGE would accept the increase and pay for the
audit. If the increase was less than [ * ] then
the price would remain where it was and CI would pay for the
audit.
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2.5.
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All Supply
Prices quoted shall be understood as excluding VAT at the statutory
tax rate or custom duties, to the extent payable. All taxes and
duties due on the Products are the responsibility of
DOLIAGE.
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2.6.
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DOLIAGE will
not sell materials which are provided to them free of
charge.
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2.7.
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DOLIAGE may
return goods, including vacuum units which may require service, to
CI only in accordance with CI’s returned goods policy. Used
PNT rings cannot be returned to CI. In general CI’s returned
goods policy allows for the return of goods which are received
damaged (Section 16 below) from CI. Such damaged goods may be
returned to CI at CI’s expense. CI will provide shipping
instructions for such returns. All other returned goods will be at
the cost of DOLIAGE and such costs may be charged against the PPL
(Section 5.2.2.2).
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*
Confidential treatment has been requested with respect to
certain portions of this exhibit. Omitted portions have been
filed separately with the Securities and Exchange Commission.
This exhibit omits the information subject to the confidentiality
request. Omissions are designated as [ * ].
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2.8.
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CI will warrant
the controller for a period of [ * ] . DOLIAGE
will coordinate return of equipment under warranty, as per the
instructions of CI, for repair or replacement. The costs of
shipping the equipment under warranty from DOLIAGE’s facility
to CI’s facility will be the responsibility of CI.
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2.9.
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CI will attempt
to repair equipment, which is out of warranty, at the request of
DOLIAGE. DOLIAGE will be responsible for return shipping of the out
of warranty equipment to CI. CI will provide a cost estimate for
the repair and will only proceed if agreed to by DOLIAGE. The cost
of shipping repaired equipment back to DOLIAGE will be born by
DOLIAGE and all costs incurred by DOLIAGE, which are not reimbursed
by DOLIAGE’s customers, associated with repair of out of
warranty equipment can be charged against the PPL
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2.10.
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CI will be
responsible for the production of the Products, including sourcing
of raw materials, CI guarantees that all Products shipped to
DOLIAGE will be free from defects and in compliance with relevant
regulatory and governmental requirements, including compliance with
the requirements of an EU 2a device classification and applicable
cGMP Rules and will have sufficient expiry dating to allow for
distribution through normal distribution channels.
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3.
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SALES
OF PRODUCT OUTSIDE OF TERRITORY
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3.1.
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DOLIAGE shall
not actively sell the PRODUCTS in territories or to customers
groups which (i) CI allocated exclusively to a third party or (ii)
CI reserves for itself or for a company affiliated with
CI.
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3.2.
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Passive sales
outside the TERRITORY and sales on part of the customers of DOLIAGE
shall not be restricted by this provision.
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4.
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PROFIT
and LOSS CALCULATIONS
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4.1.
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A separate
PRODUCT Profit and Loss statement (herein referred to as the
“PPL”) will be established and maintained under this
AGREEMENT. All charges against and income credited to the PPL will
be in line with the following guidelines. In the event that a
specific charge or income item is not addressed below the PARTIES
will discuss, in good faith, how to incorporate the specific item
so that it is consistent and in the spirit of the guidelines
outlined below.
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4.1.1.
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[ *
] in support of the
PRODUCTS within the TERRITORY will be born by DOLIAGE and included
in the PPL.
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4.1.2.
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[ *
] will be credited
towards the PPL.
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4.1.3.
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DOLIAGE will
use best efforts to maximize the profits from sales of the PRODUCTS
which is credited to the PPL
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4.1.4.
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DOLIAGE will
not purposely offer discounts on PRODUCTS within the TERRITORY in
order to increase sales or achieve acceptance of other products
which DOLIAGE or one of its partners sell without the written
approval of CI. In such situations the PARTIES will agree to what
additional compensation will be credited to CI or the PPL in
consideration of the discounts that were offered on the PRODUCTS
within the TERRITORY.
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*
Confidential treatment has been requested with respect to
certain portions of this exhibit. Omitted portions have been
filed separately with the Securities and Exchange Commission.
This exhibit omits the information subject to the confidentiality
request. Omissions are designated as [ * ].
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4.1.5.
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CI will share
the cost of a clinical trial [ * ] , up to a
maximum contribution of [ * ] per year
during the first two years of the contract for a total contribution
not to exceed [ * ] . Payment will be made at the
end of each calendar year upon receipt of an invoice with
sufficient detail to explain the actual costs incurred in
performing the trial. Any payments made by CI to DOLIAGE in support
of the clinical trial will be accounted for in the P&L and
accounted for in the calculation of any profit sharing (for example
as income or an expense offset in the collaboration) so as to avoid
an inappropriate charge against the calculation of the profit
sharing. The actual schedule of the clinical trial being beyond
DOLIAGE’s control, any delay encountered while undertaking
the trial will be reported by DOLIAGE to CI in order to extend
accordingly the two years time frame originally planned for CI
participation to the cost.
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4.2.
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The PARTIES
shall agree on the marketing plan and develop a mutually agreed
upon budget for marketing activities related to the
PRODUCTS
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4.2.1.
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DOLIAGE will be
responsible for all marketing costs for the PRODUCTS within the
TERRITORY.
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4.2.2.
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All external
costs [ * ] can be charged against the PPL at full
costs
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4.3.
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DOLIAGE will
build and maintain a sales organization commensurate with the sales
potential of the Products in the Territory and employ sales
personnel trained with sufficient product knowledge to sell the
Products adequately within the Territory;
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*
Confidential treatment has been requested with respect to
certain portions of this exhibit. Omitted portions have been
filed separately with the Securities and Exchange Commission.
This exhibit omits the information subject to the confidentiality
request. Omissions are designated as [ * ].
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5.1.
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Revenue sharing
shall be based on a profit sharing model as outlined
below.
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5.2.
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Profit/loss
from the sales of PRODUCTS will be calculated as
follows;
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5.6.
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The budget year
for the PPL will coincide with DOLIAGE’s budget year, which
currently runs from October 1 st to September 30
th .
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5.7.
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DOLIAGE will
submit the final detailed PPL for the prior budget year, from which
the profit/loss will be calculated, by October 31 st of
the current budget year. For example, the final detailed PPL for
the budget year October 1, 2006 to September 30, 2007 will be
submitted to CI by October 31, 2007. CI will have the right to
review the detailed PPL and if they disagree with specific aspects
of PPL can request that they be adjusted. For the budget period
from contract initiation until September 30, 2006 the PPL will be
prepared and agreed to by May 30, 2006.
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*
Confidential treatment has been requested with respect to
certain portions of this exhibit. Omitted portions have been
filed separately with the Securities and Exchange Commission.
This exhibit omits the information subject to the confidentiality
request. Omissions are designated as [ * ].
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