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:
|
1.
|
APPOINTMENT AND ACCEPTANCE
|
|
|
1.1.
|
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
|
|
|
1.2.
|
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
|
____________
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 [ * ].
|
|
1.3.
|
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:
|
|
|
1.3.1.
|
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.
|
|
|
1.3.2.
|
solicit
prospective purchasers who may specify or utilize the
Products;
|
|
|
1.3.3.
|
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.
|
|
|
1.3.4.
|
take
no action which might impair the goodwill or reputation of CI
or any of its affiliated companies or of the
Products;
|
|
|
1.3.5.
|
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”;
|
|
|
1.3.6.
|
interface
with customers and potential customers on behalf of CI for
inquiries with respect to the Products and use of the
Products;
|
|
|
1.3.7.
|
not
make claims with respect to indications for the Products that
are not approved by the appropriate Health Authority or other
appropriate regulatory body;
|
|
|
1.3.8.
|
purchase
sufficient quantities of the Products from CI so as to be able
to maintain an adequate supply for resale of the
Products;
|
|
|
1.3.9.
|
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;
|
|
|
1.4.
|
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;
|
|
|
1.5.
|
follow
all CI marketing and promotion policies.
|
|
|
1.6.
|
handle
and store all Products in accordance with French and European
laws and the labeling and instructions for the
Products.
|
|
|
1.7.
|
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.
|
|
|
2.1.
|
The
Supply Price of the Products to DOLIAGE shall be as outlined
below;
|
|
|
2.1.1.
|
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.
|
|
|
2.1.2.
|
[ * ] per
box of 100 rings. Each ring is individually packaged in a sterile
sachet with current labeling.
|
|
|
2.2.
|
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.
|
|
|
2.3.
|
Payment
under Clause 2.11 and 2.22 shall be Net 45 days upon delivery
of goods to DOLIAGES' facility.
|
|
|
2.4.
|
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.
|
|
|
2.5.
|
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.
|
|
|
2.6.
|
DOLIAGE
will not sell materials which are provided to them free of
charge.
|
|
|
2.7.
|
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).
|
____________
*
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 [
* ].
|
|
2.8.
|
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.
|
|
|
2.9.
|
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
|
|
|
2.10.
|
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.
|
|
3.
|
SALES OF PRODUCT OUTSIDE OF TERRITORY
|
|
|
3.1.
|
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.
|
|
|
3.2.
|
Passive
sales outside the TERRITORY and sales on part of the customers
of DOLIAGE shall not be restricted by this
provision.
|
|
4.
|
PROFIT and LOSS CALCULATIONS
|
|
|
4.1.
|
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.
|
|
|
4.1.1.
|
[ * ] in
support of the PRODUCTS within the TERRITORY will be born by
DOLIAGE and included in the PPL.
|
|
|
4.1.2.
|
[ * ] will
be credited towards the PPL.
|
|
|
4.1.3.
|
DOLIAGE
will use best efforts to maximize the profits from sales of
the PRODUCTS which is credited to the PPL
|
|
|
4.1.4.
|
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.
|
____________
*
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 [
* ].
|
|
4.1.5.
|
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.
|
|
|
4.2.
|
The
PARTIES shall agree on the marketing plan and develop a
mutually agreed upon budget for marketing activities related
to the PRODUCTS
|
|
|
4.2.1.
|
DOLIAGE
will be responsible for all marketing costs for the PRODUCTS
within the TERRITORY.
|
|
|
4.2.2.
|
All
external costs
[ * ] can
be charged against the PPL at full costs
|
|
|
4.3.
|
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;
|
____________
*
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 [
* ].
|
|
5.1.
|
Revenue
sharing shall be based on a profit sharing model as outlined
below.
|
|
|
5.2.
|
Profit/loss
from the sales of PRODUCTS will be calculated as
follows;
|
|
|
5.6.
|
The
budget year for the PPL will coincide with DOLIAGE's budget
year, which currently runs from October 1
st to
September 30
th .
|
|
|
5.7.
|
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.
|
____________
*
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. O
|
