MARKETING, SALES and DISTRIBUTION AGREEMENT Between LABORATORIES DOLIAGE and CORONADO INDUSTRIESAdvertising or Marketing Agreement |
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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 [ *
].
1/17
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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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2/17
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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.
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SUPPLY
PRICE
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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 [ * ].
3/17
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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 [ * ].
4/17
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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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4.2.3.
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[
* ]
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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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4.3.1.
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[
* ]
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4.3.2.
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[
* ]
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4.4.
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[
* ]
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4.5.
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[
* ]
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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 [ * ].
5/17
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5.
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PROFIT
SHARING
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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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5.2.1.
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[
* ]
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5.2.1.1.
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[
* ]
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5.2.1.2.
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[
* ]
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5.2.2.
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[
* ]
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5.2.2.1.
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[
* ]
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5.2.2.2.
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[
* ]
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5.2.2.3.
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[
* ]
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5.2.2.4.
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[
* ]
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5.2.2.5.
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[
* ]
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5.2.2.6.
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[
* ]
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