MARKETING, SALES and DISTRIBUTION AGREEMENT Between LABORATORIES DOLIAGE and CORONADO INDUSTRIES
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 ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ ▇▇▇▇., ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇
▇▇▇▇▇, its subsidiaries, affiliates and partners (hereinafter Coronado
Industries referred to as “CI”), and Laboratoires DOLIAGE having a place of
business located at ▇▇ ▇▇▇ ▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇, (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 [ * ].
1/17
| 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
▇▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇
▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇
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.
|
2/17
| 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. |
SUPPLY
PRICE
|
| 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 [ * ].
3/17
| 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 [ * ].
4/17
| 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
|
| 4.2.3. |
[
* ]
|
| 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;
|
| 4.3.1. |
[
* ]
|
| 4.3.2. |
[
* ]
|
| 4.4. |
[
* ]
|
| 4.5. |
[
* ]
|
____________
*
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
| 5. |
PROFIT
SHARING
|
| 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;
|
| 5.2.1. |
[
* ]
|
| 5.2.1.1. |
[
* ]
|
| 5.2.1.2. |
[
* ]
|
| 5.2.2. |
[
* ]
|
| 5.2.2.1. |
[
* ]
|
| 5.2.2.2. |
[
* ]
|
| 5.2.2.3. |
[
* ]
|
| 5.2.2.4. |
[
* ]
|
| 5.2.2.5. |
[
* ]
|
| 5.2.2.6. |
[
* ]
|
| 5.2.2.7. |
[
* ]
|
| 5.2.2.8. |
[
* ]
|
| 5.2.3. |
[
* ]
|
| 5.3. |
[
* ]
|
| 5.4. |
[
* ]
|
| 5.5. |
[
* ]
|
| 5.6. |
The
budget year for the PPL will coincide with DOLIAGE’s budget year, which
currently runs from October 1st
to
September 30th.
|
| 5.7. |
DOLIAGE
will submit the final detailed PPL for the prior budget year, from
which
the profit/loss will be calculated, by October 31st
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. Omissions are designated as [ * ].
6/17
| 5.8. |
In
the event that the PARTIES cannot agreed on whether a specific
charge or
income item should be included on the PPL, the PARTIES will have
an
independent auditor, acceptable to both PARTIES with such acceptance
not
to be unreasonably withheld, review the PPL and render a decision
on
whether the charge is valid. The PARTIES will share the costs of
the
audit
|
| 5.9. |
CI
can request once a year that an independent auditor, acceptable
to both
PARTIES with such acceptance not to be unreasonably withheld, review
the
entire PPL and all supporting documentation to verify that the
PPL was
prepared in compliance with this AGREEMENT. If it is found that
additional
monies are owed CI as a result of the audit then DOLIAGE will pay
the
additional funds. If the amount of the additional monies owed CI
is
greater than 10% of the monies originally calculated in the PPL
the costs
of the external auditor will be borne by DOLIAGE otherwise the
costs of
the external auditor will be the responsibility of CI. DOLIAGE
will
provide its own resources for such audit at no cost. Reasonable
advance
notice should be given by CI of its intention to perform such an
audit,
and reasonable usage of DOLIAGE resources will be made, so as not
to
affect DOLIAGE’s operation.
|
| 5.10. |
The
PARTIES will use best efforts to finalize and close the PPL for
the prior
budget year by December 1st
of
the current budget year. For example, the PPL for the period October
1st,
2006, to September 30th, 2007 should be finalized and closed by
December
1st,
2007.
|
| 5.11. |
[
* ]
|
| 6. |
BUDGETS
|
| 6.1. |
DOLIAGE
will prepare a budget in line with the Sales and Marketing plan
agreed to
by the PARTIES. The PARTIES must mutually agree and approve each
annual
budget by December 31st
of
the prior year. For example the annual budget for the period October
1st
2006 to September 30th
2007 should be approved by December 31st,
2006.
|
| 6.2. |
If
the PARTIES do not agree on the budget submitted by DOLIAGE the
PARTIES
will discuss in good faith such differences and utilize best efforts
to
reach agreement on the annual
budget.
|
| 7. |
FORECASTING
|
| 7.1. |
On
the first day of each calendar quarter, DOLIAGE shall provide CI
with a
written rolling forecast of the requirement for the Products, per
month,
for the then current calendar quarter and the next 3 (three) calendar
quarters. The forecast for the then current calendar quarter shall
be
binding, for the remaining calendar quarter’s non-binding.
|
| 7.2. |
At
least three (3) months in advance of the requested delivery date
of the
Products, DOLIAGE shall submit to CI a written purchase order for
the
desired quantities of the Products (hereinafter referred to as
“Purchase
Order”). All Purchase Order shall be firm and binding upon the Parties
and
shall bear the exact quantity ordered and the agreed upon delivery
date.
|
____________
*
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 [ * ].
7/17
| 8. |
RELATIONSHIP
OF THE PARTIES
|
DOLIAGE
shall be an independent contractor of CI. This Agreement does not create
any
employer-employee, agency, joint venture or partnership relationship between
CI
and DOLIAGE. DOLIAGE is not authorized or empowered to act as agent for CI
for
any purpose, except those specifically outlined in this AGREEMENT, and shall
not
on behalf of CI either enter into any contract, undertaking, or agreement
of any
kind whatever, or make any promise, warranty, or representation with respect
to
the Products other than those published by CI in the advertising and sales
promotional material provided to DOLIAGE
| 9. |
NOTICES
|
Any
notices will be sent via facsimile and by a recognized express mail
carrier:
| If to DOLIAGE: | Laboratories DOLIAGE |
| ▇▇ ▇▇▇ ▇▇ ▇▇▇▇▇▇, | |
| ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, | |
| ▇▇▇▇▇▇ | |
| Facsimile: (▇▇) ▇ ▇▇ ▇▇ ▇▇ ▇▇ | |
| Attention: CEO | |
| If to CI: | Coronado Industries |
| ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ | |
| ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ | |
| ▇▇▇ | |
| Attention: CEO | |
| CC: Director of Operations | |
| Facsimile ▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ |
or
to
such other address as either Party may hereafter designate by notice to the
other Party. The date of giving of any such notice shall be on the date received
from an express mail carrier.
| 10. |
FORCE
MAJEURE
|
Neither
Party hereto will be liable to the other for its failure to perform hereunder
due to act of God, accident, fire, flood, storm, riot, sabotage, explosion,
strike, labor disturbance, national defense requirement, governmental law,
ordinance, rule or regulation, whether valid or invalid, inability to obtain
electricity or other type of energy, raw materials, labor, equipment or
transportation, or any other contingency beyond its reasonable control which
would make performance commercially impracticable. In the event of a shortage
of
Products, CI reserves the right to allocate its inventory of Products as
it may
determine in its sole discretion. Either Party may terminate this Agreement
by
giving notice in writing to the other Party should an event of force majeure
continue for more than 6 (six) months.
8/17
| 11. |
TRADEMARKS
AND PATENTS
|
| 11.1. |
CI
will be responsible for registering and maintaining all applicable
Patents
within the Territory as listed in Schedule B (hereinafter referred
to as
“Patents”) relating to the Products in the Territory at CI’s
costs.
|
| 11.2. |
By
virtue of the Agreement and DOLIAGE’s performance hereunder, DOLIAGE shall
acquire no interest in CI trademarks or corporate names, label
designs or
other identifying marks used to distinguish CI’s Products. Except for
undertaking such activities as are directly related to promoting
the sale
of the Product under this Agreement, DOLIAGE shall not make use
of the
name CI, or make use of any trademark or trade name which in the
judgment
of CI is confusingly similar thereto without the written consent
of
CI.
|
| 11.3. |
The
Parties will use their best efforts to discover any infringement
of any
Patent, Trademark or corporate name of Coronado Industries and
will
promptly notify each other of any such infringement or wrongful
use. Any
Proprietary Information provided shall be and remain the property
of CI,
and CI will impose any conditions with respect thereto which it
deems
reasonably necessary to preserve the confidential nature thereof.
DOLIAGE
will retain all Proprietary Information in strict confidence as
trade
secrets of CI and will not disclose, or permit any employee or
agent of
DOLIAGE to disclose, any Proprietary Information to anyone without
the
prior written approval of CI, provided, however, that such disclosure
may
be made to any employee of DOLIAGE who has a reasonable need for
access
thereto. For the purpose of this Agreement, the term “Proprietary
Information” shall mean all formulae, processes, and other information
relating to the distribution, sale, and use of any Product which
has been
or may hereafter be furnished to DOLIAGE and which would not be
available
to the general public otherwise than through violation of this
Agreement.
|
| 11.4. |
CI
shall use its best efforts so that DOLIAGE will not incur any claim
of
patent infringement as a result of distribution of the Products
within the
Territory under this Agreement. If such claims arise, and are attributable
to the actions of DOLIAGE allowed under this Agreement, CI will
at its own
costs use reasonable efforts to interfere and resolve the issue.
DOLIAGE
will notify CI immediately of any claims of patent infringement.
Any
liability for damages from an infringement as a direct result of
the sale
of the Products by DOLIAGE under the terms of this Agreement, will
be the
responsibility of CI. DOLIAGE will cooperate fully with CI to resolve
and/or defend against any claim of infringement under this
Agreement.
|
| 11.5. |
If
DOLIAGE is aware of a patent infringement on its territory, DOLIAGE
will
inform CI, and CI will at its own cost take any action to protect
the
patent rights.
|
| 11.6. |
Upon
the expiration or prior termination of this Agreement, DOLIAGE
will
exercise all necessary precautions to safeguard the secrecy of
Proprietary
Information and to prevent the unauthorized disclosure thereof,
DOLIAGE
will consult CI as to the procedures established by it for this
purpose
and will from time to time, if requested by CI, advise CI of the
procedures which it then has in effect.
|
| 12. |
REGISTRATIONS
AND HEALTH AUTHORITY
INTERACTIONS
|
| 12.1. |
CI,
with the assistance of DOLIAGE, will be responsible for all interactions
with the relevant Health Authorities (HA’s), including but not limited to
the Type 2a device classification filling of the Product and any
maintenance of the Type 2a filling with the relevant
authorities.
|
9/17
| 12.2. |
DOLIAGE
will bear the costs associated with any additional registration(s)
with or
applications to the relevant Health Authority(s) within in the
Territory
which are required to sell the
Products.
|
| 12.3. |
DOLIAGE,
as reasonably requested by CI, will assist, provide expertise and
interact
as required in dealing with the relevant HA’s in the
Territory.
|
| 12.4. |
CI
and DOLIAGE agree that a Type 2a device classification is required
to
allow the sale of the Products in the Territory. CI agrees to supply
DOLIAGE with Products meeting this classification and will not
knowingly
or negligently ship Products which does not meet this
classification.
|
| 13. |
CLINICAL
TRIAL
|
| 13.1. |
DOLIAGE
will be allowed to perform, in collaboration with CI, clinical
trials in
order to enhance the marketability of the PRODUCTS within the
TERRITORY
|
| 13.2. |
The
clinical trials will involve up to 2/4 centers and approximately
100
patients.
|
| 13.3. |
The
protocols for the clinical trials will be approved by both Parties
and
respective Ethical Committees prior to initiation of the
study.
|
| 13.4. |
The
costs of performing the clinical trial will be born by DOLIAGE.
CI will
reimburse DOLIAGE as outlined Section 4.1.5
above
|
| 13.5. |
DOLIAGE
will have in place confidentiality agreements with all clinicians
involved
with the clinical trial. DOLIAGE will do its best to prevent any
non-agreed dissemination regarding the clinical trial or its results
without the prior consent of CI.
|
| 13.6. |
All
information developed as part of the clinical trial will be considered
as
Confidential Information (as defined below under Section 14) and
cannot be
used for any other purpose by DOLIAGE other than to promote the
Products
in a way which is beneficial for the Product. In the event the
AGREEMENT
is terminated then all information collected under this Agreement,
including the information gathered as part of the clinical trial
will
become the property of CI. DOLIAGE also acknowledges that it will
not use
any of the information obtained under this Agreement, including
information obtained as part of the clinical trial, to promote
another
device which would compete with the
PRODUCTS.
|
| 14. |
TERM
AND TERMINATON
|
| 14.1. |
The
term of this Agreement shall be for a period of eight (8) years
from the
Effective Date of this Agreement (hereinafter referred to as “Initial
Term”). Following the Initial Term outlined above, this Agreement will
be
automatically renewable on an annual basis, unless either Party
notifies
the other 6 months prior to expiration of the Initial Term, or
each annual
extension, of their intention not to
renew.
|
10/17
| 14.2. |
If
DOLIAGE’s cumulative losses, which will be calculated as their costs
directly associated with the AGREEMENT less any monies from the
envisioned
profit share, over the first two years of the AGREEMENT exceed
150,000
Euros DOLIAGE will have an option to request a renegotiation of
the
AGREEMENT and if CORONADO declines to terminate the
AGREEMENT
|
| 14.3. |
CI
shall have the option to terminate, upon ninety (90) days’ written notice,
if ownership or control (for example. greater than 50.01 % of the
shares)
of DOLIAGE is transferred to a third party, which is considered
by CI to
be detrimental for CI’s interests. Either Party may terminate this
Agreement if the other Party is adjudged bankrupt, files or has
filed
against it any petition under any bankruptcy or insolvency law,
has a
receiver appointed for its business or property, or makes a general
assignment for the benefit of its
creditors.
|
| 14.4. |
DOLIAGE
hereby accords CI upon termination or expiration of this Agreement
an
option to repurchase from DOLIAGE all or any part of DOLIAGE’ inventory of
that Products, which DOLIAGE will not need in order to fulfill
its
delivery commitments towards its customers for commitments which
can be
documented were made prior to termination of expiration of this
Agreement
(hereinafter referred to as “Inventory Products”), at the price paid
therefore by DOLIAGE (hereinafter referred to as “Repurchase Price”),
pursuant to the following
procedures:
|
| 14.4.1. |
Within
five (5) days after the effective date of termination, DOLIAGE
shall
submit to CI a written schedule reflecting all Inventory Products
then
owned by or in DOLIAGE’ possession. Said schedule shall identify each
Inventory Product and shall indicate the quantity thereof on
hand.
|
| 14.4.2. |
Within
ten (10) days after the receipt of such schedule by CI, CI shall
have the
right to inspect the inventory reflected on such
schedule.
|
| 14.4.3. |
Within
five (5) days after completion of CI’s inspection of said inventory, CI
shall give written notice of its election to repurchase all or
any part of
the Inventory Products.
|
| 14.4.4. |
Upon
receipt of said notice of repurchase, DOLIAGE shall forthwith deliver
such
Inventory Products as may be specified therein to a carrier designated
by
CI and at the costs of CI. Payment of the Repurchase Price as hereinabove
provided shall be made by CI to DOLIAGE within five (5) days after
the
delivery of said Products to
carrier.
|
| 14.5. |
Upon
termination or expiration of this Agreement, DOLIAGE shall immediately
cease to represent itself as an authorized distributor of CI with
respect
to the Products.
|
| 14.6. |
CI
can elect, but will have no obligation, to provide additional product
in
order to allow DOLIAGE’ to fulfill commitments towards its customers
following termination or expiration of this
Agreement.
|
| 14.7. |
The
termination or expiration of this Agreement shall not release either
Party
from the obligation to pay any sum that may be owing to the other
Party or
operate to discharge any liability that had been incurred by either
Party
prior to any such termination.
|
11/17
| 14.8. |
Failure
by a Party to comply with any of its material obligations contained
in
this Agreement, including payment term obligations, shall entitle
the
non-defaulting Party to give to the defaulting Party written notice
specifying the nature of the default and requiring the defaulting
Party to
make good such default. If such default is not cured within sixty
(60)
days after the receipt of such notice (or, if such default is not
capable
of being cured within such sixty (60) day period, within such amount
of
time as may be reasonably necessary to cure such breach, as long
as the
Defaulting Party is making diligent efforts to do so, except in
the case
of payment default, as to which the defaulting Party shall have
only a
sixty (60) day cure period), the non-defaulting Party shall be
entitled
immediately to terminate this Agreement by giving written notice
to the
defaulting Party. The right of a Party to terminate this Agreement,
as
hereinafter provided, shall not be affected in any way by its waiver
or
failure to take action with respect to any previous
default.
|
| 14.9. |
The
Parties may agree in writing, signed by both Parties, to terminate
this
Agreement in its entirety. In such an event, the Parties shall
agree to
the effects of such termination at that
time.
|
| 14.10. |
If
the PARTIES cannot agree on the annual budget as outlined under
Clause 6
by November 15th
of
the prior year then either PARTY may elect to terminate this
AGREEMENT.
|
| 14.11. |
In
the event this AGREEMENT is terminated under clause 14.10 above
then
Clauses 14.4, 14.4.1, 14.4.2, 14.4.3, 14.4.4, 14.4.5, 14.5, 14.6
and 14.7
will apply.
|
| 15. |
CONFIDENTIALITY
|
A
separate Confidentiality Agreement has been previously executed by the PARTIES
and is incorporated by reference into this AGREEMENT
| 16. |
ASSIGNMENT
|
| 16.1. |
This
Agreement shall be binding upon the successors and assignees of
CI and
DOLIAGE.
|
| 16.2. |
Either
Party may assign this Agreement to a wholly owned subsidiary or
other
entity in which the transferring Party has a majority share and
operational control. In case of such an assignment, the assigning
party
will remain jointly and severally liable for all of its obligations
under
this Agreement.
|
| 16.3. |
This
Agreement shall not be assignable by either Party to an independent
third
party, without the prior written consent of the other Party, such
consent
not to be unreasonably withheld.
|
| 17. |
INDEMNIFICATION
/ DEFECTS OF THE PRODUCTS
|
| 17.1. |
CI
will indemnify, defend and hold harmless DOLIAGE from any and all
liability, loss, or damage DOLIAGE may suffer as a result of claims,
demands, costs, or judgment against it arising from product liabilities
of
any kind under any jurisdiction provided that such product liability
is
not based on DOLIAGE’ negligence in storing, maintaining, labeling,
promoting or selling the Products or otherwise failing to comply
with
applicable laws and regulations and the terms of this Agreement.
In the
latter case, DOLIAGE will indemnify, defend and hold harmless CI
from any
and all liability, loss or damage CI may suffer as a result of
such
claims, demands, costs or judgments against it.
|
12/17
| 17.2. |
For
the duration of this Agreement, each Party will maintain, at each
Party’s
own expense, insurance coverage from a reputable insurance carrier
in the
amount of a minimum of USD $1.0 million per incidence. Upon request
of a
Party, the other Party shall submit a copy of the respective certificate
of insurance.
|
| 17.3. |
DOLIAGE
shall inspect the delivered Products immediately following delivery
by CI
insofar it is practicable in the orderly course of business and
notify
apparent defects to CI within 14 days after their discovery. All
other
defects, such as hidden defects, will be notified by DOLIAGE within
14
days after their discovery.
|
| 17.4. |
If
(i) the Products delivered by CI are agreed by the Parties to be
defective
and/or (ii) if it turns out and the Parties agree that the Products
were
damaged prior to receipt by DOLIAGE and/or (iii) the Parties agree
that
the Products do not have the agreed upon quality, DOLIAGE shall
have the
right to request defect-free goods as replacement. In the event
that CI
cannot deliver within 45 days following notification by DOLIAGE
and
agreement between the Parties that the Products are defective as
described
under (i) - (iii) above DOLIAGE will have the right to cancel the
respective individual orders involving the above goods and receive
a
refund of any monies paid to CI. Removal and return deliveries
of
defective Products shall be effected at CI´s costs and
risk.
|
| 18. |
MISCELLANEOUS
|
| 18.1. |
The
provisions of this Agreement shall be construed and the performance
thereof governed in accordance with the laws of the State of New
York,
USA.
|
| 18.2. |
All
sub-distributors selected by DOLIAGE must be pre-approved by CI.
The
consent of CI shall not be unreasonably withheld. In the event
that
DOLIAGE becomes aware that a sub-distributor is in violation of
any part
of this Agreement DOLIAGE will immediately inform CI and will take
all
necessary actions to ensure compliance with this Agreement by the
sub-distributor.
|
| 18.3. |
The
article headings in this Agreement are inserted for convenience
only and
shall not be deemed to be part of this Agreement or considered
in
construing this Agreement.
|
| 18.4. |
This
Agreement constitutes the entire understanding between the Parties
and
supersedes any previous written or oral agreements or understandings
between the Parties.
|
| 18.5. |
No
modification to or waiver of the terms or conditions hereof shall
be
binding upon either Party unless approved in writing by an authorized
representative and no modification can be made by the acknowledgment
of
acceptance or by the use of purchase order forms containing other
or
different terms or conditions.
|
| 18.6. |
This
Agreement may be executed in one or more counterparts, each of
which shall
be deemed an original but all of which shall constitute one and
the same
instrument.
|
13/17
| 18.7. |
Should
the effects of this Agreement resulting from future unforeseen
events and
developments lead to an unjust hardship for either Party and which
hardship does not correspond with the intention of the Parties
in good
faith, the Parties shall without delay enter into negotiations
to see in
what way the conditions of the Agreement can be modified to suit
altered
circumstances.
|
| 18.8. |
Neither
the general terms of sale and delivery of CI nor the general terms
of
purchase of DOLIAGE shall apply to this Agreement or the individual
transactions concluded on its basis. This shall also apply if either
Party
refers to its general terms and conditions when concluding an individual
transaction.
|
| 18.9. |
All
disputes arising out of or in connection with this Agreement shall
first
be attempted to be settled between the Parties on a good faith
basis. If
the Parties are unable to resolve the dispute within 60 (sixty)
days from
the receipt by one Party of the other Party’s written notice asking for
such amicable settlement discussions, then such dispute shall be
finally
settled by arbitration in accordance with the International Chamber
of
Commerce (ICC) Rules of Arbitration by three arbitrators, appointed
in
accordance with said rules. The place of arbitration shall be New
York
City, New York, USA. The proceedings shall be conducted and all
documentation shall be presented in
English.
|
14/17
| 19. |
SCHEDULES
|
| 19.1. |
Schedule
A: Products
|
| 19.2. |
Schedule
B: Patent
|
IN
WITNESS THEREOF,
the
Parties have executed this Agreement as of the day and year first written
above.
| CORONADO INDUSTRIES, Inc. | Laboratories DOLIAGE | |||
| By: | /s/ | By: | /s/ | |
|
|
|
|||
| Name Title |
Name Title |
|||
15/17
SCHEDULE
A
| Products | ||
| PNT Vacuum Controller - Model 1000 | ||
| PNT Sterilized/Single Use/Disposable Ring - pre-sterilized polypropylene 3-port PNT ring. One (1) sterilized ring per sealed Tyvek® pouch. 100 rings per carton |
16/17
SCHEDULE
B
| Patents | ||
| Patent Number 0790803 ‘Open Angle Glaucoma Treatment Apparatus’ issued February 19, 2003 |
17/17