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EXHIBIT 10.28
IVUS GUIDED STENT DELIVERY SYSTEM DEVELOPMENT, SUPPLY AND DISTRIBUTION
AGREEMENT
This IVUS Guided Stent Delivery System Development, Supply and Distribution
Agreement is made this 15th day of December, 1998,
by and between
EndoSonics Europe B.V., ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇
▇▇▇▇▇▇▇▇▇▇▇ ("EndoSonics"), a wholly owned subsidiary of EndoSonics Corporation,
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇,
and
JOMED ▇.▇., ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇.▇. ▇▇▇ ▇▇▇▇▇, ▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇
▇▇▇▇▇▇▇▇▇▇▇, and any of its wholly owned subsidiaries ("JOMED").
In consideration of the mutual promises and covenants contained herein, the
parties agree as follows:
1. DEFINITIONS
As used herein the following terms when used in their capitalized form
shall have the following meanings:
1.1. "Agreement" shall mean this IVUS Guided Stent Delivery System
Development, Supply and Distribution Agreement, as amended, modified, or
supplemented from time to time by the parties as set forth herein.
1.2. "Confidential Information" shall have the meaning provided in Section 0
hereof.
1.3. "Development Plan" means the development program containing a schedule
of milestones for the completion of the Product as shall be mutually
agreed upon in writing between JOMED and EndoSonics during the
Specification Phase.
1.4. "Distribution Agreement" means the agreement so named of even date
herewith between EndoSonics Europe B.V. and JOMED N.V.
1.5. "Dollars" or "$" shall mean United States Dollars.
1.6. "Product Specifications" shall have the meaning set forth in Section 0
hereof.
1.7. "Product" means the products to be developed and manufactured under this
Agreement. The specific product and design specifications will be
defined and mutually agreed upon in writing by the parties during the
Specification Phase.
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1.8. "RGA Number" shall have the meaning set forth in Section 0 hereof.
1.9. "Specification Phase" shall have the meaning set forth in Section 0
hereof.
1.10. "Subassembly" shall mean EndoSonics' catheter shaft and intravascular
ultrasound scanner, which is suitable for integrating with JOMED's
balloons and stents.
1.11. "Term" shall have the meaning provided in Section 0 hereof.
1.12. "Territory" shall have the meaning set forth in Exhibit 4.
2. DEVELOPMENT
2.1. Specification Phase:
EndoSonics and JOMED shall use best efforts to jointly define, and agree
in writing on, the product specifications ("Product Specifications") and
Development Plan within a period of thirty (30) days following the date
of this Agreement. If EndoSonics and JOMED are unable to agree on
Product Specifications or the Development Plan either party shall have
the right to terminate this Agreement without any further obligations.
2.2. Project Manager:
EndoSonics and JOMED shall each appoint a Project Manager to act as
contact persons for the exchange of information during the development
program. The Project Managers shall provide progress reports on a
regular basis. Such reports shall enable EndoSonics and JOMED to review
the progress and activities carried out under the Development Plan.
2.3. Development Plan:
EndoSonics and JOMED shall use best efforts to carry out the Development
Plan for the Product in accordance with the terms of the Development
Plan and within all agreed upon timetables and milestones set forth
therein. Each party shall be responsible for its own expenses and
development costs under the Development Plan. Either party's failure to
meet the agreed upon milestones for a period of more than ninety (90)
days shall constitute a material breach and basis for termination of
this Agreement under Section 0.
2.4. Development Support:
Each party shall use best efforts to timely provide the other with all
support required in accordance with the Development Plan. Any material
change in the Development Plan shall be agreed to in writing between
EndoSonics and JOMED.
2.5. Disclosure of Information:
Each party shall use best efforts to assist the other to obtain, and
make available to the other on a timely basis, all information needed
for the successful completion of
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the Development Plan, including, but not limited to, results of medical
and clinical trials and results of technical, regulatory and safety
studies and evaluations performed by such party. All disclosures
hereunder are subject to the confidentiality provisions of Section 0
below.
3. MANUFACTURING; PURCHASE OF SUBASSEMBLIES
3.1. Manufacturing Scope:
The Product shall consist of a JOMED balloon and stent, incorporated
into a modular EndoSonics intravascular ultrasound catheter. During the
Term, EndoSonics and JOMED shall mutually review and agree on the most
appropriate logistics of the manufacturing process. The initial
manufacturing logistics, and the resulting obligations between the
parties are set forth in Exhibit 1.
Under the Medical Device Directive 93/42/EWG, JOMED shall be considered
as the manufacturer of Product.
3.2. Purchase of Subassemblies:
EndoSonics shall supply JOMED with all of those quantities of
Subassemblies as ordered by JOMED pursuant to this Agreement. The
Subassemblies shall be packaged by EndoSonics in its standard packaging
configuration and shall be shipped to JOMED non-sterile. Nothing
contained herein shall restrict the right of EndoSonics to sell
Subassemblies to other parties or to utilize the Subassemblies in other
products. JOMED agrees that it is buying the Subassemblies solely for
incorporation in the Product and that it will sell such Product only in
accordance with the distribution rights as set forth in Section 0.
3.3. Prices:
Prices to JOMED for Subassemblies shall be as set forth in Exhibit 2..
The price for each Subassembly shall include any labor and overhead
charges incurred for the mounting of a JOMED balloon onto an EndoSonics
catheter. EndoSonics shall provide at least 60 days prior written notice
of changes in said prices. Price changes shall not affect unfulfilled
purchase orders accepted by EndoSonics prior to the effective date of
such changes.
3.4. Forecasts:
At least thirty (30) days prior to the beginning of each calendar month
commencing with the month of February 1999, JOMED shall provide
EndoSonics with a written forecast of JOMED's expected order
requirements for Subassemblies during each of the following six (6)
months. All such forecasts shall be good faith estimates of JOMED's
requirements; provided, however, that JOMED shall be obligated to
purchase all Subassemblies specified for the initial month of each such
forecast, and provided further, that JOMED's subsequent order for the
second month of each such forecast shall not deviate by more than 30%
from said forecast.
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The initial forecast for 1999 as agreed between the parties is attached
as Exhibit 3.
3.5. Orders:
JOMED shall place any binding orders for Subassemblies by written or
electronic purchase order (or by any other means agreed to by the
parties) to EndoSonics. Such purchase orders shall set forth the desired
date of delivery with respect to the Subassemblies ordered and shall be
placed at least thirty (30) days prior to such desired date of delivery,
in accordance with the foregoing Section 0. No order shall be binding
upon EndoSonics until accepted by EndoSonics in writing. EndoSonics
shall use best efforts to deliver Subassemblies at the times specified
in its written acceptance of JOMED's purchase orders.
3.6. Payment Terms:
All invoices submitted by EndoSonics shall be payable within 60 days
net, 30 days -1% discount, from the date of such invoices. Any invoice
which is not paid in a timely manner shall accrue interest until paid at
a rate equal to the lesser of 1.5% interest per month or the highest
rate permitted by law.
3.7. Shipment:
EndoSonics shall ship, F.O.B. EndoSonics' factory, at JOMED's cost to
any location chosen by JOMED utilizing carriers approved by JOMED.
EndoSonics will pack all Subassemblies ordered hereunder in a manner
suitable for shipment and sufficient to withstand the effects of
shipping, including handling during loading and unloading. Title to the
Subassemblies sold hereunder shall pass to JOMED upon delivery to a
carrier designated by JOMED, whereupon JOMED shall assume all risk of
loss.
3.8. Pilot Manufacturing:
Immediately upon the completion of the development program, EndoSonics
and JOMED shall manufacture a total of 200 Products intended to be used
in the Registry as set forth under Section 0.
3.9. Defective Subassemblies:
Claims concerning any failure of any Subassembly to meet the warranties
set forth in Section 0 below shall be promptly made by JOMED following
such failure being discovered by JOMED. At EndoSonics' request and after
EndoSonics' issuance of a Returned Goods Authorization number ("RGA
Number"), JOMED shall forward for inspection all Subassemblies that are
the subject of JOMED's claim. EndoSonics shall inspect such
Subassemblies and, if it concurs with JOMED's claim, shall, within
fifteen (15) days from the date EndoSonics concurs with JOMED's claim,
replace the defective Subassemblies without any cost to JOMED or refund
the purchase price. If either party does not agree with the other
party's decision regarding such claim and the parties are unable to
resolve their differences within fifteen (15) days of such initial
claim, then either party may refer the matter to an independent
specialized firm of international reputation agreeable to both parties
for
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final analyses within a thirty (30) day period, which shall be a final
resolution of such issue, binding on both parties hereto. No
Subassemblies shall be returned without the prior written consent of
EndoSonics, as evidenced by the issuance of an RGA Number.
3.10. Improvements and Enhancements; Change Notices:
EndoSonics shall notify JOMED of any material changes or modifications
which may improve or enhance the performance of the Subassemblies and
shall use best efforts to timely incorporate such changes and
modifications in future deliveries of said Subassemblies.
In addition, EndoSonics shall provide JOMED with prompt notice of any
change or modification to the Subassemblies (or any change or
modification to the Specifications) to be implemented or made by
EndoSonics, to the extent such change or modification may affect the
manner in which JOMED handles the Subassemblies or markets or sells
Products incorporating the Subassemblies.
4. MINIMUM PURCHASE COMMITMENT
During the first 12 months of the Term, JOMED shall purchase a minimum
amount of [*] Subassemblies (the "Minimum Purchase Commitment"). For the
purposes of this provision, a "purchase" of Subassemblies shall mean
EndoSonics' shipment of such Subassemblies on or before the last day of
the agreed upon time period. JOMED's failure to meet the Minimum
Purchase Commitment shall constitute a material breach and basis for
termination of this Agreement under Section 0.
JOMED's purchase order 1/98SE dated 30 September 1998 for *
pilot-production catheter Subassemblies shall count towards the Minimum
Purchase Commitment as specified above.
5. REGULATORY COMPLIANCE; QUALITY ASSURANCE AND CORRECTIVE ACTIONS
5.1. Regulatory Compliance:
As the finished device manufacturer, JOMED shall be responsible for
fulfillment of all regulatory obligations including, but not limited to,
obtaining the CE ▇▇▇▇, filing medical device reports and compliance with
all other pre- and post-marketing governmental requirements. JOMED shall
use best efforts to timely fulfill said regulatory obligations. At the
request of JOMED, EndoSonics shall cooperate to permit cross-referencing
by the Food and Drug Administration ("FDA") of data from the FDA master
file for the Subassembly or parts thereof, and timely provide such
information as may be necessary to enable JOMED to comply fully with all
applicable regulatory requirements ("Regulatory Information") to a
mutually agreed upon notified body, provided that such notified body has
agreed in writing not to disclose such Regulatory Information to JOMED
or any third party except to a competent governmental authority in
connection with a regulatory process. Third
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party costs and expenses incurred in connection with the retention of
any notified body and providing such information shall be shared between
the parties.
[ * ] COFIDENTIAL TREATMENT REQUESTED. COFIDENTIAL PORTION HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.2. Quality Assurance:
With respect to the manufacturing, supply and market introduction of
Product, EndoSonics and JOMED have entered into a Quality Assurance
Agreement which is hereby incorporated as Exhibit 5..
5.3. Corrective Actions:
In the event any governmental agency having jurisdiction shall request
or order, or if JOMED shall determine to undertake any corrective action
with respect to any Product which incorporates a Subassembly, including
any recall, corrective action or market action, and the cause or basis
of such recall or action is attributable to a fault of JOMED, then JOMED
shall be liable, and shall reimburse EndoSonics, for the reasonable
costs of such action. In the event such recall is due to the fault of
EndoSonics, such costs shall be the responsibility of EndoSonics.
6. DISTRIBUTION
6.1. Distribution rights:
During the Term, and provided that the Development Plan has been
successfully completed, EndoSonics and JOMED shall mutually agree on the
geographic territories in which the Product shall be distributed and on
the most appropriate distribution channels for each of these
territories. The initial territories and distribution channels are set
forth in Exhibit 4.
Neither party shall appoint any distributor, sales agent or other
representative with respect to the Product within or outside of the
Territory, or shall solicit any business from customers outside of the
Territory, without the prior written consent of the other party.
6.2. Product Transfer Price:
In the event EndoSonics wishes to distribute Product through its direct
sales force or through a third party distributor other than JOMED, the
parties shall negotiate in good faith a reasonable transfer price to be
paid by EndoSonics to JOMED for specified quantities of the Product to
be purchased by EndoSonics. Such transfer price shall in no event be
less favorable than the price afforded by JOMED to its most favored
customer.
6.3. Exclusive Arrangement:
During the first 12 months of this Agreement, EndoSonics shall not enter
into agreements with any other parties for the sale of a product for use
in the coronary
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intravascular ultrasound market, which is substantially similar to
Product, in the Territory.
Notwithstanding the above, EndoSonics shall be free to market any
products, similar to Product, incorporating a balloon and stent
manufactured by EndoSonics, its subsidiaries, affiliates, or any other
party in which EndoSonics has a controlling interest.
6.4. Product Labeling and Promotion:
JOMED shall distribute any Product incorporating the Subassembly under a
joint EndoSonics and JOMED label, clearly identifying the corporate
names of each of the parties. Similarly, JOMED shall clearly identify
the corporate names of each of the parties in connection with the
promotion, advertising or distribution of any Product incorporating the
Subassembly.
6.5. Product Registry:
Upon completion of the pilot manufacturing of the first 200 Products as
set forth in Section 0, JOMED shall initiate a Registry including up to
20 centers in Europe which will each complete a total of 10 clinical
cases using the Product. For each clinical case, a case evaluation form
shall be completed. The information from the completed case evaluation
forms shall be shared with EndoSonics.
7. TERM - TERMINATION
7.1. Term:
The term ("Term") of this Agreement shall commence the date hereof, and,
unless terminated sooner pursuant to the provisions of Section 0, shall
terminate two (2) years from the date hereof; provided, however, that
this Agreement may be extended upon the mutual written consent of the
parties.
7.2. Termination of Agreement:
This Agreement shall terminate upon the happening of any of the
following events :
(a) either party's failure to cure the breach of any material term,
covenant, or condition of this Agreement within 60 days after
the breaching party receives notice of such breach;
(b) immediately upon written notice to one party upon a material
change in control of the other party including, without
limitation, the acquisition or merger of the other party;
(c) immediately upon either parties' cessation to function as a
going concern;
(d) immediately upon either parties' dissolution, liquidation,
insolvency, bankruptcy, assignment for the benefit of creditors
or admission in writing of its inability to pay its debts as
they mature.
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7.3. Obligations upon Termination or Expiration:
Upon termination of this Agreement for other than JOMED's breach,
EndoSonics shall continue to fulfill all orders for Subassemblies
accepted by EndoSonics prior to the date of termination.
If this Agreement is terminated by JOMED, pursuant to Section 0, JOMED
shall have no further obligation to EndoSonics except with respect to
payment for Products accepted by JOMED or shipped by EndoSonics prior to
such termination.
In the event of termination by either party in accordance with any of
the provisions of this Agreement, neither party shall be liable to the
other because of such termination, for compensation, reimbursement or
damages on account of the loss of prospective profits or anticipated
sales or on account of expenditures, inventory, investments, leases or
commitments in connection with the business or goodwill of EndoSonics or
JOMED. Termination shall not, however, relieve either party of
obligations incurred prior to the termination.
Upon termination or expiration of this Agreement, all rights granted by
EndoSonics to JOMED shall cease immediately, except that JOMED may sell,
market or distribute any Products for a period of three months following
such termination.
8. PROPRIETARY RIGHTS AND THIRD PARTY INFRINGEMENT
8.1. Proprietary Rights:
Except as expressly agreed in writing between the parties, all
proprietary rights, title, and interest (including all patent rights,
copyrights, trade secret rights and other intellectual property rights
throughout the world ("Proprietary Rights")) with respect to the
Product, including, but not limited to, all inventions (whether or not
patentable), know-how, discoveries, ideas and improvements thereof,
which are
(a) developed or conceived solely by employees of JOMED as a result
of the work performed hereunder shall be owned by JOMED;
(b) developed or conceived solely by employees of EndoSonics as a
result of the work performed hereunder shall be owned by
EndoSonics;
(c) inseparably contributed by employees of both parties shall be
jointly owned by EndoSonics and JOMED.
8.2. Third Party Infringement:
(a) JOMED shall promptly notify EndoSonics if it becomes aware of
any infringement by a third party of any patent owned or
otherwise controlled by EndoSonics. Any decision concerning the
taking of any action against such infringer shall be solely that
of EndoSonics. In the event EndoSonics decides to take any such
action, EndoSonics shall bear all expenses of any suit brought
by it based upon such infringement and shall retain all damages
or other monies awarded or received in settlement of such suit.
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(b) EndoSonics shall promptly notify JOMED if it becomes aware of
any infringement by a third party of any patent owned or
otherwise controlled by JOMED. Any decision concerning the
taking of any action against such infringer shall be solely that
of JOMED. In the event JOMED decides to take any such action,
JOMED shall bear all expenses of any suit brought by it based
uponsuch infringement and shall retain all damages or other
monies awarded or received in settlement of such suit.
9. CONFIDENTIALITY
During the Term it is anticipated that the parties shall disclose to
each other confidential or proprietary information, including but not
limited to trade secrets, know-how, documentation, pre-clinical and
clinical data, product development plans, specifications, forecasts,
customer information, notes, reports, models, and samples ("Confidential
Information"). Only such information that is marked or labeled by a
party as "Confidential Information" shall be considered Confidential
Information.
If a party orally transmits information that it deems to be of a
confidential nature, such party shall, within thirty (30) days from the
transmittal thereof, summarize such information in a written form and
▇▇▇▇ such information "Confidential" and provide a copy of such writing
to the other party. The duty of confidentiality set forth herein shall
not apply to information that:
(a) is, at the time of disclosure, in the public domain and
generally available;
(b) after disclosure, enters the public domain except where such
entry is a direct result of a breach of this Agreement;
(c) prior to disclosure, was already known to the party receiving
such information, as evidenced by its written records;
(d) subsequent to disclosure, is obtained from a third party in
possession of such information and not under a contractual or
fiduciary obligation to keep such information in confidence;
(e) is developed by the receiving party in the course of work
entirely independent of any disclosure hereunder by employees
without access or use of the disclosing party's Confidential
Information and such development can be documented to the
reasonable satisfaction of the other party hereto;
(f) is filed with any governmental or regulatory authority to the
extent required or desirable to secure governmental or
regulatory approval for marketing of the Product (provided the
receiving party shall first notify the disclosing party of the
extent of the proposed disclosure and seek to limit disclosure
and to obtain confidential treatment) and
(g) is provided to pre-clinical and clinical investigators where
necessary or desirable for their information to the extent
normal and usual in the custom of the trade and under a
confidentiality agreement with essentially the same
confidentiality provisions contained in this Section 0;
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(h) is disclosed pursuant to any judicial or governmental
requirement or order.
Except as expressly allowed herein, the receiving party shall hold in
confidence and not use or disclose any Confidential Information of the
disclosing party and shall similarly bind its employees in writing. All
Confidential Information heretofore disclosed in writing by either
party, including any Confidential Information which may be exchanged
between the parties during the term of this Agreement, shall be deemed
to have been disclosed under this Agreement and shall be subject to the
provisions of this Section 0.
10. CLAIMS AND WARRANTS
10.1. Product Claims:
JOMED shall limit claims of safety and efficacy of a Subassembly to
those statements that EndoSonics itself utilizes in connection with its
sale of Products which incorporate said Subassemblies. JOMED shall
promptly notify EndoSonics of any customer complaints and shall
cooperate with EndoSonics in the resolution of such complaints.
10.2. EndoSonics Subassembly Warrants:
EndoSonics represents and warrants to JOMED that all Subassemblies
supplied in connection with this Agreement shall, at the time of
delivery to JOMED, (i) meet the Product Specifications, (ii) be produced
in compliance with good manufacturing practices and (iii) be in
compliance with all applicable laws and regulations applicable to the
manufacture of the Subassemblies. In addition, EndoSonics represents and
warrants to JOMED that, as of the date hereof, it is aware of no patent
or patent applications, not already known to JOMED and not licensed to
JOMED or EndoSonics, owned by a third party that would present an issue
of patent infringement with respect to the manufacture, use or sale of
the Subassemblies supplied hereunder, which issue of patent infringement
would also be present in the manufacture, use or sale of such
Subassemblies without such Subassemblies ever being incorporated into a
product by JOMED. THE FOREGOING WARRANTIES ARE THE SOLE AND EXCLUSIVE
WARRANTIES OFFERED BY ENDOSONICS REGARDING SUBASSEMBLIES SUPPLIED
HEREUNDER. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, ARE DISCLAIMED. IN NO EVENT SHALL ENDOSONICS BE
LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL OR
PUNITIVE DAMAGES (INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS) ARISING
OUT OF A BREACH OF WARRANTY OR OTHER OBLIGATION UNDER THIS AGREEMENT.
JOMED shall make no warranties or claims with respect to any
Subassemblies that exceed the warranties made by EndoSonics to JOMED
herein or the claims that are utilized by EndoSonics in connection with
its sale of products incorporating the Subassemblies.
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10.3. JOMED Product Warrants:
JOMED represents and warrants to EndoSonics that all Product
manufactured in connection with this Agreement shall (i) meet the
Product Specifications, (ii) be produced in compliance with good
manufacturing practices and (iii) be in compliance with all applicable
laws and regulations applicable to the manufacture of the Product. In
addition, JOMED represents and warrants to EndoSonics that, as of the
date hereof, it is aware of no patent or patent applications, not
already known to EndoSonics and not licensed to JOMED or EndoSonics,
owned by a third party that would present an issue of patent
infringement with respect to the manufacture, use or sale of the Product
manufactured hereunder, which issue of patent infringement would also be
present in the manufacture, use or sale of such Product without such
Subassemblies ever being incorporated into a product by JOMED. THE
FOREGOING WARRANTIES ARE THE SOLE AND EXCLUSIVE WARRANTIES OFFERED BY
JOMED REGARDING PRODUCT MANUFACTURED HEREUNDER. ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE DISCLAIMED.
IN NO EVENT SHALL JOMED BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL
OR CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING WITHOUT LIMITATION, LOSS
OF PROFITS) ARISING OUT OF A BREACH OF WARRANTY OR OTHER OBLIGATION
UNDER THIS AGREEMENT.
11. INDEMNIFICATION
11.1. Indemnification by JOMED:
Except with respect to any of the following that arises from gross
negligence or willful misconduct of EndoSonics or its agents and subject
to Section 0, JOMED shall indemnify, defend and hold harmless
EndoSonics, its directors, officers, employees, customers,
representatives and agents from and against any and all claims, suits,
awards, losses, damages, demands, costs, fees and expenses incurred by
EndoSonics (including reasonable attorney's fees), and other liabilities
asserted by parties, both governmental and non-governmental, resulting
from or arising out of (a) any misrepresentation of JOMED contained
herein or breach of any warranty made by JOMED; (b) any material breach
or violation of this Agreement by JOMED; (c) the material inaccuracy of
any representation of the Product made by JOMED; or (d) a claim that the
JOMED balloon and/or stent provided under this Agreement by JOMED
individually or in combination infringes any patent.
In the event the balloon and/or stent provided by JOMED under this
Agreement, is subject to a claim of infringement, JOMED may, at its own
expense and at its option, either (a) procure for EndoSonics the right
to continue using said balloon and/or stent, (b) modify them to become
non-infringing, or (c) substitute another interchangeable balloon and/or
stent with substantially the same performance but which is
non-infringing.
11.2. Indemnification by EndoSonics:
Except with respect to any of the following that arises from the gross
negligence or
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willful misconduct of JOMED or its agents and subject to Section 0,
EndoSonics shall indemnify, defend and hold harmless JOMED, its
directors, officers, employees, customers, representatives and agents
from and against any and all claims, suits, awards, losses, damages,
demands, costs, fees and expenses (including reasonable attorneys'
fees), and other liabilities asserted by third parties, both
governmental and nongovernmental, resulting from or arising out of (a)
any misrepresentation of EndoSonics contained herein or breach of any
warranty made by EndoSonics; (b) any material breach or violation of
this Agreement by EndoSonics; (c) the material inaccuracy of any
representation of the Subassemblies made by EndoSonics; or (d) a claim
that EndoSonics' Subassembly provided under this Agreement infringes any
patent.
In the event the Subassembly provided by EndoSonics under this
Agreement, or any part thereof, is subject to a claim of infringement,
EndoSonics may, at its own expense and at its option, either (a) procure
for JOMED the right to continue using said Subassembly, (b) modify the
Subassembly to become non-infringing, or (c) substitute another
interchangeable Subassembly with substantially the same performance but
which is non-infringing.
11.3. Limitations to Indemnity:
The indemnities of Sections 0 and 0 shall not apply (a) if the
indemnified party fails to give the indemnifying party prompt notice of
any claim it receives and such failure materially prejudices the
indemnifying party, or (b) unless the indemnifying party is given the
opportunity to approve any settlement. Furthermore, the indemnifying
party shall not be liable for attorneys' fees or expenses of litigation
of the indemnified party unless the indemnified party gives the
indemnifying party the opportunity to assume control of the defense or
settlement. In addition, if the indemnifying party assumes such control,
it shall only be responsible for the legal fees and litigation expenses
of the attorneys it designates to assume control of the litigation. In
no event shall the indemnifying party assume control of the defense of
the indemnified party without the consent of the indemnified party
(which consent shall be given or not at its sole discretion).
12. MISCELLANEOUS
12.1. Relationship of Parties:
The relationship of JOMED to EndoSonics hereunder shall be solely that
of an independent contractor. JOMED and EndoSonics each acknowledge and
agree that neither JOMED nor EndoSonics is an employee, employer, agent,
partner, or joint venturer of the other.
Neither JOMED nor EndoSonics shall have or hold itself as having the
right or authority to assume or create any obligation or responsibility,
whether express or implied, on behalf of or in the name of the other,
except with the express written authority of the other.
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12.2. Notices:
All notices, requests, demands and other communications required or
permitted to be given hereunder shall be in writing, shall be deemed to
have been duly given when delivered in person, or when sent by telex or
telecopy or other facsimile transmission (with the receipt confirmed),
or on the fifth business day after posting thereof by registered or
certified mail, return receipt requested, prepaid and addressed as
follows (or such other address as the parties may designate by written
notice in the manner of aforesaid):
If to JOMED:
JOMED International AB
▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇
Attention: ▇. ▇▇▇▇▇▇, President
Telephone: +46-42-490.6000
Telefax: +46-42-490.6001
If to EndoSonics:
EndoSonics Europe ▇.▇.
▇.▇. ▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇
Attention: Dr. J.P.C. de Weerd, Managing Director
Telephone: +31-70-307.3929
Telefax: +31-70-307.3922
12.3. Governing Law:
This Agreement shall be governed by and construed in all respects in
accordance with the laws of The Netherlands.
12.4. Non-Assignment:
This Agreement may not be assigned by either party without the prior
written consent of the other party.
12.5. Entire Agreement:
This Agreement sets forth the entire understanding of the parties with
respect to the subject matter hereof. This Agreement supersedes all
prior representations, agreements and understandings among the parties
with respect to such subject matter.
12.6. Remedies Cumulative:
The rights, powers and remedies set forth herein are cumulative and
shall be in
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addition to any and all other rights, powers and remedies provided by
law. The exercise of any right or remedy hereunder shall not in any way
constitute a cure under this Agreement, or prejudice either party in the
exercise of any of its rights under this Agreement or law.
12.7. Attorneys' Fees:
If litigation between the parties arises out of or relates to this
Agreement, the prevailing party of any such litigation shall, for as
long as allowed by the law and jurisdiction ruling the litigation, be
entitled to recover from the other party its reasonable attorneys' and
legal assistants' fees and other costs incurred in such litigation.
12.8. Amendment:
No changes or amendments or alterations shall be effective unless in
writing and signed by all parties hereto.
12.9. Waiver:
No waiver of any default in the performance of any of the duties or
obligations arising out of this Agreement shall be valid unless in
writing and signed by the waiving party. Waiver of any one default shall
not constitute or be construed as creating waiver of any other default
or defaults. No course of dealing between the parties shall operate as a
waiver or preclude the exercise of any rights or remedies under this
Agreement.
Failure on the part of either party to object to any act or failure to
act of the other party, or declare the other party in default,
regardless of the extent of such default, shall not constitute a waiver
by the party of its rights hereunder.
12.10. Severability:
If any provision of this Agreement shall be held to be unenforceable in
whole or in part, then the invalidity of such provision shall not be
held to invalidate any other provision herein and all other provisions
shall remain in full force and effect.
12.11. Force Majeure:
No delay or failure of EndoSonics or JOMED to perform any of their
respective obligations under this Agreement shall be considered a breach
of this Agreement if it results from any cause beyond the control of
EndoSonics or JOMED, as the case may be, including, without limitation,
any act of God, earthquake, hurricane, fire, flood, strike, lockout or
other dispute, natural catastrophe, severe weather or public emergency,
insurrection, riot, war, transportation shortage, or actions of
governmental authorities.
12.12. Survival of Sections:
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The obligations set forth in Sections 0, 0, 0, 0, 0, 0, and 0 shall
survive the termination of this Agreement.
12.13. Counterparts:
This Agreement may be executed in one or more counterparts, including
facsimile counterparts, each of which shall be deemed an original and
all which together shall constitute one and the same agreement.
12.14. Captions:
The captions contained in this Agreement are inserted only as a matter
of convenience and in no way define, limit or extend the scope or intent
of this Agreement or any provision hereof.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first written above.
EndoSonics Europe B.V. JOMED N.V.
-------------------------- ---------------------------
Dr. J.P.C. de ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Managing Director President
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EXHIBIT 1.
INITIAL MANUFACTURING LOGISTICS
1. Responsibilities of the Parties:
In order to minimize time-to-market for the JOSONICS Flex System, the
parties have agreed on the following initial manufacturing logistics:
(a) JOMED will ship its balloons to EndoSonics.
(b) EndoSonics will integrate said balloons in its modular intravascular
ultrasound catheters, and ship fully tested Subassemblies to JOMED.
(c) JOMED will crimp its Flex Stent onto the balloon portion of the
Subassembly, final test the Product, package it and have it sterilized.
2. Supply of JOMED balloons:
Concurrent with JOMED placing a binding purchase order for Subassemblies,
pursuant to Section 0 of this Agreement, JOMED shall supply EndoSonics, free
of charge, with all balloons required to fill JOMED's purchase order for
Subassemblies plus 10%, to allow for manufacturing scrap. If EndoSonics'
manufacturing scrap exceeds 10%, EndoSonics shall order additional balloons
from JOMED, and JOMED shall supply said balloons to EndoSonics at its
manufacturing cost.
Prior to February 1, 1999, JOMED shall supply EndoSonics, free of charge,
with an initial manufacturing stock of 400 balloons.
EndoSonics agrees that it is obtaining the balloons solely for incorporation
in the Subassemblies and that it will sell such Subassemblies to JOMED only
in accordance with the terms of this Agreement.
3. Balloon Shipments:
JOMED shall ship its balloons, F.O.B. JOMED's factory, at EndoSonics' cost
to any location agreed between the parties, utilizing carriers approved by
EndoSonics. JOMED shall package all balloons hereunder in a manner suitable
for shipment and sufficient to withstand the effects of shipping, including
handling during loading and unloading.
4. Defective Balloon Claims:
Claims concerning any failure of any balloons to meet the Product
Specifications shall be promptly made by EndoSonics following such failure
being discovered by EndoSonics. At JOMED's request and after JOMED's
issuance of a Returned Goods Authorization number ("RGA Number"), EndoSonics
shall forward for inspection all balloons that are the subject of
EndoSonics' claim. No balloons shall be returned without the prior written
consent of JOMED, as evidenced by the issuance of an RGA Number. JOMED shall
use best efforts to timely resolve any balloon deficiencies and
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replace defective balloons, and shall proportionally excuse EndoSonics from
meeting its delivery schedule pursuant to Section 0 of this Agreement.
5. Improvements and Enhancements; Change Notices:
JOMED shall notify EndoSonics of any material changes or modifications which
may improve or enhance the performance of the balloons and shall use best
efforts to timely incorporate such changes and modifications in future
deliveries of said balloons.
In addition, JOMED shall provide EndoSonics with prompt notice of any change
or modification to the balloons (or any change or modification to the
Specifications) to be implemented or made by JOMED, to the extent such
change or modification may affect the manner in which EndoSonics handles the
balloons or incorporates these into the Subassemblies.
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EXHIBIT 2.
ENDOSONICS MODULAR IVUS CATHETER
SUBASSEMBLY PRICING
UNITS PRICE (US$)
----- -----------
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
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[ * ] COFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
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EXHIBIT 3.
ENDOSONICS MODULAR IVUS CATHETER
INITIAL FORECAST
[ * ]
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[ * ] COFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
EXHIBIT 4.
JOSONICS FLEX SYSTEM
TERRITORY AND DISTRIBUTION CHANNEL
TERRITORY DISTRIBUTION CHANNEL
--------- --------------------
Baltic States (Estonia, Latvia, - JOMED Distributor
Lithuania)
Turkey - JOMED Distributor
Middle East (Lebanon, Syria, Jordan, - JOMED Direct Organization / Distributors
Saudi Arabia, Kuwait, Qatar, Bahrain,
United Arab Emirates, Oman, Egypt)
Russia - JOMED Direct Organization / Distributor
Benelux - JOMED Direct Organization
France - JOMED Direct Organization
Germany - JOMED Direct Organization
Hungary - JOMED Direct Organization
Israel - JOMED Direct Organization
Italy - JOMED Direct Organization
Scandinavia (Sweden, Norway, Denmark, - JOMED Direct Organization
Finland)
United Kingdom - JOMED Direct Organization
Spain - Joint distributor Diagnostic Grifols
- JOMED's distributor Cormax (t.b.d.)
Czech Republic - Joint distributor A-Care
Slovakia - Joint distributor A-Care
Portugal - EndoSonics' distributor Material Hospitalar Lda.
Austria - EndoSonics' distributor Euromed
Bosnia - EndoSonics' distributor Euromed
Croatia - EndoSonics' distributor Euromed
Switzerland - EndoSonics' distributor Euromed
Distribution rights in the Territory include the right to sell or place
Oracle(R) Intracoronary Imaging Systems with In-Vision(TM) option, ChromaFlo
and/or 3D at customer sites in conjunction with the sale of JOSONICS Flex
Systems to said sites.
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EXHIBIT 5.
QUALITY ASSURANCE AGREEMENT
This Agreement is made this 15th day of December, 1998 between
EndoSonics Europe B.V., a company incorporated under the laws of The Netherlands
with its principal office located in Rijswijk, The Netherlands, represented by
Dr. J.P.C. de Weerd (hereinafter referred to as the "Supplier").
and
JOMED / SITOmed GmbH, a company incorporated under the laws of Germany with its
principal office located in Unterschlei(beta)▇▇▇▇, Germany, represented by ▇▇.
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ (hereinafter referred to as the "Manufacturer").
1. This Agreement governs the manufacturing, supply and market introduction of
the "VisionStent", in accordance with the Medical Device Directive
93/42/EWG. The "VisionStent" is manufactured per the specifications set
forth in attached Technical Information Sheet.
The "VisionStent" shall consist of Manufacturer's balloon and stent,
incorporated into Supplier's modular intravascular ultrasound catheter
("Modular Catheter").
2. The Manufacturer, according to the Medical Device Directive 93/42/EWG, is
JOMED Implantate GmbH.
3. This Agreement shall commence the date hereof and may be terminated at the
end of any calendar quarter by either party giving the other party at least
three (3) months written notice in advance of said date.
4. The "VisionStent" is a class III device according to Medical Device
Directive 93/42/EWG, Appendix IX.
The intended use and the specification will be described by a manufacturing
product file determined by the manufacturer.
The essential requirements according to Medical Device Directive 93/42/EWG
for the Modular Catheter, as well as the production of the Modular Catheter,
are the responsibility of the Supplier.
5. The Modular Catheter documentation according to Medical Device Directive
93/42/EWG, Appendix II, is provided by the Supplier. These documents will be
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stored for the duration of at least 5 years after the final circulation and
shall be presented on request to the notified body and the competent
national authorities. This obligation exists independent of the validation
of this Agreement.
The "VisionStent" final product documentation and filing thereof will be the
responsibility of the Manufacturer, in accordance with the Medical Device
Directive 93/42/EWG.
6. Manufacturer and Supplier shall each build up a QM-System and shall maintain
this system according to standard EN ISO 9001, EN 46001 and the Medical
Device Directive 93/42/EWG, Appendix II.
The QM-Systems of both parties shall be certified by a notified body. Each
party shall promptly inform the other, should there be any changes in the
certification of the other party.
6. Upon notification of any risk and/or malfunction (incident, near incident)
concerning the product which could result in death or serious injury to a
patient, user or other person or lead to a product recall (according to the
guidelines of the Medical Device Vigilance System, MEDDEV 2.1271 - rev. 3),
each party shall inform the other immediately. In such event both parties
shall promptly define, agree on, and implement preventive and corrective
actions and shall inform the designated competent national authorities
accordingly.
7. The Supplier shall inform the Manufacturer immediately of any changes to the
Modular Catheter and shall support these changes with suitable documentation
to the Manufacturer.
Any decision to implement design changes shall be made by the Manufacturer
in consultation with the Supplier. The documentation for such design
changes, if any, shall be in accordance with the Medical Device Directive
93/42/EWG.
8. The Supplier agrees to support any Quality audits by the notifying body, the
competent authority and/or the Manufacturer, provided proper advance
notification is given.
EndoSonics Europe B.V. JOMED GmbH
Rijswijk, The Netherlands Unterschlei(beta)▇▇▇▇
---------------------------- ------------------------------
Dr. ▇.▇.▇. ▇▇ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
▇▇
▇▇
Managing Director Vice President
Sr. Vice President Sales & Marketing Europe
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