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EXHIBIT 10.1
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (the "Agreement") is made and entered
into as of the 15th day of July, 1996 (the "Effective Date"), between
CARDIOVASCULAR DYNAMICS, INC. ("CVD" as defined below), a California
corporation, and MEDTRONIC, INC. (as defined below, "Medtronic"), a Minnesota
corporation.
WITNESSETH:
WHEREAS, CVD is engaged in the business of developing and
manufacturing medical devices including angioplasty balloon catheters and
related devices and components; and
WHEREAS, Medtronic is engaged in the business of developing,
manufacturing, and marketing of a variety of medical devices worldwide; and
WHEREAS, Medtronic and CVD have entered into an OEM Agreement
(hereafter "OEM Agreement") with the same effective date as this Supply
Agreement whereby CVD manufactures and sells balloon catheters to Medtronic;
and
WHEREAS, CVD and Medtronic desire to enter into this Supply
Agreement whereby CVD will manufacture selected components for Medtronic.
NOW THEREFORE, in consideration of the representations,
warranties, covenants and agreements contained herein, and for other valuable
consideration, the receipt and adequacy of which is hereby acknowledged, the
parties mutually agree as follows:
ARTICLE 1
DEFINITIONS
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1.1) Specific Definitions. The Capitalized Terms in this
Agreement shall have the same definitions as set forth in the OEM Agreement
between the parties. In addition to the defined terms in the OEM Agreement, the
following terms have the meanings set forth or referenced below:
"Component" shall mean the specific angioplasty balloon
component subassembly listed on Exhibit A hereto manufactured by CVD for
Medtronic to be used in the Field of Use.
"Component Product" means any product which contains a
Component manufactured by CVD under this Agreement.
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ARTICLE 2
MANUFACTURE & SALE OF PRODUCTS
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2.1) Scope. CVD hereby agrees to manufacture and sell to
Medtronic and Medtronic agrees to purchase from CVD the Components set forth on
Exhibit A, subject to the terms and conditions of this Agreement.
2.2) CVD Distribution Rights. CVD represents and warrants
that no terms of any agreement with any third party would prohibit CVD from
selling Components to Medtronic for use with a Medtronic catheter platform in
any territory worldwide.
ARTICLE 3
GENERAL OBLIGATIONS OF MEDTRONIC
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3.1) Marketing. Medtronic shall use commercially
reasonable efforts to further the manufacture, promotion, marketing, sale
and/or other distribution of Component Products.
3.2) Quality Control. Medtronic agrees to follow
reasonable quality control standards with respect to the storage, preservation,
sale and use of the Components purchased under this Agreement. In addition,
Medtronic and CVD shall each maintain inventory and sales records with respect
to Components purchased under this Agreement in sufficient detail to enable
Medtronic to conduct an effective recall of products containing Components if
Medtronic determines that such a recall is required or otherwise necessary or
appropriate.
3.3) Import Documentation and Government Import Approvals.
Medtronic shall be responsible for obtaining all import licenses and permits as
may be required to import the Component Products into countries as selected by
Medtronic in accordance with then prevailing laws and regulations of such
countries. All such filings and registrations of the Component Products shall
be in the name of Medtronic. CVD shall cooperate fully with Medtronic in its
efforts to obtain any such approvals.
3.4) MDR Filings. Medtronic will be responsible under
Food & Drug Administration ("FDA") regulations, to the extent use of the
Components results in the requirement for Medical Device Reporting ("MDR")
filings with the FDA, Medtronic will be responsible for complying with such
reporting. Medtronic will notify CVD of any event which Medtronic deems, in
its sole discretion, requires MDR filing. CVD will assist Medtronic with
coordinating the MDR filing.
3.5) Regulatory Approvals. Except to the extent such
approvals are already held by CVD, Medtronic shall have primary responsibility
for obtaining at its expense and in its name any necessary "device" or
"medical" regulatory approvals from the U.S. Food and Drug Administration, and
applicable regulatory agencies of such other countries in the Markets as
Medtronic deems appropriate, prerequisite to the commercial sale of Component
Products (referred to herein as "Device Approval Efforts").
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ARTICLE 4
GENERAL OBLIGATIONS OF CVD
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4.1) Development, Manufacture and Supply of Components.
CVD shall use its best efforts to design, develop, and manufacture the
Components in a manner such that the Components comply with the Specifications.
CVD shall manufacture and supply the component in the quantities ordered by
Medtronic, in accordance with the specifications agreed to by the parties and
with Medtronic's schedule for delivery. CVD will not unreasonably refuse to
incorporate changes requested by Medtronic provided that Medtronic shall agree
to pay the incremental costs of manufacture to implement such changes.
4.2) Information. CVD shall upon request from time to
time by Medtronic provide Medtronic with all information in CVD's possession
reasonably necessary to enable Medtronic to discharge its responsibilities
hereunder, and CVD agrees further to consult with and advise Medtronic in
matters relating to the performance of the responsibilities of Medtronic
hereunder.
4.3) Compliance With Laws and Regulations. CVD shall be
responsible for compliance with present and future applicable statutes, laws,
ordinances and regulations of national, federal, state and local governments
now or hereafter in effect relating to its manufacture of Components. Without
limitation of the foregoing, CVD represents and warrants to Medtronic that all
Components sold and delivered to Medtronic under this Agreement will have been
manufactured in accordance with FDA Good Manufacturing Practices and all other
applicable manufacturing requirements, and that continually during the term of
this Agreement no Components delivered by CVD to Medtronic shall be adulterated
or misbranded at the time of delivery within the meaning of the U.S. Food, Drug
and Cosmetic Act and regulations thereunder. CVD shall cause Medtronic's
regulatory personnel to be provided with reasonable access from time to time to
the facilities and records of CVD for the purpose of confirming CVD's
compliance with any applicable FDA Good Manufacturing practices and all other
applicable requirements noted in this Section.
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ARTICLE 5
ORDERS FOR PRODUCTS
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5.1) Purchase Orders. Medtronic shall submit purchase
orders for Components to CVD in writing, whether by mail, telecopier, telegram,
electronic data interchange ("EDI"), or otherwise, which shall, at a minimum,
set forth the product numbers, quantities, delivery dates, and shipping
instructions and shipping addresses for all Components ordered. All orders
shall be subject to acceptance in accordance with the terms of this Agreement
by CVD at its office. Each purchase order shall, upon acceptance by CVD, give
rise to a contract between Medtronic and CVD for the sale of the Components
ordered and shall be subject to and governed by the terms of this Agreement.
The terms and conditions of this Agreement shall so govern and supersede any
additional or contrary terms set forth in Medtronic's purchase order or any CVD
or Medtronic acceptance, confirmation, invoice or other document unless duly
signed by an officer of Medtronic and an executive officer of CVD and expressly
stating and identifying which specific additional or contrary terms shall
supersede the terms and conditions of this Agreement. All purchase orders
shall be submitted at least forty-five (45) days in advance of the earliest
scheduled delivery date for such order.
5.2) Modification of Orders. No purchase order shall be
modified or canceled except upon the mutual agreement of the parties. Mutually
agreed change orders shall be subject to all provisions of this Agreement,
whether or not the change order so states. Notwithstanding the foregoing, any
purchase order may be canceled by Medtronic as to any Components which are not
delivered within thirty (30) days of the delivery date requested by Medtronic,
and any such cancellation shall not limit or affect any contract remedies
available to Medtronic with respect thereto. Any such cancellation by
Medtronic must be by written notice to CVD given within fifteen (15) business
days after such 30th day.
5.3) Delivery Terms. All deliveries of Components shall
be F.O.B. Medtronic's facility located at San Diego, California, Minneapolis,
Minnesota, or Kerkrade, The Netherlands, at Medtronic's request. CVD shall
have no further responsibility for Components, and all risk of damage to or
loss or delay of Components shall pass to Medtronic, upon their delivery at the
aforesaid F.O.B point. All Component deliveries shall be made by a common
carrier specified by Medtronic or, in the event that no carrier shall have been
specified by Medtronic on or before the date fifteen (15) days prior to the
requested shipment date, a common carrier reasonably selected by CVD. CVD
reserves all rights with respect to delivered Components which are permitted by
law, including, without limitation, the rights of rescission, repossession,
resale and stoppage in transit until the amount due from Medtronic with respect
to delivered Components has been paid in full.
5.4) Component Changes. CVD shall not, without reasonable
prior written notice to Medtronic, alter the specifications for Components used
in the manufacture of Components. CVD shall accomplish such changes in a
commercially reasonable time frame or as otherwise agreed by the parties in
writing.
4.
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5.5) Custom Components. In the event Medtronic is
requested by a customer to provide customized Components, Medtronic shall
provide the specifications for the customized Component to CVD. CVD will
promptly determine and provide to Medtronic the additional cost, if any, and
the feasibility of providing the customized Component. Medtronic will
thereafter notify CVD if it intends to provide the customer with the customized
Component and place an order.
5.6) Medtronic's Forecasts. Medtronic agrees to provide
CVD, at least forty five (45) days prior to first Commercial Release of a
Component Product in the first market, with a twelve-month forecast indicating
Medtronic's forecast purchases of Components during the twelve months following
first Commercial Release. Such forecast shall be updated by Medtronic on a
quarterly basis (based upon the calendar year) for a rolling successive
twelve-month period, which updated forecast must be received by CVD no later
than thirty (30) days prior to the first day of each succeeding quarter. Such
rolling forecasts by Medtronic shall be used for purposes of facilitating
Medtronic's marketing plans and meeting the lead times required by certain of
CVD's suppliers, but they are not legally binding on Medtronic except as set
forth in Section 5.8. Medtronic's initial forecast shall be provided no later
than August 10, 1996 or 30 days after the execution of this Agreement,
whichever is later.
5.7) Purchase Commitment. The first three months of each
quarterly forecast provided under Section 5.6 shall be a binding purchase
commitment upon Medtronic. The remainder of the forecast for each quarter
shall not be legally binding on Medtronic.
Notwithstanding any other provisions of this Agreement, the
parties agree that the minimum purchase commitment for the first year of the
agreement must be [ * ] ([*]) Components. Failure of Medtronic to purchase the
first year minimum quantity as reflected in the initial forecast to be provided
under Article 5.6 shall give CVD the right to terminate this Supply Agreement
(but not the OEM Agreement) upon written notice to Medtronic.
The minimum purchase commitment under this Article shall be
reduced by an amount equal to 0.5 times the amount of Components not supplied
by CVD within thirty (30) days of their scheduled delivery date, including but
not limited to a failure to deliver Components which conform to the then
current specifications for the Components ("Specifications"), and by an amount
equal to 1.5 times the amount of Components recalled or withdrawn from the
market if the Component covered by this Agreement is the cause of a recall from
the market or withdrawal from sale for reasons of product safety or quality as
determined by any applicable governmental authority or by the mutual agreement
of the parties.
5.8) Capacity - Preferred Status. Should CVD be unable to
meet its delivery obligations for Components, including amounts or delivery
dates, Medtronic shall be a preferred customer for delivery of what Components
are available and shall receive [ * ] ([*]%) of [ * ]. In addition, should
CVD be unable to meet its delivery obligations for Components, CVD will commit
[ * ] ([*]%)
* Confidential Treatment Requested
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of [ * ] until its delivery obligations to Medtronic are fulfilled.
ARTICLE 6
PRICES AND PAYMENTS
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6.1) Prices. Unless and until otherwise mutually agreed
by the parties in writing, the purchase prices per unit of Components to
Medtronic under this Agreement shall be as follows:
(i) Initial Price. The initial purchase price of a
Component shall remain in effect for twelve (12) months from the date
of Commercial Release (the "Initial Price Period"). The price for
such Component during the Initial Price Period shall be as set forth
in Exhibit B attached hereto.
(ii) Adjustments to Price.
(a) If the prices of comparable U.S. catheter products
[ * ]% during any period in which a Component Product is sold (as
determined from IMS surveys or other reputable industry data surveys),
then Medtronic may request that the purchase price be adjusted by an
equivalent percentage change. Provided, such change [ * ]% in any 12
month period. Such adjusted price to apply until further adjusted
pursuant to this paragraph or agreed by the parties.
(b) If CVD's cost of manufacture of Components [ * ]% CVD
may increase its prices for Components by providing Medtronic with at
least ninety (90) days prior written notice; provided that any price
increases [ * ] ([*]) percent of the price in effect during the
immediately preceding twelve (12) month period. CVD shall provide
Medtronic with evidence substantiating such an increase in its cost of
production or raw materials of such product. Increased prices shall
not apply to purchase orders accepted prior to the effective date of
the price increase unless such orders provide for delivery, and
delivery is in fact made, more than one hundred and twenty (120) days
after acceptance of the order. In the event CVD increases its price
under this section, Medtronic shall have the right to adjust its
forecasts and quotas as mutually agreed by the parties to reflect such
price changes. Medtronic shall have the right, no more than once in
any eighteen month period, upon written notice to CVD and during
regular business hours, to have an independent representative audit
the relevant books and records of CVD to verify compliance with this
provision. The report of such representative to Medtronic shall be
limited to an opinion that CVD is, or is not, in compliance with this
provision.
* Confidential Treatment Requested
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(c) CVD agrees that cost savings or cost reductions made
possible due to volume or technological improvements shall be shared
with Medtronic and price adjustments shall be made in an amount equal
to one-half of such savings or reduction in cost. Medtronic shall
have the right, no more than once in any eighteen month period, upon
written notice to CVD and during regular business hours, to have an
independent representative audit the relevant books and records of CVD
to verify compliance with this provision. The report of such
representative to Medtronic shall be limited to an opinion that CVD
is, or is not, in compliance with this provision.
(d) CVD agrees that if Components are delivered and
accepted by Medtronic more than [*] ([*]) days after the scheduled
delivery date for such Components, the price of any such Components
will be reduced by [*] ($[*]) [*].
6.2) Records. Medtronic agrees to keep accurate written
records sufficient in detail to enable the purchase volume of each Component to
be determined and verified by CVD. Such records for each six-month period
subsequent to the Initial Price Period shall be retained by Medtronic for a
period of not less than three years after the end of such six-month period.
6.3) Audit of Records. Upon reasonable notice and during
regular business hours, Medtronic shall from time to time (but no more
frequently than once annually) make available the records referred to in
Section 6.2 for audit at CVD's expense by independent representatives selected
by CVD to verify the accuracy of the reports provided to CVD. Such
representatives shall execute a suitable confidentiality agreement reasonably
acceptable to Medtronic prior to conducting such audit. Such representatives
may disclose to CVD only its conclusions regarding the accuracy of Medtronic's
calculation of the purchase volume of each Component, and shall not disclose
Medtronic's confidential business information to CVD without the prior written
consent of Medtronic.
6.4) Payment Terms. Payments made by Medtronic for
Components purchased hereunder shall be due and payable in full within thirty
(30) days after the date of receipt of Components by Medtronic.
6.5) Taxes. Medtronic shall be responsible for and shall
pay, or reimburse CVD for, all taxes, duties, import deposits, assessments and
other governmental charges (except net income taxes) which relate to the import
of the Components into countries, other than the United States, which are now
or hereafter imposed under or by any governmental authority or agency.
* Confidential Treatment Requested
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ARTICLE 7
INSPECTION, WARRANTY AND SERVICE
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7.1) Inspection of Component. Medtronic shall conduct any
incoming inspection tests not later than thirty (30) days after the date of
receipt of such shipment at the shipping destination and may reject Components
that do not conform substantially to the Specifications. Any Component not
rejected by Medtronic by written notice to CVD within such period shall be
deemed accepted, with the exception of latent defects not readily observable by
Medtronic. In the event of any damage in or to a shipment of Components or in
the event any of the Components fail to comply with the then current
Specifications for the Component, Medtronic shall report the same to CVD and
furnish such written evidence or other documentation as CVD reasonably may deem
appropriate. If the substantiating evidence delivered by Medtronic indicates
that such damage or non-conformity with Specifications existed at the time of
delivery of the Components at the F.O.B. point, Medtronic may return the
Components to CVD at CVD's expense, and at Medtronic's request CVD shall use
all reasonable efforts to deliver promptly replacement Components to Medtronic
in accordance with the delivery procedures set forth herein.
7.2) Warranty. CVD warrants to Medtronic that such
Components shall, when delivered at the F.O.B. point, meet the Specifications
and shall be free from defects in materials and workmanship, with such warranty
running for the period of time stipulated for each Component in Exhibit C,
attached hereto, commencing with the receipt of Components by Medtronic.
7.3) Limited Warranty. THE WARRANTIES SET FORTH ABOVE ARE
IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY
DISCLAIMED AND EXCLUDED BY CVD, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE, EXCEPT CVD SHALL
ALSO PROVIDE WITH RESPECT TO AN ORDER OF COMPONENTS SUCH OTHER ADDITIONAL
WARRANTIES, IF ANY, AS CVD CUSTOMARILY PROVIDED TO ITS CUSTOMERS OR END-USERS
OF THE COMPONENTS IMMEDIATELY PRECEDING THE DATE OF THIS AGREEMENT.
MEDTRONIC'S SOLE AND EXCLUSIVE REMEDY FOR BREACH OF THE FOREGOING WARRANTY
SHALL BE ITS RIGHTS UNDER ARTICLE 7.1 OR IF REPLACEMENT IS IMPRACTICAL, REFUND
OF THE AMOUNT PAID FOR THE NONCONFORMING COMPONENTS.
ARTICLE 8
TERM AND TERMINATION
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8.1) Term. This Agreement shall take effect as of the
date hereof and shall continue in force for a period of three (3) years from
the first delivery of Products under the OEM Agreement unless terminated
pursuant to the provisions hereof or extended by mutual agreement of the
parties.
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8.2) Termination. Notwithstanding the provisions of
Section 8.1 above, this Agreement may be terminated in accordance with the
following provisions:
(a) A party may terminate this Agreement by giving notice
in writing to the other party if the other party is in breach
of any material representation, warranty or covenant of this
Agreement and shall have failed to cure such breach within
ninety (90) days of receipt of written notice thereof from the
first party;
(b) A party may terminate this Agreement at any time by
giving notice in writing to the other party, which notice
shall be effective upon dispatch, should the other party
become insolvent, make an assignment for the benefit of
creditors, go into liquidation or receivership or otherwise
lose legal control of its business; or
(c) A party may terminate this Agreement by giving notice
in writing to the other party should an event of Force Majeure
preventing performance by such other party continue for more
than one hundred eighty (180) consecutive days as provided in
Article 11 below; or
(d) Medtronic may terminate this agreement within ninety
(90) days of execution in the event use of the Components in
Medtronic technology platforms is, in Medtronic's discretion,
technologically or otherwise unworkable or impractical.
8.3) Rights and Obligations on Termination. In the event
of termination of this Agreement for any reason, the parties shall have the
following rights and obligations:
(a) Termination of this Agreement shall not release
either party from the obligation to make payment of all
amounts previously due and payable;
(b) The terminating party shall have the right, at its
option, to cancel any or all purchase orders which provide for
delivery after the effective date of termination. CVD hereby
acknowledges Medtronic's right to continue to sell Components
purchased from CVD to any person or entity until such time as
Medtronic's entire inventory of Components is sold; and
(c) Without limitation of Section 13.6 hereof, the
parties' obligations pursuant to Articles 7, 11 and 12 hereof
shall survive termination of this Agreement. Upon termination
all rights and licenses granted to Medtronic hereunder shall
terminate.
8.4) License of Technology. In the event CVD is unable,
for any reason, to manufacture or deliver any quantities of any Components for
Medtronic hereunder for a period in excess of ninety (90) days, CVD agrees that
Medtronic shall be automatically granted a non- exclusive, fully paid up,
non-sublicensable, worldwide license to all patents, technology and know-how
necessary to make, use, and sell the Components for use or benefit of
Medtronic. The license shall be for the earlier of the term of this Agreement
or until CVD
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can demonstrate, to Medtronic's satisfaction, its ability to manufacture and
deliver Components ordered by Medtronic. Provided, Medtronic's license under
this section shall be limited to an annual production of Components no greater
than the amount reflected in Medtronic's most recent forecast for the following
twelve (12) month period. Provided further, that Medtronic agrees that for any
Components produced under this paragraph by Medtronic, Medtronic will waive any
other remedy with respect to such Component.
ARTICLE 9
FORCE MAJEURE
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9.1) Force Majeure. "Force Majeure" shall mean any event
or condition, not existing as of the date of signature of this Agreement, not
reasonably foreseeable as of such date and not reasonably within the control of
either party, which prevents in whole or in material part the performance by
one of the parties of its obligations hereunder, such as act of God, act of
government, war or related actions, civil insurrection, riot, sabotage, strike,
epidemic, fire, flood, windstorm, and similar events.
9.2) Notice. Upon giving notice to the other party, a
party affected by an event of Force Majeure shall be released without any
liability on its part from the performance of its obligations under this
Agreement, except for the obligation to pay any amounts due and owing
hereunder, but only to the extent and only for the period that its performance
of such obligations is prevented by the event of Force Majeure.
9.3) Suspension of Performance. During the period that
the performance by one of the parties of its obligations under this Agreement
has been suspended by reason of an event of Force Majeure, the other party may
likewise suspend the performance of all or part of its obligations hereunder to
the extent that such suspension is commercially reasonable.
ARTICLE 10
INTELLECTUAL PROPERTY
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10.1) Ownership. CVD owns and retains all right, title and
interest in and to all Intellectual Property used in the research, design,
development, manufacture or sale of the Components (the "CVD Intellectual
Property"). To the knowledge of CVD, the CVD Intellectual Property is valid
and has not been challenged in any judicial or administrative proceeding.
Neither any shareholder, employee or consultant of CVD or its Affiliates (or
the employer of any such consultant) has any rights in or to any of the CVD
Intellectual Property. To the knowledge of CVD, no person or entity nor such
person's or entity's business or products has infringed, misused,
misappropriated or conflicted with the CVD Intellectual Property or currently
is infringing, misusing, misappropriating or conflicting with the CVD
Intellectual Property. CVD has the right and authority to enter into this
Agreement.
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ARTICLE 11
IDEAS, INVENTIONS & PATENT RIGHTS
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11.1) Protect Licensed Know-How. CVD and Medtronic each
agree to maintain the confidentiality of all non-public information regarding
the Component, including but not limited to the status of any patent
applications relating to the same.
11.2) Protection of Component Technology and Improvements.
During the term of this Agreement, CVD shall promptly inform Medtronic of any
invention, improvement, upgrading or modification relating to the Components.
CVD agrees to reasonably protect the Components by, if appropriate in CVD's
reasonable judgment, obtaining and maintaining appropriate patent rights as
recommended by reputable patent counsel.
11.3) Ownership of Intellectual Property. All Intellectual
Property of Medtronic existing on the Effective Date, and any Intellectual
Property developed solely by employees of, or consultants (other than CVD and
its employees or consultants) working for, Medtronic in the course of this
Agreement, shall be and remain the property of Medtronic. All Intellectual
Property of CVD existing on the Effective Date, and any Intellectual Property
developed solely by employees of, or consultants working for, CVD in the course
of this Agreement, shall be the property of CVD and Medtronic shall not acquire
any rights therein except as may be provided pursuant to a license agreement.
Any Intellectual Property developed jointly by employees or consultants of
Medtronic and CVD in the course of this Agreement ("Joint Inventions") shall be
jointly owned by Medtronic and CVD, with each party having an undivided
interest therein. For purposes of this Section, Intellectual Property which is
the subject of a patent application shall be deemed to have been developed
jointly by employees or consultants of Medtronic and CVD, and thus be a Joint
Invention, if at least one employee or consultant of each of Medtronic and CVD
is required to be named as an inventor in such application in order for such
patent to be valid.
11.4) Employees and Consultants. Each Party shall ensure
that all employees, consultants and third parties who perform any portion of
its obligations under this Agreement have entered into written agreements
whereby such employee, consultant or third party either assigns all ownership
rights, or grants an exclusive worldwide fully-paid license (with the right to
sublicense), in any inventions or discoveries made or developed by such
employee, consultant or third party in the course of such development work.
Each party shall provide copies of such agreements to the other upon request.
ARTICLE 12
LIMITATION OF LIABILITY
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12.1) Limitation of Damages. NOTWITHSTANDING ANYTHING ELSE
IN THIS AGREEMENT OR OTHERWISE, CVD SHALL NOT BE RESPONSIBLE OR LIABLE WITH
RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT OR ANY PRODUCT ORDER RELATED
THERETO UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY FOR
ANY AMOUNTS IN EXCESS, IN THE AGGREGATE, OF THE AMOUNTS PAID TO CVD FOR
COMPONENTS HEREUNDER.
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ARTICLE 13
MISCELLANEOUS
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13.1) Non-Disclosure. Except as permitted or required for
performance by the party receiving such Confidential Information of its rights
or duties hereunder, for a period of five (5) years after receipt thereof, each
party agrees (i) not to disclose or use any Confidential Information of the
other party obtained in connection with the performance of this Agreement, and
(ii) not to disclose or provide any of such Confidential Information of the
other party to any third party and to take appropriate measures to prevent any
such disclosure by its present and future employees, officers, agents,
subsidiaries, or consultants.
13.2) Relationship. This Agreement does not make either
party the employee, agent or legal representative of the other for any purpose
whatsoever. Neither party is granted any right or authority to assume or to
create any obligation or responsibility, express or implied, on behalf of or in
the name of the other party. In fulfilling its obligations pursuant to this
Agreement, each party shall be acting as an independent contractor.
13.3) Assignment. This Agreement shall be binding upon and
inure to the benefit of the parties hereto and the successors or assigns of the
parties hereto; provided, that (i) the rights and obligations of CVD herein may
not be assigned except to any person who succeeds to substantially all of the
stock, assets and/or business of CVD, and (ii) the rights and obligations of
Medtronic herein may not be assigned except to any person who succeeds to
substantially all of that portion of Medtronic's business to which this
Agreement relates.
13.4) Complete Agreement. The Exhibits to this Agreement
shall be construed as an integral part of this Agreement to the same extent as
if they had been set forth verbatim herein. This Agreement and the Exhibits
hereto constitute the entire agreement between the parties hereto with respect
to the subject matter hereof and supersede all prior agreements whether written
or oral relating hereto.
13.5) Governing Law. This Agreement shall be governed by
and interpreted in accordance with the laws of the State of Minnesota,
including all matters of construction, validity, performance and enforcement,
without giving effect to principles of conflict of laws.
13.6) Survival. All of the representations, warranties,
and covenants made in this Agreement, and all terms and provisions hereof
intended to be observed and performed by the parties after the termination
hereof, shall survive such termination and continue thereafter in full force
and effect.
13.7) Waiver, Discharge, Amendment, Etc. The failure of
any party hereto to enforce at any time any of the provisions of this Agreement
shall in no way be construed to be a waiver of any such provision, nor in any
way to affect the validity of this Agreement or any part thereof or the right
of the party thereafter to enforce each and every such provision. No waiver of
any breach of this Agreement shall be held to be a waiver of any other or
subsequent
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breach. Any amendment to this Agreement shall be in writing and signed by the
parties hereto.
13.8) Counterparts. This Agreement may be executed in
any number of counterparts, each of which shall be deemed as original and all
of which together shall constitute one instrument.
13.9) Titles and Headings; Construction. The titles and
headings to Sections herein are inserted for the convenience of reference only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement. This Agreement shall be construed without regard to any
presumption or other rule requiring construction hereof against the party
causing this Agreement to be drafted.
13.10) Benefit. Nothing in this Agreement, expressed or
implied, is intended to confer on any person other than the parties to this
Agreement or their respective successors or assigns, any rights, remedies,
obligations or liabilities under or by reason of this Agreement.
13.11) Notices. All notices or other communications to a
party required or permitted hereunder shall be deemed given if in writing and
delivered personally or sent by telecopy (with confirmation of transmission) or
certified mail (return receipt requested) to such party at the following
addresses (or at such other addresses as shall be specified by like notice):
if to Medtronic to:
Medtronic Interventional Vascular
9410 Carroll Park Drive
San Diego, CA 92121
Attention: General Manager
FAX (619) 453-0637
with a copy to:
Medtronic, Inc.
7000 Central Avenue N.E.
Minneapolis, MN 55432
Attention: Vice President, Corporate Development
FAX (612) 572-5404
if to CVD to:
Cardiovascular Dynamics, Inc.
13900 Alton Parkway, Suite 122
Irvine, California 92718
Attention: President and CEO
FAX (714) 457-9561
13.
14
Medtronic or CVD may change their respective above-specified recipient and/or
mailing address by notice to the other party given in the manner herein
prescribed. All notices shall be deemed given on the day when actually
delivered as provided above (if delivered personally or by telecopy) or on the
day shown on the return receipt (if delivered by mail).
13.12) Illegality. In case any provision of this Agreement
shall be invalid, illegal or unenforceable, the validity, legality and
enforceability of the remaining provisions shall not in any way be affected or
impaired thereby.
13.13) Public Announcement. Each of the parties to this
Agreement hereby agrees with the other parties hereto that, except as may be
reasonably required to comply with the requirements of applicable law, the New
York Stock Exchange, and Nasdaq, no press release or similar public
announcement or communication will be made or caused to be made concerning the
execution or performance of this Agreement unless specifically approved in
advance by Medtronic and CVD. The foregoing shall not restrict Medtronic's or
CVD's communications with employees or customers.
13.14) Execution of Further Documents. Each party agrees to
execute and deliver without further consideration any further applications,
licenses, assignments or other documents, and to perform such other lawful acts
as the other party may reasonably require to fully secure and/or evidence the
rights or interests herein.
13.15) Designated Contact. The designated manager contact
for communication under this agreement shall be James L. Pacek, Vice President
of Marketing, for Medtronic and Jeff O'Donnell, Vice President of Marketing,
for CVD.
IN WITNESS WHEREOF, each of the parties has caused this Supply
Agreement to be executed in the manner appropriate to each, as of the date
first above written.
CARDIOVASCULAR DYNAMICS, INC.
By /s/ Michael R. Henson
---------------------------------
Its CHAIRMAN
---------------------------------
MEDTRONIC, INC.
By /s/ B. Kristine Johnson
---------------------------------
Its PRESIDENT, VASCULAR
---------------------------------
EXHIBITS: A - List of Components
B - Initial Prices
C - Warranties
14.
15
SUPPLY AGREEMENT
EXHIBIT A
Components Included:
- --------------------
COMPONENTS: Focal Technology Component Sets including:
o Distal Shaft Subassembly
o Focal Technology
o [ * ]
o [ * ]
o [ * ]
And any improvements to the foregoing.
Detailed Specifications for Components to be provided by CVD will be agreed to
by the parties and attached hereto and incorporated herein by reference.
* Confidential Treatment Requested
16
SUPPLY AGREEMENT
EXHIBIT B
Initial Component Pricing:
- --------------------------
COMPONENTS: $[*]
* Confidential Treatment Requested
17
SUPPLY AGREEMENT
EXHIBIT C
Warranty Periods:
- -----------------
COMPONENTS: