This
Distributor Agreement is
made, effective as of the 24 th day of January 2006 (the “Effective
Date”), by and among Medtronic USA, Inc.
(“Medtronic”) and VNUS Medical Technologies,
Inc. (“VNUS”).
a)
Medtronic. Medtronic is a Minnesota
corporation with its principal place of business at 710 Medtronic
Parkway, Minneapolis, MN 55432-5604. Medtronic is a leading
manufacturer of medical technologies including products, therapies
and services used to treat conditions such as heart disease,
neurological disorders, and vascular illnesses. The maintenance of
Medtronic’s reputation as the industry leader in performance
and quality is a material element of this Agreement.
b)
VNUS. VNUS is a Delaware corporation, with
its principal place of business at 2200 Zanker Road, Suite F,
San Jose, CA 95131. VNUS is in the business of manufacturing and
selling products for minimally invasive treatment of venous
disease. VNUS has an existing marketing and sales force which can
economically and effectively address the Market Segment (as defined
below).
NOW, THEREFORE,
the parties agree as follows:
Whenever the
following terms appear capitalized in this Agreement they shall
have the indicated meanings.
1.1
Market Segment and Territory.
The terms “Market
Segment” and “Territory” shall have the meanings
described on Schedule 1.1, attached hereto and may be revised
from time to time as mutually agreed in writing by Medtronic and
VNUS.
1.2
Product(s). The terms “Product” or
“Products” shall mean those Products described in
Schedule 1.2 as amended from time to time (the
“Products”).
1.3
User Warranty. The term “User Warranty” shall mean
the written Medtronic warranty or disclaimer of warranty which
accompanies the Product when sold to a customer as such warranty is
established or revised by Medtronic from time to time, including
all restrictions and limitations on damages and
remedies.
1.4
Customer. The term “Customer” shall mean any
potential or existing customer of Product in the Market Segment in
the Territory except those existing Medtronic accounts that decline
to be converted to VNUS accounts pursuant to Sections 2.5 and
2.6.
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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II. APPOINTMENT OF
DISTRIBUTOR
2.1
Appointment of VNUS as Distributor.
Subject to the terms and conditions
of this Agreement, Medtronic hereby appoints VNUS, and VNUS accepts
such appointment, as Medtronic’s authorized exclusive
distributor with the exclusive right (even as to Medtronic but
subject to Sections 2.5 and 2.6 below) to promote, market,
sell, and distribute Products in the Market Segment in the
Territory. The parties acknowledge and agree that VNUS shall not
sublicense any of its rights or obligations to distribute Products
in the Territory.
2.2
Term. Subject to the termination provisions in
Article 9, VNUS’ appointment shall be effective as of
the Effective Date and shall continue for an initial term of five
(5) years (the “ Initial Term ”). This
Agreement will automatically renew for two (2) additional
twelve (12) month terms (“ Renewal Terms ”)
unless either party has given the other party written notice at
least one hundred twenty (120) days prior to the end of either
the Initial Term or the first Renewal Term that it intends to not
renew the Agreement; provided, however, Medtronic may only give
notice of non-renewal if VNUS fails to satisfy its Minimum Annual
Quota pursuant to Section 3.15. As used in this Agreement, the
Initial Term and any Renewal Term shall collectively be referred to
as the “ Term ”.
2.3
Products. If Medtronic decides to cease manufacture and
sale of any particular Product, Medtronic may delete such Product
from Schedule 1.2, provided (i) Medtronic provides
VNUS with at least ninety (90) days prior written notice of
such proposed removal of a particular Product from
Schedule 1.2, and (ii) such Product does not represent
ten percent (10%) or more of VNUS’ averaged unit sales during
the six consecutive months immediately preceding Medtronic’s
written notice to VNUS of such proposed removal. Notwithstanding
the removal of a particular Product from Schedule 1.2, VNUS
shall have the right to continue selling its existing inventory of
any such removed Product. At any time Medtronic may offer to add
new products to those authorized for promotion and distribution by
VNUS, and VNUS may elect whether or not to accept such new product
(in which instance Schedule 1.2 shall be amended to add such
new Product). Without limiting the foregoing, Medtronic shall
promptly notify VNUS of any new U-CLIP technology-related products
that are in development (or that otherwise become available to
Medtronic) and are applicable for use in the Market Segment and
Territory, and in accordance with the foregoing provision, VNUS may
elect whether or not to accept such new product (in which instance
Schedule 1.2 shall be amended to add such new Product). If
VNUS elects not to accept such Product, Medtronic may, in its sole
discretion, market such Product or seek and retain other
distributors for such Product.
2.4
Direct Sales to New Customers.
If Medtronic receives orders or
requests for Products from New Customers, Medtronic will refer such
Customers to VNUS for the sale. Sales by VNUS to Customers using
Products in the Territory but outside the Market Segment (such as
cardiac, bariatric and other non-vascular applications) will not be
included in the total sales by VNUS for purposes of determining
whether VNUS has met the Minimum Annual Quota pursuant to
Section 3.15 for the period in which the sale is
made.
2.5
Medtronic Limited Right to Sell in Market
Segment. Notwithstanding
VNUS’ appointment as the exclusive distributor of Product,
Medtronic may sell Products in the Market Segment in the Territory
if such Products are sold as part of a kit or other combination
with another Medtronic product for use in a procedure in which the
other Medtronic product is used. Medtronic may also sell Products
in the Market Segment in the Territory solely to those existing
Medtronic accounts that decline to be
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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converted to
VNUS accounts pursuant to Section 2.6. Except for
Medtronic’s limited foregoing right, Medtronic shall not sell
in the Market Segment in the Territory any Products, either alone
or in combination, that are used in arterial-venous access grafts
(AVG), arterial-venous access fistulas (AVF), and peripheral bypass
procedures.
2.6
Existing Medtronic Accounts.
Medtronic shall, upon execution of
this Agreement, provide to VNUS in writing a list of existing
Medtronic accounts for Products that are within the VNUS Market
Segment and Territory as defined in Schedule 1.1. It is
understood and agreed by the Parties that VNUS shall affirmatively
contact these accounts and offer to convert them to VNUS
accounts.
III. DISTRIBUTOR’S
RESPONSIBILITIES
Subject to the
other terms and conditions of this Agreement, VNUS shall perform
the following responsibilities:
3.1
Promote and Sell. VNUS shall use commercially reasonable efforts
to promote, sell and support the Products in the Market Segment in
the Territory. Without limiting the generality or extent of the
foregoing, VNUS and anyone acting on its behalf shall not knowingly
make any false or misleading statements with regard to the Products
of Medtronic or any of its competitors. All representations and
claims that VNUS or any of its representatives makes with respect
to the Products shall be fully consistent with all Medtronic
labeling and shall conform to any commercially reasonable policies
or guidelines that Medtronic may from time to time reasonably
establish for its Products and inform VNUS in writing
thereof.
3.2
Clinical Trials. Upon obtaining prior written approval from
Medtronic, not to be unreasonably withheld or delayed, VNUS may
conduct and participate in the design, implementation, analysis and
publication of all studies and clinical trials associated with the
Product(s) in the Market Segment in the Territory.
3.3
Facility and Staff. VNUS shall maintain a place of business
sufficient to carry out its duties hereunder in a manner consistent
with the standards commonly required of a company that sells
medical devices of commercial potential similar to the Products.
VNUS shall also maintain a trained sales staff that is
(i) capable of promoting and selling the Products in a manner
consistent with all applicable laws and regulations,
(ii) trained on the use and function of the Products, and
(iii) skilled and experienced in selling medical devices to
the medical practice areas in which the Products are used within
the Market Segments and the Territory. To assure that VNUS
possesses thorough knowledge on the safe and effective use of the
Products, VNUS shall participate in Product training courses as
reasonably requested by it or by Medtronic pursuant to
Section 4.4 below.
3.4
Inventory. VNUS shall maintain an inventory of Products
reasonably necessary to fill its forecasted sales under this
Agreement. To assure the effectiveness and quality of the Products,
Medtronic may establish, and inform VNUS in writing of, reasonable
policies or guidelines with regard to the rotation, storage, or
shelf life of Products. VNUS shall use commercially reasonable
efforts to comply with all such policies or guidelines and shall
properly dispose of any Products (consistently with all applicable
laws and regulations concerning waste and the environment) which
are not useable as a result of the application of such policies or
guidelines. Such policies may include a requirement for
minimum
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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remaining shelf
life at the time such Product is delivered to a Customer. In no
event shall Medtronic be responsible to accept return of or
reimburse VNUS as a result of any Product which becomes unusable
due to the expiration of such minimum shelf life; provided,
however, the foregoing limitation shall not apply to any Product
that has a shelf life less than six (6) months when received
by VNUS from Medtronic. All returned Products shall be dealt with
pursuant to Medtronic’s Returned Inventory Policy which is
attached hereto as Schedule 3.4, as amended from time to
time.
3.5
Product In-Service. VNUS shall perform post-sale delivery,
instruction, and training to Customers in a manner that is
consistent with commercially reasonable standards or guidelines
which Medtronic may from time to time establish and inform VNUS in
writing thereof.
3.6
No Modification of Products.
VNUS shall sell the Products only in
the form, condition and packaging as provided or approved by
Medtronic. VNUS shall not alter, modify or change any Product or
its package without Medtronic’s prior written
consent.
3.7
User Warranty Delivery to Customer.
VNUS shall deliver to each of the
Customers the User Warranty furnished by Medtronic with each
Product, as revised from time to time.
3.8
Credit/Finance. VNUS shall make full payment to Medtronic of the
purchase price for each shipment of Product and of any other
payment obligations it owes to Medtronic when due. VNUS shall
initially be granted credit terms of **** from date of receipt of
invoice for its purchase of Product. Such credit terms are
contingent upon VNUS’ continued material compliance with all
of its monetary obligations to Medtronic. If, at any time in the
reasonable opinion of Medtronic, VNUS’ creditworthiness has
materially deteriorated, Medtronic may modify or terminate such
credit terms; provided that such modification or termination shall
not apply to any order which has been previously accepted by
Medtronic.
3.9
Device Tracking . VNUS shall maintain a system to track each
Product in accordance with applicable law, including 21 CFR 821, as
amended, and such other reasonable requirements as Medtronic may
from time to time establish with respect to Product tracking. Such
system will, at a minimum, be able to track a Product to its final
destination and shall have procedures in place which facilitate
locating each Product shipped in the event customer notifications
or product modifications are required. By the 15th of each calendar
month during the term of this Agreement, VNUS shall provide
Medtronic with a written report identifying all Products which were
placed in service the preceding calendar month (“ Product
Tracking Report ”). Such Product Tracking Report shall be
in the form requested by Medtronic but at a minimum shall include
the name of the Customer, the specific address where the Product
was delivered, the date the Product was delivered, the serial
number (if any), model and Product name. The tracking system and
the records documenting the tracking shall be subject to audit by
Medtronic at reasonable times upon reasonable notice. Upon
termination or expiration of this Agreement, VNUS shall, at
Medtronic’s request, deliver all then current records to
Medtronic relating to the location of Products sold by VNUS in the
Market Segment in the Territory.
3.10
Customer Complaints, Incident Reports, and
Recalls. VNUS shall use
diligent, commercially reasonable efforts to resolve all Customer
complaints that relate solely to the quality of services provided
by VNUS in connection with Products. VNUS shall refer all
complaints relating to Products and all requests for service to
Products to the Medtronic Product Complaint Coordinator at ****, or
such other number as Medtronic may from time to time designate in
writing to
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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VNUS. Medtronic
shall resolve all such complaints and requests for service as soon
as practicable using diligent, commercially reasonable efforts.
VNUS shall immediately report to Medtronic any incident of which
VNUS becomes aware that involves or may involve the failure or
malfunction of a Product or might constitute a reportable event
under 21 CFR Section 803 (Medical Device Reporting). Medtronic
as the manufacturer of the Products shall be solely responsible for
all medical device reporting to regulatory agencies with respect to
the Products. In the event either party has reason to believe that
one or more of the Products might be the subject of a recall or
withdrawal from distribution, such party shall immediately notify
the other. Any decision as to whether or not to initiate a recall
or product replacement or product enhancement in accordance with
Section 4.5, shall be Medtronic’s, in its sole
discretion. If such recall is required because of the negligent act
or wrongful omission of VNUS, then the costs and expenses of such
recall shall be reimbursed by VNUS to Medtronic. VNUS shall
provide, at Medtronic’s expense, assistance reasonably
requested by Medtronic in connection with any reporting, recall,
legal, or regulatory matter relating to the Products. If VNUS in
good faith disagrees in writing with Medtronic’s decision not
to withdraw or recall the Product, then VNUS may discontinue its
distribution of such Product under this Agreement until the issue
is resolved.
3.11
Restriction on Sales of Competitive
Products.
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a.) Restriction.
VNUS, including without
limitation its employees, officers, and agents, shall not sell,
handle, promote, or be involved, directly or indirectly, in the
offering for sale, promotion, or manufacture of any product which
may be used in creating anastomoses or vascular approximation in
the Territory (such product, a “ Competitive Product
”). If VNUS, upon Medtronic’s offer, elects to add a
new Product to Schedule 1.2, VNUS shall have ninety
(90) days after such amendment to cease distributing any
Competitive Product to the new Product added to Schedule 1.2.
Failure by VNUS to abide by the terms of this Section 3.11
shall be deemed a material failure of VNUS’ obligations under
this Agreement; provided, however, VNUS may cure such failure
immediately by ceasing to sell, distribute, and promote such
Competitive Product.
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b.) Duration of
Restriction. The restriction contained in this
Section shall continue for ****; provided, however, that if this
Agreement is terminated by VNUS for Medtronic’s Breach under
Section 9.1(c), the restriction shall end upon termination of
the Agreement.
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3.12
Accessories and Other Supplies.
VNUS shall sell only Medtronic
approved accessories, supplies and consumables for use with the
Products. VNUS may seek Medtronic’s approval to sell other
accessories, and such approval shall not to be unreasonably
withheld.
3.13
Compliance with Laws and Medtronic
Policies. VNUS recognizes
that compliance with all applicable laws and maintaining a high
standard of ethical behavior in the conduct of its activities under
the Agreement is an essential requirement of this Agreement. VNUS,
therefore, agrees as follows:
(a)
To comply with all applicable laws, rules, and regulations in its
activities relating to the marketing, promotion, and sale of
Products, including without limitation, those promulgated by the
U.S. Food and Drug Administration as applicable to the
Products,
(b)
To conduct all activities under this Agreement in accordance with
the provisions of the Medtronic Code of Conduct and U.S. Business
Conduct Standards attached hereto as Schedule 3.13
(the
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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“
Medtronic Compliance Requirements ”) as amended from
time to time by Medtronic with written notice to VNUS,
(c)
To require its employees who interact with customers who purchase
Products, or who are in a position to influence customer purchasing
decisions regarding Products, to complete training on the Medtronic
Compliance Requirements, and
(d)
To provide Medtronic access to VNUS’ relevant books and
records relating to the sale of Products for the sole purpose of
verifying VNUS’ compliance with the requirements of this
Article 3, provided, such access shall be conducted after
reasonable prior notice by Medtronic to VNUS during VNUS’
ordinary business hours and shall not be more frequent than twice
during any calendar year.
Failure to
comply with any requirement of this Article shall be deemed a
material breach of this Agreement by VNUS and shall entitle
Medtronic to terminate this Agreement in accordance with
Section 9.1(b).
3.14
Exclusive Source for Medtronic
Products. VNUS shall only
sell Products obtained directly from Medtronic to Customers; that
is, VNUS may not sell any new or used Product that has been
obtained from any source other than Medtronic.
3.15
Purchase Quota. During the Term, VNUS shall purchase the minimum
annual requirements specified in Schedule 3.15 (the “
Minimum Annual Quota ”), provided that Medtronic
supplies on a timely basis the amounts of Product ordered by VNUS.
The Minimum Annual Quota will be allocated over the applicable year
in minimum quarterly amounts also specified in Schedule 3.15
(the “ Minimum Quarterly Quota ”). Subject to
Section 5.6 and the remaining terms of this Section 3.15,
if VNUS fails to purchase the Minimum Annual Quota in any contract
year or the Minimum Quarterly Quota for any two consecutive
quarters (whether or not the quarters are in the same contract
year), that failure shall be deemed a material breach of the
Agreement and Medtronic shall have the right to terminate this
Agreement upon ninety (90) days written notice to VNUS;
provided that VNUS may cure the breach within the ninety
(90) day notice period by paying Medtronic an amount equal to
**** of the amount by which VNUS failed to meet the applicable
Minimum Quota. Waiver by Medtronic of its right to terminate this
Agreement under this Section 3.15 in any one or more instance
shall not be deemed a waiver of such right for any subsequent
failure by VNUS to meet the Minimum Annual Quota or the Minimum
Quarterly Quota. The parties agree that for **** of this Agreement,
the Minimum Annual Quota will increase at a rate of ****
year-over-year.
3.16
Product Sales Outside Market Segment or
Territory. If VNUS
receives orders or requests for Products from customers outside the
Territory and Market Segment, VNUS will refer such customers to
Medtronic for the sale. During the Term, VNUS shall not sell
Products outside the Market Segment or Territory without
Medtronic’s prior written consent which may be granted in
Medtronic’s sole discretion.
3.17
Business Review. A VNUS representative shall meet quarterly with
Vice President, Sales for Medtronic Cardiac Surgery (or such other
person designated by Medtronic) to report on and discuss sales and
operations during the prior quarter and discuss future objectives,
plans and strategies.
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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IV. MEDTRONIC’S
RESPONSIBILITIES
Subject to the
other terms and conditions of this Agreement, Medtronic shall
undertake to perform the following responsibilities:
4.1
Manufacture and Provide Products.
Medtronic shall use commercially
reasonable efforts to manufacture (or have manufactured) the
Products and shall supply the Products to VNUS, subject to
availability, upon the terms and conditions of this Agreement.
Products shall, at the time of delivery to VNUS, (i) have been
manufactured in accordance with the specifications and all
applicable laws and regulations including without limitation all
FDA regulations and QSR and cGMP (as applicable); (ii) be
sterile; (iii) have the standard minimum shelf life
customarily applicable to such Products when sold by Medtronic; and
(iv) be packaged in accordance with the Product labeling
provisions of Section 4.2. Upon VNUS’ reasonable
request, Medtronic shall provide access to Medtronic’s
facilities that manufacture and distribute the Product; such access
shall be conducted after reasonable prior notice by VNUS to
Medtronic during Medtronic’s ordinary business hours and
shall not be more frequent than twice during an annual
period.
4.2
Product Labeling. All Product labeling shall be mutually
acceptable to both parties and shall be in compliance with all
Medtronic policies and all applicable laws and regulations. In
order to minimize the potential for cross-selling in the Market
Segment in the Territory, Products shall be labeled and packaged as
VNUS product with VNUS look and styling, including different part
numbers and statements that the Products were manufactured by
Medtronic for distribution by VNUS.
4.3
Promotional Materials. Medtronic shall provide to VNUS such sales
literature, advertising and promotional materials, and other
information, programs, and sales support by VNUS in selling the
Products. Notwithstanding the foregoing, VNUS may develop and/or
use unique promotional materials and sales tools other than those
supplied by Medtronic, provided VNUS has received Medtronic’s
prior written approval, such approval not to be unreasonably
withheld. Medtronic agrees to review all marketing and promotional
materials within ten (10) business days after initial receipt
from VNUS. If editing changes or approval are not received within
the aforementioned period, Medtronic’s approval will be
deemed granted. VNUS shall comply with applicable Medtronic
policies with regard to the use of Medtronic’s copyright
notice. Other than the cost for materials provided by Medtronic
pursuant to this section, VNUS will be responsible for all expenses
associated with its advertising and promotion of the Products,
unless otherwise agreed to in writing prior to the
expenditure.
4.4
Training and Support. Medtronic shall offer such general and
specialized sales and technical training, materials and support as
necessary to adequately train all appropriate VNUS personnel. The
costs and expenses of training VNUS representatives shall be ****.
Such clinical and technical support shall be provided by Medtronic
to VNUS personnel at reasonable locations of VNUS’ choice,
and shall include at a minimum (a) **** of technical and Product
training of appropriate VNUS personnel during **** of this
Agreement; (b) an additional **** of follow up training during
the subsequent ****; and (c) appropriate training as the
parties mutually determine is necessary for any and all new
Products.
4.5
Product Changes. Medtronic may, at any time, modify, alter,
change, or improve a Product. Any such change shall be effective
sixty (60) days after Medtronic provides VNUS with a written
notice
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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to that effect
however changes to a Product based upon requirements under
applicable federal law or regulation shall not be subject to a
sixty (60) day notice requirement.
4.6
Sales outside the Market Segment and
Territory. Except as
provided in Sections 2.5 and 2.6, in the event that either
party becomes aware that Products are being sold or have been sold
at any time within the previous six (6) month period by
Medtronic or its distributors, licensees or agents in the Market
Segment in the Territory, such party shall provide the other party
with written notice of such sales activity. Medtronic shall cease
such sales activity in the Market Segment and in the Territory
within thirty (30) days of such notice. Within sixty
(60) days of the foregoing written notice, Medtronic will
compensate VNUS in an amount equal to **** of the sale price of all
such products in the Market Segment in the Territory. Likewise, in
the event that either party becomes aware that Products are being
sold or have been sold at any time within the previous six
(6) month period by VNUS outside the Market Segment and
Territory, such party will provide written notice to the other
party of any such VNUS sales activity outside of the Market Segment
and Territory. VNUS shall cease such activity within thirty
(30) days. Within sixty (60) days of the foregoing notice,
VNUS will compensate Medtronic in an amount equal to **** of the
sale price of all such products outside the Market Segment and
Territory.
V. ORDERING; DELIVERY AND
ACCEPTANCE
5.1
Initial Stocking Order. VNUS shall be entitled to purchase a one-time
initial stocking order of Products at a **** discount off of
the Product Transfer Price set forth in Schedule 6.1.
5.2
Purchase Orders. VNUS shall order Products from Medtronic by
submitting written purchase orders identifying the number(s) and
type(s) of Products ordered, the requested delivery date(s) and any
additional information required to enable Medtronic to fill the
order. All orders for Products will be pursuant to such standard
terms as the parties may establish from time to time at the prices
set forth in Section 6.1 below. All orders for Products will
be subject to acceptance by Medtronic, provided Medtronic will not
unreasonably reject any purchase order for Products that meet this
Section 5.2 and is for a quantity of Products not in excess of
**** of VNUS’ most recent forecast pursuant to
Section 5.5. Medtronic will accept or reject each such order
submitted by VNUS within ten (10) business days after receipt
of the order. Accepted orders will be non-cancelable. For clarity,
any documents submitted to Medtronic in addition to
Medtronic’s standard terms are for informational purposes
only and are not part of the terms of sale.
5.3
Delivery. Medtronic shall use commercially reasonable
efforts to deliver accepted orders for Products on time pursuant to
the purchase order. However, in no event shall Medtronic be
responsible for any loss or damage which is claimed to have been
caused by a delay in shipping an order, whether or not Medtronic
may have been advised of the possibility of such loss or damages.
Medtronic shall not be responsible for any loss or damage which is
claimed to have been caused by a delay in shipping an order,
whether or not Medtronic may have been advised of the possibility
of such loss or damages, provided Medtronic performed its
manufacture and delivery obligations with commercially reasonable
care. Medtronic shall ship Product by a commercially reasonable
carrier of VNUS’ choice. All Products shall be shipped to
VNUS FOB (Incoterms 2000) Medtronic’s distribution facility.
Title and risk of loss shall transfer to VNUS upon delivery of
Product to the carrier for transport to VNUS.
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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5.4
Inspection and Rejection.
(a) Returned Goods. If any Product does not conform to
the order or is defective at the time it was shipped to VNUS then
VNUS may return the defective Product to Medtronic within thirty
(30) days of receipt by VNUS; provided that VNUS
(i) notifies Medtronic or such agent as Medtronic may
designate, (ii) describes the defect or non-conformity,
(iii) obtains approval for return in accordance with
Schedule 5.4, and (iv) complies with such other return
instructions as Medtronic may reasonably require. Upon receiving
return authorization VNUS may ship the defective or non-conforming
Product to the Medtronic location authorized by Medtronic, properly
labeled, freight prepaid, and fully insured at face value. Subject
to Medtronic’s right to verify that the Product was defective
or non-conforming at the time of shipment to VNUS, Medtronic shall,
at VNUS’ option, either replace the Product and reimburse
VNUS for its out of pocket shipping and insurance expenses or
refund the purchase price paid for by VNUS for the Product
involved. In the event that VNUS elects replacement, Medtronic
shall supply such replacement Product at no additional cost within
fifteen (15) days of Medtronic’s receipt of such
Product. In no event shall Medtronic be responsible to replace or
refund for any Product (a) that has been damaged by abuse or
misuse, (b) for which any unauthorized service or repair was
performed or attempted, (c) that was repossessed, (d) has
been used as a demonstration unit, or (e) was damaged by or
during transport to VNUS. The repair and replacement provided for
in this section shall be VNUS’ sole and exclusive remedy for
any claim relating to any alleged defect or nonconformity in the
Products. In the case of Product having latent defect(s) that are
not reasonably detectable at the time of acceptance, VNUS may
reject such Product by giving written notice to Medtronic of
VNUS’ rejection of such Product within ten (10) days
after discovery of such defects, but such notice may in no event be
later than one (1) year after receipt of such
shipment.
(b)
Notwithstanding anything to the contrary in Section 5.4(a),
Medtronic shall not be responsible for replacing or refunding any
Product (i) that has been damaged in transit by VNUS’
carrier or by abuse or misuse by VNUS or its agent or customer,
(ii) for which any unauthorized service or repair was
performed or attempted, (iii) that was re-processed,
(iv) has been used as a demonstration unit, or (e) was
damaged by or during transport to VNUS. The repair and replacement
provided for in this Section 5.4 shall be VNUS’ sole and
exclusive remedy for any claim relating to any alleged defect or
nonconformity in the Products, but subject to
Article 10.
5.5
Forecasts. VNUS will provide Medtronic with a
**** month rolling non-binding forecast of Product purchases
on a **** basis by ****.
5.6
Failure to Supply. If Medtronic fails to supply on a timely basis
any material amounts of Product(s) ordered by VNUS, the parties
shall confer in good faith to solve the supply problem and
Medtronic shall use its best efforts to cure such problem and to
keep VNUS informed on a regular basis until such cure is
implemented. If Medtronic is forced to allocate production and
distribution of the Products among its various distributors and
customers, Products will be allocated to VNUS in a share
proportional to that percentage of Medtronic’s total sales of
the Product, which VNUS’ sales comprised in the preceding
twelve (12) month period, with the exception of the initial
twelve month period of this Agreement, which proportion shall be
determined on the basis of projected twelve (12) month sales.
If, as a result of such allocation, VNUS is unable to purchase on a
timely basis the Minimum Annual Quota or Minimum Quarterly Quota
(as applicable), the applicable Quota will be reduced by the amount
of bona fide orders from VNUS that Medtronic is unable to
fill.
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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VI. PRICE AND RESALE
TERMS
6.1
Product Transfer Pricing. For all orders of Product other than the
initial stocking order pursuant to Section 5.1 above,
Medtronic will charge VNUS the current list price for the Products,
less the discount set forth on Schedule 6.1 (the result, the
“Product Transfer Price”). The current list price for
the Products is attached hereto in Schedule 6.1. All Product
pricing information, including list price, distributor discount,
and Product Transfer Prices, shall be deemed Confidential
Information under this Agreement. The Product Transfer Prices set
forth on Schedule 6.1 shall be applicable for **** following
the Effective Date. After ****, the Parties agree that the Product
Transfer Price may increase once every **** months for the
remaining term of the Agreement, at a maximum rate of ****
.
(a)
Increased Product Transfer Prices will not apply to purchase orders
accepted by Medtronic before the effective date of the price
increase unless such orders provide for delivery more than thirty
(30) days after the date of acceptance of the order.
****.
(b)
All listed Product Transfer Prices are exclusive of delivery
charges, freight, insurance, state and local use, sales and similar
taxes. When such charges apply they may appear as separate items on
Medtronic invoices.
6.2
Resale Price. VNUS retains the sole and exclusive right to
establish the prices at which it distributes and resells the
Products in the Market Segment in the Territory, in its sole
discretion.
VII. WARRANTY; DISCLAIMER;
LIMITATION OF LIABILITY
7.1
Mutual Representation and Warranties.
Each of Medtronic and VNUS
represents and warrants to the other that as of the Effective Date
(a) it has the full corporate power to enter into and perform
this Agreement; and (b) this Agreement constitutes a legal,
valid and binding obligation.
7.2
Medtronic Representations and
Warranties. Medtronic
represents, warrants, and covenants that:
(a)
at the time of shipment, Product supplied by Medtronic hereunder
(i) shall meet the specifications provided by Medtronic for
such Product, (ii) shall not be adulterated or misbranded
within the meaning of the U.S. Federal Food, Drug and Cosmetic Act
(the “ Act ”), and (iii) shall be
manufactured in accordance with QSR and cGMP (as applicable) and as
defined by the Act;
(b)
as of the Effective Date, (i) Medtronic has not granted any
rights to any third party to promote or sell Products in the Market
Segment in the Territory, and (ii) all Products listed on
Schedule 1.2 have been approved by the FDA for sale and
distribution in the Territory; and
(c)
during the Term, (i) neither Medtronic nor its affiliates
shall, nor shall they cause, license, or permit others to, promote,
license, sell or cause to be sold Products within the Market
Segment in the Territory, except to the extent permitted under
Section 2.6 hereto, and (ii) Medtronic shall obtain
and
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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maintain all
necessary approvals and clearances for all Products that are
promoted and/or sold by VNUS in the Market Segment in the
Territory.
7.2
VNUS Representations and Warranties.
VNUS represents, warrants, and
covenants that it will direct its sales and marketing personnel to
promote and/or sell Products for use solely in the Market Segment
in the Territory.
7.3 User Warranty.
The User Warranty, attached hereto
as Schedule 7.3, is the only warranty granted by Medtronic to
a Customer of a Product covering such Product. Medtronic will
provide a copy of the User Warranty with each Product sold
hereunder to which it applies. In addition, Medtronic may supply
VNUS with point-of-sale copies of the User Warranty for pre-sale
disclosure to prospective users. VNUS shall comply with all
applicable federal or state laws relating to disclosure of product
warranties and limitations, including but not limited to those of
the Federal Trade Commission. NO WARRANTY OTHER THAN THE USER
WARRANTY IS EXPRESSED OR IMPLIED BY MEDTRONIC. MEDTRONIC
SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE. The User Warranty shall be
deemed to commence on the earlier of (1) the date VNUS
delivered the Product to the Customer as reported to Medtronic in
the monthly Product Tracking Report or (2) six (6) months
from the date on which the Product was received by VNUS from
Medtronic.
VIII. INTELLECTUAL
PROPERTY
8.1
Rights to Intellectual Property.
Except as expressly set forth in
Section 8.2 below, VNUS shall have no right or license under
this Agreement to utilize any information, know-how, proprietary
data, trademarks, or patent rights which VNUS may have or may
secure in the future relating to any of the Products, except as may
be incidental only to the marketing, promotion, distribution and/or
sale of the Products and the right to use such Products by
VNUS’ Customers. VNUS may not reproduce any copyrighted
material of Medtronic without the prior written consent of
Medtronic.
8.2
Trademark Use. Subject to the terms and conditions of this
Agreement, including with limitations of this Section 8.2
below, Medtronic hereby grants to VNUS a non-exclusive license
under the Medtronic logos, trademarks, and service marks that
appear on the Products or in any Medtronic-furnished marketing
collateral specific to the Products (“ Medtronic Marks
”) in the Territory solely to market and promote the Products
to the Market Segment in the Territory for the Term. VNUS shall not
use Medtronic’s name, or any other similar name or any other
trademark of Medtronic except in advertising, pamphlets, or other
materials promoting the Products. VNUS may label the Products with
the statement “Manufactured by Medtronic for Distribution by
VNUS.” All such materials referencing Medtronic or Products
must be approved in writing by Medtronic prior to their use or
dissemination, such approval not to be unreasonably withheld. VNUS
may not use Medtronic’s name or any of Medtronic’s
trademarks in its corporate or business name, or in any other
manner which Medtronic deems adverse to its interests. Use of any
Medtronic trademark or trade name associated with the Products may
be done only in accordance with usage guidelines as established by
Medtronic from time to time. Upon the termination of VNUS’
appointment it shall immediately discontinue any further use or
display of Medtronic trademarks, trade names or any mark or name
(except as to sales of remaining inventory of Products as permitted
in Section 9.3). VNUS shall notify Medtronic if it becomes
aware of any unauthorized use of Medtronic trademarks or trade
names or of the use of any mark or name which might
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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9.1
Termination . This Agreement may be terminated prior to the
expiration of its Term pursuant to any of the following
provisions:
(a) Failure to Satisfy Minimum Annual Quota or Minimum
Quarterly Quota.
(i) Subject to Section 3.15, and only after giving
effect to any payment by VNUS to Medtronic pursuant to such
Section 3.15, if VNUS does not satisfy the applicable Minimum
Annual Quota or the Minimum Quarterly Quota for two consecutive
quarters (but provided such inability was not caused by Medtronic
failing to timely supply Products ordered by VNUS), Medtronic shall
have the right to terminate the Agreement.
(b) Breach of Agreement . If either party materially
fails to perform an obligation or condition of this Agreement
(other than VNUS’ failure to satisfy the Minimum Annual Quota
and/or the Minimum Quarterly Quota) and fails to cure such default
within sixty (60) days of receipt of written notice of such
default from the other party specifying the nature of such default,
then the party giving the notice may terminate this Agreement by
sending a separate written notice of termination to the defaulting
party. Any material violation of any material law or regulation
applicable to this Agreement or any violation of the Medtronic Code
of Conduct or U. S. Business Conduct Standards shall be deemed an
incurable breach. In the event of a breach that cannot reasonably
be cured within sixty (60) days of receipt of written notice
of a breach, then the alleged breaching party shall have such
additional time as necessary not to exceed an additional thirty
(30) days (for a total of ninety [90] days) to cure the breach
if the alleged breaching party (i) during such sixty
(60) day period has submitted a plan, that if successfully
carried out, would be effective in curing such breach, and has
commenced execution of such plan, and (ii) diligently pursues such
plan thereafter.
(c) Bankruptcy . Either party may terminate this
Agreement effective immediately upon delivery of written notice to
the other party, if the other party (i) ceases to actively
conduct its business, (ii) files a voluntary petition for
bankruptcy or has filed against it an involuntary petition for
bankruptcy, (iii) makes a general assignment for the benefit
of its creditors, or (iv) applies for the appointment of a receiver
or trustee for substantially all of its property or assets or
permits the appointment of any such receiver or trustee who is not
discharged within thirty (30) days of such
appointment.
9.2
Effect of Termination. Upon the effective date of termination or
expiration of VNUS’ appointment for any reason, VNUS shall
immediately cease to be an authorized Medtronic distributor (except
as to sales of remaining inventory of Products as permitted in
Section 9.3 below) and there shall be nothing payable by
either party except as may be due as a result of prior sales and
these shall be paid as they become due. Either party may, at its
option, cancel any outstanding orders for purchase which have not
been shipped by the effective date of the termination. All
obligations with respect to Confidentiality, return of intellectual
property and other obligations which by their nature are continuing
shall survive the termination of this Agreement. Neither party
shall be liable to the other for damages of any kind resulting from
or caused by said termination, including, but not limited to,
damages related to losses through commitments on obligation or
leases, loss of investment, or present or prospective
profits,
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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inability to
meet obligations, or any other causes or reasons
whatsoever.
9.3
Repurchase/Sale of Inventory.
Upon any termination of this
Agreement, Medtronic shall have the right, exercisable in its sole
discretion, to buy back from VNUS all or any of the Products owned
by VNUS on the date of termination. The price Medtronic shall pay
for the Products will be ****. Products repurchased from VNUS by
Medtronic pursuant to this Section 9.3 shall be shipped
promptly by VNUS as instructed by Medtronic, at Medtronic’s
commercially reasonable expense, to a location specified by
Medtronic. For a period not to exceed six (6) months from the
date of termination, VNUS may in its sole discretion, sell or
otherwise properly dispose of any Products which are not purchased
by Medtronic, provided such sales and disposal are performed in
accordance with the terms set forth in this Agreement.
9.4
Return of Materials. Upon termination of its appointment, VNUS shall
immediately return to Medtronic all promotional and other Product
related materials previously provided by Medtronic to VNUS (except
for a reasonable quantity as needed by VNUS to sell the remaining
inventory of Products, as permitted in Section 9.3). If VNUS
has paid Medtronic for any of the materials returned, Medtronic
shall reimburse VNUS the purchased price of such returned materials
to the extent, and only to the extent that such materials are
currently useable by Medtronic.
9.5
Non-solicitation . For a period of twelve (12) months after
expiration or termination of this Agreement for whatever reason,
VNUS will not solicit for employment, directly or through a third
party agent, or hire any person who was a Medtronic Cardiac Surgery
employee during the twelve months preceding the termination date of
this Agreement. For a period of twelve (12) months after
expiration or termination of this Agreement for whatever reason,
Medtronic’s Cardiac Surgery business unit will not solicit
for employment, directly or through a third party agent, or hire
any person who was an employee of VNUS during the twelve
(12) months preceding the termination date of this Agreement.
Nothing contained in this Agreement will prevent either party from
hiring any employee of the other party if the employee’s
application for employment was in response to an advertisement of
general circulation and such employee was not solicited by the
hiring party directly or through a third party agent.
10.1
Medtronic’s Indemnification.
Medtronic shall indemnify, defend
and hold harmless VNUS and each of its subsidiaries, officers,
directors, employees, shareholders and distributors from and
against and in respect of any and all assessments, losses, damages,
liabilities, interest and penalties, costs and expenses (including,
without limitation, reasonable legal fees and disbursements
incurred in connection therewith and in seeking indemnification
therefore, and any amounts or expenses required to be paid or
incurred in connection with any action, suit, proceeding, claim,
appeal, demand, assessment or judgment) finally awarded (“
Indemnifiable Losses ”), resulting from, arising out
of, or imposed upon or incurred by any person to be indemnified
hereunder by reason of any third party demands, claims, suits,
actions or causes of action against such person based upon:
(i) any breach of representation, warranty, covenant or
agreement by Medtronic under this Agreement, (ii) Product
Liability Damages with respect to the Products, or (iii) other
negligence or intentional misconduct of Medtronic, provided that in
no event shall Medtronic be liable for matters for which VNUS is
responsible under Section 10.2 below or for punitive or
exemplary damages. Medtronic shall maintain product liability
insurance or self-insurance in such amounts as ordinary good
business practice for its type of business would make advisable and
shall upon
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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request provide
VNUS with evidence of this coverage. “Product Liability
Damages” means any liability, claim or expense, including but
not limited to reasonable attorneys’ fees and medical
expenses, arising in whole or in part out of claims of third
parties for personal injury or loss of or damage to property
relating to or arising out of the Products, whether based on strict
liability in tort, negligent manufacture of product, or any other
allegation of liability arising directly from the design, testing,
manufacture, packaging, labeling (including instructions for use),
or sale of the Products.
10.2
VNUS’ Indemnification.
VNUS shall indemnify, defend and
hold harmless Medtronic and each of its subsidiaries, officers,
directors, employees, shareholders and suppliers from and against
and in respect of any and all Indemnifiable Losses resulting from,
arising out of, or imposed upon or incurred by any person to be
indemnified hereunder by reason of any third party demands, claims,
suits, actions or causes of action against such person based upon:
(i) any breach of representation, warranty, covenant or
agreement by VNUS under this Agreement, (ii) product claims
whether written or oral, made or alleged to be made, by VNUS in its
advertising, publicity, promotion, or sale of any Products where
such product claims were not provided by or approved by Medtronic,
(iii) negligent handling by VNUS of the Products or changes,
additions or modifications to the Products by VNUS,
(iv) Product Liability Damages with respect to the Products to
the extent they are caused by the negligent or intentionally
wrongful acts of VNUS, (v) Product Liability Damages caused by
non-Medtronic products sold by VNUS, or (vi) other negligence
or intentional misconduct of VNUS; provided that in no event shall
VNUS be liable for matters for which Medtronic is responsible under
Section 10.1 above or for punitive or exemplary damages. VNUS
shall maintain liability insurance or self-insurance in such
amounts as ordinary good business practice for its type of business
would make advisable and shall provide Medtronic with evidence of
this coverage.
10.3
Procedure. If a claim by a third party is made and a party
(the “ Indemnitee ”) intends to claim
indemnification under this Article 10, the Indemnitee shall
promptly notify the other party (the “Indemnitor”) in
writing of any claim in respect of which the Indemnitee or any of
its subsidiaries, directors, officers, employees, shareholders,
suppliers or distributors intends to claim such indemnification and
the Indemnitor shall have sole control of the defense and/or
settlement thereof, provided that the Indemnitee may participate in
any such proceeding with counsel of its choice at its own expense.
The indemnity agreement in this Article 10 shall not apply to
amounts paid in settlement of any Indemnifiable Losses if such
settlement is effected without the consent of the Indemnitor, which
consent shall not be withheld unreasonably. The failure to deliver
written notice to the Indemnitor within a reasonable time after the
commencement of any such action, if adversely prejudicial to its
ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Article 10, but the
omission to so deliver written notice to the Indemnitor shall not
relieve the Indemnitor of any liability that it may otherwise have
to any Indemnitee other than under this Article 10. If the
Indemnitor fails to provide defense of the claim, and diligently
defend or settle the same, the Indemnitee may defend or settle the
claim without prejudice to its rights to indemnification hereunder.
The Indemnitee under this Article 10, its employees and
agents, shall cooperate fully with the Indemnitor and its legal
representatives and provide full information in the investigation
of any Indemnifiable Losses covered by this
indemnification.
10.4
Patent. Medtronic shall indemnify, defend and hold
harmless VNUS from any cost, expense, liability or damage to the
extent that it is based upon a claim that any Product purchased or
sold by VNUS infringes a patent of the United States (or the
manufacture or use of such Product infringes such a patent);
provided that VNUS shall promptly notify Medtronic of such claim,
permit Medtronic to assume control
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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of the defense
of such claim, and fully cooperate in the defense of such claim. If
the use or sale of a Product is enjoined by order or settlement,
then Medtronic shall have the option to (1) procure for VNUS
the right to continue using or selling the Product,
(2) replace the Product with a non-infringing Product or to
modify the Product, (3) modify the Product so it becomes
non-infringing, or (4) accept return of the infringing Product
and grant VNUS a credit for VNUS’ purchase price of such
Product. The foregoing shall be the entire liability of Medtronic
for patent infringement by Products furnished hereunder.
THIS SECTION
10.4 STATES MEDTRONIC’S TOTAL RESPONSIBILITY AND LIABILITY,
AND THE VNUS’ SOLE REMEDY, FOR ANY ACTUAL OR ALLEGED
INFRINGEMENT OF ANY PATENT, TRADEMARK OR COPYRIGHT BY ANY PRODUCT
DELIVERED HEREUNDER OR ANY PART THEREOF. THIS ARTICLE IS IN LIEU OF
AND REPLACES ANY OTHER EXPRESS, IMPLIED OR STATUTORY WARRANTY
AGAINST INFRINGEMENT. IN NO EVENT SHALL MEDTRONIC BE LIABLE FOR ANY
INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING
FROM ANY SUCH INFRINGEMENT.
10.5
LIMITATION OF LIABILITY
IN NO EVENT
SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR COSTS OF PROCUREMENT
OF SUBSTITUTE GOODS BY ANYONE. IN NO EVENT SHALL EITHER PARTY BE
LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON FOR ANY SPECIAL,
CONSEQUENTIAL, INDIRECT OR INCIDENTAL DAMAGES, HOWEVER CAUSED AND
ON ANY THEORY OF LIABILITY ARISING OUT OF THIS AGREEMENT, AND
WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH DAMAGE. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY
FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.
NOTWITHSTANDING THE FOREGOING PROVISIONS OF THIS SECTION, THE
LIMITATIONS OF LIABILITY SET FORTH IN THIS SECTION SHALL NOT APPLY
TO (i) CLAIMS ARISING UNDER ARTICLE 8 (INTELLECTUAL PROPERTY)
OR (ii) THIRD PARTY CLAIMS FOR PERSONAL INJURY, DEATH OR
PHYSICAL DAMAGE TO PROPERTY WHICH ARE SUBJECT TO THE
INDEMNIFICATION PROVISIONS OF ARTICLE 10.1 OR 10.2.
XI. CONFIDENTIAL
INFORMATION
11.1
Definition. A party’s “ Confidential
Information ” is defined as any information of one party
(the “ Disclosing Party ”) that is disclosed to
the other party (the “ Receiving Party ”),
including without limitation, technical product data, business
plans, product pricing, sales goals, marketing information and
other information not generally available to the public.
Notwithstanding anything to the contrary in this Agreement,
Confidential Information does not include information that (a) is
already known by the Receiving Party at the time of disclosure by
evidence of such Receiving Party’s written records;
(b) becomes, through no act or fault of the Receiving Party,
publicly known; (c) is received by the Receiving Party without
restriction on the Receiving Party’s disclosure or use, from
a third party which itself had no obligation to keep such
information confidential; or (d) is independently developed by
the Receiving Party without access or reference to the Confidential
Information of the Disclosing Party.
11.2
Restrictions. Each party shall maintain in confidence any
Confidential Information received
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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from the other
party or, in the case of Medtronic, of any of its suppliers or
purchasers during the Term and shall not publish, disseminate, or
disclose such Confidential Information except to the extent
necessary to carry out its duties hereunder without the express
written permission of the Disclosing Party. Each Receiving Party
shall use at least the same degree of care to protect the
Confidential Information of the Disclosing Party as it does to
protect its own Confidential Information and in all cases shall use
commercially reasonable efforts to protect such information. This
obligation of confidentiality shall expire five (5) years
after the termination or expiration of this Agreement.
11.3
Exceptions. A party may disclose Confidential Information of
the other party to the extent required to be disclosed by a court
or governmental agency pursuant to a statute, regulation, or valid
order; provided, however, that the Receiving Party first notifies
the Disclosing Party and gives the Disclosing Party the opportunity
to seek a protective order, or to contest such required
disclosure.
11.3
Return of Confidential Information.
All Confidential Information shall
be returned to the Disclosing Party at the request of the
Disclosing Party upon the termination or expiration of this
Agreement.
12.1
Independent Contractor Relationship.
VNUS is and shall remain an
independent contractor and is not and shall not be deemed to be an
employee, joint venturer, partner, or franchisee of Medtronic for
any purpose. Accordingly, VNUS shall be exclusively responsible for
the manner in which it performs its duties under this Agreement and
for the profitability or lack thereof of its activities under this
Agreement. All financial obligations associated with VNUS’
business are the sole responsibility of VNUS. VNUS does not have,
and shall not represent itself as having, any right or authority to
obligate or bind Medtronic in any manner whatsoever.
12.2
Waivers. Failure of either party at any time to require
strict performance of the other party of the provisions of this
Agreement shall not act as a waiver of such provisions, nor shall
the waiver of a breach of the Agreement by either party constitute
a waiver of such provision for any subsequent breach.
12.3
Entire Agreement and Modifications.
This Agreement, together with its
schedules, exhibits and addendums, if any, contains the entire and
only agreement between the parties with respect to the sale and
purchase of Medtronic products. Any representations or terms and
conditions not incorporated in this Agreement shall not be binding
upon either party. No attempted modification of this Agreement
shall be binding upon either party unless in writing and signed in
the same manner as the original Agreement. If any provision of this
Agreement is held to be invalid, it shall not affect the
enforceability of the remaining provisions.
12.4
Assignment. VNUS may not transfer, assign, nor delegate the
rights or the duties of this Agreement without the prior written
consent of Medtronic. Notwithstanding the foregoing, either party
may assign its rights and obligations under this Agreement with the
prior written consent of the non-assigning party, such consent not
to be unreasonably withheld or delayed, to any person or entity
with which such party is merged or by which it is acquired or which
purchases all or substantially all of its assets or stock;
provided, if the non-assigning party does not give its consent,
this Agreement is automatically terminated at the time of the
merger, acquisition, or sale, as applicable.
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
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12.5
Governing Law. This Agreement and the relationship between the
parties shall be governed by the laws of the State of New York,
without giving effect to its conflicts of law
provisions.
12.6
Dispute Resolution. All disputes and disagreements between the
parties arising out of or relating to any provision of this
Agreement or the breach, termination, or validity thereof, shall be
resolved in accordance with the following provisions:
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a)
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For
any dispute that cannot be resolved in the normal course of
business, the parties shall attempt in good faith to resolve such
dispute by negotiation between senior level executives who have
authority to settle the controversy and who are at a higher level
of management than the persons with direct responsibility for
administration of this Agreement. Any party may give the other
party written notice that a dispute has not been resolved in the
normal course of business.
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b)
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Any
dispute which has not been resolved within a reasonable time by
negotiation under subsection (a), above, shall be resolved through
binding arbitration in accordance with the Center for Public
Resources Non-Administered Arbitration Rules in effect on the date
of this Agreement. Unless the parties agree otherwise, the
arbitration shall be conducted by three independent and impartial
arbitrators who shall be appointed by CPR in accordance with
CPR’s rules governing the arbitration. The arbitration shall
be governed by the United States Arbitration Act, 9 U.S.C. 1-16.
The place of arbitration shall be New York County, New York, USA
and shall be conducted in the English language. The arbitrators are
not empowered to make any award in excess of compensatory damages
and each party hereby irrevocably waives any right to recover such
damages with respect to any dispute resolved by arbitration. Any
judicial proceeding to enforce a decision of the arbitrators under
this Agreement shall be instituted and conducted in U.S. District
Court in New York County, New York, U.S.A.
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c)
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The
statute of limitations of the State of New York applicable to the
commencement of a lawsuit shall apply to the commencement of an
arbitration hereunder.
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d)
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All
negotiations pursuant to this Section 12.6 are confidential
and shall be treated as compromise and settlement negotiations for
purposes of applicable rules of evidence.
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12.7
Force Majeure. If the performance of any obligation of this
Agreement except for the payment of money is prevented, restricted,
or interfered with by reason of strike, labor dispute, natural
disaster, war, the acts of government or any other cause outside
the reasonable control of the parties, then the party so affected
shall give prompt notice to the other party and shall be excused
from such performance to the extent made necessary by such
event.
12.8
Notices . Any notice required or permitted by this
Agreement shall be in writing and shall be sent by prepaid
registered or certified mail, return receipt requested,
internationally recognized courier or personal delivery, or by fax
with confirming letter mailed under the conditions described above
in each case addressed to the other party at the address shown
below or at such other address for which such party give notice
hereunder. Such notice shall be deemed to have been given when
delivered:
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
Â!
Medtronic USA,
Inc.
7601 Northland Drive North
Minneapolis, MN 55428
Attn: VP and General Manager, Cardiac Surgery
Medtronic USA,
Inc.
7601 Northland Drive North
Minneapolis, MN 55428
Attn: VP and Senior Counsel, Cardiac Surgery
VNUS Medical
Technologies, Inc.
2200 Zanker Road, Suite F
San Jose, CA 95131
Attn: Chief Financial Officer
12.9
Counterparts. This Agreement may be executed in counterparts,
each of which will be considered an original, but all of which
together will constitute the same instrument.
IN WITNESS
WHEREOF, the parties have caused this Agreement to be executed on
the date first written above.
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VNUS MEDICAL
TECHNOLOGIES, INC.
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/s/ R.
McCrae
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Name
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Vice President
& General Manager RST
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VP, Bus. Dev.
& Mfg.
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Title
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1/25/06
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Date
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****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
Â!
MARKET SEGMENT &
TERRITORY
Market
Segment
All vascular surgery procedures.
Exclusions:
All non-vascular surgical procedures .
Territory
Entire United States
Exclusions :
Markets outside the United States
****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
Â!
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UCLIP™ Anastomotic
Devices
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All
U-CLIP™ 2 - pack configurations are shipped as 24 packs per
carton, all 8 - pack configurations are shipped as 18 packs per
carton.
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Product Order
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U-CLIP™
Count
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Number
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Product
Description
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(clips per carton)
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****Certain
confidential information contained in this document, marked with 4
asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange A
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