EXHBIT 10.1
AMENDED AND RESTATED SALES AGREEMENT
THIS AMENDED AND RESTATED SALES AGREEMENT (the "Agreement") is made and
entered into this 26th day of June, 1998 to be effective as of July 1, 1998
(the "Effective Date") between VISTA MEDICAL TECHNOLOGIES, INC. ("Vista"), a
Delaware corporation, and MEDTRONIC, INC. (as defined below, "Medtronic"), a
Minnesota corporation.
WITNESSETH:
WHEREAS, Vista has developed visualization and related information
systems for use in, among other areas, cardiothoracic surgical procedures; and
WHEREAS, Vista and Medtronic Asset Management, Inc., a wholly-owned
subsidiary of Medtronic ("MAMI") entered into a Series C Preferred Stock
Purchase Agreement dated November 27, 1996 (the "Investment Agreement")
pursuant to which MAMI purchased Series C Preferred Stock of Vista; and
WHEREAS, MAMI is a party to the Amended and Restated Investor Rights
Agreement dated November 27, 1996 (the "Investors' Rights Agreement")
pursuant to which MAMI received certain registration and other rights; and
WHEREAS, Vista and MAMI entered into a Sales Agreement dated November
27, 1996 (the "Original Sales Agreement"), as amended by an Amendment Number
One to Sales Agreement dated June 9, 1998 ("Amendment No. 1"; the Original
Sales Agreement as amended thereby referred to as the "Amended Sales
Agreement"); and
WHEREAS, Vista and MAMI desire to further amend and to restate the
Amended Sales Agreement in its entirety to read as set forth herein.
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 to amend and restate the Amended Sales Agreement in
its entirety as follows effective from and after the Effective Date:
ARTICLE 1
DEFINITIONS
1.1) SPECIFIC DEFINITIONS. As used in this Agreement, the following
terms have the meanings set forth or referenced below:
"AFFILIATE" of a specified person (natural or juridical) means a person that
directly, or indirectly through one or more intermediaries, controls, or is
controlled by, or is under common control with, the person specified.
"Control" shall mean ownership of more than 50% of the shares of
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stock entitled to vote for the election of directors in the case of a
corporation, and more than 50% of the voting power in the case of a business
entity other than a corporation.
"CHANGE OF CONTROL" means, with respect to Vista, any of the following
events: (1) any "person" (as such term is used in Sections 13(d) and 14(d) of
the Exchange Act) in a single transaction acquires "beneficial ownership" (as
defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of
securities of Vista representing 50% or more of the combined voting power
(with respect to the election of directors) of Vista's then outstanding
securities; (2) the consummation of a merger, combination or consolidation of
Vista with or into any other corporation, other than a merger, combination or
consolidation which would result in the voting securities of Vista
outstanding immediately prior thereto continuing to represent (either by
remaining outstanding or by being converted into voting securities of the
surviving entity) more than 50% of the combined voting power (with respect to
the election of directors) of the securities of Vista or of such surviving
entity outstanding immediately after such merger, combination or
consolidation; or (3) the consummation of a plan of complete liquidation of
Vista or of an agreement for the sale or disposition by Vista of all or
substantially all of Vista's business or assets.
"CONFIDENTIAL INFORMATION" means know-how, trade secrets, and other
unpublished or proprietary information disclosed (whether before or during
the term of this Agreement) by one of the parties (the "disclosing party") to
the other party (the "receiving party") or generated under this Agreement,
excluding information which:
(a) is now or comes to be in the public domain through no fault of the
receiving party;
(b) is released without restriction to the receiving party by the
disclosing party in writing;
(c) is lawfully obtained by the receiving party from third parties;
(d) can be demonstrated by competent proof to have been known or hereafter
developed by the receiving party independently of any disclosure of
"Confidential Information by the disclosing party;
(e) has been in the possession of the receiving party, as a result of
disclosure under this Agreement, for a period of five (5) years; or
(f) is required by law to be disclosed; provided that the receiving party
has given the disclosing party prompt written notice of such disclosure
requirement and has cooperated with the disclosing party so that the
disclosing party may seek a protective order or other appropriate remedy to
avoid or limit such disclosure.
All Confidential Information disclosed by one party to the other under
this Agreement shall be in writing and bear a legend "Company Proprietary,"
"Company Confidential" or words of similar import or, if disclosed in any
manner other than writing, shall be preceded by an oral statement indicating
that the information is Company proprietary or confidential, and shall be
followed by transmittal of a reasonably detailed written summary of the
information provided to
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the receiving party with identification as Confidential Information
designated as above within thirty (30) days.
"EUROPE, THE MIDDLE EAST, AND AFRICA" means those countries included within
Medtronic's currently designated "Europe", "Middle East" and "Africa" sales
regions as more fully described on Schedule 1.1 hereto.
"EXTENDED GEOGRAPHIES" means the following countries: Japan, Australia, New
Zealand, Canada and India.
"FDA" means the U.S. Food and Drug Administration.
"FDA GOOD MANUFACTURING PRACTICES" means as defined in 21 Code of Federal
Regulations Part 820.
"FIELD OF USE" means cardiothoracic surgical procedures.
"INTELLECTUAL PROPERTY" means all patents, trade names, trademarks, service
marks, copyrights, and applications or registrations for any of the foregoing,
inventions, discoveries, know-how, trade secrets, data, information, technology,
processes, formulas, drawings, designs, computer programs, licenses, and all
amendments, modifications, and improvements to any of the foregoing.
"MEDTRONIC" means Medtronic, Inc. and its Affiliates.
"PRIME RATE" means, for any calendar quarter, the prime commercial lending rate
quoted by the Wall Street Journal, as in effect on the first day of such
quarter.
"SPECIFICATIONS" means the current (as of the date of the Original Sales
Agreement) specifications for the Systems, as have been or may be amended from
time to time after the date of the Original Sales Agreement by written
agreement of the parties hereto.
"SYSTEMS" means Vista's current (as of the date of the Original Sales Agreement)
and future (from and after the date of the Original Sales Agreement)
visualization and related information systems, together with all associated
accessories and disposables specific to the visualization system in the Field of
Use.
"TERRITORY" means the United States, Europe, the Middle East, and Africa and the
Extended Geographies.
"UNITED STATES" means The United States of America, including all territories
and possessions thereof.
"VISTA" means Vista Medical Technologies, Inc. and its Affiliates.
1.2) OTHER TERMS. Other terms may be defined elsewhere in the text of this
Agreement and shall have the meaning indicated throughout this Agreement.
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1.3) OTHER DEFINITIONAL PROVISIONS.
(a) The words "hereof," "herein," and "hereunder" and words of
similar import, when used in this Agreement, shall refer to this Agreement
as a whole and not to any particular provisions of this Agreement.
(b) The terms defined in the singular shall have a comparable
meaning when used in the plural, and vice versa.
(c) References to an "Exhibit" are, unless otherwise specified,
to one of the Exhibits attached to or referenced in this Agreement, and
references to an "Article" or a "Section" are, unless otherwise specified,
to one of the Articles or Sections of this Agreement.
(d) The term "person" includes any individual, partnership,
joint venture, corporation, trust, unincorporated organization or
government or any department or agency thereof.
(e) The term "Dollars" or "$" shall refer to the currency of the
United States of America.
(f) The term "knowledge" means actual knowledge of a fact or the
knowledge which such person or its officers or employees could reasonably
be expected to have based on reasonable investigation and inquiry.
(g) All references to time shall refer to Minneapolis, Minnesota
time.
ARTICLE 2
MEDTRONIC AS DISTRIBUTOR IN THE UNITED STATES
2.1) Appointment.
(a) Vista hereby appoints Medtronic, and Medtronic hereby accepts
appointment, as Vista's exclusive distributor, with the exclusive right to sell
and distribute the Systems in the Field of Use in the United States, including
the right to place Systems with hospitals or other users under contracts
providing for a per procedure pricing basis (as defined in Section 2.4). Vista
represents and warrants to Medtronic that all other distributorship agreements
and independent sales representative agreements, written or oral, with any third
party permitting the sale of Systems in the Field of Use in the United States
will be terminated within 90 days after signing this Agreement at Vista's sole
cost and expense.
(b) The initial term ("Initial Term") for Medtronic's rights and
obligation as the exclusive distributor for Systems in the United States shall
commence on the Effective Date and continue until April 30, 2003. The Initial
Term shall have two phases: The first phase ("Phase I") shall commence on the
Effective Date and continue until November 30, 1999. The second phase ("Phase
II") shall commence on December 1, 1999 and continue until April 30, 2003.
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2.2) EMPLOYEES.
(a) Within 60 days after the Effective Date, Medtronic shall hire
*** persons to serve as Medtronic's sales and clinical specialist force
dedicated to selling and placing the Systems in the United States (the "Field
Organization"). In hiring such Field Organization, Medtronic shall make
offers of employment to up to *** members of Vista's current sales and
clinical specialist force who meet the requirements for the needed positions
that Medtronic has identified are necessary to support sales and/or placement
of the Systems. The Field Organization shall be integrated into the ***
sales organization and become Medtronic employees effective as of specific
dates to be determined. During Phase I, Vista shall reimburse Medtronic on a
monthly basis for all expenses associated with the Field Organization,
including salaries, commissions, bonuses, medical benefits, and travel
expenses, up to a maximum of *** in the aggregate. Vista shall also
reimburse Medtronic on a monthly basis for any termination expenses (not to
exceed 3-months salary per individual) related to the termination or
dismissal by Medtronic for performance reasons of any members of Vista's
current sales and clinical specialist force who are hired by Medtronic.
(b) As of the beginning of Phase II, Medtronic shall cover all
expenses associated with the Field Organization, including salaries,
commissions, bonuses, medical benefits, and travel expenses.
2.3) SPECIAL PROVISIONS REGARDING PHASE I
(a) During Phase I, the Medtronic Cardiac Surgery USCV sales
organization shall actively generate leads of interested customers and work
cooperatively with the Field Organization to complete sales/placements of
Systems.
(b) Within 45 days of commencement of Phase I, Medtronic shall hire a
Marketing/Education Manager fully devoted to Vista and the System.
(c) During Phase I:
(i) Contracts with the hospitals for the sale or placement of
Systems shall be entered into by Medtronic in Medtronic's name;
(ii) Vista shall cooperate with Medtronic to transfer and assign to
Medtronic all contracts for the placement of Systems on a per procedure
pricing basis that Vista entered into with hospitals prior to the beginning
of Phase I. Vista will remain responsible for servicing the Systems placed
under such contracts pursuant to Section 2.5. Medtronic shall pay Vista an
amount equal to the total *** of such Systems (including
service and upgrade components) placed under such contracts, and Vista shall
assign title to such systems and any deposits or prepayments under such
contracts to Medtronic. Such *** shall be based on
straight-line depreciation over three years pursuant to Vista's standard
accounting principles.
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Confidential Treatment and filed separately with the Commission.
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Medtronic shall thereafter pay Vista a portion of Medtronic's gross margin
pursuant to Section 2.4(b) on payments received by Medtronic under such
transferred contracts. Vista shall use all commercially reasonable efforts
to obtain the consent of such hospitals to such assignment, if required by
such contract. If any such consent is not obtained, the parties shall
cooperate in good faith to cause Vista to continue to perform its obligations
under such contract for the benefit of Medtronic.
(iii) Medtronic shall be responsible for invoicing of all Systems
and the collection of accounts receivable; provided that during Phase I, Vista
shall retain the billing function with respect to Systems placed on a per
procedure pricing basis until such time that the administrative services would
be transferred to Medtronic. Medtronic shall record for its account all
revenues recognized.
2.4) PRICING.
(a) Medtronic shall purchase Systems from Vista for resale to
customers in the United States at a price (the "Transfer Price") determined
as follows:
(i) For Phase I, the Transfer Price for units to be sold
to customers shall equal Vista's ***
and to be reasonably determined in accordance with
generally accepted accounting principles as then currently
applied by Vista, as applicable), plus a xxxx-up equal to ***;
and
(ii) For Phase II, the Transfer Price for units to be
sold to customers shall equal Vista's *** plus
a xxxx-up equal to *** of such *** *** plus
an amount equal to one-half of Medtronic's gross margin
percentage in excess of ***.
(b) Medtronic shall purchase Systems from Vista for placement on a
"per procedure pricing basis" (as defined below) with customers in the United
States at a price (the "Transfer Price") equal to Vista's *** .
With respect to such Systems placed on a per procedure pricing basis in the
United States, Medtronic shall also pay Vista a percentage of Medtronic's
"gross margin" (as defined below) as follows:
(i) with respect to payments received by Medtronic
during Phase I from customers for Systems placed on a per
procedure pricing basis, Medtronic shall pay Vista *** of
Medtronic's gross margin on such System placement.
(ii) with respect to payments received by Medtronic
during Phase II from customers for Systems placed on a per
procedure pricing basis, Medtronic shall pay Vista *** of
Medtronic's gross margin, up to a *** gross margin percentage,
plus *** of
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Confidential Treatment and filed separately with the Commission.
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Medtronic's gross margin in excess of a *** gross margin
percentage, on such System placement, calculated on a
cumulative basis since the beginning of Phase II.
(c) The Transfer Price to Medtronic of a standard System shall in
no event exceed U.S. *** . (The components of the current standard
System, exclusive of accessories and disposables, are listed on Schedule 3.3).
(d) As used in this Agreement "per procedure pricing" is defined
as a System placed in a cardiothoracic operating room where the amount of the
fee billed to the customer is based on System configuration and usage. As
used in this Article 2, Medtronic's "gross margin" on the sale of Systems or
the placement of Systems on a per procedure basis shall mean Medtronic's Net
Sales (as defined below) minus Medtronic's "cost of goods sold", which in the
case of a sale of a System shall mean the price paid to Vista by Medtronic
for purchase of the System (calculated prior to any gross margin sharing) and
in the case of placement of a System on a per procedure basis shall mean the
depreciation charge allocated to that System by Medtronic during the relevant
period based on a three-year straight-line depreciation of the System. As
used in this Article 2, "Medtronic's Net Sales" means the amount that
Medtronic, any Affiliate of Medtronic, or any subdistributor of Medtronic
under this Agreement receives from third parties (excluding transactions
between or among Affiliates of Medtronic, subdistributor's, and/or Medtronic)
for sales or placements of Systems pursuant to the terms of this Agreement,
less all amounts charged for sales, use, occupation or excise tax, freight,
duty or insurance included therein, returns, discounts of any type, and
allowances, credits or repayments due to rejections, defects or returns. As
used in this Article 2, Medtronic's "gross margin percentage" shall mean
Medtronic's gross margin as a percentage of Medtronic's Net Sales.
(e) Medtronic shall pay the Transfer Price for Systems purchased
under Article 2 in full within forty-five (45) days after the date of invoice
by Vista. Medtronic's payments to Vista of a percentage of Medtronic's gross
margin on Systems placed on a per procedure pricing basis pursuant to
subsections 2.4(b) shall be made quarterly within forty-five (45) days after
the end of each Medtronic fiscal quarter. Medtronic and Vista shall work
together to establish a method for reporting or estimating such per procedure
pricing payments on a monthly and quarterly basis to enable both Vista and
Medtronic to satisfy their respective internal and external financial
reporting obligations.
(f) In addition, Medtronic shall be entitled to purchase from
Vista up to *** of Vista's current demonstration units at a price equal
to the total *** of the Systems as described in Section 2.3(c)(ii). In
addition, Medtronic shall be entitled to purchase a reasonable number of
demonstration units at a price equal to Vista's *** . The total
number of demonstration units purchased by Medtronic under this Article 2
would not exceed *** over the initial term of Medtronic's distribution
pursuant to this Article 2.
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Confidential Treatment and filed separately with the Commission.
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2.5) UNITED STATES INSTALLATION; REPAIRS AND SERVICE; TRAINING.
(a) Medtronic shall be solely responsible for selling and
installing all Systems in the Field of Use in the United States.
(b) During the initial one-year warranty period, Vista shall be
solely responsible for all repairs and service of Systems in the United
States at Vista's expense. With respect to repairs and service after the
warranty period for Systems sold by Medtronic, the purchaser of such System
shall be offered by Medtronic on behalf of Vista successive one-year fixed
price service contracts. Such service contracts shall be between Vista and
such purchaser, but the terms and provisions of such contract shall be
reasonably acceptable to Medtronic. If a purchaser fails to accept a service
contract, Vista will, if requested by such purchaser, perform repairs and
service for a fee from such purchaser based on time and materials spent (with
a target *** gross margin to Vista). With respect to repairs and
service after the warranty period for Systems placed by Medtronic with a
customer on a per procedure pricing basis, Vista shall upon Medtronic's
request perform such repairs and service and Medtronic shall pay Vista its
*** thereof plus a *** xxxx-up, subject to a maximum of *** per System
per year. With respect to repairs and service under per procedure pricing
contracts assigned by Vista to Medtronic pursuant to Section 2.3(c)(ii),
Vista shall perform all such repairs and service at no additional cost (the
depreciated cost thereof is included in the price paid by Medtronic pursuant
to such Section 2.3(c)(ii)). Vista's repair and service obligations under
this Section shall not include damage due to the System user's abuse or
neglect, and shall not include software or hardware upgrades.
(c) Subject to Section 2.6 below, Medtronic shall be solely
responsible for providing customer and physician training to any purchaser of
Systems for use in the Field of Use in the United States.
2.6) TRAINING. Vista and Medtronic shall mutually agree on a plan
to transition customer training in the United States to Medtronic with a
target date of September 30, 1998 but no later than November 1, 1998. Vista
shall, at its cost, provide initial technical training of Medtronic's sales
specialists and field service supervisors in the United States in the use,
installation and service of the Systems at such reasonable times and places
as the parties shall agree. Medtronic shall reimburse Vista for Vista's
costs of providing ongoing training of Medtronic's field sales and service
representatives in the United States (such ongoing training costs to include
travel costs, a reasonable mutually agreed upon per diem rate for Vista's
sales training personnel, and a reasonable mutually agreed upon cost of sales
training materials).
2.7) FORECASTS. Within 60 days after the Effective Date, Medtronic
shall provide Vista with a twelve-month forecast indicating by month the
number of Systems anticipated to be sold by Medtronic or purchased by
Medtronic for use as demonstration units (as updated as provided herein, the
"Plan"). The Plan shall be updated by Medtronic on a monthly basis (on or
before the first day of each subsequent month) for a rolling successive
twelve-month period. The first two months of each Plan shall constitute a
firm purchase commitment by Medtronic for delivery of
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the number of Systems specified therein. The third month of each Plan shall
constitute a firm purchase commitment only insofar as Medtronic agrees not to
reduce the quantity specified therein by more than 25%, but Medtronic
otherwise may modify such quantity in the next Plan. The fourth through
twelfth months of each Plan shall be used for purposes of facilitating
Medtronic's marketing plans and meeting the lead times required by certain of
Vista's suppliers, but are not legally binding on Medtronic in any manner.
2.8) REGULATORY APPROVALS.
(a) Vista shall be solely responsible for obtaining, at Vista's
expense and in Vista's name all necessary regulatory and other approvals from
the FDA and any other applicable regulatory agencies prerequisite to the
commercial sale of the Systems in the Field of Use in the United States.
Such approval efforts shall include, but not necessarily be limited to, the
preparation and filing of any required Investigational Device Exemption,
Pre-Market Approval or Section 510(k) filings and the establishment and
oversight of any required clinical investigations and clinical follow-up
relating to future commercial sale of the Systems. Vista shall promptly
notify Medtronic of receipt of any such approvals, and shall provide
Medtronic with such information regarding the status of pending approvals as
Medtronic may reasonably request.
(b) Vista shall be responsible for obtaining all import licenses and
permits as may be required to import the Systems into the United States (if
applicable) in accordance with then prevailing laws and regulations. All such
filings and registrations of the Systems shall be in the name of Vista.
Medtronic shall cooperate fully with Vista in its efforts to obtain any such
approvals.
(c) Vista shall be considered the manufacturer of the Systems for
purposes of any United States regulatory requirements, including medical
device reporting and recalls. If Medtronic becomes aware of any reportable
event involving Systems which Medtronic has sold or placed on a per procedure
pricing basis pursuant to this Agreement, it shall promptly notify Vista of
such event. Vista shall promptly notify Medtronic if Vista files an MDR with
the FDA. Furthermore, Medtronic shall maintain complete and accurate records
of all Systems sold or placed by Medtronic and its subdistributors in
sufficient detail to enable Vista to conduct an effective recall of Systems
if Vista determines that such a recall is required or otherwise necessary or
appropriate. Vista shall have the responsibility of initiating all recalls
if necessary. In the event of a recall of any of the Systems, Medtronic will
cooperate with and assist Vista in effecting such recall, including promptly
contacting any customers that Vista reasonably desires to be contacted and
promptly communicating to such customers the information or instructions
Vista reasonably desires to be transmitted relating to such recall. Vista
shall pay, or reimburse Medtronic, for all costs of effecting such recall,
including any shipping costs related to returning recalled Systems to Vista
and replacing such recalled Systems with new Systems at Vista's expense.
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2.9) SALES AND MARKETING.
(a) Medtronic and Vista shall develop mutually agreed upon
marketing, selling, and pricing strategies for the Systems in the United
States.
(b) Medtronic shall be responsible for designing, developing and
producing, at Medtronic's expense, Systems sales and marketing materials for
use in the Field of Use in the United States.
(c) At Medtronic's discretion and expense, Medtronic shall
demonstrate the Systems in the trade shows booth in connection with its other
cardiac surgery products.
2.10) NONCOMPETITION. During the term of Medtronic's distribution
of Systems pursuant to this Article 2, Medtronic shall not market or sell in
the United States direct visualization products which are competitive with
the Systems in the Field of Use ("Competitive Products"); provided that, for
purposes of clarification, Competitive Products shall not include
intra-vascular or intra-cardiac imaging or visualization products or systems.
ARTICLE 3
MEDTRONIC AS DISTRIBUTOR IN EUROPE, MIDDLE EAST AND
AFRICAAND EXTENDED GEOGRAPHIES
3.1) APPOINTMENT.
(a) Vista hereby appoints Medtronic, and Medtronic hereby accepts
appointment, as Vista's exclusive distributor, with the right to sell and
distribute the Systems in the Field of Use in Europe, the Middle East and
Africa and the Extended Geographies, including the right to place Systems
with hospitals or other users under contracts providing for a "per procedure
pricing basis" (as defined in Section 2.4). Vista represents and warrants to
Medtronic that all other distributorship agreements or sales representative
agreements, written or oral, with any third party permitting the sale of
Systems in the Field of Use in Europe, the Middle East and Africa and the
Extended Geographies have been terminated at Vista's sole cost and expense.
(b) During the term of Medtronic's distribution rights pursuant to
this Article 3, Medtronic shall not market or sell Competitive Products (as
defined in Section 2.10) in Europe, the Middle East and Africa or the
Extended Geographies.
3.2) REGULATORY APPROVALS.
(a) Medtronic shall be solely responsible for obtaining, at
Medtronic's expense and in Medtronic's name, all necessary regulatory and
other approvals from the applicable regulatory agencies prerequisite to the
commercial sale of the Systems in the Field of Use in the Middle East, Africa
and the Extended Geographies (excluding Canada). Such approval efforts shall
include, but not necessarily be limited to, the preparation and filing of any
required filings and the establishment and oversight of any required clinical
investigations and clinical follow-up
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relating to future commercial sale of the Systems in the Field of Use in the
Middle East, Africa and the Extended Geographies (excluding Canada).
(b) In Europe, Vista will be responsible for gaining, at Vista's
expense and in Vista's name, the CE Xxxx under the appropriate Medical Device
Directive. Medtronic will be responsible for all dealings with the
appropriate Competent Authority such as Notification, Medical Device
Vigilance and national labeling issues, provided that Vista will bear final
legal responsibility for the content of all its own labeling. Medtronic will
also be named as the "Authorized Representative" as defined in the
Directives. Medtronic may also distribute Systems in particular countries
within Europe under country-specific regulatory approvals prior to Vista's
gaining the CE Xxxx or in particular countries where CE Xxxx approval is not
the requisite form of commercial sale approval, and in such circumstances
Vista shall (i) provide Medtronic with such information and cooperation as is
necessary to obtain any such country-specific approvals in Europe, (ii) bear
the expenses of meeting any applicable product design and manufacturing
facility requirements, and (iii) take all steps as are necessary to meet the
EMC Directive.
(c) In Canada, Vista shall be responsible for obtaining, at
Vista's expense and in Vista's name, cETL agency approval prerequisite to the
commercial sale of Systems in the Field of Use in Canada. Such approval
efforts shall include, but not necessarily be limited to, the preparation and
filing of any required filings and the establishment and oversight of any
required clinical investigations and clinical follow-up relating to future
commercial sale of the Systems in the Field of Use in Canada. Medtronic
shall provide Vista reasonable assistance upon request, at Medtronic's
expense, in obtaining any necessary Canadian health or regulatory approval.
3.3) PRICING.
(a) For the period from the date of the Original Sales Agreement
until December 31, 1998, Medtronic shall purchase Systems for sale or
placement in Europe, Middle East, Africa and the Extended Geographies from
Vista at a price (the "Transfer Price") *** *** plus a projected
xxxx-up presently estimated to be *** but in no event less than ***
subject to final determination as hereinafter provided. Such transfer price
shall be finally determined by the parties based on market conditions at the
time of commercial introduction of the Systems; provided that in no event
shall the price to Medtronic of a standard System exceed U.S. *** . (The
components of the current standard System, exclusive of accessories and
disposables, are listed on Schedule 3.3). No later than December 31, 1998,
and by each December 31 thereafter, the parties shall amend the Transfer
Price for the following twelve-month period pursuant to a formula to be
mutually agreed to by the parties, taking into account then market conditions.
(b) In addition, Medtronic shall be entitled to purchase from
Vista a reasonable number of demonstration Systems at a price equal to
Vista's *** for a System as determined above. Such reasonable number
of demonstration Systems (not to
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request for Confidential Treatment and filed separately with the
Commission.
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exceed *** per year) shall be consistent with the number of Medtronic's
"sales specialists" and the number of demonstrations to be conducted by such
sales specialists in connection with selling the Systems, and shall include,
without limitation, *** demonstration System for each country within
the Extended Geographies.
(c) Payments made by Medtronic for Systems purchased hereunder
shall be due and payable in full within sixty (60) days after the date of
invoice by Vista.
3.4) SALES AND SERVICE.
(a) Medtronic shall be solely responsible for selling, installing
and servicing all Systems in the Field of Use in Europe, the Middle East and
Africa and the Extended Geographies. The Systems shall be sold under Vista
trademarks and trade names subject to Medtronic's right to indicate its
status as distributor thereof on sales and marketing materials for the
Systems.
(b) Subject to Section 3.5 below, Medtronic shall be solely
responsible for providing customer and physician training to any purchaser of
Systems for use in the Field of Use in Europe, the Middle East and Africa and
the Extended Geographies.
(c) Medtronic shall be solely responsible for establishing,
subject to Vista's right to be consulted with respect thereto, the marketing,
selling and pricing strategies for the Systems in the Field of Use in Europe,
the Middle East and Africa and the Extended Geographies.
3.5) TRAINING.
(a) Vista shall, at its cost, provide initial technical training
of Medtronic's sales specialists and field service supervisors in Europe, the
Middle East and Africa in the use, installation and service of the Systems at
such reasonable times and places as the parties shall agree. Medtronic shall
reimburse Vista for Vista's costs of providing ongoing training of
Medtronic's field sales and service representatives in Europe, the Middle
East and Africa (such ongoing training costs to include travel costs, a
reasonable mutually agreed upon per diem rate for Vista's sales training
personnel, and a reasonable mutually agreed upon cost of sales training
materials).
(b) Vista shall, at its cost, provide initial technical training
of Medtronic's sales specialists, field service supervisors and customers in
the Extended Geographies in the use, installation and service of the Systems
at such reasonable times and places as the parties shall agree; provided
however, that Vista will be required to make available a minimum of one
trainer for a minimum of one week. Medtronic shall reimburse Vista for
Vista's cost of providing ongoing training of Medtronic's field sales and
service representatives in the Extended Geographies (such ongoing training
costs to include travel costs, a reasonable mutually agreed
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upon per diem rate for Vista's sales training personnel, and a reasonable
mutually agreed upon cost for sales training materials).
3.6) FORECASTS. On or before January 1, 1997, Medtronic shall
provide Vista with a twelve-month international sales plan indicating by
month the number of Systems anticipated to be sold by Medtronic or purchased
by Medtronic for use as demonstration units (as updated as provided herein,
the "Plan"). The Plan shall be updated by Medtronic on a monthly basis (on
or before the first day of each subsequent month) for a rolling successive
twelve-month period. The first two months of each Plan shall constitute a
firm purchase commitment by Medtronic for delivery of the number of Systems
specified therein. The third month of each Plan shall constitute a firm
purchase commitment only insofar as Medtronic agrees not to reduce the
quantity specified therein by more than 25%, but Medtronic otherwise may
modify such quantity in the next Plan. The fourth through twelfth months of
each Plan shall be used for purposes of facilitating Medtronic's marketing
plans and meeting the lead times required by certain of Vista's suppliers,
but are not legally binding on Medtronic in any manner.
3.7) EXPORT/IMPORT APPROVALS.
(a) Vista shall be responsible for obtaining all export licenses
and permits as may be required to export the Systems from the country of
manufacture into the particular countries within Europe, the Middle East and
Africa and the Extended Geographies.
(b) Medtronic shall be responsible for obtaining all import
licenses and permits as may be required to import the Systems into particular
countries within Europe, the Middle East and Africa and the Extended
Geographies as selected by Medtronic in accordance with then prevailing laws
and regulations of such countries. All such filings and registrations of the
Systems shall be in the name of Medtronic, whenever feasible in accordance
with prevailing laws and regulations. Vista shall cooperate fully with
Medtronic in its efforts to obtain any such approvals.
3.8) ADDITIONAL ORDER. Prior to the Effective Date, Medtronic
shall have placed an order with Vista for the purchase and shipment of the
following number of Systems for the Extended Geographies:
Japan *** Systems (*** of which shall be a
demonstration System)
Australia/New Zealand *** System
Canada *** Systems (*** of which shall be a
demonstration System)
On or prior to December 31, 1998, Medtronic will place an order for purchase
and shipment of one System for India.
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ARTICLE 4
DISTRIBUTION GENERALLY
4.1) SUBDISTRIBUTORS. Medtronic may appoint subdistributors for
the sale or distribution of Systems in the Field of Use in the Territory, and
will provide Vista a list of such subdistributors from time to time.
Notwithstanding such appointment of subdistributors, Medtronic shall remain
fully responsible for the performance of all of its covenants and obligations
hereunder, and any sales by Vista to such Medtronic subdistributors shall be
billed by Vista to Medtronic directly.
4.2) SALES LEADS. Vista shall promptly forward to Medtronic all
leads for sales of Systems in the Field of Use in the Territory.
4.3) INSPECTION AND WARRANTY
(a) In the event of any shortage, damage or discrepancy in or to a
shipment of Systems or in the event any of the Systems fail to comply with
the then current specifications for the Systems, Medtronic shall report the
same to Vista and furnish such written evidence or other documentation as
Vista reasonably may deem appropriate. If the substantiating evidence
delivered by Medtronic demonstrates that such shortage, damage or discrepancy
or non-conformity with specifications existed at the time of delivery of the
Systems at the F.O.B. point, Medtronic may return the Systems to Vista at
Vista' expense, and at Medtronic's request Vista shall use all reasonable
efforts to deliver promptly replacement Systems to Medtronic in accordance
with the delivery procedures set forth herein.
(b) Vista represents and warrants to Medtronic that all Systems
sold and delivered to any account under this Agreement will have been
manufactured, if required by law, in accordance with FDA Good Manufacturing
Practices, European Medical Device Directive requirements, ISO 9001
certification or successor requirements, and all other applicable
manufacturing requirements, and that continually during the term of this
Agreement no Systems delivered by Vista to Medtronic or to any Medtronic
Account 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.
Vista shall cause Medtronic's regulatory personnel to be provided with
reasonable access from time to time to the facilities and records of Vista
for the purpose of confirming Vista's compliance with all applicable
requirements noted in this Section.
(c) Vista warrants to Medtronic and to Medtronic's customers that
Systems sold by Vista will not infringe any currently issued patents, trade
secrets, trademarks, or other intellectual property rights of any third
party, and that such products shall, when delivered at the F.O.B. point, meet
the Specifications and shall be free from defects in materials and
workmanship. Medtronic shall invoice Vista for, and Vista shall promptly
pay, Medtronic's reasonable labor charges and Medtronic's out-of-pocket
materials, handling, shipping, transportation, insurance and other expenses
actually incurred in replacing defective Systems which were under warranty.
(d) THE WARRANTIES SET FORTH ABOVE ARE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY DISCLAIMED AND
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EXCLUDED BY VISTA, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE, EXCEPT VISTA
SHALL ALSO PROVIDE WITH RESPECT TO SYSTEMS SOLD TO MEDTRONIC OR TO
MEDTRONIC'S CUSTOMERS SUCH OTHER WARRANTIES AS VISTA CUSTOMARILY PROVIDES TO
ITS CUSTOMERS OR END-USERS OF THE SYSTEMS IN THE FIELD OF USE (A COPY OF THE
CURRENT VERSION OF SUCH CUSTOMER WARRANTY IS ATTACHED HERETO AS SCHEDULE
4.3). VISTA MAY CHANGE ITS STANDARD CUSTOMER WARRANTY FROM TIME TO TIME.
4.4) TRADEMARKS. The Systems shall be sold under Vista trademarks
and trade names subject to Medtronic's right to indicate its status as
distributor thereof on sales and marketing materials for the Systems.
4.5) ORDERS.
(a) Medtronic and Vista shall jointly develop order and delivery
procedures and guidelines for the Systems. Medtronic's orders shall be given
no less favorable treatment by Vista than orders from any other customers.
The parties intend that Medtronic will maintain mutually agreed upon adequate
inventories of Systems, and that under most circumstances, Vista will ship
Systems directly to locations designated by Medtronic.
(b) Medtronic shall submit purchase orders for Systems to Vista in
writing, whether by mail, telecopier, telegram or otherwise, which shall, at
a minimum, set forth the product numbers, quantities, delivery dates, and
shipping instructions and shipping addresses for all Systems ordered. All
orders shall be subject to acceptance in accordance with the terms of this
Agreement by Vista at its office. Each purchase order shall, upon acceptance
by Vista, give rise to a contract between Medtronic and Vista for the sale of
the Systems 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 Vista or Medtronic acceptance, confirmation, invoice or other
document unless duly signed by an officer of Medtronic and an officer of
Vista and expressly stating and identifying which specific additional or
contrary terms shall supersede the terms and conditions of this Agreement.
(c) Vista shall not be required to deliver quantities in excess of
100% of forecasted requirements unless Vista has been given at least 120 days
advance written notice of the quantities to be delivered which exceed the
forecasted amounts; provided, however, that Vista shall use all commercially
reasonable efforts to supply such excess.
(d) 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 cancelled
by Medtronic as to any Systems which are not delivered within sixty (60) 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
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cancellation by Medtronic must be by written notice to Vista given within
fifteen (15) business days after such 60th day.
(e) All deliveries of Systems shall be F.O.B. Vista's manufacturing
facility located at Westborough, Massachusetts. Except as provided in Section
4.3 above, Vista shall have no further responsibility for Systems, and all risk
of damage to or loss or delay of Systems shall pass to Medtronic, upon their
delivery at the aforesaid F.O.B point. All Systems 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 Vista.
(f) Vista shall inform Medtronic of any material changes in the
Specifications for the Systems and, if such changes affect the applicable
regulatory approvals of the Systems, Medtronic shall not be obligated to
purchase such altered Systems.
(g) Vista shall be responsible for packaging and any necessary
sterilization of Systems purchased under this Agreement in accordance with
specifications which are mutually satisfactory to the parties.
(h) Vista's *** , for purposes of determining the Transfer
Price, shall be mutually determined on a semi-annual basis as of the end of
December and June of each year during the Initial Term, commencing December
31, 1998.
4.6) UPGRADES. Vista shall make software and hardware upgrades
available to Medtronic for the Systems at prices and on terms and conditions
no less favorable than those offered to any other customers of Vista;
provided that Vista shall provide upgrades to Systems placed under per
procedure pricing contracts assigned by Vista to Medtronic pursuant to
Section 2.3(c)(ii) at no additional cost (the depreciated cost of such
upgrades is included in the price paid by Medtronic pursuant to such Section
2.3(c)(ii)). Except as provided in Section 4.3 with respect to warranty
replacement parts, Vista shall sell replacement parts for the Systems to
Medtronic at prices equal to Vista's *** thereof plus ***.
4.7) REPORTS AND AUDITS.
(a) Medtronic shall provide Vista, on a quarterly basis, with current
customer lists for Systems sold by Medtronic and physician users (of which
Medtronic is aware) of the Systems in the Field of Use in the Territory.
Medtronic also will periodically provide Vista with the customer name and
address for each System installation in the Field of Use in the Territory for
warranty and regulatory purposes. Medtronic shall report any "adverse events"
(as defined by FDA regulations) promptly to Vista.
(b) Medtronic shall keep accurate written records sufficient in
detail to enable Medtronic's gross margin on Systems placed on a per
procedure pricing basis, as reported by
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Medtronic to Vista, to be determined on a quarterly basis and verified by
Vista. Vista shall keep accurate written records sufficient in detail to
enable Vista's fully burdened manufacturing cost, as reported by Vista to
Medtronic, to be determined on a semi-annual basis and verified by Medtronic.
Such records shall be retained by the reporting party for a period of not
less than five years after the end of such period. Upon reasonable notice
and during regular business hours, the reporting party shall from time to
time (but no more frequently than semi-annually) make available such records
for audit by independent accounting representatives selected by the other
party (the "reviewing party") and reasonably acceptable to the reporting
party to verify the accuracy of the statements provided. Such
representatives shall execute a suitable confidentiality agreement reasonably
acceptable to the reporting party prior to conducting such audit. Such
representatives may disclose to Medtronic or Vista only their conclusions
regarding the accuracy of Medtronic's calculation of its gross margin on
Systems placed on a per procedure pricing basis or of Vista's calculation of
its fully burdened manufacturing cost of the System, respectively, and shall
not disclose the reporting party's confidential business information to the
reviewing party without the prior written consent of the reporting party.
All audit fees and costs shall be paid by the reviewing party; provided that
if such audit demonstrates that Medtronic's gross margin was understated, or
Vista's fully burdened manufacturing cost was overstated, by more than 5% for
any of the quarterly or semi-annual periods audited, then the reporting party
shall pay such audit fees and costs of such representative.
ARTICLE 5
FIRST REFUSAL FOR DISTRIBUTION IN OTHER REGIONS
5.1) RIGHT OF FIRST REFUSAL.
(a) In the event that Vista proposes to enter into any
distribution or sales representative agreement with any third party regarding
the sale or distribution of the Systems in the Field of Use in any region
outside of the Territory (such regions consisting of Asia Pacific (excluding
Japan) and Central/South America), then, prior to entering into any
discussions regarding such distribution or sales representative agreement,
Vista shall notify Medtronic in writing of such intention to enter into such
discussions, including the material terms and provisions upon which Vista
would be willing to enter into such a distribution or sales representative
agreement for such region ("Vista's Notice").
(b) For a period of 45 days after Medtronic's receipt of Vista's
Notice (the "Exclusive Period"), Vista shall negotiate in good faith
exclusively with Medtronic regarding such distribution or sales
representative agreement for the applicable region specified in Vista's
Notice. During the Exclusive Period, Vista will not solicit offers from,
negotiate with, or provide information to any third party regarding any
distribution or sales representative relationship for Systems in such region.
(c) If Medtronic and Vista fail to reach mutual agreement upon the
terms and provisions of a definitive agreement for such distribution or sales
representative relationship, then Vista shall have 90 days from the earlier
of expiration of the Exclusive Period or termination by Medtronic of
negotiations between Vista and Medtronic in which to enter into a
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definitive agreement for such distribution or sales representative
relationship with a third party for the applicable region specified in
Vista's Notice; provided that Vista may not enter into such definitive
agreements unless the terms and provisions thereof are, in the aggregate,
more favorable to Vista than the terms and provisions proposed by Medtronic
during the Exclusive Period. If Vista fails to enter into such definitive
agreement for the applicable region within such 90-day period, then
Medtronic's rights under this Section shall be reinstated and Vista may not
enter into any distribution or sales representative relationship for the sale
of Systems in such region without first giving Medtronic a new Vista's Notice
and complying with the terms of this Section.
ARTICLE 6
PRODUCT DEVELOPMENT
6.1) CUSTOMIZED SYSTEMS. Medtronic may refer new product ideas or
product customization requests for the Systems in the Field of Use to
designated Vista marketing representatives. Vista shall consider development
of Medtronic's custom product requests in a reasonable and timely manner
consistent with the way in which Vista undertakes custom product requests for
any other Vista customers.
6.2) NEW PRODUCTS. Vista and Medtronic shall each have the right
to offer to the other party the opportunity to co-develop products or
technologies with potential application in the Field of Use which the
offering party owns or has the right to use, subject to such mutually
acceptable terms and conditions as the parties may agree. The cost of such
co-development efforts shall be shared as may be mutually agreed to by the
parties.
ARTICLE 7
TERM AND TERMINATION
7.1) INITIAL TERM. The initial term (the "Initial Term") for
Medtronic's rights and obligations as (i) the exclusive distributor for
Systems in the United States shall be as set forth in Section 2.1(a), and
(ii) the exclusive distributor for Systems in Europe, the Middle East and
Africa and the Extended Geographies, shall commence on the date of the
Original Sales Agreement (or the date of Amendment No. 1 with respect to the
Extended Geographies) hereof and continue until April 30, 2003.
7.2) RENEWAL TERM; PERFORMANCE OBJECTIVES.
(a) The Initial Term shall be automatically renewed for an
additional two-year period (the "Renewal Term"), unless such Initial Term has
been terminated by Vista due to Medtronic's failure to achieve certain
reasonable and mutually agreeable performance objectives to be established by
the parties (the "Performance Objectives"). There shall be annual Performance
Objectives with respect to Medtronic's rights and obligations as the exclusive
distributor for Systems in the United States on an aggregate basis, and annual
Performance Objectives with
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respect to Medtronic's rights and obligations as the exclusive distributor for
Systems in Europe, the Middle East and Africa and the Extended Geographies on
an aggregate basis.
(b) Vista and Medtronic shall negotiate in good-faith to establish
(i) on or before December 31, 1997 and annually thereafter, annual aggregate
Performance Objectives for Europe, the Middle East and Africa and the
Extended Geographies during the Initial Term, and (ii) on or before the
beginning of Phase II and annually thereafter, annual Performance Objectives,
including pricing and marketing strategies, for the United States during the
Initial Term. The Performance Objectives shall take into account such factors
as the size of the market, price of the Systems, potential applications of
the Systems, selling cycle, Vista's manufacturing capacity, size of the
relative sales forces, and other relevant factors. The Performance
Objectives for Europe, the Middle East and Africa and the Extended
Geographies shall include aggregate sales volume targets and regulatory
approval requirements.
(c) The parties shall, within 90 days preceding the commencement
of the Renewal Term, establish mutually acceptable Performance Objectives for
such Renewal Term.
7.3) TERMINATION FOR FAILURE TO MEET PERFORMANCE OBJECTIVES OR
ABANDONMENT OF AREA.
(a) Subject to Article 9 hereof, if Medtronic fails to meet the
Performance Objectives for the United States, Vista shall have the right to
terminate Medtronic's rights and obligations as exclusive distributor of
Systems in the United States. Subject to Article 9 hereof, if Medtronic
fails to meet the Performance Objectives for Europe, the Middle East, and
Africa and the Extended Geographies, Vista shall have the right to terminate
Medtronic's rights and obligations as distributor for Europe, the Middle East
and Africa and the Extended Geographies. Vista shall give Medtronic written
notice of any such intent to terminate, and Medtronic shall have sixty (60)
days in which to cure such failure to meet the Performance Objectives.
Vista's rights under this Section 7.3(a) shall be Vista's sole and exclusive
remedy for Medtronic's failure to meet the Performance Objectives.
(b) In addition to Vista's rights under subsection (a) above and
whether or not Medtronic has met the aggregate Performance Objectives for
Europe, the Middle East and Africa and the Extended Geographies, if at any
time after commercial release of the Systems Medtronic is making no efforts
(and has no plans to make such efforts) to sell, distribute, or promote the
Systems in Europe, the Middle East, Africa or the Extended Geographies, then
Vista shall have the right to terminate Medtronic's rights and obligations as
distributor with respect to such geographic area in which no efforts are
being made or are planned (i.e. either Europe, the Middle East or Africa, as
applicable). Vista shall give Medtronic written notice of any such intent to
terminate, and Medtronic shall have sixty (60) days in which to commence such
sales efforts (or provide a plan to commence such sales efforts) in such
geographic area. Except as provided in Subsection 7.3(a), Vista's rights
under this Subsection 7.3(b) shall be Vista's sole and exclusive remedy for
any failure by Medtronic to sell, distribute or promote the Systems.
(c) Upon any such termination pursuant to Subsections 7.3(a) or
7.3(b) above, Vista will repurchase from Medtronic, at Medtronic's cost,
Medtronic's entire inventory of Systems
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(excluding demonstration Systems) and related accessories that do not contain
Medtronic's name or trademarks as of the termination date relating to the
geographic area to which such termination relates.
7.4) TERMINATION FOR CHANGE OF CONTROL.
(a) Vista shall be entitled to terminate Medtronic's rights and
obligations as exclusive distributor in the United States if a bona fide
third-party transaction has resulted in a Change of Control of Vista. On or
before such Change of Control, Vista shall give Medtronic written notice of
any such intent to terminate, which termination shall be effective six months
after the effective date of the Change of Control.
(b) Upon any such termination pursuant to Subsection 7.4(a) above,
Vista will (i) pay Medtronic *** plus an amount equal to Medtronic's
cumulative losses before interest and taxes, if any, up to ***
incurred by Medtronic from and after the beginning of Phase I; and (ii)
repurchase from Medtronic, at Medtronic's cost, Medtronic's entire inventory
of Systems (including demonstration Systems) and related materials that do
not contain Medtronic's name or trademarks as of the termination date
relating to the geographic area to which such termination relates.
(c) In no event, however, shall Vista have the right to terminate
Medtronic's rights as the exclusive distributor for the Systems in Europe, the
Middle East and Africa and the Extended Geographies, or any other region other
than the United States, by reason of any "Change of Control" of Vista.
7.5) MEDTRONIC'S TERMINATION FOR VISTA BREACH.
(a) Subject to Article 9 hereof, if Vista breaches any of its
material obligations under this Agreement with respect to Article 2 and/or
Article 3 of this Agreement, then Medtronic shall be entitled to terminate
Medtronic's rights and obligations under Article 2 and/or, at Medtronic's
election, Article 3 of this Agreement. Medtronic shall give Vista written
notice of any such intent to terminate, specifying whether such termination
will apply to Medtronic's rights and obligations under Article 2 or Article
3, or both, and Vista shall have sixty (60) days in which to cure such
material breach.
(b) Upon any such termination pursuant to Subsection 7.5(a) above,
Vista will repurchase from Medtronic, at Medtronic's cost, Medtronic's entire
inventory of Systems (including demonstration Systems) and related materials
that do not contain Medtronic's name or trademarks as of the termination date
relating to Medtronic's rights and obligations under Article 2 and/or Article
3 of this Agreement, as applicable.
7.6) VISTA'S TERMINATION FOR MEDTRONIC BREACH.
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(a) Subject to Article 9 hereof and except as otherwise provided
in Section 7.3, if Medtronic breaches any of its material obligations under
this Agreement with respect to Article 2 and/or Article 3 of this Agreement,
then Vista shall be entitled to terminate Medtronic's rights and obligations
under Article 2 and/or, at Vista's election, Article 3 of this Agreement.
Vista shall give Medtronic written notice of any such intent to terminate,
specifying whether such termination will apply to Medtronic's rights and
obligations under Article 2 or Article 3, or both, and Medtronic shall have
sixty (60) days in which to cure such material breach.
(b) Upon any such termination pursuant to Subsection 7.6(a) above,
Vista will repurchase from Medtronic, at Medtronic's cost, Medtronic's entire
inventory of Systems (excluding demonstration Systems) and related materials
that do not contain Medtronic's name or trademarks as of the termination date
relating to Medtronic's rights and obligations under Article 2 and/or Article
3 of this Agreement, as applicable.
7.7) RIGHTS AND OBLIGATIONS ON TERMINATION. In the event of
termination of all or a portion of this Agreement for any reason, the parties
shall have the following rights and obligations:
(a) Termination of all or a portion of this Agreement shall not
release either party from the obligation to make payment of all amounts
previously due and payable;
(b) In the event of the termination of Medtronic's distribution
rights with respect to all of Europe, the Middle East and Africa and the
Extended Geographies in accordance with Section 7.3(a), Section 7.5 or
Section 7.6, or with respect to Europe, the Middle East, Africa or the
Extended Geographies in accordance with Section 7.3(b), then (i) Vista shall
have the right, at its option, to cancel any or all purchase orders for
Systems which provide for delivery to such geographic area after the
effective date of termination, (ii) Medtronic shall assign, at Vista's cost,
all regulatory approvals and files regarding sales of Systems in such
geographic area to Vista, and (iii) Medtronic and Vista shall cooperate to
assure continued service and support to customers in such geographic area who
purchased Systems from Medtronic. Vista hereby acknowledges Medtronic's
right to continue to sell Systems purchased from Vista to any person or
entity until such time as Medtronic's entire inventory of Systems is sold; and
(c) Without limitation of Section 11.6 hereof, the parties'
payment and audit obligations pursuant to Articles 2 and 3 hereof, and the
parties obligations pursuant to Articles 8, 10 and 11 hereof, shall survive
termination of this Agreement.
(d) Upon any termination of Medtronic's exclusive distribution of
Systems in any portion of the Territory, (i) Vista will repurchase from
Medtronic all Systems on Medtronic's books that have been placed in such
portion of the Territory with respect to which Medtronic's rights are
terminated with a customer on a per procedure pricing basis and all
demonstration units related to such portion of the Territory with respect to
which Medtronic's rights are terminated for a price equal to the total ***
of such Systems, and (ii) Medtronic shall
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cooperate with Vista to transfer and assign to Vista all contracts for the
placement of Systems on a per procedure pricing basis in such portion of the
Territory that Medtronic entered into prior to such termination.
ARTICLE 8
INDEMNIFICATION
8.1) VISTA'S LIABILITY. Vista shall indemnify, defend and hold
harmless Medtronic and each of its subsidiaries, officers, directors,
employees, shareholders and distributors from and against and in respect of
any and all demands, claims, actions or causes of action, 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 therefor, and
any amounts or expenses required to be paid or incurred in connection with
any action, suit, proceeding, claim, appeal, demand, assessment or judgment)
("Indemnifiable Losses"), resulting from, arising out of, or imposed upon or
incurred by any person to be indemnified hereunder by reason of (i) any
breach of representation, warranty, covenant or agreement on the part of
Vista under this Agreement, (ii) total or partial Systems recalls, or (iii)
alleged defects in materials, workmanship, product performance, or design of
the Systems, but in any event excluding matters for which Medtronic is
responsible under Section 8.2 below. Vista shall maintain product liability
insurance or self-insurance in such amounts as is advisable pursuant to
ordinary good business practice for a similar company in a similar type of
business, and shall provide Medtronic with evidence of this coverage.
8.2) MEDTRONIC'S LIABILITY. Medtronic shall indemnify, defend and
hold harmless Vista and each of its subsidiaries, officers, directors,
employees, shareholders and suppliers from and against and in respect of any
and all demands, claims, actions or causes of action, 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 therefor, and any amounts
or expenses required to be paid or incurred in connection with any action,
suit, proceeding, claim, appeal, demand, assessment or judgment)
("Indemnifiable Losses"), resulting from, arising out of, or imposed upon or
incurred by any person to be indemnified hereunder by reason of (i) any
breach of representation, warranty, covenant or agreement on the part of
Medtronic under this Agreement, (ii) product claims whether written or oral,
made or alleged to be made, by Medtronic in its advertising, publicity,
promotion, or sale of any Systems where such product claims were not provided
by or approved by Vista, or (iii) negligent handling by Medtronic of the
Systems, but in any event excluding matters for which Vista is responsible
under Section 8.1 above.
8.3) THIRD PARTY CLAIMS. If a claim by a third party is made
against any indemnified party, and if the indemnified party intends to seek
indemnity with respect thereto under this Article 8, such indemnified party
shall promptly notify the indemnifying party of such claim; provided,
however, that failure to give timely notice shall not affect the rights of
the indemnified party so long as the failure to give timely notice does not
materially adversely affect the indemnifying party's ability to defend such
claim against a third party. The indemnifying party
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shall be entitled to settle or assume the defense of such claim, including
the employment of counsel reasonably satisfactory to the indemnified party,
as provided below. If the indemnifying party elects to settle or defend such
claim, it shall notify the indemnified party within thirty (30) days (but in
no event less than twenty (20) days before any pleading, filing or response
on behalf of the indemnified party is due) of its intent to do so. If the
indemnifying party elects not to settle or defend such claim or fails to
notify the indemnified party of its election within thirty (30) days (or such
shorter period provided above) after receipt of the indemnified party's
notice of a claim of indemnity hereunder, the indemnified party shall have
the right to contest, settle or compromise the claim without prejudice to any
rights to indemnification hereunder. Regardless of which party is
controlling the settlement or defense of any claim, (i) both the indemnified
party and indemnifying party shall act in good faith, (ii) the indemnifying
party shall not thereby permit to exist any lien, encumbrance or other
adverse charge upon any asset of any indemnified party or of its
subsidiaries, (iii) the indemnifying party shall permit the indemnified party
to participate in such settlement or defense through counsel chosen by the
indemnified party, provided that all fees, costs and expenses of such counsel
in an action controlled by the indemnifying party shall be borne by the
indemnified party, unless the indemnifying party and indemnified party have
different available defenses to such third party claim, in which case such
fees, costs and expenses shall be borne by the indemnifying party, (iv) no
entry of judgment or settlement of a claim may be agreed to without the
written consent of both the indemnified party and the indemnifying party,
which consents shall not be unreasonably withheld, and (v) the indemnifying
party shall agree promptly to reimburse the indemnified party for the full
amount of such claim pursuant to this Article 8. So long as the indemnifying
party is reasonably contesting any such claim in good faith as permitted
herein, the indemnified party shall not pay or settle any such claim;
provided that the indemnified party may settle any such claim so long as the
indemnifying party is not adversely affected thereby. The controlling party
shall deliver, or cause to be delivered, to the other party copies of all
correspondence, pleadings, motions, briefs, appeals or other written
statements relating to or submitted in connection with the settlement or
defense of any such claim, and timely notices of, and the right to
participate pursuant to (iii) above in any hearing or other court proceeding
relating to such claim.
8.4) COOPERATION AS TO INDEMNIFIED LIABILITY. Each party hereto
shall cooperate fully with the other parties with respect to access to books,
records, or other documentation within such party's control, if deemed
reasonably necessary or appropriate by any party in the defense of any claim
which may give rise to indemnification hereunder.
ARTICLE 9
FORCE MAJEURE
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.
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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
10.1) TRADEMARK LICENSE. Medtronic shall have a royalty-free
license to use all trademarks, trade names and logotypes of Vista relating to
the Systems solely in connection with the sale or other distribution,
promotion, advertising and/or maintenance of the Systems in the Field of Use.
Medtronic shall acquire no right, title or interest in such Vista trademarks,
trade names and logotypes, other than as provided for above, and Medtronic
shall not use any Vista trademarks, trade names and logotypes as part of
Medtronic's corporate or trade name or permit any third party under
Medtronic's control to do so without the prior written consent of Vista. All
rights under this Section 10.1 shall terminate upon termination of this
Agreement under Article 7, subject to Section 7.5(b).
10.2) OWNERSHIP. Vista represents and warrants to Medtronic the
following: Vista is the exclusive owner or licensee of all right, title and
interest in and to all Intellectual Property used in the research, design,
development, manufacture or sale of the Systems (the "Vista Intellectual
Property") free and clear of any liens, charges, security interests,
mortgages, pledges, restrictions, adverse claims or any other encumbrances of
any kind. Neither Vista, its business, any of the Systems, nor the execution
and performance of this Agreement and the transactions contemplated herein,
infringes, misuses, misappropriates or conflicts with the rights, including
patent and other intellectual property rights or contract rights, of others.
To the knowledge of Vista, the Vista Intellectual Property is valid and has
not been challenged in any judicial or administrative proceeding. To the
knowledge of Vista, Vista has not failed to take any necessary steps or
appropriate actions to record its interests, or to protect its rights, in the
Vista Intellectual Property. To the knowledge of Vista, no person or entity
nor such person's or entity's business or products has infringed, misused,
misappropriated or conflicted with the Vista Intellectual Property or
currently is infringing, misusing, misappropriating or conflicting with the
Vista Intellectual Property.
10.3) PROTECTION OF VISTA'S INTELLECTUAL PROPERTY AND IMPROVEMENTS.
During the term of this Agreement, Vista shall promptly inform Medtronic of
any invention, improvement, upgrading or modification relating to the Systems
or Vista's Intellectual Property relating to the Systems.
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ARTICLE 11
MISCELLANEOUS
11.1) NON-DISCLOSURE. Except as permitted or required for
performance by the party receiving such Confidential Information of its
rights or duties hereunder, 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.
11.2) 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.
11.3) 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 Vista herein
may not be assigned except to any person who succeeds to substantially all of
the assets and business of Vista to which this Agreement relates, and (ii)
the rights and obligations of Medtronic herein may not be assigned except to
an Affiliate of Medtronic or to any person who succeeds to substantially all
of that portion of Medtronic's business to which this Agreement relates.
11.4) COMPLETE AGREEMENT. This Agreement, the Investment Agreement,
the Investors' Rights Agreement, the Supplemental Rights Agreement, and the
Exhibits hereto and thereto 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. This Agreement
replaces the Original Sales Agreement and Amendment No. 1 as of the Effective
Date.
11.5) GOVERNING LAW. This Agreement shall be governed by and
interpreted in accordance with the laws of the State of California, including
all matters of construction, validity, performance and enforcement, without
giving effect to principles of conflict of laws.
11.6) 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.
11.7) 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 breach. Any amendment to this Agreement shall be in writing and
signed by the parties hereto.
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11.8) 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.
11.9) 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.
11.10) 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.
11.11) 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, Inc.
Corporate Center
0000 Xxxxxxx Xxxxxx X.X.
Xxxxxxxxxxx, XX 00000
Attention: General Counsel
FAX (000) 000-0000
with a copy to:
Medtronic, Inc.
Corporate Center
0000 Xxxxxxx Xxxxxx X.X.
Xxxxxxxxxxx, XX 00000
Attention: Vice President, Marketing and Minimally
Invasive Cardiac Surgery
FAX (000) 000-0000
and if to Vista, to:
Vista Medical Technologies, Inc.
0000 Xxxxxxx Xxxxxxx, Xxxxx X
Xxxxxxxx, XX 00000
Attention: Xxxx Xxxx
FAX (000) 000-0000
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with a copy to:
Xxxxxxx Xxxxxxx & Xxxxxxxx LLP
000 Xxxx X Xxxxxx, Xxxxx 0000
Xxx Xxxxx, XX 00000
Attention: Xxxxx Xxxxxxx
FAX (000) 000-0000
Medtronic or Vista 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).
11.12) 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.
11.13) PUBLIC ANNOUNCEMENT. Each of the parties to this Agreement
hereby agrees with the other parties hereto that, except as may be required
to comply with the requirements of applicable law or any exchange upon which
such party's capital stock is listed or traded, 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 Vista. The foregoing shall not restrict
either party's communications with employees, customers or private investors.
11.14) 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.
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IN WITNESS WHEREOF, each of the parties has caused this
Amended and Restated Sales Agreement to be executed in the manner appropriate
to each, as of the date first above written.
VISTA MEDICAL TECHNOLOGIES, INC.
By /s/ Xxxx X. Xxxx
-------------------------------------
Its Chief Executive Officer
-------------------------------------
MEDTRONIC, INC.
By /s/ Xxxxxxx X. Xxxxx
-------------------------------------
Its Vice President, Marketing and
Minimally Invasive Cardiac Surgery
-----------------------------------
ATTACHMENTS:
Schedule 1.1 - "Europe, the Middle East, and Africa"
Schedule 3.3 - System Components
Schedule 4.3 - Vista's current System product warranty
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Schedule 1.1
"EUROPE, THE MIDDLE EAST AND AFRICA"
1. EUROPE. Europe shall include all of continental Europe, and further
include the United Kingdom, Ireland and the Scandinavian countries and
Eastern Europe, including the Czech Republic, Serbia, Russia and Central
Independent States of the former USSR.
2. MIDDLE EAST. The Middle East shall include all of the Middle East north
and east of the Red Sea, from Turkey in the north and west, to Iran in the
east and Yemen in the south, excluding Afghanistan and Pakistan.
3. AFRICA. Africa shall include the entire continent of Africa and all
islands appurtenant thereto.
Schedule 3.3
SYSTEM COMPONENTS
CardioView advanced visualization and information management system:
Cardio 3DScope - A complete set of stereo cameras and endoscopes (either
Miniature or Traditional).
-A miniature camera 1.3" in length capable of attaching to retractor
systems or delivered within the surgical field by attachment to
malleable or rigid guide; or
-Traditional 4.7 mm rotable Thoracoscope.
CardioCamera - 1.3" in length miniature one chip mono camera to be placed
within the body.
CardioView - head mounted display system.
-Lightweight, ergonomic display with LCD chips providing real time 3D
video.
-Image resolution equivalent to conventional TV monitor.
-Can be worn with surgical loops.
-Providing voice activated command for the delivery of patient
information.
-First generation to include TEE (Trans Esophageal Echo), "picture in
picture".
-Consisting of up to four head mounted displays operating off one
central control unit. Standard system includes two HMDs.
CardioConsole - Elegant, user friendly system to rack mount a customized
information management system for Cardiothoracic surgery. CardioConsole
will contain:
CardioController - High resolution stereo image processor.
-Will operate either the mono or stereo cameras.
-Capable of running all cameras in cardiac surgery.
-Can "slave" to other medical monitors in O.R.
CardioRecorder - 3 dimensional CD ROM image recorder.
CardioLight, Advanced single fiber light delivery technology.
-Cogent Light xenon light source
Standard 13" medical monitor.
-For setup, calibration, and trouble shooting
Schedule 4.3
VISTA'S CURRENT SYSTEM PRODUCT WARRANTY
[INCORPORATED BY REFERENCE TO SCHEDULE 4.3 TO ORIGINAL SALES AGREEMENT]