EXHIBIT 10.18
SOFTWARE DEVELOPMENT, LICENSE AND
DISTRIBUTION
AGREEMENT
This software development, license
and distribution agreement (Agreement”) is entered into as of
December 19, 2005 (the “Effective Date”) by and
between EPMed Systems, Inc. (“EPMD”) and Biosense
Webster Inc. (“Biosense”) (collectively the
“Parties”) according to the terms below.
WHEREAS EPMD develops and
distributes the EP WorkMate, which provides electrophysiology
monitoring that offers fully integrated computerized stimulator,
real-time interval analysis, recording capabilities of up to 192
intracardiac signals, and a powerful query engine.
WHEREAS Biosense develops and
distributes the CARTO™ XP Mapping System, which displays
intracardiac electrical activity and timing, and accurate catheter
tip location in real time, allowing 3-D electroanatomical map
reconstruction;
WHEREAS the Parties desire to
cooperate in the development of an accessory that allows the
CARTO™ XP Mapping System to interface with the EP WorkMate
System;
WHEREAS as part of the cooperation
between the Parties EPMD will design and develop the physical
hardware necessary for the interface accessory, as well as
interface software modules for the EP WorkMate System, and Biosense
will develop certain interface software scripts for the WorkMate
interface software modules, as well as interface software modules
for the CARTO™ XP Mapping System; and
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WHEREAS EPMD will distribute the
interface accessory to end users and distributors (as described
herein) and pay Biosense a royalty per system for the right to
license the software scripts and to interface the EP WorkMate
Systems to CARTO™ XP Mapping Systems.
NOW, THEREFORE, in consideration of
the foregoing and other good and valuable consideration, the
receipt and legal sufficiency of which are hereby acknowledged by
the Parties, the Parties agree as follows:
TERMS
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a.
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“Affiliate” means any corporation,
association or other entity which directly or indirectly controls,
is controlled by or is under common control with the party in
question. As used in this definition of “Affiliate”,
the term “control” shall mean direct or indirect
beneficial ownership of more than 50% of the voting or income
interest in such corporation or other business entity.
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b.
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“Amplifier” means the component of
the WorkMate System where the cable connections to the patient are
made.
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c.
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“Biosense
Module” means the software module(s) designed, developed and
owned by Biosense, which will work with the software owned by
Biosense and distributed by Biosense with its CARTO™ XP
System, to help enable the interfacing of the WorkMate System with
the CARTO™ XP System.
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d.
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“WorkMate
System” means the product sold by EPMD as the EP-WorkMate
Computerized Recording System version 3.1.8 version and later
versions of this product.
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e.
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“CARTO™ XP System” means the
product sold by Biosense as the CARTO™ XP System version 7.0,
and all later versions of this platform.
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f.
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“End
Users” are persons who purchase the Interface Kit for their
own use in their business and not for resale, redistribution, or
other commercial purposes.
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g.
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“EPMD
Module” means the software module(s) designed, developed and
owned by EPMD, which will work with the software owned by EPMD and
distributed by EPMD with the WorkMate System, to help enable the
interfacing of the WorkMate System with the CARTO™ XP
System.
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h.
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“Interface” means, collectively, the
Biosense Module, the EPMD Module, the Software Script, the
Interface Hardware, the Connecting Cables, and the related
documentation distributed to End Users that enables the interfacing
of the WorkMate System with the CARTO™ XP System according to
the specifications in Appendix A.
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i.
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“Interface Hardware” means the
physical cabling system, not including the Connecting Cables, to be
designed, developed and distributed by EPMD, that will be used by
End Users to interface one WorkMate System to one CARTO™ XP
System.
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j.
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“Interface Kit” means, collectively,
the Interface Hardware, Connecting Cables, any enabling mechanisms
and related documentation distributed to End Users necessary to
enable the interfacing of the WorkMate System with the CARTO™
XP System.
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k.
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“Object
Code” means code for the Software Script resulting from the
translation of Source Code into machine-readable format.
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l.
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“Patient
Interface Unit” means the component of the CARTO™ XP
System where the cable connections to the patient are
made.
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m.
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“Connecting Cables” mean the
interface cables, to be designed and developed by EPMD, useful for
connecting the Patient Interface Unit of the CARTO™ XP System
to the Amplifier of the WorkMate System. The Connecting Cables may
include, but are not limited to, the ECG connection, Intracardiac
connection, and stimulator connection.
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n.
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“Software
Script” means the software scripts designed and developed by
Biosense, and owned by Biosense, that will be licensed by Biosense
to EPMD and used by the EPMD Module to help enable the interfacing
of the WorkMate System with the CARTO™ XP System.
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o.
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“Source
Code” means the program listing for the Software Script in
paper form and magnetic media written in the syntax of a well-known
programming language.
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p.
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“Programming Interface Manual” means
all related documentation that Biosense will supply to EPMD in
order for EPMD to correctly understand and identify the software
interface that so that EPMD can correctly design and develop the
EPMD Module.
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q.
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“Competitor” means a third party
that creates, develops, manufactures, markets, sells, distributes
or otherwise is involved with 3D navigation and mapping systems,
including but not limited to, Medtronic, St. Jude and Boston
Scientific.
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a.
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Biosense shall
deliver the Software Script that complies according to the
specifications and schedule set forth in Appendix A
(“Development Work”) in Object Code. Biosense shall
deliver to EPMD the Software Script in Object Code in electronic
format, and all related documentation necessary to embed it in the
EPMD Module, along with any necessary enabling mechanisms (such as
key-stroke instructions to enable the Interface to operate in
accordance with the specifications in Appendix A) which shall be
subject to the license set forth in Section 3(a) below.
Biosense shall use its commercially reasonable efforts to deliver
the Software Script in Object Code, Programming Interface Manual
and such enabling mechanisms in substantial accordance with the
schedule set forth in Appendix A. The Development Work is NOT a
work for hire and all right, title and interest in the Development
Work shall belong to Biosense.
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b.
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EPMD shall be
responsible for the development of the WorkMate System and related
software, EPMD Module, and the Interface Kit, including all costs
of development, to enable the interfacing of the WorkMate System
with the CARTO™ XP System in accordance with the
Specifications set forth in Appendix A.
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c.
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Biosense
warrants that it will perform the Development Work in a
professional and workmanlike manner and that the Software Script
when delivered will reasonably conform to the specifications of
Appendix A. Biosense shall be responsible for developing the
Biosense Module, Software Script and the CARTO™ XP System and
related software, including all costs of development, to enable the
interfacing of the WorkMate System with the CARTO™ XP System.
BIOSENSE DISCLAIMS ANY AND ALL OTHER WARRANTIES, IMPLIED OR
EXPRESS, WITH RESPECT TO THIS DEVELOPMENT, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. IN NO EVENT WILL BIOSENSE’S LIABILITY
INCLUDE ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING
LOST PROFITS, EVEN IF BIOSENSE HAS KNOWLEDGE OF THE POTENTIAL LOSS
OR DAMAGE.
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d.
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EPMD shall
maintain the specifications of their respective components of the
Interface Kit in accordance with Appendix A, and continue to make
such functioning Interface Kit components commercially available,
for all future versions of the WorkMate System and the CARTO™
XP System while this Agreement is valid. EPMD shall maintain the
specifications of the port in its WorkMate System to which the
Interface Hardware connects. Biosense shall maintain the
specifications of the port in its CARTO™ XP System to which
the Interface Hardware connects
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e.
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EPMD and
Biosense shall not be obligated to implement the Interface for
products prior to the Current System Version 3.1.8
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and the CARTO™ XP version 7.0.
During the term of this agreement, all versions of CARTO™ XP
that are designed and developed by Biosense will be compatible and
maintain the interface capabilities, and all versions of WorkMate
Systems that are designed and developed by EPMD will be compatible
and maintain the interface capabilities.
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f.
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EPMD and
Biosense shall provide to each other, free of charge, two WorkMate
Systems and CARTO™ XP Systems, respectively, with appropriate
cabling and simulators exclusively for development with respect to
the Interface, demonstration, trade shows and training purposes.
EPMD and Biosense each agree not to use the Systems of the other
provided pursuant to this provision for any other
purpose.
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g.
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Each Party will
be responsible for providing the latest software for their
respective systems throughout the term of the definitive
agreement.
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a.
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EPMD shall
have, and Biosense hereby grants to EPMD, the right to distribute
(and to perform any required installation of) the Interface Kit
throughout the world. EPMD shall have the sole and exclusive right
to determine the price charged for the Interface Kit. EPMD shall
have the right to distribute the Interface Kit through distributors
and sub-distributors, provided, with respect to any country, such
distributors or sub-distributors shall not include third parties
that sell in such country mapping systems competitive with Biosense
mapping systems such as Medtronic (LocaLisa) and St. Jude (EnSite
and NavX). Distributors or sub-distributors that distribute the
Boston Scientific (RPM) system are acceptable. The terms of any
agreement concerning the distribution of the Interface Kit will be
between the End User and EPMD or its distributor or sub-distributor
and shall not create any contractual obligations between Biosense
and the End User. EPMD shall have the sole right to set the terms
of the agreement it reaches with End Users. EPMD may distribute the
Interface Kit to End Users, subsidiaries, and distributors only and
may not delegate, sublicense, assign or
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otherwise sell its right to
distribute the Interface Kit to any other person or entity without
the written consent of Biosense. EPMD shall be responsible for the
development, assembly, packaging and maintenance of the Interface
Kit. EPMD shall sell a minimum of 15 Interface Kits per
year.
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b.
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The parties
understand that this Agreement affects only the distribution of the
Interface Kit and the components thereof and does not create or
bestow any distribution or other rights with respect to the
WorkMate System, Biosense Module or the CARTO™ XP System.
EPMD will be the party responsible for the distribution of its
WorkMate System, including any related software, and Biosense will
be the party responsible for the distribution its Biosense Module
and CARTO™ XP System, including any related software. This
Agreement in no way affects each Party’s right to determine
the price and other terms reached with their respective customers
concerning the distribution of their respective systems and
modules.
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c.
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Biosense will
provide to EPMD the Software Script in Object Code, including any
revisions, upgrades or updates, under the license described in
Section 3.a. below, for distribution with the EPMD Module.
Biosense warrants to EPMD the reasonable, commercial performance of
the Software Script in accordance with the specifications set forth
in Appendix A for twelve months from the first commercial sale of
the EMPD Module by EPMD or a distributor or sub-distributor to an
End User with the exclusive remedy for any breach of the warranty
being repair or replacement of the Software Script at
Biosense’s discretion. BIOSENSE DISCLAIMS ANY AND ALL
OTHER WARRANTIES, IMPLIED OR EXPRESS, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. IN NO EVENT WILL BIOSENSE’S LIABILITY
INCLUDE ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING
LOST PROFITS, EVEN IF BIOSENSE HAS KNOWLEDGE OF THE POTENTIAL LOSS
OR DAMAGE.
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d.
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If the
CARTO™ XP System of an End User lacks necessary hardware
(i.e. Ethernet card in the CARTO™ XP computer) beyond the
Interface Kit, Biosense, at its own expense, shall provide and
install the hardware in the End User’s CARTO
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XP System.
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e.
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Biosense shall
have the right to sell the Interface Hardware and the Connecting
Cables to End Users during post sales service calls. EPMD shall use
commercially reasonable efforts to sell such cables to Biosense at
its cost + 30%, or to arrange for Biosense to purchase such cables
directly from EPMD’ supplier of such cables at EPMD’
negotiated price.
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a.
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Biosense grants
EPMD for the term of this Agreement, subject to the payment of the
royalty fees as set forth in Section 4(b), a non-exclusive,
non-transferable, worldwide license to copy, distribute to End
Users and to sublicense End Users to use the Software Script
provided by Biosense in Object Code solely as part of the EPMD
Module. EPMD shall have the right to sublicense its distributors
and sub-distributors its license to copy, distribute to End Users
and to sublicense End Users to use the Software Script provided by
Biosense to EPMD in Object Code solely as part of the EPMD Module;
provided however, that such distributors or sub-distributors shall
not include third parties that sell mapping systems of a
Competitor. The terms of any such sub-license shall not create any
contractual obligations between Biosense and any other party.
Biosense also grants EPMD the nonexclusive, non-transferable right
throughout the world to distribute the Interface Kit for use with
the CARTO™ XP System and to sublicense its distributors and
sub-distributors the rights to do the same; provided however, that
such distributors or sub-distributors shall not include third
parties that sell mapping systems to a Competitor. The terms of any
such sub-license shall not create any contractual obligations
between Biosense and any other party. EPMD and/or its distributors
or sub-distributors, shall enter into with each End User an
appropriate end user license agreement that protects
Biosense’s ownership in the intellectual property of the
Software Script.
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b.
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For each
Interface Kit sold or distributed by EPMD (whether directly to an
End User or to a distributor or sub-distributor), EPMD shall pay to
Biosense a license fee of
$[ ].
A report will be generated indicating the average selling price
(ASP) for kits sold and payments shall be due within forty five
days (45) after the end of each calendar quarter for Interface
Kits delivered by EPMD to End Users, distributors or
sub-distributors during such quarter. Interface kits that are
placed at up to 5 beta and reference sites will not be included in
ASP calculation.
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c.
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On a quarterly
basis EPMD and Biosense will review ASP for all new system
Interface kits sold by EPMD in the previous quarter. If the ASP for
the interface kit is below
$[ ]
then the license fee will be increased by the difference between
$[ ]
and the ASP, up to a maximum of
$[ ].
If the ASP for the interface kit is above
$[ ]
then the license fee will be decreased by the difference between
the ASP and
$[ ],
down to a minimum of
$[ ]
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d.
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If EPMD fails
to make any payment (other than payments reasonably disputed by
EPMD) in the manner described in this Section 4, within forty
five (45) days after the end of the calendar quarter, then an
interest rate of 10% (ten percent) per year shall be paid by EPMD
on such payment. If EPMD fails to make such payment within ninety
(90) days of EPMD’s receipt of a notice from Biosense
that a payment has not been made within forty five (45) days
after the end of the calendar quarter, then such failure may, at
Biosense’s discretion, be deemed a material breach of a
material term of this Agreement by EPMD for which Biosense may
terminate this Agreement in accordance with
Section 8(b)
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e.
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EPMD shall keep
records of all Interface Kits sold or distributed by EPMD for the
Term of this Agreement and for a period of two years thereafter.
Biosense shall have the right, through its own representative or
shall have the right to appoint an independent certified public
accounting firm, to audit such EPMD’s records, as well as
other documents as may be reasonably required solely for
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the purpose of verifying
EPMD’s compliance with its payment obligations hereunder.
Such audit shall be conducted during EPMD’s normal working
hours, at the EPMD location(s) where such records are maintained
and shall be co
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