Confidential Materials omitted and
filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
BISx INTERNATIONAL LICENSE
AGREEMENT
THIS Agreement
is made and entered into as of April 14, 2009 (the
“Effective Date”), by and between ASPECT MEDICAL
SYSTEMS, INC. (“Aspect”), a Delaware, U.S.A.
corporation having offices at One Upland Road, Norwood,
Massachusetts 02062, U.S.A. and Philips Medizin Systeme
Böblingen GmbH with offices at Hewlett-Packard-Strasse 2,
71034 Boeblingen, Germany (“Philips”).
WHEREAS, Aspect
possesses certain intellectual and industrial property
rights;
WHEREAS, Aspect is
willing to grant, and Philips desires to acquire, non-exclusive
worldwide rights to use such rights in accordance with the terms
and conditions hereinafter set forth; and
WHEREAS, Aspect
and Philips wish to provide Philips customers with a more effective
supply of BIS Sensors (as defined below) at competitive
prices.
NOW, THEREFORE, in
consideration of the premises and mutual promises, terms and
conditions hereinafter set forth, and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, Aspect and Philips (the “Parties”) do
hereby agree as follows:
As used herein,
the following terms shall have the following
definitions.
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1.1
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Affiliates. “Affiliates”
of a Party hereto shall mean companies which are controlled by,
control or are under common control with such Party. A company
shall be considered an “Affiliate” for only so long as
such control exists. For the purposes of this definition,
partnerships or similar entities where a majority-in-interest of
its partners or owners are a Party hereto and/or Affiliates of such
Party shall also be deemed to be Affiliates of such
Party.
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1.2
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Agreement Term. “Agreement
Term” shall mean the period beginning on the Effective Date
and ending on the date of termination or expiration of this
Agreement, as the case may be.
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1.3
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Aspect Products. “Aspect
Products” shall mean those products available for purchase by
Philips and its Affiliates as set forth in Exhibit A (Aspect
Products and Purchase Prices).
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1.4
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BIS. “BIS” shall mean
the Bispectral Index™ which is Aspect’s proprietary
processed EEG parameter that directly measures the hypnotic effects
of anesthetic and sedative agents on the brain.
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1.5
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BIS
Engine. “BIS Engine” shall mean Aspect’s
processing unit for deriving the BIS from the raw EEG
signal.
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1.6
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BIS
Product. “BIS Product” shall mean the BISx System
and/or the BIS Engine, as the case may be.
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1.7
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BIS
Ready. “BIS Ready” shall mean a Philips Patent Monitor
with (a) a BIS port standard on the monitor ready to accept a
BISx System, with BIS software installed on the host monitor, or
(b) at least one available multi-connector port if such a
dedicated BIS port is not utilized.
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1.8
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BIS
Sensor. “BIS Sensor” shall mean a single use disposable
or semi-reusable sensor manufactured by Aspect for use with the
BISx System or the BIS Engine/DSC-XP in the OR, ICU and other
sedation locations that is required to generate Aspect’s
Bispectral Index. These sensors include the BIS Quatro Sensor, the
BIS Extend Sensor and the BIS Pediatric Sensor.
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1.9
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BISx. “BISx” shall mean
a device that acquires up to two channels of EEG and computes BIS
and other EEG parameters, uniting the functionality of the existing
Aspect’s BIS Engine and DSC-XP. BISx shall include
enhancements and new features relating to consciousness monitoring
that are made generally available by Aspect during the term of this
Agreement.
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1.10
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BISx System. “BISx
System” shall mean the system comprised of a BISx device with
a Monitor Cable and a Patient Interface Cable (“PIC”)
designed for use with the Philips Patient Monitor and is also
known, including in Exhibit A, as a “BISx
Kit”.
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1.11
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Business Day. “Business
Day” shall mean a day on which Aspect’s offices are
open for business in Norwood, Massachusetts, U.S.A., and on which
Philips’ offices are open for business in Boeblingen,
Germany.
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1.12
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Contract Year. “Contract
Year” shall mean the 12-month period commencing on the
Effective Date, and then each 12-month period
thereafter.
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1.13
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Documentation.
“Documentation” shall mean any and all user manuals,
programmer’s guides, configuration guides, circuit diagrams,
and help files related to the Software.
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1.14
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DSC-XP. “DSC-XP” shall
mean Aspect’s digital signal converter using XP technology.
The DSC-XP is a small box that is kept close to the patient that
converts the analog EEG signals to digital signals for processing
the BIS value.
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1.15
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Intellectual Property Rights.
“Intellectual Property Rights” shall mean all forms of
protection afforded by law to inventions, models, designs or
technical information, and applications therefor or which otherwise
arise or are enforceable under the laws of the United States, any
other jurisdiction or any bi-lateral or multi-lateral treaty
regime, including, but not limited to, any and all patents and
patent applications (including additions, reissues, divisionals,
continuations, continuations-in-part, substitutions,
re-examinations, patent term extensions, registrations,
supplemental protection term certificates, and renewals
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of
any of the foregoing), utility models, trademarks, trade secrets,
registered and unregistered designs including mask works,
copyrights, and moral rights.
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1.16
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IntelliVue Clinical Network.
“IntelliVue Clinical Network” shall mean the software
that enables wireless and wire line communications transmission of
physiologic measurement data between Philips IntelliVue bedside
monitors, central stations, applications servers, database servers
and telemetry devices.
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1.17
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Licensed Technology. “Licensed
Technology” shall mean the Aspect Products, the Software,
Documentation and the Technical Information.
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1.18
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License Term. “License
Term” shall mean the period beginning on the Effective Date
and ending on the date of termination or expiration of this
Agreement, as the case may be.
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1.19
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Material Product Change.
“Material Product Change” shall mean any of the
following changes to a BIS Product or any component
thereof:
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(a)
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BIS
Product or service design changes that affect regulatory compliance
or safety or materially affect form, fit, function, reliability,
serviceability, performance, functional interchangeability or
interface capability of the BIS Product;
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(b)
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production process changes that
materially affect design and/or production
specifications;
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(c)
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change of manufacturing facility
location or change of ownership of the manufacturing facility (to
the extent such change in ownership is known to Aspect);
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(d)
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changes that modify Aspect’s
quality system beyond editorial enhancements or continuous
efficiency improvements in workflows; or
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(e)
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changes to regulatory status
(including environmental compliance status) which affect any
certification of Aspect or the manufacturing facility for the BIS
Product.
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1.20
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Monitor Cable. “Monitor
Cable” is a cable that connects the BISx to the Philips
Patient Monitor and is also known, including in Exhibit A, as
a “Host Cable”. The Monitor Cable connector will be
supplied by Aspect or its manufacturer using designs supplied by
Philips for final assembly with the BIS Products.
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1.21
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“Open Source Software”
shall mean any software that is licensed under Open License
Terms.
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1.22
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“Open License Terms”
shall mean terms that require as a condition of use, modification
and/or distribution of a work:
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1. the making
available of source code or other materials preferred for
modification, or
2. the granting
of permission for creating derivative works, or
3. the
reproduction of certain notices or license terms in derivative
works or accompanying documentation, or
4. the granting
of a royalty-free license to any party under Intellectual Property
Rights regarding the work and/or any work that contains, is
combined with or otherwise is based on the work.
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1.23
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Philips Patient Monitor.
“Philips Patient Monitor” shall mean all Philips
multi-parameter patient monitors designed by Philips to accept a
BIS Product.
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1.24
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Software. “Software”
shall mean Aspect software programs that are integrated into the
BIS Product.
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1.25
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Technical Information.
“Technical Information” shall mean the trade secrets,
know-how, computer programs (including copyrights in said
software), knowledge, technology, means, methods, processes,
practices, formulas, techniques, procedures, technical assistance,
designs, drawings, apparatus, written and oral rectifications of
data, specifications, assembly procedures, schematics and other
valuable information of whatever nature, whether confidential or
not, and whether proprietary or not, which is now (or hereafter,
during the Agreement Term, becomes) licensable by Aspect and which
is necessary for Philips’ integration, sale, distribution,
use, installation, servicing or testing of an Aspect Product as
permitted under this Agreement.
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1.26
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U.S. Dollars. “U.S.
Dollars” shall mean lawful money of the United States of
America, in immediately available funds.
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1.27
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Philips BIS Products Solution.
“Philips BIS Products Solution” shall mean the BIS
Products in combination with Philips Patient Monitors.
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2.
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LICENSES TO INTELLECTUAL
PROPERTY
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(a)
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For
the term of this Agreement, subject to the terms and conditions of
this Agreement, Aspect agrees to sell and Philips agrees, on behalf
of itself and its Affiliates, to purchase the Aspect Products
listed in Exhibit A (Aspect Products and Purchase Prices) and
each Party agrees to negotiate an amendment to Exhibit A to
include BIS-x4 when available (including the negotiation of the
price thereof).
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The
Aspect Products purchased from Aspect under this Agreement shall
only be used as part of, incorporated into, or integrated with,
systems and products of Philips which Philips, its Affiliates,
distributors or sub-distributors sell or lease to third-party users
in the regular course of business. Philips, its Affiliates,
distributors or sub-distributors shall only sell Aspect-approved
accessories in connection with any BIS Product. Aspect agrees to
provide Philips with all information in its possession
that
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is
necessary for the interfacing and operation of the BIS Products
with Philips Patient Monitors. Aspect agrees to provide Philips
with information in its possession that will allow Philips to
provide Aspect Products-specific service and support to the
end-user.
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(b)
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Subject to the terms and conditions
of this Agreement, during the term of this Agreement and,
thereafter, solely as provided in Section 12.3(b)(i), Aspect
hereby grants Philips a non-exclusive and non-transferable
world-wide license (i) with the right to sublicense solely to
Philips’ Affiliates, distributors and sub-distributors, to
import, and (ii) with the right to sublicense solely to
Philips’ Affiliates, distributors, sub-distributors and
customers, to use, display and copy the Software provided by Aspect
solely in connection with the sale and operation of the Aspect
Products for use with a Philips Patient Monitor.
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(c)
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Subject to the terms and conditions
of this Agreement, during the term of this Agreement and,
thereafter, solely as provided in Section 12.3(b)(i), Aspect
hereby grants Philips a non-exclusive and non-transferable
world-wide license (i) with the right to sublicense solely to
Philips’ Affiliates, distributors and sub-distributors, to
copy, make alterations and derivative works, sell copies of,
distribute, and import the Documentation provided by Aspect, and
(ii) with the right to sublicense solely to Philips’
Affiliates, distributors, sub-distributors and customers, to use
and display such Documentation and the derivative works thereof
created in accordance with clause 2.1(c)(i), in each case solely in
connection with the sale and operation of the Aspect Products for
use with a Philips Patient Monitor.
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(d)
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All
rights granted to customers to use the Software and Documentation
with the Aspect Products shall survive any termination of the
Agreement as long as the Software and Documentation is distributed
to customers who are bound by terms at least as protective of the
Software and Aspect’s Intellectual Property Rights therein as
the terms set forth in Sections 2.1(e) and 2.1(f) of this
Agreement; Philips shall be responsible for communicating these
requirements to its customers and the customers of its Affiliates,
distributors and sub-distributors. Any sublicense to a customer to
use the Software and Documentation shall automatically terminate on
the customer’s breach of any of the terms set forth in
Section 2.1(e) or 2.1(f).
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(e)
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Philips shall not, without the
express written consent of Aspect, disassemble, decompile or
otherwise reverse engineer the Aspect Products or any part thereof
(including the Software). Philips agrees to obligate its
distributors, sub-distributors, its Affiliates and purchasers of
Aspect Products not to disassemble, decompile or otherwise reverse
engineer the Aspect Products or any part thereof without the
express written consent of Aspect. If applicable law requires that
Philips or any of its distributors, sub-distributors, Affiliates or
customers have access to the source code of the Software, Philips
shall notify Aspect if any such party desires such access and
Aspect shall have the option to (i) perform the work to derive
any required information at Aspect’s usual consulting rate,
payable by
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such party, or (ii) allow such
party to access the source code solely for the legally required
purpose.
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(f)
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Title to and ownership of any and
all proprietary rights in or related to the Software and
Documentation thereof shall at all times remain with Aspect or its
licensor(s). Nothing in this Agreement shall be construed as a sale
of any rights in the Software or Documentation. Any references in
this Agreement to sale, resale or purchase of the Aspect Products,
or similar references, shall, with respect to the Software and the
Documentation, mean licenses of the Software and Documentation
pursuant to Sections 2.1(b) and (c).
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(g)
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Philips and its customers shall have
the right to create a reasonable number of backup copies of the
Software, Documentation and any Technical Information solely for
disaster recovery and/or contingency purposes.
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2.2
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Use of Technical
Information.
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Subject to the terms and conditions
of this Agreement, Aspect grants to Philips a paid-up,
non-exclusive worldwide right and license, with the right to
sublicense solely to Philips’ Affiliates, during the
Agreement Term to use, display, copy and import the Technical
Information in connection with the exercise by Philips and its
Affiliates of its rights and licenses granted in Section 2.1,
and for no other purpose and Philips may distribute such Technical
Information to its Affiliates solely for such purpose. All
Technical Information shall be considered to be the Proprietary
Information of Aspect for the purposes of
Section 8.
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2.3
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Philips Trademarks, Service Marks,
and Trade Names .
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Philips on behalf of its ultimate
parent Koninklijke Philips Electronics NV (“KPENV”)
hereby grants Aspect a non-exclusive license under those certain
trademarks as listed on Exhibit F (the “Philips
Trademarks”) for the sole purpose of promoting the Aspect
Products in promotional material, advertisement and/or in written
technical literature [**] (“Purpose”). Such license is
granted provided Aspect fully satisfies all of the provisions
relating to/imposed on Aspect as set forth below:
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(a)
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Aspect in its use of the Philips
Trademarks shall adhere to the trademark guidelines of Philips and
KPENV;
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(b)
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Aspect shall use the Philips
Trademarks consistent and solely in accordance with the
Purpose;
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(c)
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Aspect shall use the Philips
Trademarks only at trade shows and for advertising within brochures
and marketing materials (“Licensed Use”);
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(d)
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Aspect shall not use the Philips
Trademarks without Philips’ prior written permission wherein
permission must be agreed to by Philips for each type of Licensed
Use;
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(e)
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Aspect agrees to use the Philips
Trademarks only in the form and manner provided and approved by
Philips;
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(f)
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Aspect shall make available to
Philips a sample of each type of Licensed Use (final version) for
purposes of verification of usage being in accordance with the
terms and conditions of this Section 2.3.
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(g)
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Notwithstanding anything to the
contrary in this Section 2.3, (i) Aspect may identify
Philips as a customer of Aspect, including without limitation on
Aspect’s web site during the Agreement Term, the form and
content of which is subject to Philips’ review and approval
as set forth in this Section 2.3, such approval not to be
unreasonably withheld or delayed; and (ii) all promotional
material, advertisements and/or written technical literature using
Philips Trademarks that were previously developed and approved by
Philips under the agreement dated the 6th day of August, 1999, by
and between Aspect and Philips (formerly Hewlett-Packard GmbH), as
amended through the Effective Date (“1999 Agreement”)
during the period from January 1, 2007 until the Effective
Date of this Agreement shall remain approved under this
Agreement;
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(h)
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Philips hereby reserves all rights,
title and interest in and to the Philips Trademarks not
specifically granted herein;
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(i)
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Philips shall at all times, anywhere
in the world, and whether or not in competition with Aspect, have
the right to use and/or authorize the use of the Philips
Trademarks, or any portion thereof, in any way Philips may
desire;
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(j)
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Aspect shall indemnify, defend and
hold Philips, and all other legal entities which are, directly or
indirectly, owned or controlled by KPENV and all of each of their
respective officers, directors and employees harmless from and
against any and all losses, costs, claims, damages (including court
costs and attorney’s fees), liability, demands or expenses,
which may arise out of or derive in any way from Aspect’s use
of the Philips Trademarks except in the event of a breach of the
representations or warranties by Philips as set forth in this
Section 2.3. Philips hereby agrees to defend, indemnify and
hold Aspect harmless from any claims arising out of Philips breach
of any representations, warranties or agreements as set forth in
this Section 2.3;
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(k)
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Philips represents and warrants that
the use of the licensing rights under the Philips Trademarks
granted to Aspect under this Section 2.3 shall not infringe
upon the common law or statutory trademark rights of any third
parties;
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(l)
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Aspect agrees that it will do
nothing inconsistent with the ownership of the Philips Trademarks
by KPENV and that all uses of same shall inure to the benefit of
and be on behalf of KPENV;
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(m)
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Aspect agrees that nothing in this
Agreement shall give Aspect any right, title or interest in the
Philips Trademarks other than the right to use the Philips
Trademarks in accordance with this Section 2.3;
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(n)
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Philips shall have the sole right
and discretion to bring infringement or unfair competition
proceedings involving the Philips Trademarks. Under no
circumstances shall Aspect take any action or has any right to
enforce Philips’s rights in the Philips
Trademarks;
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(o)
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Aspect’s license of the
Philips Trademarks in accordance with this Section 2.3 is
expressly conditioned on Aspect’s execution and delivery of
this Agreement and continued compliance with the terms of this
Section 2.3. Philips may terminate this Agreement immediately
if Aspect breaches any term or condition contained in this
Section 2.3 which has not been cured within thirty
(30) days after written notice of breach is delivered to
Aspect. Aspect agrees to immediately discontinue the use of the
Philips Trademarks if such cure is not complete within this thirty
(30) day time period. Aspect further agrees that upon
termination of this Agreement, all rights in the Philips Trademarks
and the goodwill connected therewith shall remain the property of
KPENV;
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(p)
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In
the event that Philips decides, at its sole discretion, as a result
of a cease and desist demand from a third party (or an agreement
resulting therefrom) or a judicial order to cease and desist from
using any one or more of the Philips Trademarks, Aspect shall
immediately cease using said any one or more of the Philips
Trademarks;
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(q)
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Aspect shall not use any other
trademark in combination with any of the Philips Trademarks without
prior written approval of Philips which shall be in Philips’
sole discretion; and
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(r)
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In
the event of expiration or termination of this Agreement, the
licensing rights under the Philips Trademarks of this
Section 2.3 immediately terminates. Upon termination of this
Agreement any reference to Philips and its trademarks must be
promptly removed from any literature or other display and any
existing literature containing any reference to Philips and its
trademarks must no longer be distributed. Aspect may not use the
Philips Trademarks in connection with the delivery by Aspect of any
services.
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2.4
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Aspect Trademarks, Service Marks and
Trade Names .
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(a)
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Aspect hereby grants Philips the
right to use the trademarks, service marks and trade names claimed
by Aspect listed in Exhibit E hereto, as may be
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amended from
time to time by mutual agreement of the Parties’ respective
relationship managers (the “Aspect Trademarks”) on a
non-exclusive basis only for the License Term and solely for
display or advertising purposes in connection with the Aspect
Products manufactured and sold in accordance with this Agreement,
the form and content of which is subject to Aspect’s review
and approval, such approval not to be unreasonably withheld or
delayed. All display and advertising material using the Aspect
Trademarks that were developed and approved under the 1999
Agreement shall remain approved under this Agreement. During the
License Term, Philips and its Affiliates may also use, without
Aspect’s prior written consent, Philips or third-party
trademarks, service marks and trade names other than the Aspect
Trademarks in connection with the BIS Products; provided, however
Philips shall, and shall ensure that its Affiliates, will make
reasonable efforts to use the Aspect Trademarks in a manner which
makes them at least as large and prominent as any other similar
third party trademarks, service marks, or trade names appearing on
any such label, display or advertisement. Philips may not use the
Aspect Trademarks in connection with the delivery by Philips of any
services.
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(b)
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Philips and its Affiliates shall be
required to mark those Philips Patient Monitors that are BIS Ready
with Aspect’s “BIS Ready” logo in form of a laser
printed, printed, or sticky label. The marking will be of a
mutually agreeable size and will be placed at a mutually agreeable
location on such Philips Patient Monitor. Notwithstanding the
foregoing, if no mutually agreeable place or size can be determined
then Philips’ labeling obligations shall be considered
fulfilled with providing one loose sticky label “BIS
Ready” with each such monitor shipped. Aspect shall provide
the required number of “BIS Ready” sticky labels to
Philips free of charge.
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(c)
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Each of Philips and its Affiliates
shall
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(i)
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whenever it uses the Aspect
Trademarks in any technical literature, product literature or
advertisement, include a statement at least once in each piece of
literature that the Aspect Trademarks are trademarks claimed by
Aspect;
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(ii)
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use
the Aspect Trademarks in compliance with Aspect’s guidelines
for using the Aspect Trademarks;
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(iii)
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not
modify any of the Aspect Trademarks in any way and not use any of
the Aspect Trademarks on or in connection with any goods or
services other than the Aspect Products.
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2.5
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Right to Sublicense
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Except as agreed to subject to the
terms of this Agreement, Philips shall not have the right to
sublicense any of the rights or licenses granted hereunder without
Aspect’s prior written consent in Aspect’s sole
discretion; provided, however it is understood that Philips shall
have the right to grant sublicenses consistent with the terms and
conditions of this Agreement to Philips’ Affiliates,
distributors, sub-distributors, and customers without
Aspect’s prior written consent,
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provided, however, that Philips
shall not have the right to grant any sublicense to customers under
the Aspect Trademarks.
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2.6
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No Rights by Implication
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No
rights or licenses with respect to Licensed Technology are granted
or deemed granted hereunder or in connection herewith, other than
those rights or licenses expressly granted in this
Agreement.
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2.7
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Software and Computer
Programs .
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Philips shall retain and shall not,
without the express written consent of Aspect, alter or obscure any
notices, markings or other insignia which are affixed to the
Software, the Documentation or any part thereof at the time of
delivery of such Software or such Documentation. The Software shall
be considered to be the Proprietary Information of Aspect for the
purposes of Section 8.
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2.8
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Limited Warranty
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Aspect represents and warrants to
Philips that, as of the Effective Date, Aspect knows of no claim by
any third-party of infringement by Aspect on such party’s
patent, trademark, copyright, trade secret or other Intellectual
Property Rights covering the Aspect Products, Software,
Documentation, or Technical Information. Aspect further represents
and warrants that it owns all right, title, and interest in and to
the Aspect Products, Software, Documentation, and Technical
Information, including all Intellectual Property Rights thereto, or
has the full lawful right to grant the licenses to the Licensed
Technology as set forth herein.
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2.9
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DISCLAIMER OF WARRANTY
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EXCEPT FOR THE EXPRESS WARRANTIES
SET FORTH HEREIN, INCLUDING BUT NOT LIMITED TO EXHIBIT D, ASPECT
MAKES NO OTHER EXPRESS OR IMPLIED WARRANTY, STATUTORY OR OTHERWISE,
CONCERNING THE LICENSED TECHNOLOGY OR ANY OTHER INFORMATION
COMMUNICATED TO PHILIPS, INCLUDING WITHOUT LIMITATION NO WARRANTY
OF FITNESS FOR A PARTICULAR PURPOSE, AND NO WARRANTIES AS TO
QUALITY OR THE USEFULNESS OF THE LICENSED TECHNOLOGY FOR ITS
INTENDED PURPOSE.
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3.
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CHANGES TO BIS PRODUCTS AND PATIENT
MONITORS
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3.1
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Notifications of Changes to BIS
Products .
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Aspect shall have the right, at any
time and from time to time, to make substitutions and modifications
to BIS Products that, in Aspect’s reasonable judgment, do not
constitute Material Product Changes, and Aspect shall not be
required to provide Philips with notification of any such
substitutions or modifications.
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3.2
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Material Product Changes
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In
the event that any proposed substitution or modification is
expected by Aspect to be a Material Product Change, Aspect shall
give Philips written notice of such
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proposed
substitution or modification as early as possible in the
development process, but in any case no later than the earlier of
(i) at least [**] days prior to the planned release of such
change if no significant changes are likely to be required to be
implemented by Philips in Philips Patient Monitors, or
(iii) at least [**] prior to the planned release of such
modifications if significant changes are also likely to be required
to be implemented by Philips in Philips Patient Monitors. If
Philips does not provide written approval of any such proposed
changes (which approval shall not be unreasonably withheld) Aspect
shall continue to deliver the unchanged version of the BIS Product
for at least [**] according to the regular forecast mechanism and,
[**] prior to the termination of supply, offer Philips a final
opportunity to purchase up to [**]% of the volume ordered in the
previous [**]. Aspect shall provide the appropriate verification
and validation information for evaluating the effect of the change
on the BIS Products.
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3.3
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Required Changes
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Notwithstanding anything contained
in this Agreement to the contrary, Aspect reserves the right from
time to time during the License Term to require Philips, after
consulting with Philips, to modify or improve any Aspect Product
(including without limitation the software programs used in
connection with the BIS Product) if the modification or improvement
reasonably relates to efficacy or patient safety. Provided that
such modifications are feasible and commercially reasonable,
Philips shall implement those modifications to the BIS Products and
associated Philips Patient Monitors being manufactured or to be
manufactured and to modify and improve BIS Products previously
manufactured and shipped to customers in order to incorporate such
changes on a schedule at Philips’ reasonable discretion. If
such modifications, improvements, or changes are implemented by
Philips, it will be with Aspect’s reasonable assistance and,
to the extent that the required change is caused by the BIS Product
(other than the Monitor Cable), at Aspect’s
expense.
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3.4
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Notification of
Discontinuance .
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Aspect agrees to notify Philips in
writing not less than [**] in advance of the discontinuance of any
BIS Product. Philips shall be able to place orders for [**] after
receipt of the written notice in any case. In addition, Philips
shall be entitled to determine its lifetime-buy quantities and
place a corresponding last purchase order no later than [**] prior
to the planned obsolescence date.
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4.
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INCIDENT REPORTING AND CORRECTIVE
ACTIONS
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4.1
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Aspect shall immediately, but no
later than within 48 hours, provide Philips with a written notice
upon Aspect becoming aware of the occurrence of any of the
following events: (i) Aspect recalls any BIS Product, or
ceases or suspends the sale of any BIS Product due to any problem
which relates to such BIS Product’s efficacy or patient
safety in any country; (ii) any defect of any Licensed
Technology, which relates to such BIS Product’s efficacy or
patient safety, is published, publicly reported or made known to
the public by any third party, or found by or reported to Aspect;
or (iii) any Licensed Technology is determined to have
contributed to or caused a death or serious injury.
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4.2
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Philips shall immediately, but no
later than within 48 hours, provide Aspect with a written notice
upon Philips becoming aware of the occurrence of any of the
following events: (i) Philips identifies the need to recall
its BIS Products, or ceases or suspends the sale of its BIS
Products due to any problem which Philips believes relates to such
BIS Product’s efficacy or patient safety in any country, it
being understood that any decision to proceed with a recall of BIS
Products sold hereunder shall not be made by Philips before
consulting with Aspect; (ii) any defect of any BIS Product or
the Licensed Technology, which relates to such BIS Product’s
efficacy or patient safety, is published, publicly reported or made
known to the public by any third party, or found by or reported to
Philips; or (iii) any BIS Product or the Licensed Technology
is determined to have contributed to or caused a death or serious
injury, or any BIS Product or the Licensed Technology malfunctioned
and if that malfunction occurred again, it would be likely to
contribute to or cause a death or serious injury.
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4.3
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Aspect, itself or through its
Affiliates, is responsible for determining complaints and Medical
Device Reporting (“MDRs”) and related submissions to
the FDA and other regulatory authorities for the BIS Products.
Philips, itself or through its Affiliates, is responsible for
determining complaints and MDRs and related submissions to the FDA
and other regulatory authorities for the Philips BIS Products
Solution (other than the BIS Products).
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4.4
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Subject to the provisions of
Sections 4.1, 4.2 and 4.3 above, Philips is responsible for
the overall Philips BIS Products Solution and is therefore
responsible to perform recalls and corrective actions with respect
thereto.
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4.5
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Any
corrective action will be at Philips’ expense if clearly
caused by the Philips Patient Monitor. Philips will reimburse
Aspect for Aspect’s documented cost directly resulting from
such corrective actions within 60 days of completion of the
corrective action.
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4.6
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Aspect will reimburse Philips for
Philips’ documented cost directly resulting from such
corrective actions within 60 days of completion of the
corrective action if clearly caused by any BIS Product, as
described in Exhibit B.
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4.7
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Philips and Aspect will share the
cost if both Parties’ products contribute to the cause,
proportionate to the extent of each Party’s respective degree
of cause as mutually agreed. Aspect’s Vice President of
Regulatory and Quality Affairs and a senior business director,
together with the most senior executive with regulatory
responsibility and a senior business director from Philips
Healthcare Informatics/Patient Monitoring business unit, will
negotiate in good faith a reasonable settlement of the issue. If
after twenty (20) Business Days, the Parties in good faith
fail to agree the issue will be escalated for resolution in
accordance with Section 13.4(b).
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5.
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PRODUCT DEVELOPMENT (BIS PRODUCTS
AND MONITOR CABLE)
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The
existing implementation of BIS in Philips Patient Monitors
utilizing the BIS Products has been developed under a previous
development contract. Both Parties anticipate that there will be
advances in the BIS technology over time and agree that reasonable
efforts should be made, if mutually agreed, to keep the Philips BIS
implementation up-to-date according to the latest Aspect technology
and performance. Therefore, an ongoing project is established
between the companies to cover these ongoing improvement
efforts.
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5.1.1
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Each Party shall appoint a
“Project Manager” who shall oversee and manage the
joint R&D project on a day-to-day basis.
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5.1.2
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The
Project Managers shall meet regularly based on the project needs to
assess the project status and discuss and resolve any issues or
problems. These meetings may be held face-to-face or as telephone
or videoconferences.
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5.1.3
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Each Party shall bear its own
development, communication and travel costs.
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5.2
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Philips Development
Responsibilities .
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Philips will be responsible for any
changes (design or material) to the Philips Patient Monitor to
integrate the BIS Products with the Philips Patient Monitor and the
visualization of BIS data. This includes the Philips Patient
Monitor connector and the appropriate communication software to
interface the BIS Products with Philips Patient
Monitors.
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5.2.1
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Philips will be responsible for the
necessary Philips Patient Monitors hardware and software (changes,
upgrades, maintenance) to allow the user to configure BIS
parameters, to display the BIS-related information on the Philips
Patient Monitor display, and to pass on BIS-related data through
the IntelliVue Clinical Network and other Philips Patient Monitor
outputs.
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5.2.2
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Philips shall make reasonable
commercial efforts to follow Aspect’s guidelines and
recommendations concerning processing and visualization of BIS data
with respect to the operation and visualization logic, philosophy
and visual, audible and haptic experience
(“look-and-feel”) of Philips Patient Monitors and other
Philips products that store, process, display or provide patient
data.
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5.2.3
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Philips shall be responsible for
testing and validation of the BIS Products integration with the
Philips Patient Monitors.
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5.2.4
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Depending on the complexity of the
connector assembly, Philips acknowledges, subject to good faith
negotiation and mutual agreement of the Parties, that it may be
involved in the manufacturing and assembly process of any new
Monitor Cable required to interface Philips Patient Monitors with
the BISx System.
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5.2.5
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Philips shall assume regulatory
responsibility for the combination of the BIS Products with Philips
Patient Monitors as provided in Section 9 of this
Agreement.
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5.3
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Aspect Development
Responsibilities .
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For
changes to the current BIS Products, Aspect shall provide Philips
with the necessary Technical Information to support the integration
of the new or modified BIS Products with Philips Patient Monitors.
This includes information to facilitate the development and/or
refinement of a Philips Patient Monitor connector, of an
appropriate communications software to interface the BIS Products
to the Philips Patient Monitors, and of an appropriate user
interface for BIS in the Philips Patient Monitor. Aspect shall
inform Philips and provide said Technical Information as early in
the development process as possible, in any case no later than
(i) any other Aspect partner (who has an agreement with
similar terms and conditions as this Agreement) gets informed about
the plans and specifications, (ii) six (6) months prior
to commercial availability for any change that may affect the
specifications and documentation of the Philips BIS Products
Solution, or (iii) twelve (12) months prior to commercial
availability for any change that requires changes in the Philips
Patient Monitors as well.
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5.3.1
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Aspect shall design, develop and
test the BIS Products according to the mutually agreed upon
specifications.
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5.3.2
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Aspect shall make commercially
reasonable efforts to maintain backward compatibility with
installed base Philips Patient Monitors for any new or changed BIS
Products and/or 2-channel BIS sensors.
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5.3.3
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Upon Philips completing the
integration of the BIS Products into a Philips Patient Monitor
(including when any new model of a BIS Ready Philips Patient
Monitor is developed/introduced), Aspect will “certify”
this integration. This entails Aspect verifying the accurate
display on the Philips Patient Monitor. Once successfully verified,
Aspect will provide Philips with a letter so certifying. To
facilitate the certification process, Philips will lend to Aspect a
Philips Patient Monitor for testing purposes. Said Philips Patient
Monitor will be provided to Aspect, at Philips’ cost and
expense, within thirty (30) days after execution of this
Agreement, and will be kept updated by Philips to the latest
available state as far as the BIS functionality is concerned.
Aspect will return such equipment to Philips, at Aspect’s
cost and expense, within thirty (30) days after termination of
this Agreement.
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6.
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SALES BY ASPECT TO
PHILIPS
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6.1
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Offer and Acceptance;
Pricing .
Philips’ and its Affiliates’ purchases of Aspect
Products during the first calendar year shall be at the prices set
forth in Exhibit A (Aspect Products and Purchase Prices), except as
noted in Sections 6.2 and 6.4. The Parties have agreed,
subject to applicable law, to initiate at least once a year
discussions on market conditions and trends as well as transfer
pricing of Aspect Products.
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6.2
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Additional costs which have been
agreed upon in writing (both NRE and incremental unit cost) for
customi
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