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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Exhibit 10.7
ASPECT MEDICAL SYSTEMS, INC.
OEM DEVELOPMENT AND PURCHASE AGREEMENT
Agreement dated this Sixth day of August, 1999 , by and between Aspect
Medical Systems, Inc, a Delaware corporation with its principal offices located
at Two Vision Drive, Natick, Massachusetts ("Aspect") and Hewlett-Packard GmbH
("HP"), a German corporation with its principal offices located in Germany at
71034 Boblingen, Herrenberger Str. 110-140, for the purchase and/or license by
HP of products under the terms and conditions contained in this Agreement.
1. BACKGROUND.
(a) Aspect is a developer, manufacturer and distributor of medical
devices, equipment, accessories and related hardware, software
and related products and accessories.
(b) HP is a manufacturer of medical equipment, in particular of
multiparameter patient monitors.
(c) Aspect and HP intend to make available to HP customers a solution
to integrate Aspect's BIS technology with HP's patient monitors.
In a first phase of the cooperation Aspect and HP will develop
appropriate components in a joint project (the "BIS Project").
In the second phase of the cooperation, HP intends to purchase
and/or license specified products for integration with its own
systems and products. Aspect agrees to sell and/or license to HP
the products described below, subject to the terms and conditions
contained in this Agreement.
(d) It is the intention of both Parties to negotiate a separate,
independent distribution agreement (the "Distribution Agreement")
under which HP will also sell the Aspect 2000 BIS Monitor and
Aspect BIS Sensors in certain geographies.
2. DEFINITIONS.
"Aspect's Bispectral Index" or "BIS" is Aspect's proprietary processed
EEG parameter that measures the hypnotic effects of anesthetic and
sedative agents on the brain during surgery.
"HP Patient Monitors" means a family of multi-parameter modular
patient monitoring systems manufactured by or for HP. When the HP BIS
System is complete, HP Patient Monitors will display BIS data
(waveforms, numerics, status info), and provide setup and operation
information (user interface), alarming, and network connectivity.
"HP BIS System" is the sum of all components involved in integrating
the BIS with HP Patient Monitors.
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"HP BIS Module" is a standard size parameter module for HP Patient
Monitors to convert the data as delivered by the HP BIS Engine from
the BIS Protocol to the HP Patient Monitor's internal format.
"Module Cable" is a cable used to connect the HP BIS Engine to the HP
BIS Module.
"DSC Cable" is a cable used to connect the Digital Signal Converter to
the HP BIS Engine.
"HP BIS Engine" is the processing unit for deriving the BIS data from
the raw EEG signal and consists of Aspect's "BIS Engine" board
modified for HP and built into a housing with appropriate connectors
to connect to the DSC Cable and the Module Cable.
"Digital Signal Converter" (or "DSC") is used to amplify the analog
EEG signals as acquired by the BIS sensors and convert it from analog
to digital signals.
"Aspect BIS Module Kit" means the bundle of all components of the HP
BIS System that are developed and manufactured by Aspect and
licensed/sold to HP under this Agreement: DSC, DSC Cable, HP BIS
Engine, and Module Cable.
"Aspect BIS Sensor" means a single use disposable sensor manufactured
by Aspect for use with the Aspect A2000 BIS monitor or with the Aspect
BIS Module Kit and that is required to generate Aspect's Bispectral
Index.
"Sensor Startup Kit" is a set of Aspect BIS Sensors that may be part
of each HP BIS System sale by HP in selected geographies outside ▇▇▇▇▇
▇▇▇▇▇▇▇.
"▇▇▇▇▇" means Aspect's stand-alone BIS monitor for use with the Aspect
BIS Sensor and that generates Aspect's Bispectral Index.
"Aspect Products" means Aspect BIS Module Kits and any other product
that can be ordered by HP as listed in Exhibit A (Aspect Products and
Purchase Prices).
"Software" means Aspect software programs in binary code form which
are designed for use with the Aspect BIS Module Kit.
"BIS Protocol" is Aspect's proprietary communication protocol provided
for purposes of communication between the HP BIS Engine, the HP BIS
Module and HP Patient Monitors
"Documentation" means the BIS Engine Serial Interface Specification.
"Territory" shall mean all countries in which HP is permitted under
this Agreement to distribute Aspect Products.
"Party" or "Parties" shall mean Aspect and HP each individually or
jointly.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
3. BIS MODULE DEVELOPMENT PROJECT.
3.1. PROJECT SCOPE
(a) Aspect and HP will be performing activities to develop a HP BIS
System. Aspect will modify Aspect's standard BIS Engine product
described in Exhibit B to create a HP BIS Engine. HP will develop
a HP BIS Module to interface with Aspect's modified BIS Engine.
(b) The following specifications/documents will be created and agreed
upon by both parties prior to completion of Phase 1 of the Module
Development Project:
- Functional Technical Specification (FTS): This is a
specification that defines the interface between the HP BIS
Engine and the HP BIS Module. This document is an HP
specification that is derived principally from
specifications and materials from Aspect.
- System Hazard Analysis: To be performed in Phase 1 of the
project.
- External Specification: Specification describing the HP BIS
Module and the Aspect BIS Module Kit as a system from the
customer's viewpoint.
- Project Plan: The project plan will include a detailed
project schedule, detailed project description, and other
information not included in the FTS.
3.2. PROJECT TIMING
The overall project duration is expected to be approximately [**]. The product
introduction is planned for [**]. The expected major project milestones are
described below:
[**] [**]
3.3. PROJECT PHASE DESCRIPTIONS
The following phases of the project closely correlate with the standard internal
project phases of the HP development process.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
PHASE 1: PROJECT DEFINITION
Phase 1 defines the project at a high level.
The principal technical issues to resolve are [**].
At the end of Phase 1 the following documents are created: External
Specification (preliminary), Functional Technical Specification (preliminary),
an initial Hazard Analysis, and a detailed Project Schedule., In addition, HP
shall create internal Functional Plans, including a development plan,
verification and validation plan, manufacturing plan, marketing plan,and
regulatory plan.
PHASE 2A: SPECIFICATION
In Phase 2A the detailed design specifications are created: External
Specification (Final), Technical Specification (Final), Hazard Analysis (Final)
and definition of Aspect's Qualification Test Procedure (verification and
validation plan for all items identified under the Functional Technical
Specification).
PHASE 2B: DESIGN (IMPLEMENTATION)
The actual electrical, circuit schematics, and mechanical design and
implementation is performed in Phase 2B. The output of Phase 2B is a functional
prototype. This functional prototype is intended to be a faithful representation
of the product, including actual molded materials, electronics and software.
During this phase, the Outgoing Inspection Procedure from Aspect is also
defined.
PHASE 3: VERIFICATION
Design verification testing of software, electronics and mechanical components
is performed in Phase 3. Additionally EMI testing of the system is performed in
this phase of the project. Aspect will perform [**] with the BIS Module.
Clinical field trials are started in Phase 3. It is anticipated that field
trials of the BIS Module System will be conducted in [**] hospitals in Europe
and [**] hospitals in the US. The completion of field trials occurs by the end
of Phase 4.
During this phase, results of the Qualification Tests and Outgoing Inspection
will also be reviewed for all prototypes.
PHASE 4: VALIDATION
The following tasks are accomplished during Phase 4: Software Validation: Formal
validation testing of the BIS Module System.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Manufacturing Pilot Build: It is expected that [**] systems will be built, of
which [**] units will be required at the beginning of Phase 3 for clinical field
trials. The systems will be used for clinical trials, engineering test, and for
sales demos. Final Test Procedure: Used to 100% test the Aspect BIS Module Kit
and HP BIS Module as a final test in manufacturing.
3.4 PROJECT MANAGEMENT.
(a) Each party shall appoint a "Project Manager" who oversees and
manages the joint project on a day-to-day basis.
(b) 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 video conferences.
(c) Both Parties' project teams shall conduct project meetings from
time to time as deemed useful.
(d) Each Party shall bear its own communication and travel costs.
(e) All communication in conjunction with this Agreement shall be
directed to the appropriate person and address as listed in
Exhibit C (Contact Persons/Addresses).
3.5. JOINT RESPONSIBILITIES.
(a) Both Parties will actively work together in performing a joint
Hazard Analysis for the HP BIS System at the beginning of the BIS
Project.
(b) Both Parties will generate a joint External Specification of the
HP BIS System.
(c) The parties will jointly develop and agree on a Verification and
Validation Plan for testing the performance and safety of the
entire BIS System prior to its release to shipment.
(d) The verification and validation of the HP BIS System will be
performed under HP's overall responsibility at HP's Boeblingen
premises. Aspect agrees to support this effort as defined in the
Verification and Validation Plan and as may be required in case
of problems. Verification and validation of Aspect's BIS Module
Kit will be performed by Aspect in Aspect's Natick facility.
After successful validation by HP of the HP BIS System, Aspect
will also validate the HP BIS System output and confirm in a
written certificate that the BIS value as displayed on the HP
Patient Monitor is equivalent to Aspect's BIS implementation.
(e) Both parties will inform each other of any planned change in its
products that may affect compatibility of the HP BIS System
components or the available regulatory approvals. The Change
Notification Agreement Form (attached as Exhibit D) will be used
for this purpose.
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(f) Both parties will provide each other reasonable engineering
consultation free of charge.
(g) Aspect and HP will provide each other free of charge with certain
number of prototypes and product samples for development,
verification and validation, and getting regulatory approvals.
3.6. HP RESPONSIBILITIES.
(a) HP shall develop the HP BIS Module according to the mutually
agreed Functional Technical Specification and External
Specification at HP's own cost.
(b) HP will take responsibility for the development, design and
performance of the HP BIS Module and for the combination of the
Aspect components (BIS Module Kit) with the HP components (HP BIS
Module, HP Patient Monitor) of the HP BIS System.
3.7. ASPECT RESPONSIBILITIES.
(a) Aspect shall develop the HP BIS Engine, the DSC Cable and the
Module Cable according to the mutually agreed specifications at
Aspect's own cost.
(b) Aspect will take responsibility for the development, design and
performance of the Aspect BIS Module Kit.
(c) Aspect shall make available the BIS Protocol specification to HP
for implementation into the HP BIS Module or otherwise into HP
Patient Monitors.
(d) Aspect will undertake reasonable efforts to maintain backward
compatibility for future versions of the BIS Protocol, however no
guarantee is given.
(e) Aspect will inform HP of future changes to the BIS Protocol as
early as possible and make available such changed BIS Protocol
specification to HP. The Change Notification Agreement Form
(attached as Exhibit D) will be used for this purpose.
Notwithstanding anything to the contrary in the Change
Notification Agreement Form, HP shall not withhold its approval
of any future changes to the BIS Protocol as provided in Section
3.7 (d).
4. PURCHASE AND SALE OBLIGATIONS; LICENSES.
(a) General. Subject to the terms and conditions of this Agreement,
Aspect agrees to sell to HP the Aspect Products listed on Exhibit
A (Aspect Products and Purchase Prices). For these products,
Aspect grants to HP or HP's subdistributors a non-exclusive,
worldwide distribution right for the term of this Agreement. HP
represents and warrants that the components of the Aspect BIS
Module Kits purchased from Aspect under this Agreement shall be
used as components in, incorporated into, or integrated with,
systems and products which HP sells or leases to third-party
users in the regular course of business. HP further certifies
that the components of the Aspect BIS Module Kits will only be
resold, leased, rented, licensed or otherwise transferred to
third parties for use as a part of an HP BIS System or as
replacement parts used in HP BIS Systems.
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(b) BIS Sensors. Apart from section 4.a., Aspect hereby grants HP the
right to distribute Aspect BIS Sensors solely to HP's customers
outside North America and solely for use with HP BIS Systems.
(c) Sensor Startup Kit. Aspect hereby grants HP the right to sell the
Sensor Startup Kit for use with the HP BIS System in geographies
outside North America.
(d) Software License. Aspect hereby grants to HP a non-exclusive and
non-transferable worldwide license, without the right to
sublicense (except to purchasers of HP BIS Systems and to HP's
subdistributors), during the term of the Agreement to use the
Software and related Documentation provided by Aspect solely in
connection with operation of the components of Aspect BIS Module
Kit in the HP BIS System. Thereafter, Aspect grants to HP a right
to use the Software and related Documentation used in conjunction
with the HP BIS Systems being sold by HP on the date of
termination with respect to service and support of installed HP
BIS Systems for a period of 10 years, after termination of the
Agreement. All rights granted to HP customers to use the HP BIS
System shall be irrevocable as long as such customers are in
compliance with the terms of use for such HP BIS Systems and does
not cure such non-compliant use within 90 days of being notified.
HP shall not disclose, furnish, transfer, distribute or otherwise
make available the Software, the Documentation or any portion
thereof in any form to any third party (other than to purchasers
of HP BIS Systems and to HP's subdistributors) and shall not
duplicate the Software, the Documentation or any part thereof
(other than for HP's internal use). Title to and ownership of and
all proprietary rights in or related to the Software, the
Documentation and all partial or complete copies thereof shall at
all times remain with Aspect or its licensor(s). This Agreement
shall not be construed as a sale of any rights in the Software,
the Documentation, any copies thereof or any part thereof. All
references in this Agreement to sale, resale or purchase of the
BIS Module Kits or the components thereof, or references or like
effect, shall, with respect to the Software and the Documentation
mean licenses or sublicenses of the Software and the
Documentation pursuant to this Section 4. HP shall not
disassemble, decompile or otherwise reverse engineer the Software
or any part thereof, except if Aspect is required under
applicable law to permit HP to reverse engineer any Software. In
such event, HP may reverse engineer the Software but only to the
extent Aspect is required to permit such reverse engineering. HP
shall retain and shall not alter or obscure any notices, markings
or other insignia which are affixed to the Software, the
Documentation or any part thereof at the time it receives such
Software or such Documentation.
(e) BIS Protocol License. Aspect hereby grants to HP a non-exclusive,
worldwide, irrevocable, royalty-free license to implement
Aspect's proprietary BIS Protocol and sell it to HP's end
customers as part of its products for use solely with the Aspect
BIS Module Kit.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
5. ROYALTIES.
(a) For each BIS Module Kit that HP is purchasing from Aspect HP
shall pay a purchase price for the BIS Module Kit and a royalty
fee as specified in Exhibit A (Aspect Products and Purchase
Prices).
(b) Within 30 days after the Effective Date, HP shall pay Aspect an
amount of [**] US$ as prepaid royalties, which will be credited
against the actual royalty component of the purchase price that
is due for the sale of the first [**] Aspect BIS Module Kits.
[**].
(c) In the event that the Agreement is terminated by HP because
Aspect is unable to deliver a HP BIS Engine before October
31st,[**](in accordance with Section 23.2, paragraph b), or in
the event Aspect fails to deliver the first [**] Aspect BIS
Module Kits for whatever reason, excluding breach by HP or
failure to order then Aspect shall refund HP according to the
following rules:
(i) Aspect shall refund to HP that part of the prepayment that
is not yet consumed by unit royalties, however not more than
[**] US$.
(ii) Aspect shall [**].
(d) Aspect agrees [**] in accordance with Section 5 (c) [**]. HP
agrees [**] in connection with [**]. At such time [**].
6. SCOPE OF DELIVERY
(a) Purchase Orders. Purchase orders (via Fax, e-mail, other
electronic transmission or paper) for Aspect Products to be
purchased under this Agreement (the "Orders") must be received by
Aspect during the term of this Agreement and must specify a
delivery date in accordance with the lead-time schedule outlined
below under Section 6, paragraph e) All HP Purchase Orders will
make reference to the appropriate engineering drawing or
manufacturing reference numbers.
(b) Order Acknowledgements. HP purchase orders will be acknowledged
by Aspect within 5 days after receipt of the order, provided that
the order is technically correct and that the requested delivery
time is within the agreed lead time and that the latest forecast
provided by HP is not exceeded by more than [**] and the quantity
ordered does not exceed by more than [**] the quantity ordered in
the preceding month. If the requested delivery time is lower than
the agreed lead time, or if HP's latest forecast is exceeded by
more than [**], Aspect shall use reasonable efforts to complete
the order requirements and to acknowledge the order within 10
days of its receipt. Order acknowledgements shall not be
unreasonably withheld.
(c) Forecasts. HP shall furnish to Aspect a non-binding monthly
forecast during the term of this Agreement with the number and
type of Aspect Products for which HP expects to submit orders for
the following twelve months. Existing open purchase orders are
not usually reflected in these forecast numbers.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(d) Cancellation Charges. In the event of the cancellation of any
Order by HP, HP shall be liable for the payment of cancellation
charges based on the number of days prior to scheduled delivery
that written notice of cancellation is received by Aspect, as
outlined below:
> 10 weeks prior to acknowledged delivery [**]
6 - 10 weeks prior to acknowledged delivery [**] of order value
4 - 6 weeks prior to acknowledged delivery [**] of order value
2 - 4 weeks prior to acknowledged delivery [**] of order value
< 2 weeks prior to acknowledged delivery [**] of order value
(e) Lead Times. Lead times for the Aspect BIS Module Kit are expected
to be 12 weeks.
7. PRICES.
(a) Purchase Prices. The prices of Aspect Products purchased by HP
hereunder (the "Purchase Prices") which are ordered during the
term of the Agreement shall be as set forth in Exhibit A (Aspect
Products and Purchase Prices).
(b) Purchase Price Changes. In consideration of the market situation
and after consultation with HP, the Purchase Prices set forth in
Exhibit A (Aspect Products and Purchase Prices) will be reviewed
12 months after first delivery of production units and annually
thereafter. Any price increase will become effective only after
mutual agreement between both Parties, subject to the following:
(i) In the event the materials cost for the Aspect BIS Module
Kit increases by more than [**]. Aspect shall have the right
no more than once per year during the term of this Agreement
to increase the Purchase Price of the Aspect BIS Module Kit
by an equivalent amount by giving HP written notice of such
increase not less than [**] days prior to the date upon
which the increased Purchase Price is to become effective.
No Purchase Price increase shall apply to Orders for Aspect
Products accepted by Aspect prior to or during such [**] day
period which are to be delivered within [**] days of the
date of such notice.
(a) Aspect may reduce the Purchase Price of any Aspect Product at any
time. Such reduction shall be applicable to all Aspect Products
not shipped at the time of the reduction.
(b) [**] the Purchases Prices [**].
(c) Taxes. All prices for Aspect Products are exclusive of all
federal, state and local taxes, levies and assessments, and HP
shall be responsible for the payment of all such taxes, levies
and/or assessments imposed on Aspect Products purchased and/or
licensed by HP hereunder, excluding taxes based on Aspect's net
income
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from the transaction. HP shall be responsible for providing in a
timely manner all documentation, in the nature of exemption
certificates or otherwise, necessary to allow Aspect to refrain
from collections, such as sales tax, which it would otherwise be
obligated to make
8. TERMS OF PAYMENT.
(a) Invoices. HP shall pay to Aspect the Purchase Price of all Aspect
Products shipped hereunder within 30 days after the receipt of
Aspect's invoice. Nothing herein shall affect Aspect's right to
withhold shipment or otherwise exercise its rights under Section
24 (Termination) hereof in the event of HP's failure to make
payment when due for Aspect Products delivered to HP. Aspect's
invoices to HP for Aspect Products purchased under this Agreement
shall be addressed to:
Hewlett-Packard GmbH
Department ASC-AP
▇▇▇▇▇▇▇▇ ▇▇▇▇
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
Late Payment Charge. Subject to applicable law, service and/or
interest charges not exceeding the lesser of 1-1/2% per month
or the highest amount permitted by law may, at the election of
Aspect, be assessed on amounts past due more than 30 days.
9. SHIPMENT AND DELIVERY.
(a) Delivery Location. Each shipment must indicate the exact address
of the recipient on the outside of the packaging as follows:
Hewlett-Packard GmbH
HSG-E Healthcare Solution Group Europe
c/o Js. ▇▇▇▇▇▇▇ Spedition GmbH
▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇. ▇
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
(▇) All shipments hereunder shall be freight collect, F.C.A. point of
origin (Incoterms 1990). All Aspect Products shall be deemed
delivered and subject to HP's dominion and control when placed in
the possession of the carrier, packed and ready for shipment to
HP.. Aspect shall cooperate with HP in the documentation and
proof of loss claims promptly presented by HP to the appropriate
carrier and/or insurer.
(c) Delivery and Packaging Instructions Delivery and Packaging
requirements will need to conform to the standards outlined in
the HP Delivery and Packaging Standard (attached as Exhibit E)
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(d) Delivery Date and Date of Dispatch. The requested delivery date
will be specified on the HP Purchase Order. Aspect will utilize
reasonable efforts to ensure that the order is delivered in
accordance with Aspect's order acknowledgement and that the the
date of dispatch is 10 days prior to the delivery date.
10. ACCEPTANCE.
Any Aspect Product shipped hereunder may be subjected to inspection and
performance testing by HP, in accordance with applicable product specifications
in effect at the time of delivery of such Aspect Products to HP. HP shall
provide written notice to Aspect of the rejection of any such Aspect Product
within [**] days of the date of receipt of any Aspect Product; if more than [**]
of Aspect Products received in any single shipment do not pass HP's inspection
or performance testing HP may reject the entire shipment lot. Aspect shall have
[**] days from receipt of a notice from HP rejecting an Aspect Product either,
at its option, to make any necessary repairs to the defective Aspect Product or
to replace it. If Aspect replaces an Aspect Product, HP shall dispose of the
replaced Aspect Product in accordance with Aspect's instructions and at Aspect's
expense. HP's sole remedy for rejected Aspect Products shall be limited to
repair or replacement of such Aspect Products.
11. WARRANTY.
(a) General. Aspect warrants solely to HP that Aspect Products
(including Software) delivered hereunder shall perform
substantially in accordance with the specifications in Exhibit B
(Aspect's Standard Module Kit) or other applicable product
specifications as published by Aspect in effect at the time of
delivery of such Aspect Product (including Software), and shall
be free from defects in materials and workmanship, when given
normal, proper and intended usage, for [**] from the date of
installation of the HP BIS System at HP's end customer site, or
[**] from the date of shipment by Aspect to HP, whichever is less
. Aspect agrees, during the applicable warranty period, to repair
or replace (at Aspect's option) all defective Aspect Products
within [**] after date of return to Aspect and without cost to
HP. This warranty shall not apply to expendable components and
supply items, such as, but not limited to, cables (except for
failures occurring within [**] of receipt of shipment), fuses and
bulbs (or disposable items such as an Aspect BIS Sensor after the
expiration date marked on the Sensor packaging); nor shall Aspect
have any obligation under this Agreement to make repairs or
replacements which are required by normal wear and tear, or which
result, in whole or in part, from catastrophe, fault or
negligence of HP, or anyone claiming through or on behalf of HP,
or from improper or unauthorized use of Aspect Products, or use
of Aspect Products in a manner for which they were not designed,
or by causes external to Aspect Products such as, but not limited
to, power or air conditioning failure.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(b) Warranty Procedures. HP shall notify Aspect of any Aspect
Products which it believes to be defective during the applicable
warranty period and which are covered by the warranties set forth
in paragraph (a). At Aspect's option, such Aspect Products shall
be returned by HP to Aspect's designated facility for examination
and testing, or may be repaired on site by Aspect. Aspect shall
either repair or replace, within [**] of receipt by Aspect, any
such Aspect Product found to be so defective and promptly return
such Aspect Products to HP. Transportation and insurance costs,
and/or risk of loss or damage during shipments, shall be borne by
Aspect. Should Aspect's examination and testing not disclose any
defect covered by the foregoing warranty, Aspect shall so advise
HP and dispose of or return the Aspect Product in accordance with
HP's instructions and at HP's sole expense.
(c) Repair Warranty. Aspect warrants its repair work and/or
replacement parts for the duration of the original warranty
period as set forth in paragraph (a) or at least [**] whichever
is longer.
(d) LIMITATION. THE PROVISIONS OF THE FOREGOING WARRANTIES ARE IN
LIEU OF ANY OTHER WARRANTY, WHETHER EXPRESS OR IMPLIED, WRITTEN
OR ORAL (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE). THE FOREGOING WARRANTIES EXTEND TO HP ONLY
AND SHALL NOT BE APPLICABLE TO ANY OTHER PERSON OR ENTITY
INCLUDING, WITHOUT LIMITATION, CUSTOMERS OF HP.
12. SERVICE AND SUPPORT.
(a) Service and Support. HP shall be responsible for providing
installation, customer training, service and support (including
repair) to its end customers for the Aspect Products sold
hereunder and HP shall bear all related costs incurred for labor,
parts, or travel to perform such service.
(b) Central Repair Service. For the term of this Agreement, Aspect
agrees to provide central repair service to HP for Aspect
Products sold hereunder at a charge and as further detailed in
Exhibit F (Service/Repair).
(c) Excessive Failure Rate. If the Annual Failure Rate of Aspect's
BIS Module Kit excluding out-of-box failures and cables exceeds
the value as specified in Exhibit B (Aspect's Standard Module
Kit) by more than [**] then Aspect shall reimburse HP for any
additional cost (including material and labor, ) incurred by HP
for repairing the units in excess of the above limit.
(d) Service Period. For a period of [**] following the last delivery
to HP of the applicable Aspect Product ordered by HP hereunder,
Aspect shall make available repair service (or at Aspect's sole
discretion, exchange units for the Aspect Products) for purchase
by HP and third party users of the Aspect products at
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Aspect's then-current prices for such repair services and
exchange units. After expiry of this [**] period, Aspect may, in
its sole discretion, continue to supply repair services (and/or
exchange units for the Aspect Products) subject to the mutual
written agreement of the Parties.
(e) Service Reporting. Aspect shall maintain a complete record of all
repair activities performed on any Aspect products received for
repair, and will provide HP with a monthly report on all service
actions including failure and repair statistics at a sub-
assembly levelas laid down in Exhibit F (Service/Repair). Service
Reports for each product shall be sent electronically by email to
responsible procurement and technical marketing engineer (Contact
Persons shown in Exhibit C, Contact Persons / Addresses).
Rootcause analysis is to be performed and reported by Aspect in
case of abnormal failures, incidents and malfunctions.
13. QUALITY ASSURANCE.
(a) Both parties agree to maintain ISO900x, EN460x, European
directive 93/42/EEC Annex II ("MDD AX-II") certification status
and compliance with the U.S. Food and Drug Administration's
("FDA") Quality System Regulation ("QSR"), the European Medical
Device Directive ("MDD"), and other appropriate regulations
pertinent to the development, manufacturing and marketing of this
kind of medical product.
(b) All Products developed under this Agreement shall fully comply
with the above quality requirements and guidelines (MDD AX-II,
FDA QSR, etc.)
(c) If the actual Annual Failure Rate (,,AFR") of the BIS Module Kit
or subcomponents thereof exceeds the expected value specified in
Exhibit B (Aspect's Standard Module Kit) by more than [**] then
Aspect agrees to investigate the root cause of the problem and
take the appropriate corrective actions to bring the AFR back
into the specified range.
14. REGULATORY MATTERS.
(a) Aspect shall assume full regulatory responsibility for the Aspect
Products, including obtaining and maintaining all applicable
governmental authorizations and regulatory approvals required to
distribute the BIS Module Kit. Both Parties will work together to
develop a regulatory plan during phase 1 of the Project which
defines precisely what these regulatory and localization
requirements are for all countries where the HP BIS System is
intended to be sold. In particular, Aspect shall be responsible
for generating its own Device Master Record for the BIS Module
Kit and obtaining the ▇▇-▇▇▇▇. It is understood that the BIS
Module Kit will be a component of the HP BIS System for which HP
assumes full regulatory responsibility as provided in Section 14
(c).
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(b) HP shall assume full regulatory responsibility for the HP
Products, including obtaining and maintaining all applicable
governmental authorizations and regulatory approvals required to
distribute the HP Patient Monitors and the HP BIS Module in all
countries in the Territory.
(c) HP shall assume the regulatory responsibility for the combination
of the Aspect and HP components in the HP BIS System. Aspect
shall fully support HP as required in the process of obtaining
regulatory approvals by making available to HP any required
information, data, certificates, or technical files in the
requested formats.
(d) For bringing the Aspect Products into the market in countries
affected by the European Medical Device Directive ("MDD"), Aspect
is the legally responsible manufacturer under the MDD as named in
detail in Exhibit C (Contact Persons/Addresses). The Aspect
Products shall be marked accordingly.
(e) HP and Aspect shall inform each other in writing immediately
about any event that may require incident reporting in any
country of the Territory.
(f) In the event of any recall of an Aspect Product required by a
governmental agency for safety or efficacy reasons, or requested
by Aspect at its sole discretion, which is the result of Aspect's
failure to supply Aspect Products that (1) conform in all
material respects to the applicable published specifications
(including the specifications set forth in Exhibit B (Aspect's
Standard Module Kit)) or (2) are free from defects in material
and workmanship (when given normal, proper and intended usage),
Aspect agrees to repair or replace at its own costs all Aspect
Products subject to the recall and previously delivered to HP.
Aspect also agrees to consult with HP to establish a reasonable
process for managing the recall and Aspect shall [**] that are
consistent with the recall process agreed to by the Parties.. In
the event the recall is not required by a governmental agency for
safety or efficacy reasons, but is instead requested by Aspect at
its sole discretion, Aspect will be responsible for determining
the scope of the recall, including the number of units, timeframe
for the recall, and criteria for completion. HP agrees to
maintain all necessary sales records to facilitate the recall.
(g) HP may at its sole discretion delegate some of the obligations
under this Section 14 to its subdistributors.
(h) For the purpose of facilitating product traceability, all
Products purchased from Aspect by HP will require identification
of an internal order number and tracking code.
15. PRODUCT CHANGES; DISCONTINUED PRODUCTS; FUTURE PRODUCTS; CONTINUED SUPPLY.
(a) Product Changes. Aspect shall have the right, at any time and
from time to time, to make substitutions and modifications to
Aspect Products, provided that such substitutions or
modifications will not materially affect form, fit or function of
Aspect
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Products. In the event that any proposed substitution or modification
affects, in Aspect's reasonable judgment, the form, fit or function of
a Aspect Product, Aspect shall give HP written notice of such proposed
substitution or modification at least [**] prior to its taking effect
and HP shall have the right, during such [**] period and for [**]
thereafter, to order Aspect Products without such substitution or
modification for delivery within [**] after such substitution or
modification takes effect. Aspect shall give written notice of any
proposed change to the Aspect Products using the Supplier Change
Notification Agreement Form (attached as Exhibit D) and provide the
appropriate verification and validation information evaluating the
affect on the HP BIS System. Notwithstanding anything to the contrary
in the Change Notification Agreement Form, HP shall not unreasonably
withhold its approval of any such changes.
(b) Discontinued Products. Aspect agrees to notify HP in writing not less
than [**] in advance of the discontinuance of any Aspect Product. HP
shall be able to place orders for at least [**] after receipt of the
written notice in any case. In addition, HP shall be entitled to
determine its lifetime-buy quantities and place a corresponding last
purchase order.
(c) Future Products. The Aspect Products are designed for use in measuring
the effects of anesthetic and sedative agents on the brain during
surgery. In the event that Aspect develops a product involving a
different type of index, patient sensor, or application, Aspect and HP
agree to discuss a new agreement for the purchase of such new product
or products by HP.
(d) Continued Supply. In the event that (a) Aspect makes an assignment for
the benefit of creditors, or a receiver, trustee in bankruptcy or
similar officer is appointed to take charge of any or all of Aspect's
property, or Aspect files a voluntary petition under federal
bankruptcy laws or similar state statutes or such a petition is filed
against Aspect and is not dismissed within sixty (60) days, and (b)
Aspect fails to deliver Aspect Products ordered by HP under this
Agreement within [**] of the delivery date specified on a purchase
order complying with Section 4 and accepted by Aspect in accordance
with Section 4, upon request of HP, Aspect shall grant to HP, a
nonexclusive license to use the Manufacturing Materials to make and
have made the Aspect Products for use in the HP BIS System, until [**]
after Aspect is ready and able to deliver Aspect Products to HP under
the terms of this Agreement and has notified HP thereof. This includes
a non-exclusive license to use any tools, design documentation, or any
other manufacturing materials which may be necessary. The
manufacturing materials supplied by Aspect shall include a list of the
Aspect suppliers of parts for Aspect Products. Upon exercise by HP of
the manufacturing license set forth above, HP shall pay Aspect a
"Manufacturing License Fee" equal to the royalty specified on Exhibit
A (Aspect's Products and Purchase Prices).
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16. OWNERSHIP AND PROTECTION OF RESULTS.
(a) It is expressly agreed that neither Aspect nor HP will transfer to any
Party any patent rights, copyrights or intellectual property of any
kind that either Party owns at the effective date of this agreement.
(b) Aspect shall retain the title to and possession of any models,
patterns, dies, molds, jigs, fixtures, and other tools made for or
obtained in connection with this Agreement and solely related to the
Aspect Products, even if made for, obtained by or paid for by HP.
(c) If there are developments (including patentable inventions) conceived,
created or reduced to practice as part of the joint development
project then the rights to such developments shall be retained (a) by
Aspect if conceived, created or reduced to practice solely by Aspect,
or (b) by HP, if solely conceived, created or reduced to practice by
HP, or (c) jointly by HP and Aspect (without any duty to account to
the other) if jointly developed by HP and Aspect provided that:
HP shall assign to Aspect all rights to any development relating to
Aspect's BIS Module Kit
and Aspect shall assign to HP all rights to any development relating
to the HP Patient Monitor or HP BIS Module subject to Aspect's
retained rights to the BIS Protocol.
17. DOCUMENTATION AND TRAINING.
Aspect agrees to provide HP with such product literature, operations
and maintenance manuals, other information and training (including training to
avoid possible misrepresentation of Aspect's Bispectral Index) as is mutually
agreed, to enable HP properly to sell and maintain Aspect Products, provided
that in no event shall the source code or source listings of Aspect Software be
required to be disclosed or provided by Aspect to HP pursuant to this Section 17
or otherwise. Such training needs to begin at least three months prior to
introduction of the HP BIS System and will be defined as part of the Project's
marketing plan.
18. CONFIDENTIALITY.
No confidential information disclosed by either party to the other in
connection with this Agreement shall be disclosed to any person or entity other
than the recipient party's employees and contractors directly involved with the
recipient party's use of such information who are bound by written agreement to
protect the confidentiality of such information, and such information shall
otherwise be protected by the recipient party from disclosure to others with the
same degree of care accorded to its own confidential information of like
importance. In addition, each party and its representatives shall use the
confidential information only for the purposes specified under this Agreement
and such information shall not be used for any other purpose without the prior
written consent of the disclosing party. To be subject to this provision,
information must be delivered in writing and designated as proprietary or, if
initially delivered orally, must be confirmed
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in writing as confidential within 30 days after the oral disclosure. Information
will not be subject to this provision if it is or becomes a matter of public
knowledge without the fault of the recipient party, if it was a matter of
written record in the recipient party's files prior to disclosure to it by the
other party, or if it was or is received by the recipient party from a third
person under circumstances permitting its unrestricted disclosure by the
recipient party. Upon termination of this Agreement, each party shall promptly
deliver to the other all confidential information of the other party in the
possession or control of such party and all copies thereof, provided that each
party may retain a copy thereof for archival purposes. The obligations under
this Section 18 shall continue for both parties for a period of 10 years after
delivery by Aspect to HP of the last Aspect Product under this Agreement. HP is
entitled to transmit confidential information of Aspect to Hewlett-Packard
Company and to its subsidiaries and affiliated companies. In this case these
companies may only use such information to the same extent as HP is entitled to
under this Agreement. HP will be responsible that these companies comply with
the confidentiality provisions of this Agreement.
19. INDEMNITIES.
19.1. INDEMNITIES BY ASPECT.
(a) Except as provided below, Aspect shall defend and indemnify HP
from and against any damages, liabilities, costs and expenses
(including reasonable attorneys' fees and court costs) arising
out of any claim that Aspect Products purchased and/or licensed
hereunder infringe any patent or copyright or misappropriate a
trade secret of a third party, provided that (i) HP shall have
promptly provided Aspect written notice thereof and reasonable
cooperation, information, and assistance in connection therewith,
and (ii) Aspect shall have sole control and authority with
respect to the defense, settlement, or compromise thereof. Should
any Aspect Products delivered hereunder become or, in Aspect's
opinion, be likely to become the subject of such a claim, Aspect
may, at its option, either (x) procure for HP the right to
continue purchasing and using such Aspect Products, or (y)
replace or modify such Aspect Products so that they become
non-infringing or if (x) and (y) are not reasonably available to
Aspect, then (z) terminate HP's rights under this Agreement to
purchase the allegedly infringing Product and refund to HP the
amount which HP has paid to Aspect for such Products which are in
the possession of HP, upon return of such Products in their
unopened packages to Aspect at its principal facility in the
United States (freight and insurance at Aspect's expense). In
such event, Aspect may withhold further shipments of infringing
or potentially infringing Aspect Products.
Aspect shall have no liability or obligation to HP hereunder with
respect to any patent, copyright infringement or trade secret
misappropriation or claim thereof based upon
(i) compliance with designs, plans or specifications of HP,
(ii) use of Aspect Products by HP in combination with devices or
products not purchased and/or licensed hereunder where the
Aspect Products would not themselves be infringing,
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(iii)use of the Aspect Products by HP in an application or
environment for which such Aspect Products were not designed
or contemplated, or
(iv) modifications of the Aspect Products by HP
(b) Aspect's liability hereunder shall not exceed the purchase and/or
license price paid by HP for the Aspect Products found to be
infringing. The foregoing states the entire liability of Aspect
with respect to infringement or misappropriation of patents,
copyrights and trade secrets by the Products or any part thereof
or by their operation.
(c) In the event that any claim is brought against HP as a result of
personal injuries and/or property damages resulting from that
portion of the HP BIS System developed and manufactured by
Aspect, and provided further that such claims do not arise as a
result of the misuse of the HP BIS System , or the use of the HP
BIS System in an application for which it was not designed by
Aspect, where such claim would not have occurred but for such
misuse or use, Aspect agrees that it shall indemnify and hold HP
harmless from and against any damages, liabilities, costs and
expenses arising out of such claim, provided that HP shall
promptly provide Aspect written notice thereof and reasonable
cooperation, information and assistance in connection therewith
and Aspect shall have sole control and authority with respect to
the defense, settlement or compromise.
19.2. INDEMNITIES BY HP.
(a) Except as provided below, HP shall defend and indemnify Aspect
from and against any damages, liabilities, costs and expenses
(including reasonable attorneys' fees and court costs) incurred by
Aspect as a result of or arising from HP's activities under this
Agreement, including, without limitation, product liability,
customer warranty and service claims, provided that
(i) Aspect shall have promptly provided HP written notice
thereof and reasonable cooperation, information and
assistance in connection therewith, and
(ii) HP shall have sole control and authority with respect to the
defense, settlement or compromise thereof, and provided
further that
(iii) HP shall not be liable to Aspect under this Section 19.2 to
the extent that such damages, liabilities, costs and
expenses arise from Aspect's negligence or a breach of any
representation or warranty by Aspect hereunder.
20. TRADEMARKS.
20.1. ASPECT TRADEMARKS.
(a) Ownership. HP acknowledges and agrees that Aspect is the sole and
exclusive owner of all right, title and interest in and to the
trademarks (the "Aspect Trademarks") identified on Exhibit H
(Aspect Trademarks). HP recognizes the value of the Aspect
Trademarks and the good will associated with the Aspect
Trademarks. HP agrees that its use of the Aspect Trademarks and
any good will
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arising therefrom shall inure to the benefit of Aspect. Nothing
contained herein shall create, nor shall be construed as an assignment
of, any right, title or interest in or to the Aspect Trademarks to HP,
other than the grant of a license in Section 20.1 (c) below; it being
acknowledged and agreed that all other right, title and interest in
and to the Aspect Trademarks is expressly reserved by Aspect. HP shall
keep the Aspect Trademarks free from all liens, mortgages or other
encumbrances. HP agrees that it will not attack or otherwise challenge
the title, validity or any other rights of Aspect in or to the Aspect
Trademarks.
(b) Notice. All HP BIS Systems that use the Aspect Trademarks shall
be accompanied, where reasonable and appropriate, by a
proprietary notice consisting of the following elements:
(i) The statement "[insert trademark(s)] is a trademark(s) of
Aspect Medical Systems, Inc."
(ii) HP will include the "(TM)" or "(R)" symbol, as instructed by
Aspect, after the first prominent use of the Aspect
Trademark in the HP Patient Monitor and related materials.
HP shall have a period of 30 days in which to begin to use
the "(R)" symbol in replacement of the "(TM)" symbol upon
receiving instruction to do so by Aspect. HP may continue to
deliver stocked literature before the change becomes
effective.
(iii) HP shall reproduce copyright and trademark notices of Aspect
on the "splash screen" or in the same location where HP
reproduces its own copyright notices .
(c) License. Aspect hereby grants to HP a nonexclusive, worldwide,
royalty-free license (without the right to sublicense) to use the
Aspect Trademarks to designate and promote Aspect Products in HP
BIS Systems. HP shall have no other right to use, display or
utilize the Aspect Trademarks for any other purpose or in any
other manner.
(d) Quality Standards.
(i) Upon reasonable notice and request, and at a mutually
acceptable date and location, Aspect may inspect the
advertising and promotional materials on which the Aspect
Trademarks are used so that Aspect may monitor compliance
with this Agreement.
(ii) Compliance. Aspect acknowledges the high standards of
quality and excellence established by HP with respect to
products bearing HP's trademarks. HP acknowledges the high
standards of quality and excellence established by Aspect
with respect to products bearing the Aspect Trademarks. HP
agrees that HP Patient Monitors with which the Aspect
Trademarks are used shall be of such quality so as to
maintain such high standards and to reflect well upon
Aspect. HP agrees to adhere to HP's own or the following
quality standards (whichever may be more rigorous) for use
of the Aspect Trademarks by HP:
- In order to ensure that Aspect Products and HP Patient
Monitors distributed under the Aspect Trademarks comply
with the consistent quality standards of Aspect, all
Aspect Products and HP Patient Monitors distributed by
or for HP
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
which bear an Aspect Trademark shall conform to those
standards which Aspect provides to HP in writing. HP
shall cause each major new release of such HP Patient
Monitors to comply with such standards or remove the
Aspect Trademark(s) from any such new release, which
does not comply with such standards. HP shall have a
period of 30 days in which to bring newly shipped HP
Patient Monitors into compliance with any standard
provided to it by Aspect following the date of this
Agreement.
- HP acknowledges that if Aspect Products or HP Patient
Monitor products bearing the Aspect Trademarks fail to
satisfy the quality standards set forth above, the
substantial good will which Aspect have built and now
possess in the Aspect Products and in the Aspect
Trademarks will be impaired.
(e) Protection and Infringement. HP agrees to cooperate with and
assist Aspect in obtaining, maintaining, protecting, enforcing
and defending Aspect' proprietary rights in and to the Aspect
Trademarks. In the event that HP learns of any infringement,
threatened infringement or passing-off of the Aspect Trademarks,
or that any third party claims or alleges that the Aspect
Trademarks infringe the rights of the third party or are
otherwise liable to cause deception or confusion to the public,
HP shall notify Aspect giving the particulars thereof, and HP
shall provide necessary information and assistance to Aspect in
the event that Aspect decides that proceedings should be
commenced.
(f) Termination. In addition to the termination rights set forth in
Section 23 hereof, in the event that HP is in material breach of
any provision of this Section 20, Aspect may, upon [**] written
notice, terminate the license granted in Section 20.1 (c) if HP
does not cure such breach or default within such [**] period. The
parties recognize that curing such breach or default may require
development of a new version of HP BIS System. If this is the
case, then HP will be deemed to have cured such breach or default
if, within the [**] cure period, HP presents to Aspect a plan for
revision of HP Product that will cure such breach or default,
such plan is reasonably acceptable to Aspect, and such revision
is released and distributed within three months following written
notice of such breach or default.
In addition to the provisions of Section 23 hereof, upon
termination of the license granted in Section 20.1 (c), or upon
termination of this Agreement, for whatever cause:
(i) HP shall immediately cease and desist from any further use
of the Aspect Trademarks and any trademarks confusingly
similar thereto, either directly or indirectly;
(ii) All rights in the Aspect Trademarks granted to HP hereunder
shall immediately revert to Aspect;
(iii) In the event that this Agreement is terminated for any
reason other than a material breach or material default by
HP, HP shall have a period of 30 days thereafter to dispose
of all of the unsold HP BIS Systems bearing the
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Trademarks and advertising and promotional materials
relating thereto which had been completed by it prior to
such termination, provided such HP BIS Systems and materials
were in the process of manufacture more than [**] before
such termination.
(g) Promotional Claims. The general form of any promotional claims by
HP regarding Aspect's Bispectral Index technology and/or the
integration of this technology in HP Patient Monitors, and the
specific form of the use of Aspect's trade names and trademarks,
and of intended use claims regarding Aspect's Bispectral Index
technology, in promotional material, advertisement, and/or in
written technical literature shall be subject to review and
approval by Aspect prior to its publication or display.
20.2. HP TRADEMARKS.
(a) The general form of any potential claim by Aspect that HP uses
Aspect's Bispectral Index technology as part of the HP Patient
Monitors, and the specific form of the use of HP's trade names
and trademarks in promotional material, advertisement, and/or in
written technical literature shall be subject to review and
approval by HP prior to its publication or display.
(b) Upon termination of this Agreement any reference to HP and it's
trademarks must be immediately removed from any literature or
other display and must no longer be distributed.
21. EXPORT.
HP shall not export, directly or indirectly, HP BIS Systems or other
products, information or materials provided by Aspect hereunder, to any
country for which the United States requires any export license or other
governmental approval at the time of export without first obtaining such
license or approval. It shall be HP's responsibility to comply with the
latest United States export regulations, and HP shall defend and indemnify
Aspect from and against any damages, fines, penalties, assessments,
liabilities, costs and expenses (including reasonable attorneys' fees and
court costs) arising out of any claim that HP BIS Systems or other
products, information or materials provided by Aspect hereunder were
exported or otherwise shipped or transported in violation of applicable
laws and regulations.
22. CO-MARKETING PROGRAM.
(a) HP and Aspect may agree to undertake co-marketing programs in certain
geographies.
(b) HP and Aspect have agreed on a co-marketing program in North America
as described in Exhibit G (Co-Marketing Program) to this Agreement.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
23. TERM; DEFAULT AND TERMINATION.
23.1. TERM AND RENEWAL.
The initial term of this Agreement shall commence on the date first
specified above (the "Effective Date") and shall continue for a period
of 6 years. The term of this Agreement shall be automatically renewed
for successive 12 month periods unless either party provides written
notice of termination to the other party at least 60 days prior to
expiration of the Agreement.
23.2. TERMINATION FOR GOOD CAUSE.
(a) The Agreement may be terminated by Aspect giving 30 days written
notice to HP in the event HP has not commercially introduced an
HP BIS System by October 31st [**].
(b) The Agreement may be terminated by HP giving 30 days written
notice to Aspect if Aspect has failed to provide a BIS Module Kit
with the necessary regulatory approvals to HP by October 31st
[**].
(c) Events of Default. The following shall constitute events of
default under this Agreement:
(i) if either Party assigns this Agreement or any of its rights
or obligations hereunder except in connection with the sale
of such Party's business to which this Agreement relates
(the word "assign" to include, without limiting the
generality thereof, a transfer of a majority interest in the
Party) without the prior written consent of the respective
other Party. Notwithstanding the foregoing, it is understood
that this Agreement shall be assigned to Agilent
Technologies GmbH, at ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ - ▇▇▇,
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ and that Aspect consents to such
assignment.; or
(ii) if either Party shall neglect or fail to perform or observe
any of its obligations to the other Party hereunder,
including, without limiting the generality thereof, the
timely payment of any sums dueor Aspect's inability to
deliver Aspect Products, and such failure is not cured
within [**] in the event of a default in the payment of
amounts owed the other Party) after written notice thereof
from the other Party; or
(iii) if there is (w) a dissolution, termination of existence,
liquidation, insolvency or business failure of either Party,
or the appointment of a custodian or receiver of any part of
either Party's property, if such appointment is not
terminated or dismissed within thirty (30) days; (x) a
composition or an assignment or trust mortgage for the
benefit of creditors by either Party; (y) the commencement
by either Party of any bankruptcy proceeding under
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks
denote omissions.
the United States Bankruptcy Code or any other federal or
state bankruptcy, reorganization, receivership, insolvency
or other similar law affecting the rights of creditors
generally; or (z) the commencement against either Party of
any proceeding under the United States Bankruptcy Code or
any other federal or state bankruptcy, reorganization,
receivership, insolvency or other similar law affecting the
rights of creditors generally, which proceeding is not
dismissed within thirty (30) days.
(d) Remedies. Upon any event of default, and in addition to any other
remedies either Party may have at law or in equity, the
non-defaulting Party may cancel any outstanding Order, refuse to
make or take further Orders or deliveries, cancel any discount
given, and declare all obligations immediately due and payable.
The non-defaulting Party shall have all the remedies of a secured
party under the Uniform Commercial Code and any other applicable
law. The defaulting Party shall be liable for the other Party's
expense of retaking, holding, preparing for sale, selling and the
like, including reasonable attorneys' fees and legal expenses in
the event of default. Cancellation fees shall not be due and
payable.
23.3. INSURANCE.
Upon request, Aspect shall provide evidence of product liability,
general liability and property damage insurance against an insurable
claim or claims which might or could arise regarding Aspect products
purchased from Aspect. Such insurance will contain a minimum limit of
liability for bodily injury and property damage of not less than [**]
US$.
24. GENERAL PROVISIONS.
(a) Force Majeure. In the event that either Party is prevented from
performing, or is unable to perform, any of its obligations under this
Agreement due to any act of God, fire, casualty, flood, war, strike,
lock out, failure of public utilities, injunction or any act,
exercise, assertion or requirement of governmental authority,
epidemic, destruction of production facilities, insurrection,
inability to procure materials, labor, equipment, transportation or
energy sufficient to meet manufacturing needs, or any other cause
beyond the reasonable control of the Party invoking this provision,
and if such Party shall have used its best efforts to avoid such
occurrence and minimize its duration and has given prompt written
notice to the other Party, then the affected Party's performance shall
be excused and the time for performance shall be extended for the
period of delay or inability to perform due to such occurrence.
(b) Publicity. Neither Party shall originate any publicity, news release
or other public announcement relating to this Agreement or the
existence of an arrangement between the Parties without the prior
written approval of the other Party, except as otherwise required by
law.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(c) Waiver. The waiver by either Party of a breach or a default of any
provision of this Agreement by the other Party shall not be construed
as a waiver of any succeeding breach of the same or any other
provision, nor shall any delay or omission on the part of either Party
to exercise or avail itself of any right, power or privilege that it
has, or may have hereunder, operate as a waiver of any right, power or
privilege by such Party.
(d) No Agency. Nothing contained in this Agreement shall be deemed to
constitute either Party as the agent or representative of the other
Party, or both Parties as joint ventures or partners for any purpose.
Neither Party shall be responsible for the acts or omissions of the
other Party, and neither Party will have authority to speak for,
represent or obligate the other Party in any way without prior written
authority from the other Party.
(e) Survival of Obligations. All obligations of either Party which, by
their nature, require performance after the expiration or termination
of this Agreement, namely the sections on Royalties (5.(c)), Warranty
(11), Service and Support (12), Regulatory Matters (14), Ownership and
Protection of Results (16), Confidentiality (18), Indemnities (19),
Trademarks (20) shall survive the expiration or termination of this
Agreement and continue to be enforceable.
(f) LIMITATION ON LIABILITY. EXCEPT AS PROVIDED IN SECTION 19.1, ASPECT'S
LIABILITY ARISING OUT OF THE MANUFACTURE, SALE OR SUPPLYING OF ASPECT
PRODUCTS OR THEIR USE OR DISPOSITION, WHETHER BASED UPON WARRANTY,
CONTRACT, TORT OR OTHERWISE, SHALL NOT EXCEED THE AMOUNT OF [**] US$ .
IN NO EVENT SHALL ASPECT BE LIABLE TO HP OR ANY OTHER PERSON OR ENTITY
FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR OTHER INDIRECT DAMAGES
(INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS, LOSS OF DATA OR LOSS
OF USE DAMAGES) ARISING OUT OF THE MANUFACTURE, SALE OR SUPPLYING OF
ASPECT PRODUCTS.
(g) Severability. In the event that any provision of this Agreement is
held by a court of competent jurisdiction to be unenforceable because
it is invalid or in conflict with any law of any relevant
jurisdiction, the validity of the remaining provisions shall not be
affected and the rights and obligations of the Parties shall be
construed and enforced as if the Agreement did not contain the
particular provisions held to be unenforceable.
(h) Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the Commonwealth of Massachusetts.
(i) Notices. Any notice or communication with regard to the termination of
or changes to this Agreement from one Party to the other shall be in
writing and either personally delivered or sent via certified mail,
postage prepaid and return receipt requested addressed, to such other
Party at the address of such Party specified in this Agreement or such
other address as either Party may from time to
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
time designate by notice hereunder.
(j) Entire Agreement. This Agreement constitutes the entire agreement
between the Parties. No waiver, consent, modification or change of
terms of this Agreement shall bind either Party unless in writing
signed by both Parties, and then such waiver, consent, modification or
change shall be effective only in the specific instance and for the
specific purpose given. There are no understandings, agreements,
representations or warranties, expressed or implied, not specified
herein regarding this Agreement or the Aspect Products purchased
and/or licensed hereunder. Only the terms and conditions contained in
this Agreement shall govern the transactions contemplated hereunder,
notwithstanding any additional, different or conflicting terms which
may be contained in any Order or other document provided by one Party
to the other. Failure of Aspect to object to provisions contained in
any Order or other document provided by HP shall not be construed as a
waiver of the terms and conditions of this Agreement nor an acceptance
of any such provision. Retention by HP of Aspect Products delivered
hereunder shall be conclusively deemed to be a confirmation of the
terms and conditions hereof.
(k) Headings. Captions and headings contained in this Agreement have been
included for ease of reference and convenience and shall not be
considered in interpreting or construing this Agreement.
(l) Exhibits: The following Exhibits shall be part of this Agreement:
Exhibit A: Aspect Products and Purchase Prices
Exhibit B: Aspect's Standard Module Kit
Exhibit C: Contact Persons/Addresses Prices
Exhibit D: Change Notification Agreement
Exhibit E: Delivery and Packaging Standard
Exhibit F: Service/Repair
Exhibit G: Co-Marketing Program
Exhibit H: Aspect Trademarks
Exhibit I: [**]
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IN WITNESS WHEREOF, this Agreement has been duly executed as a sealed
instrument as of the date specified above.
Aspect Medical Systems, Inc. Hewlett-Packard GmbH
By: ▇. ▇▇▇▇▇▇▇▇▇▇▇▇ Eagle By: ▇▇▇▇▇▇▇ [illegible]
------------------------ ------------------------------
Title: Chairman Title: General Manager
--------------------- ---------------------------
Patient Monitoring Division
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT (A):ASPECT'S PRODUCTS AND PURCHASE PRICES
ORDERABLE ASPECT HP UNITS (EA) Aspect HP ROYALTIES
PARTS / PRODUCTS PART NO. ID Number CASES (PK) List Price Base Price (US$)
(US$) (US$) - Note A
---------------------------------- -------- --------- ---------- ---------- --------------- ---------
BIS MODULE KIT (new unit, includes ▇▇▇ ▇▇▇ 1 ea [**] [**] [**]
DSC, DSC Cable, HP BIS Engine,
Module Cable, User Manual)
Sensor Startup Kit 5 ea [**] [**]
DSC (replacement) [**] [**]
DSC Cable (replacement) [**] [**]
HP BIS Engine (replacement) [**] [**]
Module Cable (replacement) [**] [**]
User Manual [**] [**]
Service Manual [**] [**]
BIS Application Note (english) [**] [**]
BIS Application Note (french) [**] [**]
... [**]
BIS Brochure [**] [**]
[**]
Note A:
The HP Purchase Price is the sum of the HP Base Price (based on number of units
purchased per year) and the Royalties (based on cumulative number of units
sold). In addition to the HP Base Price specified above, HP shall pay to Aspect
for each BIS Module Kit purchased an additional sum to allow Aspect [**]. It is
currently estimated [**] per module kit.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT (B): ASPECT'S STANDARD MODULE KIT
ASPECT'S STANDARD BIS MODULE KIT.
Aspect's BIS 'Module Kit' is designed specifically for OEM applications and
allows the integration of Aspect's BIS monitoring technology into OEM equipment.
The BIS Engine will interface to the patient via the Aspect BIS sensor and to
the OEM equipment utilizing a serial (RS-232) 3-wire interface and the necessary
power connections.
The BIS Module Kit consists of a Digital Signal Converter (DSC-2) that is placed
in proximity to the patient and a small circuit board that resides in the OEM
equipment. The DSC-2 is a small (palm sized) front-end to the BIS Engine circuit
board that provides the patient interface and performs the high performance
analog to digital conversion of the EEG signals. The EEG signals are transmitted
in digital format from the DSC-2 to the BIS engine circuit board via a 12 foot
cable that is hard wired connected at the DSC-2.
The BIS Engine circuit board measures 3 x 4 inches. This board performs digital
signal processing on the digitized EEG signal and outputs the Bispectral Index
to the OEM system via the RS-232 serial connection. The board is constructed
using double sided surface mount techniques. The connections to the BIS Engine
circuit board are a serial interface (RS-232), power, and DSC connections.
Detailed Technical Specifications:
----------------------------------
Digital Output: [**]
[**]
Main Parameters: [**]
[**]
Electrical Safety: [**]
Power: [**]
[**]
[**]
Artifact Rejection: [**]
Bispectral Index: [**]
Digital Signal Converter (DSC-2)
--------------------------------
Description: [**]
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Weight: [**]
Dimensions: [**]
[**]
Cable Length: [**]
BIS Engine PCB
Physical: [**]
Processing Power: [**]
Software Upgrades
The BIS engine software is stored in reprogrammable FLASH memory.
Software upgrades can be accomplished on-site or remotely via the serial
interface.
Serial Identifier
Each BIS engine is given a unique serial identifier. This allows for
electronic identification/tracking of every BIS Engine.
Annual Failure Rate
The current combined annual failure rate for the BIS Engine and the DSC
is [**]. ▇▇▇▇▇▇ ▇▇▇▇▇ ▇ of the Project, this information will need to be
broken down by age of equipment
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