<PAGE>
Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission.
Asterisks denote omissions.
PURCHASE AGREEMENT NO. __________
THIS AGREEMENT
is made as of this 30th day of August 2005 ("Effective
Date"), between General Electric Company, a
corporation organized under the laws
of the State of New York, acting by and
through its GE Healthcare division
("Buyer" or "GE Healthcare"), and Aspect
Medical Systems Inc., a corporation
organized under the laws of the State of
Delaware (together with its Affiliates
(as hereinafter defined), "Seller").
WHEREAS, Seller
is a developer, manufacturer and distributor of medical
devices, equipment, related hardware,
software and related products and
accessories; and
WHEREAS, Buyer
wishes to have Seller sell certain products to Buyer in
accordance with the requirements of Buyer
as more fully set forth in the terms
and conditions of this Agreement, including
its Attachments and schedules.
WHEREAS, Buyer
and Buyer's Affiliates have entered into a number of
agreements with Seller, which include, but
are not limited to, that certain OEM
Development and Purchase Agreement dated
December 22, 1999 ("Marquette OEM
Purchase Agreement"), that certain
OEM-Purchase Agreement for Aspect BIS
technology dated September 1, 2000 ("DO OEM
Purchase Agreement"), that certain
OEM-Purchase Agreement for Custom
Datex-Ohmeda Sensors dated September 1, 2000
("DO Custom OEM Purchase Agreement"), and
that certain Aspect/Datex-Ohmeda
Principles of Research and Development
Cooperation agreement dated September 1,
2000 ("Cooperation Agreement" and together
with the Marquette OEM Purchase
Agreement, the DO OEM Purchase Agreement
and the DO Custom OEM Purchase
Agreement, the "Prior Agreements").
NOW THEREFORE,
Seller and Buyer agree as follows:
1. INTRODUCTION AND DEFINITIONS
(a) Scope. THIS AGREEMENT
AND ITS ATTACHMENTS AND SCHEDULES STATE THE TERMS
AND CONDITIONS UNDER WHICH SELLER SHALL
SELL TO BUYER, AND BUYER SHALL PURCHASE
FROM SELLER, THOSE PRODUCTS IDENTIFIED IN
ATTACHMENT D, AS WELL AS ALL
COMPONENTS, SPARE PARTS, SERVICE TOOLS,
MANUALS, SOFTWARE LICENSES, DATA AND
RELATED
<PAGE>
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INTERFACES WITH RESPECT THERETO (THE
"PRODUCTS"). UNLESS OTHERWISE EXPRESSLY
STATED, REFERENCES TO THIS "AGREEMENT"
INCLUDE ALL ATTACHMENTS AND SCHEDULES.
(b) Parties.
Seller expressly acknowledges that this Agreement is not
intended to govern or obligate General
Electric Company itself or any business,
division or Affiliate of General Electric
Company other than General Electric
Company's GE Healthcare division. Seller
agrees that General Electric Company's
GE Healthcare division and any domestic or
international Affiliate of General
Electric Company that operates as part of
General Electric Company's GE
Healthcare division may place a Purchase
Order under this Agreement, and that
any such Affiliate shall be entitled to the
same rights and obligations of
"Buyer" as if it were an original signatory
hereto. If any transaction-specific
or country-specific modifications to this
Agreement are required to facilitate
the sale of the Products to any such
Affiliate, both parties agree to negotiate
such modifications in good faith, and to
make only such modifications as are
required by local law or as are required
for logistics purposes. An "Affiliate"
shall mean, with respect to any specified
party, any other legal entity that
directly or indirectly controls, is
controlled by or is under common control
with, such specified party.
(c) Effect on
Prior Agreements. Upon execution, this Agreement shall be the
sole agreement effective for the purchase
of Products after the Effective Date,
regardless of any inconsistent information
contained on or incorporated into any
purchase order. As of the Effective Date,
and notwithstanding any requirements
of notice prior to termination, the parties
agree that the Prior Agreements
shall be terminated, and effective only for
determining the parties' respective
rights and obligations with respect to any
products or services ordered, or
information exchanged or obtained, under
such agreements. Notwithstanding the
foregoing, and without determining whether
any party has violated any of its
obligations, or acted contrary to the
prohibitions, contained in any of the
foregoing agreements, the parties
specifically agree that each party and its
Affiliates are relieved of: (i) any
obligation to exchange confidential
information, experiences and know-how and
to conduct good faith negotiations as
set forth in the Cooperation Agreement; and
(ii) except as provided in Section
21(b), any restrictions on their ability to
offer competitive products or to
offer, initiate development, promote or
market, including without limitation, as
set forth in the penultimate sentence of
Section 4.1 of the Marquette OEM
Purchase Agreement and as set forth in
Sections 11.7 and 11.8 of the DO OEM
Purchase Agreement, and are hereby released
from any liability that they may
have incurred as a result of any violations
of any such obligations or
restrictions.
(d) No
Obligation. Notwithstanding anything to the contrary in this
Agreement, it is the express understanding
of the parties that Buyer shall have
no obligation to purchase Products
exclusively from the Seller, and may use
other suppliers for any and all products
that perform the same or similar
function as the Products.
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(e) Documents.
The following attachments are an integral part of this
Agreement (the "Attachments"). The
provisions of each Attachment shall be
incorporated by reference into and be
deemed to be a part of this Agreement. If
any conflict exists between the provisions
of this Agreement and of the
Attachments, or between the provisions of
Attachments themselves, the order of
precedence shall be:
1. This
Agreement
2. Attachment D
(Product Schedule)
3. Attachment A
(Product Specifications)
4. Attachment C
(Quality Systems Certifications)
5. Attachment F
(Standard Terms and Conditions)
6. Attachment B
(Quality Plan)
7. Attachment H
(Seller Change Notice Form)
8. Attachment M
(Purchased Material Quality Requirements)
9. Attachment N
(Seller Trademarks)
10. Attachment O
(Buyer Trademarks)
(f)
Definitions.
"BISx System"
means the integrated solution of Seller's BIS Engine
processing technology and the DSC-XP. The
BISx System includes a patient
interface cable and a host monitor
cable.
"Buyer BIS/EEG
Engine" is the processing unit for deriving the BIS and EEG
data from the raw EEG signal and consists
of Seller's "BIS Engine" board
modified for Buyer.
"Buyer BIS/EEG
Module" is all components involved in integrating the BIS
and EEG with Buyer Patient Monitors.
"Buyer Patient
Monitor" means any multi-parameter patient monitoring system
manufactured by or for Buyer.
"BIS/EEG Module
Kit" means the bundle of all components of the Buyer
BIS/EEG Module that are developed and
manufactured by or for Seller and
licensed/sold to Buyer under this
Agreement: DSC-4, DSC-XP, DSC Cable, Buyer
BIS/EEG Engine, and module cable. "Digital
Signal Converter" or "DSC" means the
processing unit that amplifies the analog
EEG signals as acquired by the BIS
sensors and converts them from analog to
digital signals. The DSC-XP is used by
Buyer BIS/EEG Module customers to obtain
the BIS.
"Custom Sensor"
means a single use sensor that incorporates
level-of-consciousness monitoring
technology developed by Buyer, as more fully
described in the attached product
specifications.
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"BIS Sensor"
means a single use disposable sensor developed and
manufactured by Seller for use with the
A2000, the BIS/EEG Module Kit or the
BISx System and that is required to
generate Seller's Bispectral Index.
"Bispectral
Index" or "BIS" is Seller's proprietary processed EEG parameter
that measures the hypnotic effects of
anesthetic and sedative agents on the
brain.
"Smart Sensor
Technology" or "SST" means the Seller technology which may be
used by Buyer Patient Monitors to interface
with the Custom Sensors.
"Sensor
Connector" means the sensor connector currently being used with
the
Custom Sensor, or any replacement sensor
connector where the change was made in
accordance with the terms of this
Agreement.
"Entropy module"
is the processing unit for deriving Buyer's proprietary
processed EEG parameter that measures the
hypnotic effects of anesthetic and
sedative agents on the brain.
"Cable
Connector" means the mating connector to the Sensor Connector
currently being used with the Custom
Sensor, or any replacement mating connector
where the change was made in accordance
with the terms of this Agreement.
"Purchase Order"
means a purchase order released by Buyer for Products.
2. TERM
(a) Initial
Term. The term of this Agreement is from the Effective Date
through December 31, 2008 (the "Initial
Term" and, together with any Extension
Term (as hereinafter defined), the
"Term").
(b) Extensions.
The then current Term shall automatically renew for all of
the Products for additional one year
periods (the "Extension Term(s)") unless
one party notifies the other party three
(3) months prior to the expiration of
the Term that it intends to terminate the
Agreement at the end of the then
current Term.
3. QUANTITIES
(a) Forecast. At
least quarterly, Buyer shall submit to Seller forecasts of
its anticipated Product needs for the next
twelve (12) months. Any such forecast
shall not be binding in any way on Buyer
and may be modified at any time by
Buyer in its sole discretion. During any
month, any failure by Seller to deliver
in a timely manner an amount of Products
equal to the
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greater of one hundred fifty (150) units or
thirty percent (30%) more than the
greatest quantity of such Products ordered
in any one of the three (3) preceding
months (the "Guaranteed Amounts") will
subject Seller to the charges set forth
in Section 12. If Buyer orders Products in
excess of the Guaranteed Amounts or
requests a delivery time that is less than
the applicable lead time, Seller
shall exercise commercially reasonable
efforts to deliver the Products so
ordered within the delivery time requested
by Buyer, provided that if Seller is
not able to supply the quantity of Products
ordered by Buyer, and Seller is
permitted to sell similar products to other
customers, Seller shall allocate
such products on a pro-rata basis among all
of its customers of the applicable
products that also ordered products in
excess of their guaranteed amounts.
(b) Commitment.
Buyer's commitment to purchase Products from Seller shall
be limited to Purchase Orders released by
Buyer and accepted by Seller pursuant
to Section 5. Unless agreed otherwise in
writing by the parties, Buyer shall not
be responsible or in any way liable to
Seller or any third party with respect to
any material commitments or production
arrangements in excess of the amounts or
in advance of the times necessary to meet
Buyer's delivery schedules set forth
in its accepted Purchase Orders.
(c) Cancellation
Charges. In the event of the cancellation of any Purchase
Order by Buyer for products other than
sensors, Seller has the right to charge a
cancellation charge based on actual damages
caused to Seller. The maximum amount
of damage may not, however, exceed the
following charges listed below. The
cancellation charges are based on the
number of days prior to the scheduled
delivery date that written notice of
cancellation is received by Seller, as
outlined below:
<TABLE>
<S>
<C>
> 8 weeks
prior to acknowledged delivery [**]
6 - 8 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
</TABLE>
In the event of the cancellation of any
Purchase Order by Buyer for Custom
Sensors or BIS Sensors, Seller has the
right to charge a cancellation charge
based on actual damages caused to Seller.
The maximum amount of damage may not,
however, exceed the following charges
listed below. The cancellation charges are
based on the number of days prior to the
scheduled delivery date that written
notice of cancellation is received by
Seller, as outlined below:
<TABLE>
<S>
<C>
> 4 weeks
prior to acknowledged delivery [**]
3 - 4 weeks
prior to acknowledged delivery [**]% of order value
2 - 3 weeks
prior to acknowledged delivery [**]% of order value
1 - 2 weeks
prior to acknowledged delivery [**]% of order value
< 1 week
prior to acknowledged delivery [**]% of
order value
</TABLE>
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(d) Lead Times.
Lead times for the Products are set forth in Attachment D.
Notwithstanding the foregoing, it is
Seller's intention to operate with lead
times for BIS/EEG Module Kits and BISx
Systems of less than four (4) weeks and
lead times for BIS Sensors of less than
three (3) business days.
4. PRICING
(a) Price
Protection. The prices specified in Attachment D for Products
(the "Prices") are firm for the Term and
include all reasonable charges,
packaging, date of manufacture and bar code
labeling. In no event shall the
Prices be increased by Seller without the
express written consent of Buyer.
(b)
Software/Firmware. The Price includes a perpetual, paid-up,
worldwide,
license to Buyer and its distributors,
sub-distributors, field organization,
channel partners and customers or users of
the Products or Buyer's products
containing Products to use, in the
operation, of the Products, any software
and/or firmware supplied by Seller to Buyer
or incorporated into the Products.
Seller hereby grants to Buyer all
sublicense rights required to sell the
Products in accordance with this Agreement.
All rights granted hereunder shall
survive any termination of this Agreement
as long as the applicable party
remains in compliance with the terms of use
for such Products. Buyer shall not
duplicate the software or any part thereof.
Title to and ownership of any and
all proprietary rights in or related to the
software shall at all times remain
with Seller or its licensor(s). Nothing in
this Agreement shall be construed as
a sale of any rights in the software. Buyer
shall not disassemble, decompile or
otherwise reverse engineer the software or
any part thereof, except if Seller is
required under applicable law to permit
Buyer to reverse engineer any software.
In such event, Buyer may reverse engineer
the software but only to the extent
Seller is required to permit such reverse
engineering. Buyer shall retain and
shall not alter or obscure any notices,
markings or other insignia affixed to
the software or any part thereof at the
time it receives such software.
(c) NRE. Seller
agrees to provide reasonable engineering support, including
support for integration efforts of the
Products into Buyer's other products, to
Buyer free of charge. If Buyer requests
engineering support for purposes of
modifying a custom sensor, and for which
Buyer's prior approval has been
provided, Buyer shall pay for such
engineering support at Seller's standard
billing rates, which are currently US $[**]
per hour. Seller shall have the
right to change such rates charged to Buyer
by no more than the average
percentage change in the wage level of the
engineering support staff, but not
more than ten percent (10%) per year during
the Term of this Agreement.
(d) Price Reductions.
Seller represents to Buyer that the Prices are as low
as the prices at which Seller is currently
selling items similar to the Products
in the same or similar quantities under
substantially similar terms and
conditions. If during the Term, Seller
reduces the price of
<PAGE>
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such similar items, Seller shall: (i)
promptly notify Buyer in writing of such
reduction; and (ii) apply an equivalent
reduction in Price to all Products
ordered by Buyer which have not been
previously shipped and invoiced at the time
of such reduction. The Prices shall
thereafter be adjusted to reflect such
reduction for as long as Seller sells such
products at the reduced price or
until the Prices are further reduced
pursuant to this Agreement.
(e) Cost
Reductions. Buyer and Seller shall undertake a program to
achieve
reductions in the cost of Products by
utilizing cost-effective design, lower
cost components, new technology,
productivity improvements and automation of the
manufacturing process. To assist each other
in this joint program, Buyer and
Seller shall meet periodically to discuss
the feasibility and potential savings
from alternative actions. Seller agrees to
evaluate the impact of any cost
reduction realized based on such program on
future prices for Products sold
after the term of this Agreement.
(f) Sales Taxes
And Duties. Prices are exclusive of all taxes or duties
after delivery to the designated
destination (other than taxes levied on
Seller's income) that Seller may be
required to collect or pay upon shipment of
the Products. Any such taxes or duties must
appear as a separate item on
Seller's invoice. Buyer agrees to pay such
taxes or duties unless Buyer is
exempt from such taxes or duties. Where
applicable, Buyer will provide Seller
with an exemption resale certificate. If
Seller is the importer of record in the
country of receipt, Seller shall, upon
Buyer's request, provide Buyer the
document required by the customs
authorities of the country of receipt to prove
importation and to transfer duty drawback
rights to Buyer.
(g) BIS Sensor
Commission. During the term of this Agreement, for each BIS
Sensor sold by Seller to Buyer's customers
in the United States for use with
Buyer BIS/EEG Modules and BISx Systems
(regardless of whether such Products were
sold under this Agreement or any of the
Prior Agreements), Seller shall pay
Buyer a commission equal to [**] percent
([**]%) of the sales revenue realized
by Seller for such BIS Sensors. Seller
shall pay such commissions to Buyer on a
calendar quarterly basis. With such
quarterly payments, Seller shall provide to
Buyer a list of Buyer customers to which
such sales were made, the number of BIS
Sensors sold in that quarter, and the
revenue realized from the sale of the BIS
Sensors by Seller. All such information
shall be treated as Seller Confidential
Information in accordance with the terms of
this Agreement. This quarterly
payment shall be provided to Buyer no later
than thirty (30) days following the
end of each calendar quarter. In the event
that Seller's standalone BIS monitors
and/or the BIS modules of other
manufacturers have also been installed at such
sites in addition to Buyer BIS/EEG Modules
and BISx Systems, Buyer will be
entitled to a [**] percent ([**]%)
commission only on BIS Sensor sales intended
for use with Buyer BIS/EEG Modules and BISx
Systems. The parties will agree upon
a reasonable basis for estimating the
number of BIS Sensor sales intended for
use with Buyer BIS/EEG Modules and BISx
Systems in such an event (e.g. a pro
rata determination based on the total
number of BIS units of different types
installed at such locations during the
period) and will calculate the total BIS
Sensor commissions due to Buyer
accordingly. To facilitate such calculations,
Buyer will be responsible for providing
Seller with
<PAGE>
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documentation, on a quarterly basis, of the
total number of Buyer BIS/EEG
Modules and BISx Systems installed, the
locations of such Buyer BIS/EEG Modules
and BISx Systems, and the dates of
installation. All such information shall be
treated as Buyer Confidential Information
in accordance with the terms of this
Agreement.
(h) Audit.
Seller shall keep full and accurate records and books of
account
containing all necessary information to
calculate the commission due hereunder.
Seller shall permit an independent
certified public accountant to examine its
records and books of account for the two
(2) year period prior to the date of
the audit to determine compliance with
Section 4(g). Any examination shall be at
the expense of Buyer, shall occur during
regular business hours at Seller's
offices and shall not interfere
unreasonably with Seller's regular activities.
Buyer shall give Seller at least thirty
(30) days notice of the date of each
such examination and the name of the
accountant who will be conducting the
examination. Seller agrees to pay Buyer any
amounts owning as a result of
Seller's non-compliance with the payment
provisions of Section 4(g), and Buyer
shall return any amounts overpaid by
Seller, within fourteen (14) days of the
date of the examination report, which
details such non-compliance. In the event
such amounts owed by Seller to Buyer during
the audited period exceeds five
percent (5%) of total commissions due,
Seller shall pay the costs of such
examination.
5. PURCHASE ORDER RELEASES
(a) Contents. A
Purchase Order may consist of an electronic message
pursuant to Section 15 or a written
communication from Buyer to Seller that
complies with the requirements of this
Agreement. Purchase Orders released by
Buyer shall reference this Agreement,
identify the delivery date or dates and
identify the quantities to be released for
delivery within the lead times
specified in Attachment D. REGARDLESS OF
FORM, EVERY PURCHASE ORDER IS DEEMED TO
INCLUDE THIS AGREEMENT, INCLUDING BUYER'S
STANDARD TERMS AND CONDITIONS SET
FORTH IN ATTACHMENT F.
(b) Acceptance.
Seller shall accept Purchase Orders if they are placed by
Buyer under agreed prices and other
conditions of this Agreement. Seller may
reject any Purchase Order of Buyer if the
requested delivery time is shorter
than the agreed upon lead time, the
quantity ordered exceeds the Guaranteed
Amounts or the Purchase Order is not
otherwise in compliance with this
Agreement.
(c) Order
Acknowledgements. Purchase Orders shall be acknowledged by
Seller
within five (5) days after receipt of the
Purchase Order, provided that the
Purchase Order is technically correct and
that the requested delivery time is
within the agreed lead time and the
Guaranteed Amounts. All other Purchase Order
acknowledgements shall not be unreasonably
withheld.
<PAGE>
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(d) Changes.
Buyer may change the quantities and delivery dates on
individual Purchase Orders one time without
penalty (provided that the delivery
date(s) for the original quantity of
ordered Products are rescheduled within
three (3) months of the original delivery
date and such Purchase Orders cannot
be subsequently canceled).
6. DOCUMENTATION
(a) Seller
agrees to provide Buyer with such product literature,
operations
and maintenance manuals, and other
information and training as is mutually
agreed, to enable Buyer to properly sell
and maintain Products, provided that in
no event shall the source code for source
listings of any software of Seller be
required to be disclosed or provided by
Seller to Buyer and provided that Buyer
shall be responsible for providing Seller
with product literature and operations
and maintenance manuals for the Custom
Sensors. Seller hereby grants to Buyer
the right to use or reproduce its user
documentation for incorporation into
Buyer's documentation (excluding source
code or source listings as previously
mentioned) without charge. Such
documentation shall be provided in electronic
format. Seller shall be given the
opportunity to review and approve Buyer
documentation that incorporates Seller
documentation prior to publication.
Unless agreed otherwise in writing by
Buyer, each Product that is a sensor shall
include instructions for use. If any change
in the Product (other than the
Custom Sensor) requires a change in the
documentation, Seller shall promptly
notify Buyer of the change and provide a
revised reproducible master copy
without charge. Seller shall promptly
revise and update any such documentation
for agency or regulatory requirements.
7. TRAINING
Service
Training. Seller agrees to provide periodic (annually at a
minimum)
ongoing training for existing and new Buyer
service personnel.
8. SPARE PART TESTING AND CONTINUING
AVAILABILITY
(a) Testing.
Seller shall test all repaired Products and spare parts using
the test plan or procedure set forth on
Attachment B or, if not specified on
Attachment B, then the highest quality test
plan or procedure used by Seller to
test products similar to the Products.
(b) Duration.
Seller guarantees that either compatible spare parts or
compatible replacement products will be
available on reasonable commercial terms
for a period of at least seven (7) years
from the delivery by Seller of the
Product in question.
(c) Last Time
Buy. Seller acknowledges its obligation to manufacture,
supply and support the Products without
interruption for the Term. If, however,
Seller plans to remove any of the Products
(including spare parts and
components) from its product line, it shall
notify Buyer about the intended
removal in writing at least six (6) months
in advance. Before the
<PAGE>
-10-
expiration of the six (6) months notice
period, Buyer shall have the right to
place a final order for the applicable
Products (including spare parts and
components) required by Buyer. Seller shall
use its reasonable efforts to
deliver the Products so ordered, however
the delivery times regarding such final
order shall be agreed separately between
the parties.
9. COMMERCIAL TERMS
Provisions
concerning delivery, transportation, packaging, freight
insurance, risk of loss, title, and other
commercial terms are contained in
Buyer's Standard Terms and Conditions set
forth in Attachment F.
10. INVOICES/PAYMENT
(a) Content of
Invoice. Seller's invoices shall contain the Purchase Order
release number, item number on such
release, Buyer's part number, invoice
quantity, unit of measure, unit price,
total invoice amount, name of Seller,
phone number, address to which remittance
should be sent, and such other
information as may reasonably be required
by Buyer.
(b) Payment.
Unless otherwise agreed in writing, and except for disputed
amounts, payment for all Products shall be
made by Buyer in the currency
specified in Attachment D by SWIFT transfer
within sixty (60) days from shipment
date of the Products to Buyer's premises or
such other destination as may have
been specified in the Purchase Order,
provided that the quantity and quality of
the Products delivered conforms to this
Agreement and the respective Purchase
Order. Any late payments shall bear
interest at one percent (1%) per month.
11. WARRANTY/REPAIR
(a) Terms. The
terms of the warranties of Seller with respect to Products
are stated in Attachment F. Seller
additionally represents and warrants that the
Products (excluding the Custom Sensor) have
received the 510(k) certifications
and CE mark. Seller's warranties set forth
in the warranty section of Attachment
F for Products other than BIS Sensors and
Custom Sensors shall be for the lesser
of: (a) [**] months following the date such
Product is received by the end user
or (b) [**] months after the date such
Product is received by Buyer, and for BIS
Sensors and Custom Sensors shall be [**]
months from the date of manufacture.
Seller agrees that the date of shipment for
BIS Sensors and Custom Sensors shall
be less than three (3) months from the date
of manufacture.
(b) Return of
Non-conforming or Defective Product. Buyer may return to
Seller without prior authorization any
Product that does not conform or perform
in accordance with the warranties contained
herein. Any such Product shall be
returned to Seller's facility or authorized
service center, with all
transportation charges paid by Seller and
the risk of loss
<PAGE>
-11-
passing to Seller when the Product is
delivered to the carrier of Seller's
choice. Seller will return the replacement
or repaired Products as soon as
possible but in no event later than thirty
(30) days after receipt of the
non-conforming or defective Product. The
warranty on such returned Products
shall be the greater of the remainder of
the original warranty period or [**]
months from the date such returned Product
is received by the Buyer, unless a
shorter warranty is provided in Attachment
D.
(c) Credit. To
the extent a defective Product is not promptly repaired or
replaced by Seller pursuant to the terms of
this Agreement, Seller shall
promptly refund or credit Buyer for any
payment Buyer made with respect to such
Product. Buyer may elect to take such
credit on any open invoices of Seller.
(d) Records. Seller
shall maintain serial and/or lot number and date of
shipment records for all Products so that,
for tracing or recall purposes, the
manufacturing and delivery of the Products
can be identified.
12. PERFORMANCE MEASUREMENTS
(a) Product
Quality. Seller and Buyer are committed to quality in the
performance of this Agreement. Accordingly,
all Products shall be manufactured
and tested in accordance with the quality
plan set forth in Attachment B. With
reasonable advance notice, Buyer may
request to perform an audit of Seller's
manufacturing facilities to verify that
Seller's operations for manufacturing
the Products are consistent with industry
standards and in conformance with the
requirements of this Agreement.
(b) Delivery.
Seller shall notify Buyer immediately if Seller ever has
reason to believe that any Product will not
be delivered as ordered, or a
shipment will not be made as scheduled.
Late deliveries are subject to late fees
of one percent (1%) per month (pro rated
daily) if the Product was ordered with
the required lead times listed in
Attachment D. In the event of late deliveries
by Seller, Seller will also promptly
reimburse Buyer for expedited shipment
charges that Buyer incurs as a direct
result of late shipments of the Products
from Seller.
13. COMPLIANCE
(a) General.
Seller shall comply with all applicable laws and regulations
in manufacturing and furnishing Products to
Buyer with the intended distribution
of such Products in the countries listed
under such Products on Attachment D.
Such laws may include, but not be limited
to, United States and foreign medical
device laws, labor laws, employment
opportunity laws, environmental laws,
import/export laws, and product safety
laws. Seller shall ensure that its
Products comply with the electro-magnetic
product standards identified in
Attachment A. Seller shall keep Buyer
informed of the status of all required
approvals and will provide to Buyer
<PAGE>
-12-
evidence of all such compliance upon
request. Seller shall maintain quality
control procedures in compliance with the
requirements of the following quality
systems, including but not limited, ISO
13485, EN 46001, US GMP 21 CFR 820 (the
"US GMP") and the Council Directive
93/42/EEC concerning medical devices
promulgated by the Council of the European
Communities as amended (the "MDD").
If Seller receives additional regulatory
approvals, it shall promptly update
Attachment D; if Buyer wishes to distribute
the Products in countries in
addition to those listed on Attachment D,
Buyer shall be responsible for
obtaining all required certifications and
approvals, and Seller shall provide
Buyer with all information necessary for
Buyer to obtain and maintain such
certifications and approvals.
(b) Product
Certification. Seller shall maintain at its expense all
regulatory approvals listed on Attachment D
and all UL, IEC, CE and CSA or
equivalent listings acceptable to Buyer for
all Products. Unless otherwise
agreed to in writing, if a party proposes a
change in purchase specifications
pursuant to Section 14, such party shall be
responsible for any additional
product certification costs that may be
necessary.
(c) Custom
Sensor. In relation to the MDD requirements, Buyer shall be
regarded as the manufacturer of the Custom
Sensors. Seller warrants that the
Custom Sensors conform to the requirements
established in the MDD and will
affix, at the direction of Buyer, the
Buyer's CE mark to all Custom Sensors and
packaging. Buyer agrees that the
appropriate labeling of the Custom Sensors and
the obtaining of registrations, tests
and/or approvals from relevant
authorities, where necessary, is the
responsibility of Buyer and will be done at
Buyer's cost. Buyer shall, during the term
of this Agreement for so long as it
sells the Custom Sensor, keep all
regulatory approvals for the Custom Sensor in
full force and effect at Buyer's expense.
Seller agrees to deliver to Buyer all
information reasonably required by Buyer to
obtain and maintain regulatory
approvals including but not limited to the
MDD CE marking and the US FDA 510(k).
(d) Any act or
notification of authorities, that might lead to cancellation
or modification of any approvals or
certifications, shall be immediately
communicated to the other party in writing
and the parties will jointly agree on
appropriate corrective measures.
(e) Seller
Certification. Seller shall notify Buyer in writing if Seller
is
qualified as a small business concern,
small disadvantaged business concern, or
women-owned small business concern as
defined in 48 CFR 52.219-8.
(f) Seller's
Quality Systems Certifications is attached hereto as Exhibit
C. From time to time, Seller may make
changes to its Quality Systems
Certifications. The Seller shall maintain
this quality system and certifications
for the duration of this Agreement and
design, manufacture, examine, mark and
pack the Products in accordance with this
quality system.
(g) Seller's
Quality Plan is attached hereto as Exhibit B. From time to
time, Seller may make changes to its
Quality Plan. The Seller shall maintain
this Quality Plan for the duration of
<PAGE>
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this Agreement and design, manufacture,
examine and pack the Products in
accordance with this Quality Plan.
(h) Buyer
reserves the right, by itself, through its appointed
representative or independent third
parties, during regular business hours and
following reasonable notice to Seller, to
inspect Seller's physical facilities
and Seller's quality control procedures in
order to assure compliance with the
Specifications, quality requirements and
other applicable regulations and
standards. In the event that Buyer believes
that the quality procedures applied
by Seller are insufficient as to ensure
consistent acceptable quality, Buyer
shall inform Seller of any nonconformities
and Seller agrees to investigate the
nonconformities and to determine
appropriate corrective actions. Seller agrees
to notify Buyer for any such corrective
action taken. Seller agrees to take all
appropriate measures in order to ensure
compliance of its sub-suppliers with the
foregoing.
(i) Seller
guarantees that all Products (other than the Custom Sensor) at
the time of shipment are:
a. manufactured
and released as finished devices in accordance with
the applicable provisions of the Federal Food, Drug and
Cosmetic
Act (FDCA) as amended (21 U.S.C. section 301 et seq.) relating
to
adulterated or misbranded devices;
b. not an
article which may not, under the provisions of sections
404 or 405 of the FDCA, be introduced into interstate commerce;
and
c. in compliance
with the provisions of sections 510, 513 and 515 of
the FDCA.
14. CHANGES IN PURCHASE SPECIFICATIONS
(a)
Buyer-Proposed Changes. Buyer may propose changes in Attachment A
by
submitting the proposed changes
(identifying those changes which it deems
mandatory to make the Product suitable for
use) to the agreement manager of
Seller, utilizing the Product Change Notice
(PCN). Seller shall respond in
writing to the agreement manager of Buyer
within ten (10) days after receipt of
such changes with the following
information, as applicable: (i) lead time
required to implement proposed changes;
(ii) impact of proposed changes on
pricing of Product, including parts and
tools; (iii) impact of proposed changes
on scrap material and work in process; and
(iv) non-recurring engineering
charges to implement proposed changes.
Within no more than ten (10) days after
Buyer receives Seller's response to Buyer's
proposed changes, the parties shall
begin negotiations with respect to the
changes to Attachment A and any related
changes to the price and delivery
schedules. If the parties fail to negotiate
appropriate changes to the Agreement, the
terms in effect prior to the
commencement of the negotiations shall
remain in full force and effect.
<PAGE>
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(b)
Seller-Proposed Changes - Custom Sensors. Seller may not make
any
changes to Buyer's engineering designs for
a Custom Sensor without obtaining
Buyer's written consent, as evidenced in a
Supplier Change Notice (SCN). Changes
to a Custom Sensor proposed by Seller, both
material and process changes, which
may affect regulatory compliance or safety
or materially affect form, fit,
function, reliability, serviceability,
performance, interchangeability or
interface with Buyer's equipment must be
submitted along with a written Seller
Change Notice (SCN) utilizing the form that
can be found at www.gesmp.com, at
least ninety (90) days before the change is
implemented. If Seller makes any
such change to a Custom Sensor without such
documentation, Seller shall, in
addition to any other costs, expenses or
damages incurred by Buyer, be
responsible for labor and material costs to
repair or replace said Custom Sensor
regardless of whether the Custom Sensor is
in or out of warranty. A change shall
be deemed to be material if such
substitution or modification requires any
modifications or adjustments of Buyer's
products that work with the Custom
Sensor.
(c)
Seller-Proposed Changes - All Other Products. Seller shall have
the
right, at any time and from time to time,
to make substitutions and
modifications to the Products other than
Custom Sensors, provided that such
substitutions or modifications shall not
affect regulatory compliance or safety
or materially affect form, fit, function,
reliability, serviceability,
performance, functional interchangeability
or interface capability of the
Products. In the event that any proposed
substitution or modification materially
affects the form, fit, function,
reliability, serviceability, performance,
functional interchangeability or interface
capability of a Product, Seller shall
give Buyer written notice of such proposed
substitution or modification using
the Buyer SCN process at least ninety (90)
days prior to its taking effect and
Buyer shall have the right, during such
ninety (90) day period and for ninety
(90) days thereafter, to order Products
without such substitution or
modification for delivery up to ninety (90)
days after such substitution or
modification takes effect. Seller shall
provide the appropriate verification and
validation information for evaluating the
effect of the change on the Products.
A substitution or modification shall be
deemed to be material if such
substitution or modification requires any
modifications or adjustments of
Buyer's products that work with the
Products.
15. ELECTRONIC DATA INTERCHANGE
(a) Access.
Buyer, in its sole discretion, may permit Seller to have
on-line access to designated computer
systems of Buyer in order to facilitate
Seller's ability to perform its obligations
under this Agreement. If such access
is granted, Seller shall give to Buyer the
names of Seller's employees who have
a legitimate business need for such access
to Buyer's computer systems, and
Buyer shall provide a separate user
identification code for each person. Seller,
at its own expense, shall provide and
maintain any hardware, telecommunications
services and software not furnished by
Buyer, which are needed to communicate
reliably with Buyer's computer systems.
Buyer, in its sole discretion, may
terminate Seller's access to Buyer's
computer network at any time.
<PAGE>
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(b) Use
Restrictions. Seller shall ensure that: (i) computer access is
limited to those employees with a
legitimate business need whose names have been
furnished to Buyer; and (ii) such employees
with access agree to keep any
information so obtained strictly
confidential, to use such information only to
perform Seller's contract obligations to
Buyer and to cease accessing Buyer's
computer systems when no longer required to
perform work under this Agreement.
Seller shall promptly notify Buyer if it
becomes aware of any unauthorized
access to Buyer's computer systems or
unauthorized use of the information on the
systems.
(c) Legal
Effect. Any document properly transmitted by computer access
shall be considered a writing delivered in
connection with this Agreement.
Electronic documents shall be considered
signed by a party if they contain an
agreed upon electronic identification
symbol or code. Electronic documents shall
be deemed received by a party when
accessible by the recipient on the computer
system.
16. TERMINATION
(a) Termination
of Purchase Order. Buyer may terminate any Purchase Order
in whole or in part at any time upon
written notice to Seller, subject to the
other terms of this Agreement.
(b) Termination
of Purchase Agreement. If Buyer terminates any Purchase
Order for cause, or if there is a breach of
any material term of this Agreement
by either party and such breaching party
fails to correct such breach within
thirty (30) days after receiving written
notice of such breach from the
non-breaching party, the non-breaching
party may terminate this Agreement and
all unfilled Purchase Orders without any
liability except for the price of any
Products previously delivered and accepted
by Buyer (subject to any set-off
available to Buyer). Either party may also
terminate this Agreement immediately
by giving written notice to the other party
if: (i) the other party fails to
meet its financial obligations as they
become due, or if any proceeding under
the bankruptcy or insolvency laws is
brought against the other party, or a
receiver is appointed for the other party
or the other party makes an assignment
for the benefit of creditors or (ii) there
has been an effective change in
control of the Seller. Upon ninety (90)
days prior written notice to Buyer,
Seller shall also have the right to
terminate its obligation to provide Custom
Sensors under this Agreement in the event
that Buyer does not purchase at least
thirty percent (30%) of its annual volume
of Custom Sensors from Seller. If
Seller terminates its obligation to provide
Custom Sensors, Seller shall also
have the right to terminate all rights
granted to Buyer for the SST.
Any such termination shall not relieve the
breaching party of its obligations
and the non-breaching party shall retain
all legal and equitable remedies after
such termination. A material breach shall
include, without limitation, the
failure to comply with any Attachment
and/or the failure of Seller to comply
with applicable product quality and
delivery obligations.
<PAGE>
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17. INFORMATION
(a) Confidential
Information. During the Term, a party (the "Recipient")
may receive or have access to certain
information of the other party (the
"Discloser") that is Confidential
Information of the Discloser. For purposes of
this Agreement, "Confidential Information"
shall mean any information disclosed
by the Discloser to the Recipient, whether
technology-related or
business-related, whether furnished before
or after the Effective Date and
irrespective of the form of communication,
that is considered competitive,
confidential or proprietary in nature
including, though not limited to,
information or data concerning the
Discloser's products or product plans,
business operations, strategies, customers
and related business information,
design documents, drawings, engineering
information, financial analysis,
forecasts, formulae, hardware configuration
information, know-how, ideas,
inventions, market information, marketing
plans, processes, products, product
plans, research, specifications, software,
source code and trade secrets. The
Recipient will protect the confidentiality
of Confidential Information with the
same degree of care as the Recipient uses
for its own similar information, but
no less than a reasonable degree of care.
Confidential Information may only be
used by those employees of the Recipient
who have a need to know such
information for the purposes related to
this Agreement, and the Recipient shall
inform such employees of the confidential
nature of such Confidential
Information and the obligations of the
Recipient hereunder. The Recipient agrees
to be responsible for any breach of this
Agreement by it or its employees to the
same extent as though such employees were
parties hereto. The parties
acknowledge that all forecasts and the
terms of this Agreement are deemed
Confidential Information to be protected
for a term of three years from the date
of disclosure and that all other
Confidential Information shall be protected
indefinitely.
(b) Exclusions.
The foregoing confidentiality obligations will not apply to
any information that is (a) already known
by the Recipient prior to disclosure
other than pursuant to another agreement
between the parties, (b) independently
developed by the Recipient prior to or
independent of the disclosure, (c)
publicly available through no fault of the
Recipient, (d) rightfully received
from a third party with no duty of
confidentiality, (e) disclosed by the
Recipient with the Discloser's prior
written approval, (f) disclosed under
operation of law, or (g) with respect to
the terms of this Agreement, disclosed
pursuant to a confidentiality agreement to
existing and potential investors,
strategic partners and acquirers.
(c) Within
fourteen (14) days after termination of this Agreement each
party shall return all Confidential
Information of the other party and all
copies thereof (in any media) unless a
party is required to retain such material
under applicable laws or regulations. All
information consisting of documents,
notes and other writings prepared by one
party based on non-public data of the
other party shall be destroyed.
<PAGE>
-17-
(d) Each party
shall not, and each party shall ensure that its officers and
employees will not, whether during the term
or after the termination of this
Agreement, use any Confidential Information
of the other party or any of its
Affiliates or their products, technology,
designs or tools for other purposes
than the fulfillment of such party's
obligations hereunder.
(e) Seller shall
not during the term of this Agreement or thereafter sell
to third parties any products that are
manufactured in accordance with
proprietary technical specifications,
technology, designs or tools provided by
Buyer.
(f) In case of
unauthorized use by either party, its Affiliates or
employees of the such non-public
technologies, designs or tools of the other
party, the Recipient shall be obliged to
compensate any costs, damages and
losses incurred by the Discloser due to
such unauthorized use.
(g) The
obligations set forth in this Section shall continue even after
the
expiration of this Agreement.
18. AGREEMENT MANAGER/NOTICES
(a) Managers.
Each party shall appoint an agreement manager as the point of
contact for all matters relating to
performance of this Agreement. Buyer's
agreement manager shall be Marianne Metso
and Seller's agreement manager shall
be Joan Rubin. Either party may change its
agreement manager by providing notice
of such change to the other party. The
managers agree to meet quarterly to
discuss issues related to this Agreement.
Additional meetings can be called by
either party upon thirty (30) days prior
written notice.
(b) Addresses.
Any notice required under this Agreement shall be sent by
fax (with the original to promptly follow
by applicable national mail service or
a nationally recognized overnight courier),
by a nationally recognized overnight
courier, or transmitted electronically
pursuant to the terms of Section 15.
Notices will be deemed given on the date
delivered to the recipient if sent by
fax or overnight courier (it being agreed
that the sender shall retain proof of
transmission or delivery, as the case may
be), or when accessible electronically
if sent electronically under Section 15.
Notices shall be sent to the persons
identified below (or as otherwise directed
in writing by a party):
Buyer:
GE Healthcare
P.O. Box 900
FI-00510 Helsinki, Finland
Attention: Marianne Metso
Fax: 358 9 140597
Seller: Aspect
Medical Systems, Inc.
<PAGE>
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141 Needham Street
Newton, MA 02464
Attention: Joan Rubin
Fax: 617 559-7400
19. DISPUTE RESOLUTION
All disputes
with respect to any Purchase Order or this Agreement shall be
resolved as set forth in Attachment F.
20. [Reserved]
21. MARKETING AUTHORITY
a. Seller hereby
grants to Buyer and its distributors, subdistributors,
field organization and channel partners:
(1) the exclusive, perpetual,
irrevocable, royalty-free right to promote,
sell, resell, license, sub-license,
distribute and service the Products listed
as "Exclusive Products" on Attachment
A and purchased from Seller on a world-wide
basis; (2) the non-exclusive,
perpetual, irrevocable, royalty-free right
to promote, sell, resell, license,
sub-license, distribute and service the
Products listed as "non-US Products" on
Attachment A and purchased from Seller on a
world-wide basis (except for the
United States) solely to Buyer customers
outside of United States who have
purchased BIS/EEG Modules or BISx Systems
from Buyer; and (3) the non-exclusive,
perpetual, irrevocable, royalty-free right
to promote, sell, resell, license,
sub-license, distribute and service all
other Products purchased from Seller on
a world-wide basis. The Products may be
promoted, sold, resold, licensed,
sublicensed and distributed by Buyer
directly and/or indirectly through its
distributors, subdistributors, field
organization and channel partners, and may
be used as components in, or be
incorporated into, or integrated with, systems
and products of Buyer, which Buyer, its
distributors, sub-distributors, field
organization and/or channel partners sell
or lease to third party users in the
regular course of business. The provisions
of this Section 21(a) will survive
any change in control of Seller and Seller
agrees that, if it sells all or
substantially all of the assets relating to
the business that produces the
Products, it will require that the
purchaser of the assets agrees to assume this
Agreement as well.
b. General. The
components of the Buyer BIS/EEG Module or BISx Systems
shall only be resold, leased, rented,
licensed or otherwise transferred to third
parties for use as a part of a Buyer
BIS/EEG Module or BISx System or as
replacement parts used in Buyer BIS/EEG
Modules or BISx Systems and Buyer shall
only sell Seller approved accessories
including cables and sensor products in
connection with any Buyer BIS/EEG Module or
BISx System. During the term of this
Agreement, Buyer agrees that it may offer
complementary but not directly
competitive products to the Buyer BIS/EEG
Module and BISx System, with the
exception of Buyer's Entropy module. Buyer
products other than the Buyer BIS/EEG
Module, BISx System,
<PAGE>
-19-
and the Entropy module that display a
parameter claiming to be a measure of the
hypnotic effect of anesthesia and sedation
are considered to be directly
competitive products for purposes of this
Section, provided that such
obligations of Buyer shall terminate in the
event Seller's Products do not have
material competitive features for measuring
the hypnotic effects of anesthetic
and sedative agents on the brain and Seller
does not incorporate such features
into the Products within six (6) months of
receipt of notice of such deficiency.
c. Seller shall
not directly or indirectly provide the Products listed as
"Exclusive Products" on Attachment A to any
third party during the Term or
thereafter, unless requested to do so in
writing by Buyer.
d. Exclusivity.
Except to the extent Buyer and Seller may agree in the
future to undertake co-marketing programs,
Seller shall not, directly or
indirectly, sell, distribute or license to
any third party the Buyer BIS/EEG
Module, the Buyer BIS/EEG Engine, the Buyer
BISx Systems or the Custom Sensor.
It is understood, however, that Seller
sells, distributes, and licenses to other
third parties both generic and customized
BIS/EEG engines, BIS/EEG module kits
and BISx systems to meet the needs of other
OEM customers, and nothing in this
Agreement shall prohibit Seller from
continuing to sell, distribute, or license
these products or components thereof to
customers other than Buyer.
e. Buyer shall
not disclose, furnish, transfer, distribute or otherwise
make available the SST or any portion
thereof in any form to any third party
(other than making the use of the SST
available to purchasers of Custom Sensors
and to Buyer's distributors,
sub-distributors, field organizations, channel
partners and Affiliates that are
distributing the Custom Sensors) and shall not
use the SST or any part thereof (other than
for Buyer's internal use), except as
permitted under Section 23. Title to and
ownership of any and all proprietary
rights in or related to the SST shall at
all times remain with Seller and/or its
licensor(s). Nothing in this Agreement
shall be construed as a sale of any
rights in the SST. All references in this
Agreement to sale, resale or purchase
of the Products or the components thereof,
or references or like effect, shall,
with respect to the SST mean licenses or
sublicenses of the SST.
f. Recognizing
that the Buyer has a product that is competitive to BIS,
Buyer agrees to devote "reasonable sales
and marketing efforts" to support the
Buyer BIS/EEG Module and the BISx Systems.
"Reasonable sales and marketing
efforts" shall mean:
i. Buyer communicating to
Buyer's Monitoring Solutions GMs in the
respective pole organizations the fact that Buyer has
alternative
product offerings for patient consciousness monitoring, with a
reasonably detailed description of the features, benefits and
customer
support available for each product;
ii. Buyer communicating to Buyer's
Monitoring Solutions GMs in the
respective pole organizations, first, that customers interested
in
consciousness monitoring should be informed that Buyer has two
technologies (BIS and Entropy modules) that are
<PAGE>
-20-
available to meet their needs, and second, that sales
representatives,
distributors, and dealers should permit customers to choose
freely
between these alternative solutions;
iii. In the
event that Buyer elects to display or otherwise advertise the
availability of the Entropy module at any of the following
meetings:
the annual meetings of the American Society of Anesthesiologists,
the
European Society of Anesthesiologists, the Japanese Society of
Anesthesiologists, and the World Congress, Buyer agrees to
utilize
commercially reasonable efforts within the context of a complex
worldwide organization to display or otherwise advertise the
availability of Buyer BIS monitoring solutions for Buyer
customers;
iv. Buyer's customers interested in
BIS technology shall be provided a
fair representation of the features, benefits and customer
support
available with BIS;
v. Buyer BIS/EEG Modules and BISx
Systems will be available to Buyer's
sales representatives, dealers and distributors on the same basis
that
Buyer provides demonstration equipment of its Entropy module;
vi. if a Buyer customer requests BIS,
Buyer will submit the quote for the
Buyer BIS/EEG Module or BISx System within the normal Buyer
turnaround
time;
vii. all of
Buyer's customer requests for BIS and BIS product support will
be fulfilled within the normal Buyer turnaround time; and
viii. any other
matters agreed to in writing by the agreement managers.
Seller agrees that its direct and indirect
customers shall not be provided
unfair representations of the features,
benefits and customer support available
for Entropy.
Any failure of either party to comply with
these provisions will be escalated to
the agreement managers and discussed at the
next quarterly meeting.
g. The Products
shall be packed, marked and labeled by Seller in accordance
with the reasonable instructions given by
Buyer. In case no instructions have
been given, the Products shall be packed
with due care to avoid damages during
shipment. If any Products (or component)
that is marked with Buyer's or its
Affiliate's name, product numbers,
trademark, or other identifiers are rejected
or otherwise returned to Seller, Seller
shall remove such trademarks or
identifiers (unless such Products are being
repaired in accordance with this
Agreement), even if the removal would
require destruction of the Product.
22. TRADEMARKS
a. Ownership.
Buyer acknowledges and agrees that Seller is the sole and
exclusive owner of all right, title and
interest in, or has valid licenses to
the trademarks (the "Seller's Trademarks")
identified on Attachment N (Seller's
Trademarks). Seller acknowledges and agrees
that Buyer is the sole and exclusive
owner of all right, title and interest in
and to the trademarks (the "Buyer's
Trademarks") identified on Attachment O
(Buyer's Trademarks). Each party
recognizes the value of the other party's
Trademarks and the good will
associated with the
<PAGE>
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other party's Trademarks. Buyer agrees that
its use of the Seller Trademarks and
any good will arising therefrom shall inure
to the benefit of Seller. Seller
agrees that its use of the Buyer's
Trademarks and any good will arising
therefrom shall inure to the benefit of
Buyer. Nothing contained herein shall
create, nor shall be construed as an
assignment of, any right, title or interest
in or to the Seller's Trademarks to Buyer,
or the Buyer's Trademarks to Seller,
other than the grant of the licenses in
Section 22 below; it being acknowledged
and agreed that all other right, title and
interest in and to the Seller's
Trademarks is expressly reserved by Seller
and its licensors, and all other
right, title and interest in and to the
Buyer's Trademarks is expressly reserved
by Buyer. Each party shall keep the other
party's Trademarks free from all
liens, mortgages or other encumbrances.
Each party agrees that it shall not
attack or otherwise challenge the title,
validity or any other rights of the
other party in or to its Trademarks.
b. License.
Subject to the restrictions set forth in this Section 22,
Seller hereby grants to Buyer and its
distributors, subdistributors, field
organization and channel partners the
nonexclusive, worldwide, royalty-free
license (without the right to sublicense)
to use Seller's Trademarks in
connection with the authority granted to
such parties in Section 21(a) and (f).
Subject to the restrictions set forth in
this Section 22, Buyer hereby grants to
Seller the nonexclusive, worldwide,
royalty-free license (without the right to
sublicense) to use Buyer's Trademarks in
connection with the manufacture and
packaging of the Custom Sensor in
accordance with the terms of this Agreement.
Neither party shall have any other right to
use, display or utilize the other
party's Trademarks for any other purpose or
in any other manner.
c. Termination.
In addition to the termination rights set forth in Section
16 hereof, in the event that either party
is in material breach of any provision
of this Section 22, the non-breaching party
may, upon thirty (30) days written
notice, terminate the license granted in
Section 22 (b) if the breaching party
does not cure such breach or default within
such thirty (30) day period. In
addition to the provisions of Section 16
hereof, upon termination of the license
granted in Section 22 (b), or upon
termination of this Agreement, for whatever
cause:
(i) each party shall immediately cease and desist from any further
use
of the other party's Trademarks and any
trademarks confusingly similar thereto,
either directly or indirectly;
(ii) All rights in the Seller's Trademarks granted to Buyer
hereunder
shall immediately revert to Seller, and all
rights in the Buyer's Trademarks
granted to Seller hereunder shall
immediately revert to Buyer;
(iii) In the event that this Agreement is terminated for any
reason
other than a material breach or material
default by Buyer, Buyer shall
thereafter have the right to dispose of all
of the unsold Products bearing the
Trademarks and advertising and promotional
materials
<PAGE>
-22-
relating thereto which had been completed
by it prior to such termination,
provided such Products and materials were
in the process of manufacture before
such termination.
d. Promotional
Claims. The general form of any promotional claims by Buyer
regarding Seller's Bispectral Index
technology and/or the integration of
Seller's Bispectral Index technology in
Buyer's Patient Monitors, and the
specific form of the use of Seller's trade
names and trademarks, and of intended
use claims regarding Buyer's Bispectral
Index technology, in promotional
material, advertisement, and/or in written
technical literature shall be subject
to review and approval by Seller prior to
is publication or display. The general
form of any promotional claims by Seller
regarding Buyer's Patient Monitors or
the integration of Seller's Bispectral
Index technology in Buyer's Patient
Modules, and the specific form of the use
of Buyer's trade names and Trademarks,
and of intended use claims regarding the
Products in promotional material,
advertisement, and/or in written technical
literature shall be subject to review
and approval by Buyer prior to its
publication or display.
23. PRODUCT DEVELOPMENT AND TECHNICAL
INFORMATION
a. Seller shall
provide Buyer with all information in its possession that
is necessary for the interfacing of the
Products with the Buyer BIS/EEG Modules
or Buyer's Patient Monitors.
b. Seller shall
keep Buyer informed of the manufacturer of the Sensor
Connectors and/or Cable Connectors used
with the Custom Sensor. Seller agrees
that Buyer may purchase the Sensor
Connectors and/or Cable Connectors directly
from the manufacturer. If the manufacturer
is not able to manufacture sufficient
quantities of connectors for Buyer using
the tooling and molds used for Seller's
requirements of connectors or if the
connectors are different than the
connectors sold for use with Seller's
products, Buyer may pay the manufacturer
to acquire additional tooling and molds to
manufacture the connectors for Buyer.
During the Term Seller hereby grants to
Buyer and its Affiliates a
non-exclusive, non-transferable (except as
provided in Section 26(c)),
irrevocable and royalty-free worldwide
license, without the right to sublicense,
for Buyer, its Affiliates, distributors,
sub-distributors, field organization
and channel partners to sell, market and
distribute Sensor Connectors and/or
Cable Connectors.
c. Upon
expiration of this Agreement or a termination for any reason
other
than on the grounds of an uncured breach or
failure by Buyer as provided in
Section 16, Seller hereby grants to Buyer,
its Affiliates, distributors or
sub-distributors a non-exclusive,
non-transferable (except as provided in
Section 26(c)), perpetual, irrevocable and
royalty-free worldwide license,
without the right to sublicense, to use the
SST solely for purposes of
manufacturing or having manufactured
sensors to be used to measure Buyer's
proprietary processed EEG parameter that
measures the hypnotic effects of
anesthetic and sedative agents on the brain
or interfacing such
<PAGE>
-23-
sensor to Buyer Patient Monitors and
distributing object code versions of the
SST for use with such sensor.
d. Further upon
termination or expiration of this Agreement, Seller hereby
grants to Buyer and its Affiliates a
non-exclusive, non-transferable (except as
provided in Section 26(c)), perpetual,
irrevocable and royalty-free worldwide
license, without the right to sublicense,
to manufacture, have manufactured or
purchase Sensor Connectors and/or Cable
Connectors and the right for Buyer, its
Affiliates, distributors, sub-distributors,
field organization and channel
partners the right to sell, market and
distribute these products.
Any equipment and tools provided or paid
for by Buyer and used in the
manufacture of the Products shall remain
the property of Buyer. Such equipment
or any equipment which Buyer has designed
or which has been designed for Buyer
for its purposes and paid for by Buyer, may
not be used for the manufacture of
any other products supplied to anyone but
Buyer. Seller shall store such
equipment and tools and mark them as
Buyer's property.
e. Future
Products. The Products are designed for use in measuring the
effects of anesthetic and sedative agents
on the brain. In the event that Seller
develops a product involving this or a
different type of index, patient sensor,
or application for which Seller has not
granted any third party exclusive
rights, Seller and Buyer agree to discuss
in good faith adding new product to
this Agreement for the purchase of such new
product or products by Buyer.
f. Seller shall
provide reasonable engineering support to Buyer free of
charge. If Buyer requests engineering
support that exceeds a reasonable amount,
the parties will mutually agree on possible
reimbursement for Seller.
g. For a period
of ten (10) years following the last delivery to Buyer of
the applicable Product ordered hereunder,
Seller shall make available repair
services (or at Seller's sole discretion,
exchange units for the Products) for
purchase by Buyer and end users of the
Products at Seller's then-current list
prices for such repair services and
exchange units.
h. Seller shall
maintain a complete record of all repair activities
performed on any Products received for
repair, and shall provide Buyer with a
quarterly report on all service actions
including failure and repair statistics
at a sub-assembly level. Root cause
analysis is to be performed and reported by
Seller to Buyer in the case of abnormal
failures, incidents and malfunctions.
24. PRODUCT COMPLAINTS, EVENT REPORTING AND
FIELD RECALLS
a. Product
Complaints. Buyer shall be responsible for resolving all
product
complaints relating to the Custom Sensors
using Buyer's existing product
complaint policies and
<PAGE>
-24-
procedures. Both parties shall cooperate
and work together to resolve all
product complaints relating to the other
Products sold to Buyer. Closure of any
product complaint relating to the other
Products will occur when Buyer notifies
Seller that the complaint is resolved. Each
party shall promptly inform the
other in writing of any product complaints
and shall keep the other party
advised of their progress in resolving such
complaints and any and all steps
taken to resolve such complaints. Within
one week of the resolution of a product
complaint, the party responsible for
resolving such complaint shall supply the
other with a written report summarizing the
root cause and any corrective
actions required.
b. Duty to
Report Incidents. Buyer and Seller shall inform each other in
writing, within two (2) business days of
becoming aware of a reportable event,
in accordance with FDA Medical Device
Reporting regulation (21 CFR Part 803) or
the European Medical Device Vigilance
regulations or that must be registered
according to other national regulations
such as Canadian medical devices
regulations (SOR/98-282), including without
limitation incidents involving death
or serious injury, malfunctions that, if
recurrent, may cause or contribute to
death or serious injury or other material
quality problems or concerns, of all
incidents relating to the subject matter of
the Agreement. Buyer will be
responsible for reporting such incidents to
the appropriate regulatory authority
for the Custom Sensors. Seller will be
responsible for reporting such incidents
to the appropriate regulatory authority for
all other Products. Both parties
shall fully cooperate with each other as
may be necessary to comply with any
reporting obligations regarding such
incidents or quality concerns. If FDA or
other authorities contact either party to
inquire about or investigate the
Products sold to Buyer under this
Agreement, the contacted party, unless
required to maintain confidentiality by
such authorities, shall inform the other
party immediately thereof. The parties
shall cooperate closely to clear any
regulatory issues or potential regulatory
issues promptly.
c. Recalls. In
the event that a corrective action (including notifications
or recalls) is required with respect to any
Product, and such action (i) is
required by Seller to comply with
applicable laws or regulations, (ii) is
determined by Seller in its discretion for
a reasonable business purpose or for
safety reasons or (iii) is the result of
Seller's failure to supply Products
that conform in all material respects to
the applicable standards, Seller shall
be responsible for the repair or
replacement of the Products without cost to
Buyer, its Affiliates, distributors and
sub-distributors. Seller agrees to
consult with Buyer to establish a
reasonable process for managing the corrective
action and Seller shall be responsible for
all reasonable out-of-pocket
expenditure (including shipping and labor
costs) incurred by Buyer, its
Affiliates, distributors and
subdistributors if Seller fails to take such
action. In the event that Seller is
required to take such action to comply with
applicable laws or regulations or such
action is reasonably necessary for safety
and efficacy reasons and for the failure of
the Products to comply with
specifications (other than a minor
deviation from such specifications) and fails
to do so, Buyer shall have the right to
take such action and Seller shall
reimburse Buyer for all reasonable
out-of-pocket expenditures (including
shipping and labor costs) incurred in
connection with such action by Buyer. If
it is determined by an arbitrator that such
action was not necessary for safety
and
<PAGE>
-25-
efficacy reasons and for the failure of the
Products to comply with
specifications (other than a minor
deviation from such specifications), Buyer
shall return any amounts paid to Buyer by
Seller in connection with such action.
d. Record
Retention/Maintenance. Seller shall maintain serial and/or lot
number and date of shipment records for
each Product and Buyer shall maintain
serial and/or lot number and date of
shipment records for each Product so that,
if necessary for tracing or recall
purposes, the manufacturing and delivery of
the Products can be identified. Each party
shall give its assistance to the
other party in tracing or recall situations
by making the records available.
Each party shall promptly make such records
available to the other party if any
authority in any country requests such
records from such party. Each party shall
be responsible for record keeping under any
and all medical device reporting
regulations such as (US) 21 CFR Part 803,
(European Union) MDD regulations and
under the record keeping requirements of
any other country as may be applicable
and shall retain quality records for at
least seven (7) years from the date of
the last shipment of the applicable
Product.
e. Regulatory
Agency Inquiries. If the FDA or any other regulatory body
with authority over medical devices
provides written notice to either party to
inquire about or investigate any Product
sold to the Buyer, the party notified
shall use its best efforts to give notice
thereof to the other party within two
(2) business days of receipt of such
contact from the FDA or other body.
f. Survival. All
subsections of this Section 24 shall survive term