Pre-Effective Amendment to Registration Statement (General Form) — Form S-1
Filing Table of Contents
Document/Exhibit Description Pages Size
1: S-1/A Amendment No.1 to Form S-1 110 528K
2: EX-10.1 Material Contract 25 87K
5: EX-10.10 Material Contract 22 77K
6: EX-10.11 Material Contract 2± 9K
3: EX-10.2 Material Contract 52 103K
4: EX-10.3 Material Contract 31 101K
7: EX-23.2 Consent of Experts or Counsel 1 5K
8: EX-23.3 Consent of Experts or Counsel 1 6K
EXHIBIT 10.3
PURCHASING AND LICENSING AGREEMENT, DATED APRIL 17, 1997, BETWEEN ZOLL MEDICAL
CORPORATION AND MASIMO CORPORATION.
CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE
BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
PURCHASING AND LICENSING AGREEMENT
BETWEEN
ZOLL MEDICAL CORPORATION
AND
MASIMO CORPORATION
DATED: APRIL 17,1997
EXHIBITS
Exhibit A. MASIMO SET(R) Definition
Exhibit B. Licensed Trademark
Exhibit C. List of Patents and Patent Applications
Exhibit D. Price of Products
Exhibit E. ZOLL Product Line
Exhibit F. Form of Purchase Order
Exhibit G. Specifications for Products
Exhibit H. End-User License Agreement
Exhibit I. Zoll Distributors
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PURCHASING AND LICENSING AGREEMENT
THIS PURCHASING AND LICENSING AGREEMENT ("Agreement") is made and entered
into as of this 17th day of April, 1997 by and between ZOLL Medical Corporation,
a Massachusetts corporation ("ZOLL"), and MASIMO CORPORATION, a Delaware
corporation ("MASIMO"), with reference to the following:
R E C I T A L S
A. MASIMO has developed a new technology known as Signal Extraction
Technology ("MASIMO SET" as defined in Exhibit A) MASIMO SET(R) incorporates
circuitry and software which, among other things, acquires and detects signals
generated by red and infrared LEDs, and which is designed to extract oxygen
saturation and pulse rate values from such signals.
B. ZOLL is engaged in the design, development and manufacturing of medical
equipment and desires to incorporate MASIMO SET for SpO2 into its medical
equipment for distribution by ZOLL throughout the world.
C. MASIMO has acquired substantial Know-How (as defined below) in
extracting signals from signals contaminated by noise.
D. MASIMO and ZOLL have acquired and expect to continue to acquire a
reputation for excellence, and their trademarks have and will continue to
acquire valuable goodwill.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
hereinafter set forth, ZOLL and MASIMO hereby agree as follows:
1. DEFINITIONS. As used in this Agreement, the following terms, whether
used in the singular or the plural shall have the following meaning:
1.1 Accessory means cables (including, but not limited to the MASIMO
PC08 and PC 12 8 ft. and 12 ft. patient cables) or any other accessory
manufactured by MASIMO and used with any of the SpO, Sensors or Licensed
Devices.
1.2 Improvement means any invention, adaptation, modification or
change made to the MASIMO Technology.
1.3 Licensed Devices means ZOLL's products incorporating MASIMO SET
whether made in circuit board, software or integrated circuit form for
SP02 Measurements. Licensed Devices shall not include ZOLL products which
include any methods other than MASIMO SET for calculating arterial blood
oxygen saturation. Licensed Devices specifically excludes all Fetal
Oximetry applications and venous oxygen saturation applications.
1.4 Licensed Reviver Devices means ZOLL's line of
pacemaker/defibrillator/patient monitor products designated ZOLL's Reviver
(and related platform derivatives), incorporating MASIMO SET whether made
in circuit board, software or integrated circuit form for SpO2,
Measurements. The Licensed Reviver Device is only one of a series of
devices within ZOLL's Reviver series. Licensed Reviver Devices shall not
include ZOLL products which include any methods other than MASIMO SET for
calculating arterial blood oxygen saturation.
1.5 Licensed Trademark means the MASIMO SET product designation set
forth on Exhibit B to this Agreement.
1.6 MASIMO confidential Information means information and
proprietary materials designated by MASIMO as Confidential Information and
which ZOLL may obtain as a result of MASIMO's relationship with ZOLL or
access to MASIMO's premises. Confidential Information includes, but is not
limited to, the following types of information and other information of a
similar nature: ideas, concepts,
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materials, techniques, models, data, designs, documentation, flow charts,
budgets, projections, forecasts, marketing, manufacturing and development
plans, the Masimo Technology, the Software, MASIMO's communication protocols,
and MASIMO's testing procedures.
1.7 MASIMO Products means SpO(sub 2), Sensors, Accessories and MS-1
Boards.
1.8 MASIMO Technology means technical information, inventions,
products, components, concepts, trade secrets, know-how, techniques, designs,
processes, communications protocols, the Software, whether patentable or not
patent applications, copyright applications, the Patent Rights, and copyrights
and all other intellectual property rights owned by MASIMO and relating to
MASIMO SET alone or incorporated in MS-1 Boards, SpO(sub 2), Sensors,
Improvements and related documentation generated prior to or pursuant to this
Agreement.
1.9 MS-1 Boards means MASIMO's standard circuit board or chip set
(manufactured now or in the future) which contains MASIMO SET and algorithms
necessary to process the information transmitted from the SpO(sub 2), Sensor
and convert it into SpO(sub 2) Measurements.
1.10 Panel has the meaning set forth in Section 3.10 ("Excuses from
Integration Commitment").
1.11 Party means ZOLL or MASIMO; Parties means ZOLL and MASIMO.
1.12 Patent Rights means all patents owned by MASIMO on technology
developed by MASIMO which cover the SpO(sub 2), Measurement in the Licensed
Devices. The present patent numbers and patent application are set forth on
Exhibit C to this Agreement.
1.13 Purchase Orders has the meaning set forth in Section 4.1
("Purchase Orders").
1.14 Software means any and all computer/instrument software and/or
firmware developed by MASIMO that is used or useful in connection with MASIMO
Technology.
1.15 SpO(sub 2), Measurements means noninvasive measurement of arterial
oxygen saturation (accounting for Hb and HbO(sub 2), only) and pulse rate from
neonate, pediatric and adult subjects (excludes fetal measurement and venous
oxygen saturation).
1.16 SpO(sub 2), Sensor means reusable and disposable MASIMO adult,
pediatric or neonatal probes which together with the accessories and when
affixed to a human subject projects light on one side of the tissue and
detects the specific emitted light on the opposite side of the tissue
(transluminance) or on the same side of the tissue (reflectance) and transmits
this data to the MS-1 Board or any other pulse oximetry board supplied by
MASIMO for processing and display. SpO(sub 2), Sensors currently manufactured
by MASIMO have the following model numbers:
LNOP(R) o Neo-Pt; Disposable Neonatal Sensor (Pre-Term)
LNOP(R) o Neo; Disposable Neonatal Sensor
LNOP(R) o Adt; Disposable Adult Sensor
LNOP(R) o Pdt Pediatric/Slender Digit Sensor
LNOP(R) o DC1; Reusable Adult/Pediatric Digit Clip Sensor
MASIMO intends to produce additional standard models of the SpO(sub 2), Sensors.
As MASIMO produces such additional models, the Parties agree to negotiate in
good faith their inclusion in this agreement. While this Agreement is in effect,
ZOLL shall have the right to purchase any such additional standard models of
SpO(sub 2), Sensors on the same material terms contained in this Agreement.
1.17 ZOLL Confidential Information means information and proprietary
material designated by ZOLL as Confidential Information and which MASIMO may
obtain as a result of MASIMO's
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relationship with ZOLL or access to its premises. Confidential Information
includes, but is not limited to, the following types of information and other
information of a similar nature: ideas, concepts, materials, techniques, models,
data, designs, documentation, flow charts, budgets, projections, forecasts,
marketing and development plans, distributors lists and sales reports.
1.18 ZOLL Subsidiary means any majority owned subsidiary of ZOLL or any
of ZOLL's wholly owned subsidiaries.
2. LICENSES GRANTED
2.1 Licenses Granted to Licensee.
2.1.1 MASIMO grants to ZOLL a personal, non-transferable, and
non-exclusive worldwide license to incorporate the MS-1 Boards into the
Licensed Devices, to demonstrate Licensed Devices, and to distribute
Licensed Devices to (i) end user customers (not to an OEM or other medical
equipment manufacturer) and (ii) ZOLL distributors and other medical
equipment manufacturers specifically set forth on Exhibit I. This license
includes the right of ZOLL to have the Licensed Devices manufactured by a
third party for ZOLL; however, such Licensed Devices may only be supplied
to the marketplace with ZOLL's or ZOLL's and ZOLL's distributors' private
label and logo exclusively and distributed exclusively through ZOLL
distribution channels. Nothing in this Agreement shall be construed to
grant any rights to ZOLL in fetal oximetry, venous oximetry or any other
application of MASIMO SET other than the use of the Licensed Devices to
make SpO(sub2), Measurements as defined in 1.15, and nothing in this
Agreement shall be construed to grant any rights to Zoll to distribute or
otherwise market MS-1 Boards separate from Licensed Devices.
2.1.2 Zoll may add distributors to Exhibit I, and agrees to promptly
notify MASIMO of such additions. Notwithstanding the above, ZOLL may not
distribute or otherwise sell Licensed Devices to [*] or [*] without the
prior written consent of MASIMO.
2.1.3 ZOLL agrees that it will not reproduce or disclose to any
third party any portion of the Software and that it may transfer the
Software only in conjunction with a transfer of a Licensed Device to end
users and distributors listed on Exhibit I. ZOLL agrees to include the
terms of the End-User License Agreement attached as Exhibit H in
documentation shipped with the Licensed Devices.
2.1.4 MASIMO retains all rights, title, and interest in the Software
and in all patents, copyright, trade secret, and any other intellectual
property and proprietary rights applicable to the Masimo Technology.
Nothing in this Agreement should be construed as a sale of the Software or
any copy of the Software.
2.1.5 ZOLL agrees that the Masimo Technology contains trade secrets
and proprietary information belonging to MASIMO. ZOLL agrees to maintain
the confidential nature of such trade secrets and proprietary information
and agrees not to use, print, copy, provide, or otherwise make available,
in whole or in part, any portion of the Software except in accordance with
this Agreement. ZOLL will not be provided access to source code for MASIMO
SET. ZOLL agrees not to attempt to decipher, decompile, or modify the
Software or develop source code for the Software or allow others to do so.
2.1.6 No Implied License. ZOLL agrees to include the following
legend in the users manual for Licensed Devices:
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express
or implied license to use the device with replacement parts which
would, alone, or in combination with this device, fall within the
scope of one or more of the patents relating to this device.
* Confidential material redacted and filed separately with the Commission.
3
2.2 Limitation of Licenses Granted
2.2.1 No license is granted under this Agreement with respect to the
MS-1 Boards other than as integrated parts of the Licensed Devices. ZOLL shall
not have the right to manufacture MS-1 Boards or SpO(sub2), Sensors or any
circuity or software that performs the functions of the MS-1 Boards for the
Licensed Devices.
2.2.2 Except for a license to end users and distributors on Exhibit I,
no right to grant sublicenses is granted under this Agreement.
2.3 Use of Licensed Trademark.
2.3.1 Grant by Masimo. MASIMO hereby grants to ZOLL a non-exclusive
license to use the Licensed Trademarks with the Licensed Devices for
identification purpose and for publicity and promotional purposes when it is
advertising one of its Licensed Devices.
2.3.2 Quality Control. In order for ZOLL to maintain its trademark
license hereunder, ZOLL agrees that the Licensed Devices bearing the Licensed
Trademark shall be of a high standard of quality, at least as high as ZOLL's
historical products, so as to protect and enhance the goodwill pertaining to
the MS-1 Boards and SpO(sub2) Sensors. MASIMO has the right to inspect, at its
own expense, the manufacturing points of ZOLL for the Licensed Devices, at any
reasonable time, to ensure the ongoing quality of the Licensed Devices. Should
MASIMO at any time determine that the quality of any Licensed Device does not
adhere to the quality standards set forth in the first section of this Section
2.3.2. MASIMO will provide written notice to ZOLL. ZOLL shall have three
months from such notice to bring the quality of such Licensed Device up to
standard or to cease any further use of the Licensed Trademark in connection
with the promotion or sale of such Licensed Device until MASIMO has indicated
that it is satisfied that the deficiencies in quality of the Licensed Device
have been corrected.
2.3.3 Trademark Marking. ZOLL agrees that it shall use the MASIMO
Product Designation as set forth in Exhibit B on all Licensed Devices. This
obligation shall be excused for any period for which Masimo has indicated to
ZOLL that ZOLL has failed to comply with the quality standards set forth in
Section 2.3.2. ZOLL shall place the Product Designation of Exhibit B on or
near the sensor interface (connector), in a space no smaller than 1/2" x 1/4"
so long as it is in a plainly visible site.
2.3.4 Advertising. All advertising for Licensed Devices must include one
or more of the Licensed Trademarks. ZOLL shall accurately reproduce the
Licensed Trademark, and shall refrain from inappropriate or inaccurate claims
about Masimo SET, and improper trademark usage as defined in Sections 2.3.5
and 2.3.6.
2.3.5 The Licensed Trademarks may not be used on or in reference to any
products other than the family of Licensed Devices.
2.3.6 The trade names, trademarks, or symbols of one party may not be
used in any way which may suggest that one party is a division, affiliate, or
subsidiary of the other party or of a third party.
2.3.7 ZOLL acknowledges the validity and exclusive ownership of the
Licensed Trademark by MASIMO. ZOLL agrees not to use the Licensed Trademark in
any way which might endanger MASIMO's rights in and ownership of the Licensed
Trademark.
2.3.8 The expense of obtaining and maintaining Licensed Trademark
registrations shall be borne by MASIMO.
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2.3.9 Patent Marking. ZOLL agrees to mark each Licensed Device
manufactured or sold by it in accordance with the patent marking shown
in Exhibit B. MASIMO will, from time to time, update the patent marking
for ZOLL as patents issue. Provided, however, ZOLL's obligation to
update its product marking shall not exceed once every two years and
shall never exceed six MASIMO, patents. Initial Patent marking is shown
in Exhibit B.
3. ZOLL COMMITMENTS/LICENSE FEE
3.1 ZOLL agrees to purchase all SpO(sub 2) Sensors from MASIMO.
3.2 Best Efforts. ZOLL agrees to use its best efforts to make MASIMO SET
its primary pulse oximetry technology, including, but not limited to by
integrating SET into its products for SpO(sub 2), Measurement and by promoting
the sale of such Licensed Devices over devices which do not incorporate MASIMO,
SET. MASIMO expressly acknowledges and agrees that ZOLL intends, and shall have
the right, to incorporate products from manufacturers of pulse oximetry products
other than MASIMO.
3.3 Product Lines. Set forth on Exhibit E hereto are ZOLL's current
product lines (Licensed Devices) into which the MASIMO SET or MS-1 Boards will
be integrated together with the corresponding projected market release dates. In
the event ZOLL elects to integrate the MS-1 Boards into additional Licensed
Devices, at least ninety (90) days prior to the projected launch date of any
such product into which the MS-1 Boards are being integrated, ZOLL agrees to
inform MASIMO of its intent to integrate it into the product together with a
description and model number of the product. ZOLL agrees to provide MASIMO with
all customer product literature and published technical specifications on each
unit into which the MS-1 Boards are integrated.
3.4 Delivery of ZOLL Systems to MASIMO. ZOLL agrees to deliver free of
charge, one (1) complete prototype system to MASIMO which demonstrates the final
integration of the MS-1 Board into each ZOLL product line. In order to ensure
the quality of the Licensed Devices, MASIMO will have the right to test and make
recommendations for improvements to the Licensed Devices, at its own expense,
for compliance with the specifications of Exhibit G. After such testing, the
Licensed Device shall remain with MASIMO for further technical assistance and as
a demonstration unit. Title to this system shall remain vested in ZOLL.
3.5 License Fee. As additional consideration for the license granted to
ZOLL hereunder, ZOLL shall pay a license fee to MASIMO in the amount of [*],
payable upon execution of this Agreement.
3.6 Integration Commitment. ZOLL agrees that throughout the term of this
Agreement, ZOLL will adopt MASIMO SET as the primary pulse oximetry technology
in its Licensed Reviver Devices, and agrees to an integration plan such that, at
a minimum, Licensed Reviver Devices exclusively containing MASIMO SET for blood
oxygen saturation calculation will constitute eighty percent (80%) of ZOLL's
annual shipments of products within ZOLL's entire Reviver series of products
which incorporate SpO(sub 2), Measurement. The foregoing commitment is subject
to the continuing viability of MASIMO SET technology as determined pursuant to
Section 3.10 excuses from ("Integration Commitment") below.
3.7 Quarterly Accounting. In order to insure compliance with the
integration commitment as specified in Section 3.6 ("Integration Commitment")
above, ZOLL agrees to provide MASIMO with a Quarterly Accounting of total pulse
oximetry product shipments and its shipments containing MASIMO MS-1 Boards.
3.8 LIQUIDATED DAMAGES. IF ZOLL SHOULD FAIL TO MEET THE INTEGRATION
CONDITIONS AS SPECIFIED IN 3.6 ABOVE, ZOLL AND MASIMO AGREE THAT THE AMOUNT OF
DAMAGES WHICH MASIMO WILL SUFFER WILL BE EXTREMELY DIFFICULT AND IMPRACTICAL TO
ASCERTAIN, THEREFORE, IF ZOLL SHALL FAIL TO MEET
* Confidential material redacted and filed separately with the Commission.
5
THE INTEGRATION COMMITMENT AS SPECIFIED IN 3.6 ABOVE, AND SUCH FAILURE IS NOT
EXCUSED PURSUANT TO THE TERMS OF SECTION 3.10 ("EXCUSES FROM INTEGRATION
COMMITMENT"). BELOW, MASIMO'S SOLE AND EXCLUSIVE REMEDY FOR SUCH DEFAULT BY
ZOLL SHALL BE THE PAYMENT BY ZOLL TO MASIMO OF [*] (THE "PAYMENT") AT THE END
OF EACH YEAR IN WHICH IT FAILS TO MEET ITS INTEGRATION COMMITMENT WHILE THIS
AGREEMENT IS IN EFFECT; PROVIDED THAT TOTAL PAYMENTS TO MASIMO PURSUANT TO
THIS LIQUIDATED DAMAGES PROVISION SHALL NOT EXCEED [*]. TO FURTHER EVIDENCE
THAT THIS IS AN APPROPRIATE CASE FOR LIQUIDATED DAMAGES TO SELLER AND THAT THE
SUM SET FORTH HEREIN IS A REASONABLE ESTIMATE OF MASIMO'S DAMAGES, MASIMO AND
ZOLL HAVE SET FORTH THEIR INITIALS TO THIS PARAGRAPH.
/s/ DRB /s/ JEK
--------- ----------
ZOLL MASIMO
3.9 Audit Rights. MASIMO shall have the right to verify, at its expense,
and not more frequently than once per year and upon not less than ten (10)
business days prior written notice to ZOLL, the accuracy of the accounting
reports provided by ZOLL hereunder, through inspection of ZOLL's pertinent
records and books of accounts maintained in the ordinary course of business.
Such audit shall be conducted by a certified public accountant (the "CPA")
chosen by MASIMO in it reasonable discretion, and which CPA is reasonably
acceptable to ZOLL. MASIMO shall pay all costs, expenses and fees of the CPA
unless (i) ZOLL has overstated its integration commitment as set forth in
Section 3.6 by more than 10% and (ii) the corrected level of integration as
described in Section 3.6 ("Integration Commitment") above is less than eighty
percent (80%) for the entire annual period audited, in which event the CPA's
costs, fees and expenses shall be paid by ZOLL.
3.10 Excuses from Integration Commitment and Best Efforts. ZOLL will be
excused from its commitment set forth in Section 3.6 ("Integration Commitment")
and Section 3.2 ("Best Efforts"), if any of the following events occurs:
3.10.1 [*]
3.10.2 [*]
3.10.3 MASIMO is prevented from delivering MASIMO Products or ZOLL
is unable to ship Licensed Devices due to regulatory restrictions placed
upon MASIMO or the MASIMO Products; or
3.10.4 MASIMO breaches any material term of this Agreement with
respect to the MASIMO Products; or
3.10.5 Masimo fails to deliver Exhibit G compliant MASIMO Products
according to the schedule stated in purchase orders accepted by Masimo,
and as a Result ZOLL is unable to meet its commitments to deliver
Licensed Devices or SpO(sub 2) Sensors to its customers for a period of
45 days or more.
Upon the occurrence of any of the foregoing events, ZOLL's obligations pursuant
to Section 3.6 ("Integration Commitment") and Section 3.2 ("Best Efforts") shall
be excused for the duration of such foregoing event plus six (6) months, and
MASIMO shall not be entitled to any liquidated damage or other penalty for
ZOLL's failure to meet its commitment as set forth in Section 3.6 ("Integration
Commitment") during such period. Whether one of the events of Section 3.10.1
or 3.10.2 has occurred, shall be
* Confidential material redacted and filed separately with the Commission.
6
determined by an independent three (3) member clinical evaluation panel (the
"Panel"). Each party shall select one member of the Panel, and the two Panel
members shall select a third member. No panel member may be an employee,
officer, director, or owner of five percent (5%) or more of the shares of either
Party, or related to any employee, officer, director or owner of five percent
(5%) or more of the shares of either Party, or otherwise affiliate with either
party such that such affiliation would tend to influence such persons ability to
independently evaluate the foregoing events.
4. PURCHASE AND SALE
4.1 Purchase Orders. During the term of this Agreement and in accordance
with its provisions, the purchase and sale of MASIMO Products between the
Parties shall be made by means of purchase orders placed by ZOLL or its designee
to MASIMO ("Purchase Orders"). Except for the initial Purchase Order, the
minimum quantity of MASIMO Products that may be purchased on a Purchase Order is
50 units of a cable-part number (e.g., PC08) or a reusable sensor (e.g.,
LNOP-DC1) or MS-1 Boards or 200 units of a disposable sensor (e.g., LNOP-Neo).
Purchase Orders and change orders may be placed by facsimile or mail. A Purchase
Order may provide for delivery for a period of up to ninety (90) days following
normal expiration of this Agreement and all terms and conditions of this
Agreement shall govern. No Purchase Order must be accepted by MASIMO after the
expiration or the termination of this Agreement. Any Purchase Order issued, or
to be issued, for any firm commitment or purchase hereunder shall be
non-cancelable, and ZOLL shall be responsible for taking deliveries of and
paying for all MASIMO Products set forth in such Purchase Order.
4.2 Confirmation. MASIMO will notify ZOLL of receipt of Purchase Orders
within five (5) working days after receipt of ZOLL's Purchase Orders.
Confirmation of receipt and acceptance by MASIMO may be by facsimile or mail.
4.3 Contents. All Purchase Orders submitted by ZOLL shall state the
following: (i) price, (ii) the quantities ordered, (iii) the requested delivery
dates, (iv) destination, (v) requested method of shipment, and (vi) model or
number of the MASIMO Products in accordance with the terms and conditions
hereof, ZOLL shall use the form of Purchase Order attached hereto as Exhibit F.
Any language on the Purchase Order of ZOLL or acknowledging form of MASIMO which
is inconsistent with any term or provision hereof shall be void and without any
force or effect.
4.4 Initial Commitment. The first Purchase Order submitted by ZOLL will
include a non-binding forecast for 180 days, in addition to ZOLL's first firm
order, with shipments contemplated to begin on November 1, 1997.
4.5 Ongoing Purchase Orders. After the initial Purchase Order ZOLL's
Purchase Orders issued as needed to MASIMO calling for delivery in ninety (90)
days or less are non-cancelable. Purchase Orders to MASIMO calling for delivery
in more than 90 days shall be alterable and cancelable by ZOLL up until ninety
days prior to the shipment date, after which such Purchase Orders become
binding.
4.6 Emergency Orders. Any Purchase Orders placed by ZOLL calling for
delivery of MASIMO Products in less than ninety (90) days shall be considered
emergency Purchase Orders. MASIMO agrees to use reasonable efforts to deliver
such units of MASIMO Products on the requested schedule. MASIMO may require a
price modification for emergency orders.
5. PRICES AND PAYMENT
5.1 Price. MASIMO's transfer prices for the MASIMO Products delivered to
ZOLL in accordance with the terms of this Agreement shall be as set forth at
Exhibit D attached hereto. All prices are F.O.B. MASIMO's shipping dock and are
inclusive of each MS-1 Board, SpO(sub 2), Sensor or Accessory. Each SpO(sub 2),
Sensor is individually packaged and labeled per MASIMO guidelines with
ZOLL-supplied artwork and logos. Payment by ZOLL to MASIMO shall be made thirty
(30) days following receipt of invoice by ZOLL.
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5.2 Pricing Adjustments. MASIMO shall have the right to adjust prices for
the MS-1 Boards annually, provided that any annual price increase shall be
limited to the percentage increase in the prior year's U.S. Consumer Price
Index.
5.3 Currency Basis. Prices for the MASIMO Products to ZOLL shall be in
U.S. Dollars.
5.4 F.O.B. Point. Risk of loss for MS-1 Boards, SpO(sub 2), Sensors and
Accessories shall pass to ZOLL, F.O.B. MASIMO's manufacturing facility or
distribution point, as selected by MASIMO.
6. DELIVERY
6.1 Transportation. The method of transportation and carrier selected
shall be as specified by ZOLL in its Purchase Orders. Unless otherwise agreed,
all transportation charges, including insurance, shall be paid by ZOLL.
6.2 Packaging. MASIMO shall package the SpO(sub 2) Sensors, MS-1 Boards
and Accessories for shipment. Each shipment shall include a packing list
containing: (i) Purchase Order number, (ii) model number of the MASIMO Products,
(iii) quantity, (iv) serial number or date code of shipped products, and (v) the
results of applicable quality assurance and other tests performed with respect
to the MASIMO Products being shipped.
6.3 Delivery. MASIMO shall use best efforts to fill all Purchaser Orders
by delivery dates and in the quantities specified by ZOLL in its Purchase
Orders. If a Purchase Order by ZOLL calls for more than a 25% increase as
compared to the previous 3-month average of MASIMO Products ordered, on a
product-by-product basis, MASIMO shall use best efforts to deliver an amount at
least equal to the previous three month average within ninety (90) days, and
shall use best efforts to ship the remainder within 120 days of receipt of the
Purchase Order.
7. COMPATIBILITY
7.1 ZOLL agrees that its Licensed Devices will not be configured to
operate with oximetry sensors other than authorized Masimo SpO(sub 2) Sensors.
ZOLL agrees that it will not market Licensed Devices which operate with any
MASIMO probe except probes referenced in Section 1.16 hereof manufactured now or
in the future by MASIMO.
7.2 ZOLL agrees that it will not market oximetry instrument(s), or any
other device(s) or accessory(ies), except Licensed Devices, that operate with or
are compatible with any MASIMO SpO(sub 2) Sensors.
7.3 Future Upgrades. ZOLL agrees that by incorporating the MS-1 Board and
MASIMO SET into its Licensed Devices that it will not modify the functionality
of the MS-1 Board. ZOLL agrees that it will accept all future upgrades or
changes to products as long as (i) the upgrades or changes remain compatible
with previous versions in connections and functionality; (ii) the upgrade does
not increase the transfer price; (iii) such upgrades and changes do not result
in material degradation in performance or functionality of the MASIMO Products;
(iv) such upgrades and changes meet and continue to meet all applicable
regulatory requirements; and (v) such upgrades and changes are compatible with
ZOLL's current products.
7.4 MASIMO Probes. ZOLL agrees that the SpO(sub 2) Sensors are designed to
be used with the MS-1 Board only, and that if ZOLL uses sensors by other
manufacturers that the MS-1 Board may yield different results. MASIMO SET will
be enabled for SpO(sub 2) Sensors only. ZOLL agrees to use its best efforts to
provide that its customers not use SpO(sub 2) Sensors with non-MS-1 Boards. ZOLL
agrees not to configure any non-MS-1 Boards in order for them to be used in
connection with SpO(sub 2) Sensors and agrees not to promote or instruct others
to so configure non-MS-1 Boards.
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7.5 Engineering Support. MASIMO shall provide reasonable engineering
support to ZOLL for the integration of MASIMO SET into Licensed Devices, at
the cost of $150.00 per hour. Such support and payment by ZOLL shall be
authorized in advance, in writing by ZOLL. Such services shall be provided at
MASIMO's facility unless travel is required, in which event ZOLL shall
additionally pay for necessary travel expenses.
8. INSPECTION AND ACCEPTANCE
8.1 MASIMO Inspection. MASIMO shall provide and maintain an inspection
procedure and quality assurance program for the MASIMO Products and its
production processes. Complete records of all inspection and quality assurance
work done by MASIMO shall be made available to ZOLL upon its request at
reasonable times during the term of this Agreement.
8.2 ZOLL Inspection
8.2.1 ZOLL may inspect the products upon receipt. For SpO(sub 2),
Sensors, any lots of MASIMO Products ("Lot") which fail (as defined only
as a failure under statistical lot sampling standard ANSI/ASQC Z1.4:1993
AQL 1.0), or for MS-1 Boards, any board which fails, to meet MASIMO's
written specifications as set forth in Exhibit G, may be rejected by
ZOLL and returned to MASIMO for replacement; provided however, that ZOLL
shall have the right to reject and return to MASIMO for replacement any
MASIMO Products which fails to meet MASIMO's specification as set forth
in Exhibit G. Prior to returning any MASIMO Products to MASIMO, ZOLL
shall notify MASIMO by facsimile that ZOLL has rejected the MASIMO
Products, inclusive of the reason or basis of such rejection. Within
five (5) working days of the receipt of the notification, MASIMO will
issue a "Return to Vendor" ("RTV") number to ZOLL by facsimile, which
RTV number will be ZOLL's authorization to return the MASIMO Products.
8.2.2 ZOLL shall promptly notify MASIMO of any incoming Lot
failure. MASIMO Products which do not conform to MASIMO's specifications
as set forth in Exhibit G shall be returned by ZOLL to MASIMO freight
collect and insured for full replacement value. Within twenty (20) days
after the date of receipt of the nonconforming MASIMO Products by
MASIMO, replacement Product will be shipped to ZOLL at MASIMO's expense.
Should MASIMO fail to replace rejected MASIMO Products by shipping
conforming MASIMO Products to ZOLL within thirty (30) days of its
receipt of the nonconforming MASIMO Products, ZOLL shall have the option
to cancel without cost or liability the purchase of such MASIMO Products
and receive, at ZOLL's option, a credit or rebate if payment has been
made. ZOLL shall pay freight charges, insurance and other customary
charges for transportation for improperly rejected MASIMO Products.
8.2.3 If ZOLL attempts to correct deficiencies to the MASIMO
Products purchased under this Agreement without prior written
authorization from MASIMO, then MASIMO shall have no further obligations
with respect to such MASIMO Products.
8.3 Nonconforming Acceptance. ZOLL may choose to accept the MASIMO
Products which fail to conform in a minor aspect to the specifications
established by this Agreement without prejudice to its right to reject
nonconforming items in the future. If ZOLL so chooses, ZOLL will notify MASIMO
of its intent to accept nonconforming items. However, MASIMO accepts no
responsibility for nonconforming items accepted by ZOLL.
9. CONFIDENTIALITY
9.1 MASIMO's Confidential Information. ZOLL shall not use MASIMO's Confidential
Information for any purpose other than performance of this Agreement or the
maintenance or repair of the MASIMO Products in accordance with this Agreement.
ZOLL shall not disclose MASIMO's Confidential Information to any third party
without the prior written consent of MASIMO.
9
9.2 ZOLL's Confidential Information. MASIMO shall not use ZOLL's
Confidential Information, specifically and without limitation ZOLL's sales
reports, for any purpose other than performance of this Agreement, without the
prior written consent of ZOLL. MASIMO shall not disclose ZOLL's Confidential
Information to any third party without the prior written consent of ZOLL.
9.3 Neither party's obligations under this confidentiality provision
shall apply to information that:
9.3.1 prior to the transmittal was of general public knowledge;
9.3.2 becomes a matter of general public knowledge otherwise
than as a consequence of a breach under this Agreement;
9.3.3 is made public by the Party claiming confidentiality;
9.3.4 is required to be disclosed by applicable law; provided
however, that the Party who may be required to disclose such information
shall notify the other Party in sufficient time for the owner of such
Confidential Information to file the appropriate documents with the
court to obtain a protective order to enforce the confidentiality
requirements of this Agreement;
9.3.5 information which the receiving Party can establish by
competent proof was in its possession at the time of disclosure by the
disclosing Party and was not acquired, directly or indirectly, from the
disclosing Party;
9.3.6 information which is received from a third party; provided,
however, that the receiving Party has no reason to know such information
was obtained by said third party, directly or indirectly, from the other
Party under a nondisclosure agreement; or
9.3.7 can be documented was independently developed without
reference to or reliance upon the other party's confidential
information.
9.4 Injunctive Relief. The Parties acknowledge that (a) the covenants set
forth in this Section 9 ("CONFIDENTIALITY") are essential elements of this
Agreement and that, but for the agreement of the parties to comply with such
covenants, this Agreement would not have been entered into; (b) neither party
will have any adequate remedy at law if the other party violates the terms of
this Section 9 ("CONFIDENTIALITY"); and (c) each party shall have the right, in
addition to any other rights it may have, to obtain in any court of competent
jurisdiction temporary, preliminary and permanent injunctive relief to restrain
any breach, threatened breach, or otherwise to specifically enforce any, of the
covenants in this Section 9 ("CONFIDENTIALITY") if the other party fails to
perform any of such covenants under this Section 9 ("CONFIDENTIALITY").
9.5 Press Release
9.5.1 Within 30 days following the signing of a definitive
Agreement, MASIMO and ZOLL agree to issue a joint press release
announcing the existence and general content of the Agreement. Except
for the press release and discussing the existence and general nature of
the Agreement, neither Party shall, without the other's prior written
approval, disclose any terms of this Agreement. This provision shall not
be interpreted to bar either Party from making any disclosure required
of it by law, but if such disclosure includes the terms or provisions of
this Agreement, then the other Party shall be given the opportunity to
review the disclosure prior to its release.
10. PROPRIETARY RIGHTS
10.1 MASIMO Inventions and Improvements. Any Improvement made by ZOLL,
made jointly by ZOLL and MASIMO, or made solely by MASIMO shall be the sole
property of MASIMO, and MASIMO has the right to apply for copyrights, patents
(including utility and design patents), or other
10
protection for intellectual property rights anywhere in the world under its own
name and at its own expense. If such invention or Improvement is owned by MASIMO
and is applicable to the MS-1 Boards, SpO(sub 2), Sensors or Accessories,
provided that ZOLL has, and for so long as ZOLL continues to meet the eighty
percent (80%) integration commitment set forth in Section 3.6 ("Integration
Commitment") and its obligations under Section 3.2 ("Best Efforts"), MASIMO will
grant ZOLL, without additional compensation, a non-exclusive, non-transferable
license to use such Improvement to incorporate the MS-1 Boards having the
Improvement into the Licensed Devices, to demonstrate Licensed Devices and to
distribute Licensed Device to (i) end user customers (not to OEM or other
medical equipment manufacturer) and (ii) ZOLL distributors and other medical
equipment manufacturers specifically set forth on Exhibit I.
10.2 ZOLL Inventions. Subject to the license rights granted to ZOLL
herein, MASIMO retains all right, title and interest in and to Masimo Technology
and all Improvements. If ZOLL makes any Improvement, ZOLL shall, and hereby
does, transfer all right, title and interest in and to all such Improvements.
ZOLL agrees that it shall promptly notify MASIMO of any Improvement. ZOLL agrees
that it shall take all actions and execute all documents, at MASIMO's expense
and as MASIMO may reasonably request, to effectuate the acknowledgment of
MASIMO's ownership contained herein and the vesting in MASIMO of complete and
exclusive ownership of any Improvement. ZOLL shall, at MASIMOs expense, secure,
maintain and defend for MASIMO's benefit all rights therein, including the right
to submit any patent, copyright or trademark application or registration.
Notwithstanding anything contained in this Agreement to the contrary, MASIMO
expressly acknowledges and agrees that ZOLL is engaged in the business of
designing, developing and selling medical technology devices, and as such ZOLL
shall have the right at all times during and after this Agreement to design,
develop, sell, market and distribute medical technology and products relating to
pulse oximetry, provided that such technology or products are not based upon
non-public proprietary or confidential information owned by MASIMO and disclosed
to ZOLL under this Agreement, and MASIMO expressly acknowledges and agrees that
ZOLL shall own all proprietary rights in and to all such technology and
products.
11. WARRANTIES
11.1 MASIMO Warranties
11.1.1 MASIMO warrants the MS-1 Boards supplied by MASIMO to ZOLL
for a period of [*] following receipt by ZOLL, or [*] following receipt by
an End-User, whichever is earlier, to be free, under normal use and care,
from defects in workmanship and material and to be in material conformity
with MASIMO's specifications. Units returned to MASIMO for warranty
repairs shall be shipped to MASIMO freight collect according to MASIMO's
instruction. Within thirty (30) days of the receipt of MS-1 Boards, MASIMO
shall replace or repair such units and shall ship them to ZOLL's
designated return destination freight prepaid, if MASIMO reasonably
determines that the unit is covered under this Warranty. The foregoing
warranties extend to the MS-1 Boards returned by ZOLL's customers.
11.1.2 MASIMO warrants that for a period of [*] following receipt
by ZOLL or [*] following receipt by the End-User, whichever is earlier,
the reusable probes LNOP-DCl, the PC08 and PC12 product cables supplied by
MASIMO to ZOLL will be, under normal use and care, free from any defect in
workmanship and material and to be in material conformity with MASIMO's
specifications. Units returned to MASIMO for warranty repairs shall be
shipped to MASIMO freight collect according to MASIMO's instruction.
Within thirty (30) days of the receipt of reusable probes MASIMO shall
replace or repair such units and shall ship them to ZOLL's designated
return destination freight prepaid, if MASIMO reasonably determines that
the unit is covered under this Warranty. The foregoing warranties extend
to the covered items returned by ZOLL's customers.
11.1.3 MASIMO warrants that for a period of [*] following receipt
by ZOLL, or [*] following receipt by the End-User, or until [*],
* Confidential material redacted and filed separately with the Commission.
11
whichever is earliest, the disposable probes (e.g., LNOP-Neo, LNOP-NeoPt
and LNOP-Adt) supplied by MASIMO to ZOLL hereunder will be, under normal
use and care, and only upon first use, free from any defect in
workmanship and material and to be in material conformity with MASIMO's
specifications therefor. Units returned to MASIMO for warranty repairs
shall be shipped to MASIMO freight collect according to MASIMO's
instruction. Within thirty (30) days of the receipt of disposable
probes, MASIMO shall replace or repair such units and shall ship them to
ZOLL's designated return destination freight prepaid, if MASIMO
reasonably determines that the unit is covered under this Warranty. The
foregoing warranties extend to the covered items returned by ZOLL's
customers.
11.1.4 This warranty does not extend to any unit that has been
subject to misuse, neglect or accident; that has been damaged by causes
external to the unit; that has been used in violation of MASIMO's
instructions; that has been affixed to any nonstandard Accessory
attachment; that has been modified, disassembled, or reassembled by
anyone other than MASIMO.
11.1.5 MASIMO represents and warrants to ZOLL that MASIMO has no
knowledge that the use of MASIMO Products in compliance with the terms
of this Agreement would infringe any patent, copyright, trademark, trade
secret or any other proprietary right of any third party.
11.2 MASIMO Maintenance and Repairs. For a period of three (3) years after
the expiration or termination of the warranty set forth in Sections 11.1
("MASIMO Warranties") of this Agreement, MASIMO agrees to replace MASIMO
Products at the original unit price of the MASIMO Products
11.3 Limitation of Liability. EXCEPT FOR THE EXPRESS WARRANTIES SET
FORTH ABOVE, MASIMO GRANTS NO WARRANTIES, EITHER EXPRESS OR IMPLIED, ON THE
MASIMO PRODUCTS, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE, AND THE STATED EXPRESS WARRANTY IS IN LIEU OF ALL
LIABILITIES OR OBLIGATIONS OF MASIMO FOR DAMAGES, INCLUDING, BUT NOT LIMITED
TO, CONSEQUENTIAL DAMAGES OCCURRING OUT OF OR IN CONJUNCTION WITH THE USE OR
PERFORMANCE OF SUCH UNIT OF MASIMO PRODUCTS. IN NO EVENT SHALL MASIMO BE
RESPONSIBLE FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL DAMAGES, LOSS OF PROFIT, OR
EXPENSE SUFFERED BY THE OTHER PARTY IN CONNECTION WITH THIS AGREEMENT.
12. INDEMNIFICATION
12.1 Notice. Recognizing the objectives of this Agreement, ZOLL agrees
that if it knows of or becomes aware of any patents that may be infringed by the
manufacture and sale of the MASIMO Products, it will promptly disclose such
information to MASIMO.
12.2 MASIMO will defend, indemnify and hold ZOLL harmless against any
and all liability, loss, damages, costs or expenses which ZOLL may hereafter
incur, as a result of any injury, illness or death of any person which is caused
by any MASIMO Product, to the extent that such injury, illness or death resulted
from (i) MASIMO's design or manufacture of the MASIMO Products or (ii) failure
of the MASIMO Products at the time of shipment to ZOLL to materially comply with
the specification. MASIMO shall have no liability or responsibility of any kind
to ZOLL under this Section 12 to the extent that MASIMO's ability to defend or
settle any such claim is prejudiced by ZOLL's failure to (a) promptly notify
MASIMO in writing of any claim relating to this section, (b) provide reasonable
assistance to MASIMO, at MASIMO's expense, in connection with the defense and
settlement of any such claim, and (c) permit MASIMO to control the defense of
any such claim. MASIMO shall have no liability for settlements made without
express written consent. Should ZOLL desire to have its own counsel participate
in any such action, the cost of such counsel shall be exclusively ZOLL's.
12.3 ZOLL will defend, indemnify and hold MASIMO harmless against any and
all liability, loss, damages, costs or expenses which MASIMO may hereafter
incur, as a result of any injury, illness or
12
death of any persons, or infringement or alleged infringement of any patent,
copyright, trademark, trade secret or any other proprietary right of any third
party, to the extent that such illness, injury, death or infringement results
from the Licensed Devices and results from technology or products not supplied
by MASIMO. ZOLL shall have no liability under this Section to the extent that
ZOLL's ability to defend or settle any such suit or claim is prejudiced by
MASIMO's failure to (a) promptly notify ZOLL in writing of any claim relating to
this Section, (b) provide reasonable assistance to ZOLL, at ZOLL's expense, in
connection with the defense and settlement of such claim, and (c) permit ZOLL to
control the defense of any such claim. ZOLL shall have no liability for
settlements made without its express written consent. Should MASIMO desire to
have its own counsel participate in any such actions, the cost of such counsel
shall be exclusively MASIMO's.
12.4 MASIMO will defend, indemnify and hold ZOLL and its customers
harmless against infringement or alleged infringement by the SpO(sub 2), Sensors
furnished under this Agreement, or by the MS-1 Boards or Accessories, of any
patent, copyright, trademark, trade secret or any other proprietary right of any
third party. MASIMO shall have no liability under this section to the extent
that MASIMO's ability to defend or settle any such suit or claim is prejudiced
by ZOLL's failure to (a) promptly notify MASIMO promptly in writing of any such
claim or proceeding, (b) provide MASIMO reasonable assistance, at MASIMO's
expense, in connection with the defense and settlement of any such claim
including, but not limited to, where practical, to modify the SpO(sub 2) Sensors
and/or the MS-1 Boards to make them non-infringing or, where practical, to
obtain licenses under such intellectual property rights and (c) permit MASIMO to
control the defense of any such claim. MASIMO shall have no liability for
settlements made without its express written consent. MASIMO may, at its sole
discretion, modify the SpO(sub 2), Sensors and/or MS-1 Boards to make them
non-infringing, obtain a license to allow the continued use of the SpO(sub 2)
Sensors and/or MS-1 Boards or discontinue shipment of the SpO(sub 2) Sensors
and/or MS-1 Boards to ZOLL. In the event MASIMO discontinues shipment, and ZOLL
is restricted from selling Licensed Devices with MASIMO Products, ZOLL shall
have the right to terminate this Agreement and MASIMO agrees to buy back ZOLL's
inventory of MASIMO Products at the original transfer price. In the event that
ZOLL's ability to use the MASIMO Products is Genuinely Impaired by such a claim
under this Section and MASIMO does not, within ten (10) days after receipt of
notice of such impairment, procure for ZOLL the right to use such MASIMO
Products or replace such products with functionality equivalent products, ZOLL
shall have the right to terminate this Agreement, effective upon written notice
to MASIMO. "Genuinely Impaired" shall mean that MASIMO is temporarily or
permanently enjoined from selling the MASIMO Products or an equivalent, or that
a substantial volume of orders from ZOLL's customers are canceled due to the
infringement claim, or an infringement claim or allegation which has a material
negative impact on ZOLL's ability to sell Licensed Devices, but shall not be a
mere allegation, claim or filing of an infringement suit.
12.5 Notwithstanding the above, Masimo shall have no indemnification
obligations under Section 12.4 for any infringement or claims of infringement
relating to Licensed Devices resulting solely from (a) modifications by Zoll or
any others to MASIMO Technology or the MASIMO Products, (b) from
electrical/electronics, software/firmware, sensors or product interface not
furnished by MASIMO, (c) the combination of the MASIMO Products with apparatus
not furnished by MASIMO, (d) use of products or components not supplied by
MASIMO, or the combination of MASIMO Technology with other technology not
furnished by MASIMO, (e) use of MASIMO Technology in products not permitted by
the license granted herein, or (f) for any claims not related directly to MASIMO
Technology or the MASIMO Products.
12.6 Patent Defense. ZOLL agrees that it shall notify MASIMO of any claim
by a third party that such third party believes that MASIMO Patents or Patent
Rights are invalid. ZOLL agrees to promptly notify MASIMO of any such claim
whether or not such claim is asserted in court by such third party.
12.6.1 During and after the term of this Agreement, ZOLL agrees
not to challenge the validity of any of the Patent Rights. During the
term of this Agreement, ZOLL agrees to disclose to MASIMO any prior art
or any other information that is material to the validity of any of the
Patent Rights or to the patentability of any pending MASIMO patent
application of which ZOLL is aware.
13
12.7 Regulatory Compliance
12.7.1 ZOLL shall be solely responsible for identifying and
obtaining, at its sole cost and expense, all FDA and United States
safety agency approvals and any other agency or regulatory approvals
which are required for the development, manufacture or sale of Licensed
Devices. MASIMO will reasonably cooperate with ZOLL by providing at no
charge to ZOLL any MASIMO data in its possession that is reasonably
required to obtain the regulatory approvals, including but not limited
to 51O(k) application materials submitted by MASIMO for its own products
that incorporate MASIMO SET. Disclosure by ZOLL of any such data shall
be subject to the confidentiality provisions of Article 9
("CONFIDENTIALITY"); provided however, that notwithstanding anything to
the contrary contained in this Agreement, MASIMO expressly acknowledges
and agrees that ZOLL will be applying for Food and Drug Administration
("FDA") approval for the Licensed Devices and ZOLL shall have the right,
without prior approval from MASIMO, to furnish the FDA any information
from MASIMO's 510-k submission and any information requested by the FDA
deemed by ZOLL to be necessary or advisable to secure FDA approvals for
the ZOLL Products. For additional MASIMO Confidential Information, ZOLL
shall first seek approval from MASIMO, such approval not to be
unreasonably withheld.
12.7.2 ZOLL shall be solely responsible, at its sole cost and
expenses, (i) for identifying and obtaining any necessary approvals or
certifications by any non-U.S. governmental, safety or regulatory
entity, including testing or other procedures, for the sale by ZOLL of
Licensed Devices, (ii) for identifying and complying with any safety
precautions, safety markings, labels or consumer notices required for
ZOLL Product sales in any country other than the United States, and
(iii) for assessing the appropriateness of the ZOLL Product for any
particular Customer application. MASIMO will cooperate with ZOLL by
providing any data in its possession that is reasonably required to
obtain such approvals or certifications. Disclosure by ZOLL of any such
data to any third party shall be subject to the confidentiality
provisions of Article 9 ("CONFIDENTIALITY").
12.7.3 In the event of any recall of any product incorporating
MS-1 or SpO(sub 2), Sensors, the parties shall cooperate to the extent
reasonably necessary to conduct such recall in accordance with ZOLL's
policies and procedures.
12.7.4 Regardless of any disclosure to MASIMO by ZOLL of an
ultimate destination of the Licensed Devices or the Software, ZOLL shall
not transfer or re-export, whether directly or indirectly, the Software,
the MASIMO Products or Licensed Devices containing the Software, the
related documentation, or other related proprietary information to
anyone outside the U.S. as to which export may be in violation of the
United States Export Laws or regulations without first obtaining the
appropriate license from the U.S. Department of Commerce and/or any
agency or department of the U.S. government, as required.
13. INCIDENT REPORTING
13.1 MASIMO Reporting. MASIMO represents and warrants that all MASIMO
Products manufactured and sold to ZOLL pursuant to this Agreement shall be
manufactured materially in conformance with all applicable requirements of the
FDA and in accordance with all United States federal, state and local statutes,
ordinances and regulations, including, but not limited to, the Federal Food,
Drug and Cosmetic Act (21 U.S.C. 301 et seq.). If MASIMO is prevented from
shipping product to ZOLL (for any period of time in excess of 30 days) due to
regulatory actions imposed by FDA, the 80% commitment shall be excused for the
period of shut down plus six months. If ZOLL requests an evaluation and/or
investigation into an alleged failure of a MASIMO device, MASIMO shall promptly
perform such investigation and provide ZOLL with written results of the
investigation within 5 business days after receipt of the defective material.
13.2 ZOLL Reporting. ZOLL represents that in addition to being responsible
for all regulatory approvals for the Licensed Devices that should any incidents
of failure of the MASIMO Products which
14
result in bodily injury be reported to ZOLL, that it will promptly (i.e., within
two (2) business days) notify MASIMO of any such field performance problems or
deficiencies. ZOLL agrees to report to MASIMO any other incidents of failure
within a reasonable time.
13.3 Recall. If for any reason MASIMO determines that a recall of
Product(s) is (are) necessary as defined in FDA regulations (21, CFR Part 7),
MASIMO shall notify ZOLL of the possibility of Product recall. If MASIMO
notifies ZOLL that the Product must be recalled, ZOLL agrees that it shall as
expediently as possible issue a recall notice to all its customers recalling the
MASIMO Products in question. Provided that the MASIMO Products meet the
specifications specified in Exhibit G, MASIMO's liability for a Product recall
shall be the repair or replacement of the part that causes the recall. If the
MASIMO Products fail to meet MASIMO's specifications as set forth in Exhibit G,
then MASIMO's sole responsibility, subject to MASIMO's obligations under this
Agreement, including without limitation, MASIMO's indemnification obligations
under Section 12 hereunder, shall be the cost which it incurs for repairing
and/or replacing the Product in question and for the payment of all freight or
shipping charges involved with such recall.
14. TERM AND TERMINATION
14.1 This Agreement shall become effective as of the effective date
first set forth above, and shall remain in effect for Five (5) years, thereafter
this Agreement is renewable for one-year periods with mutual consent.
14.2 Termination
14.2.1 The default by one Party on a material obligation of such
Party under this Agreement shall entitle the other Party to give the
Party in default written notice describing such default in detail and
requiring it to remedy such default. If such default is not fully
remedied within ninety (90) days after the date of such notice, the
notifying Party shall be entitled to terminate this Agreement by a
written notice to the defaulting Party.
14.2.2 Either Party may terminate this Agreement at any time upon
or after the filing against the other Party by any third party of a
petition in bankruptcy or insolvency, or upon or after any adjudication
that the other Party is insolvent, or upon or after the filing by the
other Party of any petition or answer seeking reorganization,
readjustment or arrangement of the business of the other Party under any
law relating to bankruptcy or insolvency, or upon or after the
appointment of a receiver for all or substantially all of the property
of the other Party of any assignment or attempted assignment for the
benefit of creditors, or upon or after the institution of any
proceedings for the liquidation or winding up of the other Party's
business.
14.3 Rights Upon Termination. In the event of any valid termination of
this Agreement under Section 14.2 hereof ("Termination"), all of ZOLL's rights
under this Agreement shall be terminated. The termination of ZOLL's rights shall
include the termination of any rights of ZOLL to continue to use MASIMO
Technology, even though such technology may have entered the public domain prior
to or subsequent to termination. This restraint is agreed to be reasonable as
consideration for MASIMO's disclosing know-how to ZOLL prior to it entering the
public domain. No termination shall impact MASIMO's rights to collect for
accrued royalties and payment for delivered Product or either Parties rights to
pursue all available remedies in addition to those stated herein. ZOLL may
distribute existing inventory for a period not to exceed 12 months following
termination. Any outstanding purchase orders are automatically canceled on
termination by MASIMO.
15. DISPUTE
If any dispute or difference shall arise between the parties concerning the
construction of this Agreement or the rights or obligations of either Party, the
Parties shall strive to settle the same amicably, but if they are unable to do
so within ninety (90) days after such dispute or difference has arisen, any
claim or
15
cause of action shall be filed in any court in Orange County, California, U.S.A.
MASIMO and ZOLL each consents to personal jurisdiction in any action brought in
the United States District Court for the Central District of California. In the
event that such action should be brought in a state court, ZOLL and MASIMO each
consents to personal jurisdiction in any action brought in Municipal Court or
Superior Court of the State of California in the County of Orange ("Notice") of
this Agreement. Notwithstanding the foregoing, any dispute arising out of
Section 2.3.2 or Section 3.10 shall be resolved by binding arbitration in
Boston, Massachusetts and MASIMO and ZOLL each consents to personal jurisdiction
and exclusive venue in any action brought in any court located in the
Commonwealth of Massachusetts. Notwithstanding anything contained in this
Section, either Party shall have the right to apply for injunctive relief for
any breach of the provisions of Section 9.
16. MISCELLANEOUS
16.1 Nonassignability. Except in connection with the sale of all or
substantially all of the assets or business of ZOLL, ZOLL may not assign,
transfer or sublicense any of the rights or obligations under this Agreement,
without the prior written consent of MASIMO. Notwithstanding the foregoing if
ZOLL is involved in any assignment or sale to an entity which has a pre-existing
license with MASIMO for SpO(sub 2), Measurement having terms in the aggregate
more favorable to MASIMO than the terms of this Agreement, MASIMO may elect for
the terms of the other License Agreement to apply to the exclusion of this
Agreement. Except in connection with the sale of all or substantially all of the
assets or business of MASIMO to which this license relates, MASIMO may not
assign or transfer any of the rights or obligations under this Agreement,
without prior written consent of ZOLL. This Agreement will inure to the benefit
of and bind the Parties successors and assigns.
16.2 Failure to Enforce. The failure of either Party to enforce at any
time or for any period of time the provisions of this Agreement shall not be
construed to be a waiver of such provisions or of the right of such Party to
enforce each and every such provision.
16.3 Governing Law. This Agreement shall be deemed to have been made in
the State of California, United States of America, and shall be governed by and
construed according to the laws of the State of California.
16.4 Severability. In the event that any of the provisions of this
Agreement shall be held by a court or other tribunal of competent jurisdiction
to be unenforceable, such provisions shall be deleted from this Agreement and
the remaining portions of this Agreement shall remain in full force and effect,
except where the economic equity of both parties hereto is materially affected
by such unenforceability.
16.5 Notice. Except as either Party may hereafter notify the other with
respect to itself, the addresses of the Parties for all purposes of this
Agreement shall be:
MASIMO: MASIMO CORPORATION
23361 Madero, Suite 100
Mission Viejo, CA 92691
Attention:Joe E. Kiani
ZOLL: ZOLL MEDICAL CORPORATION
32 Second Avenue
Burlington, MA 01803
Attention: Vice President, Research and Development
With copy to: Raymond C. Zemlin, P.C.
GOODWIN, PROCTER & HOAR, LLP
Exchange Place,
Boston MA 02109-2881
16
All notices and communications pursuant to this Agreement shall be addressed as
set forth above and shall be delivered to the Party for whom intended by hand or
by postage prepaid, first class, registered or certified mail, return receipt
requested. Such notices and recommendations shall be deemed to have been given
and delivered as of the date of receipt.
16.6 Force Majeure. Neither Party shall be liable to the other Party
hereto for any loss, injury, delay, damages or other casualties suffered or
incurred by such other Party due to strikes, riots, storms, fires, acts of God,
or war or any other cause beyond the reasonable control of either Party.
16.7 Headings. Headings to paragraphs and sections of this Agreement are
to facilitate reference only, do not form a part of this Agreement, and shall
not in any way affect the interpretation hereof.
16.8 Survival From This Agreement. The rights and obligations of the
parties hereto under Articles 9, 10, 11, 12, 13 and 14 of this Agreement shall
survive and continue after any expiration or termination of this Agreement and
shall bind the Parties and their representatives, successors, heirs and
assignees.
16.9 Exhibits. All exhibits to which this Agreement refers are hereby
incorporated into and made a part of this Agreement.
16.10 Entire Agreement. This Agreement constitutes the entire agreement
between ZOLL and MASIMO, and there are no other understandings, agreements or
representations, express or implied, written or oral, not specified herein. This
Agreement may only be amended by express written agreement and signed by
authorized representatives of both Parties.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date set forth above.
MASIMO CORPORATION ZOLL MEDICAL CORPORATION
By: /s/ JOE E. KIANI By: /s/ DONALD BOUCHER
---------------------- ----------------------
Joe E. Kiani Donald Boucher
President and CEO Vice President, Research & Development
17
EXHIBIT A
MASIMO SET(R) DEFINITION
For the purpose of this agreement, MASIMO SET(R) is defined as all Masimo
Technology as contained in the Patent Rights; the claims which issue in the
patent applications listed in Exhibit C, and all legally protectable trade
secrets contained in the Masimo Confidential Information relating to LNOP(R),
AutoProCal(TM), ProCal(TM), DST(TM), and FST(TM) Technology.
EXHIBIT B
TRADEMARKS, LEGENDS, LOGOS
I. MASIMO SET(R) PRODUCT DESIGNATION:
[MASIMO SET(R) LOGO]
Panatone Red / PMS Black
185C MAT
II. LICENSED TRADEMARKS:
[MASIMO SET(R) LOGO]
[MASIMO SET(R) LOGO]
[MASIMO SET(R) LOGO]
(MASIMO WILL PROVIDE CAMERA READY ARTWORK UPON REQUEST)
III. PATENT MARKING:
EXHIBIT D
PRICE OF PRODUCTS
Price for MS-1 Boards: MASIMO's transfer prices to Zoll for the MS-1 Boards
(including the Masimo MS-3 Boards) delivered in accordance with this Agreement
are as follows:
Quantity Purchased per Year Unit Price
--------------------------- ----------
Less Than 2500 [*]
2500 or more [*]
In the first twelve month period following the first month after ZOLL places its
first Purchase Order for MASIMO Products, the price for MS-1 Boards shall be
fixed at [*] per unit. For subsequent years, MS-1 Board pricing shall be set at
the pricing for the quantity purchased by Zoll during the entire preceding year.
Transfer Price for Sensors and Accessories: MASIMO's transfer prices to ZOLL for
the SpO2 Sensors and Accessories delivered in accordance with this Agreement are
as follows:
Product Part # Price Each
------- ------ ----------
LNOP(R).Adt (Adult Disposable Probe) 1001 [*]
LNOP(R).Pdt (Pediatric Disposable Probe) 1025 [*]
LNOP(R).Neo (Neonatal Disposable Probe) 1002 [*]
LNOP(R).NeoPt (Pre-Term Neonatal Disposable Probe) 1003 [*]
LNOP(R).DC-1 (Adult Re-usable Probe) 1004 [*]
PC-08 (8 Ft. Patient Cable) 1005 [*]
PC-12 (12 Ft. Patient Cable) 1006 [*]
* Confidential material redacted and filed separately with the Commission.
EXHIBIT E
PRODUCT LINES
1. Reviver Pacemaker/Defibrillator/Patient Monitor Series
- Anticipated initial product launch in [*]
* Confidential material redacted and filed separately with the Commission.
EXHIBIT F
FORM OF PURCHASE ORDER
[Enlarge/Download Table]
ZOLL MEDICAL CORPORATION DATE NUMBER
32 Second Avenue
ZOLL Burlington, Massachusetts 01803-4420
U.S.A.
617 229-0020
800 348-9011
617 272-5578 Telefax IMPORTANT
Our Order Number must appear on invoices, Packages and
Correspondence. Acknowledge if unable to deliver by date required.
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
[ ] Confirmation Only - Do Not Duplicate
[ ] Change Order
By ______________________________________________________________
__________________________________________________________________________________________________________________
VENDOR
[Enlarge/Download Table]
ZOLL MEDICAL CORPORATION DATE NUMBER
32 Second Avenue
ZOLL Burlington, Massachusetts 01803-4420
U.S.A.
617 229-0020
800 348-9011
617 272-5578 Telefax IMPORTANT
Our Order Number must appear on invoices, Packages and
Correspondence. Acknowledge if unable to deliver by date required.
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
[ ] Confirmation Only - Do Not Duplicate
[ ] Change Order
By ______________________________________________________________
__________________________________________________________________________________________________________________
ACCOUNTS PAYABLE
[Enlarge/Download Table]
ZOLL MEDICAL CORPORATION DATE NUMBER
32 Second Avenue
ZOLL Burlington, Massachusetts 01803-4420
U.S.A.
617 229-0020
800 348-9011
617 272-5578 Telefax IMPORTANT
Our Order Number must appear on invoices, Packages and
Correspondence. Acknowledge if unable to deliver by date required.
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
[ ] Confirmation Only - Do Not Duplicate
[ ] Change Order
By ______________________________________________________________
__________________________________________________________________________________________________________________
PURCHASING
EXHIBIT G
SPECIFICATIONS FOR PRODUCTS
MS-1 is a complete pulse oximeter, based on Masimo SET, on a circuit board. The
circuit board interfaces directly to LNOP sensors, driving the LEDs in the
sensor to acquire the patient signal, calculates SpO2 and Pulse Rate, and
communicate the information off board.
PERFORMANCE SPECIFICATION:
[Enlarge/Download Table]
RANGE Saturation (SpO2): 35-100%
Pulse Rate: 25-240 BPM (Beats Per Minute)
Perfusion: ( %) Transmission (dB)
greater than or equal to 1 greater than or equal to -50 dB
0.02 - 1 greater than or equal to -23.98-SS ( %) - 26.02
ACCURACY
Adults
SpO2 Range 70%-100% 0% to 69%
Accuracy (plus or minus 1 Std. Dev.)* plus or minus 2 digits Unspecified
Pulse Rate Range 25-240 BPM
Accuracy (plus or minus 1 Std. Dev.)* plus or minus 4 BPM
Neonates
SpO2 Range 70%-95% 0% to 69%
Accuracy (plus or minus 1 Std. Dev.)* plus or minus 3 digits Unspecified
Pulse Rate Range 25-240 BPM
Accuracy (plus or minus 1 Std. Dev.)* plus or minus 4 BPM
NOTE: The MS-1 pulse oximeter board is calibrated to read oxyhemoglobin
saturation (%SpO2) of functional hemoglobin as compared to a Nellcor N-200
pulse oximeter and/or a CO-Oximeter. Significant levels of dysfunctional
hemoglobin (e.g., methemoglobin, carboxyhemoglobin) may affect the accuracy of
the instrument. Indocynnine green, methylene blue, and other intra-vascular
dyes, depending upon their concentrations, may interfere with the accuracy of
the instrument. MS-1 performance will be compromised if there is no arterial
blood at the test site due to excessive patient motion (e.g., squeezing at a
pressure close to subject's diastolic blood pressure), ultra low perfusion,
excessive electrosurgical interference, or intense environmental illumination.
* Testing is based on healthy adult volunteers in induced hypoxia studies with
LNOP(R) Adt sensors; during no motion. Testing to verify saturation
specifications is done against a Nellcor N-200 pulse oximeter and/or a
CO-Oximeter. Testing to verify pulse rate specification is done against a
Nellcor N-200 pulse oximeter and/or an ECG.
[**]
** Confidential material redacted and filed separately with the Commission.
MS-1 HARDWARE:
POWER CONSUMPTION less than or equal to 2.3 Watts (typ)
= 2.5 Watts (max)
STORAGE ENVIRONMENT
Temperature Range -50 - 100 degrees C
Relative Humidity 0 - 97% non-condensing
Atmospheric Pressure 50 - 113 kPa
OPERATING ENVIRONMENT
Temperature Range 0 - 70 degrees C
Relative Humidity 0 - 97% non-condensing
Atmospheric Pressure 68 - 113 kPa
MTBF 150,000 hours minimum
(Ground Benign)
FAILURE COVERAGE Single Fault Coverage
PLETHYSMOGRAPHIC WAVEFORM SPECS
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WAVEFORM TYPE RANGE RESOLUTION BANDWIDTH DELAY
------------- ----- ---------- --------- -----
Raw Signal 0 to 1 2(-7), 2(-15), 2(-31) Hz - greater than or equal to 8 Hz less than or equal to 0.60 sec
Band Pass Signal -1 to 1 2(-7), 2(-15), 2(-31) less than or equal to .7 Hz - less than or equal to 2.25 sec
greater than or equal to 4 Hz
Autoscaled Signal -1 to 1 2(-7), 2(-15), 2(-31) less than or equal to .7 Hz - less than or equal to 2.50 sec
greater than or equal to 4 Hz
[Enlarge/Download Table]
TYPICAL HEAT
SENSOR DESCRIPTION DISSIPATION MAXIMUM SKIN TEMP AT SITE
------ ----------- ------------ -------------------------
LNOP(R) DC-1 Adult Reusable less than or equal to 50 mW less than or equal to 41 degrees C @ 37 degrees C Ambient
LNOP(R) Adt Adult Disposable less than or equal to 50 mW less than or equal to 41 degrees C @ 37 degrees C Ambient
LNOP(R) Neo Neonatal Disposable less than or equal to 50 mW less than or equal to 39 degrees C @ 37 degrees C Ambient
LNOP(R) NeoPt Neonatal Disposable
(Pre-Term) less than or equal to 50 mW less than or equal to 39 degrees C @ 37 degrees C Ambient
LNOP(R) Neo Pediatric Disposable less than or equal to 50 mW less than or equal to 41 degrees C @ 37 degrees C Ambient
EXHIBIT H
END-USER LICENSE AGREEMENT
THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE "PURCHASER", AND
ZOLL. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE
ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR
SALES RECEIPT TO ZOLL FOR A FULL REFUND.
1. Grant of License. In consideration of payment of the license fee, which
is part of the price paid for this product, ZOLL grants to Purchaser a
nonexclusive license, without right to sublicense, to use the copy of the
incorporated software/firmware, and documentation in connection with Purchaser's
use of the MASIMO Products for their labeled purpose. ZOLL reserves all rights
not expressly granted to Purchaser.
2. Ownership of Software/Firmware. Title to, ownership of, and all rights
and interests in, any MASIMO software and/or firmware and the documentation, and
all copies thereof, remain at all times vested in MASIMO Corporation, licensor
to ZOLL, and they do not pass to Purchaser.
3. Assignment. Purchaser may assign or transfer this License except to a
person or entity engaged in the development of software/firmware competitive
with the software/firmware incorporated in this product.
4. Copy Restrictions. The software/firmware and the accompanying written
materials are copyrighted. Unauthorized copying of the software, including
software that has been modified, merged, or included with other software, or
other written materials is expressly forbidden. You may be held legally
responsible for any copyright infringement that is cause or incurred by your
failure to abide by the terms of this license. Nothing in this license provides
any rights beyond those provided by 17 U.S.C. Section 117.
5. Use Restriction. As the Purchaser, you may physically transfer the
products from one location to another provided that the software/firmware is not
copied. You may not electronically transfer the software/firmware from the
products to any other device. You may not disclose, publish, translate, release
or distribute copies of the software/firmware or accompanying written materials
to others. You may not modify, adapt, translate, reverse engineer, decompile,
disassemble, or create derivative works based on the software/firmware. You may
not modify, adapt, translate, or create derivative works based on the written
materials without the prior written consent of ZOLL.
6. Beneficiary. Masimo Corporation is a Beneficiary of this Agreement and
has the right to enforce its provisions.
Dates Referenced Herein
| Referenced-On Page |
|---|
| This ‘S-1/A’ Filing | | Date | | First | | Last | | | Other Filings |
|---|
| |  |
| Filed on: | | 11/14/00 | | | | | | | None on these Dates |
| | 11/1/97 | | 10 |
| | 4/17/97 | | 1 |
| List all Filings |
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