Exhibit 10.5
AMENDMENT TO MANUFACTURING AND DISTRIBUTION AGREEMENT
BETWEEN DIAMETRICS MEDICAL INCORPORATED
AND PHILIPS MEDICAL SYSTEMS
This Amendment, dated April 10, 2003 ("Effective Date"), is by and between
DIAMETRICS Medical Incorporated, a Minnesota corporation having its principal
place of business at 0000 Xxxxxx Xxxx, Xx. Xxxx, Xxxxxxxxx 00000 ("DIAMETRICS")
and PHILIPS Medical Systems North America Company, a division of PHILIPS
Electronics North America Corporation, a Delaware corporation with offices at
0000 Xxxxxxxxx Xxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000 ("PHILIPS"). DIAMETRICS and
PHILIPS shall each be a "Party."
RECITALS
A. DIAMETRICS and PHILIPS' predecessor Hewlett-Packard Company entered into a
distribution agreement effective June 6, 1999 for the development and
distribution of blood analysis products (the "Agreement").
B. Although the Agreement expired effective as of October 31, 2002, the
Parties desire to amend and clarify some of the surviving rights and obligations
solely as set forth herein. All other surviving rights and obligations of the
parties under the Agreement shall continue as set forth in the Agreement.
1. Definitions.
1.1. Accessories. Those accessories set forth on Exhibit 1.5. Accessories
may be deleted by mutual agreement of the Parties and DIAMETRICS may, from time
to time, add Accessories to such Exhibit.
1.2. Agreement. The agreement, originally entered into by DIAMETRICS and
HP effective June 6, 1999.
1.3. Cartridges. The cartridges used with XXXX and Portal Products.
1.4. Confidential Information. Information of any kind and form, whether
technical or business, which a Party hereto holds in confidence and regards as
valuable, but only when treated by the disclosing Party as set forth in Article
9.
1.5. Consumables. Collectively, Cartridges, Sensors, and Accessories. The
specifications for the Cartridges and Sensors as of the Effective Date are set
forth on Exhibit 1.5 as may be amended by DIAMETRICS.
1.6. idms. Information Data Management System for use with XXXX and
Portal Products (DIAMETRICS Part Numbers 464100 and 463000).
1.7. Intellectual Property. On a world-wide basis, any and all now known
or hereafter known tangible and intangible (a) patents and patent applications;
(b) rights associated with works of authorship including, without limitation,
copyrights, moral rights and mask-works; (c) trade secret rights; (d) all other
intellectual property rights of every kind and nature and however designated,
whether arising by operation of law, contract, license or otherwise; and (e) all
registrations, initial applications, renewals, extensions, continuations,
divisions or reissues hereof now or hereafter in force (including any rights in
any of the foregoing).
1.8. Interface Module. A product or component of a product whose function
includes the ability to acquire the output of any Product and make it available
to a PHILIPS patient monitor at the patient's bedside, by any means of
transmission including physical connection, cable, radio frequency and/or
infrared.
1.9. XXXX Product. The XXXX(R)SL Blood Analysis System for in-vitro
analysis of whole blood in humans, utilizing the Cartridges as described in
Exhibit 1.5.
1.10. PHILIPS Existing Customers. Will have the meaning set forth in
Section 2.1.
1.11. PHILIPS Product Inventory. Those XXXX and Trendcare Products and
their components and associated products and supplies (excluding Cartridges,
Sensors and software) which are owned by PHILIPS and set forth on the inventory
list to be provided by PHILIPS.
1.12. Portal Product. The in-vitro intermittent monitoring product
consisting of a Portal Measurement Module, custom connector, DeviceSet software,
interface software, custom cable, and a custom power Interface Module that
interfaces with a PHILIPS patient monitor, currently marketed as M3560A Portal
Blood Analysis System.
1.13. Portal Measurement Module. The Portal Cartridge reader M3561A
(M3561-60001), as more particularly described in the specifications attached to
the Portal Manufacturing Agreement.
1.14. Portal Measurement Products. Means the Portal Measurement Modules,
the Portal Measurement Accessories and the DeviceSet/DeviceCom Software (as such
latter two terms are defined in Exhibit 3.4).
1.15. Product. An XXXX, Trendcare, idms, Consumables or Portal Product.
1.16. Sensors. The disposable sensor used with the Trendcare Product.
1.17. Support. Consists of (a) help desk telephone service for customers;
(b) spare parts, on-site service and repair depot service (warranty and
out-of-warranty); (c) on-going training; (d) software upgrades and updates, and
(e) such other support activities of DIAMETRICS and/or PHILIPS described on
Exhibit 2.2.
1.18. Trendcare Product. A continuous in-vivo blood gas monitoring system
utilizing the Sensors described in Exhibit 1.5 as may be amended by DIAMETRICS.
2
1.19. Exhibit References. All Exhibit references shall mean the Exhibits
to this Amendment.
2. Transition for Consumables, XXXX, Trendcare and idms Products.
2.1. Sales and Support of Consumables. Subject to the terms and
conditions set forth herein, DIAMETRICS hereby appoints PHILIPS as a
non-exclusive distributor of Consumables in the Field (as defined in the
Agreement) through October 31, 2004, to customers who purchased a Product from
PHILIPS prior to November 1, 2002 ("PHILIPS Existing Customers"). This
appointment may not be assigned to any third party, other than regional
distributors in the normal course of business, without the prior written consent
of DIAMETRICS. PHILIPS shall be entitled to purchase Consumables from DIAMETRICS
(or its third party manufacturer, if any) for resale to PHILIPS Existing
Customers, through October 31, 2004, at the prices set forth on Exhibit 2.1,
which shall be non-discriminatory prices for non-exclusive distributors in the
territories in which PHILIPS is selling the Consumables. If PHILIPS becomes
aware that it is selling Consumables to customers other than PHILIPS Existing
Customers, PHILIPS shall so notify DIAMETRICS, and DIAMETRICS (or its
distributor) shall have the opportunity to sell Consumables to such customer,
and PHILIPS will use reasonable efforts to assign to DIAMETRICS or its designee
any long-term supply contract for Consumables, with such a customer. PHILIPS
shall inform its sales channel of its intention not to sell Consumables to
customers who are not PHILIPS Existing Customers.
2.2. Support of XXXX, Trendcare and idms Products. Subject to the terms
and conditions set forth herein, PHILIPS, its distributors and subcontractors
shall have the non-exclusive right to provide Support for XXXX, Trendcare and
idms Products through October 31, 2004, to PHILIPS Existing Customers who have
not transitioned to DIAMETRICS pursuant to an executed Country Transition Letter
as set forth in Section 2.6.
2.3. Service and Support Agreement. DIAMETRICS agrees to provide to
PHILIPS Support (including but not limited to warranty and out-of-warranty
Support) for the Consumables and the XXXX, Trendcare and idms Products on the
terms set forth in the Service and Support Agreement attached as Exhibit 2.2.
2.4. Inventory. The Parties have agreed to the purchase of PHILIPS
Product Inventory by DIAMETRICS as set forth in Exhibit 2.4.
2.5. PHILIPS Distributors.
(a) The Parties acknowledge that PHILIPS has existing distributors
of XXXX, Trendcare, and idms Products outside North America (the "PHILIPS
Distributors"). PHILIPS has taken reasonable action, at its sole expense, to
amend its agreements or understandings with the PHILIPS Distributors to delete
XXXX, Trendcare and idms Products from the list of products PHILIPS sells to
such Distributors. PHILIPS agrees to refer to DIAMETRICS any orders for XXXX,
Trendcare and idms Products that PHILIPS may receive from such Distributors;
provided however, that the Parties may agree, on a case-by-case basis, to
exceptions to permit PHILIPS to sell XXXX, Trendcare and idms Products to such
PHILIPS Distributors, with reasonable compensation to both Parties.
3
(b) In connection with the transition of sales and Support
contemplated in Section 2.6, on a country by country basis, PHILIPS shall
provide DIAMETRICS with contact information regarding PHILIPS Distributors who
sold XXXX, Trendcare, idms and Consumable Products and shall use commercially
reasonable efforts to introduce DIAMETRICS to such PHILIPS Distributors, and
DIAMETRICS shall be free to enter into distribution arrangements with such
Distributors for such Products on such terms as DIAMETRICS and such Distributors
may deem appropriate. To the extent feasible, PHILIPS will use reasonable
efforts to transfer and assign to DIAMETRICS its agreements with certain PHILIPS
Distributors for the distribution of the Products (excluding Portal Products),
subject to the prior approval of DIAMETRICS and consent of the applicable
PHILIPS Distributors, and provided that such transfer and assignment shall not
extend to any liabilities or claims arising prior to the date of the transfer or
assignment, or arising from an alleged improper assignment unless DIAMETRICS
expressly agrees in writing or except for the obligations expressly assumed by
DIAMETRICS under this Amendment (including all Exhibits hereto) and under
executed Country Transition Letters.
2.6. Transition. In order to transition responsibility for sales and
Support of Consumable Products and Support of XXXX, Trendcare and idms Products
on a country by country (or group of countries) basis, PHILIPS and DIAMETRICS
shall enter into a Country Transition Letter (a copy of which is attached hereto
as Exhibit 2.6) according to a mutually agreed timetable defined in the
transition process, provided that PHILIPS has provided DIAMETRICS with:
(a) a list of research/ reference sites with PHILIPS owned XXXX,
Trendcare and idms Products;
(b) a list of unique follow-on customer support/complaint
activities to be completed by DIAMETRICS with respect to the Products (excluding
Portal Products), to be defined during the transition process;
(c) installed base and/or distributor information (institution
name, address, contact) with respect to the Products (excluding Portal
Products). The installed base information contains contact information for the
customers to whom PHILIPS' shipped Products (other than Portal Products), and to
the best of PHILIPS' knowledge, for customers of the Products (other than Portal
Products) who have not ordered such a Product from PHILIPS;
(d) funnel information (leads, demo, evaluation) for the Products
(excluding Portal Products).
As part of the transition process, outside North America, contracts between
PHILIPS and PHILIPS Existing Customers for sales and Support of Consumables and
Support of XXXX, Trendcare and idms Products will be either (a) assigned to and
assumed by DIAMETRICS in writing or (b) canceled by PHILIPS and the applicable
customer and superceded by new customer service agreements between DIAMETRICS
and the customer. If an Existing PHILIPS Customer refuses to assign such
existing contract, PHILIPS may continue to sell Consumables to and Support
Consumables, XXXX, Trendcare and idms Products for that customer until the
4
earlier of the date on which the contract is assigned to DIAMETRICS or through
October 31, 2004 pursuant to Section 2.1.
Pursuant to the terms of the Country Transition Letter and as of the date
of execution of the Country Transition Letter, DIAMETRICS shall assume
responsibility for sales and Support of Consumables and Support (including
customer support and complaint activities) of the XXXX, Trendcare and idms
Products in the country, whether such Products were shipped or serviced by
PHILIPS or DIAMETRICS. Such responsibility shall not include any obligations of
PHILIPS accruing prior to the date of execution of such Country Transition
Letter, except for the obligations expressly assumed by DIAMETRICS under this
Amendment (including all Exhibits hereto) and under executed Country Transition
Letters.
2.7. Reversion of Rights.
(a) Except as expressly set forth herein, all rights with respect
to sales, support and distribution of the Consumables revert to DIAMETRICS,
including, without limitation, the right to sell and Support Consumables itself
or through a third party in the Field (as defined in the Agreement) for use with
any of the Products.
(b) Except as expressly set forth herein, all rights with respect
to XXXX, Trendcare, and idms Products revert to DIAMETRICS, including, without
limitation, the right to sell and Support XXXX ,Trendcare, and idms Products
itself or through a third party; provided however, that the Parties may agree,
on a case-by-case basis, to exceptions to permit PHILIPS to sell XXXX, Trendcare
and idms Products to customers, with reasonable compensation to both Parties.
2.8. Superceding Provisions. The Parties acknowledge and agree that the
rights and obligations with respect to Consumables set forth in this Amendment
supersede Section 11.4(a) of the Agreement.
3. Portal Product and Product Connectivity.
3.1. Connectivity. PHILIPS shall enable connectivity and ensure on-going
compatibility of (a) the XXXX and Trendcare Products into and with PHILIPS' CMS
and IntelliVue products using a VueLink type or other method of connectivity,
and (b) the Portal Products with PHILIPS' CMS products, in each case through
October 31, 2004; provided that DIAMETRICS supplies the necessary information
for PHILIPS to maintain such connectivity and compatibility, and that PHILIPS
shall be obligated to so modify or change its products only if the changes are
not major, or if PHILIPS desires to make changes that are major.
3.2. Access to Hardware and Software Upgrades and Support. PHILIPS
agrees to provide customers who purchase Portal Products from DIAMETRICS with
access to existing hardware and software upgrades for CMS and support for CMS on
a non-discriminatory basis from other customers who purchase Portal Products
from PHILIPS. PHILIPS shall provide its customary warranty and out-of-warranty
coverage for CMS.
3.3. License to DIAMETRICS' Technology. The Parties acknowledge that
PHILIPS' license to DIAMETRICS' Technology as set forth in Section 7.6 of the
Agreement shall survive
5
for the term of this Amendment, provided that PHILIPS complies with the terms of
Section 7.6 of the Agreement.
3.4. Manufacture of Portal Measurement Module. DIAMETRICS shall
manufacture the Portal Measurement Module solely for PHILIPS under the Portal
Manufacturing Agreement attached hereto as Exhibit 3.4. Nothing contained herein
shall restrict either Party's use of its solely and jointly owned Intellectual
Property.
3.5. Portal Product Purchases.
(a) DIAMETRICS shall have the non-exclusive right to purchase
Portal Product from PHILIPS for the term of this Amendment at prices set forth
on Exhibit 4.5 and to resell such Portal Products itself or through
distributors.
(b) DIAMETRICS shall only distribute the Portal Product directly to
end-users or through DIAMETRICS' distributors to end-users which accept software
license terms that are substantially the same as PHILIPS' standard end-user
license agreement for the Portal Product. PHILIPS standard end-user license
agreement for the Portal Product provides, inter alia, that only a personal,
nontransferable right to use any software incorporated in the Portal Product
(the "Software") is granted to such end user; that no title to the Software is
transferred to such end user; that such end user will not copy the Software
except as necessary to use such Software on a single CPU; that such end user
will not transfer the Software, except as authorized by the entity furnishing
the Software; that such end user will not in any form export, reexport, resell,
ship or divert or cause to be exported, reexported, resold, shipped or diverted,
directly or indirectly, the Software or a direct product thereof to any country
for which the United States Government or any agency thereof at the time or
export or reexport requires an export license or other governmental approval
without first obtaining such license or approval; and that such end user will
not reverse compile or disassemble the Software.
(c) PHILIPS hereby grants permission to DIAMETRICS to use any
PHILIPS trademark or trade name associated with the Portal Products if that use
is solely for the advertisement and promotion of the Portal Products during the
term of this Amendment. DIAMETRICS agrees to follow the guidelines at
xxx.xxxxxxx.xxx\brandbook, for distributors of PHILIPS products. These
guidelines may be changed by PHILIPS at any time, in its sole discretion.
PHILIPS shall have sole ownership of the following trademarks: (a) the word xxxx
"PHILIPS" and Philips Shield Emblem and (b) such other trademarks owned or
licensed to PHILIPS or its affiliates as may be designated by PHILIPS for use in
the course of performance under the terms of this Agreement (the "Trademarks".)
DIAMETRICS acknowledges all rights of PHILIPS in and to the Trademarks and
further agrees that use of the Trademarks for the purposes of this Agreement
shall not be construed as a grant of any rights in such Trademarks by or for the
benefit of DIAMETRICS. DIAMETRICS has no license to or right in the Trademarks
and shall not use them in its marketing or sales literature or in any other way,
except as provided in this section, without the prior, written consent of
PHILIPS.
6
4. Supply of Consumables, Portal Measurement Products and Portal Products.
4.1. Purchase Orders.
(a) PHILIPS shall issue to DIAMETRICS a monthly written, rolling,
non-binding three (3) month forecast of its purchase of Consumables. Such
forecasts shall be updated monthly. PHILIPS shall issue binding written purchase
orders for Consumables at least sixty (60) days prior to the proposed shipping
date for such items. All purchase orders in excess of PHILIPS' forecast shall be
subject to written acceptance by DIAMETRICS. DIAMETRICS will use reasonable
efforts to supply such items in a timely fashion, subject to DIAMETRICS'
reasonable production capabilities and provided that such purchase orders are
consistent with PHILIPS' forecasts.
(b) PHILIPS may purchase Portal Measurement Products from
DIAMETRICS in accordance with the Portal Manufacturing Agreement attached as
Exhibit 3.4.
(c) The Parties acknowledge that in order to provide the pricing
set forth herein for the Portal Measurement Products and Consumables, DIAMETRICS
may be required to purchase components and materials in reliance on PHILIPS'
non-binding forecasts. As a result, if PHILIPS fails to purchase the quantities
set forth in such non-binding forecasts and DIAMETRICS is unable, after using
commercially reasonable efforts, to cancel or delay the purchase of such
components and materials or to reallocate or reuse such components and materials
within ninety days of such forecast, PHILIPS shall reimburse DIAMETRICS for any
payments incurred by DIAMETRICS for any unusable inventory or non-cancelable
purchase commitments made in good faith reliance on the forecast for Portal
Measurement Products and Consumables, plus any actual out-of-pocket costs of
disposing of such components and materials. PHILIPS may take delivery of any
components and materials, for which it has reimbursed DIAMETRICS hereunder.
(d) To the extent that DIAMETRICS desires to purchase Portal
Products from PHILIPS, DIAMETRICS shall issue to PHILIPS a monthly written,
rolling, non-binding six (6) month forecast for such Portal Product. Such
forecasts shall be updated monthly. DIAMETRICS shall issue binding written
purchase orders for such Portal Product at least sixty (60) days prior to the
proposed shipping date. All purchase orders in excess of DIAMETRICS' forecast
shall be subject to written acceptance by PHILIPS. PHILIPS will use reasonable
efforts to supply such Portal Product in a timely fashion, subject to PHILIPS'
reasonable production capabilities and provided that such purchase orders are
consistent with DIAMETRICS' forecasts.
(e) The Parties acknowledge that in order to provide the pricing
set forth herein for the Portal Product, PHILIPS may be required to purchase
subcomponents and materials in reliance on DIAMETRICS non-binding forecasts. As
a result, if DIAMETRICS fails to purchase the quantities set forth in such
non-binding forecasts and PHILIPS is unable, after using commercially reasonable
efforts, to cancel or delay the purchase of such components and materials or to
reallocate or reuse such subcomponents and materials within ninety days of such
forecast, DIAMETRICS shall reimburse PHILIPS for any payments incurred by
PHILIPS for any unusable inventory or non-cancelable purchase commitments made
in good faith reliance on the forecast for such components, plus any actual
out-of-pocket costs of disposing of such
7
subcomponents and materials. DIAMETRICS may take delivery of any subcomponents
and materials, for which it has reimbursed PHILIPS hereunder.
4.2. Purchase Order Forms. Each Party shall be entitled to use its then
current standard purchase order for its purchases hereunder. In the event of a
conflict between the terms of any such purchase order and the terms of this
Amendment, the terms of this Amendment shall take precedence. Additional terms
included in the purchase order that are not terms of this Amendment will be
subject to prior mutual written agreement.
4.3. Delivery. All deliveries of Portal Products and Consumables shall be
made by the selling Party F.O.B. such selling Party's U.S. or European facility.
Title and risk of loss shall pass to the purchasing Party at the time of tender
at the selling Party's facility to the carrier designated by the purchasing
Party. Upon delivery to the purchasing Party's designated carrier, the
purchasing Party will assume title and risk of loss, and will be responsible for
transportation, and, if applicable, export of such products from the country of
manufacture and shall be entitled to any duty drawback for which the products
qualify. The selling Party shall provide the purchasing Party, upon the
purchasing Party's reasonable request and at the purchasing Party's expense,
reasonable substantiation and assistance with respect to such duty drawbacks.
The pricing for products excludes, and the purchasing Party shall pay, all
shipping, handling and insurance costs for and other costs of transporting such
products after delivery to the F.O.B. point.
4.4. Payment. All payments for Products shall be due and payable within
thirty-five (35) days of the date of the applicable invoice. The purchasing
Party shall make all payments in immediately available funds to the location and
in the manner reasonably designated by the selling Party from time to time. A
late fee shall be paid by the purchasing Party on any amount not received by the
selling Party when due at a rate of 1.5% per month on all unpaid amounts, or the
maximum rate permitted by law, whichever is less. As between the Parties, the
purchasing Party shall be responsible for all taxes relating to Products so
purchased (except for taxes on the selling Party's net income).
8
5. Product Warranty
5.1. Warranty for Consumables. DIAMETRICS warrants to PHILIPS that the
Consumables at the time of their delivery by DIAMETRICS to PHILIPS (a) shall
meet the agreed specifications as set forth on Exhibit 1.5; (b) shall have been
manufactured in accordance with all laws and regulations applicable to their
manufacture in those jurisdictions in which PHILIPS is distributing the
Consumables (provided that PHILIPS gives DIAMETRICS at least ninety (90) days
written notice of any jurisdictions in addition to those in effect as of the
Effective Date of this Amendment); (c) shall be new or newly manufactured; and
(d) shall be of good and merchantable title, free of liens and encumbrances.
DIAMETRICS shall, promptly, at DIAMETRICS' sole option, replace, repair or make
a purchase price (in the amount paid by PHILIPS to DIAMETRICS) refund for any of
such Consumables proved to be non-conforming, provided that written notice and
reasonable documented evidence of each warranty claim and the fact that the
failure occurred during the warranty period is received by DIAMETRICS within
thirty (30) days after the expiration thereof. DIAMETRICS shall have the sole
right to verify such non-conformance. Such replacement, repair or refund shall
be PHILIPS' sole remedy hereunder. Unless otherwise agreed by the Parties, the
warranty period under this Section 5.1 for (1) any Sensor shall be the stated
shelf life as set forth on the label for such Sensor, not to be less than ten
(10) months from the date of shipment to PHILIPS; (2) any Cartridge shall be the
stated shelf life as set forth on the label for such Cartridge, not less than
three (3) months from the date of shipment to PHILIPS, except that the shelf
life of the GL & H4 (M3587A & M3617A)) Cartridge shall be not less than nine (9)
weeks and the shelf life of H4E (M3617B) Cartridge shall be not less than eleven
(11) weeks; and (3) any Accessory shall be ninety (90) days from the date of
shipment to PHILIPS. If requested by DIAMETRICS, PHILIPS shall return the
non-conforming Consumable to DIAMETRICS at the time of submission of the
warranty claim therefore. PHILIPS agrees to provide DIAMETRICS sufficient notice
of additional countries in which it intends to distribute the Consumables to
permit DIAMETRICS to meet its obligations under subsection (b) of this Section
5.1.
5.2. Customer Complaints, Warranty Repair for Consumables. PHILIPS will
be responsible for handling customer complaints regarding the Consumables and
DIAMETRICS will provide reasonable assistance to PHILIPS in resolving such
customer complaints unless such country is transitioned pursuant to Section 2.6.
Upon transition in a particular country pursuant to Section 2.6, DIAMETRICS will
assume PHILIPS' obligations under this Section 5.2 and under any Consumables
warranties provided by PHILIPS' to its customers to the extent that such
warranties do not exceed the warranties provided by DIAMETRICS under Section
5.1. DIAMETRICS will accept the return of any Consumables that do not conform to
the warranties set forth in Section 5.1, and will repair or replace any such
defective Consumable (or refund PHILIPS' purchase price) as provided in Section
5.1.
5.3. Supply of Consumables to Customers. DIAMETRICS will continue to make
Consumables available to customers for a period of five (5) years from the last
production run of the XXXX, Trendcare and Portal Products; this obligation shall
survive the termination or expiration of this Amendment.
5.4. Warranty for Portal Products. PHILIPS shall warrant the Portal
Products to DIAMETRICS in accordance with the terms of the warranty attached
hereto as Exhibit 5.4.
9
5.5. Warranty for Products Purchased Prior to Effective Date. Sections
8.2 through 8.4 of the Agreement survive expiration of the Agreement with
respect to Products (other than Portal Measurement Products) purchased by
PHILIPS from DIAMETRICS prior to the Effective Date of this Amendment; provided
however, that upon transition in a particular country pursuant Section 2.6,
DIAMETRICS will assume PHILIPS' obligations under Sections 8.2 through 8.4 of
the Agreement for such Products in such country. Portal Measurement Products
will be warranted in accordance with the Portal Manufacturing Agreement,
attached hereto as Exhibit 3.4.
5.6. Warranty Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN SECTIONS 5.1,
5.4 and 5.5, THE SELLING PARTY MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
5.7. Customer Warranties. The purchasing Party shall be entitled to
warrant the applicable Products to its customers on terms it deems appropriate;
provided that the purchasing Party shall bear any expenses it may incur with
respect to such warranties, to the extent that such warranties exceed the scope
or term of the express warranties made by the selling Party hereunder.
6. Intellectual Property.
6.1. Intellectual Property from Agreement. Ownership of Intellectual
Property of the Products under the Agreement remains unchanged. Under the terms
of the Agreement, the Parties acknowledge and agree that the ownership of the
Intellectual Property in certain Products and the Portal Measurement Products
shall be as set forth on Exhibit 6.1. Nothing in Exhibit 6.1 shall imply any
further commitment by either party under this Amendment to develop the C-BAM or
X-BAM.
6.2. Software Licenses. To the extent that a Party (each, a "distributing
Party") receives one or more copies of any software of the other Party
hereunder, it shall have the right to use that software internally in order to
exercise its rights hereunder. The foregoing use right shall not include the
right to copy and distribute such software, copies of which must be purchased
from the other Party. In addition and subject to Section 3.5(b), the Parties
acknowledge that any software or other proprietary portion of the applicable
Products is licensed, not sold, to the distributing Party and its end user
customers, and that such license shall be pursuant to the distributing Party's
customary license terms used for the distributing Party's customary license
terms used for the distributing Party's software or proprietary products as are
in effect from time to time.
7. Regulatory Matters.
7.1. Regulatory Approvals. DIAMETRICS will retain all rights to and
ownership of all regulatory approvals for the Products (excluding Portal
Products), and will grant to PHILIPS a right of reference to its regulatory
submissions and technical files for all Products, including, without limitation,
those regulatory approvals as necessary to fulfill its obligations hereunder.
DIAMETRICS will maintain FDA and EU regulatory approvals for the Products
(excluding
10
Portal Products). PHILIPS will retain all rights to and ownership of all
regulatory approvals for Portal Products, and will grant to DIAMETRICS a right
of reference to its regulatory submissions and technical files, including,
without limitation, those regulatory approvals as necessary to fulfill its
obligations hereunder. PHILIPS will maintain FDA and EU regulatory approvals for
Portal Products. Prior to the transition contemplated in Section 2.6, PHILIPS
will use commercially reasonable efforts to transfer and assign to DIAMETRICS
such regulatory approvals in the applicable country that are held by PHILIPS (or
its distributors) and that apply specifically to the Consumables and XXXX,
Trendcare and idms Products (including approvals to import and sell the
Consumables and XXXX, Trendcare and idms Products), to the extent that such
approvals may be transferred and assigned lawfully.
7.2. Product Inserts and Labeling. DIAMETRICS shall be responsible for
the text and regulatory compliance of all package labels and Product inserts
used in connection with the Products (except Portal Products). PHILIPS shall be
responsible for the text and regulatory compliance of all package labels and
product inserts used in connection with Portal Products. All Portal Product
labels and labeling shall be as set forth in the current specifications for the
Portal Product. For purposes of this Agreement, the terms "label" and "labeling"
shall have the meanings set forth in Sections 201(k) and 201(m) respectively of
the U.S. Federal Food, Drug and Cosmetics Act.
7.3. Product Reporting.
(a) DIAMETRICS will maintain MDR and other product performance
monitoring systems for the Products (excluding Portal Products), and PHILIPS
will maintain MDR and other product performance monitoring systems for Portal
Products. The Distributing Party shall cooperate with the Manufacturing Party in
connection with the Manufacturing Party's obligations under this Section 7.3.
The Distributing Party shall provide to the Manufacturing Party, the necessary
reports relating to complaints and product performance issues relating to the
Products on a timely basis to permit the reporting party to fulfill its
regulatory obligations. Notwithstanding the foregoing, upon the execution of a
Country Transition Letter, DIAMETRICS shall become responsible for complaint
handling in that country, as set forth in the Service and Support Agreement
attached hereto as Exhibit 2.2. Upon reasonable request by the Manufacturing
Party, the Distributing Party shall promptly make such reports (on behalf of the
Manufacturing Party, if appropriate) directly to the appropriate regulatory
authorities.
(b) For the purposes of this Section 7.3(b), DIAMETRICS shall be
the Manufacturing Party for the Products, except for the Portal Product for
which PHILIPS shall be the Manufacturing Party. PHILIPS shall be the
Distributing Party for the Products, except for the Portal Product for which
DIAMETRICS shall be the Distributing Party. The Distributing Party shall
maintain sales and service records to assist it in locating the applicable
Products for the purpose of implementing recalls and other corrective actions.
If the Manufacturing Party implements a recall or corrective action in
accordance with Section 7.5 of this Amendment, the Distributing Party shall
provide such location information to the Manufacturing Party unless the
Distributing Party implements such recall or corrective action itself. Each
Party shall be responsible for bearing its own costs associated with all product
tracking, complaint analyses and related evaluations.
11
7.4. Regulatory Audits. Each Party shall permit the other Party
reasonable access to its regulatory records, no more than once in any twelve
(12) month period, to permit the auditing Party to determine that regulatory
obligations are being met. The auditing Party shall provide ten (10) days prior
written notice of such an audit.
7.5. Product Recall
(a) If either Party believes that a recall of any Product
distributed under this Amendment is desirable or required by law, it shall
promptly notify the other Party. The Parties shall then discuss reasonably and
in good faith whether such recall is appropriate or required and the manner in
which any mutually agreed recall shall be handled. This Section 7.5 shall not
limit the obligations of either Party under law with respect to recall of
Products required by law or properly mandated by governmental authority.
Voluntary recalls shall be conducted by mutual agreement (with such agreement
not to be unreasonably withheld) provided that if mutual agreement is not
reached, either Party may individually conduct the voluntary recall in question
in a manner consistent with its own regulatory guidelines and criteria. The
"Recalling Party" shall bear all costs and expenses of any voluntary recall of
any Products and shall reimburse the "Other Party" for the reasonable,
out-of-pocket costs incurred by the Other Party as a result of such recall,
including the replacement cost of any Products affected thereby, unless the
cause or basis of such recall is attributable to a condition, fact or action
that constitutes (i) a breach by the Other Party of any of its obligations
hereunder or (ii) negligence or willful misconduct of the Other Party in which
case the Other Party will be liable for the costs and expenses of such recall,
and shall reimburse the Recalling Party for the reasonable, out-of-pocket costs
incurred by Recalling Party as a result of such recall, including the
replacement cost of any Product affected thereby. The Parties shall cooperate
fully with each other in effecting any recall of the Products pursuant to this
Section 7.5, including communications with any customers or to the public.
(b) For the purposes of this Section 7.5(b) for the Products
purchased under this Amendment, DIAMETRICS shall be the Manufacturing Party for
the Products, except for the Portal Product for which PHILIPS shall be the
Manufacturing Party. PHILIPS shall be the Distributing Party for the Products,
except for the Portal Product for which DIAMETRICS shall be the Distributing
Party. If any governmental agency having jurisdiction (including without
limitation the FDA) shall request or order any corrective action with respect to
Products supplied hereunder, including any Product recall, customer notice,
restriction, corrective action or market action or any Product change, the
Manufacturing Party shall bear the costs and expenses of such corrective action
and shall reimburse the Distributing Party for the reasonable, out-of-pocket
costs incurred by the Distributing Party as a result of such corrective action,
including the replacement cost of any Products affected thereby, unless the
cause or basis of such corrective action is attributable to a condition, fact or
action that constitutes (A) a breach by the Distributing Party of any of its
obligations hereunder or (B) negligence or willful misconduct of the Other
Party, in which case, the Distributing Party shall bear the costs and expenses
of such corrective action, and shall reimburse the Manufacturing Party for the
reasonable out-of-pocket costs incurred by the Manufacturing Party as a result
of such action, including the replacement cost of any Product affected thereby.
Recalls of the Portal Measurement Products are excluded from this Section 7.5
and covered by Section 18 of the Portal Manufacturing Agreement.
12
7.6. Products for Products Purchased Prior to Effective Date. Article 6
(Regulatory) of the Agreement survives expiration of the Agreement with respect
to Products (other than Portal Measurement Products) purchased by PHILIPS from
DIAMETRICS prior to the Effective Date of this Amendment; provided however, that
upon transition in a particular country pursuant Section 2.6, for that country
DIAMETRICS shall assume PHILIPS' obligations under Section 6.4 (Product
Reporting) and 6.5 (Product Recalls) in the Agreement for those transitioned
Products and as set forth in the Service and Support Agreement attached hereto
as Exhibit 2.2.
8. Term and Termination
8.1. Term. This Amendment shall become effective upon the Effective Date
hereof and shall expire on October 31, 2004 or terminate as set forth in this
Article 8.
8.2. Termination for Material Breaches. In the event of a material
default by a Party of a material obligation hereunder, including, but not
limited to, failure to pay any material moneys due excepting amounts as to which
there is a legitimate dispute, the other Party may provide written notice to the
defaulting Party. If the defaulting Party fails to cure such default within
ninety (90) days (or ten (10) days in the case of amounts owing that are not
subject to a good faith dispute) of such notice, this Amendment shall terminate
in its entirety (except for such rights and obligations that expressly survive
pursuant to Section 8.4) effective upon the expiration of such cure period. In
the case of bankruptcy or insolvency of a Party, to the extent permitted by U.S.
bankruptcy law, the other Party may terminate this Agreement in its entirety
(except for such rights and obligations that expressly survive pursuant to
Section 8.4) effective immediately upon written notice to such Party.
8.3. No Prejudice. Termination of this Agreement for any reason shall be
without prejudice to either Party's right to receive all payments accrued and
unpaid on the effective date of termination and shall not release either party
hereto from any liability which at such time has already accrued or which
thereafter accrues from a breach or default prior to such expiration or
termination. Except as expressly provided herein, all of the parties' rights and
remedies hereunder are cumulative and non-exclusive.
8.4. Surviving Obligations of the Amendment. No termination or expiration
of this Amendment shall affect or discharge any obligations, rights,
disclaimers, conditions or limitations of either Party which arose prior to the
effective date of such termination. The following Sections of this Amendment
shall survive termination or expiration of the Amendment: Articles 5 (Product
Warranty), 6 (Intellectual Property), 7 (Regulatory Matters), 8 (Term and
Termination), 9 (Confidentiality) and 10 (Miscellaneous) and any Sections
necessary to give effect to this Section 8.4 shall survive any termination or
expiration of this Amendment.
9. Confidentiality
9.1. Non-Use and Non-Disclosure. Each Party acknowledges and agrees that
all the other Party's Confidential Information is confidential to the disclosing
Party. Each Party shall take the same reasonable measures as it uses to protect
its own confidential information from the unauthorized disclosure or misuse to
protect the other Party's Confidential Information from unauthorized disclosure
or misuse, including without limitation, any disclosure by its employees,
13
agents, contractors, permitted sublicensees, or consultants of the other Party's
Confidential Information. As used herein, the term reasonable measures shall
mean at least those measures a Party applies to the protection of its own
Confidential Information and the term misuse shall mean use for any purpose
other than as permitted or required hereunder.
9.2. Marking. To be entitled to protection as Confidential Information,
all DIAMETRICS or PHILIPS documents containing that Party's Confidential
Information shall be appropriately and clearly marked as "Proprietary,"
"Secret," "Confidential," or other words to similar effect. If a disclosure of
Confidential Information is made orally, as in a meeting, the disclosing Party
shall indicate the nature of that information at the time of its disclosure and
shall confirm such designation in writing within ten (10) days of the date of
such disclosure to the receiving Party.
9.3. Exclusions. Information shall not be considered Confidential
Information hereunder if it:
(a) was already in the possession of the receiving Party prior to
its receipt from the disclosing Party;
(b) is, or becomes, part of the public knowledge or literature
through no fault, act or omission of the receiving Party, provided, Confidential
Information shall not be deemed to have entered the public domain by reason of
its having been filed with any regulatory authority; provided the disclosing
Party has taken advantage of any procedures available to protect
confidentiality, including FOIA marking and protective orders;
(c) is, or becomes, available to the receiving Party from a source
other than the disclosing Party, which source has rightfully obtained the same
information and has no obligation of confidentiality to the disclosing Party
with respect to it;
(d) is made available on an unrestricted basis by the disclosing
Party to a third party unaffiliated with the disclosing Party; or
(e) is required to be revealed pursuant to law or requirements of
any securities exchange on which a Party's shares are listed and traded,
provided, however, the receiving Party which is under any such requirement of
law shall give reasonable notice to the disclosing Party of such requirement and
shall cooperate with the disclosing Party, at the disclosing Party's expense in
reasonable legal efforts to limit or mitigate any such revelation so as to
preserve the proprietary nature of any Confidential Information contained
therein.
9.4. Duration; Surviving Obligation. This Article 9 shall be deemed to
cover and include any non-public information disclosed by a Party to the other
during the course of their negotiations of this Amendment, whether or not marked
or indicated as provided in Section 9.2. Each Party's obligations of non-use and
non-disclosure of the other Party's Confidential Information shall apply during
the term of this Amendment and shall also survive for a period of three (3)
years after its termination for any reason.
9.5. Confidentiality of this Agreement. The terms of this Amendment
itself and the Exhibits hereto shall be deemed to be Confidential Information
hereunder. In the event that a
14
Party is required to disclose the content of this Amendment pursuant SEC
requirements or requirements of any securities exchange on which a Party's share
are listed and traded, such Party shall use its reasonable efforts to obtain
confidential treatment of at least the terms of Exhibits 2.1, 2.4 , 3.5, and
6.1.
10. Miscellaneous
10.1. Effect of this Amendment, Entire Agreement. Except as expressly
amended hereby, the surviving terms of the Agreement shall continue in full
force and effect, in accordance with its terms. In the event of any conflict
between this Amendment and the surviving terms of the Agreement, this Amendment
shall prevail. The Agreement and this Amendment, including all Exhibits thereto
and hereto, set forth the entire agreement between Parties with respect to the
subject matter hereof and as such, supersede all prior and contemporaneous
negotiations, agreements, representations, understandings and commitments with
respect thereto and shall take precedence over all terms, conditions and
provisions on any purchase order form, or order acknowledgment, or order release
purporting to address the same subject matter. Neither the Agreement nor this
Amendment shall be released, discharged, changed or modified in any manner
except by a writing signed by the duly authorized officers or agents of each
Party hereto, which writing shall make specific reference to the Agreement or
Amendment and shall express the plan or intention to modify same.
10.2. Surviving Provisions of the Agreement. Sections 3.7 (Trademarks),
3.11 (License of Product Software), 10 (Indemnification) and 13 (Miscellaneous)
(excluding Sections 13.2, 13.5, 13.6, 13.13 and 13.15) of the Agreement are
incorporated by reference and made a part of this Amendment. Sections 6.4, 6.5,
10 and 13 (excluding Sections 13.2, 13.5, 13.6, 13.13 and 13.15) of the
Agreement shall survive termination or expiration of this Amendment.
10.3. Binding Effect and Assignment. During the term of this Amendment,
the rights of either Party under this Amendment and the surviving rights under
the Agreement shall not be assigned nor shall the performance of either Party's
duties hereunder be delegated, without the other Party's written consent (which
shall not be unreasonably withheld) except that, without the other Party's prior
consent, either Party may assign this Amendment and the Agreement (i) to an
Affiliate that is an affiliate as of the date of execution of this Amendment or
(ii) to an Affiliate whose assets consist entirely of the assets of an Affiliate
or Affiliates that were Affiliates as of the date of execution of this Amendment
or (iii) in connection with a merger, consolidation, reorganization or sale of
substantially all of its assets. No sale, assignment or other transfer of any
rights of a Party hereunder shall be effective unless the purchaser, assignee or
transferee assumes such Party's obligations under this Amendment and the
Agreement. Any assignment shall not relieve the assigning Party of its
responsibility for its obligations hereunder. Nothing in this Section 10.3 shall
restrict a Party from appointing sales agents and distributors in the normal
course of business.
10.4. Communications. Within ten (10) days of the Effective Date, the
Parties will confer with each other on each Party's written communications
describing the Parties' agreement with respect to distribution and Support of
the Products; provided that each Party retains the right to communicate with
such customers in a manner that it deems appropriate.
15
10.5. Publicity. Neither Party hereto shall originate any joint publicity,
joint news release, or other joint announcement, written or oral, whether to the
public press, the trade, PHILIPS' or DIAMETRICS' customers or otherwise,
relating to this Amendment, or to performance hereunder or the existence of an
arrangement between the Parties.
10.6. Limitation on Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY UNDER THIS AMENDMENT FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL OR PUNITIVE
DAMAGES, REGARDLESS OF WHETHER SUCH PARTY HAS BEEN INFORMED OF THE POSSIBILITY
OF SUCH DAMAGE.
IN WITNESS WHEREOF, PHILIPS and DIAMETRICS have executed this Amendment by
their respective duly authorized officers or representatives as of the day first
above written.
DIAMETRICS MEDICAL PHILIPS MEDICAL SYSTEMS
INCORPORATED
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxxx
-------------------------------- -------------------------------
Schedule of Exhibits:
----------------------------------------------------------------------
Exhibit:
-------
----------------------------------------------------------------------
Exhibit 1.5 Accessories, Cartridges and Sensors
----------------------------------------------------------------------
Exhibit 2.1 Prices for Consumables and Portal Measurement Modules
----------------------------------------------------------------------
Exhibit 2.2 Service and Support Agreement
----------------------------------------------------------------------
Exhibit 2.4 PHILIPS Product Inventory
----------------------------------------------------------------------
Exhibit 2.6 Country Transition Letter
----------------------------------------------------------------------
Exhibit 3.4 Portal Manufacturing Agreement
----------------------------------------------------------------------
Exhibit 3.5 Prices for Portal Products supplied by PHILIPS
----------------------------------------------------------------------
Exhibit 5.4 PHILIPS Warranty on Portal Products
----------------------------------------------------------------------
Exhibit 6.1 IP Ownership
----------------------------------------------------------------------
16
Exhibit 1.5
Cartridges and Sensors
(Specifications are Subject to change during the term of the Agreement)
1. NEOTREND
The Neotrend system (Neotrend sensor and TrendCare hardware) is intended
for continuous monitoring of pO//2//, pCO//2//, pH and temperature in
neonatal arterial blood. An Umbilical Artery Catheter is used as an access
device.
1.1 Neotrend Sensor
The sensor incorporates optical sensors for the measurement of pO//2//,
pCO//2// and pH, and a thermocouple for temperature measurement. The sensor
is calibrated in the TrendCare Calibrator. It is a sterile, disposable
single-use device and is used in conjunction with an Umbilical Artery
Catheter as an access device.
1.2 Neotrend Sensor Specifications
Measured Parameters pO//2//, pCO//2//, pH and temperature
Range pO//2// 20 to 500mmHg
pCO//2// 10 to 160mmHg
pH 6.80 to 7.80
Temp 10DEG. to 42DEG.C
Performance specifications meet 95% confidence limits based on in vitro
evaluations using tonometered solution
In vitro Accuracy pO//2// +/- 5% or +/- 3mmHg less than
120mmHg
(whichever is greater
+/- 10% (120 - 430mmHg)
pCO//2// +/- 3mmHg (10 - 80mmHg)
pH +/- 0.03
Temp +/- 0.3DEG.C
Drift pO//2// less than 0.5%/hour
pCO//2// less than 0.5%/hour
pH less than 0.005/hour
Time to Respond Typically less than 15 seconds @
37DEG.C
Outside Diameter Less than 0.5 mm (average)
Material (in contact with blood) Polyethylene with covalently-bonded
bioactive surface treatment/1/
Sterilization Gamma irradiation. For single use
only.
----------
/1/ Carmeda Bioactive Surface - heparin
Shelf Life 18 months, indicated by expiry date on
the package.
Package Sterile product within sealed
thermoformed tray.
Storage 0DEG.C to 40DEG.C. Do not freeze.
2. PARATREND 7
The Paratrend 7 system (Paratrend 7 sensor and TrendCare hardware) is
intended for continuous monitoring of pO//2//, pCO//2//, pH and temperature
in an adult or paediatric peripheral artery. Usually a radial or femoral
arterial catheter is used as an access device.
2.1 Paratrend 7 Sensor
The sensor incorporates optical sensors for the measurement of pO//2//,
pCO//2// and pH, and a thermocouple for temperature measurement. The sensor
is calibrated in the TrendCare Calibrator and then connected to the
TrendCare monitor. It is a sterile, disposable, single use device and is
used in conjunction with an arterial catheter.
The sensor has two introducer versions: a telescopic introducer for the
Paratrend 7/FL/ and a dial-in introducer for the Paratrend 7+.
2.2 Paratrend 7+ Sensor Specifications
Measured Parameters pO//2//, pCO//2//, pH and temperature
Range pO//2// 20 to 500mmHg
pCO//2// 10 to 160mmHg
pH 6.80 to 7.80
Temp 10DEG. to 42DEG.C
Performance specifications meet 95% confidence limits based on in vitro
evaluations using tonometered solution
In vitro Accuracy pO//2// +/- 5% or +/- 3mmHg less than
120mmHg
(whichever is greater))
+/- 10% (120 - 430mmHg)
pCO//2// +/- 3mmHg (10 - 80mmHg)
pH +/- 0.03
Temp +/- 0.3DEG.C
Drift pO//2// less than 0.5%/hour
pCO//2// less than 0.5%/hour
pH less than 0.005/hour
Time to Respond Typically less than 15 seconds @
37DEG.C
Outside Diameter Less than 0.5mm (average)
Material (in contact with blood) Polyethylene with covalently-bonded
bioactive surface treatment/2/
Sterilisation Gamma irradiation. For single use
only.
Shelf Life 18 months, indicated by expiry date on
the package.
Package Sterile product within sealed
thermoformed tray.
Storage 0DEG.C to 40DEG.C. Do not freeze.
3. Intermittent Cartridge
The Cartridges are compatible with the XXXX SL Blood Analysis System & a subset
are also compatible with the Portal Product.
Cartridge Specifications (XXXX & Portal):
Category Specification
--------------------------------------------------------------------------------
Operating Temperature: 12-30C (54-86F)
Cartridge Storage Temperature: 15-30C (59-86F)
Measurement Temperature: 37C
----------
/2/ Carmeda, Bioactive Surface - Heparin
Operating Relative Humidity: 0-80%
Operating Barometric Pressure: 350-900 mmHg (measured by on-board
barometer)
Sample Size: 0.125-5.0 mL
Analysis Time: Less than 90 seconds after sample injection
(depends on parameter)
Size (LxWxH) and Weight:
Cartridge Temp Card: 2.6" x 1.3" x 0.6; 1oz.
66 x 33 x 15.24mm; 28g.
Cartridge/Analyte Configurations:
Cartridges are available in the following configurations:
--------------------------------------------------------------------------------
Cartridge Measured Calculated
================================================================================
11. BG pH, pCO//2//, pO//2// HCO//3///-/, TCO//2//, Beb,
BEecf, O//2//Sat
--------------------------------------------------------------------------------
CC pH, pCO//2//, pO//2//, HCT, HCO//3///-/, TCO//2//, Beb,
Na/+/, K/+/, iCa BEecf, O//2//Sat, tHb, iCa(N)
--------------------------------------------------------------------------------
H3 HCT, Na/+/, K/+/, iCa tHb, iCa(N)
--------------------------------------------------------------------------------
H4 HCT, Na/+/, K/+/, Cl/-/, tHb
BUN/Urea
--------------------------------------------------------------------------------
GL/3/ Glu, Na/+/, K/+/, Cl/-/
--------------------------------------------------------------------------------
Cartridge Equilibration Times:
Following removal from their shiping container, XXXX cartridges must equilibrate
to room temperature prior to use. Equilibration time depends on the product type
as follows:
---------------------------------------
Cartridge Equilibration Time (hours)
=======================================
BG 72
---------------------------------------
CC 72
---------------------------------------
H3 1
---------------------------------------
H4 1
---------------------------------------
GL/1/ 1
---------------------------------------
----------
/3/ Available only on XXXX
Reportable Ranges :
The default reportable ranges for each parameter are as follows:
-------------------------------------------------------------------
Measured
-------------------------------------------------------------------
pH 6.000 - 8.000 pH units
-------------------------------------------------------------------
pCO//2// 4.0 - 200.0 mmHg (0.53 - 26.6 kPa)
-------------------------------------------------------------------
pO//2// 20.0 - 700.0 mmHg (2.67 - 93.33 kPa)
-------------------------------------------------------------------
Hct 10.0 - 80.0 % (.100 -.800 SI)
-------------------------------------------------------------------
Na/+/ 80.0 - 200.0 (mM, mEq/L)
-------------------------------------------------------------------
K/+/ 1.00 - 20.0 (mM, mEq/L)
-------------------------------------------------------------------
iCa 0.20 - 5.00 mM (0.80 - 20.4 mg/dL; 0.40 - 10.00 mEq/L)
-------------------------------------------------------------------
Cl/-/ 30.0 - 150.0 (mM, mEq/L)
-------------------------------------------------------------------
BUN/urea (H4 P/N 055700)
-------------------------------------------------------------------
BUN 3 - 100 mg/dL (1.1 - 3.57 mM)
-------------------------------------------------------------------
Urea 6 - 321 mg/dL (1.1 - 35.6 mM)
-------------------------------------------------------------------
BUN/urea (H4 P/N 055703)
-------------------------------------------------------------------
BUN 3 - 150 mg/dL (1.1 - 53.5 mM)
-------------------------------------------------------------------
Urea 6 - 321 mg/dL (1.1 - 53.4 mM)
-------------------------------------------------------------------
Glu/1/ 20 - 500 mg/dL (1.1 - 27.8)
-------------------------------------------------------------------
Calculated
-------------------------------------------------------------------
HCO//3///-/ 0 - 99.9 mM
-------------------------------------------------------------------
TCO//2// 0 - 99.9 mM
-------------------------------------------------------------------
Beb +/- 99.9 mM
-------------------------------------------------------------------
Beecf +/- 99.9 mM
-------------------------------------------------------------------
O//2//Sat 0 - 100%
-------------------------------------------------------------------
tHb 3.4 - 27.2 g/dL (2.1 - 16.9 mM)
-------------------------------------------------------------------
iCa(N) 0.20 - 5.00 mM (0.80 - 20.04 mg/dL; 0.40 - 10.00 mEq/L
-------------------------------------------------------------------
Display Resolution:
The display resolution for each parameter is as follows:
-------------------------------------------------------------------
Measured
-------------------------------------------------------------------
pH 0.001 pH units
-------------------------------------------------------------------
pCO//2// 0.1 mmHg (0.01 kPa)
-------------------------------------------------------------------
pO//2// 0.1 mmHg (0.01 kPa)
-------------------------------------------------------------------
Hct 0.1% (.001 SI)
-------------------------------------------------------------------
Na/+/ 0.1 (mM, mEq/L)
-------------------------------------------------------------------
K/+/ 0.01 (mM, mEq/L)
-------------------------------------------------------------------
iCa 0.01 (mM, mEq/L, mg/dL)
-------------------------------------------------------------------
Cl/-/ 0.1 (mM, mEq/L)
-------------------------------------------------------------------
BUN/Urea 1 mg/dL (0.1 mM)
-------------------------------------------------------------------
Glu 1 mg/dL (0.1 mM)
-------------------------------------------------------------------
----------
/1/ Available only on XXXX
EXHIBIT 2.1
PRODUCT PRICES
1. Cartridges
------------------------------------------------------
Philips P/N DMI P/N Transfer Price
(ea box of 25)
------------------------------------------------------
M3614A 048100 BG ***
------------------------------------------------------
M3615A 048400 H3 ***
------------------------------------------------------
M3616A 039900 CC ***
------------------------------------------------------
M3680A 048102 BG ***
------------------------------------------------------
M3681A 048400 H3 ***
------------------------------------------------------
M3682A 039902 CC ***
------------------------------------------------------
M3584A 048103 BG ***
------------------------------------------------------
M3585A 048400 H3 ***
------------------------------------------------------
M3586A 039903 CC ***
------------------------------------------------------
M3617A 055700 H4 (original) ***
------------------------------------------------------
M3617B 055703 H4 (new) ***
------------------------------------------------------
M3587A 065200 GL ***
------------------------------------------------------
2. XXXX Products and accessories (used for support)
-------------------------------------------------------------------------
Philips P/N DMI P/N Transfer
price ea
-------------------------------------------------------------------------
M3664A 448700 NiMH Battery for XXXX ***
-------------------------------------------------------------------------
M3628A 442900 XxXX 00 Xxx Xxxxxxx Charger, ***
-------------------------------------------------------------------------
M3629A 573400 15 V power supply ***
-------------------------------------------------------------------------
M3669A 438000 XXXX Carrying Bag ***
(will get 5x5 number for support use)
-------------------------------------------------------------------------
M3670A 440100 AC Adapter assembly ***
-------------------------------------------------------------------------
M3666A 432001 XXXX Temp Card ***
-------------------------------------------------------------------------
M3671A 403800 XXXX print paper 5 rolls ***
-------------------------------------------------------------------------
M3624A 443800 Pole mount for XXXX (will get 5x5 ***
number for support use)
-------------------------------------------------------------------------
M3627A J&J Lifescan SureStep Pro glucose ***
module--
5x5 number M3627-60101 for support use
-------------------------------- ----------------------------------------
M3674A 040500 Capillary Collection device ***
-------------------------------------------------------------------------
----------
*** Denotes confidential information that has been omitted from the exhibit and
filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
-------------------------------------------------------------------------
M3679A 428400 XXXX edge connector ***
-------------------------------------------------------------------------
M3672A 450000 XXXX edge connector cleaner ***
-------------------------------------------------------------------------
M3677A 463120 Barcode scanner and mount (will get ***
5x5 part number)
-------------------------------------------------------------------------
M3678A 463130 Barcode scanner mount kit (will get ***
5x5 part number)
-------------------------------------------------------------------------
M3622-68701 443900 DMI-443900 XXXX, Modem (Glucose ready) ***
-------------------------------------------------------------------------
M3622-60701 443900 DMI-443900 XXXX, Modem (Glucose ready) ***
(for support only)
-------------------------------------------------------------------------
M3623-68701 443901 DMI-443901 XXXX, w/out Modem (Glucose ***
ready)
-------------------------------------------------------------------------
M3623-60701 443901 DMI-443901 XXXX, w/out Modem (Glucose ***
ready) (for support only)
-------------------------------------------------------------------------
M3622-40301 402000 XXXX printer cover ***
453563339101
-------------------------------------------------------------------------
M3622-42501 420400 XXXX printer spindle ***
453563339111
-------------------------------------------------------------------------
M3622-61610 552700 Cable RJ45 ***
453563339141
-------------------------------------------------------------------------
M3622-61620 552702 Cable - RJ45/modRJ45 ***
453563339151
-------------------------------------------------------------------------
M3622-63901 428400 Edge connector kit ***
453563339161
-------------------------------------------------------------------------
M3622-67610 552900 Adapter-RJ45/DB9 Female ***
453563339171
-------------------------------------------------------------------------
M3622-67611 552800 Adapter-RJ45 to DB9 male ***
453563339181
-------------------------------------------------------------------------
M3622-67620 514000 Adapter-RJ45 to DB25 ***
453563339191
-------------------------------------------------------------------------
M3622-67621 516000 Adapter RJ45/DB25 ***
453563339201
-------------------------------------------------------------------------
Note 1: Pricing for repair and reconditioning as follows:
XXXX SL in Warranty requiring repair only ***
XXXX SL in warranty requiring repair and reconditioning ***
XXXX SL out of Warranty requiring repair only ***
XXXX SL out of warranty requiring repair and reconditioning ***
----------
*** Denotes confidential information that has been omitted from the exhibit and
filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
3. idms Products (used for support)
-------------------------------------------------------------------------
Philips P/N DMI P/N Transfer
price each
-------------------------------------------------------------------------
M3667-10802 464100 XXXX idms SW 6.0 Disk set, Data ***
management
-------------------------------------------------------------------------
M3667-10803 463000 XXXX idms SW 4.0.7 Disk set, Data ***
management
-------------------------------------------------------------------------
M3667-20002 468600 idms v5 Assembled Binder 1.5" ***
-------------------------------------------------------------------------
M3667-9001C 464000 idms Manual Contents ***
-------------------------------------------------------------------------
4. Trendcare Products (used for support)
---------------------------------------------------------
Transfer Price each
---------------------------------------------------------
M3651-60110 Trendcare Satellite ***
TCM 6000
---------------------------------------------------------
M3651-60111 Trendcare Satellite ***
TCM 6000/Nordic
---------------------------------------------------------
M3650-60101 Senior monitor (115V) ***
---------------------------------------------------------
M3650-60102 Senior monitor (230V) ***
---------------------------------------------------------
M3652-60101 calibrator ***
---------------------------------------------------------
M3653-60101 PDM ***
---------------------------------------------------------
M3651-68101 Exchange satellite ***
---------------------------------------------------------
M3652-68101 Exchange calibrator ***
---------------------------------------------------------
M3653-68101 Exchange PDM ***
---------------------------------------------------------
5. Trendcare Sensors and accessories
-------------------------------------------------------------------------------
Philips P/N DMI P/N Transfer price
-------------------------------------------------------------------------------
XXXXX XXXXXXX Trendcare software (new features only) ***
-------------------------------------------------------------------------------
M3643A XXX0000X Xxxxxxxxx sensor, 5/pack, 7+ ***
-------------------------------------------------------------------------------
M3673A N7004L Neotrend sensor, 5/pack L N7004L ***
-------------------------------------------------------------------------------
M3654A MPP7005 Thermal printer paper MPP 7005 ***
-------------------------------------------------------------------------------
M3655A MCG7010 Gas packs, 3 cylinders, F1 ***
MCG 7010
-------------------------------------------------------------------------------
M3644A AST015 Fixation strap, 15 pack ***
-------------------------------------------------------------------------------
----------
*** Denotes confidential information that has been omitted from the exhibit and
filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
Exhibit 2.2
Support and Services Agreement between Philips Medical Systems and Diametrics
Medical, Inc.
1
Table of Contents
Sections
1.0 Introduction
2.0 Roles and Responsibilities
3.0 Repair Strategy
4.0 WW Call Flow with Distributors
5.0 Call flow for Europe/Asia Pacific
6.0 Call flow for US and Canada
7.0 Resource Definition
8.0 Training Definition
9.0 Diametrics Warranty
10.0 Service Call Coding Requirement
11.0 Service/Repair for End of Support
12.0 Repair and Return of IRMA's
13.0 Repair and Return of Trendcare
14.0 IDMS Support
15.0 Service Repair Pricing
16.0 After Hours Support Consumables
17.0 Customer Training
18.0 Customer Training Materials
19.0 Additional Customer Needs
20.0 Escalation
2
1.0 Introduction
This document is an exhibit to the Amendment to the Manufacturing and
Distribution Agreement, dated April 10, 2003. All capitalized terms not defined
in this Agreement will have the meanings set forth in the Amendment. In case of
any conflict between this exhibit and the Amendment, the Amendment will control.
The purpose of this document is to define the roles and responsibilities of
Philips Medical Systems ("Philips") and Diametrics Medical, Inc. ("Diametrics")
in support of M3622A and M3623A XXXX, the M3667A idms, the M3650A Senior
Trendcare Monitor, M3651A Trendcare Satellite Monitor, the M3652A Trendcare
Calibrator, and the M3653A Trendcare PDM. It also includes all supporting
options as well as sensors and cartridges utilized with these products sold by
Philips. A complete list of all products is included at the end of this document
Addendum F. The roles and responsibilities of Philips and Diametrics with
respect to the M3650A Portal Blood Analysis System and its components is defined
in the Amendment, including the Portal Manufacturing Agreement for Portal
(Exhibit 3.4).
Both parties agree that the ultimate responsibility for customer support could
be for 5 years or as defined by local custom or law (i.e. local law or sales and
support contracts protected by local law).
Pursuant to the Amendment, Philips has the non-exclusive right to provide
Support to the Philips Existing Customers for Products through October 31, 2004.
Diametrics may also provide Support to such Philips Existing Customers, on terms
to be mutually agreed between such Customers and Diametrics. For Products, this
document applies to those Philips Existing Customers who continue to use Philips
for Support.
It is acknowledged by both parties that a single customer may have a "mixed"
installation if additional XXXX/Trendcare/idms products are sold by Diametrics
into any Philips existing accounts after October 31/st/, 2002. This may require
the customer to utilize two support services, Philips and Diametrics.
3
----------------------------------------------------------------------------------------
2.0 Roles Function By Whom
And ----------------------------------------------------------------------------------------
Responsibilities
Performs call screening, to determine if product Local Philips Response Centers
is a Diametrics product
----------------------------------------------------------------------------------------
1/st/ level application support
Distributor Controlled Distributor who sold the Diametrics
Countries (Worldwide) product to the customer
Europe Local Philips Response Centers
USA, Canada and Latin America Field Philips Medical Systems
Organization (LAFO) Medical Response Center
Alpharetta, GA
0-000-000-0000
Asia-Pacific (AP) Appropriate Philips Response Centers
(China, Japan, Singapore, Australia,
India)
----------------------------------------------------------------------------------------
Order /send exchange unit (Via mail or Courier) Local Philips Response Centers
to customer when problem determined to be Worldwide
Diametrics hardware
----------------------------------------------------------------------------------------
Verify customer has sent their broken unit to Local Philips Response Center Admin
Philips SLI (System Logistics International) Worldwide
----------------------------------------------------------------------------------------
Performs complaint investigation and escalations 1/st/ level investigation: Philips
for Diametrics products Technical Marketing
2/nd/ level investigation Diametrics
----------------------------------------------------------------------------------------
4
----------------------------------------------------------------------------------------
Function By Whom
----------------------------------------------------------------------------------------
Reporting of all Diametrics product complaints Distributor who sold the Diametrics
and feedback to Diametrics per Section 7.3 of the product to the customer
amendment, dated April 10, 2003 as follows:
Diametrics will maintain MDR and other product
performance monitoring systems for the Local Philips Response Centers
Consumables and the XXXX, Trendcare and idms
products. Philips shall cooperate with Diametrics Philips Medical Systems Medical
in connection with Diametrics' obligations under Response Center Alpharetta, GA
Section 7.3 of the amendment (Philips Service 0-000-000-0000
Call Coding Process (A-Q2925-00134)). Philips
will provide to Diametrics the necessary reports Appropriate Philips Response
relating to complaints and product performance Centers (China, Japan,
issues relating to the Consumables, and the XXXX, Singapore, Australia, India)
Trendcare and idms products on a timely basis to
permit the reporting party to fulfill its
regulatory obligations. Upon reasonable request
by Diametrics, Philips shall promptly make such
reports (on behalf of Diametrics, if appropriate)
directly to the appropriate regulatory
authorities.
----------------------------------------------------------------------------------------
5
3.0 Repair Diametrics Products Repair Strategy is unit exchange for
Strategy XXXX/idms.
For the Trendcare products the repair strategy for Philips is
spare parts repair on-site, if possible, and unit exchange if
not possible.
For the US only the repair strategy will be unit exchange
and/or repair via Medical Repair Depot (MRD) in Dallas, TX to
Diametrics repair bench in Malvern/Roseville or other
location designated by Diametrics.
Philips may initiate extended warranty terms to its
XXXX/Trendcare/idms customers for a period NOT to exceed
October 31, 2004.
Note: After a country transitions from Philips to Diametrics,
the Diametrics TrendCare exchange policy will be unit
exchange only for Out of Box Failures. All other repairs will
be covered with loaner units from Diametrics until the
repaired customer unit can be returned.
-------------------------------------------------------------
4.0 WW Call Diametrics products worldwide call flow for countries, which
Flow When utilize distributors for the sale of the units.
Country Uses
Distributors
. Customer should call Philips local
Distributor directly, when transfer to
Diametrics is not completed.
. After transfer of customers to
------------------- Diametrics, customer will be informed of
Customer the changes to call Diametrics support
------------------- line instead of Philips Distributor, if
not the same.
Arrow (wide up) . This communication is a
Arrow (wide down) Philips/Diametrics/Distributor
responsibility as agreed by the regional
transition plans.
. Distributor will file questions
regarding Diametrics products to the
------------------- appropriate support channel (Philips
Distributor Who before/ Diametrics after transfer)
Sold The Products / . If it is determined the
Response Center hardware/software has failed, the
------------------- distributor/dealer orders / sends (via
mail or courier) an exchange unit to the
customer using the responsible supply
Arrow (wide up) channel (Philips before/ Diametrics
Arrow (wide down) after transfer)
. Philips Technical Marketing/ Diametrics
technical resources handle application
and technical questions / issues as
------------------- appropriate to the transfer situation.
Philips/Diametrics If Philips Technical Marketing is unable
Technical Support to resolve situation, they will contact
------------------- Diametrics for additional assistance.
. If it is determined the hardware /
software has failed the responsible
supply channel will send exchange part
to customer.
6
5.0 Call Flow Diametrics products call flow for EMEA and Asia Pacific
for EMEA/Asia Pacific countries, which do not utilize distributors for
Pacific the sale of the units.
. Customer should call Philips local Response Center
directly, when transfer to Diametrics is not
completed.
. After transfer of Philips customers to Diametrics,
------------------- customer will be informed of the changes to call
Customer Diametrics support line instead of Philips
------------------- Response Center.
. This communication is a
Philips/Diametrics/Distributor responsibility as
Arrow (wide up) agreed by the regional transition plans.
Arrow (wide down)
. Philips Response Center Engineer will file
questions regarding Diametrics products to the
appropriate support channel (Philips Technical
Marketing)
------------------- . After transfer the Diametrics support channel will
PMS Response take over appropriately
Center/Diametrics . If it is determined the hardware/software has
------------------- failed, the Philips Response Center
Engineer/Diametrics support orders / sends (via
mail or courier an exchange unit to the customer
Arrow (wide up) using the responsible supply channel (Philips
Arrow (wide down) before/ Diametrics after transfer)
. Philips/Diametrics technical resources handle
application and technical questions / issues as
appropriate to the transfer situation. If Philips
------------------- Technical Marketing is unable to resolve
Tech Mktg / situation, they will contact Diametrics for
Diametrics additional assistance.
------------------- . If it is determined the hardware / software has
failed the responsible supply channel will send
exchange part to customer.
Philips may initiate extended warranty terms to its XXXX customers for a period
not to exceed October 31, 2004.
7
6.0 Call Diametrics products call flow for US and Canada, which do not
Flow for utilize distributors for the sale of the units.
US and
Canada The customer should call the Philips Response Center
at 0-000-000-0000
. After transfer of Philips customers to Diametrics,
customer will be informed of the changes to call
------------------- Diametrics support line instead of Philips
Customer Response Center.
------------------- . This communication is the responsibility of
Arrow (wide up) Philips/Diametrics regional transition managers.
Arrow (wide down) . No Philips customer should call Diametrics
directly, unless support has been transferred to
Diametrics
------------------- . When call has been determined to be for Diametrics
Response products, the call is forwarded to the appropriate
Center Philips Response Center Engineer.
------------------- . If it is determined to be a hardware/software
Arrow (wide up) problem, an exchange unit is ordered / sent to
Arrow (wide down) customer.
------------------- . If that Philips Response Center Engineer needs
Technical additional assistance to resolve the customer
Marketing issue they will contact the appropriate Philips
------------------- Technical Marketing Engineer.
Arrow (wide up) . If Philips Technical Marketing Engineer is unable
Arrow (wide down) to resolve issue, they will contact Diametrics
technical support for additional assistance.
------------------- . Diametrics technical resource handles application
Diametrics questions / issues as appropriate and responds to
------------------- Philips Technical Marketing Engineer.
8
--------------------------------------------------------------------------------
7.0 Resource The following list provides the suggested resource to perform
Definition the service function.
-----------------------------------------------------------------
Function Resource
-----------------------------------------------------------------
1/st/ level application
support contacts
Distributor who sold the
Distributor Controlled Diametrics products to the
Countries (Worldwide) customer
Local country Philips Response
Europe Centers
Philips Medical Response Center
US, Canada and LAFO Alpharetta, GA
0-000-000-0000
In country dealer
AP
Diametrics or their
representatives once support
transfer has occurred.
-----------------------------------------------------------------
Local Customer Feedback Local Philips person who
Analyst processes the Customer Feedback
Forms for the local Response
Center
-----------------------------------------------------------------
Diametrics products Technical Philips Technical Marketing
Resource Engineer AND/BBN After transfer
to Diametrics then Diametrics
support
-----------------------------------------------------------------
Customer Feedback Contacts for For complaints: Philips
Diametrics Complaint coordinator Xxxxxx
Xxxxx; For non-complaints:
Philips Technical Marketing
Engineer AND/BBN
-----------------------------------------------------------------
Philips Field Service Engineer Philips Customer Service
Engineer
-----------------------------------------------------------------
Philips QSP Philips Quality Service Provider
-----------------------------------------------------------------
Philips CAS Philips Clinical Application
Specialist
-----------------------------------------------------------------
9
--------------------------------------------------------------------------------
8.0 Training The following list provides the resources that need to be trained
Definition to perform the service/training /CFA function for the Diametrics
products. It will be the responsibility of Diametrics to provide
training to the appropriate Philips personnel for software
upgrades, work around solutions for hardware or software
problems, troubleshooting for all new consumable and software
releases. In addition, with the release of new software, a
compatibility matrix defining the performance of that revision of
software with previous revisions of complimentary products will
be provided to Philips as will customer training materials,
instructions, etc. This will be provided to Philips at no charge;
however, any travel related expenses for requested on-site
training will be at the expense of Philips.
-----------------------------------------------------------------
Resource Pre-requisites
-----------------------------------------------------------------
Distributor Existing Distributors on-going
Countries (Worldwide) For transfer: transition
criteria must be met
(Addendum A)
-----------------------------------------------------------------
Local Philips Response Center According to Philips TEDS
Call Coordinator (Training and Education System)
training profile
-----------------------------------------------------------------
Local Philips Response Center According to Philips TEDS
Engineer training profile
-----------------------------------------------------------------
Philips CAS According to Philips TEDS
training profile. In addition,
the following pre-requisites are
required/desirable:
. Hospital experience in the
laboratory for at least 2
years
. Biochemical qualification
. Understanding of the stages
of biochemical analysis,
especially blood gas
analysis.
. Understanding of the role of
the nurses and doctors in the
stages of biochemical
analysis.
. Appreciate the concept of
Point of Care (POC) and be
able to discuss
. Be able to work as part of a
team both locally and across
the geography
. Speak and write English well.
. Be willing to travel
. Experience with comparison
studies would be an
advantage, but not necessary.
-----------------------------------------------------------------
10
-----------------------------------------------------------------
Philips Customer Engineer According to Philips TEDS
training profile (for US only:
No training for on-site support
for US Philips CEs, because
Philips utilizes Philips Dallas
Repair Depot)
-----------------------------------------------------------------
Philips QSP According to Philips TEDS
training profile
-----------------------------------------------------------------
Philips Customer Feedback According to Philips TEDS
Analyst training profile
-----------------------------------------------------------------
--------------------------------------------------------------------------------
-----------------------------------------------------------------
9.0 Diametrics Diametrics on-going obligations to provide products warranty and
Warranty out of warranty support to Philips and to Philips Existing
customers who have transitioned to Diametrics are set forth in
the Amendment. This is a summary of the warranty from Diametrics
to Philips for the Standalone Products:
-----------------------------------------------------------------
Warranty period for hardware 18 month period defined from
products date of Diametrics shipment to
Philips
-----------------------------------------------------------------
Service location Unit replacement via Philips RCs
-----------------------------------------------------------------
Support level Next business day
-----------------------------------------------------------------
Consumables:
Cartridges Cartridges - Stated Shelf life,
but not to be less than 3 months
from the date of shipment to
Philips for Combo product.
Minimum shelf life is 9 weeks
for GL & H4 (M3587A & M3617A))
and 11 weeks for H4E (M3617B).
-----------------------------------------------------------------
Sensors Sensors - Stated Shelf life, but
not to be less than 10 months
from the date of shipment to
Philips
-----------------------------------------------------------------
Accessories (e.g. Catheters, No warranty - customer
Gas, Printer paper etc.) dissatisfaction issues will be
dealt with via Supplier Action
Request process (Addendum B -
SAR process, A-Q2920-00224)
-----------------------------------------------------------------
idms, DeviceSet, DeviceCom 45 days after date of delivery
software to Philips customer
-----------------------------------------------------------------
--------------------------------------------------------------------------------
11
-----------------------------------------------------------------
10.0 Service Service Call Coding Requirement when taking calls for Diametrics
Call Coding products.
Requirements
-----------------------------------------------------------------
. Coding according to process A-Q2925-00134 (Addendum C)
-----------------------------------------------------------------
--------------------------------------------------------------------------------
11.0 Service / Repair for End of Support requirements
Diametrics will also provide out-of-warranty repair service on all hardware
components of the products for a period of not less than seven (7) years after
last shipment to Philips or such longer period as may required by local laws.
When applicable Philips and Diametrics will consider having an exchange program
to newer product(s) of a supported but obsolete product to guarantee at least
the functionality of the old product or will have an extended functionality
within the newer product. When applicable, Philips and Diametrics will have an
exchange program to newer product(s) of a supported but obsolete product to
provide at least the functionality of the old product or an extended
functionality within the newer product. The support of the M3650A Senior monitor
is such a case. If and when within this support period, Diametrics may deplete
its supply of spare parts to repair the obsolete Senior monitor M3650A,
Diametrics may at that time offer an exchange/replacement of the M3650A Senior
monitor with a M3651A Satellite and M3652A calibrator.
Standard repair/exchange is via SLI (System Logistics International) to
Diametrics (exceptions are described below in section 12.0 through section
15.0). Diametrics will repair and return unit within 30 days after receipt from
SLI.
11.1 Active Upgrades
The following describes the status of active Trendcare product upgrades and the
agreement between Diametrics and Philips as to the completion of these upgrades.
11.1.1 Status: Upgrade A
Low Modulation SW upgrade and Calibrator "new bracket" HW upgrade ("Upgrade A")
will be transitioned and done by Diametrics according to the following agreed
upgrade planning-
. Missing Upgrades as agreed between Philips and Diametrics to be done by
Diametrics as part of their support responsibility as countries are
transitioned.
. Diametrics will provide traceability of the upgrade records to complete
Philips files.
11.1.2 Status: Upgrade B
. Senior Spike Upgrade ("Upgrade B") NOT a required upgrade.
. Trained POCD CS completed the US Seniors upgrade.
12
. Diametrics will complete the upgrade as part of their support
responsibility as countries are transitioned
Impact:
-------
. Diametrics (DML) will provide upgrade records to Philips as available.
11.1.3 Status: Calibrator exchange
. Calibrator exchange from "old gas system" to "copper-and-brass fittings"
at customer site
. Maintain exchange program for customer calibrators through Diametrics
for all remaining calibrators
11.1.4 Status: Future Upgrades
. Future Upgrades for Products may consist of hardware, software, as well
as Installation and Verification procedures in a quality controlled
format for upgrades to be performed as corrective action as well as for
upgrades for new features
To-Do:
------
. Corrective actions and new features upgrades can only be performed by
trained individuals for support (either trained CEs and RCEs from
Philips or Diametrics engineers on mutual agreement will do upgrades)
. Diametrics will provide the tools and spare parts to Philips for
upgrades of instruments still under support of Philips or Philips and
Diametrics will mutually agree to have Diametrics engineers do upgrades.
Status of Trendcare Upgrades as of the effective date of the Amendment.
-----------------------------------------------------------------------
Asia Pacific
% Done US & Canada EMEA LAFO (AP)
-----------------------------------------------------------------------
Upgrade A 100% 95% 20% 0%
-----------------------------------------------------------------------
Upgrade B 100% 15% 0% 0%
-----------------------------------------------------------------------
Calibrator New
fittings 95% 33% 0% 0%
-----------------------------------------------------------------------
12.0 Repair/Return of IRMA's to the Customer (US only)
This process only applies to Philips Existing Customers requesting this service
(i.e., request the same serial number unit returned). The standard repair for
warranty, service contract, and T & M customers is unit exchange.
1. The customer should contact the Philips Medical Response Center at
0-000-000-0000. The RCE will log the call, do troubleshooting and
request the repair and return of their same serial number XXXX. The
Response Center Engineer ("RCE") will note if the repair is under
warranty, service contract or T & M (time and materials). For T & M
repairs, the RCE will obtain a PO number from the customer. The RCE
will inform the customer that the total Turn Around Time (TAT) for the
repair will be 10-14 business days, from the date of shipment to
Philips of the product. The RCE will determine if the customer utilizes
other complimentary products (i.e. XXXX and idms) to determine
13
compatibility if the product to be repaired is compatible with the s/w
revision of the complimentary product. If there is a compatibility
issue, the RCE will notify Diametrics that the product being returned
is not to be upgraded to the current revision of software.
2. The customers will be instructed to ship the unit to the Philips Dallas
repair depot after removing the temp card and batteries (if
applicable). If an appropriate shipping container is required, the
Philips Dallas repair depot will ship the container to the customer.
3. The Philips Dallas repair depot will perform the system decontamination
and forward it to Diametrics in Roseville, MN.
4. After the repair, Diametrics will return the unit to the Philips Dallas
repair depot. The Philips Dallas repair depot will close out the
Philips Service Call and return the unit to the customer.
5. Diametrics agrees to a 10 business day TAT (turn around time) for
repair upon arrival at the Diametrics facility. Customer units to be
repaired and returned will be treated as P-1 (Priority 1) status.
6. If Diametrics determines the repair time will exceed 10- business days,
they will notify the PMD RCE. Diametrics will provide an expected date
for the product to be returned to the customer. The Philips RCE will
contact the customer to reset expectations. All communication with
Diametrics and customer will be documented and tracked in the relevant
Service Call database.
13.0 Repair/Return of Trendcare to the Customer (Worldwide)
For those Philips Existing Customers requesting a repair and return of their
Trendcare unit the following will apply (i.e., request the same serial number
unit returned). The standard repair for warranty, service contract, and T & M
customers is unit exchange or repair on-site where applicable.
1. The customer should contact the local Philips Medical Response Center.
The RCE will log the call, do troubleshooting and request the repair if
needed (e.g. Senior monitor M3650A). The RCE will note if the repair is
under warranty, service contract or T & M. For T & M repairs, the RCE
will obtain a PO number from the customer. The customer will be
informed that the TAT will be 14- 21 business days from the date of
shipment by the customer of the product. This TAT includes the
assumption that Philips return process takes no longer than 5 day TAT
from customer to Diametrics. The equipment must also be shipped as
repairs are needed (no retention of units allowed to enable one large
shipment of product). The RCE will determine if the customer can
utilize other complimentary products (i.e. Satellite monitor M3651A and
Calibrator M3652A) to determine replacement if the product is not to be
repaired anymore. If not, the RCE will be notified by Diametrics that
the product being returned is not to be repaired anymore and offer the
customer replacement.
2. For US only: The customers will be instructed to ship the unit to the
Philips repair depot in Dallas. If an appropriate shipping container is
required, the Philips Dallas repair depot will ship the container to
the customer.
14
For ROW: The customer will be informed where to ship the unit on a
case by case basis (if to High Wycombe, UK or Malvern, PA) or other
location specified by Diametrics.
3. The Philips Dallas repair depot will perform the system decontamination
and forward it to Diametrics in Malvern/Roseville or other designated
location. In all other cases (ROW) Philips/Diametrics will perform the
decontamination according to their policies.
4. After the repair Diametrics will return the unit to the Philips Dallas
repair depot (US) or to the customer directly (ROW). For the ROW,
Diametrics needs to inform the local Philips Response Center that the
RCE can close out the Service Call. For the US: The Philips Dallas
repair depot will close out the Philips Service Call and return the
unit to the customer.
5. Diametrics agrees to a 10-15 business day TAT for repair upon arrival
at the Diametrics facility. Customer units to be repaired and returned
will be treated as P-1 status.
6. If Diametrics determines the repair time will exceed the announced TAT,
they will notify the PMD RCE. Diametrics will provide a new expected
date for the product to be returned to the customer. The Philips RCE
will contact the customer to reset expectations. All communication with
Diametrics and customer will be documented and tracked in the relevant
Service Call database.
14.0 idms Support
For all idms systems installed prior to 31 October 2002, Philips will continue
to provide first level support to Philips Existing Customers for the product
including contacting the appropriate third party vendor if the problem involves
an LIS interface. If the RCE exhausts their ability to resolve the issue, they
will escalate the issue to Philips Technical Marketing for further assistance.
For all idms systems sold into Philips accounts as part of a Portal/CMS solution
after 31 October 2002, Diametrics will be responsible for providing system
training, installation, troubleshooting, repair and support.
Any s/w upgrades to provide for bug fixes or product enhancement that are being
offered to Diametrics customers free of charge will also be supplied to Philips
to give to their customers free of charge. If any additional classroom training
is needed on these upgrades for the Philips technical support staff, the
required training program will be provided to Philips free of charge. Any
Diametrics travel related expenses for requested on-site training will be at the
expense of Philips.
15.0 Service Repair Pricing
Philips has requested Diametrics to provide reconditioning (including software
upgrades) on units returned for repair per reconditioning guidelines defined by
Philips. As a result of the additional services to be provided, the following
agreement has been reached.
.. Philips and Diametrics have established the following p/n's to reflect
refurbished XXXX Analyzers:
15
--------------------------------------------------------------------------------
Philips New P/N Philips Diametrics Product Description
(Exchange) P/N
Reconditioning
P/N
--------------------------------------------------------------------------------
M3622-60701 M3622-68701 443900 XXXX, Modem (Glucose Ready)
--------------------------------------------------------------------------------
M3623-60701 M3623-68701 443901 XXXX, w/out Modem (Glucose Ready)
--------------------------------------------------------------------------------
M3623-68701 443902 XXXX, w/out Modem(Glucose Ready)
Refurbished
--------------------------------------------------------------------------------
M3622-60721* M3622-68721 436300 XXXX, Modem(Non-Glucose Ready)
--------------------------------------------------------------------------------
M3623-60721* M3623-68721 436301 XXXX, w/out Modem (Non-Glucose
Ready)
--------------------------------------------------------------------------------
M3623-68721 436303 XXXX, w/out Modem(Non-Glucose
Ready) Refurbished
--------------------------------------------------------------------------------
*M3622-60721 and M3623-60721 are not available as new product. These parts are
obsolete and are only repaired at DMI for the installed base.
Pricing for repair and reconditioning as follows:
XXXX SL in Warranty requiring repair only ***
XXXX SL in Warranty requiring repair and reconditioning ***
XXXX SL out of Warranty requiring repair only ***
XXXX SL out of Warranty requiring repair and reconditioning ***
. Pricing will be subject to change upon 90 days written notice by
Diametrics or upon change in reconditioning requirements by Philips
Medical.
. Philips Medical will issue purchase orders to Diametrics prior to
authorization of return of instruments to Diametrics.
. This agreement to provide reconditioning service may be terminated by
either party upon 90 days written notice.
. Repair pricing is subject to 90 day notice of change.
. Repair and reconditioning will be to current built standards unless
specified otherwise.
. Out of warranty repair excludes customer abused or damaged equipment.
Out of warranty repair for Trendcare:
Senior repair ***
Satellite repair ***
PDM repair ***
Calibrator repair ***
($1000 if calibrator needs copper and brass fittings => new hard piped gas
system upgrade)
----------
*** Denotes confidential information that has been omitted from the exhibit
and filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
16
.. Repair pricing is subject to 90 day notice of change.
.. Out of warranty repair excludes customer abused or damaged equipment.
For US only:
Senior validation ***
Satellite validation ***
PDM validation ***
Calibrator validation ***
16.0 After Hours Support for Consumables and/or hardware: (US only)
Since cartridges and sensors are not able to be obtained through Philips SLI
(System Logistics International) for after hours needs (including weekends,
holidays, etc.), Philips will continue to utilize the services established by
Diametrics at Network Courier. Diametrics will maintain the inventory at Network
Courier including monitoring expirations dates of time sensitive materials. In
the event that Philips utilizes this service for consumables or hardware
shipments, the cost as well as the additional charges for next flight out and
delivery to site (if requested) will be billed to the Philips Blanket Service
Order (BPO) designated for Diametrics support/repairs.
17.0 Customer Training
For all customers who purchased equipment prior to 31 October 2002:
The Philips Clinical Application Specialist or their designee will do
installation and follow up training.
For all current XXXX and Trendcare customers who purchase incremental units from
Diametrics after 31 October 2002 and require additional training:
The Diametrics Clinical Application Specialist or their designee will do
installation and follow up training.
The Diametrics Clinical Application Specialist or their designee will do
installation and follow up training of the XXXX and idms(including method
validation, install appropriate clinical data server description file, and LIS
connectivity).
----------
*** Denotes confidential information that has been omitted from the exhibit
and filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
17
For all customers who purchase PMS Portal modules and Diametrics idms and/or
XXXX after 31 October 2002:
It is understood that this system sale will include the coordination of both
Philips and Diametrics representatives to meet the customer needs. Portal
modules can be sold by either Philips or Diametrics non-exclusively. XXXX and
idms are sold by Diametrics.
The Philips Clinical Application Specialist or their designee will do
installation and training on the Portal Module if sold by Philips.
The Diametrics Clinical Application Specialist or their designee will do
installation and follow up training of the XXXX and idms (including method
validation, install appropriate clinical data server description file, and LIS
connectivity).
While every effort will be made to coordinate the delivery of services needed
for the connectivity of the Portal/idms solution, each vendor should define
their own project management plan that defines scope, Work Break Down Structure
(WBS), deliverables, and billing milestones separately with the customer.
18.0 Customer training materials
All customer training material developed by Diametrics after 31 Oct. 2002, that
would be appropriate for XXXX, idms, and Trendcare units, will be made available
to Philips through October 31, 2004 at Diametrics' media cost, to provide to
their customers.
19.0 Additional customer support needs
Diametrics agrees to the continued responsibility of establishing and publishing
the reportable ranges for each lot of RNA controls for XXXX. Philips will
reimburse Diametrics for establishing the reportable ranges for each lot of
controls for Portal. This is done an average of 4 times per year (4 controls)
with and average estimated cost of $8000 (includes cartridges, controls and
labor) per year billable at the end of the year. This information will be made
available to the Philips RC as well as all Diametrics XXXX and Philips Portal
module customers via a posting on the Diametrics web site. In addition, Philips
will continue to share in the financial responsibility for completing the CAP
(College of American Pathologists) surveys applicable to XXXX. Surveys are
performed 3 times per year and the kits are ordered on an annual basis
(approximately $5000 for 10 kits to be paid for by Philips). Diametrics' share
of the expense will be to supply cartridges and labor costs to facilitate the
required testing and report the results to CAP to allow XXXX to be listed in a
peer group (minimum of 10 instruments) ensuring that results for these
instruments will only be compared to other results for this same instrument
(method).
In addition, any issues identified with cartridges, sensors or accessories that
may cause customer dissatisfaction and/or necessitate a recall will be
communicated to the appropriate regulatory person(s) within the Philips
organization. Product recalls are addressed per Section 6.5 of the Distribution
Agreement dated 06 June 1999 between the Companies.
18
It is recommended that a monthly conference call be established between the
Philips RC and field clinical specialists, a Philips technical marketing
engineer and the Diametrics technical support team and field clinical
specialists to discuss issues related to customer calls, product issues, etc.
If additional clinical support is needed for customer training, installations,
hot sites, etc., both parties agree that the other organization's clinical
specialists may be used and paid for by the agreed upon schedule (See Addendum
D). These requests for additional assistance should be considered only as a
one-time request for support. It does not imply that support of the customer is
being turned over to the other company unless all other agreed upon transition
parameters are met and if agreement between Philips and Diametrics Transition
Managers has been achieved.
20.0 Escalation process.
Philips will escalate issues/non-compliance arising under this Exhibit through
its SAR (Supplier Action Request) process, and Diametrics will escalate issues
arising under this Exhibit through its DAR (Distributor Action Request) process.
If a formal response is not received in a reasonable timeframe as requested on
the DAR or SAR, the issue will then be escalated to the Philips and Diametrics
Relationship Managers (currently Xxx Xxxxxxxxxx and Xxxxx Xxxxxx).
19
Addendum A:
READ ME:
The following Form shall be used regarding the transition of Philips Customers
to Diametrics. It is the responsibility of the regional transition managers to
complete the form as changes occur and to submit the records to Xxx Xxxxxxxxxx
and Xxxxxxx xxx Xxx Instruction: The following table will be used to show
conditions to be met prior to initiation of transition activities.
Please use the relevant color and indicate an appropriate reference in the cell,
which will demonstrate the evidence.
Boblingen November 25, 2002 _ Xxxxxxx xxx Xxx (revised 28 Jan 03 by Xxx
Xxxxxxxxxx)
------------------------------------------------------------------------------------------------------------------------------------
Diametrics Transition Criteria for A-P, EMEA, NA-LA
---------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Last Update: January 28, 2002
------------------------------------------------------------------------------------------------------------------------------------
Owner: name
------------------------------------------------------------------------------------------------------------------------------------
Instruction: The following table will be used to show conditions
to be met prior to initiation of transition activities. Items
marked with an asterisk (*) are those which must be completed.
Other items are for Philips/Diametrics internal purposes only.
Please use the relevant color and indicate an appropriate
reference in the cell, which will demonstrate the evidence
------------------------------------------------------------------------------------------------------------------------------------
Legend: Not Ready
------------------------------------------------------------------------------------------------------------------------------------
In
Progress
------------------------------------------------------------------------------------------------------------------------------------
Ready
------------------------------------------------------------------------------------------------------------------------------------
Complete
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Country: Country Country Country Country Country Country Country Country Country
------------------------------------------------------------------------------------------------------------------------------------
Regulatory
------------------------------------------------------------------------------------------------------------------------------------
Regulatory process clearly
defined and requirements
fulfilled. This will include all
legal vigilance requirements,
e.g. Complaint handling,
traceability.*
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Dealer (if applicable)
------------------------------------------------------------------------------------------------------------------------------------
Appropriate Dealer appointed
------------------------------------------------------------------------------------------------------------------------------------
Pricing negotiated and agreed
------------------------------------------------------------------------------------------------------------------------------------
Terms of sale agreed
------------------------------------------------------------------------------------------------------------------------------------
20
------------------------------------------------------------------------------------------------------------------------------------
Export conditions met e.g.,
Types of invoice, customs
requirements etc.*
------------------------------------------------------------------------------------------------------------------------------------
All PMS/Dealer contract/credit
issues resolved
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Sales/Support/Service
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Technical support resources*
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Clinical and sales support
clearly defined and in place*
------------------------------------------------------------------------------------------------------------------------------------
Clearly defined warranty
delineation agreed
(including End of Life Support
terms)*
------------------------------------------------------------------------------------------------------------------------------------
Escalation management defined*
------------------------------------------------------------------------------------------------------------------------------------
Research/reference site(s)
transfer agreed to and
documented, as appropriate*
------------------------------------------------------------------------------------------------------------------------------------
Post- transition follow-on
customer support/complaint
activities (by Diametrics)
documented (i.e. add'l sensors
provided at no charge) *
------------------------------------------------------------------------------------------------------------------------------------
Transition of Service
Agreement(s) Documented & in
place (as appropriate)
------------------------------------------------------------------------------------------------------------------------------------
Customer/Distributor information
provided - name,address,contact*
------------------------------------------------------------------------------------------------------------------------------------
Country demo units/consignment
inventory returned to factory
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Transition timelines
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
Start of transition*
------------------------------------------------------------------------------------------------------------------------------------
Estimated end of
transition/complete date*
------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------
21
Addendum B:
Philips SAR Process (A-Q2920-00224); excerpt of process as needed from
Diametrics can be obtained from Philips Q&R responsible personnel.
Addendum C:
Philips Service Call Coding Process (A-Q2925-00134); excerpt of process as
needed from Diametrics can be obtained from Philips Q&R responsible personnel.
22
Addendum D:
New Options and Pricing
Standard Hours (consecutive 8 hour period between 7:00AM-7:00PM M-F)
..H1027B
..A01 - 1 Day Clinical Configuration and Implementation Services - $1700.00
..A02 - 2 Days Clinical Configuration and Implementation Services - $3200.00
..A03 - 3 Days Clinical Configuration and Implementation Services - $4500.00
..A04 - 4 Days Clinical Configuration and Implementation Services - $5800.00
..A05 - 5 Days Clinical Configuration and Implementation Services - $7100.00
Other New Options
..H1027B
..IV2 - IntelliVue Screen Creation - $1900.00 per day.
..CTS - Custom Clinical Configuration and Implementation Services - Requires
AEO DM Approval.
23
Addendum E:
Diametrics DAR Form Xx. 000
Xxxxxxxx X:
Available Product List
1. Cartridges
---------------------------------------------
Type
---------------------------------------------
M3614A BG
---------------------------------------------
M3615A H3
---------------------------------------------
M3616A CC
---------------------------------------------
M3680A BG
---------------------------------------------
M3682A CC
---------------------------------------------
M3584A BG
---------------------------------------------
M3585A H3
---------------------------------------------
M3586A CC
---------------------------------------------
M3617A H4 (original)
---------------------------------------------
M3617B H4 (new)
---------------------------------------------
M3681A H3
---------------------------------------------
M3587A GL
---------------------------------------------
---------------------------------------------
---------------------------------------------
2. XXXX Products and accessories (used for support)
---------------------------------------------
---------------------------------------------
M3664A NiMH Battery for XXXX
---------------------------------------------
M3628A XxXX 00 Xxx Xxxxxxx
Charger, Power Supply
---------------------------------------------
M3629A 15 V power supply
---------------------------------------------
M3669A XXXX Carrying Bag
Will get 5x5 number for
support use
---------------------------------------------
M3670A AC Adapter assembly
---------------------------------------------
M3666A XXXX Temp Card
---------------------------------------------
M3671A XXXX print paper 5 rolls
---------------------------------------------
---------------------------------------------
M3624A Pole mount for XXXX
Will get 5x5 number for
support use
---------------------------------------------
M3627A J&J Lifescan SureStep
---------------------------------------------
---------------------------------------------
Pro glucose module
5x5 number M3627-60101
for support use
---------------------------------------------
M3674A Capillary Collection
device
---------------------------------------------
---------------------------------------------
M3679A XXXX edge connector
---------------------------------------------
M3672A XXXX edge connector
cleaner
---------------------------------------------
M3677A Barcode scanner and mount
Will get 5x5 number for
support use
---------------------------------------------
M3678A Barcode scanner mount kit
Will get 5x5 number for
support use
---------------------------------------------
M3622-68701 DMI-443900 XXXX, Modem
(Glucose ready)
---------------------------------------------
M3623-68701 DMI-443901 XXXX, w/out
Modem (Glucose ready)
---------------------------------------------
M3622-40301 XXXX printer cover
453563339101
---------------------------------------------
M3622-42501 XXXX printer spindle
453563339111
---------------------------------------------
M3622-61610 Cable RJ45
453563339141
---------------------------------------------
M3622-61620 Cable - RJ45/modRJ45
453563339151
---------------------------------------------
M3622-63901 Edge connector kit
453563339161
---------------------------------------------
M3622-67610 Adapter-RJ45/DB9
Female
453563339171
---------------------------------------------
M3622-67611 Adapter-RJ45 to DB9
male
453563339181
---------------------------------------------
M3622-67620 Adapter-RJ45 to DB25
453563339191
---------------------------------------------
M3622-67621 Adapter RJ45/DB25
453563339201
---------------------------------------------
3. IDMS Products (for support)
---------------------------------------------
---------------------------------------------
M3667-10802 XXXX IDMS SW 6.0 Disk set,
Data management
---------------------------------------------
M3667-10803 XXXX IDMS SW 4.0.7 Disk
set, Data management
---------------------------------------------
M3667-20002 IDMS v5 Assembled Binder
1.5"
---------------------------------------------
M3667-9001C IDMS Manual
---------------------------------------------
4. Trendcare Products (used for support )
---------------------------------------------
---------------------------------------------
Trendcare Satellite TCM
M3561 60110 6000
---------------------------------------------
M3651 60111 Trendcare Satellite TCM
6000/Nordic
---------------------------------------------
M3652-60101 Calibrator
---------------------------------------------
M3653-60101 PDM
---------------------------------------------
M3650-68101 Repair/Exchange Senior
monitor (115V)
---------------------------------------------
M3650-68102 Repair/Exchange Senior
monitor (230V)
---------------------------------------------
M3651-68101 Repair/Exchange satellite
---------------------------------------------
M3652-68101 Repair/Exchange calibrator
---------------------------------------------
M3653-68101 Repair/Exchange PDM
---------------------------------------------
---------------------------------------------
5. Trendcare Sensors and Accessories
---------------------------------------------
---------------------------------------------
M3643A Paratrend 7+ sensor,
5/pack
---------------------------------------------
Neotrend L sensor
M3673A 5/pack L N7004L
---------------------------------------------
M3654A Thermal printer paper MPP
7005
---------------------------------------------
M3655A Gas packs, 3 cylinders, F1
MCG 7010
---------------------------------------------
M3644A Fixation strap
---------------------------------------------
---------------------------------------------
---------------------------------------------
---------------------------------------------
Exhibit 2.4
Inventory Buy-Back Process
***
----------
*** Denotes confidential information that has been omitted from the exhibit
and filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
Exhibit 2.6
Country Transition Letter
[Philips Medical Letterhead]
[Date]
Diametrics Medical Incorporated
0000 Xxxxxx Xxxx
Xx. Xxxx, XX 00000
Re: Transfer of Support of Consumables and XXXX, TrendCare, and idms Products
from Philips to Diametrics
Dear ____________:
This letter constitutes a letter agreement between Philips and Diametrics
with respect to the transfer of sales and support for Consumables and support
for installed XXXX, TrendCare and idms products (the "Transitioned Products") in
[Country] as follows:
1. The parties confirm that to the best of each party's knowledge, the
criteria (as set forth in Addendum A to the Service and Support
Agreement between the Parties) for transitioning, from Philips to
Diametrics, the sales and support of Consumables and support for XXXX,
TrendCare and idms products installed at Philips' customer sites have
been completed in [Country]. Effective as of [Date], Diametrics shall
be responsible for sales and support for Consumables and support for
XXXX, TrendCare and idms products in [Country], whether previously
shipped or serviced by Philips or Diametrics, as defined in the
Amendment and the Service and Support Agreement. In addition,
Diametrics will resume all legal and regulatory obligations for all
Transitioned Products in [Country] shipped by Diametrics prior to June
6, 1999. The attached customer list contains contact information for
the customers to whom Philips shipped Transitioned Products, and to
the best of Philips' knowledge, customers of the Transitioned Products
who did not order such Transitioned Products from Philips.
2. With respect to the Transitioned Products in [Country] as of the date
of this letter agreement, the warranty, support and regulatory
provisions set forth in the Amendment and the Service and Support
Agreement shall apply.
3. Attached is a mutually agreed list of unique follow-on customer
support/complaint activities to be completed by Diametrics.
4. The parties confirm that for this country, Philips has provided
Diametrics:
a. installed base and/or distributor information (institution name,
address, contact) and
b. funnel information (leads, demo, evaluation).
5. In this country, Philips customer service agreements for the
Transitioned Products have been either (a) assigned to and assumed by
Diametrics in writing or (b) canceled by Philips and the applicable
customer and superceded by new customer service agreements between
Diametrics and the customer.
6. Diametrics has provided Philips contact information (name, address,
telephone number, email address) of the Diametrics person to contact
in case a customer, government agency, or third party contacts Philips
about the Transitioned Products. Furthermore, Philips and Diametrics
agree to separately communicate to customers and distributors that the
country transition has been completed and include the new Diametrics'
contact information for support to customers/distributors.
If this letter agreement is acceptable to you, please sign below.
PHILIPS MEDICAL SYSTEMS
By:
-------------------------------------
Title:
----------------------------------
Accepted and Agreed:
Diametrics Medical Incorporated
By:
----------------------------------------
Title:
----------------------------------------
Exhibit 3.5
Portal Products purchased from Philips
----------------------------------------------------------------------
Transfer Price
----------------------------------------------------------------------
M3562A Interface module (for ***
support use only)
----------------------------------------------------------------------
M3561A Portal measurement module ***
(for support use only)
----------------------------------------------------------------------
Users guide ***
----------------------------------------------------------------------
M3560A Portal Analysis Module ***
( solution totally boxed
but without cable and
without mount) (for product
sale)
----------------------------------------------------------------------
M3561-6160x Interface Cable 2m ***
----------------------------------------------------------------------
Interface cable 4m ***
----------------------------------------------------------------------
M3570A Mount ***
----------------------------------------------------------------------
M3571A Mount ***
----------------------------------------------------------------------
M3572A Mount ***
----------------------------------------------------------------------
M3573A Mount ***
----------------------------------------------------------------------
M3574A Mount ***
----------------------------------------------------------------------
* Mount price based on purchase minimum of *** each.
----------
*** Denotes confidential information that has been omitted from the exhibit and
filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
Prices will be subject to change upon 90 days written notice by Philips.
Exhibit 5.4
Portal Products
WARRANTY STATEMENT
a) Portal Products purchased by Diametrics from Philips will receive the
standard warranty of: 18 months from date of receipt (90 days for parts) or
12 months from date of installation by Diametrics whichever comes first.
b) Philips warrants Philips hardware Products against defects in materials and
workmanship. Philips further warrants that Philips hardware Products
conform to Specifications. These warranties do not include periodic
recalibration (recommended for some Philips Products).
c) Philips warrants that Software will not fail to execute its programming
instructions due to defects in materials and workmanship when properly
installed and used on the Device designated by Philips. Philips further
warrants that Philips owned standard Software will substantially conform to
Specifications. Philips does not warrant that Software will operate in
hardware and software combinations selected by Customer, or meet
requirements specified by Customer.
d) Philips does not warrant that the operation of Products will be
uninterrupted or error free.
e) If Philips receives notice of defects or non-conformance to hardware
Specifications, or substantial non-conformance to Philips owned standard
Software Specifications during the warranty period, Philips will, at its
option, repair (and recalibrate only as necessitated by repairs), or
replace the affected Products. If Philips is unable, within a reasonable
time, to repair, replace or correct a defect or non-conformance in a
Product to a condition as warranted, Diametrics will be entitled to a
refund of the purchase price upon prompt return of the Product to Philips.
Diametrics will pay expenses for return of such Products to Philips.
Philips will pay expenses for shipment of repaired or replacement Products.
f) Philips warrants that Philips Support will be provided in a professional
and workmanlike manner. Philips will replace, at no charge, parts which are
defective and returned to Philips within 90 days of delivery.
g) Some newly manufactured Philips Products may contain and warranty service
may use remanufactured parts, which are equivalent to new in performance.
h) The above warranties do not apply to defects resulting from improper or
inadequate maintenance or calibration by Customer; Customer or third party
supplied software, interfacing or supplies; unauthorized modification;
improper use or operation outside of the Specifications for the Product;
abuse, negligence, accident, loss or damage in transit; improper site
preparation; or unauthorized maintenance or repair.
i) THE ABOVE WARRANTIES ARE EXCLUSIVE AND NO OTHER WARRANTY, WHETHER WRITTEN
OR ORAL, IS EXPRESSED OR IMPLIED. PHILIPS SPECIFICALLY DISCLAIMS THE
IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
EXHIBIT 6.1
IP OWNERSHIP
***
----------
*** Denotes confidential information that has been omitted from the exhibit and
filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
Attachment A
IP Review Process
***
----------
*** Denotes confidential information that has been omitted from the exhibit and
filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
Attachment B
Philips/Diametrics Distribution Agreement
Dated 6 June 99
Contractual Provisions
***
----------
*** Denotes confidential information that has been omitted from the exhibit and
filed separately, accompanied by a confidential treatment request with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934.
