LICENSE AND SUPPLY AGREEMENT
between
Lifestream Technologies, Inc.
(a Nevada corporation)
000 Xxxxxxxxxx Xxxx
Xxxxx 000
Xxxx Xxxxx
Xxxxx 00000
Xxxxxx Xxxxxx of America
(hereinafter referred to as "Lifestream")
and
Roche Diagnostics GmbH
Sandhofer Xxxxxxx 000
00000 Xxxxxxxx
Xxxxxxx Xxxxxxxx of Germany
(hereinafter referred to as "RDG ")
*CONFIDENTIAL TREATMENT REQUESTED 0
XXXXXXX XXX has developed, has exclusive rights to and currently markets
"Cholesterol Test Strips" (as defined below) for its ***** system, which is a
device for the measurement of blood cholesterol levels and which has been
approved by the United States Food and Drug Administration for sale and use in
the "Professional Market" and the "OTC Market" (as defined below); and
WHEREAS RDG has adapted its ***** technology to produce a "Test Instrument
Module" (as defined below) which accepts Cholesterol Test Strips for the
analysis of cholesterol in blood;
WHEREAS Lifestream has developed a hand-held Lifestream Product as hereinafter
defined, originally named, the "Cholestron" and currently sold as "Lifestream
Cholesterol Monitor" which measures blood lipid levels and utilizes a
proprietary "Smart Card/lInternet" up-link technology; and
WHEREAS Lifestream wishes to have RDG make and supply Cholesterol Test Strips to
be used in the Lifestream Product device; and
WHEREAS RDG desires to supply Cholesterol Test Strips to Lifestream during the
further development and commercialization of the Lifestream Product device in
the Professional Market and the OTC Market;
NOW THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:
1. DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "Affiliate" shall mean:
(i) an organization of which fifty per cent (50%) or more of the voting
equity interests are controlled or owned, directly or indirectly, by
either party to this Agreement;
(ii) an organization which directly or indirectly owns or controls fifty per
cent (50%) or more of the voting equity interests of either party,
except if one of the parties is publicly traded, in which case direct
or indirect ownership or control of thirty per cent (30%) or more of
the voting securities of such publicly traded party;
(iii) an organization, the majority ownership of which is directly or
indirectly common to the majority ownership of either party; or
(iv) a joint venture of either party.
(v) on RDG's side, this shall include X. Xxxxxxxx Xx-Xxxxx Ltd. and its
Affiliates with the exception of Genentech Inc., 0 XXX Xxx, Xxxxx Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000-0000, unless RDG explicitly opts for such
inclusion by giving written notice.
*CONFIDENTIAL TREATMENT REQUESTED 2
1.2 "RDG Technology" shall mean the patents owned by or licensed to RDG,
including all patent applications, divisions, continuations,
continuations-in-part or reissues thereof, and all know-how,
technology, trade secrets, processes, data, methods and any physical,
electronic, chemical or biological material or other information which
RDG owns, controls or has a license to (with a right to sub-license)
relating to the development and manufacture of the Cholesterol Test
Strips and or the ROM-Key including software, the Test Instrument
Module, *****-devices and lancets for *****.
1.3 "Calibration Code" shall mean an electronic file with ***** which
enables LRE to code a ROM key for Lifestream with calibration data for
Cholesterol Test Strips as originally delivered in vials by RDG.
1.4 "Cholesterol Test Strip" shall mean an integrated unit containing whole
blood total cholesterol testing chemistry for analysis of cholesterol
levels in human capillary blood based on the technology and quality
used in connection with RDG's ***** system, which shall be packaged in
vials of 25 test strips each.
1.5 "Contract Product Specifications" shall mean the specifications to
integrate the Lifestream Product, the Test Instrument Module and the
Cholesterol Test Strips in order to develop and supply the Contract
Product.
1.6 "Effective Date" shall mean the date of signature of this Agreement by
both parties.
1.7 "FDA" shall mean the U.S. Food and Drug Administration.
1.8 "Government Approval" shall mean any approvals, licenses, registrations
or authorizations of any federal, state or local regulatory agency,
department, bureau or other government entity, necessary for the use,
marketing, sale or distribution in the United States of America of the
Contract Product including, for the avoidance of doubt, the integration
of the Cholesterol Test Strips and the Test Instrument Module within
the Contract Product.
1.9 "Lifestream Marks" shall mean all trade names, trademarks, service
names, service marks, logos and graphic designs (whether copyrighted or
not) owned by Lifestream from time to time.
1.10 "Lifestream Product" shall mean Lifestream's hand-held device which
measures blood lipid levels and utilizes a proprietary "Smart Card
Intemet" uplink technology and which has originally been named the
"Cholestron" and is currently sold as Lifestream Cholesterol Monitor",
which device is used for measurement of rapid whole blood total
Cholesterol Test Strips for analysis of cholesterol levels in human
capillary blood and is continuously improved by Lifestream and/or its
partners or suppliers.
1.11 "Lifestream Technology" shall mean the patents owned by Lifestream,
including all patent applications, divisions, continuations,
continuations in part or reissues thereof, and all know-how,
technology, trade secrets, processes, data, methods and any physical,
electronic, chemical or biological material or other information which
Lifestream owns, controls or has a license to use (with a right to
sublicense) relating to the development and manufacture of the
Lifestream Product.
*CONFIDENTIAL TREATMENT REQUESTED 3
1.12 "LRE" means LRE Technology Partner GmbH, having its registered office
and domicile (Hauptsitz) in Xxxxxxxxxxx Xxxx 00, 00000 Xxxxxx, Xxxxxxx
Xxxxxxxx of Germany and having production facilities at Xxxxx Xxx. 0,
00000 Xxxxxxxxxx, Xxxxxxx Xxxxxxxx of Germany.
1.13 "OTC Market" shall mean the sale or distribution of products directly
to consumers or other members of the general public who will use the
Lifestream Product for screening or monitoring, or to trade customers
for resale to consumers, for use or consumption without a prescription,
through any retail outlet, including without limitation drug stores,
pharmacies, general merchandise stores, food stores, catalogue sales,
mail order sales, Internet or other "on-line" service sales, direct
marketing, or other business or marketing methods aimed at consumers or
other members of the general public and any customers who conduct
testing directly relating to promotions to enhance the market share of
the Lifestream Product for any of the aforementioned areas.
1.14 "Professional Market" shall mean licensed medical professionals and
institutions such as physician's offices, commercial health clinics,
hospitals, nursing homes and stand-alone surgical centres, provided
that for purposes of this Agreement the term "Professional Market"
shall not include anything identified within the definition of the term
"OTC Market".
1.15 "Purchase Order" shall mean each of the firm, binding purchase orders
provided by Lifestream specifying the quantity of Cholesterol Test
Strips or ***** devices and lancets for ***** that Lifestream wishes to
purchase and the respective shipping dates in accordance with Articles
4 and 5 hereunder.
1.16 "Rolling Forecast" shall mean the non-binding twelve (12)-month
forecast of Lifestream's anticipated purchase requirements for
Cholesterol Test Strips.
1.17 "ROM-Key" shall mean a plastic housing containing an integrated EPROM
bearing the lot-specific calibration data regarding Cholesterol Test
Strips, to be plugged into the Test Instrument Module for the
calibration of Lifestream Product.
1.18 "Test Instrument Module" shall mean the module of an integrated system
that accepts Cholesterol Test Strips for the analysis of cholesterol,
which shall include the application specific integrated circuit (ASIC
chip), a microcontroller (masked version, provided that RDG can
determine, until an acceptable masked version is available to RDG, this
shall mean the one time programmable microcontroller version) with
software, and optro-electronic components which are used in RDG's *****
technology at the Effective Date, and which shall be configured to the
Test Instrument Module Specifications stipulated in Schedule 2.
*CONFIDENTIAL TREATMENT REQUESTED 4
1.19 "Territory" shall mean the United States of America and such other
countries as may be agreed in writing by the parties from time to time.
1.20 "UMM" shall mean UMM (United Medical Manufacturing Company)
0000 Xxxxxxxxx Xxxxx
Xxxxxxxxxxxx
Xxxxxxx, 00000
XXX.
2 LICENSE
2.1 Subject to the terms and conditions of this Agreement, RDG hereby
grants to Lifestream a license under the RDG Technology in the Temtory:
(a) to let the Test Instrument Module and ROM-Key produce at LRE,
UMM or at such other manufacturer as agreed upon by RDG in
writing for measurement of RDG's Cholesterol Test Strips, and
(b) to integrate the Test Instrument Module, ROM-Keys and the
Cholesterol Test Strips with the Lifestream Product, and
(c) to sell, offer for sale, market and distribute Cholesterol
Test Strips (including ROM-Keys) in connection with the
Lifestream Product (including Test Instrument Modules), and
(d) to use Cholesterol Test Strips, ROM-Keys and Test Instrument
Modules in connection with the Lifestream Product,
provided that:
2.1.1 The license granted hereunder does not include the right to otherwise
use RDG Technology, without prior written consent of RDG, except to
further or newly develop any variances of the Test Instrument Module;
2.1.2 Subject to Sections 2.1.3, 2.1.4 and 2.1.5, the license under Section
2.1 shall be granted as follows:
(a) The license to let the Test Instrument Module and ROM-Key
produce at LRE, UMM or such other manufacturer as agreed upon
by RDG in writing for measurement of RDG's Cholesterol Test
Strips shall be non-exclusive.
(b) the license to integrate the Test Instrument Module, ROM-Keys
and Cholesterol Test Strips with the Lifestream Product,
*CONFIDENTIAL TREATMENT REQUESTED 5
(c) the license to sell, offer for sale, market and distribute
Cholesterol Test Strips (including ROM-Keys) and Test
Instrument Modules in connection with the Lifestream Product,
and
(d) the license to use Cholesterol Test Strips, ROM-Keys and Test
Instrument Modules in connection with the Lifestream Product
shall be exclusive in the OTC Market ("sole license") and non-exclusive
in the Professional Market.
2.1.3 Exclusivity shall automatically cease with immediate effect if
Lifestream fails to order minimum quantities pursuant to Section 4.5.
2.1.4 RDG and its Affiliates shall retain the unrestricted right to produce,
market, distribute, sell, use and otherwise dispose of the Cholesterol
Test Strips and the Test Instrument Module in all markets (including,
but not limited to, the Professional Market and the OTC Market in the
Territory). In the United States of America, RDG will not, however, in
any way actively solicit, support or condone any distribution, sales
and marketing efforts of RDG's cholesterol testing products inside the
OTC Market to any third party, which party is marketing products
performing functions similar to the Lifestream Product and, which party
is seeking to market its products to different customer segments as
Lifestream does; and
2.1.5 Lifestream shall not be entitled to sub-license this license to any
party, whatsoever.
2.1.6 In accordance to 35 U.S.P. Section 287 (a), Lifestream commits to
xxxx the use of US patents 5,053,199 and 5,366,609 owned by Roche
Diagnostics Corporation, Indianapolis, on the Lifestream Product.
2.2 In consideration of the license to let the Test Instrument Modules and
ROM-Keys produce at LRE, UMM or such other manufacturer as agreed upon
by RDG in writing for measurement of RDG's Cholesterol Test Strips, as
granted in Section 2.1 (a) herein, Lifestream agrees to pay to RDG a
license fee of USD *** (*** United States Dollars) for each Test
Instrument Module received by Lifestream during the term of this
Agreement. The license regarding production of the ROM-Keys shall be
granted to Lifestream at no additional costs.
2.2.1 License fees payable hereunder shall be made without any deductions
whatsoever.
2.2.2 Throughout the term of this Agreement, Lifestream shall provide RDG at
the end of each twelve (l 2)-month period with a written account of the
number of Test Instrument Modules actually received and of the license
fee due to this Section 2.2, and shall transfer such license fee
payment due to RDG within ninety (90) days of the end of each twelve
(12)-month period, in which such license fees accrued.
*CONFIDENTIAL TREATMENT REQUESTED 6
2.2.3 Lifestream shall keep or procure to be kept complete and accurate
records of the numbers of Test Instrument Modules actually received.
Such records shall be accessible not more than once a year at any
reasonable time during business hours until the expiry of five (5)
years from the end of the respective period to which such records
relate, to a certified public accountant selected by RDG for the
purpose of verifying the number of received Test Instrument Modules and
any license fee due. Such accountant shall disclose only information
relating to the accuracy of the records and payments made. The cost of
such inspection shall be borne solely by Lifestream if such inspection
discloses that the license fee paid by Lifestream hereunder was less
than the amount actually due by 5% or more.
3 DEVELOPMENT OF CONTRACT PRODUCT
3.1 Lifestream shall integrate the Test Instrument Module, the ROM-Keys and
the Cholesterol Test Strips into the Lifestream Product and RDG shall
supply Lifestream with the Cholesterol Test Strips for such purposes.
3.2 RDG and Lifestream may, from time to time, suggest modifications to the
specifications for the Cholesterol Test Strips, provided that the
parties shall negotiate in good faith as to the terms and conditions of
effecting any such suggested modifications.
4 SUPPLY OF CHOLESTEROL TEST STRIPS
4.1 RDG shall sell to Lifestream such quantities of Cholesterol Test Strips
as Lifestream shall order from RDG from time to time in accordance with
this Article 4.
4.2 Lifestream will provide RDG with a non-binding twelve (12) months'
Rolling Forecast of its anticipated purchase requirements for
Cholesterol Test Strips at the beginning of each calendar quarter.
4.3 Lifestream shall provide RDG with firm binding Purchase Orders on the
first day of each calendar quarter specifying the number of Cholesterol
Test Strips that Lifestream wishes to purchase and a shipment date of
not less than one hundred and twenty (120)days and no more than one
year from the date of the respective Purchase Order, provided that
Lifestream's orders of Cholesterol Test Strips must always provide
forthe delivery of at least two hundred and fifty thousand individual
Cholesterol Test Strips in respect of each and every shipment date.
Orders have to be addressed to Roche Diagnostics GmbH, Xxxxxxxxx
Xxxxxxx 000, 00000 Xxxxxxxx, Xxxxxxx, to the attention of Dpt. GX-VD
(Export Order Management, Xx. Xxxxxxx). RDG shall deliver the
Cholesterol Test Strips to Lifestream in accordance with each Purchase
Order, provided that the quantity of Cholesterol Test Strips specified
in the respective Purchase Order is consistent with the quantity
specified in the respective Rolling Forecast and provided that the
quantity of Cholesterol Test Strips ordered amounts to at least two
hundred and f~fty thousand in respect of each and every shipment date
*CONFIDENTIAL TREATMENT REQUESTED 7
and provided that Lifestream complies with all other requirements of
this clause 4. However, RDG remains free to supply lesser quantities as
may be caused by RDG's manufacturing process, in which case a deviation
in quantity of not more than 5% shall not affect the calculation of
minimum quantities to be purchased by Lifestream according to Section
4.4.
4.4 Provided that the Cholesterol Test Strip may continue to be lawfully
sold in the United States of America, Lifestream hereby agrees to
purchase the following quantities of Cholesterol Test Strips during the
respective twelve (12)-months periods, starting January 1, 2001:
------------------------------------------ -----------------------------------------
Period Minimum Quantity of Cholesterol Test
Strips
per period of 12 months
------------------------------------------ -----------------------------------------
Period 1 ***
------------------------------------------ -----------------------------------------
Period 2 ***
------------------------------------------ -----------------------------------------
Perod 3 and following Periods ***
------------------------------------------ -----------------------------------------
4.5 Lifestream shall purchase the Cholesterol Test Strips supplied
hereunder from RDG at the prices stipulated in Schedule 1. After the
expiry of two years from the Effective Date, RDG may adjust the prices
for Cholesterol Test Strips stipulated in Schedule 1 of this Agreement
annually in accordance with any percentage increase in the German
consumer price index over the respective preceding twelve months,
provided that if RDG can provide evidence that its actual costs
incurred in manufacturing and supplying the Cholesterol Test Strips to
Lifestream hereunder have increased by more than the respective
percentage increase in the German consumer price index over the
respective preceding twelve months, RDG shall be entitled to increase
the prices stipulated in Schedule l of this Agreement to reflect such
actual increased costs. Any price adjustments made by RDG in accordance
with this Section 4.5 shall be effective as of sixty (60) days after
the respective notification in writing to Lifestream.
4.6 Cholesterol Test Strips shall be supplied as bulkware in unlabelled
vials containing 25 Cholesterol Test Strips each (the back-side of
Cholesterol Test Strips does not bear black marking) and without any
ROM-keys whatsoever. Each 650 vials shall be packaged into boxes. Each
box shall be labeled with the product name, the lot number and the
expiry date of the Cholesterol Test Strips contained in the vials.
4.7 *** In case of any re-packaging, re-working or re-calibration of
Cholesterol Test Strips, Lifestream will comply with all regulatory
rules and makes sure that every product sold is in compliance with
FDA-rules. Additionally, Lifestream bears the sole responsibility to
obtain and uphold FDA-approval for Cholesterol Test Strips distributed
by Lifestream. Accordingly, RDG shall not bear any liability whatsoever
for Cholesterol Test Strips from vials that have been opened and or
re-packaged and or re-worked and or re-calibrated by Lifestream.
*CONFIDENTIAL TREATMENT REQUESTED 8
5. SUPPLY OF *****-DEVICES AND LANCETS
5.1 RDG shall sell to Lifestream such quantities of *****-devices and
lancets for ***** as Lifestream shall order from RDG from time to time
in accordance with this Article 5.
5.2 Lifestream's right to purchase ***** shall be limited to a maximum
quantity of the amount of Test Instrument Modules actually supplied by
LRE to Lifestream in accordance with the license grant under Article 2
of this Agreement plus an additional margin of 10%. The right of
Lifestream to order lancets
for ***** shall be limited to a maximum quantity of Cholesterol Test
Strips actually delivered by RDG to Lifestream according to Article 4
of this Agreement plus an additional margin of 10%. ***** devices and
lancets for ***** shall be delivered in the packaging as described in
Schedule 2.
5.3 Lifestream shall provide RDG with firm binding Purchase Orders not
exceeding the maximum quantity as stipulated under Section 5.2 on the
first day of each calendar quarter specifying the number of
*****-devices and lancets for ***** that Lifestream wishes to purchase
and a shipment date of not less than one hundred and twenty (120) days
and no more than one year from the date of the respective Purchase
Order, provided that Lifestream's orders for *****-devices must always
provide for the delivery of multiples of bulks of five hundred (500)
devices and provided that Lifestream's orders for lancets for *****
must always provide for the delivery of multiples of bulks of five
thousand (5000) lancets in respect of each and every shipment date.
Orders have to be addressed to Roche Diagnostics GmbH, Sandhofer
Xxxxxxx 000, 00000 Xxxxxxxx, Xxxxxxx Xxxxxxxx of Germany, to the
attention of department GX-VD (Export Order Management, *****). RDG
shall deliver the *****-devices and lancets for ***** to Lifestream in
accordance with each Purchase Order, provided that the maximum quantity
according to Section 5.2 is not exceeded and provided that the ordered
quantity amounts to multiples of bulk size and provided that Lifestream
complies with all other requirements of this Article 5.
5.4 Lifestream shall purchase the *****-devices and lancets for *****
supplied hereunder from RDG at the prices stipulated in schedule 1.
After the expiry of two years from the Effective Date, RDG may adjust
the prices stipulated in schedule 1 and the license fees stipulated in
Section 2.2 of this Agreement annually in accordance with any
percentage increase in the German Consumer Price Index over the
respective preceding twelve (12) months, provided that if RDG can
provide evidence that its actual costs incurred in manufacturing and
supplying the *****-devices and lancets for ***** to Lifestream
hereunder have increased by more than the respective percentage
increase in the German Consumer Price Index over the respective
preceding twelve (12) months, RDG shall be entitled to increase the
prices stipulated in schedule 1 of this Agreement to reflect such
actual increased costs. Any price adjustments made by RDG in accordance
with this Section 5.4 shall be effective as of sixty (60) days after
the respective notification in writing to Lifestream.
*CONFIDENTIAL TREATMENT REQUESTED 9
6 PAYMENT AND SUPPLY TERMS
6.1 All payments shall be made in United States Dollars. The parties agree
that prices as stipulated in this Agreement and in Schedule I thereto
are calculated in EURO and that prices need to be adapted according to
significant changes (more than 20%) in the conversion rate of EURO
against United States Dollars. If, during the term of this Agreement,
the monthly average conversion rate of EURO against United States
Dollars for a certain calendar month deviates upwards or downwards for
more than 20% from the conversion rate of EURO against United States
Dollars as fixed on the Effective Date, prices as quoted in this
Agreement and the Schedules thereto shall immediately be adapted with
half of such increase or decrease of the conversion rate and remain
valid until, again, the average conversion rate of EURO against United
States Dollars for a certain calendar months deviates upwards or
downwards for more than 20% from the conversion rate of EURO against
United States Dollars as fixed on the date of the last price
adaptation, in which case prices as quoted in this Agreement and the
Schedules thereto shall be adapted by mutual consent of the parties in
good faith negotiations reflecting the changes in price calculation as
caused by such increase or decrease of the conversion rate.
6.2 Lifestream shall ensure that all payments for Cholesterol Test Strips,
***** devices and lancets for ***** shall be transferred to RDG in
United States dollars (US $) within forty-five (45) days of the date of
the respective invoice provided that the invoice shall be dated to
reflect the respective date of shipment.
6.3 RDG shall deliver or have delivered all Cholesterol Test Strips,
*****-devices or lancets for ***** ordered by Lifestream in accordance
with Article 4 and 5 of this
Agreement to arrive at Lifestream on or before the requested delivery
date provided that such date is at least one hundred and twenty (120)
days following RDG's receipt of the respective Purchase Order. The
Cholesterol Test Strips, *****-devices or lancets for ***** supplied by
RDG hereunder shall be delivered to Lifestream Technologies, Inc., 000
Xxxxxxxxxx Xxxx, Xxxxx 000, Xxxx Xxxxx, Xxxxx 00000, Xxxxxx Xxxxxx of
America, FCA, Mannheim, Germany (Incoterms 2000). RDG shall notify
Lifestream, via fax transmission, of the actual date of each shipment
of Cholesterol Test Strips, *****-devices or lancets for ***** at least
five (5) days in advance of the respective shipment.
6.4 Lifestream shall inspect all Cholesterol Test Strips, *****-devices or
lancets for ***** shipments promptly upon receipt thereof at the
delivery destination specified in Section 6.3 to determine if the
shipment meets the product specifications in accordance with the
specification inspection protocol agreed by both parties. In the event
that Lifestream determines that any shipment of Cholesterol Test
Strips, *****-devices or lancets for ***** fails to comply with the
agreed specification inspection protocol, Lifestream shall notify RDG
within seven (7) days of receipt and within fifteen (15) days of such
notification RDG may inspect the shipment at Lifestream's premises,
following which Lifestream shall return any individual Cholesterol Test
Strips, *****-devices or lancets for ***** which Lifestream alleges are
non-compliant to RDG within thirty days.
6.5 In the event that pursuant to any inspection by RDG in accordance with
Section 6.4 RDG determines that any Cholesterol Test Strips,
*****-devices or lancets for ***** fail to comply with the agreed
specification inspection protocol pursuant to Section 4. 10.1 for other
reasons than gross negligence or intent of RDG, within thirty days
thereof, RDG shall; as sole remedy for Lifestream in such case:
*CONFIDENTIAL TREATMENT REQUESTED 10
i. repair or replace the non-compliant goods at RDG's expense
without undue delay,
or
ii. credit Lifestream for the price Lifestream has paid for the
respective non- compliant goods and RDG will bear all
transportation charges incurred in returning such goods.
6.6 If RDG determines that any shipment alleged by Lifestream to be
non-compliant in RDG's opinion complies with the specification
inspection protocol, both parties will immediately use their best
efforts to resolve the issue, and if they are not able to resolve the
issue immediately, both parties will immediately select a neutral
independent third party to inspect the shipment to determine the
validity of the claims.
7 CHANGE OF SUPPLY OF TEST INSTRUMENT MODULES
7.1 From the Effective Date of this Agreement, Lifestream shall order the
Test Instrument Modules and ROM-Keys in accordance with and limited to
the terms of the license granted under Section 2 of this Agreement
directly with LRE or UMM or such other manufacturer as agreed upon by
RDG in writing for use in Lifestream's Contract Product.
7.2 Lifestream shall manufacture or let manufacture with LRE, UMM or such
other manufacturer as agreed upon by RDG in writing, sufficient number
of ROM-keys for storage of the Calibration Code, but limited to
quantities as required for the sale of Cholesterol Test Strips supplied
by RDG in accordance with the terms of this Agreement.
7.3 Furthermore, Lifestream shall enter into a supply agreement with LRE,
UMM or such other manufacturer as agreed upon by RDG in writing for the
supply of the Test Instrument Module and the ROM-Keys by LRE, UMM or
such other manufacturer as agreed upon by RDG in writing to Lifestream,
and RDG shall consent to this Agreement provided that said Supply
Agreement shall be dependant on the validity and existence of the
license granted under Section 2 of this Agreement and provided that
Lifestream must not use Test Instrument Modules or ROM-Keys for other
purposes than for integration into the Lifestream Product.
*CONFIDENTIAL TREATMENT REQUESTED 11
8 EXCLUSIVITY
Lifestream hereby agrees and warrants that it shall exclusively
purchase or otherwise acquire Cholesterol Test Strips from RDG in
respect of Lifestream's activities in the Territory, and Lifestream
furthermore undertakes not to acquire Cholesterol Test Strips from any
third party unless either party terminates this Agreement.
9 TRADEMARKS
Lifestream hereby warrants and guarantees that it has obtained all
requisite approvals from trademark tradename owners to promote, market,
distribute and sell the Lifestream Product under a respective trademark
tradename
10 LABELLING AND PACKAGING
10.1 RDG shall package the Cholesterol Test Strip in unlabelled vials a 25
test strips in accordance with specifications agreed between Lifestream
and RDG in writing. RDG agrees to provide Lifestream with one
Calibration Code per lot of Cholesterol Test Strips supplied hereunder
and Lifestream shall be responsible for packaging the Cholesterol Test
Strips together with the correct, corresponding Calibration Code. RDG
will ship the vials in boxes with minimum information as legally
required for importation into the USA. The ***** -devices will be
shipped in bulk packages (500 units per cardboard box). The lancets for
***** will be packed in polyethylene bags (5000 units per bag). These
bags will then be packed in cardboard boxes according to the respective
delivery-size.
10.2 If the packaging or labeling that Lifestream requests requires RDG to
perform any modifications to RDG's current packaging specifications or
packaging or labeling equipment for the Cholesterol Test Strips, then
Lifestream will remunerate RDG for any and all extra internal and
external costs incurred with RDG in connection with packaging the
Cholesterol Test Strips, provided that RDG provides Lifestream with
adequate reasonable documentation relating to these costs.
10.3 RDG shall be responsible for providing instructions to Lifestream on
the method for, and safety precautions to be exercised in, using
Cholesterol Test Strips in accordance with FDA requirements. Any
statements, representations or advertisements concerning the
Cholesterol Test Strips, including without limitation those made in the
labeling for the Lifestream Product or those included with instructions
for the Lifestream Product which involve the Cholesterol Test Strips
and in each case which are made solely in reliance on or supported by
information or data supplied to Lifestream by RDG, shall be the
responsibility of RDG, provided that Lifestream has complied with, and
has not in any way deviated from, the instructions or other information
provided by RDG. Lifestream shall exclusively be responsible for the
correctness of the calibration of repackaged and or re-worked
Cholesterol Test Strips and for the correctness of the labeling of
packages containing Cholesterol Test Strips including, *****-devices
and/or lancets for *****, but not limited to FDA requirements and
instructions for use.
*CONFIDENTIAL TREATMENT REQUESTED 12
10.4 Lifestream shall solely bear the full responsibility for all adverse or
negative effects occurring from the re-packaging or re-working of the
Cholesterol Test Strips.
10.5 Lifestream shall not make any express warranty regarding the
Cholesterol Test Strips, *****-devices or lancets for ***** other than
those specifically authorized by RDG hereunder.
10.6 All products supplied by RDG (including Cholesterol Test Strips, *****
and Lancets for ***** shall be delivered FCA, Mannheim, Germany
(Incoterms 2000).
11 PROMOTIONAL EFFORTS
11.1 Lifestream shall have the sole discretion to develop any and all
promotional materials, labels, advertising, marketing materials and or
informational inserts for the Lifestream Product (except to the extent
that such relate to the Cholesterol Test Strips in which case Section
10.1 shall apply) including without limitation the graphic elements and
designs associated therewith, the name or xxxx placed thereon and the
copy and layout thereof provided that no reference is made to RDG
and/or its Affiliates and to their respective trademarks and or RDG
Technology. RDG agrees that Lifestream owns all rights, titles and
interests in and to any such promotional materials for the Lifestream
Product (except to the extent that such relate to the Cholesterol Test
Strips, *****-devices and/or lancets for *****, in which case Section
10.1 shall apply) including but not limited to all copyrights in
respect thereof provided that no reference is made to RDG and or its
Affiliates and to their respective trademarks and/or RDG Technology.
11.2 Packaging, packaging insert, promotional materials etc. concerning the
***** device and concerning lancets for ***** shall be used and
distributed to the market by Lifestream without any changes whatsoever.
In case Lifestream sells the Lifestream Product together with a
*****-device and or lancets for *****, the parties agree that
Lifestream shall remain free during the term of this Agreement to
implement or copy without any changes whatsoever text elements, graphs
etc. from RDG's packaging insert into Lifestream's User's Manual
concerning the Lifestream Product, as long as due reference is made to
RDG's trademark ownership.
11.3 RDG shall provide Lifestream with such reasonable assistance as
Lifestream may request to effectuate its rights under this Article 11
at Lifestream's expense, and Lifestream shall provide RDG with such
reasonable assistance as RDG may request to effectuate its rights under
this Article 11 at RDG's expense.
11.4 RDG shall supply Lifestream with copies of all information concerning
the quality of the Cholesterol Test Strips which Lifestream reasonably
requests from time to time and which RDG considers necessary to support
the claims contained in the Lifestream Product inserts and or to
support advertising or promotional claims concerning the Cholesterol
Test Strips.
*CONFIDENTIAL TREATMENT REQUESTED 13
12 OPTION GRANT
12.1 Lifestream hereby grants to RDG a first right of refusal for a license
to use, have used, to develop or have developed for RDG's and its
affiliates' use, to market and have marketed and to distribute and have
distributed Lifestream's Smart-Card Reader/Internet Infrastructure in
connection with RDG's or RDG's Affiliates' ddiagnostic systems upon
such terms as shall be agreed between the parties in good faith.
12.2 RDG hereby grants to Lifestream a non-exclusive option to expand the
Territory during the term of this Agreement upon such terms as shall
agreed between the parties in good faith.
12.3 In case, RDG exercises its first right of refusal or, Lifestream
exercises its option hereunder, the parties agree to use their
reasonable endeavors to seek to reach agreement without undue delay,
but not later than six months following the execution of RDG's first
right of refusal according to Section 12.1 or Lifestream's option
according to Section 12.2.
13 GOVERNMENT APPROVAL
Lifestream shall use its best efforts to prepare and file all filings
necessary to maintain Government Approval for the Lifestream Product,
including, for the avoidance of doubt, the Cholesterol Test Strips, the
ROM-Key and the Test Instrument Modules as integrated therein and as
sold and used in connection therewith, to the extent that such
Government Approval has not already been obtained. The responsibility
for obtaining and maintaining such Government Approval shall remain
with Lifestream throughout the term of this Agreement.
14 COMPLIANCE
14.1 In performing their obligations under this Agreement, RDG and
Lifestream shall at all times each comply with all applicable
regulatory requirements, (including the provision of information by RDG
to Lifestream that is necessary for Lifestream to comply with its FDA
medical device reporting requirements), all health registration laws,
regulations, Government Approvals and orders of any competent
government entity in the Territory and with all other applicable
governmental requirements relating to the development, manufacture,
promotion, marketing and sale of the Lifestream Product, and in
connection therewith the Cholesterol Test Strips, *****-devices and
lancets for ***** in the Territory.
*CONFIDENTIAL TREATMENT REQUESTED 14
14.2 Upon reasonable notice during the term of this Agreement, Lifestream
and its agents shall have the right to conduct audits of RDG's or its
Affiliates' or subcontractors' manufacturing facilities and procedures
which relate to the Cholesterol Test Strips to verify RDG's compliance
with the quality system regulations, provided however that such audits
shall not occur more than once in each twelve (12) month period, and,
additionally, in case of special occurrences (including but not limited
to product liability-actions by third parties, restricting orders by
relevant authorities, etc.).
14.3 Lifestream understands and recognizes that the Test Instrument Modules
and Cholesterol Test Strips and other materials made available to it
hereunder may be subject to the import/export administration
regulations of the United States Department of Commerce and to other
government regulations as may be required within the Territory related
to the export of medical devices. Lifestream represents that it is
familiar with and agrees to comply with all such regulations, including
any future modifications thereof, in connection with the distribution
of the Test Instrument Modules, ROM-Keys, Cholesterol Test Strips,
*****-device and/or lancets for *****. To the extent legally
applicable, Lifestream agrees that it will not export or re-export
outside the Territory, directly or indirectly, any Test Instrument
Modules, ROM-Keys, Cholesterol Test Strips, *****-device and or lancets
for ***** or clinical data relating to the Test Instrument Modules,
ROM-Keys, Cholesterol Test Strips, *****-device and or lancets for
*****. Lifestream agrees to take all reasonable and legally permitted
steps to avoid that its customers do so. Lifestream hereby agrees to
indemnify and hold RDG harmless from any breach of this clause.
15 PAYMENTS
15.1 All payments payable hereunder shall be made in US Dollars on the
following account of RDG:
*****
15.2 Any withholding tax (if any) levied by US federal, state or local
authorities on payments made by Lifestream to RDG hereunder, shall be
exclusively borne by Lifestream.
16 COMPLAINTS
16.1 Lifestream shall advise RDG (Attn. Product Quality Management,
Department DQ-P, Fax: *****) by facsimile within forty-eight (48) hours
of it becoming aware of any injury which arises from, or other adverse
serious event relating to, the use or any malfunction of the Lifestream
Product with regard to the Test Instrument Module or the Cholesterol
Test Strips or *****-device or lancets for ***** and shall provide RDG
with a written report detailing the material facts known to Lifestream,
including but not limited to, customer name, address, telephone number,
instrument and lot or serial number, as appropriate, within ten (10)
business days thereof.
*CONFIDENTIAL TREATMENT REQUESTED 15
16.2 Lifestream shall regularly notify RDG in writing of quality complaints
it receives from customers using Cholesterol Test Strips or which
appear to result *****-device and/or lancets for *****
16.3 RDG shall advise Lifestream by telephone or facsimile within
forty-eight (48) hours of it becoming aware of any serious injury which
arises from, or other adverse serious event relating to, the use or any
malfunction of the Cholesterol Test Strips or the *****-device and or
lancets for ***** and to the extent practicable shall provide
Lifestream with a written report detailing the material facts known to
RDG, including but not limited to customer name, address, telephone
number, instrument and lot or serial number, as appropriate, within ten
(10) business days thereof
16.4 RDG and Lifestream shall maintain, and shall each require its
respective manufacturers and suppliers of products relating to this
Agreement to maintain, complete and accurate complaint files in
accordance with 21 United States Code of Federal Regulations 820.198
and with all other laws and regulations as applicable in countries of
the Territory. RDG shall investigate each complaint of a failure of the
Cholesterol Test Strips or the *****-devices and lancets for
*****-device and or lancets for ***** that relates to safety,
performance or efficacy and shall maintain a written record thereof
Lifestream shall investigate each complaint of a failure of the
Lifestream Product including ROM-Key and Test Instrument Module that
relates to safety, performance or efficacy and shall maintain a written
record thereof RDG and Lifestream each agrees to send the other party
copies of each such complaint and a full report on each such
investigation promptly after receiving such complaint or completing
such investigation, as the case may be, but in no event more than ten
(10) business days after the applicable event. Each party shall have
the right to send its representatives to review the other party's
related files upon five (5) days written notice. The parties agree to
cooperate fully with such reviews, and to provide the other with all
documents requested by the other during such reviews.
16.5 If either party believes that a recall of any Cholesterol Test Strips
integrated within a Lifestream Product, or a Lifestream Product, is
desirable or required by law, it will promptly notify the other party.
The parties will discuss reasonably and in good faith whether such
recall is appropriate or required and the manner in which any mutually
agreed recall shall be conducted. If possible, voluntary recalls and
recalls required by law shall be conducted by mutual agreement (not to
be unreasonably withheld). In the event that such recall is required
because of the Cholesterol Test Strips themselves and not their
integration in the Lifestream Product, RDG shall bear all costs related
to the recall. In the event that any recall results from the
integration of either the Cholesterol Test Strips or the Test
Instrument Module into the Lifestream Product, or from any repackaging,
reworking or re-calibration of the Cholesterol Test Strips, or is due
to the Lifestream Product or the Contract Product itself, Lifestream
shall bear the costs related to the recall. If the parties cannot agree
upon a recall, either party may conduct the recall and an arbitrator
acceptable to both parties shall determine which party will bear the
cost. This clause shall not limit the obligations of either party under
law with respect to the recall of Cholesterol Test Strips, Test
Instrument Modules, ROM-Keys, *****-devices or lancets for ***** or
Lifestream Products required by law or properly mandated by
*CONFIDENTIAL TREATMENT REQUESTED 16
governmental authority. If a recall is required by law or desired
either by RDG or Lifestream, Lifestream shall immediately stop its
sales of the corresponding component. The parties will cooperate
reasonably with each other in effecting any recall of the Cholesterol
Test Strips, Test Instrument Modules, ROMKeys, *****-devices, lancets
for ***** and or Lifestream Products pursuant to this clause and will
communicate with their respective purchasers or users as necessary.
16.6 Lifestream shall maintain complete and accurate records of all
Lifestream Products it sells for such periods as may be required by
applicable law.
17 INTELLECTUALPROPERTY
17.1 RDG shall retain all of its rights, title and interest in and to, and
ownership of all RDG Technology, copyrights, trademarks, trade names,
and all other industrial and intellectual property rights covering or
embodied in the Cholesterol Test Strips, *****-devices, lancets for
***** and (to the extent applicable) ROM-Keys and Test Instrument
Modules. Except as otherwise expressly provided in this Agreement,
Lifestream has no right, title or interest in any industrial or
intellectual property relating to the Cholesterol Test Strips,
*****-devices, lancets for ***** and (to the extent applicable)
ROM-Keys and Test Instrument Modules. The parties shall each execute
such documents as the other reasonably requests in order to effectuate
the terms of this clause within five (5) days of a demand for such
execution by the other.
17.2 Lifestream shall retain all of its rights, title, and interest in and
to, and ownership of, all Lifestream Marks, Lifestream Products and
Lifestream Technology. RDG has no right, title or interest in any
industrial or intellectual property relating to the Lifestream Marks,
Lifestream Products or Lifestream Technology, beyond such right, title
or interest in any industrial or intellectual property regarding the
ROM-Key and or the Test Instrument Module that may be owned by RDG. The
parties shall each execute such documents as the other reasonably
requests in order to effectuate the terms of this clause within five
(5) days of a demand for such execution by the other.
17.3 The parties agree that any new industrial or intellectual property
rights arising pursuant to this Agreement (other than those relating to
the Cholesterol Test Strips, the Test Instrument Module or the
Lifestream Product, including any improvements thereof shall be owned
by the developing party.
17.4 In the event either RDG or Lifestream learns of any third party patents
which may cover the manufacture or use or sale of the Cholesterol Test
Strips, *****-device, lancets for *****, the ROM-Key or the Test
Instrument Modules, such party will promptly notify the other. The
parties agree to confer in good faith regarding such potential
infringement risk and to explore reasonable alternatives for avoiding
such risk.
*CONFIDENTIAL TREATMENT REQUESTED 17
17.5 In the event Lifestream or RDG becomes aware of any actual or
threatened infringement of any RDG Technology, that party shall
promptly notify the other. RDG shall within its discretion prosecute
any infringement action against any person or entity infringing the RDG
Technology at its own expense. Lifestream shall cooperate with RDG as
reasonably requested. Any and all amounts recovered with respect to
such an infringement action shall be retained by RDG. If RDG fails to
bring or prosecute any such action, and such failure continues for
forty-five (45) days after written notice from Lifestream, then
Lifestream may take over such action and shall retain all amounts
recovered, and RDG shall cooperate fully with Lifestream in such suit
at Lifestream's expense.
18 WARRANTIES
18.1 RDG represents and warrants that:
(i) the Cholesterol Test Strips shall be based on the technology
and quality of RDG's ***** cholesterol test strips which have
received FDA approval for use in connection with RDG's *****
system;
(ii) the Cholesterol Test Strips supplied in vials by RDG under
this Agreement will be of merchantable quality and will
conform to the specifications stipulated for the Cholesterol
Test Strips in clause 1.3 at the time of delivery;
(iii) the Cholesterol Test Strips shall be manufactured in
accordance with applicable current standards promulgated by
the FDA and shall be manufactured in a facility registered
with and approved for such purpose by the FDA;
(iv) the RDG Technology covering the Cholesterol Test Strips
includes all rights to make, use or sell the Cholesterol Test
Strips within the scope of this Agreement;
(v) the RDG Technology does not infringe any third party rights
and RDG has no knowledge of any information which could render
any claims of the patents within the RDG Technology invalid
and or unenforceable;
(vi) there are no inventions used in the manufacture of or
otherwise incorporated in the Cholesterol Test Strips other
than those covered by the RDG Technology; and
(vii) as of the Effective Date RDG and or its suppliers (if any) of
Cholesterol Test Strips have not received any significant
complaints relating to the Cholesterol Test Strips based on
either the number or severity of complaints received so that a
reasonable person may question the safety, efficacy, accuracy
or reliability of the Cholesterol Test Strips or the method
for manufacturing or testing them.
18.2 Lifestream hereby acknowledges and agrees that RDG in no way whatsoever
guarantees or warrants that the Cholesterol Test Strips shall be fit
for use within the Lifestream Product, and moreover Lifestream agrees
that Lifestream is solely responsible and liable for their integration
within the Lifestream Product.
*CONFIDENTIAL TREATMENT REQUESTED 18
18.3 Lifestream hereby acknowledges and agree that RDG in no way whatsoever
guarantees or warrants the accuracy of results obtained by using
Cholesterol Test Strips that have been re-packaged and or re-worked,
and or the calibration thereof
18.4 Each of RDG and Lifestream respectively represents and warrants that it
is duly organized and validly existing and has full corporate power and
authority to enter into this Agreement and that the execution, delivery
and performance of this Agreement by it does not conflict with any
agreement or understanding, oral or written, to which it is a party or
by which it may be bound.
19 INDEMNIFICATION
19.1 RDG agrees to defend, indemnify and hold Lifestream harmless from and
against all third-party claims, damages, losses, costs and expenses
(with the exception of indirect, consequential or punitive damages),
including reasonable attorney's fees, which Lifestream may incur to the
extent that such claims arise or result from any Cholesterol Test
Strips supplied by RDG hereunder which result in injury, illness or
death of any person or damage to any property, except such claims
arising or resulting from any Cholesterol Test Strips that have been
re-packaged and or re-worked and or re-calibrated and except such
claims as arise or result from the integration of the Cholesterol Test
Strips, the Test Instrument Modules or the ROM-Keys in the Lifestream
Product, such integration being the sole responsibility of Lifestream,
RDG's breach of any of its representations or warranties under this
Agreement or the gross negligence, recklessness or willful misconduct
of RDG or its officers, employees or agents.
19.2 In no event shall RDG be liable under this Agreement for any failure of
any Cholesterol Test Strip, *****-devices and or lancets for ***** or
Test Instrument Module to meet their respective specifications due to
improper use, storage, re-working, re-packaging, re-calibration or
shipment of such Cholesterol Test Strips, *****-devices and/or lancets
for *****.
19.3 Lifestream agrees to defend, indemnify and hold RDG harmless from and
against all third-party claims, damages, losses, costs and expenses,
including reasonable attorney's fees, which RDG may incur to the extent
that such claims arise or result from improper sales by Lifestream in
the OTC Market or the Professional Market, any representation made or
warranty given by Lifestream to third parties with respect to the
Cholesterol Test Strips or ***** or lancets for ***** (other than the
labeling for the Cholesterol Test Strips or ***** or lancets for *****
as approved by the FDA or by RDG in writing and/or warranties or
representations approved by RDG and given in accordance with this
Agreement), any re-working and or re-packaging and or re-calibration of
Cholesterol Test Strips, Lifestream's breach of any of its
representations or warranties under this Agreement, the manufacture,
sale or use of any product which is not supplied by RDG and which is
sold or combined by Lifestream with the Lifestream Product or the
integration of the Test Instrument Module or the Cholesterol Test
Strips in the Lifestream Product which results in injury, illness or
death of any person or damage to any property or patent infringement,
or the gross negligence, recklessness or willful misconduct of
Lifestream or Lifestream's officers, employees or agents.
*CONFIDENTIAL TREATMENT REQUESTED 19
20 INSURANCE
Each party will maintain comprehensive general liability insurance covering
the indemnification, defense, hold harmless, and other obligations of
that party under this Agreement throughout the term of the Agreement.
21 CONFIDENTIALITY
21.1 Throughout the term of the Agreement and for a period of five years
following the termination thereof, each party hereto agrees to hold in
strict confidence and not disclose to any third party any and all
information received by one party from the other pursuant to this
Agreement including, but not limited to any technology, know-how,
processes or patent application disclosed by the other or derived from
information thus disclosed, trade secrets, inventions, ideas, data,
manufacturing or finance matters. Each party furthermore agrees that it
may only use such information received from the other to the extent
required to accomplish the purposes of this Agreement and to restrict
access to such information to persons entrusted to carry out the
activities provided for hereunder who are subject to an analogous
confidentiality obligation. Each party agrees to clearly xxxx as
confidential any and all information which it makes available to the
other party which the disposing party considers to be confidential.
Each party furthermore agrees to reduce to writing any such
confidential information which it discloses orally and to provide the
receiving party with a copy thereof within thirty (30) days of the date
of the oral disclosure.
21.2 The confidentiality obligations pursuant to clause 17.1 shall not apply
to information which:
21.2.1 is in the public domain at the time of its disclosure;
21.2.2 is published or otherwise becomes part of the public domain through no
fault of the receiving party or becomes available from a third party
who has the right to disclose it;
21.2.3 was in the possession of the receiving party at the time of its
disclosure as shown by prior written records;
21.2.4 was or will be independently developed by employees of the receiving
party who had no access to the information disclosed; or
21.2.5 must be disclosed in accordance with applicable laws or in order to
obtain Government Approval in accordance with the terms of this
Agreement.
21.3 Neither party shall make any press release or other similar public
announcement concerning the executed Agreement without the prior
written consent of the other party hereto, such approval not to be
unreasonably withheld, except as required by law. Approval will be
deemed granted if no response is received by the proposing party within
ten (10) working days of its delivery of a request for approval to the
other
*CONFIDENTIAL TREATMENT REQUESTED 20
22 TERM AND TERMINATION
22.1 This Agreement shall commence on the Effective Date and, subject to
Section 20.2 and 20.3 shall remain in full force and effect for the
term of the initial four (4) years period, starting January I, 2001 and
ending December 31, 2004. Following this date, this Agreement shall be
automatically renewed for additional terms of twelve months each unless
written termination notice has been given by either party twelve months
prior to the end of the initial period or any additional renewal term.
22.2 Either party has the right to terminate this Agreement at the end of
the initial period (December 31, 2004) or at the end of each additional
twelve months renewal term, by giving 12 months prior written notice to
the other party.
22.3 If either party commits any material breach of this Agreement or
becomes substantially unable to perform its obligations hereunder and
fails to remedy any such breach or default within ninety (90) days
after written notice thereof by the non-breaching party, the
non-breaching party may, at its option, immediately terminate this
Agreement by notice to such effect. For the avoidance of doubt, failure
by Lifestream to comply with its obligation to purchase a minimum of
***** Cholesterol Test Strips in each twelve (12) months period during
the term of this Agreement, starting with January I, 2001, shall
constitute a material breach on the part of Lifestream and entitle RDG
to terminate this Agreement in accordance with this clause 20.3.
22.4 Upon the termination of this Agreement, the following shall occur:
22.4.1 At the termination date, Lifestream shall be free to issue a last and
final Purchase Order for the supply of Cholesterol Test Strips,
*****-devices and or lancets for *****, which last and final Purchase
Order regarding *****-devices and or lancets for ***** shall be limited
to the extent of the amount of *****-devices and or lancets for *****
that have been supplied by RDG to Lifestream during the last
twenty-four (24) months prior to the issuing date of that last and
final Purchase Order. The last and final Purchase Order regarding
Cholesterol Test Strips shall be unlimited.
22.4.2 The license granted pursuant to Article 2 shall terminate, and
Lifestream shall discontinue the development, marketing, sales and
distribution of the Lifestream Product that utilizes the ROM-Key and or
Test Instrument Module and or Cholesterol Test Strips after a sell-out
period of twenty-four (24) months. Beyond that, Lifestream shall be
entitled to sell its remaining inventory of Cholesterol Test Strips,
*****-devices and lancets for ***** as ordered under this Agreement,
including but not limited to the final Purchase Order.
*CONFIDENTIAL TREATMENT REQUESTED 21
22.4.3 After termination neither party shall represent or hold itself out as
being an authorized distributor or sales representative for the other
party of any of the other party's products, or engage in any practices
which might make it appear that such party is an authorized distributor
or sales representative of the other party.
22.4.4 Each party shall return to the other or destroy, at the other party's
instruction, all confidential information of the other party, with the
exception of records required to be maintained to be in compliance with
FDA regulations or other governmental requirements, including
advertising matter.
22.4.5 The rights of either party which may have accrued up to the date of
termination shall not be affected by any such termination, and the
provisions concerning Indemnification, Confidentiality, Governing Law
and Jurisdiction and Miscellaneous, including this provision concerning
the Survival of Provisions, shall remain valid notwithstanding any
termination.
23 GOVERNING LAW AND JURISDICTION
This Agreement shall be construed in accordance with and governed by the
laws of the Federal Republic of Germany without regard to and excluding
the provisions of the 1980 UN Convention on Contracts for the
International Sale of Goods. The parties hereby submit to the exclusive
jurisdiction of the courts of Mannheim, Federal Republic of Germany.
24 MISCELLANEOUS
24.1 The parties' obligations under the Agreement will not be assignable to
third parties without the prior written consent of RDG.
24.2 This Agreement, together with the schedules attached hereto, embodies
the final, complete and exclusive understanding between the parties,
and replaces and supersedes all previous agreements, understandings or
arrangements between the parties with respect to its subject matter
including but not limited to the License and Supply Agreement between
the Parties, as of I October 1997. No modification or waiver of any
terms or conditions hereof shall have any force or effect unless such
modification or waiver is agreed to in writing by both parties.
*CONFIDENTIAL TREATMENT REQUESTED 22
24.3 Neither party shall be liable to the other for its failure to perform
any of its obligations under this Agreement during any period in which
such performance is delayed because of or rendered impracticable or
impossible due to, circumstances beyond its reasonable control,
including, but not limited to acts of God, embargoes, governmental
restrictions, strikes or other concerted acts of workers, fire, flood,
explosion, riots, wars, civil disorder, rebellion, sabotage or failure
to obtain supplies of components necessary to perform obligations
hereunder upon commercially reasonable terms, provided that the party
experiencing the delay promptly notifies the other of the delay.
24.4 Any notice required or permitted to be given under or in connection
with this Agreement or the subject matter hereof shall be given by
courier, first class air mail or telefax to the recipient at the
following address, or to any other address as may have been furnished
in writing by the recipient to the sending party for such purposes. Any
such aforementioned notice or request shall be effective upon receipt
by the party to which it is addressed, provided that any notice sent by
courier or first class air mail shall be deemed received within seven
working days of posting and any notice sent by telefax shall be deemed
received within one working day of being telefaxed, as the case may be.
Roche Diagnostics GmbH: Roche Diagnostics GmbH
Patient Care
Xxxxxxxxx Xxxxxxx 000
X- 00000 Xxxxxxxx
Xxxxxxx
Attention Product Marketing - Point of Care
Telephone: ***
Facsimile: ***
With copy to: Legal Counsel, Patient Care
Telephone: ***
Facsimile: ***
Lifestream: Lifestream Technologies, Inc.
000 Xxxxxxxxxx Xxxx
Xxxxx 000
Xxxx Xxxxx
Xxxxx 00000
Xxxxxx Xxxxxx of America
Attention: Xx. Xxxxxxxxxxx X. Xxxx, President
Telephone: ***
Facsimile: ***
With copy to: Xxxxxxxxx Xxxxxxxx Xxxxxxxx Marks & Xxxxxxx
Chartered Attorneys-At-Law
Xx. Xxxx Xxxxxxxxx
Lake Plaza Building
000 Xxxxx Xxxxx Xxxxxx
X.X. Xxx 0000
Xxxxxxxxx, Xxxxx 00000-0000
Fax: ***
Telephone: ***
*CONFIDENTIAL TREATMENT REQUESTED 23
24.5 Failure by one of the parties to this Agreement to assert its rights
arising from any breach of this Agreement shall not be deemed a waiver
of such rights nor shall any such waiver be implied upon acceptance of
any prepayment. The rights and remedies specified herein, except those
rights and remedies which are specified as exclusive, are in addition
to and shall not restrict any other right or remedy either party may
have at law.
24.6 All stipulations contained in this Agreement shall be so construed as
not to infringe the provisions of any applicable laws, but if any such
stipulation does infringe any such provision, the same shall be deemed
to be void and severable and shall be replaced by an appropriate
provision conforming to such law and reflecting the economic intentions
of the parties hereto, and this shall not effect the validity of the
remainder of this Agreement. In the event that the terms and conditions
of this Agreement are materially altered as a result, the parties shall
renegotiate the terms and conditions of this Agreement in order to
resolve any inequities.
24.7 Each party is acting as an independent contractor of the other under
the terms of this Agreement. Neither party is, nor shall it be deemed
to be, an employee, agent or legal representative of the other for any
purpose. Neither party shall be entitled to enter into any contracts in
the name of, or on behalf of the other, nor shall either party be
entitled to pledge the credit of the other in any way or hold itself
out as having authority to do so.
25 LIST OF SCHEDULES
Schedule 1: Supply Price List
Schedule 2: Test Instrument Module Specifications
*CONFIDENTIAL TREATMENT REQUESTED 24
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their respective duly authorized officers.
Signed for and on behalf of Signed for and on behalf of
ROCHE DIAGNOSTICS GMBH LIFESTREAM TECHNOLOGIES, INC.
i.V.
/s/ S. Ek /s/ N. Grzibek /s/ Xxxxxxxxxxx X. Xxxx
S. Xx X. Grzibek Xxxxxxxxxxx X. Xxxx
Mannheim, December 12, 2000
* CONFIDENTIAL TREATMENT REQUESTED 25
SCHEDULE 1
1. Supply Price List
------------------------
Product Price (FCA Mannheim; European Incoterms 2000)
Cholesterol Test Strip
Cat. No.: 1454412-001; US $ *** per vial containing 25 strips
Softclix(R)II
Bulk of 500 devices US $ ***
Cat. No.: 3009297-001
Lancets for Softclix(R)II
Bulk of 5,000 lancets US $ ***
Cat. No.: 1623486
2. License Fee
------------------
Test Instrument Module US $ *** per module
(masked version/one time programmable
microcontroller version)
*CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 2
Test Instrument Module Specifications
The Test Instrument Module is based on the current RDG product known as the
***** printed circuit board.
Hardware Configuration
The Test Instrument Module will consist of:
o A FR-4 circuit board, SMT and through-hole electronics, and optics,
with an injection comolded black and clear plastic "Optic Cover" with
coating, mechanically attached.
o An unattached part: "the reagent strip holder".
o OTP (one time programmable) memory component until such time as RDG
determines that an acceptable masked version is available to it, from
which time a masked microcontroller will be included instead.
o Anti-static bulk packaging of a mutually acceptable configuration (Test
Instrument Module).
o "Bag and Talk" bulk packaging (strip holder).
NOT included are:
o The conductive elastomer keypad switches
o The black plastic ROM-KEY guide and it's mounting screws o Piezio
electric beeper or it's connectors
o LCD glass, conductive connector and clear plastic window
o Battery contacts, unless required for B/M quality assurance procedures
o All plastic enclosure, keypad parts and labeling with the exception of
the loose "strip holder" mentioned above
Software Configuration
The Test Instrument Module will contain software:
o Which will utilize the current ***** whole blood cholesterol reagent
strip.
o Which will match the separate ROM-KEY for the same chemistry.
System Performance, manufacturing and quality assurance standards
The Test Instrument Module is expected to meet the performance and quality
assurance requirements of the ***** as specified in existing RDG procedures
currently supporting serial production and sales to the public.
Final calibration and testing, ATP (Acceptance Test Procedure) will utilize
RDG's current ***** process and system.
*CONFIDENTIAL TREATMENT REQUESTED
