MANUFACTURING SERVICES AGREEMENT
THIS AGREEMENT (the "Agreement") is effective as of April 1, 2002 (the
"Commencement Date"), by and between LIFESTREAM TECHNOLOGIES, INC. a(n) Nevada
corporation having a principal place of business at 000 Xxxxxxxxxx Xxxx, Xxx
000, Xxxx Xxxxx, XX 00000 ("LIFESTREAM") and SCI HOLDINGS, INC., A DIVISION OF
SANMINA-SCI CORPORATION, a United Kingdom corporation having its principal place
of business at 0 Xxxxxxxx Xxx, Xxxxx Xxxxxxx Industrial Estate, Irvine,
Ayrshire, KA11 4 HU Scotland ("SANMINA-SCI").
1. TERM
The initial term of this Agreement shall commence on the Commencement
Date and shall continue through the first anniversary of the Commencement Date
unless sooner terminated by mutual agreement or in accordance with this
Agreement. Upon the expiry of the initial term, this Agreement shall continue
from year to year until one party terminates the Agreement by giving at least
ninety (90) days' prior written notice to the other party. Notwithstanding the
foregoing, the term of this Agreement shall automatically extend to include the
term of any purchase order ("Order") issued hereunder.
2. PRICING
2.1 Pricing. During the term, LIFESTREAM shall have the right to
purchase from SANMINA-SCI the products specified in Exhibit A hereto, as such
Exhibit may be amended from time to time (the "Products") at the prices set
forth in Exhibit A (the "Prices"). Prices (a) are in U.S. Dollars, (b) include
SANMINA-SCI designed packaging (unless otherwise specified in the bid
documents), (c) exclude the items set forth in Section 2.2, and (d) are based on
(i) the configuration set forth in the specifications attached hereto as Exhibit
C (the "Specifications") and (ii) the projected volumes, minimum run rates and
other assumptions set forth in SANMINA-SCI's bid letter (if any) and Exhibit A.
The Prices shall remain fixed for the term of the Agreement, subject to
SANMINA-SCI's right to revise Prices (y) to account for any material variations
on the market prices of components, parts and raw material (collectively
"Components"), including any such variations resulting from shortages or (z) the
price adjustments set forth in Section 2.3.
2.2 Exclusions from Price. Prices do not include (a) export licensing
of the Product or payment of broker's fees, duties, tariffs or other similar
charges; (b) taxes or charges (other than those based on net income of
SANMINA-SCI) imposed by any taxing authority upon the manufacture, sale,
shipment, storage, "value add" or use of the Product which SANMINA-SCI is
obligated to pay or collect; and (c) setup, tooling, or non-recurring
engineering activities (collectively "NRE Charges"). Any charges for these items
shall be separately invoiced.
2.3 Other Price Adjustments:
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(a) LIFESTREAM acknowledges that the Prices set forth in
Exhibit A are based on the forecasted volumes provided by LIFESTREAM to
SANMINA-SCI. In the event LIFESTREAM fails to purchase Product in sufficient
volumes consistent with the quoted prices, SANMINA-SCI reserves the right to
xxxx-back LIFESTREAM for the difference between the prices paid and the prices
associated with such lower volumes.
(b) LIFESTREAM acknowledges that the Prices are based on the
Specifications and the assumptions set forth in SANMINA-SCI's bid letter and in
Exhibit A. In the event SANMINA-SCI experiences an increase in cost as a result
of changes in the pricing assumptions or the Specifications, SANMINA-SCI shall
be entitled to the Price adjustment set forth in Section 6.1.
(c) LIFESTREAM acknowledges that some components are purchased
in currencies other than US Dollars are thus subject to currency fluctuation.
The Parties shall agree at the beginning of each calendar quarter on the
exchange rate to be applied for various currencies in relation to the US dollar
during the next calendar period. SCI shall be allowed to nominate the currencies
to be covered based on suppliers' currency mix and the proposed exchange rate
for each nominated currency, which shall reasonably reflect the current exchange
rate valid for the next calendar period, both parties recognizing that neither
party controls financial market future variances from this rate. In agreeing to
the nominated exchange rate for each currency, the Parties shall apply a plus
1.5 per cent (+1.5%) and a minus 1.5 percent (-1.5%) dead zone in which the
actual exchange rate may vary during the period without either party seeking
adjustment from the other during the calendar quarter, but in all cases will be
reconciled at the end of each calendar quarter. To the extent the actual
exchange rate varies outside this dead zone during the course of the calendar
quarter, either party have the right, but not the obligation, to request a
reconciliation during the calendar period so as to achieve an equitable net
currency exchange adjustment back to the agreed exchange rates. Any such
adjustments under this Exhibit shall be made in good faith, expeditiously by
both parties, and always with the goal that the payment received for Products
should not be affected by exchange rate fluctuations, which are agreed to be
beyond the control of either party. At the end of each calendar quarter (or
earlier as the case may be) the actual SCI cost of non-US dollar currencies
utilized to purchase components and services will be reconcilied back to the
agreed US dollar exhange value, and the difference in cost will be either
invoiced by SANMINA-SCI or credited to LIFESTREAM, on a net basis.
2.4 Product Ordering. Product ordering shall be in accordance with the
schedule or method of releases by Orders set forth in Article 4.
3. PAYMENT TERMS
Payment terms are (*) after date of invoice. On any invoice not paid by
maturity date, LIFESTREAM shall pay interest from maturity to date of payment at
the rate of 1.5% per month. Payment shall be made in U.S. Dollars. Offsets and
setoffs by either party are not allowed. In the event LIFESTREAM has any
outstanding invoice for (*), SANMINA-SCI shall have the right to stop shipments
of Product to LIFESTREAM until LIFESTREAM makes a sufficient payment to bring
its account within the credit limit provided.
4. PURCHASE ORDERS/FORECAST/RESCHEDULE
4.1 Purchase Orders.
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(a) LIFESTREAM will issue to SANMINA-SCI specific Orders for
Product covered by this Agreement. Each Order shall be in the form of a written
or electronic communication and shall contain the following information: (i) a
description of the Product by model number; (ii) the quantity of the Product;
(iii) the delivery date or shipping schedule; (iv) the location to which the
Product is to be shipped; and (v) transportation instructions. Each Order shall
provide an order number for billing purposes, and may include other instructions
as may be appropriate under the circumstances.
(b) All Orders shall be confirmed by SANMINA-SCI within five
(5) business days of receipt. If SANMINA-SCI does not accept or reject the Order
within the five day period, the Order shall be deemed rejected by SANMINA-SCI
unless SANMINA-SCI has commenced performance, in which case the Order shall be
deemed accepted to the extent of such performance. In the event SANMINA-SCI is
unable to meet the delivery schedule set forth in a proposed Order, or finds the
schedule to be unacceptable for some other reason, the parties shall negotiate
in good faith to resolve the disputed matter(s).
4.2 Forecast; Minimum Buys; Excess and Obsolete Inventory.
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(a) Initial Forecast. Upon the execution of this Agreement,
LIFESTREAM shall provide SANMINA-SCI with (i) an initial ninety (90) day firm
Order and (ii) a forecast for Product requirements (in monthly buckets) for an
additional nine (9) months ("Forecast"). The Order - and all subsequent Orders -
shall be binding and may be rescheduled only in accordance with Section 4.2(d)
or cancelled in accordance with Section 4.2(g). SANMINA-SCI shall make purchase
commitments (including purchase commitments for Long Lead-time Components) to
its Component suppliers ("Vendors") based upon the Order and Forecast, and
LIFESTREAM shall be responsible for all such Components purchased in support of
LIFESTREAM's then-current Forecast. For all other purposes, however, the
Forecast shall be non-binding.
(*) Confidential treatment requested.
(b) Subsequent Forecasts. On the first business day of each
calendar month after the initial Order and Forecast, the first Forecast month
shall automatically become part of the Order, a new Forecast month shall be
added, and a new firm Order issued, so that a rolling Order of ninety (90) days
is always maintained.
(c) MRP Process.
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(1) SANMINA-SCI shall take the Order and Forecast and
generate a Master Production Schedule ("MPS") for a twelve-month period in
accordance with the process described in this Section. The MPS shall define the
master plan on which SANMINA-SCI shall base its procurement, internal capacity
projections and commitments. SANMINA-SCI shall use LIFESTREAM's Order to
generate the first three (3) months of the MPS and shall use LIFESTREAM's
Forecast to generate the subsequent nine (9) months of the MPS.
(2) SANMINA-SCI shall process the MPS through
industry-standard software (the "MRP Software") that will break down
LIFESTREAM's Product requirements into Component requirements. When no Product
testing (in-circuit or functional testing) is required by LIFESTREAM,
SANMINA-SCI will use commercially reasonable efforts to schedule delivery of all
Components to SANMINA-SCI eleven working days before the Products are scheduled
to ship to LIFESTREAM; in the event Product testing is required, SANMINA-SCI
will use commercially reasonable efforts to schedule delivery of all Components
to SANMINA-SCI sixteen working days before the Products are scheduled to ship to
LIFESTREAM.
(3) SANMINA-SCI will release (launch) purchase orders
to Vendors prior to the anticipated date that the Components are needed at
SANMINA-SCI. The date on which these orders are launched will depend on the lead
time determined between the Vendor and SANMINA-SCI and SANMINA-SCI's
manufacturing or materials planning systems.
(4) A list of all Components with lead times greater
than ninety days ("Long Lead-time Components") is set forth in Exhibit B to this
Agreement which will be amended from time to time by agreement of the Parties.
SANMINA-SCI shall use reasonable efforts to update the list of Long Lead-time
Components every quarter and present an updated list of Long Lead-time
Components to LIFESTREAM at the time SANMINA-SCI presents LIFESTREAM with the
E&O List described in section 4.2(e). Each revised Long Lead-time Item list
shall be deemed an amendment to Exhibit B. In the event SANMINA-SCI fails to
present an updated list of Long Lead-time Components, (i) the parties shall
continue to rely on the preceding list (as updated in writing by the parties)
and (ii) LIFESTREAM will accept responsibility for Long Leadtime Components
ordered outside the leadtimes set forth in the list provided that SANMINA-SCI
can demonstrate to LIFESTREAM'S reasonable satisfaction that such Components
were ordered in accordance with the then-current Vendor leadtimes. (LIFESTREAM
acknowledges that leadtimes constantly change and that SANMINA-SCI might not
always be able to present LIFESTREAM with a current Long Leadtime Component
List).
(5) LIFESTREAM acknowledges that SANMINA-SCI will
order Components in quantities sufficient to support up to six months of
LIFESTREAM's Forecast. In determining the quantity of Components to order,
SANMINA-SCI divides the Components into three classes, "Class A" "Class B" and
"Class C". Class A Components are comprised of the approximately three percent
(3%) of Components constituting approximately eighty percent (80%) of the
Product's total Component cost Class C Components are comprised of the
approximately eighty percent (80%) of Components constituting approximately
three percent (3%) of the Product's total Component cost. Class B Components are
comprised of the remaining seventeen percent (17%) of Components constituting
approximately seventeen percent (17%) of the Product's total Component cost.
SANMINA-SCI will place orders with its vendors for approximately one (1-2)
weeks' worth of Class A Components, two (2-4) weeks worth of Class B Components
and three (3) months' worth of Class C Components. A summary of SANMINA-SCI's
purchase commitments is set forth in the table below.
---------------------------- -------------------------- -------------------------- --------------------------
Part Class Expected Percentage of Expected Percentage of Periods Worth of Supply
Total Parts Total Value (of Gross to be Bought with Each
Requirements) Order
---------------------------- -------------------------- -------------------------- --------------------------
A 3% 80% 1-2 Weeks
---------------------------- -------------------------- -------------------------- --------------------------
B 17% 17% 2-4 Weeks
---------------------------- -------------------------- -------------------------- --------------------------
C 80% 3% 3 Months
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(6) LIFESTREAM acknowledges that SANMINA-SCI will be
required to order Components in accordance with the various minimum buy
quantities, tape and reel quantities, and multiples of packaging quantities
required by the Vendor. In addition, LIFESTREAM acknowledges that there is a lag
time between any Lifestream cancellation and the cancellation of the Components
required to support production.
(d) Reschedule. LIFESTREAM may reschedule all or part of a
scheduled delivery (per purchase order or forecast) one (1) time per quarter
(for a maximum of two quarters) for a period not to exceed forty-five (45) days
in accordance with the table below. At the end of this forty-five day period,
LIFESTREAM shall either accept delivery of rescheduled finished units and/or pay
SANMINA-SCI's Delivered Component Cost (as defined in Section 4.2(e)) associated
with rescheduled units not yet built.
[As an example, assume that LIFESTREAM's purchase order requested
delivery of 100 units on July 31, 100 units on August 31, 100 units on
September 30 and 100 units on October 31. On July 15, LIFESTREAM asks
SANMINA-SCI to reschedule all deliveries to the maximum extent
permitted under this Agreement. Because the Agreement does not permit
reschedules within thirty days of the delivery date, none of the units
scheduled for delivery on July 31 would be affected. SANMINA-SCI would,
however, reschedule the delivery of fifteen units scheduled to be
delivered on August 31 to October 15 (within 60 days, LIFESTREAM can
reschedule 15% of any scheduled delivery for a maximum of 45 days),
reschedule the delivery of thirty units scheduled to be delivered on
September 30 to November 15 (within 90 days, LIFESTREAM can reschedule
30% of any scheduled delivery for a maximum of 45 days), and reschedule
the delivery of 100 units scheduled to be delivered on October 31 to
December 15 (after 90 days, LIFESTREAM can reschedule 100% of any
scheduled delivery for a maximum of 45 days .]
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DAYS BEFORE P.O. DELIVERY DATE PERCENTAGE RESCHEDULE ALLOWANCE
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0 - 30 No Change
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31 - 60 15%
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61-90 30%
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> 90 100%
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SANMINA-SCI shall use reasonable commercial efforts to accommodate any
upside schedule changes beyond the firm order periods.
(e) Excess and Obsolete Inventory. Within a reasonable time
after the end of each calendar quarter, SANMINA-SCI shall advise LIFESTREAM in
writing of any excess or obsolete Components in its inventory and the Delivered
Cost of such Components (the "E&O List"). For the purpose of this Agreement,
"Delivered Cost" shall mean SANMINA-SCI's quoted cost of Components as stated on
the xxxx of materials plus a materials margin equal to fifteen percent (15%).
Within five (5) business days of receiving SANMINA-SCI's E&O List, LIFESTREAM
shall advise SANMINA-SCI of any Component on the E&O List that it believes is
not excess or obsolete. Within ten business days after receiving SANMINA-SCI's
E&O List, SANMINA-SCI and LIFESTREAM shall finalize the E&O List, and LIFESTREAM
shall issue to SANMINA-SCI an Order for all Components on the E&O List.
LIFESTREAM shall pay SANMINA-SCI its Delivered Cost for Components on the E&O
List within fifteen (15) days of the date of invoice. In the event the parties
cannot agree as to the Components on the E&O List, LIFESTREAM shall pay
SANMINA-SCI for all non-disputed Components in accordance with this Section, and
shall pay SANMINA-SCI for all other Components on SANMINA-SCI's E&O List (in the
event they remain excess or obsolete) forty-five days thereafter. For the
purpose of this Section, the phrase "obsolete Component" shall mean any
Component which is not currently used to manufacture LIFESTREAM's Product
(whether as a result of an ECO or otherwise), and the term "excess Component"
shall mean any Component which is not required to meet LIFESTREAM's Order or
LIFESTREAM's Forecast to which such Component was initially ordered. LIFESTREAM
shall not have the right to delay payment for excess Components by increasing or
pushing out its Forecast.
(g) LIFESTREAM Component Liability. LIFESTREAM acknowledges
that it shall be financially liable for all Components ordered in accordance
with this Article. Specifically, LIFESTREAM's Component Liability shall be equal
to SANMINA-SCI's Delivered Cost of all Components ordered in support of any
Order or Forecast, including any excess Components resulting from any minimum
buy quantities, tape and reel quantities, and multiples of packaging quantities
required by the Vendor less the actual cost (per the xxxx of materials) of those
Components which are returnable to Vendor (less any cancellation or restocking
charges). At LIFESTREAM'S request, SANMINA-SCI shall use commercially reasonable
efforts to minimize LIFESTREAM'S Component Liability by attempting to return
Components to the Vendor; provided, however, that SANMINA-SCI shall not be (*).
5. DELIVERY AND ACCEPTANCE
5.1 Delivery. All Product shipments shall be EX WORKS SANMINA-SCI's
facility of manufacture (INCOTERMS 2000) and freight collect. Title to and risk
of loss or damage to the Product shall pass to LIFESTREAM upon SANMINA-SCI's
tender of the Product to LIFESTREAM's carrier. SANMINA-SCI shall xxxx, pack,
package, crate, transport, ship and store Product to ensure (a) delivery of the
Product to its ultimate destination in safe condition, (b) compliance with all
requirements of the carrier and destination authorities, and (c) compliance with
any special instructions of LIFESTREAM. SANMINA-SCI shall use reasonable efforts
to deliver the Products on the agreed-upon delivery dates and shall use
reasonable efforts to notify LIFESTREAM of any anticipated delays; provided,
however that SANMINA-SCI shall not be liable for any failure to meet LIFESTREAM
delivery dates and/or any failure to give notice of anticipated delays.
5.2 Acceptance. Acceptance of the Product shall occur no later than
fifteen (15) days after the arrival of the shipment of Product and shall be
based solely on whether the Product passes a mutually agreeable Acceptance Test
Procedure or Inspection designed to demonstrate compliance with the
Specifications, to include, mutually agreed to 3rd party audit of the finished
goods as part of the quality plan Exhibit G. Product cannot be rejected based on
criteria that were unknown to SANMINA-SCI or based on test procedures that
SANMINA-SCI does not conduct. Product shall be deemed accepted if not rejected
within this fifteen-day period. Once a Product is accepted, all Product returns
shall be handled in accordance with Article 7 (Warranty). Prior to returning any
rejected Product, LIFESTREAM shall obtain an Authorized Return Material ("ARM")
number from SANMINA-SCI, and shall return such Product in accordance with
SANMINA-SCI's instructions; LIFESTREAM shall specify the reason for such
rejection in all ARM's. In the event a Product is rejected, SANMINA-SCI shall
have a reasonable opportunity to cure any defect which led to such rejection.
6. CHANGES
6.1 General. LIFESTREAM may upon sufficient notice make changes within
the general scope of this Agreement. Such changes may include, but are not
limited to changes in (1) drawings, plans, designs, procedures, Specifications,
test specifications or BOM, (2) methods of packaging and shipment, (3)
quantities of Product to be furnished, (4) delivery schedule, or (5)
Customer-Furnished Items. All changes other than changes in quantity of Products
to be furnished shall be requested pursuant to an Engineering Change Notice
("ECN") and, if accepted by LIFESTREAM, finalized in an Engineering Change Order
("ECO"). If any such change causes either an increase or decrease in
SANMINA-SCI's cost or the time required for performance of any part of the work
under this Agreement (whether changed or not changed by any ECO) the Prices
and/or delivery schedules shall be adjusted in a manner which would adequately
compensate the parties for such change.
(*) Confidential treatment requested
6.2 ECN's. SANMINA-SCI will respond to one ECN request per month
without a non-recurring administrative fee; responses to additional ECN's will
incur an administrative fee of $1,000.00 each. Within five (5) business days
after an ECN is received, SANMINA-SCI shall advise LIFESTREAM in writing (a) of
any change in Prices or delivery schedules resulting from the ECN and (b) the
Delivered Cost of any Finished Product, Work-in-Process or Component rendered
excess or obsolete as a result of the ECN (collectively the "ECN Charge").
Unless otherwise stated, ECN Charges are valid from thirty (30) days from the
date of the ECN Charge.
6.3 ECO's. In the event LIFESTREAM desires to proceed with the change
after receiving the ECN Charge pursuant to Section 6.2, LIFESTREAM shall advise
SANMINA-SCI in writing and shall immediately pay the portion of the ECN Charge
set forth in Section 6.2(b). In the event LIFESTREAM does not desire to proceed
with the Change after receiving the ECN change, it shall so notify SANMINA-SCI.
In the event SANMINA-SCI does not receive written confirmation of LIFESTREAM's
desire to proceed with the change within thirty days after SANMINA-SCI provides
LIFESTREAM with the ECN Charge, the ECN shall be deemed cancelled.
7. WARRANTY
7.1 SANMINA-SCI Warranty. SANMINA-SCI's warranty period is for one year
from date of manufacture and is limited to correction of defects in SANMINA-SCI
workmanship. For the purpose of this Section, "workmanship" shall mean
manufacture in accordance with the most current version of IPC-A-600 or
IPC-A-610, or LIFESTREAM's workmanship standards set forth in the
Specifications. SANMINA-SCI shall, at its option and at its expense, repair,
replace or issue a credit for Product found defective during the warranty
period. In addition, SANMINA-SCI will pass on to LIFESTREAM all manufacturer's
Component warranties to the extent that they are transferable, but will not
independently warrant any Components.
7.2 ARM Procedure. SANMINA-SCI shall concur in advance on all Product
to be returned for repair or rework. LIFESTREAM shall obtain an Authorized
Returned Material (ARM) number from SANMINA-SCI prior to return shipment. All
returns shall state the specific reason for such return, and will be processed
in accordance with SANMINA-SCI's Authorized Returned Material Procedure, a copy
of which is available from SANMINA-SCI upon request SANMINA-SCI shall pay all
transportation costs for valid returns of the Products to SANMINA-SCI and for
the shipment of the repaired or replacement Products to LIFESTREAM, and shall
bear all risk of loss or damage to such Products while in transit; LIFESTREAM
shall pay these charges, plus a handling charge, for invalid or "no defect
found" returns. Any repaired or replaced Product shall be warranted as set forth
in this Article for a period equal to the greater of (i) the balance of the
applicable warranty period relating to such Product or (ii) sixty (60) days
after it is received by LIFESTREAM.
7.3 Exclusions From Warranty. This warranty does not include Products
that have defects or failures resulting from (a) LIFESTREAM's design of Products
including, but not limited to, design functionality failures, specification
inadequacies, failures relating to the functioning of Products in the manner for
the intended purpose or in the specific LIFESTREAM's environment; (b) accident,
disaster, neglect, abuse, misuse, improper handling, testing, storage or
installation including improper handling in accordance with static sensitive
electronic device handling requirements; (c) alterations, modifications or
repairs by LIFESTREAM or third parties or (d) defective Customer-provided test
equipment or test software. LIFESTREAM bears all design responsibility for the
Product.
7.4 Remedy. THE SOLE REMEDY UNDER THIS WARRANTY SHALL BE THE REPAIR,
REPLACEMENT OR CREDIT FOR DEFECTIVE PARTS AS STATED ABOVE. THIS WARRANTY IS IN
LIEU OF ANY OTHER WARRANTIES EITHER EXPRESS OR IMPLIED, INCLUDING
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
8. LIFESTREAM FURNISHED EQUIPMENT AND COMPONENTS
8.1 Customer-Furnished Items. LIFESTREAM shall provide SANMINA-SCI with
the equipment, tooling, Components or documentation set forth in EXHIBIT D
(collectively the "Customer-Furnished Items"). The Customer-Furnished Items
shall be fit for their intended purposes and shall be delivered to SANMINA-SCI
in a timely manner. Documentation (including BOM's, drawings and artwork) shall
be current and complete. LIFESTREAM shall be responsible for schedule delay,
reasonable inventory carrying charges and allocated equipment down time charges
associated with the incompleteness, late delivery or non-delivery of the
Customer-Furnished Items.
8.2 Care of Customer-Furnished Items. All Customer-Furnished Items
shall remain the property of LIFESTREAM. SANMINA-SCI shall clearly identify all
Customer-Furnished Items by an appropriate tag and shall utilize such
Customer-Furnished Items solely in connection with the manufacture of
LIFESTREAM's Product. SANMINA-SCI shall not make or allow modifications to be
made to the Customer-Furnished Items without LIFESTREAM's prior written consent.
SANMINA-SCI shall be responsible for reasonable diligence and care in the use
and protection of any Customer-Furnished Items and routine maintenance and
repairs of any Customer-Furnished Equipment, but shall not be responsible for
major repairs or replacements (including service warranties and calibration to
the equipment) or repair or replacement of failed Customer-Furnished Item unless
such failure was caused by SANMINA-SCI's negligence or willful misconduct. All
Customer-Furnished Items shall be returned to LIFESTREAM at LIFESTREAM's expense
upon request and SAMINA-SCI's production and warranty obligations which require
the utilization of the returned Customer-Furnished Items will cease upon
SANMINA-SCI's fulfillment of LIFESTREAM's request.
8.3 Customer-Furnished Components. Customer-furnished Components shall
be handled in accordance with SANMINA-SCI's procedures regarding
Customer-Furnished Material, incorporated by reference herein, copies of which
are available upon request.
9. INDEMNIFICATION AND LIMITATION OF LIABILITY
9.1 SANMINA-SCI's Indemnification. SANMINA-SCI shall indemnify, defend,
and hold LIFESTREAM and LIFESTREAM's affiliates, shareholders, directors,
officers, employees, contractors, agents and other representatives (the
"Customer-Indemnified Parties") harmless from all demands, claims, actions,
causes of action, proceedings, suits, assessments, losses, damages, liabilities,
settlements, judgments, fines, penalties, interest, costs and expenses
(including fees and disbursements of counsel) of every kind (each a "Claim,"
and, collectively "Claims") (i) based upon personal injury or death or injury to
property to the extent any of the foregoing is proximately caused either by the
negligent or willful acts or omissions of SANMINA-SCI or its officers,
employees, subcontractors or agents and/or (ii) arising from or relating to any
actual or alleged infringement or misappropriation of any patent, trademark,
mask work, copyright, trade secret or any actual or alleged violation of any
other intellectual property rights arising from or in connection with
SANMINA-SCI's manufacturing processes.
9.2 LIFESTREAM's Indemnification. LIFESTREAM is responsible for the
design of the Products. LIFESTREAM shall indemnify, defend, and hold SANMINA-SCI
and SANMINA-SCI's affiliates, shareholders, directors, officers, employees,
contractors, agents and other representatives (the "SANMINA-SCI-Indemnified
Parties") harmless from all Claims (i) based upon personal injury or death or
injury to property to the extent any of the foregoing is proximately caused
either by a defective Product, by the negligent or willful acts or omissions of
LIFESTREAM or its officers, employees, subcontractors or agents, and/or (ii)
arising from or relating to any allegation that the Product has a design
defect(s), and/or (iii) arising from or relating to any actual or alleged
infringement or misappropriation of any patent, trademark, mask work, copyright,
trade secret or any actual or alleged violation of any other intellectual
property rights arising from or in connection with the Products, except to the
extent that such infringement exists as a result of use by LIFESTREAM of
SANMINA-SCI's manufacturing processes.
9.3 Procedure. A party entitled to indemnification pursuant to this
Article (the "Indemnitee") shall promptly notify the other party (the
"Indemnitor") in writing of any Claims covered by this indemnity. Promptly after
receipt of such notice, the Indemnitor shall assume the defense of such Claim
with counsel reasonably satisfactory to the Indemnitee. If the Indemnitor fails,
within a reasonable time after receipt of such notice, to assume the defense
with counsel reasonably satisfactory to the Indemnitee or, if in the reasonable
judgment of the Indemnitee, a direct or indirect conflict of interest exists
between the parties with respect to the Claim, the Indemnitee shall have the
right to undertake the defense, compromise and settlement of such Claim for the
account and at the expense of the Indemnitor. Notwithstanding the foregoing, if
the Indemnitee in its sole judgment so elects, the Indemnitee may also
participate in the defense of such action by employing counsel at its expense,
without waiving the Indemnitor's obligation to indemnify and defend. The
Indemnitor shall not compromise any Claim or consent to the entry of any
judgment without an unconditional release of all liability of the Indemnitee to
each claimant or plaintiff.
9.4 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE
TO THE OTHER FOR ANY INDIRECT, CONSEQUENTIAL, INCIDENTIAL, PUNITIVE OR SPECIAL
DAMAGES, OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS,
EVEN IF SUCH OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES;
provided, however, that this Section shall not prevent a party from incurring
the liabilities set forth in Section 9 (Indemnification) or 10 (Termination). IN
NO EVENT SHALL SANMINA-SCI'S LIABILITY UNDER THIS AGREEMENT (WHETHER ASSERTED AS
A TORT CLAIM OR CONTRACT CLAIM) EXCEED THE AMOUNTS PAID TO SANMINA-SCI
HEREUNDER. IN NO EVENT WILL SANMINA-SCI BE LIABLE FOR COSTS OF PROCUREMENT OF
SUBSTITUTE GOODS BY LIFESTREAM. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING
ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
10. TERMINATION
10.1 Termination for Cause. Either party may terminate this Agreement
or an Order hereunder for default if the other party materially breaches this
Agreement; provided, however, no right of default shall accrue until (*) after
the defaulting party is notified in writing of the material breach and has
failed to cure or give adequate assurances of performance within (*) period
after notice of material breach. Notwithstanding the foregoing, there shall be
no cure period for payment-related defaults.
10.2 Termination For Convenience. Either party may terminate this
Agreement hereunder for any reason (*) prior written notice. In addition,
LIFESTREAM may terminate an Order hereunder for any reason upon ninety days'
(before scheduled shipment) prior written notice.
10.3 Termination by Operation of Law. This Agreement shall immediately
terminate should either party (a) become insolvent; (b) enter into or file a
petition, arraignment or proceeding seeking on order for relief under the
bankruptcy laws of its respective jurisdiction; (c) enter into a receivership of
any of its assets or (d) enter into a dissolution or liquidation of its assets
or an assignment for the benefit of its creditors.
10.4 Consequences of Termination.
---------------------------
a. Termination for Reasons other than SANMINA-SCI's Breach. In
the event this Agreement or an Order hereunder is terminated for any reason
other than a breach by SANMINA-SCI (including but not limited to a force majeure
or termination for convenience), LIFESTREAM shall pay SANMINA-SCI, termination
charges equal to (1) the contract price for all finished Product existing at the
time of termination; (2) SANMINA-SCI's cost (including labor, Components and a
fifteen percent xxxx-up on Components and labor) for all work in process; and
(3) LIFESTREAM'S Component Liability pursuant to Section 4.2(f).
b. Termination Resulting From SANMINA-SCI'S Breach. In the
event LIFESTREAM terminates this Agreement or any Order hereunder as a result of
a breach by SANMINA-SCI, LIFESTREAM shall pay SANMINA-SCI, termination charges
equal to (1) the contract price for all finished Product existing at the time of
termination; (2) SANMINA-SCI's cost (including labor, Components) for all work
in process; and (3) LIFESTREAM'S Component Liability pursuant to Section 4.2(f);
provided, however, that for the purposes of this subsection only, LIFESTREAM's
Component Liability shall be calculated using "actual cost" rather than
"Delivered Cost."
11. QUALITY
11.1 Specifications. Product shall be manufactured by SANMINA-SCI in
accordance with the Specifications set forth in Exhibit C, as modified via
written ECO's in accordance with this Agreement. Neither party shall make any
change to the Specifications, to any Components described therein, or to the
Products (including, without limitation, changes in form, fit, function, design,
(*) Confidential treatment requested.
appearance or place of manufacture of the Products or changes which would affect
the reliability of any of the Products) unless such change is made in accordance
with Section 6.1 and SANMINA-SCI's ECO procedure. Notwithstanding the foregoing,
SANMINA-SCI shall be permitted to make changes in its manufacturing process at
any time, so long as such changes do not affect the form, fit or function of the
Products.
11.2 Content of Specifications. The Specifications shall include, but
shall not be limited to (i) detailed electrical, mechanical, performance and
appearance specifications for each model of Product, (ii) the BOM; (iii) tooling
specifications, along with a detailed description of the operation thereof, (iv)
art work drawings, (v) Component specifications, (vi) supplier cross references.
11.3 Quality of Components. SANMINA-SCI shall use in its production of
Products such Components of a type, quality, and grade specified by LIFESTREAM
to the extent LIFESTREAM chooses to so specify, and shall purchase Components
only from Vendors appearing on LIFESTREAM's approved vendor list ("AVL");
provided, however, that in the event SANMINA-SCI cannot purchase a Component
from a Vendor on LIFESTREAM'S AVL for any reason, SANMINA-SCI shall be able to
purchase such Component from an alternate Vendor, subject to LIFESTREAM's prior
written approval, which approval shall not be unreasonably withheld or delayed.
11.4 Quality Specifications. SANMINA-SCI shall comply with the quality
specifications set forth in its Quality Manual, incorporated by reference
herein, a copy of which is available from SANMINA-SCI upon request.
11.5 Inspection of Facility. Upon reasonable advance written notice,
LIFESTREAM may inspect the Products and Components held by SANMINA-SCI for
LIFESTREAM at SANMINA-SCI's facilities during SANMINA-SCI's regular business
hours, provided that such inspection does not unduly affect SANMINA-SCI'S
operations. LIFESTREAM and its representatives shall observe all security and
handling measures of SANMINA-SCI while on SANMINA-SCI's premises. LIFESTREAM and
its representatives acknowledge that their presence on SANMINA-SCI's property is
at their sole risk.
12. FORCE MAJEURE
12.1 Force Majeure Event. For purposes of this Agreement, a "Force
Majeure Event" shall mean (i) the occurrence of unforeseen circumstances beyond
a party's control and without such party's negligence or intentional misconduct,
including, but not limited to, any act by any governmental authority, act of
war, natural disaster, strike, boycott, embargo, shortage, riot, lockout, labor
dispute, civil commotion and (ii) the failure of a Vendor to timely deliver a
Component to SANMINA-SCI.
12.2 Notice of Force Majeure Event. Neither party shall be responsible
for any failure to perform due to a Force Majeure Event provided that such party
gives notice to the other party of the Force Majeure Event as soon as reasonably
practicable, but not later than five (5) days after the date on which such Party
knew or should reasonably have known of the commencement of the Force Majeure
Event, specifying the nature and particulars thereof and the expected duration
thereof; provided, however, that the failure of a party to give notice of a
Force Majeure Event shall not prevent such party from relying on this Section
except to the extent that the other party has been prejudiced thereby
12.3 Termination of Force Majeure Event. The party claiming a Force
Majeure Event shall use reasonable efforts to mitigate the effect of any such
Force Majeure Event and to cooperate to develop and implement a plan of remedial
and reasonable alternative measure to remove the Force Majeure Event; provided,
however, that neither party shall be required under this provision to settle any
strike or other labor dispute on terms it considers to be unfavorable to it.
Upon the cessation of the Force Majeure Event, the party affected thereby shall
immediately notify the other party of such fact, and use its best efforts to
resume normal performance of its obligations under the Agreement as soon as
possible.
12.4 Limitations. Notwithstanding that a Force Majeure Event otherwise
exists, the provisions of this Article shall not excuse (i) any obligation of
either party, including the obligation to pay money in a timely manner for
Product actually delivered other liabilities actually incurred, that arose
before the occurrence of the Force Majeure Event causing the suspension of
performance; or (ii) any late delivery of Product, equipment, materials,
supplies, tools, or other items caused solely by negligent acts or omissions on
the part of such party.
12.5 Termination for Convenience. In the event a party fails to perform
any of its obligations for reasons defined above for a cumulative period of
ninety (90) days or more from the date of such party's notification to the other
party then the other party at its option may extend the corresponding delivery
period for the length of the delay, or terminate this Agreement for Convenience
in accordance with Paragraph 10.2.
13. CONFIDENTIALITY
13.1 Definitions. For the purpose of this Agreement,
(a) "Confidential Information" means information (in any form
or media) regarding a party's customers, prospective customers (including lists
of customers and prospective customers), methods of operation, engineering
methods and processes (include any information which may be obtained by a party
by reverse engineering, decompiling or examining any software or hardware
provided by the other party under this Agreement), programs and databases,
patents and designs, billing rates, billing procedures, vendors and suppliers,
business methods, finances, management, or any other business information
relating to such party (whether constituting a trade secret or proprietary or
otherwise) which has value to such party and is treated by such party as being
confidential. Confidential Information in documentary or other tangible form
will be clearly and conspicuously marked as `Confidential' or some similar
marking. Verbal disclosures must be identified as confidential at the time of
disclosure and must be confirmed in writing as confidential within thirty (30)
days of the initial disclosure.
Confidential Information does not include information that (i)
is known to the other party prior to receipt from the disclosing party
hereunder, which knowledge shall be evidenced by written records, (ii) is
independently developed as evidenced by written records, (iii) is or becomes in
the public domain through no breach of this Agreement, or (iv) is received from
a third party without breach of any obligation of confidentiality; and provided
further, that Confidential Information does not include any information provided
by LIFESTREAM to SANMINA-SCI regarding the manufacturing process.
(b) "Person" shall mean and include any individual,
partnership, association, corporation, trust, unincorporated organization,
limited liability company or any other business entity or enterprise.
(c) "Representative" shall mean a party's employees, agents,
or representatives, including, without limitation, financial advisors, lawyers,
accountants, experts, and consultants.
13.2 Nondisclosure Covenants.
-----------------------
(a) In connection with this Agreement, each party (the
"Disclosing Party") may furnish to the other party (the "Receiving Party") or
its Representatives certain Confidential Information. For a period of three (3)
years from the date of this Agreement, the Receiving Party (a) shall maintain as
confidential all Confidential Information heretofore or hereafter disclosed to
it by the Disclosing Party, (b) shall not, directly or indirectly, disclose any
such Confidential Information to any Person other than those Representatives of
the Receiving Party whose duties justify the need to know such Confidential
Information and then only after each Representative has agreed to be bound by
this Confidentiality Agreement and clearly understands his or her obligation to
protect the confidentiality of such Confidential Information and to restrict the
use of such Confidential Information and (c) shall treat such Confidential
Information with the same degree of care as it treats its own Confidential
Information (but in no case with less than a reasonable degree of care).
(b) The disclosure of any Confidential Information is solely
for the purpose of enabling each party to perform under this Agreement, and the
Receiving Party shall not use any Confidential Information disclosed by the
Disclosing Party for any other purpose.
(c) Except as otherwise set forth in this Agreement, all
Confidential Information supplied by the Disclosing Party shall remain the
property of the Disclosing Party, and will be promptly returned by the Receiving
Party upon receipt of written request therefor.
(d) If the Receiving Party or its Representative is requested
or become legally compelled to disclose any of the Confidential Information, it
will provide the Disclosing Party with prompt written notice. If a protective
order or other remedy is not obtained, then only that part of the Confidential
Information that is legally required to be furnished will be furnished, and
reasonable efforts will be made to obtain reliable assurances of
confidentiality.
13.3 Injunctive Relief Authorized. Any material breach of this Section
by a party or its Representatives may cause irreparable injury and the
non-breaching party may be entitled to equitable relief, including injunctive
relief and specific performance, in the event of a breach. The above will not be
construed to limit the remedies available to a party. In addition, the
prevailing party will be entitled to be reimbursed for all of its reasonable
attorneys' fees and expenses at all levels of proceedings and for
investigations, from the non-prevailing party.
14. INSURANCE
SANMINA-SCI agrees to maintain during the term of this Agreement (a)
workers' compensation insurance as prescribed by the law of the state in which
SANMINA-SCI's services are performed; (*) SANMINA-SCI shall furnish to
LIFESTREAM certificates or evidence of the foregoing insurance indicating the
amount and nature of such coverage and the expiration date of each policy. Each
party agrees that it, its insurer(s) and anyone claiming by, through, under or
in its behalf shall have no claim, right of action or right of subrogation
against the other party and the other party's affiliates, directors, officers,
employees and customers based on any loss or liability insured against under the
insurance required by this Agreement.
15. MISCELLANEOUS
15.1 Integration Clause. This Agreement (including the Exhibits and
Schedules to this Agreement) constitutes the entire agreement of the parties,
superseding all previous Agreements covering the subject matter. This Agreement
shall not be changed or modified except by written Agreement, specifically
amending, modifying and changing this Agreement, signed by SANMINA-SCI and an
authorized representative of LIFESTREAM.
15.2 Order of Precedence. All quotations, Orders, acknowledgments and
invoices issued pursuant to this Agreement are issued for convenience of the
Parties only and shall be subject to the provisions of this Agreement and the
Exhibits hereto. When interpreting this Agreement, precedence shall be given to
the respective parts in the following descending order: (a) this Agreement; (b)
Schedules and Exhibits to this Agreement; and (c) if Orders are used to release
product, those portions of the Order that are not pre-printed and which are
accepted by SANMINA-SCI. The Parties acknowledge that the preprinted provisions
on the reverse side of any such quotation, Purchase Order, acknowledgment or
invoice and all terms other than the specific terms of LIFESTREAM's Purchase
Order set forth in Section 4.1(a)(i)-(v) shall be deemed deleted and of no
effect whatsoever. No modification to this Agreement, the Exhibits or any Order
shall be valid without the prior written consent of the Purchase Agreement
Coordinators of SANMINA-SCI and LIFESTREAM.
15.3 Assignment. Neither this Agreement nor any rights or obligations
hereunder shall be transferred or assigned by either party without the written
consent of the other party, which consent shall not be unreasonably withheld or
delayed.
15.4 Notices. Wherever one party is required or permitted or required
to give written notice to the other under this Agreement, such notice will be
given by hand, by certified U.S. mail, return receipt requested, by overnight
courier, or by fax and addressed as follows:
If to Buyer: with a copy to:
Lifestream Technologies, Inc. Xxxxxxxxx Xxxxxxxx Xxxxxxxx Marks & Xxxxxxx
000 Xxxxxxxxxx Xxxx #000 000 X. Xxxxx Xx.
Xxxx Xxxxx, XX 00000 P. O. Box 1049
Att'n: Xxxxxx X. Siemens COO Xxxxxxxxx, XX 00000
Phone: 000-000-0000 Att'n: Ford Xxxxxxxxx
Fax: 000-000-0000 Phone: 000-000-0000
Fax: 000-000-0000
If to Seller: with a copy to:
SANMINA-SCI Corporation SANMINA-SCI Corporation
0000 X. Xxxxx Xxxxxx 0000 Xxxx Xxxxxxx Xxxxxx
Xxx Xxxx, Xxxxxxxxxx 00000 Xxxxxxxxxx, Xxxxxxx 00000
Att'n: President Att'n: Mgr. Of Contract Management
--------- ---------------------------
Phone: (000) 000-0000 Phone: (000) 000-0000
Fax: (000) 000-0000 Fax: (000) 000-0000
All such notices shall be effective upon receipt. Either party may designate a
different notice address from time to time upon giving ten (10) days' prior
written notice thereof to the other party.
15.5 Disputes/Choice of Law. The parties shall attempt to resolve any
disputes between them arising out of this Agreement through good faith
negotiations. In the event the parties cannot resolve a dispute, the parties
acknowledge and agree that the state courts of Santa Xxxxx County, California
and the federal courts located in the Northern District of the State of
California shall have exclusive jurisdiction and venue to adjudicate any and all
disputes arising out of or in connection with this Agreement. The parties
consent to the exercise by such courts of personal jurisdiction over them and
each party waives any objection it might otherwise have to venue, personal
jurisdiction, inconvenience of forum, and any similar or related doctrine. This
Agreement shall be construed in accordance with the substantive laws of the
State of California (excluding its conflicts of laws principles).
15.6 Import/Export. Unless otherwise agreed, LIFESTREAM shall be (i)
the exporter of record for any Products and/or Product documentation exported
from the country of manufacture, and shall comply with all applicable country of
manufacture export control statutes and regulations, and (ii) the importer of
record for all Products exported from the country of manufacture and later
imported and returned to LIFESTREAM or to SANMINA-SCI. SANMINA-SCI will
cooperate with LIFESTREAM in obtaining any export or import licenses for the
Products.
LIFESTREAM hereby certifies that it will not knowingly export,
directly or indirectly, any U.S. origin technical data or software acquired from
SANMINA-SCI or any direct product of that technical data or software, to any
country for which the United States Government requires an export license or
other approval, without obtaining such approval from the United States
Government.
15.7 Electronic Data Interchange. The parties agree that transmission
of data by electronic data interchange ("EDI") will not occur until a separate
agreement governing such transmissions is executed. Upon execution, such EDI
agreement will become an attachment to this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
effective as of the date on page one, by their officers, duly authorized.
SANMINA-SCI CORPORATION LIFESTREAM TECHNOLOGIES, INC.
By: /s/ Xxx Xxxxxxxx By: /s/ Xxxxxx X. Siemens
-------------------------------- --------------------------
Signature Signature
Xxx Xxxxxxxx Xxxxxx X. Siemens
------------------------------------ ---------------------
Typed Name Typed Name
SVP for Southern Europe Chief Operating Officer
------------------------------------ ---------------------------
Title Title
4-9-02 6-18-02
------------------------------------ ----------------------------
Date Date
INDEX
1. TERM
2. PRICING
3. PAYMENT TERMS
4. PURCHASE ORDERS/FORECAST/RESCHEDULE
5. DELIVERY AND ACCEPTANCE
6. CHANGES
7. WARRANTY
8. LIFESTREAM FURNISHED EQUIPMENT AND COMPONENTS
9. INDEMNIFICATION AND LIMITATION OF LIABILITY
10. TERMINATION
11. QUALITY
12. FORCE MAJEURE
13. CONFIDENTIALITY AND NON-SOLICITATION OF EMPLOYEES
14. INSURANCE
15. MISCELLANEOUS
EXHIBITS
A. PRICES
B. LONG LEAD-TIME COMPONENTS
C. SPECIFICATIONS
D. LIFESTREAM FURNISHED EQUIPMENT, COMPONENTS AND DOCUMENTATION
E. SHIPPING LABELING
F. THE PRODUCT DESCRIPTIONS
G. THE QUALITY PLAN
EXHIBIT A
PRICING
Lifestream Technologies and Sanmina-SCI agree that the attached BOM and quote
dated March 28, 2002 represents the initial cost basis for this contract. Both
parties agree that continuous cost reduction will be carried out under the terms
of this agreement.
Non-recurring Engineering Charges:
(*)
Continuing cost reductions:
o Test automation
o Romkey connector
o Battery Contacts
o Postage Stamp assembly
(*)
Electronic components to be identified See Exhibit B Long Lead items
(*) Confidential treatment requested.
EXHIBIT B
LONG LEAD-TIME COMPONENTS
This listing is intended to identify components expected to be or become long
lead items.
(*)
(*) Confidential treatment requested.
EXHIBIT C
SPECIFICATIONS
The specifications for this product are as follows:
(*)
(*) Confidential treatment requested.
EXHIBIT D
CUSTOMER FURNISHED EQUIPMENT/CONSIGNED COMPONENTS
Lifestream will consign the following to Sanmina-SCI. The Companies agree that
these items may be replaced as may be agreed to by the parties by Sanmina-SCI
developed systems or items:
o (*)
(*) Confidential treatment requested.
EXHIBIT E
SHIPPING LABELING
Each shipment of finished goods for the SKU LSP-4000 shall have the following
shipper / Xxxx of Lading information and contents:
SHIPPING ADDRESS:
Lifestream Technologies, Inc
Xxxx. 0000
000 Xxxxxxxxxx Xxxx Xxxxx X
Xxxx Xxxxx, Xxxxx, XXX 00000
(*)
ON THE SHIPPING CONTAINER AND ON THE XXXX OF LADING:
(*)
EACH SHIPMENT TO CONTAIN:
Declaration of Conformity
CD-ROM containing Device History file
(*) Confidential treatment requested.
EXHIBIT F
THE PRODUCTS
Sanmina-SCI will provide services to: design, qualify, build, test, package,
inspect, record data and ship, box build Stock-Keeping-Unit (SKU) medical
devices to Lifestream Technologies. Sanmina-SCI will perform these activities
for the product known as:
The Lifestream BASIC Cholesterol Monitor SKU Number: LSP-4000 (*)
o Other products as specifications are developed and quotes provided.
o (*)
Sanmina-SCI will provide sub-assemblies:
o (*)
o Other sub assemblies as may be required, from time to time for
development or production activities, to include but not be limited to:
plastic enclosure parts, PCB assemblies, point of Sale boxes or trays
Sanmina-SCI will provide components:
o (*)
o Other components as may be needed from time to time for development or
production activities.
(*) Confidential treatment requested.
EXHIBIT G
THE QUALITY PLAN
The Quality Plan for Sanmina-SCI's facilities, processes, finished device,
subassemblies and components must conform to the following International and USA
regulatory standards that apply to In-vitro diagnostic devices:
o ISO-9001 (Standards for design and manufacturing processes)
o US FDA QSR, GDP/GMP (Including, Device Master Record, Device History
Record)
o US FDA Class II Registered Medical Device Manufacturing Facility
The finished Product will be manufactured according to mutually agreed upon
acceptance criteria for:
o Packaging, Plastics, labeling cosmetics, fit and finish. o Dimensional
control
o Inspection and testing of the postage stamp optic sub-assembly o The
retention of a 3rd party product auditor.
o Contents of quality records, the "Device History Record" to include as
a minimum for each device:
1. Device Serial number
2. Device calibration values
3. Date of Manufacturer
4. Manufacturing site
Device Calibration and Testing
The device must perform according to the Lifestream labeling claims for accuracy
and precision vs. the US national cholesterol reference method. Lifestream
retains sole responsibility for this quality standard
The responsibility of Sanmina-SCI will be to produce devices that meet the total
remission tolerance of +-.9% at approx 50% remission using Lifestream consigned
test hard and software, colored remission masters and Lifestream / Sanmina-SCI
approved calibration procedures(*)
Sanmina-SCI will conduct mutually agreed upon "Out of box Audit" and other
tests, such as control solution evaluations and / or audits as may be required
to insure assembly and performance standards are met.
A mutually agreed upon inspection and acceptance AQL standard will be developed.
Test software developed under the Lifestream (*)
(*) Confidential treatment requested.
