EXHIBIT 10.16
SUPPLY AGREEMENT
THIS AGREEMENT made and entered into this 13th day of April, 1999 by
and between Fuji Photo Film Co., Ltd., a corporation organized and existing
under the laws of Japan and having its principal office at 00-00, Xxxxxxxxxx 0-
xxxxx, Xxxxxx-xx, Xxxxx, Xxxxx (hereinafter referred to as "FUJI") and CARESIDE,
Inc., a corporation organized and existing under the laws of the State of
Delaware and having its principal office at 6100 Bristol Parking, Xxxxxx City,
90230 California, the United States of America (hereinafter referred to as
"CARESIDE"),
WITNESSETH THAT:
WHEREAS, FUJI has been engaged in, among other business, the
manufacturing and marketing of DRI-CHEM films, and owns proprietary technology
and know-how relating thereto;
WHEREAS, CARESIDE has been engaged in developing for commercial sale a
human diagnostic testing so-called Point of Care Testing system and owns
proprietary technology and know-how relating thereto;
WHEREAS, FUJI and Exigent Diagnostics, Inc., the predecessor of
CARESIDE, entered into the Agreement on August 23, 1996 concerning the supply of
FUJI's DRI-CHEM films, film-based chemistry tests and immunodiagnostic tests and
exchange of various technology for the development of CARESIDE POCT System (as
defined below) (hereinafter referred to as "Development Agreement"), and
CARESIDE has been developing test cartridge of CARESIDE POCT System
incorporating the DRI-CHEM films; and
WHEREAS, CARESIDE is desirous of purchasing from FUJI the DRI-CHEM
films for the commercial manufacturing and marketing of such test cartridge, and
FUJI is willing
to supply CARESIDE with the DRI-CHEM films for such purpose subject to the terms
and conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the premises and mutual covenants
hereinafter set forth, both parties agree as follows:
ARTICLE 1
DEFINITION
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For the purpose of this Agreement, the following terms have the
following meanings respectively:
1.1 The term "POCT" (Point of Care Testing) shall mean a human or
animal diagnostic testing performed anywhere, excluding any diagnostics testing
performed at a central fixed laboratory within hospitals, other health care
facilities or commercial laboratories.
1.2 The term "FDC Film" shall mean films used in FUJI's DRI-CHEM
system applicable to the tests listed in Schedule A.
1.3 The term "CARESIDE POCT System" shall mean collectively a system
and products thereof developed by or for CARESIDE for POCT, including but not
limited to chemistry, immunochemistry and coagulation, and optionally,
hematology tests (initially in a separate device), test cartridge for, among
other things, separating blood and metering samples, analyzer(s) for the said
tests including data management components and software in the analyzer.
1.4 The term "CARESIDE POCT Cartridge" shall mean a test cartridge
used in CARESIDE POCT System incorporating FDC Film supplied by FUJI.
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1.5 The term "CARESIDE Materials" shall mean the immunodiagnostic and
coagulation testing reagents, which utilize any of the technology CARESIDE has
developed, or develops or acquires in the future, including but not limited to
technology as to tests in Hemoglobin Alc, Digoxin and HCG.
1.6 The term "Competing Instruments" shall mean diagnostic
instruments and the disposables they use, which instruments and disposables are
designed for use in POCT and which directly compete with CARESIDE POCT System.
1.7 The term "FUJI Technology" shall mean FUJI's technology relating
to FDC Film which is limited to the specifications of FDC Film, its quality
assurance and other information listed in Schedule B attached hereto as amended
from time to time by agreement between the parties.
1.8 The term "FUJI's Affiliates" shall mean any and all companies,
corporations or other entities in which FUJI owns or controls directly or
indirectly a substantial portion of the nominal value or number of units of the
outstanding stocks with the right to vote at general meeting, to elect a
majority of the board of directors thereof, or to appoint or remove the
management thereof.
ARTICLE 2
SUPPLY OF FDC FILM
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2.1 FUJI shall supply CARESIDE with and CARESIDE shall purchase from
FUJI FDC Film for use in the manufacturing and marketing of CARESIDE POCT
Cartridge.
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2.2 FUJI shall supply FUJI Technology to CARESIDE, and CARESIDE may
use FUJI Technology only for the purpose of the manufacturing and marketing of
CARESIDE POCT Cartridge, and shall not use it for any other purpose.
2.3 During the term of this Agreement, including the term extended
according to Article 13.2 hereof, FUJI shall supply CARESIDE exclusively with
FDC Film for the purpose of use for CARESIDE POCT system; provided that such
exclusive supply shall be changed to non-exclusive supply if CARESIDE fails to
obtain approvals from the Food and Drug Administration ("FDA") which should be
necessary for the marketing of CARESIDE POCT System using FDC Film in the United
States of America to professional market in accordance with the following
requirements:
The tests itemized in Schedule A-1, 2 and 3 ((1) to (10)):
Thirty-one (31) or more of the tests approved by December 31, 1999
The tests itemized in Schedule A-3 ((1) to (15)):
Ten (10) or more of the tests approved by December 31, 2000
2.4 In case of a non-exclusive supply as stipulated in Article 2.3,
FUJI and CARESIDE shall discuss and agree upon the terms and conditions that
shall apply to such non-exclusive supply.
2.5 During the period of the exclusive supply of FDC Film as provided
in Article 2.3, FUJI shall not supply FDC Film to any third party which the both
parties hereto agree may develop and sell Competing Instruments; provided that
FUJI may supply FDC Film to any third party:
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(i) in the form of slide for use on an instrument manufactured by
FUJI; and
(ii) in the form of slide for use on an instrument manufactured
by any other party than FUJI which can measure up to ten (10) FDC test menu.
2.6 CARESIDE shall use FDC Film supplied by FUJI hereunder only for
the manufacturing and marketing of CARESIDE POCT System and shall not supply FDC
Film to or for use by any third party for any purpose.
2.7 CARESIDE agrees that it shall use only FDC Film in CARESIDE POCT
System for those tests listed in Schedule A. CARESIDE shall not be supplied by
any third party with any chemistry reagents for the manufacturing of CARESIDE
POCT System or performance of the tests listed in Schedule A, so long as FUJI
continues to supply CARESIDE exclusively with FDC Film in accordance with the
terms and conditions set forth in this Agreement. For CARESIDE POCT System's
tests other than those listed in Schedule A, CARESIDE may manufacture or
purchase from others its needs for reagents or technologies for carrying out
those tests.
2.8 Nothing in this Article shall be construed to prohibit or
otherwise affect:
(i) FUJI's development for or distribution to any third party of
FDC Film for use with any products other than Competing Instruments, or
(ii) the development, manufacture or distribution by or for FUJI
or FUJI's Affiliates of any product or service which competes with CARESIDE POCT
System, whether or not such product or service uses FDC Film. FUJI and CARESIDE
further confirms that FUJI DRI-CHEM systems and their disposables shall in no
event be construed as Competing
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Instruments and that FUJI shall in no way be restricted to market FUJI DRI-CHEM
Systems and their disposables.
ARTICLE 3
PURCHASE PROCEDURE
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3.1 CARESIDE shall submit to FUJI annual purchase plan, semi-annual
revised purchase plan and quarterly revised purchase plan in accordance with the
procedure detailed in Schedule C attached hereto.
3.2 CARESIDE shall submit to FUJI a firm purchase order of FDC Film
in an agreed form by 1st day of the month two month preceding the desired date
of shipment, and FUJI, so long as such purchase order has been made in
accordance with the procedure detailed in Schedule C, shall issue its acceptance
in writing to CARESIDE within ten (10) days of the receipt of the purchase
order. If the purchase order is not acceptable to FUJI, then both parties shall
discuss a solution in good faith to reach an agreement by the twentieth (20th)
day after the receipt of the purchase order by FUJI.
3.3 Each individual purchase contract for FDC Film hereunder
(hereinafter referred to as "Individual Contract") shall become effective and
binding only when CARESIDE's firm purchase order is accepted by FUJI in writing.
ARTICLE 4
PURCHASE PRICE
--------------
The purchase prices of FDC Film shall be as listed in Schedule D,
which are indicated on the basis of CIF Los Angeles Airport.
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ARTICLE 5
SHIPMENT
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It is expressly agreed that no estimate of delivery time made by FUJI
will constitute a guaranty of delivery or deliveries by such dates, that all
shipping and delivery dates will be approximate, and the FUJI will not be liable
for any damages, consequential or otherwise, for delays in delivery, except to
the extent of FUJI's own gross negligence or willful misconduct.
ARTICLE 6
SPECIFICATIONS
--------------
The specifications of FDC Films shall be as detailed in Schedule E.
ARTICLE 7
INSPECTION
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7.1 FUJI shall, prior to the shipment, inspect FDC Film in accordance
with the Inspection Manual attached hereto at Schedule F.
7.2 Upon the receipt of FDC Film supplied by FUJI, CARESIDE shall
complete the inspection of FDC Film within ten (10) days of the receipt thereof,
in accordance with the Inspection Manual attached hereto as Schedule F. Such
inspection by CARESIDE shall be considered as final.
7.3 In the event that during CARESIDE's inspection stipulated in
Article 7.2 above any FDC Film supplied by FUJI to CARESIDE hereunder is found
to have a defect which CARESIDE believes is attributable to FUJI and caused
before shipment thereof, CARESIDE shall, within ten (10) days of the receipt
thereof, so notify FUJI and return to FUJI, with a written statement explaining
the nature of the defect, the defective FDC Film, and FUJI shall inspect the
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same to determine the cause of the defect. If FUJI determines that the defect
should be attributed to it, FUJI shall replace such defective FDC Film with non-
defective FDC Film without cost to CARESIDE. It is agreed that in such case
CARESIDE shall bear the cost of returning to FUJI the defective FDC Film, and
that FUJI shall reimburse CARESIDE for such cost by means of crediting the
amount against the next FUJI's invoice if the defect is determined by FUJI to be
attributed to it. It is expressly agreed and understood that for such defective
FDC Film FUJI shall assume no other or further liability of any kind whatsoever
other than that expressly undertaken by it in this Article 7.3.
ARTICLE 8
PAYMENT
-------
Except as otherwise agreed upon by and between the parties hereto, all
payments for FDC Film supplied to CARESIDE by FUJI hereunder shall be made in
Japanese Yen, and shall be remitted, within forty-five (45) days of the custom
clearance of FDC Film, by bank-to-bank telegraphic transfer to FUJI's account
with such bank in Tokyo as designated by FUJI.
ARTICLE 9
CONFIDENTIALITY
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9.1 Each party shall hold in confidence this Agreement and any and
all proprietary technical and business information furnished or disclosed by the
other party hereunder, and shall not use such information for any other purpose
than that provided herein.
9.2 The confidentiality obligation provided in Article 9.1 shall not
apply to any information that:
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(i) is known to the public or generally available to the public
prior to the receipt thereof;
(ii) is known to the receiving party prior to the receipt
thereof;
(iii) becomes known to the public or generally available to the
public after the receipt thereof through no fault of the receiving party;
(iv) the receiving party obtains without restriction on
disclosure from a third party having a bona fide right to disclose such
information; or
(v) must be disclosed by law or regulation in order to obtain
approval to sell CARESIDE POCT System, or otherwise required to be disclosed by
law, regulation or court order.
9.3 Notwithstanding the foregoing provisions of this Article 9, the
existence of this Agreement and a summary of its terms may be disclosed by
CARESIDE to its investors, in connection with the public offering of CARESIDE's
common stock, or to federal and state regulators regulating the public or
private offer or sale of securities, in each case to the extent required by law
(which shall be determined by CARESIDE in consultation with its legal advisors)
or such regulators; provided CARESIDE shall consult with FUJI and obtain FUJI's
prior approval upon such disclosure, which approval FUJI shall not unreasonably
withhold.
ARTICLE 10
REGULATORY APPROVALS
--------------------
10.1 FUJI shall comply with FDA's Good Manufacturing Practice in
manufacturing and supplying FDC Film to CARESIDE hereunder.
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10.2 If FUJI is granted an exclusive right to distribute CARESIDE
POCT System in certain countries, FUJI shall obtain all regulatory approvals
required for marketing CARESIDE POCT System in such countries.
10.3 CARESIDE shall obtain all regulatory approvals required for
marketing CARESIDE POCT System in any country that it will market, excluding the
countries for which FUJI has been granted an exclusive right to distribute
CARESIDE POCT System.
ARTICLE 11
INDEMNIFICATION
---------------
11.1 FUJI shall indemnify and hold CARESIDE harmless from and against
any damages and costs incurred by CARESIDE which arises out of any claim or
legal action threatened or taken by any third party alleging that CARESIDE's use
and/or sales of FDC Film supplied by FUJI under this Agreement constitutes an
infringement of any intellectual property right of such third party, provided
that CARESIDE shall promptly notify FUJI of such claim or legal action in
writing, give FUJI sole control and authority with respect to the defense or
settlement of any such claim or legal action, and give FUJI reasonable
assistance with respect to the defense or settlement of any such claim or legal
action. FUJI shall have the right, with respect to any FDC Film supplied to
CARESIDE under this Agreement which becomes or is likely to become the subject
of such claim or legal action, to replace or modify such FDC Film, or in case
injunction is granted by court or FTC to withhold further shipment of such FDC
Film.
11.2 The provision of Article 11.1 shall not apply in case where the
infringement exists as a result of:
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(i) any combination of FDC Film with other material(s), part(s)
or product(s) which is not supplied by FUJI;
(ii) any use of FDC Film which is not intended by FUJI;
(iii) any modification of FDC Film made by any third party other
than FUJI; or
(iv) CARESIDE's breach of this Agreement, or negligence of
CARESIDE, its employee or agent.
11.3 Notwithstanding the provision of Article 11.1, FUJI shall in no
event be liable to CARESIDE hereunder for:
(i) consequential or incidental damages; or
(ii) labor costs or lost profits.
11.4 CARESIDE shall indemnify and hold FUJI harmless from and against
any damages and costs incurred by FUJI which arises out of any claim or legal
action threatened or taken by any third party alleging that any use and/or sales
of CARESIDE Materials manufactured by CARESIDE constitutes an infringement of
any intellectual property right of such third party, provided that FUJI shall
promptly notify CARESIDE of such claim or legal action in writing, give CARESIDE
sole control and authority with respect to the defense or settlement of any such
claim or legal action, and give CARESIDE reasonable assistance with respect to
the defense or settlement of any such claim or legal action. CARESIDE shall
have the right, with respect to any CARESIDE Materials supplied by CARESIDE
which becomes or is likely to become the subject of such claim or legal action,
to replace or modify such CARESIDE Materials, or in case
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injunction is granted by court or FTC to withhold further shipment of such
CARESIDE Materials.
11.5 The provision of Article 11.4 shall not apply in case where the
infringement exists as a result of:
(i) any combination of CARESIDE Materials with other material(s),
part(s) or product(s) which is not supplied by CARESIDE;
(ii) any use of CARESIDE Materials which is not intended by
CARESIDE ;
(iii) any modification of CARESIDE Materials made by any third
party other than CARESIDE; or
(iv) FUJI's breach of this Agreement, or negligence of FUJI, its
employee or agent.
11.6 Notwithstanding the provision of Article 11.4, CARESIDE shall in
no event be liable to FUJI hereunder for:
(i) consequential or incidental damages; or
(ii) labor costs or lost profits.
ARTICLE 12
LIMITATION OF LIABILITY
-----------------------
Except as provided for in Article 7.3 and limited by Article 11, FUJI
makes NO REPRESENTATION OR WARRANTY OF ANY KIND, WHETHER EXPRESS, STATUTORY, OR
IMPLIED REGARDING FDC FILM INCLUDING, BUT NOT LIMITED
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TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE.
ARTICLE 13
TERM
----
13.1. This Agreement shall come into effect on the date first above
set forth and continue in full force and effect until December 31, 2003.
13.2. Notwithstanding the provision of Article 13.1 hereof, the term
of this Agreement may be extended for additional term(s) of one (1) year each if
the parties hereto reach the agreement upon such extension through the
discussion in good faith, which discussion shall occur in the last six (6)
months of the then current term, and in which discussion the parties shall
consider primarily the actual purchase volume of FDC Film by CARESIDE during the
current year.
ARTICLE 14
TERMINATION
-----------
14.1. In the event the FUJI decides to discontinue manufacturing FDC
Film, FUJI may terminate this Agreement by giving a written one (1) year notice
to CARESIDE, provided that to protect the welfare of the customers of CARESIDE
POCT Systems sold by CARESIDE before such termination, FUJI shall consult with
CARESIDE and establish the necessary measures to be taken, to ensure that
CARESIDE has continued access to FDC Film and FUJI Technology before such
termination.
14.2. In the event that either party is adjudicated bankrupt or
insolvent, or enters into an agreement for the benefit of creditors, or in the
event that a petition in bankruptcy or for
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corporate reorganization or for any similar relief shall be filled by or against
either party hereto or receiver is appointed with respect to any of the assets
of either party, or if all or a significant part of the assets or either party
are transferred to a third party, then the other party hereto may immediately
terminate this Agreement by giving such party a written notice to that effect.
14.3 In the event that there arises a material change in
directorship, control or ownership of either party or material change in or
discontinuation of production of FDC Film which would adversely affect the
transaction hereunder between the parties hereto, including as regards an
acquisition of a party by either (i) a competitor of the other party whose
resulting access to the trade secrets, confidential information, know-how or
intellectual property rights of the acquired party would result in a loss of
competitive advantage, or (ii) a competitor that sells competing dry film
technology for chemistry tests, the other party may, at its sole discretion,
immediately terminate this Agreement by giving such party a written notice to
such party.
14.4 In the event that either party breaches or fails to perform any
of the material obligations, terms or conditions of this Agreement or an
Individual Contract and fails to cure such breach or default within thirty (30)
days after its receipt from the other party of written notice specifying the
nature of such breach or default, the other party may, without prejudice to any
other remedies available to it hereunder or under law or otherwise, terminate
this Agreement effective immediately by giving the defaulting party written
notice to that effect.
14.5 Termination of this Agreement shall not affect or diminish in
any way either party's rights, duties or obligations under any other agreements
between the parties, nor shall the breach or cancellation of any other
agreements between the parties affect or diminish in any way either party's
rights, duties or obligations under this Agreement.
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ARTICLE 15
FORCE MAJEURE
-------------
Neither party hereto shall in any way be held liable to the other
party for any loss or damage sustained by the other party due to any failure or
delay on its part in performance of this Agreement caused by force majeure, such
as but not limited to strikes, lock-outs, sabotage, fires, explosions, floods,
elements, acts of God, wars, hostilities, civil commotions, riots, acts,
regulations or orders of any governmental agency or authority, epidemics, and
any other circumstances, whether similar or dissimilar to any of the foregoing,
beyond the reasonable control of the first party.
ARTICLE 16
GENERAL PROVISIONS
------------------
16.1 If any provision of this Agreement is held to be ineffective,
unenforceable or illegal for any reason by court or any other governmental
authority, such decision shall not affect the validity or enforceability or any
or all of the remaining portions hereof.
16.2 This Agreement constitutes the entire agreement between the
parties as to the subject matter hereof, and supersedes and replaces all prior
or contemporaneous agreement, written or oral, regarding the subject matter.
16.3 No amendment or modification of this Agreement shall be valid
unless set forth in a writing stating that it is such an amendment or
modification and signed by an authorized representative of each of the parties
hereto.
16.4 This Agreement shall inure to the benefit of and be binding upon
any successors or assigns of either party hereto; however either party may
transfer or assign this
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Agreement or any of its rights or obligations hereunder without the prior
written consent of the other party.
16.5 Any and all disputes, controversies or differences arising
between the parties hereto out of or in relation to this Agreement or for any
breach thereof which cannot be amicably settled between the parties hereto shall
be finally settled by arbitration to be conducted in Tokyo, Japan in accordance
with the Rules of Conciliation and Arbitration of the International Chamber of
Commerce. Any award of the arbitration shall be final and conclusive and
binding upon the parties hereto.
16.6 This Agreement and its validity, performance and interpretation
shall be governed by the laws of Japan.
16.7 Any notice required or permitted by either party hereunder shall
be made in writing and shall be delivered in person, sent by registered mail or
sent by facsimile with confirmation by registered mail within ten (10) days to
the respective party as follows:
If to FUJI:
Fuji Photo Film Co., Ltd.
Asaka Research Laboratory
11-46, Senzui 3-chome
Xxxxx-xxx, Xxxxxxx 000-0000, Xxxxx
Attention: Xxxxxxxx Xxxxxxx (General Manager of Asaka
Research Laboratory)
Fax number: 00-000-000-0000
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If to CARESIDE:
CARESIDE, Inc.
0000 Xxxxxxx Xxxxxxx
Xxxxxx Xxxx, 00000 Xxxxxxxxxx,
XXX
Attention: W.V. Stoughton
Fax number: 000-000-0000
ARTICLE 17
SURVIVING PROVISIONS
--------------------
The provisions of Articles 7.3, 9, 10, 11, 12, 14.4, 14.5, 16.4, 16.5,
16.6, and 16.7 shall survive expiration or any termination of this Agreement.
Also, rights of credit or obligations of debt between the parties hereto shall
not be affected by expiration or any termination of this Agreement and shall
remain in full force until such accounts are settled.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be duly executed as of the day and year first above written.
Fuji Photo Film, Co., Ltd. CARESIDE, Inc.
/s/ Xxxxxxxx Xxxxxxx /s/ X.Xxxxxxx Stoughton
--------------------- -----------------------
Xxxxxxxx Xxxxxxx X. Xxxxxxx Stoughton
General Manager of Asaka Research Chairman & CEO
Laboratory
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Schedule A The tests to which FDC Film is applicable
1. The tests to which FDC Colorimetric Film is applicable
a. Total Bilirubin
b. Hemoglobin
c. Uric Acid
d. Ammonia
e. AST
f. GGT
g. LDH
h. ALT
i. LAP
j. Amylase
k. Alkaline Phosphatase
l. Creatine Kinase
m. Total Calcium
n. Triglycerides
o. Cholesterol
p. HDL Cholesterol
q. Glucose
r. Total Protein
s. Albumin
t. Creatinine
u. Urea Nitrogen
v. Inorganic Phosphorus
w. Magnesium
x. DBIL
y. CKMB
2. The tests to which FDC Electrolyte Slide is applicable
a. Sodium
b. Potassium
c. Chloride
3. CARESIDE POCT System tests other than the above
a. Theophylline
b. Digoxin
c. Phenytoin
d. Phenobarbital
e. T4
f. Thyroid Uptake
g. PT
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h. APTT
i. Valpronic acid
j. Carbamazepyn
k. HCG
l. Troponin
m. Myoglobin
n. PSA
o. Hemoglobin Alc
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Schedule B FUJI Technology
1. Quality control system
a. Quality control standards of FDC Film (slide)
b. Pre-calibration QC system
2. Handling and assembling conditions of FDC Film
a. Archival properties in reel and slide form
b. Room conditions of handling FDC Film
c. Mechanical handling conditions
3. Specific comments on each test and measuring instrument
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Schedule C Procedure for purchase plan and order
. A fiscal year begins on April 1 and ends on March 31, unless otherwise
indicated herein.
1. Annual purchase plan
Submitted by November 10 of the preceding year Purchase volume
indicated by items and by months, which does not exceed 40,000,000
pieces per annum
2. Semi-annual revised purchase plan
Applicable only to an annual purchase plan for the period of October 1
to March 31
Submitted by May 10
Purchase volume by items and by months
Allowance of revision: Not 30% more or less in total of each
Colorimetric film and Electrolyte slide than
the volume indicated in the applicable annual
purchase plan
3. Quarterly revised purchase plan
Applicable only to an annual purchase plan of Colorimetric film for
the period of July 1 to September 30 and to a semi-annual revised
purchase plan of Colorimetric film for the period of January 1 to
March 31
Submitted by April 10 and October 10
Purchase volume by items and by months
Allowance of revision: Not 30% more or less in each item of
Colorimetric film than the volume indicated
in the applicable annual purchase plan or
semi-annual revised purchase plan
Restriction: Total volume of Colorimetric film may not be revised.
4. Firm purchase order
Submitted by 1st day of the month two month preceding the desired date
of shipment
Purchase volume by items
Allowance of revision to purchase plan: Not 10% more or less in each
item of Colorimetric film
than the volume indicated in
the applicable purchase pla n
Restriction: Total volume of Colorimetric film may not be revised.
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5. Acceptance by FUJI
FUJI may refuse to accept CARESIDE's firm purchase order only for
Colorimetric film to the extent not 10% more or less in each item of
Colorimetric film than the volume indicated in the applicable purchase
plan; provided that the total volume of Colorimetric film may not be
revised.
Notwithstanding the foregoing, FUJI shall use reasonable efforts
to accept CARESIDE's firm purchase order which is made beyond the above
allowance during the first year of release of CARESIDE POCT System.
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Schedule D Prices of FDC Film
1. Colorimetric film
-----------------
[Omitted pursuant to a request for confidential treatment. The material
has been filed separately with the Securities and Exchange Commission.]
2. Electrolyte slide
-----------------
[Omitted pursuant to a request for confidential treatment. The material
has been filed separately with the Securities and Exchange Commission.]
3. The prices applied
------------------
The prices applied shall be tentatively determined based on the volume
indicated in a half-year estimate (annual purchase volume is estimated by
doubling the half-year estimate). The adjustment shall be made based on
the actual purchase volume, and be credited or debited to the payment
amount for the month of November and May.
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Schedule E Specifications
Specifications of FDC colorimetric film is reel form and FDC electrolyte slides
FDC colorimetric film
1. The length of the slit film
1.1 The length of the slit film will be longer than 40m.
1.2 When required volume from CARESIDE is shorter than 40m or coated film is
shorter than 40m, the film length will be determined after negotiation with
two parties
2. Shipping form and description
2.1 One reel of the film is packed in the bag individually to prevent humidity.
2.2 Test name, lot number and sealed date are described on each bag.
2.3 Several bags are packed in one large box. In some cases different film
will be packed in one box.
3. Splicing
3.1 Both the beginning and the end of the FDC film are spliced with the
transparent PET film. This transparent film is called guide base.
The length of the guide base is longer than 1m. The final film is wound
around the plastic core. The terminal of the outer guide base is adhered
by plastic tape.
3.2 The number of the junction is smaller than one per 10m in average.
The splicing is done by using aluminum laminated or plastic adhesive tape.
This junction is black marked by specific ink.
4. Core of the film reel
4.1 The core is the same one as domestic use.
4.2 The shape and diameter of the outer part and material may be changed.
4.3 The width of the core is 13mm. But this will be changed to 12mm.
5. Stains (not defects, no Fuji's liability under Article 7.3)
Black marking
5.1 In rare cases some slit film has stains. The stains are marked by specific
markers. Black ink is used for this marking.
5.2 The cut film with black marking has to be taken off from the assembly line.
The principle of detection and pick-out system will be suggested by Fuji.
5.3 The shape of the stains are mixture of dots, line and others. The number
of the stains in unite length is not predictable. The length of the line-
shaped stains should be shorter than 1m/10m.
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Blue spots;
5.4 In rare cases blue spots are observed in FDC ammonia and creatinine film.
5.5 Blue spots larger than the criteria should be detected and discarded from
assembly line like black markings.
5.6 The number of the spots are not predictable.
5.7 The blue spots and black marked portion is included in this length.
5.8 It will be determined about the price of the stained portion.
FDC electrolyte slides
6.1 900 slides are packed in the tray. The slides are covered with cushion
sheet and upper cover to prevent free moving during delivery.
6.2 The periphery of the tray is sealed with adhesive tape.
6.3 The tray is put into the bag to protect humidity.
6.4 The bags are stacked and put into the carton. The number of bags are
agreed between two parties.
(6.1, 6.2 and 6.3 will be changed in the near future;
6.1 500 slides will be packed in the tray.
6.2 This tray will be covered with the lid.
6.3 Two trays (500 x 2 = 1000 slides) are put into the bag to protect
humidity.)
Both FDC colorimetric film and FDC electrolyte slides
7. Shelf life of the FDC slides
The shelf life of the FDC slides is listed in the table 1.
The delivery time is about 2 months.
It is recommended the cartridge assembly should be done within 2 months.
-8-
Shelf life of the FDC slides
Delivery; Shelf life of the FDC slides is 9-18
months from the predetermined date
2 months prior to the of slide assembly, depending on tests
recommended date of (See the table 1)
cartridge assembly
Shipment of the Predetermined date of slide assembly
FDC film and
electrolyte slides
The shelf life (expiring time) of FDC slides is guaranteed under the condition
that these are stored at 2-8 degree C. The shelf life of individual FDC test is
listed in the table 1.
-9-
Table 1
Shelf life of FDC slide after the
predetermined date of assembly
Test name Shelf life (months)
-------------------------------
XXX-X 00 These slides must be stored at
------------------------------- 2 to 8 degrees C.
BUN-PII 18
-------------------------------
Hb-W 24
-------------------------------
UA-P 18
-------------------------------
TCHO-PII 18
-------------------------------
NH3-PII 18
-------------------------------
TG-P 18
-------------------------------
CRE-PII 18
-------------------------------
TP-P 18
-------------------------------
ALB-P 18
-------------------------------
TBIL-P 18
-------------------------------
HDLC-P 18
-------------------------------
Ca-PII 18
-------------------------------
IP-P 18
-------------------------------
GGT-P 18
-------------------------------
GOT-P 18
-------------------------------
GPT-P 18
-------------------------------
CPK-P 18
-------------------------------
LDH-P 18
-------------------------------
ALP-P 18
-------------------------------
AMYL-P 18
-------------------------------
LAP-P 18
-------------------------------
CKMB-P 12
-------------------------------
CHE-P 12
-------------------------------
Mg-P 10
-------------------------------
DBIL-P 9
-------------------------------
-------------------------------
Na 16
-------------------------------
K 16
-------------------------------
Cl 16
-------------------------------
-10-
Schedule F Inspection Manual
Material sampling and inspection
1. Colorimetric slides
1.1 Sampling the beginning (outer part) part of each reel for shipment.
1.2 Assembling slides using the sample above.
(20 slides for Fuji, 20 slides for CARESIDE)
1.3 Inspection by Fuji
Measuring sample slides using controls.
Control Low :n=5
Control High :n=5
Evaluating accuracy (using average) and precision.
1.4 Inspection by CARESIDE
Measuring sample slides which is sent with reels of film
using controls.
Control Low :n=5
Control High :n=5
Evaluating accuracy (using average) and precision.
2. Electrolyde slides
2.1 Sampling representative part of assembled slides of each lot for shipment.
(10 slides for Fuji, 10 slides for CARESIDE)
2.2 Inspection by Fuji
Measuring sample slides using a control.
Control (QE) :n=5
Evaluating accuracy (using average) and precision.
2.3 Inspection by CARESIDE
Measuring sample slides using a control
Control (QE) :n=5
Evaluating accuracy (using average) and precision
(Criteria is summarized in table2)
-11-
Inspection Manual for Colorimetric Films (in detail)
----------------------------------------------------
1. Scheme of Inspection
1.1 Inspection by Fuji prior to Shipment
(1) Sample :The representative part of the lot in slide form
(2) Specimen :QP-L, H (control serum for FDC slides)
(3) Analyzer :FDC5500 or FDC3000
1.2 Inspection by CARESIDE after delivery
(1) Sample :The representative part of the lot in slide form provided by Fuji
(2) Specimen :QP-L, H (control serum for FDC slides)
(3) Analyzer :FDC3000
(4) Method of inspection :According to the operation manual provided by Fuji.
2. Operation Manual
2.1 Preparation
(1) FDC3000
(2) FUJI Clean Tips
(3) QP-L, H (store at 20/0/C)
Reconstitute them according to the instruction below.
a) Remove aluminum cap and rubber stopper.
b) Fill each vial with 3ml of either distilled or deionized water.
The water must be kept at 25.0+0.3/0/C
-
c) Put the stopper on the vial.
d) Allow the vial to stand at 25/0/C for 15 minutes.
e) Swirl gently to mix contents for 15 minutes.
f) Use within 3 hours.
(4) FDC slides for inspection
Take out the slides from the refrigerator and allow them to stand for
at least five minutes so that they can reach room temperature.
2.2 Turning on FDC3000
(1) Switch on.
When power is turning on, the analyzer emits a short beep and the
printer prints out the indication "FUJI DRI-CHEM FDC3000 V2.1-P02E."
Analyzer begins initialization to check operation.
(2) Empty out the disposal box.
2.3 Measurement method
(1) Confirm that the LCD reads "READY."
(2) Press keys in the following sequence.
a) "Mode," "00," "enter"
b) Input passwords. "7536," "Enter"
c) "1"
d) "Mode," "109," "Enter"
e) "1"
-12-
f) "1"
g) Input the slide code of the sample slide (e.g. "1050," "Enter"
for GLU slides)
(3) Insert the slides to be measured into the cartridge. Then make sure to
put the slide weight on top.
(4) Orient the cartridge properly and set it at the set position.
(5) Insert the sample tube and Clean Tip into the rack and set it at the
set position.
(6) Press the START key.
(7) After measurement is finished, the results are printed out.
3. Evaluation
Evaluate accuracy (using average) and precision.
-13-
Inspection Manual for Electrolyte Slides (in detail)
----------------------------------------------------
1. Scheme of Inspection
1.1 Inspection by Fuji prior to Shipment
(1) Sample :The representative part of the lot in slide form
(2) Specimen :QE (control liquid for FDC electrolyte slides)
(3) Analyzer :FDC800
(4) Method of inspection :According to the operation manual provided by Fuji
1.2 Inspection by CARESIDE after delivery
(1) Sample :The representative part of the lot in slide form provided by Fuji
(2) Specimen :QE (control liquid for FDC electrolyte slides)
(3) Analyzer :FDC800
2. Operation Manual
2.1 Preparation
(1) FDC800
(2) FUJI Clean Tips
(3) QE (control liquid for FDC electrolyte slides :store at 2 to 8/0/C)
(4) RE (reference liquid for FDC electrolyte slides :store at 2 to 8/0/C)
(5) FDC slides for inspection
Take out the slides, QE and RE from the refrigerator and allow them to
stand for at least five minutes so that they can reach room
temperature.
2.2 Turning on FDC800
(1) Switch on.
When the display on the panel changes from "WAIT" to "READY," the
instrument is ready for measurement.
(2) Press the sample key until the indication lamp on the panel indicates
SERUM.
2.3 Measurement method
(1) Set a slides into the pipetting area. The arrow xxxx on the slide must
be directed to forward direction.
(2) Set the FUJI Clean Tip properly to the FDC800 pipette.
(3) Lower the open/close lever of the FDC800 pipette to the bottom to widen
the space between two nozzles.
(4) Suck the RE liquid with pipette marked "reference" (blue).
The RE liquid can be sucked by pressing and then releasing the blue
lever. If the remaining reference is allowed to stand with the bottle
uncovered for extended periods, it will evaporate, resulting in a
change in concentration.
(5) Suck the QE liquid with the pipette marked "sample" (pink).
Use a new ample of control in each series of measurement.
(6) Set the open/close lever to the uppermost position to minimize the
space between the two nozzles.
-14-
(7) Apply the tips to the pipetting guide of the analyzer, and adjust the
ends of the tips to meet two spotting holes of the slides.
(8) Press the blue lever and pink lever simultaneously to drop the liquid
into the spotting holes of the slide.
(9) After complete spotting, press the START key promptly. The slides is
automatically transferred to the incubator and one minutes later, the
values of Na, K and Cl are displayed in mEq/l units and printed out.
After measurement, the slides is automatically discharged into the
slides receiver box.
*To measure the next slides, repeat step (1) to (9).
3. Evaluation
Evaluate accuracy (using average) and precision.
-15-
Table 2
Criteria of accuracy and
precision
unit control L control H
---------------------------------------------------------------------------------------------------------------
std. val. accuracy precision std. val. accuracy precision
---------------------------------------------------------------------------------------------------------------
GLU mg/dl 107.0 + 15% CV less than 3.0% 315.0 + 15% CV less than /= 3.0%
- -
---------------------------------------------------------------------------------------------------------------
BUN mg/dl 16.1 + 15% CV less than /= 3.5% 51.7 + 15% CV less than /= 3.0%
- -
---------------------------------------------------------------------------------------------------------------
Hb g/dl 10.0* + 15% CV less than/= 3.0%
-
---------------------------------------------------------------------------------------------------------------
UA mg/dl 3.40 + 0.9 CV less than/= 3.5% 10.4 + 12% CV less than/= 3.0%
- -
---------------------------------------------------------------------------------------------------------------
TCHO mg/dl 120.3 + 18% CV less than/= 3.5%
-
---------------------------------------------------------------------------------------------------------------
NH3 /u/g/dl 90.1 + 60 SD less than/= 7.0 /u/g/dl
-
---------------------------------------------------------------------------------------------------------------
TG mg/dl 107.7 + 30 CV less than/= 3.0% 168.0 + 30 CV less than/= 3.0%
- -
---------------------------------------------------------------------------------------------------------------
CRE mg/dl 1.29 + 0.7 SD less than/= 0.15mg/dl 5.5 + 30% CV less than/= 3.0%
- -
---------------------------------------------------------------------------------------------------------------
TP g/dl 5.53 + 0.9 CV less than/= 3.0% 7.10 + 0.9 CV less than/= 3.0%
- -
-----------------------------------------------------------------------------------------------------------------
ALB g/dl 3.14 + 0.9 SD less than/= 0.15g/dl 4.00 + 0.9 SD less than/= 0.15g/dl
- -
------------------------------------------------------------------------------------------------------------------
TBIL mg/dl 1.00 + 0.3 R less than/= 0.3mg/dl 4.50 + 1.2 SD less than/= 0.25mg/dl
- -
------------------------------------------------------------------------------------------------------------------
HDLC mg/dl 26.4 + 9.0 SD less than/= 1.5mg/dl
-
------------------------------------------------------------------------------------------------------------------
Ca mg/dl 9.71 + 1.2 CV less than/= 2.5% 12.6 + 1.5 CV less than/= 2.5%
- -
------------------------------------------------------------------------------------------------------------------
IP mg/dl 3.32 + 0.6 SD less than/= 0.15mg/dl 4.90 + 18% CV less than/= 3.5%
- -
------------------------------------------------------------------------------------------------------------------
Mg mg/dl 1.54 + 40% CV less than/= 4.5% 4.35 + 30% CV less than/= 3.5%
- -
------------------------------------------------------------------------------------------------------------------
DBIL mg/dl 0.31 + 0.6 SD less than/= 0.1mg/dl 2.74 + 21% CV less than/= 4.0%
- -
------------------------------------------------------------------------------------------------------------------
GGT U/1 48.8 + 12.6 SD less than/= 2.5U/1 457.0 + 21% CV less than/= 4.0%
- -
------------------------------------------------------------------------------------------------------------------
GOT/AST U/1 25.2 + 7.2 SD less than/= 2.5U/1 84.0 + 15% CV less than/= 3.5%
- -
------------------------------------------------------------------------------------------------------------------
GPT/ALT U/1 25.6 + 7.2 SD less than/= 2.5U/1 82.0 + 15% CV less than/= 3.5%
- -
------------------------------------------------------------------------------------------------------------------
CPK U/1 74.9 + 21 SD less than/= 4.0U/1 262.0 + 21% CV less than/= 4.0%
- -
------------------------------------------------------------------------------------------------------------------
LDH U/1 154.5 + 21% SD less than/= 4.0U/1 389.0 + 21% CV less than/= 4.0%
- -
------------------------------------------------------------------------------------------------------------------
ALP U/1 114.1 + 48 SD less than/= 8.5U/1 353.0 + 21.6% CV less than/= 4.0%
- -
------------------------------------------------------------------------------------------------------------------
AMYL U/1 92.6 + 15% SD less than/= 3.0U/1 348.0 + 15% CV less than/= 3.0%
- -
------------------------------------------------------------------------------------------------------------------
LAP U/1 44.2 + 21.6 SD less than/= 4.0U/1 73.0 + 21.6% SD less than/= 4.0U/1
- -
------------------------------------------------------------------------------------------------------------------
CKMB U/1 10.0 + 21.6 SD less than/= 2.5U/1 24.0 + 21.6% SD less than/= 2.5U/1
- -
------------------------------------------------------------------------------------------------------------------
CHE U/1 236.6 + 15% CV less than/= 3.5%
-
------------------------------------------------------------------------------------------------------------------
unit std. val. accuracy precision
-----------------------------------------------------
Na mEq/1 139.7 + 2.5 CV less than/= 1.5%
-
-----------------------------------------------------
K mEq/1 4.20 + 0.25 CV less than/= 2.5%
-
-----------------------------------------------------
Cl mEq/1 96.7 + 3.5 CV less than/= 2.0%
-
-----------------------------------------------------
*Standard value of Hb is changed at each inspection because Hb is tested with
whole blood.
Accuracy is evaluated with mean value.
When either the lot number of the standard solution and type of the slide is
changed, the value in the table 2 should be replaced.
When new test menu is added, this table will be revised.
New list will be provided by Fuji.
