EXHIBIT 10.16
AGREEMENT
This Agreement made and entered into the 23rd day of August, 1996 by
and between Fuji Photo Film Co., Ltd., a corporation duly 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 Exigent
Diagnostics, Inc., a corporation duly organized and existing under the laws of
State of Delaware and having its principal office at 000 Xxxxxxxxx Xxxx, Xxxx xx
Xxxxxxx, Xxxxxxxxxxxx, the United States of America (hereinafter referred to as
"EXIGENT"),
WITNESSETH:
Whereas FUJI has been engaged in, among other businesses, developing
and manufacturing DRI-CHEM films and has proprietary technology and know-how
related thereto;
Whereas EXIGENT has been engaged in commercial lab business' in
clinical diagnostic field and in developing a human diagnostic testing so-called
Point of Care Testing system and has proprietary technology and know-how related
thereto;
Whereas FUJI and SmithKline Xxxxxxx Corporation, which is the
predecessor of EXIGENT have executed the Letter of Intent dated March 19, 1996
to confirm the parties' intent to enter into a definitive agreement concerning
supply of DRI-CHEM films, film-based chemistry tests and immunodiagnostic tests
and exchange of various technology for use in Point of Care Testing system;
NOW, THEREFORE, in consideration of the premises and their mutual
covenants hereinafter set forth, the parties hereto agree as follows:
Article 1 Definitions
-----------
1.1. "POCT (Point of Care Testing)" shall mean a human or animal
diagnostic testing performed in the immediate vicinity of the patient at the
time a test sample is obtained. POCT shall exclude any diagnostic testing, which
is performed at a central fixed laboratory within hospitals, other health care
facilities or commercial laboratories.
1.2. "FDC Film" shall mean films used in FUJI DRI-CHEM system applicable
to the tests listed in Schedules A and B.
1.3. "FUJI Technology" shall mean FUJI's technology, know-how and
technical assistance relating to the use of FDC Film, including but not limited
to the specifications of FDC Film, its quality assurance and other information
listed in Schedule B, as may be amended from time to time by agreement of the
parties.
1.4. "EXIGENT POCT System" shall collectively mean a system and products
thereof developed by EXIGENT for POCT, including but not limited to chemistry,
immunochemistry, coagulation, and optionally hematology tests, test cartridge
for separating blood and metering samples, analyzer(s) for said tests including
data management components and software and a mobile cart.
1.5. "EXIGENT Materials" shall mean the immunodiagnostic testing reagents,
which utilize any of the technology EXIGENT 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. "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 the EXIGENT POCT System.
1.7. "Southeast Asia" shall mean the People's Republic of China, the
Republic of China, South Korea, Vietnam, Thailand, Myanmar, India, the
Philippines, Indonesia, Malaysia and Singapore.
Article 2 Supply of FDC Film
------------------
2.1. FUJI shall supply EXIGENT with and EXIGENT shall purchase from FUJI
FDC Film for the development of EXIGENT POCT System in accordance with the terms
and conditions detailed in Schedules D and E. The terms and conditions for
supply of FDC Film to be required for marketing of EXIGENT POCT System shall be
separately agreed upon between the parties hereto. The FDC Film applicable to
the tests in Sodium, Potassium and Chloride shall be supplied to EXIGENT by FUJI
in a slide form on which such FDC Film is mounted.
2.2. EXIGENT shall supply FUJI with and FUJI shall purchase from EXIGENT
EXIGENT Materials under the terms and conditions of a separate supply/purchase
agreement in which the EXIGENT Materials shall be priced as the highest at cost
plus fifty percent (50%) on CIF TOKYO basis.
2.3. FUJI shall supply EXIGENT exclusively with FDC Film until December
31, 2003, provided that such exclusive supply shall be changed to non-exclusive
supply if EXIGENT fails to obtain by December 31, 1999 approvals from the Food
and Drug Administration ("FDA") which should be necessary for distribution of
EXIGENT POCT system using FDC Film in the United States of America to
professional market for more than eighty percent (80%) of the tests listed in
Schedule A, B and G.
2.4. In the event that exclusive supply is changed to non-exclusive supply
under Article 2.3, FUJI shall supply EXIGENT with FDC Film in accordance with
the terms and conditions to be separately agreed upon between the parties
hereto.
2.5. During the period of 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.
2.6. EXIGENT shall use FDC Film supplied by FUJI hereunder only for
development of EXIGENT POCT System and shall not supply FDC Film to or use for
any third party for any purpose.
2.7. EXIGENT agrees that it shall use only FDC Film in its POCT System for
those tests listed in Schedule A and B and shall not use other reagents or
technologies for carrying out said tests and shall not be supplied with by any
third party any chemistry reagents for development of EXIGENT POCT System or
performance of the tests listed in Schedules A and B. For POCT Systems tests
other than those listed in Schedules A and B, EXIGENT shall have
the right to 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 FUJI's development for or distribution to any third party of FDC Film and
FUJI Technology for use with any products other than Competing Instruments.
FUJI and EXIGENT further confirms that FUJI DRI-CHEM systems and their
disposables shall in no event be construed as Competing Instruments and that
FUJI shall in no way be restricted to market FUJI DRI-CHEM systems and their
disposables.
Article 3 Inspection and Acceptance of FDC Film
-------------------------------------
Upon the receipt of FDC Film supplied by FUJI, EXIGENT shall promptly
inspect the FDC Film in accordance with the standards mutually agreed upon
between the parties as provided in Schedule D. Such inspection by EXIGENT shall
be considered as final. In the event that EXIGENT finds during the inspection
any defects in FDC Film that could be caused prior to the receipt thereof and it
notifies FUJI to that effect within thirty (30) days of the receipt and returns
such defective FDC Film to FUJI, FUJI shall replace such defective FDC Film with
non-defective FDC Film without cost to EXIGENT. 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 Article 3.
Article 4 License Exchange
----------------
4.1. FUJI shall from time to time during the term of this Agreement
disclose to EXIGENT on a non-exclusive basis FUJI Technology, written or oral,
to the extent that both EXIGENT and FUJI consider such disclosure is necessary
for EXIGENT to develop test cartridge of EXIGENT POCT System which incorporates
FDC Film supplied by FUJI (hereinafter referred to as "EXIGENT POCT
Cartridge(s)"). EXIGENT shall use FUJI Technology so disclosed only for
EXIGENT's development, manufacture and sale of EXIGENT POCT Cartridges and shall
not use it for any other purpose than such development, manufacture and sale.
4.2. FUJI shall grant EXIGENT a fully paid-up, non-exclusive license in the
world excluding Japan to make, have made, use, sell and offer to sell EXIGENT
POCT Cartridges under FUJI's patents directed to FDC Film and under FUJI's other
rights directed to FUJI Technology disclosed to EXIGENT.
4.3. In exchange for the rights and licenses granted by FUJI in accordance
with Article 4.1 and 4.2 above, EXIGENT shall grant FUJI:
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(1) a fully paid-up, irrevocable, worldwide, exclusive license
during the term of this Agreement, and a royalty-bearing, worldwide, exclusive
license thereafter, to make, have made, use, sell and offer to sell any dry
reagents under EXIGENT's patents which are directed to the tests listed in
Schedule A and B and which are applied and issued based on inventions made
during EXIGENT's development and/or manufacture of EXIGENT POCT Cartridges. The
royalty of the royalty-bearing license above shall be established in good faith
negotiation by the parties hereto; provided, however, that an amount of the
royalty shall be reasonable and favorable to FUJI compared with a similar
license to the others. In spite of FUJI's exclusive license, EXIGENT itself
shall be able to make, have made, use, sell and offer to sell any dry reagents
under EXIGENT's said patents;
(2) a fully paid-up, exclusive sub-license in Japan and a fully
paid-up, non-exclusive sub-license in the rest of the world during the term of
this Agreement, and a royalty-bearing, exclusive sub-license in Japan and a
royalty-bearing, non-exclusive sub-license in the rest of the world thereafter,
to make, have made, use, sell and offer to sell any dry reagents for
immunoassays under EXIGENT's right to grant such sublicense which right EXIGENT
has acquired, acquires or will acquire from any third party(s) under such third
party(s)'s patent(s). The royalty of the royalty-bearing license above shall be
established in good faith negotiation by the parties hereto; provided, however,
that an amount of the royalty shall be reasonable and favorable to FUJI compared
with a similar license to the others. EXIGENT shall make best efforts to acquire
such right from such third party(s) in case EXIGENT acquires a license under
such patent(s); and
(3) upon FUJI's request, a royalty-bearing, world-wide license
to make, have made, use, sell and offer to sell any dry reagents for coagulation
under EXIGENT's patent(s) and/or know-how applied or acquired before termination
of this Agreement. In case that EXIGENT acquires before termination of this
Agreement from any third party(s) a right to grant sub-licenses under such third
party(s)'s patents and/or know-how regarding coagulation, EXIGENT also shall
grant FUJI a sub-license under such right, upon FUJI's request. Other terms and
conditions of the license and/or the sub-license shall be established in good
faith negotiation by the parties hereto; provided, however, that an amount of
royalty shall be reasonable and favorable to FUJI compared with a similar
license to the others.
Article 5 Development of EXIGENT POCT System
----------------------------------
EXIGENT shall make best efforts to develop and complete EXIGENT POCT
System which incorporates FDC Film and/or FUJI Technology supplied hereunder in
accordance with the time schedule provided in Schedule H. During the term of
this Agreement, EXIGENT shall submit to FUJI a report in writing every three
months that describes the progress of development of EXIGENT POCT System. FUJI
and EXIGENT shall discuss the schedule of development of EXIGENT POCT System if
FUJI considers it necessary.
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Article 6 Distribution Rights
-------------------
EXIGENT shall grant FUJI right of the first refusal to distribute
EXIGENT POCT System exclusively in Japan and non-exclusively in Southeast Asia
subject to a distribution agreement to be negotiated separately. Such
distribution agreement shall include, among other terms and conditions, an
indemnification by EXIGENT with regard to EXIGENT POCT System which
indemnification shall be the same as that provided in Articles 7.4 and 7.5
below.
Article 7 Indemnification
---------------
7.1. FUJI shall indemnify and hold EXIGENT harmless from and against any
damages and costs incurred by EXIGENT which arises out of any claim or legal
action threatened or taken by any third party alleging that EXIGENT's use and/or
sale of FDC Film supplied by FUJI under this Agreement constitutes an
infringement of any intellectual property right of such third party, provided
that EXIGENT 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
EXIGENT 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 FDC to withhold further shipment of such FDC
Film. The indemnification above shall be applied also to any claim or legal
action threatened or taken by any third party alleging that EXIGENT's use and/or
sale of FDC Film which is to be supplied by FUJI to EXIGENT under a separate
agreement regarding supply of FDC Film to be required for marketing of EXIGENT
POCT System.
7.2. The provision of Article 7.1 shall not apply in case where the
infringement exists as a result of:
(1) any combination of FDC Film with other material(s), part(s)
or product(s) which is not supplied by FUJI;
(2) any use of FDC Film which is not intended by FUJI;
(3) any modification of FDC Film made by any party other than
FUJI; or
(4) EXIGENT's breach of this Agreement, or any act or negligence
of EXIGENT, its employee or agent.
7.3. Notwithstanding the provision of Article 7.1, FUJI shall in no event
be liable for:
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(1) consequential or incidental damages; or
(2) labor costs or lost profits.
7.4. EXIGENT 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 FUJI's use and/or sale of
EXIGENT Materials supplied by EXIGENT under this Agreement constitutes an
infringement of any intellectual property right of such third party, provided
that FUJI shall promptly notify EXIGENT of such claim or legal action in
writing, give EXIGENT sole control and authority with respect to the defense or
settlement of any such claim or legal action, and give EXIGENT reasonable
assistance with respect to the defense or settlement of any such claim or legal
action. EXIGENT shall have the right, with respect to any EXIGENT Materials
supplied to EXIGENT under this Agreement which become or are likely to become
the subject of such claim or legal action, to replace or modify such EXIGENT
Materials or to withhold further shipment of such EXIGENT Materials.
7.5. The provision of Article 7.4 shall not apply in case where the
infringement exists as a result of:
(1) any combination of EXIGENT Materials with other materials,
part(s) or product(s) which is not supplied by EXIGENT;
(2) any use of EXIGENT Materials which is not intended by
EXIGENT;
(3) any modification of EXIGENT Materials made by any party
other than EXIGENT; or
(4) FUJI's breach of this Agreement, or any act or negligence of
FUJI, its employee or agent.
7.6. Notwithstanding the provision of Article 7.4, EXIGENT shall in no
event be liable for:
(1) consequential or incidental damages; or
(2) labor costs or lost profits.
Article 8 Regulatory Approvals
--------------------
8.1. FUJI shall comply with FDA's Good Manufacturing Practices in
manufacturing and supplying FDC Films to EXIGENT hereunder.
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8.2. If FUJI is granted an exclusive right to distribute the EXIGENT POCT
System in a country, FUJI shall obtain all regulatory approvals required for
marketing EXIGENT POCT System in any country.
8.3. EXIGENT shall obtain all regulatory approvals required for marketing
EXIGENT POCT System in any other countries or areas than those for which FUJI
shall do under Article 8.2.
Article 9 Confidentiality
---------------
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 confidential obligation provided in Article 14.1 shall not apply
to:
(1) information which is known to the public or generally
available to the public prior to the date it is received;
(2) information which is known to the receiving party prior to
the date it is received from the other party;
(3) information which becomes known to the public or generally
available to the public after the date it is received through no fault of the
receiving party;
(4) information which the receiving party obtains without
restriction on disclosure from a third party having a bona fide right to
disclose such information; or
(5) information which must be disclosed by law or regulation in
order to obtain approval to sell EXIGENT POCT System, or otherwise required to
be disclosed by law, regulation or court order.
Article 10 Term
----
This Agreement shall continue in full force and effect until
December 31, 2003 from the date first above written, and will automatically be
renewed for additional periods of one (1) year, unless either party notifies the
other party of its intention not to renew this Agreement in writing at least six
(6) months before the expiration of the initial term or any successive renewal
term of this Agreement.
Article 11 Termination
-----------
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11.1. In the event that FUJI decides to discontinue manufacturing and
marketing FDC Film, FUJI may terminate this Agreement by giving a written one
year notice to EXIGENT, provided that, to protect the welfare of the customers
of EXIGENT POCT Systems sold by EXIGENT before such termination, FUJI shall
consult with EXIGENT and establish the necessary measures to be taken, to ensure
that EXIGENT has continued access to FDC Film and FUJI Technology, before such
termination.
11.2. 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 corporate reorganization or for any similar relief
shall be filed 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 of either party are transferred to a third party, then the other
party hereto may immediately terminate this Agreement by giving written notice
to that effect.
11.3. In the event that there arises a material change in control or
ownership of either party which would adversely affect the transaction hereunder
between the parties hereto, specifically as regards an acquisition by a
competitor whose resulting access to the trade secrets, confidential
information, know-how or patent rights licensed hereunder would result in a loss
of competitive advantage, or 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 a written notice to such party.
11.4. In the event that either party breaches or fails to perform any of
material obligations, terms or conditions of this Agreement or Individual
Agreement 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.
11.5. 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.
Article 12 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
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circumstances, whether similar or dissimilar to any at the foregoing, beyond
reasonable control of the first party.
Article 13 Surviving Clauses
-----------------
The provisions of Article 4.3(i), (ii) and (iii), 6, 7, 9, 14.4,
14.5, 14.6 and 14.7 shall survive any termination or expiration of this
Agreement.
Article 14 General Provisions
------------------
14.1. If any provision of this Agreement is held to be ineffective,
unenforceable or illegal for any reason, such decision shall not affect the
validity or enforceability of any or all of the remaining portions hereof.
14.2. 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 such subject matter.
14.3. 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.
14.4. This Agreement shall inure to the benefit of and be binding upon any
successors or assigns of either party hereto; however neither party may transfer
or assign this Agreement or any of its rights or obligations hereunder without
the prior written consent of the other party.
14.5. 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 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.
14.6. This Agreement and its validity, performance and interpretation
shall be governed by the laws of Japan.
14.7. 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:
FUJI: Fuji Photo Film Co., Ltd.
11-46, Senzui 3-chome
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Xxxxx-xxx, Xxxxxxx 000, Xxxxx
Attention : Xx. Xxxxxxx Xxxxxxxxx
(Associate Director)
Fax number: 00-000-000-0000
EXIGENT: Exigent Diagnostics, Inc.
000 Xxxxxxxxx Xxxx
Xxxx xx Xxxxxxx, XX 00000, XXX
Attention : Xx. X. Xxxxxxx Stoughton
(Chairman & C.E.O.)
Fax number: 0-000-000-0000
IN WITNESS WHEREOF the parties have caused this Agreement to be
executed by their authorized representatives.
Fuji Photo Film, Co., Ltd. Exigent Diagnostics, Inc.
Title: Associate Director Title: Chairman & C.E.O.
By: /s/ Xxxxxxx Xxxxxxxxx By:/s/ X. Xxxxxxx Stoughton
------------------------------ ----------------------------
Xxxxxxx Xxxxxxxxx X. Xxxxxxx Stoughton
Date: September 10, 1996 Date: August 23, 1996
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Schedule A: The tests to which FDC Film is or to be applicable
--------------------------------------------------
1. Total Bilirubin 14. Triglycerides
2. Hemoglobin 15. Cholesterol
3. Uric Acid 16. HDL Cholesterol
4. Ammonia 17. Glucose
5. AST 18. Total Protein
6. GGT 19. Albumin
7. LDH 20. Creatinine
8. ALT 21. Urea Nitrogen
9. LAP 22. Inorganic Phosphorus
10. Amylase 23. Magnesium
11. Alkaline Phosphatase 24. Carbon Dioxide
12. Creatine Kinase 25. Ionized Calcium
13. Total Calcium
Schedule B: The tests to which FDC Electrolyte Slide is applicable
------------------------------------------------------
1. Sodium
2. Potassium
3. Chloride
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Schedule C: FUJI Technology
---------------
1. Specifications of FDC Film
1-1 List of test menu
1-2 Reaction Scheme
1-3 Structure
1-4 Assay characteristics
1-5 Principle of determination of analyte activity
1-6 Performance
2. Quality control system
2-1 Quality control standards of FDC Film (slide)
2-2 Pre-calibration QC system
3. Handling and assembling conditions of FDC Film
3-1 Archival properties in reel and slide form
3-2 Room conditions of handling FDC Film
3-3 Mechanical handling conditions
4. Specific comments on each test and measuring instrument
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Schedule D: Conditions of supplying FDC Film
---------------------------------------------
1. Estimate of order volume: SB shall submit to FUJI a non-binding estimate of
semi-annual order volume by, January 31 and July 31 every year.
2. Order schedule: SB shall submit to FUJI semi-annual orders twice a year by
April 30 and October 31 not later than three months prior to its desired
delivery date.
3. Acceptance of order: Order shall be subject to FUJI's acceptance.
4. Bulk form: Supplied in reel form with 12mm width. Length shall be decided
by FUJI according to the ordered volume.
5. Packing: Sealed in aluminum laminated polyethylene film and packed in
cardboard box
6. Freight: (Cool 2(degrees)C - 8(degrees)C) air cargo
7. Place of delivery: (To be designated by SB, but should somewhere in the
US)
8. [Omitted pursuant to a request for confidential treatment. The material has
been filed separately with the Securities and Exchange Commission.]
9. Payment term: Paid within thirty (30) days of the custom clearance in the
banking account designated by FUJI
10. Shelf life: The shelf life of eighteen (18) months from the shipment date
is guaranteed, provided that the storage condition instructed by FUJI is
met.
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Schedule E: Conditions of supplying FDC Electrolyte Slide
---------------------------------------------
1. Estimate of order volume: Same as Schedule D
2. Order schedule: Same as Schedule D
3. Acceptance of order: Same as Schedule D
4. Slide form: Supplied in the same form as used in FUJI DRI-CHEM System.
One slide contains Na, K, Cl electrode.
5. Packing: Packed in the case proposed by SB and agreed by FUJI
6. Freight: Same as Schedule D
7. Place of delivery: Same as Schedule D
8. [Omitted pursuant to a request for confidential treatment. The material has
been filed separately with the Securities and Exchange Commission.]
9. Payment term: Same as Schedule D
10. Shelf life: Same as Schedule D
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Schedule F: Inspection criteria of FDC Film
-------------------------------
1. Criteria for inspection by FUJI prior to shipment: (To be agreed by the
parties based on FUJI's proposal)
2. Criteria for inspection by SB after delivery:
2-1 Site of inspection: (To be designated by SB)
----------------------
2-2 Time of inspection: Inspected within seven (7) days of the custom
clearance
2-3 Method of inspection: Inspected in accordance with detailed operation
manual provided by FUJI. Cleared if meet the inspection standards agreed
upon between the parties.
(1) Sample: Using the end part of the reel in slide form
(2) Analyser: FDC 3000 for colorimetric film
(3) Specimen: Control serum for FDC
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Schedule G: SB POCT Systems tests other than Schedules A and B
--------------------------------------------------
1. Theophylline
2. Digoxin
3. Phenytoin
4. Phenobarbital
5. T4
6. Thyroid Uptake
7. HCG
8. Troponin
9. Myglobin
10. PSA
11. Hemoglobin Alc
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Schedule H: Time Schedule of the development of POCT System
-----------------------------------------------
September 1996 10mcl Test Cartridge completed
October 1996 First breadboard of instrument
May 1997 Second breadboard version completed
July 1997 Prototype completed (without closed tube sampling)
October 1997 FDA submission of 11-12 tests
March 1998 FDA submission of next 20-28 tests
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