EXHIBIT 10.9
SUPPLY AND PURCHASE AGREEMENT
BETWEEN
MATRITECH INC.
AND
KONICA CORPORATION
SUPPLY AND PURCHASE AGREEMENT
This Agreement, made and entered into as of this 17th day of November, 1994 by
and between MATRITECH INC., with its principal place of business at 000 Xxxxxxx
Xxxxxx, Xxxxxxxxx XX 00000, X.X.X. ("MATRITECH"), and KONICA CORPORATION, with
its principal place of business at 00-0, Xxxxx-Xxxxxxxx 0-xxxxx, Xxxxxxxx-xx,
Xxxxx, Xxxxx ("KONICA"),
WITNESSETH THAT:
WHEREAS:
(A) MATRITECH is engaged in the manufacture and sale of certain kinds of
urinary tract disorders test kit for the purpose of diagnosis, prognosis,
monitoring or treatment of human disease including cancer and is willing to
supply KONICA with such products; and
(B) KONICA wishes to purchase from MATRITECH such products as mentioned above
(A) for the marketing, distribution and servicing, subject to the terms and
conditions contained hereinafter.
NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, both parties agree as follows:
1. DEFINITIONS
(a) "PRODUCTS" as used herein means the test kit detecting the urinary tract
disorders and/or diseases which consists of a microtiter plate based enzyme
immunoassay, and quantifies NMP22 in urine of patients for the diagnosis,
monitoring or prognosis of urinary tract disorders and/or diseases, and
further includes 96 determinations per test kit; and All succeeding
PRODUCTS and improved PRODUCTS, including but not limited to all improved
test kit which consists of any kinds of immunoassay to quantify NMP22 in
urine by other methods than the microtiter plate based method.
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(b) "TERRITORY" as used herein means Japan and other countries to be agreed
upon between both parties.
(c) "TRADEMARKS" as used herein means the trademarks which consist of a
combination of i) PRODUCTS name [JAPANESE CHARACTERS] Matritech UNMP22
[JAPANESE CHARACTERS] which means "KONICA Matritech UNMP22 TEST KIT", ii)
MATRITECH's trademark "device and Matritech" and iii) KONICA's trademark
"Konica". "TRADEMARKS" shall be more specified in the Exhibit A attached
hereto.
(d) "KOSEISHO" as used herein means the Ministry of Health and Welfare of
Japan.
(e) "KOSEISHO APPROVAL" as used herein means the approval and permits of
KOSEISHO for the purpose that KONICA can import and market PRODUCTS into
Japanese market and specifically does not include the approvals necessary
for assignment of reimbursement points or compensation such as Social
Insurance Medical Fee.
(f) "SALES YEAR" as used herein means a one (1) year period starting with the
procurement of KOSEISHO APPROVAL or any of anniversary dates thereof.
2. SUPPLY AND PURCHASE
2.1 During the term of this Agreement, KONICA shall have the exclusive right
for marketing, distribution and servicing of PRODUCTS in the TERRITORY in
consideration of the non-refundable payment of the exclusivity fee pursuant
to Section 2.5 below. MATRITECH agrees to supply PRODUCTS to KONICA and
KONICA agrees exclusively to purchase PRODUCTS from MATRITECH for
marketing, distribution and servicing in the TERRITORY, subject to the
terms and conditions contained herein. KONICA agrees not to sell any other
products than the test kits to quantify NMP22 in urine, which are
competitive with PRODUCTS within the TERRITORY.
2.2 So long as KONICA fully performs its obligation hereunder within the
TERRITORY, MATRITECH agrees that, during the term of this Agreement; i) it
shall not appoint any entity other than KONICA to act as a distributor for
the PRODUCTS in the TERRITORY, and ii) it shall not sell the PRODUCTS to
the customers in the TERRITORY. MATRITECH shall prevent possible re-export
of PRODUCTS into the TERRITORY by any MATRITECH's distributor outside the
TERRITORY, but assumes no responsibility for any such re-export if such
re-export is beyond MATRITECH's
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control. MATRITECH reserves the right to sell components of the PRODUCTS to
other manufacturers within the TERRITORY; provided, however, that KONICA
shall have the right of first refusal to purchase Anti-NMP22 monoclonal
antibody ("ANTIBODY") from MATRITECH, and even if KONICA refuses to
purchase ANTIBODY, MATRITECH shall guarantee that KONICA's exclusive right
for the PRODUCTS as set forth in Section 2.1 shall not be infringed by any
products which have the purpose of quantifying NMP22 in urine and are
manufactured by other manufacturers purchasing such ANTIBODY.
2.3 KONICA hereby agrees not to sell, re-export, re-ship or otherwise engage in
distributing or servicing PRODUCTS directly in or to areas outside the
TERRITORY, without the prior written consent of MATRITECH.
2.4 MATRITECH shall establish and maintain, at its own expenses and
responsibility, an adequate production capacity to enable to manufacture at
least [REDACTED] kits of PRODUCTS per manufacturing lot for KONICA to
fulfil KONICA's one (1) purchase order in accordance with this Agreement.
2.5 KONICA agrees to pay MATRITECH the non-refundable amount of US$ 225,000 as
the exclusivity fee for marketing, distribution and servicing of PRODUCTS
in the TERRITORY. Payment shall be made by telegraphic transfer to
MATRITECH at the date of execution hereof.
3. MINIMUM QUANTITY
3.1 KONICA shall purchase yearly the following minimum quantity of PRODUCTS
("MINIMUM QUANTITY") from MATRITECH, during the term of this Agreement:
1st SALES YEAR: [REDACTED] kits
2nd SALES YEAR: [REDACTED] kits
3rd SALES YEAR: To be mutually determined at 6 months prior to the end of
the preceding SALES YEAR.
4th SALES YEAR: To be mutually determined at 6 months prior to the end of
the preceding SALES YEAR.
5th SALES YEAR: To be mutually determined at 6 months prior to the end of
the preceding SALES YEAR.
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In the event that KONICA fails to meet the MINIMUM QUANTITY obligation in a
given SALES YEAR, KONICA may forfeit, at the sole discretion of MATRITECH,
its right to serve as exclusive distributor for the PRODUCTS.
3.2 For the purpose of the foregoing Section 3.1, PRODUCTS shall be credited to
the MINIMUM QUANTITY for the relevant SALES YEAR, at the time when
MATRITECH receives KONICA's purchase order which shall be placed in
accordance with Section 4 below; provided, that such creditable purchase
order shall be limited to those to be placed at least sixty (60) days prior
to the end of relevant SALES YEAR and the quantity of PRODUCTS under the
purchase order placed after the beginning of such sixty (60) day period
shall be credited to the MINIMUM QUANTITY for the next SALES YEAR.
4. ORDERING PROCEDURE
4.1 KONICA shall place a purchase order for PRODUCTS by sending to MATRITECH a
written order based on KONICA's form.
4.2 With respect to each purchase order placed by KONICA, MATRITECH shall
notify KONICA of whether MATRITECH accepts the purchase order or not,
within five (5) MATRITECH working days after the receipt of the purchase
order; provided, however, that the purchase order placed by KONICA shall be
deemed to be accepted by MATRITECH in case no notice of acceptance or
rejection is received by KONICA within such five (5) MATRITECH working day
period. The individual sales contract ("SALES CONTRACT") hereunder shall
become effective, if and as MATRITECH accepts the purchase order in
accordance with above mentioned provision.
4.3 In case KONICA deems it necessary to revise the SALES CONTRACT, KONICA may
make such revisions by the consent of MATRITECH.
4.4 The minimum order quantity of each purchase order placed by KONICA during
the term of this Agreement shall be as follows:
Before 1st SALES YEAR: [REDACTED] kits per order
1st and 2nd SALES YEAR: [REDACTED] kits per order
3rd and 4th SALES YEAR: [REDACTED] kits per order
5th SALES YEAR and thereafter: To be negotiated
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4.5 In case of discrepancy between SALES CONTRACT and this Agreement, this
Agreement shall prevail.
5. PRICE AND PAYMENT
5.1 The transfer price per kit of PRODUCTS shall be determined by both parties
in accordance with the following chart, and shall be quoted on an Ex Works
MATRITECH's warehouse in Cambridge basis:
--------------------------------------------------------------------------------
Social Insurance Medical Fee Transfer Price per kit
--------------------------------------------------------------------------------
[REDACTED] points or less US$[REDACTED] per point
--------------------------------------------------------------------------------
[REDACTED] points to 350 points US$[REDACTED]
--------------------------------------------------------------------------------
[REDACTED] points or more US$[REDACTED] per point
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MATRITECH shall promptly transfer KONICA with free of charge the formulas
and other written informations as necessary and as required for
manufacturing the urine sample stabilizer for PRODUCTS by KONLCA. Until
February 1, 1995, MATRITECH shall supply KONICA with reasonable quantities
of stabilizer and tubes as manufactured by MATRITECH at free of charge,
upon request by KONICA.
5.2 The transfer price of PRODUCTS as set forth in Section 5.1 above shall be
fixed for a period from the execution date hereof until the end of 2nd
SALES YEAR. Following 2nd SALES YEAR, both parties shall determine with
mutual consultation and agreement, the new transfer price of PRODUCTS
applied in each SALES YEAR at least six (6) months prior to the beginning
of such SALES YEAR, taking into consideration the changes in the production
costs, market conditions in the TERRITORY and other factors; provided, that
in case the new transfer price can not be determined at such time
notwithstanding reasonable efforts of both parties, the transfer price of
the preceding SALES YEAR shall be applied in the next SALES YEAR.
5.3 Notwithstanding the provisions of Sections 5.1 and 5.2 hereof, the transfer
price of PRODUCTS shall be discounted at the rate of [REDACTED] percent
[REDACTED] from the then current price for the entire next SALES YEAR, if
KONICA purchased [REDACTED] kits or more of PRODUCTS from MATRITECH in the
preceding SALES YEAR pursuant to Section 3.1.
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5.4 For the purpose of payment, KONICA shall remit the amount of PRODUCTS by
telegraphic transfer in U.S. dollars to MATRITECH not later than thirty
(30) days after receiving MATRITECH's invoice of relevant PRODUCTS.
6. DELIVERY
6.1 MATRITECH shall make timely shipment and delivery for PRODUCTS to KONICA
within sixty (60) days after the date of relevant purchase order placed by
KONICA. The delivery shall be made on an Ex Works MATRITECH's warehouse in
Cambridge basis. MATRITECH shall exert its best efforts to deliver PRODUCTS
manufactured in the same manufacturing lot to KONICA for each SALES
CONTRACT.
6.2 Title to PRODUCTS shall pass from MATRITECH to KONICA at the point of time
when the risk of loss for PRODUCTS shall pass from MATRITECH to KONICA in
accordance with the provisions of the "Incoterms" as set forth in Section
31.1.
6.3 MATRITECH shall, at its expenses, conduct and arrange necessary measures as
required by MATRITECH and consented by KONICA, including but not limited to
packaging with ice pack and styrofoam completed at MATRITECH for the
purpose of keeping PRODUCTS in the appropriate condition under the
transportation of PRODUCTS from MATRITECH's factory to KONICA's factory.
7. QUALITY INSPECTION
7.1 It is the responsibility of MATRITECH to test and inspect, at its own
expenses and in accordance with the methods and standards agreed upon by
the parties hereto and attached hereto as Exhibit B ("INSPECTION
STANDARDS"), all PRODUCTS before delivery thereof to KONICA in order to
check and secure the conformity with such quality and characteristics of
PRODUCTS as set forth in the product specification attached hereto as
Exhibit C ("PRODUCT SPECIFICATION"). MATRITECH shall issue KONICA in
advance certificate of analysis and certificate of conformance for PRODUCTS
by facsimile and registered mail which have passed its own test and
inspection as set forth above.
7.2 KONICA shall conduct, at its own expenses and in accordance with the
INSPECTION STANDARDS, acceptance test and inspection of PRODUCTS in order
to check and secure the conformity with such quality and characteristics of
PRODUCTS as set forth in the PRODUCT SPECIFICATION, for which such quality
certificate of MATRITECH as
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set forth in Section 7.1 above has been issued, before accepting such
PRODUCTS. KONICA may reject the whole or any part of such PRODUCTS as not
being in conformity with quality and characteristics of PRODUCTS as set
forth in the PRODUCT SPECIFICATION. If the nature of non-conformance of the
PRODUCT SPECIFICATION is such that the whole lot of PRODUCTS does not have
to be rejected then KONICA will make a good faith effort to only reject the
PRODUCTS as not being in conformity with the PRODUCT SPECIFICATION.
7.3 In case any PRODUCTS have been mutually agreed not to be in conformity with
the PRODUCT SPECIFICATION as a result of test and inspection in accordance
with the INSPECTION STANDARDS, MATRITECH shall deliver to KONICA the
substitute PRODUCTS within thirty (30) days from the mutual agreement under
the INSPECTION STANDARDS. All expenses relating to delivery of substitute
PRODUCTS shall be borne by MATRITECH.
8. PACKAGING, PACKING AND MARKING
All packaging, packing and marking (including labeling and printing),
package inserted instruction and such necessary description as required by
relevant regulations, for the purpose of marketing and distribution of
PRODUCTS in the TERRITORY and transportation of PRODUCTS from MATRITECH to
KONICA, shall be made by MATRITECH in accordance with KONICA's
instructions, at MATRITECH's expenses. MATRITECH shall accept reasonable
use labeling for PRODUCTS to be sold in the TERRITORY in accordance with
KONICA's instructions; provided, however, that regarding said labeling,
each party hereto shall respect the domestic legal requirement of the other
party.
9. WARRANTY
9.1 MATRITECH warrants to KONICA that PRODUCTS to be sold hereunder shall
conform to the PRODUCT SPECIFICATION and satisfy the INSPECTION STANDARDS
for the period of shelf life of PRODUCTS. OTHER THAN ANY WARRANTIES
SPECIFIED IN THIS SECTION 9 HEREOF, THERE ARE NO WARRANTIES OF ANY KIND,
INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE RELATING TO THE PRODUCTS. MATRITECH SHALL NOT BE
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LIABLE FOR ANY LOST PROFIT, LOSS OF GOODWILL OR OTHER ECONOMIC LOSS, OR FOR
ANY COLLATERAL, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND
WITH RESPECT TO A BREACH OF MATRITECH'S WARRANTIES UNDER THIS SECTION 9.
9.2 In case, after the mutual inspection as set forth in Section 7, any
PRODUCTS sold to KONICA have not conformed to the PRODUCT SPECIFICATION
within the period of shelf life of PRODUCTS by mutual agreement, MATRITECH
shall, at its expenses and responsibility, deliver to KONICA the substitute
PRODUCTS within thirty (30) days from the mutual agreement.
9.3 If original shelf life of PRODUCTS becomes equal to or more than [REDACTED]
months, MATRITECH shall guarantee that the remaining shelf life of PRODUCTS
shall be at least [REDACTED] months at the time when PRODUCTS have been
handed over into the charge of the customs clear agent in Narita airport
designated by KONICA. If it is proved definitely that original shelf life
of PRODUCTS shall be more than [REDACTED] months, MATRITECH shall guarantee
that the remaining shelf life of PRODUCTS shall be at least [REDACTED] of
original shelf life thereof at the above mentioned time.
9.4 This Section 9 shall survive any termination or expiration of this
Agreement.
10. SALES PROMOTION AND ADVERTISING
10.1 KONICA agrees to exert its best efforts to obtain the largest possible
sales volume of PRODUCTS in the TERRITORY and to win, maintain and promote
the goodwill for PRODUCTS among customers.
10.2 KONICA will, at its responsibility in principle, maintain an adequate stock
of PRODUCTS, actively undertake advertising, hold or participate in
exhibitions and implement other means of sales promotion of PRODUCTS.
11. REPORTING
KONICA shall provide MATRITECH with annual sales report and provide
MATRITECH quarterly with rolling sales forecast covered for one (1) year
regarding PRODUCTS.
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12. CUSTOMER SERVICE
KONICA shall perform necessary customer services for PRODUCTS in the
TERRITORY at its responsibility. MATRITECH shall provide KONICA with
reasonable and adequate marketing support, including but not limited to a
copy of sales promotional brochures, catalogues, manuals and any other
literature relating to PRODUCTS in English, and shall furnish KONICA with
necessary information in writing as requested by KONICA for the purpose of
correspondence of customer's claim.
13. TRADEMARKS
13.1 The packages of PRODUCTS sold by MATRITECH hereunder shall bear the
TRADEMARKS. The parties hereto acknowledge that the trademark "device and
Matritech" and "UNMP" and the goodwill symbolized thereby shall be and
remain the sole property of MATRITECH and the trademark "Konica" and
[JAPANESE CHARACTERS] and any goodwill symbolized thereby shall be and
remain the sole property of KONICA. The trademark "device and Matritech"
shall be affixed to the packages of PRODUCTS more conspicuously than the
trademark "Konica", which is more fully specified in the Exhibit A attached
hereto.
13.2 Except as explicitly authorized by this Agreement, nothing herein contained
shall be construed as the transfer or grant of a license from MATRITECH to
KONICA or from KONICA to MATRITECH of any tradenames, trademarks, patents,
designs, copyrights and/or any other industrial property rights of
MATRITECH or KONICA, whether registered or not, used or embodied in or in
connection with PRODUCTS.
14. INABILITY OF SUPPLYING PRODUCTS
In case that the supply and/or manufacture of PRODUCTS by MATRITECH will be
impossible or suspended for whatever reasons for a period greater than
sixty (60) consecutive days at any time during the term of this Agreement
except for force majeure and after a reasonable period of cure, and that
such inability situation shall not have been cured by MATRITECH within
forty-five (45) days after such sixty (60) consecutive day period,
MATRITECH shall license, sub-license or have licensed any patent and know
how contained in or relating to PRODUCTS including the relevant patents of
Massachusetts Institute of Technology (MIT) and the trademark "UNMP" to
KONICA with the most favorable royalty and conditions, and also shall
provide KONICA with materials including cell lines and other technologies
as requested by KONICA for the
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purpose of manufacture of PRODUCTS by KONICA. This Section 14 shall survive
any termination or expiration of this Agreement.
15. KONICA'S IMPROVEMENTS
During the term of this Agreement, KONICA shall, upon request by MATRITECH,
grant to MATRITECH at the most favorable royalty and conditions, a sole,
non-transferable, worldwide, without any right to sublicense to others,
license to make, use and sell the PRODUCTS under any and all improvements
to PRODUCTS developed by KONICA. Nothing herein contained shall be
construed as a grant of a license from KONICA to MATRITECH with respect to
any other products except for PRODUCTS, and KONICA shall be free to use
such improvements to any products.
16. PROCUREMENT OF PERMITS
16.1 KONICA shall use its best efforts in performing clinical trial and other
testing of PRODUCTS required for KOSEISHO submission, KOSEISHO APPROVAL and
acquirement of Social Insurance Medical Fee ("SIMF"), subject to
MATRITECH's assistance pursuant to Section 16.2 below. The target time
frame for submission to KOSEISHO by KONICA, procurement of KOSEISHO
APPROVAL and acquirement of SIMF shall be as follows; provided that
MATRITECH shall deliver to KONICA the third lot of PRODUCTS (Order No.:
94-N008) not later than [REDACTED] and that all such PRODUCTS shall pass
KONICA's inspection under the INSPECTION STANDARDS:
(a) Time to KOSEISHO submission: [REDACTED]
(b) Time to KOSEISHO APPROVAL: [REDACTED]
(c) Time to acquire SIMF: [REDACTED]
Provided, that above target time frame may be extended on a day for day
basis for every day when the delivery of PRODUCTS (Order No.: 94-N008) is
delayed, and may be changed upon mutual consultation and agreement in good
faith, subject to the problems related to product quality, clinical
evaluation performance, uncontrollable factors by KONICA or others.
16.2 MATRITECH shall provide KONICA with reasonable and adequate technical
assistance during the period of the clinical trial, submission to KOSEISHO
and acquirement of SIMF conducted by KONICA, and shall furnish KONICA with
necessary information as requested by KONICA for the purpose of procurement
of any license or permits required
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in Japan and conforming with any relevant regulations, subject that such
information shall have been already in MATRITECH's possession. MATRITECH
shall furnish KONICA with such information relating to characteristics and
safety of materials and methods and quality control of manufacture of
PRODUCTS and other relevant information as may be required for procurement
of such license or permits at its responsibility, whether or not such
information shall be in MATRITECH's possession; provided, that if the
furnishment of such information incurs significant expenses, the parties
hereto shall negotiate in good faith and come to mutual agreement for the
reimbursement of MATRITECH's reasonable expenses by KONICA.
16.3 MATRITECH shall provide US clinical trial data in summary form and testing
data of PRODUCTS required for FDA submission in summary form to KONICA in
support of KONICA's KOSEISHO submission and subsequent marketing efforts.
16.4 MATRITECH shall be responsible for procuring any license or permits
required to manufacture and export PRODUCTS, or for otherwise complying
with the local regulations in U.S. and shall obtain such license and
permits, at its own expenses.
17. SECRECY
During the term of this Agreement and for three (3) years thereafter, each
party hereto shall keep and cause to be kept confidential and may not
disclose in any manner to any third party any information as marked
"CONFIDENTIAL" acquired from the other party during the term of this
Agreement in connection with or in the course of performance of this
Agreement or SALES CONTRACT, including but not limited to the terms and
conditions of this Agreement and SALES CONTRACT, price of PRODUCTS,
marketing strategy and technical and sales data, and shall not use those
informations for the purpose other than the performance required in this
Agreement; except for the following information:
(a) which, at the time of disclosure by the other party, is in the public
domain;
(b) which, after the time of disclosure by the other party, is published
or otherwise becomes part of the public domain without any fault on
the part of the receiving party;
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(c) which can be established in the documented form that it was rightfully
in the possession of the receiving party at the time of disclosure by
the other party and was not acquired directly or indirectly from the
other party;
(d) which is or becomes available to the receiving party or to the general
public from any third party not having a confidential relationship
with the other party;
(e) which is or becomes reasonably necessary to be disclosed to KONICA's
sales representatives, dealers and customers for sales of PRODUCTS; or
(f) which is required by law to be disclosed.
18. HOLD HARMLESS
18.1 During the term of this Agreement and thereafter, MATRITECH shall indemnify
and hold KONICA harmless against any claim or demand by any third party for
damages, losses or costs including attorney's fees directly caused by,
including without limitation, accident, injury or hazard to person,
property or human health, arising out of or resulting from such PRODUCTS as
not being in conformity with the PRODUCT SPECIFICATION.
18.2 During the term of this Agreement and thereafter, KONICA shall indemnify
and hold MATRITECH harmless against any claim or demand by KONICA's sales
representatives, dealers or customers for damages, losses or costs arising
out of or resulting from service of or advertising of PRODUCTS conducted by
KONICA, excluding any product liability claim arising out of the PRODUCTS
to be sold hereunder.
19. TERM
This Agreement shall become effective from the date of execution of this
Agreement and shall remain in force until lapse of six (6) years from the
submission of PRODUCTS to KOSEISHO or January 31, 2002 whichever comes
latest, unless earlier terminated pursuant to Section 20 below. Thereafter,
this Agreement shall be extended for further two (2) year periods, unless
either party hereto gives the other party the termination notice at least
six (6) months prior to the expiration of the original or any such extended
period of this Agreement.
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20. EARLIER TERMINATION
20.1 Each party hereto shall, without prejudice to any other remedies available
to such party, have the right to forthwith terminate this Agreement and/or
SALES CONTRACT, in whole or in part, at any time by giving the other party
a written notice:
(a) if the other party shall commit any breach or failure to observe or to
perform any of the material provisions of this Agreement and/or SALES
CONTRACT, and such breach or failure shall not have been cured within
thirty (30) days after the date of a written notice of such breach or
failure given by the non-defaulting party;
(b) if any proceeding under any bankruptcy, reorganization, arrangement or
insolvency law or similar law for the relief of debtors shall be
instituted by or against the other party whether or not resulting in
adjudication;
(c) if a receiver, trustee or liquidator shall be appointed to take charge
of all or portion of the other party's assets under any provisions of
bankruptcy or insolvency law or similar law for the relief of debtors;
or
(d) if the other party shall suspend or cease or threaten to suspend or
cease its ordinary business operations or any substantial part
thereof.
20.2 The non-defaulting party in Section 20.1 (a) above shall have the right to
suspend its performance or fulfillment of any obligation except for the
obligation to pay monies owed which are not in dispute at the time of the
default as set forth in this Agreement and SALES CONTRACT without liability
for indemnification to the defaulting party, for the period from the date
of the written notice of such breach or failure set forth in Section 20.1
(a) above to the date of the adequate cure of such breach or failure by
such defaulting party, or to the date of termination of this Agreement
and/or cancellation of SALES CONTRACT, as the case may be.
20.3 In case the parties hereto mutually determine that the KOSEISHO APPROVAL
can not be procured as to PRODUCTS notwithstanding best efforts of KONICA
under MATRITECH's assistance pursuant to Section 16.2, this Agreement shall
be terminated without incurring any liability for indemnification on each
party to the other party due to such termination.
21. BREACH OF CONTRACT
In the case of breach by either party of any material term, condition or
warranty of this Agreement and/or SALES CONTRACT, such breaching party
shall be liable to the other
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party for all losses and damages directly caused by its breach of contract,
upon request by the other party after the period of cure of such breach as
set forth in Section 20.1 (a), without prejudice to any other remedies to
the other party provided herein, including but not limited to the right of
termination hereof pursuant to Section 20.1. This Section 21 shall survive
any termination or expiration of this Agreement.
22. NOTICE
All notices specifically required by this Agreement or by SALES CONTRACT
under this Agreement shall be in writing in English and shall be sent by
registered airmail, or by facsimile subject to confirmation by registered
mail, to the following address, unless otherwise instructed by written
notice of the other party:
If to MATRITECH: Xx. Xxxxx X. Xxxxxx
President and Chief Operating Officer
MATRITECH INC.
000 Xxxxxxx Xxxxxx, Xxxxxxxxx,
XX 00000, X.X.X.
Facsimile: 000-000-0000
If to KONICA: Mr. Xxxxxxx Xxxxxx
Director and Division Executive Officer
Medical Products Marketing Division
KONICA CORPORATION 262, Nishi-shinjuku 1-chome,
Xxxxxxxx-xx, Xxxxx 000-00, Xxxxx Facsimile:
81-425-87-3335
Any notices shall be deemed to have been duly given and made, unless
otherwise specifically provided in this Agreement, i) when such registered
airmail shall have been deposited in the mail, postage prepaid, or ii) when
such facsimile shall have been
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received by the other party, subject to receipt by such other party of
confirmation thereof by registered mail, postage prepaid, within fifteen
(15) days.
23. EFFECT OF TERMINATION
No expiration or no earlier termination (collectively "termination") of
this Agreement shall release each party from any liability which at such
time has already accrued to the other party, nor shall in any way affect
the survival of any right, duty or obligation of each party which is
contemplated to be performed as of the date of or after such termination.
24. FORCE MAJEURE
Neither party hereto shall be responsible for failure or delay in the
performance of its obligations under this Agreement and/or any SALES
CONTRACT due to cause(s) beyond its control, including but not limited to
acts of God, strikes, labor troubles, inevitable accidents, shortage or
delay of carriers, shortage of raw materials, labour, power or other
utility services, war, riots, civil commotion, embargoes, blockades,
prohibition of exportation, governmental direction, intervention of
government agencies or legal restrictions. In such cases, performance by
such party of this Agreement and/or any SALES CONTRACT shall be suspended
without liability for indemnification to the extent of affected performance
and for the period of delay reasonably attributable to such causes,
including but not limited to recovery time.
25. PATENT INDEMNIFICATION
25.1 During the term of this Agreement and thereafter, MATRITECH shall indemnify
and hold KONICA harmless against any claim of infringement of any patent,
copyright, design or other intellectual property rights with respect to the
PRODUCTS purchased by KONICA hereunder, except as provided in Section 25.3
below. In the event a third party at any time brings suit against KONICA
anywhere in the TERRITORY claiming infringement of its patent rights or
unauthorized use or misappropriation of its technology, based on a claim
arising out of the use or sale of the PRODUCTS, MATRITECH shall have sole
and exclusive right to take all appropriate legal action with respect
thereto. KONICA shall, after receipt of notification of a third party claim
or notice of commencement of any action, suit or proceeding of the type
described in the preceding sentence, notify MATRITECH of such claim or the
commencement of said
-16-
action, suit or proceeding, enclosing a copy of all papers served. KONICA
shall not settle, compromise or agree to the dismissal of any such suit
involving the rights of MATRITECH without obtaining the prior written
consent of MATRITECH.
25.2 KONICA shall promptly report in writing to MATRITECH during the term of
this Agreement any i) known infringement or suspected infringement by a
third party in the TERRITORY, or ii) unauthorized use or misappropriation
by a third party in the TERRITORY, of any patent and/or trademark of
MATRITECH relating to or covering the PRODUCTS, of which it becomes aware,
and shall provide MATRITECH with all available evidence supporting said
infringement, suspected infringement or unauthorized use or
misappropriation. MATRITECH shall have the sole and exclusive right and
obligation to initiate an infringement or other appropriate suit anywhere
in the TERRITORY against any third party who at any time has infringed, or
is suspected of infringing, any patent and/or trademark of MATRITECH
pertaining to the PRODUCTS.
25.3 During the term of this Agreement and thereafter, KONICA shall indemnify
and hold MATRITECH harmless against any claim of infringement of any
patent, copyright, design or other intellectual property rights with
respect to; i) the trademarks , "Konica" and [JAPANESE CHARACTERS], and ii)
the improvements made by MATRITECH under the instruction of KONICA to the
PRODUCTS purchased by KONICA hereunder.
26. RECALL AND WITHDRAWAL
The parties hereto acknowledge that recall/withdrawal of PRODUCTS
distributed by KONICA to its customers may be made in case i) such recall
is ordered or requested by a competent governmental authority or ii) such
withdrawal is mutually agreed upon by the parties hereto ("PRODUCTS
RECALL/WITHDRAWAL"). KONICA agrees to take any action as both parties deem
necessary to facilitate and implement the PRODUCTS RECALL/WITHDRAWAL.
MATRITECH will bear the direct costs and expenses incurred in connection
with the implementation of the PRODUCTS RECALL/WITHDRAWAL if and to the
extent such PRODUCTS RECALL /WITHDRAWAL is taken place due to the PRODUCTS
not conforming to the PRODUCT SPECIFICATION; provided, however, that such
non-conformance is not due to improper transport, storage or use of the
PRODUCTS, and KONICA will bear such
-17-
direct costs and expenses if and to the extent such PRODUCTS
RECALL/WITHDRAWAL is taken place due to negligence of KONICA.
27. NON-WAIVER
No failure to exercise or delay in exercising any right under this
Agreement and/or any SALES CONTRACT shall operate as a waiver thereof, nor
shall any single or partial exercise of any of such rights thereunder
preclude any other or further exercise of such rights or the exercise of
any other rights.
28. NON-ASSIGNABILITY
Neither party hereto may, in whole or in part, assign, transfer, pledge,
encumber or otherwise dispose of this Agreement or any SALES CONTRACT or
any such rights or obligations on its part as are created thereunder to any
third party, without the prior written consent of the other party;
provided, however, that MATRITECH may assign its rights and obligations
under this Agreement in connection with the sale of its entire business
relating to the PRODUCTS, if and on condition that, KONICA confirms in
writing prior to the assignment that the assignee of such MATRITECH's
rights and obligations assumes all contractual obligations of MATRITECH
hereunder without any substantial changes thereon, and in such case, KONICA
will not withhold its consent for such assignment.
29. PARTIAL INVALIDITY
The parties hereto agree that invalidity or unenforceability of any of the
provisions, in part or in whole, of this Agreement or any SALES CONTRACT
shall not in any way affect the validity or enforceability of any other
parts or provisions thereof except those which are an integral part of or
are otherwise clearly inseparable from such invalid or unenforceable part
or provision.
30. HEADINGS
The headings to Sections or elsewhere in this Agreement are only for
convenience of reference without forming a part of this Agreement and shall
not in any way affect the interpretation thereof.
31. TRADE TERMS AND APPLICABLE LAW
31.1 The trade terms used in this Agreement and any SALES CONTRACT shall be
interpreted in accordance with the provisions of the "Incoterms" (the
International Rules
-18-
for the Interpretation of Trade Terms established by the International
Chamber of Commerce), as amended and supplemented from time to time.
31.2 This Agreement and any SALES CONTRACT shall be governed by and construed in
accordance with the substantive laws of the State of New York without
reference to other laws.
32. ARBITRATION
All disputes, controversies or differences which may arise, during the term
of this Agreement or thereafter, between the parties hereto, out of or in
connection with this Agreement or any SALES CONTRACT, or for the breach
thereof, shall be finally settled by arbitration pursuant to the
Japan-American Trade Arbitration Agreement of September 16, 1952 ("JATAA"),
by which each party hereto is bound. The place of arbitration shall be New
York, U.S.A., if the defendant party is MATRITECH, or Tokyo, Japan, if the
defendant party is KONICA; provided, however, that nothing in this Section
32 shall be construed to preclude either party from seeking provisional
remedies, including, but not limited to, temporary restraining orders and
preliminary injunctions, from any court of competent jurisdiction, in order
to protect its rights pending arbitration, but such preliminary relief
shall not be sought as a means of avoiding arbitration. The parties hereto
shall have the right of prehearing discovery, including, without
limitation; i) exchange of witness lists, ii) exchange of documentary
evidence and reasonably related documents, iii) written interrogatories,
and iv) subject to the reasonable discretion of the arbitrators and upon
good cause shown depositions under oath or any witnesses who are to be
called to testify at the arbitration hearing. As soon as the discovery is
concluded, the arbitrators shall hold one or more hearings on as expedited
a schedule as proves practicable in accordance with the aforesaid JATAA
rules. The award of the arbitration shall be final and binding upon both
parties hereto.
33. ENTIRE AGREEMENT AND MODIFICATION
33.1 This Agreement is the final expression of the entire and only agreement of
both parties with respect to the subject matter covered in this Agreement
and supersedes all previous oral or written agreements, negotiations,
commitments and representations with respect thereto.
-19-
33.2 This Agreement cannot be changed, modified or amended in any manner except
by mutual agreement in writing signed by duly authorized representatives of
both parties hereto.
33.3 This Agreement has been drafted in English but may be translated into
Japanese; provided, however, that the English language version shall be
controlling.
-20-
IN WITNESS WHEREOF, both parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the date first above
written.
MATRITECH INC. KONICA CORPORATION
/s/ Xxxxx X. Xxxxxx /s/ Xxxxxxx Xxxxxx
------------------------------- ------------------------------------
By: Xxxxx X. Xxxxxx By: Xxxxxxx Xxxxxx
Title: President and Chief Title: Director and Division
Operating Officer Executive Officer
Medical Products Marketing
Division
Date: December 1, 1994 Date: November 17, 1994
------------------------- ----------------------------
EXHIBIT A
- TRADEMARKS -
[JAPANESE CHARACTERS] Matritech UNMP 22 [JAPANESE CHARACTERS]
(Konica Matritech UNMP22 test kit)
1. PRODUCTS NAME
[JAPANESE CHARACTERS] Matritech UNMP22 [JAPANESE CHARACTERS]
2. MATRITECH'S TRADEMARK
MATRITECH
3. KONICA'S TRADEMARK
KONICA
EXHIBIT B
- INSPECTION STANDARDS -
[JAPANESE CHARACTERS] Matritech UNMP22 [JAPANESE CHARACTERS]
(Konica Matritech UNMP22 test kit)
1. TEST KIT INSPECTION
1-1 PROPER LABELING
Reagent bottles, foils, cartons and shippers shall be 100% inspected for
content, position, and quality of the information printed during
manufacturing. The 100% inspection may be changed by mutual agreement of
both Matritech and Konica.
Each lot is sampled and tested for proper labeling of reagent bottles and
foils of the kit components.
1-2 LOT NUMBERS
The items specified will have a lot number and the lot number shall be
clearly printed in the specified position.
1-3 EXPIRATION DATES
The items specified will have an expiration date and the expiration date
shall be printed in the specified position.
1-4 SOIL DAMAGE
Soil damage shall not affect the marketability of the products.
1-5 WATER DAMAGE
Water damage shall not affect the marketability of the products.
1-6 PHYSICAL DAMAGE
a) Shipper; Damage shall not affect the marketability of the products.
b) Carton; Damage shall not affect the marketability of the products.
c) Bottles; Damage shall not affect the marketability of the products.
Each bottles shall be properly sealed.
Each lot is sampled and tested for integrity of the sealing of the cap.
1-7 TEMPERATURE INTEGRITY OF SHIPMENT
When packing Test Kit for shipment, a temperature recorder is packed inside
of a randomly selected crate so that temperature changes during shipment
may be monitored.
However, said temperature recorder can be neglected or substituted to other
temperature warning method under the mutual agreement.
1-8 SHIPMENT NOTIFICATION
A Shipment Notification shall be sent to Konica such that it is received
prior to receiving the shipment. This contains a list of lot numbers,
quantities, purchase orders represented by the shipment, and a statement
that the products conform to the specification.
1-9 CERTIFICATE OF ANALYSIS
For each lot number, a certificate of analysis shall be mailed to QA
Operations at Konica.
2. PERFORMANCE TESTING
2-1 TEST KIT PERFORMANCE
Test Kit Performance is characterized by sensitivity, specificity,
reproducibility and stability.
Test Kit Performance Testing is done on each lot to determine product
performance characteristics. The protocol is specified in the SUPPLEMENTAL
RELEASE PROCEDURES.
The level of absorbance or value is determined with mean level of described
number of assay in the SUPPLEMENTAL RELEASE PROCEDURES.
2-1-1 SENSITIVITY
Sensitivity is defined as absorbance at wavelength of 492nm per unit in
zero fixed linear regression of Calibrators, and that absorbance per unit
shall be within range of allowance.
In addition, absorbance in Calibrator No.l shall be below the definite
level, and coefficient correlation of linear regression shall be within
allowance.
Mean absorbance of Calibrator No.l. at 492nm is less than the acceptance
limit listed in SUPPLEMENTAL RELEASE PROCEDURES.
Slope in zero fixed linear regression using mean absorbance of Calibrator
No. 1 to No.7. is within the acceptance limit listed in SUPPLEMENTAL
RELEASE PROCEDURES.
2-1-2 SPECIFICITY
Specificity is defined as +/-bias % having against assigned controls. Each
level of three Controls shall be within +/-bias % of allowance.
Moreover, in order to maintain the absorbance value, both sites of
Matritech and Konica shall have sufficient number of "mastercontrol" in
frozen below -80 (degree)C. These master control shall be assayed at the
same time and shall be within +/-bias % of allowance.
Each value of Control I to III is within the acceptance listed in
SUPPLEMENTAL RELEASE PROCEDURES.
The value of master control is within the acceptance limit listed in
SUPPLEMENTAL RELEASE PROCEDURES.
2-1-3 REPRODUCIBILITY
Reproducibility is defined as Coefficient of Variation (C.V.%) of values in
three Controls.
Each C.V.% of Control I to III is within the acceptance listed in
SUPPLEMENTAL RELEASE PROCEDURES.
2-1-4 DISPOSITION OF RETESTING
Results falling outside of specification may indicate an unacceptable lot.
Three possible actions may be taken ;
a) Reject the lot based in the initial test results if re-testing does
not appear to be promising.
b) Retest the lot and combine all the results together to compare to
specification.
Release if acceptable.
c) Determine through investigation that the initial performance results
were incorrect due to a specific testing error for which corrective
action has been taken. Initial data may be discarded and new data
collected.
2-2 CALIBRATOR VALUE CHECK
The assigned value of each Calibrator is checked on each lot to determine
product performance characteristics. The protocol is specified in the
SUPPLEMENTAL RELEASE PROCEDURES.
2-2-1 CALIBRATOR VALUE VERIFICATION
Absorbance of Calibrator No.l and No.7 is within the allowance listed in
SUPPLEMENTAL RELEASE PROCEDURES.
The assigned values of Calibrator from No.l to No.7 is within the allowance
listed in SUPPLEMENTAL RELEASE PROCEDURES.
The correlation coefficient in zero fixed linear regression using mean
absorbance of Calibrator from No.l to No.7 is more than the allowance shown
in SUPPLEMENTAL RELEASE PROCEDURES.
2-2-2 DISPOSITION OF RETESTING
Results falling outside of specification may indicate an unacceptable lot.
Two possible actions may be taken;
a) Reject the lot based in the initial test results if re-testing does
not appear to be promising.
b) Determine through investigation that the initial performance results
were incorrect due to a specific testing error for which corrective
action has been taken. Initial data may be discarded and new data
collected.
2-3 CONTROL VALUE CHECK
The assigned value of each Control is checked on each lot to determine
product performance characteristics. The protocol is specified in the
SUPPLEMENTAL RELEASE PROCEDURES.
2-3-1 CONTROL VALUE VERIFICATION
The assigned value in each Control from I to III is within the allowance
listed in SUPPLEMENTAL RELEASE PROCEDURES.
Each result values of Control from I to III is within each control range
described in its label on the bottle.
2-3-2 DISPOSITION OF RETESTING
Results falling outside of specification may indicate an unacceptable lot.
Two possible actions may be taken ;
a) Reject the lot based in the initial test results if re-testing does
not appear to be promising.
b) Determine through investigation that the initial performance results
were incorrect due to a specific testing error for which corrective
action has been taken. Initial data may be discarded and new data
collected.
3. VERIFICATION OF SHELF LIFE
3-1 REAL TIME SHELF LIFE VERIFICATION
Verification of Shelf Life shall be determined by the difference between
the values obtained from the Test Kits of a lot immediately after
manufacturing and the values obtained from the Test Kits of the same lot
after storage at 2(degree)C to 10(degree)C in unopened bottle for a period
not less than the expiry age for the reagent.
3-2 STRESSED LIFE VERIFICATION
Only when changing either a formula or a process, or both, a test of
putting a small trial sample in accelerated stress conditions such as 7
days at 37(degree)C is performed. The results of the test along with the
data of unstressed samples are to be submitted when released. No judgement
of the release and acceptance shall be made with performance of the
stressed samples.
4. OTHERS
4-1 PRODUCT SAMPLE
Both Matritech and Konica keeps significant amount of production sample of
the Product in each lots, in order to provide the soonest measure for
customer complaints.
Such production sample is kept for at least 3 months more than its original
expiration.
4-2 RECEIVING INSPECTION
For each shipment from Matritech to Konica, Konica shall perform the
receiving inspection referred to the EXHIBIT B -INSPECTION STANDARDS.
However, such receiving inspection can be neglected under the decision of
Konica.
EXHIBIT C
- PRODUCT SPECIFICATION -
[JAPANESE CHARACTERS] Matritech UNMP22 [JAPANESE CHARACTERS]
(Konica Matritech UNMP22 test kit)
1. DEFINITION
This Product Specification is defined in order to maintain the quality of
[JAPANESE CHARACTERS] Matritech UNMP22 [JAPANESE CHARACTERS] (Konica
Matritech UNMP22 test kit) which consists of a microtiter plate based
enzyme immunoassay and quantifies NMP22 in urine of patients for the
diagnosis, monitoring or prognosis of urinary tract disorders and/or
diseases, and further includes 96 determinations per test kit, that
Matritech Inc. (hereafter Matritech) manufactures and Konica Corporation
(hereafter Konica) distributes within the Territory.
Terminology:
Product; Test Kit, Carton and Shipper
Test Kit; Konica Matritech UNMP22 Test Kit
Carton; Box that contains components.
Shipper; Box that contains cartons.
2. SCOPE
This Product Specification is effective for the performance, standard and
packaging of [JAPANESE CHARACTERS] Matritech UNMP22 [JAPANESE CHARACTERS]
(Konica Matritech UNMP22 test kit) according to the SUPPLY AND PURCHASE
AGREEMENT executed November 17, 1994 between Matritech and Konica.
3. KIT COMPONENTS
Kit Components would be referred to Attachment 1.
4. LOT NUMBER AND EXPIRATION DATE
4-1 DEFINITION OF LOT -
Lot number of the kit is defined to as kits packaged in the same day by the
same batch in all components.
Lot number of the reagent is defined to the reagents manufactured and
assigned in the same day.
4-2 LOT NUMBER ASSIGNMENT-
Lot number is assigned in 6 digits. Each digit is named as follows;
example
1 1 4 0 0 1
| | | | | |
| | | ------------------------ manufacturing serial number (3 digits)
| | ---------------------------- the last digit of the year
|--|------------------------------ month
Table 1 : code of month
-----------------------------------------
month code
-----------------------------------------
January 01
-----------------------------------------
February 02
-----------------------------------------
March 03
-----------------------------------------
April 04
-----------------------------------------
May 05
-----------------------------------------
June 06
-----------------------------------------
July 07
-----------------------------------------
August 08
-----------------------------------------
September 09
-----------------------------------------
October 10
-----------------------------------------
November 11
-----------------------------------------
December 12
-----------------------------------------
4-3 EXPIRATION DATE -
Expiration date is defined as the date after X months from the next month
of the manufacturing.
5. SPECIFICATION
5-1 PRODUCT APPEARANCE -
5-1-1 LABELING
For each components of the kit, labeling is specified in Attachment 2.
Labeling and its printing must be proper and visibly clear.
5-1-2 PACKAGE
The carton of the Product is specified as follows.
Dimension : 219.1mm(W) x 158.8mm(L) x 89mm(H)
Material : card board -150E flute
The packing of the components of the Products in the carton are specified
in Attachment 3.
The printing to the carton is specified in Attachment 2.
Carton printing and components layout must be proper and visibly clear.
The shipper of the carton is specified as follows.
Dimension : 225mm(W) x 321mm(L) x 200mm(H)
Material : corrugated box
Contents : 6 cartons
The packing of the cartons to the shipper is specified in Attachment 3.
The printing to the shipper is specified in Attachment 2.
The printing on the shipper and cartons layout must be proper and visibly
clear.
The format of the package inserted instruction is specified in
Attachment 2.
5-1-3 APPEARANCE OF MATERIALS
There shall be no significant aesthetic defects or degradation found in
each reagent material of the components.
The appearance of each components is specified in Attachment 1.
5-1-4 OTHERS
There shall be no significant aesthetic defects to the Products.
5-2 PROTOCOL -
5-2-1 WAVELENGTH OF ABSORBANCE MEASUREMENT
492 nm
5-2-2 OPERATION TIME AND TEMPERATURE
Specimen, calibrator and control ; 200uL/well
- incubate.......... 2 hours +/- 5 min. at 18(degree)C to 25(degree)C.
- wash
Add DIG~Anti-UNMP22 ; 200uL/well
- incubate.......... 1 hours +/- 5 min. at 18(degree)C to 25(degree)C.
- wash
Add SAD-HRP ; 200uL/well
- incubate.......... 0.5 hours +/- 5 min. at 18(degree)C to 25(degree)C.
- wash
Add OPD solution ; 200uL/well
- incubate.......... 0.5 hours +/- 2 min. at 18(degree)C to 25(degree)C.
Add 0X X0X00 to stop reaction ; 50uL/well
- wait ............. 10 minutes.
- read absorbance .......... no later than 30 minutes after addition of acid.
5-3 PERFORMANCE -
5-3-1 TEST KIT PERFORMANCE
A. Sensitivity (Slope of Standard Curve)
Slope in zero fixed linear regression using absorbance of Calibrator No.l
to No.7 ;
[REDACTED]
B. Specificity
When any sample with known concentration are measured, the values obtained
are within the limits listed in Table 2.
Table 2 : sample levels and allowances
----------------------------------------------------------------------------
level true value (U/mL) Allowance
----------------------------------------------------------------------------
low [REDACTED] [REDACTED]
----------------------------------------------------------------------------
middle [REDACTED] [REDACTED]
----------------------------------------------------------------------------
high [REDACTED] [REDACTED]
----------------------------------------------------------------------------
C. Reproducibility
inter-assay C.V. [REDACTED] (across the entire assay)
intra-assay C. V. [REDACTED]
D. Assay Range
The assay range of this method is ;
[REDACTED]
E. The Low End Sensitivity
The low end sensitivity of the assay [REDACTED]
F. Recovery Rates
The recovery rates of added antigen [REDACTED]
G. Dilution Linearity Rates
The dilution linearity rates of urine samples [REDACTED]
5-3-2 REQUIREMENT FOR CALIBRATOR
Each levels of Calibrators must present the specified characteristics in
Attachment 4.
The correlation coefficient in zero fixed linear regression using mean
absorbance of the Calibrator from No.l to No.7 is more than [REDACTED]
5-3-3 REQUIREMENT FOR CONTROL
Each levels of Controls must present the specified characteristics in
Attachment 5.
6. OTHERS
6-1 DOCUMENTATION
For each released lot, a Certificate of Analysis must be prepared from
Matritech to Konica.
6-2 PRESENCE OF THE PROBLEM
If there arouse problem to the quality of the Product, Matritech and
Konica shall negotiate in good faith and do their best efforts to the
solutions.
ATTACHMENT 1. KIT COMPONENTS OF UNMP22
A. Test Kit Components
--------------------------------------------------------------------------------------------------------------
No. Name form & Volume package
--------------------------------------------------------------------------------------------------------------
#la 3 [JAPANESE CHARACTERS] - 1 [JAPANESE lyophilized 5mL flint glass bottle x3 with
CHARACTERS] split nosed stopper
UNMP22 No. l Unit/mL Calibrator
--------------------------------------------------------------------------------------------------------------
#lb 3 [JAPANESE CHARACTERS] - 2 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 No.2 Unit/mL Calibrator
--------------------------------------------------------------------------------------------------------------
#lc 3 [JAPANESE CHARACTERS] - 3 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 No.3 Unit/mL Calibrator
--------------------------------------------------------------------------------------------------------------
#ld 3 [JAPANESE CHARACTERS] - 4 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 No.4 Unit/mL Calibrator
--------------------------------------------------------------------------------------------------------------
#le 3 [JAPANESE CHARACTERS] - 5 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 No.5 Unit/mL Calibrator
--------------------------------------------------------------------------------------------------------------
#1f 3 [JAPANESE CHARACTERS] - 6 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 No.6 Unit/mL Calibrator
--------------------------------------------------------------------------------------------------------------
#l g 3 [JAPANESE CHARACTERS] - 7 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 No.7 Unit/mL Calibrator
--------------------------------------------------------------------------------------------------------------
#2a 4 [JAPANESE CHARACTERS] - 1 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 Control Level 1
--------------------------------------------------------------------------------------------------------------
#2b 4 [JAPANESE CHARACTERS] - 2 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 Control Level 2
--------------------------------------------------------------------------------------------------------------
#2c 4 [JAPANESE CHARACTERS] - 3 [JAPANESE lyophilized 5mL flint glass bottle with
CHARACTERS] split nosed stopper
UNMP22 Control Level 3
--------------------------------------------------------------------------------------------------------------
#3 8 [JAPANESE CHARACTERS] 96 [JAPANESE 1 plate foiled in zip-lock with
CHARACTERS] 8wells x 12 desiccant
Coated Plate (96 determination)
--------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------
#4 1 [JAPANESE CHARACTERS] 20mL solution 30mL HDPE bottle
clear amber
DIG~Anti-UNMP22
--------------------------------------------------------------------------------------------------------------
#5 2 [JAPANESE CHARACTERS] 20mL solution 30mL HDPE bottle
clear amber
HRP~SAD
--------------------------------------------------------------------------------------------------------------
#6 OPD Development Buffer 40mL solution 60mL HDPE amber bottle
clear
--------------------------------------------------------------------------------------------------------------
#7 OPD Tablets 4 tablets individual foil in plastic bag
--------------------------------------------------------------------------------------------------------------
#8 Wash Solution 100 x Concentrate 30mL solution 30mL HDPE bottle
clear
--------------------------------------------------------------------------------------------------------------
#9 Package Inserted Instruction 1 booklet folded paper
--------------------------------------------------------------------------------------------------------------
ATTACHMENT 3. COMPONENTS LAYOUT
A. Carton box and kit components
[graphic: Carton box and kit components]
B. Carton Box Layout in Shipper Box
[graphic: Carton Box Layout in Shipper Box top view]
[graphic: Carton Box Layout in Shipper Box side view]
CONFIDENTIAL TREATMENT
ATTACHMENT 4. REQUIREMENTS OF CALIBRATORS
A. Assigned Value and Optical Density
--------------------------------------------------------------------------------
Calibrator (Assigned Value (U/mL) Absorbance
--------------------------------------------------------------------------------
No.l [REDACTED] [REDACTED]
--------------------------------------------------------------------------------
No.2 [REDACTED]
--------------------------------------------------------------------------------
No.3 [REDACTED]
--------------------------------------------------------------------------------
No.4 [REDACTED]
--------------------------------------------------------------------------------
No.5 [REDACTED]
--------------------------------------------------------------------------------
No.6 [REDACTED]
--------------------------------------------------------------------------------
No.7 [REDACTED] [REDACTED]
--------------------------------------------------------------------------------
note: Absorbance must increase in order of calibrator number.
CONFIDENTIAL TREATMENT
ATTACHMENT 5. REQUIREMENTS OF CONTROLS
A. Assigned Value
-------------------------------------------------------------------------------
Control Assigned Value (U/mL)
-------------------------------------------------------------------------------
I [REDACTED]
-------------------------------------------------------------------------------
II [REDACTED]
-------------------------------------------------------------------------------
III [REDACTED]
-------------------------------------------------------------------------------
B. Assigned Value and Control Range
--------------------------------------------------------------------------------
Values of Control Range (U/mL)
Control -----------------------------------------------------------------
Minimum maximum
--------------------------------------------------------------------------------
I (Assigned Value x [REDACTED] (Assigned Value x [REDACTED]
--------------------------------------------------------------------------------
II (Assigned Value x [REDACTED] (Assigned Value x [REDACTED]
--------------------------------------------------------------------------------
III (Assigned Value x [REDACTED] (Assigned Value x [REDACTED]
--------------------------------------------------------------------------------
