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EXHIBIT 10.18
AGREEMENT
AGREEMENT made and entered into effective OCTOBER 1ST 2000 by and between ADL--A
DIVISION OF MATRITECH GmbH hereinafter called "DISTRIBUTOR", and HITACHI
CHEMICAL DIAGNOSTICS, INC. a California corporation with its place of business
at 000 Xxxxx Xxxxx, Xxxxxxxx Xxxx, XX 00000 (hereinafter "HCD") with respect to
the following facts and representations.
RECITALS
A. HCD has developed and is producing in commercial quantities an Allergy Test
System for the simultaneous determination of multiple allergen specific
antibody levels in human patient serum (including that identified more
specifically in the product catalogue attached as Exhibit A), said system
including test xxxxxxxx, reagents, instrumentation, equipment and
associated accessories being hereinafter collectively referred to as "the
Product"; and
B. DISTRIBUTOR desires to obtain and HCD desires to grant the [CONFIDENTIAL
TREATMENT REQUESTED]* RIGHT to market the Product in the country of
[CONFIDENTIAL TREATMENT REQUESTED]* (hereinafter the "Territory").
C. HCD has developed and acquired and is the owner of developments,
inventions, specialized design data and information, specifications,
manufacturing and testing procedures, marketing plans and diagrams and
other valuable proprietary information, which is not old and well-known in
the trade, relating to the Product and associated methods and to other
devices, apparatus and methods in the Field (hereinafter "HCD Confidential
Information"); and
D. HCD has acquired and is the owner of certain inventions relating to the
Product and associated methods and to other devices, apparatus and methods
in the Field and has acquired or is pursuing patent rights in the United
States Patent and Trademark Office and its counterparts in certain other
countries throughout the world (hereinafter "HCD Patent Rights"); and
E. HCD has acquired and is the owner of certain trademarks which it either has
registered or is seeking to register in the United States Patent and
Trademark Office and its counterparts in certain other countries throughout
the world (hereinafter "HCD Trademarks"); and
F. The parties are desirous of entering into this Agreement upon and subject
to the terms, conditions and limitations set forth.
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual
covenants hereinafter set forth, the parties agree as follows:
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1. APPOINTMENT
a) HCD grants to DISTRIBUTOR the [CONFIDENTIAL TREATMENT REQUESTED]*
right in the Territory to distribute the Products.
b) HCD further grants to DISTRIBUTOR the nonexclusive right and license
(exclusive in the Territory with respect to the Product) under the HCD
Confidential Information and HCD Patent Rights and subject to
Paragraph 7 below the HCD Trademarks to conduct such activities as are
necessary in order to exercise its rights under this Agreement and,
more specifically, those rights provided for in Paragraph 7.a) below.
c) It is understood that the parties to the Agreement are independent
contractors, each engaged in the operation of its own respective
business. Neither is to be considered an agent, employer, employee,
partner, or joint venturer of the other for any purpose. Neither party
shall have any authority to bind the other by contract, to pledge the
other's credit or to do anything to make the other liable for any tax,
contributions, or obligation of any kind except as may be expressly
provided in this Agreement.
2. RESPONSIBILITIES OF DISTRIBUTOR
a) DISTRIBUTOR shall construct a specialized and focused sales and
marketing team to manage the HCD business.
b) DISTRIBUTOR shall exercise due diligence and its best efforts to
promote, extend and supply the market with the Product throughout the
Territory. DISTRIBUTOR shall refer to HCD or its designee all
inquiries for the Product intended for delivery outside of the
Territory. DISTRIBUTOR shall not be entitled to remuneration with
respect to any sales resulting from such inquiries.
c) DISTRIBUTOR shall purchase from HCD all of its requirements in the
Territory for the Product.
d) DISTRIBUTOR shall maintain appropriate warehousing facilities and
suitable inventory of the Product to fulfill the orders it receives
adequately and timely.
e) HCD shall extend to DISTRIBUTOR its standard warranty on the Product.
Such warranty shall be effective for the standard HCD warranty period
commencing with the date shipped by HCD to the DISTRIBUTOR.
DISTRIBUTOR shall, in turn, extend to its customers a corresponding
warranty on the Product, and in no case to extend beyond the
Expiration dates stamped on the label or otherwise affixed to the
Product. Warranty service on instrumentation shall be performed by HCD
at its facility in Mountain View, California or by an authorized
service center. DISTRIBUTOR shall ship at HCD's expense Product in
need of warranty repair to HCD which, in turn, shall repair or replace
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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the same. The cost of return shipment to DISTRIBUTOR shall be borne by
HCD. CLA-xxxxxx and reagents shall be replaced by HCD free of charge
should any of said items be found faulty on arrival in the particular
market place (if local quality assurance is performed) or in the field
(if no local quality assurance is performed). Such replacement shall
cover faulty manufacture or shelf life failure of any said items. Such
faults shall be verified by DISTRIBUTOR'S quality assurance personnel
prior to requesting replacement from HCD. HCD may, at its discretion,
choose to verify any such fault. If HCD, after investigation,
determines that it disagrees with such finding or fault, it shall so
advise DISTRIBUTOR and the parties shall resolve such Agreement
through good faith negotiations.
f) DISTRIBUTOR shall conduct its business in accordance with high quality
standards and shall fully comply with all applicable laws,
regulations, rules and other governmental requirements. Distributor
facility to be open to reasonable inspection by HCD Quality Assurance
to ensure that quality standards are met. DISTRIBUTOR shall at its own
expense be responsible for obtaining and maintaining all necessary
approvals of governmental agencies and other licensing authorities for
the import and distribution of the Product in the Territory. Copies of
the original importation applications and approvals from regulatory
authorities shall be submitted to HCD. DISTRIBUTOR shall within five
(5) business days, forward all product complaints which it receives to
HCD. Pursuant to the FDA's Medical Device Reporting (MDR) regulation,
HCD is required to report to the FDA information that reasonably
suggests that a marketed product may have caused or contributed to a
death, or serious injury, and the product or a similar product would
be likely to cause or contribute to a death or serious injury if the
malfunction were to recur. DISTRIBUTOR shall supply such information
within twenty-four (24) hours after becoming aware of an MDR event, so
that HCD may comply with US FDA MDR reporting requirements.
DISTRIBUTOR shall be responsible to obtain all records of the end
users in the event of a Product recall or other quality related issue.
g) DISTRIBUTOR shall at all times conduct its business in a manner so as
to promote and maintain the goodwill and reputation of HCD and the
Product. DISTRIBUTOR warrants to Manufacturer that Distributor does
not currently represent or promote any lines or products that compete
with the Products. During the term of this Agreement, DISTRIBUTOR
shall not, without Manufacturer's prior written consent, represent,
promote or otherwise try to sell within the Territory any lines or
products that, in Manufacturer's judgment, compete with the Products
covered by this Agreement.
h) DISTRIBUTOR shall provide to HCD all promotional, advertising, and
educational materials and program and other related literature
relating to HCD marketed products at least thirty (30) days prior to
the commercial release of such materials or commencement of such
program for review and comment. DISTRIBUTOR shall provide to HCD
within thirty (30) days after publication, copies of any and all
articles, manuscripts, or other literature relating to the HCD
marketed products generated by the DISTRIBUTOR.
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i) DISTRIBUTOR shall attend all significant Allergy and clinical
laboratory meetings and congresses in the Territory, and will attach
to this Agreement a list of the current relevant meetings in the
Territory. In addition, DISTRIBUTOR shall attend all scheduled HCD
Distributor meetings.
j) DISTRIBUTOR agrees that it will not allow either Product supplied to
it by HCD, or any HCD Confidential Information, or any direct product
thereof, to be knowingly made available, either directly or
indirectly, transferred, sold or re-exported to any country in
violation of the United States Laws and Export Control Regulations or
other applicable laws.
k) DISTRIBUTOR shall ensure that appropriate clinical data is produced
within the Territory for marketing purposes. The protocols for these
studies shall be reviewed and approved by HCD prior to their
initiation.
1) DISTRIBUTOR agrees to the Technical Service, Customer Service, Order
and Shipping Policies, Quality Specifications, attached Exhibits B, C,
D, E, F.
3. RESPONSIBILITIES OF HCD
a) HCD shall sell Products to DISTRIBUTOR at prices set forth on Exhibit
G hereto, FOB HCD's point of shipment in Mountain View, California.
Freight, shipping and insurance shall be charged directly to the
ordering DISTRIBUTOR by the shipper. Such prices shall be subject to
annual negotiation by both parties in the light of market
circumstances.
b) HCD shall conduct its business in accordance with high quality
standards and shall fully comply with all applicable US laws,
regulations, rules and other governmental requirements. The HCD
production facility involved in manufacture of the Product shall, upon
notice, be open to reasonable inspection by DISTRIBUTOR's quality
assurance personnel for the purpose of insuring that DISTRIBUTOR's
quality standards are set. To the extent FDA law requires the same HCD
does hereby guarantee that all Product produced and sold by it to
DISTRIBUTOR will be in compliance with the Federal Food, Drug and
Cosmetic Act and will not, at the time of such shipment or delivery,
be adulterated or misbranded within the meaning of said Act, and will
not be an article which may not, according to the provisions of said
Act, be introduced into interstate commerce. This guarantee shall be a
continuing guarantee and shall be binding upon HCD with respect to
Product described above, shipped or delivered by HCD (including goods
in transit), before the receipt by DISTRIBUTOR of a written notice of
revocation thereof.
c) HCD shall warrant that Product is in operating condition at the time
of shipment, and shall not be relieved by any provision of the
Agreement from its legal obligations under the applicable law
concerning the design of the Product supplied, provided no
modifications or unauthorized repairs have been made. The warranty
shall be subject to the provisions of the HCD labeling applicable to
each item of the Product.
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d) HCD shall refer to DISTRIBUTOR all inquiries regarding the Products
received from addresses within the Territory. HCD will not deliver
directly any product into Territory other than through DISTRIBUTOR or
upon DISTRIBUTOR consent.
4. PURCHASE AND PAYMENT OF PRODUCT
a) DISTRIBUTOR's actual orders of the Product shall be placed by firm
Purchase Orders issued at least two (2) months in advance. DISTRIBUTOR
agrees that it shall provide updated quarterly forecasts to cover the
next succeeding six (6) month period.
b) DISTRIBUTOR shall make payment to HCD in the United States in United
States currency for the Product ordered by and delivered to the
DISTRIBUTOR within [CONFIDENTIAL TREATMENT REQUESTED]* days following
shipment.
5. MINIMUM PURCHASES
Both parties will negotiate an annual plan and agree to a minimum
commitment by DISTRIBUTOR in respect of the forthcoming year's purchases.
In addition a three (3) year plan is required and orders placed by
DISTRIBUTOR to HCD will reflect and be close to that three (3) year plan.
Exhibit H -- First Annual Minimums
Exhibit I -- Action Plan
Exhibit J -- Three Year Plan
HCD reserves the right to increase prices, and/or terminate the Agreement,
if the Distributor fails to purchase the stated minimum quantities.
6. EXPANSION OF TERRITORY
If DISTRIBUTOR receives a sales lead concerning a particular country which
is outside the Territory and HCD does not have a DISTRIBUTOR for such
country, DISTRIBUTOR may, after HCD's approval, pursue such sale.
7. TRADEMARKS AND CONFIDENTIAL INFORMATION
a) Subject to the remaining provisions of this Paragraph 7, DISTRIBUTOR
shall have the right and license to adopt and use the HCD Trademarks
in conjunction with the promotion and sale of the Products and related
services. Such rights and license shall terminate upon termination or
expiration of this Agreement.
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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b) Unless otherwise required by law, DISTRIBUTOR shall not alter or
remove any marks, patent numbers, or other HCD markings affixed to the
Product absent advance written approval from HCD.
c) Subject to Paragraph 7(e) to (h), DISTRIBUTOR has the right to develop
its own instructional books, technical pamphlets, catalogues,
advertising material and other electronic and printed promotional
material incorporating the HCD trademarks under the terms of Section
2.h) of this Agreement and subject to approval by HCD. All such
materials produced by DISTRIBUTOR shall not contain any false
statements and DISTRIBUTOR releases and indemnifies HCD and its
affiliated companies against any liabilities that might be caused by
all such material.
d) DISTRIBUTOR will be entered as the registered user of the HCD
Trademarks in the Territory where required or deemed advisable.
e) DISTRIBUTOR shall not, without the written consent of HCD and subject
to such further conditions as HCD may impose, in relation to the
Product or in its associated instructional books, technical pamphlets,
catalogues, promotional, advertising, or educational materials or
scientific articles, use the "MAST" trademark except in conjunction
with the words "CLA", and/or "PETTE", and/or "Class" and/or such other
word as HCD may specify from time to time. For the avoidance of doubt
the word "MAST" may appear before or after the said words and the
letters of the conjoined word shall be of the same size. DISTRIBUTOR
shall ensure that in all advertising and promotional material for the
Product the name of HCD or of DISTRIBUTOR is (subject to Paragraph
7(i)) featured more prominently than any xxxx using the words "MAST"
as permitted under this Agreement.
f) Use by DISTRIBUTOR of the word "MAST" on the Internet shall be limited
in the same manner as in Paragraph 7(e) above.
g) Where DISTRIBUTOR ascertains that it was in May 2000, under previous
arrangements with HCD, using any other words than those referred to in
Paragraph 7(e) in conjunction with the word "MAST" on or in relation
to the Product, DISTRIBUTOR shall immediately notify HCD after so
ascertaining and shall request consent to the continuation of such
use. HCD will use its reasonable endeavours to obtain agreement from
the relevant third party to such continued use; but such consent shall
not be available for notifications after 31st May 2002. If HCD
notifies DISTRIBUTOR that consent is refused, DISTRIBUTOR shall
forthwith cease such use.
h) To the extent that DISTRIBUTOR is hereby permitted to use the word
"MAST"; DISTRIBUTOR may also use phonetic renderings of the word in
non-English languages.
i) DISTRIBUTOR shall use the HITACHI CHEMICAL DIAGNOSTICS, INC., name
only to identify HCD and no other. In all materials and uses the
HITACHI CHEMICAL
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DIAGNOSTICS, INC. name shall be displayed less prominently than
DISTRIBUTOR's name.
j) DISTRIBUTOR shall not use the acronym, HCD, nor shall it use the word
MAST as part of its corporate name or any domain name.
k) DISTRIBUTOR shall not use the HITACHI xxxx except as permitted by
Paragraph 7(i) and DISTRIBUTOR shall not use any other xxxx owned by
any company affiliated with HCD, including the HITACHI corporate
"Sunrise Symbol" logo xxxx. DISTRIBUTOR acknowledges that unauthorized
use of the HITACHI name and xxxx constitutes trademark infringement
and constitutes grounds for a cause of legal action by Hitachi, Ltd.
1) All uses of the HCD's Trademarks by DISTRIBUTOR under this Agreement
shall be subject to prior approval by HCD.
m) It is contemplated that during the course of performance of this
Agreement, DISTRIBUTOR will have access to HCD Confidential
Information and DISTRIBUTOR shall take all necessary and reasonable
steps to maintain its confidentiality. DISTRIBUTOR shall not divulge
such information to third parties, other than its own employees with a
need to know, or use the same for any purpose other than performing
this Agreement, at any time either while this Agreement is in force or
after its termination or expiration. This obligation shall terminate
five (5) years from termination or expiration of the Agreement.
8. IMPROVEMENTS
Should HCD develop an improved Product suitable for sale in the Territory,
the same shall be made available to DISTRIBUTOR by mutual Agreement for
distribution in the Territory.
9. INDEMNITIES
a) In the event DISTRIBUTOR, or any of its customers, is charged with
patent or trademark infringement by reason of the distribution or use
in the Territory of Product supplied by HCD to DISTRIBUTOR pursuant to
this Agreement, HCD agrees to indemnify and defend and save and hold
DISTRIBUTOR harmless from any and all claims, costs liabilities and
responsibilities. This indemnity shall be satisfied in part by HCD at
its discretion defending at its expense and through mutually agreeable
attorneys thereof and HCD shall have ten (10) days in which to assume
the defense.
b) It is understood by the parties that HCD may settle or compromise
infringement claims subject to Paragraph 9(a). In the event a proposed
settlement involves withdrawing Product from any portion of the
Territory, and the parties are unable to reach Agreement to do so, the
matter shall be submitted to arbitration in accordance with the
applicable
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rules of the American Arbitration Association. Consideration shall be
given in such arbitration to the estimated cost of continued defense
of litigation and the projects market size and profitability. Should
Product be withdrawn from some portion of the Territory, minimum
purchase obligations pursuant to Paragraph 5 hereof shall be adjusted
accordingly by taking into account relative market projections.
c) In the event that HCD (or any of its group companies) is charged with
trademark infringement by reason of the distribution or use in the
Territory or elsewhere of Product supplied by DISTRIBUTOR, and such
alleged trademark infringement results from the noncompliance by
DISTRIBUTOR with the terms of this Agreement, DISTRIBUTOR agrees to
indemnify and defend and save and hold HCD harmless from any and all
claims, costs, liabilities and responsibilities.
d) DISTRIBUTOR agrees to indemnify and defend and save and hold HCD
harmless, from any and all claims, costs, liabilities and
responsibilities, regardless of the claimant or his place of filing a
claim, resulting from or in any way associated with the functioning or
performance of DISTRIBUTOR as a representative, DISTRIBUTOR, supplier,
servicer and seller, or other related descriptive classifications, for
Products supplied to DISTRIBUTOR by HCD. In the event DISTRIBUTOR
gives any warranty different from or beyond the standard HCD warranty,
it shall be the sole responsibility of DISTRIBUTOR. It is understood,
however, that nothing in this Paragraph shall alter the warranty
obligations of HCD as set forth in Paragraphs 2.(e), 3.(b) and 3.(c)
above.
e) HCD shall defend, indemnify and hold DISTRIBUTOR (including its
directors, officers, employees, agents and representatives) harmless
against all damages, costs, expenses, charges, losses or liabilities
(including claims of third parties, special, incidental or
consequential damages and legal fees) arising from or incidental to
usage of the Product or from any failure of HCD to perform and
discharge its obligations hereunder or from any breach of warranty by
HCD, provided however that this indemnity shall not apply to the
extent that these damages, costs, expenses, charges, losses or
liabilities result from the negligence of DISTRIBUTOR or from any
unauthorized or false warranty made by DISTRIBUTOR.
10. TERM
This Agreement shall continue in force for a term of [CONFIDENTIAL
TREATMENT REQUESTED]* years from its effective date stated above and shall
thereafter [CONFIDENTIAL TREATMENT REQUESTED]* years unless notice to the
contrary is given by either party at least ninety (90) days prior to the
initial or successive expiration dates.
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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11. TERMINATION
a) Without prejudice to any other remedies they may have, each party
shall have the power to immediately terminate this Agreement by giving
notice should the other party breach any material provision of the
Agreement, including the failure to pay invoices when due and the
failure of DISTRIBUTOR to take delivery of the Product in
substantially the quantities specified, provided that the breaching
party does not cure said breach within thirty (30) days after written
notice. If, under the circumstances present, it would appear that any
breach is final, the party complaining may terminate the Agreement
immediately by giving notice to that effect.
b) Either party shall have the right to terminate this Agreement
immediately by written notice upon the bankruptcy, receivership,
insolvency, liquidation or dissolution of the other party whether
voluntary or compulsory, or upon or after assignment for the benefit
of creditors.
12. RIGHTS ON TERMINATION
a) Upon termination or expiration of this Agreement, DISTRIBUTOR shall
promptly discontinue and refrain from use of the HCD Trademarks and
HCD Confidential Information.
b) Upon termination or expiration of the Agreement, DISTRIBUTOR shall
promptly deliver to HCD, or otherwise dispose of, as instructed by HCD
all sales and service materials relating directly to the Product,
including all samples, instruction books, technical pamphlets,
catalogues, advertising materials, specifications and all other
materials, documents or papers, excluding correspondence between the
parties, which DISTRIBUTOR has in its possession or under its control.
c) DISTRIBUTOR shall have the right for three (3) months following any
termination or expiration to sell off Product on hand. This right
shall be subject to the option of HCD to repurchase such inventory.
d) Upon termination or expiration of this Agreement DISTRIBUTOR shall
promptly deliver to HCD all customer information including, but not
limited to, name, address, annual volume, price and any purchase
arrangement between DISTRIBUTOR and customer for all customers
supplied with HCD products as defined in this Agreement.
e) DISTRIBUTOR shall transfer the approved registration for the
Product(s) to HCD, or its chosen DISTRIBUTOR, within thirty (30) days
of such termination date, DISTRIBUTOR will notify the German
government of transfer of the registration to HCD or it's Designee.
Until the date of effective transfer, the DISTRIBUTOR hereby duly
constitutes HCD its representative by the maximum period of six (6)
months as of
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the termination date, delegating powers hereto, in the name of the
DISTRIBUTOR, aiming at the request of all the necessary authorization
before the German or any other authorities in order to allow a third
party or company to import HCD's products.
f) The DISTRIBUTOR shall not cancel any registration of HCD's products
without prior written authorization from HCD.
13. SUCCESSION
This Agreement shall be binding upon and inure to the benefit of the
successors and assigns of the parties hereto provided, however, that
neither party shall assign any of the rights and privileges herein granted
without the prior written consent of the other party except to the
successor in ownership of substantially the whole of the business of said
party.
14. NOTICES
Any notice, request or other communications required or permitted under
this Agreement shall be effective when sent if given by certified or
registered mail and subject to proof of receipt:
To HCD: HITACHI CHEMICAL DIAGNOSTICS, INC.
000 XXXXX XXXXX
XXXXXXXX XXXX
XX 00000
Attention: President & CEO
To DISTRIBUTOR: ADL-a division of Matritech GmbH
Xxxxxxxxxx Xxxxxxx 0
X-00000 Xxxxxxxx
Xxxxxxx
Attention: Geschaftsfuhrer
Or to such other address as either party may have theretofore designated in
writing.
15. FORCE MAJEURE
The parties shall not be subject to any liability for delay in performance,
or nonperformance as a result of fire, flood, strike, labor trouble,
accident, riot, act of governmental authority, including but without
limitation withdrawal or substantial modification of the registrations of
the Product, Act of God, or other contingencies and circumstances beyond
their control, interfering with the parties' production, supply,
transportation, consumption, use/or sale of the Product covered by this
Agreement or with the supply of any materials used in connection therewith,
and quantities so affected may be eliminated from the Agreement without
liability, but the Agreement shall otherwise remain unaffected.
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16. ASSIGNMENT
Neither party shall under any circumstances assign or purport to assign
this Agreement without prior written consent of the other party.
17. FINAL AGREEMENT AND MODIFICATIONS
This Agreement is the final Agreement between the parties and supersedes
all prior Agreements and understandings, oral or written, with respect to
the subject matter hereof. No modification, promise or Agreement in
connection with subject matter of Agreement shall be binding on either
party unless made in writing and signed by an officer of each party.
18. SAVING CLAUSE
If any provision, or provisions, of the Agreement are held by a court of
competent jurisdiction to be contrary to law, such provision, or
provisions, shall be deemed to be null and void, and the remainder of this
Agreement shall be in force and effect. The parties specifically declare
that they would have entered into this Agreement if such void provision, or
provisions, if any, had been entirely omitted.
19. GOVERNING LAW
This Agreement shall be construed, interpreted and applied, and any claim
or controversy arising with respect thereto shall be determined in
accordance with the laws of the State of California, United States of
America. At the discretion of the complaining party, in case any claim or
controversy is submitted to German jurisdiction, this Agreement may be
construed, interpreted and applied in accordance with the laws of Germany.
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and seals
by their duly authorized officers as of the day and year first above written.
HITACHI CHEMICAL DIAGNOSTICS, INC. ADL-a division of Matritech GmbH
By: /s/ Xxxxx Xxxxxxxx By: /s/ Xxxxx Xxxxx
-------------------------------- ----------------------------
Director, Marketing And Sales Its Geschaftsfuhrer
Europe and Middle-East
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EXHIBIT A
PRODUCT LIST
LUMINOMETER EQUIPMENT SET CONSISTING:
CLA-1 Luminometer 3ml Luer Lock Syringes
CLA-1 Controller 400 (mu)L, Statline Micropipette (plus tips)
Workstation Rack Workstation Reservoir
Wash Buffer Dispenser Reagent Cups
2 Pette Cassettes Planner Sheets
Technical Binder Reagent Preparation Table
ALLERGY PROFILE PACKAGE CONSISTING:
CLA-Pette Test Xxxxxxxx Wash Buffer Concentrate
Antibody Rubber Plugs
4 Photoreagent Components
Package Insert
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EXHIBIT B
HITACHI CHEMICAL DIAGNOSTICS INC.
TECHNICAL SERVICE POLICY
The DISTRIBUTOR must have available at least one Technical Service
Representative to handle product complaints. Initially this person is expected
to spend at least two weeks at Hitachi Chemical Diagnostics, learning the test
by working in QA and R & D. In addition, that person needs to return to Hitachi
Chemical Diagnostics on a regular basis to update training. That person needs to
understand:
specifications for release of product
how we accept/reject product
expectations of product performance
how it compares to RAST, CAP, and other allergy tests
specificity, sensitivity, and reproducibility
local QC requirements
how to handle product and instrument complaints
how to handle and report complaints
how to report safety hazards, injury, or illness thought to be caused by
product to XXXX XX/QA
ALL DISTRIBUTORS ARE ENCOURAGED TO MAINTAIN A QUALITY CONTROL SYSTEM AT THEIR
FACILITY TO HELP TROUBLESHOOT CUSTOMER COMPLAINTS.
In the event of a product complaint from a customer, the DISTRIBUTOR's Technical
Service Representative should try to solve the problem with the customer. If
this is not possible, Technical Service at Hitachi Chemical Diagnostics should
be contacted within 48 hours, with full details of the complaint, including lot
and serial numbers, expiration dates, and test results.
Hitachi Chemical Diagnostics will acknowledge technical inquiries and complaints
from DISTRIBUTORS and customers within 48 hours, and will provide answers within
7 days for most inquiries.
Responses requiring in-house testing will be made within two to three weeks.
Responses requiring returned goods will be made within two to three weeks of
receipt of the material.
Hitachi Chemical Diagnostics will set up an account with DHL for returns in each
territory as necessary. The DISTRIBUTOR should contact DHL whenever product is
authorized to be returned to Hitachi Chemical Diagnostics.
CLAIMS of defective goods should be communicated to the Hitachi Chemical
Diagnostics Technical Service Manager for your territory.
Complaints may involve product performance, safety, reliability, appearance,
troubleshooting, or shipping issues. The following information is required to
process product complaints:
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1. Problem
2. Kit lot numbers
3. Serial numbers of CLA-1 and CLA Controller (if needed)
4. Number of tests affected per total number of tests
5. Number of customers reporting the same complaint
Replacement orders will be entered into the computer within 24 hours of being
requested by Technical Service, and consolidated with the next regularly
scheduled shipment.
A RETURN AUTHORIZATION NUMBER or TSR Number must be issued by Hitachi Chemical
Diagnostics before ANY goods are returned. Materials sent to Hitachi Chemical
Diagnostics without an issued Return Authorization number will be returned to
sender.
Returns are accepted for DEFECTIVE GOODS ONLY.
An item will only be declared defective after Hitachi Chemical Diagnostics
personnel has inspected the item or has sufficient data (i.e., lot numbers,
expiration dates, and test results) to make such a determination.
It is the responsibility of the DISTRIBUTOR to inform Hitachi Chemical
Diagnostics of any defective material within the warranty or product expiration
period. Quality Control of MAST-CLA Allergy Test Kits should be performed upon
receipt, and notification of non-performance of these kits should be made within
45 days following shipment from Hitachi Chemical Diagnostics. A RETURN
AUTHORIZATION NUMBER must be issued by Hitachi Chemical Diagnostics before ANY
goods are returned.
ALL DISTRIBUTORS ARE ENCOURAGED TO MAINTAIN A QUALITY CONTROL SYSTEM AT THEIR
FACILITY TO HELP TROUBLESHOOT CUSTOMER COMPLAINTS.
Equipment under warranty will be repaired at no charge. If not under warranty,
repairs will be made using current service charge rate and are billed to
DISTRIBUTOR.
CLA-1 LUMINOMETER:
The CLA-1 Luminometer has a warranty of 12 months, starting the day of delivery
to the DISTRIBUTOR
In the USA, BBI-Source Scientific is authorized to repair the CLA-1 Luminometer.
In Europe, Xxxxx GmbH is authorized to repair the CLA-1 Luminometer (and all
Hitachi Chemical Diagnostics equipment).
After the warranty period has expired, the following options are available:
SERVICE ARRANGEMENTS FOR THE MAST CLA-1 FOR AFTER WARRANTY PERIOD HAS EXPIRED:
1. Source or a company authorized by BBI-Source (e.g. Xxxxx) would train a
member of the DISTRIBUTOR's staff to service the Luminometer.
15
B-3
2. A Service Contract is signed with BBI-Source or a company authorized by
BBI-Source. This would cover all of the costs involved in servicing the
instrument.
3. A Maintenance Contract is signed with BBI-Source or a company authorized by
BBI-Source. This would cover all of the costs involved in servicing the
instrument, and would include yearly maintenance.
4. All freight charges for equipment out of warranty are the responsibility of
the distributor.
SERVICE ARRANGEMENTS FOR THE MAST-CLA-1 LUMINOMETER DURING THE WARRANTY PERIOD:
All Luminometers are to be installed at the end user by competent personnel
trained in the use of the Luminometer. It is the responsibility of the
DISTRIBUTOR to ensure that the end user is competent in the use of the
instrument.
1. The DISTRIBUTOR must have a member of staff sufficiently skilled in the use
of the Luminometer to be able to confirm the existence of a problem and
eliminate complaints resulting from operator error. Any attempt at repair
would invalidate the warranty.
2. In the event of instrument failure, the DISTRIBUTOR's product specialist
must make a preliminary investigation of the complaint, and, if it is
confirmed, pack the instrument securely in the original shipping container
and ship it to the authorized service center. The shipment to the service
center is at the DISTRIBUTOR's expense.
3. The product specialist should leave an instrument on loan with the
customer.
4. The service center repairs and returns the Luminometer to the DISTRIBUTOR.
The service center pays for return shipment.
5. The product specialist replaces the Luminometer on loan with the repaired
Luminometer.
Addresses:
Hans Vols BBI-Source Scientific, Inc
Xxxxx GmbH 0000 Xxxxxxx Xxx
00000 Xxxxxxx Xxxxxx Xxxxx; XX 00000
Postfach 6526 USA
Xxxxxxxxx Xxxxxxx 00 Xxxxxxx Telephone: (000) 000-0000
Telephone: x00 000 000 000 Facsimile: (000) 000-0000
Facsimile: x00 000 000 00
16
EXHIBIT C
HITACHI CHEMICAL DIAGNOSTICS'
CUSTOMER SERVICE POLICY
1. Hitachi Chemical Diagnostics Customer Service will acknowledge Purchase
Orders, Customer Inquiries, etc. from the DISTRIBUTOR within 24 hours of
receipt. Any clarifications needed regarding the Purchase Order will be
communicated to the DISTRIBUTOR by Customer Service within 48 hours.
2. Customer Service will contact the Planning Department to schedule a ship
date to include on the Sales Order Acknowledgment.
3. A Purchase Order number and requested shipping date should be included on
all orders. Purchase Orders will be entered into the computer by the
Customer Service Representative within 24 hours of receipt. This will
insure visibility of the order to other departments. A Sales Order
Acknowledgment will be sent to the DISTRIBUTOR for confirmation of product,
quantities, pricing, etc.
4. A lead time of 8 weeks is required to process most orders. All orders
submitted 8 weeks prior to the requested shipping date will be shipped
within one week of the requested shipping date. In the event that products
do not meet this date due to manufacturing or quality issues, Customer
Service will inform the DISTRIBUTOR of the delay and the reasons within 24
hours.
5. Credit memos and invoice adjustments will be submitted to Accounting within
24 hours of notification from the DISTRIBUTOR and/or Marketing. Credit
memos and revised invoices will be issued at the end of each month.
6. Replacement orders will be entered into the computer within 24 hours of
being requested by Technical Service, and consolidated with the next
regularly scheduled shipment.
7. Customer Service will notify, by fax, the DISTRIBUTOR when product is
shipped. The fax will include copies of the invoice and the airway xxxx,
containing flight information and estimated time of arrival.
8. Product will ship on a day agreed upon by Hitachi Chemical Diagnostics and
the DISTRIBUTOR. Customer Service will contact the DISTRIBUTOR should any
adjustments to this schedule be necessary. PRODUCT WILL NOT BE SHIPPED
UNTIL CONFIRMATION OF THE NEW SHIPPING DATE IS MADE BY THE DISTRIBUTOR.
9. When a partial shipment is sent, Customer Service will advise the
DISTRIBUTOR of the ship date for the back ordered items.
17
C-2
10. CUSTOMER SHIPMENT INFORMATION forms accompany all shipments. The
DISTRIBUTOR is requested to return this form via fax within 24 hours of
receipt.
Marketing personnel will be copied on all correspondences, including Order
Acknowledgements, Invoice explanations, etc., from Accounting, Shipping, and
Customer Service to the DISTRIBUTOR. The DISTRIBUTOR may contact the individual
departments or Marketing, should any questions arise.
18
EXHIBIT D
HITACHI CHEMICAL DIAGNOSTICS'
ORDER POLICY
PURCHASE ORDERS
1. Work will begin on panel orders after Hitachi Chemical Diagnostics has
received a hard copy of the Purchase Order. All Purchase Orders should
include a Purchase Order number and a requested shipping date. The Purchase
Order should be placed at least 8 weeks prior to the requested shipping
date. Orders submitted 8 weeks in advance of the requested shipping date
will be shipped within one week of this date.
2. Purchase Orders can be sent to Hitachi Chemical Diagnostics via facsimile
or mail:
Hitachi Chemical Diagnostics
000 Xxxxx Xxxxx
Xxxxxxxx Xxxx, Xxxxxxxxxx 00000, XXX
Attn: Customer Service
Fax: x0 000 000 0000
Phone: x0 000 000 0000
MINIMUM ORDER REQUIREMENTS
PANELS
The minimum quantity requirement for all Panel orders is 20 kits. We cannot
accept orders for quantities less than this minimum quantity. Additional kits
must be ordered in increments of 20 kits per panel.
RETAIL PRODUCTS
For inventory items such as Printer Ribbons, and Equipment Kits, the minimum
quantity requirement is $500.00 USD.
CANCELLATION POLICY
PANELS
1. Minimum cancellation fee is [CONFIDENTIAL TREATMENT REQUESTED]* of the
transfer price.
2. A cancellation fee of [CONFIDENTIAL TREATMENT REQUESTED]* of the transfer
price if cancelled 4-6 weeks before scheduled ship date.
3. A cancellation fee of [CONFIDENTIAL TREATMENT REQUESTED]* of the transfer
price if cancelled 2-4 weeks before scheduled ship date.
4. A cancellation fee of [CONFIDENTIAL TREATMENT REQUESTED]* of the transfer
price if cancelled less than 2 weeks before scheduled ship date.
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
19
D-2
RETAIL PRODUCTS
A cancellation fee of 25% of 80% of the transfer price regardless of scheduled
ship date.
RETURNS
Returns are accepted for DEFECTIVE GOODS ONLY. An item will only be declared
defective after Hitachi Chemical Diagnostics personnel has inspected the item or
has sufficient data (i.e., lot numbers, expiration dates, and test results) to
make such a determination.
It is the responsibility of the DISTRIBUTOR to inform Hitachi Chemical
Diagnostics of any defective material within the warranty or product expiration
period.
ALL DISTRIBUTORS ARE ENCOURAGED TO MAINTAIN A QUALITY CONTROL SYSTEM AT THEIR
FACILITY TO PERFORM INCOMING INSPECTION AND TO HELP TROUBLESHOOT CUSTOMER
COMPLAINTS.
Quality Control of MAST Allergy Test Kits should be performed upon receipt, and
notification of non-performance of these kits should be made within 45 days
following shipment from Hitachi Chemical Diagnostics. A RETURN AUTHORIZATION
NUMBER must be issued by Hitachi Chemical Diagnostics before ANY goods are
returned.
WARRANTY
PANELS
Products are guaranteed to perform through the printed expiration date on the
pette body, reagent bottle, and outer box label.
RETAIL PRODUCTS
One year material and workmanship on all retails products.
DELIVERY DATE CHANGES
Hitachi Chemical Diagnostics will make every effort to accommodate customers'
requests to change order delivery dates. ALL ORDER CHANGES WILL CARRY A 10%
PREMIUM TO COVER THE EXPENSE OF RESCHEDULING, HOLDING, OR OVERTIME. ORDERS
CANNOT BE MOVED FURTHER THAN 30 DAYS.
20
D-3
PAYMENT TERMS
[CONFIDENTIAL TREATMENT REQUESTED]* DAYS, US dollars unless otherwise
negotiated.
The Invoice will be faxed prior to shipment.
Funds should be wired to the following address:
[CONFIDENTIAL TREATMENT REQUESTED]*
Oakland, California USA
Routing No. [CONFIDENTIAL TREATMENT REQUESTED]*
Account No. [CONFIDENTIAL TREATMENT REQUESTED]*
Beneficiary: Hitachi Chemical Diagnostics
SHIPPING TERMS
F.O.B. Mountain View, California unless otherwise negotiated. Freight Collect
unless otherwise negotiated.
PRICES
Hitachi Chemical Diagnostics' prices are negotiated in good faith every year. If
the DISTRIBUTOR refuses to negotiate, Hitachi Chemical Diagnostics reserves the
right to change prices with a 30 day notice.
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
21
EXHIBIT E
HITACHI CHEMICAL DIAGNOSTICS'
SHIPPING POLICY
For best results, product should arrive at the DISTRIBUTOR's warehouse within 3
to 4 days after shipment from Mountain View, California. Product must remain at
2-8(degree)C during the entire shipping time. To assure this, Hitachi Chemical
Diagnostics and the DISTRIBUTORS must commit to their own sets of
responsibilities.
Hitachi Chemical Diagnostics' Responsibilities:
1. Package shipments properly.
A. Use adequate amounts of chemical ice for 3-4 day shipments.
B. Include Temperature Indicators.
C. Select appropriate shipping containers for maintaining cold
temperatures.
2. Use direct flights for shipments leaving the United States.
Note: This applies only in situations when a freight forwarder is used.
3. Notify the DISTRIBUTOR of shipments, providing the following information:
A. The Airway xxxx number
B. Date of departure from Hitachi Chemical Diagnostics
C. Expected date and time of arrival
D. Flight information
4. Provide special instructions to clear Customs (e.g., Tariff numbers,
product descriptions, etc).
DISTRIBUTOR's Responsibilities:
1. Distributor determines freight forwarder for all shipments and advises
Hitachi Chemical Diagnostics accordingly. If distributor does not have a
preferred freight forwarder, Hitachi Chemical Diagnostics will recommend.
However it is the ultimate decision of the distributor.
2. Make arrangements for shipments to clear Customs (if not handled by the
forwarder).
3. Instruct forwarder to use direct flights only for refrigerated products and
arrange timely transport from the airport (if a freight forwarder is used).
4. Notify Hitachi Chemical Diagnostics of the quality of the shipment, by
completing and faxing the customer shipment information form.
5. Complete and fax to Hitachi Chemical Diagnostics Customer Service the
CUSTOMER SHIPMENT INFORMATION form within 24 hours of receipt:
22
E-2
A. Note on the form the date and time of receipt of shipment.
B. Provide the readings of the Temperature Indicators (Monitor Marks).
All Temperature Indicators are labeled with the lot numbers of the
kits they accompany. (See below, CUSTOMER SHIPMENT INFORMATION FORM).
These Indicators provide critical information about shipping
conditions and are used in determining the amount of chemical ice
needed for subsequent shipments.
1. Notify Hitachi Chemical Diagnostics if the shipment is not received within
3-4 days. Refrigerate the shipment immediately upon receipt, and assure the
product is stored at 2-8(degree)C at all times.
2. Ship kits to customers under refrigeration or using adequate amounts of
chemical ice.
3. Inform customers that kits must be refrigerated immediately upon arrival,
and stored at 2-8(degree)C until use.
SHIPPING COSTS
The DISTRIBUTOR is responsible for shipping containers, chemical ice, and all
freight charges. Approximate costs are as follows:
Endurotherm Containers $40.00/each
Chemical Ice $0.70/each
Each Endurotherm container will hold up to 28 20-test kits. Generally, one pack
of chemical ice is required per kit. Additional ice may be necessary during
summer months or in warm climates.
CUSTOMER SHIPMENT INFORMATION FORM
An example of the CUSTOMER SHIPMENT INFORMATION form is attached. The following
information is provided by the Shipping Department Personnel Hitachi Chemical
Diagnostics:
Customer Name
Order No.
Customer PO No.
Ship Date
Total Number of Boxes in the Order
Carrier and Airway xxxx No.
Box # (with content description):
P/N (Part Number), Lot #, and Quantity of Product
Name of Packager and Shipper
Dates Packaged and Shipped
Spaces are available for the DISTRIBUTOR to write the Monitor Xxxx readings for
each lot of product shipped. One Monitor Xxxx is adhered to the bottom corner of
the Endurotherm Container, and the other is positioned on the opposite side of
the Container near the top row of kits.
23
E-3
The DISTRIBUTOR must:
1. Write the Monitor Xxxx readings for each lot of product on the same tine as
the product's Part Number and Lot Number.
2. Write the Date and Time of Receipt, and any pertinent information.
3. Fax the completed form to Hitachi Chemical Diagnostics.
24
E-4
[BLANK CUSTOMER SHIPMENT INFORMATION FORM]
25
E-5
ACCEPTABLE MONITOR XXXX READINGS
Upon exposure to temperatures above 8(degree)C, the Monitor Marks turn blue.
Readings in the numbered windows ("1" through "5") may indicate the following
time/temperature exposures:
--------------------------------------------------------------------------------------------------------------------
Window Temperature Hours Temperature Hours
--------------------------------------------------------------------------------------------------------------------
mid point of 1 12(degrees)C 8 23(degrees)C 5
--------------------------------------------------------------------------------------------------------------------
1 12(degrees)C 20 23(degrees)C 14
--------------------------------------------------------------------------------------------------------------------
2 12(degrees)C 40 23(degrees)C 30
--------------------------------------------------------------------------------------------------------------------
3 12(degrees)C 80 23(degrees)C 60
--------------------------------------------------------------------------------------------------------------------
4 12(degrees)C 120 23(degrees)C 90
--------------------------------------------------------------------------------------------------------------------
5 12(degrees)C 160 23(degrees)C 120
--------------------------------------------------------------------------------------------------------------------
Monitor Xxxx readings are acceptable when half or less of the first window ("1")
has turned blue. This applies to Monitor Marks placed on the lid of the
Endurotherm carton, and those affixed to the kits. ANY READINGS OUTSIDE OF THESE
MAY INDICATE POOR SHIPPING CONDITIONS, AND MUST BE REPORTED TO HITACHI CHEMICAL
DIAGNOSTICS IMMEDIATELY.
26
EXHIBIT F
HITACHI CHEMICAL DIAGNOSTICS QUALITY SPECIFICATIONS
Hitachi Chemical Diagnostics will test and release product according to the
following specifications:
ASSAY METHOD
The standard overnight assay as described in the MAST CLA User Guide and
Procedural Manual and the product's package insert.
SPECIFICATIONS FOR THE INTERNAL CONTROL THREADS
Positive Procedural Control: [CONFIDENTIAL TREATMENT REQUESTED]*
Negative Blanking Thread: [CONFIDENTIAL TREATMENT REQUESTED]*
SPECIFICATIONS FOR THE CIA IgE POSITIVE CONTROL REAGENT
[CONFIDENTIAL TREATMENT REQUESTED*] of the specified allergens listed on
the CLA IgE Positive Control Reagent package insert must correlate with the
assigned ranges
SPECIFICATIONS FOR THE CIA IgE NEGATIVE CONTROL REAGENT
[CONFIDENTIAL TREATMENT REQUESTED]* of the allergens must show a MAST class
value of [CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
27
EXHIBIT G
HITACHI CHEMICAL DIAGNOSTICS
PRICE LIST
EFFECTIVE OCTOBER 1ST 2000
PRODUCT NAME PART NO. PRICE $
CIA IgE Test Kits:
Panel Inhalation 36 86268 [CONFIDENTIAL TREATMENT REQUESTED]*
Panel Nahrung 36 86269 [CONFIDENTIAL TREATMENT REQUESTED]*
Atopy Panel 20 86285 [CONFIDENTIAL TREATMENT REQUESTED]*
Panel Inhalation 20 86286 [CONFIDENTIAL TREATMENT REQUESTED]*
Panel Nahrung 20 86287 [CONFIDENTIAL TREATMENT REQUESTED]*
IgG Panel 36 86267 [CONFIDENTIAL TREATMENT REQUESTED]*
IgG Panel 20 86279 [CONFIDENTIAL TREATMENT REQUESTED]*
+ CLA-1 LUMINOMETER & EQUIPMENT KIT 95013 110V
95019 220V [CONFIDENTIAL TREATMENT REQUESTED]*
CLA-1 Luminometer
CLA-1 Control
Pette Cassette Trays
Workstation Rack
Workstation Reservoir
2-LWash Buffer Bottle
Technical Binder
400(mu)L Statline
CLA ROTATOR 90181B [CONFIDENTIAL TREATMENT REQUESTED]*
DATE MANAGEMENT SOFTWARE (DMS) 95200 [CONFIDENTIAL TREATMENT REQUESTED]*
CONTROL SERA:
Positive Control Reagent II (9 mL) 82060 [CONFIDENTIAL TREATMENT REQUESTED]*
Negative Control Reagent V (9 mL) 82056 [CONFIDENTIAL TREATMENT REQUESTED]*
IgE REAGENTS
Antibody 93130 [CONFIDENTIAL TREATMENT REQUESTED]*
Wash Buffer Concentrate 93105 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent A 93101 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent B 93102 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent C 93103 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent D 93104 [CONFIDENTIAL TREATMENT REQUESTED]*
+ THE UNIT PRICE FOR THE CLA-1 LUMINOMETER WITH CONTROLLER AND CASSETTES
WITHOUT EQUIPMENT WILL BE REDUCED TO [CONFIDENTIAL TREATMENT REQUESTED]*.
THE UNIT PRICE FOR CLA-1 LUMINOMETERS IN SUBJECT TO NEGOTIATION FOR
MULTIPLE UNIT PURCHASE.
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
28
G-2
HITACHI CHEMICAL DIAGNOSTICS
PRICE LIST
EFFECTIVE OCTOBER 1ST 2000
PRODUCT NAME PART NO. PRICE $
IgG REAGENTS
Serum Diluent 95009 [CONFIDENTIAL TREATMENT REQUESTED]*
Antibody Diluent 95007 [CONFIDENTIAL TREATMENT REQUESTED]*
Antibody Concentrate 95008 [CONFIDENTIAL TREATMENT REQUESTED]*
Wash Buffer Concentrate 95006 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent A 0000000000 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent B 95003 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent C 95004 [CONFIDENTIAL TREATMENT REQUESTED]*
Photoreagent D 95005 [CONFIDENTIAL TREATMENT REQUESTED]*
EQUIPMENT KIT COMPONENTS
Wash Buffer Dispenser, 2L 94025 [CONFIDENTIAL TREATMENT REQUESTED]*
CLA Workstation Rack 90040 [CONFIDENTIAL TREATMENT REQUESTED]*
CLA Workstation Reservoir 90045 [CONFIDENTIAL TREATMENT REQUESTED]*
CLA-1 Control 90050 [CONFIDENTIAL TREATMENT REQUESTED]*
Pette Cassette (each) 90020 [CONFIDENTIAL TREATMENT REQUESTED]*
Luminometer Transformer 110 Volt 70244 [CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
29
G-3
HITACHI CHEMICAL DIAGNOSTICS
PRICE LIST
EFFECTIVE OCTOBER 1ST 2000
PRODUCT NAME PART NO. PRICE $
MISCELLANEOUS SUPPLIES
Serum Vials, blue cap (100/bag) 70079 [CONFIDENTIAL TREATMENT REQUESTED]*
Serum Vials, white cap (100/bag) 94081 [CONFIDENTIAL TREATMENT REQUESTED]*
Disposable Reagent Cups 50 mL (100) 70103 [CONFIDENTIAL TREATMENT REQUESTED]*
Disposable Serum Cups 5 mL (100) 70013 [CONFIDENTIAL TREATMENT REQUESTED]*
Plugs Top (12/Pkg) 80046 [CONFIDENTIAL TREATMENT REQUESTED]*
Plugs Bottom (12/Pkg) 80043 [CONFIDENTIAL TREATMENT REQUESTED]*
Printer Paper, Impact (Luminometer) 70139 [CONFIDENTIAL TREATMENT REQUESTED]*
(each roll)
Printer Paper, Thermal (Luminometer) 70269 [CONFIDENTIAL TREATMENT REQUESTED]*
(each roll)
Printer Ribbon 70140 [CONFIDENTIAL TREATMENT REQUESTED]*
750 (mu)L Statpet 70182 [CONFIDENTIAL TREATMENT REQUESTED]*
000 (xx)X Xxxxxxxx 00000 [XXXXXXXXXXXX TREATMENT REQUESTED]*
Tips (100-1000 (mu)L) for 70134 [CONFIDENTIAL TREATMENT REQUESTED]*
Statline Micropipette 100/Pkg
Micropipette, Medium (10 (mu)L) 70125 [CONFIDENTIAL TREATMENT REQUESTED]*
Tips for Micropipette, 10 (mu)L, 100/Pkg 80128 [CONFIDENTIAL TREATMENT REQUESTED]*
Technical Binder, Luminometer 60550 [CONFIDENTIAL TREATMENT REQUESTED]*
Training Video Cassette, Luminometer 94665 [CONFIDENTIAL TREATMENT REQUESTED]*
System, PAL format
SALES LITERATURE
Presentation Folder [CONFIDENTIAL TREATMENT REQUESTED]*
Product Insert Doc No.0602 [CONFIDENTIAL TREATMENT REQUESTED]*
Services Insert Doc No.0603 [CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
30
EXHIBIT H
FIRST ANNUAL MINIMUMS
i.e. FY2000 (APRIL 2000 TO MARCH 2001)
Xxxxxx: 35000
Luminometer: xxxxx
Total Transfer Sales: Not Less Than US [CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
31
EXHIBIT I
ACTION PLAN
[CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
32
EXHIBIT J
3-YEAR PLAN
SECOND YEAR MINIMUM FY i.e. April 2001 to March 2002
Xxxxxx: 60000
Luminometer XXXXXX
Total Transfer Sales Not less than US [CONFIDENTIAL TREATMENT REQUESTED]*
THIRD YEAR MINIMUM April 2002-March 2003
Xxxxxx: 70000
Luminometer XXXXXX
Total Transfer Sales Not less than US [CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
33
ADDENDUM TO AGREEMENT
BETWEEN HITACHI CHEMICAL DIAGNOSTICS INC (HCD) AND ADL.-A DIVISION OF
MATRITECH GmbH
MARKET: [CONFIDENTIAL TREATMENT REQUESTED]*
Distributor (ADL, a division of Matritech GmbH), Xxxxxxxxxx Xxxxxxx 0, X-00000
Xxxxxxxx, Xxxxxxx), desires to obtain and HCD desires to grant the [CONFIDENTIAL
TREATMENT REQUESTED]* rights to market the product in the [CONFIDENTIAL
TREATMENT REQUESTED]* with effect from 1st October 2000.
The following terms and conditions either amend or replace existing arrangements
between HCD and ADL with respect only for [CONFIDENTIAL TREATMENT REQUESTED]*:
Minimum Purchases - the following in an attachment to section 5 of the
existing agreement:
Both parties will negotiate an annual plan and agree to a minimum
commitment by Distributor in respect of the forthcoming year's
purchase as defined in Exhibit H attached. In addition a three (3)
year plan is attached (Exhibit J) and order placed by Distributor to
HCD will reflect and be close to that three (3) year plan.
Exhibit H - First annual Minimum
Exhibit I - Action Plan
Exhibit J - Three Year Plan
HCD reserves the right to increase prices and/or terminate the
agreement, if the distributor fails to purchase the stated minimum
quantities.
The first year in terms of minimum purchases will commence on January
1st 2001 and transfer sales to [CONFIDENTIAL TREATMENT REQUESTED]*
should be reported separately.
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and seals
by their duly authorized officers as of December 12th 2000
Hitachi Chemical Diagnostics Inc ADL a division of Matritech GmbH
By: /s/ Xxxxx Xxxxxxxx By: /s/ Xxxxx Xxxxx
------------------------------------ ----------------------------
Its Director Sales/Marketing Europe General Manager
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
34
EXHIBIT H
FIRST ANNUAL MINIMUMS 2001
JANUARY 2001-DECEMBER 2001
Xxxxxx: US[CONFIDENTIAL TREATMENT REQUESTED]*
Luminometers: US[CONFIDENTIAL TREATMENT REQUESTED]*
Total Transfer Sales: Not less than US[CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
35
EXHIBIT I
ACTION - PLAN
[CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
36
EXHIBIT J
3 YEAR PLAN
Second Year Minimum: 2002 January-December
Xxxxxx: US[CONFIDENTIAL TREATMENT REQUESTED]*
Luminometers: US[CONFIDENTIAL TREATMENT REQUESTED]*
Transfer Sales not less than US[CONFIDENTIAL TREATMENT REQUESTED]*
Third Year Minimum: 2003 January-December
Xxxxxx: US[CONFIDENTIAL TREATMENT REQUESTED]*
Luminometers: US[CONFIDENTIAL TREATMENT REQUESTED]*
Transfer Sales not less than US[CONFIDENTIAL TREATMENT REQUESTED]*
*[CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH MATERIAL HAS
BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.