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Title:

Agreement

Entities:

Hitachi, Ltd.; Matritech, Inc.

Date:

2001

Size:

Preview shows 14KB of 73KB total

Price:

$44

ID:

#273544

 

 

► Miscellany ► Agreements
► Capital Goods
► Biotech & Drugs ► In Vitro & In Vivo Diagnostic Substances

 

 

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                                    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 630 Clyde Court, Mountain View, CA 94043 (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 chambers, 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.
{PAGE} 2
-2-


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.
{PAGE} 3
-3-


the same. The cost of return shipment to DISTRIBUTOR shall be borne by
HCD. CLA-pettes 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.


{PAGE} 4
-4-


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.


 

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