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EXHIBIT 10.11
[CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS
DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH
THE COMMISSION]
DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT
THIS DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT dated as of
February 14, 1995 (the "Agreement"), is entered into between BIOSITE DIAGNOSTICS
INCORPORATED, a Delaware corporation ("Biosite"), having a place of business
located at 00000 Xxxxxxx Xxxxxx, Xxxxx X, Xxx Xxxxx, Xxxxxxxxxx 00000, Xxxxxx
Xxxxxx of America, and KYOTO DAI-ICHI KAGAKU CO., LTD., a Japanese corporation
("KDK"), having a place of business located at 00 Xxxxx Xxxxx-Xxx, Xxxxxxx-Xxxx,
Xxxxxx-xx, Xxxxx 000, Xxxxx.
W I T N E S S E T H:
WHEREAS, Biosite owns or has rights to certain significant technology
which may be used in the development of reagents and a test device for use with
a test device reader to form a system to quantitatively measure analytes in the
immunoassay field; and
WHEREAS, Biosite and KDK desire to collaborate in the development of a
hand held rapid in vitro immunoassay system, consisting of reagents, a testing
device and a reader, designed to quantitatively measure multiple cardiac
analytes released from damaged cardiac tissue for use in the diagnosis and
monitoring of myocardial infarction, on the terms and subject to the conditions
set forth below; and
WHEREAS, in consideration of KDK's paying the development fund referred
to in Article 3.2 of the Agreement, KDK wishes to obtain from Biosite the
exclusive rights to market, and distribute such a hand held rapid in vitro
immunoassay system in Japan, Asia, the Middle East and the Pacific Island
Countries, for use in the diagnosis and monitoring of myocardial infarction, on
the terms and subject to the conditions set forth below:
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of the Agreement, the terms defined in this Article 1
shall have the respective meaning set forth below:
1.1 "Affiliate" shall mean, with respect to any Person,
any other Person which directly or indirectly controls, is
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controlled by, or is under common control with, such Person. A Person shall be
regarded as in control of another Person if it owns, or directly or indirectly
controls, at least fifty percent (50%) of the voting stock or other ownership
interest of the other Person, or if it directly or indirectly possesses the
power to direct or cause the direction of the management and policies of the
other Person by any means whatsoever.
1.2 "Agencies" shall mean, collectively, all sole agents, subsidiaries,
partnerships and other entities directly or indirectly controlled by KDK, and
all independent distributors of KDK diagnostic products, located in the
Territory.
1.3 "Asia" shall mean, collectively, Afghanistan, Bangladesh, Bhutan,
Brunei, Burma, Cambodia, China, Hong Kong, India, Indonesia, Laos, Malaysia,
Maldives, Mongolia, Nepal, South Korea, North Korea, Pakistan, Philippines,
Singapore, Sri Lanka, Taiwan, Thailand and Vietnam.
1.4 "Biosite Marks" shall mean those certain trademarks, trade names,
designs and marking owned by or licensed to Biosite and designated from time to
time in writing by Biosite for use by KDK under the Agreement in connection with
the promotion, marketing, sale and distribution of the Testing Device and the
Reader in the Territory for use in the Field.
1.5 "Development Program" shall mean the program to develop, conduct
clinical testing and apply for regulatory approval to market the Product in the
United States of America and the Territory for use in the Field, conducted by or
on behalf of Biosite and KDK pursuant to the Agreement.
1.6 "Field" shall mean the simultaneous and quantitative measurement of
multiple cardiac analytes released from damaged cardiac tissue, including CKMB,
Troponin I and Myoglobin, for use in the diagnosis and monitoring of myocardial
infarction.
1.7 "First Commercial Sale" shall mean the date of the first sale of
the Testing Device or the Reader in the Territory for use by the general public
in the field.
1.8 "Know-How" shall mean all information and data, which is not
generally known, including formulae, procedures, protocols, techniques and
results of experimentation and testing, which are necessary or useful to make,
use, develop, sell or seek regulatory approval in any country to market the
Product for use in the Field, in which Biosite or KDK has an ownership interest
and which is in the possession of Biosite or KDK on the date of the Agreement or
thereafter during the term of the Agreement.
1.9 "Middle East" shall mean, collectively, Bahrain, Iran, Iraq,
Israel, Jordan, Kuwait, Lebanon, Oman, Saudi Arabia, Syria, Qatar, United Arab
Emirates and Yemen.
1.10 "Pacific Island Countries" shall mean, collectively,
Australia, Fiji, Kiribati, Nauru, New Zealand, Papua New Guinea, Solomon
Islands, Tonga, Tuvalu, Vanuatu and Western Samoa.
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1.11 "Patent Rights" shall mean (a) all patent applications heretofore
or hereafter filed or having legal force in any country owned by or licensed to
Biosite or to which Biosite otherwise acquires rights, which claim the Product,
any Product Component, or the process of manufacture or use of the Product or
any Product Component for use in the Field, together with any and all patents
that have issued or in the future issue therefrom, including utility model and
design patents and certificates of invention; and (b) all divisionals,
continuations, continuations-in-part, reissues, renewals, extensions or
additions, to any such patents and patent applications; all to the extent and
only to the extent that Biosite now has or hereafter will have the right to
grant licenses, immunities or other rights thereunder.
1.12 "Person" shall mean an individual, corporation, partnership,
trust, business trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, governmental
authority or any other form of entity specifically listed herein.
1.13 "Product" shall mean the hand held rapid in vitro immunoassay
system, consisting of reagents, a testing device and a reader, developed by or
on behalf of Biosite for use in the Territory for use in the Field, together
with all improvements thereto (including future generations thereof) developed
by or on behalf of Biosite for use in the Territory for use in the Field, and
all modifications thereto developed by or on behalf of Biosite for use or sale
in the Territory for use in the Field.
1.14 "Product Components" shall mean, collectively, the Reader, the
Reagents and the Testing Device as defined below:
1.14.1 "Reader" shall mean that certain testing device reader
which Biosite shall develop or cause to be developed or cause its
subcontractor(s) to develop under the Development Program, constituting a
component of the Product.
1.14.2 "Reagents" shall mean those certain reagents which
Biosite shall develop or cause to be developed under the Development Program,
constituting a component of the Product.
1.14.3 "Testing Device" shall mean that certain testing device
which Biosite shall develop or cause to be developed under the Development
Program, containing the Reagents and constituting a component of the Product.
1.15 "Specifications" shall mean the specifications for the Product
Components established by Biosite and agreed to by KDK for use in the Field in
the Territory which are attached hereto as Exhibit A as such may be revised from
time to time pursuant to the provisions of Section 3.3 below.
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1.16 "Quality Inspection Criteria" shall mean quality inspection
criteria for the Product Components established by mutual agreement of Biosite
and KDK which will be attached hereto as Exhibit __ within eighteen (18) months
from the effective date of the Agreement.
1.17 "Territory" shall mean, collectively, Japan, Asia, the Middle East
and the Pacific Island Countries.
1.18 "Third Party" shall mean any Person other than Biosite, KDK and
their respective Affiliates.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
Each party hereby represents and warrants to the other party as
follows:
2.1 Corporate Existence and Power. Such party (a) is a corporation duly
organized, validly existing and in good standing under the laws of the
jurisdiction in which it is incorporated; (b) has the corporate power and
authority and the legal right to own and operate its property and assets, to
lease the property and assets it operates under lease, and to carry on its
business as it is now being conducted and (c) is in compliance with all
requirements of applicable law, except to the extent that any noncompliance
would not have a material adverse effect on the properties, business, financial
or other condition of such party and would not materially adversely affect such
party's ability to perform its obligations under the Agreement.
2.2 Authorization and Enforcement Obligations. Such party (a) has the
corporate power and authority and the legal right to enter into the Agreement
and to perform its obligations hereunder and (b) has taken all necessary
corporate action on its part to authorize the execution and delivery of the
Agreement and the performance of its obligations hereunder. The Agreement has
been duly executed and delivered on behalf of such party, and constitutes a
legal, valid, binding obligation, enforceable against such party in accordance
with its terms.
2.3 Consents. All necessary consents, approvals and authorizations of
all governmental authorities and other Persons required to be obtained by such
party in connection with execution of the Agreement have been obtained.
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ARTICLE 3
DEVELOPMENT PROGRAM
3.1 Development Activities. Biosite and KDK shall conduct, or cause to
be conducted, the Development Program to develop, conduct all clinical testing
and apply for regulatory approval to market the Product in the Territory.
3.1.1 Development Responsibilities. Biosite shall be
responsible to conduct or cause the design, development and manufacturing
scale-up of the Product. Biosite shall be responsible for the clinical trials
and regulatory approval of the Product in the United States of America. KDK
shall be responsible for the clinical trials and regulatory approval of the
Product in the Territory for use in the Field.
3.2 Development Program Funding.
3.2.1 Development Costs. To support Biosite's Development
Program, KDK shall pay Biosite the following nonrefundable amounts upon
achievement of the applicable milestones set forth below. Biosite shall apply
the funding received from KDK under the Agreement only for the specific purpose
of carrying out its obligations under the Development Program and accomplishing
the objectives thereof.
a. Milestone 1. Prior to the date of the Agreement, KDK has
paid Biosite the sum of US$500,000 the receipt of which is hereby acknowledged.
b. Milestone 2. KDK shall pay Biosite the sum of [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] upon [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
c. Milestone 3. KDK shall pay Biosite the sum of [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] upon [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
d. Milestone 4. KDK shall pay Biosite the sum of [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] upon [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
e. Milestone 5. KDK shall pay Biosite the sum of [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
3.2.2 Milestone Timetable. Biosite shall be responsible for
developing the Product according to the Milestone Timetable set forth below.
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Milestone 2 by September end, 1995
Milestone 3 by June end, 1996
Milestone 4 by October end, 1996
.2.3 Clinical and Regulatory Costs. Biosite shall be solely
responsible for funding the costs of clinical trials and regulatory approval of
the Product in the United States of America. KDK shall be solely responsible for
funding the costs of clinical trials and regulatory approval of the Product in
the Territory.
3.3 Specifications and Quality Inspection Criteria. Biosite and KDK
shall agree upon specifications for the Product Components which are to be set
forth in writing and to be attached as final specifications to the Agreement.
The parties shall also agree upon the Quality Inspection Criteria within
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] from
the effective date of the Agreement which will be attached hereto as Exhibit.
Any modifications to the Specifications and the Quality Inspection Criteria for
the Testing Device and the Reader in the Territory shall require the prior
mutual agreement of Biosite and KDK.
ARTICLE 4
DISTRIBUTION RIGHT
4.1 Distribution Right. In consideration of KDK's paying the
development funding referred to in Article 3.2 of the Agreement, Biosite hereby
grants KDK the exclusive right to promote, market, service, sell and distribute
the Product in the Territory and hereby acknowledges that KDK has such exclusive
distribution right. KDK shall use its best efforts to promote, market,
distribute and sell the Product in the Territory and to meet the reasonably
foreseeable market demand therefor. KDK shall not sell or export the Product,
directly or indirectly, nor cause any Third Party to promote, market, sell,
export, distribute or otherwise deal in the Product, directly or indirectly,
outside the Territory. KDK shall have the right to appoint one or more Third
Parties as subdistributors in the Territory. Biosite shall not sell the Product,
directly or indirectly, nor cause any Third Party (including without limitation
LRE Reais+Elektronik GmbH) to promote, market, sell, export, distribute or
otherwise deal in the Product, directly or indirectly, in the Territory.
4.2 Noncompetition. Except as otherwise provided in the Agreement,
during the term of the Agreement, neither Biosite nor KDK shall, for itself or
with any Affiliate or Third Party, market, promote, sell or distribute any
disposable in vitro immunoassay test device in combination with a hand held
reader
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in the Territory for use in the Field without the prior express written consent
of the other party. Notwithstanding the foregoing, KDK shall have the right,
without any prior written consent of Biosite, to market, promote, sell or
distribute the bench-top dry chemistry assay system including future
modifications and improvements (currently marketed under the name SPOTCREM) or
any non-portable bench-top instruments for measurement of immunoassay tests
including cardiac analytes such as CKMB, Troponin I and Myoglobin in combination
or reagents.
4.3 Independent Purchaser Status. KDK shall be an independent purchaser
and seller of the Testing Device and the Reader. KDK shall not act as an agent
or legal representative of Biosite, nor shall KDK have any right or power to act
for or bind Biosite in any respect or to pledge its credit.
4.4 New Reader Applications. Biosite shall inform KDK first of
Biosite's intention to market new reader application products in the Territory.
Biosite shall initiate, upon request by KDK, a meeting with KDK to discuss the
right to distribute, sell or market such new reader application products in the
Territory. In the event that Biosite elects to appoint new distributor(s) for
such new application products in the Territory, Biosite shall modify or change
the color, product name and software of the Reader in the new application so
that the Readers under this Agreement may be sufficiently differentiated from
the Readers under new reader applications, and Biosite shall not sell to such
new distributor(s) new readers or any new reader applications products
virtually identical or similar to the Reader in the Agreement at prices which
are more favorable, at a comparable volume of sales, than those prices charged
to KDK pursuant to the Agreement. If more favorable prices are given to such
third party(ies), Biosite shall notify KDK in writing and the prices to KDK
shall be amended to reflect such prices.
ARTICLE 5
TERMS AND CONDITIONS OF SUPPLY
Biosite shall sell and deliver, and KDK shall purchase from Biosite,
such Testing Devices and Readers as KDK requires for sale in the Territory or
use in the Field on the terms and subject to the conditions set forth below:
5.1 Price.
5.1.1 Testing Device. The sales price for each Testing Device
(which shall contain the Reagents and shall be in finished product packages
including package insert, retail cartons, and language on such package and
insert should be English and/or Japanese) purchased by KDK for commercial sale
hereunder shall be equal to [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION] (FCA San Diego Facilities Incoterms 1990) per Testing
Device for orders received by Biosite prior to the fourth anniversary of the
First Commercial Sale of the Testing Device. The sales price for each Testing
Device for
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orders received on or after such fourth anniversary shall be determined from
time to time by the mutual agreement of the parties.
5.1.2 Reader. The sales price for each Reader (which shall be
contained in finished product packages which include operator's manual, retail
cartons, carton packing material, languages on packages should be English and/or
Japanese) purchased by KDK for commercial sale hereunder shall be equal to (a)
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] (FOB
Munich Airport, Frankfurt Airport or Hamburg Seaport Incoterms 1990) per Reader
for orders received by Biosite prior to the second anniversary of the First
Commercial Sale of the Reader, and (b) [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] (FOB Munich Airport, Frankfurt Airport or
Hamburg Seaport Incoterms 1990) per Reader for orders received by Biosite on or
after the second anniversary and prior to the fourth anniversary of the First
Commercial Sale of the Reader. The sales price for each Reader for orders
received on or after such fourth anniversary shall be determined from time to
time by the mutual agreement of the parties.
5.1.3 Revised Prices. Notwithstanding the foregoing, if either
party in good faith determines that, due to material changes in manufacturing or
marketing circumstances, it is not commercially feasible to purchase or sell the
Testing Device or the Readers hereunder for commercial sale in any country in
the Territory for use in the Field, the parties shall meet and negotiate in good
faith, and if the parties mutually agree, revise the sales price for the Testing
Device or the Reader under this Section 5.1.
5.2 Demonstration Products.
5.2.1 Testing Device. Prior to, and during the period of one
(1) year following, the date of the First Commercial Sale of the Testing Device
in the Territory, Biosite shall sell and deliver to KDK such quantity of Testing
Devices, not to exceed [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH
THE COMMISSION], as KDK requests solely for demonstration purposes in connection
with the promotion, marketing, distribution and sale of the Testing Device, but
not for commercial sale hereunder, at a price equal to [CONFIDENTIAL MATERIAL
REDACTED AND FILED SEPARATELY WITH THE COMMISSION] (FCA San Diego Facilities
Incoterms 1990) per Testing Device. During the term of the Agreement, KDK may
request from time to time any additional Testing Devices for demonstration
purposes and upon such request the parties shall negotiate in good faith terms
and conditions (including quantity and price terms).
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5.2.2 Reader. Prior to, and during the period of one (1) year
following, the date the First Commercial Sale of the Reader in the Territory,
Biosite shall sell and deliver to KDK such quantity of Readers, not to exceed
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION], as
KDK requests solely for demonstration purposes in connection with the promotion,
marketing, distribution and sale of the Reader, but not for commercial sale
hereunder, at a price equal to [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] (FOB Munich Airport, Frankfurt Airport or
Hamburg Seaport Incoterms 1990) per Reader. During the term of the Agreement,
KDK may request from time to time any additional Readers for demonstration
purposes and upon such request, the parties shall negotiate in good faith terms
and conditions (including quantity and price terms).
5.3 Order and Shipment. KDK shall make all purchases of Product by
placing firm orders with Biosite. Such purchase orders shall be in writing and
in a form reasonably acceptable to Biosite. Purchase orders shall not be binding
upon Biosite unless and until accepted by Biosite. Biosite shall notify KDK in
writing of its acceptance of purchase orders and of the scheduled deliver
therefor within two weeks after receipt of firm orders. Biosite shall use
commercially reasonable efforts to deliver the Product within three (3) months
after receipt of firm orders. The Product shall be packed in such manner as to
ensure safe and undamaged delivery.
The Testing Device shall be delivered FCA San Diego Facilities
Incoterms 1990. The Reader shall be delivered FOB Munich Airport, Frankfurt
Airport or Hamburg Seaport Incoterms 1990. The Product shall be shipped to KDK's
facility located at Kyoto, Japan or such other location as designated in advance
in writing by KDK. Biosite shall make its best effort to accept any reasonable
orders for the Product placed by KDK. In the event that Biosite decides to
discontinue the manufacture of the Product, upon KDK's request the parties
shall negotiate, in good faith, a contract under which Biosite transfers or
licenses KDK with the Patent Rights and any other proprietary information
necessary for KDK tomanufacture the Product in the Territory.
5.4 Payments. KDK shall pay Biosite within forty-five (45) days from
date of the applicable xxxx of lading or airway xxxx for all Product purchased
hereunder. KDK shall make all payments under the Agreement to Biosite in United
States dollars to Biosite's account in a financial institution located in the
United States.
5.5 Forecasts. Not less than sixty (60) days prior to the
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reasonably anticipated date of the First Commercial Sale, KDK shall provide an
initial non-binding forecast to be updated quarterly.
5.6 Warranties.
5.6.1 Testing Devices and Readers. Biosite warrants that it
will manufacture all Testing Devices and shall cause the Readers to be
manufactured in conformity with the final and latest Specifications and that
every Testing Device and Reader shipped by or on behalf of Biosite will be free
from defects in material and workmanship. With respect to the Readers, KDK will
provide to its end users a twelve-month warranty commencing on the date of
delivery to end users. In order to support such warranty, Biosite agrees that
the warranty period for each Reader shall be twenty-four (24) months from the
date of shipment to KDK. If during the above warranty period any Readers are
found to be defective or not in conformity with the Specifications, KDK shall so
notify Biosite and Biosite shall repair or replace such defective Readers
promptly at its full expense (including expense for return by KDK of the
defective Readers or parts to Biosite and shipment by Biosite of the correct and
new Readers or parts to KDK). With respect to the Testing Devices, any Testing
Devices which are found to be defective or not in conformity with the
Specifications during their dated shelf life shall promptly be replaced by
Biosite at its full and sole expense including shipping expense.
If any Testing Device or Reader does not conform to the Specifications,
and fails to pass KDK's quality control conducted following the agreed Quality
Inspection Criteria in Kyoto or such other locations as designated by KDK, KDK
shall be entitled to reject such products, or in its sole discretion, reject the
entire lot from which such nonconforming products were manufactured. KDK shall
exercise its rejection by promptly shipping back to Biosite all such rejected
products or lots at no cost to KDK. In the event of any rejection, Biosite shall
promptly replace the nonconforming or rejected products or lots as soon as
possible but no later than ninety (90) days at no cost to KDK. Biosite shall not
alter or depart from these procedures in the manufacture or testing of the
Product so as to affect its performance without KDK's prior written consent,
which consent shall not be unreasonably withheld. Any other changes made by
Biosite in manufacture or testing that affect production or testing
documentation, or service or operating manuals, or Exhibits to the Agreement,
shall require written notice to KDK. Biosite, upon prior written reasonable
notice, shall grant KDK periodic inspection and visitation rights and access to
Biosite's and its designee's manufacturing facilities and data.
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5.6.2 Patents. Biosite warrants that the patents listed on
Exhibit B hereto have issued, that it is the owner of such patents and that it
has received no notice from any Third Party of any lawsuits alleging the
invalidity of such patents. Biosite warrants, to its current actual knowledge,
that the form of the Testing Device contemplated by Biosite as of the date of
the Agreement does not infringe the issued patents of any Third Party in the
Territory. If the Testing Device is determined to infringe any issued patent in
the Territory, Biosite shall use its best efforts to obtain all appropriate
licenses and other rights so that KDK is able to continue its distribution of
the Product in the Territory lawfully.
5.6.3 Labels, Warnings and Instructions. KDK shall distribute
the Testing Devices and Readers as labeled by or on behalf of Biosite in the
Territory so as to include all warnings and instructions necessary for the
proper use of the Testing Devices and Readers; provided, however, Biosite and
KDK shall agree about the position and form of such labels, lest such labels
should violate any local laws or regulations in the Territory.
ARTICLE 6
OBLIGATIONS OF KDK REGARDING DISTRIBUTION
6.1 Sales Promotion. KDK shall use its best efforts to promote the sale
and use of the Testing Devices and the Reader in the Territory for use in the
Field. KDK shall provide necessary training of KDK's or subdistributors sales
representatives in the use of the Testing Device and the Reader.
6.2 Promotional Materials; Package Inserts. KDK shall use reasonable
efforts to ensure that all advertising, promotional literature, packaging and
package inserts comply with applicable laws and regulations in the Territory.
KDK shall prepare necessary translations of Biosite's sales literature, package
inserts and labeling.
6.3 Import Licenses and Other Governmental Approvals, Compliance.
6.3.1 KDK shall, at its own expense, obtain any registration,
license, permit or governmental approval (collectively, any "Registration") that
may be necessary to permit the purchase, distribution and resale by KDK of the
Testing Device and the Reader in each country in the Territory.
6.3.2 All registrations in the Territory of the Testing Device
and the Reader shall be made in the name of KDK and shall remain the property
of KDK.
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6.4 Quarterly Reports. KDK shall prepare and provide Biosite with
quarterly written sale reports within 30 days of the end of each calendar
quarter (January-March, April-June, July-September, October-December),
commencing with the first calendar quarter after the First Commercial Sale. The
quarterly reports shall summarize sales (sales figures only) of the Testing
Device and the Reader by KDK and its subdistributors during the preceding
quarter for Japan.
ARTICLE 7
OBLIGATIONS OF BIOSITE REGARDING DISTRIBUTION
7.1 Support. Biosite regularly shall provide KDK with literature on the
Testing Device and technical information relating to the Testing Device, the
Reader and their proper use. Biosite shall further furnish free of charge to KDK
reasonable quantities of sales manuals, brochures, and other sales promotional
documents in English. Upon KDK's request, Biosite shall furnish free of charge
to KDK reasonable quantities of available photographs, negative/positive films,
camera ready artwork, posters and panels relating to the Product, such items
shall be for use by KDK in its marketing and public relations activities.
7.2 Assistance. Biosite shall provide KDK with all data and other
information available to Biosite, and shall execute or cause to be executed such
certificates and other documents, as reasonably necessary to assist KDK in
obtaining all necessary product registration in the Territory for the Testing
Devices and the Reader. Biosite shall provide KDK with reasonable access to and
assistance of its technical, sales, and service personnel in San Diego,
California as Biosite deems appropriate. Such assistance under this section
shall be without charge to KDK except as may be otherwise mutually agreed.
7.3 Support for Product Registration. Biosite shall provide KDK with
any necessary, sufficient and reasonable backup in support of KDK's obtaining
necessary product registration. Upon KDK's request, the parties shall negotiate
the supply of the Product for clinical trials at discounted prices.
7.4 Certain Training. Where training (i.e., technical training,
application training etc.) is required Biosite shall provide the necessary
training to KDK. Biosite shall provide to KDK the particular custom tools and
other materials at cost which are prepared for proper maintenance or repair of
the Product for out of warranty service. During the term of the Agreement,
Biosite shall send its personnel (scientific,
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technical or marketing staffers), as agreed upon on a case by case basis, to
work with KDK in the Territory.
7.5 Reports. Biosite shall make periodic reports to KDK on development
and modifications of the Product, United States and European market trends
regarding the Product and important industrial news every six (6) months,
commencing with the first calendar half-year after the effective date of the
Agreement. Biosite shall send KDK, on a quarterly basis, reports on the status
and progress of the Development Program for which Biosite is responsible,
commencing with the first calendar quarter after the effective date of the
Agreement.
ARTICLE 8
CONFIDENTIALITY AND PUBLICATION
8.1 Confidential Information. During the term of the Agreement, and for
a period of five (5) years following the expiration or earlier termination
hereof, each party shall maintain in confidence all information (including
samples) disclosed by the other party and identified as, or acknowledged to be,
confidential (the "Confidential Information" to be stamped as confidential), and
shall not use, disclose or grant the use of the Confidential Information except
on a need-to know basis to those directors, officers, employees, consultants,
clinical investigators, contractors, permitted sublicensees or permitted
assignees, customers, end users, dealers, researchers, collaborators,
subdistributors, clinicians, medical technologists, laboratory technicians,
medical doctors, nurses, to the extent such disclosure is reasonably necessary
in connection with such party's activities as expressly authorized by the
Agreement. To the extent that disclosure is authorized by the Agreement, prior
to disclosure, each party hereto shall obtain agreement of any such person or
entity to hold in confidence and not make use of the Confidential Information
for any purpose other than those permitted by the Agreement. Each party shall
notify the other promptly upon discovery of any unauthorized use or disclosure
of the other party's Confidential Information.
8.2 Permitted Disclosures. The confidentiality obligations contained in
Section 8.1 above shall not apply to the extent that (a) any receiving party
(the "Recipient") is required (i) to disclose information by law, order or
regulation of a governmental agency or a court of competent jurisdiction, or
(ii) to disclose information to any governmental agency for purposes of
obtaining approval to test or market a product or (b) the Recipient can
demonstrate that (i) the disclosed
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information was public knowledge at the time of such disclosure by the other
party hereunder, or thereafter became public knowledge, other than as a result
of actions of the Recipient, its directors, officers, employees, consultants,
clinical investigators, contractors, permitted sublicensees and permitted
assignees, customers, end users, dealers, researchers, collaborators,
subdistributors, clinicians, medical technologists, laboratory technicians,
medical doctors, nurses in violation hereof; (ii) the disclosed information was
rightfully known by the Recipient or its affiliates (as shown by its written
records) prior to the date of disclosure to the Recipient by the other party
hereunder; or (iii) the disclosed information was disclosed to the Recipient or
its affiliates on an unrestricted basis from a source unrelated to any party to
the Agreement and not under a duty of confidentiality to the other party.
Notwithstanding any other provision of the Agreement, each party may disclose
Confidential Information of KDK or Biosite relating to information developed
pursuant to the Agreement to any person or entity with whom Biosite has, or is
proposing to enter into, a business relationship, as long as such person or
entity has entered into a confidentiality agreement with Biosite. Subject to the
confidentiality provisions contained in this Article 8, KDK shall have the
right, at its discretion, to issue press releases or public announcements
concerning KDK's distribution, sale/marketing of the Products, or any other
activities hereunder in the Territory. KDK shall give Biosite written notice of
any such press releases or public announcements.
8.3 Terms of the Agreement. Neither Biosite nor KDK shall disclose any
terms or conditions of the Agreement to any Third Party without the prior
consent of the other party, except as required by applicable law or to Persons
with whom KDK or Biosite has entered into or proposes to enter into a business
relationship provided that such Persons shall enter into the required
confidentiality agreement. Notwithstanding the foregoing, within sixty (60) days
of execution of the Agreement, KDK and Biosite shall agree upon the substance of
information that can be used to describe the terms of this transaction in
publicity with respect to the Agreement or otherwise, and KDK and Biosite may
disclose such information, as modified by mutual agreement from time to time.
8.4 Use of Name. Except as required by applicable law, neither party
shall use the name of the other party or the other party's employees in any
advertisement or press release, without prior written approval of the other
party, which approval shall not be unreasonably withheld. If, however, a party
has approved an advertisement or press release that contains the same or
substantially the same text, shall not be required to be submitted for approval
to the other party.
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ARTICLE 9
PATENT RIGHTS
9.1 Ownership. Biosite shall be the exclusive owner of any Patent
Rights, Know-How or other intellectual rights of the Product, the Product
Components and the process of the manufacture or use thereof, whether or not
patentable.
9.2 Prosecution, Maintenance and Enforcement. Biosite, at
its sole expense, shall be responsible for and shall control the
preparation, filing, prosecution, maintenance and enforcement of
the Patent Rights.
9.3 Third Party Infringement Actions. If KDK, its subdistributors or
their respective customers is sued by a Third Party for infringement of a patent
because of the sale of a Testing Device or Reader in the Territory, KDK promptly
shall notify Biosite in writing of the institution of such suit. Biosite and KDK
agree to use their best efforts to mutually settle any litigation relating to
the infringement of any issued patents. Biosite shall have the right, in its
sole discretion, to control the defense of such suit at its own expense, in
which event KDK shall have the right to be represented by advisory counsel of
its own selection, at its own expense, and shall, at Biosite's expense,
cooperate fully in the defense of such suit and furnish to Biosite all evidence
and assistance in its control.
9.4 No Other Technology Rights. Except as otherwise provided in the
Agreement, under no circumstances shall a party, as a result of the Agreement,
obtain any ownership interest or other right in any technology, Know-How,
patents, pending patent applications, products, vaccines, antibodies, cell lines
or cultures, or animals of the other party, including items owned, controlled or
developed by the other, or transferred by the other to such party at any time
pursuant to the Agreement. It is understood and agreed by the parties that the
Agreement does not grant to either party any license or other right in basic
technology of the other party except to the extent necessary to enable the
parties to carry out their part of the Development program or the development
and marketing of the Product.
ARTICLE 10
BIOSITE MARKS
The trade marks or trade names of the Testing Device and the Reader for
sale in the Territory shall be chosen by KDK and registered in the name of KDK
in the Territory at its expense, provided, however, that KDK shall consult with
Biosite in sincere manner in the choice of such trademarks or trade names and
respect Biosite's recommendation. KDK shall not use any
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Biosite Marks, or any word, title, expression, trademark, design or marking that
is confusingly similar thereto, as part of its corporate or business name, its
products or in any other manner. Notwithstanding the foregoing, (a) KDK may
identify itself as an authorized distributor of Biosite, and (b) KDK may use the
Biosite Marks for display purposes in connection with solicitation of orders for
the Testing Device and the Reader. KDK shall not alter, remove or modify any
Biosite Marks, nor affix any other trademarks, labels or markings to the Testing
Device and the Reader without Biosite's consent; provided, however, that KDK may
affix labels or other indices on the Testing Devices and the Readers it
distributes to identify it as the distributor of the Testing Device and the
Reader so long as such labels do not cover and are not inconsistent with the
Biosite Marks, labels or markings. All registrations of the Biosite Marks shall
be paid by Biosite. Biosite hereby grants to KDK the royalty-free exclusive
right to use Biosite Marks on the Product during the term of this Agreement and
the period of the Product being distributed by KDK. No other KDK labels, package
inserts or other material shall accompany the Testing Device and the Reader
without the prior written approval of Biosite; provided, however, that once
Biosite has so approved the use of any such KDK labels, package inserts or other
material, then any other KDK labels, package inserts or materials that contain
the same or substantially the same text shall not be required to be submitted to
Biosite for approval.
ARTICLE 11
COPYRIGHTS
KDK hereby acknowledges that Biosite may claim copyright protection
with respect to certain parts of the Testing Device and the Reader and the
labels, inserts and other materials regarding the Testing Device and the Reader.
KDK further acknowledges that Biosite has advised KDK that it has the sole and
exclusive right to claim the copyright protection with respect to all such
items. Nothing contained in this Article 11 shall prohibit KDK from copying and
distributing to its sales representatives Testing Device and Reader advertising,
literature and other materials prepared by or on behalf of Biosite for the
purpose of fulfilling KDK's obligations and rights under the Agreement. KDK
shall cooperate with Biosite, take such actions and execute such documents, as
reasonably requested by Biosite and at Biosite's expense, to assist Biosite in
the protection of copyrights owned by or licensed to Biosite. KDK shall inform
Biosite immediately of any infringements or other improper action with respect
to any such copyrights that come to the actual attention of KDK.
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ARTICLE 12
TERM AND TERMINATION
12.1 Term. Unless terminated earlier pursuant to Section 12.2 below,
the Agreement shall continue in full force and effect for an initial term
expiring ten (10) years after the date of receipt of the required marketing
approval, and pricing approval (if any), from the governing health authority in
any country in the Territory to market the Product in such country for use in
the Field; provided, however, that (a) KDK shall have the right to extend the
term of the Agreement for an additional two (2) years, by giving written notice
to Biosite not less than one hundred eighty (180) days prior to the expiration
of the initial term; and (b) if KDK exercises such option to extend the
Agreement, after expiration of such two (2) year extension and any extension
thereafter, the Agreement automatically shall be renewed for successive periods
of two (2) years each.
12.2 Termination. Either party may terminate the Agreement (a) except
as otherwise provided in Section 14.2 below, upon or after the breach of any
material provision of the Agreement by the other party if the other party has
not cured such breach within ninety (90) days after notice thereof from they
non-breaching party, or (b) at any time after the expiration of the initial ten
(10) year term and the first two (2) year extension (total twelve (12) years) if
extended of the Agreement, upon not less than one hundred eighty (180) days
prior written notice to the other party for any reason whatsoever. KDK shall
have the right to terminate the Agreement if Biosite elects to cancel, stop or
suspend the development program or any each of the Milestone Timetable is
delayed by twelve (12) months or more.
12.3 Effect of Expiration and Termination. Upon termination or
expiration of the Agreement, KDK shall have the right either to ship back the
KDK's inventory of the Product at KDK's acquisition cost which includes
air/ocean freight, insurance and duties or to continue to sell the remaining
stock of the Product. After termination or expiration of the Agreement for
whatever reasons Biosite shall continue to supply KDK for a period of five (5)
years from the date of termination of the Agreement with Testing Devices,
reagents and spare-parts necessary for the customers of KDK which have acquired
the Readers, and KDK shall have the right to distribute such products during the
same period. Expiration or termination of the Agreement shall not relieve the
parties of any obligation accruing prior to such expiration or termination. The
provisions of Articles 8, 9 and 13 shall survive the expiration or termination
of the Agreement.
ARTICLE 13
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INDEMNITY
13.1 Indemnity. Biosite shall defend, indemnify and hold KDK, its
Affiliates and/or its Agencies harmless from all costs, damages and expenses
(including reasonable attorneys' fees) that KDK may suffer as a result of any
claims or judgments in favor of any Third Party for bodily injury, property
damage, or any other damage or injury caused or alleged to have been caused by
the defective Product (including without limitation design defects,
manufacturing defects and warning defects) except to the extent that any such
damage is attributable to the gross negligence or willful misconduct of KDK.
Each party shall indemnify, defend and hold harmless the other party, its
directors, officers, employees and agents from all losses, liabilities, damages
and expenses (including reasonable attorney's fees and cost) that they may
suffer as a result of any claims, demands, actions or other proceedings made or
instituted by any Third Party against any of them and arising out of or relating
to (a) any breach of the Agreement by the indemnifying party, (b) any negligence
or intentional act or omission by or on behalf of the indemnifying party in the
performance of its activities contemplated by the Agreement, (c) any
misrepresentation or misstatements by KDK or Biosite, in each case other than
those certain losses, liabilities, damages and expenses arising out of the gross
negligence or willful misconduct of the indemnified party.
13.2 Procedure. A party (the "Indemnitee") that intends to claim
indemnification under this Article 13 shall promptly notify the other party (the
"Indemnitor") of any claim, demand, action or other proceeding with respect to
which the Indemnitee intends to claim such indemnification. The Indemnitor shall
have the right to participate in, and, to the extent the Indemnitor so desires,
jointly with any other Indemnitor similarly notices, to assume the defense
thereof with counsel selected by the Indemnitor; provided, however, that an
Indemnitee shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitor, if representation of the Indemnitee by
the counsel retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between such Indemnitee and any other party
represented by such counsel in such proceedings. The indemnity obligations under
this Article 13 shall not apply to amounts paid in settlement of any loss,
liability, damage or other expense if such settlement is effected without the
consent of the Indemnitor, which consent shall not be withheld unreasonably. The
failure to deliver notice to the Indemnitor within a reasonable time at the
commencement of any such action, if prejudicial to its ability to defend such
action, shall relieve such Indemnitor of any liability to the Indemnitee under
this Article 13, but the omission so to deliver notice to the Indemnitor will
not relieve it of any liability that it may have to any Indemnitee otherwise
than under this Article 13. The Indemnitor may not settle the action or
otherwise consent to an
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adverse judgment in such action that diminishes the rights or interests of the
Indemnitee without the express written consent of the Indemnitee. The
Indemnitee, its employees and agents, shall cooperate fully with the Indemnitor
and its legal representatives in the investigation of any action, claim or
liability covered by this indemnification.
13.3 Insurance. Biosite shall maintain, through self-insurance or
otherwise, such insurance and products liability insurance against claims
regarding the development and manufacture of the Testing Device by Biosite under
the Agreement, in such amounts as it customarily maintains for similar
activities. Biosite shall maintain such insurance during the term of the
Agreement and thereafter for so long as it maintains insurance for itself
covering similar activities.
ARTICLE 14
MISCELLANEOUS
14.1 Notices. Any consent, notice or report required or permitted to be
given or made under the Agreement by one of the parties to the other shall be in
writing, delivered personally or by facsimile (and promptly confirmed by
personal delivery, air mail, internationally-recognized delivery service or
courier), air mail, internally-recognized delivery service or courier, postage
prepaid (where applicable), addressed to such other party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and (except as otherwise provided in the
Agreement) shall be effective upon receipt by the addressee.
If to Biosite:
Biosite Diagnostics Incorporated
00000 Xxxxxxx Xxxxxx, Xxxxx X
Xxx Xxxxx, Xxxxxxxxxx 00000, U.S.A.
Attention: Xxx X. Xxxxxxxxxxxx
President
If to KDK:
Kyoto Dai-Ichi Kagaku Co., Ltd.
00 Xxxxx Xxxxx-Xxx,
Xxxxxxx-Xxxx,
Xxxxxx-Xx,
Xxxxx 000, Xxxxx
Attention: Shigeru Doi
President
14.2 Force Majeure. Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or breached the
Agreement for failure or delay in
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fulfilling or performing any term of the Agreement to the extent, and for so
long as, such failure or delay is caused by or results from causes beyond the
reasonable control of the affected party including fire, floods, embargoes, war,
acts of war (whether war be declared or not), insurrections, riots, civil
commotions, strikes, lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority.
14.3 Assignment. Except as expressly provided hereunder, the Agreement
may not be assigned or otherwise transferred, nor may any right or obligations
hereunder be assigned or transferred by either party without the consent of the
other party which may not be unreasonably withheld or delayed; provided,
however, that at any time on or after the third anniversary of the date of the
first Commercial Sale, either party may, without such consent, assign the
Agreement and its rights and obligations hereunder in connection with the
transfer or sale of all or substantially all of its business, or in the event
of its merger or consolidation or change in control or similar transaction. Any
permitted assignee shall assume all obligations of its assignor under the
Agreement.
14.4 Severability. Each party hereby acknowledges that it does not
intend to violate any public policy, statutory or common laws, rules,
regulations, treaty or decision of any government agency or executive body
thereof of any country or community or association of countries. Should one or
more provisions of the Agreement be or become invalid, the parties shall
substitute, by mutual consent, valid provisions for such invalid provisions
which valid provisions in their economic effect are sufficiently similar to the
invalid provisions that it can be reasonably assumed that the parties would have
entered into the Agreement with such provisions. In case such provisions cannot
be agreed upon, the invalidity of one or several provisions of the Agreement
shall not affect the validity of the Agreement as a whole, unless the invalid
provisions are of such essential importance to the Agreement that it is to be
reasonably assumed that the parties would not have entered into the Agreement
without the invalid provisions.
14.5 Governing Law. The Agreement shall be governed by and construed in
accordance with the laws of the State of California, U.S.A., without regard to
the conflicts of law principles thereof, and shall not be governed by the United
Nations Convention on Contracts for the International Sale of Goods.
14.6 Arbitration. Any dispute, controversy or claim originally
initiated by either party relating to, arising out of or resulting from the
Agreement, or the performance by either party of its obligations hereunder,
whether before or after termination of the Agreement, shall be finally resolved
by binding arbitration pursuant to the Japan-American Trade Arbitration
Agreement of September 16, 1952. Whenever a party shall decide to institute
arbitration proceedings, it shall give written notice to that effect to the
other party. If initiated by Biosite, such arbitration hereunder shall be
conducted under the Commercial Arbitration Rules of the Japan Commercial
Arbitration Association, and any applicable procedural laws of Japan, and shall
be held in Osaka, Japan. If initiated by KDK,
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such arbitration shall be conducted under the Commercial Arbitration Rules of
the American Arbitration Association and any applicable procedural laws of the
State of California, and shall be held in Los Angeles, California. The award
shall be
final and binding upon the parties.
14.7 U.S. Export Laws and Regulations. Each party hereby acknowledges
that the marketing rights and information disclosure requirements of the
Agreement are subject to the laws and regulations of the United States relating
to the export of products and technical information. Without limitation, each
party shall comply with all such laws and regulations.
14.8 Entire Agreement. The Agreement contains the entire understanding
of the parties with respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, heretofore made are
expressly superseded by the Agreement. The Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by both parties.
14.9 Headings. The captions to the several Articles and Sections hereof
are not a part of the Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof.
14.10 Independent Contractors. It is expressly agreed that Biosite and
KDK shall be independent contractors and that the relationship between the two
parties shall not constitute a partnership, joint venture or agency. Neither
Biosite nor KDK shall have the authority to make any statements, representations
or commitments of any kind, or to take any action, which shall be binding on the
other, without the prior consent of the party to do so.
14.11 Language. The English language version of the Agreement shall
govern and control any translations of the Agreement into any other language.
14.12 Waiver. The waiver by either party of any right hereunder or the
failure to perform or of a breach by the other party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.
14.13 Counterparts. The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed the Agreement as of the
date first set forth above.
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BIOSITE DIAGNOSTICS KYOTO DAI-ICHI KAGAKU CO. LTD.
INCORPORATED
By: /s/ Shigeru Doi
By: /s/ Xxx X. Xxxxxxxxxxxx ---------------------------
--------------------------- Title: President
Title: President ------------------------
------------------------ Date: 2/14/95
Date: 2/14/95 ------------------------
------------------------
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Exhibit A: Product Specifications
System Design Specifications
1) PROJECT GOAL: To develop and launch a panel of quantitative assays for
cardiac markers and an instrument suitable for the
point-of-care setting by Summer 1996.
2) POINT-OF-CARE
MARKET (P-O-C): P-O-C for cardiac markers is defined as the emergency
department, chest pain center or coronary care unit. In
each of these settings, the assay would be performed by
non-laboratory health care personnel.
3) CUSTOMER NEEDS:
a) Assay: o No sample processing
o Fast
o Easy to use
o Cardiac markers useful in early diagnosis of AMI
o State of the art assay performance
o Cost effective
o Reliable
o Result influences diagnostic decisions
b) Instrument: o Easy to use
o Fast
o Reliable
o Documentation of results
o Cost effective
o Minimal Maintenance
4) PRODUCT DESIGN PARAMETERS
a) Assay:
CUSTOMER NEED DESIGN PARAMETER GOAL
No sample processing Sample selection Anticoagulated whole blood,
plasma and serum
Easy to use # Assay steps 1 step
Packaging Unitized device, prepackaged
requiring no reagent preparation
1
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Useful markers Panel Myo, CKMB, Trop I
Good Performance Fast 10 minutes to result
Accuracy Agreement with reference
preparation and standards
Precision [CONFIDENTIAL MATERIAL
REDACTED AND FILED
SEPARATELY WITH THE
COMMISSION]
Agreement with [CONFIDENTIAL MATERIAL
market leaders REDACTED AND FILED
SEPARATELY WITH THE
COMMISSION]
Reliable Controls Device and instrument
o Functional check internal validation
o Calibration check controls to determine
completion of assay and
eliminate the need for
timing step, factory
determined calibration and
input calibration data via
E-prom.
Kit stability 12 mos RT at launch, 24 mos
at RT final goal.
b) Instrument
CUSTOMER NEED DESIGN PARAMETER GOAL
Easy to use Calibration o Bar coded strip on device
for lot data input
Data entry keypad, o Simplistic user interface
function
Keys o Alpha-numeric input
Maintenance o No user serviceable parts
o Spill and contamination
resistant case
Mistake resistant Controls o Instrument prompts/ok's
o Instrument electronic
checks (post)
o Results blocked if any
invalid checks occur for
assay
o Requires user ID to use
o Requires spec ID to proceed
o QC check device
Identification o Bar coded lot/exp date
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b) Instrument (continued)
CUSTOMER NEED DESIGN PARAMETER GOAL
Reliable to be determined by mutual agreement by April end 95
Portable Size o Portable or small desk top
Power requirements o Powered ac/dc converter
Result documentation Printer o Built-in printer
o Printout with date, time
user & Pt ID, Lot#, assay
results, control results,
normal range, out of range
flags for QC and patients
Data Storage o 100 patient panel results
with all data (Lot, time,
date int. QC results) and
30 QC results
o Segregated QC memory
Interface o Data downloadable to
laboratory data management
system
Cost effective Instrument cost [CONFIDENTIAL MATERIAL REDACTED
AND FILED SEPARATELY WITH THE
COMMISSION]
Accommodate new, EEPROM Update o Reprogrammable
other assays EEPROM on-site
o Panel selection by user
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ASSAY SPECIFICATIONS
1) Assay Format: A panel of sandwich immunoassays using a combination of
monoclonal and polyclonal antibodies for the quantitative detection of three
cardiac markers in 10 minutes. The assay is performed in a wholly contained
disposable device which is analyzed using a portable instrument.
2) Procedure: 1. Label device.
2. Add an unmeasured amount of anticoagulated whole
blood, plasma or serum to sample port.
3. Input specimen ID. Insert device into instrument for
incubation, assay validation and quantification of
results. Instrument will determine when assay is
finished via internal control values. Any devices
run simultaneously can be read after 1st device is
quantified.
4. Results displayed and printed.
3) Cardiac Marker Menu/Detection Limits:
Marker Minimum Detectable Dose (MDD) Assay Range
CKMB [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
Myoglobin WITH THE COMMISSION]
Troponin I
Minimum Indicating Limit of each Marker on Display
CKMB [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
Myoglobin WITH THE COMMISSION]
Troponin I
4) Internal Control: Two internal controls that control for timing and
proper assay performance.
5) Specificity: CKMB [CONFIDENTIAL MATERIAL REDACTED
Myoglobin AND FILED SEPARATELY
Troponin I WITH THE COMMISSION]
6) Precision: CKMB % CV at ng/ml*
Myoglobin % CV at ng/ml*
Troponin I % CV at ng/ml*
*to be determined through mutual agreement by April end
95
7) Correlation: Results must have [CONFIDENTIAL MATERIAL REDACTED AND
FILED SEPARATELY WITH THE COMMISSION] agreement with
market leaders for each assay.
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8) Incubation time: One incubation step of (less than) 3
minutes/not observed by user.
9) Sample requirements: An unmeasured amount of anticoagulated whole
blood; plasma or serum.
10) Standardization: CKMB - AACC Reference Material for CKMB
Myoglobin - Purified myoglobin
Troponin I - Cloned protein
11) Calibration: Factory set and recorded on E-prom provided in
each kit. Bar code on device (Lot #/expiration
date) is read when device is inserted into
Instrument for quantitation.
12) Device Failure Rate: (less than) 0.5%
13) Storage and Stability: Stored at room temperature for 24 months, 12
months at launch.
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COMPETITIVE PRODUCT MATRIX
1) CKMB DADE XXXXXX OPUS
---- ---- ------ ----
MMD 0.4 ng/ml 0.7 ng/ml (less than) 1.0 ng/ml
Range 0.4-125 0.7-300 1.0-300
Precision 5.4%-8.3% 8.6%-8.7%
TAT 8 min 30 min 20 min
Sample serum serum/plas. serum/plas.
Norm range (less than) 4.7 ng/ml (less than) 5.0 ng/ml
2) MYOGLO DADE OPUS
------ ---- ----
MMD 1.2 ng/ml (less than) 1.0 ng/ml
Range 1.2-1000 1.0-650
Precision 1.3%-8.3% 3.2%-8.9%
TAT 8 min 10 min
Sample serum/plas.
Norm range 0-110 ng/ml (less than) 90 ng/ml
3) TROP I DADE XXXXXX
------ ---- ------
MMD 0.45 ng/ml 0.75 ng/ml
Range 0-100 0-100
Precision (less than) 10% 3%-10%
TAT 8 min 2 hr (R&D)
Sample serum
Norm range (less than) 0.5 ng/ml
4) TROP T DADE XXXXXX
------ ---- ------
MMD 0.04 ng/ml
Range 0.04-10 ng/ml
Precision (less than) 5%
TAT
Sample serum
Norm range 0-0.1 ng/ml
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INSTRUMENT SPECIFICATIONS
1) Instrument design: A portable instrument designed to be used at the
point-of-care setting by non-laboratory health care
personnel. It requires minimal and self evident user
interface to operate.
2) Procedure: 1. Power on
2. Automatic POST
3. Enter user ID
4. Select operational mode
5. Enter sample ID
6. Insert device.
7. Instrument monitors control zones and determine
completion of assay
8. Multiple zones are read and results displayed
on screen and printed
9. Insert next device
3) HARDWARE
a) Dimensions: Portable and compact, maximum footprint 8"x10"x6", less
than 10 lbs.
b) Optical Reader: Capable of reading at least four assay test zones and
two control zones.
c) Device ID/data input: Each device has bar coded strip with test type, Lot #,
expiration date, calibration date, control zone data.
d) User data interface: Alpha-numeric keypad
Mode key(s)
Power key
Enter key
Timer
e) Display Screen: Alpha-numeric, minimum of six lines display.
Japanese character (Katakana)
f) Data Output: On board printer with continuous event logging. Host
computer interface with bi-directional data transfer.
g) Power requirements: Battery operated with AC adapter.
Display of operated time with Battery and requiring
time for recharging.
Indication of consumption power.
Usable with disposable battery (AAA).
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h) Memory storage: Capable of 100 patient panel results with all associated
data e.g., time, date, internal controls, etc. and 30 QC
panels.
i) Clock: Real time clock with date and time. Assay timer.
j) Serviceability: No user serviceable parts. Optics and Internal
components cleaned by operator.
k) Failure rate:
to be determined through mutual agreement by April and
95
4) SOFTWARE
a) Operational modes: Data entry
Key access for data entry e.g., normal ranges,
user ID list.
Normal ranges
Control ranges
User ID
Patient ID
Date retrieval
QC
Patient
Time/date of last QC run
Analyze assay
Print
Set clock/timer
b) Screen prompt: ID entry
Result storage remaining
Download memory
Time since last QC
Error Messages
Lockout with unacceptable electronic validation
checks.
Lockout with exp reagents.
Lockout with out of range or elapsed time QC.
Result lockout with out of range internal
control zones.
Lockout with unapproved user ID.
Improper device alignment.
Lockout with QC check device failure.
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Exhibit B
Patents
Patent Number 07/887,526 - Diagnostic device and apparatus for the controlled
movement of reagents without membranes.
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