1
EXHIBIT 10.13
[CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE
BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION]
DISTRIBUTORSHIP AGREEMENT
BETWEEN
E. Merck
Frankfurter Strasse 250
D-6100 Xxxxxxxxx 0
Xxxxxxx Xxxxxxxx of Germany
AND
BIOSITE DIAGNOSTICS INCORPORATED
00000 Xxxxxxx Xxxxxx, Xxxxx X
Xxx Xxxxx, XX 00000
July 27, 1992
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Table of Contents
Page
1. DEFINITIONS.......................................................................................... 1
1.1 Agreement................................................................................... 1
1.2 Confidential Information.................................................................... 1
1.3 Customer.................................................................................... 1
1.4 Market Segmentation......................................................................... 2
1.5 Product..................................................................................... 2
1.6 Territory................................................................................... 2
1.7 Agencies.................................................................................... 2
2. APPOINTMENT AND SCOPE................................................................................ 2
2.1 Appointment................................................................................. 2
2.2 Exclusivity................................................................................. 2
2.3 Noncompetition.............................................................................. 2
2.4 Independent Purchaser Status................................................................ 3
2.5 Perishable Products......................................................................... 3
3. TERMS AND CONDITIONS OF SALE......................................................................... 3
3.1 Price....................................................................................... 3
3.2 Terms of Sales.............................................................................. 3
3.3 Payments.................................................................................... 4
3.4 Orders...................................................................................... 4
3.5 Returned Goods.............................................................................. 4
3.6 Warranty.................................................................................... 4
4. COVENANTS OF MERCK................................................................................... 5
4.1 Sales Promotion............................................................................. 5
4.2 Expenses.................................................................................... 5
4.3 Promotional Materials; Package Inserts...................................................... 5
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4.4 Import Licenses, Exchange Controls, and Other Governmental Approvals,
Compliance.................................................................................. 6
4.5 Local Laws and Regulations.................................................................. 7
4.6 Product Control............................................................................. 7
4.7 Quarterly Reports........................................................................... 7
4.8 Indemnification............................................................................. 7
4.9 Products Liability Insurance................................................................ 8
5. OBLIGATIONS OF BIOSITE............................................................................... 8
5.1 Sales Support............................................................................... 8
5.2 Notification of Changes..................................................................... 8
5.3 Assistance.................................................................................. 8
6. CONFIDENTIALITY AND PROPRIETARY RIGHTS............................................................... 8
6.1 Confidentiality of Sales and Product Data................................................... 8
6.2 Use of Patents.............................................................................. 9
6.3 Trademarks and Trade Names.................................................................. 9
6.4 Protection of Proprietary Rights............................................................ 10
7. TERM AND TERMINATION................................................................................. 10
7.1 Term........................................................................................ 10
7.2 Termination................................................................................. 10
7.3 Rights of Parties on Termination............................................................ 11
8. CONCILIATION AND ARBITRATION......................................................................... 12
8.1 Conciliation................................................................................ 12
8.2 Arbitration................................................................................. 13
9. GENERAL PROVISIONS................................................................................... 14
9.1 Entire Agreement............................................................................ 14
9.2 Authorization............................................................................... 14
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9.3 Compliance of AGENCIES and Subsidiaries..................................................... 15
9.4 Notices..................................................................................... 15
9.5 Expenses of Arbitration and/or Litigation................................................... 16
9.6 Force Majeure............................................................................... 16
9.7 Titles and Headings......................................................................... 16
9.8 Assignments................................................................................. 16
9.9 Successors and Assigns...................................................................... 17
9.10 Severability................................................................................ 17
9.11 Language.................................................................................... 17
9.12 Applicable Law.............................................................................. 17
9.13 Waiver...................................................................................... 17
10. EXHIBITS
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DISTRIBUTORSHIP AGREEMENT
THIS DISTRIBUTION AGREEMENT is made as of this 27th day of July 1992, by and
between BIOSITE DIAGNOSTICS INCORPORATED, a corporation organized and existing
under the laws of the State of Delaware and with its principal offices at 00000
Xxxxxxx Xxxxxx, Xxxxx X, Xxx Xxxxx, Xxxxxxxxxx 00000, U.S.A. (BIOSITE) and E.
Merck, a general partnership organized and existing under the laws of The
Federal Republic of Germany and with its principal offices at Xxxxxxxxxxx
Xxxxxxx 000, D-6100 Xxxxxxxxx 0, Xxxxxxx Xxxxxxxx of Germany (MERCK).
RECITALS
BIOSITE owns or controls the right to manufacture, sell and distribute its
products described in Section 1.5 and desires assistance from MERCK in the
promotion, sale and distribution of such products, and the parties desire to
enter into this Agreement for the promotion, sale and distribution of such
products upon the following terms and conditions.
TERMS AND CONDITIONS
NOW, THEREFORE, in consideration of their mutual covenants and agreements
contained herein, and the mutual benefits to be derived therefrom, it is agreed
by the parties as follows.
1. DEFINITIONS
1.1 AGREEMENT. The term "AGREEMENT" when used herein means this document
and any exhibit or amendment thereto.
1.2 CONFIDENTIAL INFORMATION. The term "CONFIDENTIAL INFORMATION" when used
herein shall mean technical and business information relating to the
PRODUCTS and BIOSITE's business, including, where appropriate and
without limitation, any information, patent disclosures, patent
applications, structures, models, techniques, processes, compositions,
compounds and apparatus relating to the same disclosed by BIOSITE to
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MERCK or obtained by MERCK through observation or examination of
BIOSITE's information or developments, but only to the extent that such
information is maintained as confidential by BIOSITE.
1.3 CUSTOMER. The term "CUSTOMER(S)" when used herein means any purchaser
of PRODUCTS.
1.4 MARKET SEGMENTATION. The definitions of the MEDICAL SEGMENT and the
INTERVENTION SEGMENT are included in EXHIBIT I.
1.5 PRODUCT. The term "PRODUCT(S)" when used herein means the products as
described in EXHIBIT II.
1.6 TERRITORY. Subject to the provisions of EXHIBIT I, the term "TERRITORY"
when used herein means the countries listed in EXHIBIT III.
1.7 AGENCIES. For the purpose of this AGREEMENT the term "AGENCIES" means
all sole agents, either subsidiaries, partnerships and other entities
directly or indirectly controlled by MERCK or independent distributors
of Merck diagnostic products, located in the TERRITORY.
2. APPOINTMENT AND SCOPE
2.1 APPOINTMENT. Subject to the terms and conditions and for the term of
this AGREEMENT, BIOSITE hereby appoints MERCK as an independent
distributor of BIOSITE's PRODUCT(S) in the TERRITORY. MERCK shall be
the exclusive distributor of BIOSITE's PRODUCT(S) in the TERRITORY.
MERCK hereby accepts such appointment and agrees to use its best
efforts to promote, market, distribute and sell BIOSITE's PRODUCTS in
the TERRITORY. MERCK and its subsidiaries will refrain from seeking
customers, from establishing any branch and from maintaining any
distribution depot or network for the sale of the
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PRODUCTS outside of the TERRITORY. MERCK will make reasonable efforts
to see that its AGENCIES do not actively sell PRODUCT(S) outside of the
TERRITORY.
2.2 EXCLUSIVITY. For purposes of Section 2.1 above, the term "exclusive"
means that, subject to the terms and conditions of this AGREEMENT and
as long as MERCK is in full compliance with its obligations hereunder,
BIOSITE shall not appoint any other agents, representatives or
distributors in the TERRITORY to promote or sell PRODUCTS to CUSTOMERS
in the TERRITORY.
2.3 NONCOMPETITION. Unless specifically authorized in writing by BIOSITE,
MERCK shall not start selling or offering for sale, or act as sales
agent for the solicitation of orders for any products that are directly
competitive with any of the PRODUCTS except for instrument-based
reagents sold by MERCK in the TERRITORY, as of the date hereof. MERCK
will make reasonable efforts to see that its AGENCIES and subsidiaries
will comply with the provisions of this Section 2.3.
2.4 INDEPENDENT PURCHASER STATUS. MERCK is an independent purchaser and
seller of the PRODUCTS. MERCK shall not act as an agent or legal
representative of BIOSITE, nor shall MERCK have any right or power to
act for or bind BIOSITE in any respect or to pledge its credit. MERCK
shall be free to resell PRODUCTS in the TERRITORY on such terms as it
may, in its sole discretion, determine, including, without limitation,
price, returns, credits and discounts. The detailed operations of MERCK
under this AGREEMENT are subject to the sole control and management of
MERCK.
2.5 PERISHABLE PRODUCTS. MERCK acknowledges that the PRODUCTS are
perishable, and will manage its inventory such that products are
shipped throughout the TERRITORY to the extent reasonably practicable,
on a first-in-first-out basis.
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3. TERMS AND CONDITIONS OF SALE
3.1 PRICE
BIOSITE will initially charge MERCK a price as specified in EXHIBIT IV
for each TRIAGE 7 Panel or TRIAGE 8 Panel kit, which shall consist of
25 PRODUCT units. Prices shall be subject to change by BIOSITE on
1-year's notice to MERCK.
MERCK will pay BIOSITE for purchases within 30 days from date of
invoice by BIOSITE to MERCK. All payments will be in US $. The exchange
rate for Deutsche Marks is 1.65 Deutsche Marks for one US $.
Currency fluctuations of greater than 10% from this exchange rate
will be evaluated for stabilization within 90 days of the event. If
stabilization does not occur, both parties agree to discuss an
adjustment of price of PRODUCTS under this Section 3.1.
3.2 TERMS OF SALES. PRODUCTS will be shipped fca airport San Diego
(Incoterms 1990) (=free carrier arrival) freight and insurance paid by
MERCK. BIOSITE will notify MERCK of scheduled delivery dates by written
acknowledgment of MERCK's order. BIOSITE will use its reasonable
commercial efforts to meet quoted delivery dates. The lead time for
shipping of PRODUCTS shall be 4 months after receipt of MERCK's order
by BIOSITE. In the event BIOSITE is able to fill orders by MERCK in
less than 4 months BIOSITE and MERCK shall agree upon a delivery of
PRODUCTS in advance. MERCK will arrange for shipping and procure
insurance at MERCK's expense and will ship all PRODUCTS from BIOSITE's
facility in San Diego, California to MERCK's warehouse in Darmstadt,
Federal Republic of Germany, or any other location determined by MERCK.
MERCK will pay all taxes and charges,
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including without limitation all inspection fees and duties, applicable
to the sale and transport of the PRODUCTS by MERCK in the TERRITORY.
3.3 PAYMENTS. All payments under this Agreement are to be made by MERCK to
BIOSITE in US $ to BIOSITE's account in a financial institution located
in the United States.
3.4 ORDERS. Prior to the AGREEMENT term and on the first day of each
quarter during the AGREEMENT term MERCK will provide BIOSITE with a
written forecast of MERCK's estimated purchase requirements for each
quarter in the ensuing twelve month period. MERCK will be bound to
purchase the forecast quantities for the first quarter of each such
forecast to the end of the AGREEMENT term. In the event MERCK's orders
exceed the previous forecast quantities by more than 50%, BIOSITE may
reject to deliver those quantities in excess.
3.5 RETURNED GOODS. If PRODUCTS are not in accordance with the
specifications stated in EXHIBIT II and fail to pass MERCK's quality
control following the procedures as provided by BIOSITE upon arrival in
Darmstadt, MERCK may either return complained PRODUCT(S) to BIOSITE or
on BIOSITE's request dispose locally. In both cases all costs are to be
borne by BIOSITE.
Notwithstanding the foregoing, BIOSITE shall not be responsible for any
PRODUCTS which fail to pass MERCK's quality control as a result of
improper storage and handling during or after shipment to MERCK.
3.6 WARRANTY.
a) Subject to Section 3.6 (b) below, BIOSITE warrants that the
PRODUCTS will perform as stated in BIOSITE's PRODUCT(S)
specifications and current PRODUCT insert (Revised January 3,
1992), included in EXHIBIT II hereof. BIOSITE's PRODUCT
specifications are subject to change upon 30 days' notice to
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MERCK, during which period BIOSITE shall consult with MERCK on
such changes and will consider any comments MERCK has with
regard to such changes, provided, however, that BIOSITE's
PRODUCT will perform substantially as described in the
specifications and PRODUCT insert included in EXHIBIT II.
b) Other than as set forth in Section 3.6 (a) above, BIOSITE
makes no express or implied warranty of merchantability,
fitness for a particular purpose, against infringement of any
trademarks, copyrights or other proprietary rights now or
hereafter existing.
c) BIOSITE warrants that to the best of its knowledge that there
is no third party's patent right which could hinder MERCK
exercising its rights under this agreement, in particular by
distributing and selling the PRODUCTS in the Territory.
BIOSITE warrants to defend and save harmless MERCK against any
suit, damage claim or demand based on actual or alleged
infringement of any patent of any third party in any country
resulting from the breach of the warranty set forth in the
preceding sentence and relating to the purchase of PRODUCT(S)
from BIOSITE and/or from the sale of PRODUCT(S) by MERCK.
d) MERCK will distribute PRODUCT(S) labeled by BIOSITE in the
TERRITORY so as to include all warnings and instructions
necessary for the proper use of the PRODUCT(S) and will not
extend any other product warranty, express or implied, other
than the warranty included in Sections 3.6 (a) to (c) above.
4. COVENANTS OF MERCK
4.1 SALES PROMOTION. MERCK shall use its best efforts to promote the sale
and use of the PRODUCTS by all existing and potential CUSTOMERS in the
TERRITORY. MERCK will agree to provide complete training of MERCK's or
AGENCIES' sales representatives in the use of the PRODUCTS.
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4.2 EXPENSES. MERCK shall be responsible for all of its own expenses and
employees. MERCK agrees that it shall incur no expense chargeable to
BIOSITE, except as may be specifically authorized in advance in writing
in each case by BIOSITE.
4.3 PROMOTIONAL MATERIALS; PACKAGE INSERTS. MERCK shall ensure that all
advertising, promotional literature, packaging and package inserts
comply with applicable laws and regulations. MERCK shall not use any
advertising or promotional materials to promote the PRODUCTS or any
packaging or package inserts that have not been approved by BIOSITE,
which approval shall not be unreasonably withheld. MERCK shall prepare
necessary translations of BIOSITE's sales literature, package inserts
and labeling.
4.4 IMPORT LICENSES, EXCHANGE CONTROLS, AND OTHER GOVERNMENTAL
APPROVALS, COMPLIANCE.
a) MERCK shall, at its own expense: (i) obtain any registration,
license, permit, governmental approval (collectively,
"registration") that may be necessary to permit the purchase,
distribution and resale by MERCK of PRODUCTS in each country
in the TERRITORY; (ii) comply with all registration
requirements for each country in the TERRITORY; (iii) comply
with any and all governmental laws, regulations, and orders
that may be applicable to MERCK by reason of its execution of
this AGREEMENT including without limitation any requirement to
be registered as BIOSITE's independent distributor with any
governmental authority, and including any and all laws,
regulations, or orders that govern or affect the ordering,
export, shipment, import, sale (including government
procurement), delivery, or redelivery of PRODUCTS in the
TERRITORY. MERCK agrees that it shall not engage in any course
of conduct that, in BIOSITE's reasonable belief, would cause
BIOSITE to be in violation of the laws of any jurisdiction.
b) BIOSITE shall perform all necessary measurements and provide
every delivered pipette with a certificate of conformity in
accordance with German governmental regulations (MEASURING LAW
= EICHGESETZ). Subject to latter regulations, BIOSITE shall
furnish the pipette with a stylized "H". (conformatory xxxx)
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c) All registrations will be made in the name of MERCK and shall
remain the property of MERCK during the term of this
AGREEMENT. BIOSITE shall be provided with a copy of all
registrations and applications.
d) In case of termination of this AGREEMENT BIOSITE may, at its
option, take over the above mentioned registrations or, where
necessary, obtain registration under BIOSITE's name at its own
cost.
In the event of any such termination of this AGREEMENT, MERCK agrees to
continue distribution of PRODUCT(S) on the same terms and conditions in
effect on the date of termination until BIOSITE (or BIOSITE's agent) is
able to obtain any required registration for distribution of the
PRODUCT(S) in the TERRITORY; provided, however, that the
indemnification provisions set forth in Section 4.8 below will continue
during such period. Upon any such termination, MERCK shall assign to
BIOSITE and will use its best efforts to assist BIOSITE in the transfer
to or obtaining of any such registration documents in the name of
BIOSITE (or BIOSITE's agent) in a quick and efficient manner.
4.5 LOCAL LAWS AND REGULATIONS. MERCK shall notify BIOSITE of the existence
and content of any mandatory provision of law in each country in the
TERRITORY or any other applicable law that conflicts with any provision
of this AGREEMENT at the time of its execution or thereafter. MERCK
agrees to advise BIOSITE fully with respect to all regulations,
labeling laws, standards, specifications and other requirements imposed
by law, regulation or order in any country in the TERRITORY and
applicable to the PRODUCTS. MERCK agrees to promptly inform BIOSITE
should, in its opinion, any amendment or additional agreement be
required or be advisable in order to comply with the laws of any
country in the TERRITORY, or any subdivision thereof.
4.6 PRODUCT CONTROL. Each PRODUCT shipped by BIOSITE will contain numbers
identifying manufacturing lot, expiry date for control purposes, and
lot-specific quality control report.
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4.7 QUARTERLY REPORTS. MERCK will provide BIOSITE with quarterly reports
within 30 days of the end of each calendar quarter (January - March,
April - June, July - September, October - December). The quarterly
reports shall summarize PRODUCT sales during the preceding quarter for
the countries in the TERRITORY.
4.8 INDEMNIFICATION. BIOSITE and MERCK mutually agree to indemnify each
other and mutually hold the other party and its officers, directors and
agents harmless against all losses, damages, or expenses of any form or
nature, including attorneys' fees and other costs of legal defense that
they, or any of them, may incur as a result of any acts or omissions of
the other party or any of its employees or agents, including but not
limited to:
a) breach of any of the provisions of this AGREEMENT
b) negligence or other tortious conduct;
c) representations or statements not specifically authorized by
BIOSITE or MERCK herein or otherwise in writing; or
d) violation by BIOSITE or MERCK (or any of their employees or
agents) of, or failure to adhere to, any applicable law,
regulation or order in any country in the TERRITORY or of the
United States.
The provisions of this Section 4.8 shall survive the
termination of this AGREEMENT.
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4.9 PRODUCTS LIABILITY INSURANCE
BIOSITE and MERCK shall maintain products liability insurance for the
PRODUCTS covering products liability which might arise from the
development and manufacture of the PRODUCTS and the distribution, sale
or use of the PRODUCTS in the TERRITORY.
5. OBLIGATIONS OF BIOSITE
5.1 SALES SUPPORT. BIOSITE shall provide MERCK regularly with literature on
PRODUCTS and technical information relating to the PRODUCTS and their
proper use. Unless otherwise expressly agreed by BIOSITE, all such
information and materials will be furnished in the English language and
at no extra cost for MERCK.
5.2 NOTIFICATION OF CHANGES. BIOSITE shall notify MERCK of any changes in
or affecting the PRODUCTS or prices, terms and conditions of sale,
sales policies, projected delivery dates, and other matters that
BIOSITE determines may affect the business of MERCK.
5.3 ASSISTANCE. BIOSITE shall provide MERCK with reasonable access to and
assistance of its technical, sales, and service personnel in San Diego,
California as BIOSITE deems appropriate. Such assistance shall be
without charge to MERCK except as may be otherwise mutually agreed.
6. CONFIDENTIALITY AND PROPRIETARY RIGHTS
6.1 CONFIDENTIALITY OF SALES AND PRODUCT DATA. MERCK shall hold in strict
confidence all CONFIDENTIAL INFORMATION relating to the PRODUCTS
received from BIOSITE or its agents and shall not divulge the same to
any other person, firm, or corporation or use such CONFIDENTIAL
INFORMATION for any purpose without the prior written permission of
BIOSITE, except as reasonably required to perform its
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obligations under this AGREEMENT; provided, however, MERCK shall have
no liability to BIOSITE with respect to use, or disclosure to others
not parties to this AGREEMENT, of such information as MERCK can
establish by written documentation to:
a) Have been publicly known prior to the disclosure of such
information to MERCK;
b) Have become publicly known, without fault on the part of
MERCK, subsequent to disclosure by BIOSITE of such information
to MERCK;
c) Have been otherwise known by MERCK prior to communication by
BIOSITE to MERCK of such information; or
d) Have been received by MERCK at any time from a source other
than BIOSITE lawfully having the right to disclose such
information.
MERCK agrees that any disclosure of the CONFIDENTIAL INFORMATION within
MERCK will only be such as is reasonably necessary and will only be to
employees of MERCK who are bound by written agreements with MERCK to
maintain the CONFIDENTIAL INFORMATION in confidence. The obligation of
MERCK under this Section 6.1 shall survive termination of this
AGREEMENT for any reason for a period of 5 years.
6.2 USE OF PATENTS. BIOSITE does not, either expressly or impliedly, grant
any licenses to MERCK under any patents owned or controlled by BIOSITE
or under which BIOSITE has any rights, except the right to sell and use
the PRODUCTS. BIOSITE does not grant any rights to manufacture under
this AGREEMENT.
6.3 TRADEMARKS AND TRADE NAMES. MERCK shall not use any of BIOSITE's
trademarks, or any xxxx or name confusingly similar thereto, as part of
its corporate or business name or in any manner, except that
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a) MERCK may identify itself as an authorized distributor of
BIOSITE and
b) MERCK may use BIOSITE's trademarks relating to the PRODUCTS
for display purpose in connection with solicitation of orders
for PRODUCTS. MERCK will not alter, remove or modify any
BIOSITE trademarks, labels or markings, nor affix any other
trademarks, labels or markings to the PRODUCTS without
BIOSITE's consent; provided that MERCK may affix labels or
other indices on PRODUCTS it distributes to identify it as the
distributor of PRODUCTS so long as such labels do not cover
and are not inconsistent with BIOSITE's trademarks, labels or
markings. BIOSITE shall register its trademark "TRIAGE" in
major countries of the TERRITORY as determined by BIOSITE. All
trademark registrations will be paid by BIOSITE. No other
MERCK labels, package inserts or other material shall
accompany the PRODUCTS without the approval of BIOSITE.
6.4 PROTECTION OF PROPRIETARY RIGHTS. MERCK agrees to cooperate with and
assist BIOSITE, at BIOSITE's expense, in the protection of trademarks,
patents, or copyrights owned by or licensed to BIOSITE and shall inform
BIOSITE immediately of any infringements or other improper action with
respect to such trademarks, patents, or copyrights that come to the
attention of MERCK.
7. TERM AND TERMINATION
7.1 TERM. Unless terminated as provided in Section 7.2 below or by mutual
written consent, this AGREEMENT shall continue in full force and effect
for an initial term expiring five (5) years after the date hereof and
thereafter shall be automatically renewed for successive one year
terms, unless terminated by either party by written notice to the other
at least six (6) months
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prior to the expiration of the initial or any renewal term thereof.
It is understood and agreed that after the expiration of the initial or
any renewal term, both BIOSITE and MERCK shall have no obligation,
express or implied, to renew this AGREEMENT.
7.2 TERMINATION. This AGREEMENT may be terminated prior to expiration of
the initial or any renewal term, as provided in Section 7.1 above as
follows:
a) By either party, in the event the other party should fail to
perform any of its obligations hereunder and should fail to
remedy such non-performance within thirty (30) calendar days
after receiving written demand therefor;
b) By either party, effective immediately, if the other party
should become the subject of any voluntary or involuntary
bankruptcy, receivership, or other insolvency proceedings or
make an assignment of all or substantially all of its assets
for the benefit of its creditors, or if such other party
should be nationalized or have any of its material assets
expropriated;
c) By BIOSITE, effective immediately, with respect to any country
if any law or regulation should be adopted or in effect that
would restrict BIOSITE's termination rights, prohibit
performance of any obligations of BIOSITE hereunder or
otherwise invalidate any provisions hereof.
d) By BIOSITE, if MERCK fails to meet the minimum annual purchase
quantities as specified in EXHIBIT V during each of the
calendar years indicated.
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7.3 RIGHTS OF PARTIES ON TERMINATION. The following provisions shall apply
on the termination or expiration of this AGREEMENT.
a) MERCK shall cease all sales and other activities on behalf of
BIOSITE and shall return to BIOSITE and immediately cease all
use of any CONFIDENTIAL INFORMATION of BIOSITE then in MERCK's
possession; provided however, that MERCK may continue to use
any CONFIDENTIAL INFORMATION that falls within the proviso of
Section 6.1 (a) - (c).
b) Upon termination by BIOSITE after the initial term pursuant to
Section 7.1 above, BIOSITE will repurchase and MERCK agrees to
sell BIOSITE MERCK's inventory of BIOSITE's PRODUCTS at
MERCK's purchase price as defined in Section 3.1 plus
reasonable freight, insurance and duties. Upon termination by
BIOSITE or MERCK pursuant to Section 7.2 above, BIOSITE may,
at its option, repurchase and MERCK agrees to sell MERCK's
inventory of BIOSITE's PRODUCTS at MERCK's purchase price as
defined in Section 3.1 plus reasonable freight, insurance and
duties. In case BIOSITE is not willing to repurchase MERCK's
inventory, MERCK is allowed to sell off the remaining stock of
PRODUCTS.
c) MERCK shall remove from its property and immediately
discontinue all use, directly or indirectly, of trademarks,
designs, and markings owned or licensed exclusively by
BIOSITE, or any word, title, expression, trademark, design, or
marking that is confusingly similar thereto.
d) Notwithstanding Section 7.3 (c), in case of termination of
this AGREEMENT, MERCK and BIOSITE will negotiate in good faith
the continuation of the delivery of PRODUCTS due to still
effective long-term contracts with CUSTOMERS in the TERRITORY.
In case of termination of this AGREEMENT, BIOSITE warrants
either to
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- continue to sell PRODUCT(S) to such CUSTOMERS
directly, or to
- enable MERCK to continue the purchase of PRODUCTS for
CUSTOMERS holding such long term contracts, on the
terms and conditions provided for under this
AGREEMENT.
e) In accordance with Section 4.4 (d), MERCK will assist BIOSITE
in obtaining any registrations necessary for BIOSITE (or
BIOSITE's agent) to continue selling PRODUCTS in the
TERRITORY.
7.4 SOLE REMEDY. BIOSITE's repurchase of MERCK's inventory of PRODUCTS
pursuant to Section 7.3 (b), or MERCK's right to sell such inventory if
not so repurchased by BIOSITE, shall constitute MERCK's sole remedy for
the termination or nonrenewal of this AGREEMENT. Under no circumstances
shall BIOSITE be liable to MERCK by reason of termination or nonrenewal
of this AGREEMENT for compensation, reimbursement, or damages for:
a) loss of prospective compensation;
b) goodwill or loss thereof; or
c) expenditures, investments, leases, or any type of commitment
made in connection with the business of such party or in
reliance on the existence of this AGREEMENT.
8. CONCILIATION AND ARBITRATION
8.1 CONCILIATION. The parties shall exercise their best efforts to settle
between themselves in an amicable way any dispute, controversy or claim
which may arise out of or in connection with this AGREEMENT within
thirty days of notice of a dispute from the other party.
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8.2 ARBITRATION. Any dispute, controversy or claim arising out of or
relating to this AGREEMENT, its negotiations, execution,
interpretation, performance or termination, shall if not settled by the
parties in accordance with Section 8.1 be referred to and resolved by
arbitration.
The arbitration shall be conducted in accordance with the American
Arbitration Association Commercial Arbitration Rules in New York, NY,
according to the laws of the State of New York, and as follows:
a) The arbitral tribunal shall be composed of three persons each
of whom shall be neutral, independent and impartial. Each
party shall nominate an arbitrator, and the two arbitrators so
appointed shall appoint a third, who shall act as president of
the arbitral tribunal. If either party fails to nominate an
arbitrator within 30 days of receiving notice of the
nomination of an arbitrator by the other party, such (second)
arbitrator shall be appointed at the request of the first
party by the American Arbitration Association. If the two
arbitrators selected by the parties fail to select a third,
presiding arbitrator within 20 days of the appointment of the
second arbitrator, the third arbitrator shall be appointed at
the request of the first party by the American Arbitration
Association.
b) The arbitrators shall hold a preliminary meeting with the
parties within 30 days of the appointment of the third or
presiding arbitrator for the purpose of determining the issues
to be decided in the arbitration, the specific procedures to
be followed and the schedule for briefing and/or hearings. The
arbitrators shall hold a hearing which, unless the parties
otherwise agree, should be recorded by stenographic or other
means. Within 120 days of the preliminary meeting (except in
extraordinary cases), the arbitrators shall issue an award in
writing which shall state the reasons for the award and which,
except as set forth in the following sentence, shall be final
and binding between the parties. Judgment upon the award
rendered by the arbitrators may be entered in any court having
jurisdiction.
-16-
21
c) The parties agree that the award of the arbitrators shall be
the sole and exclusive remedy between them regarding any
claims, counterclaims, issues or accountings presented or pled
to the arbitrators; that it shall be made and shall promptly
by payable in U.S. dollars free of any tax, deduction or
offset; and that any costs, fees or taxes incident to
enforcing the award shall, to the maximum extent permitted by
law, be charged against the party resisting such enforcement.
d) The arbitrators shall render their decision in accordance
with, the substantive laws of the State of New York, without
regard to its choice of law rules.
Notwithstanding the foregoing sentence, questions concerning
arbitrability under this dispute resolution clause shall be
governed exclusively by the United States Arbitration Act. The
arbitrators shall be empowered to consider and decide claims
or issues arising under or relating to state and Federal
statutes governing business practices, but shall not be
empowered to nor shall they award punitive damages.
e) As part of any arbitral award rendered pursuant to this
paragraph, the arbitrators shall make an award of arbitral
costs and reasonable attorneys' fees to the prevailing party.
9. GENERAL PROVISIONS.
9.1 ENTIRE AGREEMENT. This AGREEMENT represents the entire AGREEMENT
between the parties on the subject matter hereof and supersedes all
prior discussions, agreements, and understandings of every kind and
nature between them. No modification of this AGREEMENT will be
effective unless in writing and signed by both parties.
-17-
22
9.2 AUTHORIZATION. BIOSITE and MERCK each represent and warrant to the
other that:
a) all corporate action on the part of BIOSITE or MERCK, as the
case may be, and their officers and directors, necessary for
the authorization, execution and delivery of this AGREEMENT
and the performance of all of their obligations hereunder, has
been taken prior to the date hereof;
b) that the officer signing this AGREEMENT below is the duly
authorized representative of BIOSITE and MERCK, as the case
may be; and
c) that this AGREEMENT constitutes a valid and legally binding
obligation of BIOSITE or MERCK, as the case may be,
enforceable in accordance with its terms, except as affected
by
(i) bankruptcy or insolvency laws, or
(ii) equitable principles.
9.3 COMPLIANCE OF AGENCIES AND SUBSIDIARIES
MERCK will make reasonable effort to have its AGENCIES comply with the
provisions of this AGREEMENT.
9.4 NOTICES. All notices under this AGREEMENT shall be in English and shall
be in writing and given by air mail or facsimile addressed to the
parties at the following addresses:
-18-
23
If to BIOSITE
BIOSITE Diagnostics Incorporated
00000 Xxxxxxx Xxxxxx, Xxxxx X
Xxx Xxxxx, Xxxxxxxxxx 00000
United States of America
Attn: Xxx X. Xxxxxxxxxxxx, President
With copy to:
Xxxxxx X. Xxxxxx, Xx.
Pillsbury Madison & Sutro
235 Xxxxxxxxxx St--P. O. Xxx 00 00
Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
Xxxxxx Xxxxxx of America
-19-
24
If to MERCK:
E. Merck
Xxxxxxxxxxx Xxxxxxx 000
D - 6100 Xxxxxxxxx 0
Xxxxxxx Xxxxxxxx of Germany
Attn: Xx. Xxxxxx Xxxxxxxx, General Manager Marketing and Sales
Diagnostics Division.
or to such other address of which either party may advise the other in
writing. Notices will be deemed given when sent.
9.5 EXPENSES OF ARBITRATION AND/OR LITIGATION. Should any party institute
any action or proceeding to enforce this AGREEMENT or any provision
hereof, or for damages by reason of any alleged breach of this
AGREEMENT or of any provision hereof, or for a declaration of rights
hereunder, the prevailing party in any such action or proceeding shall
be entitled to receive from the other party all costs and expenses,
including reasonable attorneys' fees, incurred by the prevailing party
in connection with such action or proceeding.
9.6 FORCE MAJEURE. Each party shall be excused from any delay or failure in
performance caused by reason of any occurrence or contingency beyond
its reasonable control, including, but not limited to an act of God,
earthquake, labor disputes, riots, government requirements, regulatory
and environmental requirements, inability to secure materials and
transportation difficulties. The obligations and rights of the party so
excused shall be extended on a day-to-day basis for the time period
equal to the period of such excusable delay.
-20-
25
9.7 TITLES AND HEADINGS. Titles and headings of sections of this AGREEMENT
are for convenience of reference only and shall not affect the
construction of any provision of this AGREEMENT.
9.8 ASSIGNMENTS. This AGREEMENT and the rights, duties and obligations
hereunder may not be assigned by any party without the prior written
consent of the other party. A merger, acquisition, or sale of all or
substantially all of the assets of a party shall not be deemed an
assignment requiring the consent of the other party hereto.
9.9 SUCCESSORS AND ASSIGNS. This AGREEMENT and the provisions hereof shall
be binding upon and inure to the benefit of each of the parties and
their respective heirs, executors, administrators, successors, and
permitted assigns.
9.10 SEVERABILITY. The illegality or unenforceability of any provision of
this AGREEMENT shall not effect the validity and enforceability of any
legal and enforceable provisions hereof.
9.11 LANGUAGE. The English language version of this AGREEMENT shall govern
and control any translations of this AGREEMENT into any other language.
9.12 APPLICABLE LAW. This AGREEMENT shall be construed and enforced in
accordance with the laws of the State of New York without regard to New
York choice of law rules.
9.13 WAIVER. MERCK agrees that the failure of BIOSITE at any time to require
performance by MERCK of any of the provisions herein shall not operate
as a waiver of the right of BIOSITE to request strict performance of
the same or like provisions or any other provisions hereof, at a later
time.
IN WITNESS WHEREOF, BIOSITE and MERCK have caused this AGREEMENT to be
executed by their duly authorized employees, as of the day and year
first above written.
BIOSITE DIAGNOSTICS E. MERCK
INCORPORATED
-21-
26
by ppa i.V.
/s/ Xxx X. Xxxxxxxxxxxx /s/ Xx. Xxxxxx Xxxxxxxx /s/ Xx. Xxxxxx Xxxxxx
----------------------- ----------------------- ---------------------
Xxx X. Xxxxxxxxxxxx Xx. Xxxxxx Xxxxxxxx Xx. Xxxxxx Xxxxxx
President General Manager Head of Department
Marketing and Sales Marketing and Sales
Diagnostics Division Clinical Chemistry and Systems
Diagnostics Division
(Title) (Title) (Title)
-22-
27
EXHIBIT I
Notwithstanding the other provisions of this AGREEMENT, MERCK and BIOSITE agree
that BIOSITE may, in consultation with MERCK, promote, market and sell
PRODUCT(S) in the INTERVENTION SEGMENT in Germany directly using sales personnel
of BIOSITE or any subsidiary of BIOSITE. BIOSITE shall take orders from such
CUSTOMERS in the INTERVENTION SEGMENT in Germany, and shall negotiate the terms
of sale for such CUSTOMERS including, without limitation, the quantity of
PRODUCT(S) sold.
BIOSITE will inform MERCK by fax of every order received, including: (i)
customer; (ii) quantity of kits; and (iii) selling price.
MERCK agrees to fill BIOSITE's orders for PRODUCT(S) in the INTERVENTION SEGMENT
in Germany. MERCK will invoice the CUSTOMER and transfer the gross proceeds from
such sales in the INTERVENTION SEGMENT less [CONFIDENTIAL MATERIAL REDACTED AND
FILED SEPARATELY WITH THE COMMISSION] per kit ( 25 devices) to BIOSITE on a
monthly basis in U.S. dollars in accordance with the rate of exchange set forth
in Section 3.1, as adjusted by agreement of MERCK and BIOSITE. MERCK and BIOSITE
agree that BIOSITE shall not sell in the MEDICAL SEGMENT and that MERCK shall
not sell in the INTERVENTION SEGMENT in Germany.
MERCK and BIOSITE mutually agree, that Igoda S.A. (Spain) and Merck Clevenot
S.A. (France) will use their best efforts to build the market and to meet the
success criteria as follows:
Igoda S.A. (Spain) 400 test kits (25 test devices each) minimum
within the first 12 months
Merck Clevenot (France) 400 test kits (25 test devices each) minimum
within the first 12 months
In case these criteria are not met, the parties will negotiate an approach along
the lines of the German model.
The INTERVENTION SEGMENT comprises:
- prisons
- parole programs
- public and private sector workplace testing
- industrial work doctors, except MERCK customers as of the date of this
AGREEMENT.
- U.S. military hospitals and on-site testing programs (i.e., Alcohol and
Drug Coordination Centers [ADCO], recruiting centers)
- high school, college, university and professional sports programs and
associations
- government agencies and customs
- public carriers
- police and criminal police
- blood drawing sites outside hospital
- specific methadone programs outside the MEDICAL SEGMENT
The MEDICAL SEGMENT comprises:
- hospitals (including government, university, non-U.S. military and
psychiatric hospitals)
- non-U.S. military on-site testing programs
- emergency rooms and ambulances
- reference labs
- industrial work doctors (MERCK customers), as of the date of this AGREEMENT
- drug information centers
- drug rehabilitation centers
- methadone programs within the MEDICAL SEGMENT
- health maintenance organizations
- xxxxxxx xxxxxxxxxx centers
- private/public forensic institutes
- private/commercial labs
- medical specialists for laboratory diagnostics
- physicians and physician group practices
EXHIBIT I continued
- wholesale dealers
- pharmacies
- police doctors
28
EXHIBIT II
(Product specifications)
Merck Cat. No. 16477
Products: (a) BIOSITE's Triage 7 Panel (the "Triage 7 Panel") for
abused drugs which includes tests for the following abused
drugs: Phencyclidine; Tetrahydrocannabinol; Cocaine;
Amphetamines/Methamphetamines; Opiates; Benzodiazepines; and
Barbiturates.
(b) BIOSITE's proposed Triage 8 Panel (the "Triage 8 Panel") for
abused drugs which includes tests for the following abused
drugs: Phencyclidine; Tetrahydrocannabinol; Cocaine;
Amphetamines/Methamphetamines; Opiates; Benzodiazepines; and
Barbiturates and Methadone.
(c) Any modified or improved versions of BIOSITE's Triage 7 Panel or
Triage 8 Panel which BIOSITE offers to MERCK for sale in the
TERRITORY.
Method of The Triage(R) Panel for Drugs of Abuse is a competitive
analysis: binding immunoassay in which a chemically labeled drug (drug
conjugate) competes with drug which may be present in the urine
for antibody binding sites. After a brief incubation, the
reaction mixture is transferred to the membrane in the Detection
Area. Free drug conjugate that is displaced from antibody
binding sites by drug in the urine, binds to a zone of
monoclonal antibody that is immobilized on the membrane. The
membrane is washed to remove the unbound conjugate and clear the
background. Test results are visually read.
A positive specimen produces a distinct colored bar in the Drug
Detection Zone adjacent to the drug name. A negative specimen
does not produce a colored bar.
Shelf-life: The current PRODUCT shelf-life is 9 months upon date of invoice.
BIOSITE will use its best efforts to extend PRODUCT shelf-life
to 12 months until market launch of the PRODUCT by MERCK, and to
18 months as soon as ongoing real-time stability tests provided
results accordingly.
Storage: The reagents contained in the Triage(R) Panel for Drugs of
Abuse should be stored at room temperature (15 degrees - 25
degrees C) and are stable until the date stamped on the outer
box. MERCK is responsible for maintaining PRODUCT temperature
during any shipment of the PRODUCT.
Package: Triage(R)7 and Triage(R)8
25 test cassettes/kit
---------------------
Test Device 25 each
Wash Solution 1 x 8 ml
Pipet 1 each
Pipet Tips 50 each
Artwork: The layouts for outer box, foil pouch and wash solution labels
and the films for insert-sheets will be sent to BIOSITE by
MERCK. Printing, packing and labeling by BIOSITE.
Reagents: Mouse monoclonal antibodies against Phencyclidine
Benzodiazepines, Cocaine, Amphetamines/Methamphetamines,
Tetrahydrocannabinol, Opiates and Barbiturates immobilized on
a membrane.
Mouse monoclonal antibodies against Phencyclidine,
Benzodiazepines, Cocaine, Amphetamines/Methamphetamines,
Tetrahydrocannabinol, Opiates and Barbiturates lyophilized in a
protein matrix containing (less than) 0.01% sodium azide.
Lyophilized TRIS and TRIS X HCI buffer (final concentration 200
mmol/1)
Reagents Wash 100 mmol/1 Boric acid
Solution: 150 mmol/1 Sodium Chloride
0.02% Triton X-100
0.02% Sodium Azide
Certificates: BIOSITE shall provide MERCK with a notarially certified copy of
a certificate confirming that BIOSITE produces according to GMP
(Good Manufacturing Practice) for all products listed above.
Quality A lot-specific quality-control report sheet is provided by
control: BIOSITE with each shipment.
A Quality control test procedure (QTP) is provided by BIOSITE.
Price per kit: See EXHIBIT IV.
[See also PRODUCT insert, attached.]
29
EXHIBIT III
(Territory)
COUNTRIES:
Europe: Including but not limited to, Germany, Austria, Switzerland,
France, Spain, Portugal, Italy, Belgium, Netherlands and
Luxembourg, Scandinavia, UK, Ireland, Turkey, Slovenia, Croatia,
Yugoslavia
East Europe: Former Warsaw Pact Countries, including CIS (former USSR)
Middle East: Israel, Syria, Saudi-Arabia, Iran, Iraq, Kuwait, United Arab
Emirates
North Africa: Egypt, Tunisia, Libya, Algeria, Morocco
Republic of South Africa
Pakistan, India
30
EXHIBIT IV
(Price)
BIOSITE and MERCK agree to following transfer prices for the PRODUCTS as defined
in EXHIBIT II fca airport San Diego, CA.
These prices are valid from the date of signature of this AGREEMENT, subject to
Section 3.1.
TRIAGE(R) 7: [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION]per test kit (25 test
devices) including packaging and labeling.
TRIAGE(R) 8: [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] per test kit (25
test devices) including packaging and labeling.
31
EXHIBIT V
BIOSITE and MERCK mutually agree on the following minimum quantities of test
devices to be purchased by MERCK from BIOSITE in the calendar year indicated
including those being sold directly by BIOSITE to CUSTOMERS in the TERRITORY, as
defined in EXHIBIT I.
1. Calendar year 1993: 70,000
2. Calendar year 1994: 90,000
3. Calendar year 1995: 130,000
4. Calendar year 1996: 150,000 to 200,000
5. Calendar year 1997: [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
Calendar year 1996 and 1997 quantities are non-binding forecasts and will be
renegotiated at the end of calendar year 1995 but in any case the quantities for
1996 and 1997 should be no less than [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] of the actual purchases of the previous calendar
year.
32
FIRST AMENDMENT
TO THE DISTRIBUTORSHIP AGREEMENT
between
E. Merck, Xxxxxxxxxxx Xxxxxxx 000, 0000 Xxxxxxxxx, Xxxxxxx Xxxxxxxx of Germany -
hereinafter called MERCK - and BIOSITE DIAGNOSTICS INCORPORATED, 00000 Xxxxxxx
Xxxxxx, Xxxxx X, Xxx Xxxxx, XX 00000, United States of America - hereinafter
called
BIOSITE -
PREAMBLE
WHEREAS, both parties have concluded a Distributorship Agreement
on July 27, 1992;
WHEREAS, due to a change in the distribution policy of BIOSITE, MERCK shall also
be the exclusive distributor of BIOSITE in the Federal Republic of Germany and
Latin America;
NOW, THEREFORE, in consideration of the premises and of the mutual promises of
the parties hereinafter set forth, the parties agree to the following changes of
the Distributorship Agreement:
Section 1
Section 1.4 will be deleted.
Section 2
Section 1.6 will read:
The term "TERRITORY" when used herein means the countries listed in Exhibit III.
Section 3
EXHIBIT I will be deleted.
Section 4
The following additional countries will be added to Exhibit III
Latin America: Including, but not limited to: Argentina, Brazil, Chile,
Mexico, Peru, Venezuela
-1-
33
Section 5
Exhibit IV (Price) will be amended the following way:
BIOSITE and MERCK agree to the following transfer prices for the PRODUCTS
purchased and distributed in Latin America by Latin American affiliates of
MERCK:
Triage(R) 7: [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] for each 25
cassette kit and [CONFIDENTIAL MATERIAL REDACTED
AND FILED SEPARATELY WITH THE COMMISSION] for
each 10 cassette kit
Triage(R) 8: [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] for each 25
cassette kit and [CONFIDENTIAL MATERIAL REDACTED
AND FILED SEPARATELY WITH THE COMMISSION] for
each 10 cassette kit
BIOSITE will be responsible for remitting a commission to MERCK (Darmstadt) of
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] per 25
cassette kit and [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION] per 10 cassette kit purchased by Latin American affiliates of MERCK
by August 15 for purchases during the period January 1 through June 30 and by
February 15 for purchases during the period July 1 through December 31 during
the term of this agreement. Payment of the commission may be in the form of
cash, credit note, or no-charge kits shipped to MERCK (Darmstadt), at the
discretion of BIOSITE.
Section 6
EXHIBIT V will be changed and amended the following way:
1. BIOSITE and MERCK mutually agree on the following minimum quantities of
test devices to be purchased by MERCK from BIOSITE in the calendar year
indicated:
1. Calendar year 1993: 70,000
2. Calendar year 1994: 90,000
3. Calendar year 1995: 130,000
4. Calendar year 1996: 150,000 TO 200,000
5. Calendar year 1997: [CONFIDENTIAL MATERIAL
REDACTED AND FILED SEPARATELY WITH THE COMMISSION]
Calendar year 1996 and 1997 quantities are non-binding forecasts and
will be renegotiated at the end of calendar year 1995 but in any case
the quantities for 1996 and 1997
-2-
34
should be no less than [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] of the actual purchases of the previous
calendar year.
2. MERCK and BIOSITE mutually agree that Igoda S.A. (Spain)
and Merck Clevenot S.A. (France) will use their best
efforts to build the market and to meet the success
criteria as follows:
Igoda S.A. (Spain) 400 test kits (25 test devices each)
minimum within the first 12 months
Merck Clevenot (France) 400 test kits (25 test devices each)
minimum within the first 12 months
If MERCK fails to meet said success criteria for Igoda S.A. (Spain) and
Merck Clevenot S.A. (France) the parties will negotiate an amendment to
the Distributorship Agreement.
Darmstadt, 10 November San Diego, /s/ Xxx Xxxxxxxxxxxx
---------------------
MERCK Biosite Diagnostics
Incorporated
ppa i.V.
/s/ Xx. Xxxxxxxx /s/ Xx. Xxxxxxx
---------------- ---------------
Xx. Xxxxxxxx Xx. Xxxxxxxx Xx. Xxxxxxxxxxxx
-3-
35
SECOND AMENDMENT
TO THE DISTRIBUTORSHIP AGREEMENT
between
E. Merck, Xxxxxxxxxxx Xxxxxxx 000, 00000 Xxxxxxxxx, Xxxxxxx Xxxxxxxx of Germany
- hereinafter called MERCK - and BIOSITE DIAGNOSTICS INCORPORATED, 00000 Xxxxxxx
Xxxxxx, Xxxxx X, Xxx Xxxxx, XX 00000, United States of America - hereinafter
called BIOSITE
PREAMBLE
WHEREAS, both parties have concluded a Distributorship Agreement
on July 27, 1992;
WHEREAS, BIOSITE and MERCK have agreed to a reduction of the
transfer prices for the PRODUCTS as defined in EXHIBIT II;
NOW, THEREFORE, in consideration of the premises and of the mutual promises of
the parties hereinafter set forth, the parties agree to the following changes of
the Distributorship Agreement:
Section 1
EXHIBIT IV (Price) will be amended the following way:
BIOSITE and MERCK agree to the following transfer prices for the PRODUCTS as
defined in EXHIBIT II fca airport San Diego, CA.
These prices are valid from January 1, 1994 for one year.
Triage(R) 6: [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] US$ per 25-test kit
and [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] US$ per 10-test kit
including packaging and labeling.
Triage(R) 7: [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] US$ per 25-test kit
and [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] US$ per 10-test kit
including packaging and labeling.
Section 2
EXHIBIT V will be amended the following way:
-1-
36
The 1994 minimum quantity of test cassettes to be purchased by MERCK and its
affiliates will be 90,000 cassettes.
The transfer price and the minimum purchase quantities for 1995 through 1997
remain as in the Distributorship Agreement subject to discussion based on
actual experiences in 1994.
Darmstadt, 12 January 1994
MERCK Biosite Diagnostics
ppa i.V. Incorporated
/s/ Xx. Xxxxxxxx /s/ Xx. Xxxxxxx /s/ Xxx X. Xxxxxxxxxxxx
---------------- --------------- -----------------------
Xx. Xxxxxxxx Xx. Xxxxxxxx Xx. Xxxxxxxxxxxx
-2-
37
11.12.95 [MERCK logo]
DIAG M
Xx. X. Xxx
6120
781337 Merck KGaA Darmstadt Deutschland
------------------------------------
AMENDMENT TO THE DISTRIBUTORSHIP AGREEMENT
between
Merck XXxX, Xxxxxxxxxxx Xxx. 000, 00000 Xxxxxxxxx, Xxxxxxx Xxxxxxxx of Germany -
hereinafter called MERCK - and BIOSITE DIAGNOSTICS Incorporated, 00000 Xxxxxxx
Xxxxxx, Xxx Xxxxx, XX 00000, Xxxxxx Xxxxxx of America - hereinafter called
BIOSITE.
BIOSITE agrees to invoice MERCK at [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] per device for TRIAGE(R) 7 and TRIAGE(R) 8
beginning November 1, 1995. The price shall be subject to change by BIOSITE on
1-year's notice to MERCK.
BIOSITE and MERCK mutually agree on the quantity of 150,000 test devices to be
purchased by MERCK from BIOSITE in 1996 including those being sold directly by
BIOSITE to CUSTOMERS in the TERRITORY, as defined in EXHIBIT I, and Thailand.
The non-binding forecast for 1997 of [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] test devices will be renegotiated at the end of
the year.
This amendment will replace the EXHIBITS IV and V in the distributorship
agreement.
Besides this, the terms and conditions of the distributorship agreement and its
amendments are applicable.
Darmstadt, 11th December 1995
Merck KGaA Biosite Diagnostics
i.V. i.V. President
38
/s/ Xx. Xxxxxxx /s/ Xx. Xxx /s/ Xxx Xxxxxxxxxxxx
--------------- ----------- --------------------
(Xx. Xxxxxxxx) (Xx. Xxx) (Xxx Xxxxxxxxxxxx)
