EXHIBIT 10.20
[METRA
BIOSYSTEMS LOGO]
INTERNATIONAL DISTRIBUTOR AGREEMENT
This International Distributor Agreement (the "Agreement") is entered
into in Palo Alto, California, as of April 8, 1993, between METRA BIOSYSTEMS,
INC., a corporation organized under the laws of California, United States of
America, with principal offices at 3181 Porter Drive, Palo Alto, California
94304, United States of America, ("Manufacturer") and Amersham K.K., an
organization organized under the laws of Japan with offices at Tokyo Toyama
Kaikan, 1-3, Kakusan 5-Chome, Bunkyo-ku, Tokyo 112, Japan ("Distributor").
In consideration of the mutual promises contained herein, the parties
agree as follows:
1. DEFINITIONS
(a) "Products" shall mean those products listed in EXHIBIT A
attached hereto to be distributed solely for research purposes. Metra
Biosystems may appoint other parties to develop and commercialize products
for clinical use. Products may be changed, abandoned or added by
Manufacturer, at Manufacturer's sole discretion, provided that Manufacturer
gives ninety (90) days' prior written notice to Distributor. Manufacturer
shall be under no obligation to continue the production of any Product,
except as provided herein.
(b) "Territory" shall mean that geographic area identified in
EXHIBIT B attached hereto.
2. APPOINTMENT AND AUTHORITY OF DISTRIBUTOR
(a) APPOINTMENT. Subject to the terms and conditions set forth
herein, Manufacturer hereby appoints Distributor as Manufacturer's
distributor for the Products in the Territory, and Distributor hereby accepts
such appointment. For so long as Distributor is performing in compliance with
this Agreement, Manufacturer shall not appoint any other distributor with
responsibility for sale of the Products in the Territory.
(b) TERRITORIAL RESPONSIBILITY. Distributor shall not promote the
Products outside the Territory or establish a facility for purposes relating
to the Products outside the Territory. Distributor shall forward to
Manufacturer all unsolicited inquiries relating to the Products from
customers or potential customers outside the Territory.
(c) OTHER DISTRIBUTORS. In the event that Manufacturer receives
requests for information relating to, or purchase orders for, the Products
from customers or potential customers within the Territory, Manufacturer
shall forward such requests or orders to Distributor. Notwithstanding the
above, nothing in this
Agreement shall prevent Manufacturer's other distributors from selling
Products in the Territory, so long as such sales are not solicited in the
Territory. In the event that Distributor becomes aware that other
distributors of Manufacturer are selling Products in the Territory, and
provides Manufacturer written notice thereof, Manufacturer will use
Manufacturer's commercially reasonable efforts to limit such sales of Products.
(d) CONFLICT OF INTEREST. Distributor warrants to Manufacturer that
Distributor does not currently represent or promote any lines or products
that compete with the Products. During the term of this Agreement,
Distributor shall not, without Manufacturer's prior written consent,
represent, promote or otherwise try to sell within the Territory any lines or
products that, in Manufacturer's judgment, compete with the Products covered
by this Agreement.
(e) INDEPENDENT CONTRACTORS. The relationship of Manufacturer and
Distributor established by this Agreement is that of independent
contractors, and nothing contained in this Agreement shall be construed to
give either party the power to direct and control the day-to-day activities
of the other or allow one party to create or assume any obligation on behalf
of the other for any purpose whatsoever. All financial obligations associated
with Distributor's business are the sole responsibility of Distributor. All
sales and other agreements between Distributor and Distributor's
customers are Distributor's exclusive responsibility and shall have no effect
on Distributor's obligations under this Agreement.
3. TERMS OF PURCHASE OF PRODUCTS BY DISTRIBUTOR
(a) TERMS AND CONDITIONS. All purchases of Products by Distributor
from Manufacturer during the term of this Agreement shall be subject to the
terms and conditions of this agreement.
(b) PRICES. All prices of Products are F.O.B. Manufacturer's
Distribution Site at the address listed for Manufacturer at the beginning of
this Agreement or as provided by written notice to Distributor. The purchase
price to Distributor for each of the Products ("Purchase Price") shall be as
set forth in EXHIBIT A attached hereto. The difference between Distributor's
Purchase Price and Distributor's selling price to Distributor's customers
shall be Distributor's sole remuneration for sale of the Products.
Manufacturer has the right at any time to revise the prices in EXHIBIT A with
sixty (60) days' advance written notice to Distributor; PROVIDED, that
Manufacturer shall not revise such prices more than once each calendar year.
Such revisions shall apply to all orders received after the effective date of
revision. Price changes shall not affect unfulfilled purchase orders accepted
by Manufacturer prior to the effective date of the price change.
(c) TAXES. Distributor's Purchase Price does not include any
federal, state or local taxes that may be applicable to the Products. In the
event that such taxes are applicable and Manufacturer has the legal
obligation to collect such taxes, Manufacturer shall be entitled to add to
Distributor's invoice the amount of such taxes and Distributor shall pay such
amount unless Distributor provides
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Manufacturer with a valid tax exemption certificate authorized by the
appropriate taxing authority.
(d) ORDER AND ACCEPTANCE. All orders for Products submitted by
Distributor shall be initiated by written purchase orders sent to
Manufacturer and requesting a delivery date during the term of this
Agreement; PROVIDED, HOWEVER, that an order may initially be placed orally or
by telecopy if a confirmational written purchase order is received by
Manufacturer within five (5) days after said oral or telecopy order. To
facilitate Manufacturer's production scheduling, Distributor shall submit
purchase orders to Manufacturer at least sixty (60) days prior to the first
day of the requested month of delivery. No order shall be binding upon
Manufacturer until accepted by Manufacturer in writing, and Manufacturer
shall have no liability to Distributor with respect to purchase orders that
are not accepted. No partial shipment of an order shall constitute the
acceptance of the entire order, absent the written acceptance of such entire
order. Manufacturer shall use Manufacturer's reasonable best efforts to
deliver Products at the times specified either in Manufacturer's quotation or
in Manufacturer's written acceptance of Distributor's purchase orders.
Notwithstanding the foregoing, Manufacturer shall have no obligation to
supply Products to Distributor during any period for which Distributor's
payments to Manufacturer hereunder are thirty (30) days or more past due.
(e) TERMS OF PURCHASE ORDERS. Distributor's purchase orders
submitted to Manufacturer from time to time with respect to Products to be
purchased hereunder shall be governed by the terms of this Agreement and
Manufacturer's published Standard Terms and Conditions of Sale as in effect
at the time of such purchase, PROVIDED that, in the event of any conflict
between the terms of this Agreement and the Standard Terms and Conditions of
Sale of Manufacturer then in effect, this Agreement shall be controlling.
Nothing contained in any purchase order of Distributor shall in any way
modify such terms of purchase of Manufacturer or add any additional terms or
conditions.
(f) PAYMENT. Full payment of Distributor's Purchase Price for the
Products (including any freight, taxes or other applicable costs initially
paid by Manufacturer but to be borne by Distributor) shall be in United States
of America dollars. All exchange, interest, banking, collection, and other
charges shall be at Distributor's expense. Payment terms shall be
[net forty-five] ([45]) days, and payment shall be made by wire transfer,
check or other instrument approved by Manufacturer. Any invoiced amount not
paid when due shall be subject to a service charge at the lower of the rate
of [one and one-half] percent ([1.5]%) per month or the maximum rate
permitted by law. If Distributor fails to make any payment to Manufacturer
when due, Manufacturer may, without affecting its rights under this
Agreement, cancel or delay any future shipments of the Products to
Distributor.
(g) SHIPPING. All Products delivered pursuant to the terms of this
Agreement shall be suitably packed for air freight shipment in Manufacturer's
standard shipping cartons, marked for shipment at Manufacturer's manufacturing
plant to Distributor's address set forth above, and delivered to Distributor
or Distributor's carrier agent F.O.B. Manufacturer's Distribution Site, at
which time title to such Products and risk of loss shall pass to Distributor.
All shipments of
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Products shall include a Certificate of Analysis for each lot. Manufacturer
shall deliver Products to the carrier selected by Distributor. In the event
that Distributor does not provide written notice of such carrier,
Manufacturer shall select the carrier. All freight, insurance, and other
shipping expenses, as well as any special packing expense, shall be paid by
Distributor. Distributor shall also bear all applicable taxes, duties,
and similar charges that may be assessed against the Products after delivery
to the carrier at Manufacturer's Distribution Site.
(h) REJECTION OF PRODUCTS. Distributor shall inspect all Products
promptly upon receipt thereof, such inspection to include, without
limitation, a quality control analysis to determine whether Products and,
where applicable, components thereof meet the specifications set forth in
then-current package inserts for such Products and components and the
Certificate of Analysis accompanying each shipment of Products. Distributor
may reject any Product or component thereof that fails in any material way to
meet such specifications. In the event that Distributor is not able to
conduct a quality control analysis, Distributor, at Distributor's expense,
may utilize contract facilities to conduct such analysis. Manufacturer will
maintain samples of each production lot of Product, and Distributor will
maintain samples of each shipment lot of Product, for archival purposes. Any
Product or component thereof not properly rejected within four (4) weeks
after receipt of that Product by Distributor ("Rejection Period") shall be
deemed accepted. If any Product is shipped by Distributor to Distributor's
customer prior to expiration of the Rejection Period, such unit shall be
deemed accepted upon shipment by Distributor. To reject a Product or a
component thereof, Distributor shall, within the Rejection Period, notify
Manufacturer in writing or by telecopy of Distributor's rejection of such
Product or component, stating the reason for such rejection. In the event
that Manufacturer, in Manufacturer's sole discretion, desires that
Distributor return a rejected Product or component thereof to Manufacturer,
Distributor shall return to Manufacturer the rejected Product or component
thereof, freight prepaid. Manufacturer will provide Distributor a credit to
be applied against Distributor's future Product orders equal to the freight
charges prepaid by Distributor for properly rejected Products or components
thereof. As promptly as possible but no later than thirty (30) working days
after receipt by Manufacturer of properly rejected Products or components
thereof, Manufacturer shall replace such Products or components. Manufacturer
shall pay shipping charges in connection with shipment of replaced Products
or components thereof to Distributor for properly rejected Products;
otherwise, Distributor shall be responsible for shipping charges. In the
event that such replaced Products or components are shipped to Distributor
together with Products corresponding to a purchase order pursuant to this
Agreement, shipping charges in connection with such shipment shall be
pro-rated between Manufacturer and Distributor. After the Rejection Period,
Distributor may not return any Products or, if applicable, components thereof
to Manufacturer for any reason without Manufacturer's prior written consent.
4. TRAINING AND SERVICE
(a) SERVICES BY DISTRIBUTOR. Distributor shall have the
responsibility to deliver the Products and train the customers with respect
to the Products sold.
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The services shall (i) be performed only by specially and properly trained
personnel of Distributor, (ii) be of the highest quality, and (iii) be
performed promptly.
(b) TRAINING BY MANUFACTURER. Manufacturer shall provide sales and
technical training, and technical support, to Distributor's personnel at
periodic intervals, with the frequency and content of the training to be
determined by agreement between Distributor and Manufacturer. Manufacturer
and Distributor shall each pay their own costs for travel, food, and lodging
during the training period. In addition to sales and technical training,
Manufacturer shall cooperate with Distributor in establishing efficient
promotional procedures and policies. Manufacturer shall promptly respond to
Distributor's reasonable technical questions relating to Product.
5. WARRANTY TO DISTRIBUTOR'S CUSTOMERS
(a) STANDARD LIMITED WARRANTY. Manufacturer warrants that the
Products sold to Distributor will comply at the time of shipment to
Distributor with the requirements of the U.S. Federal Food, Drug and Cosmetic
Act, if applicable. This warranty is contingent upon proper use of a Product
in the application for which such Product was intended and does not cover
Products that were modified without Manufacturer's approval, that have
expired or that were subjected by the customer to unusual physical, chemical
or electrical stress.
(b) NO OTHER WARRANTY. EXCEPT FOR THE EXPRESS LIMITED WARRANTY SET
FORTH IN SUBSECTION 5(a) ABOVE, MANUFACTURER GRANTS NO WARRANTIES FOR THE
PRODUCTS, (EXCEPT FOR THE IMPLIED WARRANTY OF TITLE) EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND
MANUFACTURER SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY OF QUALITY, WARRANTY
OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY
OF NONINFRINGEMENT.
(c) LIMITATION OF LIABILITY. MANUFACTURER'S LIABILITY UNDER THE
WARRANTY SHALL BE LIMITED TO A REFUND OF THE CUSTOMER'S PURCHASE PRICE. IN NO
EVENT SHALL MANUFACTURER BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE
GOODS BY THE CUSTOMER OR FOR ANY DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL OR
INCIDENTAL DAMAGES FOR BREACH OF WARRANTY, EXCEPT INSOFAR AS SUCH DAMAGES
RELATE TO DEATH OR PERSONAL INJURY RESULTING FROM MANUFACTURER'S GROSS
NEGLIGENCE.
(d) NO VERBAL REPRESENTATIONS OR WARRANTIES. Manufacturer shall not
be bound by any representations or statements on the part of its employees or
agents whether oral or in writing and including those made in catalogues and
other promotional material (excluding technical details and specifications)
except where such representations or statements are expressly made part of
this Agreement.
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6. ADDITIONAL OBLIGATIONS OF DISTRIBUTOR
(a) HEALTH AND SAFETY LAWS AND REGULATIONS. Distributor shall
comply fully, at its expense, with any and all applicable health and
safety laws and regulations of the Territory.
(b) REGISTRATIONS, LICENSES AND PERMITS. Distributor agrees to use
its best efforts to investigate, obtain government approval for, promote and
distribute the Products, (solely for research purposes) at its own expense,
in the Territory as soon as feasible after the date of this Agreement, using
generally the same channels and methods, exercising the same diligence and
adhering to the same standards which it employs with respect to other
research products sold by Distributor, as well as Distributor's own products,
if any. Unless prohibited by local law, all such registrations and approvals
obtained by Distributor shall be in the name of Manufacturer. In particular,
Distributor shall, at its own expense:
(i) Exercise due diligence to promptly obtain and maintain
government approvals to import, register and market the Products in each
jurisdiction in the Territory and to diligently proceed to secure and
maintain, as may be required from time to time, government importing,
registration and marketing approvals, customs clearances and currency
authorizations and any permits necessary in each jurisdiction in the
Territory. Distributor shall keep Manufacturer generally informed of the
regulatory requirements in each jurisdiction in the Territory and shall
submit to the government health authorities in each jurisdiction in the
Territory where sale of the Products is planned a complete application
for registration and marketing approval of the Products by the date set
forth in any marketing plan required by Manufacturer below. Distributor
shall file for regulatory approval for the sale of Products in the
Territory by Amersham K.K. If Manufacturer so requests, Distributor
shall notify Manufacturer each time it submits an application for
government registration and marketing approval for the Products and
shall, at Manufacturer's request, supply Manufacturer with copies of or
access to Distributor's filings and clinical data and shall keep
Manufacturer fully informed of the progress of each such application.
Manufacturer and Distributor agree to disclose promptly to the other all
reports and any information which they have available or which become
available to them relating to performance of, or any deleterious
physiological effects caused by or related to, the Products.
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(ii) Within thirty (30) days after the date of this Agreement,
submit to Manufacturer a complete marketing plan, prepared by
Distributor in good faith, which shall be subject to approval by
Manufacturer, for the Products in each jurisdiction in the Territory.
Such plan shall be updated and delivered to Manufacturer annually and
shall include, at a minimum, information on competitive products;
proposed labeling (including label, package insert, introductory folder
and advertising); estimated sales volume; anticipated quantities of the
Products to be purchased from Manufacturer; distribution and promotional
plans; schedule for submission of applications for government
registration and marketing approval; and marketing program. All Product
labels, package inserts and claims, which are prepared for or by
Distributor, shall meet all legal requirements of the jurisdiction in
which the Products are marketed and shall be subject to Manufacturer's
prior review and approval.
(iii) Commence marketing of the Products throughout the
Territory immediately after receipt of government health registration
approvals, if applicable. Distributor shall be deemed to have commenced
the marketing of the Products only when it shall have offered the
Products regularly for sale.
(iv) Use its best efforts to distribute and sell the Products
for research purposes only and for use only by qualified individuals, as
appropriate in the Territory, in compliance with local laws and
regulations and good commercial practice and for uses and applications
reasonably approved by Manufacturer for the Products.
In the event that all necessary registrations, licenses and permits required
to sell and distribute the Products in the Territory for clinical use (if
applicable) are not obtained within nine (9) months after the effective date
of this Agreement, Manufacturer may, in its sole discretion, terminate this
Agreement upon written notice to Distributor.
(c) QUARTERLY PURCHASE COMMITMENT. Distributor hereby agrees to
purchase from Manufacturer during the first eight (8) calendar quarter
periods commencing June 1, 1993 ("Quarterly Purchase Commitment") the number
of Products set forth on EXHIBIT C. Annually thereafter, Distributor and
Manufacturer shall mutually agree in writing on the Quarterly Purchase
Commitment for the next four calendar quarter periods. Throughout the term of
this Agreement, if (i) the parties cannot agree on Quarterly Purchase
Commitments, or (ii) Distributor fails to purchase Distributor's Quarterly
Purchase Commitment in any given calendar quarter and Distributor's Quarterly
Purchase Commitment in the next calendar quarter plus the deficit in
Distributor's Quarterly Purchase Commitment from the preceding calendar
quarter, then, without prejudice to Manufacturer's other rights under this
Agreement (including the right to terminate this Agreement upon written
notice to Distributor), Manufacturer may appoint one or more additional
distributors for sale of the Products in the Territory. Products returned to
Manufacturer under the provisions of Subsection 3(h) above shall not count
towards the fulfillment of Distributor's relevant Quarterly Purchase
Commitment.
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(d) FORECASTS. Within the first five (5) days of every month,
Distributor shall provide Manufacturer with a ninety (90) day rolling
forecast showing prospective orders by Product and Distributor's anticipated
Products purchase order submission date. Such rolling forecasts shall be
non-binding and shall be used by Manufacturer for information purposes only.
(e) PROMOTION OF THE PRODUCTS. Distributor shall, solely at
Distributor's own expense, vigorously promote the sale of the Products within
the Territory. Such promotion shall include, but not be limited to, preparing
all promotional materials intended specifically for use in the Territory in
appropriate languages for the Territory, advertising the Products in trade
publications within the Territory, participating in appropriate trade shows,
and directly soliciting orders from customers within the Territory for the
Products. Distributor and its employees and agents shall not promote the
Products for any indications not approved for such Products by applicable
regulatory authorities. All promotional materials prepared by Distributor
relating to the Products must be consistent with applicable law and
promotional materials used by Manufacturer or other distributors of
Manufacturer in connection with the Products. Distributor shall provide to
Manufacturer for purposes of review and comment by Manufacturer any and all
promotional, advertising, and educational materials and programs (in the
English language and the actual language of labeling) relating to the
Products at least thirty (30) days prior to the release of such materials or
commencement of such programs. Manufacturer shall make its best efforts to
provide to Distributor, within ten (10) business days after receipt of such
materials and/or programs, any and all comments and suggestions relating to
such materials and/or programs. In addition, Manufacturer shall be entitled,
on Manufacturer's written request, to receive copies of any promotional
materials used by Distributor and inspect such materials for purposes of
determining that such materials are consistent with promotional materials
used by Manufacturer or other distributors of Manufacturer. Distributor shall
provide Manufacturer, within ten (10) days after the end of each calendar
quarter, a description of Distributor's activities in promoting the Products
within the Territory. Distributor agrees to not promote, or solicit orders
for, the Products outside the Territory. Distributor shall use its best
efforts to locate and introduce to Manufacturer appropriate pharmaceutical
and bone densitometry companies in the Territory with which Manufacturer may
want to establish education programs with respect to Products.
(f) REPRESENTATIONS. Distributor shall make any false or
misleading representations to customers or others regarding Manufacturer or
the Products. Distributor and its employees and agents shall not make any
representations, warranties or guarantees with respect to the specifications,
features or capabilities of the Products that are not consistent with
Manufacturer's documentation accompanying the Products or Manufacturer's
literature describing the Products, including Manufacturer's standard
limited warranty and disclaimers.
(g) INVENTORY. Distributor shall, at Distributor's own expense,
maintain a sufficient inventory of the Products at all times during the term
of this Agreement as necessary in order to meet the requirements of any
customer or potential customer within the Territory.
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(h) FINANCES AND PERSONNEL. Distributor shall maintain a net worth
and working capital sufficient, in Manufacturer's reasonable judgment, to
allow Distributor to perform fully and faithfully Distributor's obligations
under this Agreement. Distributor shall devote sufficient financial resources
and technically qualified sales and training personnel to the Products to
fulfill Distributor's responsibilities under this Agreement.
(i) CUSTOMER AND SALES REPORTING. Distributor shall, at
Distributor's own expense and consistent with the sale policies of
Manufacturer: (i) place the Products in Distributor's literature as soon as
possible; (ii) provide adequate contact with existing and potential customers
within the Territory on a regular basis, consistent with good business
practice; (iii) assist Manufacturer in assessing customer requirements for
the Products, including modifications and improvements thereto, in terms of
quality, design, functional capability, and other features; and (iv) provide
Manufacturer on a quarterly basis: (1) a summary of all purchase orders
received by Distributor for Products, (2) market research information, as
reasonably requested by Manufacturer for purposes of Manufacturer's market
research, regarding competition and changes in the market within the
Territory and (3) a summary of the number of Products held by Distributor at
the end of such quarter.
(j) AUDITS. Manufacturer reserves the right to authorize a
representative of Manufacturer, at Manufacturer's expense, to audit
Distributor's records relating to the Products, including, without
limitation, records relating to preclinical and clinical trials, interactions
between Distributor and principal investigators in such preclinical and
clinical trials, inventories and sales. Upon prior written notice,
Distributor shall provide reasonable access to such records during normal
business hours at Distributor's business locations. Distributor shall maintain
all records at Distributor's location for a minimum of two (2) years after
termination of this Agreement.
(k) IMPORT AND EXPORT REQUIREMENTS. Distributor shall, at
Distributor's own expense, obtain and pay for import and export licenses and
permits, pay customs charges and duty fees, and take all other actions
required to accomplish the export and import of the Products purchased by
Distributor. Distributor understands that Manufacturer is subject to
regulation by agencies of the United States of America government, including
the United States of America Department of Commerce, which prohibit export or
diversion of certain technical products to certain countries. Distributor
warrants that Distributor will comply in all respects with the export and
re-export restrictions set forth in the export license for every Product
shipped to Distributor.
(l) LIMITATION ON DISTRIBUTOR'S RIGHTS TO THE PRODUCTS. Distributor
shall have no right to copy, modify or remanufacture any Product or part
thereof. Distributor shall not make any changes, alterations, modifications
or additions to the Products without prior written approval of Manufacturer.
(m) PRODUCT SPECIFICATIONS. Distributor shall ensure that the
specification of the Products ordered is suitable and safe for the intended
use or
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environment of use, except where it makes known details of such use to
Manufacturer in writing prior to conclusion of the Agreement in such a way as
clearly to place reliance on Manufacturer's special skills.
(n) PRODUCT HANDLING. Distributor shall handle the Products in a
suitable and safe manner and shall comply with any instructions supplied to
it by Manufacturer. Distributor shall also pass on to users (including
purchasers and users of other goods and equipment into which the Products are
incorporated) all relevant safety information.
(o) INTELLECTUAL PROPERTY. Where Distributor supplies designs,
drawings and specifications to Manufacturer to enable Manufacturer to
manufacture non-standard or custom made Products, Distributor warrants that
such manufacture will not infringe the intellectual property rights of any
third party.
7. ADDITIONAL OBLIGATIONS OF MANUFACTURER. Manufacturer shall
promptly provide Distributor with Manufacturer's core materials relating to
promotion of the Products. Such core materials shall be provided primarily in
the English language. Manufacturer shall promptly respond to all reasonable
inquiries from Distributor concerning matters pertaining to this Agreement.
Manufacturer shall refrain from giving quotations to exporters for Products
to be shipped to the Territory. Manufacturer shall inform Distributor of new
product developments relating to the Products. Manufacturer shall forward to
Distributor copies of all approval letters received from the U.S. Food and
Drug Administration with respect to Products.
8. TERM AND TERMINATION
(a) TERM. This Agreement shall commence on the date hereof and
continue in full force and effect for a fixed term of two (2) years from such
date, unless terminated earlier under the provisions of this Section 8. At
the end of such fixed term, this Agreement may be renewed for a fixed term of
two (2) years; PROVIDED, that Manufacturer and Distributor agree in writing
prior to the end of such fixed term upon the terms and conditions of such
renewal, including, without limitation, minimum quantities of Products to be
purchased by Distributor during such two (2) year fixed term. Manufacturer
shall also have the right to terminate this Agreement upon written notice to
Distributor as provided in Section 6 hereof.
(b) TERMINATION FOR CAUSE. If either party defaults in the
performance of any provision of this Agreement, then the non-defaulting party
may given written notice to the defaulting party that if the default is not
cured within thirty (30) days the Agreement will be terminated. If the
non-defaulting party gives such notice and the default is not cured during
such thirty (30) day period, then the Agreement shall automatically terminate
at the end of that period.
(c) TERMINATION FOR INSOLVENCY. This Agreement shall terminate,
without notice, (i) upon the institution by or against Distributor of
insolvency, receivership or bankruptcy proceedings or any other proceedings
for the settlement
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of Distributor's debts, (ii) upon Distributor's making an assignment for the
benefit of creditors, or (iii) upon Distributor's dissolution or ceasing to
do business.
(d) CLINICAL USE REGULATORY APPROVAL; TECHNICAL DIFFICULTIES. The
rights of Distributor hereunder with respect any one Product may be
terminated by Manufacturer, upon thirty (30) days' prior written notice, at
any time following approval from appropriate Japanese governmental
authorities to distribute such Product for clinical use. Where Manufacturer
experiences technical difficulties in the production of non-standard or
custom made Products, it may cancel this Agreement without being liable to
Distributor in any way.
(e) RETURN OF MATERIALS. All trademarks, trade names, patents,
copyrights, designs, drawings, formulas or other data, photographs, samples,
literature, and sales aids of every kind shall remain the property of
Manufacturer. Within thirty (30) days after the termination of this
Agreement, Distributor shall prepare all such items in Distributor's
possession for shipment, as Manufacturer may direct, at Manufacturer's
expense. Distributor shall not make, use, dispose of or retain any copies of
any confidential items or information which may have been entrusted to
Distributor. Effective upon the termination of this Agreement, Distributor
shall cease to use all trademarks, marks, and trade names of Manufacturer.
(f) LIMITATION ON LIABILITY. In the event of termination by either
party in accordance with any of the provisions of this Agreement, neither
party shall be liable to the other, because of such termination, for
compensation, reimbursement or damages on account of the loss of prospective
profits or anticipated sales or on account of expenditures, inventory,
investments, leases or commitments in connection with the business or goodwill
of Manufacturer or Distributor. Termination shall not, however, relieve
either party of obligations incurred prior to the termination.
(g) SURVIVAL OF CERTAIN TERMS. The provisions of Sections 3(h), 5,
6(g), 6(k), 6(l), 6(m), 8, 9, 10, 11, 12, 13 and 14 shall survive the
termination of this Agreement for any reason. All other rights and
obligations of the parties shall cease upon termination of this Agreement.
9. LIMITATION ON LIABILITY. MANUFACTURER'S LIABILITY ARISING OUT OF
THIS AGREEMENT AND/OR SALE OF THE PRODUCTS SHALL BE LIMITED TO THE AMOUNT
PAID BY THE CUSTOMER FOR THE PRODUCTS. IN NO EVENT SHALL MANUFACTURER BE
LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS BY ANYONE, EXCEPT IN THE
CASE OF DEATH OR PERSONAL INJURY RESULTING FROM MANUFACTURER'S GROSS
NEGLIGENCE. IN NO EVENT SHALL MANUFACTURER BE LIABLE TO DISTRIBUTOR OR ANY
OTHER ENTITY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, OR INDIRECT DAMAGES,
HOWEVER CAUSED, ON ANY THEORY OF LIABILITY, WHETHER OR NOT MANUFACTURER HAS
BEEN ADVISED ON THE POSSIBILITY OF SUCH DAMAGE.
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10. PROPERTY RIGHTS AND CONFIDENTIALITY
(a) PROPERTY RIGHTS. Distributor agrees that Manufacturer owns
all right, title, and interest in the product lines that include the Products
and in all of Manufacturer's patents, trademarks, trade names, inventions,
copyrights, know-how, and trade secrets relating to the design, manufacture,
operation or service of the Products. The use by Distributor of any of these
property rights is authorized only for the purposes herein set forth, and
upon termination of this Agreement for any reason such authorization shall
cease.
(b) SALE CONVEYS NO RIGHT TO MANUFACTURE OR COPY. The Products
are offered for sale and are sold by Manufacturer subject in every case to
the condition that such sale does not convey any license, expressly or by
implication, to manufacture, duplicate or otherwise copy or reproduce any
of the Products. Distributor shall take appropriate steps with Distributor's
customers, as Manufacturer may request, to inform them of and assure
compliance with the restrictions contained in this Subsection 10(b).
(c) CONFIDENTIALITY.
(i) Distributor acknowledges that by reason of Distributor's
relationship to Manufacturer hereunder, Distributor will have access to
certain information and materials concerning Manufacturer's business, plans,
customers, technology, and products that are confidential and of substantial
value to Manufacturer, which value would be impaired if such information were
disclosed to third parties. Distributor agrees that Distributor will not use
in any way for Distributor's own account or the account of any third party,
nor disclose to any third party, any such confidential information revealed
to Distributor by Manufacturer. Distributor shall take every reasonable
precaution to protect the confidentiality of such information. Upon request
by Distributor, Manufacturer shall advise whether or not Manufacturer
considers any particular information or materials to be confidential.
Distributor shall not publish any technical description of the Products
beyond the description published by Manufacturer (except to translate that
description into appropriate languages for the Territory). In the event of
termination of this Agreement, there shall be no use or disclosure by
Distributor of any confidential information of Manufacturer, and Distributor
shall not manufacture or have manufactured any compositions, devices,
components or assemblies utilizing any of Manufacturer's confidential
information.
(ii) Manufacturer acknowledges that by reason of
Manufacturer's relationship to Distributor hereunder, Manufacturer will have
access to certain information and materials concerning Distributor's
business, plans, customers, technology, and products that are confidential
and of substantial value to Distributor, which value would be impaired if
such information were disclosed to third parties. Manufacturer agrees that
Manufacturer will not use in any way for Manufacturer's own account or the
account of any third party, nor disclose to any third party, any such
confidential information revealed to Manufacturer by Distributor.
Manufacturer shall take every reasonable precaution to protect the
confidentiality of such information. Upon request by Manufacturer,
Distributor
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shall advise whether or not Distributor considers any particular information
or materials to be confidential. In the event of termination of this
Agreement, there shall be no use or disclosure by Manufacturer of any
confidential information of Distributor.
11. TRADEMARKS AND TRADE NAMES
(a) USE. During the term of this Agreement, Distributor shall
have the right to indicate to the public that Distributor is an authorized
distributor of Manufacturer's Products and to advertise within the Territory
such Products under the trademarks, marks, and trade names that Manufacturer
may adopt from time to time ("Manufacturer's Trademarks"). Distributor shall
not alter or remove any Manufacturer's Trademark applied to the Products at
the factory. Except as set forth in this Section 11, nothing contained in
this Agreement shall grant to Distributor any right, title or interest in
Manufacturer's Trademarks. At no time during or after the term of this
Agreement shall Distributor challenge or assist others to challenge
Manufacturer's Trademarks or the registration thereof or attempt to register
any trademarks, marks or trade names confusingly similar to those of
Manufacturer.
(b) APPROVAL OF REPRESENTATIONS. All representations of
Manufacturer's Trademarks that Distributor intends to use shall first be
submitted to Manufacturer for approval, which shall not be unreasonably
withheld, of design, color, and other details or shall be exact copies of
those used by Manufacturer. If any of Manufacturer's Trademarks are to be
used in conjunction with another trademark on or in relation to the Products,
then Manufacturer's mark shall be presented equally legibly, equally
prominently, and of greater size than the other but nevertheless separated
from the other so that each appears to be a mark in its own right, distinct
from the other mark.
12. PATENT, COPYRIGHT, AND TRADEMARK INDEMNITY
(a) INDEMNIFICATION. Distributor agrees that Manufacturer has the
right to defend, or at Manufacturer's option to settle, and Manufacturer
agrees, at Manufacturer's own expense, to defend or at Manufacturer's option
to settle, any claim, suit or proceeding brought against Distributor or
Distributor's customers on the issue of infringement of any United States of
America or foreign patent, copyright or trademark by the Products sold
hereunder or the use thereof, subject to the limitations hereinafter set
forth. Manufacturer shall have sole control of any such action or settlement
negotiations, and Manufacturer agrees to pay, subject to the limitations
hereinafter set forth, any final judgment entered against Distributor or
Distributor's customer on such issue in any such suit or proceeding defended
by Manufacturer. Distributor agrees that Manufacturer at Manufacturer's sole
option shall be relieved of the foregoing obligations unless Distributor or
Distributor's customer notifies Manufacturer promptly in writing of such
claim, suit or proceeding and gives Manufacturer authority to proceed as
contemplated herein, and, at Manufacturer's expense, gives Manufacturer
proper and full information and assistance to settle and/or defend any such
claim, suit or proceeding. Manufacturer shall not be liable for any costs or
expenses incurred without Manufacturer's prior written authorization.
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(b) LIMITATION. Notwithstanding the provisions of Subsection
12(a) above, Manufacturer assumes no liability for (i) infringements covering
completed equipment or any composition, assembly, circuit, combination,
method or process in which any of the Products may be used but not covering
the Products when used alone; (ii) trademark infringements involving any
marking or branding not applied by Manufacturer or involving any marking or
branding applied at the request of Distributor; or (iii) infringements
involving the modification or servicing of the Products, or any part thereof,
unless such modification or servicing was done by Manufacturer.
(c) ENTIRE LIABILITY. THE FOREGOING PROVISIONS OF THIS SECTION 12
STATE THE ENTIRE LIABILITY AND OBLIGATIONS OF MANUFACTURER AND THE EXCLUSIVE
REMEDY OF DISTRIBUTOR AND DISTRIBUTOR'S CUSTOMERS, WITH RESPECT TO ANY
ALLEGED INFRINGEMENT OF PATENTS, COPYRIGHTS, TRADEMARKS OR OTHER
INTELLECTUAL PROPERTY RIGHTS BY THE PRODUCTS OR ANY PART THEREOF.
13. INDEMNIFICATION.
(a) Manufacturer and Distributor each agree to indemnify and hold
the other party harmless from and against any and all claims made by any
person or entity arising out of the processing, marketing, distribution and
sale of the Products, where and to the extent such damages have been caused
by the fault of such party or its employees or agents. The indemnifying party
shall have the right to defend or, at its option, to settle such claims, and
if it chooses to exercise such right, it shall have control over any such
claim or settlement negotiations. The indemnifying party shall be relieved of
the foregoing obligations unless the indemnified party gives prompt notice in
writing of any such claim, suit or proceeding and, at the indemnifying
party's expense, gives the indemnifying party proper and full information and
assistance to settle and/or defend any such claim, suit or proceeding.
(b) Distributor shall indemnify Manufacturer in respect of any
claim which may be made against the Manufacturer.
(i) that the use to which the Products are put constitutes a
breach of Section 6 of The Health and Safety at Work Act 1974 or any
other relevant United Kingdom or overseas safety legislation; and/or
(ii) arising out of the failure by the Distributor to observe
the terms of the Agreement.
The provisions of this Section 13(b) shall not apply where the claim arises
as a result of the negligence of Manufacturer or use of the Products in
accordance with Manufacturer's written instructions.
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14. GENERAL PROVISIONS
(a) GOVERNING LAW AND JURISDICTION. This Agreement shall be
governed by, and construed and interpreted in accordance with, the laws of
the State of California, United States of America, without reference to
conflict of laws principles or statutory rules of arbitration. The federal
and state courts within the State of California, United States of America
shall have exclusive jurisdiction to adjudicate any dispute arising out of
this Agreement. Distributor hereby expressly consents to (i) the personal
jurisdiction of the federal and state courts within California, (ii) service
of process being effected upon Distributor by registered mail sent to the
address set forth at the beginning of this Agreement, and (iii) the
uncontested enforcement of a final judgement from such court in any other
jurisdiction wherein Distributor or any of Distributor's assets are present.
(b) ENTIRE AGREEMENT. This Agreement sets forth the entire
agreement and understanding of the parties relating to the subject matter
herein and merges all prior discussions between them. No modification of or
amendment to this Agreement, nor any waiver of any rights under this
Agreement, shall be effective unless in writing signed by the party to be
charged.
(c) NOTICES. Any notice required or permitted by this Agreement
shall be in writing (in the English language) and shall be sent by telex,
telecopier or telegram or by prepaid registered or certified mail, return
receipt requested, addressed to the other party at the address shown at the
beginning of this Agreement or at such other address for which such party
gives notice hereunder. Such notice shall be deemed to have been given upon
the earlier of receipt by the party to whom notice was sent or three (3) days
after deposit in the mail.
(d) FORCE MAJEURE. Nonperformance of either party shall be
excused to the extent that performance is rendered impossible by strike,
fire, flood, governmental acts or orders or restrictions, failure of
suppliers, or any other reason where failure to perform is beyond the
reasonable control of and is not caused by the negligence of the
non-performing party.
(e) NON-ASSIGNABILITY AND BINDING EFFECT. A mutually agreed
consideration for Manufacturer's entering into this Agreement is the
reputation, business standing, and goodwill already honored and enjoyed by
Distributor under Distributor's present ownership, and, accordingly,
Distributor agrees that Distributor's rights and obligations under this
Agreement may not be transferred or assigned directly or indirectly without
the prior written consent of Manufacturer. Subject to the foregoing sentence,
this Agreement shall be binding upon and inure to the benefit of the parties
hereto and their successors and assigns.
(f) LEGAL EXPENSES. The prevailing party in any legal action
brought by one party against the other and arising out of this Agreement
shall be entitled, in addition to any other rights and remedies that such
prevailing party may have, to reimbursement for expenses incurred by such
prevailing party, including court costs and reasonable attorneys' fees.
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(g) COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and all of which
together shall constitute one instrument.
(h) PARTIAL INVALIDITY. If any provision of this Agreement is
held to be invalid, then the remaining provisions shall nevertheless remain
in full force and effect. The parties agree to renegotiate in good faith any
term held invalid and to be bound by the mutually agreed substitute
provision.
IN WITNESS WHEREOF, the undersigned are duly authorized to execute this
Agreement on behalf of Manufacturer and Distributor, as applicable.
METRA BIOSYSTEMS, INC. AMERSHAM K.K.
("Manufacturer") ("Distributor")
By: /s/ George W. Dunbar, Jr. By: /s/ V. Chambers
--------------------------------- -------------------------------
Print Name: George W. Dunbar, Jr. Print Name: V.M.A. Chambers
------------------------- -----------------------
Title: President & CEO Title: President
------------------------------ ----------------------------
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EXHIBIT A
PRODUCT DESCRIPTION AND PURCHASE PRICE
For Research Products Only
Distributor's
Purchase Price
Product(1) (U.S. dollars)
- ----------------------------------------- --------------
Collagen Crosslinks Immunoassay in
microtiter plate enzyme-linked
immunosorbent assay (ELISA)
format, including packaging,
labeling and product inserts $[500.00]
Prolagen-C-TM- Immunoassay in
microtiter plate sandwich-assay
format, including packaging, labeling [to be determined]
and product inserts
NovoCalcin-TM- Immunoassay in
microtiter plate enzyme-linked
immunosorbent assay (ELISA) [to be determined]
format, including packaging, labeling
and product inserts
(1) Products to be sold by Distributor solely for research purposes.
METRA BIOSYSTEMS, INC. AMERSHAM K.K.
("Manufacturer") ("Distributor")
By: /s/ George W. Dunbar, Jr. By: /s/ V. Chambers
--------------------------------- -------------------------------
Print Name: George W. Dunbar, Jr. Print Name: V.M.A. Chambers
------------------------- -----------------------
Title: President & CEO Title: President
------------------------------ ----------------------------
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EXHIBIT B
TERRITORY
Distributor's Territory shall be all portions of the following:
[Japan]
METRA BIOSYSTEMS, INC. AMERSHAM K.K.
("Manufacturer") ("Distributor")
By: /s/ George W. Dunbar, Jr. By: /s/ V. Chambers
--------------------------------- ----------------------------
Print Name: George W. Dunbar, Jr. Print Name: V.M.A. Chambers
------------------------- ---------------------
Title: President & CEO Title: President
------------------------------ --------------------------
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EXHIBIT C
QUARTERLY PURCHASE COMMITMENTS
For Research Products Only
First Year Second Year
Number of Kits Number of Kits
-------------- --------------
[Crosslinks] [to be agreed] [to be agreed]
[Prolagen-C-TM] [to be agreed] [to be agreed]
[NovoCalcin-TM] [to be agreed] [to be agreed]
METRA BIOSYSTEMS, INC. AMERSHAM K.K.
("Manufacturer") ("Distributor")
By: /s/ George W. Dunbar, Jr. By: /s/ V. Chambers
--------------------------------- -------------------------------
Print Name: George W. Dunbar, Jr. Print Name: V.M.A. Chambers
------------------------- -----------------------
Title: President & CEO Title: President
------------------------------ ----------------------------
1 May 1993
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