Exclusive Distribution Agreement

Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.


Exhibit 10.16


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EXCLUSIVE DISTRIBUTION AGREEMENT -------------------------------------------------------------------------------


This Agreement is dated and effective as of January /24th/ 2002 and made
------------------- between:


BIOSPHERE MEDICAL SA, a French societe anonyme having its registered office at Parc des Nations Z.I Paris Nord II, 383, rue de la Belle Etoile 95700 Roissy-en-France, FRANCE, registered with the Registry of Commerce and Companies of BOBIGNY under the number 418.584.033, and represented by Alain Brunier in his capacity as President, Europe-Middle East-Africa


(hereinafter referred to as "BIOSPHERE MEDICAL SA")


AND ---


TERUMO EUROPE NV/SA, a Belgian societe anonyme having its registered office at 3001 Leuven, Research Park Zone 2 Haasrode, Interleuvenlaan 40, registered with the Registry of Commerce of Leuven under the number 52.311, and represented by Alain Poncet in his capacity as Senior Vice President


(hereinafter referred to as "TERUMO EUROPE")


(hereinafter collectively referred to as the "Parties" or individually
as a "Party")


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WITNESSETH ----------


WHEREAS TERUMO EUROPE is an international company manufacturing high medical technology.


WHEREAS TERUMO EUROPE has also developed a strong and capable network for the sale and distribution of medical products and devices.


WHEREAS BIOSPHERE MEDICAL SA is a company with a high reputation in manufacturing and distribution of high medical technology in EUROPE.


WHEREAS BIOSPHERE MEDICAL SA owns and/or controls a series of patents and technical information, including process and know how, and has wide experience and an international reputation in manufacturing and distribution of embolotherapy product range particularly under the trademarks of Embosphere and Embogold;


WHEREAS BIOSPHERE MEDICAL SA owns, controls and/or has right, directly or indirectly to the trademarks of Embosphere and Embogold in connection with the above mentioned products (the "Trademarks") and owns, controls and/or has right, directly or indirectly, corporate names, including BIOSPHERE MEDICAL (the "Tradenames"), through fully owned or directly controlled subsidiaries;


WHEREAS TERUMO EUROPE and BIOSPHERE MEDICAL SA manufacture and distribute medical products which are complementary.


WHEREAS TERUMO EUROPE and BIOSPHERE MEDICAL SA do not manufacture or distribute competitive products.


WHEREAS the purpose of TERUMO EUROPE and BIOSPHERE MEDICAL SA is to optimize the terms of marketing and distribution in-house or with trading partners.


WHEREAS through a not binding agreement dated November, 12, 2001, BIOSPHERE MEDICAL SA agrees to and TERUMO EUROPE wishes to be exclusive distributor of Products in the Territory specified in article 2 pursuant to the terms of this Agreement.


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NOW THEREFORE, THE PARTIES AGREE AS FOLLOWS: -------------------------------------------


Article 1 - Grant of rights
---------------


1.1. BIOSPHERE MEDICAL SA hereby grants to TERUMO EUROPE which hereby accepts
the exclusive right to distribute, market and sell the Products in the
territories of several countries specified in article 2 (the
"Territory").


1.2. BIOSPHERE MEDICAL SA hereby grants to TERUMO EUROPE the exclusive [**]
right to use the Trademarks and the Tradenames with respect to the
distribution, marketing and sale of the Products in the Territory.


1.3. TERUMO EUROPE accepts to use the Trademarks and the Tradenames with
respect to the distribution, marketing and sale of the Products in the
Territory.


1.4. TERUMO EUROPE hereby accepts the terms and conditions of such grant of
rights.


Article 2 - Products and Territory
----------------------


2.1. The term of "Products" as used herein shall mean the BIOSPHERE MEDICAL
Embolotherapy product range as listed in Schedule 1 attached thereto.


2.2. The term "Territory" as used herein shall mean Germany, UK, Scandinavia,
Switzerland, Belgium, Portugal, Ireland, Greece, Czech rep., Poland,
Tunisia, Morocco, Algeria, Russia;


The Agreement will be extended to:


[**]


Article 3 - TERUMO EUROPE's responsibilities
--------------------------------


3.1. TERUMO EUROPE shall at its own expenses:


(i) Use its best efforts to contribute to the market promotion and
distribution determined by BIOSPHERE MEDICAL SA within the Territory.


(ii) Maintain or arrange for suitable and satisfactory facilities for
the sale and servicing of products within the Territory;


(iii) Make available to BIOSPHERE MEDICAL SA every reasonable assistance
in connection with the execution of sales and advertising plans and
prepare and submit to


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BIOSPHERE MEDICAL SA sales forecasts and appraisals of market
conditions as may be requested by BIOSPHERE MEDICAL SA from time to
time


(iv) Maintain a high reputation for conducting TERUMO EUROPE's
business ethically and in accordance with all laws and regulations
applicable thereto;


(v) The costs incurred by TERUMO EUROPE in the sale of Products as
previously mentioned, including, but not limited to, shipping, billing,
invoicing, order processing, transportation insurance, customs duties,
sales taxes, VAT and other taxes, but to the exclusion of promotional
activities which will be shared by the Parties in the conditions
specified in articles 7 and 10.


(vi) TERUMO EUROPE shall maintain a system of product traceability.
During the term of this Agreement, and for twelve (12) months
thereafter, BIOSPHERE MEDICAL SA shall be entitled, at its expense and
upon reasonable notice or have examined by an independent auditing firm
acceptable to both parties, to verify the existence of such product
traceability.


(vii) TERUMO EUROPE shall at its own expense, outside of provisions
of Article 10.0 of this agreement, obtain all permits, licenses and
other approvals necessary for its activities, shall conduct its
business in compliance with all laws and regulations applicable in the
Territories and shall, when requested, provide BIOSPHERE MEDICAL SA
with information regarding TERUMO EUROPE's compliance with such laws
and regulations.


(viii) TERUMO EUROPE shall not offer Products for sale to customers
or dealers within the Territories, except if specifically agreed in
writing, when it reasonably assumes that such customers or dealers
intend to resell the Products outside any of the Territories.


Article 4 - BIOSPHERE MEDICAL's responsibilities
------------------------------------


4.1 BIOSPHERE MEDICAL SA shall at its own expenses:


(i) Use its best efforts to promote the best possible products


(ii) Develop the terms of marketing and distribution


(iii) BIOSPHERE MEDICAL SA agrees that all relevant information which
could affect the use of the product (such as product recalls or
procedural issues) to the extent known by Biosphere medical SA will be
brought to TERUMO EUROPE's attention. BIOSPHERE MEDICAL S.A will also
immediately inform TERUMO EUROPE of any change in the technical
specifications of the Product.


(iv) BIOSPHERE MEDICAL SA agrees to use all reasonable efforts to
notify TERUMO EUROPE of all market opportunities suggested to BIOSPHERE
MEDICAL SA in the Territory.


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(v) BIOSPHERE MEDICAL SA agrees to deal with the registrations and the
CEE's marking.


(vi) BIOSPHERE MEDICAL SA agrees to inform TERUMO EUROPE in due time of
its new product development to enhance the sales activity effectiveness
in the Territory.


Article 5 - TERUMO EUROPE's warranties
--------------------------


5.1. TERUMO EUROPE warrants that it is and will remain during the term of
this Agreement in full compliance with all applicable laws and
regulations in the Territory, to the extent such laws and regulations
are related to TERUMO EUROPE's performance of or ability to perform its
obligations under this Agreement.


5.2 TERUMO EUROPE acknowledges that it has received copies of technical
documentation related to each and all Products specifying their
conditions of use and application, has read them, understands them, and
agrees to comply with them as well as with any modification which is
duly notified by BIOSPHERE MEDICAL SA. A modification will be notified
in advance at least [**] days before coming into effect


Article 6 - BIOSPHERE MEDICAL SA's warranties
---------------------------------


6.1 BIOSPHERE MEDICAL SA represents and warrants that:


(i) All Products presently comply, to the best of its knowledge, with
all applicable French laws and regulations as applicable in the
Territory and governing labeling, packaging and quality of the
Products, and that such Products shall comply therewith during the term
hereof


(ii) There is no obligation of a contractual or other nature to any
person, firm, or corporation which at BIOSPHERE MEDICAL's best
knowledge is inconsistent or in conflict with this Agreement.


Article 7 - Sales Terms and payment
-----------------------


7. 1 The Parties agree the following Transfer pricing


Embosphere:
11 1 ml vial (all sizes): [**] Euro


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12 2 ml vial (all sizes): [**] Euro


Embogold:
13 1 ml vial (all sizes): [**] Euro
14 2 ml vial (all sizes): [**] Euro
The Parties agree that the transfer pricing ...