<PAGE>

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

                                                             Exhibit 10.16

-------------------------------------------------------------------------------
                        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")

<PAGE>
                                       2

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.

<PAGE>
                                       3

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

<PAGE>
                                       4

        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.

<PAGE>
                                       5

       (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

<PAGE>

                                        6

       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 of Embogold will be confirmed
     at launching time of the Products

7.2  The price of the Products is exclusive of VAT. It will be reviewed and
     discussed at every budgetary year such budgetary year defined as beginning
     January 1, and ending December 31, of any year. Such discussions shall be
     initiated at least 3 months prior to the start of the new budgetary year

7.3  TERUMO EUROPE will pay all costs of delivery or importation

7.4  The purchase orders issued by TERUMO EUROPE for Products shall be submitted
     to BIOSPHERE MEDICAL SA in writing or by fax. No order shall be binding
     upon BIOSPHERE MEDICAL SA until duly accepted by means of an order
     confirmation in the same manner or by speedier means of communication
     within [**] days of BIOSPHERE MEDICAL's receipt of purchase orders by an
     authorised representative of Biosphere Medical.

     BIOSPHERE MEDICAL SA shall deliver the Products within [**] to TERUMO
     EUROPE warehouse in Belgium.
     In case BIOSPHERE MEDICAL SA cannot deliver the Products in time, they will
     notify TERUMO EUROPE within [**] working days after receipt of the purchase
     of TERUMO's purchase order.

7.5  Unless otherwise agreed, the Products will be delivered at the delivery
     date specified in the purchase order. The Products will be shipped free on
     board ("FOB") BMSA.

7.6  The Parties agree the following payments terms:

     (i)  [**] initial stock: [**] days
     (ii) Following orders: [**] days


Article 8 - Liability
            ---------
8.1  The liability of BIOSPHERE MEDICAL SA under this Agreement and under any
     purchase order of Products accepted by BIOSPHERE MEDICAL SA pursuant to
     this Agreement shall be limited to that arising from its obligations to
     supply Products in accordance with the terms and conditions of orders
     accepted by BIOSPHERE MEDICAL SA, its obligations under this Agreement and
     its statutory obligations with regard to warranties and product



<PAGE>

                                        7

      liability. BIOSPHERE MEDICAL SA will be liable for all damages and costs
      resulting from any recall of the Products manufactured by Biosphere
      Medical resulting from the nature of product defectiveness.

      Without limiting the generality of the foregoing, Biosphere in particular
      warrants that all Products delivered pursuant to this Agreement will be
      new and in saleable condition, fit for their intended purpose.

8.02  TERUMO EUROPE agrees to hold BIOSPHERE MEDICAL SA harmless from and
      against any and all claims, losses, obligations, liabilities, costs and
      expenses (including without limitation legal and other fees):

     (i)    arising from actions or omissions of TERUMO EUROPE, its employees or
            agents, or
     (ii)   arising out of TERUMO EUROPE's breach of or failure to perform any
            of its obligations, representations, warranties, covenants and
            agreements herein, including those contained in the technical
            sheets, or
     (iii)  arising out of claims of negligence of TERUMO EUROPE, or
     (iv)   arising from Products defects caused by TERUMO EUROPE




Article 9 - Intellectual property rights
            ----------------------------

9.1   TERUMO EUROPE agrees to use Trademarks and Tradenames currently owned,
      controlled or used by BIOSPHERE MEDICAL SA and in connection with this
      Agreement, whether or not registered, only in the manner stipulated by
      BIOSPHERE MEDICAL SA or in such other manner to which BIOSPHERE MEDICAL SA
      may specifically consent in writing.

      BIOSPHERE MEDICAL SA undertakes to provide TERUMO EUROPE with all
      necessary materials (editing support) to comply with this undertaking

9.2   TERUMO EUROPE shall in no way alter any of the Trademarks or Tradenames
      appearing on Products or other merchandise supplied to TERUMO EUROPE and
      shall not use such trademarks or tradenames similar thereto on stationary,
      advertising, promotional materials or displays or in its company name or
      in any other fashion whatsoever unless prior written approval of BIOSPHERE
      MEDICAL SA is obtained, and such use, if approved, shall in no way bestow
      any rights to such trademarks or tradenames upon TERUMO EUROPE.

      Additionally, any rights acquired by TERUMO EUROPE in such trademarks or
      tradenames shall immediately inure to the benefit of, and automatically
      become transferred to BIOSPHERE MEDICAL SA.

      In the event of termination of this Agreement, TERUMO EUROPE shall
      immediately discontinue all use of such trademarks and tradenames except
      for the distribution of the


<PAGE>

                                        8

      Products still in stock a the time of termination and not re-purchased by
      BIOSPHERE MEDICAL SA

9.3   TERUMO EUROPE shall not affix any trademark or tradename to products or
      other merchandise supplied to TERUMO EUROPE other than those affixed by
      BIOSPHERE MEDICAL SA or which BIOSPHERE MEDICAL SA may request TERUMO
      EUROPE to affix, without prior written approval of BIOSPHERE MEDICAL SA.

9.4   The Trademarks and Tradenames are and shall remain the exclusive right and
      property of BIOSPHERE MEDICAL SA and BIOSPHERE MEDICAL SA agrees that they
      will not cause, allow or permit any third party to use their labels,
      Trademarks and/or Tradenames in the Territory.

9.5   TERUMO EUROPE and BIOSPHERE MEDICAL SA shall notify each other of any
      claim of infringement or any complaint of which it has knowledge based
      upon used by TERUMO EUROPE of the Trademarks and/or Tradenames or any
      simulation, counterfeiting or infringement of the Trademarks and
      Tradenames by third parties.

9.6   TERUMO EUROPE agrees not to remove any identifying marks, warning signs or
      instructions placed on Products by BIOSPHERE MEDICAL SA.

9.7   BIOSPHERE MEDICAL SA shall be solely responsible for all damages and costs
      resulting from patent, trademarks and tradenames infringement caused by
      the Products and shall at its own expense defend any such patent,
      trademarks and tradenames infringement claims raised in the Territory.
      BIOSPHERE MEDICAL SA will indemnify TERUMO EUROPE for all costs and
      expenses which TERUMO EUROPE would incur as a result of such infringement
      claims.


Article 10 - Marketing, advertising and fairs
             --------------------------------

10.1  TERUMO EUROPE and BIOSPHERE MEDICAL SA shall actively promote the Products
      in the Territory by activities consisting of:

      (i)   training,
      (ii)  congresses,
      (iii) workshops,
      (iv)  media campaigns
      (v)   advertising and more generally, all activities in connection with
            the promotion of the Products.


<PAGE>

                                        9

10.2  The development and execution of the promotional activities is in the
      first place the responsibility of TERUMO EUROPE. The costs incurred by
      TERUMO EUROPE shall be submitted to BIOSPHERE MEDICAL SA in writing or by
      fax. No cost shall be binding upon BIOSPHERE MEDICAL SA until duly
      accepted in writing in the same manner or by speedier means of
      communication within eight days of BIOSPHERE MEDICAL's receipt of such
      costs. The costs incurred by BIOSPHERE MEDICAL SA shall likewise be
      submitted to TERUMO EUROPE and shall not be binding upon TERUMO EUROPE
      until duly accepted within 8 days of TERUMO EUROPE's receipt of submission
      of expense.

10.3  The costs of mutual agreed activities shall be shared [**] by TERUMO
      EUROPE and BIOSPHERE MEDICAL SA. The Parties will settle the marketing
      costs sharing on quarterly bases with immediate payment

10.4  The Parties agree the amount for 2002 for TERUMO will be [**] Euro taking
      into consideration the countries not involved in TERUMO'S territory in
      2002.

10.5  The Parties shall inform each other in appropriate time of any
      contemplated participation in fairs and exhibitions.


Article 11 - Insurance
             ---------

11.1  At its own expense, TERUMO EUROPE shall maintain with reputable insurance
      companies insurance policies covering the distribution activities which
      TERUMO EUROPE will conduct under the present Agreement

11.2  TERUMO EUROPE agrees to furnish BIOSPHERE MEDICAL SA, within thirty (30)
      business days of the execution of this agreement, with satisfactory
      evidence of such insurance policies prior to the first purchase order and
      at such other time as BIOSPHERE MEDICAL SA may require for its activity in
      the Territory

Article 12 - Confidentiality
             ---------------

      TERUMO EUROPE, BIOSPHERE MEDICAL SA and their employees and agents shall
      at all times, during the term of this Agreement and thereafter, keep
      confidential and not disclose to any third party any trade secret and
      other information of a confidential nature acquired by either part from
      the other in the course of performance of this Agreement.

Article 13 - Non competition
             ---------------


<PAGE>

                                       10

13.1  TERUMO EUROPE hereby undertakes not to sell, directly or indirectly, nor
      assist, directly or indirectly, in selling products which may be
      identical, similar and/or competitive by reason of their nature,
      appearance, use, and/or technical features with the Products.

13.2  Such undertaking shall be valid during the terms of this Agreement.

13.3  In case BIOSPHERE MEDICAL developed products competitive to Terumo
      Corporation and Terumo Europe, then Biosphere Medical Europe would offer
      them for sale to Terumo Europe within the Territory.

Article 14 - Duration
             --------

14.1  Subject to immediate termination as mentioned in Article 15, this
      Agreement shall be with retroactive effect as of January, 1, 2002, and
      expire on January, 1, 2006. The parties will re-examine the duration of
      this Agreement after an initial period of two (2) years using qualitative
      and quantitative criteria (for example : sales achievement, competitive
      edge of the Products, products in the pipeline, Distributors' performance
      etc.). The parties can at that time agree to maintain the initial duration
      of the Agreement or to extend or reduce its duration. If one of the
      parties at that time whishes to terminate, based on the outcome of the
      "re-examination" discussions, the contract prior to the end of its initial
      term, such party may terminate the agreement unilaterally by observing the
      notice period stipulated in article 14.2

14.2  If a party decides to terminate the Agreement unilaterally, the
      terminating party will deliver to the other party a notice of termination
      by registered mail and observe a notice period of twelve (12) months

14.3  The Parties agree to meet at the latest six (6) months before the date of
      expiry of the Agreement to discuss the terms and conditions of a renewal
      of the Agreement. If the Parties do not enter into a formal contract for
      the renewal of their Agreement but yet continue to operate within the
      terms of this Agreement, the Agreement will be renewed automatically for a
      period of two (2) years.

Article 15 - Immediate termination
             ---------------------

15.1  This Agreement is subject to immediate termination by the Parties upon any
      of the following events:

      (i) Insolvency, bankruptcy, liquidation, or loss of corporate identity on
      the part of one of the Parties or the filing by one of the Parties of a
      petition seeking relief under the laws of insolvency or bankruptcy of any
      country.


<PAGE>

                                       11

         (ii) Breach of any obligation under this Agreement by one of the
         Parties, if not remedied by one of the Parties within [**] days of
         written receipt notice of breach.

         (iii) The merger of TERUMO EUROPE with another company or corporation
         other or any other transaction effecting a substantial change in
         control or ownership of TERUMO EUROPE, with the exclusion of mergers or
         transactions whereby the control or ownership of TERUMO EUROPE remains
         within the TERUMO group of companies

15.2     Without prejudice to the generality of the foregoing, the performance
         by TERUMO EUROPE of its obligations with regard all payments under
         Article 7 is of the essence of this Agreement. Conversely, it is agreed
         that the timely performance by BIOSPHERE MEDICAL SA of its delivery
         obligations as stipulated under Article 7 is also of the essence of
         this Agreement.

         Any breach of or default in the performance of such obligations shall
         entail the immediate termination of this Agreement.

Article 16 - Change of control provisions
-----------------------------------------

16.1     The present Agreement is directly linked to the present BSMD ownership.
         It will be cancelled by a majority change in BSMD's shareholder's
         equity.


16.2     Regarding the cancellation of the Agreement specified in Article 16.1,
         BIOSPHERE MEDICAL SA agrees to pay to TERUMO EUROPE in compensation for
         its investments an amount of:
         [**] Euro if end of 2002 (or pro rata if earlier in the year)
         [**] Euro if end of 2003 (or pro rata if earlier in the year)
         [**] Euro if end of 2004 (or pro rata if earlier in the year)

         Each amount non cumulative to the other


Article 17 - Assignment
             ----------

         TERUMO EUROPE shall not assign its rights and obligations under this
         Agreement to any third party without the prior written consent of
         BIOSPHERE MEDICAL SA.

Article 18 - Governing law and jurisdiction
             ------------------------------

18.1     This Agreement shall be governed by and construed in accordance with
         the laws of France


<PAGE>

                                       12

18.2.    All provisions of this Agreement are several and any provision which
         may be prohibited by law shall be ineffective to the extent of such
         prohibition without invalidating the remaining provisions.

         Notwithstanding the foregoing, the Parties shall use their best efforts
         to replace any provision which may become invalid or unenforceable by
         other adequate provisions reflecting their intents and purposes.

Article 19 - Miscellaneous
             -------------

19.1.    This Agreement constitutes the entire agreement between the Parties and
         supersedes all previous agreements or understandings between them
         covering the subject matter hereof and may be amended only in writing.

19.2.    Any failure by any Party hereto to exercise at any time any of its
         rights and/or to enforce any terms or conditions of this Agreement
         shall not be considered a waiver of such Party's right thereafter to
         exercise said rights or to enforce each and every term or condition of
         this Agreement; nor shall any such waiver be implied from the
         acceptance of any payment.

19.3.    Any notice required to be given hereunder shall be notified at the
         addresses shown on the first page hereof.



BIOSPHERE MEDICAL SA                                 TERUMO EUROPE NV/ SA




 Alain Brunier                                           Alain Poncet
-------------------------                              -------------------------
represented by                                         represented by

<PAGE>

                                       13

                                   SCHEDULE I

            LIST OF PRODUCTS TO BE DISTRIBUTED BY TERUMO EUROPE NV/SA
            ---------------------------------------------------------

               -   Embosphere
               -   Embogold



<PAGE>

                                       14

                                  Attachement 1

                              TERUMO FORECAST 2002
                         (January 2002 - December 2002)

                                    1 ml      2 ml      Total
                                    ----      ----      -----

Germany                             [**]      [**]      [**]

UK                                  [**]      [**]      [**]

Scandinavia                         [**]      [**]      [**]

Switzerland                         [**]      [**]      [**]

Belgium                             [**]      [**]      [**]

Portugal                            [**]      [**]      [**]

Ireland                             [**]      [**]      [**]

Greece                              [**]      [**]      [**]

Czech Rep.                          [**]      [**]      [**]

Russia/Poland )

Tunisia/Morocco )                   [**]      [**]      [**]
Algeria        )


TOTAL                               [**]      [**]      [**]

<PAGE>

               FIRST AMENDMENT TO EXCLUSIVE DISTRIBUTION AGREEMENT

This First Amendment to Exclusive Ditribution Agreement (the "Amendment") is
dated and effective as of January 28/th/ 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")

WITNESSETH
----------

WHEREAS the Parties entered into an Exclusive Distribution Agreement on January
___, 2002 (the "Distribution Agreement").

WHEREAS the Parties desire to amend Article 16 of the Distribution Agreement to
clarify the change of control provisions set forth therein.

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

1.  Article 16 of the Distribution  Agreement is hereby deleted in its entirety
    and the following new Article 16 is substituted in lieu thereof:

    "Article 16 - Change of control provisions
     -----------------------------------------

    16.1   Notwithstanding any other provision of this Agreement, either Party
           shall have the right to immediately terminate the Agreement in the
           event of a Change of Control of BioSphere Medical, Inc., a Delaware
           corporation and the parent corporation of BIOSPHERE MEDICAL SA
           ("BSMD"), by providing written

<PAGE>

              notice to the other Party within 30 days following such Change of
              Control. For purposes of this Article 16.1, a Change of Control
              shall mean (a) the acquisition by a person, party or group of more
              than 50% of the outstanding voting stock of BSMD, excluding
              acquisitions from BSMD, (b) the sale of BSMD by means of a
              reorganization, merger, consolidation, recapitalization or asset
              sale, unless the owners of the outstanding voting stock of BSMD
              before such transaction continue to own more than 50% of the
              outstanding voting stock of the acquiring or succeeding entity in
              substantially the same proportions, or (c) the approval of a
              complete liquidation or dissolution of BSMD.

     16.2     If the Agreement is terminated by BIOSPHERE MEDICAL SA or its
              assignee or successor pursuant to Article 16.1, BIOSPHERE MEDICAL
              SA agrees to pay to TERUMO EUROPE in compensation for its
              investments an amount of:

              [**] Euro if end of 2002 (or pro rata if earlier in the year)
              [**] Euro if end of 2003 (or pro rata if earlier in the year)
              [**] Euro if end of 2004 (or pro rata if earlier in the year)

              Each amount non cumulative to the other"


2.   Except as specifically amended by this Amendment, all terms and conditions
     of the Distribution Agreement shall remain unchanged and in full force and
     effect.


BIOSPHERE MEDICAL SA                        TERUMO EUROPE NV/SA

    Alain Brunier                               Alain Poncet
----------------------                      ----------------------------------
represented by                              represented by

                                       16