Document:

<PAGE>

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

                                                                    Exhibit 10.6

                           EXCLUSIVE LICENSE AGREEMENT
                           ---------------------------

         This Exclusive License Agreement ("Agreement"), effective as of May
8th, 2000 ("Effective Date"), is entered into by and between BIOSPHERE MEDICAL,
INC., a Delaware corporation having principal offices at BioSphere Medical,
Inc., 1050 Hingham Street, Rockland, MA 02370 U.S.A. ("BioSphere"); DR.
SHIN-ICHI HORI, an individual having an address at 3-2-4 Motomachi, Hamadera,
Sakai-shi, Osaka 592-8343, Japan ("Hori"), and Ms. TOMOKO HORI, an individual
having an address at 3-2-4 Motomachi, Hamadera, Sakai-shi, Osaka 592-8343, Japan
(together with Hori, "Licensors").

         WHEREAS, Licensors are the owners of certain patent rights in and to
super absorbing polymer microspheres ("SAP-MS") useful for, among other things;
embolotherapy; and

         WHEREAS, the parties have entered into an agreement under which
Licensors granted rights in such technology to BioSphere; and

         WHEREAS, the parties are desirous of setting forth with more
particularity their rights and obligations concerning such patent rights and new
developments based thereon.

         NOW, THEREFORE, BioSphere and Licensors agree as follows:

                                    Section 1

                                   Definitions
                                   -----------

         In this Agreement, unless otherwise provided, the following terms shall
have the meanings set forth in this section.

         1.1 Affiliate means, with respect to BioSphere, any other entity that
             ---------
directly, or indirectly through one or more intermediaries, controls or is
controlled by or is under common control with BioSphere. For purposes hereof,
the term "control" (including, with its correlative meanings, the terms
          -------
"controlled by" and "under common control with"), with respect to BioSphere,
 -------------       -------------------------
means the possession, directly or indirectly, of the power to direct or cause
the direction of the management and policies of BioSphere (whether through the
ownership of voting securities, by contract or otherwise); provided that in each
                                                           --------
event in which any entity owns directly or indirectly more than fifty percent
(50%) of the securities having ordinary voting power for the election of
directors or other governing body of a corporation or more than fifty percent
(50%) of the ownership interest of any other entity, such entity shall be deemed
to control such corporation or other entity.

         1.2 Follow-On Inventions means and includes any inventions relating to
             --------------------
SAP-MS useful for embolotherapy, conceived or reduced to practice by Hori during
the period commencing on January 1, 1992 and continuing during the term of this
Agreement.

<PAGE>

        1.3 Improvement means (a) any new or modified product or method that
            -----------
performs the same function as a Licensed Product or Licensed Method in a better
or more economical way; or (b) any new or modified product or method that
performs the same function as a Licensed Product Or Licensed Method and costs
less to manufacture than a Licensed Product or costs less to practice than a
Licensed Method.

        1.4 Know-How means unpublished research and development information,
            --------
unpatented know-how, trade secrets, and technical data necessary or useful for
practicing the Licensed Patents.

        1.5 Licensed Method means any method the practice of which, without this
            ---------------
license, would infringe a claim of a Licensed Patent.

        1.6 Licensed Patents means (i) Japan patent number JP 6056676 ("JP `676
            ----------------
patent") entitled Suspension For Blocking Blood Vessels, any patent application
any where in the world that claims or relies on the JP `676 patent for priority,
or any patent issuing on any such application, and any reissue, reexamination,
or extension of any such patent, and (ii) any patent application filed any where
in the world that discloses and claims a Follow-On Invention, any patent
application any where in the world relying on any such application for priority,
any patent issuing on either of the foregoing and, any reissue, reexamination or
extension of any such patent.

        1.7 Licensed Products means any product the manufacture, use, sale,
            -----------------
offer for sale, or import of which, without this license, would infringe a claim
of a Licensed Patent.

        1.8 "Net Sales" means the invoiced price of Licensed Products sold by
             ---------
BioSphere or its Affiliates (a) after deduction of (i) [**]; (ii) [**]; (iii)
[**] (if any); (iv) [**]; (v) [**]; (vi) [**], and (vii) [**]; but (b) [**].
Licensed Products used in testing, clinical trials, or as marketing samples to
develop or promote the Licensed Products shall not be included as sold under the
definition of Net Sales, provided, however, that such excluded Licensed Products
are (a) supplied to the user at no cost; (b) supplied to the user at a cost
which is intended to enable BioSphere or its Affiliates to recover its costs for
manufacturing such Licensed Products and/or (c) used for developing a
formulation or manufacturing process for the Licensed Products. For purposes of
this definition, except when BioSphere's Affiliates are the end users of
Licensed Products, Licensed Products shall be considered sold when billed out to
a customer other than BioSphere's Affiliates. No deductions shall be made for
commissions paid to sales persons or agents or for the cost of collections.

        In the event a Licensed Product is sold in [**], Net Sales, for purposes
of determining royalties [**] will be calculated by [**], in which [**] of the
Licensed Product [**], and [**] of the [**] in the [**]. If the Licensed
Products and the [**] in the [**], then royalties on the [**] will be calculated
by the same method, in which [**] the Licensed Product and [**]. However, in no
case shall the [**].

        1.9 Valid Claim means an issued claim of an unexpired patent, which
            -----------
shall not have been withdrawn, canceled or disclaimed, or held invalid or
unenforceable by a court of competent jurisdiction in an unappealed or
unappealable decision.

                                        2

<PAGE>

                                    Section 2

                                  License Grant
                                  -------------

        2.1 Grant. Licensors hereby grant to BioSphere an exclusive, worldwide,
            -----
right and license, with the right to grant sublicenses, under the Licensed
Patents, unpatented Follow-On Inventions, Improvements and/or Know-How to make,
have made, use, offer to sell, sell, import and otherwise dispose of Licensed
Products, and to practice Licensed Methods.

        2.2 Reservation of Rights. The license granted in Section 2.1 of this
            ---------------------
Agreement, is subject to a reserved non-exclusive license to Hori to practice
the Licensed Patents solely for (a) the conduct of clinical trials in Japan for
and on behalf of BioSphere; (b) the treatment of patients by Hori at Rinku
Medical Center and Osaka Medical Center, and (c) Hori's research at Osaka
University, provided any such research is not sponsored by or disclosed to any
third party commercial entities.

                                   Section 3

                             Payments and Royalties
                             ----------------------

        3.1 Initial Fee. BioSphere shall pay to Hori, on behalf of Licensors, as
            -----------
a license execution fee the sum of [**] dollars ($[**]), receipt of which is
hereby acknowledged by Hori, on behalf of Licensors.

        3.2 Royalties. BioSphere and/or its Affiliates shall pay to Hori, on
            ---------
behalf of Licensors, (a) a continuing royalty of [**] percent ([**]%) of the Net
Sales of Licensed Products covered by a Valid Claim of an issued patent within
the Licensed Patents or Improvements in each country in the world in which such
Valid Claim exists; (b) a continuing royalty of [**] percent ([**]%) of the Net
Sales of Licensed Products under the Know-How, unpatented Improvements or
unpatented Follow-On Inventions; and (c) [**] percent ([**]%) of royalties
actually received by BioSphere based on the sales of the Licensed Products by
its sublicensees.

        3.3 Stock Issuance. In further consideration of the rights and options
            --------------
granted to BioSphere hereunder, and pursuant to the terms and conditions of the
Stock Purchase Agreement attached hereto as Exhibit A, BioSphere shall issue to
Hori, on the Effective Date, an option to acquire ten thousand (10,000) shares
of BioSphere's Common Stock, at a par value of $0.01, through BioSphere's 1997
Stock Option Plan.

        3.4 No Multiple Royalties. No multiple royalties shall be payable in the
            ---------------------
event that any of the Licensed Products or the manufacture, use or sale thereof
is covered by more then one patent included in Licensed Patents or any
combination of Licensed Patents and Know-How and/or Improvements.

        3.5 Credits. If BioSphere is required to make royalty payments to a
            -------
third party to obtain a license or similar right necessary to make, use, offer
for sale, sell or import Licensed Products or practice Licensed Methods,
BioSphere may deduct [**] percent ([**]%) of such royalty payments due to such
third party from royalties thereafter payable to Hori, provided, however, that
in no event shall the royalty payments to Hori be reduced by more than [**].

                                        3

<PAGE>

         3.6  Royalty Payment Period. BioSphere's obligation to pay royalties to
              ----------------------
Hori under this Agreement shall commence, on a product by product basis, one
year after the Effective Date and end (i) upon the expiration of the last to
expire patent within Licensed Patents covering such product, or (ii) ten (10)
years after the Effective Date on products covered only by Know-How or
unpatented Improvements.

         3.7  Disposition of Sublicenses. If this Agreement is terminated for
              --------------------------
any reason, BioSphere shall immediately assign all of is right, title, and
interest to all sublicenses to Licensors, including all right to receive all
income from sublicensees. BioSphere shall, prior to execution of each
sublicense, make the sublicensee aware of this contingency.

         3.8  Notice of Improvements. Licensors shall provide BioSphere with
              ----------------------
prompt written notice of any improvements. Such notice shall contain a detailed
explanation of any such Improvement.

         3.9  Currency. Payments hereunder shall be made to Hori in United
              --------
States of America Dollars or in Japanese Yen.

         3.10 Withholding Taxes. The parties acknowledge and agree that there
              -----------------
may be deducted from any payments or royalties otherwise due and payable
hereunder any taxes or other payments required to be paid by Hori under
applicable law with respect to such payments or royalties or otherwise relating
to the Licensed Products.

                                   Section 4

           Payment Of Royalties, Accounting For Royalties and Records
           ----------------------------------------------------------

         4.1  Payment. Royalties payable hereunder shall be paid within [**]
              -------
days after the end of each calendar quarter, based on the Net Sales of the
Licensed Products by BioSphere and its sublicensees and Affiliates during the
preceding calendar quarter.

         4.2  Accounting Reports. With each quarterly payment, BioSphere shall
              ------------------
deliver to Hori; a full and accurate accounting that sets forth the following
information:

         (a)  total receipts for each Licensed Product sold or otherwise
              disposed of by BioSphere and/or its Affiliates subject to royalty,
              by country, and, to the extent used in any royalty calculations
              during such quarter, the exchange rate set forth in Section 4.3 of
              this Agreement;

         (b)  Royalties and other payments received by BioSphere in connection
              with any sublicense of BioSphere's rights under this Agreement,
              and compensation due to Hori on sales of Licensed Products by
              sublicensees pursuant to such sublicense; and

         (c)  total royalties and/or compensation payable to Hori.

         4.3  Accounting; Foreign Currency. The aggregate amount of the Net
              ----------------------------
Sales of the Licensed Products used for computing the royalties payable
hereunder shall be computed in U.S.

                                        4

<PAGE>

Dollars or in Japanese Yen, and all payments of such royalties shall be made in
U.S. Dollars or in Japanese Yen. For purposes of determining the amount of
royalties due, the amount of the Net Sales of the Licensed Products in any
foreign currency shall be computed by converting such amounts into U.S. Dollars
or Japanese Yen at the prevailing commercial rate of exchange for purchasing
same quoted in The Wall Street Journal, New York edition, on the last business
day of the calendar quarter with respect to which such royalty payment is
payable hereunder.

         4.4 Records. BioSphere shall keep, and shall cause each of its
             -------
Affiliates and sublicenses to keep, for three (3) years, complete and accurate
records of the Net Sales of the Licensed Products sold in sufficient detail to
allow the royalties payable by BioSphere to be accurately determined. Hori shall
have the right for a period of three (3) years after receiving any report or
statement with respect to royalties due and payable hereunder by BioSphere to
appoint an independent accounting firm to inspect and audit the relevant records
of BioSphere and its Affiliates to verify such report or statement. BioSphere
and its Affiliates shall make their records available for inspection and audit
by such independent accounting firm, no more than once per year, during regular
business hours at such place or places where such records are customarily kept,
upon reasonable notice to BioSphere, to the extent reasonably necessary to
verify the accuracy of the reports and payments required hereunder. The cost of
any such inspection and audit shall be paid by Hori unless such inspection and
audit discloses for any calendar quarter examined that there shall have been a
discrepancy of greater than ten percent (10%) between the royalties payable
hereunder by BioSphere and the royalties actually paid by BioSphere with respect
to such calendar quarter, in which case BioSphere shall be responsible for the
payment of the entire cost of such inspection and audit. In all cases, BioSphere
shall pay to Hori any underpaid royalties promptly and with interest at the
prime rate quoted by Citibank, N.A. on the date such payment was due.

                                   Section 5

                                  Due Diligence
                                  -------------

         BioSphere shall use commercially reasonable efforts to develop,
manufacture, and sell Licensed Products. For purposes of this Agreement,
commercially reasonable efforts means funding studies required to obtain
regulatory approval for marketing Licensed Products in Japan in an amount up to
[**] dollars ($[**]).

                                        5

<PAGE>

                                   Section 6

                               Patent Prosecution
                               ------------------

         6.1 Filing and Prosecution. BioSphere shall have the right, but not the
             ----------------------
obligation, to apply for, prosecute and maintain during the term of this
Agreement any and all Licensed Patents and patents on Improvements in any
countries in which BioSphere desires in its sole discretion to commercialize the
Licensed Products. All reasonable costs and expenses of the filing, prosecution
and maintenance of the Licensed Patents in such countries (including all
governmental filing fees) shall be paid by BioSphere. Licensors shall render
reasonable assistance to BioSphere in filing and prosecuting such applications
and maintaining the Licensed Patents in such countries whenever requested to do
so, at BioSphere's expense.

                                   Section 7

                         Representations And Warranties
                         ------------------------------

         7.1 By BioSphere. BioSphere hereby represents and warrants to Licensors
             ------------
that BioSphere has full legal right, power and authority to execute, deliver and
perform its obligations under this Agreement.

         7.2 By Licensors and Hori. Licensors and Hori, jointly and severally,
             ---------------------
hereby warrant and represent to BioSphere that (a) Hori and Licensors have full
legal right, power and authority to execute, deliver and perform their
respective obligations under this Agreement; (b) the execution, delivery and
performance by Hori and Licensors of this Agreement does not contravene or
constitute a default under any provision of applicable law or of any agreement,
judgment, injunction, order, decree or other instrument binding upon Hori or
Licensors; (c) all licenses, consents, authorizations and approvals, if any,
required for the execution, delivery and performance by Hori and/or Licensors of
this Agreement have been obtained and are in full force and effect and all
conditions thereof have been complied with, and no other action by or with
respect to, or filing with, any governmental authority or any other person or
entity is required in connection with the execution, delivery and performance by
Hori and/or Licensors of this Agreement, (d) Licensors are the exclusive owner
of all legal and beneficial right, title and interest in and to the Licensed
Patents, (e) as of the Effective Date, Licensors are not aware of any patent or
other right of any third party that would be infringed or violated by the
practice of the Licensed Patents as contemplated by this Agreement, and (f) this
Agreement constitutes a valid and binding agreement of Hori and Licensors,
enforceable against Hori and Licensors, in accordance with its terms.

         7.3 Survival of Representations and Warranties. The representations and
             ------------------------------------------
warranties contained herein shall survive the execution, delivery and
performance of this Agreement by the parties, notwithstanding any investigation
at any time on or prior to the date hereof made by or on behalf of any party or
parties.

                                        6

<PAGE>

                                    Section 8

                            Third Party Infringement
                            ------------------------

     8.1  Third Party Infringement.
          ------------------------

          8.1.1  Notice. In the event that either party becomes aware of any
                 ------
substantial infringement of the Licensed Patents, such party shall notify the
other party of the substantial infringement in writing and provide a summary of
the relevant facts and circumstances known to such party relating to such
infringement. Neither party will notify a third party of the substantial
infringement of any of the Licensed Patents without first obtaining consent of
the other party, which consent shall not be unreasonably withheld or delayed.

          8.1.2  BioSphere's Options. During the term of this Agreement,
                 -------------------
BioSphere shall have the right, but shall not be obligated, to prosecute, at its
own expense, any infringements of the Licensed Patents, to defend the Licensed
Patents and to recover, for its own account, any damages, awards or settlements
resulting therefrom. Licensors hereby agree that BioSphere may join Licensors as
a party plaintiff(s) in any such suit, without expense to Licensors. BioSphere
shall hold harmless and indemnify Licensors from and against any order for costs
arising without fault of Licensors that may be made against Licensors by reason
of being named a party plaintiff(s) in such proceedings. BioSphere shall have
sole control of any such suit and all negotiations for its settlement or
compromise, provided that, BioSphere shall not settle or compromise any such
suit or enter into any consent order for the settlement or compromise thereof
that adversely affects the Licensed Patents without the prior written consent of
Licensors, which consent shall not be unreasonably withheld or delayed. The
total cost of any infringement action commenced or defended solely by BioSphere
shall be borne solely by BioSphere.

          8.1.3  Licensors's Options. If, within one (1) year after having been
                 -------------------
notified of any potential infringement subject to the provisions of Sections
8.1.2, BioSphere shall have been unsuccessful in causing the alleged infringer
to desist and shall not have brought and shall not be diligently prosecuting an
infringement action, or if BioSphere notifies Licensors at any time prior
thereto of its intention not to bring suit against any alleged infringer, then,
in those events only, Licensors shall have the right, but shall not be
obligated, to prosecute, at its own expense, any infringements of the Licensed
Patents, to defend the Licensed patents and to recover, for its own account, any
damages, awards or settlements resulting therefrom. BioSphere hereby agrees that
Licensors may join BioSphere as a party plaintiff in any such suit, without
expense to BioSphere. Licensors shall hold harmless and indemnify BioSphere from
and against any order for costs arising without fault of BioSphere that may be
made against BioSphere by reason of being named a party plaintiff in such
proceedings. Licensors shall have sole control of any such suit and all
negotiations for its settlement or compromise, provided that Licensors shall not
settle or compromise any such suit or enter into any consent order for the
settlement or compromise thereof that adversely affects the Licensed Patents or
any of the licenses or rights of BioSphere hereunder, without the prior written
consent of BioSphere which consent shall not be unreasonably withheld or
delayed. The total cost of any infringement action commenced or defended solely
by Licensors shall be borne by Licensors.

                                       7

<PAGE>

     8.2  Infringement Charge Against BioSphere. In the event that any action,
          -------------------------------------
suit or proceeding is brought against, or written notice of threat thereof is
provided to, BioSphere alleging infringement of any patent or unauthorized use
or misappropriation of technology arising out of or in connection with
BioSphere's practice of Licensed Patents, BioSphere shall defend at its own
expense such action, suit or proceeding and, in furtherance of such rights,
Licensors hereby agree that BioSphere may join Licensors as a party(ies) in such
suit, without expense to Licensors. BioSphere shall hold harmless and indemnify
Licensors from and against any order for costs arising without fault of
Licensors that may be made against Licensors in such proceedings. Licensors
agrees to cooperate with BioSphere, at BioSphere's expense, in connection with
BioSphere's response to or defense of such action, suit or proceeding, or notice
or threat thereof.

     8.3  Cooperation. In the event that a party shall undertake the enforcement
          -----------
and/or defense of the Licensed Patents by legal or patent office proceedings
pursuant to this Agreement, the other party shall, at the request and expense of
the party undertaking such enforcement and/or defense, cooperate in all
reasonable respects and, to the extent possible, have its employees testify when
requested and make available relevant records, papers, information, samples and
the like.

     8.4  BioSphere's Rights. BioSphere shall have the sole right in accordance
          ------------------
with the terms and conditions hereof to sublicense any alleged infringer for
future use of the Licensed Patents to which it has exclusive rights under
Section 2.1 of this Agreement.

                                   Section 9

                                 Indemnification
                                 ---------------

     9.1  Indemnification. BioSphere hereby agrees that it shall be responsible
          ---------------
for, indemnify, hold harmless and defend Licensors and their successors and
assigns (collectively, the "Indemnitees"), from and against any and all claims,
                            -----------
demands, losses, liabilities, damages, costs and expenses (including the cost of
settlement, reasonable legal and accounting fees and any other expenses for
investigating or defending any actions or threatened actions) (collectively,
"Losses") suffered or incurred by any Indemnitee arising out of, relating to,
resulting from or in connection with (a) a claim brought by a third party of
personal injury (including death) or property damage caused by a Licensed
Product manufactured by or for BioSphere its Affiliates or sublicensees, (b) the
exercise of any of the rights and/or licenses granted herein to BioSphere, its
Affiliates, or any sublicensee, and (c) any action, suit or other proceeding, or
compromise, settlement or judgment, relating to any of the foregoing matters
described in subparagraph (a) hereof with respect to which the Indemnitees are
entitled to indemnification hereunder. The foregoing shall not apply to the
extent that such Losses are due to the willful misconduct or gross negligence of
any of the Indemnitees.

     9.2  Notice of Claims. In the event that a claim is made pursuant to
          ----------------
Section 9.1 above against any Indemnitee, the Indemnitee agrees to promptly
notify BioSphere of such claim or action and, in any such case BioSphere shall
assume control of the defense of such claim or action; provided, however, that
                                                       --------  -------
(a) all Indemnitees shall be entitled to participate therein (through a single
counsel of their own choosing) at the Indemnitees' sole cost and expense,

                                       8

<PAGE>

(b) the Indemnitees shall fully cooperate with BioSphere in all reasonable
respects, and (c) BioSphere shall not settle or compromise any such claim or
action without the prior written consent of the Indemnitees, unless such
settlement or compromise includes a general release of the Indemnitees from any
and all liability with respect thereto and does not include an admission of
liability on the part of any Indemnitee, and does not impose any restriction on
the conduct by such Indemnitee of any of its activities.

                                   Section 10

                            Limitations on Liability

     10.1  No Warranties. Except as expressly set forth in Section 7 hereof,
           -------------
neither party makes any representations or warranties as to any matter
whatsoever. EACH PARTY HEREBY DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS AND
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED PATENTS, THE
KNOW-HOW AND THE LICENSED PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

     10.2  Limitations of Liability. UNDER NO CIRCUMSTANCES SHALL EITHER PARTY
           ------------------------
BE LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON FOR ANY SPECIAL, CONSEQUENTIAL
OR INDIRECT DAMAGES OF ANY KIND WHATSOEVER.

     10.3  Force Majeure. No party shall be liable for failure or delay in
           -------------
performing any of its obligations hereunder if such failure or delay is
occasioned by compliance with any governmental regulation, request or order, or
by circumstances beyond the reasonable control of the party so failing or
delaying, including, without limitation, Acts of God, war, insurrection, fire,
flood, accident, labor strikes, work stoppage or slowdown (whether or not such
labor event is within the reasonable control of the parties), or inability to
obtain raw materials, supplies, power or equipment necessary to enable such
party to perform its obligations hereunder. Each party shall (a) promptly notify
the other party in writing of any such event of force majeure, the expected
duration thereof and its anticipated effect on the ability of such party to
perform, its obligations hereunder, and (b) make reasonable efforts to remedy
any such event of force majeure.

                                   Section 11

                              Term and Termination

     11.1  Term. The term of this Agreement will commence on the Effective Date
           ----
of this Agreement and remain in full force and effect until either the later of
(i) expiration of the term of the last patent of the Licensed Patent covering
any Licensed Product, or (ii) ten (10) years.

     11.2  Termination By BioSphere. BioSphere may terminate this Agreement in
           ------------------------
part or in whole at any time upon one hundred eighty (180) days' written notice
in advance to Licensors.

     11.3  Termination By Default. If either party shall be in default of any
           ----------------------
obligation hereunder, or shall be adjudged bankrupt, or become insolvent, or
make an assignment for the

                                        9

<PAGE>

benefit of creditors, or be placed in the hands of a receiver or a trustee in
bankruptcy; the other party may terminate this Agreement by giving sixty (60)
days' notice by Registered Mail to the other party, specifying the basis for
termination. If within sixty (60) days after the receipt of such notice, the
party who received notice shall remedy the condition forming the basis for
termination, such notice shall cease to be operative, and this Agreement shall
continue in full force.

                                   Section 12

                                 Export Controls
                                 ---------------

     All obligations to furnish goods, technology, or software under this
Agreement may be subject to various laws and regulations governing the export of
goods, including U.S. and/or Japanese Export Control Laws and Regulations.
BioSphere agrees to comply fully with all applicable laws and regulations before
exporting any goods, technology, or software. BioSphere recognizes and agrees
that its obligations to comply with such export control laws and regulations
survive the termination or expiration of this Agreement.

                                   Section 13

                                  Miscellaneous
                                  -------------

     13.1  Notices. All notices, reports and/or other communications made in
           -------
accordance with this Agreement, shall be deemed to be duly made or given (i)
when delivered by hand, (ii) three days after being mailed by registered or
certified mail (air mail if mailed overseas), return receipt requested, or (iii)
when received by the addressee, if sent by facsimile transmission or by Express
Mail, Federal Express or other express delivery service (receipt requested), in
each case addressed to such party at its address set forth below (or to such
other address as such party may hereafter designate as to itself by notice to
the other party hereto):

     In the case of BioSphere:

          John Carnuccio
          BioSphere Medical, Inc.
          1050 Hingham Street
          Rockland MA 02370 U.S.A.

     In the case of Licensors or Hori:

          Dr. Shin-ichi Hori
          3-2-4 Motomachi, Hamadera
          Sakai-shi, Osaka 592-8343
          Japan

     13.2  Amendments. This Agreement may not be amended or modified, nor may
           ----------
any right or remedy of any party be waived, unless the same is in writing and
signed by such party or a duly authorized representative of such party. The
waiver by any party of the breach of any

                                       10

<PAGE>

term or provision hereof by any other party shall not be construed as a waiver
of any other subsequent breach.

     13.3  No Waiver; Remedies. No failure or delay by any party in exercising
           -------------------
any of its rights or remedies hereunder shall operate as a waiver thereof, nor
shall any single or partial exercise of any such right or remedy preclude any
other or further exercise thereof or the exercise of any other right or remedy.
The rights and remedies of the parties provided in this Agreement are cumulative
and not exclusive of any rights or remedies provided by law.

     13.4  Assignment. Licensors may not assign or otherwise transfer this
           ----------
Agreement or any of their rights, duties or obligations hereunder without the
prior written consent of BioSphere.

     13.5  Expenses. Unless otherwise provided herein, all costs and expenses
           --------
incurred in connection with this Agreement and the transactions contemplated
hereby shall be paid by the party which shall have incurred the same and the
other party shall have no liability relating thereto.

     13.6  Entire Agreement. This Agreement and that certain Medical Advisory
           ----------------
Board Agreement entered into between Hori and BioSphere in September 1999
constitute the entire agreement between the parties and supersedes all prior
proposals, communications, representations and agreements, whether oral or
written, with respect to the subject matter hereof.

     13.7  Severability. Any term or provision of this Agreement which is
           ------------
invalid or unenforceable in any jurisdiction shall, as to such jurisdiction, be
ineffective to the extent of such invalidity or unenforceability without
rendering invalid or unenforceable the remaining terms and provisions of this
Agreement or affecting the validity or enforceability of any of the terms or
provisions hereof in any other jurisdiction.

     13.8  Counterparts. This Agreement may be signed in any number of
           ------------
counterparts, each of which shall be deemed an original, with the same effect as
of the signatures thereto and hereto were upon the same instrument.

     13.9  Headings. The headings used in this Agreement are for convenience of
           --------
reference only and shall not affect the meaning or construction of this
Agreement.

     13.10 Governing Law. This Agreement, including the performance and
           -------------
enforceability hereof, shall be governed by and construed in accordance with the
laws of the Commonwealth of Massachusetts, U.S.A. without reference to choice of
law doctrine. Each party hereby submits itself for the sole purpose of this
Agreement and any controversy arising hereunder to the jurisdiction of the
courts located in the Commonwealth of Massachusetts, and any courts of appeal
therefrom, and waives any objection (on the grounds of lack of jurisdiction or
forum non conveniens or otherwise) to the exercise of such jurisdiction over it
by any such courts.

     13.11 Official Language. The official language of this Agreement and any
           -----------------
communication, notice or proceeding relating thereto shall be English.

                                       11

<PAGE>

     IN WITNESS WHEREOF, the undersigned are duly authorized to execute this
Agreement on behalf of BIOSPHERE, HORI, and LICENSORS as applicable.

FOR BIOSPHERE MEDICAL, INC.:                  FOR LICENSORS:

                                              DR SHIN-ICHI-HORI
("BioSphere")                                 ("Hori")

By:  /s/ Jean-Marie Vogel                         /s/ Shinichi Hori
   ---------------------------------          ---------------------------------

Print Name: Jean-Marie Vogel                  Print Name:   Shinichi Hori
           -------------------------                     -----------------------

Title:  Chairman
      ------------------------------

                                              Tomoko Hori

                                                  /s/ Tomoko Hori
                                              ----------------------------------

                                              Print Name:   Tomoko Hori
                                                         -----------------------

                                       12<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

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