Exhibit 10.52

 

*** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY
ASTERISKS) HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER 17
C.F.R. SECTIONS 200.80(B)(4), 200.83 AND 230.406.

 

 

AMENDED AND RESTATED

 

UNITED STATES

 

DISTRIBUTION AGREEMENT

 

 

                THIS AMENDED AND RESTATED UNITED STATES DISTRIBUTION AGREEMENT
(this “Agreement”) is made as of the 29th day of November, 2004 by and between
GENZYME CORPORATION, a corporation duly organized and existing under the laws of
the Commonwealth of Massachusetts (“Genzyme”) and INAMED MEDICAL PRODUCTS
CORPORATION, a corporation duly organized and existing under the laws of the
State of California (the “Distributor”).

 

                WHEREAS, Genzyme, as assignee of and successor in interest to
Biomatrix, Inc. and Inamed, as assignee of an successor in interest to Collagen
Corporation, on June 14, 1996 entered into a United States Distribution
Agreement (the “Original Agreement”), as amended by Genzyme and Inamed on
September 30, 2002 by the Development Agreement and Amendment to United States
Distribution Agreement (the “Development Agreement and Amendment”), pursuant to
which Genzyme granted to Inamed exclusive promotion, marketing and distribution
rights for certain products in the United States on the terms and subject to the
conditions set forth therein; and

 

WHEREAS, Genzyme and the Distributor wish to amend and restate the Original
Agreement, as amended, in order to include certain additional products as
Agreement Products (as such term is hereinafter defined), and to make such
further amendments upon the terms and conditions set forth in this Agreement,
which incorporates in its entirety the Original Agreement and Section 16 of the
Development Agreement and Amendment.

                NOW, THEREFORE, in consideration of the premises and of the
mutual covenants of the parties hereto, it is hereby agreed as follows:

 

                1.             Definitions and Interpretation.

 

                1.1.          In this Agreement, the following words and
expressions shall have the following meanings:

 

“Affiliate” shall mean, with respect to any party, any Person which, directly or
indirectly, is controlled by, controls or is under common control with such
party.  For

 

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purposes of this definition, the term “control” (including with correlative
meanings, the terms “controlled by” and “under common control with”) shall mean,
with respect to any Person, the direct or indirect ownership of more than fifty
percent (50%) of the voting or income interest in such Person or the possession
otherwise, directly or indirectly, of the power to direct the management or
policies of such Person.

 

“Agreement Products” shall mean (a) the two products made of hylan B and called
Hylaform® and Hylaform® Plus, respectively, and (b) the one product made with
bacterial hyaluronan that has been cross-linked using the hylan B cross-linking
process and called Captique™; the specifications of each of which are set forth
on Exhibit A, for use in the correction of wrinkles and depressed scars.  In
addition, upon mutual written agreement, the parties may include additional
products as “Agreement Products” by attaching the specifications for such
product(s) to Exhibit A, which specifications shall including the initial
Minimum Price for such additional product(s).  Upon attaching such
specifications, each additional product shall be deemed an “Agreement Product”
hereunder.

 

“Agreement Product Specifications” shall mean the specifications for the
Agreement Products set forth in Exhibit A, as such specifications may be
modified or supplemented by Genzyme from time to time in accordance with Product
License Approvals or to reflect any Improved Agreement Product(s).

 

“Agreement Year” shall mean the twelve (12) month period commencing on  ***   
   ***    and each separate successive twelve (12) month period thereafter.

 

“Binding Forecast” shall mean that term as defined in Section 7.3(a).

 

“Captique” shall mean the Agreement Product made with bacterial hyaluronan that
has been cross-linked using the hylan B cross-linking process and called
Captique™.

 

“Committee” shall mean that term as defined in Section 11.

 

“Contract Quarter” shall mean, for sales of Agreement Products, the period
commencing on         ***          and ending on          ***           and each
three (3) month period thereafter throughout the term of this Agreement.

 

“Dermal Tissue Augmentation Products” shall mean
biomaterial(s)                                             ***

                                                                                   
***

                                                                                   
***

                                                                                   
***

 

“Development Costs” shall have the meaning set forth in the Development
Agreement and Amendment and, for the avoidance of any doubt, shall include the
fully loaded costs incurred by either party in connection with maintaining FDA
Approvals, including, without limitation, any Phase IV post-marketing clinical
trials

 

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performed in connection with any Agreement Product(s) or Improved Agreement
Products.  For the purposes of this definition, “fully loaded costs” shall mean
(a) all direct costs of labor, raw materials, supplies, services, fees
(including external costs incurred by third parties) and other resources
consumed or used in the conduct of the applicable activity, and (b) all indirect
costs of rent, utilities, insurance, facility and equipment depreciation,
administrative support and other overhead charges related to the applicable
activity.  Indirect costs shall be allocated based upon the portion of such
costs directly attributable to the support of the applicable activity.  All cost
determinations made hereunder shall be made in accordance with generally
accepted accounting principles consistently applied.

 

“Dollars” and “$” shall mean the lawful currency of the United States of
America.

 

“Effective Date” shall mean          ***

 

“EU Countries” shall mean, collectively, Austria, Belgium, Denmark, Finland,
France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal,
Spain, Sweden and the United Kingdom.

 

“European Territory” shall mean, collectively, the EU Countries, Switzerland,
Norway, Liechtenstein and Iceland.

 

“FDA” shall mean the U.S. Food and Drug Administration.

 

“FDA Approval” shall mean, with respect to an Agreement Product, receipt by
Genzyme of an approval letter from the FDA to promote, market, distribute and
sell such Agreement Product in the Territory.

 

“Fee Payment Default” shall mean that term as defined in Section 7.1(c).

 

“Formula Price” shall mean an amount equal to                          ***

                                                                  ***

                                                                  ***

                                                                  ***

 

“Hylaform” shall mean the Agreement Product made of hylan B and called
Hylaform®.

 

“Hylaform Plus” shall mean the Agreement Product made of hylan B and called
Hylaform® Plus.

 

“Improved Agreement Product(s)” shall mean (i) any modification of an Agreement
Product (that is made entirely from hylan B) regarding the formulation of hylan
B in such Agreement Product, that is changes of concentration of the polymer or
other changes in the applicable Agreement Product Specifications for such

 

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Agreement Product, whether or not requiring new regulatory approval in the EU
Countries or in the United States, and (ii) any modifications or changes related
to the packaging of an Agreement Product, including the syringe used, mode of
application or dosage.

 

“Incremental Royalties” shall mean that term as defined in Section 8.2.

 

“Initial Term” shall mean that term as defined in Section 3.2.

 

“International Agreement” means the Distribution Agreement between Genzyme and
Distributor, dated as of June 14, 1996, as amended from time to time, relating
to the sale of Agreement Products in the EU Countries, Switzerland, Norway,
Liechtenstein, Iceland, Australia, New Zealand, Canada, Israel, Argentina,
Mexico, Chile and Brazil.

 

“International Territory” shall mean, collectively, the EU Countries,
Switzerland, Norway, Liechtenstein, Iceland, Australia, New Zealand, Japan,
Israel, Argentina, Brazil, Chile, Mexico and Canada.

 

“Launch” shall mean the commencement by the Distributor of sales of an Agreement
Product in commercial quantities in the Territory for use in the Territory.

 

“Minimum Price” shall initially mean (a)                              ***

                           ***                       ($   ***   ) for each
Treatment Syringe, (b)   ***

                                              ***            
                       ($   ***   ) for each Treatment Syringe, (c) with respect
to any Improved Agreement Product(s), the parties shall attempt in good faith to
agree in writing upon mutually acceptable minimum pricing, and (d) with respect
to any additional Agreement Products added to this Agreement by mutual written
consent of the parties, the amount set forth on Exhibit A with respect to such
additional Agreement Product.               ***

                                                                                   
***

                                                                                   
***

                                                                                   
***

                                                                                   
***                                       .  If the Distributor’s rights to
distribute the Agreement Products in the Territory become non-exclusive pursuant
to Section 2.3, the then applicable Minimum Price payable (i) during the
          ***           Agreement Years immediately following such conversion to
non-exclusivity shall be adjusted
                                 ***                                      
    ***    for each Treatment Syringe, and (ii) during the
                  ***                    
Agreement Years following such conversion to non-exclusivity shall
       ***          
   ***   ($  ***  ) for each Treatment Syringe.

 

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“Net Retail Sales” shall mean, with respect to sales of a Dermal Tissue
Augmentation Product in the Territory

 

 

***

 

 

***

 

 

***

 

 

***

 

 

 

“New Products” shall mean any and all Dermal Tissue Augmentation Products made
of:

 

 

***

 

 

***

 

 

***

 

 

***

 

“Non-Binding Forecast” shall mean that term as defined in Section 7.3(a).

 

“Patents” shall mean Letters Patent or similar statutory rights relating to any
Agreement Products and any Improved Agreement Product(s) (including any
continuation-in-part, continuation or division thereof or substitute thereof),
and patent applications which are pending as of the Effective Date, in each case
as set forth in Exhibit B, together with any supplementary or complementary
protection certificates therefor if and when such are granted.

 

“Person” shall mean an individual, a corporation, limited liability company, a
partnership, a trust, an unincorporated organization or a government or any
agency or political subdivision thereof.

 

“Product Guidelines” shall mean the product promotional guidelines jointly
developed by Genzyme and the Distributor related to the promotion, marketing and
sale of the Agreement Products and any Improved Agreement Product(s) in the
United States entitled, “Hylaform® (hylan B gel) Product Family - Product
Promotional Guidelines & Style Guide” and any changes in writing thereto
mutually agreed upon by the Parties.

 

“Product License Approvals” shall mean those regulatory approvals required for
the importation, promotion, marketing and sale of the Agreement Products and any
Improved Agreement Product(s) in the United States (including any reimbursement
or pricing approvals).

 

“Region” shall mean any one of the following countries or groups of countries: 
***

                                                                               
***

                                                                               
***

                                                                               
***

 

“Territory” shall mean the United States.

 

“Trademarks” shall mean (a) the registered trademark Hylaform® and the trademark
Captique™, the details of each of which are described in Exhibit B, and

 

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(b) any other trademarks, as may be agreed upon in writing from time to time by
the parties hereto for use by the Distributor in connection with the promotion,
marketing and sale of the Agreement Products and any Improved Agreement
Product(s) under this Agreement.

 

“Treatment Syringe” shall mean a ready-for-injection 0.9cc syringe of an
Agreement Product.

 

“United States Consumer Price Index” shall mean the Consumer Price Index, All
Items, United States, as published by the Bureau of Labor Statistics.

 

                1.2.          In this Agreement, unless the context otherwise
requires:

 

                (a)           clause headings are inserted for convenience of
reference only and have no legal effect;

 

                (b)           references to sections, exhibits and schedules are
to be construed as references to the sections of, and exhibits and schedules to,
this Agreement and references to this Agreement include its exhibits and
schedules;

 

                (c)           references to (or to any specified provision of)
this Agreement or any other document shall be construed as references to this
Agreement, that provision or that document as in force for the time being and as
amended, varied, substituted, supplemented, restated or novated in accordance
with the terms thereof or, as the case may be, with the agreement of the
relevant parties and (where such consent is, by the terms of this Agreement or
the relevant document, required to be obtained as a condition to such amendment
being permitted) the prior written consent of Genzyme;

 

                (d)           words importing the plural shall include the
singular and vice versa;

 

                (e)           references to a person shall be construed as
including references to an individual, firm, consortium, company, corporation,
unincorporated body of persons or any State or any agency thereof; and

 

                (f)            references to statutory provisions shall be
construed as references to those provisions as replaced, amended or re-enacted
from time to time.

 

                2.             Appointment; Best Efforts; Exclusivity.

 

                2.1.          Appointment.

 

                (a)           Subject to the terms and conditions hereinafter
set forth, Genzyme hereby appoints the Distributor as its exclusive
             ***             (except to the extent set forth in Section 2.3)
distributor for the promotion, marketing, sale and distribution within the
Territory of the Agreement Products and any Improved Agreement Product(s)
supplied by

 

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Genzyme or an Affiliate of Genzyme to the Distributor pursuant to this
Agreement.  Such appointment does not include the right to sublicense or appoint
subdistributors except to an Affiliate of Distributor without the approval of
Genzyme (and only for such time as such an Affiliate remains an Affiliate of
Distributor).

 

                (b)           Except as specifically provided to the contrary
herein, the foregoing appointment shall not be construed, by implication or
otherwise, (i) to effect any sale of proprietary Genzyme technology, (ii) to
grant any license relating to Genzyme’s proprietary methods of formulating,
fabricating and manufacturing the Agreement Products or any Improved Agreement
Product(s), or (iii) to grant the Distributor any rights in or to any
proprietary technology or patents or trademarks of Genzyme.

 

                2.2.          Acceptance of Obligations; Best Efforts.  The
Distributor hereby accepts the appointment described in Section 2.1 and hereby
agrees to use its best efforts at all times during the term hereof to promote,
market, sell and distribute the Agreement Products and any Improved Agreement
Product(s) in the Territory.  Distributor’s “best efforts” in this Section 2.2
shall mean that Distributor shall use generally the same channels and methods,
exercise the same degree of effort and diligence, and adhere to the same
standards as Distributor and its Affiliates would apply in distributing their
own actively-promoted pharmaceutical products, and shall be such as are
commercially reasonable.

 

                2.3.          Conversion to Non-Exclusive Distributorship.  In
the event that in any Agreement Year including and after the    ***    Agreement
Year (and so long as (i) no force majeure condition of Distributor exists at
such time pursuant to Section 20, (ii) Genzyme has met its supply obligations
under Section 7.4 and (iii) Distributor is able to lawfully sell any Agreement
Products or any Improved Agreement Product(s) in the Territory), the
Distributor’s Net Retail Sales of the Agreement Products and any Improved
Agreement Product(s) in the Territory in such Agreement Year comprise less than
             ***

                                                                                               
***

                                                                                               
***                                        , either Genzyme or the Distributor
may elect upon        ***          notice, but in any event not later than 
***  
                   ***        after the end of the applicable Agreement Year, to
convert the Distributor’s distribution rights under this Agreement in the
Territory from exclusive to non-exclusive; provided, however, that Distributor
may cure, within           ***        after receipt of any such notice from
Genzyme, a shortfall of Net Retail Sales with respect to the Territory for an
Agreement Year by paying to Genzyme within            ***         after such
Agreement Year an amount equal to
                                ***                                                
                       ***                        in such Agreement Year for
such Territory; further provided that at Genzyme’s election, Genzyme may refuse
to allow such cure if Distributor has taken advantage of such cure provision in
each of the two preceding Agreement Years.

                                                                                    
***

                                                                                    
***

                                                                                    
***

                                                                                    
***                                             .  Upon conversion of
Distributor’s rights to a non-exclusive distribution arrangement in the

 

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Territory, Genzyme shall have the right to distribute the Agreement Products and
Improved Agreement Products and/or engage another distributor for the
Territory.  From and after the date of a conversion to a non-exclusive
distribution arrangement within the Territory, the Distributor shall lose its
rights hereunder to promote, market, sell and distribute within the Territory
any Improved Agreement Product(s) commercialized on or after such date. 
Notwithstanding the foregoing, the Distributor shall retain the exclusive right
to use all trademarks under which the Distributor launched the Agreement
Products or any Improved Agreement Product(s) in the Territory.

 

                3.             Term and Termination.

 

                3.1.          Effective Date.  This Agreement shall take effect
as of the Effective Date.

 

                3.2.          Term.

 

                (a)           Unless this Agreement is sooner terminated in
accordance with the provisions of this Agreement, the term of the appointment
hereunder for shall commence on the first day of the first Agreement Year and
shall end on the last day of the      ***      Agreement Year (the “Initial
Term”).

 

                (b)           Unless this Agreement is sooner terminated in
accordance with the provisions of this Agreement, the appointment of the
Distributor hereunder as exclusive distributor of the Agreement Products shall
be renewable by the Distributor, at its option, upon written notice to Genzyme
received at least           ***        prior to the end of the Initial Term, for
an additional consecutive term of         ***        following the date of
expiration of the Initial Term, provided that the Distributor shall only be
entitled to exercise such renewal option if as of the date of expiration of the
Initial Term the Distributor is not in material breach of any of its obligations
under this Agreement.  Thereafter, the appointment of the Distributor as
exclusive distributor of the Agreement Products shall be renewable upon the
expiration of such additional        ***       term, upon written notice to
Genzyme received at least     ***    
      ***     prior to the end of such term for one additional consecutive
renewal term of  ***  
*** years, provided that, as of the date of expiration of the first renewal
term, the Distributor is not in material breach of any of its obligations under
this Agreement.  For the avoidance of any doubt, Distributor’s rights with
respect to any Improved Agreement Product(s) commercialized after the
commencement of the       ***       Agreement Year shall terminate upon the last
day of the       ***       Agreement Year.  Subject to the terms of this
Agreement, Distributor shall have the right to continue to sell the Agreement
Products and any Improved Agreement Product(s) it is then currently selling.

 

                (c)           In the event that in any Agreement Year including
and after the  ***    Agreement Year (and so long as (i) no force majeure
condition of Distributor exists at such time pursuant to Section 20, (ii)
Genzyme has met its supply obligations under Section 7.4, and (iii) Distributor
is able to lawfully sell any Agreement Product and/or any Improved Agreement
Product(s) in the Territory), in the event that the Distributor’s Net Retail
Sales of

 

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the Agreement Products and any Improved Agreement Product(s) in the Territory in
any Agreement Year comprise less than                                       ***

***

                                          ***                            , the
Distributor’s distribution rights (including, without limitation, its right to
use the Trademarks) under this Agreement for the Agreement Products and any
Improved Agreement Product(s) in the Territory shall terminate upon
          ***         notice, but in any event not later than
                      ***

                                                     
                ***                                                  ; provided,
however, that Distributor may cure a shortfall of Net Retail Sales for an
Agreement Year by paying to Genzyme an amount equal to
                                  ***

                                              ***                            
        ; further provided that, at Genzyme’s election, Genzyme may refuse to
allow such cure if Distributor has taken advantage of such cure provision in
each of the two preceding Agreement Years.      ***

                                                                                   
***

                                                                                   
***

                                                                                   
***

Upon any such termination of the Distributor’s distribution rights in the
Territory, the Distributor’s obligation to pay any royalties pursuant to
Sections 8.1 and 8.2 for any sales in the Territory after such termination shall
cease, but the Distributor shall remain obligated to pay all such royalties for
sales in the Territory accrued prior to such termination.

 

                (d)           In the event the Distributor has not commenced a
Launch of Captique by ***  
   ***   , the Distributor’s distribution rights (including, without limitation,
its right to use the Captique Trademark) under this Agreement for Captique in
the Territory shall terminate upon        ***        notice at the election of
Genzyme.

 

                3.3.          Inventory.

 

                (a)           Upon termination of this Agreement for any reason,
Genzyme shall have the right (but not the obligation) to repurchase all or part
of the inventory of the Agreement Products and any Improved Agreement Product(s)
held by the Distributor or its Affiliates.

 

                (b)           The price for inventory to be repurchased by
Genzyme pursuant to Section 3.3(a) above shall be the landed cost thereof
actually paid by the Distributor to Genzyme.  With respect to any quantities not
repurchased by Genzyme, the Distributor shall have the right to sell such
inventory of the Agreement Products and any Improved Agreement Product(s), in
its usual and customary manner, in the ordinary course of business, for a period
of        ***        following termination of this Agreement and notwithstanding
such termination the terms and conditions of this Agreement shall apply to such
sales.

 

                3.4.          Insolvency.  This Agreement may be immediately
terminated by either party, upon giving written notice to the other party, in
the event that the other party shall become insolvent or be declared bankrupt by
a court of competent jurisdiction or shall be the subject of any reorganization
(other than a corporate reorganization effected in the ordinary course of
business and not arising out of any insolvency) or winding up, receivership or
dissolution,

 

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bankruptcy or liquidation proceeding, or any proceeding or action similar to one
or more of the above, in which case termination shall be effective upon such
written notice.  The failure of either party to give notice of termination upon
obtaining knowledge of any such event shall not be interpreted as a waiver of
such party’s rights under this Section 3.4, and such party reserves the right to
exercise any such rights at any time after the occurrence of any such event.

 

                3.5.          Breach.  This Agreement may be terminated by
either party if the other party shall breach any of its payment obligations
hereunder (in the event of a Fee Payment Default, Genzyme shall have the right
to terminate only the Distributor’s rights with respect to Captique) or if
either party shall commit a material breach of any of its warranties, covenants,
conditions, obligations or agreements contained herein, provided that such
breach shall continue for a period of
                                          ***

                     ***                after written notice thereof and
provided further that such termination shall be immediately effective upon
further written notice to that effect to the breaching party after its failure
to cure such breach within such applicable notice period.

 

                3.6.          Certain Rights Upon Termination.  Upon termination
of this Agreement for any reason whatsoever, Genzyme shall have the following
rights:

 

                (a)           Genzyme shall have the unrestricted right to
review, access, use and permit others to review, access and use, either directly
or by cross-reference or incorporation or otherwise, all information, data,
investigations, preclinical and clinical protocols, marketing information
disseminated by Distributor publicly to customers and patients and all
information required to be provided to Genzyme by law, information relating to
laboratory, animal and human studies, and related regulatory approvals
pertaining to the Agreement Products or any Improved Agreement Product(s) (the
“Information”) which are possessed or controlled by the Distributor or any of
its Affiliates, or to which the Distributor or any of its Affiliates has a right
to review, access or use.  The Distributor unconditionally agrees promptly to
take any action and to execute and deliver to Genzyme any documents or
instruments reasonably requested by Genzyme to permit Genzyme to make full use
of such unrestricted right.

 

                (b)           Further, Genzyme shall have exclusive ownership
rights to the Trademarks and to all other product specific logos, slogans and
other intangibles used by the Distributor solely in association with the
independent sale of the Agreement Products and any Improved Agreement Product(s)
(including any and all good will associated with the Agreement Products and any
Improved Agreement Product(s) and all registrations relating thereto) possessed
or controlled by the Distributor or any of its Affiliates, and the Distributor
unconditionally agrees, subject to the provisions of Section 3.3(b), (i)
immediately upon termination to cease using the Trademarks and any such logos,
slogans, and marketing rights of Genzyme or any imitations thereof and (ii)
immediately to execute and deliver to Genzyme any documents or instruments
reasonably requested by Genzyme to give full effect to the provisions of this
Section 3.6.

 

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                (c)           In addition, the Distributor unconditionally
agrees, subject to the provisions of Section 3.3(b), that it shall, upon the
request of Genzyme, immediately inform all relevant regulatory authorities that
the Distributor is no longer a distributor of the Agreement Products or the
Improved Agreement Product(s) and shall take all action and execute and deliver
all documents and instruments necessary in order to transfer to the fullest
extent permitted under applicable law all registrations and Product License
Approvals, or applications therefor, for the Agreement Products or any Improved
Agreement Product(s) to Genzyme or any Person nominated by Genzyme.

 

                3.7.          Effects of Termination.

 

                (a)           Upon termination of this Agreement for any reason,
the Distributor shall immediately discontinue making any representations
regarding its status as a distributor for Genzyme and shall immediately cease
conducting any activities with respect to the marketing, promotion, sale or
distribution of the Agreement Products and any Improved Agreement Product(s),
provided, however, that the Distributor shall be permitted to sell inventory not
repurchased by Genzyme in accordance with Section 3.3.

 

                (b)           Termination of this Agreement shall not affect
obligations of either party that may have accrued prior to the effective date of
termination.  Subject to Clause 3.8 below, termination of this Agreement shall
be in addition to, and shall not be exclusive of or prejudicial to, any other
grounds for termination or rights or remedies at law or in equity which either
party may have on account of any default of the other party.

 

                3.8.          Waiver.  The Distributor hereby waives, to the
extent it is able to do so under the laws of the United States and other
applicable law, any statutory rights it may have or acquire in respect of the
termination of the relationship established hereby pursuant to the terms hereof,
and agrees that the rights available to it hereunder in the event of such
termination are adequate and reflect the agreement of the parties.  The
Distributor shall not have any right to claim any indemnity for goodwill or lost
profits or any damages arising from the rightful termination of this Agreement
in accordance with the terms hereof.

 

                4.             Payments.  All payments hereunder shall be made
in Dollars.  Payments to Genzyme shall be wired to an account designated by
Genzyme and the costs of any such remittance shall be borne by the Distributor.

 

                5.             Withholding. All payments to be made by the
Distributor under this Agreement shall be made in full, free and clear of and
without any deduction of or withholding for or on account of any taxes levied in
any country of the Territory or elsewhere; provided that if the Distributor
shall be required by law to make any deduction or withholding from any payment
to Genzyme then:

 

                (a)           the Distributor shall ensure that such deduction
or withholding does not exceed the minimum legal liability therefor; and

 

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                (b)           not later than     ***    days before each
deduction or withholding of any taxes, the Distributor shall forward to Genzyme
such documentary evidence as may be required by Genzyme in respect of the
proposed deduction, withholding or payment; and

 

                (c)           prior to any deduction or withholding the parties
shall attempt in good faith to agree upon revised mutually acceptable pricing
and/or payment terms.

 

                6.             Trademarks; Agreement Product Marking;
Promotional Information.

 

                6.1.          Trademarks.  Subject to the provisions of Section
3.6, Genzyme hereby licenses to the Distributor the right to use, and hereby
requires solely in association with the independent sale by the Distributor of
the Agreement Products and any Improved Agreement Product(s) the use of, the
Trademarks in the Territory during the term of this Agreement.  The Distributor
agrees that any and all goodwill developed in the Trademarks used by Distributor
hereunder shall inure to and be owned by Genzyme.  The Distributor warrants that
it shall not use any of the Trademarks at any time outside the Territory or use
any of the Trademarks for any products other than the Agreement Products and any
Improved Agreement Product(s) within the Territory.  The Distributor shall not
use a trademark or other mark (other than a Trademark) in connection with its
distribution of the Agreement Products and any Improved Agreement Product(s)
unless and until it has been agreed upon in writing by each of the parties and
become a Trademark as defined herein.  Genzyme shall prosecute, maintain and
defend the Trademarks throughout the Term of this Agreement in the Territory. 
The parties shall execute a short form Trademark assignment agreement to the
extent that it is necessary to record the Trademark license under this Section
6.1.

 

                6.2.          Termination of Right to Use Trademarks.  Subject
to the sell-out right of Section 3.3(b) and except as otherwise provided in
Section 3.6, upon termination of this Agreement, the license to use the
Trademarks in the Territory shall terminate, and the Distributor unconditionally
agrees promptly to take all necessary action and execute and deliver to Genzyme
all necessary documents and instruments to remove the Distributor as a
registered user and/or a recorded licensee of the Trademarks and to confirm that
the goodwill in the Trademarks shall inure to the benefit of Genzyme.  In the
event that the Distributor fails promptly upon written request by Genzyme to
comply with any of its agreements in the preceding sentence of this Section 6.2,
the Distributor hereby irrevocably consents to Genzyme’s taking any action
necessary to give effect to such agreements.

 

                6.3.          Notice.  Each party hereto agrees promptly to
notify the other in writing of any infringements or imitations of the Trademarks
by third parties which may come to its attention.

 

                6.4.          Labelling; Promotional Materials; Approved Use of
Agreement Products.

 

                (a)           Genzyme shall provide the Distributor with copies
of labelling masters, packaging, instructions and specifications relating to the
Agreement Products and any Improved Agreement Product(s) prior to their use. 
The Distributor shall not change or alter

 

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the packaging or labelling identified in the Product License Approvals without
the prior written approval of Genzyme.

 

(b)           The Distributor shall provide Genzyme with copies of all marketing
and promotional material relating to the Agreement Products and any Improved
Agreement Product(s) prior to their use.  All marketing and promotional material
shall be consistent with the Product Guidelines and the relevant Product License
Approvals, and deemed acceptable in such case.  Any marketing and promotional
material outside the scope of the Product Guidelines shall require the written
approval of Genzyme prior to their use.

 

                (c)           The Distributor agrees that its promotion,
marketing, sale and distribution of the Agreement Products and any Improved
Agreement Product(s) in the Territory, and the promotional materials and
labelling used in connection therewith, shall be strictly in accordance with the
approved use of the Agreement Products and any Improved Agreement Product(s) as
specified in the Product License Approvals and as further provided in this
Agreement.

 

                6.5.          Legend.  Subject to applicable laws and
regulations in the Territory, all relevant packaging and promotional material
for the Agreement Products and any Improved Agreement Product(s) used or sold by
the Distributor shall contain (i) all applicable markings needed to keep the
Trademarks enforceable throughout the Territory as reasonably specified by
Genzyme to the Distributor and (ii) a legend which shall be displayed in a
reasonably conspicuous manner on all packaging of such Agreement Products and
any Improved Agreement Product(s) containing the corporate identification logo
of Genzyme and indicating that such product has been developed and manufactured
by Genzyme Corporation, and its affiliates, 500 Kendall Street, Cambridge,
Massachusetts 02142 U.S.A.

 

                6.6.          Promotional Support.  Genzyme and the Distributor
shall provide to each other on an ongoing basis and without charge (to the
extent not prevented by law or contract from doing so) all medical information
relating to the Agreement Products and any Improved Agreement Product(s)
(including summary data from studies, clinical trials and the like as well as
information regarding adverse events associated with the use of the Agreement
Products), the proceedings of all symposia on the Agreement Products and any
Improved Agreement Product(s) and all promotional information that is available
to such party relating to the Agreement Products and any Improved Agreement
Product(s).  In addition, Genzyme and the Distributor shall provide each other
with access to such primary data and information in its possession as the other
may reasonably request regarding the results of the studies contained in such
summary data referred to above.

 

                6.7.          Recalls of the Agreement Products.

 

                (a)           If either party in good faith determines that a
recall of any Agreement Products and/or any Improved Agreement Product(s) in the
Territory is warranted, such party shall immediately notify the other party in
writing and shall advise such other party of the reasons underlying its
determination that a recall is warranted.  The parties shall consult

 

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with each other as to any action to be taken in regard to such a recall, but in
any event if after consultations either party in good faith still believes that
such a recall should be undertaken, the parties shall cooperate in carrying out
such recall.

 

                (b)           Except as otherwise provided in (c) below, in the
event of a recall of any Agreement Product(s) and/or any Improved Agreement
Product(s), Genzyme shall correct any deficiency relating to its manufacturing,
packaging, testing, labelling, storing or handling of the such Agreement
Product(s) and any Improved Agreement Product(s) for which it is responsible, if
applicable, and shall at its cost replace the such Agreement Product(s) and any
Improved Agreement Product(s) recalled.

 

                (c)           Genzyme shall reimburse Distributor for all direct
costs and expenses (including without limitation shipping, quality control
testing and notification costs) incurred by Distributor and its Affiliates as a
result of any recall, except where such recall (i) is the result of the failure
of Distributor or its Affiliates to comply with their obligations under this
Agreement and/or (ii) was opposed by Genzyme and proved to be unwarranted, in
which case Distributor shall reimburse Genzyme for all direct costs and expenses
(including without limitation shipping, quality control testing and notification
costs) incurred by Genzyme and its Affiliates as a result of such recall.

 

                6.8           Product Vigilance System.  The Distributor shall
be responsible for maintaining medical device vigilance systems, as established
for the Agreement Products and/or any Improved Agreement Product(s) by Genzyme,
and shall promptly provide Genzyme with notice of all product complaints,
including medical complaints.  Genzyme shall be solely responsible for
processing, analyzing and, if necessary, reporting medical complaints to
regulatory authorities.  The Distributor shall provide all necessary support to
Genzyme for carrying out such activities.

 

                7.             Supply of Agreement Products.

 

                7.1.          General; Fee.

 

                (a)           Genzyme agrees to sell the Agreement Products and
any Improved Agreement Product(s) to the Distributor, on the terms and subject
to the conditions set forth herein, for resale by the Distributor within the
Territory, and the Distributor shall obtain the Agreement Products and any
Improved Agreement Product(s) for resale in the Territory only from Genzyme or
its Affiliates.  Genzyme shall not sell the Agreement Products or any Improved
Agreement Product(s) itself or supply or license the manufacture of the
Agreement Products or any Improved Agreement Product(s) to any third party for
resale within the Territory, provided that Genzyme’s obligations under this
sentence shall be subject to (i) applicable law and (ii) the provisions of this
Agreement, including Section 2.3.

 

                (b)           Genzyme and the Distributor acknowledge that the
payments made by the Distributor as set forth in Section 3.8 of the Development
Agreement and Amendment were

 

14

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made in consideration of certain rights granted by Genzyme under Section 2.1 of
this Agreement.     ***

                                                                                   
***

                                                                                   
***

                                                                                   
***

 

(c)           The failure by Genzyme to receive all or any portion of the
payments set forth in Section 7.1(b) above shall not invalidate, rescind,
diminish or otherwise effect the grant of the distribution rights by Genzyme to
Distributor, unless such payment is earned by Genzyme and Distributor
subsequently fails to make such payment in a full or timely manner (a “Fee
Payment Default”).

 

(d)           The Distributor shall pay all Development Costs with respect to
all Agreement Products and any Improved Agreement Product(s).  Any Development
Costs incurred shall be billed to the Distributor        ***       and paid in
Dollars within            ***           after the Distributor’s receipt of the
invoice for such costs.

 

                7.2.          Price; Adjustment; Reports; Payment.

 

                (a)           The supply pricing for the Distributor’s purchase
of the Agreement Products and any Improved Agreement Product(s) shall not be
less than the greater of (i) the applicable Minimum Price for each Agreement
Product or Improved Agreement Product(s), or (ii) the applicable Formula Price
for each Agreement Product or Improved Agreement Product(s), except as provided
in subsection (b) below.  The parties shall attempt in good faith to agree in
writing upon mutually acceptable minimum pricing for the Agreement Products in
sizes other than the 0.9cc Treatment Syringe and for any Improved Agreement
Product(s); provided, however, the Distributor shall pay the reasonable up-front
costs incurred in connection with changes to the syringe size.

 

                (b)           If Genzyme has appointed a new distributor in the
Territory pursuant to Section 2.3 and the Distributor has the right to
distribute the Agreement Products and any Improved Agreement Product(s) in the
Territory, the supply pricing for the Distributor’s purchase of the Agreement
Products and any Improved Agreement Product(s) for resale in the Territory shall
not exceed the supply pricing paid for the Agreement Products and any Improved
Agreement Product(s) by such new distributor appointed by Genzyme within the
Territory.  For the avoidance of doubt, in such event Genzyme or any Affiliate
of Genzyme shall have the right to sell the Agreement Products or any Improved
Agreement Product(s) in any such country at any price, including a price that is
lower than the then applicable Minimum Price.

 

                (c)           The price initially payable by the Distributor to
Genzyme for each unit of the Agreement Products during each month of each
Agreement Year shall be the applicable Minimum Price (subject to adjustment at
the close of each applicable Contract Quarter and Agreement Year in accordance
with Section 7.2(d) below).

 

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                (d)           Within          ***          after the end of each
Contract Quarter and Agreement Year, the applicable Formula Price for each
Agreement Product shall be calculated and an adjustment resulting from the
difference between the applicable Formula Prices determined for each month of
each Contract Quarter and Agreement Year and the applicable Formula Price
calculated for the applicable Contract Quarter and Agreement Year shall be paid
by the Distributor or Genzyme, as appropriate, to the other party with respect
to all units of the Agreement Products sold by the Distributor in the Territory
during such Contract Quarter and Agreement Year, such payment to be made within
              ***              after the end of such         ***        period
following the end of such Contract Quarter and Agreement Year.  The price
calculated annually in this manner shall be the final price payable for all
units of the Agreement Products sold by the Distributor or any Affiliate during
such Agreement Year.  For the avoidance of doubt, the aggregate amount payable
by Distributor for the Agreement Products and any Improved Agreement Product(s)
for any Agreement Year shall in no event be lower than the applicable Minimum
Price for each Agreement Product multiplied by the total units sold in such
Agreement Year in the Territory.

 

                (e)           Within                  ***    
          following the end of each calendar month in each Agreement Year, the
Distributor shall submit to Genzyme written reports detailing the units and
value of the Distributor’s and its Affiliates’ Net Retail Sales and aggregate
number of units sold of the Agreement Products and any Improved Agreement
Product(s) in the Territory during the immediately preceding calendar month.

 

                (f)            Within             ***            following the
end of each Agreement Year, the Distributor shall submit to Genzyme written
reports detailing the Distributor’s and its Affiliates’ sales of the Agreement
Products and any Improved Agreement Product(s) during the immediately preceding
Agreement Year, which reports shall contain the Net Retail Sales of the
Agreement Products and any Improved Agreement Product(s) in the Territory, and
the aggregate number of units of the Agreement Products and any Improved
Agreement Product(s) sold in the Territory during the applicable Agreement Year.

 

                (g)           All purchases of the Agreement Products and any
Improved Agreement Product(s) hereunder shall be billed and paid in Dollars
within           ***        after the later of the date of delivery or the date
of the Distributor’s receipt of the invoice for each shipment of same to the
Distributor.

 

                7.3.          Sales and Supply Forecasts; Accounts.

 

                (a)           At least          ***        prior the end of each
Contract Quarter, the Distributor shall provide to Genzyme an updated rolling
            ***            supply forecast of units of all unit sizes of each
Agreement Product and any Improved Agreement Product(s) in the Territory to be
obtained by the Distributor for resale (“Supply Forecast”).  The first    ***

    ***    of each Supply Forecast shall constitute a binding commitment by the
Distributor to purchase such quantity of Agreement Products and any Improved
Agreement Product(s) (“Binding Forecast”) and the remaining           ***    
    shall be based on the Distributor’s good faith estimate as of the date
thereof and shall not bind Distributor in any way (“Non-

 

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Binding Forecast”).  Any Binding Forecast for any             ***            may
differ from the Non-Binding Forecast for such             ***    
       previously provided by the Distributor; provided, that Binding Forecast
for any             ***            shall not vary (whether up or down) from the
Non-Binding Forecast for such                 ***            by more than
     ***

          ***         with respect to each month.

 

                (b)           The Distributor shall maintain books of account
with respect to its sales of the Agreement Products and any Improved Agreement
Product(s) in the Territory.  Genzyme shall have the right, not more than once
during each calendar year, to have an independent accountant selected and
retained by Genzyme (reasonably acceptable to Distributor, provided that any
“big four” accounting firm shall be deemed reasonable) to inspect and examine
such books of the Distributor during regular business hours for the purpose of
verifying the statements of the aggregate Net Retail Sales of all Dermal Tissue
Augmentation Products for all purposes hereunder, including verification of
applicable Formula Price and the royalties described in Section 8.  The cost of
each such audit shall be borne by Genzyme unless a material error is discovered
in the course of such audit, in which case the cost shall be borne by the
Distributor.  For purposes of this Section 7.3(b), a material error shall be
defined as an understatement of             ***            or more of the
aggregate amount owed to Genzyme with respect to sales of Dermal Tissue
Augmentation Products in the Territory.  Any additional payments required as a
result of such inspection and examination shall be immediately paid to Genzyme
and shall bear interest from the date such amount would otherwise have been paid
until the date of actual payment at the rate per annum set forth in Section 20. 
Such independent accounting firm shall conduct such inspections and examinations
under conditions of confidentiality.

 

                7.4.          Shipment and Delivery; Packaging; Shelf Life.

 

                (a)           Genzyme or an Affiliate of Genzyme shall arrange
for shipment to the Distributor of the Agreement Products and any Improved
Agreement Product(s) ordered by the Distributor             ***           .  The
Distributor shall pay all customs duties, sales taxes and other governmental
charges relating to the Agreement Products and any Improved Agreement
Product(s), and shall be solely responsible for clearing such products through
customs throughout the Territory.

 

                (b)           The Distributor shall submit a binding purchase
order setting forth the quantities, delivery date and shipping instructions with
respect to each shipment of the Agreement Products and any Improved Agreement
Product(s), such purchase orders to be received by Genzyme at least
          ***          prior to the requested delivery date; provided that the
Distributor shall not submit any purchase order for fewer than         ***    
   of the Agreement Products or the Improved Agreement Product(s) (although
multiple delivery site for purchase orders shall be allowed).  Genzyme shall
have no obligation to supply Distributor with quantities of the Agreement
Product(s) and Improved Agreement Product(s) in excess of the amounts in the
then current Supply Forecast for the relevant period.  For the avoidance of
doubt, all purchase orders submitted with respect to any Agreement Products
prior to the Launch of such Agreement Product shall be binding.

 

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                (c)           Each unit of an Agreement Product and any Improved
Agreement Product(s) shipped to the Distributor shall have, as of the time of
delivery, a remaining shelf life of no less than          ***         less than
the maximum shelf life for such product, as approved by the FDA.  Genzyme shall
continually use its best efforts at all times during the term hereof to maintain
a                  ***                 shelf life for the Agreement Products and
any Improved Agreement Product(s).  Genzyme’s “best efforts” in this section
shall mean that Genzyme shall use such methods, exercise such degree of effort
and diligence, and adhere to such standards as are commercially reasonable.

 

                7.5.          Title.  Legal title to all quantities of the
Agreement Products and any Improved Agreement Product(s) sold hereunder shall
remain in Genzyme until delivery of the Agreement Products and any Improved
Agreement Product(s) to Distributor or its agent and acceptance thereof, and
upon such delivery and acceptance the title to such Agreement Products and any
Improved Agreement Product(s) shall, without further action, be transferred to
and vested in the Distributor.

 

                7.6.          Risk of Loss.  Genzyme shall bear all risk of loss
of, or damage to, all units of the Agreement Products and any Improved Agreement
Product(s) to the extent the same is in its possession or the possession of its
Affiliates, nominees or agents.  The Distributor shall bear all risk of loss of,
or damage to, all units of the Agreement Products and any Improved Agreement
Product(s) after delivery to a common carrier for shipment to the Distributor in
accordance with Section 7.4.

 

                7.7.         
Acceptance.                                          ***

                                                                               
***

                                                                               
***

                                                                               
***                           .  All units of the Agreement Products and any
Improved Agreement Product(s) delivered to Distributor pursuant to this
Agreement shall be              ***

                                                                               
***

                                                                               
***

                                                     
***                           , the applicable specification listed in Exhibit
A.  Any non-conformity which arises after acceptance by Distributor directly
associated with Product specification shall be the responsibility of Genzyme
unless such non-conformity is due to improper storage conditions subsequent to
delivery of the Agreement Products.  All other non-conformities of the Agreement
Products shall be the responsibility of the Distributor.  Genzyme and the
Distributor agree to consult with each other in order to resolve the discrepancy
between each other’s determinations.  If such consultation does not resolve the
discrepancy, the parties agree to nominate a reputable independent laboratory,
acceptable to both parties, that shall carry out tests on representative samples
taken from such shipment, and the results of such tests shall be binding on the
parties.  Genzyme shall at its expense replace any such shipment to the extent
that it does not conform to the Agreement Product Specifications.  All defective
units of the Agreement Products or any Improved Agreement Product(s) shall be
returned to Genzyme at the address set forth in

 

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Section 24 of this Agreement, accompanied or preceded by a reasonably detailed
statement of the claimed defect or non-conformity and proof of date of purchase,
and packed and shipped according to instructions provided by Genzyme.  The
shipping costs of any such returned units shall be borne by Genzyme, unless such
units are determined not to be defective under the terms of this Agreement, in
which case such shipping costs shall be borne by the Distributor.

 

                7.8.          Purchase Orders.  The provisions of this Agreement
shall prevail over any inconsistent statement or provisions contained in any
document related to this Agreement passing between the parties hereto including,
but not limited to, any purchase order, acknowledgment, confirmation or notice.

 

                7.9.          Limited Warranty; Limitation on Liability.

 

                Genzyme represents and warrants that the Agreement Products and
any Improved Agreement Product(s) supplied to the Distributor hereunder shall:

 

                (a)           conform to the Agreement Product Specifications,
as applicable; and

 

                (b)           be manufactured, labelled, packaged and tested
(while in the possession or control of Genzyme) in accordance with the
applicable Product License Approvals therefor and all applicable laws and
regulations in the Territory relating to the manufacture, labelling, packaging
and testing of the Agreement Products, and shall be manufactured for use for the
indications specified in the applicable Product License Approvals therefor.

 

                THE FOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN
BY GENZYME WITH RESPECT TO THE AGREEMENT PRODUCTS, AND GENZYME GIVES AND MAKES
NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE
FOREGOING.  WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, NO IMPLIED
WARRANTY OF MERCHANTABILITY, NO IMPLIED WARRANTY OF FITNESS FOR ANY PARTICULAR
PURPOSE, AND NO IMPLIED WARRANTY ARISING BY USAGE OF TRADE, COURSE OF DEALING OR
COURSE OF PERFORMANCE IS GIVEN OR MADE BY GENZYME OR SHALL ARISE BY OR IN
CONNECTION WITH ANY SALE OR PROVISION OF THE AGREEMENT PRODUCTS BY GENZYME, OR
THE DISTRIBUTOR’S (OR ITS AFFILIATES’) USE OR SALE OF THE AGREEMENT PRODUCTS, OR
GENZYME’S AND/OR THE DISTRIBUTOR’S (OR ITS AFFILIATES’) CONDUCT IN RELATION
THERETO OR TO EACH OTHER.  NO REPRESENTATIVE OF GENZYME IS AUTHORIZED TO GIVE OR
MAKE ANY OTHER REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN
ANY WAY.

 

                The limited warranty set forth in this Section 7.9 does not
apply to any non-conformity of the Agreement Products or any Improved Agreement
Product(s) resulting from (a) repair or alteration by any party other than
Genzyme or its Affiliates, (b) misuse,

 

19

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negligence, abuse, accident, mishandling or storage in an improper environment
by any party other than Genzyme or its Affiliates, or (c) use, handling, storage
or maintenance other than in accordance with instructions and recommendations
provided by Genzyme or its Affiliates.

 

                Genzyme’s obligation with respect to units of the Agreement
Products and any Improved Agreement Product(s) which do not meet the warranty
contained herein is limited to replacement of such units of the Agreement
Products or Improved Agreement Product(s) as applicable, provided that such
units are returned to Genzyme accompanied by a reasonably detailed statement of
the claimed defect or non-conformity and proof of purchase, and packed and
shipped according to instructions provided by Genzyme, and only if, upon
examination by Genzyme, such units of the Agreement Products or the Improved
Agreement Product(s) are determined to have been defective under the terms of
this Agreement.

 

                GENZYME’S LIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION
WITH THE SALE OR USE OF THE AGREEMENT PRODUCTS AND ANY IMPROVED AGREEMENT
PRODUCT(S) (WHETHER BASED ON CONTRACT, NEGLIGENCE, BREACH OF WARRANTY, STRICT
LIABILITY OR ANY OTHER LEGAL THEORY), SHALL BE STRICTLY LIMITED TO GENZYME’S
OBLIGATIONS AS SPECIFICALLY AND EXPRESSLY PROVIDED IN THIS SECTION 7.9 AND IN
SECTION 9 BELOW.  EXCEPT AS SPECIFICALLY PROVIDED IN THIS SECTION 7.9 AND IN
SECTION 9 BELOW, GENZYME SHALL HAVE NO LIABILITY, OBLIGATION OR RESPONSIBILITY
OF ANY KIND, IN ANY WAY OR TO ANY EXTENT, FOR ANY DAMAGES, LOSSES, COSTS,
EXPENSES OR LIABILITIES FOR ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH
RESPECT TO THE AGREEMENT PRODUCTS AND ANY IMPROVED AGREEMENT PRODUCT(S) OR THE
PERFORMANCE THEREOF, OR ARISING IN ANY WAY IN CONNECTION WITH THE PURCHASE OR
USE OR INABILITY TO USE THE AGREEMENT PRODUCTS OR ANY IMPROVED AGREEMENT
PRODUCT(S), EVEN IF GENZYME HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES.  IN NO EVENT WHATSOEVER SHALL GENZYME HAVE ANY LIABILITY, OBLIGATION OR
RESPONSIBILITY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY
DAMAGES ARISING IN ANY WAY IN CONNECTION WITH THE AGREEMENT PRODUCTS OR ANY
IMPROVED AGREEMENT PRODUCT(S) OR THEIR SALE OR USE.

 

                8.             Royalty Payments by Distributor.

 

                8.1.          Royalties for Sales of Dermal Tissue Augmentation
Products.  The Distributor shall pay to Genzyme a royalty of
                                  ***                             by the
Distributor and its Affiliates of all Dermal Tissue Augmentation Products (other
than sales of the Agreement Products and any Improved Agreement Product(s)) in
the Territory, including any countries that are added to the Territory after the
Effective Date,       ***

 

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***

                                                                               
***

                                                                               
***

                ***             .  Such royalty shall be effective commencing on
the date of first commercial sale of an Agreement Product in the Territory
(i.e.,       ***       ) and shall be paid by not later than       ***      
 days after the end of each Contract Quarter.

 

                8.2.          Incremental Royalties.  The Distributor shall pay
to Genzyme the following annual royalties (the “Incremental Royalties”) on the
Distributor’s and its Affiliates’ total incremental increases in Net Retail
Sales of all Dermal Tissue Augmentation Products (including the Agreement
Products and any Improved Agreement Product(s)), in the Territory based on the
incremental increases, if any, in Net Retail Sales of all Dermal Tissue
Augmentation Products in each Agreement Year over a base year amount comprised
of Net Retail Sales of Dermal Tissue Augmentation Products in the
             ***                      immediately preceding the first commercial
sale of either any Agreement Product or any Improved Agreement Product(s):

 

Increase in Total Sales
Over Base Year Amount

 

Royalty on Total
Incremental Sales

 

 

 

***

 

***

***

 

***

***

 

***

 

 

The Distributor’s obligation to pay the Incremental Royalties shall
              ***

                                                                               
***

                                                                               
***

                             ***                      .  The Incremental Royalty
shall be paid by not later than           ***           after the end of each
Agreement Year.  For the avoidance of doubt, if the Distributor had no sales of
any Dermal Tissue Augmentation Products prior to the first commercial sale of
either the Agreement Products or any Improved Agreement Product(s), the
Distributor shall be obligated to pay a        ***         royalty on Net Retail
Sales of all Dermal Tissue Augmentation products sold after such first
commercial sale.

 

                9.             Indemnification; Confidentiality; Public
Announcement.

 

                9.1.          Indemnification from the Distributor.  Subject to
the provisions of Section 9.3, the Distributor shall defend, indemnify and hold
Genzyme and its Affiliates and their respective directors, officers, agents and
employees harmless from and against any and all liabilities, claims, damages and
expenses (including without limitation actual court costs and reasonable
attorneys’ fees regardless of outcome) resulting from claims of third parties or
arising out of:

 

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(a)

***

 

***

 

***

 

 

(b)

***

 

***

 

 

(c)

***

 

***

 

***

 

provided, however, that upon Genzyme being advised of any assertions of any such
third party claims or suits or upon the bringing or filing of such claims or
suits by any third party against Genzyme, Genzyme will promptly notify the
Distributor thereof and Genzyme may, at its option, permit the Distributor’s
attorneys to handle and control the defense of such claims or suits at the
Distributor’s cost and Genzyme will co-operate with the Distributor in the
defense thereof.  The parties agree that there shall be no settlements, whether
agreed to in court or out of court, without the prior written consent of the
indemnifying party.

 

                9.2.          Indemnification from Genzyme.  Subject to the
provisions of Section 9.3, Genzyme shall defend, indemnify and hold the
Distributor and its Affiliates and their respective directors, officers, agents
and employees harmless from and against any and all liabilities, claims, damages
and expenses (including without limitation actual court costs and reasonable
attorneys’ fees regardless of outcome) resulting from claims of third parties
arising out of:

 

(a)

***

 

***

 

***

 

 

(b)

***

 

***

 

 

(c)

***

 

***

 

***

 

provided, however, that upon the Distributor being advised of any assertions of
any such third party claims or suits or upon the bringing or filing of such
claims or suits by any third party against the Distributor, the Distributor will
promptly notify Genzyme thereof and, at Genzyme’s cost, permit Genzyme’s
attorneys to handle and control the defense of such claims or suits and will
co-operate with Genzyme in the defense thereof.  The parties agree that there
shall be no settlements, whether agreed to in court or out of court, without the
prior written consent of the indemnifying party.

 

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22

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                9.3.          Limitation on Liability.

 

                NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN SECTIONS 9.1
AND 9.2 ABOVE, OR ANY OTHER PROVISION OF THIS AGREEMENT, IN NO EVENT (INCLUDING
THE FAULT, NEGLIGENCE OR STRICT LIABILITY OF EITHER PARTY) SHALL EITHER PARTY BE
LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR
EXEMPLARY DAMAGES OTHER THAN TO THE EXTENT NECESSARY TO REIMBURSE SUCH OTHER
PARTY FOR DAMAGES ACTUALLY PAID TO A NON-AFFILIATED THIRD PARTY, PROVIDED THAT
SUCH DAMAGES ARE OTHERWISE COVERED BY THE PROVISIONS OF SECTION 9.1 OR SECTION
9.2, AS THE CASE MAY BE.

 

                9.4.          Confidential Information.  All information
acquired by either party (the “Recipient”) from the other party or any of its
Affiliates (the “Discloser”) during the term of this Agreement or prior to the
Effective Date, relating directly or indirectly to the present or potential
business, operations, corporate, technical or financial situation of the
Discloser, or to manufacturing know-how, patents, data, test results,
techniques, processes, procedures, raw materials, dealer, supplier and customer
lists, pre-clinical and clinical protocols or any improvements thereof of the
Discloser (“Confidential Information”) is confidential, and shall be held in
trust by the Recipient for the exclusive benefit of the Discloser.  Unless
otherwise agreed to in writing by the Discloser, the Recipient shall not at any
time, either during or subsequent to the term of this Agreement, use for itself
(other than in accordance with the terms of this Agreement) or any other Person,
or disclose or divulge to any Person, other than to those of its employees and
advisors and Affiliates who require the same for the purposes hereof and who are
bound by the same obligations of confidentiality, non-disclosure and non-use as
set forth herein, any Confidential Information or any other confidential or
proprietary information of the Discloser of which the Recipient may acquire
knowledge; provided, however, that the confidentiality, non-disclosure and
non-use provisions contained in this Section 9.4 shall not apply to any
information or data to the extent that the Recipient:

 

                (a)           shall demonstrate by clear and convincing evidence
that such information or data is known generally to persons in the trade through
no act or omission of the Recipient or any of its Affiliates;

 

                (b)           is required by any government authority to
disclose such information or data, including without limitation for the purposes
of obtaining and maintaining any Product License Approvals under this Agreement;
or

 

                (c)           shall demonstrate by its written records was
disclosed to or created by it or its Affiliates on a non-confidential basis from
a source other than the Discloser or its Affiliates and that such disclosure or
creation did not constitute a breach of any applicable confidentiality
obligations.

 

23

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Confidential Information shall be immediately returned to the Discloser upon
termination of this Agreement, along with any copies, reproductions, digests,
abstracts or the like of all or any part thereof in the Recipient’s possession
or under the Recipient’s control, and upon such return any computer entries or
the like relating thereto shall, to the extent legally permissible, be
destroyed.  Such return (and destruction) will not affect the Recipient’s
obligations hereunder which shall survive indefinitely.  Notwithstanding
anything herein to the contrary, the provisions of this Section 9.4 shall be
subject to Genzyme’s rights under Section 3.6.

 

                9.5.          Public Announcement.  Except as shall be necessary
for governmental notification purposes or to comply with applicable laws and
regulations, and except as otherwise agreed to by the parties hereto in writing,
the parties agree to keep the existence of this Agreement, and the transactions
contemplated hereby, strictly confidential.  In the event that a party must file
this document or otherwise disclose any of its subject matter pursuant to public
filing requirements, such party shall seek confidential treatment of those
portions of the Agreement as the parties shall mutually agree upon.  The parties
shall agree upon the text of an initial public announcement (including any Form
8-K) relating to the transactions contemplated by this Agreement as soon as
possible.  Any subsequent public announcements regarding this Agreement or the
transactions contemplated herein shall also be agreed upon in writing between
the parties prior to any release thereof.

 

                10.          New Products.

 

               
10.1                                                                         ***

                                             
***                                        ,  Distributor shall not
commercialize nor begin the commercialization process with respect to or acquire
any New Product anywhere in the International Territory or the United States,
either independently or in conjunction with one or more third parties, unless
and until the following conditions have been satisfied:

 

                (a)           Distributor has made a commercially reasonable
written offer to Genzyme to participate with Distributor in the development and
commercialization of such New Product; and

 

                (b)           Genzyme has failed to accept such written offer
within        ***         of its receipt of such offer.

 

                In the event that Genzyme fails to accept any written offer made
by Distributor pursuant to this Section 10.1 within        ***         of
Genzyme’s receipt thereof, then Distributor, subject to the terms of this
Agreement, shall have the right to independently or with other parties develop
and/or commercialize any New Product to which such written offer relates;
provided, however, that any such New Product does not infringe upon any
intellectual property rights of Genzyme.  Distributor shall not be required to
make the written offer to Genzyme set forth in Section 10.1(a) above only to the
extent that it is prevented from doing so due to the patented proprietary rights
of a third party.

 

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Confidential Treatment and filed separately with the commission.

 

24

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                (c)           At all times during the term of this Agreement,
Distributor shall notify Genzyme in writing within                   ***      
        of each occurrence of one or more of the following:

 

 

 

(i)

 

Distributor’s entering into an agreement with one or more third parties with
regard to the development, acquisition and/or commercialization of any New
Product, and Distributor shall provide to Genzyme notice of such agreement and
any and all agreements relating thereto and a non-confidential summary of such
agreements; or

 

 

 

 

 

 

 

(ii)

 

Distributor’s commencing a clinical trial (either alone or in conjunction with a
third party) with respect to any New Product, together with a notice of the
commencement of such clinical trial and a list of all countries where such
clinical trials will take place; or

 

 

 

 

 

 

 

(iii)

 

Distributor’s filing of an application (either alone or in conjunction with a
third party) for marketing approval with the FDA or an equivalent regulatory
agency in any country with respect to any New Product stating in which countries
any such filings have been made.

 

10.2

 

***

 

 

***

 

 

***

 

 

 

 

(i)

***

 

 

***

 

 

***

 

 

 

 

(ii)

***

 

 

***

 

 

 

 

 

***

 

 

***

 

 

***

 

 

 

 

                10.3.        Nothing in this Section 10 shall be construed, by
implication or otherwise, (i) to effect any sale or license of proprietary
Genzyme technology (including any New Products), (ii) to grant any license
relating to Genzyme’s proprietary methods of formulating, fabricating and
manufacturing the Agreement Products, Improved Agreement Product(s) or New
Products, or (iii) to grant Distributor any rights in or to any proprietary
technology or patents or trademarks of Genzyme.

 

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Confidential Treatment and filed separately with the commission.

 

25

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                11.          Steering Committee.  To facilitate the performance
of the parties under this Agreement, the parties shall establish a steering
committee (the “Committee”).  The Committee shall be comprised of not less than
       ***         representatives, with    ***

 members designated by each party.  The initial members of the Committee shall
be identified by the parties within sixty (60) days of the Effective Date.  The
size of the Committee may be changed from time to time by mutual agreement of
the parties so long as the number of representatives designated by each party is
equal.  Upon the request of either party, the Committee may allow persons other
than its voting members to attend and participate on a non-voting basis at the
meeting of the Committee.  The Committee shall meet either in person or by
teleconference at least                    ***                .  The Committee
may appoint a member who shall be responsible for the preparation of written
minutes of each meeting, which minutes shall be subject to Committee approval. 
The Committee shall be responsible for ensuring that any and all obstacles or
issues that arise are resolved promptly and efficiently.  Decisions of the
Committee shall be made by consensus (a majority of the members of the
Committee).  If, after a period of seven (7) days, a matter is still not
resolved, it shall be resolved in accordance with Section 19.  The Committee
shall not have authority to change the responsibilities or either party under
this Agreement or to otherwise amend this Agreement.

 

                12.          Representations of Genzyme.  Genzyme represents,
warrants and covenants as follows:

 

                12.1.        It is a corporation duly organized and validly
existing under the laws of the Commonwealth of Massachusetts with the full power
to conduct its affairs as currently conducted and contemplated hereunder.  All
necessary action has been taken to enable it to execute and deliver this
Agreement and perform its obligations hereunder.

 

                12.2.        This Agreement is a valid and binding obligation of
Genzyme enforceable in accordance with its terms.  Genzyme has the unencumbered
right to enter into this Agreement and to fulfill its duties hereunder.  It is
not and will not become a party to any agreement in conflict herewith. 
Accordingly, Genzyme has the right to appoint the Distributor as the exclusive
distributor of the Agreement Products in the Territory in accordance with the
terms of this Agreement and such appointment will not constitute a breach of any
existing contractual or other arrangements between Genzyme and any Affiliated or
non-Affiliated third party, nor shall it infringe the rights of any Affiliated
or non-Affiliated third party.

 

                12.3         No approval, consent, order, authorization or
license by, giving notice to or taking any other action with respect to, any
governmental or regulatory authority is required in connection with the
execution and delivery of this Agreement by Genzyme and the performance by
Genzyme of its obligations hereunder.

 

                13.          Representations of the Distributor.  The
Distributor represents, warrants and covenants as follows:

 

--------------------------------------------------------------------------------

***            Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.

 

26

--------------------------------------------------------------------------------

 

                13.1         It is a corporation duly organized and validly
existing under the laws of California with full power to conduct its affairs as
currently conducted and contemplated hereunder.  All necessary action has been
taken to enable it to execute and deliver this Agreement and perform its
obligations hereunder.

 

                13.2.        This Agreement is the Distributor’s valid and
binding obligation enforceable in accordance with its terms.  The Distributor
has the unencumbered right to enter into this Agreement and to fulfill its
obligations hereunder.  It is not and will not become a party to any agreement
in conflict herewith.  Accordingly, the Distributor has the right to act as the
exclusive distributor of the Agreement Products in the Territory in accordance
with the terms of this Agreement and the performance of its obligations
hereunder will not constitute a breach of any existing contractual or other
arrangements between the Distributor and any Affiliated or non-Affiliated third
party, nor shall it infringe the rights of any Affiliated or non-Affiliated
third party.

 

                13.3.        No approval, consent, order, authorization or
license by, giving notice to or taking any other action with respect to any
governmental or regulatory authority is required in connection with the
execution and delivery of this Agreement by the Distributor and the performance
by the Distributor of its obligations hereunder.

 

                14.          Insurance.  Each party hereto shall (a) obtain and
maintain such insurance policies as are adequate to cover its respective
obligations hereunder and which are consistent with normal business practices of
prudent companies similarly situated and (b) provide the other party, upon
request, with certificates of insurance confirming the existence of such
insurance policies.

 

                15.          Infringement.  Each of the Distributor and Genzyme
will promptly notify the other party in writing of any infringement of a Patent
or Trademark or unauthorized disclosure or use of any Confidential Information,
of which it becomes aware in the Territory.  Genzyme shall have the exclusive
right at its own cost to take all legal action in the Territory it deems
necessary or advisable to eliminate or minimize the consequences of such
infringement of a Patent or Trademark in the Territory.  For the purpose of
taking any such legal action, Genzyme shall have the right, subject to the
Distributor’s consent which consent shall not be unreasonably withheld or
delayed, to use the name of the Distributor as plaintiff, either solely or
jointly in accordance with the applicable rules of procedure; provided that
Genzyme shall give the Distributor prior notice of such use of the Distributor’s
name.  The Distributor shall promptly furnish Genzyme with whatever written
authority may be required in order to enable Genzyme to use the Distributor’s
name in connection with any such legal action, and shall otherwise cooperate
fully and promptly with Genzyme in connection with any such action.  All
proceeds realized upon any judgment or settlement regarding such action shall
belong to Genzyme.

 

27

--------------------------------------------------------------------------------

 

                16.          Regulatory Activities; Clinical Trials and
Marketing Studies.

 

                16.1.        General.

 

                (a)           Except as otherwise set forth in Section 7.1(d),
Genzyme shall be responsible for maintaining at its cost the Product License
Approvals required for the marketing and sale of the Agreement Products and any
Improved Agreement Product(s) in the Territory throughout the term of this
Agreement.

 

                (b)           Genzyme shall hold in its name all regulatory
approvals required for the marketing and sale of the Agreement Products and any
Improved Agreement Product(s) in the Territory.

 

                (c)           The Distributor and Genzyme shall provide
reasonable advice and assistance to each other as may be necessary to obtain and
maintain Product License Approvals.

 

                (d)           During the term of this Agreement, each party
shall immediately notify the other in writing in the event that such party
becomes aware of any failure of the Agreement Products and any Improved
Agreement Product(s) to comply with any of the requirements therefor specified
in any Product License Approvals.

 

                (e)           Each of the Distributor and Genzyme shall keep the
other advised of regulatory interactions, activities and correspondence relating
to the Agreement Products and any Improved Agreement Product(s) on at least a
quarterly basis, and any matters requiring immediate attention shall be
communicated as soon as practicable.  Notwithstanding the foregoing, within
       ***         of receipt by Genzyme of any letter from the FDA indicating
that any Agreement Product is approvable, Genzyme shall deliver a copy of such
letter to the Distributor.

 

                (f)            The parties shall attempt in good faith to agree
in writing upon the roles and responsibilities of each party with respect to the
performance of any Phase IV post-marketing clinical trials with respect to the
Agreement Products, including (i) the overall management of such clinical
trails, including supervision of any third party contract research
organizations, investigators and site monitors; (ii) the management and analysis
of data resulting from such clinical trials, including supervision of third
party reviewers, biostatisticians and other persons participating in the
organization and analysis of the clinical trail; and (iii) drafting the final
clinical study report.

 

                16.2.        Marketing Studies.  The parties agree that if any
marketing-related studies are deemed necessary, such studies will not delay the
Launch of Captique in the Territory.  The protocols for any marketing-related
studies requested by the Distributor will be developed jointly by Genzyme and
the Distributor, and the Distributor will be responsible for conducting and
managing such studies at its own expense.  Genzyme shall have the right to audit
the performance of any marketing-related studies performed by or on behalf of
the

 

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Confidential Treatment and filed separately with the commission.

 

28

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Distributor.  The results of such studies will not be published or publicized in
any way without the prior written approval of Genzyme.

 

                17.          Further Assurances.  The parties hereto agree to
execute such further or other documents and assurances as are necessary from
time to time in order to give effect to the provisions of this Agreement.

 

                18.          Assignment.  The rights and obligations of the
parties hereto shall inure to the benefit of and shall be binding upon the
authorized successors and permitted assigns of each party.  Neither party may
assign its rights or obligations under this Agreement or may designate another
person to perform all or part of its obligations under this Agreement, or to
have all or part of its rights and benefits under this Agreement without the
prior written consent of the other party, except to an Affiliate or to a
successor of the business, by merger or otherwise, to which this Agreement
relates, provided that in the case of an assignment to an Affiliate the
assigning party shall promptly notify the other party in writing of such
assignment and shall remain liable (both directly and as guarantor) with respect
to all obligations so assigned.  In the event of any assignment or in the event
that an Affiliate of either party shall exercise rights and/or perform
obligations hereunder pursuant to the terms of this Agreement, the assignee or
Affiliate, as the case may be, shall specifically assume and be bound by the
provisions of the Agreement by executing and agreeing to an assumption agreement
satisfactory to the other party hereto.

 

                19.          Governing Law; Arbitration; Injunctive Relief.

 

                (a)           Governing Law.  This Agreement shall be governed
by and construed in accordance with the internal and substantive laws of the
Commonwealth of Massachusetts, United States of America.

 

(b)           Dispute Resolution.  In the event of any dispute touching or
concerning this Agreement, the parties hereby agree to submit such dispute:

 

(i)            first, to the Committee, and if the dispute is not successfully
resolved by the Committee within a period of seven (7) days though good faith
discussions; then

 

(ii)           second, to the most senior executive officer of the business unit
of each party responsible for the business of the Agreement Products, or their
designees, and if the dispute is not successfully resolved by these senior
executive officers within a period of twenty (20) days through good faith
discussions, or such other period as is agreed upon in writing by the parties;
then

 

(iii)          third, for arbitration in Boston, Massachusetts under the Rules
of the American Arbitration Association in effect on the date of this Agreement
(the “Rules”) by arbitrators appointed in accordance with said Rules.  Any
decision of such arbitrators shall be written and shall be final and binding
upon the parties.  In any arbitration pursuant to this Section the award shall
be rendered by a majority of three (3) arbitrators, one (1) of whom

 

29

--------------------------------------------------------------------------------

 

shall be appointed by each party and the third of whom shall be appointed by
mutual agreement of the two (2) party-appointed arbitrators.  In the event of
failure of a party to appoint an arbitrator within thirty (30) days after
commencement of the arbitration proceeding or in the event of failure of the two
(2) party-appointed arbitrators to agree upon the appointment of the third
arbitrator within thirty (30) days after commencement of the arbitration
proceeding, such arbitrator shall be appointed by the American Arbitration
Association in accordance with the Rules.  The arbitrators shall apply the
governing law set forth in this Section.  Judgment upon an award rendered by the
arbitrators may be entered in any court having jurisdiction thereof.

 

                (c)           Each of the parties hereto acknowledges and agrees
that damages will not be an adequate remedy for any material breach or violation
of this Agreement if such material breach or violation would cause immediate and
irreparable harm (an “Irreparable Breach”).  Accordingly, notwithstanding the
provisions of Section 19(a) to the contrary, in the event of a threatened or
ongoing Irreparable Breach, each party hereto shall be entitled to seek, in any
state or federal court in the state of the principal offices of the other party,
equitable relief of a kind appropriate in light of the nature of the ongoing
threatened Irreparable Breach, which relief may include, without limitation,
specific performance or injunctive relief; provided, however, that if the party
bringing such action is unsuccessful in obtaining the relief sought, the moving
party shall pay the non-moving party’s reasonable costs, including attorney’s
fees, incurred in connection with defending such action.   Such remedies shall
not be the parties’ exclusive remedies, but shall be in addition to all other
remedies provided in this Agreement.

 

                20.          Severability.  In the event that any provision of
this Agreement shall be held by a court of competent jurisdiction or by any
governmental body to be invalid or unenforceable, such provision shall be deemed
severable and the remaining parts and provisions of this Agreement shall remain
in full force and effect.

 

                21.          Force Majeure.  Each of the parties shall be
excused from the performance of its obligations hereunder in the event such
performance is prevented by force majeure, and such excuse shall continue as
long as the condition constituting such force majeure continues.  For the
purpose of this Agreement, force majeure is defined as contingencies beyond the
reasonable control of either party, including, without limitation, acts of God,
judicial or regulatory action, war, civil commotion, destruction of production
facilities or materials by fire, earthquake or storm and labor disturbances
(whether or not any such labor disturbance is within the power of the affected
party to settle).

 

                22.          Interest.  Any overdue amounts payable by either
party hereunder shall bear interest compounded monthly at
                                 ***

                                                             
***                                          , or, if lower, the highest rate
permissible by applicable law, from the due date until the date of payment.

 

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***

 

Portions of this page have been omitted pursuant to a request for Confidential
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30

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                23.          No Partnership or Agency.  This Agreement and the
relations hereby established by and between Genzyme and the Distributor do not
constitute a partnership, joint venture, agency or contract of employment
between them.

 

                24.          Notices.  All communications in connection with
this Agreement shall be in writing and delivered personally or sent by postage
prepaid first class mail, nationally recognized overnight courier service, or
facsimile, and if relating to default, late payment or termination, delivered
personally or by certified mail, return receipt requested, facsimile or courier,
addressed to each party as set forth below:

 

To
Genzyme:                                                                          
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts  02142
Attention:  General Counsel
Facsimile:  (617) 252-7553

 

with a copy to:                                                                
Genzyme Corporation
55 Cambridge Parkway
Cambridge, Massachusetts  02142

Attention:  President, Genzyme Biosurgery
Facsimile:  (617) 761-8918

 

To Distributor:                                                                
Inamed Medical Products Corporation

                                                                                                                                               
5540 Ekwill Street, Suite D

                                                                                                                                               
Santa Barbara, California 93111

                                                                                                                                               
Attn: Nicholas L. Teti and Joseph A. Newcomb, Esq.

 

 or to such other address as the addressee shall last have designated by notice
to the communicating party.  The date of giving any notice shall be the date of
its actual receipt.

 

                25.          Survival.  The provisions of Sections 3.3, 3.6,
3.7, 3.8, 6.2, 9.1, 9.2, 9.3, 9.4, 9.5, 18 and 25 of this Agreement shall
survive the termination or expiration of this Agreement (as the case may be) and
shall remain in full force and effect.  The provisions of this Agreement that do
not survive termination or expiration hereof (as the case may be) shall,
nonetheless, be controlling on, and shall be used in construing and interpreting
the rights and obligations of the parties hereto with regard to, any dispute,
controversy or claim which may arise under, out of, or in connection with this
Agreement.

 

                26.          Miscellaneous.  This Agreement sets forth the
entire agreement between the parties with respect to the transactions and
arrangements contemplated hereby and supersedes all prior oral or written
arrangements, including the Original Agreement and Section 16 of the Development
Agreement and Amendment.  This Agreement may be modified or amended only by a
written instrument executed and delivered by both parties.  None of the
provisions of this Agreement shall be deemed to have been waived by any act or
acquiescence on the part of either party except by an instrument in writing
signed and

 

31

--------------------------------------------------------------------------------

 

delivered by the party executing the waiver.  This Agreement may be executed in
several identical counterparts, each of which shall be an original, but all of
which constitute one instrument, and in making proof of this Agreement it shall
not be necessary to produce or account for more than one such counterpart.

 

[The remainder of this page is intentionally left blank.]

 

32

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                IN WITNESS WHEREOF, the parties hereto have executed this
Agreement as of the date and year first above written.

 

 

 

 

 

 

 

INAMED MEDICAL PRODUCTS CORPORATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/ Nicholas L. Teti, Jr.

 

 

 

 

 

 

 

Nicholas L. Teti, Jr.

 

 

 

 

 

 

 

Chairman and Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GENZYME CORPORATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/ C. Ann Merrifield

 

 

 

 

 

 

 

C. Ann Merrifield

 

 

 

 

 

 

 

President, Genzyme Biosurgery

 

 

33

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EXHIBITS

 

 

Exhibit A                                —            Agreement Products
Specification and Approval Documents

 

Exhibit B                                —            Patents and Trademarks

 

 

--------------------------------------------------------------------------------

 

EXHIBIT A

 

 

Agreement Products Specification and Approval Documents

 

1.  Hylaform

 

 

***

***

***

 

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Confidential Treatment and filed separately with the commission.

 

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2.  Hylaform Plus

 

 

***

***

***

 

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Confidential Treatment and filed separately with the commission.

 

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3.  Captique

 

 

***

***

***

 

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Confidential Treatment and filed separately with the commission.

 

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EXHIBIT B

 

 

Patents and Trademarks

 

 

Patents

 

 

***

***

***

 

 

 

Trademarks

 

 

***

***

 

 

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