Document:

Exhibit 10.37

 

CLAYTON WILLIAMS ENERGY, INC.

OPTION AGREEMENT

1993 STOCK COMPENSATION PLAN

 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Optionee

  	
   

  	
  Date of Grant

  

 

At
the direction of the Compensation Committee appointed by the Board of Directors
of Clayton Williams Energy, Inc. (the “Company”), you are hereby notified that
you have been granted an option pursuant to the 1993 Stock Compensation Plan
(the “Plan”).  The grant of this option
is specifically subject to the terms and conditions of the Plan.

 

The
option granted to you is to purchase                  
shares of the $.10 par value common stock of the Company at a price of $               per
share.  The date of grant of this option
is the date of this Option Agreement.

 

The
option granted to you will expire ten (10) years from the date of grant.

 

A
copy of the Plan and the Prospectus which relates thereto are enclosed for your
information.  To the extent you wish a
copy of the documents incorporated by reference in the enclosed Prospectus,
please contact Paul Latham, the Company’s compliance representative.

 

At
the time or times you wish to exercise this option, in whole or in part, please
refer to the Plan and the Prospectus for the details regarding the formalities
required.

 

	
   

  	
  CLAYTON WILLIAMS ENERGY, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
  L.
  Paul Latham

  
	
   

  	
   

  	
  Executive
  Vice-President

  
	
   

  	
   

  	
   

  
	
  Acknowledged:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Optionee
  –Exhibit
10.38

 

CLAYTON
WILLIAMS ENERGY, INC.

OPTION
AGREEMENT

OUTSIDE
DIRECTORS STOCK OPTION PLAN

 

 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Optionee

  	
   

  	
  Date of Grant

  

 

At the direction of the
Stock Option Committee appointed by the Board of Directors of Clayton Williams
Energy, Inc. (the “Company”), you are hereby notified that you have been
granted an option pursuant to the Outside Directors Stock Option Plan (the “Plan”).  The grant of this option is specifically
subject to the terms and conditions of the Plan.

 

The option granted to you
is to purchase             
shares of the $.10 par value common stock of the Company at a price of $                
per share.  The date of grant of this
option is the date of this Option Agreement.

 

The option granted to you
will expire ten (10) years from the date of grant.

 

A copy of the Plan and
the Prospectus that relates thereto has previously been provided to you.  Should you desire another copy or require a
copy of the documents incorporated by reference in the Prospectus, please contact
L. Paul Latham, the Company’s compliance representative.

 

At the time or times you
wish to exercise this option, in whole or in part, please refer to the Plan and
the Prospectus for the details regarding the formalities required.

 

	
   

  	
  CLAYTON WILLIAMS ENERGY, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
  L. Paul Latham

  
	
   

  	
   

  	
  Executive Vice
  President

  
	
   

  	
   

  	
   

  
	
  Acknowledged:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  OptioneeExhibit 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 

 

 

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 CaptiqueTM; 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 CaptiqueTM.

 

“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 

 

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

 

2

 

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 

 

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

 

3

 

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.

 

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

 

4

 

“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 CaptiqueTM, the details of each of which are described in Exhibit
B, and 

 

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

 

5

 

(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 

 

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

 

6

 

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 

 

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

 

7

 

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 

 

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

 

8

 

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, 

 

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

 

9

 

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.

 

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

 

10

 

                (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

 

11

 

                (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 

 

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

 

12

 

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 

 

13

 

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

 

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).

 

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

 

15

 

                (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-

 

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

 

16

 

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.

 

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

 

17

 

                (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 

 

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

 

18

 

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

 

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,       ***

 

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

 

20

 

                                                                                ***

                                                                                ***

                                                                                ***

                ***             . 
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:

 

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

 

21

 

	
  (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.

 

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

 

22

 

                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

 

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.

 

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

 

24

 

                (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.

 

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

 

25

 

                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 

 

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

 

28

 

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.

 

	
  ***

  	
   

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

  

30

 

                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

 

                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

 

EXHIBITS

 

 

Exhibit A                                —            Agreement Products Specification and
Approval Documents

 

Exhibit B                                —            Patents and Trademarks

 

 

 

EXHIBIT
A

 

 

Agreement
Products Specification  and  Approval  Documents

 

1.  Hylaform

 

 

***

***

***

 

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

 

 

2.  Hylaform Plus

 

 

***

***

***

 

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

 

 

3.  Captique

 

 

***

***

***

 

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

 

 

EXHIBIT
B

 

 

Patents and  Trademarks

 

 

Patents

 

 

***

***

***

 

 

 

Trademarks

 

 

***

***

 

 

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

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00080-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00080-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00080-of-00352.parquet"}]]