**Exhibit 10.52**

 

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

 

 

**AMENDEDAND RESTATED**

 

**UNITEDSTATES**

 

**DISTRIBUTIONAGREEMENT**

 

 

                **THIS AMENDEDAND 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 andexisting under the laws of the Commonwealth of Massachusetts (“Genzyme”) and **INAMED MEDICAL PRODUCTS CORPORATION**, a corporation dulyorganized and existing under the laws of the State of California (the “Distributor”).

 

                **WHEREAS,**Genzyme, as assignee of and successor in interest to Biomatrix, Inc. andInamed, as assignee of an successor in interest to Collagen Corporation, onJune 14, 1996 entered into a United States Distribution Agreement (the “OriginalAgreement”), as amended by Genzyme and Inamed on September 30, 2002 by theDevelopment Agreement and Amendment to United States Distribution Agreement(the “Development Agreement and Amendment”), pursuant to which Genzyme grantedto Inamed exclusive promotion, marketing and distribution rights for certainproducts in the United States on the terms and subject to the conditions setforth therein; and

 

**WHEREAS,**Genzyme and the Distributor wish to amend andrestate the Original Agreement, as amended, in order to include certain additionalproducts as Agreement Products (as such term is hereinafter defined), and tomake such further amendments upon the terms and conditions set forth in thisAgreement, which incorporates in its entirety the Original Agreement andSection 16 of the Development Agreement and Amendment.

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

 

                **1.**             **Definitionsand Interpretation**.

 

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

 

**“Affiliate”** shall mean, with respect to any party, any Personwhich, directly or indirectly, is controlled by, controls or is under commoncontrol with such party.  For 

 

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

 

**“Agreement Products”** shall mean (a) the two productsmade of hylan B and called Hylaform® and Hylaform® Plus, respectively, and (b) theone product made with bacterial hyaluronan that has been cross-linked using thehylan B cross-linking process and called CaptiqueTM; the specifications of eachof which are set forth on Exhibit A, for use in the correction ofwrinkles and depressed scars.  Inaddition, upon mutual written agreement, the parties may include additionalproducts as “Agreement Products” by attaching the specifications for suchproduct(s) to Exhibit A, which specifications shall including the initialMinimum Price for such additional product(s). Upon attaching such specifications, each additional product shall bedeemed an “Agreement Product” hereunder.

 

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

 

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

 

**“Binding Forecast”** shall mean that term asdefined in Section 7.3(a).

 

**“Captique”** shall mean the Agreement Product made with bacterialhyaluronan that has been cross-linked using the hylan B cross-linking process andcalled CaptiqueTM.

 

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

 

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

 

**“Dermal Tissue AugmentationProducts”** shall mean biomaterial(s)                                             ***

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**“Development Costs”** shall have the meaning setforth in the Development Agreement and Amendment and, for the avoidance of anydoubt, shall include the fully loaded costs incurred by either party inconnection with maintaining FDA Approvals, including, without limitation, anyPhase IV post-marketing clinical trials 

 

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performed in connection with any Agreement Product(s) or ImprovedAgreement Products.  For the purposes ofthis definition, “fully loaded costs” shall mean (a) all direct costs of labor,raw materials, supplies, services, fees (including external costs incurred bythird parties) and other resources consumed or used in the conduct of theapplicable activity, and (b) all indirect costs of rent, utilities, insurance,facility and equipment depreciation, administrative support and other overheadcharges related to the applicable activity. Indirect costs shall be allocated based upon the portion of such costsdirectly attributable to the support of the applicable activity.  All cost determinations made hereunder shallbe made in accordance with generally accepted accounting principlesconsistently 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, theNetherlands, 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 AgreementProduct, 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 asdefined in Section 7.1(c).

 

**“Formula Price”** shall mean anamount equal to                          ***

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**“Hylaform”** shall mean the Agreement Product made of hylan Band called Hylaform®.

 

**“Hylaform Plus”** shall mean the Agreement Product made ofhylan B and called Hylaform® Plus.

 

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

 

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

 

**“Incremental Royalties”** shall mean that term asdefined in Section 8.2.

 

**“Initial Term”** shall mean that term as defined in Section3.2.

 

**“International Agreement”** means the DistributionAgreement between Genzyme and Distributor, dated as of June 14, 1996, asamended from time to time, relating to the sale of Agreement Products in the EUCountries, 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, NewZealand, Japan, Israel, Argentina, Brazil, Chile, Mexico and Canada.

 

**“Launch”** shall mean the commencement by the Distributor ofsales of an Agreement Product in commercial quantities in the Territory for usein the Territory.

 

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

                           ***                       ($  ***   ) for each TreatmentSyringe, (b)   ***

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

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                                                                                    ***                                       .  If the Distributor’s rights to distribute theAgreement Products in the Territory become non-exclusive pursuant to Section2.3, the then applicableMinimum Price payable(i) during the           ***           Agreement Yearsimmediately following such conversion to non-exclusivity shall be adjusted                                  ***                                         ***    for each Treatment Syringe, and (ii) duringthe                   ***                    Agreement Years following such conversion to non-exclusivity shall        ***             ***  ($  ***  ) for each Treatment Syringe.

 

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**“Net Retail Sales**” shall mean, with respect to sales of aDermal Tissue Augmentation Product in the Territory
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|--------|--------|--------|
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**“New Products”** shall mean any and all Dermal TissueAugmentation Products made of:
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|--------|--------|-----|
|   |   | *** |
|   |   | *** |
|   |   | *** |

 

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

 

**“Patents”** shall mean Letters Patent or similar statutoryrights relating to any Agreement Products and any Improved Agreement Product(s)(including any continuation-in-part, continuation or division thereof orsubstitute thereof), and patent applications which are pending as of theEffective Date, in each case as set forth in Exhibit B, together withany supplementary or complementary protection certificates therefor if and whensuch are granted.

 

**“Person”** shall mean an individual, a corporation, limitedliability company, a partnership, a trust, an unincorporated organization or agovernment or any agency or political subdivision thereof.

 

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

 

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

 

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

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**“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 ExhibitB, and 

 

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

 

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

 

**“United States Consumer Price Index”** shall mean the ConsumerPrice Index, All Items, United States, as published by the Bureau of LaborStatistics.

 

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

 

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

 

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

 

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

 

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

 

                (e)           references to a person shall be construed as includingreferences 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 asreferences to those provisions as replaced, amended or re-enacted from time totime.

 

                **2.**             **Appointment; Best Efforts; Exclusivity**.

 

                2.1.          Appointment.

 

                (a)           Subject to the terms and conditionshereinafter set forth, Genzyme hereby appoints the Distributor as its exclusive             ***             (except to the extent set forth in Section2.3) distributor for the promotion, marketing, sale and distribution within theTerritory of the Agreement Products and any Improved Agreement Product(s)supplied by 

 

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Genzyme or an Affiliate of Genzyme to the Distributor pursuant to thisAgreement.  Such appointment does notinclude the right to sublicense or appoint subdistributors except to anAffiliate of Distributor without the approval of Genzyme (and only for suchtime 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 grantany license relating to Genzyme’s proprietary methods of formulating,fabricating and manufacturing the Agreement Products or any Improved AgreementProduct(s), or (iii) to grant the Distributor any rights in or to anyproprietary technology or patents or trademarks of Genzyme.

 

                2.2.          Acceptance of Obligations; Best Efforts.  The Distributor hereby accepts theappointment described in Section 2.1 and hereby agrees to use its best effortsat all times during the term hereof to promote, market, sell and distribute theAgreement Products and any Improved Agreement Product(s) in the Territory.  Distributor’s “best efforts” in this Section2.2 shall mean that Distributor shall use generally the same channels andmethods, exercise the same degree of effort and diligence, and adhere to the samestandards as Distributor and its Affiliates would apply in distributing theirown actively-promoted pharmaceutical products, and shall be such as arecommercially reasonable.

 

                2.3.          Conversion to Non-Exclusive Distributorship.  In the event that in any Agreement Yearincluding and after the    ***    Agreement Year (and so long as (i) no forcemajeure 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 AgreementProduct(s) in the Territory), the Distributor’s Net Retail Sales of the AgreementProducts and any Improved Agreement Product(s) in the Territory in such AgreementYear comprise less than              ***

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                                                                                                ***                                        , either Genzymeor the Distributor may elect upon        ***          notice,but in any event not later than ***                     ***        after the end of the applicable AgreementYear, to convert the Distributor’s distribution rights under this Agreement inthe 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 AgreementYear by paying to Genzyme within            ***         after such Agreement Year an amount equal to                                 ***                                                                       ***                        insuch Agreement Year for such Territory; further providedthat at Genzyme’selection, Genzyme may refuse to allow such cure if Distributor has takenadvantage of such cure provision in each of the two preceding Agreement Years.

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

 

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Territory, Genzyme shall have the right to distribute the AgreementProducts and Improved Agreement Products and/or engage another distributor forthe Territory.  From and after the dateof a conversion to a non-exclusive distribution arrangement within theTerritory, 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 theexclusive right to use all trademarks under which the Distributor launched the AgreementProducts or any Improved Agreement Product(s) in the Territory.

 

                **3.**             **Term andTermination**.

 

                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 accordancewith the provisions of this Agreement, the term of the appointment hereunderfor shall commence on the first day of the first Agreement Year and shall endon the last day of the      ***     Agreement Year (the “InitialTerm”).

 

                (b)           Unless this Agreement is sooner terminated in accordancewith the provisions of this Agreement, the appointment of the Distributorhereunder as exclusive distributor of the Agreement Products shall be renewableby the Distributor, at its option, upon written notice to Genzyme received atleast           ***       prior to the end of the Initial Term, for anadditional consecutive term of         ***       following the date ofexpiration of the Initial Term, providedthat the Distributorshall only be entitled to exercise such renewal option if as of the date ofexpiration of the Initial Term the Distributor is not in material breach of anyof its obligations under this Agreement. Thereafter, the appointment of the Distributor as exclusive distributorof the Agreement Products shall be renewable upon the expiration of such additional       ***      term, upon written notice to Genzyme receivedat least     ***          ***    prior to the end of such termfor one additional consecutive renewal term of  ***  *** years, providedthat, as of the date of expiration of the firstrenewal term, the Distributor is not in material breach of any of itsobligations under this Agreement.  Forthe avoidance of any doubt, Distributor’s rights with respect to any Improved AgreementProduct(s) commercialized after the commencement of the       ***       Agreement Year shall terminate upon the lastday of the       ***       Agreement Year.  Subject to the terms of this Agreement,Distributor shall have the right to continue to sell the Agreement Products andany Improved Agreement Product(s) it is then currently selling.

 

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

 

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

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

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

                                              ***                                     ; further providedthat,at Genzyme’s election, Genzyme may refuse to allow such cure if Distributor hastaken advantage of such cure provision in each of the two preceding AgreementYears.      ***

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Uponany such termination of the Distributor’s distribution rights in the Territory,the Distributor’s obligation to pay any royalties pursuant to Sections 8.1 and8.2 for any sales in the Territory after such termination shall cease, but theDistributor shall remain obligated to pay all such royalties for sales in theTerritory accrued prior to such termination.

 

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

 

                3.3.          Inventory.

 

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

 

                (b)           The price for inventory to be repurchased by Genzymepursuant to Section 3.3(a) above shall be the landed cost thereof actually paidby the Distributor to Genzyme.  Withrespect to any quantities not repurchased by Genzyme, the Distributor shallhave the right to sell such inventory of the Agreement Products and anyImproved Agreement Product(s), in its usual and customary manner, in theordinary course of business, for a period of        ***        following termination of this Agreement andnotwithstanding such termination the terms and conditions of this Agreementshall apply to such sales.

 

                3.4.          Insolvency. This Agreement may be immediately terminated by either party, upongiving written notice to the other party, in the event that the other partyshall become insolvent or be declared bankrupt by a court of competentjurisdiction or shall be the subject of any reorganization (other than acorporate reorganization effected in the ordinary course of business and notarising out of any insolvency) or winding up, receivership or dissolution, 

 

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bankruptcyor liquidation proceeding, or any proceeding or action similar to one or moreof the above, in which case termination shall be effective upon such writtennotice.  The failure of either party togive notice of termination upon obtaining knowledge of any such event shall notbe interpreted as a waiver of such party’s rights under this Section 3.4, andsuch party reserves the right to exercise any such rights at any time after theoccurrence of any such event.

 

                3.5.          Breach.  ThisAgreement may be terminated by either party if the other party shall breach anyof its payment obligations hereunder (in the event of a Fee Payment Default,Genzyme shall have the right to terminate only the Distributor’s rights withrespect to Captique) or if either party shall commit a material breach of anyof its warranties, covenants, conditions, obligations or agreements containedherein, providedthat such breach shall continue for a period of                                           ***

                     ***                after written notice thereof and providedfurther that such termination shall be immediately effective uponfurther written notice to that effect to the breaching party after its failureto cure such breach within such applicable notice period.

 

                3.6.          Certain Rights Upon Termination.  Upon termination of this Agreement for anyreason 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 bycross-reference or incorporation or otherwise, all information, data,investigations, preclinical and clinical protocols, marketing informationdisseminated by Distributor publicly to customers and patients and allinformation required to be provided to Genzyme by law, information relating tolaboratory, animal and human studies, and related regulatory approvalspertaining 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 Distributorunconditionally agrees promptly to take any action and to execute and deliverto Genzyme any documents or instruments reasonably requested by Genzyme topermit Genzyme to make full use of such unrestricted right.

 

                (b)           Further, Genzyme shall have exclusive ownership rights tothe Trademarks and to all other product specific logos, slogans and otherintangibles used by the Distributor solely in association with the independentsale of the Agreement Products and any Improved Agreement Product(s) (includingany and all good will associated with the Agreement Products and any ImprovedAgreement Product(s) and all registrations relating thereto) possessed orcontrolled by the Distributor or any of its Affiliates, and the Distributorunconditionally 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 instrumentsreasonably requested by Genzyme to give full effect to the provisions of thisSection 3.6.

 

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

 

                3.7.          Effects of Termination.

 

                (a)           Upon termination of this Agreement for any reason, theDistributor shall immediately discontinue making any representations regardingits status as a distributor for Genzyme and shall immediately cease conductingany activities with respect to the marketing, promotion, sale or distributionof the Agreement Products and any Improved Agreement Product(s), provided,however, that the Distributor shall be permitted to sell inventory notrepurchased by Genzyme in accordance with Section 3.3.

 

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

 

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

 

                **4.**             **Payments**.  All payments hereunder shall be made inDollars.  Payments to Genzyme shall bewired to an account designated by Genzyme and the costs of any such remittanceshall be borne by the Distributor.

 

                **5.             Withholding**. Allpayments to be made by the Distributor under this Agreement shall be made infull, free and clear of and without any deduction of or withholding for or onaccount of any taxes levied in any country of the Territory or elsewhere; providedthat if the Distributor shall be required by law to make any deduction orwithholding from any payment to Genzyme then:

 

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

 

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

 

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

 

                **6.             Trademarks; Agreement ProductMarking; Promotional Information**.

 

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

 

                6.2.          Termination of Right to Use Trademarks.  Subject to the sell-out right of Section3.3(b) and except as otherwise provided in Section 3.6, upon termination ofthis Agreement, the license to use the Trademarks in the Territory shallterminate, and the Distributor unconditionally agrees promptly to take allnecessary action and execute and deliver to Genzyme all necessary documents andinstruments to remove the Distributor as a registered user and/or a recordedlicensee of the Trademarks and to confirm that the goodwill in the Trademarksshall inure to the benefit of Genzyme. In the event that the Distributor fails promptly upon written request byGenzyme to comply with any of its agreements in the preceding sentence of thisSection 6.2, the Distributor hereby irrevocably consents to Genzyme’s takingany action necessary to give effect to such agreements.

 

                6.3.          Notice.  Eachparty hereto agrees promptly to notify the other in writing of anyinfringements or imitations of the Trademarks by third parties which may cometo its attention.

 

                6.4.          Labelling; Promotional Materials; Approved Use of AgreementProducts.

 

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

 

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thepackaging or labelling identified in the Product License Approvals without theprior written approval of Genzyme.

 

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

 

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

 

                6.5.          Legend. Subject to applicable laws and regulations in the Territory, allrelevant packaging and promotional material for the Agreement Products and anyImproved Agreement Product(s) used or sold by the Distributor shall contain (i)all applicable markings needed to keep the Trademarks enforceable throughoutthe Territory as reasonably specified by Genzyme to the Distributor and (ii) alegend which shall be displayed in a reasonably conspicuous manner on allpackaging of such Agreement Products and any Improved Agreement Product(s)containing the corporate identification logo of Genzyme and indicating thatsuch product has been developed and manufactured by Genzyme Corporation, andits 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 ongoingbasis and without charge (to the extent not prevented by law or contract fromdoing so) all medical information relating to the Agreement Products and anyImproved Agreement Product(s) (including summary data from studies, clinicaltrials and the like as well as information regarding adverse events associatedwith the use of the Agreement Products), the proceedings of all symposia on theAgreement Products and any Improved Agreement Product(s) and all promotionalinformation that is available to such party relating to the Agreement Productsand any Improved Agreement Product(s). In addition, Genzyme and the Distributor shall provide each other withaccess to such primary data and information in its possession as the other mayreasonably request regarding the results of the studies contained in suchsummary data referred to above.

 

                6.7.          Recalls of the Agreement Products.

 

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

 

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witheach other as to any action to be taken in regard to such a recall, but in anyevent if after consultations either party in good faith still believes thatsuch a recall should be undertaken, the parties shall cooperate in carrying outsuch recall.

 

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

 

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

 

                6.8           Product Vigilance System.  The Distributor shall be responsible formaintaining medical device vigilance systems, as established for the AgreementProducts and/or any Improved Agreement Product(s) by Genzyme, and shallpromptly provide Genzyme with notice of all product complaints, includingmedical complaints.  Genzyme shall besolely responsible for processing, analyzing and, if necessary, reportingmedical complaints to regulatory authorities. The Distributor shall provide all necessary support to Genzyme forcarrying out such activities.

 

                **7.             Supply of Agreement Products**.

 

                7.1.          General; Fee.

 

                (a)           Genzyme agrees to sell the Agreement Products and anyImproved Agreement Product(s) to the Distributor, on the terms and subject tothe conditions set forth herein, for resale by the Distributor within theTerritory, and the Distributor shall obtain the Agreement Products and anyImproved Agreement Product(s) for resale in the Territory only from Genzyme orits Affiliates.  Genzyme shall not sellthe Agreement Products or any Improved Agreement Product(s) itself or supply orlicense the manufacture of the Agreement Products or any Improved AgreementProduct(s) to any third party for resale within the Territory, provided that Genzyme’sobligations 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 Distributoracknowledge that the payments made by the Distributor as set forth in Section3.8 of the Development Agreement and Amendment were 

 

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

                                                                                    ***

                                                                                    ***

                                                                                    ***

 

(c)           The failure byGenzyme 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 ofthe distribution rights by Genzyme to Distributor, unless such payment isearned by Genzyme and Distributor subsequently fails to make such payment in afull or timely manner (a “Fee Payment Default”).

 

(d)           The Distributor shallpay all Development Costs with respect to all Agreement Products and anyImproved Agreement Product(s).  AnyDevelopment Costs incurred shall be billed to the Distributor        ***       and paid in Dollars within            ***          after the Distributor’sreceipt of the invoice for such costs.

 

                7.2.          Price; Adjustment; Reports; Payment.

 

                (a)           The supply pricing for the Distributor’s purchase of the AgreementProducts and any Improved Agreement Product(s) shall not be less than thegreater of (i) the applicable Minimum Price for each Agreement Product orImproved Agreement Product(s), or (ii) the applicable Formula Price for eachAgreement Product or Improved Agreement Product(s), except as provided insubsection (b) below.  The parties shallattempt in good faith to agree in writing upon mutually acceptable minimumpricing for the Agreement Products in sizes other than the 0.9cc TreatmentSyringe and for any Improved Agreement Product(s); provided, however,the Distributor shall pay the reasonable up-front costs incurred in connectionwith changes to the syringe size.

 

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

 

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

 

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                (d)           Within          ***         after the end of eachContract Quarter and Agreement Year, the applicable Formula Price for each AgreementProduct shall be calculated and an adjustment resulting from the differencebetween the applicable Formula Prices determined for each month of eachContract Quarter and Agreement Year and the applicable Formula Price calculatedfor the applicable Contract Quarter and Agreement Year shall be paid by theDistributor or Genzyme, as appropriate, to the other party with respect to allunits of the Agreement Products sold by the Distributor in the Territory duringsuch Contract Quarter and Agreement Year, such payment to be made within               ***              after the end of such         ***        period following the end of such ContractQuarter and Agreement Year.  The pricecalculated annually in this manner shall be the final price payable for allunits of the Agreement Products sold by the Distributor or any Affiliate duringsuch Agreement Year.  For the avoidanceof doubt, the aggregate amount payable by Distributor for the AgreementProducts and any Improved Agreement Product(s) for any Agreement Year shall inno event be lower than the applicable Minimum Price for each Agreement Productmultiplied by the total units sold in such Agreement Year in the Territory.

 

                (e)           Within                  ***               following the end of each calendar month ineach Agreement Year, the Distributor shall submit to Genzyme written reportsdetailing the units and value of the Distributor’s and its Affiliates’ NetRetail Sales and aggregate number of units sold of the Agreement Products andany Improved Agreement Product(s) in the Territory during the immediatelypreceding calendar month.

 

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

 

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

 

                7.3.          Sales and Supply Forecasts; Accounts.

 

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

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

 

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

          ***         with respect to each month.

 

                (b)           The Distributor shall maintain books of account withrespect to its sales of the Agreement Products and any Improved Agreement Product(s)in the Territory.  Genzyme shall have theright, not more than once during each calendar year, to have an independentaccountant selected and retained by Genzyme (reasonably acceptable toDistributor, provided that any “big four” accounting firm shall be deemedreasonable) to inspect and examine such books of the Distributor during regularbusiness hours for the purpose of verifying the statements of the aggregate NetRetail Sales of all Dermal Tissue Augmentation Products for all purposes hereunder,including verification of applicable Formula Price and the royalties describedin Section 8.  The cost of each suchaudit shall be borne by Genzyme unless a material error is discovered in thecourse of such audit, in which case the cost shall be borne by theDistributor.  For purposes of thisSection 7.3(b), a material error shall be defined as an understatement of             ***           or more of the aggregate amount owed to Genzymewith respect to sales of Dermal Tissue Augmentation Products in theTerritory.  Any additional paymentsrequired as a result of such inspection and examination shall be immediatelypaid to Genzyme and shall bear interest from the date such amount wouldotherwise have been paid until the date of actual payment at the rate per annumset forth in Section 20.  Suchindependent accounting firm shall conduct such inspections and examinationsunder conditions of confidentiality.

 

                7.4.          Shipment and Delivery; Packaging; Shelf Life.

 

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

 

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

 

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

 

                7.5.          Title.  Legaltitle to all quantities of the Agreement Products and any Improved AgreementProduct(s) sold hereunder shall remain in Genzyme until delivery of the AgreementProducts and any Improved Agreement Product(s) to Distributor or its agent andacceptance thereof, and upon such delivery and acceptance the title to such AgreementProducts 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 AgreementProducts and any Improved Agreement Product(s) to the extent the same is in itspossession or the possession of its Affiliates, nominees or agents.  The Distributor shall bear all risk of lossof, or damage to, all units of the Agreement Products and any Improved AgreementProduct(s) after delivery to a common carrier for shipment to the Distributorin accordance with Section 7.4.

 

                7.7.          Acceptance.                                          ***

                                                                                ***

                                                                                ***

                                                                                ***                           .  All units of the Agreement Products and any ImprovedAgreement Product(s) delivered to Distributor pursuant to this Agreement shallbe              ***

                                                                                ***

                                                                                ***

                                                      ***                           , the applicable specificationlisted in ExhibitA.  Anynon-conformity which arises after acceptance by Distributor directly associatedwith Product specification shall be the responsibility of Genzyme unless suchnon-conformity is due to improper storage conditions subsequent to delivery ofthe Agreement Products.  All othernon-conformities of the Agreement Products shall be the responsibility of theDistributor.  Genzyme and the Distributoragree to consult with each other in order to resolve the discrepancy betweeneach other’s determinations.  If suchconsultation does not resolve the discrepancy, the parties agree to nominate areputable independent laboratory, acceptable to both parties, that shall carryout tests on representative samples taken from such shipment, and the resultsof such tests shall be binding on the parties. Genzyme shall at its expense replace any such shipment to the extentthat it does not conform to the Agreement Product Specifications.  All defective units of the Agreement Productsor any Improved Agreement Product(s) shall be returned to Genzyme at theaddress set forth in 

 

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Section24 of this Agreement, accompanied or preceded by a reasonably detailedstatement of the claimed defect or non-conformity and proof of date ofpurchase, and packed and shipped according to instructions provided by Genzyme.  The shipping costs of any such returned unitsshall be borne by Genzyme, unless such units are determined not to be defectiveunder the terms of this Agreement, in which case such shipping costs shall beborne by the Distributor.

 

                7.8.          Purchase Orders. The provisions of this Agreement shall prevail over any inconsistentstatement or provisions contained in any document related to this Agreementpassing between the parties hereto including, but not limited to, any purchaseorder, acknowledgment, confirmation or notice.

 

                7.9.          Limited Warranty; Limitation onLiability.

 

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

 

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

 

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

 

                **THEFOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN BY GENZYME WITHRESPECT TO THE AGREEMENT PRODUCTS, AND GENZYME GIVES AND MAKES NO REPRESENTATIONSOR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE FOREGOING.  WITHOUT LIMITING THE GENERALITY OF THEFOREGOING, NO IMPLIED WARRANTY OF MERCHANTABILITY, NO IMPLIED WARRANTY OFFITNESS FOR ANY PARTICULAR PURPOSE, AND NO IMPLIED WARRANTY ARISING BY USAGE OFTRADE, COURSE OF DEALING OR COURSE OF PERFORMANCE IS GIVEN OR MADE BY GENZYMEOR SHALL ARISE BY OR IN CONNECTION WITH ANY SALE OR PROVISION OF THE AGREEMENTPRODUCTS BY GENZYME, OR THE DISTRIBUTOR’S (OR ITS AFFILIATES’) USE OR SALE OF THEAGREEMENT 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 OTHERREPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN ANY WAY.**

 

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

 

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

 

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

 

                **GENZYME’SLIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION WITH THE SALE OR USE OF THE AGREEMENTPRODUCTS 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 ANDEXPRESSLY PROVIDED IN THIS SECTION 7.9 AND IN SECTION 9 BELOW.  EXCEPT AS SPECIFICALLY PROVIDED IN THISSECTION 7.9 AND IN SECTION 9 BELOW, GENZYME SHALL HAVE NO LIABILITY, OBLIGATIONOR RESPONSIBILITY OF ANY KIND, IN ANY WAY OR TO ANY EXTENT, FOR ANY DAMAGES,LOSSES, COSTS, EXPENSES OR LIABILITIES FOR ANY REPRESENTATION OR WARRANTY OFANY KIND WITH RESPECT TO THE AGREEMENT PRODUCTS AND ANY IMPROVED AGREEMENTPRODUCT(S) OR THE PERFORMANCE THEREOF, OR ARISING IN ANY WAY IN CONNECTION WITHTHE PURCHASE OR USE OR INABILITY TO USE THE AGREEMENT PRODUCTS OR ANY IMPROVED AGREEMENTPRODUCT(S), EVEN IF GENZYME HAS BEEN ADVISED OF THE POSSIBILITY OF SUCHDAMAGES.  IN NO EVENT WHATSOEVER SHALL GENZYMEHAVE ANY LIABILITY, OBLIGATION OR RESPONSIBILITY FOR ANY INDIRECT, INCIDENTAL,CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES ARISING IN ANY WAY IN CONNECTIONWITH THE AGREEMENT PRODUCTS OR ANY IMPROVED AGREEMENT PRODUCT(S) OR THEIR SALEOR USE.**

 

**                8.             Royalty Payments by Distributor**.

 

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

 

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                                                                                ***

                                                                                ***

                                                                                ***

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

 

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

 

| **Increase in Total Sales  Over Base Year Amount** | ** ** | **Royalty  on Total  Incremental Sales** |
|----------------------------------------------------|------------|------------------------------------------|
|                                               |       |                                     |
| ***                                                |       | ***                                      |
| ***                                                |       | ***                                      |
| ***                                                |       | ***                                      |

 

 

TheDistributor’s obligation to pay the Incremental Royalties shall               ***

                                                                                ***

                                                                                ***

                             ***                      .  The Incremental Royalty shall be paid by notlater than           ***           after the end of each Agreement Year.  For the avoidance of doubt, if theDistributor had no sales of any Dermal Tissue Augmentation Products prior tothe first commercial sale of either the Agreement Products or any Improved AgreementProduct(s), the Distributor shall be obligated to pay a        ***         royalty on Net Retail Sales of all DermalTissue Augmentation products sold after such first commercial sale.

 

**                9.             Indemnification;Confidentiality; Public Announcement**.

 

                9.1.          Indemnification from theDistributor.  Subject to theprovisions of Section 9.3, the Distributor shall defend, indemnify and hold Genzymeand its Affiliates and their respective directors, officers, agents andemployees harmless from and against any and all liabilities, claims, damagesand expenses (including without limitation actual court costs and reasonableattorneys’ fees regardless of outcome) resulting from claims of third partiesor arising out of:

 

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| (a)    | ***    |
|--------|--------|
|   | ***    |
|   | ***    |
|   |   |
| (b)    | ***    |
|   | ***    |
|   |   |
| (c)    | ***    |
|   | ***    |
|   | ***    |

 

provided, however,that upon Genzyme being advised of any assertions of any such third partyclaims or suits or upon the bringing or filing of such claims or suits by anythird party against Genzyme, Genzyme will promptly notify the Distributorthereof and Genzyme may, at its option, permit the Distributor’s attorneys tohandle and control the defense of such claims or suits at the Distributor’scost and Genzyme will co-operate with the Distributor in the defensethereof.  The parties agree that thereshall be no settlements, whether agreed to in court or out of court, withoutthe prior written consent of the indemnifying party.

 

                9.2.          Indemnification from Genzyme.  Subject to the provisions of Section 9.3, Genzymeshall defend, indemnify and hold the Distributor and its Affiliates and theirrespective directors, officers, agents and employees harmless from and againstany and all liabilities, claims, damages and expenses (including withoutlimitation actual court costs and reasonable attorneys’ fees regardless ofoutcome) 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 thirdparty claims or suits or upon the bringing or filing of such claims or suits byany third party against the Distributor, the Distributor will promptly notify Genzymethereof and, at Genzyme’s cost, permit Genzyme’s attorneys to handle andcontrol the defense of such claims or suits and will co-operate with Genzyme inthe defense thereof.  The parties agreethat there shall be no settlements, whether agreed to in court or out of court,without the prior written consent of the indemnifying party.

 

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                9.3.          Limitation on Liability.

 

**                NOTWITHSTANDINGANY PROVISION TO THE CONTRARY IN SECTIONS 9.1 AND 9.2 ABOVE, OR ANY OTHERPROVISION OF THIS AGREEMENT, IN NO EVENT (INCLUDING THE FAULT, NEGLIGENCE ORSTRICT LIABILITY OF EITHER PARTY) SHALL EITHER PARTY BE LIABLE TO THE OTHERPARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGESOTHER THAN TO THE EXTENT NECESSARY TO REIMBURSE SUCH OTHER PARTY FOR DAMAGESACTUALLY PAID TO A NON-AFFILIATED THIRD PARTY, PROVIDED THAT SUCHDAMAGES 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, relatingdirectly or indirectly to the present or potential business, operations,corporate, technical or financial situation of the Discloser, or tomanufacturing know-how, patents, data, test results, techniques, processes,procedures, raw materials, dealer, supplier and customer lists, pre-clinicaland clinical protocols or any improvements thereof of the Discloser (“ConfidentialInformation”) is confidential, and shall be held in trust by the Recipient forthe exclusive benefit of the Discloser. Unless otherwise agreed to in writing by the Discloser, the Recipientshall not at any time, either during or subsequent to the term of thisAgreement, use for itself (other than in accordance with the terms of thisAgreement) or any other Person, or disclose or divulge to any Person, otherthan to those of its employees and advisors and Affiliates who require the samefor the purposes hereof and who are bound by the same obligations ofconfidentiality, non-disclosure and non-use as set forth herein, anyConfidential Information or any other confidential or proprietary informationof the Discloser of which the Recipient may acquire knowledge; provided,however, that the confidentiality, non-disclosure and non-use provisionscontained in this Section 9.4 shall not apply to any information or data to theextent that the Recipient:

 

                (a)           shall demonstrate by clear and convincing evidence thatsuch information or data is known generally to persons in the trade through noact or omission of the Recipient or any of its Affiliates;

 

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

 

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

 

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ConfidentialInformation shall be immediately returned to the Discloser upon termination ofthis Agreement, along with any copies, reproductions, digests, abstracts or thelike of all or any part thereof in the Recipient’s possession or under theRecipient’s control, and upon such return any computer entries or the likerelating thereto shall, to the extent legally permissible, be destroyed.  Such return (and destruction) will not affectthe 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 underSection 3.6.

 

                9.5.          Public Announcement. Except as shall be necessary for governmental notification purposes orto comply with applicable laws and regulations, and except as otherwise agreedto by the parties hereto in writing, the parties agree to keep the existence ofthis Agreement, and the transactions contemplated hereby, strictlyconfidential.  In the event that a partymust file this document or otherwise disclose any of its subject matterpursuant to public filing requirements, such party shall seek confidentialtreatment of those portions of the Agreement as the parties shall mutuallyagree upon.  The parties shall agree uponthe text of an initial public announcement (including any Form 8-K) relating tothe transactions contemplated by this Agreement as soon as possible.  Any subsequent public announcements regardingthis Agreement or the transactions contemplated herein shall also be agreedupon in writing between the parties prior to any release thereof.

 

**                10.          New Products**.

 

                10.1                                                                         ***

                                             ***                                        ,  Distributor shall not commercialize nor beginthe commercialization process with respect to or acquire any New Productanywhere in the International Territory or the United States, eitherindependently or in conjunction with one or more third parties, unless anduntil the following conditions have been satisfied:

 

                (a)           Distributor has made a commerciallyreasonable written offer to Genzyme to participate with Distributor in thedevelopment 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 failsto accept any written offer made by Distributor pursuant to this Section 10.1within        ***         of Genzyme’s receipt thereof, thenDistributor, subject to the terms of this Agreement, shall have the right toindependently or with other parties develop and/or commercialize any NewProduct to which such written offer relates; provided, however,that any such New Product does not infringe upon any intellectual propertyrights of Genzyme.  Distributor shall notbe 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 patentedproprietary rights of a third party.

 

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

 
|   |   | (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 implicationor otherwise, (i) to effect any sale or license of proprietary Genzymetechnology (including any New Products), (ii) to grant any license relating to Genzyme’sproprietary methods of formulating, fabricating and manufacturing the AgreementProducts, Improved Agreement Product(s) or New Products, or (iii) to grantDistributor any rights in or to any proprietary technology or patents or trademarksof Genzyme.

 

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

 members designated by each party.  The initial members of the Committee shall beidentified by the parties within sixty (60) days of the Effective Date.  The size of the Committee may be changed fromtime to time by mutual agreement of the parties so long as the number ofrepresentatives designated by each party is equal.  Upon the request of either party, theCommittee may allow persons other than its voting members to attend and participateon a non-voting basis at the meeting of the Committee.  The Committee shall meet either in person orby teleconference at least                    ***                .  The Committee may appoint a member who shallbe responsible for the preparation of written minutes of each meeting, whichminutes shall be subject to Committee approval. The Committee shall be responsible for ensuring that any and allobstacles or issues that arise are resolved promptly and efficiently.  Decisions of the Committee shall be made byconsensus (a majority of the members of the Committee).  If, after a period of seven (7) days, amatter is still not resolved, it shall be resolved in accordance with Section19.  The Committee shall not haveauthority to change the responsibilities or either party under this Agreementor to otherwise amend this Agreement.

 

                **12.          Representations of Genzyme**.  Genzyme represents, warrants and covenants asfollows:

 

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

 

                12.2.        This Agreement is a valid and binding obligation of Genzymeenforceable in accordance with its terms. Genzyme has the unencumbered right to enter into this Agreement and tofulfill its duties hereunder.  It is notand will not become a party to any agreement in conflict herewith.  Accordingly, Genzyme has the right to appointthe Distributor as the exclusive distributor of the Agreement Products in theTerritory in accordance with the terms of this Agreement and such appointmentwill not constitute a breach of any existing contractual or other arrangementsbetween Genzyme and any Affiliated or non-Affiliated third party, nor shall itinfringe 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 governmentalor regulatory authority is required in connection with the execution anddelivery of this Agreement by Genzyme and the performance by Genzyme of itsobligations hereunder.

 

                **13.          Representations of the****Distributor**.  The Distributor represents, warrants andcovenants as follows:

 

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

 

                13.2.        This Agreement is the Distributor’s valid and bindingobligation enforceable in accordance with its terms.  The Distributor has the unencumbered right toenter into this Agreement and to fulfill its obligations hereunder.  It is not and will not become a party to anyagreement in conflict herewith. Accordingly, the Distributor has the right to act as the exclusivedistributor of the Agreement Products in the Territory in accordance with theterms of this Agreement and the performance of its obligations hereunder willnot constitute a breach of any existing contractual or other arrangementsbetween the Distributor and any Affiliated or non-Affiliated third party, norshall 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 orregulatory authority is required in connection with the execution and deliveryof this Agreement by the Distributor and the performance by the Distributor ofits obligations hereunder.

 

                **14.          Insurance**.  Each party hereto shall (a) obtain andmaintain such insurance policies as are adequate to cover its respectiveobligations hereunder and which are consistent with normal business practicesof prudent companies similarly situated and (b) provide the other party, uponrequest, with certificates of insurance confirming the existence of suchinsurance policies.

 

                **15.**          **Infringement**.  Each of the Distributor and Genzyme willpromptly notify the other party in writing of any infringement of a Patent orTrademark or unauthorized disclosure or use of any Confidential Information, ofwhich it becomes aware in the Territory. Genzyme shall have the exclusive right at its own cost to take all legalaction in the Territory it deems necessary or advisable to eliminate orminimize the consequences of such infringement of a Patent or Trademark in theTerritory.  For the purpose of taking anysuch legal action, Genzyme shall have the right, subject to the Distributor’sconsent which consent shall not be unreasonably withheld or delayed, to use thename of the Distributor as plaintiff, either solely or jointly in accordancewith the applicable rules of procedure; providedthat Genzymeshall give the Distributor prior notice of such use of the Distributor’sname.  The Distributor shall promptlyfurnish Genzyme with whatever written authority may be required in order toenable Genzyme to use the Distributor’s name in connection with any such legalaction, and shall otherwise cooperate fully and promptly with Genzyme inconnection with any such action.  Allproceeds realized upon any judgment or settlement regarding such action shallbelong to Genzyme.

 

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                **16.          RegulatoryActivities; Clinical Trials and Marketing Studies.**

 

                16.1.        General.

 

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

 

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

 

                (c)           The Distributor and Genzyme shall provide reasonableadvice and assistance to each other as may be necessary to obtain and maintainProduct License Approvals.

 

                (d)           During the term of this Agreement, each party shallimmediately notify the other in writing in the event that such party becomesaware of any failure of the Agreement Products and any Improved AgreementProduct(s) to comply with any of the requirements therefor specified in anyProduct License Approvals.

 

                (e)           Each of the Distributor and Genzyme shall keep the otheradvised of regulatory interactions, activities and correspondence relating tothe Agreement Products and any Improved Agreement Product(s) on at least aquarterly basis, and any matters requiring immediate attention shall becommunicated as soon as practicable. Notwithstanding the foregoing, within        ***         of receipt by Genzyme of any letter from the FDAindicating that any Agreement Product is approvable, Genzyme shall deliver acopy of such letter to the Distributor.

 

                (f)            The parties shall attempt in good faith to agree inwriting upon the roles and responsibilities of each party with respect to theperformance of any Phase IV post-marketing clinical trials with respect to theAgreement Products, including (i) the overall management of such clinicaltrails, including supervision of any third party contract researchorganizations, investigators and site monitors; (ii) the management andanalysis of data resulting from such clinical trials, including supervision ofthird party reviewers, biostatisticians and other persons participating in theorganization and analysis of the clinical trail; and (iii) drafting the finalclinical study report.

 

                16.2.        Marketing Studies. The parties agree that if any marketing-related studies are deemednecessary, such studies will not delay the Launch of Captique in theTerritory.  The protocols for anymarketing-related studies requested by the Distributor will be developedjointly by Genzyme and the Distributor, and the Distributor will be responsiblefor conducting and managing such studies at its own expense.  Genzyme shall have the right to audit theperformance of any marketing-related studies performed by or on behalf of the 

 

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

 

                **17.          Further Assurances**.  The parties hereto agree to execute suchfurther or other documents and assurances as are necessary from time to time inorder to give effect to the provisions of this Agreement.

 

                **18.          Assignment**.  The rights and obligations of the partieshereto shall inure to the benefit of and shall be binding upon the authorizedsuccessors and permitted assigns of each party. Neither party may assign its rights or obligations under this Agreementor may designate another person to perform all or part of its obligations underthis Agreement, or to have all or part of its rights and benefits under thisAgreement without the prior written consent of the other party, except to anAffiliate or to a successor of the business, by merger or otherwise, to whichthis Agreement relates, providedthat in the case of anassignment to an Affiliate the assigning party shall promptly notify the otherparty in writing of such assignment and shall remain liable (both directly andas guarantor) with respect to all obligations so assigned.  In the event of any assignment or in theevent that an Affiliate of either party shall exercise rights and/or performobligations hereunder pursuant to the terms of this Agreement, the assignee orAffiliate, as the case may be, shall specifically assume and be bound by theprovisions of the Agreement by executing and agreeing to an assumptionagreement satisfactory to the other party hereto.

 

                **19.          Governing Law; Arbitration; InjunctiveRelief**.

 

**               **(a)**          **Governing Law.** **This Agreement shallbe governed by and construed in accordance with the internal and substantivelaws of the Commonwealth of Massachusetts, United States of America.

 

(b)           DisputeResolution.  In the event of any disputetouching or concerning this Agreement, the parties hereby agree to submit suchdispute:

 

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

 

(ii)           second, to the mostsenior executive officer of the business unit of each party responsible for thebusiness of the Agreement Products, or their designees, and if the dispute isnot successfully resolved by these senior executive officers within a period oftwenty (20) days through good faith discussions, or such other period as isagreed upon in writing by the parties; then

 

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

 

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shallbe appointed by each party and the third of whom shall be appointed by mutualagreement of the two (2) party-appointed arbitrators.  In the event of failure of a party to appointan arbitrator within thirty (30) days after commencement of the arbitrationproceeding or in the event of failure of the two (2) party-appointedarbitrators to agree upon the appointment of the third arbitrator within thirty(30) days after commencement of the arbitration proceeding, such arbitratorshall be appointed by the American Arbitration Association in accordance withthe Rules.  The arbitrators shall applythe governing law set forth in this Section. Judgment upon an award rendered by the arbitrators may be entered in anycourt having jurisdiction thereof.

 

                (c)           Each of the parties hereto acknowledges and agrees thatdamages will not be an adequate remedy for any material breach or violation of thisAgreement if such material breach or violation would cause immediate andirreparable harm (an “Irreparable Breach”). Accordingly, notwithstanding the provisions of Section 19(a) to thecontrary, in the event of a threatened or ongoing Irreparable Breach, eachparty hereto shall be entitled to seek, in any state or federal court in the stateof the principal offices of the other party, equitable relief of a kindappropriate in light of the nature of the ongoing threatened IrreparableBreach, which relief may include, without limitation, specific performance orinjunctive relief; provided, however, that if the party bringingsuch action is unsuccessful in obtaining the relief sought, the moving partyshall 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 inthis Agreement.

 

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

 

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

 

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

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

 

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

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                **23.          No Partnership or Agency.** This Agreement and the relations herebyestablished by and between Genzyme and the Distributor do not constitute apartnership, joint venture, agency or contract of employment between them.

 

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

 

To Genzyme:                                                                           GenzymeCorporation500 Kendall StreetCambridge, Massachusetts  02142Attention:  General CounselFacsimile:  (617) 252-7553

 

with a copy to:                                                                 GenzymeCorporation55 Cambridge ParkwayCambridge, Massachusetts  02142

Attention:  President, Genzyme BiosurgeryFacsimile:  (617) 761-8918

 

To Distributor:                                                                 Inamed MedicalProducts Corporation

                                                                                                                                                5540 EkwillStreet, Suite D

                                                                                                                                                Santa Barbara,California 93111

                                                                                                                                                Attn: NicholasL. Teti and Joseph A. Newcomb, Esq.

 

 or to such other address as the addresseeshall last have designated by notice to the communicating party.  The date of giving any notice shall be thedate 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 thetermination or expiration of this Agreement (as the case may be) and shallremain in full force and effect.  Theprovisions of this Agreement that do not survive termination or expirationhereof (as the case may be) shall, nonetheless, be controlling on, and shall beused in construing and interpreting the rights and obligations of the partieshereto 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 entireagreement between the parties with respect to the transactions and arrangementscontemplated hereby and supersedes all prior oral or written arrangements,including the Original Agreement and Section 16 of the Development Agreementand Amendment.  This Agreement may bemodified or amended only by a written instrument executed and delivered by bothparties.  None of the provisions of thisAgreement shall be deemed to have been waived by any act or acquiescence on thepart of either party except by an instrument in writing signed and 

 

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deliveredby the party executing the waiver.  ThisAgreement may be executed in several identical counterparts, each of whichshall be an original, but all of which constitute one instrument, and in makingproof of this Agreement it shall not be necessary to produce or account for morethan one such counterpart.

 

[Theremainder of this page is intentionally left blank.]

 

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                **IN WITNESSWHEREOF**, the parties hereto have executed this Agreement as of thedate 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 |   |

 

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EXHIBITS

 

 

ExhibitA                                —            Agreement Products Specification andApproval Documents

 

ExhibitB                                —            Patents and Trademarks

 

 

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**EXHIBITA**

 

 

AgreementProductsSpecificationandApprovalDocuments

 

**1.  Hylaform**

 

 

***

***

***

 

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**2.  Hylaform Plus**

 

 

***

***

***

 

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**3.  Captique**

 

 

***

***

***

 

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**EXHIBITB**

 

 

PatentsandTrademarks

 

 

Patents

 

 

***

***

***

 

 

 

Trademarks

 

 

***

***

 

 

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