**Exhibit10.1**

*** ConfidentialTreatment Requested

**AMENDED AND RESTATEDNON-EXCLUSIVE DISTRIBUTION AGREEMENT**

This AMENDED AND RESTATEDNON-EXCLUSIVE DISTRIBUTION AGREEMENT (the “Agreement”) is made as of the30th day ofMarch 2004, by and between Poly Implants Protheses, S.A., a French corporation(“Supplier”) and III Acquisition Corp., a Delaware corporation and/or itswholly owned subsidiaries (“Distributor”).

## **RECITALS**

**WHEREAS** the Supplier is the manufacturer of smoothand textured breast implant products (the “Breast Implants”) which Supplierdesires to have distributed throughout North America, including the UnitedStates of America and Canada, and any territories of the United States ofAmerica and Canada (the “Territory”);

**WHEREAS** the Distributor desires to distribute theBreast Implants, along with any other products manufactured or sold by theSupplier (collectively, the “Products”) in the Territory on a non-exclusivebasis;

**WHEREAS** Supplier and Distributor have previouslyentered into a Non-Exclusive Distribution Agreement dated as of October27, 1999 (the “Original Agreement”) in which Supplier granted Distributor thenon-exclusive right to distribute the Products in the Territory; and

**WHEREAS** Supplier and Distributor desire in thisAgreement to amend and restate the Original Agreement in its entirety to setforth in full the agreements and understandings of the parties with respect tothe distribution of the Products in the Territory and certain related matters,including the filing, prosecution and ownership of the Pre-MarketApproval (“PMA”) application currently in preparation for Supplier’s pre-filledsaline Breast Implant products, which the parties anticipate will be submittedto the United States Department of Health and Human Resources, Food and DrugAdministration (the “FDA”) no later than 2005.

**NOW,THEREFORE,** inconsideration of the premises and of the mutual covenants set forth below, theparties hereto agree as follows:

**1.             DistributionRights.**  Supplier hereby grants to Distributor anon-exclusive right and license to distribute the Products for sale throughoutthe Territory during the term of this Agreement.  Supplier agrees that if the othernon-exclusive distributor of the products, PIP/USA, Inc., breaches itsagreement with Supplier or PIP/USA, Inc.’s agreement is cancelled or terminatedfor any reason, Supplier will not execute any other non-exclusive distributionagreement with any other party and this Agreement shall become exclusive withrespect to distribution of the Products in the Territory.  Distributor has only distribution rightsunder this Agreement.  At no time whilethis Agreement is in effect will Distributor, directly or indirectly (throughother companies, agents, subsidiaries or otherwise), manufacture equivalentbreast implants that conform with the PMA contemplated in this Agreement.  At no time while this

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Agreement is in effect will Supplier, directly orindirectly (through other customers, agents, subsidiaries or otherwise), withthe exception of the non-exclusive distribution agreement already in placebetween Supplier and PIP/USA, Inc.:

**(a)**           sellthe Products in the Territory; or

**(b)**           sellthe Products to any person or entity with reasonable basis to believe that suchperson or entity, or someone acting on their behalf, will resell the Productsinto the Territory; or

**(c)**           appointor license any other person or entity as a distributor or representative of theProducts without specifically prohibiting such person or entity, in writing,from selling or reselling the Products into the Territory; or

**(d)**           sellany components and/or parts for the Products that may be used in manufacturingthe Products for any person or entity in the Territory other than theDistributor.

**2.             Terms and Renewal.**  ThisAgreement and the rights granted Distributor hereunder shall be for an initialterm of ten (10) years, beginning on the date first written above.  Thereafter, the Distributor shall have theoption of renewing this Agreement on the same terms and conditions for three(3) additional five (5) year terms, provided Distributor is not in default ofany provisions of this Agreement at the date of renewal, which renewal shall beautomatic unless the Distributor notifies Supplier of Distributor’s intent notto renew at least sixty (60) days prior to the renewal date.

**3.             Orders and Shipping.**

**(a)**           Order Placement and Allocation.  Distributor shall place all orders for theProducts with Supplier in writing on a weekly basis (the “Purchase Orders”).  Supplier shall use commercially reasonableefforts to ship the Products on the Purchase Orders to Distributor withinthirty (30) days of the date of the Purchase Order.  Distributor shall provide to Supplier monthlyan estimate of Products to be required for the following three months.  In the event an order (prorated from a weeklybasis to a monthly basis) is in excess of 20% above the budgeted order amount,then Supplier shall not be required to fulfill such excess above 20% withinsuch 30-day period but shall use commercially reasonable efforts to shipthe excess Products as soon as practicable.

**(b)**           Title and Risk of Loss.  All Products shall be shipped C.I.F. to theDistributor at such location designated by Distributor or such other locationas Distributor may notify Supplier of from time to time.  Supplier shall pay all costs associated withshipping the Products to Distributor, including, without limitation, freightcosts, license fees and taxes. Distributor shall pay any applicable customs duties and United Statesfreight handling charges.

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**(c)**           Incorrect or Erroneous Shipment.  In the event the Products shipped toDistributor do not conform to the Purchase Order, Supplier shall correct anysuch errors at no cost to Distributor within ten (10) days written notice byDistributor of such error.

**(d)**           Late Shipments.  In the event that Supplier has not shippedProducts under the Purchase Order within forty five (45) days of the date ofthe Purchase Order (a “Late Shipment”), Supplier agrees to allow Distributor totake a discount equal to ten percent (10%) per month (prorated for parts ofmonths) that the Product in such Purchase Order remains unshipped.

**(e)**           Minimum Purchases.  The minimum number of Breast Implant units tobe purchased by Distributor from Supplier in each calendar year of thisAgreement following Clearance (as defined in Section 4(c) below) shall, unlessotherwise agreed by the parties in writing, be the figure set forth oppositeeach year of this Agreement set forth below, with Year 1 being the year inwhich Clearance occurs and with the amounts in Year 1 being prorated based onthe number of days in such year following the date of Clearance:

| Year 1           |   | * * * |
|------------------|--------|-------|
| Year 2           |   | * * * |
| Year 3           |   | * * * |
| Year 4           |   | * * * |
| Year 5 and after |   | * * * |

 

In the event silicone filled Breast Implants shall hereafter beapproved or cleared for marketing in the United States, the amounts set forthabove for each year of this Agreement (or part thereof on a prorated basis)shall be reduced to a number equal to * * *% of the number for such year setforth above (or such actual lesser percentage amount as shall equal the actualpercentage of the total United States Breast Implant market captured by salinefilled Breast Implants).

**4.             Pricing and Payment Terms.**

**(a)**           Price.  Distributor shall pay $* * * per salineBreast Implant unit.  In the event ofunforseen market forces, including predatory pricing by competitors and/orsubstantial increases in raw material costs, the parties shall engage in goodfaith efforts to renegotiate the price of the saline Breast Implants.  Any agreed price increase will only beeffective after a ninety (90) day written notice by Supplier toDistributor.  The price and terms for anyProducts other than the saline Breast Implants shall be as mutually agreed uponby the parties hereto.  Subject to theterms of this Agreement, Distributor shall pay a minimum price of $* * * persaline Breast Implant unit.  If theweighted average of the net sales price of saline Breast Implant Products soldby Distributor exceeds $* * * per saline Breast Implant unit during anycalendar quarter (the amount of such excess, the “Excess Amount”), thenDistributor shall pay within 45 days of the end of such quarter to Supplier asadditional purchase price for each unit sold during such quarter an amount equalto the product of (1) * * * and (2) the Excess Amount.  The foregoing calculation shall be made byDistributor after the end of each calendar quarter beginning with the

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first full calendar quarter commencing after Clearance(as defined in Section 4(c) below). Example:

Weighted Average Resale price $* * *            Purchaseprice $* * *

Weighted Average Resale price $* * *            Purchaseprice per unit sold in quarter $* * * + $* * * = $* * *, with additional payment due of $* * * x *n*,where *n* equals the number of units sold in thequarter

**(b)**           Terms for Payment.  Distributor agrees to pay invoices as shippedand billed by Supplier within Forty Five (45) after delivery, less anydiscounts for Late Shipments as described in Section 3(d) above.  If Distributor fails to make payment underthis Section 4(b) within the time specified, Supplier may during the time suchpayments remain unpaid cease making shipments to Distributor under Section 3.

**(c)          **Additional Payment Agreements. Following the date an amount equal to the Offset Amount (as calculatedunder Section 4(d) below) has been accrued under this Section 4(c), Distributoragrees to pay to Supplier the following sums to the extent the cumulative sumscalculated hereunder exceed the Offset Amount, such payments to be calculatedand paid on a calendar quarterly basis within 45 days of the end of eachquarter (the first such period ending at the end of the first complete calendarquarter following the date of Clearance (as defined below), with Distributorpreparing an annual reconciliation (to account for product returns,replacements, discounts, etc.) and any adjustments not implemented in priorquarters being implemented in the fourth quarter payment.  Commencing with FDA approval of the PMA andclearance (including customs and labeling clearance) to market the pre-filledsaline Breast Implant Products in the United States (the date of suchclearance, “Clearance”), Distributor shall pay to Supplier for Productpurchased and accepted for sale in the United States an amount equal to thefollowing percentages of Distributor’s Product profit (surgeon selling priceless (i) landed cost of Product to Distributor and (ii) any shipping andhandling costs paid by Distributor):

| Year 1 |   | * * *% |
|--------|--------|--------|
| Year 2 |   | * * *% |
| Year 3 |   | * * *% |
| Year 4 |   | * * *% |
| Year 5 |   | * * *% |

 

The years set forth above will commence with the first sale of Productfollowing Clearance and the first year will be the first consecutive 12-monthperiod beginning with the month in which Clearance occurs.  Distributor shall retain any amount otherwisepayable under this Section 4(c) that equals the Offset Amount.

**(d)**           Offset Amount.  Notwithstanding anything to the contrarycontained in Section 4(c), Distributor shall not be obligated to pay toSupplier any sums calculated under Section 4(c) above until such time that thecumulative amounts calculated under Section 4(c) exceed US$* * * (the “OffsetAmount”).  After such time, Distributorshall have no obligation to 

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Supplier with respect to the Offset Amount and itssole obligation under Section 4(c) will be to pay the future amounts in excessof the Offset Amount as calculated under Section 4(c).

**(e)**           Product Warranty Claims/PromissoryNote.  As of February 29, 2004,Supplier had certain obligations to patients and doctors in respect of claimsrelated to products sold by PIP/USA, Inc. and Distributor (“Existing Claims”).  Distributor will undertake to administer andpay up to US$1,657,675 of such Existing Claim amounts, with Distributorconsulting with Supplier prior to paying any such Existing Claim amounts.  If Distributor determines in its solediscretion that payment of any Existing Claim amount is necessary or advisableto (1) prosecute or maintain the PMA, (2) settle any presently existinglitigation or any related or similar case, (3) avoid any adverse regulatoryaction, or (4) continue to market Products in any geographical market, thenDistributor may without consent of Supplier pay any such Existing Claimamount.  If with respect to any ExistingClaim amount Distributor does not make the determination set forth in theimmediately preceding sentence, then Distributor will consult with Supplier inthe administration of such Existing Claim. Unless Supplier (i) engages counsel reasonably acceptable to Distributorto consult on such Existing Claim administration and (ii) separatelyindemnifies Distributor from and against any loss, claim or liability relatedto such Existing Claim in a manner reasonably acceptable to Distributor,Distributor may pay such Existing Claim amount. If Supplier engages counsel and provides the indemnity as set forth inthe immediately preceding sentence in respect of an Existing Claim covered bysuch sentence, then Distributor will not pay the respective Existing Claimamount without Supplier’s consent, which consent will not unreasonably bewithheld.  In consideration of theforegoing undertaking by Distributor, Supplier will issue to Distributor arevolving promissory note (the “Note”) in the initial nominal principal amountof US$1,657,675 (and an actual principal amount equal to the Existing Claimamounts paid by Distributor), with interest on the principal amount at a rateper annum equal to 6.75%.  The principalamount payable under the Note shall be increased by any additional amounts paidby Distributor on Supplier’s or PIP/USA, Inc.’s behalf with respect to productssold by Supplier, PIP/USA, Inc. or Distributor in the Territory that are not inrespect of Existing Claims.

**(f)**            Limitations on Obligations in theEvent of No Clearance.  In the eventthe FDA does not approve the PMA and grant marketing clearance to Distributorfor the pre-filled saline Breast Implant as a result of the action orinaction of Supplier, including Supplier’s failure to meet FDA GMP requirementsor provide adequate pre-clinical data and other information, then theamount owed under Section 4(e) above shall equal US$* * *, plus the principalamount of the Note, and such amount shall be immediately due and payable.  In the event the FDA does not approve the PMAand grant marketing clearance to Distributor for the pre-filled salineBreast Implant as a result of the action or inaction of Distributor, butexcluding Supplier’s failure to provide any necessary modules, information,assistance or access, then the amount owed under the Note referred to inSection 4(e) above shall be immediately due and payable.

**(g)**           Right to Inspect.  From time to time during the term of thisAgreement, Supplier and its representatives shall have the right to inspect andmake copies of the books and

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records of Distributor relating to sales of Productsfor the purpose of confirming Distributor’s compliance with the terms of thisAgreement.  Such inspection may occur notmore frequently than once in any three consecutive month period and shall beduring ordinary business hours at Distributor’s place of business upon not lessthan three business days advance notice. Supplier shall bear all of the costs of such inspection unless it isdetermined that Distributor has underpaid Supplier by an amount equal to fivepercent (5%) or more of the amounts paid during the period covered by theinspection, in which case Distributor shall reimburse Supplier for all of suchcosts.

**5.             Marketing Assistance.** Supplier will provide Distributor with marketing assistance as requestedby Distributor at no cost to Distributor, including but not limited to,provision of samples, “sizers” and up-to-date brochures for theProducts in languages appropriate to the Territory.  Symposia costs from the date hereof shall bethe responsibility of the Distributor. Any other promotional materials, promotional assistance and relatedissues shall be determined by the mutual, written agreement of the parties.

**6.             The Products.**

**(a)**           Definition.  As used in this Agreement, the terms “Products”includes not only the products of the Supplier in existence as of the datehereof or licensed to Supplier by any third party, but any and all products ofthe Supplier in existence or licensed to Supplier by any third party at anytime while this Agreement is in effect, including all upgrades, changes,amendments, improvements and modifications thereto, as well as, any parts andcomponents necessary for the repair and replacement thereof.

**(b)**           Packaging.  Supplier shall adequately label, package anddeliver the Products in accordance with all applicable regulations, includingapplicable regulations in the Territory, using references to and trademarks ofthe Supplier, and Supplier shall bear all costs associated with packaging ofthe Products except that Distributor shall bear all costs associated withprinting of labels and package inserts for the Products to be sold in theTerritory.

**(c)**           Defective Products.  Supplier shall accept the return of anyProducts that Distributor’s Quality Assurance and/or Regulatory departmentsfind unacceptable (“Rejected Products”) and upon return of such RejectedProducts, shall provide Distributor with new Products at no cost.

**(d)**           Replacement Program.  Supplier agrees to credit Distributor asfollows for payments made to and replacement product sent to surgeons (the “ReplacementProduct”) under a product warranty program. The Supplier agrees to the following reimbursement to the Distributorfor saline Breast Implants:

                              (i)            Ifa saline Breast Implant deflates within five (5) years of the date ofimplantation, the Distributor shall receive a credit of * * * Dollars (US$* **) and two replacement implants at * * *.

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                              (ii)           If a saline BreastImplant deflates at any time between five (5) and ten (10) years following thedate of implantation, the Distributor shall receive a credit for * * *replacement implants at * * *.

                              (iii)          If a saline Breast Implant deflates atany time after ten (10) years from the date of implantation, the Distributorshall receive a credit for one replacement implant at * * *.

**(e)**           Replacement Procedure.  Supplier agrees that Distributor, in its solediscretion, may send Replacement Product and payments to surgeons to coverre-implantation (the “Re-Implantation Fees”) and, upon written notice byDistributor describing the original product, the Replacement Product and theRe-Implantation Fees, Supplier agrees to credit the Distributor for One HundredPercent (100%) of the cost of * * * Replacement Products and theRe-Implantation Fee of * * * Dollars (US$* * *).

**(f)**            Representations, Warranties andCovenants.  Supplier represents,warrants and covenants that:

                              (i)        Supplierhas the right, title and interest in and to the distribution of the Productsnecessary to enter into and perform its obligations to Distributor hereunder;and

                              (ii)       TheProducts operate and perform as intended; and

                              (iii)      Supplierhas complied with all applicable laws and regulations with respect to theProducts, including, without limitation, FDA approval and compliance; and

                              (iv)      Subjectto Sections 7 and 8 below, during the term of this Agreement Supplier will besolely responsible for, and have a continuing obligation to obtain andmaintain, all necessary non-Territory government and regulatory approvalsand compliance with respect to the Products, including ISO certification, andall necessary GMP certification relating to the Territory; and

                              (v)       Supplierwill be responsible for funding for all of its non-PMA application costs,including (A) Supplier’s United States litigation and settlement costs(including indemnity responsibilities), (B) United States warranty anddeflation costs and (C) other product liability claims arising from Supplier’sBreast Implants sold in the United States; and

                              (vi)      Supplierwill immediately pay all accrued sums presently owed * * * and terminate thecurrent contract with * * * and release him from any conflict of interest inworking with Distributor through delivering to * * * any letter reasonablyrequested by him; and

                              (vii)     Supplierwill immediately pay all accrued sums presently owed * * * and terminate itsrelationship with * * * and release * * * from any conflict of interest inworking with Distributor through delivering to * * * any letter reasonablyrequested by * * * ; and

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                              (viii)    Except as provided inSection 7 below with respect to the PMA and future PMA-related (and otherTerritory regulatory approval) costs, Supplier will remain responsible for itsoperations and related financial obligations, including PIP/USA, Inc. deflationcosts and indemnification costs and its other obligations under this Agreement.

**(g)**           Indemnification.  Supplier agrees to hold Distributor harmlessand indemnify, reimburse and defend Distributor, upon request, at Supplier’scost, with mutually acceptable counsel, from any proceeding related to anyclaim asserted against Distributor or its customers with respect to theProducts (including without limitation, Product liability claims) or withrespect to any previous agreements that the Supplier may have had with anyother party regarding the distribution in the Territory of the Products orwhich otherwise arises out of Supplier’s relationship with Distributor(including without limitation any action arising out of the failure of Supplierto comply with any government or regulatory requirements) and shall payDistributor for all amounts owed by Distributor to third persons and expensesincurred by Distributor in connection with any such claim or suit.

**7.             Regulatory Responsibilities.**

**(a)**           From and after the date hereof,Distributor shall assume (subject to Section 6(f) and Section 7(b)) atDistributor’s expense all responsibilities for the PMA application and program,and for other similar Territory regulatory approvals, for the pre-filledsaline Breast Implant.  Additionally,Distributor shall assume general management responsibilities for the explantinvestigation program.

**(b)**           Supplier agrees to conduct at itsexpense any additional or revised pre-clinical testing required for thePMA application.  Supplier will beresponsible for mechanical or other testing to be performed at Supplier’slocation and all manufacturing, process and production record, report andcompliance preparation and maintenance. Supplier agrees immediately after the date hereof to provide access toDistributor to all records (including all past PMA-related records and all pastand future manufacturing, process and production records), data, information,reports, clinical programs and consultants requested by Distributor to completethe PMA submission and subsequent FDA requests and to provide at its ownexpense all additional assistance requested by Distributor in connection withthe PMA application, other regulatory applications in the Territory and futuremanagement and maintenance of marketing clearances in the Territory.  Supplier shall notify Distributor immediatelyshould Supplier become aware of any defect or condition which may render any ofthe Products in violation of the United States Food, Drug and Cosmetic Act, FDAregulations, other Territory regulations or which in any way alters thespecification and quality of the Products.

**(c)**           For the purpose of maximizing thelikelihood of FDA GMP approval and clearance, Supplier agrees to allow aninspector of Distributor’s selection to inspect Supplier’s facilities,processes, operations and records prior to the FDA’s GMP inspection of Supplier’sfacilities.  Supplier further agreespromptly to implement the recommendations the inspector reasonably makes asnecessary or appropriate for the purpose of obtaining FDA GMP approval

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and clearance. In addition, Supplier agrees to permit one or more representatives ofDistributor or other experts to participate directly in cooperation withSupplier in the preparation of PMA application modules.

**(d)**           All Territory regulatory approvals(including the PMA application) shall be applied for, issued and registered inDistributor’s name.  Commencingimmediately, the ownership of the PMA application (and related applications andPMA application work in process) for Supplier’s pre-filled saline breastimplant will be transferred to Distributor. For avoidance of doubt, Distributor will own in its own name the PMA andrelated marketing clearance once issued.

**8.             Quality Assurance Responsibilities.** Supplier agrees that, in order to expedite the acceptance of Products byDistributor’s Quality Assurance and/or Regulatory departments, that Distributorwill, at Supplier’s expense, implement Quality Assurance and/or Regulatoryprograms and/or personnel into the Supplier’s manufacturing facilities.  Supplier grants Distributor the right toconduct Quality Assurance and/or Regulatory audits (based on Distributor’sQuality Assurance standards, which at all times shall incorporate applicableFDA and GMP requirements) using Distributor’s personnel, Supplier’s personneland/or independent consultants on a quarterly basis or more frequent spotbasis.  Supplier agrees that Supplierwill cure any curable deficiencies within ten (10) days of written notice byDistributor of any such Quality Assurance and/or Regulatory audits and commencecuring all other curable deficiencies that are curable but not reasonablysubject of cure within 10 days.  Supplieragrees to credit Distributor’s account in the amount of Five Thousand Dollars(US$5,000.00) per day for every calendar day that any deficiencies remainuncured following the ten (10) day written notice period described above.  Similarly, following Clearance Distributoragrees to credit Supplier’s account in the amount of Five Thousand Dollars(US$5,000.00) per day for every calendar day that any deficiencies imposed bythe FDA on Distributor and relating to Distributor’s obligations under thisAgreement remain uncured following the 10-day period commencing on thelater of the date of Distributor’s receipt of notice thereof from the FDA orthe date imposed by the FDA for cure or compliance.

**9.             Distributor’s Representations and Warranties.**

**(a)**           Product Warranties of Supplier.  Distributor acknowledges that Supplier hasthe exclusive right to determine the product guarantees and warranties to beprovided on each of its products, with the exception of the Replacement Programand other specific and implied warranties contained herein.

**(b)**           Conduct of Distributor and itsRepresentatives.  Distributor agreesnot to make any commitments either orally or in writing with respect toSupplier or on Supplier’s behalf unless such commitment is specificallyauthorized hereunder or Supplier specifically authorizes Distributor in writingmake such commitment.  Distributor agreesnot to make any representations outside the agreed Territory specified in thisAgreement or subsequently agreed to in writing by the parties hereto.  Any leads or contacts outside the Territorygenerated through the

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efforts of the Distributor will be promptly forwardedto the Supplier.  Distributor furtheragrees to conduct all representations in a positive and professional manner.

**(c)**           Regulatory Approvals.  Subject to Sections 6(f), 7 and 8 above, fromand after the date hereof, during the term of this Agreement Distributor willbe solely responsible for, and have a continuing obligation to obtain andmaintain, all necessary Territory government and regulatory approvals andcompliance with respect to the Products, including prosecution of the PMAapplication for pre-filled saline implants, related clinical studies, andreporting and monitoring of implant recipients. Subject to Sections 6(f), 7 and 8 above, Distributor will pay all futurecosts of prosecuting the PMA application with the FDA.

**(d)**           Costs.  Distributor will be responsible for its ownnon-indemnified litigation costs, its distributor warranty obligationsand its other obligations under this Agreement.

**10.          Operational Commitments.** Distributor agrees to the following:

**(a)**           Rotation of Stock.  Distributor shall rotate its stock of salinebreast implants on a first-in/first-out basis of shelf life basedon the time of receipt from Supplier. For any given size, the oldest saline breast implants in Distributor’sstock will be dispatched first and the most recently received saline breastimplants in any size will be sold last.

**(b)**           Controlled Conditions of SalineBreast Implant Storage.  Distributoragrees to store the Products within a restricted access storage area that issecure, clean (with a documented regular cleaning program in force),infestation fee, temperature controlled and organized according to establishedQuality Assurance and/or Regulatory requirements.

**(c)**           Maintenance of Quarantine Area.  Distributor shall maintain a clearlysegregated and marked out quarantine area which is labeled as such and which ismaintained with Distributor’s Quality Assurance and/or Regulatory policies,including a quarantine log book.

**(d)**           Complaint Procedure.  All complaints shall be handled by Distributor’sestablished complaint procedure and the details of each complaint shall beforwarded by fax to Supplier on a regular basis.

**(e)**           Returned Products.  All returned Products shall be handled byDistributor’s established return procedure and the details of each return shallbe documented.

**(f)**            Implant Tracking and ProductRecalls.  All Products sold byDistributor shall have Lot Number and Serial Number records as established byDistributor’s Regulatory and/or Quality Assurance departments and Distributorshall maintain these records so that each and every Product, up to andincluding when the Product is used or implanted, can be tracked in accordancewith the USFDA tracking requirements then in effect.

**(g)**           Medical Device Reports (“MDRs”).  Any adverse effect reported by a patient,whether critical or chronic, which may be associated with a potential Productmalfunction

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shall be immediately reported by Distributor accordingto the FDA MDR requirements then in effect.

**(h)**           Monitoring Implant Clinical Studies.  From and after the date hereof, Supplier willprovide non-financial cooperation to Distributor in the clinical studiesof Supplier’s saline breast implants, including providing non-financialcooperation to Distributor in collecting information and documentation fromparticipating surgeons and communicating any problems with the clinical studiesto Distributor.

**(i)**            Product Warranty Procedure.  Distributor agrees to return to the Supplier(after suitable liquid sterilization), in compliance with FDA requirements notlater than the first Tuesday of the month following each calendar month, allbreast implants returned to Distributor in such month that are subject to awarranty claim.  Each returned implantwill be accompanied by (i) the related Medical Device Registration Form and(ii) the related Explant Data Form.  Ifprovided to Distributor by the physician, Distributor will also supply toSupplier on the later of the date set forth in the previous sentence or withinthree business days of receipt thereof (1) the related Implantation OperativeReport, (2) the related Pre-Explantation Operative Report, and (3) in the caseof implant deflation, related photos.

**11.          Notification of Material or Process Change**. Supplier shall notify Distributor prior to implementing any changes inthe manufacture, assembly, labeling of the Product or the processes used toproduce the Product (the “Change Notification”).  No such change will be made by Supplierwithout first obtaining the approval of Distributor’s Quality Assurance managerin writing.  Supplier agrees to giveDistributor one full and complete set of Supplier’s Standard OperatingProcedures (“SOPs”) and Manufacturing Procedures and to provide Distributorwith any and all revisions, corrections and/or additions to the SOPs andManufacturing Procedures as implemented at Supplier’s facilities.

**12.          Product Documentation**. Supplier agrees to forward to Distributor with each shipment of Productall documentation generated during the production of the Product including, butnot limited to:

**(a)**           all raw material testing records;

**(b)**           all manufacturing records;

**(c)**           all sterilization reports; and

**(d)**           all final Product testing reports.

Supplier agrees that anydiscrepancies shall be cured at Supplier’s expense.

**13.          Patents and Trademarks.**

**(a)**           Patents.  Supplier shall notify Distributor promptly ofany United States and foreign patents which may now or hereafter be pendingcovering any of the Products.

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Supplier shall diligently prosecute any applicationsfor United States and foreign patents which may now or hereafter be pendingcovering any of the Products and, on issuance of any such patent, prosecuteeach infringer thereof.  Supplier shalldefend, indemnify and hold harmless Distributor from and against any liabilityarising out of a claim of patent infringement made with respect to any of theProducts.  Supplier agrees to repurchasefrom Distributor, at a price equivalent to the full purchase price paid byDistributor, any quantity of Products in Distributor’s inventory which ProductsDistributor reasonably believes it should not or cannot sell, based upon anopinion of counsel that future sales of such Product by Distributor may resultin patent infringement, or because of a decision, whether interlocutory orfinal, rendered in any patent infringement action.  Supplier hereby grants to Distributor aroyalty free perpetual license to all such patents.  This license will survive during the term ofthis Agreement.

**(b)**           Trademarks and Trade Names.          Distributor recognizes that Supplieris the owner of the trademarks and trade names which are used in the promotionand sale of the Products and that Distributor has no right or interest in suchtrademarks and trade names.  Supplierhereby grants Distributor the royalty free right to use Supplier’s trademarkson the Products during the term of this Agreement, it being understood thatDistributor shall discontinue the use of such trademarks upon the terminationof this Agreement and disclaims any rights in the trademarks other than thesaid license.

**14.          Product Liability Insurance**.  IfSupplier obtains product liability insurance for the Products, such insuranceshall contain either a vendor’s endorsement or contractual liability coveragereferencing the indemnification provisions contained herein on allProducts.  Upon issuance of any suchproduct liability insurance, Supplier shall immediately furnish to Distributora certificate of insurance issued by the carrier evidencing the foregoingendorsements, coverages and limits and such insurance shall not be cancelableby Supplier without at least fifteen (15) days prior written notice toDistributor.

**15.          Default; Termination.** Subject to the provisions of Section 17 below, either party shall havethe right to terminate this Agreement upon written notice if the other partyhereto:

**(a)**           commits or suffers any act ofbankruptcy or insolvency; or

**(b)**           shall fail to perform or fulfill, atany time and in the manner herein provided, any obligation or conditionrequired to be performed or fulfilled by such party hereunder, and if suchparty fails to remedy any such failure within sixty (60) days after noticethereof from the non-defaulting party.

The non-defaulting party shall have the right to terminate thisAgreement by giving written notice of termination to the defaulting party atany time within ninety (90) days after the 60-day default period setforth in clause (b) above.  Terminationunder this Section 15 shall not be deemed an election, but shall be in additionto other rights and remedies available to the non-defaulting party.

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On the termination of thisAgreement, for whatever reason, Supplier shall continue to honor Distributor’sorders for Products up to the effective date of termination and, other than inconnection with expiration of the term of this Agreement, for a period of sixty(60) days thereafter and Distributor shall pay for such Products all on theterms and conditions of this Agreement. Upon effectiveness of termination, Distributor shall have the option ofreturning all Products then in inventory to Supplier for full credit orcontinue to sell the Products for a period of no more than One Hundred andTwenty (120) days after termination, at the end of which period Distributor maythen return all unsold Products in inventory for full credit.

**16.          Confidentiality.**  The parties acknowledge andagree that, pursuant to this Agreement, valuable information of a confidentialnature may be disclosed by one or more parties to another; that suchinformation shall be retained by either party in confidence; and that thetransmittal of such information by any party to the another party is upon theexpressed condition that the information is to be used solely for the purposeof effectuating this Agreement.  No partyshall, either during the term of this Agreement or after its termination, use,publish or disclose or cause anyone else to use, publish or disclose the termsand conditions hereunder, any marketing information supplied by another partyor any other information considered by either party hereto to be confidential,proprietary or a trade secret. Notwithstanding anything in the foregoing, the above restrictions ondisclosure and use shall not apply to any information which a party can show bywritten evidence was known to it at the time of receipt from the other party orwhich may subsequently be obtained from sources other than the other party whoare not bound by a confidentiality agreement with either party.

**17.          Contingencies.**  Except with respect toobtaining or maintaining GMP compliance and with respect to failure to maintaincompliance with the Quality Assurance programs in accordance with Section 8above,

**(a)**           neither Supplier or Distributor shallbe liable for its failure to perform hereunder (except for obligations to makepayments hereunder) if performance is made impossible due to any occurrencebeyond its reasonable control, including, but not limited to, acts of God,fires, floods, wars, sabotage, accidents, equipment failure, labor disputes orshortages, government laws, ordinances, rules, regulations, standards ordecrees, whether valid or invalid (including but not limited to, priorities,requisitions, allocations and price adjustment restrictions), inability toobtain raw materials, equipment or transportation, and any other similaroccurrence, and

**(b)**           neither Supplier nor Distributorshall be liable for its failure to perform hereunder if Supplier or Distributorceases or suspends the operation of all facilities where Distributor is sellingor Supplier is producing the Products deliverable hereunder, because saidfacilities, the operation thereof, and/or the product therefrom fails to complywith any governmental law, regulation, ordinance, standard, order or decreerelating to health, safety or environmental matters.

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Notwithstanding anything to the contrary contained herein, the failureto cure a condition set forth in this Section 17 within the times specified inSection 15 shall be grounds for termination of this Agreement as provided inSection 15.

If either party reasonably believes it is impossible to take correctiveaction to remedy any occurrence under clause (a) above or to achieve ormaintain compliance under clause (b) above, such party may suspend or terminatethis Agreement upon written notice to the other party in accordance withSection 15.  The party who fails toperform as a result of any occurrence described in clause (a) or (b) aboveshall notify the other party of any such occurrence, setting forth the fullparticulars in connection therewith, and shall promptly notify the other partyof the cessation of such occurrence.  Inno event shall either party be required by this Section 17 to settle strikes,lockouts or other labor difficulties contrary to its best interest.

**18.          Dispute Resolution.**  Anydispute or controversy arising under or in connection with this Agreement shallbe settled exclusively by **arbitration**conducted in the State of Delaware, before a single arbitrator in accordancewith the rules of the American Arbitration Association then in effect.  Judgment may be entered on the arbitrator’saward in any court having jurisdiction. This Agreement and the parties’ performance under it shall be construedin accordance with the laws of the State of Delaware.

**19.          Miscellaneous.**

**(a)**           Assignment.  Except as expressly provided herein, neitherthis Agreement nor any rights or obligations hereunder may be assigned byeither party without the written consent of the other party; provided, however,that the rights and obligations of Distributor or MediCor hereunder may beassigned to any entity controlled by MediCor; provided that such entity assumesall rights and obligations of Distributor or MediCor, as applicable, hereunderand Distributor remains liable for all of its obligations hereunder incurredprior to the effective date of such assignment.

**(b)**           Waiver.  Failure of either party to exercise orenforce any right under this Agreement upon one occasion shall not waive theright to exercise or enforce the same on another occasion.  The waiver by either party of one or moreterms, conditions or defaults of this Agreement shall not constitute a waiverof the remaining terms and conditions or of any future defaults of thisAgreement.

**(c)**           Governing Law.  The validity, interpretation and performanceof this Agreement shall be controlled by and construed under the laws of theState of Delaware.

**(d)**           Headings.  The headings appearing in this Agreement areinserted only as a matter of convenience and in no way define, limit, construeor describe the scope or extent of such section or in any way affect suchparagraph.

**(e)**           Counterparts.  This Agreement may be executed in one or morecounterparts, all of which taken together shall constitute a single instrumentand agreement.

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**(f)**            Notices.  Any notices under this Agreement shall be inwriting addressed to the Chief Executive Officer of such party at the addressset forth on the signature page hereof, or such other addresses as a party maynotify the other party in writing) and shall be delivered by certified mail,return receipt requested or by an overnight delivery service of internationalstanding.

**(g)**           Acknowledgment.  The parties, and each of them, represent andwarrant that, in entering into this Agreement, they have read this Agreement,they have had this Agreement explained by counsel of their choice, they areaware of the contents and legal effect of this Agreement and they are acting onthe advice of counsel of their choice.

**(h)**           Expenses.  Each party shall bear his or its ownexpenses, including attorneys’ fees, incurred by it, in connection with thenegotiation, execution, delivery and performance of this Agreement.

**(i)**            Severability.  In the event that any provision of thisAgreement shall be held invalid, such provision shall not affect the validityof the remainder of this Agreement, and the remainder of this Agreement shallbe construed as if the invalid provision or provisions had not been included.

**(j)**            Entire Agreement.  The parties acknowledge that norepresentation, promise or inducement has been made other than as set forth inthis Agreement, and that they are not entering into this Agreement in relianceupon any representation, promise or inducement not set forth herein.  This Agreement supersedes all priornegotiations, understandings and agreements (including the Original Agreementwhich it amends and restates in its entirety) of any kind, written or oral,with respect to the subject matter hereof and contains all of the terms andprovisions of agreement between the parties hereto with respect to the subjectmatter hereof  provided, however, thatnothing in this Agreement shall supersede rights or obligations of the partiesunder the Original Agreement with respect to events occurring prior to the datehereof, except that Distributor’s claims under the Original Agreement forreimbursement for PMA-related clinical study costs under the OriginalAgreement shall be canceled hereby in consideration of the transfer toDistributor of the PMA and Distributor’s claims under the Original Agreement inrespect of product replacement costs and legal expenses accrued throughFebruary 29, 2004 shall be canceled hereby.

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**INWITNESS WHEREOF****,** and intending to be legally bound hereby,the parties hereto have executed this Agreement the day and year first abovewritten.
| “Supplier”           |                          |   | “Distributor” |                 |
|--------------------------------|-------------------------------|--------|-------------------------|----------------------|
| Poly Implants  Protheses, S.A. |                          |   | III Acquisition Corp.   |                 |
|                           |                          |   |                    |                 |
|                           |                          |   |                    |                 |
| By:                            |                          |   | By:                     |                 |   |
|                           |                          |   |                    |                 |   |
| Title:                         |                          |   | Title:                  |                 |   |
|                           |                          |   |                    |                 |   |
| Address:                       | 337 Avenue de Bruxelles       |   | Address:                | 4560 S. Decatur Blvd |
|                           | 83514 La Seyne Sur Mer France |   |                    | Suite 300            |
|                           |                          |   |                    | Las Vegas, NV 89103  |
|                           |                          |   |                    |                 |
| Phone:                         | +33 (04)  94-10-98-10         |   | Phone:                  | +1 (702) 932-4560    |
|                           |                          |   |                    |                 |
| Fax:                           | +33 (04)  94-10-98-11         |   | Fax:                    | +1 (702) 932-4561    |
|                                |                               |        |                         |                      |  |  |  |  |  |

 

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