**Exhibit10.1**

 

# **AMENDED AND RESTATED NON-EXCLUSIVE DISTRIBUTIONAGREEMENT**

 

This AMENDED AND RESTATED NON-EXCLUSIVEDISTRIBUTION AGREEMENT (the “Agreement”) is made as of the 30th dayof March 2004, by and between Poly Implants Protheses, S.A., a Frenchcorporation (“Supplier”) and III Acquisition Corp., a Delaware corporationand/or its wholly 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 * * * (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 ofOctober 27, 1999 (the “Original Agreement”) in which Supplier grantedDistributor the non-exclusive right to distribute the Products * * *; 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-Market Approval(“PMA”) application currently in preparation for Supplier’s pre-filled salineBreast Implant products, which the parties anticipate will be submitted to theUnited States Department of Health and Human Resources, Food and DrugAdministration (the “FDA”) * * *.

 

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

 

**1.****                                     ****Distribution Rights.**  Supplier hereby grants toDistributor a non-exclusive right and license to distribute the Products forsale throughout the 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 Agreement is in effectwill Supplier, directly or indirectly (through other customers, agents,subsidiaries or otherwise), with the exception of the non-exclusivedistribution agreement already in place between Supplier and PIP/USA, Inc.:

 

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

 

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**(b)**                                  sell the Products to any person or entitywith reasonable basis to believe that such person or entity, or someone actingon their behalf, will resell the Products into the Territory; or

 

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

 

**(d)**                                  sell any components and/or parts for theProducts that may be used in manufacturing the Products for any person orentity in the Territory other than the Distributor.

 

**2.****                                     ****Terms and Renewal.**  This Agreement and the rightsgranted Distributor hereunder shall be for an initial term of * * *, beginningon the date first written above. Thereafter, the Distributor shall have the option of renewing thisAgreement on the same terms and conditions for * * *, provided Distributor isnot in default of any provisions of this Agreement at the date of renewal,which renewal shall be automatic unless the Distributor notifies Supplier ofDistributor’s intent not to renew * * *.

 

**3.****                                     ****Orders and Shipping.**

 

**(a)**                                  Order Placement and Allocation. Distributor shall place all orders for the Products with Supplier inwriting on a weekly basis (the “Purchase Orders”).  Supplier shall use commercially reasonable efforts to ship theProducts on the Purchase Orders to Distributor within thirty (30) days of thedate of the Purchase Order.  Distributorshall provide to Supplier monthly an estimate of Products to be required forthe following three months.  In theevent an order (prorated from a weekly basis to a monthly basis) is in excessof * * * above the budgeted order amount, then Supplier shall not be requiredto fulfill such excess above * * * within such 30-day period but shall usecommercially reasonable efforts to ship the excess Products as soon aspracticable.

 

**(b)**                                  Title and Risk of Loss.  AllProducts shall be shipped * * * to the Distributor at such location designatedby Distributor or such other location as Distributor may notify Supplier offrom time to time.  * * *

 

**(c)**                                  Incorrect or Erroneous Shipment.  Inthe event the Products shipped to Distributor do not conform to the PurchaseOrder, Supplier shall correct any such errors at no cost to Distributor withinten (10) days written notice by Distributor of such error.

 

**(d)**                                  Late Shipments.  Inthe event that Supplier has not shipped Products under the Purchase Orderwithin * * * days of the date of the Purchase Order (a “Late Shipment”),Supplier agrees to allow Distributor to take a discount equal to * * * permonth (prorated for parts of months) that the Product in such Purchase Orderremains unshipped.

 

**(e)**                                  * * *

 

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**4.****                                     ****Pricing and Payment Terms.**

 

**(a)**                                  Price.  Distributor shall pay * * *per saline Breast Implant unit.  * **  The price and terms for any Productsother than the saline Breast Implants shall be as mutually agreed upon by theparties hereto.  Subject to the terms ofthis Agreement, Distributor shall pay * * * per saline Breast Implantunit.  * * *

 

**(b)**                                  Terms for Payment. Distributor agrees to pay invoices as shipped and billed by Supplierwithin * * * after delivery, less any discounts for Late Shipments as describedin Section 3(d) above.  IfDistributor fails to make payment under this Section 4(b) within the timespecified, Supplier may during the time such payments remain unpaid ceasemaking shipments to Distributor under Section 3.

 

**(c)****                                 ***** * ***

 

**(d)**                                  * * *

 

**(e)**                                  * * *

 

**(f)**                                    * * *

 

**(g)**                                 Right to Inspect.  Fromtime to time during the term of this Agreement, Supplier and itsrepresentatives shall have the right to inspect and make copies of the booksand records of Distributor relating to sales of Products for the purpose ofconfirming Distributor’s compliance with the terms of this Agreement.  Such inspection may occur not morefrequently than once in any three consecutive month period and shall be duringordinary business hours at Distributor’s place of business upon not less thanthree 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 * * *or more of the amounts paid during the period covered by the inspection, inwhich case Distributor shall reimburse Supplier for all of such costs.

 

**5.****                                     ****Marketing Assistance.**  Supplier will provideDistributor with marketing assistance as requested by Distributor at no cost toDistributor, including but not limited to, provision of samples, “sizers” andup-to-date brochures for the Products in languages appropriate to theTerritory.  Symposia costs from the datehereof shall be the responsibility of the Distributor.  Any other promotional materials, promotionalassistance and related issues shall be determined by the mutual, writtenagreement of the parties.

 

**6.****                                     ****The Products.**

 

**(a)**                                  Definition.  As used in this Agreement,the terms “Products” includes not only the products of the Supplier inexistence as of the date hereof or licensed to Supplier by any third party, butany and all products of the Supplier in existence or licensed to Supplier byany third party at any time while this Agreement is in effect, including allupgrades, changes, amendments, improvements and modifications thereto, as wellas, any parts and components necessary for the repair and replacement thereof.

 

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**(b)**                                  Packaging.  Supplier shall adequatelylabel, package and deliver the Products in accordance with all applicableregulations, including applicable regulations in the Territory, usingreferences to and trademarks of the Supplier, and Supplier shall bear all costsassociated with packaging of the Products except that Distributor shall bearall costs associated with printing of labels and package inserts for theProducts to be sold in the Territory.

 

**(c)**                                  Defective Products. Supplier shall accept the return of any Products that Distributor’sQuality Assurance and/or Regulatory departments find unacceptable (“RejectedProducts”) and upon return of such Rejected Products, shall provide Distributorwith new Products at no cost.

 

**(d)**                                  * * *

 

**(e)**                                  * * *

 

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

 

(i)                                     Supplier has the right, title and interest inand to the distribution of the Products necessary to enter into and perform itsobligations to Distributor hereunder; and

 

(ii)                                  The Products operate and perform as intended;and

 

(iii)                               Supplier has complied with all applicable laws and regulations withrespect to the Products, including, without limitation, FDA approval andcompliance; and

 

(iv)                              Subject to Sections 7 and 8 below, during the term of this AgreementSupplier will be solely responsible for, and have a continuing obligation toobtain and maintain, all necessary non-Territory government and regulatoryapprovals and compliance with respect to the Products, including ISOcertification, and all necessary GMP certification relating to the Territory;and

 

(v)                                 Supplier will be responsible for * * *; and

 

(vi)                              Supplier will immediately pay all accrued sums presently owed * * * andterminate the current contract with * * * and release him from any conflict ofinterest in working with Distributor through delivering to * * * any letterreasonably requested by him; and

 

(vii)                           Supplier will immediately pay all accrued sums presently owed * * * andterminate its relationship with * * * and release * * * from any conflict ofinterest in working with Distributor through delivering to * * * any letterreasonably requested by * * * ; and

 

(viii)                        Except as provided in Section 7 below with respect to the PMA andfuture PMA-related (and other Territory regulatory approval) costs, Supplierwill remain responsible for its operations and related financial obligations,including * * * and its other obligations under this Agreement.

 

**(g)**                                 Indemnification. Supplier agrees to hold Distributor harmless and indemnify, reimburseand defend Distributor, upon request, at Supplier’s cost, with mutually

 

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acceptable counsel, fromany proceeding related to any claim asserted against Distributor or itscustomers with respect to the Products (including without limitation, Productliability claims) or with respect to any previous agreements that the Suppliermay have had with any other party regarding the distribution in the Territoryof the Products or which otherwise arises out of Supplier’s relationship withDistributor (including without limitation any action arising out of the failureof Supplier to comply with any government or regulatory requirements) and shallpay Distributor for all amounts owed by Distributor to third persons andexpenses incurred by Distributor in connection with any such claim or suit.

 

**7.****                                     ****Regulatory Responsibilities.**

 

**(a)**                                  From and after the date hereof, Distributorshall 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-filled salineBreast Implant.  Additionally,Distributor shall assume general management responsibilities for the explantinvestigation program.

 

**(b)**                                  Supplier agrees to conduct at its expense anyadditional or revised pre-clinical testing required for the PMAapplication.  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 Distributorimmediately should Supplier become aware of any defect or condition which mayrender any of the Products in violation of the United States Food, Drug andCosmetic Act, FDA regulations, other Territory regulations or which in any wayalters the specification and quality of the Products.

 

**(c)**                                  For the purpose of maximizing the likelihoodof FDA GMP approval and clearance, Supplier agrees to allow an inspector ofDistributor’s selection to inspect Supplier’s facilities, processes, operationsand records prior to the FDA’s GMP inspection of Supplier’s facilities.  Supplier further agrees promptly toimplement the recommendations the inspector reasonably makes as necessary orappropriate for the purpose of obtaining FDA GMP approval and clearance.  In addition, Supplier agrees to permit oneor more representatives of Distributor or other experts to participate directlyin cooperation with Supplier in the preparation of PMA application modules.

 

**(d)**                                  All Territory regulatory approvals (includingthe 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.

 

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**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 * * * 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 * * *.  Supplieragrees to credit Distributor’s account in the amount of * * * for * * * thatany deficiencies remain uncured following * * *.  Similarly, following Clearance Distributor agrees to creditSupplier’s account in the amount of * * * for * * * that any deficienciesimposed by the FDA on Distributor and relating to Distributor’s obligationsunder this Agreement remain uncured following * * * commencing on the later ofthe date of Distributor’s receipt of notice thereof from the FDA or the dateimposed by the FDA for cure or compliance.

 

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

 

**(a)**                                  Product Warranties of Supplier. Distributor acknowledges that Supplier has the exclusive right todetermine the product guarantees and warranties to be provided on each of itsproducts, with the exception of the Replacement Program and other specific andimplied warranties contained herein.

 

**(b)**                                  Conduct of Distributor and itsRepresentatives.  Distributor agrees not to make anycommitments either orally or in writing with respect to Supplier or onSupplier’s behalf unless such commitment is specifically authorized hereunderor Supplier specifically authorizes Distributor in writing make suchcommitment.  Distributor agrees not tomake 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 efforts of the Distributor will be promptly forwarded tothe Supplier.  Distributor further agreesto conduct all representations in a positive and professional manner.

 

**(c)**                                  Regulatory Approvals. Subject to Sections 6(f), 7 and 8 above, from and after the date hereof,during the term of this Agreement Distributor will be solely responsible for, andhave a continuing obligation to obtain and maintain, all necessary Territorygovernment and regulatory approvals and compliance with respect to theProducts, including prosecution of the PMA application for pre-filled salineimplants, related clinical studies, and reporting and monitoring of implantrecipients.  Subject to Sections 6(f), 7and 8 above, Distributor will pay all future costs of prosecuting the PMAapplication with the FDA.

 

**(d)**                                  Costs.  Distributor will beresponsible for its own * * * and its other obligations under this Agreement.

 

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**10.****                              ****Operational Commitments.**  Distributor agrees to thefollowing:

 

**(a)**                                  Rotation of Stock. Distributor shall rotate its stock of saline breast implants on a first-in/first-outbasis of shelf life based on the time of receipt from Supplier.  For any given size, the oldest saline breastimplants in Distributor’s stock will be dispatched first and the most recentlyreceived saline breast implants in any size will be sold last.

 

**(b)**                                  Controlled Conditions of Saline BreastImplant Storage.  Distributor agrees to store the Productswithin a restricted access storage area that is secure, clean (with adocumented regular cleaning program in force), infestation fee, temperaturecontrolled and organized according to established Quality Assurance and/orRegulatory requirements.

 

**(c)**                                  Maintenance of Quarantine Area. Distributor shall maintain a clearly segregated and marked outquarantine area which is labeled as such and which is maintained withDistributor’s Quality Assurance and/or Regulatory policies, including aquarantine log book.

 

**(d)**                                  Complaint Procedure.  Allcomplaints shall be handled by Distributor’s established complaint procedureand the details of each complaint shall be forwarded by fax to Supplier on aregular basis.

 

**(e)**                                  Returned Products.  Allreturned Products shall be handled by Distributor’s established returnprocedure and the details of each return shall be documented.

 

**(f)**                                    Implant Tracking and Product Recalls.  AllProducts sold by Distributor shall have Lot Number and Serial Number records asestablished by Distributor’s Regulatory and/or Quality Assurance departmentsand Distributor shall maintain these records so that each and every Product, upto and including when the Product is used or implanted, can be tracked inaccordance with the USFDA tracking requirements then in effect.

 

**(g)**                                 Medical Device Reports (“MDRs”).  Anyadverse effect reported by a patient, whether critical or chronic, which may beassociated with a potential Product malfunction shall be immediately reportedby Distributor according to the FDA MDR requirements then in effect.

 

**(h)**                                 Monitoring Implant Clinical Studies. From and after the date hereof, Supplier will provide non-financialcooperation to Distributor in the clinical studies of Supplier’s saline breastimplants, including providing non-financial cooperation to Distributor incollecting information and documentation from participating surgeons andcommunicating any problems with the clinical studies to Distributor.

 

**(i)**                                    Product Warranty Procedure. Distributor agrees to return to the Supplier (after suitable liquidsterilization), in compliance with FDA requirements not later than * * *, allbreast implants returned to Distributor in * * * that are subject to a warrantyclaim.  Each returned implant will beaccompanied by (i) the related Medical Device Registration Form and (ii) therelated Explant Data Form.  If providedto Distributor by the physician, Distributor will also supply to Supplier onthe later of the date set forth in the previous sentence or within * * * (1)the related

 

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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 Supplier without first obtainingthe approval of Distributor’s Quality Assurance manager in writing.  Supplier agrees to give Distributor one fulland complete set of Supplier’s Standard Operating Procedures (“SOPs”) andManufacturing Procedures and to provide Distributor with any and all revisions,corrections and/or additions to the SOPs and Manufacturing Procedures asimplemented at Supplier’s facilities.

 

**12.****                              ****Product Documentation**.  Supplier agrees to forward toDistributor with each shipment of Product all documentation generated duringthe production of the Product including, but not 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 any discrepancies shallbe cured at Supplier’s expense.

 

**13.****                              ****Patents and Trademarks.**

 

**(a)**                                  Patents.  Supplier shall notifyDistributor promptly of any United States and foreign patents which may now orhereafter be pending covering any of the Products.  Supplier shall diligently prosecute any applications for UnitedStates and foreign patents which may now or hereafter be pending covering anyof the Products and, on issuance of any such patent, prosecute each infringerthereof.  Supplier shall defend,indemnify and hold harmless Distributor from and against any liability arisingout 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 a royalty free perpetuallicense to all such patents.  Thislicense will survive during the term of this Agreement.

 

**(b)**                                  Trademarks and Trade Names. Distributor recognizes that Supplier is the owner of the trademarks andtrade names which are used in the promotion and sale of the Products and thatDistributor has no right or interest in such trademarks and trade names.  Supplier hereby grants Distributor theroyalty free right to use Supplier’s trademarks on the Products during the termof this Agreement, it being understood that Distributor shall discontinue theuse of such trademarks

 

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upon the termination ofthis Agreement and disclaims any rights in the trademarks other than the saidlicense.

 

**14.****                              ****Product Liability Insurance**.  If Supplier obtains productliability insurance for the Products, such insurance shall contain either avendor’s endorsement or contractual liability coverage referencing theindemnification provisions contained herein on all Products.  Upon issuance of any such product liabilityinsurance, Supplier shall immediately furnish to Distributor a certificate ofinsurance issued by the carrier evidencing the foregoing endorsements,coverages and limits and such insurance shall not be cancelable by Supplierwithout at least fifteen (15) days prior written notice to Distributor.

 

**15.****                              ****Default; Termination.**  Subject to the provisions ofSection 17 below, either party shall have the right to terminate thisAgreement upon written notice if the other party hereto:

 

**(a)**                                  commits or suffers any act of bankruptcy orinsolvency; or

 

**(b)**                                  shall fail to perform or fulfill, at any timeand in the manner herein provided, any obligation or condition required to beperformed or fulfilled by such party hereunder, and if such party fails to remedyany such failure within sixty (60) days after notice thereof from thenon-defaulting party.

 

The non-defaulting party shall have the rightto terminate this Agreement by giving written notice of termination to thedefaulting party at any time within ninety (90) days after the 60-day defaultperiod set forth in clause (b) above. Termination under this Section 15 shall not be deemed an election,but shall be in addition to other rights and remedies available to thenon-defaulting party.

 

On the termination of this Agreement, forwhatever reason, Supplier shall continue to honor Distributor’s orders forProducts up to the effective date of termination and, other than in connectionwith expiration of the term of this Agreement, for a period of * * * thereafterand Distributor shall pay for such Products all on the terms and conditions ofthis Agreement.  Upon effectiveness oftermination, Distributor shall have the option of returning all Products thenin inventory to Supplier for full credit or continue to sell the Products for aperiod of no more than * * * after termination, at the end of which periodDistributor may then 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.  Noparty shall, either during the term of this Agreement or after its termination,use, publish or disclose or cause anyone else to use, publish or disclose theterms and conditions hereunder, any marketing information supplied by anotherparty or any other information considered by either party hereto to beconfidential, 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

 

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subsequently be obtainedfrom sources other than the other party who are not bound by a confidentialityagreement 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 withSection 8 above,

 

**(a)**                                  neither Supplier or Distributor shall beliable 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 Distributor shall beliable for its failure to perform hereunder if Supplier or Distributor ceasesor suspends the operation of all facilities where Distributor is selling orSupplier 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.

 

Notwithstanding anything to the contrarycontained herein, the failure to cure a condition set forth in thisSection 17 within the times specified in Section 15 shall be groundsfor termination of this Agreement as provided in Section 15.

 

If either party reasonably believes it isimpossible to take corrective action to remedy any occurrence under clause (a)above or to achieve or maintain compliance under clause (b) above, such partymay suspend or terminate this Agreement upon written notice to the other partyin accordance with Section 15.  Theparty who fails to perform as a result of any occurrence described in clause(a) or (b) above shall notify the other party of any such occurrence, settingforth the full particulars in connection therewith, and shall promptly notifythe other party of the cessation of such occurrence.  In no event shall either party be required by thisSection 17 to settle strikes, lockouts or other labor difficultiescontrary to its best interest.

 

**18.****                              ****Dispute Resolution.**  Any dispute or controversyarising under or in connection with this Agreement shall be settled exclusivelyby arbitration conducted in the State of Delaware, before a single arbitratorin accordance with the rules of the American Arbitration Association then ineffect.  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 providedherein, neither this Agreement nor any rights or obligations hereunder may beassigned by either party without the written consent of the other party;provided, however, that the rights and obligations of Distributor or MediCor

 

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hereunder may be assignedto any entity controlled by MediCor; provided that such entity assumes allrights and obligations of Distributor or MediCor, as applicable, hereunder andDistributor remains liable for all of its obligations hereunder incurred priorto the effective date of such assignment.

 

**(b)**                                  Waiver.  Failure of either party toexercise or enforce any right under this Agreement upon one occasion shall notwaive the right 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.  Thevalidity, interpretation and performance of this Agreement shall be controlledby and construed under the laws of the State of Delaware.

 

**(d)**                                  Headings.  The headings appearing inthis Agreement are inserted only as a matter of convenience and in no waydefine, limit, construe or describe the scope or extent of such section orin any way affect such paragraph.

 

**(e)**                                  Counterparts. This Agreement may be executed in one or more counterparts, all of whichtaken together shall constitute a single instrument and agreement.

 

**(f)**                                    Notices.  Any notices under thisAgreement shall be in writing addressed to the Chief Executive Officer of suchparty at the address set forth on the signature page hereof, or such otheraddresses as a party may notify the other party in writing) and shall bedelivered by certified mail, return receipt requested or by an overnightdelivery service of international standing.

 

**(g)**                                 Acknowledgment.  Theparties, and each of them, represent and warrant that, in entering into thisAgreement, they have read this Agreement, they have had this Agreementexplained by counsel of their choice, they are aware of the contents and legaleffect of this Agreement and they are acting on the advice of counsel of theirchoice.

 

**(h)**                                 Expenses.  Each party shall bear his orits own expenses, including attorneys’ fees, incurred by it, in connection withthe negotiation, execution, delivery and performance of this Agreement.

 

**(i)**                                    Severability.  Inthe event that any provision of this Agreement shall be held invalid, suchprovision shall not affect the validity of the remainder of this Agreement, andthe remainder of this Agreement shall be construed as if the invalid provisionor provisions had not been included.

 

**(j)**                                    Entire Agreement.  Theparties acknowledge that no representation, promise or inducement has been madeother than as set forth in this Agreement, and that they are not entering intothis Agreement in reliance upon any representation, promise or inducement notset forth herein.  This Agreement supersedesall prior negotiations, understandings and agreements (including the OriginalAgreement which it amends and restates in its entirety) of any kind, written ororal, with respect to the subject matter hereof and contains all of the termsand provisions of agreement between the parties hereto with respect to thesubject matter hereof * * *.

 

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**IN WITNESSWHEREOF,** andintending to be legally bound hereby, the parties hereto have executed thisAgreement the day and year first above written.

 

 
| “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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