Exhibit
10.1


 


AMENDED AND RESTATED NON-EXCLUSIVE DISTRIBUTION
AGREEMENT


 


This AMENDED AND RESTATED NON-EXCLUSIVE
DISTRIBUTION AGREEMENT (the “Agreement”) is made as of the 30th day
of March 2004, by and between Poly Implants Protheses, S.A., a French
corporation (“Supplier”) and III Acquisition Corp., a Delaware corporation
and/or its wholly owned subsidiaries (“Distributor”).


 


RECITALS


 


WHEREAS the Supplier is the manufacturer of smooth
and textured breast implant products (the “Breast Implants”) which Supplier
desires to have distributed throughout * * * (the “Territory”);


 


WHEREAS the Distributor desires to distribute the
Breast Implants, along with any other products manufactured or sold by the
Supplier (collectively, the “Products”) in the Territory on a non-exclusive
basis;


 


WHEREAS Supplier and Distributor have previously
entered into a Non-Exclusive Distribution Agreement dated as of
October 27, 1999 (the “Original Agreement”) in which Supplier granted
Distributor the non-exclusive right to distribute the Products * * *; and


 


WHEREAS Supplier and Distributor desire in this
Agreement to amend and restate the Original Agreement in its entirety to set
forth in full the agreements and understandings of the parties with respect to
the 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 saline
Breast Implant products, which the parties anticipate will be submitted to the
United States Department of Health and Human Resources, Food and Drug
Administration (the “FDA”) * * *.


 


NOW,
THEREFORE, in
consideration of the premises and of the mutual covenants set forth below, the
parties hereto agree as follows:


 


1.                                      Distribution Rights.  Supplier hereby grants to
Distributor a non-exclusive right and license to distribute the Products for
sale throughout the Territory during the term of this Agreement.  Supplier agrees that if the other
non-exclusive distributor of the products, PIP/USA, Inc., breaches its
agreement with Supplier or PIP/USA, Inc.’s agreement is cancelled or terminated
for any reason, Supplier will not execute any other non-exclusive distribution
agreement with any other party and this Agreement shall become exclusive with
respect to distribution of the Products in the Territory.  Distributor has only distribution rights
under this Agreement.  At no time while
this Agreement is in effect will Distributor, directly or indirectly (through
other companies, agents, subsidiaries or otherwise), manufacture equivalent
breast implants that conform with the PMA contemplated in this Agreement.  At no time while this Agreement is in effect
will Supplier, directly or indirectly (through other customers, agents,
subsidiaries or otherwise), with the exception of the non-exclusive
distribution 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 entity
with reasonable basis to believe that such person or entity, or someone acting
on their behalf, will resell the Products into the Territory; or


 


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


 


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


 


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


 


3.                                      Orders and Shipping.


 


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


 


(b)                                  Title and Risk of Loss.  All
Products shall be shipped * * * to the Distributor at such location designated
by Distributor or such other location as Distributor may notify Supplier of
from time to time.  * * *


 


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


 


(d)                                  Late Shipments.  In
the event that Supplier has not shipped Products under the Purchase Order
within * * * days of the date of the Purchase Order (a “Late Shipment”),
Supplier agrees to allow Distributor to take a discount equal to * * * per
month (prorated for parts of months) that the Product in such Purchase Order
remains 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 Products
other than the saline Breast Implants shall be as mutually agreed upon by the
parties hereto.  Subject to the terms of
this Agreement, Distributor shall pay * * * per saline Breast Implant
unit.  * * *


 


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


 


(c)                                  * * *


 


(d)                                  * * *


 


(e)                                  * * *


 


(f)                                    * * *


 


(g)                                 Right to Inspect.  From
time to time during the term of this Agreement, Supplier and its
representatives shall have the right to inspect and make copies of the books
and records of Distributor relating to sales of Products for the purpose of
confirming Distributor’s compliance with the terms of this Agreement.  Such inspection may occur not more
frequently than once in any three consecutive month period and shall be during
ordinary business hours at Distributor’s place of business upon not less than
three business days advance notice. 
Supplier shall bear all of the costs of such inspection unless it is
determined that Distributor has underpaid Supplier by an amount equal to * * *
or more of the amounts paid during the period covered by the inspection, in
which case Distributor shall reimburse Supplier for all of such costs.


 


5.                                      Marketing Assistance.  Supplier will provide
Distributor with marketing assistance as requested by Distributor at no cost to
Distributor, including but not limited to, provision of samples, “sizers” and
up-to-date brochures for the Products in languages appropriate to the
Territory.  Symposia costs from the date
hereof shall be the responsibility of the Distributor.  Any other promotional materials, promotional
assistance and related issues 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 date hereof or licensed to Supplier by any third party, but
any and all products of the Supplier in existence or licensed to Supplier by
any third party at any time while this Agreement is in effect, including all
upgrades, changes, amendments, improvements and modifications thereto, as well
as, any parts and components necessary for the repair and replacement thereof.


 


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


 


(c)                                  Defective Products. 
Supplier shall accept the return of any Products that Distributor’s
Quality Assurance and/or Regulatory departments find unacceptable (“Rejected
Products”) and upon return of such Rejected Products, shall provide Distributor
with 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 in
and to the distribution of the Products necessary to enter into and perform its
obligations to Distributor hereunder; and


 


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


 


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


 


(iv)                              Subject to Sections 7 and 8 below, during the term of this Agreement
Supplier will be solely responsible for, and have a continuing obligation to
obtain and maintain, all necessary non-Territory government and regulatory
approvals and compliance with respect to the Products, including ISO
certification, 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 * * * and
terminate the current contract with * * * and release him from any conflict of
interest in working with Distributor through delivering to * * * any letter
reasonably requested by him; and


 


(vii)                           Supplier will immediately pay all accrued sums presently owed * * * and
terminate its relationship with * * * and release * * * from any conflict of
interest in working with Distributor through delivering to * * * any letter
reasonably requested by * * * ; and


 


(viii)                        Except as provided in Section 7 below with respect to the PMA and
future PMA-related (and other Territory regulatory approval) costs, Supplier
will 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, reimburse
and defend Distributor, upon request, at Supplier’s cost, with mutually


 


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acceptable counsel, from
any proceeding related to any claim asserted against Distributor or its
customers with respect to the Products (including without limitation, Product
liability claims) or with respect to any previous agreements that the Supplier
may have had with any other party regarding the distribution in the Territory
of the Products or which otherwise arises out of Supplier’s relationship with
Distributor (including without limitation any action arising out of the failure
of Supplier to comply with any government or regulatory requirements) and shall
pay Distributor for all amounts owed by Distributor to third persons and
expenses incurred 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)) at
Distributor’s expense all responsibilities for the PMA application and program,
and for other similar Territory regulatory approvals, for the pre-filled saline
Breast Implant.  Additionally,
Distributor shall assume general management responsibilities for the explant
investigation program.


 


(b)                                  Supplier agrees to conduct at its expense any
additional or revised pre-clinical testing required for the PMA
application.  Supplier will be
responsible for mechanical or other testing to be performed at Supplier’s
location and all manufacturing, process and production record, report and
compliance preparation and maintenance. 
Supplier agrees immediately after the date hereof to provide access to
Distributor to all records (including all past PMA-related records and all past
and future manufacturing, process and production records), data, information,
reports, clinical programs and consultants requested by Distributor to complete
the PMA submission and subsequent FDA requests and to provide at its own
expense all additional assistance requested by Distributor in connection with
the PMA application, other regulatory applications in the Territory and future
management and maintenance of marketing clearances in the Territory.  Supplier shall notify Distributor
immediately should Supplier become aware of any defect or condition which may
render any of the Products in violation of the United States Food, Drug and
Cosmetic Act, FDA regulations, other Territory regulations or which in any way
alters the specification and quality of the Products.


 


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


 


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


 


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8.                                      Quality Assurance Responsibilities. 
Supplier agrees that, in order to expedite the acceptance of Products by
Distributor’s Quality Assurance and/or Regulatory departments, that Distributor
will, at Supplier’s expense, implement Quality Assurance and/or Regulatory
programs and/or personnel into the Supplier’s manufacturing facilities.  Supplier grants Distributor the right to
conduct Quality Assurance and/or Regulatory audits (based on Distributor’s
Quality Assurance standards, which at all times shall incorporate applicable
FDA and GMP requirements) using Distributor’s personnel, Supplier’s personnel
and/or independent consultants on a quarterly basis or more frequent spot
basis.  Supplier agrees that Supplier
will cure any curable deficiencies within * * * of written notice by
Distributor of any such Quality Assurance and/or Regulatory audits and commence
curing all other curable deficiencies that are curable but not reasonably
subject of cure within * * *.  Supplier
agrees to credit Distributor’s account in the amount of * * * for * * * that
any deficiencies remain uncured following * * *.  Similarly, following Clearance Distributor agrees to credit
Supplier’s account in the amount of * * * for * * * that any deficiencies
imposed by the FDA on Distributor and relating to Distributor’s obligations
under this Agreement remain uncured following * * * commencing on the later of
the date of Distributor’s receipt of notice thereof from the FDA or the date
imposed 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 to
determine the product guarantees and warranties to be provided on each of its
products, with the exception of the Replacement Program and other specific and
implied warranties contained herein.


 


(b)                                  Conduct of Distributor and its
Representatives.  Distributor agrees not to make any
commitments either orally or in writing with respect to Supplier or on
Supplier’s behalf unless such commitment is specifically authorized hereunder
or Supplier specifically authorizes Distributor in writing make such
commitment.  Distributor agrees not to
make any representations outside the agreed Territory specified in this
Agreement or subsequently agreed to in writing by the parties hereto.  Any leads or contacts outside the Territory
generated through the efforts of the Distributor will be promptly forwarded to
the Supplier.  Distributor further agrees
to 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, and
have a continuing obligation to obtain and maintain, all necessary Territory
government and regulatory approvals and compliance with respect to the
Products, including prosecution of the PMA application for pre-filled saline
implants, related clinical studies, and reporting and monitoring of implant
recipients.  Subject to Sections 6(f), 7
and 8 above, Distributor will pay all future costs of prosecuting the PMA
application with the FDA.


 


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


 


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10.                               Operational Commitments.  Distributor agrees to the
following:


 


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


 


(b)                                  Controlled Conditions of Saline Breast
Implant Storage.  Distributor agrees to store the Products
within a restricted access storage area that is secure, clean (with a
documented regular cleaning program in force), infestation fee, temperature
controlled and organized according to established Quality Assurance and/or
Regulatory requirements.


 


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


 


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


 


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


 


(f)                                    Implant Tracking and Product Recalls.  All
Products sold by Distributor shall have Lot Number and Serial Number records as
established by Distributor’s Regulatory and/or Quality Assurance departments
and Distributor shall maintain these records so that each and every Product, up
to and including when the Product is used or implanted, can be tracked in
accordance with 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 Product malfunction shall be immediately reported
by 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-financial
cooperation to Distributor in the clinical studies of Supplier’s saline breast
implants, including providing non-financial cooperation to Distributor in
collecting information and documentation from participating surgeons and
communicating any problems with the clinical studies to Distributor.


 


(i)                                    Product Warranty Procedure. 
Distributor agrees to return to the Supplier (after suitable liquid
sterilization), in compliance with FDA requirements not later than * * *, all
breast implants returned to Distributor in * * * that are subject to a warranty
claim.  Each returned implant will be
accompanied by (i) the related Medical Device Registration Form and (ii) the
related Explant Data Form.  If provided
to Distributor by the physician, Distributor will also supply to Supplier on
the later of the date set forth in the previous sentence or within * * * (1)
the related


 


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Implantation Operative
Report, (2) the related Pre-Explantation Operative Report, and (3) in the case
of implant deflation, related photos.


 


11.                               Notification of Material or Process Change. 
Supplier shall notify Distributor prior to implementing any changes in
the manufacture, assembly, labeling of the Product or the processes used to
produce the Product (the “Change Notification”).  No such change will be made by Supplier without first obtaining
the approval of Distributor’s Quality Assurance manager in writing.  Supplier agrees to give Distributor one full
and complete set of Supplier’s Standard Operating Procedures (“SOPs”) and
Manufacturing Procedures and to provide Distributor with any and all revisions,
corrections and/or additions to the SOPs and Manufacturing Procedures as
implemented at Supplier’s facilities.


 


12.                               Product Documentation.  Supplier agrees to forward to
Distributor with each shipment of Product all documentation generated during
the 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 shall
be cured at Supplier’s expense.


 


13.                               Patents and Trademarks.


 


(a)                                  Patents.  Supplier shall notify
Distributor promptly of any United States and foreign patents which may now or
hereafter be pending covering any of the Products.  Supplier shall diligently prosecute any applications for United
States and foreign patents which may now or hereafter be pending covering any
of the Products and, on issuance of any such patent, prosecute each infringer
thereof.  Supplier shall defend,
indemnify and hold harmless Distributor from and against any liability arising
out of a claim of patent infringement made with respect to any of the
Products.  Supplier agrees to repurchase
from Distributor, at a price equivalent to the full purchase price paid by
Distributor, any quantity of Products in Distributor’s inventory which Products
Distributor reasonably believes it should not or cannot sell, based upon an
opinion of counsel that future sales of such Product by Distributor may result
in patent infringement, or because of a decision, whether interlocutory or
final, rendered in any patent infringement action.  Supplier hereby grants to Distributor a royalty free perpetual
license to all such patents.  This
license will survive during the term of this Agreement.


 


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


 


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upon the termination of
this Agreement and disclaims any rights in the trademarks other than the said
license.


 


14.                               Product Liability Insurance.  If Supplier obtains product
liability insurance for the Products, such insurance shall contain either a
vendor’s endorsement or contractual liability coverage referencing the
indemnification provisions contained herein on all Products.  Upon issuance of any such product liability
insurance, Supplier shall immediately furnish to Distributor a certificate of
insurance issued by the carrier evidencing the foregoing endorsements,
coverages and limits and such insurance shall not be cancelable by Supplier
without at least fifteen (15) days prior written notice to Distributor.


 


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


 


(a)                                  commits or suffers any act of bankruptcy or
insolvency; or


 


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


 


The non-defaulting party shall have the right
to terminate this Agreement by giving written notice of termination to the
defaulting party at any time within ninety (90) days after the 60-day default
period 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 the
non-defaulting party.


 


On the termination of this Agreement, for
whatever reason, Supplier shall continue to honor Distributor’s orders for
Products up to the effective date of termination and, other than in connection
with expiration of the term of this Agreement, for a period of * * * thereafter
and Distributor shall pay for such Products all on the terms and conditions of
this Agreement.  Upon effectiveness of
termination, Distributor shall have the option of returning all Products then
in inventory to Supplier for full credit or continue to sell the Products for a
period of no more than * * * after termination, at the end of which period
Distributor may then return all unsold Products in inventory for full credit.


 


16.                               Confidentiality.  The parties acknowledge and
agree that, pursuant to this Agreement, valuable information of a confidential
nature may be disclosed by one or more parties to another; that such
information shall be retained by either party in confidence; and that the
transmittal of such information by any party to the another party is upon the
expressed condition that the information is to be used solely for the purpose
of effectuating this Agreement.  No
party 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 the
terms and conditions hereunder, any marketing information supplied by another
party or any other information considered by either party hereto to be
confidential, proprietary or a trade secret. 
Notwithstanding anything in the foregoing, the above restrictions on
disclosure and use shall not apply to any information which a party can show by
written evidence was known to it at the time of receipt from the other party or
which may


 


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subsequently be obtained
from sources other than the other party who are not bound by a confidentiality
agreement with either party.


 


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


 


(a)                                  neither Supplier or Distributor shall be
liable for its failure to perform hereunder (except for obligations to make
payments hereunder) if performance is made impossible due to any occurrence
beyond its reasonable control, including, but not limited to, acts of God,
fires, floods, wars, sabotage, accidents, equipment failure, labor disputes or
shortages, government laws, ordinances, rules, regulations, standards or
decrees, whether valid or invalid (including but not limited to, priorities,
requisitions, allocations and price adjustment restrictions), inability to
obtain raw materials, equipment or transportation, and any other similar
occurrence, and


 


(b)                                  neither Supplier nor Distributor shall be
liable for its failure to perform hereunder if Supplier or Distributor ceases
or suspends the operation of all facilities where Distributor is selling or
Supplier is producing the Products deliverable hereunder, because said
facilities, the operation thereof, and/or the product therefrom fails to comply
with any governmental law, regulation, ordinance, standard, order or decree
relating to health, safety or environmental matters.


 


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


 


If either party reasonably believes it is
impossible to take corrective action to remedy any occurrence under clause (a)
above or to achieve or maintain compliance under clause (b) above, such party
may suspend or terminate this Agreement upon written notice to the other party
in accordance with Section 15.  The
party 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, setting
forth the full particulars in connection therewith, and shall promptly notify
the other party of the cessation of such occurrence.  In no 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.  Any dispute or controversy
arising under or in connection with this Agreement shall be settled exclusively
by arbitration conducted in the State of Delaware, before a single arbitrator
in accordance with the rules of the American Arbitration Association then in
effect.  Judgment may be entered on the arbitrator’s
award in any court having jurisdiction. 
This Agreement and the parties’ performance under it shall be construed
in accordance with the laws of the State of Delaware.


 


19.                               Miscellaneous.


 


(a)                                  Assignment.  Except as expressly provided
herein, neither this Agreement nor any rights or obligations hereunder may be
assigned 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 assigned
to any entity controlled by MediCor; provided that such entity assumes all
rights and obligations of Distributor or MediCor, as applicable, hereunder and
Distributor remains liable for all of its obligations hereunder incurred prior
to the effective date of such assignment.


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


(j)                                    Entire Agreement.  The
parties acknowledge that no representation, promise or inducement has been made
other than as set forth in this Agreement, and that they are not entering into
this Agreement in reliance upon any representation, promise or inducement not
set forth herein.  This Agreement supersedes
all prior negotiations, understandings and agreements (including the Original
Agreement which 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
and provisions of agreement between the parties hereto with respect to the
subject matter hereof * * *.


 


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IN WITNESS
WHEREOF, and
intending to be legally bound hereby, the parties hereto have executed this
Agreement 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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