Exhibit 10.35

[****] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
EXCHANGE ACT OF 1934, AS AMENDED.

SUPPLY AND DISTRIBUTION AGREEMENT

This agreement is made as of January 1, 2005 (the “Effective Date”) by and
between Biomateriali Srl, an Italian limited liability company having its
registered offices at Cittadella della Ricerca s.s.7 per Mesagne, 72100
Brindisi, Italy (“BIOMATERIALI”) and Edwards Lifesciences AG, a corporation
organised under the laws of Switzerland and having its business office at Chemin
du Glapin 6, 1162 Saint-Prex, Switzerland (“EDWARDS”).

WHEREAS, BIOMATERIALI is a manufacturer of medical devices for vascular surgical
procedures and has developed, manufactured and marketed proprietary
interventional medical device products as set forth in Exhibit A (the
“Products”).

WHEREAS, EDWARDS desires and has the facilities, personnel and expertise to
distribute the Products on a comprehensive basis throughout the Territory.

WHEREAS, BIOMATERIALI wishes to appoint EDWARDS, and EDWARDS wishes to be
appointed as a distributor of the Products in the territory set forth in
Exhibit B (the “Territory”).

NOW, THEREFORE, in consideration of the mutual undertakings, obligations and
covenants contained herein, and for other good and valuable consideration, the
receipt and sufficiency of which are acknowledged, the parties agree as follows
(“Agreement”):

 

1. APPOINTMENT

 

  1.1 Scope. Subject to the terms and conditions contained in this Agreement,
BIOMATERIALI hereby appoints EDWARDS, and EDWARDS hereby accepts appointment, as
BIOMATERIALI’s exclusive distributor of the Products listed in Exhibit A in the
Territory listed in Exhibit B during the term of this Agreement. BIOMATERIALI
agrees that it will not sell or distribute the Products in the Territory,
directly or through third parties, nor shall it to appoint any other agents,
representatives or distributors for the purpose of selling the Products in the
Territory.

 

  1.2 Additional Territory. BIOMATERIALI recognizes EDWARDS as a prior and
primary partner for the distribution of the Products therefore commits to offer
any distribution rights for the Products in countries outside the Territory
initially to EDWARDS to accept or refuse such distribution right within 90
ninety days from the written notification of BIOMATERIALI.

 

  1.3 Sub-distributors. EDWARDS may appoint sub-distributors or agents to
promote and/or distribute the Products within the Territory.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

1

--------------------------------------------------------------------------------

2. OBLIGATIONS/LIMITATIONS OF EDWARDS

 

  2.1 Marketing Efforts. EDWARDS shall have the following obligations with
respect to the marketing and distribution of the Products:

 

  (a) To use reasonable commercial efforts to further the promotion, marketing,
and distribution of the Products in the Territory;

 

  (b) To provide adequate and appropriate training to its staff concerning the
Products;

 

  (c) To use sales and technical literature as well as promotional artwork and
training materials provided by BIOMATERIALI. EDWARDS may alter such materials or
develop any other materials in connection with the marketing and distribution of
Products (product brochures and sales aids), which shall be subject to
BIOMATERIALI’s prior written approval. BIOMATERIALI retains all right, title and
interest in and to such materials thereof;

 

  (d) To provide twice any calendar year BIOMATERIALI with a report showing the
purchased Products allocated to Group A and Group B Territory.

 

  (e) Where appropriate according to EDWARDS’ own judgement, to translate
Product-related materials into the language or languages of any parts of the
Territory and provide BIOMATERIALI with copies of such translations. Should this
Agreement be terminated prior to its term for reasons other than EDWARDS’
malfeasance, BIOMATERIALI will reimburse EDWARDS for such translations.
BIOMATERIALI retains all right, title and interest in and to such translated
versions thereof.

 

  2.2 Inventory. EDWARDS shall at all times make his best efforts to maintain an
inventory of the Products sufficient to meet anticipated demand but calculated
to result in the minimum possible return of Products under Section 2.5.

 

  2.3 Customer Service. EDWARDS shall provide customer service, including, but
not limited to, taking orders, responding to customer inquiries, fulfilling
requests for quotes on Product pricing, forwarding Product complaints to
BIOMATERIALI on a timely basis and providing such assistance and information as
is reasonably requested.

 

  2.4 Defective Products. EDWARDS shall process and return any defective
Products to BIOMATERIALI for credit or replacement, as EDWARDS shall determine.
Should the Product in question be defective, all expenses related to its return
and replacement shall be borne by BIOMATERIALI.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

2

--------------------------------------------------------------------------------

  2.5 Expired Products. EDWARDS shall not sell any Products beyond their stated
expiration date. Expired products will be handled according to the verified
EDWARDS quality control systems guidelines and will be discarded. Alternatively,
at EDWARDS’ election, the products will be shipped back to BIOMATERIALI for
disposal.

 

  2.6 Alteration of Products. EDWARDS shall not alter the Products or any
Product packaging or labelling except with the prior written consent of
BIOMATERIALI.

 

  2.7 Target Purchase Quantities. During the term of this Agreement, Edwards
shall use its commercially reasonable effort to purchase the target quantities
of [*****] ([***]) units of Product (“Target Purchase Quantity”) at the prices
shown in Exhibit A, for any twelve month period starting with the Effective Date
of the Agreement (“Supply Year”).

 

  2.8 Forecasts. EDWARDS agrees to provide BIOMATERIALI with a non-binding
twelve (12) month forecast indicating EDWARDS’ projected purchase of Products
for the Territory. Such forecast shall be updated by EDWARDS on a rolling
quarterly basis for each succeeding twelve (12) month period, and each updated
forecast must be received by BIOMATERIALI no later than thirty (30) days prior
to the first day of the period to which it relates. Such forecasts by EDWARDS
shall be used for purposes of facilitating BIOMATERIALI and its suppliers’
planning to meet lead times delivery for the Products, and shall not constitute
binding commitments to purchase upon EDWARDS. EDWARDS will use its best efforts
to notify BIOMATERIALI promptly of any changes in its forecast.

 

  2.9 Import and Others Sales Governmental Requirements. Except as otherwise
agreed by BIOMATERIALI in writing, EDWARDS shall be responsible for compliance
with applicable requirements for importing the Products into, marketing and
distributing the Products within the Territory, including but not limited to all
custom requirements. BIOMATERIALI shall provide EDWARDS with assistance in this
matter as EDWARDS may reasonably request. EDWARDS shall obtain any necessary
import licenses, at its own expense.

 

  2.10 Notice of Intellectual Property Infringement. EDWARDS shall promptly
notify BIOMATERIALI in writing of any patent, copyright infringement or
unauthorized use of BIOMATERIALI’s trade secrets or trademarks in the Territory
of which EDWARDS has become aware. BIOMATERIALI reserves the right in its sole
discretion to institute any proceedings against such third party infringers in
its name and on its behalf. EDWARDS shall cooperate fully with BIOMATERIALI in
any legal action taken by BIOMATERIALI against such third parties, provided that
BIOMATERIALI shall pay all expenses of such action and all damages relating to
damage suffered personally by BIOMATERIALI which may be awarded or agreed upon
in settlement of such action shall accrue to BIOMATERIALI, without prejudice to
the right of EDWARDS to initiate any proceedings against third party infringers
in order to obtain compensation for damages suffered.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

3

--------------------------------------------------------------------------------

  2.11 Compliance with Laws of the Territory. Upon knowledge, EDWARDS will do
its commercial reasonable efforts to inform BIOMATERIALI of any legal
requirements in the Territory that may affect the use or distribution of the
Products, marketing materials or Product packaging and labelling.
Notwithstanding the above BIOMATERIALI will remain fully responsible to comply
with any legal and regulatory requirements related to the Products in the
countries belonging to the European Union.

 

  2.12 Insurance. EDWARDS shall maintain in force, during the term of this
Agreement, one or more policies of liability insurance in amounts adequate to
cover all obligations of EDWARDS hereunder.

 

  2.13 Adverse Reactions. In the event that either party receives any complaint
regarding the Product, it shall notify the other party immediately after
becoming aware of it. EDWARDS will make an assessment of each complaint it
receives, provide BIOMATERIALI with these complaint assessments and will
coordinate all follow-up and customer communication that it deems appropriate.
EDWARDS will assist BIOMATERIALI in its decision process about whether a
complaint shall have to be notified to a local competent authority and the
Notified Body or not and for implementing of appropriate Field Corrective
Actions.

In the event that any customer of EDWARDS rejects or returns a Product to
EDWARDS as a result of a Product performance problem, EDWARDS shall immediately
so notify BIOMATERIALI and confirm in writing. If the reason for such
performance problem is reasonably determined to be failure of the Product to
meet its specifications, then BIOMATERIALI will replace, at its sole expense,
the non-conforming Product which EDWARDS elects to so replace. In such case,
BIOMATERIALI will pay all shipping and handling costs of EDWARDS relating to the
handling, replacement and return of the rejected Product.

 

3. OBLIGATIONS OF BIOMATERIALI

 

  3.1 Sales and Technical Literature. BIOMATERIALI shall provide to EDWARDS
reasonable quantities of such sales, advertising and technical literature and
materials as BIOMATERIALI may have prepared and shall make available copies of
promotional artwork it may have prepared. If available, BIOMATERIALI may provide
the same to EDWARDS in electronic format. Any adjustments or modifications of
sales, advertising and technical literature to the requirements of EDWARDS shall
be charged to and covered by EDWARDS in full.

 

  3.2 Marketing and Training Support. BIOMATERIALI shall provide EDWARDS with
marketing and training support to enable EDWARDS to perform its obligations
under this Agreement. In addition, BIOMATERIALI shall provide EDWARDS with all
necessary training and technical assistance related to the Products and related
services at BIOMATERIALI’s sole cost.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

4

--------------------------------------------------------------------------------

  3.3 Sterile Samples for Customers. BIOMATERIALI shall provide EDWARDS with a
maximum annual volume of sterile samples equal to 5% of the agreed Target
Purchase Quantity in Section 2.7 at the special prices for Samples listed in
Exhibit A in order for EDWARDS to perform its commercial obligations. The annual
volume of sterile samples shall be included in the calculation of the Target
Purchase Quantity.

 

  3.4 Non-sterile Demonstration Samples. BIOMATERIALI shall provide, free of
charge and upon EDWARDS’ request, up to a maximum of 50 non-sterile
demonstration sample sets each year (1 sample set consist of: 1 AMC 1809, 1 ATC
1528, 1 AMC1508 graft) for the duration of this Agreement.

 

  3.5 Product Specifications, Packaging and Labelling.

 

  (a) Product Release. BIOMATERIALI is responsible for producing and releasing
the Product in compliance with the specifications as communicated to and agreed
with EDWARDS. BIOMATERIALI warrants that the Product will (i) conform to
specifications and may be used for, and in the manner identified in, the Product
Label and directions for use (if any), (ii) be free from defects in design,
formulation, workmanship and material, and (iii) are manufactured and tested,
and at the time of delivery to EDWARDS will be, in accordance/conformity with
the state of the scientific and technological art as well as the EC-guidelines
for good manufacturing and practice for drugs, and applicable provisions for
quality and documentation for approved registration/regulatory files.

 

  (b) Packaging and Labelling. BIOMATERIALI, at its expense, shall provide
EDWARDS with any product instruction for use and labelling required for the
distribution in the Territory. BIOMATERIALI shall take care of all the
appropriate changes on all product instructions for use and labelling of the
Products, if any, in order to comply with European and national regulations. The
Product labelling shall include the statement “Manufactured exclusively for
EDWARDS Lifesciences by BIOMATERIALI” and be provided in a multi-language format
that will enable it to be sold throughout the Territory.

 

  3.6 Insurance. BIOMATERIALI shall obtain and maintain in force, during the
term of this Agreement, and for so long as necessary to cover any claims that
may be made thereafter regarding the Products sold by EDWARDS, for coverage, a
product liability insurance policy in a amount not less than Euro [*****]
([****]) each occurrence and in the aggregate, in a form reasonable acceptable
to EDWARDS. BIOMATERIALI’s insurance policy will be considered primary. The
insurance carrier(s) shall be a reputable international company reasonably
acceptable by EDWARDS and will have an AM Best rating of no less than A-. A copy
of the above BIOMATERIALI confirmation of coverage shall be given to EDWARDS at
the Effective Date and then as soon as practicable at the beginning of each new
policy term.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

5

--------------------------------------------------------------------------------

During the term of this Agreement and for so long as necessary to cover any
claims that may he made thereafter regarding the Products, EDWARDS, its
Affiliates and subsidiaries shall be additionally insured (so-called vendor
endorsement). EDWARDS shall be provided with 30 days prior written notice of any
cancellation, non-renewal or material change in the terms of such policy.

For the purpose of this Agreement, the term “Affiliates or Affiliate Entity”
shall mean (i) any other entity/person of which the securities or other
ownership interests representing fifty percent (50%) or more of the equity or
fifty percent (50%) or more of the ordinary voting power or fifty percent
(50%) or more of the general partnership interests are, at the time of such
determination, owned, controlled or held, directly or indirectly, by such
entity/person, or (ii) any other entity/person, which at the time of such
determination, is controlling, controlled by or under common control with such
entity/person. As used herein, the term “Control”, whether used as a noun or
verb, refers to the possession, directly or indirectly, of the power to direct,
or cause the direction of, the management or policies of a entity/person,
whether through the ownership of voting securities, by contract or otherwise.

 

4. PURCHASES AND PAYMENT TERMS

 

  4.1 Orders. EDWARDS shall order Products by means of written, individual
Purchase Orders. The Purchase Order shall specify applicable prices, quantities
by catalogue number, shipping schedule, shipping instructions, and, if
applicable, any relevant export control information or documentation to enable
BIOMATERIALI to comply with Territory export control laws and regulations, any
special requirements and other similar matters that are necessary for the
individual transaction in accordance with this Agreement to be adequately
described.

 

  4.2 Order Acceptance. BIOMATERIALI shall accept or refuse in writing EDWARDS’
issuance of any Purchase Order within ten (5) business days from the date when
the order has been received and shall not be refused without just cause. Any
Purchase Order that is not rejected within the above stated period shall be
deemed accepted. BIOMATERIALI shall accept Purchase Orders and deliver the
Products that the EDWARDS has ordered in accordance with this Agreement but
shall have no liability to EDWARDS with respect to purchase orders that exceed
the Target Purchase Quantity in Section 2.7 by twenty percent (20%). No accepted
Purchase Order may he modified or cancelled except as agreed in writing by the
parties. EDWARDS’ Purchase Orders or mutually agreed change Purchase Orders
shall be subject to all provisions of this Agreement. Any terms or conditions of
such Purchase Order or change Purchase Order that conflict the terms or
conditions of this Agreement shall be deemed excluded.

 

  4.3

Shipment and Delivery Terms. BIOMATERIALI shall use its best efforts to fill
orders that are within EDWARDS’ forecast plus ten percent (10%), within sixty
(60) calendar days from the confirmation of the relevant Purchase Order. In
addition BIOMATERIALI shall use its reasonable efforts to fill orders to the
extent

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

6

--------------------------------------------------------------------------------

 

they exceed EDWARDS’ by ten percent (10%) the forecast. Unless otherwise agreed
in writing by BIOMATERIALI and EDWARDS, all deliveries of the Products shall be
FCA, INCOTERMS 2000, at Biomateriali’s facilities in Brindisi, Italy and, upon
request, BIOMATERIALI shall organize and coordinate the shipment to EDWARDS’
premises according to EDWARDS’ reasonable instructions provided that shipping
charges shall be paid by EDWARDS.

 

  4.4 Acceptance of the Products. EDWARDS shall inspect each shipment of
Products and give BIOMATERIALI written notice of any defects in or
non-conformity of any Products receipt at EDWARDS’ warehouse within thirty
(30) days from their delivery. All Products or parts thereof claimed to be
non-conforming with the Product specifications, with the Purchase Order, damaged
or in whatever manner defective, must be kept at EDWARDS’ warehouse for
inspection by BIOMATERIALI. EDWARDS shall return any non-conforming or defective
Products as directed by BIOMATERIALI and at BIOMATERIALI’s expense for credit or
replacement at EDWARDS’ discretion. In case of replacement, BIOMATERIALI will
ship the replaced Product within a reasonable time, DDU at EDWARDS’ warehouse in
Nijmegen, The Netherlands, according to INCOTERMS 2000. The parties understand
and agree that Products shipped to EDWARDS with an use-before-period
(shelf-life) of less than twenty (20) months will not be accepted.

 

  4.5 Prices and Annual True-Up. Pricing will be in Euro. EDWARDS shall pay
BIOMATERIALI the prices as stated in Exhibit A for Products (including Sterile
Samples) sold in Group A and Group B countries. BIOMATERIALI will invoice for,
and EDWARDS shall initially pay, all delivered and accepted Products (including
Sterile Sample) at prices set forth for Group A country in the Territory during
each Supply Year irrespective where in the Territory the Products are finally
sold. Not later than February 28th of each next Supply Year, EDWARDS shall
provide BIOMATERIALI with the report of the total sales of the Products in
Group A and Group B countries in the Territory for the previous Supply Year, in
order to calculate the annual payment adjustments and credit EDWARDS with the
amount based on the difference between the amount actually invoiced and the
amount that should have in fact been invoiced and paid by EDWARDS in accordance
with the then-current related prices listed in the Exhibit A, as amended, and
considering the volume of Products sold in the Group A, Group B countries in the
Territory and the Sterile Samples in Section 3.3. Any special packing or
handling requested by EDWARDS shall be at the sole expense of EDWARDS.

 

  4.6

Price Adjustments. The prices set forth in Exhibit A shall be firm for the first
Supply Year and afterwards adjusted for each subsequent Supply Year based on
changing market conditions and competition as well as material and production
costs. The revised prices shall be mutually agreed upon the parties at least
thirty (30) days prior to commencement of the succeeding Supply Year and will be
applied to Purchase Orders executed after the date of the agreed price
adjustment. Increased prices shall not apply to any Purchase Order issued prior
to the agreed

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

7

--------------------------------------------------------------------------------

 

applicable date of such price increase. It is furthermore understood and agreed
by the parties that the Target Purchase Quantity in Section 2.7 are strictly
related to the purchase prices of the Products; therefore, in case of any price
increase, the annual Target Quantities for the subsequent Supply Year will be
reviewed accordingly.

In the event the parties fail to agree on the purchase prices for the subsequent
Supply Year on or before December 1st of each Supply Year, the purchase prices
for such subsequent Supply Year shall remain the purchase prices in force plus
[**] of the inflation rate in Italy of the previous year as published by the
Italian institute of statistic (ISTAT) and both parties may terminate this
Agreement with twelve month notice in accordance Article 11.1 below.

The parties may at any time agree to negotiate fixed prices other than as
specified in Exhibit A, in response to changing market conditions (including if
labour costs or raw material costs increase by more than [****] ([***])) or
facing a high-volume opportunity.

 

  4.7 Payment Terms. BIOMATERIALI shall issue an invoice for each shipment and
EDWARDS shall make payment of relevant invoice within sixty (60) days after
receipt of BIOMATERIALI’s invoice by wire transfer to an Italian bank designated
by BIOMATERIALI. All payments shall be made in Euro.

 

  4.8 Resale Prices. EDWARDS may offer the Products in the Territory at such
prices as EDWARDS, in its sole discretion, shall determine.

 

  4.9 Product Changes. Provided that BIOMATERIALI gives ninety (90) days prior
notice to EDWARDS and indemnifies and holds harmless EDWARDS for all legal and
contractual consequences or other commitments for Products made by EDWARDS prior
to the date such notice becomes effective, BIOMATERIALI may at its sole
discretion:

 

  (a) Change the specification or discontinue the production of one or more
Products. In such case of changed of discontinued Product, BIOMATERIALI and
EDWARDS shall evaluate in good faith the ongoing supply contract with the
EDWARDS’ customers and shall make all reasonable commercial efforts to secure,
supply of the changed or discontinued product for existing supply contracts with
EDWARDS’ customers.

 

  (b) Commence the development and distribution of new products or of
modifications or improvements to the Products having features which may make the
Products wholly or partially obsolete. Subject to the terms set forth below,
EDWARDS shall have exclusive right to distribute new products and modifications
or improvements to Products. The parties shall negotiate in good faith for the
applicable prices for such new products.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

8

--------------------------------------------------------------------------------

5. REGULATORY AFFAIRS

 

  5.1 CE-Mark. BIOMATER1AL1 shall obtain and maintain in its own name the CE
mark and other required regulatory approvals for the Products in the European
Union. All costs incurred for the CE marking application are BIOMATERIALI’s.
BIOMATERIALI agrees to notify EDWARDS immediately upon any action or situation
that may change the CE marking compliance status, such as regulatory or Notified
Body inspection findings or manufacturing malfunctions which materially affect
the quality of shipped Products or result in the material deterioration of
Product performance. BIOMATERIALI shall be responsible for creating and
maintaining the Technical Documentation for the Product and agrees to provide
EDWARDS with four copies of technical files and any documentation in case of
request from an Authority (Ministry of Health or Notified Body). BIOMATERIALI
will certify via a Declaration of Conformity that the Product conforms to the
relevant Harmonized Standards.

 

  5.2 Other Approvals. BIOMATERIALI will use best efforts to obtain approval of
the Products for any other country if so requested by EDWARDS and agreed to by
BIOMATERIALI. No representation is made as to whether approvals for countries
that are not accepting the CE-Mark can be achieved. If required, BIOMATERIALI
will promptly notify EDWARDS to the regulatory authorities as the exclusive
distributor of the Products in the Territory.

 

  5.3 Regulatory Support. EDWARDS or the respective sub-distributors of EDWARDS
shall provide BIOMATERIALI with all reasonable required support to comply with
any local regulatory law and requirement including but not limited to assisting
and executing all documents necessary to satisfy all regulatory requirements in
the jurisdictions in which the Products are distributed, whenever is mandatory
or necessary to register the Products in such country.

 

  5.4 Compliant Use. EDWARDS shall make all reasonable commercial efforts to
inform its customer for proper use of the Products and in full compliance with
BIOMATERIALI instructions for the use and the handling of the Products. Neither
Party shall be responsible to the other for any application outside the national
regulatory approvals or any use without any regulatory approval.

 

  5.5 Changes in Regulations. BIOMATERIALI is under no obligation to adapt the
Products to more restrictive regulatory requirements entering into force after
conclusion of this Agreement, that trigger more than insignificant additional
costs. In such cases, BIOMATERIALI may stop selling the Products to EDWARDS for
ultimate sale or distribution into those countries which require such
restrictive requirements.

 

6. QUALITY MANAGEMENT SYSTEM, TRACEABILITY

 

  6.1

Product Quality. BIOMATERIALI shall use its best efforts to maintain the highest
standard of quality for the Products. BIOMATERIALI shall communicate to

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

9

--------------------------------------------------------------------------------

 

EDWARDS any significant changes in the production and quality assurance team for
the Products in existence at the time the present Agreement is executed,
including but not limited to the team members and quality assurance procedures.
Such communication is to be made on a timely basis prior to making any projected
changes. Should EDWARDS be dissatisfied with any projected changes, the parties
agree to review and discuss them. The parties agree to attempt to resolve their
differences within a period not to exceed six (6) weeks, after which, should no
agreement be reached, the distribution Agreement may he amicably terminated.

 

  6.2 Quality Management System. BIOMATERIALI has established and maintains a
Quality Management System in accordance with EN ISO 9001, EN 46001 and ISO 13485
and other relevant quality management standards and legal provisions.
BIOMATERIALI represents that the actual production of the Products takes place
under the CE-certified Quality Management System.

 

  6.3 Compliance Inspection. BIOMATERIALI shall inspect and test Products prior
to delivery to EDWARDS to ensure compliance with the Product Specifications.

 

  6.4 Traceability. EDWARDS is responsible for product traceability to its
customers. In accordance with the relevant quality standards and internal
BIOMATERIALI procedures, traceability of critical or major components,
processes, manufacturing and release inspection results will be maintained by
BIOMATERIALI to the individual Product identified by serial or lot number. The
collected records will be archived by BIOMATERIALI for a period of at least one
year after the expiration date of the respective Product.

 

  6.5 Product Storage Conditions. EDWARDS shall preserve BIOMATERIALI guidelines
for storage conditions in its warehouses, which shall not he below 0°C and above
30°C. EDWARDS will inform all its sub-distributors regarding adequate storage
conditions for the product. BIOMATERIALI acknowledges that EDWARDS is using
third party warehouse facilities and logistic services, therefore subject to
acceptance of this service provider of any visit request during normal business
hours and BIOMATERIALI compliance with its third party access policy, EDWARDS
will allow BIOMATERIALI to visit the warehouse premises to verify the above said
storage conditions only.

 

7. REPORTING, VIGILANCE, RECALL

 

  7.1 Reporting. It is BIOMATERIALI sole responsibility to file Medical Device
Reports or Vigilance Reports to any legal authority for the Products in order to
comply with the applicable laws and regulations in the Territory. Only, if
EDWARDS by any applicable law or regulation is obliged to report medical device
incidents, this Agreement shall not prevent EDWARDS to do so.

 

  7.2

Safety Notification. In case a Product is potentially deviating from its
Specification, or under any other circumstance where such Product might cause,
or already has caused harm to a patient, user or other person, each party shall
notify

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

10

--------------------------------------------------------------------------------

 

the other party in writing (“Safety Notification”), irrespective of the time or
location of detection of the potentially faulty Product, as soon as the
respective party gains knowledge of such circumstance. Safety Notifications and
any other complaints on the Products are to be effected to the following
addresses:

BIOMATERIALI Srl, Mr. Cosimo Saponaro

Citadella della Ricerca s.s.7 per Mesagne

72100 Brindisi

Italy (tel. +39 0831 588 028, Fax: +39 0831 588 030)

email: m.saponaro@tiscali.it

Edwards Lifesciences S.L., Mrs. Maite Llacer

Avda. Juan de la Cierva 27

Parque Tecnologico de Valencia

46980 Paterna, Valencia

Spain (tel. +34 9 63 05 37 14, Fax +34 9 63 05 37 07)

email: maite_llacer@edwards.com

 

  7.3 No Statement. In the event of a (alleged) malfunction or defect of a
Product, EDWARDS or its representatives or agents will not make any statement as
to the cause, before having informed BIOMATERIALI and having received
BIOMATERIALI written analysis of the malfunction or defect, and will then not
render statements different from the results of such analysis.

 

  7.4 Sales Records. EDWARDS will maintain complete and accurate lists and
records reflecting all Product sales and related transactions as may be required
by law and to comply with the EU regulations, regulations of the EC-Council
Directive concerning medical devices or other legal requirements applicable for
a country of the Territory to secure full traceability of each Product.

 

  7.5 Product Recall. If either party believes that a recall of any Products in
the Territory is desirable or required by law in the Territory or elsewhere, it
shall immediately notify the other party. The parties shall then discuss
reasonably and in good faith whether such recall is appropriate or required and
the manner in which any mutually agreed recall shall be handled. BIOMATERIALI
will be responsible for making the decision whether to inform the local
competent authority and the Notified Body or not. EDWARDS shall make
commercially reasonable efforts to assist BIOMATERIALI in giving effect to the
recall, including communication with any customer or user. BIOMATERIALI shall
bear all costs and expenses of any recall, including, without limitation,
expenses or obligations to third parties, the costs of notifying customers and
costs associated with the shipment of recalled Product from customer to EDWARDS
or BIOMATERIALI, and replacement of such Products.

 

  7.6

Remedial Actions. It is BIOMATERIALI exclusive right and obligation to issue
recalls, safety alerts, advisory notices or similar remedial actions on the
Products. In such case, EDWARDS will support and fully co-operate with
BIOMATERIALI

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

11

--------------------------------------------------------------------------------

 

to comply with the applicable laws and regulations. Furthermore, in such case
EDWARDS will notify its customers and, upon BIOMATERIALI’s request retrieve
identified Products. BIOMATERIALI shall bear all direct costs and expenses of
any recall, including, without limitation, expenses or obligations to third
parties, the costs of notifying customers and costs associated with the shipment
of recalled Product from customer to EDWARDS or BIOMATERIALI, and replacement of
such Products.

 

  7.7 Survival. The provisions of this section Reporting, Vigilance, Recall
shall survive the termination of the Agreement.

 

8. LIABILITY AND INDEMNIFICATION

 

  8.1 Indemnification by BIOMATERIALI. Notwithstanding anything else in this
Agreement to the contrary, BIOMATERIALI shall defend, indemnify and hold the
EDWARDS and its affiliated entities, and each of their officers, directors,
agents and employees harmless against any and all claims, demands, losses,
liabilities, damages, costs and expenses (including reasonable attorneys’ fees)
made or incurred by a third party resulting from (a) any breach by BIOMATERIALI
of this Agreement, (b) personal injury or death resulting from the use of a
Product, (c) Product defects, (d) infringement of patents, copyrights,
trademarks, or other intellectual property rights, (e) product recalls,
(f) failure by BIOMATERIALI to maintain the regulatory approvals. The
indemnification contained in this Section shall survive the expiration or
termination of this Agreement for any reason whatsoever.

 

  8.2 Indemnification by EDWARDS. EDWARDS shall defend, indemnify and hold
BIOMATERIALI its officers, directors, employees, and agents harmless against any
and all claims, demands, suits, proceedings, losses, liabilities, damages, costs
and expenses (including reasonable attorneys’ fees) resulting from (a) any
breach by EDWARDS of this Agreement, or (b) any act, error or omission of
EDWARDS or any of its officers, directors, employees, agents, or
representatives, with respect to the marketing, distribution, sale of the
Products within the Territory, including, failure to train customers on how to
use the Products. The indemnification contained in this Section shall survive
the expiration or termination of this Agreement for any reason whatsoever.

 

  8.3 Indemnification Procedure. A party seeking indemnification (an
“indemnified party”) shall give the other party (an “indemnifying party”)
written notice of any Legal Action within ten (10) days of first knowledge
thereof. The indemnifying party shall have sole and exclusive control of the
defense of any Legal Action, including the choice and direction of legal
counsel. The indemnified party shall have the right to engage its own counsel,
at its own expense. The indemnified party may not settle or compromise any Legal
Action without the written consent of the indemnifying party.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

12

--------------------------------------------------------------------------------

9. CONFIDENTIALITY

 

  9.1 Confidential Information; Term. All Confidential Information (as defined
below) shall be deemed confidential and proprietary to BIOMATERIALI or EDWARDS
(The “Disclosing Party”). The Party receiving any Confidential Information (the
“Receiving Party”) may use these Confidential Information during the term of
this Agreement only as permitted or required for its performance hereunder and
shall not disclose or provide any Confidential Information to any third party
and shall take reasonable measures to prevent any unauthorized disclosure by its
employees, agents, contractors or consultants, including appropriate individual
nondisclosure agreements. The foregoing duty shall survive any termination or
expiration of this Agreement for three (3) years.

 

  9.2 Definition. As used in this Agreement, the term “Confidential Information”
shall mean all information disclosed by BIOMATERIALI to EDWARDS and vice versa
or embodied in the Products when clearly marked by BIOMATERIALI as being
confidential in nature, relating to the other Party’s markets, customers,
products, patents, inventions, procedures, methods, designs, strategies, plans,
assets, liabilities, prices, costs, revenues, profits, organisation, employees,
agents, resellers or business in general. The following shall not be considered
Confidential Information for purposes of this Section 9:

 

  (a) Information which is or becomes in the public domain through no fault or
act of Receiving Party;

 

  (b) Information which was independently developed by Receiving Party without
the use of or reliance on Confidential Information;

 

  (c) Information which was provided to Receiving Party by a third party under
no duty of confidentiality to the Disclosing Party; or

 

  (d) Information which is required to be disclosed by law, provided, however,
prompt prior notice thereof shall be given to Disclosing Party and disclosure
shall be limited to the maximum extent possible.

 

10. TRADEMARKS

 

  10.1

Use of Trademarks. BIOMATERIALI hereby grants to EDWARDS, and EDWARDS hereby
accepts from BIOMATERIALI, a non-exclusive, non-transferable, and royalty-free
license to use BIOMATERIALI trademark (Albograft™) as the same may be revised by
BIOMATERIALI from time to time, during the term of this Agreement, solely in
connection with the distribution, promotion and advertising of the Products.
EDWARDS may use the BIOMATERIALI trademark in promotional brochures and in
connection with trade fairs. EDWARDS shall not use any other marks or trade
names in connection with the marketing and distribution of the Products except
for EDWARDS’ proprietary trade names and marks. BIOMATERIALI may inspect and
monitor EDWARDS’

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

13

--------------------------------------------------------------------------------

 

use of the BIOMATERIALI trademark. EDWARDS shall not remove or alter any
BIOMATERIALI trade names, trademarks, copyright notices, serial numbers, labels,
tags or other identifying marks, symbols or legends affixed to any Products,
documentation or containers or packages. EDWARDS shall not adopt, use or
register any words, phrases or symbols, which are identical to or confusingly
similar to any of BIOMATERIALI’s trademarks.

 

11. TERM AND TERMINATION

 

  11.1 Term. This Agreement shall come into force on the date first written
above (the “Effective Date”) and shall continue in force for a period of five
(5) years (the “Initial Term”), unless earlier terminated as provided in this
Article 11.2. To the extent permitted by the laws in any single country of the
Territory, this Agreement, the exclusive rights and non-compete provisions
thereof shall be automatically for an indefinite period at the end of the
Initial Term, unless either party provides the other party with twelve
(12) months prior written notice of its intent to terminate the Agreement.

 

  11.2 Termination. Either party may terminate this Agreement at any time with
immediate effect by either party:

 

  (a) if the other party shall be or become bankrupt or insolvent or if there
are instituted by or against it proceedings in bankruptcy or under insolvency
laws or for its reorganization, receivership, liquidation or dissolution;

 

  (b) if the other party is in serious material breach of this Agreement and has
failed to cure such breach within sixty (60) days of receipt of written notice
thereof from the first party;

 

  (c) either party or either party’s employees, officers, sub-distributors or
agents engages in unethical business conduct or is convicted of a crime (other
than a misdemeanour) that, in the reasonable discretion of either party, is
likely to cause or has caused harm or disrepute to the reputation of the other
party, or harm to the public;

 

  (d) there is a major material change in the management of or operation of
either party’s business; or

 

  (e) any law or government-enacted regulation or decree renders the performance
by either party of its respective obligations hereunder unduly onerous or
otherwise inexpedient.

 

  11.3 Additionally BIOMATERIALI may terminate this Agreement immediately upon
written notice to EDWARDS if EDWARDS breaches any obligation to BIOMATERIALI
regarding BIOMATERIALI’s intellectual property, alters any Product or the
labelling therefore without BIOMATERIALI’s prior written consent or sells a
Product beyond its expiration date; or

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

14

--------------------------------------------------------------------------------

  11.4 Rights and Obligations on Termination. In the event of termination of
this Agreement for any reason, and subject to Article 11.6 below concerning the
sell-off period, the parties shall have the following rights and obligations:

 

  (a) Neither party shall be released from the obligation to make payment of all
amounts then or thereafter due and payable;

 

  (b) The duties of confidentiality under Article 10 and the duties of both
parties concerning dispute resolution under Article 13 shall survive the
termination of this Agreement;

 

  (c) Except as provided in Section 11.6, EDWARDS shall cease to distribute the
Products and shall return to BIOMATERIALI all copies of promotional and
technical materials and artwork provided by BIOMATERIALI;

 

  (d) BIOMATERIALI will repurchase EDWARDS’ inventory of non-obsolete and
non-expired Products at the price paid by EDWARDS for such Products or direct
EDWARDS to sell them to the third party or parties selected by BIOMATERIALI;

 

  (e) EDWARDS shall return or, if requested by BIOMATERIALI, destroy all
Confidential Information, including, if applicable all electronic copies thereof
and shall certify in writing that it has done so; and

 

  (f) EDWARDS shall cease any use of the BIOMATERIALI trademark in any manner.
In addition, EDWARDS hereby empowers BIOMATERIALI and shall assist BIOMATERIALI,
if requested, to cancel, revoke or withdraw any governmental registration or
authorisation, permitting EDWARDS to use BIOMATERIALI trademark in the
Territory.

 

  11.5 Sell-off Period. Notwithstanding the above, upon expiration or
termination of this EDWARDS shall have the right to continue to distribute its
existing inventory of non-expired Products for an unlimited period after the
expiration or termination and until the inventory exists, either is in his
possession or in consignment at client premises. In addition, if termination
arises other than through breach by EDWARDS and EDWARDS has outstanding
contracts or tenders for Products, the terms and conditions of this Agreement
shall remain in effect with respect only to the supply of Products for such
contracts or tenders for the remaining term of such contracts or tenders.

 

12. CHANGE OF CONTROL, RIGHT OF FIST REFUSAL

 

  12.1

If BIOMATERIALI ceases, or threatens to cease, to carry on its business or the
production of the Products, BIOMATERIALI shall immediately inform EDWARDS of its
intention before informing any third party and, in such cases; EDWARDS shall
have the option right to place an offer to acquire BIOMATERIALI or part of its
business related to the Products. EDWARDS shall

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

15

--------------------------------------------------------------------------------

 

notify BIOMATERIALI its intention to exercise such option right within sixty
(60) days from the notification of BIOMATERIALI intention to abandon or sell in
full or in part its business.

 

  12.2 In the event BIOMATERIALI receives a bona fide offer for all or part of
its business from any third party, during the term of this Agreement, EDWARDS
shall have the right of first refusal to purchase business. If this occurs
EDWARDS shall notify BIOMATERIALI its intention to proceed with a due diligence
on BIOMATERIALI business and eventually match the purchase offer of such third
party within sixty (60) days from the date it receives the notification of the
intended transaction.

 

  12.3 Notwithstanding Articles 12.1 and 12.2 above, in the event of a Change of
Control (as defined below) of either party occurs, the party with respect to
which the Change of Control has occurred shall give notice to the other party
(the “Non-Affected Party”) within thirty (30) days after the occurrence of such
Change of Control. The Non-Affected Party may terminate the Agreement upon the
expiry of a twelve (12) months’ notice. In the event of a Change in Control of
BIOMATERIALI, if this Agreement is terminated on notice to EDWARDS, BIOMATERIALI
shall pay EDWARDS a cancellation fee (the “Cancellation Fee”) in an amount equal
to EDWARDS’ purchase orders for Products (the “Product Purchases”) for the
twelve (12) months immediately preceding the date on which EDWARDS is notified
by BIOMATERIALI of such Change of Control. For the purpose of this Article 11.3,
“Change of Control” shall mean:

 

  (i) the acquisition, directly or indirectly, by any individual or legal entity
of at least fifty percent (50%) of the voting stock of any party to this
Agreement or any individual or legal entity that controls either party.

 

  (ii) a merger involving either party which, directly or indirectly, controls
or is controlled by or is under the same control as either party hereto,
“control” meaning the ability to exercise or to procure the exercise, directly
or indirectly, of at least fifty percent (50%) of the voting stock of a company.

 

13. GOVERNING LAW AND ARBITRATION

 

  13.1 This Agreement shall be governed by and construed and enforced in
accordance with the Italian law.

 

  13.2 Any dispute, controversy or claim arising under, out of or relating to
this contract and any subsequent amendments of this contract, including, without
limitation, its formation, validity, binding effect, interpretation,
performance, breach or termination, as well as non-contractual claims, shall be
referred to and finally determined by arbitration in accordance with the WIPO
Arbitration Rules. The arbitral tribunal shall consist of three arbitrators and
the place of arbitration shall be Geneva, Switzerland. The language to be used
in the arbitral proceedings shall be English.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

16

--------------------------------------------------------------------------------

  13.3 The arbitral award will be final and binding on the parties, and the
prevailing party shall be entitled to recover attorney’s fees and costs awarded
by the arbitration. The provision of this Section shall not restrict the right
of either party to seek and obtain provisional remedies from any court of
competent jurisdiction.

 

14. MISCELLANEOUS

 

  14.1 Compliance with Laws. EDWARDS and BIOMATERIALI shall comply with all
applicable laws affecting this Agreement and its performance hereunder and,
without limiting the generality of the foregoing, shall maintain all
registrations with governmental agencies, commercial registries, chambers of
commerce, or other offices which may be required under local law in order to
enable it lawfully to conduct its business and perform its obligations under
this Agreement. Upon written notice from either party hereto, the notified party
shall provide such information, as it may reasonably consider necessary to
verify compliance by the other party with the provisions of this Section.

 

  14.2 Force Majeure. If the performance of this Agreement or any obligation
hereunder (other than the payment of monies due owing hereunder) is prevented,
restricted or interfered with by reason of any event or condition beyond the
reasonable control of such party (including without limitation acts of state or
governmental action, riots, disturbance, war, strikes, lockouts, slowdowns,
prolonged shortage of energy or other supplies, epidemics, fire, flood,
hurricane, typhoon, earthquake, lightning and explosion or any refusal or
failure of any governmental authority to grant any export license legally
required), the party so affected shall be excused from such performance, only
for so long as and to the extent that such a force prevents, restricts or
interferes with the party’s performance and provided that the party affected
gives notice thereof to the other party and uses diligent efforts to remedy such
event or conditions.

 

  14.3 Relationship. This Agreement does not make either party the employee,
agent or legal representative of the other for any purpose whatsoever. Neither
party is granted any right or authority to assume or to create any obligation or
responsibility, express or implied, on behalf of or in the name of the other
party. Each party is acting as an independent contractor.

 

  14.4 Assignment. Either party shall not have the right to assign or otherwise
transfer its rights and obligations under this Agreement except with the prior
written consent of the other party. Any prohibited assignment shall be null and
void.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

17

--------------------------------------------------------------------------------

  14.5 Notices. Notices permitted or required to be given hereunder shall be
given:

 

  (a) by EDWARDS to BIOMATERIALI’s statutory seat at the address set forth on
page 1 or such other address of which BIOMATERIALI may notify EDWARDS in
writing;

 

  (b) by BIOMATERIALI to EDWARDS’ statutory seat at the address set forth on
page 1 or such other address of which EDWARDS may notify BIOMATERIALI in
writing.

Notices shall be deemed sufficient if given by (a) registered or certified mail,
postage prepaid, return receipt requested, (b) private courier service, or
(c) facsimile with electronic confirmation of receipt, addressed to the
respective addresses of the parties as first above written or at such other
addresses as the respective parties may designate by like notice from time to
time. Notices so given shall be effective upon (a) receipt by the party to which
notice is given, or (b) on the fifth (5th) day following domestic mailing or the
tenth (10th) day following international mailing, as may be the case, whichever
occurs first.

 

  14.6 Entire Agreement. This Agreement, including the Exhibits hereto which are
incorporated herein, constitutes the entire agreement of the parties with
respect to the subject matter hereof and supersedes the European Distribution
Agreement effective as of November 9, 2000 (including all its amendments), as
well as all proposals, oral or written, and all negotiations, conversations,
discussions or previous distribution agreements or arrangements heretofore
between the parties. EDWARDS hereby acknowledges that it has not been induced to
enter into this Agreement by any representations or statements, oral or written,
not expressly contained herein.

 

  14.7 Amendment. This Agreement may be modified, amended, rescinded, cancelled
or waived, in whole or in part, by written amendment signed by both parties.

 

  14.8 Severability. If any provision of this Agreement is found unenforceable
under any of the laws or regulations applicable thereto, such provision terms
shall be deemed stricken from this Agreement, but such invalidity or
unenforceability shall not invalidate any of the other provisions of this
Agreement.

 

  14.9 Counterparts. This Agreement may be executed in two or more counterparts
in the English language, and each such counterpart shall be deemed an original
hereof. In case of any conflict between the English version and any translated
version of this Agreement, the English version shall govern.

 

  14.10 Waiver. No failure by either party to take any action or assert any
right hereunder shall be deemed to be a waiver of such right in the event of the
continuation or repetition of the circumstances giving rise to such right.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

18

--------------------------------------------------------------------------------

  14.11 Employee Solicitation. During the term of this Agreement and for one
(1) year after its termination for any reason, neither party will solicit or
hire the other’s employees involved in performance of the agreement, without
prior written consent of the other party.

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

19

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the parties have caused this Agreement to he executed by
their duly authorized representatives below.

 

BIOMATERIALI SRL     EDWARDS LIFESCIENCES AG

/s/ Pierpaolo Cerani

   

/s/ Patrick Verguet

Pierpaolo Cerani     Patrick Verguet Managing Director     President Europe

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

20

--------------------------------------------------------------------------------

List of Exhibits

 

A. Products, Prices

 

B. Territory

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

21

--------------------------------------------------------------------------------

BIOMATERIALI

EXHIBIT A - PRODUCTS, PRICES

 

Graft Type/Length

   Unit Price     Sterile Sample Price      Group A     Group B     Group A    
Group B   Albograft without Collagen (AMO, ATO)   Straight tube    Any length   
[***] €   [***] €   [***]     [***]   Bifurcation    [***] €   [***] €   [***]  
  [***]   Albograft with Collagen (AMC, ATC)   Straight tube    7.5cm length   
[***] €   [***] €   [***] €   [***] €    15cm length    [***] €   [***] €  
[***] €   [***] €    30cm length    [***] €   [***] €   [***] €   [***] €    40
cm length    [***] €   [***] €   [***] €   [***] €    60 cm length    [***] €  
[***] €   [***] €   [***] €    100cm length    [***] €   [***] €   [***] €  
[***] € Bifurcation    [***] €   [***] €   [***] €   [***] € Albopass with
Collagen (ATC 90XX)   Tube with side arm    60cm tube/ 40cm side arm    [***] €
  [***] €   [***] €   [***] €

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

22

--------------------------------------------------------------------------------

EXHIBIT B—DISTRIBUTION TERRITORY

 

GROUP A

 

GROUP B

Europe

 

Europe

 

Middle East / Far East and Africa

Andorra   All EU Accession countries   All Middle East countries acc. to British
definition Austria   Albania   China Belgium   Armenia   Hong-Kong Denmark  
Azerbaijan   Indonesia Finland   Belarus   Korea France   Bosnia-Herzegovina  
Malaysia Germany   Bulgaria   Morocco Greece   Croatia   Philippines
Lichtenstein   Georgia   Singapore Luxembourg   Iceland   South Africa Monaco  
Ireland   Taiwan Norway   Italy   Thailand San Marino   Macedonia   Tunisia
Spain   Moldova   Vietnam Sweden   Montenegro   Switzerland   Netherlands    
Portugal     Romania     Russia     Serbia     Turkey     United Kingdom (UK)  
  Ukraine     Vatican City  

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

23

--------------------------------------------------------------------------------

AMENDMENT TO THE SUPPLY AND DISTRIBUTION AGREEMENT

entered into between

Biomateriali Srl, an Italian limited liability company having its registered
offices at Cittadella della Ricerca s.s.7 per Mesagne, 72100 Brindisi, Italy

and

Edwards Lifesciences AG, a corporation organised under the laws of Switzerland
and having its business office at Chemin du Glapin 6, 1162 Saint-Prex,
Switzerland.

*****

By signing this Amendment, the Parties agree to amend their “Supply and
Distribution Agreement” made as of January 1, 2005 (hereinafter: “the
Agreement”) as follows:

 

1. The amendments to the Agreement stated hereafter shall take effect on
January 1, 2007.

 

2. The Agreement shall last until December 31, 2011, this date referring to the
“Initial Term” as mentioned under section 11.1.

 

3. The following sections of the Agreement shall not be effective anymore:

 

  •  

2.1. d)

 

  •  

3.3.

 

  •  

3.4.

 

4. Section 2.7 is amended and replaced as follows:

“Target Purchase Quantities. During the term of this Agreement, Edwards shall
use its commercially reasonable effort to purchase the target quantities of
[***] ([***]) units of Product (“Target Purchase Quantity”) at the prices shown
in Exhibit A, for any twelve month period starting on January 1, 2007 (“Supply
Year”).”

 

5. Section 4.5 is amended and replaced as follows:

“Prices. Pricing will be in Euro. BIOMATERIALI shall invoice for, and EDWARDS
shall pay BIOMATERIALI all delivered and accepted Products at prices set forth
in Exhibit A in the Territory set forth in Exhibit B during each Supply Year.
Any special packing or handling requested by EDWARDS shall be at the sole
expense of EDWARDS.”

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

24

--------------------------------------------------------------------------------

6. Exhibits A and B of the Agreement are replaced by the Exhibits A and B
attached to the present Amendment.

 

BIOMATERIALI SRL     EDWARDS LIFESCIENCES AG

/s/ Pierpaolo Cerani

   

/s/ Patrick Verguet

Pierpaolo Cerani     Patrick Verguet Managing Director     President Europe

 

    23 Jan 2007 Place and Date:     Place and Date:

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

25

--------------------------------------------------------------------------------

List of Exhibits

 

A. Products, Prices

 

B. Distribution Territory

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

26

--------------------------------------------------------------------------------

EXHIBIT A—PRODUCTS AND PRICES

 

Graft Type / Length

   Unit Price
effective from Jan 1, 2007   Albograft without Collagen (AMO, ATO)   Straight
tube   Any length    [***] € Bifurcation    [***] € Albograft with Collagen
(AMC, ATC)   Straight tube   7.5cm length    [***] €   15cm length    [***] €  
30cm length    [***] €   40cm length    [***] €   60cm length    [***] €   100cm
length    [***] € Bifurcation    [***] € Albograft with Collagen (ATC 90XX)  
Straight tube with 1 side arm   60cm tube length/ 40cm side arm    [***] €

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

27

--------------------------------------------------------------------------------

EXHIBIT B—DISTRIBUTION TERRITORY

 

Europe

 

Middle East / Far East and Africa

Andorra   All EU Accession countries   All Middle East countries acc. to British
definition Austria   Albania   China Belgium   Armenia   Hong-Kong Denmark  
Azerbaijan   Indonesia Finland   Belarus   Korea France   Bosnia-Herzegovina  
Malaysia Germany   Bulgaria   Morocco Greece   Croatia   Philippines
Lichtenstein   Georgia   Singapore Luxembourg   Iceland   South Africa Monaco  
Ireland   Taiwan Norway   Italy   Thailand San Marino   Macedonia   Tunisia
Spain   Moldova   Vietnam Sweden   Montenegro   Switzerland   Netherlands    
Portugal     Romania     Russia     Serbia     Turkey     United Kingdom (UK)  
  Ukraine     Vatican City  

 

FOIA CONFIDENTIAL TREATMENT REQUESTED

 

28