Document:

Supply and Distribution Agreement

 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. 

  

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	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. 

  

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	 	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. 

  

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	 	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. 

  

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	 	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. 

  

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 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 

  

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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 

  

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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.

  

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	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

  

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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
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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 

  

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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. 

  

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	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 (AlbograftTM) 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’ 

  

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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 

  

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	 	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 

  

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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. 

  

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	 	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. 

  

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	 	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. 

  

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	 	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. 

  

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 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

  

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 20 

 List of Exhibits 
  

	A.	Products, Prices 

  

	B.	Territory 

  

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 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	  	[***]	€	 	[***]	€	 	[***]	€	 	[***]	€

  

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 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	 	

  

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 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.” 
  

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	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:

  

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 25 

 List of Exhibits 
  

	A.	Products, Prices 

  

	B.	Distribution Territory 

  

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 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	  	[***]	€

  

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 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	 	

  

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 28Credit Agreement dated as of November 21, 2007, between our Company and SVCH

 Exhibit 10.36 
 CREDIT AGREEMENT 
 $32,500,000.00 Credit Facility 
 by and between 
 FOREFRONT HOLDINGS,
INC., 
 a Florida corporation, 
 “Borrower” 
 and 
 STANFORD VENTURE CAPITAL HOLDINGS, INC., 
 a Delaware corporation 
 “Lender” 
 Dated as of
November 21, 2007 

 CREDIT AGREEMENT 
 THIS CREDIT AGREEMENT (the “Agreement”), dated as of November 21, 2007 (the “Effective Date”), is made by and between FOREFRONT HOLDINGS, INC., a Florida
corporation (the “Borrower”) and STANFORD VENTURE CAPITAL HOLDINGS, INC., a Delaware corporation (the “Lender”). 
 W I T N E S S E T H 
 WHEREAS, the Borrower desires to obtain a commitment from the
Lender to make loans to the Borrower; and 
 WHEREAS, the Lender is willing to extend the commitment to the Borrower on the terms and
subject to the conditions hereinafter set forth. 
 NOW, THEREFORE, in consideration of the premises and the mutual covenants and
agreements set forth herein, and other good and valuable consideration exchanged between the parties, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows: 
 ARTICLE I - DEFINITIONS 
 Section 1.1 Definitions. In addition to terms defined elsewhere in this Agreement, the following terms have the meanings indicated which meanings shall be equally applicable to both the singular and the plural forms of such
terms: 
 1.1.1 “Affiliate” shall mean any Person (other than a Subsidiary) which directly or indirectly
through one or more intermediaries controls, or is controlled by or is under common control, with a Borrower, or 5% or more of the equity interest of which is held beneficially or of record by the Borrower or a Subsidiary. The term
“control” means the possession, directly of indirectly, of the power to cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise. 
 1.1.2 “Agreement” means this Credit Agreement, as the same may from time to time be amended. 
 1.1.3 “Borrower” has the meaning assigned to that term in the introduction to this Agreement. 
 1.1.4 “Borrowing” shall mean the drawing down by the Borrower of a loan or loans from the Lender on any given Borrowing
Date. 
 1.1.5 “Borrowing Date” shall mean the date as of which a Borrowing is consummated. 
 1.1.6 “Business Day” shall mean a day on which commercial banks are open for business in the state of Florida.

 1.1.7 “Code” shall mean the Internal Revenue Code of 1986 as amended
from time to time, and the regulations and published interpretations thereof. 
 1.1.8 “Commencement Date”
shall mean the date of execution by the Borrower of this Agreement. 
 1.1.9 “Commission” shall mean the
Securities and Exchange Commission. 
 1.1.10 “Default” means any event which, with the lapse of time, the
giving of notice, or both, would become an Event of Default. 
 1.1.11 “Default Rate” shall mean 24% per
annum. 
 1.1.12 “Director” shall mean any member of the Board of Directors of the Borrower. 
 1.1.13 “Effective Date” means the date all parties hereto have executed this Agreement and the Loan Documents and
Borrower has complied with all conditions precedent thereto. 
 1.1.14 “Entity Authorizations” shall mean
certified copies of Borrower’s articles of incorporation and bylaws and current certificates of good standing and certified resolutions or authorizations as may be required to establish the power and authority of the Borrower to execute,
deliver and perform its respective obligations under, as the case may be, the Loan Documents. 
 1.1.15 “Event of
Default” has the meaning assigned to that term in Section 7.1 hereof. 
 1.1.16 “Exchange Act”
shall mean the Securities and Exchange Act of 1934, as amended. 
 1.1.17 “Governmental Authority” shall mean
any court, board, agency, commission, office or authority of any nature whatsoever or any governmental unit (federal, state, county, district, municipal, city or otherwise) whether now or here-after in existence. 
 1.1.18 “Indebtedness” of any Person shall mean (i) all indebtedness or liability for borrowed money or for the
deferred purchase price of any property (including accounts payable to trade creditors under customary trade credit terms) or services for which the Person is liable as principal, (ii) all indebtedness (excluding unaccrued finance charges)
secured by a Lien on property owned or being purchased by the Person, whether or not such indebtedness shall have been assumed by the Person, (iii) any arrangement (commonly described as a sale-and-leaseback transaction) with any financial
institution or other lender or investor providing for the leasing to the Person of property which at the time has been or is to be sold or transferred by the Person to the lender or investor, or which has been or is being acquired from another
Person, and (iv) all obligations of partnerships or joint ventures in respect of which the Person is primarily or secondarily liable as a partner or joint venturer or otherwise (provided 

  

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that in any event for purposes of determining the amount of the Indebtedness, the full amount of such obligations, without giving effect to the contingent
liability or contributions of other participants in the partnership or joint venture, shall be included). 
 1.1.19
“Lender” has the meaning assigned to that term in the introduction to this Agreement. 
 1.1.20
“Lien” shall mean a mortgage, pledge, lien, hypothecation, assignment, security interest or other charge or encumbrance or any segregation of assets or revenues or other preferential arrangement (whether or not constituting a
security interest) with respect to any present or future assets, including fixtures, revenues or rights to the receipt of income of the Person referred to in the context in which the term is used. 
 1.1.21 “Loan” shall mean the aggregate principal amount advanced by the Lender as a loan or loans to the Borrower under
Article 2 and Article 6 hereof, or, where the context so requires. 
 1.1.22 “Loan Documents” shall mean
those documents executed or submitted in connection with the Loan, including, without limitation, (i) the Note; (ii) this Credit Agreement; and (iii) all other documents and instruments executed by the Borrower in connection with the
Loan and/or as may be required by Lender or Lender’s counsel, including those referred to in Section 6 hereof. 
 1.1.23 “Loan Funding Period” shall mean the period between the Effective Date and the Maturity Date. 
 1.1.24 “Maturity Date” shall mean September 30, 2009. 
 1.1.25 “Note” shall
mean the Subordinated Promissory Note described in Section 2.2 hereof, in the principal amount of $32,500,000.00 dated the initial Borrowing Date and payable to the order of the Lender, substantially in the form of Exhibit “A”
attached hereto and made a part hereof, and any modifications, renewals, replacements or substitutions therefor made from time to time hereafter, and to the extent applicable. 
 1.1.26 “Obligations” shall mean any and all liabilities, obligations, covenants, duties and debts, owing by the Borrower
to the Lender, arising under this Agreement or any other Loan Document, including without limitation, all interest, charges, indemnities, expenses, fees, attorneys’ fees, filing fees and any other sums chargeable to the Borrower hereunder or
under any other Loan Document, or any other contractual agreement between the Lender and the Borrower. 
 1.1.27
“Person” shall mean any natural person, corporation, unincorporated organization, trust, joint-stock company, joint venture, association, company, partnership or government, or any agency or political subdivision of any government,
or other entity of whatever nature. 
  

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 1.1.28 “Securities Act” shall mean the Securities Act of 1933, as
amended and the rules promulgated thereunder. 
 1.1.29 “Subsidiary” shall mean any Person in which the
Borrower may own, directly or indirectly, an equity interest of more than 50%, or which may effectively be controlled by the Borrower, during the term of this Agreement. 
 Section 1.2 Accounting Terms. Accounting terms not specifically defined in this Agreement shall have the meaning given to them under accounting principles and practices generally accepted in the United
States, applied on a consistent basis with the financial statements referred to in Section 3.3 hereof, and shall be determined both as to classification of items and amounts in accordance therewith. All Subsidiaries shall be consolidated to the
fullest extent permitted by such principles and practices, and any accounting terms, financial covenants and financial statements referred to herein shall be determined and prepared on the basis of such consolidation. 
 Section 1.3 Other Definitional Provisions. The words “hereof,” “herein,” and “hereunder” and words of similar
import when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement, and Section, Subsection and Exhibit references are to this Agreement unless otherwise specified. 
 ARTICLE II - LOAN 
 Section 2.1
Loan. Lender shall loan to the Borrower a gross amount of $32,500,000.00 in accordance with draw requests made by the Borrower from time to time. The Borrower shall submit each draw request to Lender at least four weeks before the desired
funding date. All draw requests shall be subject to approval by Lender in its sole and absolute discretion. 
 Section 2.2 Note.
In consideration of the Loan, the Borrower shall execute and deliver in favor of Lender a subordinated promissory note in the form and content substantially the same as Exhibit “A” attached hereto (the “Note”).

 Section 2.3 Use of Proceeds. The Borrower will use the net proceeds of the Loan (i) to refinance the loans from Lender to
the Borrower in the outstanding principal amount of $5,950,000 initially made by Stanford International Bank Limited (“SIBL”) to the Borrower; (ii) to refinance the loan of $5,030,000 from SIBL to the Borrower in
connection with various corporate restructuring transactions consummated in September 2007; (iii) to pay all of Lender’s reasonable costs and expenses incurred in connection with the Loan as described in Section 2.4, below;
(iv) for the general working capital purposes of Forefront Group, Inc., the Borrower’s Subsidiary. 
 Section 2.4
Expenses. Immediately upon the execution of this Agreement, Borrower shall pay all of Lender’s reasonable costs and expenses including, without limitation, reasonable attorneys’ fees, incurred in connection with the Loan.

  

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 ARTICLE III - REPRESENTATIONS AND WARRANTIES 
 In order to induce the Lender to enter into this Agreement and to make the Loan provided for herein, the Borrower makes the following representations and
warranties to the Lender, all of which are true and correct as of the date hereof and shall be true and correct as of the date of each draw of Loan funds, and all of which shall survive the execution and delivery of this Agreement, the Note and the
other Loan Documents: 
 Section 3.1 Corporate Existence and Power. The Borrower is duly organized validly existing and in good
standing under the laws of its state of organization and is duly qualified or licensed to transact business in all places where such qualification or license is necessary. The Borrower has the power to enter into and perform this Agreement and the
Loan Documents, to the extent that it has executed such documents, and this Agreement does, and the Loan Documents when duly executed and delivered for value will, constitute the legal, valid and binding obligations of the Borrower enforceable in
accordance with their respective terms. 
 Section 3.2 Authority. The making and performance by the Borrower of this Agreement,
the Note, the Loan Documents, and any additional documents pursuant hereto, has been duly authorized by all necessary legal action of the Borrower, and does not and will not violate any provision of law or regulation, or any writ, order or decree of
any court, governmental, regulatory authority or agency, and does not and will not, with the passage of time or the giving of notice, result in a breach of, or constitute a default or require any consent under, or result in the creation of any lien,
charge or encumbrance upon any property or assets of the Borrower, pursuant to any instrument or agreement to which the Borrower is a party or by which the Borrower or its properties may be bound or affected. 
 Section 3.3 Financial Condition. The financial statements of the Borrower set forth in the periodic filings made by the Borrower with the
Commission through the quarter ended September 30, 2006 were prepared in accordance with generally accepted accounting principles consistently applied, are complete and correct and fairly present the consolidated financial condition of the
Borrower, and its Subsidiaries, as of that date. Monthly unaudited balance sheets and statements of income and cash flow for the Borrower as of and for the months ended on October 31, 2006 through September 30, 2007 have been provided to
the Lender (the “Interim Financial Statements”). All such Interim Financial Statements are true, complete and correct in all material respects, were prepared in accordance with accounting practices and procedures historically
used by the Borrower applied on a consistent basis throughout the periods covered thereby and present fairly the financial condition of the Borrower as of such dates and the results of operations and cash flows for the periods then ended. Other than
as disclosed by the financial statements described in this Section 3.3, the Borrower has no direct or contingent obligations or liabilities which would be material to the financial position of the Borrower or any material unrealized or
anticipated losses from any commitments of the Borrower. Since the date of such financial statements, there has been no material adverse change in the business or financial condition of the Borrower. 
 Section 3.4 Full Disclosure. The financial statements referred to in Section 3.3 do not, nor does this Agreement, nor any written
statement furnished by the Borrower to the Lender in connection with the negotiation of this Agreement or the Loan, contain any untrue statement of a material fact or omit a material fact necessary to make the statements contained therein or herein
not misleading. 

  

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There is no fact which the Borrower has not disclosed to the Lender in writing which materially and adversely affects nor, so far as the Borrower can now
foresee, is reasonably likely to prove to materially and adversely affect the business or financial condition of the Borrower or the ability of the Borrower to perform this Agreement, the Note or any other Loan Document. 
 Section 3.5 Litigation. Except to the extent disclosed in Schedule 3.5 attached hereto, there are no suits, actions or proceedings pending,
or to the knowledge of the Borrower, threatened before any court or by or before any governmental or regulatory authority, commission, bureau or agency or public regulatory body against or affecting the Borrower which, if adversely determined, would
have a material adverse effect on the business or financial condition of the Borrower. 
 Section 3.6 Payment of Taxes. As of the
date of execution of this Agreement, federal income tax returns of the Borrower have been filed with Internal Revenue Service and no deficiencies have been assessed. The Borrower has filed or caused to be filed, or has obtained extensions to file
all federal, state and local tax returns which are required to be filed, and have paid or caused to be paid, or have reserved on their books amounts sufficient for the payment of, all taxes as shown on said returns or on any assessment received by
them, to the extent that the taxes have become due, except as otherwise permitted by the provisions hereof. The Borrower has established reserves which are reasonably believed by the Borrower to be adequate for the payment of said taxes for the
years that have not been audited by the respective tax authorities. 
 Section 3.7 No Adverse Restrictions or Defaults. Except as
set forth in Schedule 3.7 attached hereto, the Borrower is not a party to any agreement or instrument or subject to any court order or judgment, governmental decree, charter or other restriction adversely or materially affecting its business,
properties or assets, operations or condition (financial or otherwise). The Borrower is not in material default in the performance, observance or fulfillment of any of the obligations, covenants or conditions contained in any material agreement or
instrument to which it is a party or by which the Borrower and its properties, may be bound or affected, or under any material law, regulation, decree, order or the like, which default would have a material adverse effect on the Borrower.

 Section 3.8 Authorizations. All material authorizations, consents, approvals and licenses required under applicable law or
regulation for the ownership or operation of the property owned or operated by the Borrower or for the conduct of business in which the Borrower is engaged, have been duly issued and are in full force and effect, and to the best of Borrower’s
knowledge, the Borrower is not in default under any material order, decree, ruling, regulation, closing agreement or other decision or instrument of any government commission, bureau or other administrative agency or public regulatory body having
jurisdiction over the Borrower, which default would have a material adverse effect on the Borrower. No approval, consent or authorization of or filing or registration with any governmental commission, bureau or other regulatory authority or agency
is required with respect to the execution, delivery or performance of this Agreement, the Note or any of the Loan Documents executed in connection with the making of the Loan, other than filings required under applicable securities laws which shall
have been duly made by the Borrower as of the Effective Date. 
  

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 Section 3.9 Title to Property. The Borrower and each of its Subsidiaries have, respectively,
good and marketable title to all of its property and assets, reflected in the latest financial statements referred to in Section 3.3 or purported to have been acquired by any of them subsequent to such date, except property and assets sold or
otherwise disposed of subsequent to such date in the ordinary course of business. Except as set forth on Schedule 3.9 attached hereto and as disclosed on the financial statements provided to the Lender and referred to in Section 3.3 hereof, all
property and assets of any kind of the Borrower, and each of its Subsidiaries, are free from any liens, claim or encumbrances. The Borrower and each of its Subsidiaries enjoy peaceful and undisturbed possession under all of the leases under which
they are operating, if any, none of which contain any provisions that will materially impair or adversely affect the operations of the Borrower, as the case may be. 
 Section 3.10 Indemnification by Borrower. All of the representations and warranties of the Borrower, as set forth in this Agreement shall survive the making of this Agreement and the full repayment of the
Loan; accordingly, in the event of any claims against Lender, resulting from the breach of any of the foregoing warranties and representations, the Borrower shall and hereby agrees to indemnify Lender for any such claims notwithstanding the full
repayment of the Loan. Each and every requisition submitted by Borrower for funds under this Agreement shall constitute a new and independent representation and warranty to Lender with respect to all of the matters set forth in this Agreement, as of
the date of such requisition. 
 ARTICLE IV - AFFIRMATIVE COVENANTS 
 The Borrower covenants and agrees that from and after the Effective Date and until payment in full of the principal of and interest on the Note, unless
the Lender shall otherwise consent in writing, the Borrower will: 
 Section 4.1 Loan Proceeds. Use the proceeds of the Loans only
for the purposes set forth in Section 2.3 and furnish the Lender with all evidence that it may reasonably require with respect to such use. 
 Section 4.2 Existence. Do or cause to be done all things necessary to preserve and keep in full force and affect its legal existence, rights, franchises and privileges in the jurisdiction of its organization, and qualify and
remain qualified in each jurisdiction where qualification is necessary or desirable in view of its business operations or the ownership of its properties. 
 Section 4.3 Maintenance of Business and Property. Continue to conduct and operate its business substantially as conducted and operated during the present and preceding calendar year and as currently
contemplated for the future; at all times maintain, preserve and protect all franchises and trade names and preserve all the remainder of its property used or useful in the conduct of its business and keep the same in good repair, working order and
condition, and from time to time make, or cause to be made, all needful and proper repairs, replacements, betterments and improvements thereto so that the business carried on in connection therewith may be conducted properly and advantageously at
all times. 
 Section 4.4 Insurance. Insure and keep insured in good and financially sound and responsible insurance companies
reasonably satisfactory to the Lender, all insurable property owned by it which is of a character usually insured by companies similarly situated 

  

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and operating like properties, against loss or damage from such hazards or risks, including fire, flood and windstorm as are insured by companies similarly
situated and operating like properties, insure and keep insured employers’ and public liability risks in responsible insurance companies to the extent usually insured by companies similarly situated; and maintain such other insurance as may be
required by law or as may reasonably be required in writing by the Lender. 
 Section 4.5 Payment of Indebtedness, Taxes, Etc.

 4.5.1 Pay all of its indebtedness and obligations promptly and in accordance with normal terms; and 
 4.5.2 Pay and discharge or cause to be paid and discharged promptly all taxes, assessments and governmental charges or levies imposed upon
it or upon its property or upon any part thereof, before the same shall become in default, as well as all lawful claims for labor, materials and supplies or otherwise which, if unpaid, might become a lien or charge upon such properties or any part
thereof; provided however, that the Borrower shall not be required to pay and discharge or to cause to be paid and discharged any tax, assessment, charge, levy or claim so long as the validity thereof shall be contested in good faith by appropriate
proceedings and the Borrower shall have set aside on its books adequate reserves with respect to any tax, assessment, charge, levy or claim, so contested. 
 Section 4.6 Compliance with Laws. Duly observe, conform and comply with all laws, decisions, judgments, rules, regulations and orders of all governmental authorities applicable to the conduct of its
business, its properties, and assets, except those being contested in good faith by appropriate proceedings diligently pursued; and maintain and keep in full force and effect all licenses and permits necessary to the proper conduct of its business.

 Section 4.7 Notice of Default. Upon the occurrence of any Default or Event of Default, promptly furnish written notice thereof
to the Lender. 
 Section 4.8 Inspection. At reasonable times and after reasonable prior written notice, the Borrower shall
permit any representatives of Lender to visit and inspect any of the properties of the Borrower, to examine and copy all books of account, records, reports and other papers, and to discuss the affairs, finances and accounts with Borrower’s
employees and independent accountants at all such reasonable times and as often as may be reasonably requested. 
 Section 4.9 Notice
of Litigation and Other Proceedings. Give prompt notice in writing to the Lender of the commencement of: (a) all material litigation which, if adversely determined, might adversely affect the business or financial condition of the Borrower;
(b) all other litigation involving a claim against the Borrower for $25,000 or more in excess of applicable insurance coverage; and (c) any citation, order, decree, ruling or decision issued by, or any denial of any application or petition
to, or any proceeding before any governmental commission, bureau or other administrative agency public regulatory body against or affecting the Borrower, or any property of the Borrower or any lapse, suspension or other termination or modification
of any certification, license, consent or other authorization of any agency or public regulatory body, or any refusal of any thereof to grant any application therefor, in connection with the operation of any business conducted by the Borrower.

  

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 ARTICLE V - NEGATIVE COVENANTS 
 The Borrower covenants and agrees that from the Effective Date and until payment in full of the principal of and interest on the Note, unless the Lender
shall otherwise consent in writing, the Borrower will not: 
 Section 5.1 Limitation of Liens. Except as otherwise permitted by
the Loan Documents, create, assure, incur or suffer to exist any Lien upon, or transfer or assignment of, any of its property or revenues or assets now owned or hereafter acquired to secure any Indebtedness of obligations, or enter into any
arrangement for the acquisition of any property subject to conditional sale agreements or leases or other title retention agreements; excluding, however, from the operation of this covenant: (i) deposits or pledges to secure payment of
worker’s compensation, unemployment insurance, old age pensions or other social security; (ii) deposits or pledges to secure performance of bids, tenders, contracts (other than contracts for the payment of money) or leases, public or
statutory obligations, surety or appeal bonds or other deposits or pledges for purposes of like general nature in the ordinary course of business; (iii) Liens for property taxes not delinquent and Liens for taxes which in good faith are being
contested or litigated; (iv) mechanics’, carriers’, workmen’s, repairmen’s or other like liens arising in the ordinary course of business securing obligations which are not overdue for a period of 60 days or more or which
are in good faith being contested or litigated; (v) Liens securing the unpaid purchase price of equipment purchased by the Borrower in the ordinary course of its business and Liens existing upon assets acquired by the Borrower; (vi) Liens
on the capital stock of Forefront Group, Inc. and Miller Golf Company pursuant to a stock pledge in favor of FCC, LLC, d/b/a First Capital, a Florida limited liability company (“FCC”); and (vii) any existing Liens reflected in the
financial statements referred to in Section 3.3 hereof. 
 Section 5.2 Limitation on Indebtedness. Incur, create, assume or
permit to exist any Indebtedness, except 
 5.2.1 The Note and any other Indebtedness of the Borrower to the Lender;

 5.2.2 Indebtedness which is subordinated to the prior payment in full of the principal of, and interest on, the Note(s) on
terms and conditions approved in writing by the Lender; 
 5.2.3 Indebtedness representing the unpaid purchase price of
equipment purchased by the Borrower in the ordinary course of its business and Indebtedness existing upon assets acquired by the Borrower; 
 5.2.4 Existing Indebtedness reflected in the audited financial statements and Interim Financial Statements referred to in Section 3.3 hereof. 
 Section 5.3 Mergers, Consolidations and Acquisition of Assets. Wind up, liquidate, dissolve, merge or consolidate with any corporation or
entity, or acquire all or substantially all of the assets of any corporation except that the Borrower may merge or consolidate with any Subsidiary provided that the Borrower is the surviving corporation. 
  

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 Section 5.4 Sale, Lease, Etc. Sell, lease, assign, transfer or otherwise dispose of any of
its assets or revenues (other than obsolete or worn-out personal property or personal property or real estate not used or useful in its business) whether now owned or hereafter acquired, other than in the ordinary course of business. 
 Section 5.5 Management and Ownership. Permit any material change in its ownership or management. 
 Section 5.6 General. 
  

	 	(i)	engage, directly or through other Persons, in any business other than the business now carried on; 

  

	 	(ii)	change its articles of incorporation, bylaws or other charter documents except as contemplated hereby; 

  

	 	(iii)	declare or pay dividends or make any other distribution or redeem any of its equity securities; or 

  

	 	(iv)	enter into or modify a material related-party transaction. 

 ARTICLE VI - CONDITIONS TO LENDER’S OBLIGATIONS TO MAKE THE LOAN 
 The conditions listed below are precedent to any
obligations of the Lender hereunder and shall be complied with in form and substance satisfactory to Lender and its counsel prior to the Lender’s obligation to advance any portion of the Loan: 
 Section 6.1 Each Advance. The obligation of the Lender to make each advance pursuant to Article 2 herein is subject to no adverse change in
the condition, financial or otherwise of the Borrowers and no default or the occurrence of any event which with notice or passage of time would become a default under this Agreement or any of the Loan Documents, and is subject to the following
conditions precedent, each of which shall have been met or performed by the Borrowing Date: 
 6.1.1 Lender Approval.
The Lender shall have approved the advance; 
 6.1.2 No Default. (i) No Default or Event of Default shall have
occurred and be continuing or will occur upon the making of the Loan on such Borrowing Date, and all representations and warranties made by the Borrower herein or otherwise in writing in connection herewith shall be true and correct in all material
respects with the same effect as though the representations and warranties had been made on and as of such Borrowing Date, and (ii) a certificate to this effect shall have been issued to the Lender on such Borrowing Date by the Borrower’s
Chief Financial Officer; and 
  

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 6.1.3 Use of Proceeds. The Loan proceeds shall have theretofore been applied in
accordance with the use of proceeds as set forth in Section 2.3 hereof. 
 Section 6.2 Release of Guaranty. At or prior to
the Effective Date, the Borrower shall have provided evidence to the Lender of the unconditional release of the Guaranty, and all obligations thereunder, executed by the Borrower in favor of FCC in connection with the FCC Loan Agreement. 

Section 6.3 Note. The Note shall have been duly executed and delivered to the Lender. 
 Section 6.4 Supporting Documents. The Borrower shall have executed and delivered, or caused to be executed and delivered, to the Lender each
of the certificates and the other Loan Documents and all additional documents and certificates that the Lender or its counsel may require, and all such certificates and documents specified in this Article 6 shall be reasonably satisfactory in form
and substance to the Lender and its counsel. The Lender shall cause SIBL to execute the waiver in the form of Exhibit “B” attached hereto. 
 Section 6.5 Expenses. The Borrower shall have paid all of Lender’s reasonable fees and expenses incurred in connection with this Agreement. In addition, the Borrower shall have paid all applicable
documentary stamp taxes, intangible taxes and other closing costs. 
 Section 6.6 Pre-Funding Conditions and Requirements.
Borrowers shall furnish to Lender each of the following items, satisfactory in form and content to Lender, at Borrower’s sole expense prior to any Loan disbursements: 
 6.6.1 Certificate of Status and certified copy of articles of incorporation of the Borrower, issued by the state of formation, together
with certified copies of Borrower’s by-laws, and a certificate as to incumbency and adoption of authorizing resolutions by the Borrower. 
 6.6.2 Current financial statements of the Borrower and the Guarantor. 
 6.6.3 There shall
have been no material adverse change in the financial condition of the Borrower or the Guarantor; nor any material adverse event or condition affecting the Borrower or the Guarantor, or the validity or enforceability of the Loan. 
 6.6.4 Compliance with all conditions, requirements, agreements, instruments, and financial statements required herein must be satisfactory
in form and content to Lender and its counsel. 
 6.6.5 The Loan shall be evidenced and secured by final, definitive Loan
Documents all effectuating the Loan terms and conditions set forth herein and containing such other provisions as Lender shall require. 
 6.6.6 Borrower shall provide such other documents as may be reasonably required by Lender’s counsel, including documents which verify and confirm Borrower’s representations, warranties and covenants to
Lender. 
  

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 ARTICLE VII - EVENTS OF DEFAULT 
 Section 7.1 Events of Default. If any one of the following “Events of Default” shall occur and shall not have been
remedied: 
 7.1.1 Any representation or warranty made or deemed made by the Borrower herein or in any of the other Loan
Documents, or in any certificate or report furnished by the Borrower at any time to the Lender, shall prove to have been incorrect, incomplete or misleading in any material respect on or as of the date made or deemed made; or 
 7.1.2 The Borrower shall fail to pay, when due, any principal of or interest on the Note, or to pay when due any other sum payable under
this Agreement and the same is not paid within 10 days after written notice from Lender; or 
 7.1.3 Any default by the
Borrower under any Indebtedness or other obligation to the Lender or any of its Affiliates which is not cured within any grace periods provided thereunder or otherwise is not otherwise waived by the Lender or its Affiliate; or 
 7.1.4 The Borrower shall default in any material respect in the performance of any agreement, covenant or obligation contained herein or
in any of the other Loan Documents if the default continues for a period of 30 days after notice of default to the Borrower by the Lender; or 
 7.1.5 Final judgment for the payment of money in an amount in excess of $50,000 shall be rendered against the Borrower and the same shall remain undischarged for a period of 30 days, during which period execution
shall not effectively be stayed, provided the Borrower, as applicable, will have the right to contest in good faith by appropriate proceedings and provided the Borrower shall have set aside on its books adequate reserves for payment of such money;
or 
 7.1.6 The Borrower’s default in the performance of its obligations with respect to any Indebtedness in excess of
$25,000 or as lessor or as lessee under any lease of all or any material portion of its property, after the expiration of any applicable cure periods other than any default which is waived; or 
 7.1.7 The Borrower shall cease to exist or to be qualified to do or transact business in the states in which its property, assets or
business are located, or shall be dissolved or terminated or shall be a party to a merger or consolidation, or shall sell all or substantially all of its assets; or 
 7.1.8 If, without the prior written consent of Lender, which consent shall be in Lender’s sole and absolute discretion, any equity
interest in the Borrower is issued, sold, transferred, conveyed, assigned, mortgaged, pledged, or otherwise disposed of, whether voluntarily or by operation of law, and whether with or without consideration, or any agreement for any of the foregoing
is entered into; or 
 7.1.9 The Borrower shall (i) voluntarily terminate operations or apply for or consent to the
appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator of the Borrower, as the case may be, or of all or of a substantial part of 

  

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the assets of the Borrower, as the case may be, (ii) admit in writing its inability, or be generally unable, to pay its debts as the debts become due,
(iii) make a general assignment for the benefit of its creditors, (iv) commence a voluntary case under the United States Bankruptcy Code (as now or hereafter in effect), (v) file a petition seeking to take advantage of any other law
relating to bankruptcy, insolvency, reorganization, winding-up, or composition or adjustment of debts, (vi) fail to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed against it in an involuntary case
under the Bankruptcy Code, or (vii) take any corporate action for the purpose of effecting any of the foregoing; or 
 7.1.10 The Borrower shall fail to furnish to the Lender notice of default in accordance with Section 4.7 hereof, within 10 days after any such notice of default becomes known to the Chief Executive Officer or Chief Financial Officer of
the Borrower, whether or not notification to the Borrower is furnished by the Lender. 
 Section 7.2 Remedies. In the case of any
such Event of Default, the Lender may, by written notice to the Borrowers, at its option: (A) immediately terminate the commitment of the Lender to advance funds hereunder, (B) to the extent permitted by law, the rate of interest on the
unpaid principal amount of the Loan shall be increased, at the Lender’s option, to the Default Rate, (C) immediately declare the principal of, and interest accrued on, the Note immediately due and payable without presentment, demand,
protest or notice, whereupon the same shall become immediately due and payable and/or (D) exercise any and all rights available under applicable law. 
 ARTICLE VIII - MISCELLANEOUS 
 Section 8.1 No Waiver, Remedies Cumulative. No failure on
the part of the Lender to exercise and no delay in exercising any right hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right hereunder preclude any other or further exercise thereof or the exercise of
any other right. The remedies herein provided are cumulative and are not exclusive of any remedies provided by law. 
 Section 8.2
Survival of Representations. All representations and warranties made herein shall survive the making of the loans hereunder and the delivery of the Note, and shall continue in full force and effect so long as the Note is outstanding and
unpaid and the commitment to make the Loan has not been terminated. 
 Section 8.3 Notices. Any notice or other communication
hereunder to any party hereto shall be by hand delivery, facsimile, recognized overnight courier or registered or certified mail, return receipt requested, and shall be deemed to have been given or made when delivered to the party at its address or
fax number specified next to its signature hereto (or at any other address that the party may hereafter specify to the other parties in writing). 
 Section 8.4 Construction. This Agreement and the Note shall be deemed a contract made under the law of the State of Florida and shall be governed by and construed in accordance with the law of said state and any suit, action or
proceeding arising out of or relating to this Agreement may be commenced and maintained in any court of competent subject matter jurisdiction in Miami-Dade County, Florida, and any objection to such jurisdiction and venue is hereby expressly waived.

  

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 Section 8.5 Successors and Assigns. This Agreement shall be binding upon and shall inure to
the benefit of the Borrower and the Lender, and their respective successors and assigns, provided, that the Borrower may not assign any of its rights hereunder without the prior written consent of the Lender, which may be arbitrarily withheld, and
any such assignment will be void. 
 Section 8.6 Limit on Interest. Anything herein or in the Note to the contrary
notwithstanding, the obligations of the Borrowers under this Agreement and the Note to the Lender shall be subject to the limitation that payments of interest to the Lender shall not be required to the extent that receipt of any such payment by the
Lender would be contrary to provisions of law applicable to the Lender (if any) which limit the maximum rate of interest which may be charged or collected by the Lender; provided however, that nothing herein shall be construed to limit the Lender to
presently existing maximum rates of interest, if any increased interest rate is hereafter permitted by reason of applicable federal or state legislation. 
 Section 8.7 Counterparts. This Agreement may be executed in any number of counterparts and by different parties hereto in separate counterparts, each of which when so executed and delivered shall be deemed
to an original and all of which when taken together shall constitute but one and the same instrument. 
 Section 8.8 Headings.
The headings are for convenience only and are not to affect the construction of or to be taken into account in interpreting the substance of this Agreement. 
 Section 8.9 Severability. In the event that any one or more of the provisions contained in this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any other provision of this Agreement, but this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein. 
 Section 8.10 Entire Agreement. This Agreement is intended by the parties as a final expression of their agreement with respect to the subject
matter hereof and is intended as a complete and exclusive statement of the terms and conditions thereof, and this Agreement supersedes and replaces all prior negotiations and agreements between the parties hereto, or any of them, whether oral or
written. Each of the parties hereto acknowledges that no other party, agent or attorney of any other party, has made any promise, representation or warranty whatsoever, expressed or implied, not contained herein concerning the subject matter hereof
to induce the other party to execute this Agreement or any of the other documents referred to herein, and each party hereto acknowledges that it has not executed this Agreement or such other documents in reliance upon any such promise,
representation or warranty not contained herein. 
 Section 8.11 Construction. The Loan Documents were drafted with the joint
participation of the Borrower and Lender, and their respective counsel, and shall be construed neither against nor in favor of any of them, but rather in accordance with the fair meaning thereof. 
  

 14 

 Section 8.12 Course of Dealing; Amendment; Supplemental Agreements. No course of dealing
between the Lender and the Borrower shall be effective to amend, modify or change any provision of this Agreement. This Agreement or any document executed in connection herewith, may not be amended, modified, or changed in any respect except by
agreement in writing signed by the Lender and the Borrower. 
 Section 8.13 Indemnification. The Borrower hereby agrees to hold
the Lender and its officers, directors, employees, affiliates, shareholders, representatives, attorneys and agents harmless from and against all claims, damages, liabilities and expenses, including reasonable attorney fees and disbursements of
counsel, which may be incurred by or asserted against any of them in connection with or arising out of any investigation, litigation, or proceeding relating to the Loan, except that the Borrowers shall not be required to indemnify the Lender to the
extent that such claims, damages, liabilities or expenses arise from the gross negligence or willful misconduct of Lender. 
 Section 8.14 Waiver of Jury Trial. BORROWER AND LENDER KNOWINGLY, VOLUNTARILY AND INTENTIONALLY WAIVE THE RIGHT EITHER MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION BASED HEREON OR ARISING OUT OF, UNDER, OR IN
CONNECTION WITH, THIS AGREEMENT OR ANY DOCUMENT EXECUTED IN CONJUNCTION HEREWITH, OR ANY COURSE OF CONDUCT, COURSE OF DEALING, STATEMENTS (WHETHER VERBAL OR WRITTEN) OR ACTIONS OR EITHER PARTY. THIS PROVISION IS A MATERIAL INDUCEMENT TO THE LENDER
ENTERING INTO THIS AGREEMENT AND MAKING ANY LOAN, ADVANCE OR OTHER EXTENSION OF CREDIT TO THE BORROWER. 
 (Signatures on next page)

  

 15 

 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be effective on the date
first written above. 
  

			
	BORROWER:
	
	FOREFRONT HOLDINGS, INC.
		
	By:	 	  

	Name:	 	  

	Title:	 	  

		
	Address:	 	 Forefront Holdings, Inc.

		 	 835 Bill Jones Industrial Drive

		 	 Springfield, Tennessee 37172

		 	 Attention: Chief Executive Officer

		 	 Facsimile: (615) 384-1290

	
	LENDER:
	
	STANFORD VENTURE CAPITAL HOLDINGS, INC.
		
	By:	 	  

	Name:	 	  

	Title:	 	  

		
	Address:	 	 Stanford Venture Capital Holdings, Inc.

		 	 6075 Poplar Avenue

		 	 Memphis, Tennessee 38119

		 	 Facsimile: (901) 680-5265

  

 16 

 SCHEDULE 3.5 
 LITIGATION 
 None. 

 SCHEDULE 3.7 
 NO ADVERSE RESTRICTIONS OR DEFAULTS 
 None. 

 SCHEDULE 3.9 
 TITLE TO PROPERTY 
 None.

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