Document:

Exhibit 10.8

 

THIS SUBORDINATED
CONVERTIBLE NOTE IS SUBJECT, IN ALL RESPECTS TO THE  SUBORDINATION AGREEMENT DATED MARCH 31,
2010 BY AND AMONG HEALTHPOINTCAPITAL
PARTNERS II, L.P., EACH OF THE ENTITIES LISTED ON THE SIGNATURE PAGE
ATTACHED THERETO, AND MIDCAP FUNDING I,
LLC, AS AGENT FOR THE SENIOR LENDERS REFERRED TO THEREIN.

 

AMENDED
AND RESTATED

SUBORDINATED
CONVERTIBLE NOTE

 

$ 36,869,813.00

 

January 1, 2010

 

FOR VALUE RECEIVED, BIOHORIZONS,
INC., a Delaware corporation (“Borrower”), promises to pay to HEALTHPOINTCAPITAL
Partners II, LP, a Delaware limited partnership (“Lender”), at its principal
offices at 505 Park Avenue, 12th Floor, New York, New York 10022 or such other
location as Lender may designate, the principal amount of THIRTY-SIX MILLION
EIGHT HUNDRED SIXTY-NINE THOUSAND EIGHT HUNDRED THIRTEEN DOLLARS (U.S.
$36,869,813.00) (the “Principal Amount”),
plus interest accrued and accruing from and after December 31, 2009, and
any other amounts that may be due hereunder, upon the terms and conditions specified
below.

 

THIS AMENDED AND RESTATED
SUBORDINATED CONVERTIBLE NOTE REPLACES IN ITS ENTIRETY THAT CERTAIN
SUBORDINATED CONVERTIBLE NOTE ORIGINALLY ISSUED IN JUNE 2009 MADE BY BORROWER
TO LENDER, OF LIKE TENOR HEREWITH.

 

TERMS OF THIS NOTE

 

1.             Interest. 
Interest shall be due or payable under this Note at the rate of ten
percent (10.0%) per annum, calculated from and after December 31,
2009.  Interest shall be paid, in the
sole discretion of Lender, in either cash or Conversion Units (as hereinafter
defined).  The Principal Amount, together
with interest payable thereon and any and all costs and expenses that may
become due pursuant to paragraph 6 hereof, is referred to herein as the “Note
Amount.”

 

2.             Repayment. 
The entire unpaid Note Amount shall be due and payable on the earlier to
occur of (i) an initial public offering of Borrower’s capital stock, (ii) a
merger, consolidation or similar transaction resulting in a change of control
of Borrower, a sale of all or substantially all of the Borrower’s assets, a
sale of a majority of Borrower’s capital stock, or any other change of control
of Borrower, in each case occurring in one transaction or a series of related
transactions, or (iii) upon demand by Lender at any time after the date
eighteen months after the date hereof.

 

3.             Optional Conversion.  Any time prior to the full repayment of this
Note pursuant to paragraph 2 hereof, Lender may, at its sole discretion,
convert all or part of the then outstanding Note Amount into that number of
units consisting of shares of common stock and preferred stock of Borrower (or
equivalent securities) (the “Conversion Units”), as equals (i) 

 

 

such Note Amount divided
by (ii) the per unit price (the “Conversion Unit Price”) calculated by
valuing Borrower’s currently outstanding shares of common and preferred stock
(on a fully diluted and fully converted basis) at $500 million.  Any fraction of a share resulting from this
calculation shall be rounded upward or downward to the nearest whole
share.  The conversion right described in
this paragraph 3 may be exercised by Lender by delivery of a written notice to
Borrower, and the conversion shall be deemed to be effective on the date that
Borrower receives such written notice.

 

4.             Prepayment. 
At the election of Borrower, this Note may be prepaid in full or in part
at any time without penalty.

 

5.             Events of Acceleration.  The entire unpaid Note Amount shall become
immediately due and payable upon the insolvency of the Borrower; the filing of
a petition in bankruptcy by Borrower; the execution by Borrower of a general
assignment for the benefit of creditors; the filing by or against Borrower of a
petition in bankruptcy or a petition for relief under the provisions of the
federal bankruptcy act or another state or federal law for the relief of
debtors and the continuation of such petition without dismissal for a period of
sixty (60) days or more; or Borrower’s ceasing to carry on business.

 

6.             Collection. 
If action is instituted to collect this Note, Borrower promises to pay
to Lender all reasonable costs and expenses (including reasonable attorneys’
fees) incurred in connection with such action, which amounts shall constitute
part of the “Note Amount”.

 

7.             Default Interest. 
In the event this Note is not paid in full when due, interest shall be
payable on the outstanding Principal Amount at the rate of fifteen percent
(15%) per annum, accruing monthly, calculated from and after the date of this
Note.

 

8.             Subordination. 
Notwithstanding anything to the contrary set forth herein, this Note
shall be subordinated and subject in right and time of payment to the payment
in full of all obligations of Borrower and/or its subsidiaries for borrowed
money from any bank, commercial lender or other financial institution, together
with any interest accruing thereon after the commencement of a bankruptcy
proceeding, without regard to whether or not such interest is an allowed claim
(the “Senior Indebtedness”).  Each holder
of the Senior Indebtedness, whether now outstanding or hereafter created,
incurred, assumed or guaranteed, shall be deemed to have acquired Senior
Indebtedness in reliance upon the provisions contained in this Note.

 

9.             Waivers. 
No delay on the part of Lender in exercising any right or remedy
hereunder shall operate as a waiver of such right or remedy.  No single or partial exercise of a right or
remedy shall preclude other or further exercise of that or any other right or
remedy.  The failure of Lender to insist
upon the strict performance of any term of this Note, or to exercise any right
or remedy hereunder, shall not be construed as a waiver or relinquishment by
Lender for the future of that term, right or remedy.  No waiver of any right of Lender hereunder
shall be effective unless in writing executed by the Lender.  The parties hereby expressly waive
presentment, demand for payment, dishonor, notice of dishonor, protest, notice
of protest, and any other formality.

 

10.           Interest Savings Clause.  If any interest payment (or other payment
which is deemed by law to be interest) is due hereunder is determined to be in
excess of the then legal maximum rate, then that portion of each interest
payment representing an amount in excess of 

 

2

 

the then legal maximum rate shall instead be deemed a
payment of principal and applied against the principal of the obligations
evidenced by this Note.

 

11.           Severability.  The unenforceability or invalidity of any
provision or provisions of this Note as to any persons or circumstances shall
not render that provision or those provisions unenforceable or invalid as to
any other provisions or circumstances, and all provisions hereof, in all other
respects, shall remain valid and enforceable.

 

12.           Governing Law.  This Note shall be governed by and construed
under the laws of the State of New York as applied to agreements among New York
residents entered into and to be performed entirely within New York.

 

	
   

  	
  BIOHORIZONS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Kendyl D. Lowe

  
	
   

  	
   

  	
  Name: Kendyl D. Lowe

  
	
   

  	
   

  	
  Title: CFO

  

 

3Exhibit 10.10

 

DISTRIBUTION AGREEMENT

 

THIS
DISTRIBUTION AGREEMENT, effective this 1st day of January 2010,
between Osteotech, Inc., a Delaware corporation having its registered
office at 51 James Way, Eatontown, New Jersey 07724 USA (hereinafter “OTI”), and
BioHorizons Implant Systems, Inc. a corporation duly organized under the
laws of USA having its registered offices at 2300 Riverchase Center,
Birmingham, Alabama 35244, its affiliates and subsidiaries (hereinafter “DISTRIBUTOR”).

 

WHEREAS,
OTI develops, manufactures or processes and markets tissue-based products and
other medical devices and desires to develop the distribution and sales of such
tissue-based products and devices in the dental markets in all regions and
provinces as set forth in Exhibit 2 of this Agreement.

 

WHEREAS,
DISTRIBUTOR is engaged in the distribution, promotion and market support of
dental implants and devices in the Countries described in Exhibit 2
attached hereto and desires to distribute OTI tissue-based products and devices
in its dental markets; and

 

WHEREAS,
OTI is willing to appoint DISTRIBUTOR and DISTRIBUTOR is willing to accept such
appointment as distributor of OTI’s tissue-based products and devices in the
Territory defined herein;

 

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

 

ARTICLE 1.

 

DEFINITIONS

 

For
purposes of this Agreement, the following words, terms and phrases, where
written with an initial capital letter, shall have the meanings assigned to
them in this Article 1 unless the context otherwise requires:

 

1.1          Business Day.  “Business
Day” shall mean any day other than a Saturday, a Sunday or any day on which
banking or government institutions in the Countries described in Exhibit 2
attached hereto or the United States of America (“USA”) are authorized or
obligated by law or executive order to be closed.

 

1.2          Products.  “Products”
shall mean the tissue based products and devices described in Exhibit 1,
attached hereto, as amended by OTI, at its sole discretion, from time to time.

 

1.3          Territory.  “Territory”
shall mean the area specifically described in Exhibit 2, attached hereto.

 

1.4          OTI Information.  “OTI
Information” shall mean all information, other than information in published
form or expressly designated by OTI as non-confidential, which is directly or
indirectly disclosed to DISTRIBUTOR or embodied in Products provided hereunder,
regardless of the form in which it is disclosed, relating in any way to OTI’s
markets, customers, tissue-based products. products, devices, patents,
inventions, procedures, methods, designs, strategies, plans, assets,
liabilities, costs, revenues, profits, organization, employees, agents,
distributors or business in general.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

1.5          Transfer Prices.  “Transfer
Prices” shall mean the prices, listed in Exhibit 3, which OTI charges the
DISTRIBUTOR for Products.

 

1.6          Market.  “Market”
shall refer to the “Dental Market” referred to in this agreement and consists
of oral surgeons, periodontists, implantologists and the dental community other
than hospitals.

 

ARTICLE 2.

 

APPOINTMENT

 

2.1          Scope.  OTI hereby
appoints DISTRIBUTOR, and DISTRIBUTOR hereby accepts such appointment, as OTI’s
distributor during the term of this Agreement with the exclusive right to sell
or otherwise distribute Products for dental applications within the Territory
and to provide customer service under OTI’s as well as OTI’s affiliates’ and
licensors’ names, logotypes, and trademarks, subject to all the terms and
conditions of this Agreement.  DISTRIBUTOR
is not authorized to actively distribute Products in the Orthopedic, Spinal and
Neurosurgical markets and DISTRIBUTOR shall not do so.  The distribution of Products in the
Orthopedic, Spinal and Neurosurgical markets within the Territory and outside
of the Territory is exclusively reserved by OTI, subject to any exclusive
distribution arrangement between OTI and another authorized distributor
relating to such markets.

 

2.2          Sales Force.  DISTRIBUTOR
shall employ, train and manage sales representatives that are experienced in
dental devices sales (or are otherwise qualified by DISTRIBUTOR as
appropriate).  The sales representatives
shall be sufficient in number and skills to execute the Marketing Plan (See Section 5.4),
and to call upon dentists who are potential users of Products. DISTRIBUTOR
shall ensure that its sales representatives work co-operatively with OTI and
OTI personnel to develop the market for OTI products in the Territory.

 

2.3          New Products.  OTI may
from time to time submit additional products for resale and distribution by
DISTRIBUTOR in the Territory.  OTI agrees
to provide DISTRIBUTOR with the right of first refusal for distribution rights
of new products in the Territory if in OTI’s reasonable judgment (1) such
new products fit in DISTRIBUTOR’s sales and service program and (2) DISTRIBUTOR
is effectively marketing OTI’s existing Products. OTI shall notify DISTRIBUTOR
of the availability of new products by written notice and DISTRIBUTOR shall
within a period of [***] ([***]) days of receipt of such notice indicate to OTI
whether or not it accepts the distribution of such new products.

 

2.4          Discontinued Products.  OTI may
discontinue, modify, reformulate, rename or repackage any of the Products on
[***] ([***]) days prior written notice to DISTRIBUTOR. Orders received and
accepted by OTI prior to the effective date of such notice shall be honored.

 

ARTICLE 3.

 

ORDERS AND CONDITIONS OF SALE

 

3.1          Order Procedure.

 

(a)           DISTRIBUTOR must submit in writing
directly to OTI Customer Service department all orders concerning the Products
for the acceptance of OTI.  DISTRIBUTOR
must place at least one purchase order per calendar quarter corresponding to
the 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

amount of Product covered by the next calendar quarter minimum purchase
requirement or forecast.  All purchase
orders are considered firm purchase orders and should be submitted at least
three months before the expected delivery.

 

All
orders transmitted by DISTRIBUTOR must clearly identify the product code,
description and quantity of the Products ordered.  Upon request by OTI, DISTRIBUTOR will provide
a [***] report of Product sales to DISTRIBUTOR to countries in the Territory.

 

(b)           Laddec® and OsteopureTM
will be shipped and invoiced by OTI French subsidiary (OST) to DISTRIBUTOR’s
European headquarters in the United Kingdom. 
All other Products will be shipped to by OTI to DISTRIBUTOR’S global
headquarters in Birmingham, Alabama.

 

(c)           Orders are not definite until OTI
issues written acceptance of the order. OTI will use best efforts to confirm
DISTRIBUTOR’s orders and delivery schedule within ([***]) [***] working days of
receipt of order.  OTI may exercise its
sole discretion in determining whether and to what extent to accept and fill
any order. DISTRIBUTOR will remain obligated for purchase of any Products
contained within accepted purchase orders.

 

(d)           DISTRIBUTOR shall provide payment
on all orders via bank wire transfer in the corresponding currency as set forth
in exhibit 3 of this Agreement no later than [***] ([***]) days from the
invoice date.

 

(e)           All sales of Products to
DISTRIBUTOR shall be executed from OTI facility. [***].

 

(f)            OTI may refuse the execution of
any order in the event of the non—payment, of any previous order in accordance
with Section 3.1(c).  OTI’s refusal
to execute any order under this section does not limit its rights to any other
remedies, including those available under this Agreement.OTI will submit
invoices to DISTRIBUTOR in US dollars in the corresponding currency as set
forth in exhibit 3 of this Agreement, with exception of Laddec® which is
invoiced in Euros.

 

(g)           Without prejudice to any other
rights of OTI set forth in this agreement, including the right to refuse to
ship Products or to terminate this agreement for breach, until any unpaid
amounts are paid in full by DISTRIBUTOR, OTI may at its sole discretion require
payment for any additional shipments of the Products in cash in advance or by
irrevocable letter of credit confirmed by a bank specified by OTI.  Late payments will bear interest at the
lesser of [***] percent ([***] %) [***] or the highest rate otherwise permitted
under applicable law.

 

3.2          Product Returns.

 

(a)           DISTRIBUTOR may return Product
that is recalled by OTI or any competent authority, or is out of specification,
for credit or replacement.  DISTRIBUTOR
must contact OTI Customer Service department with any service or Product
complaint, adverse event or similar event within 48-72 hours of
occurrence.  A return of product will
only be accepted with a return authorization number that is provided by
OTI.  Countries that require a 24 hour
response concerning product complaints, DISTRIBUTOR will agree to comply.

 

(b)           Except for Product that is
returned pursuant to Section 3.2(a) above, during the term of the
Agreement, OTI is neither required to accept Products returned by DISTRIBUTOR
nor provide replacement, credit or refund.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

ARTICLE 4.

 

TRANSFER PRICES AND INVENTORY PURCHASE TARGETS

 

4.1          Inventory Purchase Requirements. 
DISTRIBUTOR shall purchase Product from OTI during calendar year(s) as
set forth in Exhibit 5 of this Agreement.

 

4.2          Transfer Prices.  OTI shall
provide DISTRIBUTOR with a schedule of Transfer Prices, in the form of Exhibit 3
attached hereto.  OTI shall announce to
DISTRIBUTOR in writing annual changes in Transfer Prices each year by [***] to
become effective on [***] of the succeeding year.  Notice of other changes to Transfer Prices
shall be in writing, given to DISTRIBUTOR at least [***] ([***]) calendar days
in advance of their effective date.  OTI
agrees to accept and honor at the prevailing price all orders that are placed
by DISTRIBUTOR in writing and accepted in writing by OTI at least [***] ([***])
Business Days prior to the effective date of any Transfer Price changes.  At the time of the announcement of any
Transfer Price changes, OTI will issue an amended Exhibit 3.

 

ARTICLE 5.

 

GENERAL OBLIGATIONS OF DISTRIBUTOR

 

5.1          Marketing.  DISTRIBUTOR
has the following obligations with respect to the marketing and distribution of
OTI Products:

 

(a)           DISTRIBUTOR shall distribute only
Products purchased directly from OTI or any entity designated in advance by OTI
in writing;

 

(b)           DISTRIBUTOR shall not actively
distribute the Products into the exclusive territory of another authorized
distributor of the Products or any exclusive territory reserved by OTI;

 

(c)           DISTRIBUTOR shall use its best
efforts to promote, market, sell and distribute Products to all potential
customers in the Territory;

 

(d)           DISTRIBUTOR shall utilize OTI
trademarks and service marks at all times in all promotional materials, subject
to the prior written approval of OTI;

 

(e)           DISTRIBUTOR shall promptly respond
to all inquiries from customers, including complaints, process all orders, and
effect all shipments of Products;

 

(f)            DISTRIBUTOR shall diligently and
promptly investigate and follow up all leads with respect to potential
customers referred to it by OTI within [***] ([***]) business days of first
contact;

 

(g)           Subject to prior written notice to
DISTRIBUTOR and accompanied by DISTRIBUTOR, DISTRIBUTOR shall permit OTI to
visit DISTRIBUTOR’S customers and to visit DISTRIBUTOR’S place of business and
inspect its distribution records, other relevant quality system documents, and
other records regarding performance under this Agreement;

 

(h)           DISTRIBUTOR shall assume the
marketing responsibilities for the Dental Market sales. Osteotech will review
all marketing materials prior to production to ensure logo treatment and
product claims are accurate. 
Notwithstanding the above, reformatting or reuse of previously approved
marketing materials will not require approval from OTI.  OTI will confirm marketing activities within
[***] ([***]) business days of DISTRIBUTOR submitting. The responsibilities
include but are not limited to best efforts to complete:

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

	
   

  	
  i.

  	
  Production of promotional materials to meet sales
  goals

  
	
   

  	
  ii.

  	
  Development and production of materials to
  support new product introductions.

  
	
   

  	
  iii.

  	
  Development of videos and technique sheets to
  support marketing efforts

  
	
   

  	
  iv.

  	
  Clinical Reprints of journal articles

  
	
   

  	
  v.

  	
  Conducting Continuing Medical Education
  Osteobiologics courses

  
	
   

  	
  vi.

  	
  Development of Key Opinion Leaders and local
  product champions

  
	
   

  	
  vii.

  	
  Create and implement ongoing advertising
  campaigns

  

 

(i)            DISTRIBUTOR shall coordinate with
OTI in forecasting future sales of the Products.

 

5.2          Promotion.  DISTRIBUTOR
shall diligently undertake to promote the Products in the Territory.  DISTRIBUTOR shall not alter any graphics or
logos on brochures or exhibit graphics without prior written approval from OTI,
and DISTRIBUTOR shall not produce any promotional materials incorporating
representations of Products, OTI logos and trade names, or other proprietary
OTI names or marks without prior written approval of OTI.

 

5.3          Purchase Forecasts.  During the
term of this Agreement, DISTRIBUTOR shall provide OTI with documented [***]
forecasts which will detail Product forecast inventory purchases by product
code for each Product for the next [***] ([***])[***] period.  DISTRIBUTOR shall utilize the forecast
template or form provided by OTI for this purpose.  This forecast shall be due on the [***]
([***]) Business Day of [***] during the term of this Agreement and any renewal
period thereafter.

 

5.4          Annual Marketing Plans. 
DISTRIBUTOR shall prepare and submit to OTI a written annual marketing
plan for OTI products for each calendar year of this Agreement. This plan shall
specify the following: (i) sales forecast by product group for each
calendar quarter; (ii) number and location of DISTRIBUTOR sales reps,
agents and sub-distributors; (iii) dates and locations of meetings and
congresses at which the DISTRIBUTOR plans to exhibit; and (iv) major
Medical Education and promotion programs that the DISTRIBUTOR plans in support
of OTI products.  DISTRIBUTOR shall
deliver the first Initial Marketing Plan to OTI within [***] ([***]) days of
the effective date of this Agreement, and shall during the term of this
Agreement submit the Annual Marketing plan for each subsequent year by [***] of
the preceding year.

 

5.5          Product and Sales Training. 
DISTRIBUTOR shall make its sales employees and representatives
available, at its sole expense, for an initial training session in the Products
for a period of [***] ([***]) Business Days to occur at a mutually agreeable
site at a mutually agreed date defined within [***] ([***]) Business Days after
the execution of this Agreement. 
DISTRIBUTOR shall make its sales employees and representatives
available, at its sole expense, for two days of planning and training in the
Products in each subsequent year, at a mutually agreeable time and place.  In the event DISTRIBUTOR sales employees are
not available for training, DISTRIBUTOR will assign a representative to be
responsible for training of all sales employees.

 

5.6          Reports.  Upon
request, DISTRIBUTOR shall provide a [***] summary of Product sales in the
Territory.

 

5.7          Manufacture or Distribution of Competitive Goods. 
DISTRIBUTOR will not manufacture, process, distribute or promote any
products for bone grafting, hard tissue repair and replacement without
providing OTI a [***] ([***]) day written notice first and the 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

opportunity
to negotiate mutually agreed revised terms on a country by country basis.  If the parties cannot agree, then Distributor
has the right to market the specific competing product and OTI has the right to
remove exclusivity of the specific product for the specific country where the
product will be marketed. Competitive goods for tissue repair exclude collagen
membranes or matrix meant for soft tissue repair or guided tissue regeneration.

 

5.8          Clinical Research.  DISTRIBUTOR
shall not engage in, support or contribute to any clinical research and/or
studies of any of the Products without the prior written consent of OTI and OTI’s
prior review and written approval of the protocol for such clinical research or
study.

 

5.9          Customer Support.  DISTRIBUTOR
shall cooperate with OTI in dealing with any customer complaints concerning the
Products, and shall take any reasonable or legally required action requested by
OTI to resolve such complaints.  OTI
shall bear the costs of any such actions specifically requested by OTI.

 

5.10        Expenses.  DISTRIBUTOR
shall be solely responsible for all costs and expenses it incurs in carrying
out its obligations under this Agreement, including but not limited to all
rentals, salaries, commissions, advertising, demonstration, travel and
accommodation expenses, without the right to reimbursement for any portion
thereof from OTI.

 

5.11        Foreign Corrupt Practices Act. 
DISTRIBUTOR shall not (i) make any payment to any political party,
government official, candidate for political office or any person acting on
behalf of such parties or persons for the purpose of obtaining or furthering
sales of the Products in the Territory or (ii) otherwise engage in any
other activities that would violate the terms of the United States Foreign
Corrupt Practices Act or any similar laws enacted in the Territory or otherwise
applicable to the Parties hereto.

 

5.12        Insurance.  DISTRIBUTOR
shall acquire and maintain all insurance policies necessary or appropriate for
the marketing, distribution and clinical use of the Products in the
Territory.  This insurance coverage shall
include the following minimum levels of insurance: commercial general liability
insurance or self-insurance with limits of not less than $[***] per occurrence
and $[***] in the aggregate.

 

5.13        Regulatory Requirements.

 

(a)           OTI shall cooperate with
DISTRIBUTOR to obtain all necessary regulatory and marketing approvals for
dental applications by providing all requested material in a timely manner.
Where product is currently marketed but not distributed by DISTRIBUTOR, OTI
shall provide DISTRIBUTOR with documented evidence of registration of the
affected products within the Territory. 
DISTRIBUTOR shall promptly inform OTI of all communications with
regulatory officials, submissions of product registrations, and similar
applications to any governmental authority. 
OTI shall inform DISTRIBUTOR, in writing, of any proposed changes to the
product(s) being distributed that affect registration status prior to
making the change.

 

(b)           Notwithstanding anything in this
Agreement to the contrary, DISTRIBUTOR shall hold in trust for OTI all
regulatory registrations, license and marketing approvals issued for the
Products in the Territory.  DISTRIBUTOR
shall transfer all such approvals to OTI or to OTI’ s designee effective upon
the final day of the term of this Agreement, whether the Agreement expires of
its own accord or is terminated in accordance with any provision provided
herein.  International countries where
regulations require registration to be in name of DISTRIBUTOR will be managed
on a per country basis.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

(c)           Upon termination of this Agreement
for any reason, DISTRIBUTOR shall promptly deliver to OTI or to OTI’s designee
all materials and records associated with the issuance or maintenance of all
regulatory registrations, license and marketing approvals for the Products.

 

(d)           Upon expiration or termination of
this Agreement for any reason, and upon DISTRIBUTOR’s successful completion of
all obligations set forth in Section 5.13(a), (b) and (c),
DISTRIBUTOR may invoice OTI for the actual and documented out-of-pocket
expenses it incurred in obtaining the necessary regulatory and marketing
approvals.  OTI shall pay DISTRIBUTOR any
undisputed amounts within [***] ([***]) Business Days after receipt of said
invoice and documentation.

 

(e)           DISTRIBUTOR will refer all
inquiries and information concerning OTI or OCE Product complaints, adverse
events, and similar events directly to OTI within 48-72 hours, using the
methods and contact points provided by OTI. 
DISTRIBUTOR will refer all inquiries and information concerning NBF
Product complaints, adverse events, and similar events directly to NBF within
48-72 hours, using the methods and contact points provided by NBF on the
respective product insert. DISTRIBUTOR shall assist and carry out any action or
activity as requested by OTI with the investigation, evaluation, execution and
completion of a complaint, adverse event or other similar event. Countries that
require a 24 hour response concerning product complaints, DISTRIBUTOR will
agree to comply.

 

(f)            DISTRIBUTOR will refer all
regulatory inquiries by governmental authorities directly to OTI without
attempting to answer the inquiries itself.

 

(g)           Should the DISTRIBUTOR be audited
or inspected by a governmental authority the Department Head for OTI Regulatory
Affairs shall be notified of such action within 24 hours of the initiation of
the inspection or audit.  All corrections
and communication responses as the result of a governmental inspection or audit
that affect OTI products shall be reviewed and approved by OTI Regulatory
Department within an agreed upon time period prior to submission to a
governmental authority.  OTI Regulatory
Department shall ensure all corrections affecting the product design,
processing, packaging, or labeling are completed within an agreed upon time
period.

 

(h)           DISTRIBUTOR shall maintain a
record keeping system that will allow traceability or record of distribution of
each Product unit sold or delivered to each medical establishment.  The DISTRIBUTOR distribution records must be
capable of ensuring traceability to the corresponding OTI and NBF product donor
number.  At a minimum a distribution
record must identify the type of tissue product, part or product number identification,
control number e.g. lot, serial number etc., date of distribution, and the
identification of the clinician or end user/facility.  DISTRIBUTOR shall maintain distribution
records for traceability for 30 years after the distributed date as identified
by the Commission Directive 2006/86/EC Article 9 Traceability or in
accordance with Country requirements for the maintenance of records whichever
is longest.  DISTRIBUTOR shall furnish
all and any traceability information to OTI and NBF as required for OTI and NBF
to fulfill its regulatory and public health responsibilities.  Upon expiration or termination of this
Agreement for any reason, DISTRIBUTOR is required to maintain distribution
records with all applicable laws and regulations.  DISTRIBUTOR shall notify OTI Legal Department
when storage and maintenance of distribution records is no longer feasible by
the DISTRIBUTOR.

 

(i)            DISTRIBUTOR shall assist and carry
out any action or activity as requested by OTI or NBF with the investigation,
evaluation, execution and completion of a product recall. OTI agrees to
reimburse DISTRIBUTOR for direct costs incurred, including, but not limited to,
postage, shipping, and replacement products.

 

5.14        Compliance with Laws.  In carrying
out its obligations under this Agreement, DISTRIBUTOR shall comply with all
applicable laws and regulations of any jurisdiction within the Territory, and
in accordance with the current recognized ethical standards 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Registrant’s application
requesting confidential treatment pursuant to Rule 406 of the Securities
Act of 1933, as amended.

 

 

in place
in the Territory, including without limitation all laws and ethical standards
regarding relationships with physicians, hospitals, or other health care
providers who may prescribe or use the Products.

 

5.15        Non-Competition Covenant. 
During the term of this Agreement and during [***] ([***])[***] period
immediately following the termination of this Agreement for cause, neither the
Distributor nor any of its employees or agents will, directly or indirectly,
perform any services in connection with, or represent, promote, market or
distribute in any manner, any products or services that compete with the
Products listed in Exhibit 1.  In
addition, during the term of this Agreement and during a [***] ([***])[***]
period immediately following the termination of this Agreement for cause, OTI
will not make any efforts to market the Products listed in Exhibit 1
within the territory for the dental market. 
In consideration for DISTRIBUTOR and OTI acknowledge that (a) the
provisions of will result in irreparable injury to OTI, the exact amount of
which will be difficult to ascertain, and that the remedies at law for any such
violation would not be reasonable or adequate compensation to OTI for such a
violation.  Accordingly, if DISTRIBUTOR
violates the provisions of Section 5.15, in addition to any other remedy
that may be available at law or in equity, the other party is entitled to
specific performance and injunctive relief, without posting bond or other
security, and without the necessity of proving actual damages.

 

ARTICLE 6.

 

GENERAL OBLIGATIONS OF OTI

 

6.1          Marketing Support.  OTI shall
provide DISTRIBUTOR with a reasonable support to implement its marketing and
sales responsibilities as set forth in Section 5.1(h), of this Agreement.

 

6.2          Training.  OTI will
provide DISTRIBUTOR. to a reasonable extent, with technical assistance concerning
the Products.  OTI may also provide
DISTRIBUTOR’s personnel with training in Product information and basic
Osteobiologic science at its registered office or at any location chosen by OTI
and agreed to by DISTRIBUTOR.  OTI will
provide such training free of charge to DISTRIBUTOR; however DISTRIBUTOR will
nevertheless remain fully responsible for all salary, travel, lodging, meals
and other expenses related to the training of its personnel.

 

6.3          Insurance.  OTI shall
maintain a general insurance policy in an amount sufficient to reasonably cover
its potential liabilities based on claims or legal action regarding the
manufacture, sale, function or use of its Products in the Territory.

 

ARTICLE 7.

 

ARTICLE 7. CONFIDENTIALITY

 

Each
of the Parties hereby acknowledges that in the course of performing its
obligations hereunder, the other party may disclose to it certain information
and know-how of a technical, financial, operational, or other sort, which the
disclosing party has identified as such that is non-public and otherwise
proprietary or confidential to the disclosing party.  Each party acknowledges that any such
proprietary or confidential information disclosed to it is of considerate
commercial value and that the disclosing party would likely be economically or
otherwise disadvantaged or harmed by the direct or indirect disclosure thereof,
except as specifically authorized by the disclosing party.  Each party therefore agrees to keep in strict
confidence and trust all such information that may from time to time be
disclosed 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

to
it, and agrees not to disclose such information to any third party for any
purpose without the prior consent of the other. 
Each of the Parties agrees that because of the extraordinary nature of
such information the disclosing party’s breach or threatened breach of its
nondisclosure obligation, and that the disclosing party would suffer
irreparable injury and damage as a result of any such breach,  Accordingly, in the event either party
breaches or threatens to breach the obligations of confidentiality set forth in
this section, in addition to and not in lieu of any legal or other remedies
such party may pursue hereunder or under applicable law, each party hereby
consents to the granting of equitable or other relief against it by the International
Chamber of Commerce pursuant to article 12 or other arbitrator or a court of
competent jurisdiction, without the necessity of proving actual damages or
posting any bond or other security thereof, prohibiting any such breach or
threatened breach. In any proceeding upon a motion for such relief, a party’s
ability to answer in damages shall not be a bar, and shall not be interposed as
a defense, to the granting of such relief. 
The provisions of this section shall survive the termination of this Agreement
for any reason.  The provisions of this
section shall not apply to any information identified as confidential if and to
the extent it was (i) independently developed by the receiving party after
Closing as evidenced by documentation in such party’s possession, (ii) lawfully
received by it free of restrictions from another source having the right to
furnish the same or (iii) generally known or available to the public
without breach of this Agreement by the receiving party.

 

ARTICLE 8.

 

INTELLECTUAL PROPERTY

 

8.1          Use of Trademarks and Service Marks.

 

(a)           OTI hereby grants to DISTRIBUTOR a
non-exclusive, non-transferable, and royalty-free right and license to use the
trademarks and service marks specified in Exhibit 4, attached hereto (as
such Exhibit may be modified from time to time during the term of this
Agreement), in connection with the sale or other distribution, promotion,
advertising and maintenance of the Products for so long as such trademarks and
service marks are used by DISTRIBUTOR in accordance with this Agreement and
with OTI’s standards, specifications and instructions, but in no event beyond
the term of this Agreement and further provided that any proposed use of such
trademarks and service marks are submitted to OTI by DISTRIBUTOR in advance and
has been approved by OTI in writing.

 

(b)           DISTRIBUTOR shall use only those
promotional and informational materials or literature, publicity releases and
other materials regarding the Products as OTI provides to the DISTRIBUTOR under
Section 6.1 of this Agreement, and only in a manner approved by OTI in
writing.  DISTRIBUTOR shall not make
copies of such materials without OTI’s express written consent. DISTRIBUTOR
shall acquire no right, title or interest in such OTI, affiliate or licensor
trademarks other than the foregoing limited license, and DISTRIBUTOR shall not
use any OTI, affiliate or licensor trademarks or service marks as part of
DISTRIBUTOR’S corporate or trade name or permit any third party to do so
without the prior written consent of OTI.

 

8.2          Registration.  OTI shall
use its best efforts to register the OTI, affiliate and licensor trademarks and
service marks specified in Exhibit 4 in such jurisdictions within the
Territory in which OTI determines that registration is necessary or useful to
the successful distribution of the Products. 
In addition, in the event OTI believes that it is advisable to affect
any filing or obtain any governmental approval or sanction for the use by
DISTRIBUTOR of any of OTI’s trademarks pursuant to this Agreement, the parties
shall fully cooperate in order to do so. 
All expenses relating to the registration of OTI’s trademarks in the
Territory as well as the making of any filing or obtaining any governmental
approvals for the use by DISTRIBUTOR of OTI’s, its affiliates’ and its
licensors’ trademarks shall be borne by OTI.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

8.3          Markings.  DISTRIBUTOR
shall not, without the prior written consent of OTI, remove or alter any patent
numbers, trade names, trademarks, service marks, notices, serial numbers,
labels, tags or other identifying marks, symbols or legends affixed to any
Products or containers or packages. 
DISTRIBUTOR is permitted to affix a sticker on the outer carton or
package of each Product listing DISTRIBUTOR’s name, address, contact
information and inventory bar code, provided that such sticker not cover or
obstruct any other information or graphics provided by OTI.

 

8.4          Infringements.  DISTRIBUTOR
shall promptly notify OTI of any use by any third party of OTI’s, its
affiliates’ or its licensors’ trademarks or service marks or any use by such
third parties of similar marks which may constitute an infringement or passing
off of OTI’s, its affiliates’ or its licensors’ trademarks or service
marks.  OTI reserves the right in its
sole discretion to institute any proceedings against such third party
infringers and DISTRIBUTOR shall refrain from doing so.  DISTRIBUTOR shall cooperate fully with OTI in
any action taken by OTI against such third parties, provided that all expenses
of such action shall be borne by OTI and all damages which may be awarded or
agreed upon in settlement of such action shall accrue to OTI.

 

8.5          Termination of Use.  DISTRIBUTOR
acknowledges OTI’s proprietary rights in and to the OTI, affiliates or
licensors trademarks, service marks and any trade names regularly applied by
OTI to the Products, and DISTRIBUTOR hereby waives in favor of OTI all rights
to any trademarks, trade names, service marks and logotypes now or hereafter
originated by OTI. DISTRIBUTOR shall not adopt, use or register any words,
phrases or symbols which are identical to or confusingly similar to any of OTI’s,
affiliates’ or licensors’ trademarks or service marks.  Upon termination of this Agreement,
DISTRIBUTOR shall immediately cease and desist from use of the OTI trademarks
or service marks in any manner, except to facilitate disposition of Product
inventory in DISTRIBUTOR’s possession. 
In addition, DISTRIBUTOR hereby empowers OTI and agrees to assist OTI,
if requested, to cancel, revoke or withdraw any governmental registration or
authorization permitting DISTRIBUTOR to use OTI, affiliates’ or licensors’
trademarks or service marks in the Territory.

 

ARTICLE 9.

 

INDEMNIFICATION

 

9.1          Indemnification by OTI.

 

(a)           OTI shall indemnify, defend and
hold DISTRIBUTOR harmless from any damages, costs or liabilities (including,
without limitation, reasonable costs and legal fees thereby incurred by
DISTRIBUTOR) arising out of any suit, claim or other legal action (“Legal
Action”) brought by a third party (i) arising out of the manufacture,
processing, use, function or sale of the Products or OTI-produced promotional
material relating to the Products for the Territory, including the gross
negligence or willful misconduct of OTI in connection with such Products, (ii) arising
out of the breach by OTI of any of its obligations, representations, warranties
or covenants made in this Agreement or (iii) that alleges the Products, or
any of them, infringe any patent, copyright, trademark, service mark or trade
secret rights of a third party in the Territory.

 

(b)           OTI shall indemnify, defend and
hold DISTRIBUTOR harmless form any damages, costs or liabilities (including,
without limitation, reasonable costs and legal fees thereby incurred by
DISTRIBUTOR) arising out of any Legal Action alleging that any Product
infringes any third party intellectual right. 
After any such Legal Action is resolved, at OTI’s sole discretion and
expense

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

with respect to future sales of the allegedly infringing Product, OTI may
(1) obtain a license from such third party for the benefit of DISTRIBUTOR;
(ii) replace or modify the Product so that it is no longer infringing; or (iii) if
neither of the foregoing is commercially feasible, terminate this Agreement
with no further liability to DISTRIBUTOR.

 

9.2           Indemnification by DISTRIBUTOR. 
DISTRIBUTOR shall indemnify, defend and hold OTI harmless from any
damages, costs or liabilities (including, without limitation, any reasonable
costs or legal fees thereby incurred by OTI) arising out of any Legal Action
that arises from or results out of (i) the breach by DISTRIBUTOR of any of
its obligations, representations, warranties or covenants made in this
Agreement or (ii) the marketing, distribution or sale of the Products by
DISTRIBUTOR, including, without limitation, (a) any act or omission by
DISTRIBUTOR or any of its subdistributors or agents; (b) any unfair
business practice of DISTRIBUTOR or any of its subdistributors or agents; or (c) any
violation by DISTRIBUTOR or any of its subdistributors or agents of any law,
regulation or order of the Territory.

 

9.3           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.

 

9.4           Limitation of Obligation. 
Notwithstanding the provisions of Section 9.1 hereof, OTI shall
have no liability whatsoever to DISTRIBUTOR with respect to any patent
infringement or claim thereof which is based upon or arises out of (i) the
use of any Product in combination with an apparatus or device not manufactured
or supplied by OTI, if such combination causes or contributes to the
infringement, (ii) the use of any Product in a manner for which it was
neither designed nor contemplated, or (iii) any modification of any
Product by DISTRIBUTOR or any third party which causes the Product to become
infringing.  Section 9.1 hereof
states the entire liability of OTI for or arising out of any patent
infringement or claim thereof with respect to Products furnished to DISTRIBUTOR
under this Agreement.

 

ARTICLE 10.

 

TERM AND TERMINATION

 

10.1         Term.  This
Agreement and its obligations shall take effect with respect to the Territory
as of the date first above written and shall continue in force until December 31,
2012 (the “Initial Period”).  This Agreement
shall be automatically renewed for successive additional periods of one (1) year
each, (“Renewal Period”) commencing on January 1, immediately after the
end of the Initial Period or immediately after the end of the Renewal Period,
provided that DISTRIBUTOR has successfully achieved performance goals as
follows and upon mutual agreement of new minimum inventory purchase target and
requirements for the additional period, reached at the latest 120 days prior
commencing date of the renewal period :

 

(a)           Achievement of Quotas as set forth
in Exhibit 5;

 

(b)           Implementation of the submitted
annual marketing plan as set forth in Section 5.4 of this Agreement.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

 

OTI
in its sole discretion may agree to renew the Agreement if some or all of the
conditions in this Section are not met. 
OTI’s determination to do so shall not constitute a waiver of rights
with respect to any past, current, or future failures by DISTRIBUTOR to meet
the conditions in this Section.

 

10.2         Termination. 
Notwithstanding the provisions of Section 10.1 above, this
Agreement may be terminated in accordance with the following provisions:

 

(a)           By either Party upon thirty (30)
days written notice, should the other Party file a petition of any type as to
its bankruptcy, be declared bankrupt, become insolvent, make an assignment for
the benefit of creditors, go into liquidation or receivership, or otherwise
lose legal control of its business, or should a Party or a substantial part of
its business come under the control of a third party (except for assignments as
otherwise allowed under Section 13.2 of this Agreement); or

 

(b)           By OTI at any time during the term
of this Agreement without cause, upon one hundred eighty (180) days prior
written notice to DISTRIBUTOR; or

 

(c)           By either Party by giving notice
in writing to the other Party in the event the other Party is in material
breach of this Agreement and shall have failed to cure such breach within
thirty (30) days of receipt of written notice thereof from the first Party.

 

10.3         Partial Termination.  In the
event OTI shall have the right pursuant to the provisions of Sections 10.2(b) or
10.2(c) to terminate this Agreement in its entirety, OTI may elect to
terminate this Agreement solely as it applies to any specific portion of the
Territory upon providing DISTRIBUTOR with written notice in accordance with the
relevant Section referred to above; provided, that nothing in this Section 10.3
shall be construed as creating a precondition to or otherwise precluding OTI
from terminating this Agreement in its entirety in accordance with the terms of
Section 10.2.

 

10.4         Rights and Obligations on Termination. 
In the event of termination of this Agreement for any reason, the
parties shall have the following rights and obligations;

 

(a)           Termination of this Agreement shall
not release either Party from the obligation to make payment of all amounts
then or thereafter due and payable, or to ship all open orders.  Notwithstanding any payment schedule set
forth herein, DISTRIBUTOR shall pay all amounts owed to Osteotech by the date
such payments initially were due, or within [***] ([***]) days of termination
of this Agreement, whichever is sooner;

 

(b)           DISTRIBUTOR’S obligations pursuant
to Article 7, Section 5.13(b) and the obligations of OTI and
DISTRIBUTOR pursuant to Articles 9 and 12 hereof shall survive termination of
this Agreement; and

 

(c)           DISTRIBUTOR will retain the right
to distribute existing inventory and will be allowed to sell to depletion this
inventory.

 

10.5         Other.  In the
event either Party terminates this Agreement for any reason in accordance with
the terms hereof, the parties hereby agree that:

 

(a)           Where legally possible,
DISTRIBUTOR shall transfer to OTI or its designee as of the termination date of
the Agreement all regulatory approvals and licenses necessary for the
promotion, advertising and sale of the Products in the Territory; and

 

(b)           The DISTRIBUTOR shall not be
entitled to any indemnity or payment for goodwill or similar compensation as a
result of such termination.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

 

ARTICLE 11.

 

FORCE MAJEURE

 

11.1         Definition.  Force
Majeure shall mean any event or condition, not existing as of the date of
signature of this Agreement, not reasonably foreseeable as of such date and not
reasonably within the control of either Party, which prevents in whole or in
material part the performance by one of the parties of its obligations
hereunder or which renders the performance of such obligations so difficult or
costly as to make such performance commercially unreasonable.  Without limiting the foregoing, the following
shall constitute events or conditions of Force Majeure: acts of State or
governmental action, riots, disturbance, war, strikes, lockouts, slowdowns,
prolonged shortage of energy supplies, epidemics, fire, flood, hurricane,
typhoon, earthquake, lightning and explosion. 
It is in particular expressly agreed that any refusal or failure of any
governmental authority to grant any export license legally required for the
fulfillment by OTI of its obligations hereunder shall constitute an event of
Force Majeure.

 

11.2         Notice.  Upon giving
notice to the other Party, a Party affected by an event of Force Majeure shall
be released without any liability on its part from the performance of its
obligations under this Agreement, except for the obligation to pay any amounts
due and owing hereunder, but only to the extent and only for the period that
its performance of such obligations is prevented by the event of Force
Majeure.  Such notice shall include a
description of the nature of the event of Force Majeure, and its cause and possible
consequences.  The Party claiming Force
Majeure shall promptly notify the other Party of the termination of such event.

 

11.3         Confirmation.  The Party
invoking Force Majeure shall provide to the other Party confirmation of the
existence of the circumstances constituting Force Majeure.  Such evidence may consist of a statement or
certificate of an appropriate governmental department or agency where
available, or a statement describing in detail the facts claimed to constitute
Force Majeure.

 

11.4         Suspension of Performance. 
During the period that the performance by one of the parties of its
obligations under this Agreement has been suspended by reason of an event of
Force Majeure, the other Party may likewise suspend the performance of all or
part of its obligations hereunder to the extent that such suspension is
commercially reasonable.

 

11.5         Termination.  Should the
period of Force Majeure continue for more than three (3) consecutive
months, either Party may terminate this Agreement without liability to the
other Party, except for payments due to such date, upon giving written notice
to the other Party.

 

ARTICLE 12.

 

DISPUTE RESOLUTION

 

12.1         Disputes.  With the
exception of termination notices, which shall not be subject to this Article 12,
in the event of any dispute, controversy or claim arising out of or relating to
this Agreement, the parties shall negotiate in good faith to resolve such
dispute.  If a resolution is not achieved
within ninety (90) days of written notification regarding the dispute, the
parties agree that the differences shall be settled under the Rules for
Expedited Arbitration of Disputes of the International Chamber of Commerce by
one or more arbitrators appointed in accordance with said Rules in New
York City, New York.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

 

12.2         Sole Recourse.  This Article 12
provides the sole recourse for the settlement of any dispute arising under or
in connection with this Agreement.

 

12.3         Governing Law.  This
Agreement shall be governed by, and interpreted and construed in accordance
with, the internal laws of the State of New Jersey, USA, without regard to
choice of law provisions thereof.  The UN
Convention on Contracts for the International Sale of Goods shall not apply to
this Agreement or any sale of the Products hereunder.

 

ARTICLE 13.

 

MISCELLANEOUS

 

13.1         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.  In fulfilling its obligations pursuant to
this Agreement each Party shall be acting as an independent contractor, where
the relationship between OTI and DISTRIBUTOR is that DISTRIBUTOR is an
independent reseller of OTI tissue-based products and devices.

 

13.2         Assignment.  Neither
Party shall 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; provided, however, OTI shall be entitled to assign any or all of
its rights and obligations hereunder to any of its subsidiaries, provided that
OTI shall remain fully liable for the performance of all its obligations
hereunder; and further provided that a successor in interest by merger, by
operation of law, assignment, purchase or otherwise of all of the assets and
the entire business of either Party shall acquire all rights and obligations of
such Party hereunder without the prior written consent of the other Party.

 

13.3         Notices.  Notices
permitted or required to be given hereunder shall be deemed sufficient if given
by registered or certified air mail, postage prepaid, return receipt requested,
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 (i) receipt by the Party to which notice is given,
or (ii) on-the fourteenth (14th) day following the date such notice was
posted, whichever occurs first.

 

13.4         Entire Agreement.  This
Agreement, including Exhibits 1 through 5 attached hereto and incorporated as
an integral part of this Agreement, constitutes the entire Agreement of the
Parties with respect to the subject matter hereof, and supersedes all previous
marketing Agreements by and between OTI and DISTRIBUTOR as well as all
proposals, oral or written, and all negotiations, conversations or discussions
heretofore had between the parties related to this Agreement.  DISTRIBUTOR acknowledges that it has not been
induced to enter into this Agreement by any representations or statements, oral
or written, not expressly contained herein.

 

13.5         Amendment.  This
Agreement shall not be deemed or construed to be modified, amended, rescinded,
canceled or waived, in whole or in part, except by written amendment signed by
the parties hereto.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

 

13.6         Publicity.  This
Agreement is confidential and no Party shall issue press releases or engage in
other types of publicity of any nature dealing with the commercial and legal
details of this Agreement without the other Party’s prior written approval,
which approval shall not be unreasonably withheld. However, approval of such
disclosure shall be deemed to be given to the extent such disclosure is
required to comply with governmental rules, regulations or other governmental
requirements. In such event, the publishing Party shall furnish a copy of such
disclosure to the other Party.

 

13.7         Severability.  In the
event that any of the terms of this Agreement are in conflict with any rule of
law or statutory provision or are otherwise unenforceable under the laws or
regulations of any government or subdivision thereof, such terms shall be
deemed stricken from this Agreement, but such invalidity or unenforceability
shall not invalidate any of the other terms of this Agreement and this
Agreement shall continue in force, unless the invalidity or unenforceability of
any such provisions hereof does substantial violence to, or where the invalid
or unenforceable provisions comprise an integral part of, or are otherwise
inseparable from, the remainder of this Agreement.

 

13.8         Counterparts.  This
Agreement shall 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.

 

13.9         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.

 

{Signature page to follow}

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

 

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

 

 

	
  OSTEOTECH, INC.

  	
   

  	
  BIOHORIZONS
  IMPLANT SYSTEMS, INC.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /S/
  Sam Owusu-Akyaw

  	
   

  	
  By:

  	
  /S/
  Steve Boggan

  
	
  Name:
  Sam Owusu-Akyaw

  	
   

  	
  Name:
  Steve Boggan

  
	
  Title:
  President and Chief Executive Officer

  	
   

  	
  Title:
  President and Chief Executive Officer

  

 

Portions
of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933,
as amended.

 

 

EXHIBIT 1

 

EFFECTIVE DATE —January 1, 2010

 

PRODUCTS

 

	
  Product

  	
   

  	
  Sizes/Product

  Codes

  
	
   

  	
   

  	
   

  
	
  GRAFTON@

  	
   

  	
  0.5cc GRAFTON® DBM GEL

  1 cc GRAFTON® DBM GEL

  1.5cm x1.5cm GRAFTON® DBM
  FLEX

  8mm x 10mm GRAFTON® DBM
  MATRIX PLUG

  0.5cc GRAFTON® DBM PUTTY

  lcc GRAFTON® DBM PUTTY

  2.5cc GRAFTON® DBM PUTTY

  0.25cc GRAFTON® DBM PUTTY(Syringe)

  0.5cc GRAFTON® DBM PUTTY(Syringe)

  lcc GRAFTON® PLUS DBM PASTE

  
	
   

  	
   

  	
   

  
	
  ILIUM CREST WEDGE

  	
   

  	
  Ilium Crest Wedge 10-12mm

  Ilium Crest Wedge 13-15mm

  
	
   

  	
   

  	
   

  
	
  MINEROSSTM

  	
   

  	
  MinerOssTM c/c crushed 0.60 - 1.25mm 0.5cc

  MinerOssTM c/c crushed 0.60 - 1.25mm lcc

  MinerOssTM c/c crushed 0.60 - 1.25mm 2.5cc

  
	
   

  	
   

  	
   

  
	
  LADDEC®

  	
   

  	
  LADDEC® 1 BLOCK (25 X 15 X 8 mm)

  LADDEC(R) 1 CUBE (8 X 8 X 8 mm)

  LADDEC(R) 3 CUBE (8 X 8 X 8 mm)

  LADDEC(R) 1 JAR 250 mg (600μm) (200μm — 1,000μm)

  LADDEC(R) 1 JAR 500 mg (600μm) (200μm — 1,000μm)

  LADDEC(R) 1 JAR 1000 mg (600μm (200μm — 1,000μm)

  LADDEC(R) 1 SYRINGE 250
  mg (600μm) (200μm — 1,000μm)

  LADDEC(R) 3 JARS 250 mg (600μm) (200μm — 1,000μm)

  LADDEC(R) 3 JARS 500 mg (600μm) (200μm — 1,000μm)

  LADDEC(R) 3 JARS 1000 mg (600μm) (200μm — 1,000μm)

  
	
   

  	
   

  	
   

  
	
  OSTEOPURETM

  	
   

  	
  OSTEOPURETM JAR lcc (300-2,000μm)

  

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

EXHIBIT 2

 

EFFECTIVE DATE — January 1, 2010

 

TERRITORY

 

Territory
shall mean the following:

 

	
  COUNTRY

  	
   

  	
  PRODUCTS

  
	
   

  	
   

  	
   

  
	
  Argentina

  	
   

  	
  Laddec®

  MinerOssTM

  
	
   

  	
   

  	
   

  
	
  Australia

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton
  ®*

  
	
   

  	
   

  	
   

  
	
  Austria

  	
   

  	
  Laddec®

  MinerOssTM*

  
	
   

  	
   

  	
   

  
	
  Belgium

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Brazil*

  	
   

  	
  Laddec®

  
	
   

  	
   

  	
   

  
	
  Canada

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®*

  Ilium
  Crest Wedge

  
	
   

  	
   

  	
   

  
	
  Chile

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  France

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Germany

  	
   

  	
  LaddecTM

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Greece

  	
   

  	
  MinerOssTM

  

 

*Importation of human
tissue/product is not approved by Brazil tissue/product is not approved by
Brazil

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

	
  Holland

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Hungary

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Israel

  	
   

  	
  Laddec®

  MinerOss

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Italy

  	
   

  	
  Laddec®

  MinerOss

  Grafton®
  Matrix only

  
	
   

  	
   

  	
   

  
	
  Kuwait

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Lithuania

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Poland

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Portugal

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Romania

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Spain

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Sweden

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Switzerland

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

	
  Thailand

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  Turkey

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  UK

  	
   

  	
  Laddec®

  MinerOssTM

  Grafton®

  
	
   

  	
   

  	
   

  
	
  All Other Countries

  	
   

  	
  MinerOssTM

  

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

EXHIBIT 3

 

EFFECTIVE DATE — January 1, 2010

 

TRANSFER PRICES

 

The
following schedule sets out the current Transfer Prices for products.

 

	
  Code

  OCE

  	
   

  	
  Code

  OTI

  	
   

  	
  Code

  NBF

  	
   

  	
  Description

  	
   

  	
  Pricing

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  

 

	
  Product

  Code

  OCE

  	
   

  	
  Product

  Code

  OTI

  	
   

  	
  Product

  Code

  NBF

  	
   

  	
  [***]

  Description

  	
   

  	
  BioHorizons

  Pricing

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  

 

	
  Product

  Code

  OCE

  	
   

  	
  Product

  Code

  OTI

  	
   

  	
  Product

  Code

  NBF

  	
   

  	
  [***]

  Description

  	
   

  	
  BioHorizons

  Pricing

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  

 

	
  Product

  Code

  OCE

  	
   

  	
  Product

  Code

  OTI

  	
   

  	
  Product

  Code

  NBF

  	
   

  	
  [***]

  Description

  	
   

  	
  BioHorizons

  Pricing

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

	
  Product

  Code

  OCE

  	
   

  	
  Product

  Code

  OTI

  	
   

  	
  Product

  Code

  NBF

  	
   

  	
  [***]

  Description

  	
   

  	
  BioHorizons

  Pricing

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  €

  	
  [***]

  	
   

  
											

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

EXHIBIT 4

 

EFFECTIVE DATE - January 1, 2010

 

TRADE NAMES

 

Trade
Names include the following trademarks, service marks, trade names, and
organization names:

 

Osteotech, Inc.

 

And
all trade names and trademarks, service marks associated with the Products.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

EXHIBIT 5

 

EFFECTIVE DATE — JANUARY 1, 2010

 

MINIMUM INVENTORY PURCHASE TARGETS AND REQUIREMENTS

 

	
   

  	
   

  	
   

  	
   

  	
  Q1

  	
   

  	
  Q2

  	
   

  	
  Q3

  	
   

  	
  Q4

  	
   

  	
  Total

  	
   

  
	
  International Market Year 2010*

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  

 

[***]

 

International
Market — Years 2011-2012

 

[***]

 

[***]

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Registrant’s application
requesting confidential treatment pursuant to Rule 406 of the Securities
Act of 1933, as amended.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00175-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00175-of-00352.parquet"}]]