Exhibit 10.62

Portions of this exhibit have been omitted pursuant to a request for
confidential treatment by BioMimetic Therapeutics, Inc. The omitted portions,
marked by [**], have been separately filed with the Securities and Exchange
Commission.

FOURTH AMENDMENT TO DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT

This Fourth Amendment (the “Amendment”) to the Development, Manufacturing and
Supply Agreement (the “Agreement”) dated as of September 30, 2010 between Kensey
Nash Corporation, a Delaware corporation, having its principal place of business
at 735 Pennsylvania Drive, Exton, PA 19341 (hereinafter referred to as “KNC”)
and BioMimetic Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.), a
Delaware corporation, having its principal place of business at 389-A Nichol
Mill Lane, Franklin, TN 37067 (hereinafter referred to as “BMTI”).

WHEREAS, KNC and BMTI previously entered the Agreement dated June 28, 2005, as
amended; and

WHEREAS, KNC and BMTI desire to amend the Agreement as set forth herein.

NOW, THEREFORE, in consideration of the mutual agreements contained herein, and
pursuant to Section 16.2 of the Agreement, the parties agree as follows:

 
1.
Capitalized terms not otherwise defined herein shall have the meaning ascribed
to such terms in the Agreement.

 
2.
Section 6.1 of the Agreement is hereby deleted in its entirety, including all
amendments to Paragraph 6., and restated in its entirety as follows:

“6.1    Milestone Payments.  BMTI agrees to make Milestone Payments to KNC
according to Schedule G, which is attached hereto and made part of the
Agreement.  If BMTI (i) fails to make any Milestone Payment within forty-five
(45) days of the occurrence of the specified event, and (ii) does not cure such
failure to pay within thirty (30) days of receiving notice of such failure from
KNC, KNC will have the option but not the obligation to terminate this
Agreement.  Upon such termination, KNC shall be relieved of all obligations to
BMTI under this Agreement.”

 
3.
Schedule A to the Agreement, “Development Plan”, is hereby amended and restated
in its entirety to read as indicated in the Amended Schedule A, attached hereto.

 
4.
Schedule B to the Agreement, “Material Specifications”, is hereby amended and
restated in its entirety to read as indicated in the Amended Schedule B,
attached hereto.

 
5.
Schedule C to the Agreement, “Product Specifications”, is hereby amended and
restated in its entirety to read as indicated in the Amended Schedule C,
attached hereto.

 
6.
Schedule D to the Agreement, “Transfer Price”, as amended, is hereby amended and
restated in its entirety to read as indicated in the Amended Schedule D,
attached hereto.

 
7.
Schedule F to the Agreement, “Certificate of Conformance and Certificate of
Analysis”, is hereby amended and restated in its entirety to read as indicated
in the Amended Schedule F, attached hereto.

 
 

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

 

 
8.
Schedule G, attached hereto, is hereby added to the Agreement.

 
9.
The parties will negotiate in good faith a Quality Agreement.

 
10.
This Amendment is meant to amend, modify or supersede only those specific
sections, rights, responsibilities, liabilities and/or covenants expressly
referred to in this Amendment, and only to the extent so referred to; and
accordingly all other sections and covenants of the Agreement shall remain
unaffected and shall continue to have full force and effect.

IN WITNESS WHEREOF, the parties have executed this Amendment through their duly
authorized representatives as of the date first written above.

BIOMIMETIC THERAPEUTICS, INC.
 
KENSEY NASH CORPORATION
         
By:  
/s/ Earl Douglas
 
By:  
/s/ Joseph W. Kaufman
 
  Earl Douglas
   
  Joseph W. Kaufmann
 
  General Counsel
   
  President & CEO

 
 

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

 

Kensey Nash Corporation and BioMimetic Therapeutics, Inc.
DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT

Amended Schedule A: Development Plan
Augment Injectable (AUGMENT™ INJECTABLE BONE GRAFT) Mixing System and Final
Development
Dated: August 30, 2010

Program Objective:
 
To design a new methodology/system for supplying the matrix component and mixing
the matrix component with PDGF that improves the speed and ease of product
mixing and reduces waste as compared to the existing manual kneading of the **
matrix and PDGF in a bowl.

Indications:
 
 
·
Initially: Open surgical applications.

 
·
Future: Percutaneous delivery/injection.

Proposed Product Description:
 
Proposed final packaged kit containing:
 
·
Matrix tray: the following components to be held in an open tray inside an
Aclar-coated outer tray, sealed with a foil lid to act as a moisture barrier,
terminally sterilized via gamma radiation (provided by KNC).

 
o
Matrix component packaged inside a suitably sized, capped ** syringe,

 
o
a second identical empty syringe,

 
o
one female-female luer lock connector,

 
o
one ** Blunt Fill Needle,

 
o
one ** Blunt Needle.

 
·
PDGF component, packaged and terminally sterilized via EtO (This component and
the final kit packaging to be performed by BMTI).

Functional Specifications:
 
 
·
System will utilize current formulation of the collagen/β-TCP ceramic material
(**: β-TCP: ** bovine type I collagen, ** format).

 
·
System design will need to accommodate **, **, and ** (PDGF) configurations.
This corresponds to **, **, and ** of ** collagen/ceramic matrix, respectively.

 
·
System will be designed to release approximately **% of the rhPDGF from the
implant within ** of application (exact number to be further defined by BMTI).

 
·
System should allow product materials to be hydrated for **.  Product should
form a homogeneous paste following mixing for ** (approximately ** mixing
cycles).

 
·
System components that may contact product must be made from biocompatible
polymer.

 
·
PDGF should be extracted from the vial directly into the mixing system.

 
·
System should allow clinician to present mixed material to a clinical site of no
less than ** inches in diameter directly from mixing device.

 
·
Mixed material shall be able to pass through a cannula of ** gauge and ** in
length.

[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.

 
 

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

 

Amended Schedule A: Development Plan (continued)
Dated: August 30, 2010
 
Responsibilities/Milestones/Proposed Targets:
 
Item
 
Description
 
Responsibility
 
Target
Completion Date
1.
 
Conduct design review (matrix and KNC-provided accessories)
 
KNC/BMTI
 
**
2.
 
Receive packaging materials
 
KNC
 
**
3.
 
Initiate commercial stability program (product/packaging)
 
KNC
 
**
4.
 
Complete validations (sterilization, LAL, product, packaging)
 
KNC
 
**
5.
 
Submit PMA
 
BMTI
 
**
6.
  
Launch product (est.)
  
BMTI
  
**

Marketing Projections (Augment™ Injectable Bone Graft):
 
Production Yr
 
2014
 
2015
 
2016
Est. Kit Sales
 
**
 
**
 
**

 
Note:
Estimated kit sales figures represent the aggregate sales of all product
sizes.  All product sizes are not necessarily required to begin commercial
launch.

Program Resources:
 
KNC:
Program Manager: **
 
Commercialization: **
 
Syringe System Development: **
 
Development/Technical Support: **, **, **
   
BMTI:
Program Manager: **

Meeting Schedules:
 
 
·
Internal meetings as needed

 
·
Joint conference calls/meetings no less frequent than monthly

 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.
 
 
 

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

 

Kensey Nash Corporation and BioMimetic Therapeutics, Inc.
DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Amended Schedule B: Material Specifications
Dated: August 30, 2010

Definitions:
KNC Design Spec – Specification tested/confirmed during KNC validations only.
KNC Final Product Spec – Specification tested on every lot during KNC lot
release testing (i.e., recorded on KNC Inspection History Record [IHR]).  “CoA”
is included if the attribute will be reported to BMTI on the Certificate of
Analysis.
BMTI AIBG Design Spec – Specification included as part of AIBG overall design
features but not tested by either KNC or BMTI on every lot.
BMTI Incoming Spec – Specification tested on every lot during BMTI incoming
receipt testing.
For all Tables: All specifications apply to non-sterile material unless
otherwise noted.

Table B.1: Collagen Component [Raw Material] (KNC PN **, **, **)
Attribute
 
Specification
 
Test Method
 
KNC Design
Spec
 
KNC Final Product
Spec
 
BMTI AIBG
Design Spec
 
BMTI Incoming
Spec
 
Tested in
Stability
 
Purpose
Animal Age
 
**
 
Verify cert from vendor
     
ü
             
Ensures material is suitable for creating ** collagen component
                                 
Regulatory Requirements
  
Must meet definition of closed herd as specified in ISO 22442-2
  
Verify cert from vendor
  
 
  
ü
CoA
  
 
  
 
  
 
  
Ensures safety of starting material with regard to TSE/BSE

Table B.2: Collagen Component [Intermediate Material] (KNC PN **, **; **)
Attribute
 
Specification
 
Test Method
 
KNC Design
Spec
 
KNC Final Product
Spec
 
BMTI Design
Spec
 
BMTI Incoming
Spec
 
Tested in
Stability
 
Purpose
Total Bacterial Count
  
**/gm (Average of 2 plate counts)
  
KNC SOP **, Bioburden Determination by Pour Plate
  
 
  
ü
  
n/a
  
n/a
  
 
  
Intermediate check at KNC verifies bioburden is adequately low before continuing
with downstream processing

Table B.3: Collagen Component [Intermediate Material] (KNC PN **, **; **)
Attribute
 
Specification
 
Test Method
 
KNC Design
Spec
 
KNC Final
Product Spec
 
BMTI Design
Spec
 
BMTI Incoming
Spec
 
Tested in
Stability
 
Purpose
Nitrogen Content
 
**% -**%
 
KNC SOP **, Nitrogen Determination (Kjeldahl Method)
     
ü
             
Verifies that manufacturing process has adequately removed non-protein materials
                                 
Hydroxyproline Content
  
**%-**%
  
KNC SOP **, Determination of  Hydroxyproline
  
 
  
ü
  
 
  
 
  
 
  
Used to indirectly estimate collagen content in tissue preparations

 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.
 
 
 

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

 

Amended Schedule B: Material Specifications (continued)
Dated: August 30, 2010

Table B.4: b-TCP Component (KNC PN **)
Attribute
 
Specification
 
Test Method
 
KNC Design
Spec
 
KNC Final Product
Spec
 
BMTI AIBG
Design Spec
 
BMTI Incoming
Spec
 
Tested in
Stability
 
Purpose
Chemical Formula
 
b-Ca3(PO4)2
 
Verify cert from vendor
 
ü
                 
Ensures proper ceramic is used
                                 
Composition
 
Meets ASTM 1088-04A for b-TCP
 
Verify cert from vendor
 
ü
     
ü
         
Ensures proper ceramic is used
                                 
Particle Size
 
**µm-**µm
 
Verify cert from vendor
 
ü
     
ü
         
Ensures ceramic range needed for clinical efficacy
                                 
Trace Elements
 
As: < 3ppm
Cd: < 5ppm
Hg: < 5ppm
Pb: < 30ppm
Total Heavy Metal as Lead: less than 50ppm
 
Verify cert from vendor
 
ü
                 
Ensures purity of raw ceramic
                                 
X-Ray Diffraction (XRD)
 
The XRD pattern results are required from the vendor and must conform to JCPDS
9-169
 
Verify cert from vendor
 
ü
                 
Ensures purity of raw ceramic
                                 
Wetability
  
**%
  
KNC SOP **, Beta Tricalcium Phosphate Wetability Testing Procedure
  
 
  
ü
  
 
  
 
  
 
  
Confirms adequate b-TCP wetting properties prior to downstream processing

 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.
 
 
 

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

 

Kensey Nash Corporation and BioMimetic Therapeutics, Inc.
DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT

Amended Schedule C: Proposed Product Specifications
Dated: August 30, 2010

Table C.1: Injectable Product 1: “**”
Specification
 
Requirement
Implant Level: KNC PN **
         
Physical Appearance
 
White to light yellow, light yellow and/or yellow speckling is acceptable when
tested in accordance with KNC SOP **
     
Mass
 
** device: ** when tested in accordance with KNC SOP **
     
Allowable Particulate
 
Maximum of ** (**) particle that has an area less than or equal to ** per
individual matrix sub-component when tested in accordance with KNC SOP **;
Multiple sub-components may make up a matrix component
     
Dry Weight Ratio (ash testing)
 
**% b-TCP by mass, average of 3 measurements when tested in accordance with KNC
SOP **
     
Porosity
 
**% minimum, average of 3 measurements when tested in accordance with KNC SOP **
     
Loss on Drying (% Solids)
 
**% solids minimum, average of 3 measurements when tested in accordance with KNC
SOP **
     
Hydration/Kneading Test
 
Homogenous construct devoid of nodules/hard spots when tested in accordance with
KNC SOP **
     
Packaged Level: KNC PN **
         
Configuration
 
“**” implant sealed within an inner pouch, sealed within a labeled outer pouch
     
Allowable Particulate
 
Inner Pouch - Maximum of ** (**) observed particle that has an area less than or
equal to ** (per TAPPI Dirt Estimation Chart) is allowed.
Outer Pouch - Maximum of ** (**) observed particle that has an area less than or
equal to ** (per TAPPI Dirt Estimation Chart), or ** (**) observed particles
that each have areas less than or equal to ** (per TAPPI Dirt Estimation Chart).
     
LAL Endotoxin Level
 
** EU/device maximum, post sterilization
     
Sterility
 
Gamma sterilized at a range of **; validated method
     
Package Integrity – Peel Strength
  
**./linear in. minimum for both inner and outer pouch

Standard Lead Time: 8 weeks
 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.
 
 
 

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

 

Amended Schedule C: Proposed Product Specifications (continued)
Dated: August 30, 2010

Table C.2: ** Matrix Material [Bulk, Non-Sterile] (KNC PN **)
Attribute
 
Specification
 
Test Method
 
KNC Design
Spec
 
KNC Final
Product Spec
 
BMTI AIBG
Design Spec
 
BMTI Incoming
Spec
 
Tested in
Stability
 
Purpose
Material
 
Manufactured from collagen raw material that meets ASTM F2212-02 and ceramic
that meets ASTM F1088-04
 
Component material certificates of conformance, lot release results
 
ü
CoA
         
ü
CoA
     
Ensures medical grade components are used
                                 
Physical Appearance
 
White to off-white non-sterile ** material
 
Visual examination per 6453-01.xls Inspection History Record (IHR)
 
ü
     
n/a
 
n/a
     
Verifies visual quality of intermediate material at KNC
                                 
Contamination
 
No foreign or denatured collagen material
 
Visual examination per KNC SOP**, Particulate Inspection for Ground Collagen
Powders
     
ü
 
n/a
 
n/a
     
Intermediate check at KNC ensures no foreign particulates contaminate the **
material
                                 
Dry Weight Ratio
 
** b-TCP by mass, average of 3 measurements
 
KNC SOP **, Low Temperature Microwave Ash Content Determination
     
ü
CoA
     
ü
CoA
     
Verifies components were mixed in proper ratio for clinical efficacy
                                 
Loss on Drying (% Solids)
 
** average of 3 measurements
 
KNC SOP **, Total Dry Solids Determination
     
ü
CoA
     
ü
CoA
 
ü
 
Verifies matrix does not contain excessive moisture [potential impact on product
preparation/handling characteristics]
                                 
Bulk Density
 
** grams/cc (to be finalized)
 
KNC SOP TBD (based on ASTM standard)
     
ü
 
n/a
 
n/a
     
Possible indicator at KNC of particle size distribution and/or hydration
properties
                                 
Hydration/Extrusion
 
Material must be able to be hydrated
 
KNC SOP TBD
     
ü
 
n/a
 
n/a
     
Intermediate check at KNC verifies acceptable product handling prior to release
for matrix loading/packaging

 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.
 
 
 

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

 

Table C.3: ** Matrix Material [Packaged, Sterile] (KNC PN **: Tray
Configuration; KNC PN **: Pouch Configuration)
Attribute
 
Specification
 
Test Method
 
KNC Design
Spec
 
KNC Final
Product Spec
 
BMTI AIBG
Design Spec
 
BMTI Incoming
Spec
 
Tested in
Stability
 
Purpose
Mass
 
KNC PN 2080X-02 (3cc product): **
 
Balance Scale
     
ü
CoA
     
ü
     
Ensures appropriate amount of dry material to generate desired post-hydration
volume
                                 
Physical Appearance [** Material, post sterilization]
 
White to light yellow; light yellow and/or yellow speckling is acceptable
 
Visual examination per 20801-01.xls IHR
 
ü
(for PN **)
 
ü
CoA (for PN **)
     
ü
     
Verifies visual integrity of the matrix material
                                 
Allowable Particulate
 
Maximum of ** (**) observed particle that has an area ** (per TAPPI Dirt
Estimation Chart) is allowed on or in each component
 
Visual examination per ** or **
     
ü
CoA
     
ü
CoA
     
Verifies visual integrity of the packaged components
                                 
** Content [post sterilization]
 
** ppm maximum
 
BMTI SOP TBD
             
ü
     
Ensures ** level does not adversely affect clinical efficacy
                                 
Configuration
 
One ** syringe filled with ** collagen/ceramic matrix, one empty ** syringe, one
female luer style coupler, one female luer style cap, one ** cannula, and one **
cannula
 
Visual examination per ** or **
     
ü
     
ü
     
Verifies all required matrix sub-kit components are included
                                 
Hydration/Extrusion [post sterilization]
 
Material must be able to be mixed and produce a homogenous paste after ** mixing
cycles with minimal material left unmixed; material must be able to extrude
through ** cannula, ** long
 
KNC SOP **, BioMimetic Collagen Beta TCP Component Physical Testing Procedure
     
ü
CoA
     
ü
CoA
 
ü
 
Verifies acceptable product handling
                                 
Package Integrity – Peel Strength
 
Foil pouch seals: ** lb/linear inch
PETG tray with foil lid: **/linear inch
 
KNC SOP **, Peel Test Procedure
     
ü
CoA
     
ü
CoA
 
ü
(Separate packaging stability study)
 
Verifies product package can maintain product sterility
                                 
Sterility
 
Sterile per ISO 11137-2 requirements (SAL 10-6)
 
Verify cert from contract sterilizer
     
ü
CoA
     
ü
CoA
     
Verifies final product meets safety requirements
                                 
LAL Endotoxin Level [post sterilization]
 
**/device
 
Verify CoA from contract test laboratory
     
ü
CoA
     
ü
CoA
     
Verifies final product meets safety requirements

Standard Lead Time: 8 weeks
 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.
 
 
 

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

 

Amended Schedule C: Proposed Product Specifications (continued)
Dated: August 30, 2010

Table C.4: ** Product
**.

 
Table C.5: ** Product
**.
 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.

 
 

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

 
 
Kensey Nash Corporation and BioMimetic Therapeutics, Inc.
DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT

Amended Schedule D: Transfer Price
Revision Dated: August 30, 2010
Effective as of: January 1, 2011

Combined Annual Unit Volume Pricing

KNC Part
Number
 
Product Size and
Configuration
 
1 – ** Units*
   
** – ** Units*
   
** – ** Units*
   
>** Units*
  **  
**** **
  $ **      $ **      $ **      $ **                                          **
 
**** **/Syringe
  $ **      $ **      $ **      $ **   

* Any combination of product configurations purchased annually.
** Volume after hydration with PDGF.
 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.

 
 

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

 

Kensey Nash Corporation and BioMimetic Therapeutics, Inc.
DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT

Amended Schedule F: Certificate of Conformance and Certificate of Analysis
Dated: August 30, 2010

An example of a Certificate of Conformance/Certificate of Analysis is included
below.
 
[logo]
 
CERTIFICATE OF CONFORMANCE/CERTIFICATE OF ANALYSIS

Supplier:
Kensey Nash Corporation
Address:
735 Pennsylvania Drive
 
Exton, PA 19341
   
Customer:
BioMimetic Therapeutics, Inc.

Attn:      Penn Pharmaceuticals
 

 
Reference:
 
Description
BioMimetic Augmentä Injectable Bone Graft
 
KNC Part Number
**
 
KNC Lot Number
**
 
Quantity Shipped
330
 
Manufacture Date
March 2009

We hereby certify that the products shipped on the above purchase order conform
to all dimensions and specifications referenced or required on the specification
sheet or the purchase order. Exceptions, if any, will be noted.
We hereby confirm that materials of animal origin used in the products specified
above meet current regulatory and BioMimetic requirements for TSE/BSE
minimization, including:
 
·
The materials were sourced from animals considered to be low risk for TSE/BSE
using a documented Quality Management System.

 
·
Materials were sourced, collected and handled per ISO 22442-2 (2007) and
applicable regulatory requirements from the source and destination countries,
including feeding, veterinary care and slaughtering methods.

 
·
Identification and traceability of the material to the animal origin was
maintained and documented with means for controlling cross contamination.

 
Certifications and/or chemical/physical test reports for the materials used are
on file and will be available to your company or to the government on request.
Manufactured in the USA.
Product Specifications:
Attribute
 
Analytical Method
 
Specification
 
Result
Physical Appearance
 
Visual examination (KNSY **)
 
White to light yellow, light yellow and/or yellow speckling is acceptable
 
PASS
             
Mass
 
Gravimetric (KNSY **)
 
** g
 
PASS
Avg. = **
             
Particulate
 
Visual examination (KNSY **)
 
Maximum of one (1) particle that has an area less than or equal to **
 
PASS
             
Dry Weight Ratio (Ash Test)
 
Gravimetric (KNSY **)
 
**-**% b-TCP by mass
 
PASS
Avg. = **%
             
Porosity
  
He-Pycnometry (KNSY **)
  
**% minimum
  
PASS
Avg. = **%

 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.

 
 

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

 

Attribute
 
Analytical Method
 
Specification
 
Result
Loss on Drying (Solids Test)
 
Gravimetric (KNSY **)
 
**% solids minimum
 
PASS
Avg. = **%
             
Hydration/Kneading Test
 
Manual Mix (KNSY **)
 
Homogenous construct devoid of nodules/hard spots
 
PASS
             
Endotoxin Level
 
USP <85>
 
** EU per matrix component
 
PASS
             
Sterility
 
Review Certificate of Processing
 
Irradiated with **-** kGy
 
PASS
(** - ** kGy)
             
Min. Peel Strength, Inner Pouch
 
Peel Strength (KNSY **)
 
** lb / linear inch minimum, 3 measurements
 
PASS
Avg. = ** lbs.
             
Min. Peel Strength, Outer Pouch
  
Peel Strength (KNSY **)
  
** lb / linear inch minimum, 3 measurements
  
PASS
Avg. = ** lbs.

 

 
Scott Meixell
     
Quality Control Manager
 
Kensey Nash Corporation
 
March 9, 2011

 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.

 
 

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

 

Kensey Nash Corporation and BioMimetic Therapeutics, Inc.
DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT

Schedule G: Milestone Payments
Dated: August 30, 2010

Subsection
   
Amount
 
Description
 
Forecasted Completion
Date
  G.1     $ **   
Upon the filing of the first PMA for US Approval of the first Commercial Product
    **   G.2     $ **   
Upon receipt of Approval for marketing of the first Commercial Product in the
United States from the FDA (generally "Approved Commercial Product") for open
and/or closed fractures via an open approach
    **   G.3     $ **   
Upon receipt of Approval for marketing of the first Approved Commercial Product
for percutaneous applications of such Approved Commercial Product for closed
fractures
    **   G.4     $ **   
Upon the First Commercial Sale of the first Approved Commercial Product as noted
in G.2, above
    **   G.5     $ **   
Upon the one-year anniversary of the First Commercial Sale of the first Approved
Commercial Product for use in procedures as noted in G.2, above
    **   G.6     $ **   
Upon the First Commercial Sale of the first Approved Commercial Product as noted
in G.3, above
    **   G.7     $ **   
Upon the one-year anniversary of the First Commercial Sale of the first Approved
Commercial Product, as noted in G.3, above
    **  

*BMTI makes no representations or warranties regarding the forecasted
dates.  Failure to meet any of the dates shall not effect either party’s rights
or obligations under this Agreement.
 
[**]  Redacted pursuant to confidential treatment request by BioMimetic
Therapeutics, Inc.

 
 

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