DISTRIBUTION AND LICENSE AGREEMENT

Contract Categories: Intellectual Property - License Agreements
EX-10.22 2 dex1022.htm 2ND AMEND - DISTRIBUTION AND LICENSE AGREEMENT 2nd Amend - Distribution and License Agreement

Exhibit 10.22

CONFIDENTIAL TREATMENT REQUESTED BY REGENERATION TECHNOLOGIES, INC. FOR CERTAIN PORTIONS OF THIS AGREEMENT IN ACCORDANCE WITH RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

SECOND AMENDMENT TO FIRST AMENDED EXCLUSIVE

DISTRIBUTION AND LICENSE AGREEMENT

THIS SECOND AMENDMENT TO FIRST AMENDED EXCLUSIVE DISTRIBUTION AND LICENSE AGREEMENT (this “Amendment”) is made and entered into as of December 15, 2005 by and between Regeneration Technologies, Inc., a Delaware corporation (“RTI”), and Medtronic Sofamor Danek USA, Inc., a Tennessee corporation (“MSD”).

WITNESSETH:

WHEREAS, MSD and RTI are parties to a First Amended Exclusive Distribution and License Agreement having an effective date of April 15, 2004, and parties to a First Amendment to First Amended Exclusive Distribution and License Agreement having an effective date of March 1, 2005 (collectively, the “Agreement”).

WHEREAS, MSD and RTI desire to amend the Agreement on the terms and conditions set forth herein;

AGREEMENT

NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties mutually agree as follows:

1. Definitions. Capitalized terms used herein and not otherwise defined herein shall have the meanings set forth in the Agreement.

2. Amendments.

(a) Schedule 2.1. Schedule 2.1 of the Agreement is hereby amended and restated to read in its entirety in the form attached hereto as Attachment A.

(b) Minimum Volume Commitment. The fees set forth in the Column B entitled “LSF Effective 7/1/2005” on Schedule 2.1 shall be effective on the date this Second Amendment is signed by both parties and apply retroactive to July 1, 2005. The fees in Column B relative to Cornerstone SR and Cornerstone Pinnacle/Cornerstone Lordotic Pinnacle shall be remain effective provided that RTI produces and delivers to MSD the minimum monthly quantities of specialty allografts indicated below, subject to receipt by RTI of Binding Forecasts from MSD in those amounts or greater during the relevant month.

 

     Minimum Monthly Quantities

Cornerstone SR (mono only)

    [***]/month

Cornerstone Pinnacle/

    [***]/month

Cornerstone Lordotic Pinnacle

   

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

If RTI fails to produce and deliver to MSD the indicated Minimum Monthly Quantities of Cornerstone SR or Cornerstone Pinnacle/Cornerstone Lordotic Pinnacle allografts for any two (2) months during a particular calendar quarter, subject to receipt by RTI of Binding Forecasts from MSD in those amounts or greater during the relevant month, then the fees for Cornerstone SR and Cornerstone Pinnacle/Cornerstone Lordotic Pinnacle allografts for that quarter only shall thereafter shall revert back to that indicated in Column A entitled “LSF through June 30, 2005” on Schedule 2.1.

Fees for the Cornerstone SR and Cornerstone Pinnacle/Cornerstone Lordotic Pinnacle allografts in subsequent quarters shall be in accordance with Column B fees provided RTI supplies the Minimum Monthly Quantities for at least two (2) of the months in the subsequent calendar quarter, subject to receipt by RTI of Binding Forecasts from MSD in those amounts or greater.

RTI shall not be responsible for producing and delivering the Minimum Monthly Quantities specified herein for a particular month to the extent that, during that month, the percentage of allografts orders for Cornerstone SR (mono only) and Cornerstone Pinnacle/Cornerstone Lordotic Pinnacle in the range of [***]mm through [***]mm in size is greater than [***]% of the total number of allografts constituting the Minimum Monthly Quantity for that month.

3. Acknowledgement and Agreement. The parties acknowledge that the binding orders for Specialty Allografts and Bone Paste indicated in Attachment B attached hereto were placed by MSD in December 2004. The parties acknowledge and agree that, for purposes of calculating the exclusivity provision set forth in Section 3.1(d) of the Agreement, [***] percent ([***]%) of such orders shall be treated as having been placed in the first quarter of 2005 and [***] percent ([***]%) of such orders shall be treated as having been placed in the second quarter of 2005.

4. Ratification. Except as amended hereby, the Agreement is hereby ratified and confirmed in all respects. As amended hereby, the Agreement shall be read and construed as one and the same instrument.

[THE REMAINDER OF THIS PAGE IS INTENTIONALLY BLANK.]

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

IN WITNESS WHEREOF, each of the parties has caused this Second Amendment to the First Amended Exclusive Distribution and License Agreement to be executed by their respective duly authorized representatives as of the date first above written.

 

REGENERATION TECHNOLOGIES, INC.
By:  

/s/ Roger W. Rose

Its:   Executive Vice President
MEDTRONIC SOFAMOR DANEK USA, INC.
By:  

/s/ Peter L. Wehrly

Its:   President Medtronic Sofamor Danek

Attachment “A” to Second Amendment to First Amendment to First Amended Exclusive License and

Distribution Agreement

Amended Schedule 2.1

Effective December 2005

EXCLUSIVE

 

Product Code

   

Description

   

Column A

LSF through

6/30/2005

  

Column B

LSF Effective

7/1/2005

Cornerstone L-SR (Lordotic SR Cortical Block)     

            300511

   

Cornerstone Lordotic SR Cortical Block 5 x 11 x 11mm

    [***]   [***]

            300541

   

Cornerstone Lordotic SR Cortical Block 5 x 14 x 11mm

    [***]   [***]

            300544

   

Cornerstone Lordotic SR Cortical Block 5 x 14 x 14mm

    [***]   [***]

            300611

   

Cornerstone Lordotic SR Cortical Block 6 x 11 x 11mm

    [***]   [***]

            300641

   

Cornerstone Lordotic SR Cortical Block 6 x 14 x 11mm

    [***]   [***]

            300644

   

Cornerstone Lordotic SR Cortical Block 6 x 14 x 14mm

    [***]   [***]

            300711

   

Cornerstone Lordotic SR Cortical Block 7 x 11 x 11mm

    [***]   [***]

            300741

   

Cornerstone Lordotic SR Cortical Block 7 x 14 x 11mm

    [***]   [***]

            300744

   

Cornerstone Lordotic SR Cortical Block 7 x 14 x 14mm

    [***]   [***]

            300811

   

Cornerstone Lordotic SR Cortical Block 8 x 11 x 11mm

    [***]   [***]

            300841

   

Cornerstone Lordotic SR Cortical Block 8 x 14 x 11mm

    [***]   [***]

            300844

   

Cornerstone Lordotic SR Cortical Block 8 x 14 x 14mm

    [***]   [***]

            300911

   

Cornerstone Lordotic SR Cortical Block 9 x 11 x 11mm

    [***]   [***]

            300941

   

Cornerstone Lordotic SR Cortical Block 9 x 14 x 11mm

    [***]   [***]

            300944

   

Cornerstone Lordotic SR Cortical Block 9 x 14 x 14mm

    [***]   [***]
Cornerstone SR (SR Cortical Block)     

            200511

   

Cornerstone SR Cortical Block 5 x 11 x 11mm

    [***]   [***]

            200541

   

Cornerstone SR Cortical Block 5 x 14 x 11mm

    [***]   [***]

            200544

   

Cornerstone SR Cortical Block 5 x 14 x 14mm

    [***]   [***]

            200611

   

Cornerstone SR Cortical Block 6 x 11 x 11mm

    [***]   [***]

            200641

   

Cornerstone SR Cortical Block 6 x 14 x 11mm

    [***]   [***]

            200644

   

Cornerstone SR Cortical Block 6 x 14 x 14mm

    [***]   [***]

            200711

   

Cornerstone SR Cortical Block 7 x 11 x 11mm

    [***]   [***]

            200741

   

Cornerstone SR Cortical Block 7 x 14 x 11mm

    [***]   [***]

            200744

   

Cornerstone SR Cortical Block 7 x 14 x 14mm

    [***]   [***]

            200811

   

Cornerstone SR Cortical Block 8 x 11 x 11mm

    [***]   [***]

            200841

   

Cornerstone SR Cortical Block 8 x 14 x 11mm

    [***]   [***]

            200844

   

Cornerstone SR Cortical Block 8 x 14 x 14mm

    [***]   [***]

            200911

   

Cornerstone SR Cortical Block 9 x 11 x 11mm

    [***]   [***]

            200941

   

Cornerstone SR Cortical Block 9 x 14 x 11mm

    [***]   [***]

            200944

   

Cornerstone SR Cortical Block 9 x 14 x 14mm

    [***]   [***]

            201041

   

Cornerstone SR Cortical Block 10 x 14 x 11mm

    [***]   [***]

            201141

   

Cornerstone SR Cortical Block 11 x 14 x 11mm

    [***]   [***]

            201241

   

Cornerstone SR Cortical Block 12 x 14 x 11mm

    [***]   [***]
Cornerstone ASR (Composite cortical-Cancellous Block)     

            245041

   

ASR Cortical-Cancellous Block 10 x 14 x 11mm

    [***]   [***]

            245141

   

ASR Cortical-Cancellous Block 11 x 14 x 12mm

    [***]   [***]

            245241

   

ASR Cortical-Cancellous Block 12 x 14 x 11mm

    [***]   [***]

            245341

   

ASR Cortical-Cancellous Block 13 x 14 x 11mm

    [***]   [***]

            245741

   

ASR Cortical-Cancellous Block 7 x 14 x 11mm

    [***]   [***]

            245841

   

ASR Cortical-Cancellous Block 8 x 14 x 11mm

    [***]   [***]

            245941

   

ASR Cortical-Cancellous Block 9 x 14 x 11mm

    [***]   [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

EXCLUSIVE

 

Product Code

   

Description

   

Column A

LSF through

6/30/2005

  

Column B

LSF Effective

7/1/2005

Cornerstone LASR (Lordotic Composite Cortical-Cancellous Block)

     

            345011

   

Lordotic ASR Cortical-Cancellous Block 10 x 11 x 11mm

    [***]   [***]

            345041

   

Lordotic ASR Cortical-Cancellous Block 10 x 14 x 11mm

    [***]   [***]

            345044

   

Lordotic ASR Cortical-Cancellous Block 10 x 14 x 14mm

    [***]   [***]

            345111

   

Lordotic ASR Cortical-Cancellous Block 11 x 11 x 11mm

    [***]   [***]

            345141

   

Lordotic ASR Cortical-Cancellous Block 11 x 14 x 11mm

    [***]   [***]

            345144

   

Lordotic ASR Cortical-Cancellous Block 11 x 14 x 14mm

    [***]   [***]

            345211

   

Lordotic ASR Cortical-Cancellous Block 12 x 11 x 11mm

    [***]   [***]

            345241

   

Lordotic ASR Cortical-Cancellous Block 12 x 14 x 11mm

    [***]   [***]

            345244

   

Lordotic ASR Cortical-Cancellous Block 12 x 14 x 14mm

    [***]   [***]

            345711

   

Lordotic ASR Cortical-Cancellous Block 7 x 11 x 11mm

    [***]   [***]

            345741

   

Lordotic ASR Cortical-Cancellous Block 7 x 14 x 11mm

    [***]   [***]

            345744

   

Lordotic ASR Cortical-Cancellous Block 7 x 14 x 14mm

    [***]   [***]

            345811

   

Lordotic ASR Cortical-Cancellous Block 8 x 11 x 11mm

    [***]   [***]

            345841

   

Lordotic ASR Cortical-Cancellous Block 8 x 14 x 11mm

    [***]   [***]

            345844

   

Lordotic ASR Cortical-Cancellous Block 8 x 14 x 14mm

    [***]   [***]

            245911

   

Lordotic ASR Cortical-Cancellous Block 9 x 11 x 11mm

    [***]   [***]

            345941

   

Lordotic ASR Cortical-Cancellous Block 9 x 14 x 11mm

    [***]   [***]

            345944

   

Lordotic ASR Cortical-Cancellous Block 9 x 14 x 14mm

    [***]   [***]

Cornerstone Pinnacle

     

            545541

   

Cornerstone Pinnacle 5 x 14 x 11

    [***]   [***]

            545641

   

Cornerstone Pinnacle 6 x 14 x 11

    [***]   [***]
      [***]  

Cornerstone Lordotic MASR Pinnacle

      [***]

            645611

   

Lordotic MASR Cortical-Cancellous Block 6 x 11 x 11mm

    [***]   [***]

            645641

   

Lordotic MASR Cortical-Cancellous Block 6 x 14 x 11mm

    [***]   [***]

            645644

   

Lordotic MASR Cortical-Cancellous Block 6 x 14 x 14mm

    [***]   [***]

            645511

   

Lordotic MASR Cortical-Cancellous Block 5 x 11 x 11mm

    [***]   [***]

            645541

   

Lordotic MASR Cortical-Cancellous Block 5 x 14 x 11mm

    [***]   [***]

            645544

   

Lordotic MASR Cortical-Cancellous Block 5 x 14 x 14mm

    [***]   [***]

Cornerstone Reserve (Cortical-Cancellous Ring)

     

            270050

   

Cortical Ring w/ Cancellous Plug 5mm

    [***]   [***]

            270060

   

Cortical Ring w/ Cancellous Plug 6mm

    [***]   [***]

            270070

   

Cortical Ring w/ Cancellous Plug 7mm

    [***]   [***]

            270080

   

Cortical Ring w/ Cancellous Plug 8mm

    [***]   [***]

            270090

   

Cortical Ring w/ Cancellous Plug 9mm

    [***]   [***]

            270100

   

Cortical Ring w/ Cancellous Plug 10mm

    [***]   [***]

            270110

   

Cortical Ring w/ Cancellous Plug 11mm

    [***]   [***]

            270120

   

Cortical Ring w/ Cancellous Plug 12mm

    [***]   [***]

            270130

   

Cortical Ring w/ Cancellous Plug 13mm

    [***]   [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

EXCLUSIVE

 

Product Code

   

Description

   

Column A

LSF through

6/30/2005

  

Column B

LSF Effective

7/1/2005

Cornerstone Select (Fibula Wedge)

     

            210500

   

Cornerstone Select 5mm

    [***]   [***]

            210600

   

Cornerstone Select 6mm

    [***]   [***]

            210700

   

Cornerstone Select 7mm

    [***]   [***]

            210800

   

Cornerstone Select 8mm

    [***]   [***]

            210900

   

Cornerstone Select 9mm

    [***]   [***]

            211000

   

Cornerstone Select 10mm

    [***]   [***]

            211100

   

Cornerstone Select 11mm

    [***]   [***]

            211200

   

Cornerstone Select 12mm

    [***]   [***]

            211300

   

Cornerstone Select 13mm

    [***]   [***]

            213500

   

Cornerstone Select 35mm

    [***]   [***]

            215000

   

Cornerstone Select 50mm

    [***]   [***]

            217000

   

Cornerstone Select 70mm

    [***]   [***]

Humeral Ring

     

            692017

   

Humeral Ring

    [***]   [***]

Unicortical Dowel

     

            280012

   

Unicortical Dowel 12mm

    [***]   [***]

            280014

   

Unicortical Dowel 14mm

    [***]   [***]

            280016

   

Unicortical Dowel 16mm

    [***]   [***]

Cornerstone Iliac Block, Tricortical

     

            310107

   

Iliac Block, Tricortical 7mm x 15mm

    [***]   [***]

            310108

   

Iliac Block, Tricortical 8mm x 15mm

    [***]   [***]

            310109

   

Iliac Block, Tricortical 9mm x 15mm

    [***]   [***]

            310110

   

Iliac Block, Tricortical 10mm x 15mm

    [***]   [***]

            310112

   

Iliac Block, Tricortical 12mm x 15mm

    [***]   [***]

            310114

   

Iliac Block, Tricortical 14mm x 15mm

    [***]   [***]

            310115

   

Iliac Block, Tricortical 15mm x 15mm

    [***]   [***]

            310116

   

Iliac Block, Tricortical 16mm x 15mm

    [***]   [***]

            310118

   

Iliac Block, Tricortical 18mm x 15mm

    [***]   [***]

            310120

   

Iliac Block, Tricortical 20mm x 15mm

    [***]   [***]

            310225

   

Iliac Block, Tricortical 25mm x 15mm

    [***]   [***]

Cornerstone Unicortical Block

     

            850612

   

Unicortical Block 6 x 12mm

    [***]   [***]

            850712

   

Unicortical Block 7 x 12mm

    [***]   [***]

            850812

   

Unicortical Block 8 x 12mm

    [***]   [***]

            850912

   

Unicortical Block 9 x 12mm

    [***]   [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

EXCLUSIVE

 

Product Code

   

Description

   

Column A

LSF through

6/30/2005

  

Column B

LSF Effective

7/1/2005

Tangent

     

            160820

   

Tangent Impacted Wedge FZ 8 x 20

    [***]   [***]

            161020

   

Tangent Impacted Wedge FZ 10 x 20

    [***]   [***]

            161220

   

Tangent Impacted Wedge FZ 12 x 20

    [***]   [***]

            160826

   

Tangent Impacted Wedge FZ 8 x 26

    [***]   [***]

            161026

   

Tangent Impacted Wedge FZ 10 x 26

    [***]   [***]

            161226

   

Tangent Impacted Wedge FZ 12 x 26

    [***]   [***]

            161426

   

Tangent Impacted Wedge FZ 14 x 26

    [***]   [***]

            170820

   

Tangent Impacted Wedge FZD 8 x 20

    [***]   [***]

            170826

   

Tangent Impacted Wedge FZD 8 x 26

    [***]   [***]

            171020

   

Tangent Impacted Wedge FZD 10 x 20

    [***]   [***]

            171026

   

Tangent Impacted Wedge FZD 10 x 26

    [***]   [***]

            171220

   

Tangent Impacted Wedge FZD 12 x 20

    [***]   [***]

            171226

   

Tangent Impacted Wedge FZD 12 x 26

    [***]   [***]

            171426

   

Tangent Impacted Wedge FZD 14 x 26

    [***]   [***]

            171626

   

Tangent Impacted Wedge FZD 16 x 26

    [***]   [***]

Cancellous Block

     

            260130

   

Cancellous Block 13-17(H) x 13-17(W) x 20-60(L)mm

    [***]   [***]

            260230

   

Cancellous Block 18-22(H) x 18-22(W) x 20-60(L)mm

    [***]   [***]

            260330

   

Cancellous Block 23-27(H) x 23-27(W) x 20-60(L)mm

    [***]   [***]

Patellar Tricortical Wedge

     

            340015

   

Patellar Tricortical Wedge 15(H) x 25(L)mm

    [***]   [***]

            340018

   

Patellar Tricortical Wedge 18(H) x 25(L)mm

    [***]   [***]

            340020

   

Patellar Tricortical Wedge 20(H) x 25(L)mm

    [***]   [***]

Fibular Ring

     

            661106

   

Fibular Ring 6mm

    [***]   [***]

            661107

   

Fibular Ring 7mm

    [***]   [***]

            661108

   

Fibular Ring 8mm

    [***]   [***]

            661109

   

Fibular Ring 9mm

    [***]   [***]

            661110

   

Fibular Ring 10mm

    [***]   [***]

Bicortical Block

     

            862010

   

Bi-Cortical Block 10mm x 20mm

    [***]   [***]

            862012

   

Bi-Cortical Block 12mm x 20mm

    [***]   [***]

            862014

   

Bi-Cortical Block 14mm x 20mm

    [***]   [***]

            862512

   

Bi-Cortical Block 12mm x 25mm

    [***]   [***]

            862514

   

Bi-Cortical Block 14mm x 25mm

    [***]   [***]

            862516

   

Bi-Cortical Block 16mm x 25mm

    [***]   [***]

            872007

   

Bi-Cortical Block 7mm

    [***]   [***]

            872008

   

Bi-Cortical Block 8mm

    [***]   [***]

            872009

   

Bi-Cortical Block 9mm

    [***]   [***]

            872010

   

Bi-Cortical Block 10mm

    [***]   [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

EXCLUSIVE

 

Product Code

   

Description

   

Column A

LSF through

6/30/2005

  

Column B

LSF Effective

7/1/2005

Tricortical Block

     

            320105

   

Tricortical Block 5mm

    [***]   [***]

            320106

   

Tricortical Block 6mm

    [***]   [***]

            320107

   

Tricortical Block 7mm

    [***]   [***]

            320108

   

Tricortical Block 8mm

    [***]   [***]

            320109

   

Tricortical Block 9mm

    [***]   [***]

            320110

   

Tricortical Block 10mm

    [***]   [***]

Freeze-Dried Precision Graft

     

            439012

   

FZD Machined Cortical Ring 12 x 26 x 26mm

    [***]   [***]

            439014

   

FZD Machined Cortical Ring 14 x 26 x 26mm

    [***]   [***]

            439016

   

FZD Machined Cortical Ring 16 x 26 x 26mm

    [***]   [***]

            439018

   

FZD Machined Cortical Ring 18 x 26 x 26mm

    [***]   [***]

            439020

   

FZD Machined Cortical Ring 20 x 26 x 26mm

    [***]   [***]

Frozen Precision Graft

     

            451066

   

Precision Impacted Cortical ring 10 x 26 x 26

    [***]   [***]

            451244

   

Precision Impacted Cortical ring 12 x 24 x 24

    [***]   [***]

            451266

   

Precision Impacted Cortical ring 12 x 26 x 26

    [***]   [***]

            451444

   

Precision Impacted Cortical ring 14 x 24 x 24

    [***]   [***]

            451466

   

Precision Impacted Cortical ring 14 x 26 x 26

    [***]   [***]

            451644

   

Precision Impacted Cortical ring 16 x 24 x 24

    [***]   [***]

            451666

   

Precision Impacted Cortical ring 16 x 26 x 26

    [***]   [***]

            451844

   

Precision Impacted Cortical ring 18 x 24 x 24

    [***]   [***]

            451866

   

Precision Impacted Cortical ring 18 x 26 x 26

    [***]   [***]

            452044

   

Precision Impacted Cortical ring 20 x 24 x 24

    [***]   [***]

            452066

   

Precision Impacted Cortical ring 20 x 26 x 26

    [***]   [***]

            452466

   

Precision Impacted Cortical ring 24 x 26 x 26

    [***]   [***]

Assembled ALIF

     

            939012

   

Precision Plus 12mm

    [***]   [***]

            939014

   

Precision Plus 14mm

    [***]   [***]

            939016

   

Precision Plus 16mm

    [***]   [***]

            939018

   

Precision Plus 18mm

    [***]   [***]

            939020

   

Precision Plus 20mm

    [***]   [***]

MDII Threaded Cortical Bone Dowel Frozen

     

            401114

   

MDII Threaded Dowel 14 x 20mm

    [***]   [***]

            401116

   

MDII Threaded Dowel 16 x 20mm

    [***]   [***]

            401118

   

MDII Threaded Dowel 18 x 20mm

    [***]   [***]

            401120

   

MDII Threaded Dowel 20 x 20mm

    [***]   [***]

            401214

   

MDII Threaded Dowel 14 x 23mm

    [***]   [***]

            401216

   

MDII Threaded Dowel 16 x 23mm

    [***]   [***]

            401218

   

MDII Threaded Dowel 18 x 23mm

    [***]   [***]

            401220

   

MDII Threaded Dowel 20 x 23mm

    [***]   [***]

            401316

   

MDII Threaded Dowel 16 x 26mm

    [***]   [***]

            401318

   

MDII Threaded Dowel 18 x 26mm

    [***]   [***]

            401320

   

MDII Threaded Dowel 20 x 26mm

    [***]   [***]

            401222

   

MDII Threaded Dowel 22 x 23mm

    [***]   [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

EXCLUSIVE

 

Product Code

   

Description

   

Column A

LSF through

6/30/2005

  

Column B

LSF Effective
7/1/2005

MDII Threaded Cortical Bone Dowel Frozen

     

            401224

   

MDII Threaded Dowel 24 x 23mm

    [***]   [***]

            401322

   

MDII Threaded Dowel 22 x 26mm

    [***]   [***]

MDIV Threaded Cortical Bone

     

            441218

   

MDIV Threaded Dowel 18 x 23mm

    [***]   [***]

            441220

   

MDIV Threaded Dowel 20 x 23mm

    [***]   [***]

            441222

   

MDIV Threaded Dowel 22 x 23mm

    [***]   [***]

            441224

   

MDIV Threaded Dowel 24 x 23mm

    [***]   [***]

            441318

   

MDIV Threaded Dowel 18 x 26mm

    [***]   [***]

            441320

   

MDIV Threaded Dowel 20 x 26mm

    [***]   [***]

            441322

   

MDIV Threaded Dowel 22 x 26mm

    [***]   [***]

Osteofil RT ICM Moldable

     

            004505

   

Osteofil RT ICM Moldable 5cc

    [***]   [***]

            004510

   

Osteofil RT ICM Moldable 10cc

    [***]   [***]

            004520

   

Osteofil RT ICM Moldable 20cc

    [***]   [***]

Osteofil RT Paste

     

            004401   *

   

Osteofil Paste - RT 1cc

    [***]   [***]

            004601

   

Osteofil Paste - RT 1cc

    [***]   [***]

            004405   *

   

Osteofil Paste - RT 5cc

    [***]   [***]

            004605

   

Osteofil Paste - RT 5cc

    [***]   [***]

            004410   *

   

Osteofil Paste - RT 10cc

    [***]   [***]

            004610

   

Osteofil Paste - RT 10cc

    [***]   [***]

            044005   *

   

Osteofil Paste - RT 0.5cc

    [***]   [***]

            046005

   

Osteofil Paste - RT 0.5cc

    [***]   [***]

                           *

   

Product code being phased out

     

Osteofil Frozen Paste

     

            002401

   

Osteofil Paste Frozen 1cc

    [***]   [***]

            002405

   

Osteofil Paste Frozen 5cc

    [***]   [***]

            002410

   

Osteofil Paste Frozen 10cc

    [***]   [***]

            024005

   

Osteofil Paste Frozen 0.5cc

    [***]   [***]

Osteofil -IC

        

            002705

   

Osteofil - IC 5cc

    [***]   [***]

            002710

   

Osteofil - IC 10cc

    [***]   [***]

            002720

   

Osteofil - IC 20cc

    [***]   [***]

Osteofil ICM Frozen Strips

     

            002350

   

Osteofil - ICM 50mm

    [***]   [***]

            002390

   

Osteofil - ICM 90mm

    [***]   [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

NEW PRODUCT ADDITIONS May 1, 2005

EXCLUSIVE

 

Product Code

     

Description

   

Column B

LSF Effective
5/1/2005

Cornerstone SR Assembled Cortical

   

            330511

     

ACSR Cortical Block 5 x 11 x 11mm

    [***]

            330541

     

ACSR Cortical Block 5 x 14 x 11mm

    [***]

            330544

     

ACSR Cortical Block 5 x 11 x 14mm

    [***]

            330611

     

ACSR Cortical Block 6 x 11 x 11mm

    [***]

            330641

     

ACSR Cortical Block 6 x 14 x 11mm

    [***]

            330644

     

ACSR Cortical Block 6 x 14 x 14mm

    [***]

            330711

     

ACSR Cortical Block 7 x 11 x 11mm

    [***]

            330741

     

ACSR Cortical Block 7 x 14 x 11mm

    [***]

            330744

     

ACSR Cortical Block 7 x 14 x 14mm

    [***]

            330811

     

ACSR Cortical Block 8 x 11 x 11mm

    [***]

            330841

     

ACSR Cortical Block 8 x 14 x 11mm

    [***]

            330844

     

ACSR Cortical Block 8 x 14 x 14mm

    [***]

            330911

     

ACSR Cortical Block 9 x 11 x 11mm

    [***]

            330941

     

ACSR Cortical Block 9 x 14 x 11mm

    [***]

            330944

     

ACSR Cortical Block 9 x 14 x 14mm

    [***]

            331011

     

ACSR Cortical Block 10 x 11 x 11mm

    [***]

            331041

     

ACSR Cortical Block 10 x 14 x 11mm

    [***]

            331044

     

ACSR Cortical Block 10 x 14 x 14mm

    [***]

            331111

     

ACSR Cortical Block 11 x 11 x 11mm

    [***]

            331141

     

ACSR Cortical Block 11 x 14 x 11mm

    [***]

            331144

     

ACSR Cortical Block 11 x 14 x 14mm

    [***]

            331211

     

ACSR Cortical Block 12 x 11 x 11mm

    [***]

            331241

     

ACSR Cortical Block 12 x 14 x 11mm

    [***]

            331244

     

ACSR Cortical Block 12 x 14 x 14mm

    [***]

            331311

     

ACSR Cortical Block 13 x 11 x 11mm

    [***]

            331341

     

ACSR Cortical Block 13 x 14 x 11mm

    [***]

            331344

     

ACSR Cortical Block 13 x 14 x 14mm

    [***]

Cornerstone Lordotic SR Assembled Cortical

   

            340511

     

L-ACSR Cortical Block 5 x 11 x 11mm

    [***]

            340541

     

L-ACSR Cortical Block 5 x 14 x 11mm

    [***]

            340544

     

L-ACSR Cortical Block 5 x 14 x 14mm

    [***]

            340611

     

L-ACSR Cortical Block 6 x 11 x 11mm

    [***]

            340641

     

L-ACSR Cortical Block 6 x 14 x 11mm

    [***]

            340644

     

L-ACSR Cortical Block 6 x 14 x 14mm

    [***]

            340711

     

L-ACSR Cortical Block 7 x 11 x 11mm

    [***]

            340741

     

L-ACSR Cortical Block 7 x 14 x 11mm

    [***]

            340744

     

L-ACSR Cortical Block 7 x 14 x 14mm

    [***]

            340811

     

L-ACSR Cortical Block 8 x 11 x 11mm

    [***]

            340841

     

L-ACSR Cortical Block 8 x 14 x 11mm

    [***]

            340844

     

L-ACSR Cortical Block 8 x 14 x 14mm

    [***]

            340911

     

L-ACSR Cortical Block 9 x 11 x 11mm

    [***]

            340941

     

L-ACSR Cortical Block 9 x 14 x 11mm

    [***]

            340944

     

L-ACSR Cortical Block 9 x 14 x 14mm

    [***]

            341011

     

L-ACSR Cortical Block 10 x 11 x 11mm

    [***]

            341041

     

L-ACSR Cortical Block 10 x 14 x 11mm

    [***]

            341044

     

L-ACSR Cortical Block 10 x 14 x 14mm

    [***]

            341111

     

L-ACSR Cortical Block 11 x 11 x 11mm

    [***]

            341141

     

L-ACSR Cortical Block 11 x 14 x 11mm

    [***]

            341144

     

L-ACSR Cortical Block 11 x 14 x 14mm

    [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

NEW PRODUCT ADDITIONS May 1, 2005

EXCLUSIVE

 

Product Code

   

Description

   

Column B

LSF Effective

5/1/2005

Cornerstone Lordotic SR Assembled Cortical

   

            341211

   

L-ACSR Cortical Block 12 x 11 x 11mm

    [***]

            341241

   

L-ACSR Cortical Block 12 x 14 x 11mm

    [***]

            341244

   

L-ACSR Cortical Block 12 x 14 x 14mm

    [***]

Cornerstone ASR/Lordotic ASR (Assembled Cortical-Cancellous)

   

            245541

   

ASR Cortical-Cancellous Block 5 x 14 x 11mm

    [***]

            245641

   

ASR Cortical-Cancellous Block 6 x 14 x 11mm

    [***]

            345511

   

Lordotic ASR Cortical-Cancellous Block 5 x 11 x 11mm

    [***]

            345541

   

Lordotic ASR Cortical-Cancellous Block 5 x 14 x 11mm

    [***]

            345544

   

Lordotic ASR Cortical-Cancellous Block 5 x 14 x 14mm

    [***]

            345611

   

Lordotic ASR Cortical-Cancellous Block 6 x 11 x 11mm

    [***]

            345641

   

Lordotic ASR Cortical-Cancellous Block 6 x 14 x 11mm

    [***]

            345644

   

Lordotic ASR Cortical-Cancellous Block 6 x 14 x 14mm

    [***]

Boomerang TLIF Assembled

   

            293007

   

Boomerang / Crescent Bone 7mm

    [***]

            293008

   

Boomerang / Crescent Bone 8mm

    [***]

            293009

   

Boomerang / Crescent Bone 9mm

    [***]

            293010

   

Boomerang / Crescent Bone 10mm

    [***]

            293011

   

Boomerang / Crescent Bone 11mm

    [***]

            293012

   

Boomerang / Crescent Bone 12mm

    [***]

            293013

   

Boomerang / Crescent Bone 13mm

    [***]

            293014

   

Boomerang / Crescent Bone 14mm

    [***]

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

NON-EXCLUSIVE

 

Product Code

   

Description

   

Column A

LSF 2004

  

Column B
LSF Effective

7/1/2005

Cancellous Chips

     

            100015

   

Cancellous Chips (1-4mm) 15cc

    [***]   [***]

            100030

   

Cancellous Chips (1-4mm) 30cc

    [***]   [***]

            100415

   

Cancellous Chips (4-10mm) 15cc

    [***]   [***]

            100430

   

Cancellous Chips (4-10mm) 30cc

    [***]   [***]

Cancellous Cubes

     

            100315

   

Cancellous Cubes (6-10mm) 15cc

    [***]   [***]

            100330

   

Cancellous Cubes (6-10mm) 30cc

    [***]   [***]

            100215

   

Cancellous Cubes (4-6mm) 15cc

    [***]   [***]

            100230

   

Cancellous Cubes (4-6mm) 30cc

    [***]   [***]

Cortical and Cancellous Chips

     

            110115

   

Cortical Cancellous Chips (1-3mm) 15cc

    [***]   [***]

            110130

   

Cortical Cancellous Chips (1-3mm) 30cc

    [***]   [***]

Cortical Strips

     

            271160

   

Cortical Strip 45-65mm (L) x 2-3

    [***]   [***]

            271260

   

Cortical Strip 45-65mm (L) x 4-5

    [***]   [***]

            271460

   

Cortical Strip 45-65mm (L) x 6-7

    [***]   [***]

            273210

   

Cortical Strip 90-110mm (L) x 9-11

    [***]   [***]

            273215

   

Cortical Strip 111-179mm (L) x 9-11

    [***]   [***]

            273415

   

Cortical Strip 111-179mm (L) x 14-16

    [***]   [***]

            273615

   

Cortical Strip 111-179mm (L) x 18-20

    [***]   [***]

Ilium Strips

     

            330030

   

Ilium Strip, Tricortical 28-45mm (L)

    [***]   [***]

            330050

   

Ilium Strip, Tricortical 46-57mm (L)

    [***]   [***]

            330060

   

Ilium Strip, Tricortical >58mm (L)

    [***]   [***]

Cortical Cancellous Strips

     

            351260

   

Cortical Cancellous Strips 58-62mm (L) x 4-6mm

    [***]   [***]

Cortical Wedge

     

            752020

   

Cortical Wedge 10mm, FZD

    [***]   [***]

            752820

   

Cortical Wedge 8mm, FZD

    [***]   [***]

Bicortical Block2

     

            882006

   

Bicortical Block (Parallel) 6mm

    [***]   [***]

            882007

   

Bicortical Block (Parallel) 7mm

    [***]   [***]

            882008

   

Bicortical Block (Parallel) 8mm

    [***]   [***]

            882009

   

Bicortical Block (Parallel) 9mm

    [***]   [***]

            882010

   

Bicortical Block (Parallel) 10mm

    [***]   [***]
2 RTI agrees that it will not distribute these bicortical parallel blocks in the Exclusive Territory

Exclusive in the Exclusive Territory and non-exclusive elsewhere in the Territory subject to Section 3.1(e).

 

[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Attachment B to Second Amendment to First Amended Exclusive License and Distribution

Orders for Exclusivity Provision Calculation

 

Product Number

     

Description

    Total   75%   25%

002350

     

Osteofil ICM Moldable 50mm

    [***]   [***]   [***]

002390

     

Osteofil ICM Moldable 90mm

    [***]   [***]   [***]

002401

     

Osteofil Paste 1cc

    [***]   [***]   [***]

002405

     

Osteofil Paste 5cc

    [***]   [***]   [***]

002410

     

Osteofil Paste 10cc

    [***]   [***]   [***]

004401

     

Osteofil RT Paste 1cc

    [***]   [***]   [***]

004410

     

Osteofil RT Paste 10cc

    [***]   [***]   [***]

004505

     

Osteofil RT ICM Moldable 5cc

    [***]   [***]   [***]

004510

     

Osteofil RT ICM Moldable 10cc

    [***]   [***]   [***]

024005

     

Osteofil Paste 0.5cc

    [***]   [***]   [***]

100015

     

Cancellous Chips (1-4mm) 15cc

    [***]   [***]   [***]

100030

     

Cancellous Chips (1-4mm) 30cc

    [***]   [***]   [***]

100090

     

Cancellous Chips (1-4mm) 90cc

    [***]   [***]   [***]

100460

     

Cancellous Chips (4-10mm) 60cc

    [***]   [***]   [***]

110130

     

Cort/Canc Blend(1-3mm) 30cc

    [***]   [***]   [***]

170820

     

Impacted Wedge FZD 8x20

    [***]   [***]   [***]

170826

     

Impacted Wedge FZD 8x26

    [***]   [***]   [***]

171020

     

Impacted Wedge FZD 10x20

    [***]   [***]   [***]

171026

     

Impacted Wedge FZD 10x26

    [***]   [***]   [***]

171220

     

Impacted Wedge FZD 12x20

    [***]   [***]   [***]

171226

     

Impacted Wedge FZD 12x26

    [***]   [***]   [***]

171426

     

Impacted Wedge FZD 14x27

    [***]   [***]   [***]

200511

     

SR Bone 5 x 11 x 11 FZD

    [***]   [***]   [***]

200541

     

SR Bone 5 x 14 x 11 FZD

    [***]   [***]   [***]

200611

     

SR Bone 6 x 11 x 11 FZD

    [***]   [***]   [***]

200641

     

SR Bone 6 x 14 x 11 FZD

    [***]   [***]   [***]

200644

     

SR Bone 6 x 14 x 14 FZD

    [***]   [***]   [***]

200744

     

SR Bone 7 x 14 x 14 FZD

    [***]   [***]   [***]

201041

     

SR Bone 10 x 14 x 11 FZD

    [***]   [***]   [***]

201141

     

SR Bone 11 x 14 x 11 FZD

    [***]   [***]   [***]

201241

     

SR Bone 12 x 14 x 11 FZD

    [***]   [***]   [***]

210600

     

Select Bone 6mm FZD

    [***]   [***]   [***]

210700

     

Select Bone 7mm FZD

    [***]   [***]   [***]

210900

     

Select Bone 9mm FZD

    [***]   [***]   [***]

211000

     

Select Bone 10mm FZD

    [***]   [***]   [***]

211100

     

Select Bone 11mm FZD

    [***]   [***]   [***]

213500

     

Select Bone 35mm FZD

    [***]   [***]   [***]

245241

     

ACC-SR 10 x 14 x 11mm

    [***]   [***]   [***]

245741

     

ACC-SR 7 x 14 x 11mm

    [***]   [***]   [***]

245841

     

ACC-SR 8 x 14 x 11mm

    [***]   [***]   [***]

245941

     

ACC-SR 9 x 14 x 11mm

    [***]   [***]   [***]

270060

     

Cortical Ring w/ Cancellous Plug 6mm

    [***]   [***]   [***]

270070

     

Cortical Ring w/ Cancellous Plug 7mm

    [***]   [***]   [***]

270080

     

Cortical Ring w/ Cancellous Plug 8mm

    [***]   [***]   [***]

270090

     

Cortical Ring w/ Cancellous Plug 9mm

    [***]   [***]   [***]

270110

     

Cortical Ring w/ Cancellous Plug 11mm

    [***]   [***]   [***]

271260

     

Cortical Strips 45-65mmL x 4-5mm

    [***]   [***]   [***]

273210

     

Cortical Strips 90-110mm x 9-11mm

    [***]   [***]   [***]

373415

     

Cortical Strips 111-179mm x 14-16mm

    [***]   [***]   [***]
[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Product Number

     

Description

    Total   75%   25%

280016

     

15mm Unicortical Dowel

    [***]   [***]   [***]

300511

     

Cornerstone L-SR 5 x 11 x 11

    [***]   [***]   [***]

300541

     

Cornerstone L-SR 5 x 14 x 11

    [***]   [***]   [***]

300544

     

Cornerstone L-SR 5 x 14 x 14

    [***]   [***]   [***]

300611

     

Cornerstone L-SR 6 x 11 x 11

    [***]   [***]   [***]

300644

     

Cornerstone L-SR 6 x 14 x 14

    [***]   [***]   [***]

310109

     

Ilium Block Tricortical 9mm x 15mm

    [***]   [***]   [***]

345041

     

Cornerstone L-ASR 10 x 14 x 11

    [***]   [***]   [***]

345044

     

Cornerstone L-ASR 10 x 14 x 14

    [***]   [***]   [***]

345111

     

Cornerstone L-ASR 11 x 11 x 11

    [***]   [***]   [***]

345141

     

Cornerstone L-ASR 11 x 14 x 11

    [***]   [***]   [***]

345211

     

Cornerstone L-ASR 12 x 11 x 11

    [***]   [***]   [***]

345241

     

Cornerstone L-ASR 12 x 14 x 11

    [***]   [***]   [***]

345244

     

Cornerstone L-ASR 12 x 14 x 14

    [***]   [***]   [***]

345711

     

Cornerstone L-ASR 7 x 11 x 11

    [***]   [***]   [***]

345744

     

Cornerstone L-ASR 7 x 14 x 14

    [***]   [***]   [***]

345811

     

Cornerstone L-ASR 8 x 11 x 11

    [***]   [***]   [***]

345841

     

Cornerstone L-ASR 8 x 14 x 11

    [***]   [***]   [***]

345844

     

Cornerstone L-ASR 8 x 14 x 14

    [***]   [***]   [***]

345941

     

Cornerstone L-ASR 9 x 14 x 11

    [***]   [***]   [***]

345944

     

Cornerstone L-ASR 9 x 14 x 14

    [***]   [***]   [***]

351260

     

Cancellous/Cortical Strip 58-60mmx4-6

    [***]   [***]   [***]

401114

     

MDII Threaded Dowel FZ 14x20

    [***]   [***]   [***]

401116

     

MDII Threaded Dowel FZ 16x20

    [***]   [***]   [***]

401118

     

MDII Threaded Dowel FZ 18x20

    [***]   [***]   [***]

401120

     

MDII Threaded Dowel FZ 20x20

    [***]   [***]   [***]

401214

     

MDII Threaded Dowel FZ 14x23

    [***]   [***]   [***]

401220

     

MDII Threaded Dowel FZ 20x23

    [***]   [***]   [***]

401316

     

MDII Threaded Dowel FZ 16x26

    [***]   [***]   [***]

401318

     

MDII Threaded Dowel FZ 18x26

    [***]   [***]   [***]

401320

     

MDII Threaded Dowel FZ 20x26

    [***]   [***]   [***]

439012

     

12mm x 26mm Cortical Ring FZD

    [***]   [***]   [***]

439014

     

14mm x 26mm Cortical Ring FZD

    [***]   [***]   [***]

439016

     

16mm x 26mm Cortical Ring FZD

    [***]   [***]   [***]

441220

     

MDIV 20 x 23

    [***]   [***]   [***]

451266

     

12x26x26 Precision Graft

    [***]   [***]   [***]

545541

     

Cornerstone Pinnacle 5x14x11

    [***]   [***]   [***]

645511

     

Cornerstone Pinnacle-L 5x11x11

    [***]   [***]   [***]

645541

     

Cornerstone Pinnacle-L 5x14x11

    [***]   [***]   [***]

645611

     

Cornerstone Pinnacle-L 6x11x11

    [***]   [***]   [***]

850912

     

Unicortical Block 9x12mm

    [***]   [***]   [***]

862012

     

Bicortical Block 12mm x 20mm

    [***]   [***]   [***]

872008

     

Bicortical Block 8mm

    [***]   [***]   [***]
[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.