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.
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Minimum Monthly Quantities
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Cornerstone SR (mono only)
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[***]/month
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Cornerstone Pinnacle/
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[***]/month
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Cornerstone Lordotic Pinnacle
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[***]
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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.
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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.]
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[***]
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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.
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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.
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REGENERATION
TECHNOLOGIES, INC.
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By:
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Its:
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Executive Vice
President
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MEDTRONIC
SOFAMOR DANEK USA, INC.
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By:
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Its:
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President
Medtronic Sofamor Danek
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Attachment “A” to Second Amendment
to First Amendment to First Amended Exclusive License
and
Distribution Agreement
Amended Schedule 2.1
Effective December 2005
EXCLUSIVE
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Description
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Column A
LSF through
6/30/2005
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Column B
LSF Effective
7/1/2005
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Cornerstone
L-SR (Lordotic SR Cortical Block)
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300511
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Cornerstone Lordotic SR Cortical Block 5 x 11 x
11mm
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[***]
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[***]
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300541
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Cornerstone Lordotic SR Cortical Block 5 x 14 x
11mm
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[***]
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[***]
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300544
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Cornerstone Lordotic SR Cortical Block 5 x 14 x
14mm
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[***]
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[***]
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300611
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Cornerstone Lordotic SR Cortical Block 6 x 11 x
11mm
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[***]
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[***]
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300641
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Cornerstone Lordotic SR Cortical Block 6 x 14 x
11mm
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[***]
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[***]
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300644
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Cornerstone Lordotic SR Cortical Block 6 x 14 x
14mm
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[***]
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[***]
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300711
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Cornerstone Lordotic SR Cortical Block 7 x 11 x
11mm
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[***]
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[***]
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300741
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Cornerstone Lordotic SR Cortical Block 7 x 14 x
11mm
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[***]
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[***]
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300744
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Cornerstone Lordotic SR Cortical Block 7 x 14 x
14mm
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[***]
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[***]
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300811
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Cornerstone Lordotic SR Cortical Block 8 x 11 x
11mm
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[***]
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[***]
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300841
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Cornerstone Lordotic SR Cortical Block 8 x 14 x
11mm
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[***]
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[***]
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300844
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Cornerstone Lordotic SR Cortical Block 8 x 14 x
14mm
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[***]
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[***]
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300911
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Cornerstone Lordotic SR Cortical Block 9 x 11 x
11mm
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[***]
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[***]
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300941
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Cornerstone Lordotic SR Cortical Block 9 x 14 x
11mm
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[***]
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[***]
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300944
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Cornerstone Lordotic SR Cortical Block 9 x 14 x
14mm
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[***]
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[***]
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Cornerstone
SR (SR Cortical Block)
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200511
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Cornerstone SR Cortical Block 5 x 11 x
11mm
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[***]
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[***]
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200541
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Cornerstone SR Cortical Block 5 x 14 x
11mm
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[***]
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[***]
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200544
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Cornerstone SR Cortical Block 5 x 14 x
14mm
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[***]
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[***]
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200611
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Cornerstone SR Cortical Block 6 x 11 x
11mm
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[***]
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[***]
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200641
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Cornerstone SR Cortical Block 6 x 14 x
11mm
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[***]
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[***]
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200644
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Cornerstone SR Cortical Block 6 x 14 x
14mm
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[***]
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[***]
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200711
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Cornerstone SR Cortical Block 7 x 11 x
11mm
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[***]
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[***]
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200741
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Cornerstone SR Cortical Block 7 x 14 x
11mm
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[***]
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[***]
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200744
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Cornerstone SR Cortical Block 7 x 14 x
14mm
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[***]
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[***]
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200811
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Cornerstone SR Cortical Block 8 x 11 x
11mm
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[***]
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[***]
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200841
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Cornerstone SR Cortical Block 8 x 14 x
11mm
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[***]
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[***]
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200844
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Cornerstone SR Cortical Block 8 x 14 x
14mm
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[***]
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[***]
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200911
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Cornerstone SR Cortical Block 9 x 11 x
11mm
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[***]
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[***]
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200941
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Cornerstone SR Cortical Block 9 x 14 x
11mm
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[***]
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[***]
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200944
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Cornerstone SR Cortical Block 9 x 14 x
14mm
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[***]
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[***]
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201041
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Cornerstone SR Cortical Block 10 x 14 x
11mm
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[***]
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[***]
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201141
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Cornerstone SR Cortical Block 11 x 14 x
11mm
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[***]
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[***]
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201241
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Cornerstone SR Cortical Block 12 x 14 x
11mm
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[***]
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[***]
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Cornerstone
ASR (Composite cortical-Cancellous Block)
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245041
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ASR Cortical-Cancellous Block 10 x 14 x
11mm
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[***]
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[***]
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245141
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ASR Cortical-Cancellous Block 11 x 14 x
12mm
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[***]
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[***]
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245241
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ASR Cortical-Cancellous Block 12 x 14 x
11mm
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[***]
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[***]
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245341
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ASR Cortical-Cancellous Block 13 x 14 x
11mm
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[***]
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[***]
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245741
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ASR Cortical-Cancellous Block 7 x 14 x
11mm
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[***]
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[***]
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245841
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ASR Cortical-Cancellous Block 8 x 14 x
11mm
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[***]
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[***]
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245941
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ASR Cortical-Cancellous Block 9 x 14 x
11mm
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[***]
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[***]
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Exclusive in the Exclusive Territory
and non-exclusive elsewhere in the Territory subject to Section
3.1(e).
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[***]
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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.
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EXCLUSIVE
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Description
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Column A
LSF through
6/30/2005
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Column B
LSF Effective
7/1/2005
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Cornerstone LASR (Lordotic Composite
Cortical-Cancellous Block)
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345011
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Lordotic ASR Cortical-Cancellous Block 10 x 11
x 11mm
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[***]
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[***]
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345041
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Lordotic ASR Cortical-Cancellous Block 10 x 14
x 11mm
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[***]
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[***]
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345044
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Lordotic ASR Cortical-Cancellous Block 10 x 14
x 14mm
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[***]
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[***]
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345111
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Lordotic ASR Cortical-Cancellous Block 11 x 11
x 11mm
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[***]
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[***]
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345141
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Lordotic ASR Cortical-Cancellous Block 11 x 14
x 11mm
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[***]
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[***]
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345144
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Lordotic ASR Cortical-Cancellous Block 11 x 14
x 14mm
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[***]
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[***]
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345211
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Lordotic ASR Cortical-Cancellous Block 12 x 11
x 11mm
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[***]
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[***]
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345241
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Lordotic ASR Cortical-Cancellous Block 12 x 14
x 11mm
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[***]
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[***]
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345244
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Lordotic ASR Cortical-Cancellous Block 12 x 14
x 14mm
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[***]
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[***]
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345711
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Lordotic ASR Cortical-Cancellous Block 7 x 11 x
11mm
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[***]
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[***]
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345741
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Lordotic ASR Cortical-Cancellous Block 7 x 14 x
11mm
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[***]
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[***]
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345744
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Lordotic ASR Cortical-Cancellous Block 7 x 14 x
14mm
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[***]
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[***]
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345811
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Lordotic ASR Cortical-Cancellous Block 8 x 11 x
11mm
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[***]
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[***]
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345841
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Lordotic ASR Cortical-Cancellous Block 8 x 14 x
11mm
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[***]
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[***]
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345844
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Lordotic ASR Cortical-Cancellous Block 8 x 14 x
14mm
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[***]
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[***]
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245911
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Lordotic ASR Cortical-Cancellous Block 9 x 11 x
11mm
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[***]
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[***]
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345941
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Lordotic ASR Cortical-Cancellous Block 9 x 14 x
11mm
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[***]
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[***]
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345944
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Lordotic ASR Cortical-Cancellous Block 9 x 14 x
14mm
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[***]
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[***]
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Cornerstone Pinnacle
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545541
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Cornerstone Pinnacle 5 x 14 x 11
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[***]
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[***]
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545641
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Cornerstone Pinnacle 6 x 14 x 11
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[***]
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[***]
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[***]
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Cornerstone Lordotic MASR
Pinnacle
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[***]
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645611
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Lordotic MASR Cortical-Cancellous Block 6 x 11
x 11mm
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[***]
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[***]
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645641
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Lordotic MASR Cortical-Cancellous Block 6 x 14
x 11mm
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[***]
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[***]
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645644
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Lordotic MASR Cortical-Cancellous Block 6 x 14
x 14mm
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[***]
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[***]
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645511
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Lordotic MASR Cortical-Cancellous Block 5 x 11
x 11mm
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[***]
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[***]
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645541
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Lordotic MASR Cortical-Cancellous Block 5 x 14
x 11mm
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[***]
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[***]
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645544
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Lordotic MASR Cortical-Cancellous Block 5 x 14
x 14mm
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[***]
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[***]
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Cornerstone Reserve (Cortical-Cancellous
Ring)
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270050
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Cortical Ring w/ Cancellous Plug 5mm
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[***]
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[***]
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270060
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Cortical Ring w/ Cancellous Plug 6mm
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[***]
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[***]
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270070
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Cortical Ring w/ Cancellous Plug 7mm
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[***]
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[***]
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270080
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Cortical Ring w/ Cancellous Plug 8mm
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[***]
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[***]
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270090
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Cortical Ring w/ Cancellous Plug 9mm
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[***]
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[***]
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270100
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Cortical Ring w/ Cancellous Plug
10mm
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[***]
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[***]
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270110
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Cortical Ring w/ Cancellous Plug
11mm
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[***]
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[***]
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270120
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Cortical Ring w/ Cancellous Plug
12mm
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[***]
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[***]
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270130
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Cortical Ring w/ Cancellous Plug
13mm
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[***]
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[***]
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Exclusive in the Exclusive Territory
and non-exclusive elsewhere in the Territory subject to Section
3.1(e).
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[***]
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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.
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EXCLUSIVE
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Description
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Column A
LSF through
6/30/2005
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Column B
LSF Effective
7/1/2005
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Cornerstone Select (Fibula
Wedge)
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210500
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Cornerstone Select 5mm
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[***]
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[***]
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210600
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Cornerstone Select 6mm
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[***]
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[***]
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210700
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Cornerstone Select 7mm
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[***]
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[***]
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210800
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Cornerstone Select 8mm
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[***]
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[***]
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210900
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Cornerstone Select 9mm
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[***]
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[***]
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211000
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Cornerstone Select 10mm
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[***]
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[***]
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211100
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Cornerstone Select 11mm
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[***]
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[***]
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211200
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Cornerstone Select 12mm
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[***]
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[***]
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211300
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Cornerstone Select 13mm
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[***]
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[***]
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213500
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Cornerstone Select 35mm
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[***]
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[***]
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215000
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Cornerstone Select 50mm
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[***]
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[***]
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217000
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Cornerstone Select 70mm
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[***]
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[***]
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Humeral Ring
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692017
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Humeral Ring
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[***]
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[***]
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Unicortical Dowel
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280012
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Unicortical Dowel 12mm
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[***]
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[***]
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280014
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Unicortical Dowel 14mm
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[***]
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[***]
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280016
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Unicortical Dowel 16mm
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[***]
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[***]
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Cornerstone Iliac Block,
Tricortical
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310107
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Iliac Block, Tricortical 7mm x 15mm
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[***]
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[***]
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310108
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Iliac Block, Tricortical 8mm x 15mm
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[***]
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[***]
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310109
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Iliac Block, Tricortical 9mm x 15mm
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[***]
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[***]
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310110
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Iliac Block, Tricortical 10mm x 15mm
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[***]
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[***]
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310112
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Iliac Block, Tricortical 12mm x 15mm
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[***]
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[***]
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310114
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Iliac Block, Tricortical 14mm x 15m
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