Exhibit 10.2.1

 

A16138

 

SECOND AMENDMENT TO THE AMENDED AND RESTATED

STANDARD EXCLUSIVE LICENSE AGREEMENT NO. A5140

 

WHEREAS, the University of Florida Research Foundation, Inc., a not-for-profit
corporation duly organized and existing under the laws of the State of Florida
and having its principal office at 223 Grinter Hall, Gainesville,
Florida  32611  U.S.A. (hereinafter referred to as “UFRF”), and AxoGen
Corporation, a corporation duly organized under the laws of the State of
Delaware, and having its principal office at Progress Park, 13631 Progress Blvd.
Suite 400, Alachua, FL 32615 (hereinafter referred to as “Licensee”) entered
into an Amended And Restated Standard Exclusive License Agreement With
Sublicensing Terms effective February 21, 2006 (hereinafter “License
Agreement”);

 

WHEREAS, the parties amended the License Agreement by a Letter Amendment dated
on November 10, 2014;

 

WHEREAS, the parties now wish to further amend the Amended and Restated License
Agreement by this Second Amendment (the “Second Amendment”);

 

WHEREAS, the terms of the November 10, 2014, Letter Amendment do not apply to
this Second Amendment;

 

THEREFORE, in consideration of the premises and mutual covenants contained
herein the parties agree as follows. 

 

1.

Licensee shall pay to UFRF an Amendment Fee of Ten Thousand Dollars ($11,000)
within thirty (30) days of execution of this Second Amendment.

 

2.

The License Agreement shall be amended as follows.

 

a.Section 1.1.4 shall be replaced with:

 

“the United States Patent applications entitled ‘Method for Decellularization of
Nerve Allografts,’ filed in the US Patent Office March 15, 2013, serial number
61/794,012 UF docket #14347) and entitled ‘Method for Decellularization of
Tissue Grafts’ filed in the US Patent Office September 15, 2015, serial number
14/776,765 UF docket #14347) (the “Section 1.1.4 Patents”).”

 

b.Section 1.1.5 shall be replaced with:

 

“all foreign counterparts, and divisionals and continuations both US and
foreign, of the patent applications described in sections 1.1.1, 1.1.2, 1.1.3
and 1.1.4 all to the extent owned and controlled by the University of Florida:”
and

 

c.Section 1.1.6 shall be added as follows:

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“any reissues and re-examinations of the patents described in sections 1.1.1,
1.1.2, 1.1.3 and 1.1.4.” 

 

d.Section 1.12 shall be replaced with:

 

“’Licensed Field’ shall be limited to the field of medical devices, human
therapeutics and human and animal tissue, and processing of any tissues.”

 

e.Section 2.2.3 shall be amended to provide an additional last sentence as
follows:

 

If Sublicense of a Licensed Product or Licensed Process from Section 1.1.4
Patents then 20%.

 

f.The first sentence of Section 3.1.1 will be replaced with the following:

 

“Licensee agrees to and warrants with respect only to the Section 1.1.4 Patents
the following:”

 

g.Section 3.1.3 including subsections (a) through (i) shall be modified by
replacing the first paragraph, including subsections (a) through (i), with the
following:

 

“Licensee agrees that it shall utilize the Licensed Process containing Section
1.1.4 Patents to manufacture a Licensed Product, and/or to provide services to
third parties to manufacture products containing Section 1.1.4 Patents for sale
pursuant to the timing provided in the Development Plan.”

 

h.Section 4.3.1 shall be modified by replacing the first paragraph with the
following:

“Licensee agrees to pay to UFRF a royalty, on a country-by-country basis, on Net
Sales that, but for the license granted under this Agreement, would infringe one
or more Valid Claims of Licensed Patents, in such country, as follows: 

 

1)for Licensed Processes and Licensed Products that do not utilize Section 1.1.4
Patents, three percent (3%); 

 

2)for Licensed Processes and Licensed Products, that but for the license granted
under this Agreement would infringe one or more Valid Claims, that do utilize
Section 1.1.4 Patents, three and three quarter percent (3.75%); and 

 

3)for Licensed Processes and Licensed Products that only utilize Section 1.1.4
Patents, one and three quarter percent (1.75%). 

 

Licensee shall notify UFRF in writing within thirty (30) days when a Licensed
Product is manufactured using the Licensed Process containing the Section1.1.4
Patents or when Licensee or its Sublicensee uses the Licensed Process containing
the Section 1.1.4 Patents.”

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i.Section 4.3.2 shall be amended as follows:

 

a.New last sentence will be added: “Notwithstanding the foregoing, Licensed
Products, Licensed Processes and Licensed Patents shall not include Section
1.1.4 Patents for purposes of this paragraph.”

 

b.New paragraph will be added as follows:

 

“Licensee agrees to pay to UFRF a royalty, on a country by country basis, on Net
Sales of Licensed Products and/or Licensed Process that utilize Section 1.1.4
Patents that do not infringe any Valid Claims of Licensed Patents in such
country, in an amount equal to one percent (1%) of Net Sales of such Licensed
Product or Licensed Process in such country by Licensee, its Affiliates, or its
Sublicensees, as long as the Licensed Products and /or Licensed Processes are
covered by an issued, and unexpired claim, valid in the United States.

 

c.New paragraph will be added as follows:

 

“Licensee agrees to pay to UFRF a royalty, on a country by country basis, on Net
Sales of Licensed Products and/or Licensed Process that utilize Section 1.1.4
Patents that do not infringe any Valid Claims of Licensed Patents in such
country, in an amount equal to one percent (1%) of Net Sales of such Licensed
Product or Licensed Process in such country by Licensee, its Affiliates, or its
Sublicensees, as long as the Licensed Products and /or Licensed Processes that
utilize Section 1.1.4 Patents are covered by an issued, and unexpired claim,
valid in the United States and contained in the Section 1.1.4 Patents. 

 

j.Section 4.4.1 shall be amended to replace all but the last paragraphas
follows:

 

In addition to all other payments required under this Agreement, Licensee agrees
to pay UFRF Milestone Payments thirty (30) days after the events in the table
below as follows:

 

“Payment

 

Event

$2,000

    

FDA approval of Licensee Avance Nerve Graft

 

 

 

$25,000

 

first commercial use of Licensed Process that utilize Section 1.1.4 Patents to
provide services to manufacture products for third parties

 

 

 

$10,000

 

first use to manufacture Licensed Products that utilize Section 1.1.4 Patents

 

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Licensee may not deduct the above milestone payments paid to UFRF from any other
amounts due under this agreement.” 

 

k.Section 4.4.2 shall be added as follows: 

 

“4.4.2Licensee shall pay an annual license maintenance fee for the Section 1.1.4
Patents of Five Thousand Dollars ($5,000) due on each anniversary date of the
execution of this Second Amendment until such time as the Section 1.1.4 Patents
are no longer subject to the license provided for in this Second Amendment.”

 

l.Section 9.3 shall be replaced with the following:

 

“UFRF may terminate the license to the Patent Rights for the Section 1.1.4
Patents by giving Licensee at least sixty (60) days’ written notice (which shall
state UFRF’s intent to terminate such Section 1.1.4 Patents Patent rights and
the basis therefor) if commercial development milestones (to the extent
relevant) are not satisfied as specified in Section 3.1.3, and if such failure
to achieve such milestones was solely due to Licensee’s lack of commercially
reasonable diligence in pursuing such milestones.  In such event, the
license  for the Section 1.1.4 Patents rights shall terminate at the end of the
notice period specified by UFRF in such notice of termination (at least 60 days)
unless (i) the milestone at issue has been achieved prior to the end of such
notice period, in which case this Agreement shall continue in full force and
effect as to the relevant Section 1.1.4 Patent Rights, or unless (ii) prior to
the end of such sixty (60) day period, Licensee disputes in writing that its
lack of commercially reasonable diligence was the sole cause of the failure to
achieve such milestone and commences the dispute resolution procedures under
Section 11.  In such case, the license to the Section 1.1.4 Patents (including
the parties’ respective rights and obligations hereunder) shall remain in full
force and effect until the conclusion of the proceedings described in Sections
11.1 and 11.2 regarding the relevant Section 1.1.4 Patents Patent Rights.”

 

m.Section 9.4 shall be replaced with the following:

 

“a. If Licensee at any time defaults in the timely payment of any monies due to
UFRF as to the Patent Rights described in Sections 1.1.1, 1.1.2, and 1.1.3 or
commits any breach of any other covenant herein contained, except for those
related to Section 1.1.4 Patents which are provided for in Section in subsection
(b) hereof, and Licensee fails to remedy, or take steps to diligently remedy,
any such breach or default within sixty (60) days after written notice thereof
by UFRF, UFRF may at its option immediately terminate this Agreement by giving
notice of termination to Licensee.

 

b. If Licensee at any time defaults in the timely payment of any monies due to
UFRF or, as to the Section 1.1.4 Patents, in the timely submission to UFRF or
any Development Report or fails to actively pursue the Development Plan or
commits any breach of any other covenant herein contained, and Licensee fails to
remedy, or take steps to diligently remedy, any such breach or default within
sixty (60) days after written notice thereof by

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UFRF, UFRF may at its option immediately terminate the license to the Section
1.1.4 Patents Patent Rights by giving notice of termination to Licensee.”

 

n.Section 15.2 shall be replaced with the following:

 

“If to Licensee:

Corporate Counsel

AxoGen Corporation

13631 Progress Blvd

Suite 400

Alachua, FL 32615

 

With Copy to:

Attorney

Fahd Riaz

DLA Piper LLP (US)

One Liberty Place

1650 Market Street, Suite 4900

Philadelphia, Pennsylvania 19103-7300

 

o.Appendix A shall be replaced with the new Development Plan in Appendix A
attached to this Second Amendment.

 

3.         All other provisions of the License shall remain in full force and
effect and unmodified by this Second Amendment.

 

4.         This Second Amendment shall be effective July 5, 2016

 

 

UNIVERSITY OF FLORIDA

 

AxoGen, Inc.

RESEARCH FOUNDATION, INC.

 

 

 

 

 

By: /s/David L. Day

 

By: /s/Karen Zaderej

Name: David L. Day

 

Name: Karen Zaderej

Title: Director of Technology Licensing

 

Title: President, CEO, Director

 

 

 

Date: July 7, 2016

 

Date: July 1, 2016

 

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Appendix A – Development Plan

 

AxoGen is currently the only peripheral nerve tissue processor currently
commercializing processed nerve allograft technology. FDA in their December 2014
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based
Products state that peripheral nerve tissue is a non-structural tissue and that
processing that would alter the relevant function of peripheral nerve tissue (in
this case, removal of the cellular components) is more than minimally
manipulated and should be regulated under a biologic license.  AxoGen has an
active IND with the FDA Center for Biologics Evaluation and Research for its
processed nerve allograft technology and is currently progressing towards a
Biological License Application (BLA) submission for Avance® Nerve Graft.

 

Changes and updates to the manufacturing of Avance® Nerve Graft are subject to
review by FDA and depending on the extent of that review may result in minor or
major changes to the BLA, or may require an entirely new IND/BLA submission.

 

To incorporate the UF/Muir processing modifications, AxoGen will follow FDA
guidelines for changes to the manufacture of a biological product. Our
development plan and timing reflects those and internal requirements to
successfully incorporate this into the manufacture of Avance® Nerve Graft.

 

Table A. reflects the development work and projected timeline for a minor and
major change to the FDA regulated process. Table B. reflects the additional
timing that maybe required if clinical trials are deemed necessary to establish
the performance of the new processing methods. We believe the need for clinical
trials is a low risk, but is included as the risk cannot be completely ruled out
at this time.

 

AxoGen will diligently pursue the least timely path to market for this
processing change, while maintaining regulatory compliance. This timeline is
subject to change.

 

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