Exhibit 10.10

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.  THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY AN ASTERIK IN
BRACKETS [*].  THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.

 

AMENDMENT NO. 6 TO

MATRIX COMMERCIALIZATION COLLABORATION

AGREEMENT

 

THIS AMENDMENT NO. 6 TO MATRIX COMMERCIALIZATION COLLABORATION AGREEMENT (this
“Amendment No. 6”) is dated as of December 29, 2017 (the “Amendment No. 6
Effective Date”) by and between Musculoskeletal Transplant Foundation, Inc., a
non-profit corporation formed under the laws of the District of Columbia, and
having a principal place of business at 125 May Street, Suite 300, Edison, New
Jersey 08837 (“MTF”), and Orthofix Holdings, Inc., a corporation organized under
the laws of the State of Delaware, and having a principal place of business at
3451 Plano Parkway, Lewisville, Texas 75056 (“Orthofix”) (each individually a
“Party” and collectively the “Parties”).

 

W I T N E S S E T H:

 

WHEREAS, the Parties have entered into that certain Matrix Commercialization
Collaboration Agreement dated as of July 28, 2008, as amended by that certain
Amendment No. 1 to Matrix Commercialization Collaboration Agreement dated as of
December 15, 2010, that certain Amendment No. 2 to Matrix Commercialization
Collaboration Agreement dated as of January 9, 2012, that certain Amendment No.
3 to Matrix Commercialization Collaboration Agreement dated as of June 25, 2013,
that certain Amendment No. 4 to Matrix Commercialization and Collaboration
Agreement dated as of January 1, 2014, and that certain Amendment No. 5 to
Matrix Commercialization and Collaboration Agreement dated as of March 10, 2016
(collectively, the “Matrix Agreement”), pursuant to which the Parties have
collaborated on the commercialization of the Matrix;

 

WHEREAS, the Parties desire to expand and extend their relationship under the
Matrix Agreement concerning the development and commercialization of an
additional allogeneic cancellous bone matrix containing viable mesenchymal stem
cells and/or osteoprogenitor cells (hereinafter identified as the “Matrix IV”)
and conforming to the Matrix IV Specifications (as defined herein);

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

1

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

Exhibit 10.10

WHEREAS, neither Party currently makes the Matrix IV commercially available and
the Parties believe that they can develop and commercialize the Matrix IV more
effectively and efficiently together than on their own;

 

WHEREAS, to effectuate that collaboration, the Parties wish, subject to the
terms and conditions of the Matrix Agreement, as amended hereby, to (a) give
responsibility to (i) MTF to develop and improve the Matrix IV and (ii) provide
specified funding to MTF for MTF’s development and improvement of the Matrix IV,
and (b) share responsibility for contributing scientific or medical personnel,
technical expertise and other resources to the development and improvement of
the Matrix IV, communicating findings and discoveries to one another with
respect to the Matrix IV and exchanging information related to such
collaboration and (c) give exclusive responsibility, following the Matrix IV
Commercialization Date (as defined herein), to (i) MTF to Process quantities of
the Matrix IV using human tissue from deceased donors procured by MTF and
fulfill orders for the Matrix IV solicited by Orthofix and (ii) Orthofix to
exclusively market the Matrix IV; and

 

WHEREAS, the Parties acknowledge that, although the Development Agreement has
expired by its terms, the references to the Development Agreement herein and in
the Matrix Agreement are nevertheless intentional;

 

NOW, THEREFORE, in consideration of the foregoing premises and mutual covenants
contained herein, the Parties agree as follows:

 

ARTICLE I

 

SUPPLEMENTAL ARRANGEMENTS AND AMENDMENTS

 

A. Initial Matrix IV Forecast.  Section 2.2 of the Matrix Agreement is hereby
amended by inserting the following at the end thereof:

 

“Orthofix shall have submitted to MTF, not later than the thirty (30) days after
the date on which the second Matrix IV Development Milestone has been achieved
and MTF has delivered to Orthofix the Matrix IV Notice of Achievement with
respect thereto, a Forecast setting forth the orders that Orthofix reasonably
believes will be solicited by Orthofix during (a) the calendar quarter in which
the third Matrix IV Development Milestone is achieved, which will be presented
in two (2) individual, consecutive forty-five (45) day periods and (b) the three
calendar quarters immediately succeeding (the “Initial Matrix IV
Forecast”).  The Initial Matrix IV Forecast may be amended from time to time
pursuant to the

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

2

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

Exhibit 10.10

terms of this Agreement and, as so amended, will be deemed incorporated into
each Forecast as aforesaid pertaining to the same calendar quarters.”

 

B.Matrix IV Development Collaboration.  The Matrix Agreement is hereby amended
by inserting the following new Article VI-C immediately following Article VI-B
thereof:

 

“ARTICLE VI-C

 

MATRIX IV DEVELOPMENT COLLABORATION

 

6C.1 General.  MTF and Orthofix will engage in the Matrix IV Development
Collaboration upon the terms and conditions set forth in this Agreement.  In
furtherance of the foregoing, this Agreement will from time to time be deemed
amended as hereinafter set forth to attach, respectively, the Matrix IV
Specifications, the Matrix IV Release Criteria and the Matrix IV Development
Plan if and to the extent determined pursuant to the provisions hereof and
subject to revision if and to the extent applicable.

 

6C.2 MTF Obligations.  Subject to the terms and conditions of this Agreement,
MTF will, during the Matrix IV Development Term, use Reasonable Commercial
Efforts to develop the Matrix IV in a good scientific manner in accordance with
applicable Law and the Matrix IV Development Plan so as to meet the Matrix IV
Development Milestones, including, without limitation, so that the Matrix IV
meets the Matrix IV Specifications and conforms to and complies with applicable
Law.  In addition, MTF will, during the Matrix IV Development Term, provide
consulting, medical and/or other expertise within the capability of MTF, as
reasonably necessary and appropriate, in support of Orthofix’s obligations under
this ARTICLE VI-C.

 

6C.3 Orthofix Obligations.  During the Matrix IV Development Term, Orthofix will
timely disclose to MTF and provide information in Orthofix’s possession or
within its control, as reasonably necessary or appropriate, for MTF to perform
MTF’s obligations under this ARTICLE VI-C and will also provide consulting,
medical and/or other expertise within the capability of Orthofix, as reasonably
necessary and appropriate, in support of MTF’s performance of such
obligations.  Orthofix may, if required, as mutually agreed by the Parties, use
Reasonable Commercial Efforts to develop application tools and instruments in
connection with the Matrix IV, including such application tools and instruments
as may be proposed by MTF and reasonably acceptable to Orthofix, and MTF will,
during the Matrix IV Development Term, provide consulting, medical and/or other
expertise, in each case within the capability of MTF, as reasonably necessary or
appropriate, in support of such activities.  Orthofix will be entitled to have a

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

3

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

Exhibit 10.10

representative present from time to time during normal business hours upon
reasonable prior notice during the performance at any Facility of MTF of MTF’s
development activities under this ARTICLE VI-C to monitor the performance of
such activities, subject in all respects to all safety and security procedures
reasonably adopted by MTF and communicated to Orthofix.

 

6C.4  Change Management Procedure.  Either Party may request a change to the
Matrix IV Development Plan, the Matrix IV Specifications (including line
extensions) or the Matrix IV Release Criteria at any time by giving a written
request to the other Party.  Any change requested by MTF will describe the
requested change and explain the anticipated impact of such change on MTF’s
performance of its obligation to develop the Matrix IV in accordance with this
Agreement, including the Matrix IV Development Milestones; and in response to
any change requested by MTF, Orthofix will advise MTF, as promptly as
practicable, of the anticipated impact of such change on Orthofix’s performance
of its obligations hereunder.  Any change requested by Orthofix will describe
the requested change and explain the anticipated impact of such change on
Orthofix’s performance of its obligations in accordance with this Agreement; and
in response to any change requested by Orthofix, MTF will advise Orthofix, as
promptly as practicable, of the anticipated impact of such change on MTF’s
performance of its obligation to develop the Matrix IV in accordance with this
Agreement, including the Matrix IV Development Milestones.  No change to the
Matrix IV Specifications, Matrix IV Development Plan or the Matrix IV Release
Criteria will become effective unless and until approved by the Steering
Committee.

 

6C.5  Research Funding.  Subject to Orthofix’s obligations hereunder to make
payments in respect of MTF’s achievement of the Matrix IV Development
Milestones, each Party will pay its own costs and expenses associated with the
technical expertise, scientific personnel, facilities, equipment, materials and
other resources it provides in performing its obligations under this ARTICLE
VI-C.

 

6C.6  Project Managers; Progress Reports; Steering Committee.  Each Party will
appoint and maintain during the Matrix IV Development Term a project manager who
will be primarily responsible to the other Party for all communications relating
to the performance of the appointing Party’s obligations under this ARTICLE VI-C
(“Matrix IV Project Manager”).  At each meeting of the Steering Committee during
the Matrix IV Development Term, each Party will provide the other Party a report
on the performance of its obligations under this ARTICLE VI-C so as to enable
the Steering Committee to evaluate the progress of the Matrix IV Development
Collaboration and the work performed in relation to the Matrix IV Development
Plan.  In addition to its authority set forth in Section 3.3 hereof, the
Steering Committee is authorized to take the

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

4

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

Exhibit 10.10

following actions: (i) review and evaluate data and progress of the activities
under the Matrix IV Development Plan; subject to the terms and provisions of
this Agreement, resolve any issues and questions that may arise with respect to
the Matrix IV Development Plan or the Matrix IV Development Collaboration; (ii)
ensure open communication between the Parties as related to the Matrix IV
Development Collaboration and as provided under this Agreement; (iii) determine
the initial Matrix IV Specifications (based on the requirements in Attachment 1
hereto) and approve any changes thereto (including any line extensions), and
determine the initial Matrix IV Development Plan and the initial Matrix IV
Release Criteria, and approve any changes thereto, in accordance with the change
management procedures set forth in Section 6C.4 of this Agreement; and (v)
manage and supervise the activities of the Parties under the Matrix IV
Development Plan and the Matrix IV Development Collaboration.  

 

6C.7 Milestone Payments.  Orthofix will make the following one-time,
non-refundable payments to MTF upon the completion of the applicable milestones
described below (each a “Matrix IV Development Milestone” and collectively the
“Matrix IV Development Milestones”) as confirmed by Orthofix pursuant to the
procedures set forth in Section 6C.8.  The payment amount for each Matrix IV
Development Milestone is paid only once.

 

 

Development Milestones

No.

Description

Payment Amount

1

Execution of Amendment No. 6 by MTF and Orthofix

$[*]

2

Delivery of the [*] that (a) includes the deliverable requirements set forth in
Exhibit B attached hereto; and (b) reasonably indicates that the Matrix IV meets
the Matrix IV Specifications.

 

$[*]

3

Delivery of the [*] that (a) includes the deliverable requirements set forth in
Exhibit B attached hereto; and (b) reasonably indicates that the Matrix II meets
the Matrix II Specifications.

 

$[*]

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

5

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

Exhibit 10.10

Development Milestones

No.

Description

Payment Amount

4

(a) Completion by MTF of the [*] that includes the deliverable requirements set
forth in Exhibit B attached hereto, (b) creation by MTF of an inventory of a
commercially-saleable quantity of the Matrix IV that is sufficient to satisfy
Orthofix’s requirements for the Matrix IV for the first two (2) months as
reflected in the Matrix IV Forecast, as may be amended pursuant to the terms of
this Agreement; and (c) MTF’s demonstration that its work in process supports
the ongoing release by MTF, on a [*] basis, of sufficient commercially-saleable
quantities of the Matrix IV to satisfy Orthofix’s [*] requirements for the
Matrix IV as reflected in the Initial Matrix IV Forecast, as may be amended
pursuant to the terms of this Agreement.

$[*]

 

6C.8  Matrix IV Milestone Determination Procedures.  

 

(a)Payment Obligations.  MTF will, in each case, provide to Orthofix written
notice (the “Matrix IV Notice of Achievement”) in the event it has achieved a
Matrix IV Development Milestone (other than the first Matrix IV Development
Milestone, which shall be deemed achieved upon execution and delivery of
Amendment No. 6 by both Parties; and it being acknowledged and agreed that the
Matrix IV Notice of Achievement with respect to the third and fourth Matrix IV
Development Milestone may not be provided unless and until MTF has achieved the
second and third Matrix IV Development Milestone, respectively, and provided to
Orthofix the Matrix IV Notice of Achievement with respect thereto).  Subject to
the foregoing, as soon as reasonably practicable following the date of the
Matrix IV Notice of Achievement of each Matrix IV Development Milestone and in
any event within ten (10) business days after the date of the Matrix IV Notice
of Achievement of any such Matrix IV Development Milestone, Orthofix will pay to
MTF the applicable payment amount for such Matrix IV Development Milestone set
forth in Section 6C.7; provided, however, that each such payment shall be
subject to Orthofix’s confirmation, as hereinafter set forth, that the Matrix IV
Development Milestone covered by such Matrix IV Notice of Achievement has been
achieved and in no event with Orthofix be liable for, and MTF will not be
entitled to, the applicable payment amount for any Matrix IV Development
Milestone that is not achieved.  The payment amounts for each Matrix IV
Development Milestone

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

6

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

Exhibit 10.10

do not include expenses that MTF may incur, which are necessary for MTF to meet
production capacity and related to capital equipment for MTF’s manufacturing of
the Matrix IV in accordance with the Initial Matrix IV Forecast.  In the event
any such expenses are anticipated by MTF, the Parties may agree to amend the
applicable payment amounts to take into account such reasonable expenses that
are actually and directly incurred by MTF.

 

(b)Standards for Confirmation.  Orthofix shall have the right to withhold
payment due in respect of a Matrix IV Notice of Achievement covering the second
and third Matrix IV Development Milestones solely in the event that (i) MTF has
not provided a Notice of Achievement with respect to the applicable Matrix
Development Milestone thereto, or (ii) the initial Matrix IV Specifications for
the applicable Matrix IV Development Milestone have not been determined by the
Steering Committee or otherwise pursuant to ARTICLE XIX, or (iii) the data
contained in the Matrix IV [*] or the [*], as applicable, does not include all
the deliverable requirements set forth in Exhibit B attached hereto or otherwise
fails reasonably to indicate that the Matrix IV meets the Matrix IV
Specifications.  Orthofix shall have the right to withhold payment due in
respect of a Matrix IV Notice of Achievement covering the fourth Matrix IV
Development Milestone solely in the event that (x) MTF has not provided a Notice
of Achievement with respect thereto or with respect to the second or third
Matrix IV Development Milestones, (y) the [*] does not include all the
deliverable requirements set forth in Exhibit B attached hereto or otherwise
fails reasonably to indicate that the Matrix IV meets the Matrix Specifications,
or (z) the results of a physical inventory of the Matrix IV and inspection of
MTF’s books and records related to the production of the Matrix IV fail to
reasonably demonstrate the existence of the required amount of inventory and
work in process and the capacity to support ongoing release of the Matrix IV, as
previously mutually agreed upon.

 

(c)Changes to Matrix IV Development Milestone Payment Amounts.  Upon the
completion and confirmation of any Matrix IV Development Milestone, MTF may
reasonably request a change to the applicable payment amount for a future Matrix
IV Development Milestone (if any) in the event that MTF anticipates that it will
be required to incur additional expenses in order to achieve such future Matrix
IV Development Milestone that were not anticipated by the Parties in the
original cost estimate.  Any such change requested by MTF will be submitted to
Orthofix in writing, will describe the requested change and explain the reasons
for such change.  No such change to the applicable payment amount for a future
Matrix IV Development Milestone shall apply unless mutually agreed by the
Parties in writing.    

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

7

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

Exhibit 10.10

(d)Cancellation by Orthofix.  Orthofix may cancel the Matrix IV Development
Collaboration at any time, for any reason in Orthofix’s sole discretion.  In the
event of any such cancellation by Orthofix, Orthofix shall be responsible to pay
to MTF (i) the applicable payment amount for such Matrix IV Development
Milestone for which MTF has provided Orthofix the Matrix IV Notice of
Achievement and such Matrix IV Development Milestone has been confirmed in
accordance with the terms of this ARTICLE 6C.8; and (ii) any early termination
liability actually incurred by MTF to Third Parties as of the effective date of
the cancellation for any non-cancellable obligations undertaken by MTF in
furtherance of the applicable Matrix IV Development Milestone which are in
excess of the applicable payment amount for the Matrix IV Development
Milestone.  

 

(e)Cancellation by MTF.  MTF may cancel the Matrix IV Development Collaboration
upon thirty (30) days’ written notice to Orthofix, in the event that Orthofix
fails to pay MTF the applicable payment amount for a Matrix IV Development
Milestone pursuant to Section 6C.8, and Orthofix fails to cure such non-payment
within thirty (30) days’ of receipt of such written notice.

 

(f)Dispute Resolution.  If Orthofix disagrees with MTF’s claim regarding the
achievement of a Matrix IV Development Milestone as set forth in a Matrix IV
Notice of Achievement, then Orthofix will refer the dispute to the Steering
Committee as promptly as practicable and, in any event, prior to the date on
which payment relating thereto is due, and will provide the Steering Committee
with an explanation of the basis for Orthofix’s determination that the
applicable Matrix IV Development Milestone was not achieved on the date claimed
by MTF.  The Steering Committee will meet as promptly as practicable to resolve
the dispute.  If the Steering Committee has not resolved the dispute within ten
(10) business days after referral of the dispute by Orthofix, the dispute will
be resolved in accordance with ARTICLE XIX.  In the event of any determination
by the Steering Committee pursuant to ARTICLE XIX that a Matrix IV Development
Milestone has not been achieved as set forth in a Matrix IV Notice of
Achievement, MTF shall thereafter deliver to Orthofix a new Matrix IV Notice of
Achievement in the event it has achieved such Development Milestone.”

 

C.Ownership of Fourth Phase Developed Technology.  Sections 7.2(a) and 7.2(b) of
the Matrix Agreement shall not apply with respect to the Fourth Phase Developed
Technology.  With respect to any Fourth Phase Developed Technology only, MTF
shall own any and all Fourth Phase Developed Technology (subject to its express
license grants to Orthofix set forth herein).  In furtherance of the foregoing
Orthofix hereby assigns and agrees to assign to MTF, all right, title and
interest, if any, Orthofix may have in all Fourth Phase Developed Technology,
including all intellectual property rights therein, whether developed solely by
MTF

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

8

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

Exhibit 10.10

or its employees, agents or subcontractors, or whether developed jointly by the
Parties, their employees, agents, or subcontractors under this
Agreement.  Orthofix will, upon request by MTF, execute specific assignments and
take any action necessary to enable MTF to secure its interest in the Fourth
Phase Developed Technology or any component thereof.  Notwithstanding the
foregoing, during the Term, MTF shall not supply, distribute, or license the
Matrix IV to or on behalf of any Third Party other than through Orthofix in
accordance with the terms of the Agreement unless Orthofix declines to
commercialize and promote the Matrix IV and provides written notice to MTF of
such decision by Orthofix.  

 

 

(a)

Exclusive License Grant.  Without limiting the foregoing sentence in Article I.C
above, MTF hereby grants to Orthofix, an exclusive, irrevocable, worldwide,
royalty-free license, with the right to sublicense, for the Term, under the
Fourth Phase Developed Technology, to market, sell, and offer to sell the Matrix
IV.  

 

 

(b)

Non-Exclusive License Grant.  In addition, MTF hereby grants to Orthofix, (x) a
non-exclusive, worldwide, royalty-free license, together with the right to
sublicense, during the Term, under such Fourth Phase Developed Technology, to
exercise any of Orthofix’s privileges and to perform any of Orthofix’s
obligations under the Matrix Agreement in connection with the Collaboration, and
to perform any of MTF’s obligations under the Matrix Agreement in the event that
MTF fails to fulfill its obligations under the Matrix Agreement and (y) a
non-exclusive, perpetual, irrevocable, worldwide, royalty-free license, together
with the right to sublicense, under such Fourth Phase Developed Technology to
make, use, sell, offer to sell and import bone-growth allograft products
containing viable allogeneic stem cells derived from cadavers, which grant will
be exercised by Orthofix only on and after any expiration of the Matrix
Agreement or any termination of the Matrix Agreement (I) pursuant to Section
13.4 of the Matrix Agreement or (II) by Orthofix pursuant to Section 13.2 of the
Matrix Agreement and a determination in a final non-appealable decision by a
court of competent jurisdiction that MTF has committed, and failed to cure
within the permitted cure period, a material breach or material default under
the Matrix Agreement.  

 

D.Prosecution of Fourth Phase Developed Technology.  Fourth Phase Developed
Technology will be treated as Existing MTF Technology, rather than Developed
Technology for purposes of Section 7.4(c) of the Matrix Agreement.

 

E.Representations and Warranties of MTF.  The first paragraph of Article VIII of
the Matrix Agreement is hereby deleted in its entirety, and the following is
inserted in lieu thereof:

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

9

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

Exhibit 10.10

“Except for the representations and warranties in Section 8.7(a), Section 8.7
(b), Section 8.7(c) and Section 8.8, each of which will be given for the entire
Term, MTF hereby represents and warrants to Orthofix as of the Effective Date,
and again as of the Amendment No. 2 Effective Date and again as of the Amendment
No. 3 Effective Date, and again as of the Amendment No 6. Effective Date, as
follows:”

 

F.Representations and Warranties of Orthofix.  The first paragraph of Article IX
of the Matrix Agreement is hereby deleted in its entirety, and the following is
inserted in lieu thereof:

 

“Orthofix hereby represents and warrants to MTF as of the Effective Date, and
again as of the Amendment No. 2 Effective Date, and again as of the Amendment 3
Effective Date, and again as of the Amendment 6 Effective Date, as follows:”

 

G. Specifications.  Section 10.1 of the Matrix Agreement is hereby amended by
inserting the following after the last sentence thereof:

 

“The Matrix IV Specifications and the Matrix IV Release Criteria shall be added
to Exhibits C and D, respectively, upon approval by the Steering Committee, and
each of the foregoing may be subsequently amended in accordance with Section
6C.4 (if prior to the Matrix IV Commercialization Date) or in accordance with
Section 10.4 (in all other cases).”

 

H. Term.  The Parties hereby agree to extend the term of the Matrix Agreement as
set forth in Section 13.1 of the Matrix Agreement by a period of two (2) years
until July 28, 2027.  

 

I.Infringement Claims. (i) Section 14.1 of the Matrix Agreement is hereby
amended by deleting Sub-paragraph (i) thereunder and inserting the following in
lieu thereof:

 

“(i) the provisions of clause (d) immediately preceding shall not extend to, and
Orthofix shall have no obligations to MTF under clause (d) immediately preceding
with respect to, any Matrix II Infringement Claim, any Matrix III Infringement
Claim, or any Matrix IV Infringement Claim; and”

 

(ii) Section 14.2 of the Matrix Agreement is hereby amended by deleting “and”
immediately before clause (e) and inserting the following at the end thereof
immediately prior to the period:

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

10

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

Exhibit 10.10

“and (f) any Matrix IV Infringement Claim; provided, however, that (i) in the
event of a Matrix IV Infringement Claim or a reasonable determination by MTF
that a Matrix IV Infringement Claim is likely to be initiated, MTF will have the
right to direct Orthofix, by written notice, to cease marketing the Matrix IV
during the period beginning upon Orthofix’s receipt of such notice and
continuing until Orthofix’s receipt of written notice from MTF that the Matrix
IV Infringement Claim has been satisfactorily resolved in MTF’s reasonable
determination or is no longer expected to be initiated (the “Matrix IV Cessation
Period”), (ii) MTF will have no obligation to indemnify or hold harmless
Orthofix or any other Person otherwise indemnified hereunder from or against any
Damages attributable to any development or marketing of the Matrix IV during the
Matrix IV Cessation Period, and (iii) the foregoing obligation in (f) shall not
be construed to limit Orthofix’s indemnification obligation with respect to
Matrix I pursuant to Section 14.1(d).  ”

 

 

J.Reimbursement of Shipping Expenses.  The Parties agree that, from and after
the Amendment No. 6 Effective Date, Orthofix shall reimburse MTF up to Two
Hundred Thousand Dollars ($200,000) annually, for the actual, documented,
out-of-pocket expenses incurred by MTF that arise solely and directly from MTF’s
shipment, courier services, storage, fulfillment, and other logistics with
respect to orders of the Matrix that originate from the western seaboard of the
U.S. from Washington to California. MTF shall provide, with any request for
reimbursement under this Section K, documentation that is consistent with
industry standards and reasonably sufficient for Orthofix to verify the amount
and nature of the expenses incurred.

 

K.Non-Accountable R&D Charge.  The Parties agree that, from and after the
Amendment No. 6 Effective Date, instead of the non-accountable annual charge of
One Hundred Thousand Dollars paid to MTF pursuant to Amendment No. 4 to the
Matrix Agreement, Orthofix shall be obligated to pay to MTF a non-accountable
annual charge of Two Hundred Thousand Dollars ($200,000), to be used by MTF, in
its sole discretion, to fund research and development activities by MTF with
respect to bone growth allograft products containing viable allogeneic stem
cells derived from cadavers (the “R&D Charge”).  Any and all products,
technologies and discoveries, other than the Matrix, developed or discovered as
a result of such activities shall constitute “Product Concepts” subject to
Section 6.2(a) of the Matrix Agreement, and shall be subject to the right of
first offer, right of first refusal and other terms and conditions set forth in
Section 6.2 of the Matrix Agreement.  As requested by the Steering Committee
from time to time, MTF shall provide a summary of and reasonable documentation
regarding the activities conducted by MTF pursuant to this Paragraph K and the
results of such activities.  Accordingly, contemporaneously with the Effective
Date of this Amendment No. 6 and thereafter at the beginning of each calendar
quarter during the Term of the Matrix Agreement, MTF shall submit

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

11

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

Exhibit 10.10

to Orthofix an invoice for a quarterly payment of Fifty Thousand Dollars
($50,000), and Orthofix shall pay such amount to MTF within forty-five (45) days
after receipt of such invoice.  In the event Orthofix fails timely to pay any
such amounts, MTF may, in addition to any other remedies available to it, assess
interest at a rate of one percent (1%) per month on all such unpaid amounts.  In
the event that MTF has not been able to achieve a Matrix IV Development
Milestone due to technical challenges after using commercially reasonable
efforts to do so and provided that MTF is without fault in causing such failure
or delay in achieving such Matrix IV Development Milestone, MTF may submit a
written request to Orthofix to request an increase in the R&D Charge.  The
written request shall include a detailed review of MTF’s progress with respect
to such Matrix IV Development Milestone and any increase in the R&D Charge shall
be mutually agreed by the Parties in writing.

 

L.Definitions.  (a) Addendum 1 of the Matrix Agreement is hereby amended by
inserting the following definitions in appropriate alphabetical sequence,
respectively:

 

“Amendment No. 6” means that certain Amendment No. 6 to Matrix Commercialization
Collaboration Agreement dated December 29, 2017 entered into by the Parties.

 

“Amendment No. 2 Effective Date” has the meaning set forth in Amendment No. 6

 

“Fourth Phase Developed Technology” means all Technology, Inventions, Know-How
arising during the Matrix IV Development Term under or in connection with the
activities of the Parties pursuant to the Matrix IV Development Plan under
ARTICLE VI-C hereof, and all Improvements after the beginning of the Matrix IV
Development Term and during the remainder of the Term with respect thereto,
including without limitation, all Patents relating to the foregoing.

 

“Initial Matrix IV Forecast” has the meaning set forth in Section 2.2

 

“Matrix IV” means the version of Trinity ELITE allograft [*] conforming to the
Matrix IV Specifications.

 

“Matrix IV Cessation Period” has the meaning set forth in Section 14.2.

 

“Matrix IV Commercialization Date” means the date of completion of the last
Matrix IV Development Milestone pursuant to the Matrix IV Development Plan.

 

“Matrix IV Development Collaboration” means the development of the Matrix IV
undertaken by the Parties pursuant to the terms and conditions of ARTICLE VI-C
of this Agreement.

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

12

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

Exhibit 10.10

 

“Matrix IV Development Milestones” has the meaning set forth in Section 6C.7.

 

“Matrix IV Development Plan” means the plan for development of the Matrix IV
initially determined by the Steering Committee, as subsequently amended from
time to time in accordance with the procedures set forth in this Agreement.

 

“Matrix IV Development Term” means the period commencing on the Amendment No. 6
Effective Date and continuing under the completion of the last Matrix IV
Development Milestone.

 

“Matrix IV Infringement Claim” means any Third Party claim that the exploitation
of the Matrix IV Subject Intellectual Property in the development, Processing,
supply or distribution under this Agreement and for purposes of the
Collaboration of the Matrix IV in accordance with the Matrix IV Specifications
violates the intellectual property rights of a Third Party and/or infringes the
valid claim of an existing Patent of a Third Party; it being understood that a
Third Party Claim regarding the development, Processing, supply or distribution
of the Matrix IV independent of the Collaboration shall not be within the
definition of Matrix IV Infringement Claim.

 

“Matrix IV Project Manager” has the meaning set forth in Section 6C.6.

 

“Matrix IV Release Criteria” means the procedures and release criteria for
verification that each Lot of the Matrix IV complies with the Matrix IV
Specifications to be determined initially by the Steering Committee and set
forth in Exhibit D attached hereto, as subsequently amended from time to time in
accordance with the procedures set forth in this Agreement.

 

“Matrix IV Specifications” means the specifications from the Matrix IV to be
initially determined by the Steering Committee (based on the specifications set
forth in Exhibit A to Amendment No. 6) and set forth in Exhibit C attached
hereto, as subsequently amended from time to time in accordance with the
procedures set forth in this Agreement.

 

“Matrix IV Subject Intellectual Property” means any intellectual property
exploited, in any manner, directly or indirectly, in whole or in part, in
connection with the Matrix IV and not also exploited in any manner directly or
indirectly, in whole or in part, in connection with the Matrix I, Matrix II, or
Matrix III.  

 

“Notice of Achievement” has the meaning set forth in Section 6C.8(a).

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

13

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

Exhibit 10.10

 

(b)Addendum 1 of the Matrix Agreement is further amended by deleting the
definitions of “Collaboration,” “Developed Technology,” “Existing MTF
Technology,” “Existing Orthofix Technology,” “Matrix,” and “Minimum Service Fee”
and inserting the following in lieu thereof respectively:

 

“Collaboration” means the Processing and Commercialization of the Matrix
pursuant to the terms and conditions of this Agreement, and except for purposes
of Section 2.7, the Matrix II Development Collaboration, the Matrix III
Development Collaboration, and the Matrix IV Development Collaboration.

 

“Developed Technology” means the First Phase Developed Technology, the Second
Phase Developed Technology, the Third Phase Developed Technology, and the Fourth
Phase Developed Technology.

 

“Existing MTF Technology” means (a) for all purposes of this Agreement other
than Section 7.1(a)(ii), such Technology, Inventions and Know-How Controlled by
MTF (x) in existence as of the date of this Agreement (including without
limitation, all Patents), in each case solely insofar as necessary or useful for
making, using, selling, offering to sell and importing the Matrix and (y) in
existence as of the beginning of the Matrix IV Development Term (including,
without limitation, all Patents, but excluding First Phase Developed Technology,
Second Phase Developed Technology, and Third Phase Developed Technology), in
each case solely insofar as necessary or useful for making, using, selling,
offering to sell and importing the Matrix, and (b) solely for purposes of
Section 7.1(a)(ii), such Technology, Inventions and Know-How Controlled by MTF
(x) in existence as of the Effective Date (including, without limitation, all
Patents), in each case solely insofar as necessary for making, using, selling,
offering to sell and importing the Matrix and (y) in existence as of the
beginning of the Matrix IV Development Term (including, without limitation, all
Patents, but excluding First Phase Developed Technology, Second Phase Developed
Technology and Third Phase Developed Technology), in each case solely insofar as
necessary for making, using, selling, offering to sell and importing the Matrix.

 

“Existing Orthofix Technology” means (a) for all purposes of this Agreement
other than Section 7.1(b)(ii), such Technology, Inventions and Know-How
Controlled by Orthofix (x) in existence as of the date of this Agreement
(including without limitation, all Patents), in each case solely insofar as
necessary or useful for making, using, selling, offering to sell and importing
the Matrix and (y) in existence as of the beginning of the Matrix IV Development
Term (including without limitation, all Patents, but excluding First Phase
Developed Technology, Second Phase Developed Technology, and Third

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

14

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

Exhibit 10.10

Phase Developed Technology), in each case solely insofar as necessary or useful
for making, using, selling, offering to sell and importing the Matrix, and (b)
solely for purposes of Section 7.1(b)(ii), such Technology, Inventions and
Know-How Controlled by Orthofix (x) in existence as of the Effective Date
(including, without limitation, all Patents), in each case solely insofar as
necessary for making, using, selling, offering to sell and importing the Matrix
and (y) in existence as of the beginning of the Matrix IV Development Term
(including, without limitation, all Patents, but excluding First Phase Developed
Technology, Second Phase Developed Technology and Third Phase Developed
Technology), in each case solely insofar as necessary for making, using,
selling, offering to sell and importing the Matrix.

 

“Matrix” means the Matrix I, Matrix II, Matrix III and the Matrix IV, and each
of them; provided, however, that, prior to the Matrix IV Commercialization Date,
each reference to “Matrix” under ARTICLE II (except for Section 2.9), IV, V, X
and XII, and under Section 7.3, the proviso under Section 17.1 and under Section
17.3, means the Matrix I, the Matrix II, and the Matrix III.  

 

“Minimum Service Fee” means $[*] per cc of the Matrix I, $[*] per cc of the
Matrix II, $[*] per cc of the Matrix III, and $[*] per cc of the Matrix IV.

 

“Release Criteria” means the Matrix I Release Criteria, the Matrix II Release
Criteria, the Matrix III Release Criteria and the Matrix IV Release Criteria, as
the case may be; provided, however, that, prior to the Matrix IV
Commercialization Date, each reference to “Release Criteria” under ARTICLE X
means the Matrix I Release Criteria, the Matrix II Release Criteria and the
Matrix III Release Criteria.  

 

“Specifications” means the Matrix I Specifications, the Matrix II
Specifications, the Matrix III Specifications and the Matrix IV Specifications,
as the case may be; provided, however, that, prior to the Matrix IV
Commercialization Date, each reference to “Specifications under ARTICLE X means
the Matrix I Specifications, the Matrix II Specifications and the Matrix III
Specifications.

 

(c) Addendum 1 of the Matrix Agreement is further amended by adding the phrase
“development of the Matrix IV and the” immediately following the phrase
“development of the Matrix III” contained under the definition of “Reasonable
Commercial Efforts.”

 

ARTICLE II

 

MISCELLANEOUS

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

15

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

Exhibit 10.10

 

A. The Parties each hereby acknowledge and agree that, by entering into this
Amendment No. 6, they have satisfied any obligations under Section 6.2 of the
Matrix Agreement with respect to the Matrix IV as a Product Concept
thereunder.  In addition, and without limiting any provision of Article IX of
the Matrix Agreement, as amended hereby, Orthofix hereby represents, warrants,
and confirms to MTF that it has complied with the provisions of the NuVasive
License (as defined in the Matrix Agreement), including without limitation,
Section 3.2 thereof, with respect to this Agreement.

 

B.Except as amended hereby, the Matrix Agreement shall remain in full force and
effect.

 

C.This Amendment No. 6 may be executed in counterparts, each of which shall be
deemed to be an original, and all of which taken together will constitute one
and the same instrument.

 

IN WITNESS WHEREOF, the Parties have caused this Amendment No. 6 to be executed
and delivered as of the date first written above.

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

16

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

Exhibit 10.10

MUSCULOSKELETAL TRANSPLANT
FOUNDATION, INC.

 

ORTHOFIX HOLDINGS, INC.

 

By

/s/ Michael J. Kawas

 

By

/s/ Bradley R. Mason

Name

Michael J. Kawas

 

Name

Bradley R. Mason

Title

EVP / CFO

 

Title

President & Chief Executive Officer

Date

December 29, 2017

 

Date

December 29, 2017

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

17

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

Exhibit 10.10

Exhibit A: Matrix IV Project [*] Requirements

 

1.

Allogeneic cancellous bone matrix containing viable cancellous [*]

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

18

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

Exhibit 10.10

Exhibit B: Matrix IV Project Milestone Deliverables

 

[*]

 

 

 

 

 

 

 

[*]

Certain confidential information contained in this document, marked with an
asterisk in brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 

19