Portions of this exhibit have been omitted pursuant to a request for confidential treatment. The omitted portions, marked by [***], have been separately filed with the Securities and Exchange Commission. SECOND AMENDMENT TO DEVELOPMENT, MANUFACTURING...
EXHIBIT
10.59
Portions
of this exhibit have been omitted pursuant to a request for confidential
treatment. The omitted portions, marked by [***], have been separately filed
with the Securities and Exchange Commission.
SECOND
AMENDMENT TO
This
Second Amendment is made effective as of the first day of November, 2006, to the
Development, Manufacturing and Supply Agreement made June 28, 2005 (“the
Agreement”) by and between Xxxxxx Xxxx Corporation, a Delaware corporation,
having its principal place of business at 000 Xxxxxxxxxxxx Xxxxxx, Xxxxx,
XX 00000 (hereinafter referred to as “KNC”) and BioMimetic
Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.),
a Delaware corporation, having its principal place of business at
000-X Xxxxxx Xxxx Xxxx, Xxxxxxxx, XX 00000 (hereinafter referred to
as “BMTI”)(each,
individually a “Party” and collectively, the “Parties”).
WHEREAS
the Agreement provides for certain milestone payments to be made to KNC relating
to the commercialization of an Approved Commercial product for tendon or
ligament injury treatment; and
WHEREAS
BMTI and KNC have agreed to redefine the milestones triggering payments for
research & development services to be performed under a Research &
Development Plan (the R&D Plan) attached as Exhibit A to this Second
Amendment to the Agreement over an approximate 2 year period ending December 31,
2008.
NOW,
THEREFORE, IN CONSIDERATION of the mutual agreements contained herein, pursuant
to Section 16.2 of the Agreement the Parties agree to amend the Agreement as
follows:
1. The
following new section 2.3 shall be added to the Agreement:
2.3
|
BMTI
Termination. BMTI may at anytime upon thirty (30) days
notice to KNC terminate the development project relating to a product for
tendon and ligament injury treatment if BMTI concludes in its sole
discretion that the contemplated Commercial Product is not commercially
viable for any reason.
|
2. Sections
6.1(k) and 6.1(l) of the Agreement shall be replaced by the
following:
|
k.
|
[***]
upon the First Commercial Sale of the first Approved Commercial Product
for tendon or ligament injury
treatment;
|
|
l.
|
[***]
upon the one-year anniversary of the First Commercial Sale of the first
Approved Commercial Product for tendon or ligament injury
treatment.
|
[***] Redacted
pursuant to confidential treatment request.
1
3. The
following new sections 6.1(m) – (o) shall be added to the
Agreement:
|
m.
|
[***]
upon execution of this Second Amendment to recognize development work
completed under the R&D Plan between the date of execution of the
Agreement and the date of this Second Amendment on the ligament and tendon
development project;
|
|
n.
|
[***]
payable in eight quarterly installments of [***] upon the close of each
calendar quarter in 2007 and 2008 for development work yet to be performed
under the R&D Plan on the ligament and tendon project over the
specified period;
|
|
o.
|
In
the event that BMTI terminates the ligament and tendon project pursuant to
Section 2.3 of the Agreement prior to the end of 2008, the payments
provided for in 6.1(n) shall cease, however KNC shall be entitled to
receive a final pro-rated payment up to the date of termination of the
project.
|
4. This
Second Amendment is meant to amend, modify or supersede only those specific
Sections, rights, responsibilities, liabilities and/or covenants expressly
referred to in this Second Amendment, and only to the extent so referred to; and
accordingly all other Sections and covenants of the Agreement, as amended by the
First Amendment, shall remain unaffected and shall continue to have full force
and effect.
IN
WITNESS WHEREOF, the parties have executed this Agreement Amendment through
their duly authorized representatives as of the date first written
above.
XXXXXX
XXXX CORPORATION
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||||
By:
|
/s/ Xxxxxx X. Xxxxx
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By:
|
/s/ Xxxxxx X. Xxxxxxxx
|
|
Xxxxxx
X. Xxxxx, DDS
|
Xxxxxx
X. Xxxxxxxx
|
|||
President
& CEO
|
President
& CEO
|
[***] Redacted
pursuant to confidential treatment request.
2
Schedule
D3
Xxxxxx
Xxxx Corporation and BioMimetic Therapautics Inc.
November,
2006
Tendon
Repair Product Transfer Price
Product
|
Price
Per Unit
|
|||||||||||
Annual
Order Quantities
|
||||||||||||
<
[***] Units
|
[***]
Units
|
>
[***]Units
|
||||||||||
[***]
cm x [***] cm Sheet
|
$ | [*** | ] | $ | [*** | ] | $ | [*** | ] |
[***] Redacted
pursuant to confidential treatment request.
3
Exhibit A
to the Second Amendment
Tendon
Product Research and Development Plan
[***]
[***] Redacted
pursuant to confidential treatment request.
4