[LETTERHEAD OF MEDTRONIC SOFAMOR XXXXX, INC.]
EXHIBIT 10.35
September 18,2001
VIA FACSIMILE AND FEDERAL EXPRESS
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Regeneration Technologies, Inc.
Attention: Xx. Xxxxx X. Xxxxxx, President
Xxx Xxxxxxxxxx Xxxxx
Xxxxxxx, Xxxxxxx 00000
RE: Amendment to Management Services Agreement
Dear Xxxxx:
Please allow this letter to serve as a confirmation of our discussions and
as an amendment to the Management Services Agreement, dated as of July 23, 1996,
by and between Medtronic Sofamor Xxxxx, Inc. ("MSD"), formerly Sofamor Xxxxx
Group, Inc., and Regeneration Technologies, Inc. ("RTI"), as assignee of The
University of Florida Tissue Bank, Inc., as amended on April 21, 1997, January
2, 1998 and March 9, 1998 (the "Agreement"). The purpose of this amendment is to
add two products to the definition of Current Products under the Agreement.
1. Schedule A of the Agreement is hereby amended by adding the following
products to the list of Current Products: (i) the Cornerstone SR cervical
cortical/cancellous composite allograft, and (ii) the Cornerstone SR
cervical composite allograft, each of which is described in more detail in
Schedule 2.1 hereto (the "Additional Current Products").
2. The Agreement is hereby amended at add a new Section 3.4(a)(iii):
(iii) Notwithstanding the foregoing, the calculation of the
Management Services Fee described above shall not include the actual
net invoiced amount for the Additional Current Products, and the
Management Services Fee for the Additional Current Products shall be
fifty percent (50%) of the actual net invoiced amount from RTI to RTI
Customers for the Additional Current Products subject to RTI Customer
Instructions submitted by MSD to RTI. If the FDA and any other
applicable state or federal agencies state in writing that the
combination of tissue from multiple donors in single graft ("Pooling")
is not in violation of the statutes, regulations, policies, standards
or guidelines of such agencies, then RTI may do so and the Management
Services Fee for the Additional Current Products produced utilizing
such process shall be sixty percent (60%) of the actual net invoiced
amount.
When Life Depends on Medical Technology
Regeneration Technologies, Inc.
Page 2
September 18, 2001
3. Schedule 2.1 is hereby amended by adding the following:
Additional Current Products: (i) the Cornerstone SR cervical
cortical/cancellous composite allograft is to be assembled by
mechanical means; shown in the attached reference print to be pinned,
but not limited to this mechanical assembly technique. The Cornerstone
SR cervical cortical/cancellous composite allograft will have sizes
similar, but not limited to, those currently provided in the
Cornerstone SR cortical blocks. Surface grooves, similar to the
Cornerstone SR cortical blocks, may or may not be included on these
Cornerstone SR cervical cortical/cancellous composite allografts. (ii)
The Cornerstone SR cervical cortical composite allograft is to be
assembled by mechanical means from all cortical tissue; shown in the
attached reference print to be pinned, but not limited to this
mechancial assembly technique. The Cornerstone SR cervical cortical
composite allograft will have similar sizes, but not limited to, those
currently provided in the Cornerstone SR cortical blocks. Surface
grooves, similar to the Cornerstone SR cortical blocks, may or may not
be incorporated into this Cornerstone SR cervical cortical composite
allograft.
Section 3.1(d) of the Agreement provides that MSD "will use its best
efforts to actively support the distribution and use of the UFTB Product
consistent with Xxxxx'x standards." MSD acknowledges that this obligation
applies to the Additional Current Products described in this amendment.
If this amendment is agreeable to you, please sign both of these originals
and return one of them to MSD. Your execution of this amendment shall serve as
an agreement that RTI will not utilize the process of Pooling, as defined above,
to produce the Additional Current Products until such time as the FDA and any
other applicable state or federal agency confirms in writing that such process
is not a violation of the statutes, regulations, policies, standards and
guidelines of such agencies. In addition, as we discussed, MSD is prepared to
meet with you and other RTI representatives to resolve certain disputes under
the Agreement with respect to the payment terms and the application of the
definitions of "line extensions" and "new products." Please contact me to
discuss the timing and location of such a meeting.
Very truly yours,
/s/ Xxxxx X. Xxxxxx
Xxxxx X. Xxxxxx
Regeneration Technologies, Inc.
Page 3
September 18, 2001
AGREED TO AND ACCEPTED:
REGENERATION TECHNOLOGIES, INC.
/s/ Xxxxx X. Xxxxxx
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Xxxxx X. Xxxxxx
President
