EXHIBIT 10.26
SHAFT RECOVERY
AND
SERVICE REIMBURSEMENT AGREEMENT
THIS AGREEMENT (the "Agreement") effective as of the 29th day of
September, 1998 (the "Effective Date") by and between Regeneration
Technologies, Inc. a Florida, USA corporation having offices at One Innovation
Drive, Alachua, Florida, USA (hereinafter referred to as "RTI") and Tutogen
Medical, Inc., a Florida, USA corporation having offices at 0000 Xxxxx 00,
Xxxxx 000, Xxxxxxxxxx, XX, XXX (hereinafter referred to as "TTGN").
WITNESSETH:
WHEREAS, RTI wishes to increase the availability of a certain human
donor tissue, defined below as "Shaft Donors", which it processes for use as
allograft implant tissue; and
WHEREAS, TTGN wishes to coordinate and provide for the recovery
services in its territory to increase the availability of Shaft Donors for
RTI.
NOW, THEREFORE, in consideration of the above and the covenants and
obligations hereinafter set forth, the parties hereby agree as follows
I - DEFINITIONS
The following definitions shall apply throughout this agreement:
1.1 TTGN shall mean the Florida corporation named above and any of its
affiliates in which it owns or controls at least 20% of the voting stock.
1.2 TMI shall mean Tutogen Medical, GmbH, which is a subsidiary of TTGN
located at Xxxxxxxxxxxxxxxx 0, Xxxxxxxxxxx Am Xxxxxx, Germany 91077.
1.3 RTI shall mean the Florida corporation named above and any of its
affiliates in which it owns or controls at least 20% of the voting stock.
1.4 UFTB shall mean the University of Florida Tissue Bank, Inc. which
is a non-profit Direct Support Organization of the University of Florida,
with corporate offices at One Innovation Drive, Alachua, Florida, USA.
1.5 CONFIDENTIALITY AGREEMENT shall mean the confidentiality agreement
executed between the parties hereto on the 8th of September 1998.
1.6 SHAFT(S) shall mean the entire diaphysial portion of a femur,
humerus, or tibia which meets or exceeds the specifications set forth on the
"Cortical Bone Specifications and Reimbursement Schedule" and "Recovery
Protocols," and "Donor Selection Criteria" attached hereto.
1.7 OTHER TISSUE shall mean any tissue which is not a Shaft.
1.8 SHAFT DONORS shall mean the total of six (6) Shafts taken from the
femurs, humeri, and tibiae of a single human donor, each of which meets or
exceeds the specifications set forth on the Cortical Bone Specifications and
Reimbursement Schedule and Recovery Protocols and Donor Selection Criteria.
1.9 SPECIFICATIONS shall mean the specifications set forth on the
Cortical Bone Specifications and Reimbursement Schedule, Recovery Protocols
and Donor Selection Criteria collectively. Such specifications may be changed
from time to time upon mutual agreement of the parties hereto.
II - CONSIDERATION
2.1 As consideration for entering this Agreement:
a. RTI shall pay TTGN the "Advance Fund" amount of [*****] dollars
U.S. ([*****]) upon the Effective Date, which amount may be permanently
retained by TTGN subject to TTGN meeting the requirements set forth in
Section 5 herein;
b. TTGN shall, within one week from receipt of the Advance Fund set
forth in 2.1(a) herein: (i) activate Shaft recovery at two (2) recovery sites
in Europe and each such site shall thereupon recover and provide not less
than [*****] Shaft Donors per month, or a respective equivalency in
Shafts per month, to RTI; and (ii) begin Shaft recovery training at an
additional two (2) recovery sites in Europe, and as soon as possible (but not
later than five (5) weeks from receipt of the Advance Fund set forth in
Section 2.1(a)) each additional such site shall begin recovering and
providing not less than [*****] Shaft Donors per month or a
respective equivalency in Shafts per month to RTI;
c. for the term herein RTI shall diligently endeavor to maintain
and exceed the quantity of dura and pericardium currently being supplied to
TTGN; and
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d. For the term herein TTGN shall diligently endeavor to meet or
exceed the Shaft Donor quantities set forth as the "Target Minimums" attached
hereto, and shall not supply any Shaft Donors or Shafts within its control to
any party other than RTI or TTGN. The foregoing notwithstanding, TTGN shall
be allowed to directly distribute allograft implants, under Tutogen
trademarks, which are processed from Shafts taken from Shaft Donors, so long
as such implants do not compete with the implants being processed by RTI from
Shaft Donors or Shafts, and TTGN shall be allowed to distribute its planned
new product TriAplast-TM- and those cortical-shaft-derived implants which are
listed in the TTGN catalog in effect at the date of this Agreement, which
catalog pages are attached as an exhibit hereto and made part of this
Agreement. The Target Minimums have been established as an incentive for
TTGN, and failure to attain the Target Minimums will not result in penalties
for TTGN.
III - SHAFT DONOR TRANSACTIONS
3.1 SUPPLY AND ACCEPTANCE. RTI shall accept all Shaft Donors supplied
by TTGN, provided that such Shaft Donors meet the Specifications, and that
the quantity of such Shaft Donors falls within the RTI Forecast. RTI may not
change such RTI Forecast without first providing TTGN with one hundred eighty
(180) days written notice. Acceptance by RTI shall be deemed to occur upon
the delivery of such qualifying Shaft Donors from TTGN to RTI's facilities in
Alachua, Florida.
3.2 SHIPPING. Shaft Donors supplied to RTI under this Agreement shall be
shipped, on a regular basis as requested by RTI, at RTI expense to TTGN's
Alachua, Florida facility by a delivery service which is mutually negotiated
between RTI and TTGN and which is subject to RTI's acceptance. Shaft Donors
should normally be packed six (6) to a shipping carton unless otherwise
specified by RTI. Transportation of Shaft Donors from TTGN's Alachua, Florida
facility to RTI's facilities shall be arranged by RTI and be at RTI's expense.
3.3 REJECTIONS. Within thirty (30) days of RTI's rejection of any Shaft
Donors due to a failure to meet the Specifications, RTI shall notify TTGN in
writing of such rejections, the reason(s) for such rejection(s), including,
if applicable, a request for a RTI credit based upon the original invoice
paid by RTI. In the event TTGN elects to have any such rejected Shaft Donors
returned to TTGN, it shall be responsible for the payment of such return
shipping charges. RTI
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hereby warrants that there is no factor which can result in a rejection after
recovery, which factor would not have been known by or apparent to the
recovery team doing the actual recovery of the tissue.
3.4 REIMBURSEMENT TERMS.
a. RTI shall reimburse TTGN for Shaft Donor recovery services, per
Shaft Donor accepted by RTI, as set forth in Section 3.1 herein, at a rate of
[*****] dollars U.S. ([*****]) for Shaft Donors ages 15 to 55; and [*****]
dollars U.S. ($[*****]) for Shaft Donors ages 56 to 65. The quantity of Shaft
Donors ages 56 to 65 accepted by RTI from TTGN shall not exceed [*****]
percent ([*****]%) of the total Shaft Donors accepted by RTI from TTGN. RTI
may, at any time, provide TTGN with one hundred twenty (120) days written
notice of its intention to no longer accept Shaft Donors ages 56 to 65. In
the event TTGN provides RTI with Shafts not comprising a complete Shaft
Donor, RTI shall reimburse TTGN for recovery services per-Shaft as set forth
on the Cortical Bone Specifications and Reimbursement Schedule. TTGN may
conduct an annual review of their costs for recovery services provided under
this Agreement and, in the event such review reflects a TTGN cost increase of
greater than 10% over the period since the later of the Effective Date or the
last cost adjustment, RTI and TTGN will negotiate a mutually-acceptable
increase in the recovery reimbursement fees to be paid to TTGN from the time
of such annual review until the earlier of the end of the Agreement or the
next cost adjustment.
b. For a six (6) month period commencing with the Effective Date
herein, RTI shall reimburse TTGN one-half the rate amounts set forth in
Section 3.4(a) herein upon RTI's receipt of written confirmation that TTGN
has shipped Shaft Donors from Europe to the United States under the terms of
this Agreement. Upon RTI's subsequent receipt and acceptance of the
partially-reimbursed Shaft Donors, RTI shall promptly reimburse TTGN the
remaining one-half amount due. Written confirmation of shipment from Europe
to the United States shall include evidence of shipment and an invoice
bearing the quantity, age and other relevant specifications of the Shaft
Donors included in the respective shipment.
c. For the remainder of the term beyond the six (6) month period
set forth in Section 3.4(b) herein, RTI shall reimburse TTGN for its recovery
services performed hereunder at the rates set forth in Section 3.4(a) herein,
net 30 days from Shaft Donor acceptance, as set forth in Section 3.1 herein,
F.O.B. TTGN shipping dock.
3.5 SEROLOGIES AND FREEZER STORAGE. RTI shall be responsible for
performing all Shaft Donor serologies and Shaft Donor freezer storage,
including the expense thereof, at RTI. RTI shall
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provide adequate freezers at TTGN's facilities in Alachua, Florida for the
storage of Shafts while awaiting release by TTGN to RTI, which freezers shall
remain the property of RTI. RTI shall provide up to six thousand five hundred
dollars U.S. ($6,500) to TTGN to apply toward the purchase of a freezer for
each active recovery group trained by TTGN that is recovering and providing
Shaft Donors to RTI in at least the quantities set forth in Section 2.1(b)
herein.
IV - ADDITIONAL RECOVERY FEES
4.1 Whenever the Shaft Donors per calendar quarter, supplied to and
accepted by RTI, exceeds one thousand three hundred fifty (1,350) Shaft
Donors per calendar quarter, (commencing on October 1, 1998 and for the
remainder of the term herein), RTI shall reimburse TTGN with an additional
recovery fee of [twenty five thousand] dollars U.S. ($25,000) within forty
five (45) days from the end of the respective calendar quarter. In no event
shall the amount of Shaft Donors supplied to and accepted by RTI carry over
into any future calendar quarter for the purpose of calculating such
additional recovery fee.
V - ADVANCE FUNDS
5.1 If, by December 15, 1998, TTGN supplies at least one hundred (100)
Shaft Donors to RTI meeting the Specifications, RTI will transfer to TTGN an
additional [twenty five thousand] dollars U.S. ($25,000) in Advance Funds.
5.2 TTGN shall permanently retain seventy five dollars U.S. ($75) of
the Advance Fund for each Shaft Donor supplied to and ultimately accepted by
RTI, as set forth in Section 3.1 herein, for each Shaft Donor received at
TTGN's Alachua, Florida facility in excess of the respective monthly
quantities of Shaft Donors set forth on the "Target Minimums" attached hereto.
Additionally, TTGN shall permanently retain one hundred dollars U.S. ($100)
of the Advance Fund for every Shaft Donor which is shipped from Germany to
the United States in the months of October and November, 1998 under this
Agreement and is subsequently accepted by RTI as set forth in Section 3.1
herein. Such retained Advance Fund amounts shall be in addition to the
recovery reimbursement fees provided in Section 3.4(a).
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5.3 In the event that, by July 31, 1999, TTGN has supplied at least
[three hundred (300)] Shaft Donors per month to RTI for any three (3)
consecutive calendar months, where such Shaft Donors meet the Specifications,
then TTGN shall permanently retain any remaining balance of the Advance Fund
not yet retained as set forth in Section 5.2 herein.
5.4 In no event shall the aggregate amount retained by TTGN as set forth
in this Section 5 exceed the sum total of the Advance Fund.
5.5 As of July 31, 1999, any amount of the Advance Fund not retained by
TTGN, as set forth in this Section 5, shall be repaid to RTI by August 31,
1999. Such repayment shall be in U.S. Dollars or in the form of credits
against recovery service fees due TTGN by RTI hereunder.
VI - SHAFT DONOR RECOVER TRAINING
6.1 RTI shall provide TTGN with Shaft Donor recover training if
requested by TTGN and such training information shall be considered
confidential information subject to the terms of the Confidentiality
Agreement. If requested by TTGN, RTI shall endeavor to complete such training
within thirty (30) days of the Effective Date herein. RTI shall make available
two (2) RTI staff members and TTGN shall make a TTGN representative available
for such training. Staff of TTGN or related recovery groups may travel to the
United States for training by RTI, as well.
6.2 RTI shall pay its own training related expenses including travel and
staff salaries for the first month of Shaft Donor recovery training, and
thereafter the cost of additional training, if requested, shall be shared by
RTI and TTGN on a basis mutually agreed to in advance.
VII - TERM AND TERMINATION
7.1 The term of this Agreement shall be for a period of five (5) years
commencing with the Effective Date herein; however, absent notice by either
party, by or before one year prior to the termination date, of the intent to
terminate, the term shall automatically extend for an additional year. The
preceding notwithstanding, this Agreement may be terminated early:
a. by either party due to a material breach by the other party of any
of its obligations or covenants herein upon ninety (90) calendar days written
notice to the breaching
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party, but only if such breaching party fails to remedy said breach within
ninety (90) calendar days of such written notice; or
b. by either party promptly upon the insolvency or filing for
receivership or bankruptcy by the other party.
VIII - ASSIGNMENT AND SUBLICENSING
8.1 The rights and obligations of either party hereto shall not be
sublicensed or assigned unless first approved in writing by the other party
hereto and such approval shall not be unreasonably withheld.
8.2 Section 8.1 herein notwithstanding, the parties hereto acknowledge
that they are contemplating the formation of the University of Florida Tissue
Bank/Europe ("UFTB/E"), a non-profit tissue bank located in Europe, for the
purpose of enhancing the supply of Shaft Donors for RTI, and Other Tissues
for TTGN. In this event, RTI, TTGN, TMI, UFTB AND UFTB/E would negotiate a
separate agreement between the parties. It is further contemplated that the
Board of Directors of UFTB/E shall be comprised of (i) one member selected by
UFTB, (ii) one member selected by RTI, (iii) two members selected by TTGN,
(iv) one member who is not an employee of TTGN, RTI, or UFTB, selected by
TTGN, and (v) one member who is not an employee of TTGN, RTI, or UFTB,
selected by RTI.
IX - GOVERNING LAW AND ARBITRATION
9.1 Any disputes arising out of or in connection with this Agreement,
including any question regarding its existence, validity or termination,
shall be referred to and finally resolved by arbitration under the rules of
the American Arbitration Association, which Rules are deemed to be
incorporated by reference into this clause.
9.2 The tribunal shall consist of a sole arbitrator, selected according
to the rules of the American Arbitration Association.
9.3 The decision of the tribunal shall be final and binding upon the
parties to this Agreement and upon persons who participated, or had a right to
participate as party in such
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arbitration proceedings, and they will comply in good faith with the
decision. The parties to this Agreement further agree that judgment upon the
award may be entered in any court of competent jurisdiction.
9.4 The place of arbitration shall be determined by agreement of the
parties. In the event the parties cannot agree on a venue, the arbitration
shall occur in Orlando, Florida, USA.
9.5 The arbitration shall be conducted in the English language.
9.6 This Agreement is governed by and shall be construed and enforced in
accordance with the laws of the State of Florida, United States of America.
X - NON-COMPETE AND EXCLUSIVITY
10.1 Except as provided for herein, for the term of this Agreement and
for a period of three years thereafter, RTI shall not become involved in any
business activity with any recovery group that recovers Shafts under this
Agreement without the prior written approval of TTGN unless: (i) TTGN is no
longer an active company; or (ii) such group was not introduced to RTI by
TTGN during the term of the Agreement. This obligation of RTI to TTGN would
survive in the event of the assignment of the Agreement by TTGN to UFTB/E.
10.2 Except as provided for in Section 2.1(d), during the term of this
Agreement TTGN shall supply Shaft Donor recovery services exclusively to RTI.
In the event TTGN terminates this Agreement absent breach by RTI, then for
the term of this Agreement and for a period of three years thereafter TTGN
shall not supply Shaft Donor recovery services to any other party such that
any party other than RTI or TTGN receives Shafts or Shaft Donors. This
obligation of TTGN to RTI would survive in the event of the assignment of the
Agreement by TTGN to UFTB/E.
XI - OTHER
11.1 RTI represents and warrants to the best of its knowledge that it
has the right to grant the rights granted to TTGN herein and that the rights
granted herein do not violate any rights previously granted by RTI to any
third party.
11.2 Nothing in this Agreement shall be construed as:
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a. an obligation of RTI to furnish any manufacturing or technical
information except as specifically provided herein; or
b. a granting by implication, estoppel, or otherwise, any license or
rights under patents, trade secrets, know-how, copyrights, or other intangible
rights of RTI other than those specifically set forth herein.
11.3 TTGN shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold RTI, RTI Affiliates (as hereinafter
defined) or any of its assigns, harmless against all claims and expenses,
including legal expenses and reasonable attorney fees, arising out of any
other claims, proceeding, demand, expense, loss and liability of any kind
whatsoever (collectively "RTI losses") resulting from activities of TTGN
hereunder, except where such RTI losses result solely from RTI's gross
negligence. As used herein, "RTI Affiliates" shall mean RTI's directors,
officers, agents, and employees. The foregoing notwithstanding, RTI at all
times reserves the right to retain counsel of its own, at its own expense, to
defend RTI's interests.
11.4 RTI shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold TTGN, TTGN Affiliates (as hereinafter
defined) or any of its assigns, harmless against all claims and expenses,
including legal expenses and reasonable attorney fees arising out of any
other claims, proceeding, demand, expense, loss and liability of any kind
whatsoever (collectively "TTGN losses") resulting from activities of RTI
hereunder, except where such TTGN losses result solely from TTGN's gross
negligence. As used herein, "TTGN Affiliates" shall mean TTGN's directors,
officers, agents, and employees. The foregoing notwithstanding, TTGN at all
times reserves the right to retain counsel of its own, at its own expense, to
defend TTGN's interests.
11.5 Both parties hereto warrant that they now maintain and shall
continue to maintain liability insurance coverage in the amount of one
million dollars U.S. ($1,000,000) and that such insurance coverage lists the
other as an additional insured. Upon request by either party hereto, the
other party shall present evidence that such coverage is being maintained
with the other party listed as an additional insured. Each party hereto shall
provide the other party with at least thirty (30) days notice of any change
in, or cancellation of, such insurance coverage.
11.6 Both parties hereto represent that they shall, for the term
herein, conduct their business in a manner consistent with the highest
standards of industry business customs, that they shall comply with all
applicable laws and regulations, and that they shall not represent any
relationship with the other party hereto or any entity affiliated with the
other party other than as set forth herein.
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11.7 The right of either party to terminate under this Agreement shall
not be an exclusive remedy, and either party shall be entitled, if the
circumstances warrant, alternatively or cumulatively to damages for breach of
this Agreement, or to an order requiring performance of the obligations of
this Agreement or to any other remedy available at law or equity.
11.8 This Agreement and its attachments constitute the entire agreement
and understanding of the parties with regard to the subject matter hereof
and, except for the Confidentiality Agreement, supersedes all prior
discussions, negotiations, understandings and agreements between the parties
concerning the subject matter hereof and neither party shall be bound by any
definition, condition, warranty, right, duty or covenant other than as
expressly stated in this Agreement or as subsequently set forth in a written
document signed by both parties. Each party expressly waives any implied
right or obligation regarding the subject matter hereof.
11.9 Each party hereto agrees to execute, acknowledge and deliver all
such further instruments as may be necessary or appropriate to carry out the
intent and purposes of this Agreement.
11.10 The headings contained in this Agreement are for reference
purposes only and shall not affect in any way the meaning or interpretation of
this Agreement.
11.11 Neither party shall be responsible or liable to the other party
for nonperformance or delay in performance of any terms or conditions of this
Agreement, except for those relative to the protection of proprietary rights,
due to acts or occurrences beyond the control of the nonperforming or delayed
party including, but not limited, to acts of God, acts of government, wars,
riots, strikes or other labor disputes, shortages of labor or materials,
fires and floods; provided the nonperforming or delayed party provides to the
other party written notice of the existence and the reason for such
nonperformance or delay; the nonperformance or delay by either party in
excess of one hundred eighty (180) days shall constitute cause for
termination of this Agreement with such notice given in writing by one party
to the other.
11.12 Upon the end of the term of this Agreement, or in the event of
early termination for any reason, the provisions governing any payments due
hereunder shall remain in full force and effect until same are paid in full.
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XII - NOTICES
12.1 Any notice, report, or consent required or permitted by this
Agreement to be given or delivered, shall be in writing and shall be deemed
given or delivered if delivered in person, sent by courier, expedited
delivery service, or sent by registered or certified mail, postage prepaid,
return receipt requested, or sent by telecopy (if confirmed), as follows:
If to RTI:
Regeneration Technologies, Inc.
Attn: Xxxxx Xxxxxx, President and C.E.O.
Xxx Xxxxxxxxxx Xxxxx
Xxxxxxx, XX 00000 X.X.X.
If to TTGN:
TTGN
Attn: Xxxx X. Xxxxxxx, President and C.E.O.
0000 Xxxxx 00, Xxxxx 000
Xxxxxxxxxx, XX 00000
IN WITNESS WHEREOF, the parties have caused this instrument to be
executed in duplicate as of the day and year first above written.
ATTEST: Regeneration Technologies, Inc.
/s/ Xxxxxxx Xxxxx By /s/ Xxxxxxx X. Xxxxx
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Title Chief Financial Officer
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ATTEST: Tutogen Medical, Inc.
/s/ [Illegible] By /s/ Xxxx X. Xxxxxxx
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Title President and CEO
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AMENDMENT TO
SHAFT RECOVERY AND SERVICE REIMBURSEMENT AGREEMENT
This AMENDMENT dated June 28, 1999 (the "Amendment") is an amendment to
the Shaft Recovery and Service Reimbursement Agreement of September 29, 1998
by and between Regeneration Technologies, Inc. ("RTI") and Tutogen Medical,
Inc., ("TTGN") (the "Agreement").
A. GENERAL Defined terms as contained in `I-DEFINITIONS' and elsewhere in the
Agreement, as well as schedules and exhibits thereto, shall apply to this
Amendment. All terms and provisions, as set forth in the Agreement, shall
remain in full force and effect unless otherwise amended herein.
B. SECTION 2.1 d. This paragraph is replaced, in its entirety, with the
following:
"For the term herein, TTGN shall diligently endeavor to meet or exceed
the Shaft Donor quantities set forth as the `Target Minimums' attached
hereto. For the term herein, TTGN agrees not to supply any Shaft Donors
or Shafts within its control to any party other than RTI or TTGN. The
Target Minimums have been established as an incentive for TTGN, and
failure to attain the Target Minimums will not result in penalties for
TTGN. TTGN may develop and distribute products, which products may or may
not compete with RTI. TTGN acknowledges that RTI holds intellectual
property rights on certain RTI products, which rights RTI intends to
maintain and defend and which rights are not granted to TTGN."
C. SECTION 3.4 a. This paragraph is replaced, in its entirety, with the
following:
"RTI shall reimburse TTGN for Shaft Donor recovery services, per Shaft
donor accepted by RTI as set forth in Section 3.1 herein, at a rate of:
ANY DONOR ACCEPTABLE TO RTI:
Entire shaft donor $[*****]
Partial shaft donor (per shaft):
Femoral Shaft $[*****]
Tibial Shaft $[*****]
Humeral Shaft $[*****]
Amendment to Shaft Recovery
and Service Reimbursement Agreement
Page Two
Such reimbursement fee shall be paid in U.S. dollars. The quantity of
Shaft Donors ages 56 to 65 accepted by RTI from TTGN in any month shall
not exceed twenty percent (20%) of the total Shaft Donors accepted by RTI
from TTGN during that month. TTGN may conduct an annual review of their
costs for recovery services provided under this Agreement and, in the
event such review reflects a TTGN cost increase of greater than ten
percent (10%) over the period since the later of the Effective Date or
the last mutually acceptable recovery reimbursement fee increase, RTI and
TTGN will negotiate toward a mutually acceptable increase in the recovery
reimbursement fees to be paid to TTGN from the time of such annual review
until the earlier of the end of the Agreement or the next mutually
acceptable recovery reimbursement fee increase."
D. SECTION 8.2 This paragraph is replaced, in its entirety, with the
following:
"Section 8.1 notwithstanding, the parties hereto acknowledge that they
are contemplating the formation of a non-profit tissue bank to be located
in Europe (the "ETB"). The parties further acknowledge that a separate,
negotiated, agreement will be required to cover the operations of ETB and
that, pursuant to that agreement, control of ETB will be shared, in
principle, equally between RTI and TTGN."
IN WITNESS WHEREOF, the parties have caused this instrument to be
executed in duplicate this 30th day of June, 1999.
Regeneration Technologies, Inc. Tutogen Medical, Inc.
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxxxx Xxxxxxx
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Title: President and CEO Title: Chairman of the Board
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